# United States **Court of Appeals**  **for the Federal Circuit**

______________________
EILISE MORIARTY, A M INOR, BY HER PARENTS
AND NATURAL GUARDIAN S, 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 Thoma s C.
Wheeler.

______________________

Decided: April 6, 2016

______________________

C LIFFORD J OHN S HOEMAKER , Shoe maker and Assoc iates, Vienna, VA, argued for petitioners

- appellants.

G LENN A LEXANDER M AC L EOD , Vaccine/Torts Branch, Civil Division, United States Department of Justice, Washington, DC, argued for respondent

- appellee. Also represented by A LEXIS B. B ABCOCK

, C ATHARINE E. R EEVES

, V INCENT J. M ATANOSKI

, R UPA B HATTACHARYYA

, B ENJAMIN C. M IZER

.MORIARTY v. HHS 2

______________________

Before M OORE

, C LEVENGER

, and R EYNA

, Circuit Judges.

M OORE

, 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 affirm ed a special ma ster ’s decision denying their petition fo r compensation under the National Childhood Vaccine Injury C ompens ation P rogram, 42 U.S.C. § 300aa

– 1 to

– 34 (2006) (“Vaccine Act”). W e vacate and remand for further proceedings

.
B ACKGROUND
Eilise Moriarty was born in August 1996. Prior to r eceiving the v accination at issue in this case, Eilise had problems with her gross motor skills and language deve lopment and was diagnosed with hypotonia and develo pmental 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 vaccin ations, 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 numb er of seizures, he later
testified that Eilise had a seizure that day

. The Moria rtys, 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 ru nning a fev er in the late afternoon . Over the next two weeks, Eilise attended schoo l 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 anotherMORIARTY v. HHS 3

seizure the re the following day. She was tr ansferred to another hospital where she underwent magnetic res onance 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 di scharged 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 Ho pkins Medical Center, examined Eilise and her medical
records and not ed that she had a new onset of seizure s 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 a ttacks” 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 Len nox

- 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 havin g a clinical seizure disorder.

In April and May 2001, Eilise underwent v arious 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.”MORIARTY v. HHS 4

was delayed, especially verbally. In June 2001, Eilise was admitted to Johns Hopkins Hospital because of intract able seizures and to begin a ketogenic diet. Eilise was a “super

- responder” to the ketogenic diet, and i n 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 treati ng 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 Va ccin e 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 sectio ns 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 refe rence to autism, alleg ing 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 ped iatric 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 ma ster ’s offer of a nother hear ing.

The special master denied Eilise’s petition. He d etermined that the Moriartys failed to prove either the firstMORIARTY v. HHS 5

or second prongs of our three part test in Althen v. Secr etary of Health and Human Services , 418 F.3d 1274 (Fed. Cir. 2005), as required fo r Eilise’s “off

- Table” injury. Regarding prong one, which requires a petitioner to show a medical theory caus ally connecting the vaccination at issue to the injury, Althen , 418 F.3d at 1278, the special

master noted that the Moriartys’ theory connecting E ilise’s MMR vaccination to her condition had “evolved” over time, ultimately becoming that the MMR vaccine triggered an immune

- mediated reaction that led to epile ptic encephalopathy. Eilise’s expert, Dr. Shafrir, cited eight articles in his second report supporting this point

, but t he special master declined to consider the contents of that report or all of the cited articles because the Moria rtys “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 g overnment’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. Ult imately, the special master determined that Dr. Shafrir was unpersuasive

, a nd consequently concluded that the Moriartys failed to meet Althen prong one by “fail[ing] to
demonstrate that the MMR vaccine can cause an aut oimmune epileptic encephalopathy

. ” J.A. 22.

The special master also determined that the Moria rtys failed to pr ove Althen prong two, which requires showing a logical sequence of cause and effect showing
that the vaccination at issue was the reason for the inj ury. 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 discountedMORIARTY v. HHS 6

Dr. Shafrir’s testimony that Eilise suffered from this
condition because “Dr. Shafrir was relying upon his ‘clinical experience’ and the seq uence of events in which the vaccination preceded Eilise’s January 7, 2001 se izure.” J.A. 24. Dr. MacDonald testified that patients with autoimmune epileptic encephalopathy “most co mmonly present with ‘lethargy, behavioral issues, confusion, speech loss, aphasia, a whole host of cognitive problems, balance problems, hemiparesis ’ ” and that

auto immune encephalopathy “may include” various objective evidence such as “brain swelling on an MRI
scan.” J.A. 24. The special master noted that “it is un usual for a disease not to have any typical clinical sym ptoms” and found Dr. MacDonald “more credible [than
Dr. Shafrir] when he provided a list of clinical signs and diagnostic assessments” for autoimmune epileptic e ncephalopathy

. J.A. 25. He cited Dr. MacDonald’s test imony that Eilise did not have autoimmune epileptic encephalopathy “because in his experience, patients are ‘desperately sick’ if they have immune

- mediated enceph alopathies that result in seizures” and stated that “Dr. MacDonald’s suggestion that an a utoimmune 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 opi nion,” id. , and that, ultimately, Dr. MacDonald was more persuasiv e o n this point than Dr. Shafrir.

