VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-01016
Package ID: USCOURTS-cofc-1_15-vv-01016
Petitioner: CK
Filed: 2015-09-11
Decided: 2020-08-11
Vaccine: DTaP
Vaccination date: 2012-10-02
Condition: afebrile infantile spasms and a non-Table chronic encephalopathy
Outcome: denied
Award amount USD: 

AI-assisted case summary:
On September 11, 2015, Maryellen and Nicholas Kottenstette filed a petition on behalf of their daughter, CK, alleging that the DTaP, Hib, IPV, and Prevnar vaccines administered on October 2, 2012, caused her to develop infantile spasms and a chronic encephalopathy. CK, who was approximately four months old and behind on her immunizations, received her two-month vaccines on this date. The first episodes of abnormal movements began within hours of vaccination. A video of these movements, observed by Dr. Irina Anselm, was consistent with infantile spasms, and an EEG showed hypsarrhythmia. CK was prescribed ACTH, and her parents were advised to avoid further immunizations for six months. 

Initially, Special Master Laura D. Millman ruled in favor of the petitioners on entitlement in December 2017, relying on the ten-hour onset of symptoms and literature suggesting vaccines could trigger infantile spasms in susceptible children. A damages award was subsequently made, but the respondent sought review. The Court of Federal Claims vacated the entitlement decision in February 2020, finding the legal standard and evidentiary basis unclear, and remanded the case for a renewed analysis under the Althen standard. 

On remand, Special Master Horner denied compensation. The petitioners argued that the DTaP vaccine could lower the seizure threshold and, in CK's case, triggered infantile spasms early enough to cause severe psychomotor regression. Their theory involved DPT/DT infantile spasm literature, ACTH response, corticotropin-releasing hormone, and an innate immune-response "double hit" mechanism. Special Master Horner found the evidence insufficient to establish that DTaP can cause infantile spasms or that it did so in CK. Judge Richard A. Hertling denied the petitioners' motion for review and sustained the denial on August 11, 2020. The final outcome was a denial of compensation.

Following the denial, the petitioners sought review of Special Master Horner's decision. Judge Hertling denied the motion for review, sustaining the Special Master's decision. The judge found that the petitioners had not met their burden of proof under the Althen test, particularly regarding the link between the DTaP vaccine and infantile spasms, and the evidence presented was insufficient to establish causation. The public record does not describe the specific clinical course after the denial of compensation.

Theory of causation field:
Petitioners alleged that DTaP, Hib, IPV, and Prevnar vaccines administered on October 2, 2012, to four-month-old CK caused afebrile infantile spasms and a non-Table chronic encephalopathy. The first episodes of rhythmic movements began approximately ten hours after vaccination, with no fever, fussiness, or postictal state. An EEG showed hypsarrhythmia, and ACTH was prescribed. Special Master Millman initially granted entitlement, finding a causal link based on early onset and vaccine trigger literature. This decision was vacated and remanded by the Court of Federal Claims for reconsideration under the Althen standard. On remand, Special Master Horner denied compensation, finding insufficient evidence that DTaP can cause infantile spasms or did so in CK. Petitioners' theory involved DTaP lowering the seizure threshold, triggering early infantile spasms via stress/CRH/innate immune "double hit" mechanisms, citing Dr. Marcel Kinsbourne and DPT/DT studies. Respondent challenged the applicability of DPT studies to DTaP and the causal showing. Judge Hertling sustained the denial, finding the evidence insufficient to establish causation under the Althen test. The final outcome was denial of compensation. Attorneys for petitioners included John F. McHugh. Attorneys for respondent included Camille M. Collett and Voris E. Johnson. Special Master Millman issued the initial entitlement decision and damages award, while Special Master Horner issued the final denial on remand, and Judge Hertling reviewed and sustained the denial.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_15-vv-01016-1
Date issued/filed: 2017-12-27
Pages: 19
Docket text: PUBLIC ORDER/RULING (Originally filed: 12/12/2017) regarding 78 Ruling on Entitlement Signed by Special Master Laura D Millman. (tlf) Service on parties made.
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Case 1:15-vv-01016-RAH Document 81 Filed 12/27/17 Page 1 of 19
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 15-1016V
Filed: December 12, 2017
Not to be Published
*************************************
MARYELLEN KOTTENSTETTE and *
NICHOLAS KOTTENSTETTE as best *
friends of their daughter (CK), *
*
Petitioners, *
* Diphtheria-tetanus-acellular pertussis
v. * (“DTaP”), haemophilus B influenzae
* (“HiB”), inactivated polio vaccine
SECRETARY OF HEALTH * (“IPV”), and pneumococcal vaccine
AND HUMAN SERVICES, * (“Prevnar”); cryptogenic infantile spasms
*
Respondent. *
*
*************************************
John F. McHugh, New York, NY, for petitioners.
Camille M. Collett, Washington, DC, for respondent.
MILLMAN, Special Master
RULING ON ENTITLEMENT1
On September 11, 2015, petitioners filed a petition under the National Childhood Vaccine
Injury Act, 42 U.S.C. § 300aa-10-34 (2012), alleging that diphtheria-tetanus-acellular pertussis
(“DTaP”), haemophilus B influenza (“HiB”), inactivated polio vaccine (“IPV”), and
pneumococcal (“Prevnar”) vaccines administered to their daughter CK on October 2, 2012,
caused her a Table encephalopathy or, in the alternative, a non-Table encephalopathy, and
1 Because this unpublished decision contains a reasoned explanation for the special master’s action in this
case, the special master intends to post this unpublished decision on the United States Court of Federal
Claims’ website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012)
(Federal Management and Promotion of Electronic Government Services). Vaccine Rule 18(b) states that
all decisions of the special masters will be made available to the public unless they contain trade secrets
or commercial or financial information that is privileged and confidential, or medical or similar
information whose disclosure would constitute a clearly unwarranted invasion of privacy. When such a
decision is filed, petitioner has 14 days to identify and move to redact such information prior to the
document’s disclosure. If the special master, upon review, agrees that the identified material fits within
the banned categories listed above, the special master shall redact such material from public access.

Case 1:15-vv-01016-RAH Document 81 Filed 12/27/17 Page 2 of 19
infantile spasms. Pet. at ¶¶ 4, 5-7, 10.
On November 20, 2015, the undersigned held the first telephonic status conference in this
case and encouraged the parties to settle. The undersigned gave petitioner until April 15, 2015 to
make a demand on respondent.
On August 10, 2016, petitioners filed a CD containing the expert report of Dr. Marcel
Kinsbourne, with attached medical articles. A day later, after petitioners moved for numerous
extensions of time to make a demand, they made a demand on respondent on August 11, 2016.
Although each party had prepared life care plans, respondent wanted to file a Rule 4(c)
Report and an expert report. The undersigned gave respondent until November 7, 2016 to file a
Rule 4(c) Report and an expert report.
Respondent moved for numerous extensions of time to file a Rule 4(c) Report and an
expert report and, on February 6, 2017, filed his Rule 4(c) Report and the expert report of Dr.
John Zempel, with attached medical articles. On February 14, 2017, during a telephonic status
conference, respondent’s counsel stated HHS was not interested in settlement.
On April 10, 2017, petitioners filed a supplemental expert report from Dr. Kinsbourne.
On July 31, 2017, the undersigned held a hearing in this case. Testifying for petitioners
were Mrs. Kottenstette and Dr. Marcel Kinsbourne, a pediatric neurologist. Testifying for
respondent was Dr. John Zempel, a pediatric neurologist and pediatric epileptologist.
On September 12, 2017, petitioners filed a post-hearing brief.
On November 27, 2017, respondent filed a post-hearing brief.
The undersigned finds that petitioners have prevailed on their allegations that CK’s
vaccinations administered on October 2, 2012 caused her afebrile infantile spasms and a non-
Table chronic encephalopathy. Petitioners have not prevailed on their allegation that CK had a
Table encephalopathy.
FACTS
On June 1, 2012, CK was born.
On October 2, 2012, at the age of four months, CK received DTaP, HiB, IPV, and
Prevnar vaccinations. Med. recs. Ex. 2, at 21.
Later on October 2, 2012, CK was taken to the University of Massachusetts Children’s
Medical Center because she was having abnormal arm and shoulder movements multiple times
2

Case 1:15-vv-01016-RAH Document 81 Filed 12/27/17 Page 3 of 19
that evening. Med. recs. Ex. 4, at 1. Her temperature was 98.4 degrees. Id. At 8:30 p.m., she
had repetitive jerking arm movements for about five minutes with bilateral shrugging and then a
hugging motion. Id. at 9. CK was alert. Her eyes or legs were not involved in these
movements. She did not have a post-ictal state. She had no change in urinary output or bowel
movement. She did not have fevers, chills, or fussiness. She had received DPT, HiB, polio, and
pneumonia vaccinations that day. She was sleeping quietly. CK was alert and oriented. She
looked well. Id. Her family history was an uncle with epilepsy. Id. at 10. CK was
neurologically and developmentally normal. She had a normal well-child check-up that day.
She had normal tone and 2+ reflexes. She had been previously well. She had been behind on
her immunizations, receiving her two-month vaccinations that day. She was alert and active.
The diagnosis was rhythmic movement/possible seizure. Id.
From October 6-10, 2012, CK was at Boston Children’s Hospital. Med. recs. Ex. 2, at 1.2
Dr. Irina M. Anselm wrote the discharge summary. CK had received vaccinations on Tuesday
morning and was mildly fussy, but otherwise well. She did not have fever or signs of illness.
She awoke out of sleep and suddenly had a series of jerks with her arms extended outward and
jerking inward every five seconds for about three to five minutes. She seemed to be alert
throughout the entire episode. Afterward she went back to baseline immediately. Her
pediatrician recommended against an EEG because the pediatrician felt that the episode was just
a mild reaction to the vaccinations. CK had a second episode that evening that was again three
to five minutes long, but the mother did not seek further medical attention due to her discussion
with the pediatrician. On October 6, 2012, at around 5:30 a.m., CK had another three- to five-
minute episode which was captured on video. Dr. Anselm watched the video. CK was in her
mother’s arms, looking around, and was appropriately alert, with intermittent episodes of rapid
arm extension and then shoulder abduction and arm jerks inwards. These movements were
consistent with infantile spasms occurring every 10-15 seconds on the video. CK had otherwise
been well appearing and in her usual state of health. She was otherwise a healthy baby who had
been feeding and growing well and progressing appropriately. Id. An EEG result was consistent
with hypsarrhythmia. Id. at 3. She was prescribed ACTH and her parents were instructed that
CK was not to have immunizations for six months. Id.
On October 30, 2012, CK saw Dr. Michel N. Fayad, a neurologist. Id. at 10. The history
was CK was alert and well during her first episode of infantile spasms. She did not have any
regression in development. Id. at 11. She was very alert, smiled, laughed, vocalized, and
reached for objects frequently. She had a history of reflux. She has a maternal uncle with
difficult-to-control seizures which CK’s mother believed a lesion caused. CK had a paternal
second cousin’s daughter with seizures since she was young. On physical examination, CK was
extremely alert and made excellent eye contact with her parents and Dr. Fayad. Id. On physical
examination, CK had mildly increased tone in both legs. Id. at 12. The EEG result showed an
abnormal background but did not meet the criteria for hypsarrhythmia. However, her
2 Petitioners’ counsel filed this collection of records as Exhibit 3, but marked each page as Exhibit 2. This would be
the second Exhibit 2 since the first Exhibit 2 consists of CH’s pediatric records. For ease of reference to the Boston
Children’s Hospital records, the undersigned refers to these pages as Exhibit 2 as petitioners’ counsel marked them.
3

