VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_09-vv-00489
Package ID: USCOURTS-cofc-1_09-vv-00489
Petitioner: E.R.
Filed: 2009-07-27
Decided: 2016-05-31
Vaccine: DTaP
Vaccination date: 2007-06-21
Condition: infantile spasms
Outcome: compensated
Award amount USD: 1400787

AI-assisted case summary:
On July 27, 2009, Dulce and Sean Reilly, parents and natural guardians of E.R., filed a petition under the National Vaccine Injury Compensation Program. They alleged that E.R. suffered from infantile spasms, a seizure disorder, allegedly caused by his DTaP vaccination administered on June 21, 2007. E.R. was born on December 15, 2006. His parents observed seizure activity beginning the evening of June 21, 2007, described as stiffening, tenseness, unresponsiveness, with facial redness and eyes rolling back. The episodes were likened to a "touchdown." E.R. received his third dose of DTaP (as part of Pediarix), Prevnar, and Haemophilus influenzae type b vaccine on June 21, 2007. His pediatrician noted contemporaneous concerns about a vaccine reaction, specifically identifying the pertussis component as the likely culprit for neurologic events after immunizations. An EEG on June 28, 2007, confirmed hypsarrhythmia, and E.R. was started on ACTH. A neurologist, Dr. Duffy, evaluated E.R. on July 10, 2007, noting that the sudden onset of infantile spasms was unusual unless triggered by an immunization. In July 2010, an MRI revealed focal cortical dysplasia (FCD) in the anterior right temporal lobe, an abnormality with inherent epileptogenic potential. E.R. underwent surgery for this FCD in October 2010, but his seizures continued, though his parents noted improvements in social engagement. Petitioners' expert, Dr. Marcel Kinsbourne, proposed a "second hit" theory: the FCD was the first hit (a pre-existing vulnerability), and the acellular pertussis component of the DTaP vaccine was the second hit, triggering clinical epilepsy by lowering the seizure threshold through the release of pro-inflammatory cytokines like interleukin-1 beta. Special Master Janet Hamilton-Fieldman issued a Ruling on Entitlement on May 31, 2016, finding that Petitioners met the three prongs of the Althen test. She concluded that Dr. Kinsbourne's theory was medically plausible, that the sequence of events and medical observations supported causation, and that the temporal proximity was met. Special Master Herbrina Sanders issued a Decision Awarding Damages on November 6, 2017. E.R. was awarded a lump sum of $1,268,787.00 for lost earnings, pain and suffering, and Year One life care expenses, plus $130,000.00 for past unreimbursable expenses, and an amount for a life-contingent annuity for future life care. The total award was $1,398,787.00 plus the annuity. Petitioners' counsel was Edward M. Kraus. Respondent's counsel was Ryan D. Pyles.

Theory of causation field:
On June 21, 2007, E.R., approximately six months old, received the DTaP (Pediarix), Prevnar, and Hib vaccines. That evening, he experienced seizure activity. Petitioners alleged that the DTaP vaccine caused infantile spasms. Special Master Hamilton-Fieldman found entitlement based on a "second hit" theory proposed by Petitioner's expert, Dr. Marcel Kinsbourne. This theory posited that E.R. had a pre-existing focal cortical dysplasia (FCD), identified in July 2010, which represented the first hit, creating an inherent epileptogenic potential. The acellular pertussis component of the DTaP vaccine acted as the second hit, triggering clinical epilepsy by causing the release of pro-inflammatory cytokines, such as IL-1 beta, which lowered the seizure threshold. This theory satisfied the Althen prongs: (1) medical plausibility of the second hit theory connecting FCD and vaccine-induced cytokine release; (2) logical sequence of cause and effect supported by contemporaneous pediatrician notes, Dr. Duffy's observations, and the confirmed FCD; and (3) proximate temporal relationship with seizure onset on the evening of vaccination. Respondent's expert, Dr. Mary Anne Guggenheim, argued against the second hit theory, stating that FCD itself is often the cause of infantile spasms and that there was no evidence linking vaccines to infantile spasms. Special Master Hamilton-Fieldman ruled that while FCDs have inherent epilepsy potential, evidence showed not all FCDs lead to epilepsy, suggesting a trigger is sometimes necessary. She found the pertussis vaccine could act as this trigger. Damages were awarded by Special Master Sanders on November 6, 2017, totaling $1,398,787.00 plus a life-contingent annuity. Petitioners' counsel was Edward M. Kraus; Respondent's counsel was Ryan D. Pyles.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_09-vv-00489-0
Date issued/filed: 2016-06-21
Pages: 22
Docket text: PUBLIC ORDER/RULING (Originally filed: 5/31/2016) regarding 107 Ruling on Entitlement. Signed by Special Master Lisa Hamilton-Fieldman. (mb) Copy to parties.
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Case 1:09-vv-00489-UNJ Document 110 Filed 06/21/16 Page 1 of 22
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 09-489V
Filed: May 31, 2016
* * * * * * * * * * * * * * * * * * * * * * * * *
DULCE and SEAN REILLY, parents and * TO BE PUBLISHED
natural guardians of E.R., a minor, *
* Special Master
Petitioners, * Hamilton-Fieldman
*
v. * Vaccine Act Entitlement;
* Causation-in-Fact; Diphteria-
SECRETARY OF HEALTH AND * Tetanus-Acellular-Pertussis
HUMAN SERVICES * (“DTaP”) Vaccine; Infantile
* Spasms; Two-Hit Theory
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Edward M. Kraus, Law Offices of Chicago Kent, Chicago, IL, for Petitioners.
Ryan D. Pyles, United States Department of Justice, Washington, DC, for Respondent.
RULING ON ENTITLEMENT
This is an action in which the Petitioners, Dulce and Sean Reilly,1 seek an award under
the National Vaccine Injury Compensation Program (hereinafter “the Program”),2 on behalf of
their minor son, E.R., who suffered from “encephalopathy and intractable seizures”3 allegedly
caused-in-fact by his receipt of the Diphtheria-Tetanus-Pertussis (“DTaP” or “DPT”)
1 The Petition was filed naming only Dulce Reilly as Petitioner. The caption was amended on
May 14, 2013, to reflect that both of E.R.’s parents are Petitioners. Order (May 14, 2013), ECF
No. 73. For ease of reference, they are referred to as Petitioners throughout this decision.
2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2012) (hereinafter “the
Act”).
3 These were the injuries originally alleged in the Petition. In their pre- and post-hearing
briefing, Petitioners allege that E.R.’s injury is a “seizure disorder.”
1

Case 1:09-vv-00489-UNJ Document 110 Filed 06/21/16 Page 2 of 22
vaccination,4 which was administered on June 21, 2007. Pet. at 1, ECF No. 1. For the reasons
set forth below, the undersigned concludes that Petitioners have met their burden of proof under
the Act and Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005), and are therefore entitled to
a Program award.
I. FACTUAL BACKGROUND
E.R. was born on December 15, 2006. Pet’rs’ Ex. 3 at 1.5 E.R.’s mother had been
admitted to the hospital at 37 and 1/7 weeks’ gestation “for induction due to worsening
ulcerative colitis.” Pet’rs’ Ex. 2 at 6. Her pregnancy had “been complicated by A2 gestational
diabetes mellitus,” and “she also had a history of malignant hyperhermia.”6 Id. Delivery,
however, was “uncomplicated.” Id. E.R. received a Hepatitis B vaccination at the hospital and
was discharged after two days. Id. E.R. received pediatric care at Cape Fear Pediatrics. See
generally Pet’rs’ Ex. 4.
On February 15, 2007, E.R. was diagnosed with an acute upper respiratory infection. Id.
at 81. He received the DTaP (as a component of the Pediarix) and pneumococcal conjugate
(“Prevnar”) vaccines at this appointment. Id. at 81, 95. E.R. had well-child examinations on
February 28 and March 20, 2007. Id. at 80. During these examinations, E.R. was diagnosed
with “[a]cute suppurative otitis media,” “vomiting,” and a “viral syndrome.” Id. On April 16,
4 The DTaP vaccination administered on June 21, 2007 was a component of the Pediarix
vaccination which was administered to E.R. as part of his routine childhood vaccinations. See
Pet’rs’ Ex. 3 at 81, 95. Pediarix is a vaccine “indicated for active immunization against
diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and
poliomyelitis.” Pediarix: Product Overview, gsksource, https://www.gsksource.com/pediarix
(last visited May 30, 2016). Pediarix is a combination vaccine, containing diphtheria, tetanus
toxoids, acellular pertussis, hepatitis B (recombinant), and inactivated poliovirus. Pediarix,
Dorland’s Illustrated Med. Dictionary (32nd ed. 2012) (hereinafter “Dorland’s”). Pediarix “is
approved for “use as a three-dose series in infants born of hepatitis B surface antigen (HBsAg)-
negative mothers.” Pediarix: Dosing and Administration, gsksource,
https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/pediarix/pi/dosing.html
(last visited May 30, 2016).
5 Where no citation to the electronic docket is provided, the relevant filing was only made
available via hard copy or compact disc.
6 Malignant hypothermia is “a disease that causes a fast rise in body temperature and severe
muscle contractions when someone with the disease gets general anesthesia. It is passed down
through families.” Malignant Hyperthermia, MedlinePlus,
www.nlm.nih.gov/medlineplus/ency/article/001315.htm (last visited May 31, 2016).
2