Finally , the special master determined that the Mor iartys 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 Mor iartys appeal. We have jurisdiction under 42 U.S.C. §

300aa

– 12(f).MORIARTY v. HHS 7

D ISCUSSION

We review the Court of Federal Claims’ decisions in Vaccine Act cases de novo, applying the same stan dard used by that court to review the special master ’s de term ination

. Moberly ex rel. Moberly v. Sec’y of Health &
Human Servs. , 592 F.3d 1315, 1321 (Fed. Cir. 2010). W e only set aside findings of fact or conclusions of law that are arbitrary, capricious , an abuse of discretion, or othe rwise 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 admi nistration 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 ha s 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 va ccination brought about her injury by providing: (1) a medical theory causally connecting the vaccin ation 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 pro ximate temporal relationship between vaccination and injury.

Id. Only the first and second prongs of the Althen test are at issue in this appeal because t he special master found, and the parties do not dispute, that the Moriartys proved the third prong of the Althen test.MORIARTY v. HHS 8

I.

T he Moriartys argue that the special master erred in determining that they did not meet their burden to prove
Althen prongs one and two for nume rous 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.
Th e 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. W e 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 i nstructs 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 compe nsation, 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 rel evant medical and scientific evidence co ntained in the record.” Id. § 300aa

– 13(b ). This section also requires that special master s “ shall consider the entire
record and the course of the injury” when evaluating the weight to be afforded to any medical re cords 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. ItMORIARTY 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 fail ing 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 consi dered the relevant record evidence even though he does not explicitly reference such evidence in his decision. Hazelhurst 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 e pileptic encephalopathy sits within the spectrum of MMR vaccine encephalopathy. Id. But the special master never consi dered 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 co nsider 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. T he special master

wrote :
Although Dr. Shafrir had cited various articles in support of his opinion in his second report, exhibitMORIARTY v. HHS 10

37, petitioners did not elicit testimony from
Dr. Shafrir about these articles as part of the d irect examination. When an expert does not e xplain 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 a ddressed 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 co nsidered 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 ma ster did not consider Dr. Shafrir’s written testimony in his

r eport 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 va ccine can cause an autoimmune epileptic encephalop athy.”)

. And the special master relied on Dr. MacDonald’s testimony that “there is no evidence to support the co nclusion that the MMR vaccine can cause autoimmune epileptic encephalopathy.” J.A. 22. T he 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 co nsider the articles cited by Dr. Shafrir in his second expertMORIARTY v. HHS 11

report. One such article, a five

- page article by Weibel et al., 2 cited and explained b y Dr. Shafrir in his second report, teaches the very point that the special master faulted the Moriartys for failing to pre sent evidence to
establish

— that the MMR vaccine can cause autoimmune epileptic encephalopathy.

Weibel analyzed data from claims sub mitted to the National Vaccine Injury Compensation Program

— claims such as the one the Moriartys filed for Eilise here. The objective of this article i s “[t]o determine if there is ev idence for a causal relationship between acute encephal opathy 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 pl eocytosis (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 i ncrease in their number can indicate, inter alia , an i mmune 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 Pe rmanent Brain Injury or Dea th Associated With Further Attenuated Measles Vaccines: A Review of Claims Submi tted to the National Vaccine Injury Compensation Pr ogram , 101(3) P EDIATRICS 383

– 87 (1998) (“Weibel”). We
note that the authors all work at either the Division of Vaccine Injur y 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 Se rvices.MORIARTY v. HHS 12

this article that, in cases of post

- measles

- infection e ncephalopathy where pleocytosis is present, “the absen ce of a detectable virus in the brain is obscure, but may be suggestive of an autoimmune encephalopathy .” Id. (e mphasis added). The authors then explain that prior case reports and review articles suggest that similar neur ologic complications can also fo llow 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
th at their data “suggests that a causal relationship b etween 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 recei ving 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 exhibi ted 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 a cute encephalopathy described after natural measles and other live measles vaccines.” J.A. 1462 (emphasis added).

T his article unmistakably talks about Eilise’s injury. It suggests that the measles vaccine can cause encephal o-

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 impai rment or death.MORIARTY v. HHS 13

pathy, and it reports that the clinical features of this encephalopathy include seizures (i.e., epileptic encephal opathies) in a subset of children. Moreover, the article explains that infection with the measles virus may cause an autoimmune encephalopathy in some situations, and

t hat the medical evidence suggests that similar complic ations 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 reasona bly disputed that this
article constitutes relevant scientific evidence.