Case 1:15-vv-01016-RAH Document 81 Filed 12/27/17 Page 4 of 19
presentation was consistent with infantile spasms. Id.
As of June 22, 2017, CK has physical disabilities that impact her functional mobility,
postural stability, eye-hand coordination, fine motor control, pre-writing skills, and self-care
skills. Med. recs. Ex. 16, at 5. CK also has a visual impairment that affects her performance on
visually-based activities. Id. CK can differentiate sounds and turn her head toward unfamiliar
sounds, but she does not yet respond to her name. Id. at 9. She does not yet understand any
words and does not yet use gestures to communicate. Id.
EXPERT REPORTS AND MEDICAL LITERATURE
Petitioners filed an expert report from Dr. Marcel Kinsbourne, dated July 28, 2016. Ex.
6. He describes CK’s refractory seizures as cryptogenic infantile spasms, meaning the cause is
unknown. Relying on the Bellman study (1983),3 based on the data underlying the National
Children’s Encephalopathy Study (“NCES”),4 Dr. Kinsbourne states that DPT vaccine can
trigger infantile spasms and thus accelerate the onset of infantile spasms in cryptogenic cases.
Ex. 6, at 3.
The Bellman study is entitled Infantile Spasms and Pertussis Immunisation, LANCET
1:1031-34 (1983). M.H. Bellman, E.M. Ross, and D.L. Miller, the co-authors of this study, were
also three of the five co-authors of the much larger NCES study and took data of the incidence of
infantile spasms occurring post-DPT vaccination from the NCES data, dividing the infantile
spasms children into groupings by one-week intervals for up to four weeks post-vaccination.
They divided the cases as well by whether the infantile spasms were cryptogenic (unknown
cause) or symptomatic (known cause). Id. at 1031. Whereas the NCES showed no significant
association between DPT vaccination and onset of infantile spasms by looking at the entire 28-
day period as a whole, Bellman and his co-authors in their separate study analyzed incidence of
infantile spasms week by week. They found more cases of infantile spasms occurring within one
week of vaccination compared to controls, whereas they also found fewer cases of infantile
spasms occurring during the second week after vaccination compared to controls. The third and
fourth weeks of onset of infantile spasms post-vaccination did not differ from the incidence
among controls. Bellman and his co-authors surmised that pertussis vaccine “may precipitate the
onset of spasms in those children in whom the disorder is already destined to develop.” Id. at
1033. Bellman and his co-authors regarded vaccination as a trigger, rather than a cause, of
infantile spasms. Id.
Dr. Kinsbourne also relies on the Melchior study (1977)5 which analyzed the effect of a
change in scheduling DPT vaccination in Denmark from initially 5 months of age to vaccination
at 5 weeks of age. Ex. 6, at 3. When Danish children received DPT at age five months of age,
3 Bellman is Ex. 6-4. Respondent filed the same article as Ex. D, Tab. 1.
4 The National Childhood Encephalopathy Study. Whooping Cough, by R. Alderslade, M.H. Bellman, N.S.B.
Rawson, E.M. Ross, and D.L. Miller (London: Her Majesty’s Stationery Office, 1981).
5 Melchior is Ex. 6-16. Respondent filed the same article as Ex. D, Tab 2.
4

Case 1:15-vv-01016-RAH Document 81 Filed 12/27/17 Page 5 of 19
the rate of infantile spasm onset before the age of two months was 12 percent. However, when
the schedule changed and Danish children received DPT at five weeks of age, almost twice as
many Danish children had onset of infantile spasms before the age of two months. Id.
The Melchior study is entitled Infantile spasms and early immunization against whooping
cough. Danish survey from 1970 to 1975, 52 ARCH OF DIS IN CHILDHOOD 134-37 (1977).
Melchior, noting the increase in the number of infantile spasms before the age of two months
when the only variable was earlier vaccination, wrote that vaccination might have been a trigger
mechanism in three cases of symptomatic infantile spasms. Id. at 135 (Table 2). He concludes
“that a causal connection between whooping cough immunization and infantile spasms is very
unlikely except in a few cases and that time-coincidence is the most likely factor . . . .” Id. at
136.
Citing Kivity,6 Dr. Kinsbourne states that since CK had cryptogenic infantile spasms, her
outcome without the DPT vaccine trigger would not have been necessarily poor, unlike those
children with symptomatic infantile spasms in whom a poor outcome is expected. Ex. 6, at 3-4.
Long-term Cognitive Outcomes of a Cohort of Children with Cryptogenic Infantile Spasms
Treated with High-dose Adrenocorticotropic Hormone by S. Kivity, et al., 45 EPILEPSIA 3:255-
62 (2004). Adrenocorticotropic hormone is also known as “ACTH.”
Kivity and her co-authors compared children who had early treatment with ACTH of
cryptogenic infantile spasms with the outcomes of those treated after one month of onset and
found the former group had a favorable cognitive outcome. The authors focused solely on
cryptogenic infantile spasms because children with symptomatic infantile spasms were more
likely to have a poor intellectual outcome due to their underlying disorder. Id. at 255, 260.
Dr. Kinsbourne states that infantile spasms can be considered both a seizure disorder and
an encephalopathy. Ex. 6, at 4. CK was started on ACTH within a week of onset. Id. at 5. Yet,
instead of her outcome being optimal, she became severely developmentally delayed, with daily
refractory seizures. Dr. Kinsbourne attributes CK’s severe brain damage due to her continuing
refractory seizure disorder. Id.
Citing articles by Jensen,7 Baram and Haralski,8 and Dichter,9 Dr. Kinsbourne attributes
the onset of infantile spasms to injurious or stressful stimuli which trigger the seizures in early
postnatal life. Ex. 6, at 6. Relationship between encephalopathy and abnormal neuronal activity
in the developing brain, by F.E. Jensen, 49 INTERNATIONAL REVIEW OF NEUROBIOLOGY 23-35
(2002) (a chapter in EPILEPSY, INFANTILE SPASMS, AND DEVELOPMENTAL ENCEPHALOPATHY
(P.A. Schwartzkroin & J.M. Rho, eds. 2002). Jensen states that infantile spasms originate from a
highly age-specific hyperexcitable network. Id. at 23. Jensen notes that infantile spasms most
6 Kivity is Ex. 6-13.
7 Jensen is Ex. 6-12.
8 Baram and Haralski is Ex. 6-2.
9 Dichter is Ex. 6-7.
5

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commonly occur between the ages of three and eight months. Id. at 24. She states that
glutamate is the major excitatory neurotransmitter in the brain with several subtypes of glutamate
receptors. Id. at 26. In animal models, decreased expression of glutamate transporters can lead
to seizures or lower seizure thresholds. Id. at 27. ƴ-Amino butyric acid (“GABA”) is the
predominant inhibitory neurotransmitter in the brain. Id. at 27. Jensen writes the delayed onset
of functional GABAergic inhibition may contribute to the enhanced excitability of the immature
brain. Id. She also states the expression of certain neuromodulatory peptides that influence
neuronal excitability is developmentally regulated. Id. at 28. She thinks it possible that infantile
spasms might worsen the underlying encephalopathy if one exists, leading to later neuronal
injury via mechanisms such as excitotoxicity which glutamate receptors mediate. Id. at 28.
Jensen notes that seizures are associated with long-term functional changes in surviving neurons,
leading to a dysmature and often chronically epileptic state. Id. at 30. She suggests that
maturational state, seizure activity, and subsequent encephalopathy which subtle molecular
abnormalities define may interact, having a “feed forward” effect. Id. at 31.
T.Z. Baram and C.G. Haralski wrote Neuropeptide-mediated excitability: a key triggering
mechanism for seizure generation in the developing brain 21 TRENDS NEUROSCI 11:471-76
(1998). Baram and Hatalski write that seizures early in life are consistent with the developing
brain’s excitability, and the excitatory neuropeptide corticotropin-releasing hormone (“CRH”) is
implicated in this triggering process. Id. at 471. They write that injurious or stressful stimuli are
involved in this triggering. Id.
M.A. Dichter wrote Emerging Concepts in the Pathogenesis of Epilepsy and
Epileptogenesis 66 ARCH NEUROL 4:443-47 (2009). Dichter writes that an epileptic region in the
brain consists of multiple small distributed hyperexcitable networks. Id. at 444.
For a proposed model of how stress provokes infantile spasms, Dr. Kinsbourne discusses
another Baram10 article, Pathophysiology of Massive Infantile Spasms: Perspective on the
Putative Role of the Brain Adrenal Axis, by T.Z. Baram, 33 ANN NEUROL 3:231-36 (1993).
Baram states that Dr. West first described infantile spasms in 1841. Id. at 231. Focusing on
corticotropin-releasing hormone (“CRH”), Baram posits that various types of brain injury have
different effects on CRH gene expression and secretion. Id. at 233. He surmises that what in
other infants would be normal stresses may result in certain infants the development of
cryptogenic massive infantile spasms (“MIS”) because of excessive CRH activation. Id. at 234.
For a discussion of how immune recognition of an infectious challenge rapidly activates
the stress response which includes secretion of interleukin-1 (“IL-1”) that activates the release of
corticotropin-releasing factor (“CRF”), Dr. Kinsbourne discusses the Sapolsky11 article,
Interleukin-1 Stimulates the Secretion of Hypothalamic Corticotropin-Releasing Factor, by R.
Sapolsky, et al., 238 SCIENCE (NEW SER.), 4826:522-24 (1987). Sapolsky and his co-authors
state that during times of antigenic challenge to the immune system, the immune system can
10 This Baram article is Ex. 6-1.
11 The Sapolsky article is Ex. 6-20.
6

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rapidly activate the stress response. Id. at 522. Chemical mediators of immunologic activation
called lymphokines provoke glucocorticoid secretion. Among many lymphokines is interleukin-
1 (“IL-1”), which releases substantial quantities of corticotropin-releasing factor (“CRF”).
For a discussion of how vaccines engage toll-like receptors (“TLRs”) to trigger an
adaptive immune response, Dr. Kinsbourne discusses the van Duin article,12 Triggering TLR
signaling in vaccination, by D. van Duin, et al., 27 TRENDS IN IMMUNOLOGY 1:49-55 (2006).
Van Duin and his co-authors state that TLRs are a family of pattern-recognition receptors that
recognize structural components that many bacteria, viruses, and fungi share. Id. at 49.
Because the onset of CK’s infantile spasms was quite abrupt, i.e., within hours, Dr.
Kinsbourne assumes that TLRs were activated because only the innate immune system can
mount so rapid a response. In addition, CK’s neural network, being hyperexcitable, made her
susceptible to these effects. Ex. 6, at 8. Dr. Kinsbourne states that once a seizure disorder
begins, if it is not immediately brought under control, the child experiences “ever worsening and
ultimately devastating psychomotor regression.” Id. He states CK was predisposed to react
adversely to stresses in infancy, which include vaccinations. Id. The purpose of vaccinations is
to evoke an innate immune system response, which of necessity generates proinflammatory
cytokines. Id. CK’s vaccinations triggered her infantile spasms and long-lasting
hyperresponsiveness of her hypothalamic-pituitary-adrenal (“HPA”) axis. Id. As a result, CK
has severe and mainly refractory seizures that degraded her mental development so that she is
now profoundly mentally retarded. Id. at 8-9.
Dr. Kinsbourne concludes that, but for her vaccinations, CK’s cryptogenic infantile
spasms would not have led to such a devastating result. Id. at 9. He also writes that the one-day
interval between vaccinations and first infantile spasms is medically reasonable since her innate
immune system rapidly responded to the vaccinations. Id. He also states that it is plausible that
routine vaccinations can trigger infantile spasms in a susceptible child, resulting in severe
psychomotor regression. Id.
At the end of his opinion, Dr. Kinsbourne states that CK’s vaccinations, including DTaP,
significantly aggravated her pre-existing condition, the consequence being severe ongoing
neurological impairments. Id. at 10.
On February 6, 2017, respondent filed the expert report of Dr. John Zempel, a pediatric
neurologist and pediatric epileptologist. Ex. A. In detail, Dr. Zempel takes issue with Dr.
Kinsbourne’s statements. Id. Dr. Zempel’s first criticism is that Dr. Kinsbourne has not shown
data in medical literature that vaccinations cause infantile spasms. Id. Dr. Zempel’s second
criticism is that Dr. Kinsbourne’s did not provide a reasonable mechanism of injury and cannot
cite data in the medical literature to support his vaccine-caused mechanism of injury. Id. Dr.
Zemple’s third criticism is that the temporal interval between CK’s vaccinations and onset of her
infantile spasms is not medically reasonable because Dr. Kinsbourne did not prove that vaccines
12 The van Duin article is Exhibit 6-26.
7