Case 1:09-vv-00489-UNJ Document 110 Filed 06/21/16 Page 3 of 22
2007, E.R. received one dose each of the rotavirus tetravalent and haemophilus influenza B
vaccines, and second doses of the Pediarix and Prevnar vaccines. Id. at 79-80. During this April
examination, E.R. was also diagnosed with esophageal reflux. Id. at 79. Thereafter, E.R. was
seen on May 2 for an upper respiratory illness and was prescribed Zantac for gastroesophageal
reflux disease. Id. at 79, 84.
E.R. next had a well-child visit on June 21, 2007. Id. at 76. E.R.’s mother reported that
E.R. had not been “eating well,” was “pulling at [his] ears,” and was “more fussy than usual.”
Id. at 77. It was noted that prior to this visit, E.R. had been “very upset” and “irritable” and had
“a mild fever.” Pet’rs’ Ex. 3 at 107. E.R. received third doses of the Pediarix and Prevnar
vaccines, and a second dose of the haemophilus influenza B vaccine. Pet’rs’ Ex. 15 at 2.
On June 22, 2007, Petitioners took E.R. to the doctor due to seizure activity that began
the previous night. Pet’rs’ Ex. 4 at 73. E.R. was noted to have seizure activity at 7:30 PM, 12:30
AM, and again at 7:30 AM. Id. The child’s seizure activity was described as “stiff and tense,
[and] unresponsive,” during which time his “face turned red” and his “eyes rolled into [the] back
of [his] head.” Id. The episodes of posturing that E.R. experienced looked “‘like he had done a
touchdown.’” Id. All episodes occurred within 30-45 minutes of consuming Tylenol, although
he had taken Tylenol in the past without incident. Id. The notes from this visit also document a
“[f]amily history of febrile seizures and malignant hyperthermia,” but “no epilepsy history.” Id.
The assessment from this visit was “neuroleptic-induced acute dystonia,”7 and the plan going
forward was to switch E.R. from Tylenol to Motrin and observe him for further activity. Id. at
75. The visit notes further indicated that if E.R.’s seizure activity persisted or worsened, the
doctor would start a seizure evaluation for a 6 month old; if the same, the doctor would wait “72
hours under the supposition that this [wa]s a vaccine reaction, which w[ould] be reported to the
registry and cataloged as a relative contraindication to further immunization with pertussis
component, the most likely culprit in neurologic events after 6 month immunizations.” Id. at 75-
76.
E.R. returned to the pediatrician on June 24, 2007, with a chief complaint of seizures. Id.
at 71. The doctor provided the following assessment: “Neuroleptic-induced acute dystonia ? rare
neurologic SE from DTAP vs pain response secondary to teething or early viral illness.” Id. at
72. A neurology consultation was also scheduled on this day. Id.
E.R. returned to the pediatrician twice more, on June 25 and 28, 2007, for his “reaction to
shots” and “post immunization” seizures, respectively. Id. at 64, 68. On the former date,
Petitioners were given a medication instruction plan and told to treat the reflux with Zantac. Id.
7 Dystonia is “dyskinetic movements due to disordered tonicity of muscle.” Dystonia,
Dorland’s.
3

Case 1:09-vv-00489-UNJ Document 110 Filed 06/21/16 Page 4 of 22
at 70. On the latter, Petitioners were told that E.R. had “gastroesophageal reflux.” Id. at 67. Dr.
Hill noted the possibility of “Sandifer’s syndrome.”8 Id.
E.R. “was admitted to the hospital by Dr. Pollock [on June 28, 2007], after an EEG[9]
performed by Dr. Bachman confirmed a diagnosis of hypsarrhythmia.”10 Pet’rs’ Ex. 3 at 104.
The diagnosis was “seizure disorder,” and “infantile spasms.” Id. E.R. was begun on ACTH.11
Id. By “the end of his hospitalization,” E.R. “seemed to be showing some early signs of
response with the ACTH.” Id. E.R. was discharged by Dr. Edwards on June 30, 2007 “to follow
up with Cape Fear Pediatrics.” Id.
On July 10, 2007, Dr. Duffy, a neurologist at Boston Children’s Hospital, evaluated E.R.
Pet’rs’ Ex. 7 at 1. An EEG was conducted “on an urgent basis.” Id. Dr. Duffy’s impression of
the EEG found it “suggestive of an underlying problem that is asymmetrical and by default []
may have represented an encephalopathic response to the immunizations.” Id. E.R. was seen
again by Dr. Duffy on July 19, 2007. Id. at 9. Dr. Duffy noted that the previous visit’s EEG
noted no presence of infantile spasms. Id. Dr. Duffy observed some improvement, as E.R. was
not as irritable as before. Id.
Beginning on August 9, 2007, E.R. was evaluated by another neurologist, Dr. Weig.
Pet’rs’ Ex. 8 at 16-17. Dr. Weig noted, “the etiology of [E.R.’s] infantile spasms is not clear at
this point. It certainly appears to be ‘vaccine related’ at least in a temporal sense, if not in a
pathophysiologic one.” Id. at 21. Dr. Weig indicated that a prognosis for E.R. was not definite,
but that he “certainly is at high risk for ongoing developmental disabilities and seizures.” Id.
8 Sandifer’s syndrome “involves spasmodic torsional dystonia with arching of the back and rigid
opisthotonic posturing, mainly involving the neck, back, and upper extremities, associated with
symptomatic gastroesophageal reflux, esophagitis, or the presence of hiatal hernia.” Pegeen
Eslami, Sandifer Syndrome: Overview, Medscape (Nov. 11, 2015),
http://emedicine.medscape.com/article/931761-overview.
9 An EEG, or electroencephalogram, records “the potentials on the skull generated by currents
emanating spontaneously from nerve cells in the brain.” Electroencephalogram, Dorland’s.
10 Hypsarrhythmia is “an electro-encephalographic abnormality sometimes observed in infants,
with random, high-voltage slow waves and spikes that arise from multiple foci and spread to all
cortical areas.” Hypsarrhythmia, Dorland’s.
11 ACTH refers to the adrenocorticotropic hormone. ACTH, Dorland’s. The
adrenocorticotropic hormone, also known as the adrenocorticotrophic or corticotrophic hormone,
is one that has “a stimulating effect on the adrenal cortex.” Adrenocorticotropic, Dorland’s.
4

Case 1:09-vv-00489-UNJ Document 110 Filed 06/21/16 Page 5 of 22
In January of 2008, E.R. began a ketogenic diet. Pet’rs’ Ex. 9 at 83. An MRI of E.R.’s
brain in February was normal, but his EEGs remained abnormal. Id. at 87-88, 90. In April, a
treating physician, Dr. Thiele, observed that since starting the diet and his anticonvulsant
medications, E.R.’s seizure control thereafter “improved dramatically.” Id. at 84.
That being said, on July 16, 2010, physicians noted that an MRI showed “abnormal
thickening of the cortex and loss of gray-white differentiation in the anterior right temporal lobe,
involving the amygdala, parahippocampal gyrus, and inferior temporal gyrus.” Pet’rs’ Ex. 27 at
366. This, they explained, was “consistent” with a focal cortical dysplasia (“FCD”).12 Pet’rs’
Ex. 27 at 366.
E.R. was hospitalized from October 13-18, 2010, for surgical removal of the FCD with a
right temporal craniotomy and temporal lobectomy. Pet’rs’ Ex. 35 at 1, 101; see Kabat & Król at
41 (explaining surgical treatment of FCD). Because the surgery was primarily performed using
cauterization, little tissue was available for pathological examination. Tr. at 281-83, ECF No.
84.13 Despite the surgery, E.R. continued to have seizures; but Petitioners reported progress in
social engagement, feeding, and eating. Pet’rs’ Ex. 36 at 3.
II. PROCEDURAL BACKGROUND
The petition was filed in this case on July 27, 2009, alleging that the DTaP vaccination
caused E.R. to suffer encephalopathy and intractable seizures. Pet. at 1. The petition included a
Motion for a Ruling on the Record pursuant to Rule 8 of the Vaccine Rules of the United States
Court of Federal Claims, which governs summary judgment. Id. at 20-30. The case was
originally assigned to Special Master Abell. See Notice of Assignment, ECF No. 2. Petitioners’
counsel of record was Ronald Homer, Esq. Pet. at 30.
Respondent’s Rule 4(c) Report was filed on October 26, 2009. Resp’t’s Report, ECF No.
7. In the report, Respondent asserted that Petitioners had failed to provide sufficient evidence
regarding causation and requested that the case be dismissed. Id. at 8-9.
On November 9, 2009, a Rule 5 status conference was scheduled for January 19, 2010, to
address Respondent’s Rule 4(c) Report and Petitioners’ Motion for a Ruling on the Record,
which was construed as a partial motion for summary judgment. Rule 5 Order at 1-2, ECF No.
8. The special master ordered Petitioners to file an expert report, a curriculum vitae (“CV”) of
12 FCD is an umbrella term, forming “a very heterogenous group of cortical lesions.” Joanna
Kabat & Przemyslaw Król, Focal cortical dysplasia – review, 77 Polish J. Radiology 35, 36
(2012) (hereinafter “Kabat & Król”).
13 Unless specified otherwise, “Tr.” refers to the transcript of the June 18, 2013 proceedings.
5

