Moriarty v. Hhs , 643 F. App'x 997 ( 2016 )

United States Court of Appeals
for the Federal Circuit
______________________
EILISE MORIARTY, A MINOR, BY HER PARENTS
AND NATURAL GUARDIANS, MARIE LOUISE
MORIARTY, AND STEPHEN MORIARTY,
Petitioners-Appellants
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee
______________________
2015-5072
______________________
Appeal from the United States Court of Federal
Claims in No. 1:03-vv-02876-TCW, Judge Thomas C.
Wheeler.
______________________
Decided: April 6, 2016
______________________
CLIFFORD JOHN SHOEMAKER, Shoemaker and Associ-
ates, Vienna, VA, argued for petitioners-appellants.
GLENN ALEXANDER MACLEOD, Vaccine/Torts Branch,
Civil Division, United States Department of Justice,
Washington, DC, argued for respondent-appellee. Also
represented by ALEXIS B. BABCOCK, CATHARINE E. REEVES,
VINCENT J. MATANOSKI, RUPA BHATTACHARYYA, BENJAMIN
C. MIZER.
2 MORIARTY v. HHS
______________________
Before MOORE, CLEVENGER, and REYNA, Circuit Judges.
MOORE, Circuit Judge.
Marie Louise and Stephen Moriarty (the “Moriartys”),
on behalf of their daughter Eilise, appeal the judgment of
the Court of Federal Claims that affirmed a special mas-
ter’s decision denying their petition for compensation
under the National Childhood Vaccine Injury Compensa-
tion Program, 42 U.S.C. § 300aa–1 to –34 (2006) (“Vaccine
Act”). We vacate and remand for further proceedings.
BACKGROUND
Eilise Moriarty was born in August 1996. Prior to re-
ceiving the vaccination at issue in this case, Eilise had
problems with her gross motor skills and language devel-
opment and was diagnosed with hypotonia and develop-
mental delay. But, following focused therapy to improve
her fine motor and speech skills, Eilise showed dramatic
improvement by October 2000.
On January 2, 2001, Eilise received three vaccina-
tions, including her second dose of the measles, mumps,
and rubella (“MMR”) vaccine. Five days later, Eilise’s
elder brother witnessed her arching her back, thrusting
her head back, rolling her eyes, and her left side jerking
in a strange, almost rhythmic pattern. Eilise’s brother
did not know what was happening at the time, but, after
having seen his sister have a number of seizures, he later
testified that Eilise had a seizure that day. The Moriar-
tys, who did not witness this seizure, noted that Eilise
was feverish and lethargic that night. Eilise went to
school the next day, but came home early and was run-
ning a fever in the late afternoon. Over the next two
weeks, Eilise attended school but was tired and lethargic.
On January 23, 2001, Eilise had a grand mal seizure
at school and was taken to a hospital. She had another
MORIARTY v. HHS 3
seizure there the following day. She was transferred to
another hospital where she underwent magnetic reso-
nance imaging (“MRI”) and electroencephalogram (“EEG”)
testing. Eilise’s MRI results were generally normal, but
her EEG results were abnormal, which the clinician noted
were “consistent with a clinical diagnosis of epilepsy.”
J.A. 600–01. Eilise continued to have seizures over the
next two days while her doctors adjusted her medication.
Once Eilise’s seizures were under control, she was dis-
charged on January 28, 2001. Dr. Elgin, a pediatric
neurologist, noted at Eilise’s discharge that she had a
“new onset of seizure disorder” and that “there seem to be
no precipitating factors causing the seizures.” J.A. 10.
Two days later, Dr. Vining, a neurologist at Johns Hop-
kins Medical Center, examined Eilise and her medical
records and noted that she had a new onset of seizures
with unknown etiology.
Eilise’s seizures continued to worsen throughout the
spring of 2001. Eilise was hospitalized twice for seizures
in March 2001. Some of these seizures were “drop at-
tacks” where Eilise would drop her head suddenly and
sometimes her entire body would collapse. During this
time, Dr. Elgin expressed her concern in a clinic report
that, while she showed some signs of improvement, Eilise
may have Lennox-Gastaut syndrome, which is a form of
age-dependent epileptic encephalopathy. 1 A second EEG
test performed during one of Eilise’s March hospital stays
was consistent with her having a clinical seizure disorder.