Case 1:15-vv-01016-RAH Document 81 Filed 12/27/17 Page 8 of 19
are the cause. Since children receive vaccines at the time they develop infantile spasms, some
spasms will necessarily occur in close temporal relationships to vaccination, which is why
epidemiologic studies are necessary to evaluate causation. Id. Dr. Zempel’s fourth criticism is
that the absence of an alternative cause of CK’s infantile spasms does not prove vaccine
causation. Many children have intractable infantile spasms of unknown cause. Id. Dr. Zempel’s
fifth criticism is that Dr. Kinsbourne has not specifically shown biologic plausibility through
medical literature describing experiments on animal models to prove vaccinations cause infantile
spasms in humans, or through data from human diagnostic testing. Id. Dr. Zempel continues by
emphasizing it is important to show mechanistically or in medical literature such as or
epidemiologic studies that vaccination causes infantile spasms. Id.
Dr. Zempel’s approach is to analyze Dr. Kinsbourne’s statements to see if medical
literature supports them. Id. at 6. Dr. Zempel does not accept any statement that does not have
support in the medical literature. Id. Dr. Zempel disagrees with Dr. Kinsbourne’s relying on
studies such as the NCES from the 1970s that discuss whole-cell DTP vaccine and infantile
spasms because they do not discuss acellular DTP, i.e., DTaP. Id. Dr. Zempel quotes the
concluding paragraph of the 1983 Bellman study (Tab 1), based on the NCES data, which
concludes that pertussis vaccine is not a direct cause of infantile spasms but may precipitate the
onset of spasms in those children already destined to develop them. Id.
Dr. Zempel then quotes the conclusion of the abstract from the 1977 Melchior study (Tab
2) analyzing the difference in onset of infantile spasms after Denmark changed the vaccine
schedule for infants. Id. at 7. Melchior wrote there was no change in age of onset of infantile
spasms, but admitted there may be an occasional connection between immunization and infantile
spasms, which he attributed to coincidence. Id.
Dr. Zempel then quotes a chapter from Aicardi in a textbook in epilepsy in children by
Arzimangoglou (Tab 3) to the effect that onset of infantile spasms after immunization is
coincidental. Id. Dr. Zempel says that medical literature does not support Dr. Kinsbourne’s
opinion that CK would not have developed infantile spasms without her having been vaccinated.
Id. If she had, since they were cryptogenic, her outcome would have been better, which Dr.
Zempel states is assuming causation in the first place. Id. at 7-8.
Dr. Zempel agrees that children with cryptogenic infantile spasms have better outcomes
than children with symptomatic infantile spasms. Id. at 8. Dr. Kinsbourne writes that CK’s
profound impairment puts her at the severe end of the spectrum of infantile spasms outcome,
which is quite atypical for cryptogenic infantile spasms. Id. Dr. Zempel does not believe CK
would have ever been normal developmentally. Id. at 9. In his clinical experience, Dr. Zempel
has treated many cryptogenic infantile spasms patients who do not have a good outcome
developmentally although they received similar treatment as CK, except for cannabidiol. Id. He
cites two articles, both of which have the primary author as Knupp,13 for the proposition that a
13 Response to second treatment after initial failed treatment in a multicenter prospective infantile spasms cohort, by
K.G. Krupp, et al., 57 EPILEPSIA 11:1834-42 (2016) (Tab 8); Response to treatment in a prospective national
8

