In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

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

EILISE MORIARTY, a minor, *

by her parents and natural guardians, * No. 03-2876V

MARIE LOUISE and STEPHEN *

MORIARTY, * Special Master Christian J. Moran

*

Petitioners, * Filed: August 15, 2014

*

v. * Entitlement; measles, mumps, rubella

* (“MMR”) vaccine; autoimmune

SECRETARY OF HEALTH * epileptic encephalopathy. 

AND HUMAN SERVICES, *

*

Respondent. *

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

Clifford J. Shoemaker, Shoemaker, Gentry & Knickelbein, Vienna, VA, for 

petitioners;

Alexis B. Babcock, United States Dep’t of Justice, Washington, DC, for 

respondent. 

PUBLISHED DECISION DENYING COMPENSATION1

Marie Louise and Stephen Moriarty alleged that measles, mumps, rubella 

(“MMR”) vaccine caused their daughter, Eilise, to develop seizures, 

encephalopathy, and a decline in cognitive and motor functions. Am. Pet. at 2. 

 

1

The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 

2002), requires that the Court post this decision on its website. Pursuant to Vaccine Rule 18(b), 

the parties have 14 days to file a motion proposing redaction of medical information or other 

information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special 

master will appear in the document posted on the website. 
2

The Moriartys seek compensation pursuant to the National Childhood Vaccine 

Injury Compensation Program, 42 U.S.C. §§ 300aa-10 through 34 (2006). In 

support of their petition, the Moriartys rely upon the testimony of Yuval Shafrir, a 

board-certified pediatric neurologist. 

Dr. Shafrir’s opinion was opposed by respondent’s expert, John MacDonald, 

who is also a pediatric neurologist. On May 6, 2013, a hearing was held in which 

the Moriartys, Eilise’s brother (Harris), Dr. Shafrir, and Dr. MacDonald testified. 

Because the Moriartys did not prove that the MMR vaccine administered on 

January 2, 2001 could cause Eilise’s injury and did not provide a logical sequence 

of cause and effect linking Eilise’s vaccination to the onset of her injuries, the 

Moriartys did not meet their statutory burden. Thus, they are not entitled to 

compensation. 

I. Background

Because the parties relied upon Dr. Shafrir and Dr. MacDonald to explain 

the significance of the events in Eilise’s life, their qualifications are discussed 

below in section A. Their comments on Eilise’s history are presented in Section B, 

below.

A. Brief Biographies of Testifying Witnesses

1. Dr. Shafrir

Dr. Shafrir attended medical school in Israel and graduated in 1982. Exhibit 

38 at 3. After graduation, he spent two and a half years in pediatric residency. He 

moved to the United States and continued to study pediatrics at North Shore 

University Hospital in New York from February 1986 through June 1988. Next, 

Dr. Shafrir went to Washington University in St. Louis to complete a pediatric 

neurology fellowship, which he finished in June 1991. He continued to Miami 

Children’s Hospital to complete an epilepsy fellowship. Id. 

Dr. Shafrir is board-certified in psychiatry and neurology with a special 

competence in child neurology and in clinical neurophysiology. Exhibit 38 at 4. 

Currently, Dr. Shafrir works in private practice as a pediatric neurologist in 

Baltimore, MD. Id. Dr. Shafrir also works in academia as an assistant professor 

for the Department of Pediatrics at the University of Maryland School of Medicine,
3

and also teaches residents at Sinai Hospital. Id. He describes himself as an 

“epitologist.” Tr. 145. 

2. Dr. MacDonald 

Dr. MacDonald studied medicine at the University of Michigan. Exhibit A 

at 1. He stayed in Ann Arbor after graduation in 1970 to study pediatrics. Id. 

After next serving in the Navy, Dr. MacDonald completed a child neurology 

fellowship at the University of Miami in 1977. Id. He then spent 30 years as a 

private practitioner in Minneapolis. Tr. 220. 

Dr. MacDonald is board-certified in psychiatry and neurology with a special 

competence in child neurology. Exhibit A at 2. He has worked in academia for 

the past 10 years, and currently holds an appointment in the Department of 

Neurology at the University of Minnesota. Tr. 220; exhibit A at 1. Dr. 

MacDonald teaches pediatric neurology to pediatric residents, fellows, and 

neurology residents and supervises clinical rotations. Exhibit A at 10. 

B. Medical History

The parties generally agree that the medical records created 

contemporaneously with the events they describe set forth Eilise’s history 

accurately. Thus, there is relatively little dispute about the facts. The most 

prominent point of contention on factual matters concerns whether Eilise suffered a 

seizure on January 7, 2001. This issue is addressed and is resolved in section 2.a

below. 

1. Eilise’s Health before her MMR Vaccination 

Eilise was born in 1996. Exhibit 4 at 1; Tr. 19. Ms. Moriarty described 

Eilise as a “very energetic, motivated child,” but Eilise also had trouble walking 

and talking from a young age. Tr. 19-20. The first record of Eilise’s 

developmental delay was in June 1997, when Eilise was ten months old. Id. at 52. 

During this visit, Eilise’s pediatrician, Dr. Vojisla Russo, noted that Eilise had 

delayed gross motor development. Exhibit 8 at 75. At two years old, Eilise was 

still not talking, and she was accordingly referred to Children’s National Medical 

Center (“Children’s”) for a developmental evaluation. Id. at 76.
4

On August 26, 1999, when Eilise was three, Dr. Susan Berman evaluated 

Eilise. Exhibit 8 at 112-14. Dr. Berman described Eilise as a “slow walker” 

because she did not start walking until the age of 21 months. Id. During her 

evaluation, Eilise was able to walk up and down stairs, run, jump, and climb. Id. 

However, because Eilise could not balance on one foot, Dr. Berman did not 

complete a gross motor skills evaluation. Id. at 113. He concluded that Eilise was 

“at least in the 24 to 27 month age range in terms of gross motor skills.” Id. Her 

fine motor skills were in the 18 month range. Id. Eilise had diminished muscular 

tone in all of her extremities, but more in her upper extremities than lower. Id.

Ms. Moriarty expressed her concern about Eilise’s language development to 

Dr. Berman. Exhibit 8 at 113. Eilise’s vocabulary consisted of only 

approximately ten words, and most of her speech was unintelligible. Id. 

Ultimately, Dr. Berman concluded that Eilise’s speech and language skills were in 

the 18 to 24 month range. Id. 

After the evaluation, Dr. Berman diagnosed Eilise with hypotonia and 

developmental delay. Exhibit 8 at 113. According to Dr. Shafrir, a child with 

developmental delay is the same as a child with static encephalopathy. Tr. 185 

(“when you see a child with developmental delay[,] you say that they have static 

encephalopathy”). Dr. Berman also noted that the department of physical medicine 

and rehabilitation at Children’s had followed Eilise’s older sister, Mairin, who was 

diagnosed with cerebral hypotonia and learning disabilities. Id. at 112.

2

 

Dr. Berman recommended a hearing test to determine whether Eilise’s 

language delay was not “secondary to hearing impairment.” Exhibit 8 at 113. She 

also recommended that Eilise begin occupational therapy once a week for at least 

twelve weeks to address “the same visual motor issues that her sister had.” Id. 

On November 15, 1999, Eilise was found to have normal hearing. Exhibit 8 

at 118. After a subsequent speech and language evaluation on November 24, 1999, 

 

2 Dr. Shafrir believes that Mairin’s medical history is significant because she also had 

delayed walking and delayed speaking. Dr. Shafrir opined that Eilise and her sister “probably 

have the same cause of their static encephalopathy, which is likely genetic.” Tr. 163-64. 

Although he was speculating, he added that in his view the medical records support the 

possibility. Id.
5

Eilise was diagnosed as having a moderate receptive language disorder and a 

severe expressive language disorder, and her speech skills were said to be

“severely impaired.” Id. at 116. The examiner recommended that Eilise attend 

speech therapy sessions. Exhibit 27 at 29. 

In addition to numerous evaluations, Eilise had several surgeries as a young 

child. In April 1999, she had surgery to correct exotropia in her left eye, with 

similar surgery to correct the same defect in her right eye the next year. Exhibit 8

at 110, 112. In March 2000, Eilise’s tonsils and adenoids were removed. Exhibit 

49 at 1. Eilise’s sister, Mairin, also had a tonsillectomy when she was around 

Eilise’s age. Before surgery, Mairin was developmentally delayed, but after 

surgery, Mairin improved dramatically. Tr. 118-19, 121-22, 298. Ms. Moriarty

testified that after the surgery, Eilise had never “[spoken] so clearly or engage[d]

and [paid] such close attention to anything.” Tr. 21. She added that Eilise’s 

“whole demeanor was more confident” after her surgery. Tr. 81.