In April and May 2001, Eilise underwent various
tests to determine her continued eligibility for special
education services. Eilise’s test results showed that she
1 The Vaccine Injury Table, 42 U.S.C. § 300aa–
14(b)(3)(A), defines “encephalopathy” as “any significant
acquired abnormality of, or injury to, or impairment of
function of the brain.”
4 MORIARTY v. HHS
was delayed, especially verbally. In June 2001, Eilise was
admitted to Johns Hopkins Hospital because of intracta-
ble seizures and to begin a ketogenic diet. Eilise was a
“super-responder” to the ketogenic diet, and in October
2001, Eilise became seizure-free. Eilise stayed on the
ketogenic diet for over two years, remaining seizure-free,
before tapering off the diet. Eilise’s treating neurologist
during this time, Dr. Rubenstein, diagnosed her with
“[s]tatic encephalopathy of unknown etiology” and
“[i]ntractable seizures, resolved with ketogenic diet.” J.A.
396–97, 400–01.
In 2003, the Moriartys filed a petition under the Vac-
cine Act, alleging that Eilise suffered from autism as a
result of her vaccinations. Eilise’s petition was grouped
and stayed with other autism cases pending resolution of
lead cases in the omnibus autism proceedings. While her
petition was stayed, Eilise underwent examinations by a
clinical psychologist, an occupational therapist, and a
speech and language pathology clinician, all of whom
noted in the background sections of their reports that
Eilise’s seizures were attributed to her second MMR
vaccination. After decisions in the lead autism cases, the
Moriartys amended Eilise’s petition to remove the refer-
ence to autism, alleging instead that Eilise suffered from
a “seizure disorder and encephalopathy.” In May 2013, a
special master held a hearing where Eilise’s parents and
brother testified, along with Eilise’s expert, Dr. Shafrir,
and the government’s expert, Dr. MacDonald (both pedi-
atric neurologists). At the time of this hearing, Eilise was
17 years old but was reading at an “easy” fifth grade level
and had third grade level math skills. During the post-
hearing briefing process, Eilise’s petition was re-assigned
to a new special master because the previous one’s service
term ended. Both parties declined the new special mas-
ter’s offer of another hearing.
The special master denied Eilise’s petition. He de-
termined that the Moriartys failed to prove either the first
MORIARTY v. HHS 5
or second prongs of our three part test in Althen v. Secre-
tary of Health and Human Services, 418 F.3d 1274 (Fed.
Cir. 2005), as required for Eilise’s “off-Table” injury.
Regarding prong one, which requires a petitioner to show
a medical theory causally connecting the vaccination at
issue to the injury, Althen, 418 F.3d at 1278, the special
master noted that the Moriartys’ theory connecting Ei-
lise’s MMR vaccination to her condition had “evolved”
over time, ultimately becoming that the MMR vaccine
triggered an immune-mediated reaction that led to epilep-
tic encephalopathy. Eilise’s expert, Dr. Shafrir, cited
eight articles in his second report supporting this point,
but the special master declined to consider the contents of
that report or all of the cited articles because the Moriar-
tys “did not elicit testimony from Dr. Shafrir about these
articles as part of the direct examination.” J.A. 19.
Instead, the special master limited his consideration to
only two of the articles cited in Dr. Shafrir’s second expert
report, on the basis that the government had cross-
examined Dr. Shafrir about their contents. The special
master also noted that the government’s expert,
Dr. MacDonald, testified that “there is no evidence to
support the conclusion that the MMR vaccine can cause
autoimmune epileptic encephalopathy.” J.A. 22. Ulti-
mately, the special master determined that Dr. Shafrir
was unpersuasive, and consequently concluded that the
Moriartys failed to meet Althen prong one by “fail[ing] to
demonstrate that the MMR vaccine can cause an auto-
immune epileptic encephalopathy.” J.A. 22.
