             In the United States Court of Federal Claims
                                              No. 03-2876V
                                  (Filed Under Seal: February 10, 2017)
                                      (Reissued: February 27, 2017) 1

**************************************** *
                                          *
EILISE MORIARTY, a minor, by her          *
parents and natural guardians, MARIE      *
LOUISE MORIARTY and STEPHEN               *
MORIARTY,                                 *
                         Petitioners,     * National Childhood Vaccine Injury
                                          * Act; Review of Special Master’s
                                          * Remand Decision Denying Relief;
 v.                                       * MMR Vaccination; Application of
                                            Althen Test; Assessment of Expert
                                          * Testimony.
SECRETARY OF HEALTH AND                   *
HUMAN SERVICES,                           *
                                          *
                         Respondent.      *
                                          *
**************************************** *
Clifford J. Shoemaker, Shoemaker, Gentry & Knickelbein, Vienna, Virginia, for
Petitioners.

Alexis B. Babcock, with whom were Benjamin C. Mizer, Principal Deputy Assistant
Attorney General, C. Salvatore D’Alessio, Acting Director, Catharine E. Reeves, Acting
Deputy Director, and Gabrielle M. Fielding, Assistant Director, Torts Branch, Civil
Division, U.S. Department of Justice, Washington, D.C., for Respondent.

                                OPINION AND ORDER ON REMAND

WHEELER, Judge.

       This vaccine case once again is before the Court, on a motion for review of the
special master’s opinion issued after remand from the U.S. Court of Appeals for the Federal
Circuit. Moriarty ex rel. Moriarty v. Sec’y of Health & Human Servs., 844 F.3d 1322 (Fed.
Cir. 2016) (hereinafter “Federal Circuit remand”). The Federal Circuit vacated this Court’s


1
 Pursuant to Rule 18(b) of the Court’s Vaccine Rules, this opinion and order was initially filed under seal. As required
under the Rules, each party was afforded 14 days from the date of issue, until February 24, 2017, to object to the
public disclosure of any information furnished by that party. Neither party submitted any proposed redactions.
affirmance of the special master’s original denial of compensation, 2 and remanded it “to
allow the special master to consider the entire record including the relevant medical and
scientific evidence . . . .” Id. at 1333. The special master has now issued his opinion after
remand, again denying compensation to Petitioners. Moriarty v. Sec’y of Health & Human
Servs., No. 03-2876V, 2016 WL 5390172 (Fed. Cl. Spec. Mstr. Aug. 23, 2016) (hereinafter
“Moriarty II”). Petitioners have again filed a motion for review with this Court. The Court
has carefully reviewed the parties’ briefs and the entire record. The Court heard oral
argument on December 20, 2016.

        At issue in this case is the three-prong Althen test, established by the Federal Circuit
in 2005, and well known to the vaccine bar. Althen v. Sec’y of Health & Human Servs.,
418 F.3d 1274 (Fed. Cir. 2005). The three-prong test that must be met is as follows: (1) a
medical theory causally connecting the vaccination and the injury; (2) a logical sequence
of cause and effect showing that the vaccination was the reason for the injury; and (3) a
proximate temporal relationship between vaccination and injury. Id. at 1278. The Althen
test provides the factors that a petitioner must satisfy by a preponderance of the evidence
to prevail in an off-table vaccine case such as this one. See 42 U.S.C. §§ 300aa-
11(c)(1)(C)(ii), 300aa-13(a)(1)(A).

       In this case, prongs one and three are established, leaving only prong two in
question. For the reasons explained below, the Court concludes that the special master’s
remand decision denying relief to Petitioners must be vacated. In light of the Federal
Circuit’s remand instructions, the special master as a matter of law set the bar too high for
prong two, imposing an unreasonable, if not impossible, burden of proof on Petitioners.
The Court finds in favor of Petitioners on liability, and remands the case to the special
master for a determination of damages.

                                             Factual Background 3

        Eilise Moriarty was born in 1996, and faced developmental challenges at a young
age, receiving treatment beginning at age two. At age three she was diagnosed with
hypotonia and developmental delays, which included delayed language development. In
the fall of 2000, she began a special education preschool program. A progress report in
October 2000 showed that she was making improvements in her fine motor and speech
skills. Eilise’s school required her to have vaccinations before returning to class in January
2001. On January 2, 2001, Eilise received the measles, mumps, and rubella (MMR)
vaccine at issue in this case. Five days later she suffered a seizure at home, as reported by
her older brother.