Case 1:09-vv-00489-UNJ Document 110 Filed 06/21/16 Page 6 of 22
the opining expert, and any articles of medical literature relied upon in forming the expert
opinion. Id. at 1.
On December 1, 2009, Petitioners filed a Renewed Motion for Partial Summary
Judgment, alleging that the affidavit from E.R.’s mother, “the medical records, and the opinions
of [E.R]’s treating physicians contained in those records, demonstrate by preponderant evidence
that the DTaP vaccine, not something else, caused his injury.” Notice (Dec. 1, 2009) at 6, ECF
No. 9. Respondent thereafter filed a “Response to Renewed Motion for Partial Summary
Judgment,” see Resp. to Notice at 1, ECF No. 11, and a study from the Institute of Medicine
(“IOM”), see Resp’t’s Ex. A, ECF No. 10-1 (excerpt from Comm. to Review the Adverse
Consequences of Pertussis & Rubella Vaccines, Div. of Health Promotion & Disease Prevention,
Inst. of Med., Adverse Effects of Pertussis and Rubella Vaccines (Christopher P. Howson et al.
eds., 1991)). Respondent contended that “[P]etitioner[s] ha[d] not proven, nor does the current
record establish, that the vaccinations at issue in this case can cause infantile spasms.” Resp. to
Notice at 2. Respondent quoted the aforementioned study, which concluded, “[t]he evidence
does not indicate a causal relationship between DPT vaccine or the pertussis component of DPT
and infantile spasms.” Id. at 2-3 (internal quotation marks omitted). Respondent also asserted
that Petitioners had “not proven in a case-specific manner that the DTaP vaccine did cause
[E.R.’s] condition.” Id. at 3.
On March 8, 2010, Petitioner filed a medical expert report from Paul Maertens, M.D.,
with supporting medical literature and his CV. Pet’rs’ Exs. 18 and 19, ECF Nos. 15-1 to -10.
On March 30, 2010, pursuant to Vaccine Rule 3(c), the case was reassigned to Special
Master Campbell-Smith. Order Reassigning Case, ECF No. 17. On May 21, 2010, Respondent
submitted the expert report of Dr. Mary Anne Guggenheim, M.D., seven articles that Dr.
Guggenheim relied upon in formulating her opinion, and Dr. Guggenheim’s CV. Resp’t’s Exs.
B and C, ECF Nos. 18-1 to -9.
On June 24, 2010, the parties appeared before Special Master Campbell-Smith for a
status conference. Order (June 24, 2010) at 1, ECF No. 22. During that status conference, an
evidentiary hearing was scheduled for November 3, 2010, in Boston, Massachusetts. Id. at 2.
On October 6, 2010, Respondent apprised the Court that E.R.’s “most recent MRI from
June 16, 2010, showed, inter alia, ‘[a]bnormal cortical thickening . . . consistent with [FCD]’
that was not evident on previous MRI’s [sic].” Notice of Filing (Oct. 6, 2010) at 1, ECF No. 31
(quoting Pet’rs’ Ex. 27 at 365). Respondent indicated that “[c]ortical dysplasia is a
developmental malformation” and a “cause of infantile spasms.” Id.
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A status conference was held on October 28, 2010, at the request of the parties.
Scheduling Order (Oct. 29, 2010) at 1, ECF No. 36. During the status conference, “Petitioner[s’]
counsel noted that [E.R.] had recently undergone surgery for cortical dysplasia.” Id. “In light of
this recent hospitalization which suggests that a congenital causal factor might have been at play
in the development of [E.R.]’s epilepsy,” Petitioners’ counsel argued, “it would be prudent to
postpone the upcoming expert hearing.” Id. Respondent’s counsel agreed, and the entitlement
hearing scheduled for November was canceled. Id.
A status conference was held on December 13, 2010, and the parties discussed the need
for supplemental briefing following E.R.’s recent surgery for cortical dysplasia. Scheduling
Order (Dec. 15, 2010) at 1, ECF No. 39. The parties were instructed to file supplemental reports
from their experts, as informed by E.R.’s recent hospitalization, and deadlines were set. Id.
On July 28, 2011, Petitioners indicated that the case was receiving review by alternative
counsel. Pet’rs’ Mot. for Extension of Time (July 28, 2011) at 1, ECF No. 45. On August 25,
2011, Petitioners moved to substitute Anne C. Toale as the primary attorney for Petitioners.
Mot. to Substitute Attorney, ECF No. 46. Petitioners’ motion was granted. Unnumbered Order
dated Aug. 25, 2011.
Petitioners did not ultimately file a supplemental report from Dr. Maertens. Instead, they
filed the expert report and CV of Dr. Marcel Kinsbourne, M.D., on April 16, 2012. Pet’rs’ Exs.
39-40, ECF Nos. 53-1 to -2. On September 25, 2012, Respondent filed the supplemental expert
report of Dr. Guggenheim and the medical literature on which Dr. Guggenheim relied. Resp’t’s
Ex. G, Tabs 1 to 5, ECF Nos. 62-1 to -6.
The parties conducted a status conference on October 17, 2012. Scheduling Order (Oct.
23, 2012) at 1, ECF No. 64. During the status conference, the parties agreed that an entitlement
hearing would be held on June 18, 2013 in Washington, DC. Id. at 2.
Petitioners thereafter filed the supplemental expert report of Dr. Kinsbourne and all
exhibits that Dr. Kinsbourne relied upon in this report. Pet’rs’ Exs. 61-70, ECF Nos. 66-1 to -10.
On March 4, 2013, pursuant to Vaccine Rule 3(d), this case was reassigned to the
undersigned. Order Reassigning Case, ECF No. 67. On March 22, 2013, Respondent filed the
second supplemental expert report of Dr. Guggenheim and the medical literature that Dr.
Guggenheim relied on in that report. Resp’t’s Ex. H, Tabs 1 to 7, ECF Nos. 68-1 to -8.
The parties filed pre-hearing memoranda on May 14 and 23, 2013, respectively. Pet’rs’
Prehearing Submissions, ECF No. 75; Resp’t’s Prehearing Submissions, ECF No. 77. On June
7

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4, 2013, Petitioners’ counsel filed an affidavit identifying the reason for Dr. Maertens’
withdrawal from this case.14 Pet’rs’ Ex. 80 at 4, ECF No. 79-1.
The entitlement hearing began on June 18, 2013. See generally Tr. On June 19, 2013,
the undersigned postponed the remainder of the hearing because of a previously undisclosed
potential conflict involving one of the attorneys. See Order (Aug. 14, 2013) at 5-7, ECF No. 85.
On October 31, 2013, Petitioners’ counsel moved to substitute attorney Edward Kraus in place of
Anne Toale. Mot. to Substitute Attorney, ECF No. 95. The undersigned granted this request on
November 6, 2013. Order (Nov. 6, 2013), ECF No. 97. The entitlement hearing was concluded
on June 12, 2014, with Edward Kraus representing Petitioners, and Ryan Pyles representing
Respondent. See Minute Entry dated June 12, 2014. Post-hearing briefing was completed
October 3, 2014. See Pet’rs’ Post Hr’g Br., ECF No. 104; Resp’t’s Post Hr’g Br., ECF No. 106.
III. LEGAL STANDARD
To receive compensation under the Program, Petitioners must prove either (1) that E.R.
suffered a “Table Injury,” i.e., an injury falling within the Vaccine Injury Table,15 corresponding
to one of his vaccinations, or (2) that E.R. suffered an injury that was actually caused by a
vaccine. See 42 U.S.C. §§ 300aa-11(c)(1), 13(a)(1)(A) (2012). Petitioners must show that the
vaccine was “not only a but-for cause of the injury but also a substantial factor in bringing about
the injury.” Moberly v. Sec’y of HHS, 592 F.3d 1315, 1321-22 (Fed. Cir. 2010) (internal
quotation marks omitted).
Because Petitioners do not allege a Table injury in this case, they must prove that E.R.’s
injury was caused-in-fact by a covered vaccine. To do so, Petitioners must satisfy all prongs of
the test established by the Federal Circuit in Althen. The Althen test requires Petitioners to set
forth: “ (1) a medical theory causally connecting the vaccination and the injury [(“Althen Prong
One”)]; (2) a logical sequence of cause and effect showing that the vaccination was the reason
for the injury [(“Althen Prong Two”)]; and (3) a showing of a proximate temporal relationship
between vaccination and injury [(“Althen Prong Three”)].” 418 F.3d at 1278. To establish
14 Petitioners did not cite Dr. Maertens’ report at hearing or in their pleadings, and the report was
drafted before the existence of the FCD was known, which changed Petitioners’ theory of the
case. The undersigned did not rely on Dr. Maertens’ report.
15 The Vaccine Injury Table “lists the vaccines covered under the Act; describes each vaccine's
compensable, adverse side effects; and indicates how soon after vaccination those side effects
should first manifest themselves.” Bruesewitz v. Wyeth, LLC, 562 U.S. 223, 228 (2011).
“Claimants who show that a listed injury first manifested itself at the appropriate time are prima
facie entitled to compensation.” Id.
8