On May 1 and May 24, 2000, Eilise went to the Devonshire Center to be 

evaluated for a special education preschool program. Exhibit 27 at 9. To assess 

her cognitive functioning, Eilise took the Bayley Scales of Infant Development –

Second Edition. Exhibit 27 at 12. Eilise’s performance resulted in an overall 

cognitive age equivalent of 20 months. Id. The assessment team warned that 

“[h]er performance should be interpreted cautiously as it was affected by her 

limited expressive language, hypotonia, and ocular difficulties.” Id. at 17. 

To assess her speech and language skills, Eilise took several tests. On the 

Peabody Picture Vocabulary Test – Revised (Form L), she earned a score matching 

that of a two year old, a “very significant delay.” Exhibit 27 at 16. The Preschool 

Language Scale – 3 revealed a “severe receptive and expressive language delay.” 

Id. Her pragmatic communication skills also were “very significantly delayed” 

and her articulation skills were “severely delayed.” Id. 

After reviewing Eilise’s assessments, the Fairfax County school system 

approved Eilise for special education services. Exhibit 27 at 38-44. On June 30, 

2000, Eilise underwent an IEP. Tr. 60; exhibit 27 at 198-201. The IEP report 

described Eilise as having a “normal activity level” but also as “having difficulty 

fully participating in the preschool environment.” Exhibit 27 at 37. The team 

recommended that Eilise receive “adult guidance and modeling” for developing 

fine motor skills, interacting and playing with peers, and for communicating more 

effectively. Id. 
6

Eilise started a preschool program in fall 2000. Tr. 23. She continued to 

improve in her development and was “very chatty,” according to Ms. Moriarty. Id. 

A progress report in October 2000 showed that Eilise was making improvements, 

particularly after focused therapy to improve fine motor and speech skills. Exhibit 

31 at 13-15. Dr. MacDonald attributed Eilise’s progress to the fact that she was 

receiving therapy during that time. Tr. 227. Dr. Shafrir doubts that Eilise was 

completely normal after the surgeries, but that she “definitely improved 

dramatically.” Tr. 185. 

2. Eilise’s Health from the Date of Vaccination until the End 

of January 2001

The school required Eilise to have certain vaccinations before returning to 

school in January 2001. Exhibit 51 at 2. Thus, on January 2, 2001, at Dr. Russo’s 

office, Eilise received the second dose of the MMR vaccine. Exhibit 8 at 77, 134; 

Tr. 135. Although Dr. Russo also gave Eilise a dose of the DTaP and IPV vaccines

on the same occasion, the Moriartys’ claim and Dr. Shafrir’s opinion are based 

upon the MMR vaccine. 

a) Episode on January 7, 2001, and Following Weeks 

The Moriartys allege that Eilise suffered a seizure on January 7, 2001. 

Pet’rs’ Posthr’g Br., filed Sept. 25, 2013, at 2. The basis is a report from Harris, 

Eilise’s older brother, who provided an affidavit (exhibit 47) and testified. The 

Secretary has some questions about Harris’s account because a medical record was 

not created contemporaneously. See Resp’t’s Posthr’g Br., filed Nov. 25, 2013, at 

16-17. 

According to Harris, on Sunday, January 7, 2001, Eilise and he stayed at 

home alone while the rest of the family attended Catholic Mass. Tr. 25-26. While 

watching television, he witnessed Eilise as her back “arched into the couch,” her 

head “thrust back,” her eyes “rolled back,” and her left side jerked “very strangely, 

almost in a rhythmic pattern” for about 45 seconds. Tr. 6. Eilise was disoriented 

and dazed after the episode, so Harris put Eilise to bed and then called their 

parents. Tr. 6-7, 10-11. Although Harris did not know it on that day, he now 

believes, after witnessing many other seizures, that what he witnessed was Eilise 

having a seizure. Tr. 7. According to Mr. and Ms. Moriarty, Eilise was feverish 

and lethargic the night of January 7, 2001. Tr. 27, 121; see also Tr. 12.
7

Harris’s testimony raises two questions. First, did anything happen to Eilise, 

and, second, if something unusual did occur, was it a seizure? Dr. Shafrir believes 

that this episode was a seizure, constituting the onset of Eilise’s epileptic 

encephalopathy. Exhibit 37 at 2; Tr. 148. Dr. MacDonald stated that he agreed 

“there was probably an event” on January 7, 2001, but that he “would not 

characterize it as unequivocally a seizure.” Tr. 229; see also exhibit B at 3 (Dr. 

MacDonald’s report stating that he could not accept Harris’s report “to a 

reasonable degree of medical certainty”). 

Here, strong evidence supports a finding that Eilise behaved unusually 

during the evening of January 7, 2001. Less than three weeks later, when Eilise 

was in Inova Fairfax Hospital following an unquestioned seizure, Harris told one 

of Eilise’s doctors about what he saw. Exhibit 7 at 162. Harris’s report to Dr. 

Elgin was made to facilitate his sister’s treatment and was not made in the context 

of litigation. Consequently, Harris’s account has sufficient indicia of reliability to 

be accepted. See Cucuras v. Sec'y of Health & Human Servs., 993 F.2d 1525, 

1528 (Fed. Cir. 1993). 

The ensuing question is: was this behavior was a seizure? The evidence 

preponderates in favor of finding it was. First, in the years between this episode 

and his appearance in court, Harris has learned how Eilise acts during a seizure. 

Second, Dr. Shafrir, someone with medical training, accepted Harris’s description 

of Eilise’s behavior and characterized her as suffering a seizure. Third, the 

contrary position taken by Dr. MacDonald seems to be a consequence of an overly 

demanding burden of proof. Under the simpler more-likely-than-not evidentiary 

standard, the Moriartys have established that on January 7, 2001, Eilise suffered a 

seizure.3

On the next day, January 8, 2001, Eilise went to school, but returned home 

early. Later that afternoon, Eilise was running a fever. Tr. 28. The following day, 

Ms. Moriarty took Eilise to see Dr. R. A. Comunale. Id.; exhibit 10 at 2. The 

 

3 Although Dr. MacDonald disagreed, he stated that even if it were a seizure, he still 

believed that Eilise did not have autoimmune epileptic encephalopathy. Tr. 245-46, 273. 

Whether Eilise suffered from an autoimmune epileptic encephalopathy is discussed in section V

below. 
8

doctor noted that Eilise’s only symptom was a fever and he prescribed an 

antibiotic, Zithromax. Tr. 29; exhibit 10 at 2.4 Dr. MacDonald assumed that Eilise 

was being treated for a “viral type illness,” but he was not sure because Dr. 

Comunale prescribed an antibiotic, which likely would not have helped a viral 

illness. Tr. 228, 262. 

Over the next two weeks, Eilise continued to attend school, but she was 

“glassy and tired and lethargic and put herself to bed.” Tr. 28. Ms. Moriarty 

described Eilise as “under the weather and not sure how or why.” Tr. 69. Eilise 

did not go to the doctor during this period. See id. Commenting on this two week 

period, Dr. MacDonald stated that Eilise was apparently eating well because she 

was gaining weight and she did not appear to be seriously ill. Tr. 228. 

b) Seizure on January 23, 2001, and Associated 

Hospitalizations

On January 23, 2001, Eilise had a seizure at school and was taken in an 

ambulance to Columbia Reston Hospital (“Reston”). Exhibit 17 at 2-3. The 

Emergency Department record indicated that Eilise “had a grand mal seizure at 

school consisting of arching back of head [and] rolling back of eyes and tonic 

clonic movement of extremities.” Exhibit 24 at 3. Her seizure lasted several 

minutes. Id. at 6. As part of the “history of present illness,” the doctor noted that 

Eilise had no cough or cold. Id. at 3. Overall, she was described as alert, active, 

and in no acute distress. Exhibit 24 at 6; see also Tr. 232. 5 Eilise’s CT scan was 

normal. Exhibit 8 at 106. Dr. MacDonald believes that these descriptions are 

inconsistent with a diagnosis of acute encephalopathy. Tr. 232 (“a child who 

comes in [to the emergency room] and doesn’t wake up, has focal neurological 

signs, signs of intracranial pressure, other signs that would point me to more than a 

seizure.”). 

 

4 Dr. Comunale’s report did not memorialize Eilise having any seizure-like behaviors the 

evening before. 

5 Despite the doctor’s description of Eilise as alert, active, and in no acute distress, Dr. 

Shafrir opined that she was encephalopathic. Tr. 169-70.
9

On January 24, 2001, Ms. Moriarty and a nurse witnessed Eilise having a 

left-sided focal seizure lasting approximately 40 seconds. Exhibit 24 at 45; Tr. 30. 