Case 1:15-vv-01016-RAH Document 81 Filed 12/27/17 Page 9 of 19
sizable number of children with infantile spasms are unresponsive to drugs. Id.
Dr. Zempel cites data demonstrating that good neurodevelopmental outcome is not
dependent on successful treatment of infantile spasms, whether or not they are cryptogenic. Id.
at 10. He criticizes Dr. Kinsbourne for opining that vaccination caused CK’s infantile spasms or
worsened their outcome when Dr. Kinsbourne did not provide epidemiologic support or strong
mechanistic data. Id. at 12. Dr. Zempel states that such evidence is not present in medical
literature. Id.
Dr. Zempel notes that because infantile spasms occur in a particular age window, this
strongly suggests that developmental gene expression shapes their appearance during a specific
time in human development. Id. at 12-13. Specific mechanisms responsible for the development
of seizures in general are still the subject of current epilepsy research. Id. at 13. Animal models
of infantile spasms are an aspirational goal. Id. Dr. Zempel then analyzes Dr. Kinsbourne’s
“two-hit” theory, whereby CK was born with a susceptibility to develop infantile spasms (the
first hit) and the vaccinations (the second hit) triggered their onset. Dr. Zempel rejects the first
hit, i.e., CK’s susceptibility, because basic research has not determined the mechanism for
infantile spasms. Dr. Zempel rejects the second hit, i.e., the role of vaccinations in causing or
triggering infantile spasms, because Dr. Kinsbourne does not cite objective independent evidence
from treating physicians or the medical literature. Although Dr. Zempel accepts that vaccination
provokes an immune response, he does not accept that this provoked immune response is a risk
factor for causing infantile spasms. Id.
Dr. Zempel states that CK clearly has drug-resistant infantile spasms which are closely
associated with developmental delay. Id. at 17. Dr. Zempel also states he does not know the
etiology of her infantile spasms. Id. Dr. Zempel agrees that CK’s neurodevelopmental issues are
clearly related to her intractable and drug-resistant infantile spasms. Id. at 20.
On April 10, 2017, petitioners filed Dr. Kinsbourne’s supplemental expert report. Ex. 6-
A. He admits that scientific proof is lacking that vaccinations can cause infantile spasms, but he
says his opinion is based on a reasonable degree of medical probability. Id. at 1. Referring to
Dr. Zempel’s quotations from the Bellman study and the Melchior study, Dr. Kinsbourne states
that saying vaccines may precipitate infantile spasms is the same as saying vaccines may cause
infantile spasms. Id. Melchior even says there may be an occasional connection between
vaccines and infantile spasms. Id. Dr. Kinsbourne notes that no explanatory model for the
genesis of infantile spasms has been scientifically proven. Id. at 3.
TESTIMONY
CK’s mother testified first. Tr, at 4. She used to be an emergency department nurse. Id.
at 5. She and her husband have five children. Id. at 6. CK seemed normal for four months. Id.
at 8. CK’s mother brought CK to the pediatrician in the morning for her four-month well-baby
infantile spasms cohort, by K.G. Krupp, et al., 79 ANN NEUROL 3:475-84 (2016) (Tab 9).
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checkup where CK received her vaccinations. Id. That evening, while CK’s mother was nursing
CK, CK’s arms and head went forward and her legs came up. This was her first cluster of
seizures. Id. CK’s father called the pediatrician who told him to bring CK into the emergency
room right away. Id. CK has never run a temperature with her seizures. Id. at 13. Dr. Riordan,
CK’s pediatrician, thought CK had either gastroesophageal reflux or a reaction to her
vaccinations. Id.
CK’s mother said that she and her husband have watched CK deteriorate with every
seizure. Id. at 14. CK withdrew eye contact and has a hard time interacting with the world. She
does not speak. She walks with severe ataxia and will walk into objects and seize into the
ground. CK’s parents have watched CK go from a normal, healthy, developing child to a
catastrophically ill one. Id. Nothing has eradicated CK’s seizures. Id. at 15. CK currently
seizes from 30 to 50 times a day. Id.
The next witness was petitioners’ expert, Dr. Marcel Kinsbourne, a pediatric neurologist.
Id. at 32, 35. He has seen hundreds of cases of seizure disorder in his professional career. Id. at
36. He has seen 20 to 40 infantile spasms cases in his professional career. Id. He was a resident
at the Great Ormond Street Hospital for Sick Children [located in London, England] when the
first studies were done on whether ACTH benefits children with infantile spasms. Id.
Dr. Kinsbourne’s opinion is that CK’s vaccinations caused or triggered her infantile
spasms that occurred 10 hours later. Id. at 38. His basis is that CK was a normal baby before the
vaccinations and, after vaccinations, she had a very definite, clear onset of a cluster of 30 or 40
successive spasms within hours. Id. at 39. In addition, vaccines discharge proinflammatory
cytokines to stimulate the innate immune system to produce a response but in CK, this response
was infantile spasms. Id. at 41. Pertussis vaccine is known to be epileptogenic at times. Id. at
43. Although in acellular DPT, the pertussis is toxoided, there is still some high-toxoided toxin
in it. Id. Dr. Kinsbourne accepts that although DTaP is less reactogenic than whole-cell DTP,
recipients of DTaP can still have adverse reactions. Id.
Dr. Kinsbourne said 10 hours between CK’s vaccinations and her onset of infantile
spasms was very appropriate for causation because innate immune system reactions are very fast.
Id. at 44. He also said there was a logical sequence of cause and effect between CK’s receipt of
four vaccines, including DTaP, well-known to be capable of stimulating the innate immune
system, and the production of proinflammatory cytokines which can occur even without causing
a fever. Id. at 44-45.
Dr. Kinsbourne was impressed with the clear and decisive manner of the onset of CK’s
infantile spasms as infantile spasms do not usually begin that way. Id. at 46. Infantile spasms
often have an insidious onset. Id. at 70. CK’s abrupt onset of infantile spasms suggests to Dr.
Kinsbourne that a definite event provoked the seizures. Id. at 47.
Dr. Kinsbourne testified that infantile spasms destroy the brain. Id. at 48. CK is very
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typical as a demonstration of that because infantile spasms did not immediately affect her
development. Id. at 49. As CK’s seizures got worse and her medicines became less effective,
her development became worse and worse. Id. at 49. Her seizures still continue and, thus, CK
never had the chance to develop as a normal child. Id. Dr. Kinsbourne said if CK had not
received her vaccinations at the age of four months but when she was substantially older and
then began to seize, her brain damage would not be as severe as it is now. Id. Later in life, CK’s
seizures would have taken a form that is not as damaging to the brain as infantile spasms. Id. at
59.
Dr. Kinsbourne said that CK’s infantile spasms are cryptogenic because no one knows
the cause of them. Id. If we knew the cause of them, she would have symptomatic infantile
spasms, which are more common. Id. at 49-50.
Dr. Kinsbourne described his “two-hit” theory. Id. at 51. The first hit is that something
is different in CK’s brain to make her susceptible to vaccination. Id. The second hit is the risk
factor, in this case, the vaccinations, which triggered the onset of the infantile spasms. Id. He
posited that if CK had not received these vaccines, either she would not have had infantile
spasms or she would have had them at a later age and had a better outlook for development. Id.
at 53. The amount of brain damage depends on how early someone starts to have infantile
spasms. Id. Dr. Kinsbourne saw CK seize the day before the trial and testified she still has
severe seizures. Id. at 54. They are still infantile spasms. Id.
The undersigned asked Dr. Kinsbourne if he agreed that the results of the Bellman, Ross,
and Miller study which compared the incidence of cryptogenic infantile spasms among children
who received whole-cell DPT with the baseline occurrence of children the same age who had
cryptogenic infantile spasms and concluded that DPT triggered infantile spasms among DPT
vaccinees within the first week of vaccination was applicable to children who receive acellular
DPT, just at a lower incidence. Id. at 55-57. Dr. Kinsbourne said he absolutely agreed. Id. at
57. He also agreed that the conclusion of the Bellman study that DPT vaccination triggers onset
of cryptogenic infantile spasms if they occur within one week of vaccination applied to CK
because her onset was within one week of vaccination. Id. He said that the Bellman study
shows clearly that pertussis vaccine can trigger the onset of infantile spasms. Id. at 58.
The third witness was respondent’s expert Dr. John Zempel, a pediatric neurologist and
pediatric epileptologist. Id. at 106. He has seen thousands of patients with epilepsy over the last
15 years with 10 to 15 of them per year having infantile spasms. Id. at 110, 113. He defined
infantile spasms as an age-dependent epileptic encephalopathy. Id. at 111. An overall
encephalopathy coexists with the seizures. Id. Parents are very concerned about their children
having infantile spasms because of the dire developmental outcomes occurring in these patients.
Id. at 112. A small fraction of children with infantile spasms respond to aggressive treatment.
Id. at 113. CK’s case is unusual because she has refractory or drug-resistant infantile spasms and
did not have a remission. Id. at 114.
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Dr. Zempel’s opinion is that CK’s vaccinations did not cause or exacerbate her infantile
spasms. Id. at 118. The basis of his opinion is his clinical experience and the medical literature
in which doctors broadly do not recognize vaccination as a cause of infantile spasms. Id. Dr.
Zempel said that Bellman’s study does recognize a causal factor, but it is an old paper. Dr.
Zempel stated the more recent medical literature does not include vaccination as a likely or even
uncommon cause of infantile spasms. Id. He said the preferred current way of viewing
cryptogenic infantile spasms is that they have no identified etiology, i.e., there must be an
etiology but it is as yet unknown. Id. at 119. In other words, there is an underlying propensity in
the population of these children to have infantile spasms. Id.
Dr. Zempel said that infantile spasms have a unique identity and mostly tend to cluster
when the children are waking or falling asleep. Id. at 120-21. Each seizure lasts a few seconds
and may recur every 30 seconds, every minute, or every several minutes for a period of time. Id.
at 121. Because of the dire outcome associated with infantile spasms, pediatric neurologists are
well-trained to recognize infantile spasms. Id. An EEG particularly during the sleep phase will
capture the high-amplitude chaos in the brain known as hypsarrhythmia. Id. at 123. This means
the entire brain is not working well which is what encephalopathy means. Id. Because doctors
want to diagnose infantile spasms expeditiously in order to get the child into treatment, infantile
spasms are the only seizure disorder for which a hospital will do an EEG at night or on a
Saturday or Sunday for diagnostic purposes. Id. Generally, infantile spasms start between three
to nine months of age. Id.
Dr. Zempel thinks that both the infantile spasms and the encephalopathy destroy the
brain. Id. at 127. The medical community thinks that more severe infantile cases have earlier
onset. Id. at 131. In most people with epilepsy, we do not know why they have a seizure each
time they seize. Id. at 137. Stress can cause a seizure but we do not know how. Id. at 138.
Dr. Zempel said we do not know the mechanism by which any epilepsy occurs. Id. at
144. A seizure occurs as a hyperexcitability of neuronal circuits but we do not know why. Id.
Dr. Zempel said circuits are a group or a network of neurons that are discharging, like an
electrical storm. Id. But then during this electrical storm, there is a breakdown of normal
mechanisms that keep that electrical activity in a small area. Id. at 144-45. How big the seizure
becomes or where it spreads defines many types of epilepsies. Id. at 145. In a classic case of
hypsarrhythmia, there is chaos everywhere in the brain. Id. In some cases of infantile spasms,
there is focality, but in other cases, there is not. Id. at 146. Those who read CK’s EEGs found
more focality at various times and then less focality at other times. Id.
Dr. Zempel discussed the Coppola article,14 not mentioned in his expert report, but filed
as Exhibit E, which describes three sets of identical twins whose onset of infantile spasms was
essentially on the same day of each twin’s life, a strong argument for a genetic determinant. Id.
at 150-51. He thinks that genetics influences all infantile spasms. Id. at 153. Some are likely
14 Simultaneous Onset of Infantile Spasms in Monozygotic Twins, by G. Coppola, et al. 43 PEDIATR NEUROL 127-30
(2010). Ex. E. The long-term outcome was poor in all six twins. Id. at 130.
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directly causative. Id. Other cases may have indirect genetic causation. Id. at 154. He believes
CK has some underlying condition of her brain. Id. at 182.
Dr. Zempel stated that vaccinations are not known in the medical community to be a
cause of infantile spasms. Id. at 160. He thinks that recall bias explains the temporal shift in
onset of infantile spasms after DPT which the Bellman study reflects. Id. at 161. Dr. Zempel
said the statistics in the Bellman paper are not very statistically significant. Id. at 162. It
depends on a very small number of cases. Id. As to whether or not CK’s outcome would have
been better if her onset of infantile spasms occurred later than it did, Dr. Zempel replied that we
do not truly know on a day-to-day, week-to-week, or perhaps even month-to-month basis that
timing influences ultimate outcome. Id. at 163-64. “It is always better to get rid of seizures
earlier.” Id. at 164. But Dr. Zempel questioned how important it is to get rid of infantile
seizures as rapidly as possible because of the variety of treatments for them which involve
different improvement times, if they work at all. Id. at 163, 164. He said there is a dearth of
long-term data in studies looking at longer term outcomes. Id. at 164.
Dr. Zempel testified that there is a small fraction of children with cryptogenic infantile
spasms that do better than symptomatic infantile spasms children, but not a majority of them. Id.
at 165. The evolving opinion of the medical community is that someone with infantile spasms
has an abnormal brain. Id. Using the diagnosis of cryptogenic infantile spasms means doctors
just do not understand yet why that particular child has infantile spasms. Id. Dr. Zempel said
that one of the depressing thoughts is that things are not that much better now than they were in
the prior era for children with infantile spasms. Id. at 168. He thinks that CK had a very typical
presentation and initial course of infantile spasms. Id. at 169. But by being drug-resistant and
continuing to have spasms beyond a typical age when they remit, CK is unfortunately in a more
selective category of infantile spasms that have not remitted. Id. The fact that she is having brief
seizures has significant consequences. Id.
Dr. Zempel said that steroids, like ACTH, do not just modulate the immune system; they
directly modulate the brain when used in infantile spasms cases. Id. at 171. He thinks whether
the immune system has a pathogenic role in the development of infantile spasms is a complicated
question. Id. Dr. Zempel thinks CK got excellent treatment with aggressive identification of her
illness and institution of ACTH. Id. at 172.
Dr. Zempel said that medical literature in the form of peer-reviewed articles does not
exist for vaccine causation of infantile spasms. Id. at 176. One of the holy grails, as Dr. Zempel
termed it, of pediatric epilepsy research is to develop an animal model of infantile spasms,
particularly rodent models. Id. at 177. He said it is very, very difficult to created animal models
for infantile spasms because the rat or mouse brain may be different than the human brain. Id.
The only experiments used on animals to try to develop something that looks like infantile
spasms has been by doctors using neurotoxins as very severe insults to the brains of young
animals. Id. at 178-79. But whether these animal experiments truly reflect infantile spasms is a
very complicated and very controversial subject. Id. at 179. The new term for infantile spasms
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is epileptic spasms. Id. at 180.
DISCUSSION
To satisfy their burden of proving causation in fact, petitioners must prove by
preponderant evidence: “(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 v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit
quoted its opinion in Grant v. Secretary of Health and Human Services, 956 F.2d 1144, 1148
(Fed. Cir. 1992):
A persuasive medical theory is demonstrated by “proof of a logical
sequence of cause of and effect showing that the vaccination was
the reason for the injury [,]” the logical sequence being supported
by a “reputable medical or scientific explanation[,]” i.e., “evidence
in the form of scientific studies or expert medical testimony[.]”
418 F.3d at 1278.
Without more, “evidence showing an absence of other causes does not meet petitioner’s
affirmative duty to show actual or legal causation.” Grant, 956 F.2d at 1149. Mere temporal
association is not sufficient to prove causation in fact. Id. at 1148.
Petitioners must show not only that but for CK’s vaccinations, she would not have
infantile spasms and chronic neuropathy, but also that her vaccinations were substantial factors
in causing her infantile spasms and chronic neuropathy. Shyface v. Sec’y of HHS, 165 F.3d
1344, 1352 (Fed. Cir. 1999).
In Capizzano v. Sec’y of HHS, 440 F.3d 1317, 1325 (Fed. Cir. 2006), the Federal Circuit
said: “we conclude that requiring either epidemiologic studies, rechallenge, the presence of
pathological markers or genetic disposition, or general acceptance in the scientific or medical
communities to establish a logical sequence of cause and effect is contrary to what we said in
Althen . . . .” Such an approach is inconsistent with the use of circumstantial evidence. Id. The
Federal Circuit in Althen rejected the assertion that the Vaccine Act;s preponderant evidence
standard requires objective confirmation. 418 F.3d at 1279. The Federal Circuit stated that “the
purpose of the Vaccine Act’s preponderance standard is to allow the finding of causation in a
field bereft of complete and direct proof of how vaccines affect the human body.” Id. at 1280.
Close calls are to be resolved in favor of petitioners. Capizzano, 1440 F.3d at 1327;
Althen, 418 F.3d at 1280. In Althen, the Federal Circuit ruled in favor of a causal link between
tetanus toxoid vaccine and optic neuritis and acute disseminated encephalomyelitis, which it
recognized was “a sequence hitherto unproven in medicine.” Id.
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In essence, the special master is looking for a medical explanation of a logical sequence
of cause and effect (Althen, 418 F.3d at 1278; Grant, 956 F.2d at 1148), and medical probability
rather than certainty (Knudsen v. Sec’y of HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994)). To the
undersigned, medical probability means biologic credibility rather than specification of an exact
biologic mechanism. As the Federal Circuit stated in Knudsen:
Furthermore, to require identification and proof of specific biological mechanisms
would be inconsistent with the purpose and nature of the vaccine compensation
program. The Vaccine Act does not contemplate full blown tort litigation in the
Court of Federal Claims. The Vaccine Act established a federal “compensation
program” under which awards are to be “made to vaccine-injured persons quickly,
easily, and with certainty and generosity.” House Report 99-908, [99th Cong. 2d
Sess. 18], at 3, 1986 U.S.C.C.A.N. at 6344.
The Court of Federal Claims is therefore not to be seen as a vehicle for ascertaining
precisely how and why DTP and other vaccines sometimes destroy the health and lives of
certain children while safely immunizing most others.
35 F.3d at 549.
As for epidemiological support for causation, the Federal Circuit in Knudsen, 35 F.3d at
551, ruled for petitioners even when epidemiological evidence directly opposed causation from
DPT vaccine. The case concerned the cause of a baby’s encephalopathy after a vaccination.
Respondent provided evidence that more encephalopathies are caused by viruses than by
vaccines, convincing the special master to rule against petitioners. But the Federal Circuit
thought the epidemiologic evidence should not bar petitioners from prevailing. Even though
epidemiological evidence supported respondent’s view that viruses were more likely to cause
encephalopathy than vaccinations, the Federal Circuit held that that fact alone was not an
impediment to recovery of damages. In Knudsen, the Federal Circuit stated:
The bare statistical fact that there are more reported cases
of viral encephalopathies than there are reported cases of DTP
encephalopathies is not evidence that in a particular case an
encephalopathy following a DTP vaccination was in fact caused by
a viral infection present in the child and not caused by the DTP
vaccine.
35 F.3d at 550.
Interestingly, the Federal Circuit in Knudsen also stated that when a vaccinee would fit
within an epidemiological study, that alone is sufficient proof of vaccine causation:
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Causation in fact under the Vaccine Act is thus based on the
circumstances of the particular case, having no hard and fast per se
scientific or medical rules. The determination of causation in fact
under the Vaccine Act involves ascertaining whether a sequence of
cause and effect is “logical” and legally probable, not medically or
scientifically certain. [citing cases] Thus, for example, causation
can be found in vaccine cases based on epidemiological evidence
and the clinical picture regarding the particular child without
detailed medical and scientific exposition on the biological
mechanisms. [citing case].
Id. at 548, 549.
Both Dr. Kinsbourne for petitioners and Dr. Zempel for respondent agreed on a number
of issues. CK’s cryptogenic infantile spasms have an unknown cause. In addition, before she
received her four-month vaccinations, her brain was abnormal even though her behavior until her
four-month vaccinations was normal. For reasons scientists and doctors have not been able to
discover, within hours of her four-month vaccinations, CK had her first infantile spasms cluster.
She has been seizing ever since, even though the expectation is that aggressive treatment, such as
ACTH, will stop the spasms, or even getting older than eight or nine months will lead to
normalcy. CK kept seizing. She is now severely delayed in all categories and she still has
infantile spasms.
Respondent defends based on all the criteria that the Federal Circuit has rejected in
Knudsen, Althen, and Capizzano: (1) we do not know the specific mechanism for how vaccines
can cause cryptogenic infantile spasms or the biological mechanisms explaining why cryptogenic
infantile spasms occur at all; (2) we do not have epidemiological studies that confirm that
vaccines can cause cryptogenic infantile spasms; (3) we do not have animal models of vaccines
causing cryptogenic infantile spasms; (4) whether CK seized early in life (at four months) or
later makes no difference because we cannot predict the outcome of a child who has cryptogenic
infantile spasms; (5) the Bellman study (1983) used a very small number of cryptogenic infantile
spasms children to determine that whole-cell DPT triggered the vaccinees’s onset of infantile
spasms within one week of vaccination; and (6) the Melchior study (1977) found just a few
infantile spasms related to DPT vaccination, below statistical significance. The undersigned
rejects all of these criteria as not being consistent with the Federal Circuit’s repeated guidance in
causation in fact cases.
Both parties filed the Bellman study (1983) and the Melchior study (1977). Pet’rs’ Ex. 6-
4; Resp’t’s Ex. D, Tab 1, and Pet’rs’ Ex. 6-16; Resp’s Ex. D, Tab 2. The undersigned asked
petitioners’ expert Dr. Kinsbourne if adverse reactions to acellular DPT (which CK received)
could occur, but just at a lower incidence than adverse reactions to whole-cell DPT. He said yes.
The undersigned finds Dr. Kinsbourne’s opinion credible and finds that CK would have fit into
the Bellman study which, based on a week-by-week analysis, found that among cryptogenic
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infantile spasms vaccinees, their onset of infantile spasms occurring within the first week after
vaccination was higher than baseline cryptogenic infantile spasms children. Because the onset of
cryptogenic infantile spasms vaccinees within the second week after vaccination was lower than
baseline cryptogenic infantile spasms children, Bellman concluded that DPT vaccine was a
trigger to the onset of infantile spasms in children so that the spasms occurred sooner than they
would have without vaccination, but also that the children were destined to have infantile
spasms. Bellman concluded that pertussis immunization “is not a direct causal factor for
infantile spasms in children with structurally normal brains, but . . . it may precipitate the onset
of spasms in those children in whom the disorder is already destined to develop.” Pet’rs’ Ex. 6-
4, at 1033; Resp’t’s Ex. D, Tab 1, at 1033.
Similarly in the Melchior study (1977), Melchior analyzed the number of infantile
spasms after Denmark changed its vaccination schedule and concluded that there were three
cases of infantile spasms in which vaccination could be considered as a triggering mechanism.
Pet’rs’ Ex. 6-16, at 135; Resp’t’s Ex. D, Tab 2, at 135. Neither Bellman nor Melchior viewed
their respective triggering conclusions as based on statistical significance. Melchior concluded
that a causal connection between DPT and infantile spasms was very unlikely “except in a few
cases.” Id. at 136.
Does it make any difference that DTaP was a trigger rather than a cause of CK’s infantile
spasms? The undersigned asked petitioner’s expert Dr. Kinsbourne if CK’s having infantile
spasms at the age of four months was worse for her ultimate outcome than if she had had them
when she was older, i.e., if she was, as Bellman concluded, destined to have infantile spasms
anyway? He answered in the affirmative. The seizures destroy the brain. The concern, which
Dr. Zempel shared, with children with infantile spasms is to treat them aggressively because
infantile spasms do tremendous damage to the brain. The evidence of the horrible outcome of
these seizures is that CK is irreparably damaged. That doctors may not know looking forward
what the outcome of an infantile spasms child would be is irrelevant when we already know the
outcome of CK’s infantile spasms.
Putting this all together, the undersigned finds that CK, even though she received DTaP,
not DPT, would have qualified to have been in the Bellman and Melchior studies because she
had infantile spasms within a week of pertussis vaccination and the vaccination was a trigger,
according to both the Bellman and Melchior studies, which prompted the onset of her spasms.
We are not dealing with the niceties of statistical significance in the Vaccine Program under the
guidance of the Federal Circuit’s decisions in Knudsen, Althen, and Capizzano. The principle
the Federal Circuit pronounced in Knudsen, i.e., that causation can be found in vaccine cases
based on epidemiological evidence and the clinical picture regarding the particular child without
detailed medical and scientific exposition on the biological mechanisms governs the outcome of
this decision.
Because CK would have qualified to have been in the Bellman and Melchior studies, the
undersigned finds that her four-month vaccinations triggered the onset of her cryptogenic
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seizures. The undersigned further finds that but for her onset of cryptogenic infantile spasms at
four months of age, she would have not had the disastrous outcome she had.
Similar analysis is in H.J. v. Sec’y of HHS, No. 110301V, 2015 WL 6848357 (Fed. Cl.
Spec. Mstr. Nov. 6, 2015), in which petitioner prevailed on the theory that Tdap (tetanus-
diphtheria-acellular pertussis) vaccine triggered her rheumatoid arthritis (“RA”) based on the
theory that an environmental trigger such as a vaccine can cause preclinical RA to develop into
clinical RA. 2015 WL 6848357, at *10. In the instant action, CK was clinically normal, but
both Dr. Kinsbourne and Dr. Zempel agreed that CK had an abnormal brain. Similarly, in H.J.,
petitioner had pre-vaccination autoimmune diseases, but not RA. H.J.’s expert stated that further
proof of vaccine causation was that H.J.’s onset of RA was explosive, unlike the usually
insidious onset of RA. Id. at *11. The special master in H.J. accepted petitioner’s expert’s
explanation for H.J.’s abrupt onset of RA. Id. at 12.
Similarly, Dr. Kinsbourne in the instant action focused on the abrupt onset of CK’s
cryptogenic infantile spasms as further proof of DTaP vaccine causation. As both he and Dr.
Zempel testified, the usual onset of infantile spasms is insidious. But CK’s onset of cryptogenic
infantile spasms was explosive, sudden, and dramatic. This proved to Dr. Kinsbourne that DTaP
was a trigger of CK’s cryptogenic infantile spasms. The undersigned finds Dr. Kinsbourne’s
testimony credible and accepts his opinion on causation in CK’s case as further support for the
Bellman study and Melchior study conclusions that pertussis vaccine can trigger the onset of
infantile spasms.
The undersigned need not comment on Dr. Kinsbourne’s two-hit theory in that both
experts agree that CK brain was abnormal pre-vaccination and the undersigned finds that DTaP
triggered the onset of CK’s cryptogenic infantile spasms. Moreover, as Dr. Zempel testified, CK
has a chronic encephalopathy.
The undersigned is satisfied with the evidence in the record that the medical literature
acceptance of pertussis vaccine as a trigger to onset of infantile spasms in a few cases within one
week of vaccination is sufficient to prove causation in this case, buttressed by the evidence of an
explosive onset of infantile spasms rather than the normal insidious onset of infantile spasms.
Althen Analysis
Under Althen Prong One, the undersigned finds that DTaP vaccine can trigger the onset
of infantile spasms. Under Althen Prong Two, the undersigned finds that there was a logical
sequence of cause and effect in DTaP causing CK’s onset of infantile spasms. Under Althen
Prong Three, the undersigned finds that an onset within hours of DTaP vaccination is consistent
with the effect of the vaccine’s triggering an abrupt onset.
The undersigned rules in favor of petitioners on entitlement. This case is now in
damages. The undersigned will schedule a status conference soon to discuss how the parties will
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proceed with damages. Because of their prior life care plans, there should be an expedited
process to settle damages. Since the prior settlement negotiations that failed, petitioners have
bought a house, raising the issue of whether or not there needs to be any house modification.
The undersigned orders petitioners to file updated medical records and IEPs, as well as any other
information relevant to the issue of damages, including the existence of any Massachusetts
Medicaid lien.
IT IS SO ORDERED.
Dated: December 12, 2017 /s/ Laura D. Millman
Laura D. Millman
Special Master
19