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entitlement to compensation under the Program, Petitioners must establish each of the three
prongs of Althen by a preponderance of the evidence. Id.
The preponderance of the evidence standard has been interpreted to mean that Petitioners
must show that the fact to be proven is more likely than not. Moberly, 592 F.3d at 1322 n. 2.
Proof of medical certainty is not required. Bunting v. Sec’y of HHS, 931 F.2d 867, 873 (Fed. Cir.
1991). “[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.”
Althen, 418 F.3d at 1280.
In determining whether Petitioners are entitled to compensation, the undersigned will
consider all relevant material contained in the record. 42 U.S.C. § 300aa-13(b)(1). That material
can include circumstantial evidence. Capizzano v. Sec’y of HHS, 440 F.3d 1317, 1325 (Fed. Cir.
2006). As the finder of fact, the undersigned is “entitled--indeed, expected--to make
determinations as to the reliability of the evidence presented . . . and, if appropriate, as to the
credibility of the persons presenting that evidence.” Moberly, 592 F.3d at 1326.
The Vaccine Act was created to award compensation to vaccine-injured persons “quickly,
easily, and with certainty and generosity.” Graves v. Sec’y of HHS, 109 Fed. Cl. 579, 595 (2013)
(internal quotation marks omitted). Therefore, “close calls regarding causation are resolved in
favor of injured” petitioners. Althen, 418 F.3d at 1280.
To satisfy the first prong of the Althen test, Petitioners must provide “a medical theory
causally connecting the vaccination and the injury.” Althen, 418 F.3d at 1278 (internal quotation
marks omitted). Petitioners’ theory must show that it is more likely than not that the vaccine
E.R. received “can” cause the type of injury Petitioners allege the vaccine caused. Pafford v.
Sec’y of HHS, 451 F.3d 1352, 1356 (Fed. Cir. 2006) (internal quotation marks omitted).
The medical theory set forth by Petitioners need only be “legally probable, not medically
or scientifically certain.” Knudsen v. Sec’y of HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994). When
a petitioner proffers a medical opinion is proffered to support the theory alleged, the basis for the
opinion and the reliability of that basis must be considered in determining how much weight to
afford the offered opinion. Broekelschen v. Sec’y of HHS, 618 F.3d 1339, 1347 (Fed. Cir. 2010).
To satisfy the second prong of the Althen test, Petitioners must establish “’a logical
sequence of cause and effect showing that the vaccination was the reason for the injury.’”
Althen, 418 F.3d at 1278. That is, Petitioners must show, by preponderant evidence, that the
vaccination E.R. received did cause the injuries Petitioners allege that it caused. Capizzano v.
Sec’y of HHS, 440 F.3d 1317, 1326 (Fed. Cir. 2006). Petitioners may satisfy their burden by
presenting circumstantial evidence and reliable medical opinions from treating physicians as well
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as experts; they not required to offer “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.” Id. at 1325-26. Ultimately, the
“logical sequence of cause and effect must be informed by sound and reliable medical or
scientific explanation.” Knudsen, 35 F.3d at 548 (internal quotation marks omitted).
To satisfy the third prong of Althen, Petitioners must produce preponderant evidence of
“a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278.
This prong helps to establish the connection between the causal theory of Prong One and the
more fact-based cause and effect arguments of Prong Two by demonstrating “that the onset of
symptoms occurred within a timeframe for which, given the medical understanding of the
disorder’s etiology, it is medically acceptable to infer causation-in-fact.” De Bazan v. Sec’y of
HHS, 539 F.3d 1347, 1352 (Fed. Cir. 2008).
If Petitioners satisfy all three prongs of Althen by a preponderance of the evidence, they
establish a prima facie case. Walther v. Sec’y of HHS, 485 F.3d 1146, 1149 (Fed. Cir. 2007).
After Petitioners have established a prima facie case, the burden shifts to Respondent to
demonstrate, also by a preponderance of the evidence, that the injury was actually caused by
factors unrelated to the administration of the vaccine. Walther, 485 F.3d at 1151. Accordingly,
“[i]f the evidence is seen in equipoise, then the government has failed in its burden of persuasion
and compensation must be awarded.” Knudsen, 35 F.3d at 550.
IV. ANALYSIS
A. Background on Infantile Spasms
Infantile spasms refers to “a syndrome of severe myoclonus appearing in the first 18
months of life and associated with general cerebral deterioration; it is marked by severe flexion
spasms of the head, neck, and trunk and extension of the limbs.” Spasm, infantile, Dorland’s. In
addition to a condition, Dr. Kinsbourne described an infantile spasm as an event that “takes
about a second in which the child does the following: the head drops, the arms fling up, the legs
pull up.” Tr. at 25. This, according to Dr. Kinsbourne, is sometimes called “jackknifing.” Id.
Dr. Kinsbourne stated that most children who suffer from infantile spasms begin with one event,
with time, the events gather in “frequency and prominence.” Id. at 26.
Dr. Guggenheim testified at hearing that West syndrome16 and infantile spasms are
synonymous. Id. at 226. Dr. Guggenheim further described infantile spasms as a “unique
16 Dr. Guggenheim explained that “West syndrome is labeled so because it was first described in
the mid-1800s by Dr. Benjamin West in England describing his own son.” Id. at 226.
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epilepsy.” Id. Moreover, Dr. Guggenheim indicated, infantile spasms are specifically
“characterized by the unique pattern of the seizures that the infant has because it’s almost always
under a year of age.” Id. at 228. That “unique pattern,” Dr. Guggenheim continued, consists of
“brief events of either tonic or flexor spasms.” Id.17 The spasms also “tend to come in clusters,”
she explained, which “may be as few as two or three or as many as 50 or 100,” but is typically
“on the order of 10 or 20.” Id. at 228-29. Infantile spasms have been described in children “as
young as a month and as old as perhaps 18 months,” she noted, “but 90 percent occur between
four and eight months of age, with the peak being at six months.” Id. at 229. Dr. Guggenheim
also mentioned the unique EEG pattern18 of those with infantile spasms, which can be described
as a “hypsarrhythmia” that appears as very chaotic. Id. Dr. Kinsbourne explained that this
means that “rhythms are lacking, or they’re diminished, and at the same time, there are high
amplitude waves, meaning excessive excitation.” Id. at 29.
B. Qualifications of the Parties’ Experts
1. Dr. Kinsbourne
Petitioners’ expert, Dr. Marcel Kinsbourne, graduated from Oxford University in 1952
with a Bachelor of Arts degree. Pet’rs’ Ex. 40 at 1. He attended Oxford University Medical
School and graduated with the equivalent of a medical degree in 1955. Id.; see Tr. at 11. Dr.
Kinsbourne also received a Master of Arts degree and a Doctor of Medicine degree from Oxford
University. Pet’rs’ Ex. 40 at 1.
Dr. Kinsbourne had nine years of post-graduate training in the areas of pediatrics,
neurology, and pediatric neurology, at several hospitals and facilities in England and the United
States. Tr. at 10-11; Pet’rs’ Ex. 40 at 1. He has also been appointed to many academic positions.
See Pet’rs’ Ex. 40 at 2. Notably, he served as a University Lecturer in Experimental Psychology
at Oxford University, from 1964 to 1967; as an Associate Professor in Pediatrics and Neurology
at Duke University Medical Center, from 1967 to 1974; as a Professor of Psychology at the
University of Waterloo, from 1974 to 1979; and as a Professor of Pediatrics at the University of
Toronto, from 1974 to 1980. Id.
17 Dr. Guggenheim clarified that “[t]onic is extension, flexor is flexion,” and both “may involve
virtually all of the body or some parts of the body.” Id. In short, they are “asymmetric jerks.”
Id.
18 Dr. Kinsbourne clarified that EEGs generally measure the brain’s “mental processes,” that is,
“what it’s doing, how it’s working,” by recording the different frequencies produced in different
parts of the brain. Id. at 27, 30.
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In 1980, Dr. Kinsbourne returned to the United States and served as Director of the
Eunice Kennedy Shriver Center for Developmental Disabilities, Lecturer in Neurology at
Harvard Medical School, and Clinical Associate in neurology at Massachusetts General Hospital,
until 1991. Id. He then served as Director of the Behavioral Neurology Unit at Sargent College
of Allied Health Professions at Boston University, from 1991 to 1992. Id. Currently, Dr.
Kinsbourne is Professor of Psychology at New School University in New York. Id.
Dr. Kinsbourne also was awarded a Fulbright Traveling Scholarship, the Queens Prize in
Neurology, the James Arthur Lectureship on Evolution of the Brain at the American Museum of
Natural History, and the Visiting Resident Scholar Award from the Rockefeller Foundation. Id.
He is licensed to practice medicine by the United Kingdom, the State of North Carolina, the
Medical Council of Canada, the Commonwealth of Massachusetts, and the Commonwealth of
Virginia. Id. at 1. He is a Member of the Royal College of Physicians and the American Board
of Pediatrics. Id.
Dr. Kinsbourne has 373 publications listed under the “Bibliography” section of his CV.
See id. at 5-35. Of note, Dr. Kinsbourne authored an article entitled, “Myoclonic
Encephalopathy of Infants,” which concerns the concept of a myoclonic disorder and how to
diagnose and understand it. Id. at 25. Dr. Kinsbourne stated that “[n]owadays it’s mostly called
opsoclonus, which is a sudden jerking of the eyes, unwilled and unpredictable, and myoclonus
syndrome or Kinsbourne’s disease,” named after Dr. Kinsbourne for his work on the disorder.
Tr. at 15-16.
Dr. Kinsbourne was offered and admitted at hearing as an expert in pediatric neurology.
Tr. at 22-24.
2. Dr. Guggenheim
Dr. Mary Anne Guggenheim attended Willamette University in Salem, Oregon from
1953 to 1957, and graduated with a Bachelor of Arts degree in Chemistry. Respt’s’ Ex. C at 1.
She attended Harvard Medical School and graduated in 1964 with a degree in medicine. Id. She
completed her post-graduate work at Cleveland Metropolitan General Hospital from 1964 to
1966, an NIH-NCI post-doctoral fellowship from 1966 to 1968 in virology research, and worked
at St. Louis Children’s Hospital in neurology and child neurology and at the University of
Colorado Health Sciences Center in neurology and neuropathology. Id.
Dr. Guggenheim has been certified by the American Board of Pediatrics since 1972, and
the American Board of Psychiatry and Neurology, with special competence in Child Neurology,
since 1973. Id. She has been appointed as an Instructor in Pediatrics at Washington University
School of Medicine, an Instructor in Pediatrics and Neurology at the University of Colorado
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School of Medicine, a Professor and Clinical Professor in Pediatrics and Neurology at the
University of Colorado School of Medicine, and an Adjunct Professor in the WAAMI Program
in Bozeman, Montana, through the University of Washington School of Medicine. Id. at 2. Dr.
Guggenheim indicated that she has “managed many children with infantile spasms.” Tr. at 222.
Her appointments include serving on the Executive Committee of the Child Neurology
Society from 1979 to 1983, including service as President from 1981 to 1982; she also served as
Vice-Chairperson of the Department of Pediatrics at the University of Colorado School of
Medicine. Pet’rs’ Ex. 40 at 2.
Dr. Guggenheim was licensed to practice medicine in Colorado in 1971 and has been
licensed in Montana since 1980. Id. at 1. She has 31 publications listed on her CV. See id. at 5-
7.
Dr. Guggenheim was offered and admitted at hearing as an expert in pediatric neurology.
Tr. at 223.
C. The Parties’ Arguments
1. The Experts
i. Dr. Kinsbourne
The parties ultimately agree that E.R. suffered from an FCD, and that this fact
predisposed him to seizure activity. Acknowledging this predisposition, Dr. Kinsbourne argues
that the seizure activity would not have occurred in the absence of a triggering event, and that, in
E.R.’s case, the triggering event was the DTaP vaccination. In his expert report and at hearing,
Dr. Kinsbourne articulated the following position.
“[I]n this possibly unique case we have a child given an agent, namely, a vaccine, which
is known to be capable of lowering seizure threshold on occasion,” id., specifically, the pertussis
vaccine, which is a component of the DTaP vaccination, and which has been linked to seizures,
albeit not to infantile spasms in particular. Id. at 121-22, 125. “[W]e have an area in that child’s
brain with really a lower seizure threshold, [the FCD,] so it seems . . . to be medically logical that
in this particular case the seizure disorder was triggered by vaccine.” Id. at 128. This could be
called the “second hit” theory; that is, the first “hit” is the dysplasia itself, the second “hit” is the
triggering event that causes the dysplasia to emit the signals that cause seizures—in this case, the
pertussis vaccination. See, e.g., Tr. at 111-12, 176-77.
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Initially, “[v]accinations cause the release of proinflammatory cytokines, including
interleukin-1 beta (IL-1 beta) as part of a reaction by the innate immune system that is a
necessary antecedent for the stimulation of an adaptive immune response that will confer
immunity.” Pet’rs’ Ex. 39 at 7 (citations omitted). In other words, vaccinations activate the
immune system “towards a relatively benign challenge so as to resist the most severe challenge
of the actual disease.” Tr. at 132-33. The innate immune system works first, and then “enables a
reaction by the adaptive immune system.” Id. at 133. The innate immune system responds with
inflammation which is local; it rallies “pro-inflammatory cytokines,” which “are chemicals that
actually jack up the likelihood of inflammation, and one aspect of the inflammation is the fever.”
Id. Subsequently, “[t]he pro-inflammatory cytokines initiate what’s called a ‘biochemical
cascade.’” Id. at 134. One particular cytokine, interleukin-1 beta or IL-1 beta, is “the main agent
in causing the fever which one gets when one has a variety of sicknesses.” Id. IL-1 beta also has
an effect on the hippocampus, “which is the particular area for generating seizures.” Id.
Regarding seizure thresholds, there are two types of neurons which play a role in a
seizure event, excitatory and inhibitory. Id. at 28. Neurons that have an excitatory effect
“increase their rate of firing” when they project to other neurons. Id. Inhibitory neurons
“decrease the rate of firing” when projected to other neurons. Id. “About 80 percent of the
neurons in the forebrain are excitatory and about 20 percent are inhibitory.” Id. Naturally, “it is
necessary for the brain to keep the ratio of excitation and inhibition under control.” Id. A
seizure might be called a “disinhibitory excitation.” Id. During a seizure, “the inhibition is
insufficient and then the amount of synchronization and rapid firing goes and goes and goes and
goes and then manifests itself in one or other of these ways.” Id.
“The infant brain is more apt to have seizures” because “the excitatory neurons develop
earlier than the inhibitory ones.” Id. at 33. Put simply, the infant brain tends to have a “lower
seizure threshold.” Id. As well, the “circuits” in an infant are not “really hooked up with each
other very much yet, so you don’t see necessarily the coordinated rhythmic activities involving
the whole body, which means that all the circuits are working together.” Id. Infantile spasms
typically appear from “about five or six months to about 18 months.” Id.at 34.
With regard to E.R., in addition to having the low seizure threshold of infants, he
suffered from an FCD (although this condition was not discovered until July 2010, when E.R
was three-and-a-half years old, and the petition had been pending almost a year). See supra Parts
I-II. Generally speaking, “a dysplasia is a condition caused by an abnormality in the
development of the nervous system.” Tr. at 62. It is an abnormality that occurs when the cells
that will become the nervous system are migrating from the “neural chest” to the cerebral cortex.
Id. at 62. This abnormality can be a lamination error, in which the cells end up in the wrong
layer of the brain; a structural error, in which the neurons themselves are malformed; a cellularity
abnormality (too many neurons, or too few); or a combination of the three. Id. at 65-66. One
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reason that E.R.’s FCD may not have been seen in MRIs is due to indistinct boundaries in the
brain. Id. at 34-35. Once a seizure happens, “the boundaries between the affected area, which is
gray matter, and the unaffected base, which . . . is white matter, become[] distinct.” Id. at 35.
Dr. Duffy, one of Petitioner’s physicians, commented on the abnormal finding by stating, “‘[m]y
impression of the EEG is that it is suggestive of an underlying problem that is assymetrical.’” Id.
at 46 (quoting Pet’rs’ Ex. 7 at 1). And “he noted it because it seemed that . . . towards the back
of the right hemisphere [of the brain]” there was an “abnormal rhythm,” which would signify “a
tumor, an abscess, something that’s generating the irritation of the nervous system which is
causing the seizures.” Id. Notably, Dr. Duffy went on to say, “‘[i]t would be quite unusual for a
full picture of infantile spasms, hypsarrhythmia, to begin so suddenly and dramatically unless
there were a trigger event such as an immunization.’” Id. at 47 (quoting Pet’rs’ Ex. 7 at 1-2).
When an MRI was taken of E.R.’s brain in July 2010, it revealed “‘abnormal thickening of
cortex and loss of gray-white differentiation in the anterior right temporal lobe involving the
amygdala, parahippocampal gyrus, and inferior temporal gyrus.’” Id. at 60 (quoting Pet’rs’ Ex.
27 at 365). The thickening was described as a “microdysplasia.” Id. at 61. After another MRI
study, physicians confirmed that it was FCD. Id. at 61-62.
Thus, in sum, the medical community is well aware that dysplasias “have lower seizure
thresholds than the rest of the cortical surface,” such that “they’re like a loaded gun waiting to
discharge,” and it is undisputed that E.R. had such a condition. Id. at 128. The relevant
question, however, is “what discharges them,” and the answer is “mostly” unknown. Id.
ii. Dr. Guggenheim
Respondent argues that a trigger is not necessary to prompt seizures in patients diagnosed
with FCD. Respondent also argues that, even E.R.’s seizures were triggered by something other
than FCD, that trigger was his infant brain maturation, not the DTaP vaccine. At hearing and in
her expert report, Dr. Guggenheim argued as follows.
Generally, Petitioner’s theory of vaccine causation does not satisfy any of the Althen
prongs. “[A]lthough there was temporal proximity,” Petitioner presented no “evidence to
support the allegation that it either aggravated or to us[e] the word ‘triggered’ . . . in any way
worsened, aggravated, uncovered the infantile spasms that [E.R.] presented with.” Id. at 225-26.
To be sure, “the term ‘second hit’ is used frequently these days in some literature relating to
epileptogenesis.” Pet’rs’ Ex. H at 2. That being said, “the hypothesis that [E.R.]’s [infantile
spasms] were ‘triggered’ by the vaccines, implying that without the immune stimulus his FCD
would have been asymptomatic, is not supported by clinical or laboratory evidence.” Id. As to
whether the pertussis vaccination delivered a “second hit” to E.R.’s brain, there is no data or
evidence that would lead one “to say that vaccines have any role in infantile spasms per se and in
the course that this particular child has had and that most children with infantile spasms take.”
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Tr. at 291. “The general consensus [in the pediatric neurologist community] is that there is no
evidence for any causative role” between vaccines and infantile spasms. Id. at 306.
Further, the medical literature suggested that there is no “need to invoke a second hit,” as
there is “considerable evidence that there is inherent epileptic -- epilepsy potential within the
dysplastic tissue itself.” Tr. (July 3, 2014) at 522, ECF No. 102. “[T]here are no clinical or
laboratory studies to refute the current assumption held by the majority of child neurologists that
when a child who develops [infantile spasms] has a FCD with demonstrated epileptogenicity, . . .
the FCD is the underlying cause.” Resp’t’s Ex. H at 4.
Admittedly, vaccinations have “been referenced by some people as being ‘a cause’ of
temporal proximity” with regard to infantile spasms. Tr. at 234. Again, however, “the vast
majority of people who work in pediatric neurology have come to the conclusion that in that
circumstance, temporal proximity does not equate with causation simply because there’s no
proven underlying pathology of the brain.” Id. Moreover, a study identifying over 200 potential
causes of infantile spasms identified FCD as one, but not vaccinations. Id. (citing Resp’t’s Ex.
B, Tab 1 at 13-19, ECF No. 18-2 (excerpt from James D. Frost, Jr. & Richard A. Hrachovy,
Infantile Spasms: Diagnosis, Management, and Prognosis, at 112-18 (2003)) (hereinafter “Frost
& Hrachovy” with pincites to internal pagination)).
2. Post-Hearing Briefs
i. Petitioners
Petitioners contend that they have satisfied their burden under all three of Althen’s prongs
by a preponderance of the evidence. Pet’rs’ Post Hr’g Br. at 1-2. Initially, Petitioners emphasize
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 2-3 (quoting Althen, 418 F.3d at 1280).
Petitioners first assert that, through Dr. Kinsbourne’s testimony, they have articulated a
plausible and reliable theory of how the DTaP vaccination could cause infantile spasms. Id. at 2-
8. As to Respondent, Petitioners argue that she merely impugns the credibility of Dr.
Kinsbourne, ignores the supporting literature, and cites epidemiological evidence in cases of
children without FCDs. Id. at 3. To the contrary, Petitioners counter, Dr. Kinsbourne has a
“long and distinguished career” as a pediatric neurologist and vaccine expert, as evidenced by his
impressive qualifications. Id. at 3-4. Further, the medical literature supports his theory,
Petitioners claim, because (1) “the pertussis vaccine causes the release of pro-inflammatory
cytokines, in particular IL 1-beta,” id. at 4; and (2) “an FCD in the cerebral cortex is a risk factor
for epilepsy,” as it lowers the seizure threshold, id. at 5; yet (3) “an individual with an FCD is not
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predestined to develop epilepsy or for developing seizure activity at a particular time.” Id. at 5-
6. In addition, Petitioners contend that Respondent’s data, which allegedly debunks the
purported link between the DTaP vaccine and infantile spasms, is out of date, general in nature,
and merely notes the absence of an observed relationship,19 not the nonexistence of one. Id. at 7.
Petitioners also argue that there is a logical sequence of cause and effect linking the
DTaP vaccine and E.R.’s infantile spasms. Id. at 8-11. Petitioners note that there are no disputes
as to E.R.’s medical records, which paint a picture compatible with their theory of causation. Id.
at 8-9. Although Respondent claims that it was E.R.’s FCD that was responsible for the infantile
spasms, Petitioners retort that E.R. had, at most, a type one FCD, which would not normally
present in the extreme fashion as it did here without aggravation. Id. at 10. While Dr.
Guggenheim stated that E.R.’s brain tissue was insufficient to draw pathologic findings, i.e., to
conclude that E.R.’s FCD was a type one, Petitioners contend that her testimony on this subject
is not persuasive, as she is not credentialed in this area of medicine. Id. at 10-11.
Finally, Petitioners assert that the manifestation of onset of E.R.’s infantile spasms was
temporally consistent with their theory of causation. Id. at 11-12. Notably, Petitioners point out,
Dr. Kinsbourne explained that “the mechanism of the vaccine triggering seizure activity in E.R.
involves a production of pro-inflammatory cytokines, including IL-1 beta, a process/reaction that
is understood to generate fever and which occurs within hours or days of vaccination.” Id. at 11.
As to Respondent’s evidence to the contrary, Petitioners explain that it “excluded cases, like
E.R.’s, which involved a cerebral malformation.” Id. at 12.
ii. Respondent
Generally, Respondent argues that “the evidence militates against the conclusion that
vaccination substantially contributes to infantile spasms.” Resp’t’s Post Hr’g Br. at 9. In any
event, Respondent continues, E.R.’s “cortical dysplasia is sufficiently explanatory as the
preponderant cause of his infantile spasms, such that the invocation of vaccination as causally
related is purely speculative.” Id. at 10.
Respondent first disputes the credibility and reliability of Dr. Kinsbourne. Id. at 10-12.
In particular, Respondent asserts that “his attribution of vaccination causation” was based “on
little more than a mere possibility, lacking the necessary indicia of reliability,” and that his
experience no longer extends to seizure cases, as he has not evaluated an epilepsy patient since
1980. Id. at 11. Respondent also points out that “Dr. Kinsbourne has historically invoked
vaccines as causing seizure disorders.” Id. at 17.
19 Petitioners also point out that children with FCDs have a “rare” condition that puts them in a
“high risk group” for developing infantile spasms; accordingly, general epidemiological studies
would not accurately represent the relationship between that group and the DTaP vaccination.
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Even accepting the credibility of Dr. Kinsbourne, Respondent argues, his theory of
causation is not reliable. Id. at 12-22. At the outset, she notes that “the scientific community’s
understanding of the basic mechanisms of infantile spasms is unfortunately nascent,” and that
“not a single other credentialed person has even hypothesized that vaccines substantially
contribute to infantile spasms.” Id. at 12. As to the theory itself, Respondent claims that it is
“rife with gaps,” including the lack of a link between the acellular pertussis vaccine and seizure
disorders, or between fever from cytokine IL-1 beta and infantile spasms (despite its connection
with benign febrile seizures). Id. at 13. Respondent also criticizes the “second hit” theory as
“working backwards in an attempt to shoehorn literature fragments into [Dr. Kinsbourne’s]
preordained conclusion of vaccine causation”; an attempt, she says, which has been rejected by
at least one other special master. Id. at 15-17 (citing Conway v. Sec’y of HHS, No. 07-857V,
2011 WL 1167632, at *10, 12 (Fed. Cl. Spec. Mstr. Mar. 7, 2011)). Furthermore, Respondent
asserts that Dr. Kinsbourne’s theory ignores the weight of medical evidence discounting any
purported link between vaccinations and infantile spasms, see id. at 18-19, as well as the
distinction between infantile spasms and other seizure disorders, see id. at 19. Respondent also
points out that Dr. Kinsbourne admitted that “the natural maturation of the brain at about the six-
month mark is at least an equally valid explanation of why an underlying predisposition for
infantile spasms might be ‘triggered.’” Id. at 21 (citing Tr. at 167). Finally, Respondent
contends that Petitioners have attempted to shift the burden of proof by arguing that Respondent
has not offered epidemiological evidence that specifically refutes Dr. Kinsbourne’s theory, when,
in reality, Petitioners have offered no evidence in support of the theory. Id. at 22.
Because Petitioners’ theory is invalid, Respondent continues, there can be no logical
sequence of cause and effect between the vaccine and the infantile spasms in this case. Id. at 22-
24. Nevertheless, Respondent singles out Dr. Duffy for criticism, claiming that his impression
was based on insufficient information and contrary to that of other treating physicians. Id. at 23-
24. Moreover, Respondent asserts, the medical records indicate that E.R. suffered from acute
irritability and gnawing before the DTaP vaccine, Dr. Kinsbourne admitted the possibility that
“such symptomatology could have represented a different ‘second hit’ to cause infantile
spasms,” and “infantile spasms often has an insidious onset,” id. at 24 (citing Tr. at 161, 202,
236-37); thus, the manifestation of onset of E.R.’s infantile spasms most likely occurred before
the vaccination.
Finally, Respondent contends that Petitioners’ timeline is inconsistent with the medical
literature because, typically, “there is a latency period of some months” between the onset of
infantile spasms and its cause. Id. at 24. While acknowledging Petitioners’ claim that this
literature does not specifically address the second-hit theory, Respondent asserts that the second-
hit theory is invalid in the first instance. Id. at 25.
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D. The Undersigned’s Decision
As Respondent notes, “the scientific community’s understanding of the basic
mechanisms of infantile spasms is unfortunately nascent.” Id. at 12. Both parties were
handicapped by this lack of scientific knowledge, as was the undersigned, who nonetheless must
make a decision based on the evidence in the record.
Much of the causation evidence presented in this case proved to be irrelevant–once it
became known that E.R. had an FCD, the causation analysis came down to two narrow and
separate, but related, questions, both of which fall under Althen’s first prong. First, are infantile
spasms inevitable in an individual with an FCD, or might the FCD need some sort of insult to
trigger it into seizure activity? Second, if an insult is necessary in some situations, can the
acellular pertussis vaccine act as that insult?
Respondent argued strongly in favor of inevitability. Dr. Guggenheim testified, “I don’t
think there’s any need to invoke a second hit. I think there’s considerable evidence that there is
inherent epileptic -- epilepsy potential with the dysplastic tissue itself.” Tr. at 522. And Dr.
Kinsbourne agreed that dysplasias “are known to have lower seizure thresholds than the rest of
the cortical surface . . . [t]hey’re like a loaded gun waiting to discharge.” Id. at 128.
However, Petitioners put forward several medical articles, including the Tezer-Filik
article, see Pet’rs’ Ex. 58 (Irsel Tezer-Filik et al., A case with an asymptomatic malformation of
cortical development diagnosed in eighth decade of life, 111 Bratisi Lek Listy 467 (2010)), and
the Kasper article, see Pet’rs’ Ex. 64 (Burkhard S. Kasper et al., Temporal Lobe Microdysgenesis
in Epilepsy Versus Control Brains, 58 J. Neuropathology & Experimental Neurology 22 (1999)),
that demonstrate that a significant proportion of the population has some form of gross cortical
dysgenesis without suffering any episodes of epilepsy. See Tr. at 114-18 (discussing articles);
see also Pet’rs’ Ex. 55 (Imad M. Najm et al., Pathophysiological Mechanisms of Focal Corticol
Dysplasia: A Critical Review of Human Tissue Studies and Animal Models, 48 Epilepsia 21, n.16
(2007)) (hereinafter “Najm”) (“[M]uch evidence has suggested to many that not all dysplastic
lesions are epileptic.”). Thus, at least in those individuals, infantile spasms or another form of
epilepsy was not an inevitable consequence of suffering from a cortical dysplasia. As Dr.
Kinsbourne put it, “it would seem that a lot of people with a similar dysplasia [to that of E.R.]
had lived a normal nonepileptic life.” Id. at 118. Beyond asserting that an FCD is inherently
epileptic, Respondent had no explanation for why some individuals with cortical dysplasias do
not develop infantile spasms, or develop epilepsy much later in life. Scientists have begun to
study this phenomenon, but they have not gotten beyond theorizing that a “second hit” may be
necessary to transform a “dormant” cortical dysplasia into an epileptic one, see Najm at 6, and
beginning to examine what mechanisms may underlie that transformation. Id.
19