Eilise was transferred to Inova Fairfax Hospital (“Fairfax”) later that day. Exhibit 

24 at 46. 

A pediatric neurologist, Virginia Elgin, saw Eilise while she was at Fairfax. 

Exhibit 7 at 169-71. Dr. Elgin noted that Eilise had another focal seizure lasting 

approximately two minutes involving left side jerking. Id. Harris and Ms. 

Moriarty both witnessed Eilise having the seizure. Tr. 32. While they were at the 

hospital, Harris spoke with Dr. Elgin about the episode on January 7, 2001. Id. 

Dr. Elgin made a note, stating that Harris witnessed Eilise’s first seizure while they 

were watching TV. Exhibit 7 at 162. Dr. Elgin assessed Eilise as “[a]lert, fussy, 

[and] cranky” and able to “follow simple commands” but having “limited” 

cooperation. Id. at 171; see also id. at 163. Ultimately, Dr. Elgin diagnosed Eilise 

with new onset seizures. Id. at 164. 

On January 25, 2001, Eilise had a seizure that lasted for approximately 75 

seconds, consisting of left-sided focal activity. Exhibit 7 at 161. Eilise initially 

was given Cerebyz, Ativan, and Dilantin. Id. at 161, 169. She later started 

Tegretol and Cerebyz was discontinued. Id. Her dose of Tegretol was “gradually 

increased after she was seizure free for 24 hours.” Id. at 161. 

Eilise had images of her brain taken while she was at Fairfax. Exhibit 7 at 

185-89. The images from her brain MRI only showed “a moderate degree of 

inflammatory change in the paranasal sinuses.” Id. at 189. 

Eilise also had an EEG. The test administrator indicated that Eilise was in 

“the drowsy, light sleep state” when the EEG was taken. Exhibit 7 at 188. The 

EEG had a single burst of spike and high voltage slow activity symmetrically. Id.

at 187. The doctors believed that her EEG was consistent with the clinical 

diagnosis of epilepsy. Id. at 185-88. Dr. Shafrir believes that EEG report was 

“supportive of a diagnosis of encephalopathy” but “not diagnostic.” Tr. 202. Dr. 

MacDonald discussed two problems with the EEG report. Tr. 234. First, he 

asserted that reading EEGs before the patient is an adult is a subjective exercise. 

Id. Second, he opined that drowsiness creates slowing on an EEG and Eilise was 

likely drowsy when the EEG was taken. Id. Dr. MacDonald believed that the 

EEG confirmed an epilepsy, but nothing more. Tr. 277. 
10

Eilise continued to have seizures for the next two days and her medications 

were adjusted accordingly. See, e.g., exhibit 7 at 175, 183. On January 27, 2001, 

Dr. T. Watkin saw Eilise, and noted that she was “still encephalopathic but 

improving.” Id. at 178. Dr. Shafrir believes that Eilise was encephalopathic at the 

time of her admission to Fairfax, even though the medical records do not mention 

“acute distress” because “many patients go in and out of a state of 

encephalopathy.” Tr. 170. However, Dr. MacDonald attributed her behavior to 

side effects of her medication, high doses of Dilatin as well as Ativan. Dr. 

MacDonald questioned how well Eilise, a small child, was sleeping while on those 

medications. Tr. 233. 

Eilise was discharged on January 28, 2001, after her seizures had been

controlled. Exhibit 21 at 55-56; Tr. 33. Upon discharge, Dr. Elgin noted that 

Eilise had a “new onset of seizure disorder,” exhibit 21 at 56, and “there seem to 

be no precipitating factors causing the seizures,” including that Eilise had no 

illnesses recently. Exhibit 7 at 160. 

On January 30, 2001, Eilise went to Johns Hopkins Medical Center and saw 

Dr. Eileen Vining. Exhibit 4 at 18-20. In her report, Dr. Vining commented that 

Eilise had recently recovered from an upper respiratory infection. Id. at 18.6 Dr. 

Vining reviewed Eilise’s MRI and EEGs from Fairfax Hospital, noting that the 

nature of Eilise’s seizures was unclear. Id. at 19. She emphasized that the nature 

of her seizures was particularly important for prescribing the correct medication. 

Id. Tegretol would help if Eilise were having complex partial seizures, but it could 

worsen her symptoms if her seizures were “poly spike and wave.” Id. In her 

assessment, Dr. Vining noted that Eilise had new onset of seizure with unknown 

etiology. Id. at 19. Dr. Vining recommended close monitoring and maintaining 

her current anti-seizure medications. Later, Ms. Moriarty corrected an inaccuracy 

in the original medical history, adding that Harris did tell his parents about Eilise’s 

episode on January 7, 2001. Tr. 73, 75; exhibit 4 at 9, 18 (note dated April 19, 

2003). 

 

6 Dr. Vining’s reference to a recent upper respiratory infection is inconsistent with the 

Reston Hospital record stating that Eilise had not had a cough or cold. Exhibit 24 at 3. 
11

3. Additional Seizures and Hospitalizations: March through 

June 2001

On March 18, 2001, Eilise was readmitted to Fairfax after exacerbation of 

her seizures. Exhibit 7 at 130; exhibit 8 at 98. Ms. Moriarty reported that Eilise’s 

seizure activity was focused on the right side. The doctor noted that Eilise had a 

history of partial and partial complex seizures. Exhibit 8 at 98. Dr. Elgin 

attributed the increased seizure activity due to auto-induction of liver enzymes and 

“increased leptic clearance.” Exhibit 7 at 132. Because Eilise had not been 

responding to changing doses of Tegretol, Dr. Elgin started Eilise on Carbatrol, a 

slow-release anticonvulsant. Exhibit 7 at 69. Eilise did not have seizures 

overnight, and was discharged. Id. at 132.

In response to “drop attacks,” on March 23, 2001, Eilise went back to 

Fairfax and saw Dr. Elgin. Exhibit 8 at 96; exhibit 21 at 40. Although Eilise 

appeared to show improvement in the partial seizures, Ms. Moriarty reported that 

during Eilise’s recent episodes, she had a tendency to drop her head suddenly and 

sometimes to collapse altogether. Exhibit 8 at 96. Overall, Dr. Elgin believed that 

Eilise was improving, but she noted concern “regarding the possibility of 

additional seizure types which had not manifest[ed] previously.” Id. In particular, 

Dr. Elgin was concerned about a “Lennox-Gastaut syndrome or some variant form 

thereof.” Id. Dr. Shafrir credited Dr. Elgin’s words as “clearly describ[ing] the 

development of the epileptic encephalopathy.” Exhibit 37 at 2. 7 

Eilise continued to have seizures. On March 26, 2001, Eilise again was 

admitted to Fairfax. Exhibit 7 at 66, 69. Ms. Moriarty reported that Eilise had 

experienced more than 20 episodes of acute onset seizures since discharge three 

days prior. During these seizures, Eilise would fall to the floor. Id. at 66. There 

was no clear evidence of myoclonic seizures, however. Id. 

Ms. Moriarty also reported that Eilise was experiencing expressive language 

regression. Exhibit 7 at 66. Dr. MacDonald believed that when Eilise began 

 

7 Dr. Shafrir described epileptic encephalopathy as progressive in nature. Tr. 186 

(“Typically [a patient has] a seizure then another one and increasing frequency, increasing 

severity, and finally they have full-blown epileptic encephalopathy.”). 
12

having daily seizures, she was recovering from both the seizures and Todd’s 

paralysis.

8

 Tr. 241. In addition, she was on multiple medications with side effects. 

Together, these likely led to transient changes in Eilise’s cognitive ability, but not a 

decline in her overall abilities, because her test scores before and after the 

vaccination were “pretty much stable.” Tr. 242; see Tr. 275. Dr. MacDonald

added that seizures interfere with the ability of the brain to function rather than 

cause damage. Tr. 250. Eilise was diagnosed with mild to moderate speech delay, 

intermittent right hemiparesis, and decreased right nasolabial fold. Exhibit 7 at 70. 

Eilise had more images taken. She had an EEG on March 27, 2001, which 

was consistent with clinical seizure disorder. Exhibit 7 at 85. The EEG was 

abnormal because of the prominent bilateral spike, poly spike, and slow wave 

activity. Exhibit 7 at 85; see Tr. 200. It also indicated an evolving disorder. Tr. 

280. Eilise was discharged on March 28, 2001. Exhibit 7 at 80.

Dr. Elgin also ordered an MRI scan, which yielded normal results, including 

“mild to moderate membrane thickening involving a few paranasal sinuses.” 

