The opinion
In the United States Court of Federal Claims
No. 03-2876V
(Filed Under Seal: February 4, 2015)
(Reissued for Publication: February 20, 2015) 1
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*
EILISE MORIARTY, a minor, by her *
parents and natural guardians, MARIE *
LOUISE MORIARTY and STEPHEN *
MORIARTY, *
Petitioners, * National Childhood Vaccine Injury
* Act; Motion for Review of Special
* Master’s Decision Denying Relief;
v. * MMR Vaccination; Application of
Althen Test; Assessment of Expert
* Testimony.
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
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Clifford J. Shoemaker, Shoemaker, Gentry & Knickelbein, Vienna, Virginia, for
Petitioners.
Alexis B. Babcock, with whom were Joyce R. Branda, Acting Assistant Attorney General,
Rupa Bhattacharyya, Director, Vincent J. Matanoski, Deputy Director, and Catharine E.
Reeves, Assistant Director, Torts Branch, Civil Division, U.S. Department of Justice,
Washington, D.C., for Respondent.
OPINION AND ORDER
WHEELER, Judge.
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This opinion originally was issued under seal on February 4, 2015. Pursuant to Rule 18(b) of the Vaccine Rules
of the United States Court of Federal Claims (“Vaccine Rules”), the parties had 14 days within which to propose
redactions to the opinion prior to publication, but no such redactions were proposed. Accordingly, the opinion is
herein reissued for publication, unsealed.
Currently before the Court is Petitioners’ Motion for Review of the Special
Master’s August 15, 2014 decision denying compensation for an injury allegedly caused
by a vaccine. The matter is fully briefed, and the Court heard oral argument on January
6, 2015. For the reasons explained below, the Court denies Petitioners’ Motion for
Review and affirms the decision of the Special Master.
On December 31, 2003, Petitioners filed a petition on behalf of their daughter
Eilise for compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. §
300aa-1 et seq. (“Vaccine Act”). The original petition was based on a claim that vaccines
had caused Eilise to have autism. The case was stayed pending the outcome of the
Omnibus Autism Proceeding (“OAP”) established by the Office of Special Masters
(“OSM”) to address large numbers of autism claims. After OSM issued several decisions
in OAP test cases, Petitioners filed an amended petition on July 14, 2011, removing
autism claims and seeking on behalf of their daughter compensation for a seizure
disorder, encephalopathy, and a decline in cognitive and motor functions caused by
vaccination. The parties filed expert reports and additional evidence, and the Special
Master then assigned to the case held an entitlement hearing. See Transcript of
Proceedings, May 6, 2013 (“Tr.”). In September 2013, the case was transferred to the
Special Master whose decision denying compensation is the subject of this review. After
both parties declined to request a new hearing in light of the reassignment, the Special
Master issued his decision based on the record. See Moriarty v. Sec’y of Health &
Human Servs., No. 03-2876V, 2014 WL 4387582 (Fed. Cl. Spec. Mstr. Aug. 15, 2014).
Petitioners filed their Motion for Review on September 15, 2014.
Background
A. Facts
Eilise Moriarty was born in 1996, and had trouble walking and talking from a
young age. At two years old she was referred to Children’s National Medical Center for
evaluation of developmental delay. At age three, she was diagnosed with hypotonia and
developmental delay, including delayed language development. Moriarty, 2014 WL
4387582, at *2. Eilise also had several surgeries to correct outward deviation of the eyes,
and in March 2000, to remove her tonsils and adenoids. Id. at *3. She continued to have
significant delays in development of motor skills, and severe delays in articulation. Id.
In fall 2000, she began a special education preschool program, and a progress report in
October 2000 showed that she was making improvements in her fine motor and speech
skills. Id.
Eilise’s school in Virginia required her to have certain vaccinations before
returning to school in January 2001. On January 2, 2001, she received her second
measles, mumps and rubella (“MMR”) vaccination together with diphtheria, tetanus, and
pertussis and inactivated polio vaccinations. Petitioners’ claim is based only on the
MMR vaccine. Id. Petitioners alleged that on January 7, 2001, five days after the
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vaccinations, Eilise suffered a seizure while she was at home with her older brother.
