United States Court of Federal Claims
No. 11-77 V
(Filed Under Seal: August 21, 2014)
(Reissued: September 5, 2014)
_________________________________________
SHERRIL K. STILLWELL,
Vaccine Act; Vaccine Injury;
Petitioner, Motion for Review; ADEM;
Diagnosis; Influenza; Flu
Vaccination; Preponderance of
v. Evidence
SECRETARY OF HEALTH
AND HUMAN SERVICES,
Respondent.
_________________________________________
Sol P. Ajalat, Esq., Ajalat & Ajalat, North Hollywood, CA, for petitioner.
Alexis B Babcock, Esq., United States Department of Justice, Vaccine/Torts Branch, Civil
Division, Washington, DC, for respondent.
OPINION
Block, Judge.
This case is before the court on a motion to review (“Pet’r’s Mot.”) then Chief Special
Master (“CSM”) Campbell-Smith’s decision to dismiss petitioner’s claim for compensation
under the National Vaccine Injury Compensation Program (the “Vaccine Program” or “Vaccine
Act”), 42 U.S.C. § 300aa-1 to -34, which provides compensation to individuals who can
establish, by a preponderance of the evidence, that they have suffered “a vaccine-related injury.”
§ 300aa-11(c)(1)(C). Petitioner, Sherril K. Stillwell, alleges that she developed acute
demyelinating encephalomyelitis (“ADEM”) as a result of an influenza (“flu”) vaccine she
received on February 22, 2008.1 Pet. at 1. After holding an evidentiary hearing on the matter,
the CSM concluded, on June 17, 2013, that petitioner had failed to prove by a preponderance of
the evidence that she was suffering from ADEM, and denied compensation. Stillwell v. Sec'y of
Health & Human Servs., (“Stillwell I”) 2013 WL 4540013 (Sp. Mstr. Fed. Cl. June 17, 2013).
This opinion originally was issued under seal on August 21, 2014. The court afforded the
parties an opportunity to propose redactions in the opinion prior to its reissue. No such
redactions were proffered. Accordingly, herewith is the reissued opinion without redactions.
1
In her petition, petitioner alleged that she suffered from “encephalomyelitis,” a general term for
inflammation of the brain and spinal cord, which includes a wide range of disorders. Dorland's
Illustrated Medical Dictionary 608 (31st ed. 2007). Subsequently, however, petitioner’s expert
witness, Dr. Marcel Kinsbourne, alleged that petitioner was suffering from acute demyelinating
encephalomyelitis or ADEM. See Pet’r’s Ex. 8 at 3, ECF No. 11.
Petitioner contends the CSM erred on two fronts. Pet’r’s Mot. at 4-13. First, petitioner
argues that the CSM applied an incorrect legal standard. Pet’r’s Mot. at 4-5. In petitioner’s
view, the CSM mistakenly applied the standard for determining whether petitioner suffered an
actual injury, set forth in Broekelschen v. Sec’y of Health and Human Servs., 618 F.3d 1339
(Fed. Cir. 2010) and Lombardi v. Sec’y of Health and Human Servs., 656 F.3d 1343, 1352 (Fed.
Cir. 2011), instead of the three-prong test for causation-in-fact established in Althen v Sec’y of
Health and Human Servs., 418 F.3d 1274 (Fed Cir. 2005). Id. Second, petitioner argues that the
CSM’s determination that petitioner was not suffering from ADEM and findings in support
thereof were arbitrary and capricious. Pet’r’s Mot. at 5-13.
For the reasons explained below, the court disagrees and concludes both that the CSM
correctly applied the Lombardi standard and that the CSM’s finding that petitioner did not suffer
from ADEM was not arbitrary or capricious. Accordingly, the court will affirm the CSM’s
decision.
I. BACKGROUND
A. Petitioner’s Recent Medical History
On February 22, 2008, petitioner received an influenza vaccination. Pet’r’s Ex. 2 at 2. In
the months following her vaccination, petitioner experienced a series of physical ailments,
including vertigo, nausea, dizziness, fatigue, numbness, and others. Pet’r’s Ex. 2, 3, 4, 7.