Exhibit 21 at 59, 62. Dr. Shafrir added that this condition would not contribute to 

encephalopathy. Tr. 206-07 (“Take every child on the street with a cold and nasal 

discharge, and they will have the same thing on the MRI.”) 

Mr. and Ms. Moriarty decided to take Eilise to Johns Hopkins Hospital to 

enroll her in the ketogenic diet program. Exhibit 51 at 5. However, there was a 

wait list and she was not able to see the doctors until June 2001. Id. 

In the meantime, on April 19, 2001, the school system administered a 

psychological assessment to determine Eilise’s continuing eligibility for special 

education services. Exhibit 27 at 94. She was four years and seven months old at 

the time of assessment. Id. at 95. During the evaluation, Eilise was administered 

the Stanford Binet Intelligence Scale: Fourth Edition, scoring in the first percentile 

in verbal comprehension, nonverbal reasoning, and overall. Id. She was 

completing only two-word sentences. Id. 

 

8

Todd’s paralysis is the loss or impairment of motor function in part due to the lesion of 

the neural or muscular mechanism. Dorland’s Illustrated Medical Dictionary 1933, 1378 (32nd 

ed. 2012). 
13

One month later, on May 10 and May 23, a speech clinician evaluated 

Eilise’s speech and language to determine her continued eligibility for special 

education services. Exhibit 27 at 117-18. Testing indicated that Eilise had severe 

delays in receptive and expressive language, and her quality of speech was slurred. 

Id. at 119. Eilise was using three to five words, gestures, and pointing to 

communicate. Id. 

In her June 2001 preschool progress report, Eilise’s teacher, Ms. Dulong, 

commented on Eilise’s communication and cognition. Exhibit 27 at 126. Ms. 

Dulong indicated that Eilise was capable of speaking in sentences, but on most 

occasions, she did not. Id. She also mentioned that Eilise had a limited 

vocabulary. Id. Eilise earned a score of 29 months on receptive language and 30 

months on expressive language after taking the Battelle Development Inventory. 

Id. 

On June 6, 2001, Eilise was admitted to Johns Hopkins Hospital for 

intractable seizures and to begin a ketogenic diet. Exhibit 8 at 89. 9 She was 

discharged four days later. Id. The attending physician noted that Eilise tolerated 

the diet well, and had only a “few little very brief seizures” on the day of 

discharge. Id. at 90. Eilise was still taking Depakote. Id. 

4. After Eilise Started Ketogenic Diet

Eilise returned to Johns Hopkins for a follow-up examination on September 

25, 2001. Exhibit 4 at 14. She was reportedly seizure-free after beginning the diet 

“except for [three] incidents.” Id. Ms. Moriarty explained that the diet was very 

strict and sometimes difficult for her to follow. Tr. 41. In July 2001, Ms. Moriarty 

misread one of the items on an ingredient list and Eilise had a seizure. Id. In 

general, Eilise’s talking and language structure improved since she started the diet. 

Exhibit 4 at 14. 

On January 15, 2002, Eilise went to Johns Hopkins for a six-month follow 

up visit. She saw Dr. James Rubenstein for her appointment. Exhibit 4 at 12. By 

 

9 According to Dr. Shafrir, Johns Hopkins is “by far the leading ketogenic diet place in 

the country and probably in the world.” Tr. 151. 
14

this time, Eilise was no longer taking any seizure medications. Id. 10 Eilise’s last 

seizure occurred on October 12, 2001. Id. Dr. Rubenstein’s diagnosis, after the 

visit, was that Eilise had intractable seizures of unknown etiology, which were 

successfully treated with the ketogenic diet. Id. at 13. Dr. Rubenstein 

recommended occupational therapy, physical therapy, and speech therapy for 

Eilise. Id.

Eilise was a “super-responder” to the ketogenic diet with respect to her 

seizure disorder. Exhibit 4 at 9 (report of Dr. Eric Kossof). After one year on the 

diet, Eilise began developing kidney stones, but had been seizure free for eight 

months. Id. at 11. Her EEG on July 23, 2002, was essentially normal. Id. at 10. 

Mr. and Ms. Moriarty wanted Eilise to be seizure free for two years before tapering 

off the diet. Id. at 9. Eilise finally began to taper off the diet in October 2003, 

finishing in winter 2005. Id. at 2, 6-7. During her October 2003 appointment and 

again in October 2005, Dr. Rubenstein indicated that Eilise’s problems or 

diagnoses were “1. Static encephalopathy of unknown etiology” and “2. Intractable 

atonic seizures, resolved with ketogenic diet.” Id. at 2-3, 6-7. 

Dr. Shafrir proposed that the ketogenic diet was an effective anti-epileptic 

medication or treatment for Eilise because the diet stopped the seizures, and the 

stopped seizures helped with her epileptic encephalopathy, but did not reverse the 

injury. Tr. 189. He commented that doctors do not have a theory for why some 

seizure patients, like Eilise, respond well to a ketogenic diet. Tr. 188. Dr. 

MacDonald attributed Eilise’s success to the ketogenic diet’s effect on Eilise’s 

metabolism, suggesting that Eilise’s problem was actually a metabolic disorder. 

Tr. 284. 

On July 21 and July 29, 2004, Eilise went to Dr. Rachna Varia for a 

psychoeducational evaluation. Exhibit 18 at 74-83. Her test results showed 

deficits in language, attention, memory, sensorimotor, and visual-spatial skills. Id.

at 81. Dr. Varia’s report noted that Eilise had a “medically acknowledged MMR 

 

10 During the hearing, Dr. Shafrir was asked whether he had ever been able to take his 

epileptic encephalopathy patients off medication. He said no, but conditioned his answer, saying

that this is not a common situation. Tr. 196. He was answering the question based on his 

experience with “one, two, maybe three patients.” Id.
15

reaction, Lennox Gasto [sic], which led to complex partial seizures and brain 

damage.” Exhibit 18 at 74. 

On August 31, 2004, Eilise underwent an audiological and occupational 

therapy evaluation. Exhibit 18 at 57. The examiners noted that Eilise had made 

progress in auditory processing and sensory integration functions in “the past two 

years,” but recommended that Eilise continue at least two hours a week of speech 

and occupational therapy. Id. at 60-61. 

On February 22, 2005, Eilise had another occupational therapy evaluation at 

Georgetown University Hospital. Exhibit 18 at 42. The examiner found that Eilise 

was at risk for further developmental delay if she did not receive direct 

occupational therapy services. Id. The examiner noted that Eilise’s “medical team 

attributed her seizures to a reaction to her MMR injection.” Id. 

During Eilise’s developmental speech and language evaluation on April 28, 

2005, the clinician indicated that Eilise presented an “expressive/receptive 

language delay as a result of seizure activity prompted by an adverse reaction to an 

MMR vaccine in January 2001.” Exhibit 18 at 62. She also stated that the seizures 

“caused regression of development and loss of all language ability.” Id. The 

clinician suggested that Eilise continue speech therapy sessions to improve her 

deficits. Id. at 63.

At the time of the hearing, Eilise was 17 years old and would have normally 

been a junior in high school. Tr. 46. However, she was reading at an “easy fifth 

grade level.” Id. Her math skills and her cursive handwriting were at a third grade 

level. Id. She was being home-schooled and attended physical therapy and special 

education sessions. Tr. 48. According to her mother, Eilise has been making 

progress and “she’s learning faster all the time.” Id. 

II. Procedural History

Acting through their attorney, the Moriartys filed a petition on December 31, 

2003. In this original petition, they alleged that vaccines caused Eilise to suffer 

autism. Their designation led to this case being grouped and stayed with other 

cases involving autism. 

After special masters issued decisions in the lead cases of the autism 

omnibus proceeding, the special master to whom this case was assigned ordered 
16

the Moriartys to file an amended petition. The amended petition no longer referred 

to autism. Eilise does not have autism. Tr. 244. Instead, the Moriartys claimed 

that she suffered a “seizure disorder and encephalopathy.” Am. Pet., filed July 14, 

2011, ¶ 12. 

Nearly eight years after the original petition was filed, the Moriartys filed 

the initial set of medical records on August 15, 2011. Another set was submitted 

on October 14, 2011. 

The Secretary reviewed this material and concluded that the evidence did not 

support an award of compensation. To the Secretary, the notations of treating 

doctors associating Eilise’s MMR vaccination with her subsequent neurological 

problems were not persuasive. The Secretary also noted that the Moriartys had not 

presented the report of an expert discussing causation. Resp’t’s Rep’t, filed Jan. 