The special master also determined that the Moriar-
tys failed to prove Althen prong two, which requires
showing a logical sequence of cause and effect showing
that the vaccination at issue was the reason for the inju-
ry. See Althen, 418 F.3d at 1278. He explained that, even
if the Moriartys had met their burden to prove Althen
prong one, they failed to show that Eilise suffered from
autoimmune epileptic encephalopathy. He discounted
6 MORIARTY v. HHS
Dr. Shafrir’s testimony that Eilise suffered from this
condition because “Dr. Shafrir was relying upon his
‘clinical experience’ and the sequence of events in which
the vaccination preceded Eilise’s January 7, 2001 sei-
zure.” J.A. 24. Dr. MacDonald testified that patients
with autoimmune epileptic encephalopathy “most com-
monly present with ‘lethargy, behavioral issues, confu-
sion, speech loss, aphasia, a whole host of cognitive
problems, balance problems, hemiparesis’” and that
autoimmune encephalopathy “may include” various
objective evidence such as “brain swelling on an MRI
scan.” J.A. 24. The special master noted that “it is unu-
sual for a disease not to have any typical clinical symp-
toms” and found Dr. MacDonald “more credible [than
Dr. Shafrir] when he provided a list of clinical signs and
diagnostic assessments” for autoimmune epileptic en-
cephalopathy. J.A. 25. He cited Dr. MacDonald’s testi-
mony that Eilise did not have autoimmune epileptic
encephalopathy “because in his experience, patients are
‘desperately sick’ if they have immune-mediated encepha-
lopathies that result in seizures” and stated that
“Dr. MacDonald’s suggestion that an autoimmune process
is likely to cause changes on neuroimaging studies rings
true.” Id. He found that the treatment ordered by Eilise’s
treating doctors “tends to support Dr. MacDonald’s opin-
ion,” id., and that, ultimately, Dr. MacDonald was more
persuasive on this point than Dr. Shafrir.
Finally, the special master determined that the Mori-
artys met their burden to prove Althen prong three by
showing a proximate temporal relationship between
Eilise’s vaccination and her injury. The Court of Federal
Claims affirmed the special master’s decision. The Mori-
artys appeal. We have jurisdiction under 42 U.S.C. §
300aa–12(f).
MORIARTY v. HHS 7
DISCUSSION
We review the Court of Federal Claims’ decisions in
Vaccine Act cases de novo, applying the same standard
used by that court to review the special master’s determi-
nation. Moberly ex rel. Moberly v. Sec’y of Health &
Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010). We
only set aside findings of fact or conclusions of law that
are arbitrary, capricious, an abuse of discretion, or other-
wise not in accordance with law. 42 U.S.C. § 300aa–
12(e)(2)(B); Moberly, 592 F.2d at 1321.
Under the Vaccine Act, there are two types of injuries:
“Table” and “off-Table.” 42 U.S.C. §§ 300aa–11(c)(1)(C)(i),
300aa–11(c)(1)(C)(ii). Causation is presumed for Table
injuries when a specified condition follows the admin-
istration of a specified vaccine within a specified period of
time. Moberly, 592 F.3d at 1321 (citing 42 U.S.C.
§§ 300aa–11(c), 300aa–14). All other injuries are off-
Table injuries where the petitioner has to prove causation
by a preponderance of the evidence. Althen, 418 F.3d at
1278. The parties do not dispute that Eilise’s injury is in
the off-Table category, meaning that, in order to receive
compensation for Eilise’s injuries, the Moriartys must:
[S]how by preponderant evidence that the vac-
cination brought about her injury by providing: (1)
a medical theory causally connecting the vaccina-
tion 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 prox-
imate temporal relationship between vaccination
and injury.
Id. Only the first and second prongs of the Althen test are
at issue in this appeal because the special master found,
and the parties do not dispute, that the Moriartys proved
the third prong of the Althen test.
8 MORIARTY v. HHS
I.
The Moriartys argue that the special master erred in
determining that they did not meet their burden to prove
Althen prongs one and two for numerous reasons. With
respect to prong one, the Moriartys argue, inter alia, that
the special master erred by not considering the whole of
the record, which includes Dr. Shafrir’s second expert
report and the scientific articles discussed in that report.
The government counters that a review of the special
master’s decision shows that he considered both
Dr. Shafrir’s testimony and Dr. Shafrir’s filed expert
reports and the literature cited therein. We hold, as
explained below, that the special master erred by failing
to consider the entire record, including Dr. Shafrir’s
second expert report and the articles he cited, which is
relevant medical and scientific evidence present in the
record.