Because physicians could not ascertain the cause of these symptoms, petitioner sought the
opinions of practitioners from several fields of medicine. Id.
On April 28, petitioner visited Chierry Anderson Poyotte, a doctor of internal medicine,
and reported that she was suffering from right ear pain, weakness, and low energy, as well as
vertigo and nausea. Pet’r’s Ex. 4 at 161. Dr. Poyotte diagnosed petitioner with “otitis media,”
commonly known as an inner ear infection, and vertigo. Id. at 163. On April 30, petitioner
returned to Dr. Poyotte, and stated that she continued to experience malaise and fatigue but Dr.
Poyotte did not make any further diagnosis. Id. at 154.
Petitioner then sought a second opinion from Natalie Ting, a doctor of osteopathic
medicine, on May 6. Id. at 147. Petitioner described her symptoms as earache, fatigue, and
dizziness. Id. She also stated that she had been experiencing numbness along the right side of
her body for the past three weeks. Id. Dr. Ting did not offer a diagnosis but noted that, in her
opinion, petitioner’s exam results were not consistent with the described symptoms. Id. at 149.
On May 9, petitioner visited a second doctor of internal medicine, Kijung Paul Sung,
reporting many of the same symptoms that she had reported to previous doctors, including
vertigo, dizziness, fatigue, and numbness along the right side of her body. Id. at 139-140. Dr.
Sung recommended, and petitioner underwent, a computer tomography (“CT”) scan and
magnetic resonance imaging (“MRI”) of petitioner’s brain, both of which produced
“unremarkable,” or normal, results. Id. at 142-3.2
2
Magnetic Resonance Imaging is “a method of visualizing soft tissues of the body by applying
an external magnetic field that makes it possible to distinguish between hydrogen atoms in
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On May 27, petitioner checked-in to an emergency room after experiencing vertigo,
anomalous tastings, numbness and weakness on her right side, and difficulty speaking and
coordinating muscle movements. Pet’r’s Ex. 4 at 128. Attending physicians conducted an MRI
of petitioner’s brain and cervical spine. Id. at 127. Neither test revealed a notable physical
abnormality and physicians noted that the cause of her symptoms was “unclear” at that time. Id.
at 128.
Petitioner next sought out a neurologist, David Shaw, on June 9, complaining of unsteady
gait, blurred vision, generalized weakness, and intermittent neck pain, in addition to her previous
symptoms. Id. at 114. Dr. Shaw suspected petitioner was afflicted with multiple sclerosis
(“MS”)3 and ordered a visual evoked response test to confirm his diagnoses. Id. at 115. But, Dr.
Shaw noted the lack of lesions or other “obvious evidence” of MS on petitioner’s MRI. On June
10, petitioner underwent an electroencephalogram (“EEG”) test and visual evoked response test,
receiving normal results. Id. 111, 120.4
Also on June 10, petitioner visited a second neurologist, William Miller, and relayed
similar, but “progressively worsen[ing],” symptoms. Pet’r’s Ex. 3 at 155. During this visit,
petitioner mentioned, for the first time, that for “several weeks” prior to the onset of her initial
different environments.” Dorland's at 916. Medical professionals use magnetic resonance
imaging to observe lesions in the brain of patients that are suspected to have demyelinating
diseases such as MS and ADEM.
Computer Tomography (also known as “CT scans” or “CAT scans”) “combines a series of X-ray
views taken from many different angles and computer processing to create cross-sectional
images of the bones and soft tissues inside [the] body.” See Mayo Clinic definition, available at
http://www.mayoclinic.org/tests-procedures/ct-scan/basics/definition/prc-20014610.
3
Multiple sclerosis is a disorder of the central nervous system that produces clinical symptoms
such as “weakness, incoordination, paresthesia, speech disturbances, and visual complaints.”