13, 2012, at 16-17. 

After the Moriartys filed two more sets of records, the parties obtained 

reports from experts. The petitioners submitted a report from Yuval Shafrir, M.D.

and his curriculum vitae. Exhibits 35-36. The respondent countered with a report 

from John MacDonald, M.D., his curriculum vitae, and articles. Exhibits A-B. 

By a March 1, 2013 order, the special master set the case for hearing on May 

6, 2013. She also set a deadline of April 5, 2013, for the submission of any 

medical literature and a deadline of April 22, 2013, for the submission of various 

other documents such as briefs. On March 26, 2013, the case was reassigned to 

another special master. 

The parties complied with the March 1, 2013 order. The Moriartys filed a 

second report from Dr. Shafrir, exhibit 37, on April 3, 2013, and additional 

medical records a few days later. The Secretary responded by filing a second 

report from Dr. MacDonald, exhibit C, on April 22, 2013. On April 22, 2013, both 

parties also filed briefs. 

The hearing was held on May 6, 2013. Five witnesses testified. Three 

witnesses testified about Eilise’s medical history: Harris Moriarty (her brother), 

Marie Louise Moriarty (her mother), and Stephen Moriarty (her father). The other 

two witnesses were Dr. Shafrir and Dr. MacDonald. 
17

The then-assigned special master set a schedule for submitting briefs. Order, 

filed July 17, 2013. In the midst of this process, the term of service for this special 

master ended and the case was re-assigned to the undersigned. The undersigned 

issued an order directing both parties to state whether they wanted a second 

hearing. The Moriartys stated that they do “not believe that conducting another 

hearing, rather than the Special Master simply relying on the evidence as 

submitted, is necessary and therefore respectfully decline[] to request a new 

hearing.” Pet’rs’ Status Rep’t, filed Oct. 8, 2013. The Secretary also declined an 

opportunity for another hearing. Resp’t’s Status Rep’t, filed Oct. 25, 2013. 

Consequently, the parties submitted their briefs. With the submission of the 

Moriartys’ reply brief, the case is ready for adjudication. 

III. Standards for Adjudication

The elements of the Moriartys’ case are set forth in the often cited passage 

from the Federal Circuit’s decision in Althen: “(1) a medical theory causally 

connecting the vaccination and the injury; (2) a logical sequence of cause and 

effect showing that the vaccination was the reason for the injury; and (3) a showing 

of a proximate temporal relationship between vaccination and injury.” Althen v. 

Sec'y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). The 

burden of proof is preponderance of the evidence. Id.

IV. Theory

The first element of petitioners’ case has been described as a “can it?” 

question which asks whether the vaccine could cause the alleged injury. See

Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352, 1356 (Fed. Cir. 2006) 

(affirming special master’s use of “can cause” and “did cause” as consistent with 

the Althen test); Veryzer v. Sec'y of Health & Human Servs., 100 Fed. Cl. 344, 352 

(2011) (describing the first prong of Althen as presenting the question of general 

causation). The theory that the Moriartys are advancing to connect the MMR

vaccination to Eilise’s condition has evolved throughout the litigation. After the 

submission of all the evidence (written medical records and oral testimony), the 

Moriartys claim that the measles vaccine “triggered an immune-mediated reaction 

in [Eilise’s] body that led to an epileptic encephalopathy.” Pet’rs’ Posthr’g Br. at 
18

6. Thus, this theory will be evaluated in this decision.11 The specific mechanism is 

the production of antibodies against measles that attack the brain. Tr. 159.12 

In Dr. Shafrir’s opinion, the measles vaccine can cause various adverse 

reactions. Manifestations of an adverse reaction include acute disseminated 

encephalomyelitis (“ADEM”) and cerebral ataxia. Tr. 159, 180. Another type of 

manifestation along this spectrum, according to Dr. Shafrir, is an epileptic 

encephalopathy. Tr. 159. 

Dr. Shafrir has a sound basis for saying vaccines can cause ADEM. Many 

cases have made that finding.13 However, petitioners failed to demonstrate how 

the measles vaccine would cause an autoimmune epileptic encephalopathy. 

 

11 Dr. Shafrir’s first report, exhibit 35, recites information about Eilise’s medical history 

for the first seven pages of the eight page report. On the final page, Dr. Shafrir asserts that Eilise

suffered an encephalopathy within the time period associated with measles vaccine on the 

Vaccine Injury Table. But, otherwise, Dr. Shafrir’s first report fails to present any theory 

explaining how any vaccine can cause an encephalopathy. The Moriartys are not pursuing an 

on-Table claim. Pet’rs’ Posthr’g Br. at 2-3. 

In his second report, exhibit 37, Dr. Shafrir discusses a connection between measles 

vaccination and encephalopathy. He chiefly relies upon the National Childhood Encephalopathy 

Study (NCES) and also discusses other articles. Although he mentioned the diphtheria-tetanuspertussis vaccine briefly, his opinion is that “Eilise’s epileptic encephalopathy sits within the 

spectrum of MMR vaccine encephalopathy.” Exhibit 37 at 4; accord Tr. 169. 

12 Dr. Shafrir rejected two other possible mechanisms – a direct invasion of the brain by 

the measles virus and a dormant infection. Tr. 157-59, 207-09. 

13 Special masters have found that various vaccines are linked to ADEM. See Daniels v. 

Sec'y of Health & Human Servs., No. 07-462V, 2012 WL 763175 (Fed. Cl. Spec. Mstr. Feb. 16, 

2012) (awarding compensation for ADEM linked to a flu vaccine); Brown v. Sec'y of Health & 

Human Servs., No. 09-426V, 2011 WL 5029865 (Fed. Cl. Spec. Mstr. Sept. 30, 2011) (awarding 

compensation for ADEM linked to a flu vaccine); Hawkins v. Sec'y of Health & Human Servs., 

99-450V, 2009 WL 711931 (Fed. Cl. Spec. Mstr. Feb. 27, 2009) (awarding compensation for 

ADEM linked to a hepatitis B vaccine); Banks v. Sec'y of Health & Human Servs., No. 02-

0738V, 2007 WL 2296047 (Fed. Cl. Spec. Mstr. July 20, 2007) (awarding compensation for 

ADEM linked to an MMR vaccine); Camerlin ex rel. Camerlin v. Sec'y of Health & Human 

Servs., No. 99-615V, 2003 WL 22853070 (Fed. Cl. Spec. Mstr. Oct. 29, 2003) (awarding 

compensation, finding that HiB vaccine was a substantial factor related to ADEM); Kuperus ex 
19

Petitioners elicited very little testimony about the basis for Dr. Shafrir’s 

opinion that the measles vaccine can cause an epileptic encephalopathy. Their 

direct examination on this topic was covered in approximately three transcript 

pages. Tr. 158-60; see also Pet’rs’ Posthr’g Br. at 6-10 (citing only these three 

pages from direct examination for petitioners’ prong one argument). It is difficult 

to find such a cursory presentation persuasive. See La Londe v. Sec'y of Health & 

Human Servs., 110 Fed. Cl. 184, 201 (2013) (the petitioner’s expert “could not 

back up his hypothesis with a reliable medical or scientific explanation. . . . [The 

special master] quite properly required petitioner to carry her burden to bring 

forward a reliable medical or scientific explanation”), aff’d, 746 F.3d 1334, 1340 

(Fed. Cir. 2014); Langland v. Sec'y of Health & Human Servs., 109 Fed. Cl. 421, 

441 (2013) (“the Special Master did not commit a legal error by requiring a 

sufficiently-detailed explanation of how” a vaccine can cause a disease); Taylor v. 

Sec'y of Health & Human Servs., 108 Fed. Cl. 807, 819 (2013) (“the mere 

existence” of expert testimony about a theory “is insufficient to satisfy the burden 

of showing a ‘persuasive’ medical theory --- this theory must also preponderate”).

Although Dr. Shafrir had cited various articles in support of his opinion in 

his second report, exhibit 37, petitioners did not elicit testimony from Dr. Shafrir 

about these articles as part of the direct examination.14 When an expert does not 

explain the relevance of the article, a special master is not required to interpret the 

study without the benefit of an expert’s guidance. Moberly v. Sec’y of Health & 

Human Servs., 85 Fed. Cl. 571, 598 (2009), aff’d, 592 F.3d 1315 (Fed. Cir. 2010). 

The lack of direct testimony from Dr. Shafrir was ameliorated to some 

extent because the Secretary and the presiding special master inquired about a few

of the articles that Dr. Shafrir cited. Tr. 174-83, 202. During cross-examination, 

the Secretary questioned Dr. Shafrir about the Pampiglione article, exhibit 42 (G. 