Case 1:09-vv-00489-UNJ Document 110 Filed 06/21/16 Page 20 of 22
In sum, the evidence that dysplastic tissue has epilepsy potential, coupled with the proof
adduced by Petitioners that at least some individuals with cortical dysplasias survive infancy
without experiencing infantile spasms, demonstrates to the undersigned that some insult is
necessary in some cases to trigger that inherent potential into the actuality of infantile spasms.20
This leads to the second question in this case: could a vaccine, specifically the pertussis
vaccine, constitute that transformational mechanism? Petitioners assert that it can, and that it did
in this case. Petitioners offered unrefuted evidence linking the pertussis component of the DTaP
vaccine and seizures, see supra Part IV-C-1, and that the toxoiding21 process was imperfect in
the formulation of the pertussis vaccine. Tr. at 184-85. Respondent fervently argued that there
is no evidence linking vaccinations and infantile spasms. In support, Respondent pointed to both
an IOM report, which concluded that the evidence that acellular pertussis vaccine causes
infantile spasms or seizures in normal children is inconclusive, see Pet’rs’ Ex. I at 6, ECF No.
76-1 (excerpt from Comm. to Review Adverse Effects of Vaccines, Board on Population Health
and Public Health Practice, Inst. of Med., Adverse Effects of Vaccines: Evidence and Causality,
at 539 (Kathleen Stratton et al., eds., 2011)) (hereinafter “IOM Report”), and the Frost &
Hrachovy study, which omitted vaccinations from its comprehensive list of potential causes of
infantile spasms, see Frost & Hrachovy at 112-18. But the undersigned finds that the former’s
conclusion was based on only one epidemiological study and two small mechanistic studies, that
it is not clear that the one epidemiological study was designed to assess the acellular pertussis
component of the vaccine, and that the studies did not address the effect of the vaccine on
children with a lowered seizure threshold, such as those with a fever. See IOM Report at 537-38.
As to the latter, the undersigned makes two observations: (1) the absence of vaccinations from
the study does not rebut the existence of a relationship, and (2) the fact that so many potential
causes of infantile spasms exist indicates, as previously noted, a certain ignorance of the true
origin of the condition. In sum, despite the relative dearth of information concerning the causes
20 There was a great deal of discussion in expert reports and at hearing about the classification of
FCDs according to their severity and structural features and how prone they are to cause
epilepsy. See, e.g., Najm; Pet’rs’ Ex. 74 (Ingmar Blümcke et al., Malformations of corticol
development and epilepsies: neuropathological findings with emphasis on focal corticoal
dysplasia, 11 Epileptic Disorders 181 (2009)); Tr. at 74-75, 118, 303. Ultimately, this discussion
proved irrelevant to the undersigned’s decision for two reasons. First, there was not enough
tissue left after E.R.’s surgery to facilitate an accurate classification. Second, as discussed
previously, both experts agreed that the source of E.R.’s seizures was the FCD. The issue was
whether the vaccine pushed the FCD into seizure activity, or whether it went there on its own.
The pathology, unfortunately, was inadequate to assist in the resolution of that question.
21 A toxoid is “a modified or inactivated bacterial exotoxin that has lost toxicity but retains the
properties of combining with, or stimulating the formation of, antitoxin.” Dorland’s, Toxoid.
20