2
 Moriarty v. Sec’y of Health and Human Servs., 120 Fed. Cl. 102 (2015), affirming Moriarty v. Sec’y of Health and
Human Servs., No. 03-2876V, 2014 WL 4387582 (Fed. Cl. Spec. Mstr. Aug. 15, 2014), (hereinafter “Moriarty I”).
3
 All facts are drawn from Moriarty II, and are presented in greater detail in previous decisions. The facts are not in
dispute.

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       Over the next six months, Eilise continued to have seizures and frequent
hospitalizations. When she was admitted to the hospital on March 26, 2001, Eilise’s
mother reported that she had experienced more than 20 episodes of seizures in the prior
three days, and that she would fall to the floor during each one. Eilise continued to suffer
seizures until her parents brought her to Johns Hopkins Hospital in June 2001 to begin a
ketogenic diet in the hope of controlling the seizures. This diet was very successful: Eilise
was reportedly seizure-free almost from the beginning of the diet, and was eventually able
to stop taking all seizure medications. In January 2002, in a follow-up visit to Johns
Hopkins, the treating physician noted that Eilise was still seizure-free and still on the
ketogenic diet, and recommended occupational, physical, and speech therapy. During her
treatment at Johns Hopkins, Eilise was diagnosed with “static encephalopathy of unknown
etiology” and “intractable atonic seizures, resolved with ketogenic diet.”

       After Eilise’s seizures ended, she continued to receive treatment for deficits in
language, attention, memory, and other skills. In August 2004, an independent educational
evaluation noted that Eilise had a “medically acknowledged MMR reaction.” Subsequent
reports of treating health professionals at Georgetown University Hospital and George
Washington University Speech and Hearing Center noted a history of seizures attributed
to an adverse reaction to her MMR vaccination. At the time of the special master’s
evidentiary hearing in 2013, Eilise was seventeen years old and reading at a fifth grade
level, with math and handwriting skills at a third grade level. She was being home-
schooled and attending physical therapy and special education sessions. Petitioners seek
compensation for damages allegedly caused by the MMR vaccination, including a seizure
disorder, encephalopathy, and a decline in cognitive and motor functions.

                                    Standard of Review

       This Court has jurisdiction to review decisions of the special masters in accordance
with 42 U.S.C. § 300aa-12(e)(1)-(2). Under those provisions, this Court will only set aside
findings of fact or conclusions of law found to be “arbitrary, capricious, an abuse of
discretion or otherwise not in accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B). With
respect to findings of fact, the special masters have broad discretion to weigh evidence and
make factual determinations. However, with respect to questions of law, the legal rulings
made by a special master in connection with a vaccine claim are reviewed de novo, under
a “not in accordance with the law” standard. Following this distinction, “[t]he allocation
of the burdens of proof under the Vaccine Act is a legal issue subject to de novo review.”
Heinzelman v. Sec’y of Health & Human Servs., 98 Fed. Cl. 808, 812 (2011); see also
Whitney v. Sec’y of Health & Human Servs., 122 Fed. Cl. 297, 304-305 (2015); Federal
Circuit remand at 1327.




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                                                    Discussion

       Petitioners filed this action fourteen years ago, and the relevant facts began
occurring in 2000, seventeen years ago. Eilise Moriarty received the MMR vaccine in
question when she was four years old, and she is now in her early 20’s. The case has been
assigned at different intervals to four special masters, and is now before this Court for the
second time. Cases arising under the Vaccine Act are not meant to be handled in this
manner. See 42 U.S.C. § 300aa-12(g), setting time restrictions of 240 to 420 days, not
including suspension or remand periods, to complete a vaccine case.

        The age of the case is the crux of the problem. As a practical matter, treating
physicians in 2001 did not have available to them the sophisticated medical technology of
today, and were not as adept at assessing vaccine injury causation as they are in 2017. This
is particularly true in trying to determine whether an MMR vaccine caused an autoimmune
encephalopathy, as in Eilise’s case. See Resp.’s Supp. Brief, Dkt. No. 102 at 3 (stating that
there are no diagnostic criteria for autoimmune encephalopathy, and that diagnosis is only
“recently recognized.”) The absence of solid diagnostic evidence from 2001 should not
serve as a basis for denial of relief in 2017.

       The evidence that we do have before us is sufficient to establish causation. The
record shows that knowledgeable health professionals pointed to the MMR vaccine as the
cause of Eilise’s autoimmune encephalopathy, and none of them even questioned this
conclusion. The Federal Circuit observed in this regard: “[w]hile 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 attributable to her second MMR vaccination.”
Federal Circuit remand at 1325. If any of these professionals had questioned the
plausibility of this causal connection, they surely would have said so in the report, or
declined to make note of it. Candidly assessed, this Court could not point to any other
cause of Eilise’s injury except the vaccine.