Pampiglione et al., Transient Cerebral Changes After Vaccination Against 

 

rel. Kuperus v. Sec'y of Health & Human Servs., No. 01-0060V, 2003 WL 22912885 (Fed. Cl. 

Spec. Mstr. Oct. 23, 2003) (awarding compensation for ADEM linked to DTaP vaccine).

14 The Moriartys did ask Dr. Shafrir about the Pampiglione and Gibbs articles in the 

rebuttal phase. Tr. 305-06. 
20

Measles, 298 (7714) Lancet 5 (1971)); Tr. 176-82, and the Gibbs article, exhibit 44

(Frederic A. Gibbs and Ira M. Rosenthal, Electroencephalopathy in Natural and 

Attenuated Measles, 103 Am J of Diseases of Children 395 (1962)); Tr. 182-83.

In the Pampiglione study, eight children received an injection of live 

attenuated measles vaccine, Beckenham 31 strain, and were observed with a 

control group of three children for a total of three weeks after vaccination. Exhibit 

42 at 2.15 The researchers established a baseline for EEGs, taking two or three for 

each child prior to vaccination. Id. Each child then underwent an EEG four times 

after vaccination: once on the date of vaccination, then seven, nine, and fourteen 

days after vaccination. Id. The researchers found EEG changes in six of the eight 

vaccinated children, but no EEG changes in the control group. Id. at 3. The EEG 

changes were characterized as “fairly uniform.” Id. (the researchers noted that “on 

no occasion did spikes or complex waves form”). All EEG changes disappeared 

within fourteen days after vaccination. Id. The researchers concluded that EEG 

changes after vaccination were more common than previously suggested, and that 

the reversible changes have a time relationship to the date of vaccination. Id. at 4. 

However, they also noted that different types of live attenuated vaccines may relate 

to the incidence and severity of EEG changes. 

When asked about the relevance of the Pampiglione study, Dr. Shafrir 

explained that he “just wanted to show that there was a very viable, well-supported 

possibility that the measles vaccination will cause EEG changes” and sometimes 

will lead to epileptic encephalopathy. Tr. 179.

16

 

 

15 The Secretary pointed out that Pampiglione studied a different strain of the measles 

vaccine than Eilise received. Tr. 179. 

16 Dr. Shafrir further explained that he included the Pampiglione study to demonstrate 

how healthy children can develop a neurological disease when they are exposed to neurological 

change, such as a vaccine or infection. Tr. 181-82. The reason some otherwise healthy children 

develop neurological change is because there is “something peculiar about them . . . [such as] 

acute cerebellar ataxia.” Tr. 181. He attributed the cause of acute cerebellar ataxia mostly to 

chicken pox. Tr. 180. However, Dr. Shafrir seems to have digressed because Eilise only 

initially had ataxia, and she did not have chicken pox. Tr. 181. 
21

Dr. MacDonald discussed the outdated eight-channel EEG method used in 

the Pampiglione article. Tr. 248. Dr. MacDonald explained that this method limits 

the reader’s “ability to interpret the EEG, but given who was reading them they did 

the best they [could].” Id. On rebuttal, Dr. Shafrir indicated that the eight-channel 

EEG has the same information as a 32-channel or 64-channel EEG, but the reader 

has to look at the brain from more directions. Tr. 305. 

The Secretary’s counsel also asked Dr. Shafrir about the Gibbs article. Tr. 

182-84; see also exhibit 44 (Gibbs & Rosenthal (1962)). In this study from 1962, 

Gibbs and Rosenthal sought to determine whether children vaccinated with 

attenuated measles virus developed EEG abnormalities similar to those seen in 

untreated (no gammaglobulin received) measles cases. The authors first screened 

for natural immunity to the measles virus and identified 28 nonimmune children. 

Of this group, 15 were classified as having normal health and the remaining 13 had 

either metabolic or neurologic diseases. Exhibit 44 at 4. Each child was 

vaccinated with attenuated measles virus then monitored by EEG twice, once 

directly following vaccination, and again 9-13 days later. Id.

Six of the children with histories of metabolic or neurologic disease had 

abnormal initial EEGs with unchanged readings 9-13 days later. Id. at 5. Of the 

remaining twenty-two children (15 normal health, 7 with disease history), all had 

normal initial EEGs and only one child’s EEG changed after vaccination. Id. This 

child was of normal health but had developed a respiratory infection two days after 

vaccination, and the observed EEG changes were attributed to this intercurrent 

infection. Id. The child underwent another EEG one month later, which was 

normal. Id. Although the authors noted that the measles vaccine could not be 

completely ruled out as the cause of the child’s abnormal EEG, they found the 

most likely cause to be the intercurrent infection and concluded that encephalitis 

from attenuated measles vaccine was “extremely unlikely.” Id. at 7. 

Dr. MacDonald made the same remarks about the eight-channel EEG 

method, which was also used in the Gibbs study. Tr. 248. Respondent argues that 

the medical literature cited by petitioners does not support their case. Resp’t’s 

Posthr’g Br. at 14-15. 

The Gibbs article does not support Dr. Shafrir’s previous point from the 

Pampiglione article discussion. The one child in the Gibbs study did not have 

cerebellar ataxia or other preexisting neurologic disease. Tr. 183. Additionally, 
22

when Dr. Shafrir was asked if “the abnormal, slow activity would quickly subside 

and the EEG [would] revert back to normal,” he answered, “Yes.” Id. 

These two articles do not establish the reliability of Dr. Shafrir’s theory. 

The Pampiglione study did not support Dr. Shafrir’s reasoning because the 

children did not develop epileptic encephalopathy and the children’s EEG changes 

disappeared after 14 days. The Gibbs article did not appear relevant to Dr. 

Shafrir’s opinion of Eilise’s condition because the study indicated that the EEG 

changes were due to intercurrent illness rather than vaccination. 

After the Secretary challenged Dr. Shafrir, the Moriartys did relatively little 

to rehabilitate his opinion by demonstrating its reliability. Rather, in their reply,

the Moriartys appear to be relying upon testimony from the Secretary’s expert, Dr. 

MacDonald. Pet’rs’ Posthr’g Reply Br., filed Feb. 3, 2014, at 5. While the 

Moriartys argue that Dr. MacDonald “conceded the plausibility of Dr. Shafrir’s 

theories,” Pet’rs’ Reply at 5, the Moriartys exaggerated the consequence of Dr. 

MacDonald’s “concession.” Dr. MacDonald did not say that Dr. Shafrir’s theories 

were “plausible.” When asked whether the measles vaccine can cause an 

encephalopathy resulting in epilepsy, Dr. MacDonald testified “it’s possible.” Tr. 

272. There’s a difference between “possibility” and “plausibility.” Additionally, 

even if Dr. MacDonald had said Dr. Shafrir’s theory was “plausible,” this 

testimony would not get the petitioners very far. The petitioners’ burden is to 

demonstrate the probability, not just the plausibility, of the theory. Bast v. Sec'y of 

Health & Human Servs., No. 01-565V, 2014 WL 3719188, at *28 (Fed. Cl. July 8, 

2014) (“[N]ot excluding a possibility is far from conceding a probability. The 

preponderance of the evidence standard requires more than proof of a mere 

possibility.”); Doe v. Sec'y of Health & Human Servs., 19 Cl. Ct. 439, 450 (1990) 

(“[A]n assertion that something is ‘highly possible’ does not rise to the level 

necessary to establish causation by a preponderance of the evidence[.]”); see also 

Moberly, 592 F.3d at 1322. In fact, Dr. MacDonald ultimately testified that there 

is no evidence to support the conclusion that the MMR vaccine can cause 

autoimmune epileptic encephalopathy. Tr. 223, 246, 260, 273-74. 

Rather than relying on the Secretary’s expert, petitioners would have been 

more persuasive if they had developed Dr. Shafrir’s medical theory. But, Dr. 

Shafrir was unpersuasive. Consequently, petitioners failed to demonstrate that the 

MMR vaccine can cause an autoimmune epileptic encephalopathy, and failed to 

meet Althen prong 1. 
23

V. Logical Sequence

The second element is to establish by preponderant evidence “a logical 

sequence of cause and effect” showing that the MMR vaccine did in fact cause

Eilise’s autoimmune epileptic encephalopathy. Althen, 418 F.3d at 1274. A 

logical presentation from petitioners would entail showing that Eilise’s response to 

the MMR vaccine was consistent with the theory Dr. Shafrir articulated. See

Hibbard v. Sec'y of Health & Human Servs., 698 F.3d 1355, 1364 (Fed. Cir. 2012); 

Dodd v. Sec'y of Health & Human Servs., 114 Fed. Cl. 43, 52-57 (2013); La 

Londe, 110 Fed. Cl. at 205. Another aspect of proof on this element is to consider 

the views of treating doctors. Capizzano v. Sec'y of Health & Human Servs., 440 

F.3d 1317, 1326 (Fed. Cir. 2006) (“[T]reating physicians are likely to be in the best 

position to determine whether ‘a logical sequence of cause and effect show[s] that 

the vaccination was the reason for the injury.’”)