Dorland's at 1706. It is characterized by “[centers] of demyelination throughout the white matter
of the central nervous system, sometimes extending into the gray matter.” Id.
Demyelination, in turn, is a medical term for deterioration or damage to the protective coating
(i.e., the “myelin sheath”) that surrounds the nerve fibers in the body’s brain and spinal cord.
Dorland's at 493. There are three variants of inflammatory demyelination diseases: MS, acute-
disseminated encephalomyelitis (“ADEM”), and acute hemorrhagic leukoencephalitis. Id.
4
An electroencephalogram test (“EEG”) is “a recording of the potentials of the skull generated
by currents emanating spontaneously from nerve cells to the brain. The normal dominant
frequency of these potentials is about 8 to 10 cycles per second and the amplitude about 10 to
100 microvolts. Fluctuations in potential are seen in the form of waves, which correlate well with
neurologic conditions and so are used in diagnostic criteria.” Dorland’s at 607.
A visual evoked response test, also known as a visual evoked potential study, measures “changes
in the evoked cortical potential when the eye is stimulated by light.” Dorland’s at 1496. Stated
otherwise, the test uses electrodes to measure the time it takes for nerves to respond to optical
stimulation.
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symptoms, she had experienced a sensation that her “socks seemed too tight” against her legs.
Id. Dr. Miller considered several diagnoses, including MS, but was puzzled by the lack of a
lesion on petitioner’s MRI to explain the symptoms and noted that it was “hard to localize [a]
lesion that would explain all of her symptoms.” Id. at 158.
On July 17, a test of petitioner’s cerebrospinal fluid displayed indicia of MS. Pet’r’s Ex.
7 at 14-15. On August 2, 2008, an MRI revealed an “unusual lesion” providing evidence of a
demyelinating disease. Pet’r’s Ex. 3 at 123.
On August 20, petitioner met with a third neurologist, Christopher Di Stasio. Pet’r’s Ex.
4 at 68-72. During her appointment, petitioner conveyed that, while her vertigo and numbness
were improving, other symptoms remained constant. Id. at 73. Dr. Di Stasio noted that
petitioner was “starting to slowly improve.” Id. at 71.
On September 8, petitioner returned to Dr. Miller, who diagnosed her with a
demyelinating disease that he believed was “improving slowly.” Pet’r’s Ex. 3 at 102. On March
20, 2010, petitioner underwent another brain MRI. Id. at 61. The results demonstrated
improvement and reinforced Dr. Miller’s diagnosis of a probable “monophasic demyelinating
event.” Pet’r’s Ex. 7 at 7. This diagnosis was confirmed on July 30, 2010, when Dr. Sung
diagnosed petitioner with a demyelinating disease and fibromyalgia. Id. at 25. After visiting
more than six different physicians, petitioner was finally diagnosed with a demyelinating disease.
B. Proceedings Before the Chief Special Master
On February 7, 2011, petitioner filed a request for compensation under the Vaccine
Program, 42 U.S.C. §§ 300aa–1 to –34, which allows petitioners to seek compensation if they
have “sustained, or ha[ve] significantly aggravated” any “vaccine-related” “illness, disability,
injury, or condition.” § 300a-11(c)(1)(C). The parties, however, disagree about the nature of
petitioner’s injury, and whether petitioner’s alleged injury can be caused by flu vaccination.
Petitioner and respondent each proffered expert reports on this issue.