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DOCUMENT 2: USCOURTS-cofc-1_15-vv-01016-2
Date issued/filed: 2019-06-24
Pages: 13
Docket text: PUBLIC DECISION (Originally filed: 5/29/2019) regarding 102 DECISION Stipulation/Proffer. Signed by Special Master Laura D. Millman. (et) Service on parties made.
--------------------------------------------------------------------------------
Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 1 of 13
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 15-1016V
Filed: May 29, 2019
Not to be Published
*************************************
MARYELLEN KOTTENSTETTE and *
NICHOLAS KOTTENSTETTE, *
as best friends of their daughter (CK) *
Damages decision based on proffer
*
Petitioners, *
*
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
*************************************
John F. McHugh, New York, NY, for petitioner.
Camille Collett, Washington, DC, for respondent.
MILLMAN, Special Master
DECISION AWARDING DAMAGES1
On September 11, 2015, petitioners filed a petition under the National Childhood Vaccine
Injury Act, 42 U.S.C. §§ 300aa-10–34 (2012), alleging that diphtheria-tetanus-acellular pertussis
(“DTaP”), haemophilus B influenza (“HiB”), inactivated polio vaccine (“IPV”), and
pneumococcal (“Prevnar”) vaccines administered to their daughter CK on October 2, 2012,
1 Because this unpublished decision contains a reasoned explanation for the special master’s
action in this case, the special master intends to post this unpublished decision on the United
States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, 44
U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government
Services). This means the decision will be available to anyone with access to the Internet.
Vaccine Rule 18(b) states that all decisions of the special masters will be made available to the
public unless they contain trade secrets or commercial or financial information that is privileged
and confidential, or medical or similar information whose disclosure would constitute a clearly
unwarranted invasion of privacy. When such a decision is filed, petitioners have 14 days to
identify and move to redact such information prior to the document’s disclosure. If the special
master, upon review, agrees that the identified material fits within the banned categories listed
above, the special master shall redact such material from public access.

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 2 of 13
caused her a Table encephalopathy or, in the alternative, a non-Table encephalopathy, and
infantile spasms. On December 12, 2017, the undersigned ruled for petitioners on entitlement.
On May 29, 2019, respondent filed Respondent’s Proffer on Award of Compensation.
The undersigned finds the terms of the proffer to be reasonable. Based on the record as a whole,
the undersigned finds that petitioner is entitled to the award as stated in the proffer. Pursuant to
the terms stated in the attached proffer, the undersigned awards the following:
a. a lump sum payment of $1,046,521.75, representing trust seed funds consisting of the
present year cost of compensation for residential facility expenses in Compensation Year
2077 through Compensation Year 2081 ($939,875.00) and life care expenses in the first
year after judgment ($106,646.75), in the form of a check payable to Regions Bank, as
Trustee of the Grantor Reversionary Trust established for the benefit of CK, as set forth
in the attached Appendix A;
b. a lump sum payment of $1,132,020.68, representing compensation for lost future
earnings ($882,020.68) and pain and suffering ($250,000.00), in the form of a check
payable to petitioners as guardian(s)/conservator(s) of CK, for the benefit of CK, in
accordance with the terms set out in the attached proffer;
c. a lump sum payment of $12,698.57, representing compensation for past unreimbursable
expenses, in the form of a check payable to petitioners, Maryellen Kottenstette and
Nicholas Kottenstette;
d. a lump sum payment of $15,528.38, representing compensation for satisfaction of the
Commonwealth of Massachusetts Medicaid lien, payable jointly to petitioners and
Commonwealth of Massachusetts – CRU
COMMONWEALTH OF MA
Casualty Recovery
P.O. Box 417811
Boston, MA 02241-7811
Attn: Alicia Villagran
SSN: XXXXX9919
e. an amount sufficient to purchase the annuity contract described in section E of the
attached proffer.
In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of
the court is directed to enter judgment herewith.2
IT IS SO ORDERED.
Dated: May 29, 2019 /s/ Laura D. Millman
Laura D. Millman
Special Master
2 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or
jointly, filing a notice renouncing the right to seek review.
2

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 3 of 13
IN THE UNITED STATES COURT OF FEDERAL CLAIMS
OFFICE OF SPECIAL MASTERS
__________________________________________
)
MARYELLEN KOTTENSTETTE and )
NICHOLAS KOTTENSTETTE as best )
friends of their daughter (CK), )
)
Petitioners, )
)
v. ) No. 15-1016V
) Special Master Millman
SECRETARY OF THE DEPARTMENT OF )
HEALTH AND HUMAN SERVICES, )
)
Respondent. )
__________________________________________)
RESPONDENT'S PROFFER ON AWARD OF COMPENSATION
I. Items of Compensation
A. Life Care Items
The respondent engaged life care planner, Laura Fox, MSN, BSN, RN, CDDN, CLCP,
and petitioners engaged Bala Care Nursing Solutions, to provide an estimation of CK’s future
vaccine-injury related needs. For the purposes of this proffer, the term “vaccine related” is as
described in the Special Master’s Ruling on Entitlement, filed December 12, 2017. All items of
compensation identified in the life care plan are supported by the evidence, and are illustrated by
the chart entitled Appendix A: Items of Compensation for CK, attached hereto as Tab A.1
1 The chart at Tab A illustrates the annual benefits provided by the life care plan. The annual benefit years
run from the date of judgment up to the first anniversary of the date of judgment, and every year thereafter up to the
anniversary of the date of judgment.
-1-