We start with the language of the statute, which in-
structs that “[c]ompensation shall be awarded under the
[Vaccine Act] to a petitioner if the special master or court
finds on the record as a whole” that the petitioner has met
his evidentiary burdens. 42 U.S.C. § 300aa–13(a)(1). The
statute then identifies matters to be considered by a
special master in determining whether to award compen-
sation, which include any medical records or reports
“contained in the record regarding the nature, causation,
and aggravation of the petitioner’s . . . injury” as well as
“all other relevant medical and scientific evidence con-
tained in the record.” Id. § 300aa–13(b). This section also
requires that special masters “shall consider the entire
record and the course of the injury” when evaluating the
weight to be afforded to any medical records or reports
present in the record. Id. Thus, this statutory language
indicates that a special master, reviewing the entire
record of the case before him, must consider all relevant
medical and scientific evidence contained in the record,
which includes any relevant medical records or reports. It
MORIARTY v. HHS 9
also instructs that the special master “shall” consider the
entire record, which includes this relevant evidence, when
assigning the weight given to particular evidence. With
this statutory guidance in mind, we now turn to the
specific issues in this case.
The issue in this case is whether the special master
erred by failing to consider relevant medical and scientific
evidence contained in the record. We conclude that he
has. The special master erred in concluding that he need
only review evidence of record which was the subject of
testimony at the hearing.
We generally presume that a special master consid-
ered the relevant record evidence even though he does not
explicitly reference such evidence in his decision. Ha-
zelhurst v. Sec’y of Health & Human Servs., 604 F.3d
1343, 1352 (Fed. Cir. 2010). However, this presumption
does not apply, as in this case, where a special master
indicates otherwise. Id. In his decision, the special
master recognized that Dr. Shafrir discussed a connection
between measles vaccination and encephalopathy in his
second expert report. J.A. 18 n.11. He noted that
Dr. Shafrir relied on and discussed several articles in this
report before stating the opinion that Eilise’s epileptic
encephalopathy sits within the spectrum of MMR vaccine
encephalopathy. Id. But the special master never consid-
ered Dr. Shafrir’s testimony contained in his second expert
report in reaching his decision that the Moriartys had
failed to prove Althen prong one. This report is relevant
medical or scientific evidence and it is part of the record
in this case. Instead, the special master refused to con-
sider both Dr. Shafrir’s written testimony and the articles
he relied upon in this report solely because he did not
testify about them at the hearing. The special master
wrote:
Although Dr. Shafrir had cited various articles in
support of his opinion in his second report, exhibit
10 MORIARTY v. HHS
37, petitioners did not elicit testimony from
Dr. Shafrir about these articles as part of the di-
rect examination. When an expert does not ex-
plain the relevance of the article, a special master
is not required to interpret the study without the
benefit of the 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).
J.A. 19 (footnote omitted). The special master then ad-
dressed only two of the articles cited in Dr. Shafrir’s
report because he found that 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.” Id.
There is thus no indication that the special master con-
sidered Dr. Shafrir’s written testimony in his second
report and the articles cited therein, and there is, in fact,
an affirmative indication that he did not do so.
Additional statements indicate that the special mas-
ter did not consider Dr. Shafrir’s written testimony in his
report or the articles he cited. In denying the Moriartys’
petition, the special master faulted them for “fail[ing] to
demonstrate how the measles vaccine would cause an
autoimmune epileptic encephalopathy,” and “elicit[ing]
very little testimony about the basis for Dr. Shafrir’s
opinion that the measles vaccine can cause an epileptic
encephalopathy.” J.A. 18–19; see also J.A. 22
(“[P]etitioners failed to demonstrate that the MMR vac-
cine can cause an autoimmune epileptic encephalopa-
thy.”). And the special master relied on Dr. MacDonald’s
testimony that “there is no evidence to support the con-
clusion that the MMR vaccine can cause autoimmune
epileptic encephalopathy.” J.A. 22. The special master
could not conclude that there is no evidence to support the
conclusion that the MMR vaccine can cause autoimmune
epileptic encephalopathy unless he was refusing to con-
sider the articles cited by Dr. Shafrir in his second expert
MORIARTY v. HHS 11
report. One such article, a five-page article by Weibel et
al., 2 cited and explained by Dr. Shafrir in his second
report, teaches the very point that the special master
faulted the Moriartys for failing to present evidence to
establish—that the MMR vaccine can cause autoimmune
epileptic encephalopathy.