Case 1:09-vv-00489-UNJ Document 110 Filed 06/21/16 Page 21 of 22
and mechanisms of infantile spasms and FCDs, the undersigned concludes that Petitioners have
shown, by a preponderance of the evidence, that an FCD needs a “second hit” to become
epileptic in some cases, and that the pertussis component of the DTaP vaccine can act as that
second hit. Petitioners have thus met their burden of proof under Althen’s Prong One.
As to Prongs Two and Three of Althen, there is no dispute that E.R. had an FCD, and
despite the lack of pathology, no dispute, ultimately, that the FCD was epileptogenic. There is
no dispute that E.R. received the Pediarix vaccine containing the pertussis component, and that
he developed infantile spasms within a few hours of that vaccination. E.R.’s pediatrician noted
the reason for his repeated visits to be “post-immunization” seizures, after stating that E.R.’s
reaction would be “catalogued as a relative contra-indication to further immunization with
pertussis component, the most likely culprit in neurologic events after 6 month immunizations.”
Pet’r’s Ex. 4 at 75-76. Neurologist Dr. Duffy evaluated E.R.’s EEG and found it “suggestive of
an underlying problem that is asymmetrical.” Pet’r’s Ex. 7 at 1. Respondent discounted Dr.
Duffy’s assertion of a vaccine connection, and suggested that the asymmetry that Dr. Duffy
observed was actually the foreshadowing of the yet undiscovered FCD and not a vaccine
reaction. But, in response to the undersigned’s questions on this point, Dr. Kinsbourne testified
that this connection was
absolutely what [Dr. Duffy] was suspecting – one of the manifestations of what he
was suspecting in general would indeed be the dysplasia, but he was looking for
an acute process. The dysplasia is not an acute process. So applying it to the
dysplasia, he was looking for an acute aggravation of the dysplasia by a vaccine
reaction.
Tr. at 190. In light of this evidence, the undersigned concludes that Petitioners have shown, by a
preponderance of the evidence that, under the unique circumstances of this case, the DTaP
vaccine was the second hit that drove E.R., who was predisposed to develop the condition due to
his FCD, into infantile spasms.22 Petitioners have also met their burden of proof under Prongs
Two and Three of Althen, and are entitled to a Program award.
V. CONCLUSION
For the reasons set forth above, the undersigned finds that Petitioners have shown by
medical records and competent medical opinion that E.R.’s medical condition was “more likely
22 The undersigned emphasizes that her conclusion is narrowly circumscribed to the facts
presented in this case. She makes no observations about the link between the Pediarix, DTaP, or
acellular pertussis vaccines and infantile spasms, generally; rather, the undersigned merely
observes that Petitioners have met their burden of proof under Althen’s first prong.
21

