Moriarty v. Secretary of Health & Human Services

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.