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 4 of 13
Respondent proffers that CK should be awarded all items of compensation set forth in the life
care plan and illustrated by the chart attached at Tab A.2 Petitioners agree.
B. Lost Future Earnings
The parties agree that based upon the evidence of record, CK will not be gainfully
employed in the future. Therefore, respondent proffers that CK should be awarded lost future
earnings as provided under the Vaccine Act, 42 U.S.C. § 300aa-15(a)(3)(B). Respondent
proffers that the appropriate award for CK's lost future earnings is $882,020.68. Petitioners
agree.
C. Pain and Suffering
Respondent proffers that CK should be awarded $250,000.00 in actual pain and suffering.
See 42 U.S.C. § 300aa-15(a)(4). Petitioners agree.
D. Past Unreimbursable Expenses
Evidence supplied by petitioners document their expenditure of past unreimbursable
expenses related to CK's vaccine-related injury. Respondent proffers that petitioners should be
awarded past unreimbursable expenses in the amount of $12,698.57. Petitioners agree.
E. Medicaid Lien
Respondent proffers that CK should be awarded funds to satisfy a Commonwealth of
Massachusetts lien in the amount of $15,528.38, which represents full satisfaction of any right of
subrogation, assignment, claim, lien, or cause of action the Commonwealth of Massachusetts
2
The parties have no objection to the proffered award of damages. Assuming the Special Master issues a damages
decision in conformity with this proffer, the parties intend to waive their right to seek review of such damages
decision, recognizing that respondent reserves his right, pursuant to 42 U.S.C. § 300aa-12(f), to seek review of the
Special Master’s December 12, 2017, decision finding CK entitled to an award under the Vaccine Act. This right
accrues following entry of judgment.
-2-

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 5 of 13
may have against any individual as a result of any Medicaid payments the Commonwealth of
Massachusetts has made to or on behalf of CK from the date of her eligibility for benefits
through the date of judgment in this case as a result of her vaccine-related injury suffered on or
about October 2, 2012, under Title XIX of the Social Security Act.
II. Form of the Award
The parties recommend that the compensation provided to CK should be made through a
combination of lump sum payments and future annuity payments as described below, and request
that the Special Master's decision and the Court's judgment award the following:3
A. A lump sum payment of $1,046,521.75, representing trust seed funds consisting of
the present year cost of compensation for residential facility expenses in Compensation Year
2077 through Compensation Year 2081 ($939,875.00) and life care expenses in the first year
after judgment ($106,646.75), in the form of a check payable to Regions Bank, as Trustee of the
Grantor Reversionary Trust established for the benefit of CK, as set forth in Appendix A: Items
of Compensation for CK;
B. A lump sum payment of $1,132,020.68, representing compensation for lost future
earnings ($882,020.68) and pain and suffering ($250,000.00), in the form of a check payable to
petitioners as guardian(s)/conservator(s) of CK, for the benefit of CK. No payments shall be
made until petitioners provide respondent with documentation establishing that they have been
appointed as the guardian(s)/conservator(s) of CK’s estate. If petitioners are not authorized by a
3 Should CK die prior to entry of judgment, the parties reserve the right to move the Court for appropriate
relief. In particular, respondent would oppose any award for future medical expenses, future lost earnings, and
future pain and suffering.
-3-

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 6 of 13
court of competent jurisdiction to serve as guardian(s)/conservator(s) of the estate of CK, any
such payment shall be made to the party or parties appointed by a court of competent jurisdiction
to serve as guardian(s)/conservator(s) of the estate of CK upon submission of written
documentation of such appointment to the Secretary.
C. A lump sum payment of $12,698.57, representing compensation for past
unreimbursable expenses, in the form of a check payable to petitioners, Maryellen Kottenstette
and Nicholas Kottenstette.
D. A lump sum payment of $15,528.38 representing compensation for satisfaction of the
Commonwealth of Massachusetts Medicaid lien, payable jointly to petitioners and
Commonwealth of Massachusetts – CRU
COMMONWEALTH OF MA
Casualty Recovery
P.O. Box 417811
Boston, MA 02241-7811
Attn: Alicia Villagran
SSN: XXXXX9919
Petitioners agree to endorse this payment to the Commonwealth of Massachusetts.
E. An amount sufficient to purchase the annuity contract,4 subject to the conditions
described below, that will provide payments for the life care items contained in the life care plan,
as illustrated by the chart at Tab A attached hereto, paid to the life insurance company5 from
4 In respondent’s discretion, respondent may purchase one or more annuity contracts from one or more life
insurance companies.
5 The Life Insurance Company must have a minimum of $250,000,000 capital and surplus, exclusive of any
mandatory security valuation reserve. The Life Insurance Company must have one of the following ratings from
two of the following rating organizations:
a. CK Best Company: A++, A+, A+g, A+p, A+r, or A+s;
b. Moody's Investor Service Claims Paying Rating: Aa3, Aa2, Aa1, or Aaa;
-4-

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 7 of 13
which the annuity will be purchased.6 Compensation for Year Two (beginning on the first
anniversary of the date of judgment) and all subsequent years shall be provided through
respondent's purchase of an annuity, which annuity shall make payments directly to the trustee
only so long as CK is alive at the time a particular payment is due. At the Secretary's sole
discretion, the periodic payments may be provided to the trustee in monthly, quarterly, annual or
other installments. The "annual amounts" set forth in the chart at Tab A describe only the total
yearly sum to be paid to the trustee and do not require that the payment be made in one annual
installment.
1. Growth Rate
Respondent proffers that a four percent (4%) growth rate should be applied to all non-
medical life care items, and a five percent (5%) growth rate should be applied to all medical life
care items. Thus, the benefits illustrated in the chart at Tab A that are to be paid through annuity
payments should grow as follows: four percent (4%) compounded annually from the date of
judgment for non-medical items, and five percent (5%) compounded annually from the date of
judgment for medical items. Petitioners agree.
c. Standard and Poor's Corporation Insurer Claims-Paying Ability Rating: AA-, AA, AA+, or
AAA;
d. Fitch Credit Rating Company, Insurance Company Claims Paying Ability Rating: AA-, AA,
AA+, or AAA.
6 Petitioners authorize the disclosure of certain documents filed by the petitioners in this case consistent with the
Privacy Act and the routine uses described in the National Vaccine Injury Compensation Program System of
Records, No. 09-15-0056.
-5-

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 8 of 13
2. Life-Contingent Annuity
The trustee will continue to receive the annuity payments from the Life Insurance
Company only so long as CK is alive at the time that a particular payment is due. Written notice
shall be provided to the trustee and the Secretary of Health and Human Services and the Life
Insurance Company within twenty (20) days of CK’s death.
3. Guardianship
No payments shall be made until petitioners provide respondent with documentation
establishing that they have been appointed as the guardian(s)/conservator(s) of CK’s estate. If
petitioners are not authorized by a court of competent jurisdiction to serve as
guardian(s)/conservator(s) of the estate of CK, any such payment shall be made to the party or
parties appointed by a court of competent jurisdiction to serve as guardian(s)/conservator(s) of
the estate of CK upon submission of written documentation of such appointment to the
Secretary.
III. Summary of Recommended Payments Following Judgment
A. Lump Sum paid to Regions Bank, as Trustee of the Grantor
Reversionary Trust for the benefit of CK: $1,046,521.75
B. Lump Sum paid to the court-appointed guardian(s)/
conservator(s) of the estate of CK for the benefit of CK: $1,132,020.68
C. Past unreimbursable expenses payable to petitioners: $ 12,698.57
D. Medicaid Lien: $ 15,528.38
E. An amount sufficient to purchase the annuity contract described
above in section II. E.
-6-

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 9 of 13
Respectfully submitted,
JOSEPH H. HUNT
Assistant Attorney General
C. SALVATORE D’ALESSIO
Acting Director
Torts Branch, Civil Division
CATHARINE E. REEVES
Deputy Director
Torts Branch, Civil Division
ALEXIS B. BABCOCK
Assistant Director
Torts Branch, Civil Division
/s/Camille M. Collett
CAMILLE M. COLLETT
Senior Trial Attorney
Torts Branch, Civil Division
U. S. Department of Justice
P.O. Box l46, Benjamin Franklin Station
Washington, D.C. 20044-0146
Direct dial: (202) 616-4098
Dated: 5/29/2019
-7-

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 10 of 13
Appendix A: Items of Compensation for CK Page 1 of 4
Lump Sum
Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation
ITEMS OF COMPENSATION G.R. * M Year 1 Years 2-6 Year 7 Year 8 Years 9-10 Year 11 Years 12-15 Years 16-19
2019 2020-2024 2025 2026 2027-2028 2029 2030-2033 2034-2037
Preferred Blue MOP 5% 3,000.00 3,000.00 3,000.00 3,000.00 3,000.00 3,000.00 3,000.00 3,000.00
Preferred Blue Rx MOP 5% 1,000.00 1,000.00 1,000.00 1,000.00 1,000.00 1,000.00 1,000.00 1,000.00
Insurance Premium 5%
Medicare Premium 5%
Medicare Deductible 5% *
Medigap 5%
Medicare Part D 5%
Specialist Care 5% *
Diagnostic Studies 5% *
ABA Therapy 4% *
Case Mngt 4% 3,288.00 3,288.00 3,288.00 3,288.00 3,288.00 3,288.00 3,288.00 1,644.00
Keppra 5% *
Onfi 5% *
Diazepam 5% *
Sabril 5% *
Vit B6 4% *
Formula 4% *
Ensure 4% *
Briefs 4% 1,368.75 1,368.75 1,368.75 1,368.75 1,368.75 1,368.75 1,368.75 1,368.75
Gloves 4% 131.00 131.00 131.00 131.00 131.00 131.00 131.00 131.00
Wipes 4% 357.00 357.00 357.00 357.00 357.00 357.00 357.00 357.00
Bed Underpads 4% 161.00 161.00 161.00 161.00 161.00 161.00 161.00 161.00
Soft Helmet 4% 126.00 126.00 63.00 63.00 63.00 63.00 63.00 63.00
Hospital Bed 4% *
Padding for Bed Rails etc 4% 130.00 43.33 43.33 43.33 43.33
Manual WC 4% *
Maint for Bed 4% *
WC Maint 4% 200.00 200.00 200.00 200.00 200.00 200.00 200.00 200.00
Van Conversion 4% 22,477.00 22,477.00
Van Maint 4% 450.00 450.00 450.00 450.00 450.00 450.00 450.00 450.00
Home Mods 0% 15,000.00

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 11 of 13
Appendix A: Items of Compensation for CK Page 2 of 4
Lump Sum
Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation
ITEMS OF COMPENSATION G.R. * M Year 1 Years 2-6 Year 7 Year 8 Years 9-10 Year 11 Years 12-15 Years 16-19
2019 2020-2024 2025 2026 2027-2028 2029 2030-2033 2034-2037
Adult Day Program 4% 27,750.00
Attendant Care 4% 59,088.00 59,088.00 59,088.00 59,088.00 59,088.00 59,088.00 59,088.00 73,200.00
Trust Seed/ Residential Care 4% 939,875.00
Lost Future Earnings 882,020.68
Pain and Suffering 250,000.00
Past Unreimbursable Expenses 12,698.57
MA Medicaid Lien 15,528.38
Annual Totals 2,206,769.38 69,169.75 69,106.75 69,236.75 69,150.08 91,627.08 69,150.08 109,368.08
Note: Compensation Year 1 consists of the 12 month period following the date of judgment.
Compensation Year 2 consists of the 12 month period commencing on the first anniversary of the date of judgment.
As soon as practicable after entry of judgment, respondent shall make the following payment to Regions Bank, Trustee of the
Grantor Reversionary Trust established for the benefit of CK for trust seed funds ($939,875.00) and Year 1 life care
expenses ($106,646.75): $1,046,521.75.
As soon as practicable after entry of judgment, respondent shall make the following payment to the court-appointed guardian(s)/
conservator(s) of CK for lost future earnings ($882,020.68) and pain and suffering ($250,000.00): $1,132,020.68.
As soon as practicable after entry of judgment, respondent shall make the following payment to petitioners, Maryellen Kottenstette
and Nicholas Kottenstette, as reimbursement for past unreimbursable expenses: $12,698.57.
As soon as practicable after entry of judgment, respondent shall make the following payment jointly to
petitioners and the Commonwealth of Massachusetts, as reimbursement of the Commonwealth's Medicaid lien: $15,528.38.
Annual amounts payable through an annuity for future Compensation Years follow the anniversary of the date of judgment.
Annual amounts shall increase at the rates indicated in column "G.R." above, compounded annually from the date of judgment.
Items denoted with an asterisk (*) covered by health insurance and/or Medicare.
Items denoted with an "M" payable in twelve monthly installments totaling the annual amount indicated.

