Moriarty v. Secretary of Health and Human Services

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.
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,
2
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.
3
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.
4
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.
5
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.
6
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.
7
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.
8
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.
9
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.
10
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.”).
11
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).
12
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.
13
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.
14
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
15
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.
16
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
17
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-tetanus-
pertussis 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
18
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.
19
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.
20
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,
21
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.
22
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
23
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
24
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
25
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).
26
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.
27
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.
28
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.
29
s/ Christian J. Moran
Christian J. Moran
Special Master
30