The Moriartys’ presentation on this point was spotty. In their direct 

examination of Dr. Shafrir, they asked relatively few questions about why he 

believed that the MMR vaccine specifically caused Eilise’s epileptic 

encephalopathy. See Tr. 161. Later, the presiding special master asked Dr. Shafrir 

to elaborate. He explained that the basis for his finding a logical sequence of cause 

and effect was that: (a) the literature demonstrates that MMR vaccine can cause an 

encephalopathy, and (b) he did not identify any other cause for Eilise’s condition. 

Tr. 216-17. 

This reasoning is not adequate. As Dr. MacDonald noted, it would be 

illogical to find that because the cause of Eilise’s problems has not been identified, 

the cause must be the vaccine. Tr. 244; see also Caves v. Sec'y of Health & 

Human Servs., 100 Fed. Cl. 119, 140-41 (2011) (explaining that the ruling out of 

other potentially known causes of a condition does not necessarily mean the 

vaccine caused the condition), aff’d, 463 Fed. Appx. 932 (Fed. Cir. 2012). More 

importantly, the Federal Circuit has consistently rejected reasoning based upon the 

postulates of “the vaccine can cause” a particular condition and “no other cause has 

been found.” Hibbard, 698 F.3d at 1365-66 (Fed Cir. 2012); accord Moberly, 592 

F.3d at 1323; Althen, 418 F.3d at 1278. 

The gaps in the Moriartys’ evidence are also reflected in their brief. Most of 

their argument regarding Althen prong 2 is devoted to explaining that Eilise suffers 

from an epileptic encephalopathy. The remainder of this section of their brief 

discusses the progression of Eilise’s epileptic encephalopathy. While these aspects 
24

are important, the Moriartys skip past the most important issue --- what caused the 

epileptic encephalopathy in the first place. See Pet’rs’ Posthr’g Br. at 10-12. 

The Moriartys’ problem stems, in part, from the vagueness in Dr. Shafrir’s 

theory for how the MMR vaccine can cause an epileptic encephalopathy. As 

described in the preceding section, the Moriartys maintain that Eilise epileptic 

encephalopathy was “immune-mediated.” Pet’rs’ Posthr’g Br. at 6. As also 

discussed in the preceding section, the Moriartys presented thin support for the 

theory that the MMR vaccine can cause an autoimmune epileptic encephalopathy. 

Hence, the Moriartys failed to meet their burden of proof on the first Althen prong. 

Even if there were persuasive evidence that a vaccine can cause an 

autoimmune epileptic encephalopathy, petitioners are required to establish that 

Eilise suffered an autoimmune epileptic encephalopathy. See Hibbard, 698 F.3d at 

1364, Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1345 (Fed. 

Cir. 2010) (stating “a petitioner must provide a reputable medical or scientific 

explanation that pertains specifically to the petitioner’s case”). Dr. Shafrir 

identified few, if any, solid bases for his conclusion that Eilise suffered from an 

epileptic encephalopathy that was autoimmune in origin. He stated that “no 

specific clinical signs” are associated with autoimmune epileptic encephalopathy 

Tr. 214, 216. Instead, Dr. Shafrir was relying upon his “clinical experience” and 

the sequence of events in which the vaccination preceded Eilise’s January 7, 2001

seizure. Tr. 214. 

Dr. MacDonald, by contrast, testified that Eilise’s presentation did not 

resemble an autoimmune epileptic encephalopathy. Tr. 293. These patients most 

commonly present with “lethargy, behavioral issues, confusion, speech loss, 

aphasia, a whole host of cognitive problems, balance problems, hemiparesis.” Tr. 

290. Additionally, objective evidence of an autoimmune encephalopathy may 

include brain swelling on an MRI scan, lateral and focal neurological damage, 

elevated white cells, and changes in gammaglobulin levels. Tr. 291. An 

autoimmune process that affects the brain is likely to be visible on an MRI. The 

MRI would be grossly abnormal and the EEG would show “total disorganization.” 

Tr. 290. Seizures stemming from an autoimmune process would not be sporadic. 

Tr. 287. 

As to whether Eilise suffered from an autoimmune epileptic encephalopathy, 

Dr. MacDonald was more persuasive than Dr. Shafrir. First, although Dr. Shafrir 

relied on his clinical experience, he admitted he was referring to only a few 
25

patients. Tr. 193-96. Second, it is unusual for a disease not to have any typical 

clinical symptoms as Dr. Shafrir asserted. Dr. MacDonald was more credible 

when he provided a list of clinical signs and diagnostic assessments. Dr. 

MacDonald’s persuasiveness on this topic was enhanced by the lack of 

contradiction from Dr. Shafrir. With respect to Eilise’s clinical presentation, Dr. 

MacDonald stated he did not “know of any clinical scenario that [he] could accept 

where [there is] an ongoing autoimmune process that’s damaging the brain” where 

there is a history of “a day and a half of fever and then two weeks with nothing.” 

Tr. 260. Dr. MacDonald disagreed with the assertion that Eilise had autoimmune 

epileptic encephalopathy because in his experience, patients are “desperately sick” 

if they have immune-mediated encephalopathies that result in seizures. Tr. 276. 

Additionally, Dr. MacDonald’s suggestion that an autoimmune process is likely to 

cause changes on neuroimaging studies rings true. See Ricci v. Sec’y of Health & 

Human Servs., No. 99-524V, 2011 WL 2260391, at *8-10 (Fed. Cl. Spec. Mstr. 

May 16, 2011), mot. for review denied, 101 Fed. Cl. 385 (2011). Dr. Shafrir, on 

the other hand, essentially identifies no criteria, and ultimately, his opinion that 

Eilise suffered from an autoimmune epileptic encephalopathy is not persuasive. 

Moreover, Eilise’s treating doctors did not identify her problem as 

autoimmune in origin. If they thought she was having an autoimmune reaction, 

then the proper course, according to Dr. Shafrir, would have been to prescribe 

intravenous immunoglobulin or steroids. But, the doctors did not, as Dr. Shafrir 

conceded. Tr. 215-16, 219. Dr. MacDonald’s assessment of how Eilise’s doctors 

would have responded was similar. In his view, Eilise’s treating doctors did not 

think that her condition was autoimmune related because, at a minimum, they 

would have done a spinal tap. Tr. 272. The treatment ordered by Eilise’s doctors, 

although not dispositive, tends to support Dr. MacDonald’s opinion that Eilise did 

not suffer an autoimmune disorder. See Capizzano, 440 F.3d at 1326 (favoring 

views of treating doctors). 

Finally, how the treating doctors viewed Eilise when they were treating her 

in 2001 makes relying upon later occasional statements linking the MMR 

vaccination to the onset of Eilise’s seizure disorder problematic. Examples include 

Dr. Varia’s report from 2004, exhibit 18 at 74 (stating Eilise had a “medically 

acknowledged MMR reaction, Lennox [Gastaut]), an occupational therapist’s 

report from 2005, exhibit 18 at 42 (stating Eilise’s “medical team attributed her 

seizures to a reaction to her MMR injection), and a speech pathologist’s report 

from 2005, exhibit 18 at 62 (indicating that Eilise presented with an 

“expressive/receptive language delay as a result of seizure activity prompted by an 
26

adverse reaction to an MMR vaccine in January 2001”). These passages occur in 

the parts of the reports giving Eilise’s remote history. Presumably, the source of 

information for this material was Ms. Moriarty. While Ms. Moriarty may 

genuinely believe that the doctors attributed Eilise’s seizure disorder to an adverse 

reaction to the MMR vaccine, she has not identified any record from a doctor 

directly. Regardless of the sincerity of Ms. Moriarty’s belief, her views about 

causation are not persuasive because she is not a medical doctor. See 42 

U.S.C. § 300aa—13 (stating the special master may not find in favor of the 

petitioner “based on the claims of a petitioner alone, unsubstantiated by medical 

records or medical opinion”). 