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 12 of 13
Appendix A: Items of Compensation for CK Page 3 of 4
Compensation Compensation Compensation Compensation Compensation Compensation Compensation
ITEMS OF COMPENSATION G.R. * M Year 20 Year 21 Years 22-23 Years 24-29 Years 30-58 Years 59-63 Years 64-Life
2038 2039 2040-2041 2042-2047 2048-2076 2077-2081 2082-Life
Preferred Blue MOP 5% 3,000.00 3,000.00 3,000.00
Preferred Blue Rx MOP 5% 1,000.00 1,000.00 1,000.00
Insurance Premium 5% 3,074.24 3,074.24 3,074.24
Medicare Premium 5% 1,626.00 1,626.00 1,626.00 1,626.00
Medicare Deductible 5% *
Medigap 5% 2,372.88 2,372.88 2,372.88 2,372.88
Medicare Part D 5% 1,399.44 1,399.44 1,399.44 1,399.44
Specialist Care 5% *
Diagnostic Studies 5% *
ABA Therapy 4% *
Case Mngt 4% 1,644.00 1,644.00 1,644.00 1,644.00
Keppra 5% *
Onfi 5% *
Diazepam 5% *
Sabril 5% *
Vit B6 4% * 99.00 99.00 99.00 99.00
Formula 4% *
Ensure 4% * 3,650.00 3,650.00 3,650.00 3,650.00
Briefs 4% 1,368.75 1,368.75 1,368.75 1,368.75 1,368.75 1,368.75 1,368.75
Gloves 4% 131.00 131.00 131.00 131.00
Wipes 4% 357.00 357.00 357.00 357.00
Bed Underpads 4% 161.00 161.00 161.00 161.00 161.00 161.00 161.00
Soft Helmet 4% 63.00 63.00 63.00 63.00 63.00 63.00 63.00
Hospital Bed 4% *
Padding for Bed Rails etc 4% 43.33 43.33 43.33 43.33
Manual WC 4% *
Maint for Bed 4% *
WC Maint 4% 200.00 200.00 200.00
Van Conversion 4% 22,477.00
Van Maint 4% 450.00 450.00 450.00 450.00
Home Mods 0%

Case 1:15-vv-01016-RAH Document 105 Filed 06/24/19 Page 13 of 13
Appendix A: Items of Compensation for CK Page 4 of 4
Compensation Compensation Compensation Compensation Compensation Compensation Compensation
ITEMS OF COMPENSATION G.R. * M Year 20 Year 21 Years 22-23 Years 24-29 Years 30-58 Years 59-63 Years 64-Life
2038 2039 2040-2041 2042-2047 2048-2076 2077-2081 2082-Life
Adult Day Program 4% 27,750.00 27,750.00 27,750.00 27,750.00
Attendant Care 4% 73,200.00 73,200.00 73,200.00 73,200.00
Trust Seed/ Residential Care 4% 187,975.00 - 187,975.00
Lost Future Earnings
Pain and Suffering
Past Unreimbursable Expenses
MA Medicaid Lien
Annual Totals 112,442.32 134,919.32 112,442.32 114,315.40 198,715.07 10,740.07 198,715.07
Note: Compensation Year 1 consists of the 12 month period following the date of judgment.
Compensation Year 2 consists of the 12 month period commencing on the first anniversary of the date of judgment.
As soon as practicable after entry of judgment, respondent shall make the following payment to Regions Bank, Trustee of the
Grantor Reversionary Trust established for the benefit of CK for trust seed funds ($939,875.00) and Year 1 life care
expenses ($106,646.75): $1,046,521.75.
As soon as practicable after entry of judgment, respondent shall make the following payment to the court-appointed guardian(s)/
conservator(s) of CK for lost future earnings ($882,020.68) and pain and suffering ($250,000.00): $1,132,020.68.
As soon as practicable after entry of judgment, respondent shall make the following payment to petitioners, Maryellen Kottenstette
and Nicholas Kottenstette, as reimbursement for past unreimbursable expenses: $12,698.57.
As soon as practicable after entry of judgment, respondent shall make the following payment jointly to
petitioners and the Commonwealth of Massachusetts, as reimbursement of the Commonwealth's Medicaid lien: $15,528.38.
Annual amounts payable through an annuity for future Compensation Years follow the anniversary of the date of judgment.
Annual amounts shall increase at the rates indicated in column "G.R." above, compounded annually from the date of judgment.
Items denoted with an asterisk (*) covered by health insurance and/or Medicare.
Items denoted with an "M" payable in twelve monthly installments totaling the annual amount indicated.

================================================================================
DOCUMENT 3: USCOURTS-cofc-1_15-vv-01016-4
Date issued/filed: 2020-02-27
Pages: 8
Docket text: **REVERSED PURSUANT TO THE C.A.F.C. MANDATE, DATED AUGUST 6, 2021. ** JUDGE VACCINE UNREPORTED OPINION re-issued for public availability. Signed by Judge Richard A. Hertling. (ah) Service on parties made. Modified on 10/3/2021 to indicate opinion has been reversed. (dls).
--------------------------------------------------------------------------------
Case 1:15-vv-01016-RAH Document 131 Filed 02/27/20 Page 1 of 8
In the United States Court of Federal Claims
No. 15-1016V
Filed Under Seal: February 12, 2020
Reissued: February 27, 2020*
NOT FOR PUBLICATION
MARYELLEN KOTTENSTETTE and
NICHOLAS KOTTENSTETTE as best
friends of their daughter, C.K.,
Petitioners, Keywords: Vaccine Act;
Motion for Review; Off-table;
v. Actual Causation; Legal
Standard
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, Torts Branch, Civil Division, U.S. Department of Justice, Washington,
D.C., for the respondent.
MEMORANDUM OPINION AND ORDER
HERTLING, Judge
The Secretary of Health and Human Services (HHS) moves this court to review the
decision of a special master under the Vaccine Act, 42 U.S.C. § 300aa-11 et seq. See
Kottenstette v. Sec’y of HHS [hereinafter Decision], No. 15-1016V, 2017 WL 6601878 (Fed. Cl.
Spec. Mstr. Dec. 12, 2017). The special master found that a pertussis vaccine administered to
Maryellen and Nicholas Kottenstette’s then-four-month old daughter, C.K., substantially caused
C.K.’s developmental disabilities. The Court grants the Secretary’s motion, vacates the special
master’s decision, and remands the case for reconsideration under the correct legal standard in
* Pursuant to Vaccine Rule 18(b), this opinion was initially filed on February 12, 2020, 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.

Case 1:15-vv-01016-RAH Document 131 Filed 02/27/20 Page 2 of 8
light of the Federal Circuit’s intervening decision in Boatmon v. Secretary of HHS, 941 F.3d
1351 (Fed. Cir. 2019).
I. BACKGROUND
A. Facts Underlying the Petitioners’ Claim
C.K. received the DTaP formulation of the pertussis 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 determined was consistent with infantile spasms, a seizure disorder. 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.” Decision at *3.
The special master found 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.
B. The Special Master’s Decision
The special master found that C.K.’s vaccinations caused C.K.’s “afebrile infantile
spasms and a non-Table chronic encephalopathy” (brain damage).1 Decision at *1.
The special master’s decision, first, summarized the facts of C.K.’s vaccination,
symptoms, and treatment along with the expert reports, medical literature, and testimony
submitted as evidence of causation. The decision then described the Vaccine Act’s preponderant
evidence standard and introduced the standard Althen “prongs” used to analyze actual causation
under that standard. See Moberly v. Sec’y of HHS, 592 F.3d 1315, 1321-22 (Fed. Cir. 2010)
(citing Althen v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005)). Then, without reference
to the specific Althen prongs, the special master articulated the following nine premises related to
proof of vaccine causation:
1. Showing an absence of alternate causes or mere temporal association is insufficient to
prove causation in fact. Decision at *12 (citing Grant v. Sec’y of Dept. of HHS, 956 F.2d
1144, 1149 (Fed. Cir. 1992)).
2. Petitioners must show that C.K.’s vaccinations were “substantial factors in causing,” not
merely a but-for cause, of C.K.’s infantile spasms and “chronic neuropathy.” Decision at
*12 (citing Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999)).
3. “[R]equiring either epidemiologic studies . . . or general acceptance in the scientific or
medical communities to establish a logical sequence of cause and effect” is contrary to
the Federal Circuit’s Althen decision, which approved the use of circumstantial evidence
1 The special master also found that the petitioners had failed to prove a Table
encephalopathy. Decision at *1.
2

Case 1:15-vv-01016-RAH Document 131 Filed 02/27/20 Page 3 of 8
to prove causation. Decision at *12 (citing Capizzano v. Sec’y of HHS, 440 F.3d 1317,
1325 (Fed. Cir. 2006)).
4. The Vaccine Act’s preponderant evidence standard does not require “objective
confirmation” of causation. Decision at *12 (citing Althen, 418 F.3d at 1279).
5. “‘[T]he purpose of the Vaccine Act’s preponderance standard is to allow the finding of
causation in a field bereft of complete and direct proof of how vaccines affect the human
body.’” Decision at *12 (quoting Althen, 418 F.3d at 1280).
6. “[C]lose calls are to be resolved in favor of petitioners.” Decision at *12 (citing
Capizzano, 1440 F.3d at 1327; Althen, 418 F.3d at 1280). As an example, the special
master explained that the Althen decision found a causal link between a vaccine and two
conditions that the Federal Circuit recognized was “‘a sequence hitherto unproven in
medicine.’” Decision at *12 (quoting Althen, 418 F.3d at 1280).
7. An explanation of causation must have “biologic credibility” rather than proof of an exact
causal mechanism. Decision at *12. The special master explained that she looked for a
“medical explanation of cause and effect and medical probability rather than certainty.”
Decision at *12 (citations omitted) (emphasis added). The special master offered her
definition of “medical probability” as “biologic credibility rather than specification of an
exact biologic mechanism.” To support this conclusion, the special master quoted
language from the Federal Circuit’s decision in Knudsen v. Secretary of the Department
of HHS providing that a requirement to identify and prove “specific biological
mechanisms would be inconsistent with the Vaccine Act’s purpose and nature” as an
easier and more generous alternative to “full-blown tort litigation” and not a “‘vehicle for
ascertaining precisely how and why DTP and other vaccines sometimes destroy the
health and lives of certain children while safely immunizing most others.’” Decision at
*12 (quoting Knudsen v. Sec’y of the Dep’t of HHS, 35 F.3d 543, 549 (Fed. Cir. 1994)
(citing H. Rep. No. 99-908, at 3, reprinted in 1986 U.S.C.C.A.N. 6344, 6348)).
8. “Bare statitistical” evidence is not probative of alternate causation. Decision at *13
(citing Knudsen, 35 F.3d at 550).
9. “[W]hen a vaccine fits within an epidemiological study, that alone is sufficient proof of
vaccine causation[.]” Decision at *13. The special master quoted language from
Knudsen to support this proposition:
Causation in fact under the Vaccine Act is thus based on the
circumstances of the particular case, having no hard and fast per se
scientific or medical rules. The determination of causation in fact
under the Vaccine Act involves ascertaining whether a sequence of
cause and effect is “logical” and legally probable, not medically or
scientifically certain. [citing cases] Thus, for example, causation can
be found in vaccine cases based on epidemiological evidence and
the clinical picture regarding the particular child without detailed
3