Weibel analyzed data from claims submitted to the
National Vaccine Injury Compensation Program—claims
such as the one the Moriartys filed for Eilise here. The
objective of this article is “[t]o determine if there is evi-
dence for a causal relationship between acute encephalo-
pathy followed by permanent brain injury or death
associated with the administration of . . . [the] combined
measles, mumps, and rubella vaccine.” J.A. 1459. The
authors explain that encephalopathy has occurred in a
number of cases following measles infection and that
pleocytosis (i.e., an increase in the number of white blood
cells in the cerebral spinal fluid (“CSF”)) is reported in
about 20% of these patients. White blood cells, also called
leukocytes, are part of the immune system, and an in-
crease in their number can indicate, inter alia, an im-
mune system disorder or that the body is fighting off an
infection. The authors go on to explain on the first page of
2 Robert E. Weibel, Vito Caserta, David E. Benor, &
Geoffrey Evans, Acute Encephalopathy Followed by Per-
manent Brain Injury or Death Associated With Further
Attenuated Measles Vaccines: A Review of Claims Submit-
ted to the National Vaccine Injury Compensation Pro-
gram, 101(3) PEDIATRICS 383–87 (1998) (“Weibel”). We
note that the authors all work at either the Division of
Vaccine Injury Compensation, National Vaccine Injury
Compensation Program within the Health Resources and
Services Administration, or the Office of the General
Counsel at the Department of Health and Human Ser-
vices.
12 MORIARTY v. HHS
this article that, in cases of post-measles-infection en-
cephalopathy where pleocytosis is present, “the absence of
a detectable virus in the brain is obscure, but may be
suggestive of an autoimmune encephalopathy.” Id. (em-
phasis added). The authors then explain that prior case
reports and review articles suggest that similar neuro-
logic complications can also follow administration of a
measles vaccine. Thus, this article squarely addresses the
same disease allegedly suffered by Eilise: autoimmune
encephalopathy caused by administration of a measles
vaccine.
Based on their results, the Weibel authors concluded
that their data “suggests that a causal relationship be-
tween measles vaccine and encephalopathy may exist as a
rare complication of measles immunization.” J.A. 1459.
In reaching this conclusion, they found that most of the
children 3 who suffered acute encephalopathy after receiv-
ing a measles vaccine also exhibited seizures (34 out of
48) and nearly half developed a seizure disorder (23 out of
48). They also found that 11 of the 40 children (about
28%) for whom CSF analysis had been performed exhibit-
ed pleocytosis. In discussing their data, the authors state
that “[m]anifestations of acute encephalopathy including
loss of consciousness, ataxia, seizures, and pleocytosis
among these 48 children is similar to the clinical features
of acute encephalopathy described after natural measles
and other live measles vaccines.” J.A. 1462 (emphasis
added).
This article unmistakably talks about Eilise’s injury.
It suggests that the measles vaccine can cause encephalo-
3 The study’s inclusion criteria were that the child
suffered an acute encephalopathy of undetermined cause
within two to fifteen days of receiving a measles-
containing vaccine followed by permanent brain impair-
ment or death.
MORIARTY v. HHS 13
pathy, and it reports that the clinical features of this
encephalopathy include seizures (i.e., epileptic encephalo-
pathies) in a subset of children. Moreover, the article
explains that infection with the measles virus may cause
an autoimmune encephalopathy in some situations, and
that the medical evidence suggests that similar complica-
tions can occur following the measles vaccine. It also
reports that, as with natural measles infections, measles
vaccines are associated with pleocytosis in a subset of
patients. It cannot be reasonably disputed that this
article constitutes relevant scientific evidence.