In short, although Dr. Shafrir claimed Eilise suffered an epileptic 

encephalopathy that was immune-mediated, he did not explain the basis for his 

opinion. Dr. Shafrir, for example, failed to list any clinical symptoms for an 

immune-mediated epileptic encephalopathy. In contrast, Dr. MacDonald provided 

an unrebutted list of symptoms and diagnostic signs most of which Eilise did not 

start experiencing in January 2001, when the alleged autoimmune epileptic 

encephalopathy began. Consequently, the Moriartys failed to demonstrate an 

autoimmune basis for Eilise’s epileptic encephalopathy. Since Dr. Shafrir’s theory 

proposes the MMR vaccine would cause an autoimmune reaction leading to 

epileptic encephalopathy, the petitioners’ case is not logical. Eilise’s presentation 

does not match Dr. Shafrir’s theory. Therefore, they necessarily failed to establish 

Althen prong 2. 

VI. Timing

In addition to presenting a reliable medical theory explaining how the MMR 

vaccine can cause an autoimmune epileptic encephalopathy and a logical sequence 

of cause and effect between Eilise’s MMR vaccination and her autoimmune 

epileptic encephalopathy, the Moriartys must also show that Eilise’s first 

manifestation of autoimmune epileptic encephalopathy occurred in a medically 

appropriate timeframe to infer causation. Bazan v. Sec’y of Health & Human 

Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). To satisfy the third Althen prong, 

the petitioners’ burden is to present “preponderant proof that the onset of 

symptoms occurred within a timeframe which, given the medical understanding of 

the disorder’s etiology, it is medically acceptable to infer causation.” Bazan, 539 

F.3d at 1352; accord Shapiro v. Sec'y of Health & Human Servs., 101 Fed. Cl. 532, 

542-43 (2011), reconsideration denied after remand, 105 Fed. Cl. 353 (2012), aff’d 

without opinion, 503 Fed. App’x 952 (Fed. Cir. 2013). 
27

For the first aspect of the third prong of Althen, Dr. Shafrir relies upon the

NCES. The NCES detected an increased risk that a person who received an MMR 

vaccine would develop an encephalopathy between 7-14 days after vaccination. 

Exhibit 39 at 29; Tr. 152-53. Dr. Shafrir shortened the anticipated interval because 

Eilise’s MMR vaccination was actually a booster dose. For a booster dose, Dr. 

Shafrir expected any reaction (adverse or not) would be “faster . . . and stronger.” 

Tr. 154.

17

 Dr. MacDonald agreed that the second exposure to an antigen may 

produce a sooner reaction. Tr. 286. 

For the second aspect of the third prong of Althen, the Moriartys maintain 

that Eilise started manifesting her epileptic encephalopathy on January 7, 2001, the 

day her brother witnessed Eilise moving unusually while watching television. 

Pet’rs’ Posthr’g Br. at 13; Pet’rs’ Posthr’g Reply Br., filed Feb. 3, 2014, at 2-3. 

Since Eilise received the MMR vaccine on January 2, 2001, exhibit 8 at 77, the 

interval between vaccination and onset is five days. The Moriartys also point out 

that since Eilise received her vaccination early on January 2, 2001, and her episode 

happened late on January 7, 2001, the interval is nearly six days. Pet’rs’ Posthr’g 

Br. at 13. 

The Secretary’s primary argument on prong 3 is to question whether Eilise 

started having neurologic problems on January 7, 2001. Resp’t’s Posthr’g Br. at 

16-18. As explained in the Facts, Dr. Shafrir and Dr. MacDonald dispute whether 

Eilise’s episode on January 7, 2001 was a seizure.18 And, as also discussed above, 

preponderant evidence established that Eilise did have a seizure on January 7, 

2001. 

 

17 According to petitioners, a stronger and faster response is part of the anamnestic 

response. Pet’rs’ Posthr’g Br. at 13 n.10. While petitioners are probably correct, they should be 

mindful that assertions of counsel are not evidence. See United States Philips Corp. v. 

Windmere Corp., 861 F.2d 695, 707 (Fed. Cir. 1988).

18 If Eilise did not manifest her epileptic encephalopathy on January 7, 2001, then her 

initial manifestation would be when she had a seizure on January 23, 2001. Exhibit 17 at 3. 

Under this scenario, the latency between vaccination and onset is 22 days. 

The Moriartys did not present any basis for lengthening the longer interval found in the 

NCES, which was 15 days. Dr. Shafrir actually acknowledged that if Eilise did not have a 

seizure on January 7, 2001, then it would be difficult to establish a connection between the MMR 

vaccination and her epileptic encephalopathy. Tr. 187. 
28

Whether petitioners met their burden of demonstrating a proximate temporal 

relationship between the date of vaccination and onset of symptoms is a close 

question. However, close calls are to be construed in the petitioners’ favor. 

Althen, 418 F.3d at 1280. Although the Moriartys met their burden on this prong, 

establishing temporal association is not sufficient to establish causation in fact. 

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

VII. Alternative Cause

For the reasons explained in the preceding sections, the Moriartys have not 

established Althen prongs 1 and 2. When petitioners fail to carry their burden, the 

Secretary is not required to present an alternative expression for the vaccinee’s 

injury. Bazan, 539 F.3d at 1352. Nevertheless, the Secretary has proposed a 

reason for Eilise’s neurologic problems and developmental delays – a deficiency in 

her ability to transport glucose. The specific medical term for this condition is 

glucose transporter I deficiency syndrome (“GLUT1”). See exhibit B (Dr. 

MacDonald’s report) at 4 (proposing this diagnosis).

In addition to Dr. MacDonald’s report, the Secretary submitted medical 

articles demonstrating that children with GLUT1 may suffer from developmental 

delay and seizures. The medical articles also stated people with this problem may 

benefit from the ketogenic diet because the brain substitutes ketones for glucose as 

an alternative energy source. Exhibit B, tab 7 (Jörg Klepper, Glucose transporter 

deficiency syndrome (GLUT1DS) and the ketogenic diet, 49 (Supp. 8) Epilepsia 

46 (2008)) at 1. 

Dr. Shafrir did not challenge the basic premise that GLUT1 may cause 

developmental delays. See Tr. 148-50, 188, 309. Instead, Dr. Shafrir questioned 

the conclusion that Eilise had GLUT1. He noted that none of Eilise’s treating 

doctors proposed GLUT1 deficiency. Tr. 151.

Dr. MacDonald relied upon Eilise’s medical history to support the 

possibility that Emily suffers from GLUT1. In his view, Eilise’s developmental 

problems before and after the vaccination reflect one continual process that was 

apparent at a very early age. Tr. 242-46. In addition, Eilise improved dramatically 

after starting the ketogenic diet. This rapid improvement suggests that the 

underlying cause of Eilise’s problems may have been metabolic. Tr. 236-37, 283.
29

Dr. Shafrir disagreed. He pointed out that after Eilise stopped the ketogenic 

diet, she did not deteriorate. In Dr. Shafrir’s opinion, if the introduction of ketones 

stopped seizures, then the removal of ketones should lead to seizures. Tr. 188. 

Without referencing any specific articles, Dr. MacDonald maintained that some 

recent studies have presented examples of children who improved on the ketogenic 

diet and remained improved after leaving the diet years later. Tr. 237.

Ultimately, this debate is largely academic. The best evidence about 

whether Eilise suffers from GLUT1 is genetic and metabolic testing that was not 

performed in this case. See Tr. 151 (Dr. Shafrir noting that the doctors at Johns 

Hopkins did not request this testing), 238 (Dr. MacDonald stating that if Eilise 

were his patient he would suggest genetic testing). Although Dr. MacDonald 

proposed genetic testing in his September 19, 2012 report, exhibit B at 4, the 

Secretary did not formally request testing. In addition, as noted at beginning of 

this section, the alternative factor analysis is required only after petitioners

otherwise demonstrate that the vaccine caused some harm. Because the Moriartys 

have not made this showing, further analysis of GLUT1 is not needed.19

VIII. Conclusion

Before her MMR vaccine, Eilise had developmental delay that was 

improving with therapy. On January 2, 2001, Eilise received her MMR vaccine. 

She developed seizures that started five to six days after the vaccine, and her 

seizures continued sporadically, until she started the ketogenic diet in June 2001. 

Eilise’s parents alleged that MMR vaccine can cause epileptic 

encephalopathy through an autoimmune process. However, the Moriartys’ proof 

was not persuasive on this point, and they did not establish Eilise suffered an 

autoimmune disorder. Thus, the Moriartys are not entitled to compensation. 

The Clerk’s Office is instructed to issue judgment in accord with this 

decision. 

IT IS SO ORDERED.

 

19 This outcome is consistent with the parties' briefing in that their submissions after the 

hearing did not discuss GLUT1.
30

s/ Christian J. Moran

Christian J. Moran

Special Master