       At the Federal Circuit, the Court found that the special master had erred in failing
to consider the entire record, notably the second written report of Petitioner’s expert, Dr.
Yuval Shafrir, which contained important causation information. That report, found at
Docket No. 40, Exhibit 37 of the Court’s record, cited and included a study referred to as
the Weibel article, 4 which the Federal Circuit found “squarely addresses” the issue here
and suggests that autoimmune encephalopathy such as that allegedly suffered by Eilise can
be caused by administration of an MMR vaccine. In Moriarty I, the special master
specifically noted that he did not consider written evidence such as the Weibel article


4
 Robert E. Weibel, Vito Caserta, David E. Benor, & Geoffrey Evans, “Acute Encephalopathy Followed by Permanent
Brain Injury or Death Associated With Further Attenuated Measles Vaccines: A Review of Claims Submitted to the
National Vaccine Injury Compensation Program,” 101(3) PEDIATRICS 383-87 (1998).

                                                      4
because it was not explained by Petitioners’ expert during oral examination. The Federal
Circuit found that this was error.

        The Federal Circuit determined that the Weibel article provided a persuasive
medical theory to explain Eilise’s injury. Referring to this article, the Federal Circuit stated
that it “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.” Federal Circuit remand, at 1329. The Federal Circuit pointed to the
expected outcome:

                     As the special master noted, much of the evidence
              relevant 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 Althen 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). 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 evidence, such as
              Dr. Shafrir’s second report and the articles cited therein.

Id. at 1333 (emphasis added).

       In his remand decision, the special master conducted an extensive review of all of
the evidence in the record including the Weibel article, as instructed by the Federal Circuit.
He reversed his finding in Moriarty I that prong one had not been proven, and found that
Petitioners had in fact met their burden of proof to establish possible causation. However,
with respect to prong two, requiring a showing that the MMR vaccination had actually
caused Eilise’s injury, the special master found again that Petitioners had failed to meet
their burden of proof. While he noted the Federal Circuit’s emphasis in its remand opinion
on proof of prong two where prongs one and three have already been established, he
declined to rely on the testimony and evidence offered by Petitioners’ expert to show that
the MMR vaccine caused Eilise’s injury. Rather, he pointed to the reports of the physicians

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treating Eilise at the time of her seizures, which showed no mention of or tests for a possible
reaction to vaccination. He concluded that there was insufficient proof of causation,
because Petitioners were unable to “present any affirmative evidence that Eilise was
antibody positive.” Moriarty II at *30. Even though health professionals treating Eilise in
years following the end of her seizures noted that her problems were attributed to the MMR
vaccination, the special master dismissed their views as either unreliable or based only on
reports from Eilise’s mother. Id., at *32-35.

        In their motion for review, Petitioners argue that the special master has discounted
the discussion of Eilise’s injury in the Federal Circuit remand, which states that the Weibel
article “unmistakably talks about Eilise’s injury. It suggests that the measles vaccine can
cause encephalopathy, and it reports that the clinical features of this encephalopathy
include seizures . . . .” Federal Circuit remand at 1330. Petitioners argue that this is a clear
discussion of prong two, Eilise’s specific clinical picture, and taken with proof of prongs
one and three, should be sufficient to meet Petitioners’ burden to prove causation. They
also argue that the special master cannot infer an absence of autoimmune reaction in
Eilise’s case merely from a lack of testing for an immunologic basis sixteen years ago,
when the science of diagnosing autoimmunity was not as well developed as it is today.

        In summary, instead of following the Federal Circuit’s direction, the special master
prepared a 60-page, single-spaced decision finding that Petitioners had failed to satisfy
prong two of the Althen test. Indeed, the special master explained away or dismissed
virtually every argument offered in Petitioner’s favor. In performing this analysis, the
special master imposed too great of a burden on Petitioners that could not reasonably or
possibly be met. Even if this case could be regarded as a “close call,” the Federal Circuit
has held that “close calls regarding causation are resolved in favor of injured claimants.”
Althen, at 1280, citing Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549
(Fed. Cir. 1994). Application of this principle results in Petitioners’ recovery.

                                         Conclusion

       Based upon the foregoing, the Court vacates the special master’s remand decision,
and finds that Petitioners shall prevail on liability. The Court remands again to the special
master to determine damages. Pursuant to RCFC App. B, Rule 28(b), the remand period
shall not exceed 90 days.

       IT IS SO ORDERED.

                                                                  s/Thomas C. Wheeler
                                                                  THOMAS C. WHEELER
                                                                  Judge



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