1. Petitioner’s Expert
Petitioner filed the report of Dr. Marcel Kinsbourne, a neurologist and author of many
medical books, articles, and other medical-related literature. Pet’r’s Ex. 8. Dr. Kinsbourne’s
opinion, petitioner suffered from “a variant of ADEM” distinguished by its “subacute,” or
delayed, onset. Pet’r’s Ex. 8 at 6. Dr. Kinsbourne stated that ADEM typically manifests within
“a few days or weeks.” Id. Dr. Kinsbourne believed this was consistent with petitioner’s
condition, which set in “[a]pproximately four weeks” following petitioner’s vaccination in the
third week of March of 2008 and “progressed for several months before it stabilized.” Id. at 5;
see also Tr. at 9, 25. In the evidentiary hearing, Dr. Kinsbourne averred that it is possible for
ADEM to set in subacutely, taking up to 42 days to surface. Tr. 34. In support of this assertion,
Dr. Kinsbourne cited a 1994 Institute of Medicine report, which stated that the latency for
ADEM can be between “5 days to 6 weeks,” as well as two other documents,5 referred to as the
Singh and Leake articles. Tr. 34; Pet’r’s Ex. 8-6 at 503.
5
Pet’r’s Ex. 8-6 at 503, Surendra Singh et al., Acute Disseminated Encephalomyelitis: MR
Imaging Features, 173 AJR 1101 (1999); Pet’r’s Ex. 8-4 at 387, John A.D. Leake et al., Acute
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Dr. Kinsbourne also relied on an article referred to by the parties as the “Sejvar” article.6
Tr. 30, 50-55, 156. The Sejvar article establishes criteria for various levels of “diagnostic
certainty” in identifying ADEM. Id. Among others, the Sejvar article cited (1) single brain
lesion, (2) trouble finding words, (3) cranial nerve abnormalities, (4) motor weakness, (5)
sensory abnormalities, (6) ataxia (uncoordinated movement) and gait dysfunction, and (7) arm
tremors as indicia of ADEM. Id. at 5776-79. Dr. Kinsbourne averred that petitioner suffered
from five of these symptoms: “decreased arousability, aphasia [or language comprehension
difficulty], motor weakness, sensory abnormalities, and ataxia.” Pet’r’s Ex. 9 at 1-2. Notably,
the Sejvar article states that an ADEM diagnosis must include discovery of diffuse or multi-focal
white matter lesions. Tr 75-76. Dr. Kinsbourne stated that petitioner’s MRI results were
consistent with a diffused white matter lesion and, thus, with ADEM. Id. at 76.
Dr. Kinsbourne also attested to the causal connection between the flu vaccine and
ADEM, calling the link “rare” but “well recognized.” Pet’r’s Ex. 8 at 7-9 (citing Hiroshi Shoji &
Mashahide Kaji, The Influenza Vaccination and Neurological Complications, 42:2 THE
JAPANESE SOC’Y OF INTERNAL MED. 1 (2003)). He discounted a 2011 study by the Institute of
Medicine that determined there was insufficient evidence to establish a causal relationship
between the flu vaccine and ADEM. Tr. 78.
2. Respondent’s Expert
Respondent presented the report of Dr. Jeffrey Allen Cohen, a clinical neurologist,
professor of neurology at Dartmouth medical school, and chief neurologist at Dartmouth
Hitchcock Medical Center. Resp’t’s Ex. A; see also Tr. 102. Dr. Cohen averred that petitioner
did not suffer from ADEM. Resp’t’s Ex. A at 1. In his opinion, petitioner’s “clinical picture was
not consistent with [that] diagnosis.” Id. at 6. Dr. Cohen also stated that the duration of
petitioner’s symptoms was “very atypical for ADEM—[a disease which generally] progresses
over weeks, not months.” Resp’t’s Ex. A at 2. In Dr. Cohen’s view, onset of ADEM, is almost
always acute and even a subacute onset of more than four weeks is “very unusual.” Id. at 5; see
also Tr. 141-42. Dr. Cohen testified that in his clinical experience, the outer range for onset of
ADEM symptoms is four weeks after the vaccination or infection. Tr. 155-56.
Dr. Cohen further noted that ADEM is a disease “that is severe and swift in its onset,
reaches a nadir, and then . . . gets better . . . to a great degree.” Tr. 178. Dr. Cohen stated that
the majority of ADEM patients’ symptoms “tend[] to resolve over a period of . . . two, three, or
four months.” Tr. 119. In Dr. Cohen’s opinion, petitioner’s condition was not consistent with
this timetable because her physicians’ treatment choices indicated they believed that “she was
getting worse.” Tr. 117.