Although Respondent disputed the characterization of this event as a seizure, the Special
Master found that this event was in fact a seizure for the purposes of determining the
timing of Eilise’s possible reaction to the MMR vaccination. Id. at *4. About two weeks
later, Eilise suffered a grand mal seizure at school and was taken to the hospital, where
she had another seizure and was transferred to Inova Fairfax hospital for treatment. At
Inova Fairfax she continued to have seizures and the treating physician diagnosed her
with “new onset seizures.” Id. at *5. On January 30, 2001, two days after she was
discharged from Inova Fairfax, Eilise was seen at Johns Hopkins Medical Center, where
the doctor assessing her record noted the seizures had unknown causes. Id. at *6. In the
next few months until June 2001, Eilise continued to have frequent seizures, and was
treated several times at Inova Fairfax. When she was admitted on March 26, 2001, her
mother reported that Eilise had experienced more than 20 episodes of seizures in the prior
three days, and that she would fall to the floor during each one. Her mother also reported
that at this same time Eilise’s expressive language skills substantially declined. Id. at *6-
*7.
In June 2001, Eilise began a ketogenic diet for treatment of her seizures under the
supervision of Johns Hopkins Hospital. The diet was very successful: she was
reportedly seizure-free after beginning the diet except for a few incidents involving
improper ingredients in her food. In January 2002 in a follow-up visit to Johns Hopkins,
the treating physician noted that Eilise was still on the ketogenic diet and free of seizures,
and no longer taking any seizure medications. He recommended occupational, physical,
and speech therapy. Eilise continued on the ketogenic diet until early 2005, checking in
periodically with Johns Hopkins. During her appointments there, the treating physician
diagnosed Eilise with “static encephalopathy of unknown etiology” and “intractable
atonic seizures, resolved with ketogenic diet.” Id. at *8.
At the time of the hearing in this case, Eilise was seventeen years old, reading at a
fifth grade level. Her math skills and handwriting were at a third grade level. Id. at *9.
B. Burden of Proof
Petitioners seek recovery in this case for an “off-Table” injury, that is, an injury
caused by a vaccine other than those injuries listed on the Vaccine Injury Table, 42
U.S.C. § 300aa-14(a). In off-Table injuries, claimants must show causation in fact by a
preponderance of the evidence. 42 U.S.C. §§ 300aa-11(c)(1)(C)(ii), 300aa-13(a)(1)(A);
see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir.
2010). The U.S. Court of Appeals for the Federal Circuit summarized the claimant’s
evidentiary burden associated with off-Table cases in Althen v. Secretary of Health and
Human Services, 418 F.3d 1274, 1278 (Fed. Cir. 2005), holding that he must establish by
preponderant evidence:
(1) a medical theory causally connecting the vaccination and the injury;
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(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.
These factors are now commonly referred to as the three Althen prongs.
C. Summary of Expert Evidence
To support their claims, Petitioners offered the opinion and testimony of Dr. Yuval
Shafrir, a board-certified pediatric neurologist in private practice as well as an assistant
professor of pediatrics. Dr. Shafrir viewed Eilise’s initial seizure in January 2001 shortly
after her vaccination as the onset of “epileptic encephalopathy” which progressed in the
next months to increasingly frequent seizures until they were successfully controlled by
the ketogenic diet. Tr. 148-49. In Dr. Shafrir’s view, the MMR vaccination caused
Eilise to have an “immune mediated” response affecting the brain and leading to the
seizures, which in turn caused her speech and behavior to regress from the improvement
she had achieved just prior to the vaccination. Id. at 159-60. To support his theory, Dr.
Shafrir offered several studies of reactions to the MMR vaccine. Expert Report of Dr.