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medical and scientific exposition on the biological mechanisms.
[citing case].
Decision at *13 (quoting Knudsen, 35 F.3d at 548-49) (alterations in original).
Relying on Knudsen and another special master’s decision, the special master asserted
that “when a [vaccine recipient] would fit within an epidemiological study, that alone is
sufficient proof of vaccine causation.” Decision at *13, 14; see Knudsen, 35 F.3d at 548-49; H.J.
v. Sec’y of HHS, No. 11-301V, 2015 WL 6848357 (Fed. Cl. Spec. Mstr. Nov. 6, 2015). The
special master then concluded, “because CK would have qualified to have been in the Bellman
and Melchior studies, the undersigned finds that her four-month vaccinations triggered the onset
of her cryptogenic seizures.”
The special master concluded her decision with a short paragraph titled “Althen Analysis”
that dedicated one sentence to each prong:
Under Althen Prong One, the undersigned finds that DTaP vaccine
can trigger the onset of infantile spasms. Under Althen Prong Two,
the undersigned finds that there was a logical sequence of cause and
effect in DTaP causing CK’s onset of infantile spasms. Under
Althen Prong Three, the undersigned finds that an onset within hours
of DTaP vaccination is consistent with the effect of the vaccine’s
triggering an abrupt onset.
Decision at *15.
II. STANDARD OF REVIEW
Under the Vaccine Act, this Court reviews a special master’s decision only 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
as 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 evidence. Porter v. Sec’y of HHS, 663 F.3d 1242, 1249 (Fed. Cir. 2011). The Court does not
re-examine the probative value of the evidence or a witness’s credibility. Id.
III. ANALYSIS
The “biologic credibility” standard the special master applied to proof of the petitioners’
causal theory under Althen’s first prong is not sufficiently distinguishable from the “plausible” or
“reasonable” standard that the Federal Circuit rejected in Boatmon. Without reweighing
particular evidence, the Court finds apparent from the special master’s description of the
4

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evidence that the petitioners’ causal theory was only plausibly linked to the DTaP vaccine at
issue, and only plausibly linked to the developmental injury C.K. suffered. This approach, along
with the special master’s alternative approach to proof of causation that fit the petitioners’ case
into an existing study—the study itself only plausibly applicable to the vaccine at issue—
indicates that the wrong standard for proof of causation, clarified by the Federal Circuit after the
special master’s decision under review, was applied in this case.
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.
The first Althen prong steps back from the question of whether the vaccine caused a
petitioner’s injury in the particular case and requires a causal theory that explains how the kind
of vaccine the petitioner received could cause the same kind of injury the petitioner alleged.
After proving the first Althen prong, a petitioner must still prove a logical sequence of events
(the second prong) and a degree of temporal proximity between vaccination and injury (the third
prong) that fit the first prong’s causal theory. The first-prong causal theory, then, influences
which facts are relevant in proving the second and third prongs. Without a general first-prong
causal theory to show the fact-finder what vaccine causation is most likely to look like, the fact-
finder has no criteria to measure the specific facts of a petitioner’s case.
Language in earlier decisions suggested that Althen’s first prong could be satisfied by
showing it was “reasonable” or “plausible” that a vaccine can cause the same kind of injury a
petitioner alleged. The Federal Circuit has now explicitly rejected that proposition in Boatmon.
941 F.3d at 1359-60. More specifically, the first prong’s medical or scientific causal theory must
be “‘reputable.’” Id. at 1359 (quoting Moberly, 592 F.3d at 1322). “While it does not require
medical or scientific certainty, it must still be ‘sound and reliable.’” Id. (quoting Knudsen, 35
F.3d at 548).
The standard of proof required for a first-prong causal theory is the fulcrum of Althen’s
usefulness. If a petitioner could satisfy Althen’s first prong with any causal theory that is merely
plausible—understood here to mean “reasonably possible”—proving the second and third Althen
prongs would only show that the petitioner’s injury was plausibly caused by receipt of the
vaccine. Evidence that the petitioner’s facts under prongs two and three are consistent with a
general causal theory does not make the general causal theory itself more likely to be true.
The special master’s explicit discussion of Althen’s first prong spanned only one
sentence. Decision at *15. This sentence and other relevant parts of the special master’s
discussion, taken together, reveal that the special master adopted the causal theory that
unexplained infantile spasms are not caused by vaccines, but that the DTaP vaccine “can trigger
the onset of infantile spasms,” id., and this earlier onset of the seizure disorder causes more
5

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severe damage to the brain’s psychomotor development than the seizures would have caused at
their natural, later time of onset. Decision at *14. The special master cited the conclusions of
the Bellman and Melchior studies and the opinion of the petitioners’ expert, Dr. Marcel
Kinsbourne, as support for this theory.2
The special master’s stated reasons for adopting critical elements of the petitioners’
causal theory could only have been sufficient under a lower legal standard than the “reputable,
sound and reliable” standard required by Boatmon. First, the special master relied on an expert’s
unsupported assertion that studies of infantile spasms caused by another vaccine applied to the
vaccine at issue in this case. Second, the special master relied on an expert’s opinion that the
overall causal theory, including the ultimate link to developmental disabilities, was—in the
special master’s own words—“plausible.” The special master’s reliance on the fit between the
facts of C.K.’s case and the cited epidemiological studies, however, is not an adequate substitute
for the analysis required under Althen’s three prongs.
A. Causal Link to the DTaP Vaccine
The special master relied on two studies as evidence connecting the pertussis vaccine
with infantile spasms. The Bellman and Melchior studies analyzed infants’ reactions to the DTP
formulation of the pertussis vaccine. The study suggested that DTP could trigger, but not cause,
unexplained infantile spasms in infants who were predisposed to have them. Decision at *13, 14.
The special master, however, offered no basis for connecting the DPT formulation of the
pertussis vaccine tested in the cited studies to the DTaP formulation of the pertussis vaccine at
issue in this case. The special master asked Dr. Kinsbourne “if he agreed that the results of the
Bellman . . . study . . . [were] applicable to children who receive [DTaP], just at a lower
incidence.” Decision at *9. The special master reported that Dr. Kinsbourne “absolutely
agreed.” Id.
The special master did not explain the basis of Dr. Kinsbourne’s opinion and did not offer
an independent basis for applying the DPT-study findings to the DTaP vaccine. Without any
explanation for the special master’s acceptance of this conclusion, the Court finds the special
master’s inference that the DPT study applies to the DTaP formulation at lower rates to be
arbitrary and capricious. See Boatmon, 941 F.3d 1360-61 (“Here there is nothing more than the
assertion of [the expert witness].”).
B. Causal Link to Developmental Injuries
The special master summarized Dr. Kinsbourne’s testimony on the connection between
the DTaP vaccine and developmental injuries. This summary implicitly addressed all three
2 See M.H. Bellman et al., Infantile Spasms and Pertussis Immunisation, 321 Lancet 1031-34
(1983); J.C. Melchior, Infantile Spasms and Early Immunization Against Whooping Cough:
Danish Survey from 1970 to 1975, 52 Archives of Disease in Childhood 134-37 (1977).
6

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Althen prongs, describing a causal link between C.K.’s disabilities and the infantile spasms,
discussing the temporal proximity, and explicitly finding the causal link “plausible”:
. . . CK has severe and mainly refractory seizures that degraded her
mental development so that she is now profoundly mentally
retarded.
Dr. Kinsbourne concludes that, but for her vaccinations,
CK’s cryptogenic infantile spasms would not have led to such a
devastating result. He also writes that the one-day interval between
vaccinations and first infantile spasms is medically reasonable since
her innate immune system rapidly responded to the vaccinations.
He also states that it is plausible that routine vaccinations can trigger
infantile spasms in a susceptible child, resulting in severe
psychomotor regression.
Decision at *5-6 (citations omitted) (emphasis added).
The special master’s characterization of Dr. Kinsbourne’s conclusion is indistinguishable
from the reasoning rejected as contrary to law in Boatmon. See Boatmon, 941 F.3d at 1359-60.
C. Proof by Epidemiological Evidence
In general, the special master’s nine premises, including the premise that articulation of
an exact biological mechanism is not necessary to prove vaccine causation, are well-taken. The
special master’s articulation of these premises, however, suggests they were offered as
alternative support for the petitioners’ causal theory, which, as discussed above, was plausible or
reasonable, but insufficient to satisfy Althen’s first prong. The special master appears to have
relied on these nine premises to put a thumb on the scale, without explicitly analyzing under
Althen’s first prong the applicability of the petitioners’ causal theory to the vaccine and the kind
of injury at issue.
Specifically, the special master noted that the close match between the immediate onset
of C.K.’s infantile spasms and the similarly immediate onset of infantile spasms among subjects
in the Bellman study were dispositive as to the issue of causation in this case. The special master
interpreted the Federal Circuit’s opinion in Knudsen to signify that causation could be found
“based on epidemiological evidence and the clinical picture regarding the particular child
without detailed medical and scientific exposition on the biological mechanisms.” Decision at
*14. The special master provided that this principle “governs the outcome of this decision.” Id.
As support, the special master cited similar reasoning in H.J. v. Sec’y of HHS, No. 11-301V,
2015 WL 6848357, at *9 (Fed. Cl. Nov. 6, 2015).
Knudsen held that the government may defeat a petitioner’s claim of vaccine causation
with a theory of viral infection even if the virus is not identified “in the particular case” by a
specific type or name. Knudsen, 35 F.3d at 549. The government still must prove, however,
“that there was in fact a viral infection, and that the viral infection ‘in the particular case [was]
7

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. . . principally responsible for causing the petitioner’s illness, disability, injury, condition, or
death.’” Id. (quoting 42 U.S.C. § 300aa–13(a)(2) (emphasis in original)).
Open-ended statements in Knudsen’s reasoning rejecting the need for “scientific
certainty” or “specific biological mechanisms” in proof of vaccine causation should not be
applied beyond that case’s narrow holding and should not be taken to loosen the requirements of
Althen, which was decided almost 11 years later. Althen cites the relevant part of Knudsen as
indirect support (“see”) for Althen’s conclusion that requiring that literature objectively confirm
the medical plausibility of a petitioner’s claim would be inconsistent with the Vaccine Act’s
legislative purpose. Althen, 418 F.3d at 1279 (citing Knudsen, 35 F.3d at 549).
As an example of causation based on fitting the petitioner’s case to an epidemiological
study, Knudsen cites Jay v. Secretary of the Department of HHS. 998 F.2d 979, 984 (Fed. Cir.
1993). In Jay, however, the Federal Circuit found a table injury, and then it found that the
vaccine caused death as a sequela of the table injury. Id. For table injuries, the mechanism may
not be known or the theory may be more uncertain, but their formal recognition by rulemaking
places them outside of the Vaccine Act’s standard of proof for actual causation for non-table
injuries. See Moberly, 592 F.3d at 1322.
In summary, the court finds no support in Federal Circuit or this Court’s case law for
proving actual causation by fitting a petitioner’s case into an epidemiological study without also
providing a “reputable,” “sound and reliable” causal theory to satisfy Althen’s first prong.
IV. CONCLUSION
The special master erred by applying the wrong legal standard to the petitioners’ causal
theory. The respondent’s motion for review is GRANTED, the special master’s decision is
VACATED, and the case is REMANDED so that the special master may consider the
petitioners’ theory and evidence under the correct legal standard.
It is so ORDERED.
s/ Richard A. Hertling
Richard A. Hertling
Judge
8

================================================================================
DOCUMENT 4: USCOURTS-cofc-1_15-vv-01016-7
Date issued/filed: 2020-08-11
Pages: 15
Docket text: **REVERSED PURSUANT TO THE C.A.F.C. MANDATE, DATED AUGUST 6, 2021. ** JUDGE VACCINE UNREPORTED OPINION and ORDER denying 140 Motion for Review. Signed by Judge Richard A. Hertling. (ah) Service on parties made. Modified on 10/3/2021 to indicate decision has been reversed. (dls).
--------------------------------------------------------------------------------
Case 1:15-vv-01016-RAH Document 146 Filed 08/11/20 Page 1 of 15
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.

Case 1:15-vv-01016-RAH Document 146 Filed 08/11/20 Page 2 of 15
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

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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

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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

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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).
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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).
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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
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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.
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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.
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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.
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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
15