Case 1:09-vv-00489-UNJ Document 110 Filed 06/21/16 Page 22 of 22
than not” vaccine-caused, and that he is entitled to compensation. This case is now ready to
proceed to damages.
IT IS SO ORDERED.
/s/ Lisa D. Hamilton-Fieldman
Lisa D. Hamilton-Fieldman
Special Master
22

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_09-vv-00489-1
Date issued/filed: 2017-12-01
Pages: 12
Docket text: PUBLIC DECISION (Originally filed: 11/06/2017) regarding 127 DECISION Stipulation/Proffer. Signed by Special Master Herbrina Sanders. (kl) Copy to parties.
--------------------------------------------------------------------------------
Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 1 of 12
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 09-489V
Filed: November 6, 2017
* * * * * * * * * * * * * * *
DULCE AND SEAN REILLY, parents * Special Master Sanders
and natural guardians of E.R., a minor, *
* Decision on Proffer; Damages; Diphtheria-
* Tetanus-Acellular-Pertussis (“DTaP”)
Petitioners, * Vaccine; Infantile Spasms.
*
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
*
Respondent. *
* * * * * * * * * * * * * * *
Edward M. Kraus, Law Offices of Chicago Kent, Chicago, IL, for Petitioners.
Ryan D. Pyles, United States Department of Justice, Washington, DC, for Respondent.
DECISION AWARDING DAMAGES1
On July 27, 2009, Dulce and Sean Reilly (“Petitioners”) filed a petition on behalf of their
minor child, E.R., pursuant to the National Vaccine Injury Compensation Program.2 42 U.S.C.
§§ 300aa-10 to -34 (2012). Petitioners allege that the diphtheria-tetanus-acellular-pertussis
(“DTaP”) vaccine administered on June 21, 2007 caused E.R. to suffer from a seizure disorder.
Ruling Entitlement (May 31, 2016) at 1-2, ECF No. 107.
1 This decision shall be posted on the United States Court of Federal Claims’ website, in
accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012) (Federal
Management and Promotion of Electronic Government Services). In accordance with Vaccine
Rule 18(b), a party has 14 days to identify and move to delete medical or other information that
satisfies the criteria in § 300aa-12(d)(4)(B). Further, consistent with the rule requirement, a
motion for redaction must include a proposed redacted decision. If, upon review, the
undersigned agrees that the identified material fits within the requirements of that provision, such
material will be deleted from public access.
2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L.
No. 99-660, 100 Stat. 3758, codified as amended, 42 U.S.C. §§ 300aa-10 to -34 (2012)
[hereinafter “Vaccine Act” or “the Act”]. Hereinafter, individual section references will be to 42
U.S.C. § 300aa of the Act.

Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 2 of 12
Special Master Hamilton-Fieldman issued a Ruling on Entitlement on May 31, 2016. Id.
She held that Petitioners’ theory and medical records satisfied the three-prong test in Althen v.
Secretary of Health and Human Services, 418 F.2d 1274, 1278 (Fed. Cir. 2005), and Petitioners
were therefore entitled to compensation. Id. at 19-22.
On June 22, 2016, Special Master Hamilton-Fieldman issued a Damages Order
encouraging the parties to identify and provide information that will be “necessary to assess the
appropriate amount of compensation to be awarded in this case.” Dam. Order at 7, ECF No. 111.
The case was reassigned to the undersigned on January 10, 2017. Not. Reassignment, ECF No.
115.
Respondent filed a Proffer on Award of Compensation (“Proffer”) on November 2, 2017.
Proffer, ECF No. 126. Based on the record as a whole, the undersigned finds that Petitioners are
entitled to an award as stated in the Proffer.
Pursuant to the terms stated in the Proffer, attached as Appendix A, the undersigned
awards Petitioners:
A. A lump sum payment of $1,268,787.00, (representing compensation for lost
future earnings ($750,984.00), pain and suffering ($250,000.00), and life care
expenses for Year One ($267,803.00)), in the form of a check payable to
[P]etitioners as guardians/conservators of the estate of E.R., for the benefit of
E.R.; and
B. A lump sum payment of $130,000.00, representing compensation for past
unreimbursable expenses, [in the form of a check] payable to Dulce Reilly and
Sean Reilly, [P]etitioners; and
C. An amount sufficient to purchase an annuity contract, subject to the conditions
described [in Section II.C.], that will provide payments for the life care items
contained in the life care plan, as illustrated by the chart [attached to the
Proffer], and paid to the life insurance company from which the annuity will be
purchased.
Proffer 3-5.
In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of
the court SHALL ENTER JUDGMENT herewith.3
IT IS SO ORDERED.
3 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of
notice renouncing the right to seek review.
2

Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 3 of 12
s/Herbrina D. Sanders
Herbrina D. Sanders
Special Master
3

Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 4 of 12
IN THE UNITED STATES COURT OF FEDERAL CLAIMS
OFFICE OF SPECIAL MASTERS
DULCE and SEAN REILLY, parents and
natural guardians of E.R., a minor,
Petitioners,
No. 09-489V
v. Special Master Herbrina Sanders
ECF
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
RESPONDENT’S PROFFER ON AWARD OF COMPENSATION
Respondent submits the following recommendations regarding items of compensation to
be awarded under the Vaccine Act.
I. Items of Compensation
A. Life Care Items
The parties engaged life care planners Tresa Johnson, RN, BSN, CNLCP, and M.
Virginia Walton, RN, MSN, FNP, CNLCP, to provide an estimation of E.R.’s future
vaccine-injury related needs, and the parties’ planners came to a joint consensus regarding
appropriate items of care. All items of compensation identified by the parties’ joint life care plan
dated October 25, 2017, are supported by the evidence, and are illustrated by the chart entitled
Summary of Life Care Items, attached hereto as Tab A. Respondent proffers that E.R. should be
awarded all items of compensation set forth in the joint life care plan and illustrated by the chart
attached at Tab A. Petitioners agree.
1

Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 5 of 12
B. Lost Earnings
The parties agree that based upon the evidence of record, E.R. will never be gainfully
employed. Therefore, respondent proffers that E.R. should be awarded full lost earnings as
provided under the Vaccine Act, 42 U.S.C. § 300aa-15(a)(3)(B). Respondent proffers that the
appropriate award for E.R.’s lost future earnings is $750,984.00 at net present value. Petitioners
agree.
C. Pain and Suffering
Respondent proffers that E.R. should be awarded $250,000.00 for actual pain, suffering,
and emotional distress, consistent with the statutory cap on awards for this element of damages.
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 E.R.’s vaccine-related injury. Respondent proffers that petitioners should be
awarded past unreimbursable expenses in the amount of $130,000.00. Petitioners agree.
E. Medicaid Lien
To the best of respondent’s knowledge and upon the representation of petitioners, E.R.
has never received Medicaid benefits. Accordingly, there is no Medicaid lien.
F. Attorneys’ Fees and Costs
This proffer does not address final attorneys’ fees and costs. Petitioners are entitled to
reasonable attorneys’ fees and costs, to be determined at a later date upon petitioners filing
substantiating documentation.
2

Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 6 of 12
II. Form of the Award
The parties recommend that the compensation provided to E.R. should be made through a
combination of one-time 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 for
all compensation1 available under 42 U.S.C. § 300aa-15(a).
Respondent proffers and petitioners agree that an award of compensation include the
following elements:
A. A lump sum payment of $1,268,787.00, (representing compensation for lost future
earnings ($750,984.00), pain and suffering ($250,000.00), and life care expenses for Year One
($267,803.00)), in the form of a check payable to petitioners as guardians/conservators of the
estate of E.R., for the benefit of E.R. No payment shall be made until petitioners provide
respondent with documentation establishing that they have been appointed as the
guardians/conservators of the estate of E.R.;
B. A lump sum payment of $130,000.00, representing compensation for past
unreimbursable expenses, payable to Dulce Reilly and Sean Reilly, petitioners; and
C. An amount sufficient to purchase an annuity contract,2 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, and paid to the life insurance company3 from
1 Should E.R. die prior to entry of judgment, respondent would oppose any award for
future medical expenses, future lost earnings and future projected pain and suffering and the
parties reserve the right to move the Court for appropriate relief.
2 To satisfy the conditions set forth herein, in respondent’s discretion, respondent may
purchase one or more annuity contracts from one or more life insurance companies.
3 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:
3

Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 7 of 12
which the annuity will be purchased.4 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 petitioners
as guardian/conservators of the estate of E.R., only so long as E.R. is alive at the time a
particular payment is due. At the Secretary’s sole discretion, the periodic payments may be
provided to petitioners in monthly, quarterly, annual or other installments. Annual totals set
forth in the far-right column of the chart at Tab A describe only the total yearly sum to be paid
for the benefit of E.R. 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 life care
items. Thus, the benefits illustrated in the chart at Tab A that are to be paid through annuity
payments should grow at four percent (4%) compounded annually from the date of judgment.
2. Life-Contingent Annuity
Petitioners as guardians/conservators of the estate of E.R. will continue to receive the
annuity payments from the Life Insurance Company only so long as E.R. is alive at the time that
a. A.M. 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;
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.
4 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.
4

Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 8 of 12
a particular payment is due. E.R.’s estate shall provide written notice to the Secretary of Health
and Human Services and the Life Insurance Company within twenty (20) days of E.R.’s death.
3. Guardianship
No payments shall be made until petitioners provide respondent with documentation
establishing that they have been appointed as the guardians/conservators of E.R.’s estate. If
petitioners are not authorized by a court of competent jurisdiction to serve as
guardians/conservators of the estate of E.R., 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 E.R. upon submission of written documentation of such appointment to the
Secretary.
III. Summary of Recommended Payments Following Judgment
A. Lump Sum paid to petitioners as guardians/conservators
of E.R.’s estate, for the benefit of E.R.: $ 1,268,787.00
B. Lump sum paid to petitioners: $ 130,000.00
C. An amount sufficient to purchase the annuity contract
described above in section II. C.
D. Reasonable final attorneys’ fees and litigation costs: TBD
Respectfully submitted,
CHAD A. READLER
Acting Assistant Attorney General
C. SALVATORE D’ALESSIO
Acting Director
Torts Branch, Civil Division
CATHARINE E. REEVES
Deputy Director
Torts Branch, Civil Division
5

Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 9 of 12
HEATHER L. PEARLMAN
Assistant Director
Torts Branch, Civil Division
s/ RYAN D. PYLES
RYAN D. PYLES
Trial Attorney
Torts Branch, Civil Division
U.S. Department of Justice
P.O. Box 146
Benjamin Franklin Station
Washington, D.C. 20044-0146
Tel: (202) 616-9847
DATED: November 2, 2017
6

Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 10 of 12
TAB A
Pet. Ethan Reilly
D.O.B. 12/15/2006
DATE: 10/25/17
TIME: 10:01 AM
SUMMARY OF LIFE CARE ITEMS - JOINT LIFE CARE PLAN dated October 25, 2017
ITEM OF CARE Insurance Medical Ancilliary Medications Supplies Home Transportation Home TOTALS TOTALS OF
Care Services Services Modifications of Items 4.0% ITEMS
with a 4.0% & APPLYING
Growth Rate THE GROWTH
GROWTH RATE 4.0% 4.0% 4.0% 4.0% 4.0% 4.0% 4.0% 4.0% RATE
AGE YEAR
11 2017 6,000.00 0.00 7,778.00 3,591.50 9,941.97 137,760.00 2,731.04 100,000.00 267,803 267,803
12 2018 6,000.00 0.00 9,478.00 3,591.50 3,200.38 137,760.00 2,731.04 0.00 162,761 169,271
13 2019 6,000.00 0.00 9,478.00 3,591.50 3,200.38 137,760.00 2,731.04 0.00 162,761 176,042
14 2020 6,000.00 0.00 9,478.00 3,591.50 3,200.38 137,760.00 2,731.04 0.00 162,761 183,084
15 2021 6,000.00 0.00 9,478.00 3,591.50 3,200.38 137,760.00 2,731.04 0.00 162,761 190,407
16 2022 6,000.00 0.00 91,750.00 3,591.50 3,200.38 137,760.00 2,731.04 0.00 245,033 298,120
17 2023 6,000.00 0.00 91,750.00 3,591.50 3,200.38 137,760.00 2,731.04 0.00 245,033 310,045
18 2024 6,000.00 0.00 91,750.00 3,591.50 3,200.38 137,760.00 2,731.04 0.00 245,033 322,447
19 2025 6,000.00 0.00 91,750.00 3,591.50 3,200.38 137,760.00 2,731.04 0.00 245,033 335,344
20 2026 6,000.00 0.00 91,750.00 3,591.50 3,200.38 137,760.00 2,731.04 0.00 245,033 348,758
21 2027 6,000.00 0.00 91,750.00 3,591.50 3,200.38 137,760.00 2,731.04 0.00 245,033 362,709
22 2028 6,000.00 0.00 91,750.00 3,591.50 3,200.38 137,760.00 2,731.04 0.00 245,033 377,217
23 2029 9,189.76 0.00 11,888.00 3,591.50 3,200.38 144,000.00 119.84 0.00 171,989 275,361
24 2030 9,189.76 0.00 11,888.00 3,591.50 3,200.38 144,000.00 119.84 0.00 171,989 286,375
25 2031 9,189.76 0.00 8,290.00 3,591.50 3,200.38 144,000.00 119.84 0.00 168,391 291,600
26 2032 13,310.76 424.40 8,290.00 3,338.01 3,200.38 144,000.00 119.84 0.00 172,683 310,993
27 2033 13,456.44 424.40 8,290.00 3,338.01 3,200.38 144,000.00 119.84 0.00 172,829 323,706
28 2034 13,677.48 424.40 8,290.00 3,338.01 3,200.38 144,000.00 119.84 0.00 173,050 337,084
29 2035 13,863.84 424.40 8,290.00 3,338.01 3,200.38 144,000.00 119.84 0.00 173,236 350,945
30 2036 9,577.68 424.40 8,290.00 2,794.01 3,200.38 144,000.00 119.84 0.00 168,406 354,807
31 2037 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 366,545
32 2038 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 381,207
33 2039 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 396,455
34 2040 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 412,313
35 2041 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 428,806
36 2042 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 445,958
37 2043 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 463,796
38 2044 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 482,348
39 2045 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 501,642
40 2046 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 521,708
PAGE 1

Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 11 of 12
TAB A
Pet. Ethan Reilly
D.O.B. 12/15/2006
DATE: 10/25/17
TIME: 10:01 AM
SUMMARY OF LIFE CARE ITEMS - JOINT LIFE CARE PLAN dated October 25, 2017
ITEM OF CARE Insurance Medical Ancilliary Medications Supplies Home Transportation Home TOTALS TOTALS OF
Care Services Services Modifications of Items 4.0% ITEMS
with a 4.0% & APPLYING
Growth Rate THE GROWTH
GROWTH RATE 4.0% 4.0% 4.0% 4.0% 4.0% 4.0% 4.0% 4.0% RATE
AGE YEAR
41 2047 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 542,576
42 2048 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 564,279
43 2049 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 586,850
44 2050 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 610,324
45 2051 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 634,737
46 2052 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 660,127
47 2053 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 686,532
48 2054 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 713,993
49 2055 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 742,553
50 2056 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 772,255
51 2057 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 803,145
52 2058 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 835,271
53 2059 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 868,682
54 2060 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 903,429
55 2061 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 939,566
56 2062 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 977,149
57 2063 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 1,016,235
58 2064 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 1,056,884
59 2065 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 1,099,159
60 2066 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 1,143,126
61 2067 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 1,188,851
62 2068 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 1,236,405
63 2069 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 1,285,861
64 2070 9,577.68 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 167,286 1,337,296
65 2071 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 1,354,188
66 2072 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 1,408,355
67 2073 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 1,464,690
68 2074 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 1,523,277
69 2075 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 1,584,208
70 2076 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 1,647,577
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Case 1:09-vv-00489-UNJ Document 131 Filed 12/01/17 Page 12 of 12
TAB A
Pet. Ethan Reilly
D.O.B. 12/15/2006
DATE: 10/25/17
TIME: 10:01 AM
SUMMARY OF LIFE CARE ITEMS - JOINT LIFE CARE PLAN dated October 25, 2017
ITEM OF CARE Insurance Medical Ancilliary Medications Supplies Home Transportation Home TOTALS TOTALS OF
Care Services Services Modifications of Items 4.0% ITEMS
with a 4.0% & APPLYING
Growth Rate THE GROWTH
GROWTH RATE 4.0% 4.0% 4.0% 4.0% 4.0% 4.0% 4.0% 4.0% RATE
AGE YEAR
71 2077 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 1,713,480
72 2078 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 1,782,019
73 2079 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 1,853,300
74 2080 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 1,927,432
75 2081 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 2,004,529
76 2082 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 2,084,710
77 2083 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 2,168,099
78 2084 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 2,254,822
79 2085 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 2,345,015
80 2086 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 2,438,816
81 2087 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 2,536,369
82 2088 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 2,637,823
83 2089 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 2,743,336
84 2090 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 2,853,070
85 2091 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 2,967,193
86 2092 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 3,085,880
87 2093 5,175.44 424.40 7,170.00 2,794.01 3,200.38 144,000.00 119.84 0.00 162,884 3,209,315
608,132 26,313 1,170,146 229,277 253,171 11,013,120 40,562 100,000 13,440,721 81,065,682
4.52% 0.20% 8.71% 1.71% 1.88% 81.94% 0.30% 0.74% 100.00%
This Report was generated using Sequoia Settlement Services, LLC Software (c) 1990
PAGE 3