Shafrir, Dkt. No. 40. Although these reactions were different from the “autoimmune
epileptic encephalopathy” he saw in Eilise’s case, Dr. Shafrir offered the studies as proof
that the MMR vaccine could cause changes in the brain. It was his opinion that the MMR
vaccine’s effects on the brain can be viewed as a spectrum, with severe, often fatal
conditions on one end, and minor challenges on the other end. Eilise’s seizures and
developmental damage would fall somewhere on that spectrum. Tr. at 179-80, 217. Dr.
Shafrir also testified that in his opinion, the five-to-six day period between Eilise’s
vaccination and her initial seizure was consistent with his theory, given that this was her
second MMR vaccination, and thus an immune response would be provoked more
quickly. Id. at 153-54, 161-62.
Respondent’s expert was Dr. John MacDonald, who is board-certified in
psychiatry and neurology, with a special competence in child neurology and clinical
neurophysiology, and an associate professor at a medical school. It was his opinion that
there was no evidence linking the MMR vaccination to the seizures, adding that it was
common for seizures to have an unknown cause. Id. at 223, 246. He did not see in the
medical records evidence of dramatic changes in Eilise’s mental status rising to the level
of an “acute” brain disorder such as autoimmune encephalopathy, attributing much of her
reactions to transitory effects of the seizures themselves together with the anti-seizure
medications she was given. Id. at 239-241. He also disputed Petitioners’ claim that the
seizures caused long term setbacks in Eilise’s motor and language development, citing
similar test scores both before the seizures began and after the seizures stopped. Id. at
242-43, 246.
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D. The Special Master’s Decision
The Special Master found that Petitioners had failed to meet the burden of proof
required to establish the first two prongs set forth in the Althen case. With respect to the
first prong requiring proof of a medical theory connecting the vaccination and the injury,
the Special Master found Dr. Shafrir’s testimony and accompanying literature
unpersuasive. He distinguished one study (the “Pampiglione” study) because effects
lasted only two weeks, and a second article (the “Gibbs” article) because the effects
found were attributed to an intercurrent illness rather than to vaccination. Moriarty, 2014
WL 4387582, at *11-*13. He concluded that “petitioners failed to demonstrate that the
MMR vaccine can cause an autoimmune epileptic encephalopathy, and failed to meet
Althen prong 1.” Id. at *13.
The second Althen prong requires proof of a logical sequence of cause and effect
between the vaccine and injury. Again, the Special Master was not convinced. “Dr.
Shafrir identified few, if any, solid bases for his conclusion that Eilise suffered from an
epileptic encephalopathy that was autoimmune in origin.” Id. at *14. The Special Master
found more persuasive Dr. MacDonald’s opinion that Eilise showed no clinical signs of
an autoimmune encephalopathy, and that patients suffering from seizures caused by that
condition are in Dr. MacDonald’s experience, “desperately sick.” Id. at *15. Further, the
Special Master noted that the doctors treating Eilise during the time of her seizures did
not identify an autoimmune reaction. Id. He acknowledged statements in medical
records from 2004 and 2005 referring to the 2001 seizures as attributed to the MMR
vaccination. However he saw them as only summaries of “remote history,” likely
provided by Eilise’s mother, and not substantiated by any medical records or opinions
dating from the period when Eilise was treated for the seizures. Id.
In addressing the third Althen prong, requiring proof of an appropriate time frame
to infer causation, the Special Master found that Eilise had suffered a seizure nearly six
days after vaccination, and that this was sufficient to prove the requisite timing. Id. at
*16-*17. However, because Petitioners did not meet their burden of proof on all three
Althen prongs, the Special Master ruled that Eilise was not entitled to compensation.
Discussion
A. 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). The Special Master’s findings of fact
receive deferential review under an “arbitrary and capricious” standard, while the Court
reviews legal conclusions under the “not in accordance with law” standard and
discretionary rulings for an “abuse of discretion.” Munn v. Sec’y of Health & Human
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Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). “The arbitrary and capricious standard
of review is difficult for [a petitioner] to satisfy with respect to any issue, but particularly
with respect to an issue that turns on the weighing of evidence by the trier of fact.”
Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000).
“Weighing the persuasiveness of particular evidence often requires a finder of fact to
assess the reliability of testimony, including expert testimony, and we have made clear
that the special masters have that responsibility in Vaccine Act cases.” Moberly, 592
F.3d at 1325.
B. Petitioners’ Contentions on Review
In support of their Motion for Review, Petitioners claim that in finding they failed
to prove both the first and second prongs required by Althen, the Special Master has
required a burden of proof beyond the preponderance of evidence standard specified by
the Vaccine Act. With respect to proof of prong one, a medical theory causally
connecting the vaccination and injury, Petitioners argue that their expert advanced a
“plausible” theory of how the vaccine could have injured Eilise, while the Special Master
impermissibly required more: he looked for evidence beyond their expert’s assertion that
the MMR vaccine can cause the seizures in Eilise’s case. Pet’rs’ Mot. for Rev. 12-13,
Dkt. No. 73. Petitioners assert that “[t]he medical theory that measles vaccination can
cause encephalopathy is neither new, nor novel,” and that the evidence proffered by
Petitioners should be sufficient to prove prong one. Id. at 12. As to proof of prong two, a
logical sequence of cause and effect, Petitioners maintain that they cannot be required to
prove how vaccines directly affected Eilise, and that proof of a “medically appropriate
time” is sufficient. Id. at 19.
Respondent answers that a “preponderance” standard requires proof of a fact more
probable than not, a standard of proof higher than the “plausibility” standard urged by
Petitioners. Resp’t’s Mem. in Resp. to Pet’rs’ Mot. for Rev. 7-8, Dkt. No. 77 (“Resp’t’s
Mem.”). Respondent notes that in proving prong one, “a causation theory must be
supported by a ‘sound and reliable’ medical or scientific explanation.” Resp’t’s Mem. 8
(citing Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994)).
Respondent argues that, in Eilise’s case, the Special Master was not persuaded by
Petitioners’ expert, and the Special Master’s opinion is entitled to deference upon review
by this Court. Id. at 11. Proof of prong two also failed for similar reasons, Respondent
claims: because the Special Master determined that Petitioners did not prove that Eilise
developed an autoimmune disorder, he properly found that they could not logically
connect the vaccine to her seizures. Id. at 15.
Conclusion
The Court has considered the parties’ arguments, the evidence of record, and the
Special Master’s decision on entitlement. The Court is satisfied that the Special Master
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set forth a rational basis for his decision. The Special Master has discretion to assess the
reliability of expert testimony when weighing the persuasiveness of the evidence.
Moberly, 592 F.3d at 1325-1326. He also appropriately weighed the studies presented by
the Petitioners, together with the records of treating physicians, and reasonably concluded
that Petitioners failed to prove the first two prongs of the Althen test. Althen mandates
that a claimant offer a “persuasive” medical theory,” supported by reputable medical or
scientific explanation. 418 F.3d at 1278 (emphasis added). The Special Master
reasonably determined that Petitioners failed to offer a reliable theory as to how the
MMR vaccine can cause autoimmune epileptic encephalopathy, and thus he did not act
contrary to law in concluding that Petitioners failed to prove the first prong. With respect
to the second prong, the Special Master saw no logical sequence of cause and effect
between the MMR vaccine and the seizures Eilise experienced. His finding that
Petitioners did not prove that Eilise suffered from an autoimmune disorder is reasonable:
there is very little evidence in the record supporting Petitioners’ assertion of an
autoimmune reaction. Because the Court is not tasked with reweighing the evidence, and
the Special Master’s decision is neither arbitrary nor capricious, the Special Master’s
decision is AFFIRMED. Accordingly, Petitioners’ Motion for Review is DENIED.
IT IS SO ORDERED.
s/ Thomas C. Wheeler
THOMAS C. WHEELER
Judge
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