Thus, to the extent that the special master ’s recit ation of Dr. MacDonald’s testimony that there is “no ev idence” to support causation is a factual finding, that factual finding is no t supported

— and, indeed, is contr adicted

— by the evidence in the record. I n ignoring Weibel
and Dr. Shafrir’s discussion of it in his second expert

repo r t , the special master ignored relevant record ev idence that tends to prove the very point that the spec ial

master faulted the Moriartys for failing to prove.

T here 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

s pecial master ’s holding that he could decline to review such evidence is legally erroneous. The s pecial 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.
Mobe rly 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 s pecial ma ster ’s claim that h e may refuse to consider relevant scie ntific 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 s pecial master to consider all relevant med ical and scientific evidence of record. As a preliminaryMORIARTY v. HHS 14

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 s tudy 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

state d although the special master may interpret a med ical 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 unde rstood 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 F ederal Claims (or our own court in its
decisi on on the appeal) state that a s pecial master is not required to consider a ref erence. Indeed, such a holding would be contrary to the statutory requireme nt that the

s pecial master consider the record as a whole, including
all relevant scientific and medical evidence. A s pecial

master is required to consider all relevant medical and scientific evidence of record. And he is obligated to co nsider such evide nce even if it i s not explained by the testimony of an expert. However, if the technical co mplexity of a particular study is such that the relevance of
the medical study or its particular findin gs cannot be understood by the s pecial master without expert assi stance that was no t provided, then the s pecial 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 arb itrary and capricious standard on appeal. But the s pecial

master made no such finding in this case. In this case

, the s pecial master found that he was not required to consider the articles which the expert, D r. Shafrir

, did not discuss in his oral testimony at the hearing. H e 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. Sh a frir about these articles as part of the direct examination.

. . . The lack of dir ect 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 h ad offered oral testimony about. T he s pecial 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 offer ed 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 s pecial 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 relationshi p between measles vaccine and e nceph a lopathy may exist as rare complications of measles
immunization.” J.A. 1382. T his is not a case where the expert simply cited a large number of references in a voluminous expert report without providing any guidance

a s to their relevance. T he 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 de termine the articles’ rel evance. Rather, it explains the relevance of each article and provides a numbered list summarizing Dr. Shafrir’sMORIARTY v. HHS 16

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.

W e 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 sp ecial master consider the entire record , including all rel evant 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 rele vant 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 act ions do not apply in Vaccine Act procee dings. 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 compe nsation 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. Whit ecotton , 514 U.S. 268, 269 (1995)).

Moreover, we have repeatedly end orsed 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 consi der either the explanations regarding the relevance of
articles that Dr. Shafrir offered in his report or the art icles themselves solely because Dr. Shafrir did not testify on these poin ts at the hearing. In so doing, the special

master erred.

Finally , contrary to the special master ’s assertion,
Dr. Shafrir testi fied 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:

S o I think that what Eilise suffered, based on a case report that we also had that was published with similar onset of epileptic encephalopathy a fter the measles vaccine that t he 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 re port, Dr. Shafrir

4 The special master found there was oral testim ony about only two of the article s. J.A. 19.MORIARTY v. HHS 18

cited and explained the relevance of a case report 5 invol ving a child who “developed epileptic encephalopathy on day 14 th [sic] after measles immunization.” J.A. 1384. He explained that this child “developed rapid nodding of the
head” a nd, 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 medic ation s

. 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 me ntioned “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 doc umented 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

exa mination of Dr. Shafrir about that article in his dec ision.
Dr. Shafrir also testified on direct about “an article on acute cerebral ataxia,” explaining that this disorder isMORIARTY v. HHS 19

Admittedly, it would have been easier for the special

master if Dr. Shafrir’s hearing testimony clearly refe renced and discussed each of the articles. B ut 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

e vidence must be considered

. Given the statutory ma ndate to consider all relevant medical and scientific ev idence of record , the s pecial 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 maste r “broad discretion in determining credibility because he saw the witnesses and heard the testimony.” Bradley v. Sec’y of Health & Human Servs. , 991 F.2d 1570, 1575 (Fed. Cir. 1993). But here that general rule carries less force because t he special maste r 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 o ther 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 “immu ne 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.MORIARTY v. HHS 20

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 re levant 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 peti tioner can prove a logical sequence of cause and effect betwee n a vaccination and the injury ( Althen prong two) with a physician’s opinion to that effect where the petitioner has proved that
the vaccin ation can cause the injury ( Althen prong one)
and that the vaccination and injury have a close temporal proximity ( Al then prong three)

. Id. While we believe that this is one such case, we hesitate to determine that in the
first instance. W e therefore vacate the decision below and
remand to allow the special master to consider the entire record including the relevant medical and scientific ev idence, such as Dr. Shafrir’s second report and the articles
cited therein.

C ONCLUSION
For the foregoing reasons, we vacate the decision of
Court of Federal Claims affirming the decision of the special master rejecting the Moriar tys’ petition. We
remand for further proceedings consistent with this opinion.

VACATED AND REMANDEDMORIARTY v. HHS 21

C OSTS

C osts to the Moriartys

.