Dr. Cohen also commented that although there is no “specific marker” for ADEM, it
would be “very unusual” for a patient not to exhibit diffused or multifocal white matter lesions.
Disseminated Encephalomyelitis in Childhood: Epidemiologic, Clincal and Laboratory
Features, 23:8 PEDIATRIC INFECTIOUS DISEASE J. 756 (2004).
6
Pet’r’s Ex. 9-1, James J. Sejvar et al., Encephalitis, myelitis, and acute disseminated
encephalomyelitis (ADEM): Case definitions and guidelines for collection, analysis, and
presentation of immunization safety data, 25 VACCINE 5771 (2007).
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Tr. 107-108. Dr. Cohen did not observe any evidence of white matter lesions on either of
petitioner’s MRI exams taken in May of 2008. Tr. 114. He also stated that there was no record
of petitioner suffering from facial weakness, a common and readily noted ADEM indicator. Tr.
113-14. Further, Dr. Cohen believed that the lack of a “markedly depressed level of
consciousness” indicated petitioner did not suffer from ADEM. Resp’t’s Ex. C at 1.
Additionally, Dr. Cohen contended that petitioner’s medical history did not support an
ADEM diagnosis because petitioner’s symptoms were not “diagnosis-specific neurologic
findings.” Id. Dr. Cohen observed that symptoms such as decreased arousability, aphasia, motor
weakness, sensory abnormalities, and ataxia can indicate conditions such as stroke, traumatic
brain injury, or MS. Id. He also stated that the location of petitioner’s demyelination, on her
brain stem, “is not the usual location for ADEM” and the area of demyelination was not “as
extensive” as Dr. Cohen would expect in an ADEM case. Resp’t’s Ex. A at 2. Dr. Cohen also
argued that “ADEM is a disease [that appears] almost exclusively . . . in children and
adolescents” and noted that petitioner was in her 50’s at the time of vaccination. Id. at 3.
Dr. Cohen critiqued Dr. Kinsbourne’s statements, arguing that Dr. Kinsbourne cited to
medical articles that were not applicable to petitioner’s clinical picture. Id. at 3; Resp’t’s Ex. C
at 1. In Dr. Cohen’s opinion, medical literature does not present “reliable evidence” that the flu
vaccine can cause ADEM. Tr. 169-70.
C. The Chief Special Master’s Decision
On June 17, 2013, the CSM issued a decision denying compensation under the Vaccine
Act. The CSM considered the evidence in the record, including Dr. Kinsbourne and Dr. Cohen’s
reports and testimony, and disagreed with Dr. Kinsbourne’s assertion that petitioner’s condition
was an “atypical ADEM variant.” Stillwell I at 16. Rather, the CSM found that the following six
factors “weigh against a finding that petitioner has ADEM.” Id.
First, the CSM found that “although it is not dispositive,” the statistics presented by both
experts on the typical age of patients who develop ADEM warranted consideration. Id. at 16-17.
The CSM noted that Dr. Kinsbourne and Dr. Cohen agreed that ADEM “primarily afflicts
children and adolescents.” Id. at 16-17 (citing Tr. 29, 38). Cases of ADEM in adults are less
common but have been reported “in young and elderly adults.” Id. at 16-17. Petitioner, 53 at the
time of vaccination, does not qualify for either of these groups. The CSM considered the
statistical unlikelihood that petitioner suffered from an adult, middle-aged case of ADEM.
Second, the CSM observed that none of the petitioner’s numerous physicians diagnosed
her with ADEM. Id. at 17. The CSM noted that petitioner’s treating physicians speculated her
condition might be due to MS before eventually diagnosing her with a general demyelinating
brain disorder. Id. The CSM found that, contrary to Dr. Kinsbourne’s assertions, the treatment
prescribed to petitioner by her physicians was not consistent with ADEM. Id.