Thus, to the extent that the special master’s recita-
tion of Dr. MacDonald’s testimony that there is “no evi-
dence” to support causation is a factual finding, that
factual finding is not supported—and, indeed, is contra-
dicted—by the evidence in the record. In ignoring Weibel
and Dr. Shafrir’s discussion of it in his second expert
report, the special master ignored relevant record evi-
dence that tends to prove the very point that the special
master faulted the Moriartys for failing to prove.
There are three errors with respect to the special
master’s assertion that he was not required to consider
the medical and scientific evidence of record. First, the
special master’s holding that he could decline to review
such evidence is legally erroneous. The special master
held: “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 Moberly decision does not support the special mas-
ter’s claim that he may refuse to consider relevant scien-
tific and medical evidence of record merely because it is
not explained by an expert. In fact, such a holding would
be in direct conflict with the governing statute which
requires the special master to consider all relevant medi-
cal and scientific evidence of record. As a preliminary
14 MORIARTY v. HHS
matter, we note that the Federal Circuit decision in
Moberly did not address this issue at all. The Court of
Federal Claims decision explained only that “a special
master may interpret and apply the conclusions of a
medical study introduced into the record by a party,
without the guidance of expert witnesses.” Moberly, 85
Fed. Cl. at 598. The Court of Federal Claims further
stated although the special master may interpret a medi-
cal study without assistance of any expert, it is possible
that a special master could conclude that “a particular
study, or aspects of a study” may not be able to be under-
stood absent such assistance and in those circumstances a
special master could decline to interpret that portion of
the study which he cannot understand. Id. Nowhere does
the Court of Federal Claims (or our own court in its
decision on the appeal) state that a special master is not
required to consider a reference. Indeed, such a holding
would be contrary to the statutory requirement that the
special master consider the record as a whole, including
all relevant scientific and medical evidence. A special
master is required to consider all relevant medical and
scientific evidence of record. And he is obligated to con-
sider such evidence even if it is not explained by the
testimony of an expert. However, if the technical com-
plexity of a particular study is such that the relevance of
the medical study or its particular findings cannot be
understood by the special master without expert assis-
tance that was not provided, then the special master may
conclude that this evidence or portion of the evidence is
entitled to little or no weight. And of course this sort of
factual determination would be reviewed under the arbi-
trary and capricious standard on appeal. But the special
master made no such finding in this case. In this case,
the special master found that he was not required to
consider the articles which the expert, Dr. Shafrir, did not
discuss in his oral testimony at the hearing. He stated
that “[a]lthough Dr. Shafrir had cited various articles in
support of his opinion in his second report, exhibit 37,
MORIARTY v. HHS 15
petitioners did not elicit testimony from Dr. Shafrir about
these articles as part of the direct examination. . . . 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
Dr. Shafrir cited.” J.A. 19. The special master then only
discussed the articles which Dr. Shafrir had offered oral
testimony about. The special master was not free to
decline to review the other medical and scientific articles
in the record simply because the expert had not testified
to them on direct or cross examination.
Second, the special master was clearly erroneous in
his assessment of which medical and scientific articles
Dr. Shafrir had offered testimony on. Since the special
master considered only oral testimony and not the expert
report of Dr. Shafrir he clearly erred in his review of the
Shafrir testimony. The special master did not consider
Dr. Shafrir’s discussion of the relevance of these articles
in his expert report. For example, Dr. Shafrir opined in
his report “that Eilise’s epileptic encephalopathy sits
within the spectrum of MMR vaccine encephalopathy”
and explained that Weibel describes “one side of the
spectrum” where measles vaccination was followed by
permanent brain injury or death and that these authors
concluded that the data they analyzed “suggests that
causal relationship between measles vaccine and en-
cephalopathy may exist as rare complications of measles
immunization.” J.A. 1382. This is not a case where the
expert simply cited a large number of references in a
voluminous expert report without providing any guidance
as to their relevance. The exact opposite is true—
Dr. Shafrir’s second report is a total of eight pages and
cites a total of eight articles. And the report does not
simply cite the eight articles without explanation, leaving
it to the special master to determine the articles’ rele-
vance. Rather, it explains the relevance of each article
and provides a numbered list summarizing Dr. Shafrir’s
16 MORIARTY v. HHS
conclusions based on these articles. It cannot be said that
Dr. Shafrir provided no guidance as to the relevance of
these articles. He did, and he did it concisely in his
second report.
We have never held that the relevance of particular
articles cited by an expert in a report must be explained
in the form of the expert’s testimony at a hearing in
Vaccine Act cases. Indeed, such a holding would be
contrary to the broad statutory instruction that the spe-
cial master consider the entire record, including all rele-
vant medical and scientific evidence contained in that
record, which includes expert reports such as the one at
issue here. Such a holding would also be contrary to the
Court of Federal Claims’ Vaccine Rule 8, which provides
that “[i]n receiving evidence, the special master will not
be bound by common law or statutory rules of evidence
but must consider all relevant and reliable evidence
governed by principles of fundamental fairness to both
parties.” Hazelhurst, 604 F.3d at 1349 (quoting Vaccine
R. 8(b)(1) (2009)). Vaccine Rule 8 also explains the forms
in which parties may present such evidence, namely “in
the form of documents, affidavits, or oral testimony which
may be given in person or by telephone, videoconference,
or videotape.” Vaccine R. 8(b)(2). As this rule instructs,
traditional rules of admissibility of evidence that apply in
district court actions do not apply in Vaccine Act proceed-
ings. See Hazelhurst, 604 F.3d at 1349. The use of more
flexible evidentiary rules, like the statutory instruction to
consider the entire record, is consistent with the purpose
of the Vaccine Act, which established “a no-fault compen-
sation program ‘designed to work faster and with greater
ease than the civil tort system.’” Bruesewitz v. Wyeth
LLC, 562 U.S. 223, 228 (2011) (quoting Shalala v. White-
cotton, 514 U.S. 268, 269 (1995)).
Moreover, we have repeatedly endorsed a special
master’s reliance on both the reports and testimony of
expert witnesses. See, e.g., Hazelhurst, 604 F.3d at 1349–
MORIARTY v. HHS 17
50 (finding no error in the “special master’s decision to
admit and consider [an expert’s] testimony and reports”);
Hibbard v. Sec’y of Health & Human Servs., 698 F.3d
1355, 1365 (Fed. Cir. 2012) (affirming a special master’s
decision where an expert’s “report and testimony made
clear” that whether the petitioner suffered a particular
injury was a necessary component of her case). Here, the
special master’s decision indicates that he did not consid-
er either the explanations regarding the relevance of
articles that Dr. Shafrir offered in his report or the arti-
cles themselves solely because Dr. Shafrir did not testify
on these points at the hearing. In so doing, the special
master erred.
Finally, contrary to the special master’s assertion,
Dr. Shafrir testified on direct about at least three of the
references cited in his second report when explaining his
opinion regarding Eilise’s injury and its causation. 4 For
example, Dr. Shafrir testified on direct that:
So I think that what Eilise suffered, based on a
case report that we also had that was published
with similar onset of epileptic encephalopathy af-
ter the measles vaccine that the same immune
mechanism that produced the [acute disseminated
encephalomyelitis], that produced the cerebral
ataxia, also it produced here a specific immune
mediated epileptic encephalopathy on top of what
she had before.
J.A. 210. And he further testified that “there is the entity
of immune mediated epileptic encephalopathy exists in
quite significant numbers. We have specific support
describing the same thing in others -- I think it was a
young man.” J.A. 211. In his second report, Dr. Shafrir
4 The special master found there was oral testimo-
ny about only two of the articles. J.A. 19.
18 MORIARTY v. HHS
cited and explained the relevance of a case report 5 involv-
ing a child who “developed epileptic encephalopathy on
day 14th [sic] after measles immunization.” J.A. 1384. He
explained that this child “developed rapid nodding of the
head” and, as his seizures increased in frequency, they
“occasionally produced falls.” Id. He noted that this child
was “finally diagnosed with Lennox-Gastaut syndrome”
and that, even so, the child’s neuroimaging and other
immunological studies were normal. Id. The case report
identified the affected child as “a 2-year-old boy with
Lennox-Gastaut syndrome,” J.A. 1488, consistent with
Dr. Shafrir’s testimony that the case report involved a
“young man.” Dr. Shafrir explained that this child had
not responded as well as Eilise to various seizure medica-
tions. Dr. Shafrir similarly testified about at least two
other articles cited and explained in his second expert
report. 6
5 Tatsuya Ishikawa, Chizuko Ogino, & Sangmi
Chang, Case Report: Lennox-Gastaut syndrome after a
further attenuated live measles vaccination, 21 Brain &
Development 563–65 (1995).
6 Dr. Shafrir’s hearing testimony specifically men-
tioned “studies by Gibbs” discussing patients with EEG
changes. J.A. 209. In his second report, Dr. Shafrir
identified and explained the relevance of two articles by
Gibbs et al., pointing out that two patients with measles
developed a “convulsive” (i.e., epileptic) disorder as docu-
mented by their changing EEG test results. J.A. 1383–86.
And, in fact, the special master recognized that
Dr. Shafrir included at least one article by Gibbs in his
second report because he relied on the government’s cross-
examination of Dr. Shafrir about that article in his deci-
sion.
Dr. Shafrir also testified on direct about “an article on
acute cerebral ataxia,” explaining that this disorder is
MORIARTY v. HHS 19
Admittedly, it would have been easier for the special
master if Dr. Shafrir’s hearing testimony clearly refer-
enced and discussed each of the articles. But that is not a
basis for the special master to refuse to consider relevant
scientific evidence in the record where the statutory
language, and even the Vaccine Rules, instruct that this
evidence must be considered. Given the statutory man-
date to consider all relevant medical and scientific evi-
dence of record, the special master’s refusal to do so is
arbitrary and capricious.
The special master’s refusal to consider Dr. Shafrir’s
second expert report and the references cited in it is
particularly concerning here given the procedural history
in this case. As noted above, a different special master
actually held the hearing at which Dr. Shafrir testified.
We generally give a special master “broad discretion in
determining credibility because he saw the witnesses and
heard the testimony.” Bradley v. Sec’y of Health & Hu-
man Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). But
here that general rule carries less force because the
special master who decided Eilise’s petition was not
present at this hearing such that he, like us, only has the
transcript of that proceeding on which to rely. See Oral
Argument at 16:00–51, available at
http://oralarguments.cafc.uscourts.gov/default.aspx?fl=20
“[an]other neuroimmune reaction to the vaccine” that is
“much less severe” than other disorders. J.A. 210. In his
second report, Dr. Shafrir explained that “[m]any of the
clinical phenomena seen with the actual infection with
measles, mumps, or rubella are seen with the vaccination”
and that some of these clinical phenomena are “immune
phenomena such as acute cerebellar ataxia” citing an
article titled “Gait disturbance interpreted as cerebellar
ataxia after MMR vaccination at 15 months of age: a
follow-up study.” J.A. 1382, 1386.
20 MORIARTY v. HHS
15-5072.mp3. In such a situation, consideration of the
entire record is particularly important in order to avoid
potentially overlooking relevant material.
II.
As the special master noted, much of the evidence rel-
evant to proving Althen prong one in this case is relevant
to proving Althen prong two. Thus, the special master’s
error in not considering relevant evidence with respect to
Althen prong one affects his analysis with respect to
prong two as well. Moreover, there is “no reason why
evidence used to satisfy one of the [Althen] prongs cannot
overlap to satisfy another prong.” Capizzano v. Sec’y of
Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir.
2006). And, in certain cases, a petitioner can prove a
logical sequence of cause and effect between a vaccination
and the injury (Althen prong two) with a physician’s
opinion to that effect where the petitioner has proved that
the vaccination can cause the injury (Althen prong one)
and that the vaccination and injury have a close temporal
proximity (Althen prong three). Id. While we believe that
this is one such case, we hesitate to determine that in the
first instance. We therefore vacate the decision below and
remand to allow the special master to consider the entire
record including the relevant medical and scientific evi-
dence, such as Dr. Shafrir’s second report and the articles
cited therein.
CONCLUSION
For the foregoing reasons, we vacate the decision of
Court of Federal Claims affirming the decision of the
special master rejecting the Moriartys’ petition. We
remand for further proceedings consistent with this
opinion.
VACATED AND REMANDED
MORIARTY v. HHS 21
COSTS
Costs to the Moriartys.