The nature of petitioner’s brain lesion formed the third basis for the CSM’s findings. Id.
at 18-20. It is uncontroverted that petitioner suffered from a brain lesion. Id. But, the parties’
experts disagree on whether petitioner’s lesion was diffuse or multifocal, the latter being a
necessary condition for ADEM. Id. Dr. Kinsbourne contended that petitioner’s solitary
brainstem lesion was both single and “diffused,” and was consistent with “classical descriptions
of ADEM” lesions. Id. (quoting from Tr. 22). Dr. Cohen argued that a solitary brainstem lesion
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was atypical, and cited articles describing lesions in ADEM patients as “typically reveal[ing]
multifocal, bilateral, often large white matter lesions.” Id. (quoting Resp’t’s Ex. A-9 at 2). The
CSM concluded that “[w]hether petitioner’s brain lesion bore the appearance of the type of
lesion usually seen in ADEM subjects is not clear from the record.” Id. at 20. The parties’
experts could not interpret petitioner’s test results because the images were not available. Id.
Consequently, the CSM determined that Dr. Kinsbourne’s contention that petitioner’s lesion
“was sufficiently diffuse” to demonstrate ADEM was not persuasive because “petitioner’s own
treating physicians,” who were able to review the image results, “were not persuaded.” Id.
Fourth, the CSM found that the timing of petitioner’s symptoms was inconsistent with
ADEM. Id. 21-25. Petitioner was vaccinated on February 22, 2008. Pet’r’s Ex. 2 at 1. She
reported her initial symptom, vertigo, during an April doctor’s visit, stating that her symptoms
dated back “several weeks.” Pet’r’s Ex. 3 at 159-60. On June 20, petitioner told her physicians
that “on reflection” she had noticed that her “socks seemed too tight on [her] legs” for several
weeks prior to the onset of her vertigo symptoms. Id. The CSM commented that “petitioner’s
own accounts of her symptom onset [are] inconsistent.” Id. The CSM then summarized the
medical literature presented by the parties’ experts and concluded that it is “clear that ADEM
most commonly manifests abruptly, although several of the articles Dr. Kinsbourne citied
furnished the barest of support for his proposition that petitioner’s subacute onset was an
appropriate—even if aberrant—presentation of ADEM.” Id. at 24. The CSM concluded that
“[t]he timing of petitioner’s symptom onset was unusually protracted” and “does not fit within
the recognized time frame for most cases of ADEM.” Id. at 25.
Fifth, the CSM further noted that the nature and severity of petitioner’s symptoms was
not indicative of ADEM. Id. at 25-27. Dr. Kinsbourne and Dr. Cohen agreed that decreased
level of consciousness, sometimes resulting in coma, is a common symptom of ADEM. Id.
Petitioner did not exhibit this symptom. Id.
The parties disputed whether the ADEM symptoms petitioner did exhibit rose to the level
of typical ADEM symptoms. Id. The CSM found that “[t]he views of the parties’ experts are
inconclusive” because they did not have the opportunity to observe petitioner firsthand. Id. As a
result, the CSM was “informed . . . by the silence of petitioner’s treaters—who did observe her—
on the matter of her symptom severity.” Id. The CSM determined that the lack of evidence
demonstrating decreased consciousness and relatively low symptom severity suggested petitioner
did not suffer from ADEM. Id.
Finally, the CSM found that the protracted course of petitioner’s injury and limited
recovery demonstrated that her condition was not caused by ADEM. Id. at 27-28. The CSM
stated that “[t]he record indicates that petitioner’s condition did not plateau and then gradually
improve—as would be expected with a case of ADEM. Instead, petitioner struggled . . . with a
protracted clinical course marked by many periods of exacerbation.” Id. The CSM concluded
that the “course of petitioner’s illness strongly suggests that she did not suffer from ADEM” and
that “[p]etitioner’s overall clinical course was inconsistent with the well-recognized course of
ADEM.” Id.
Weighing these six factors, the CSM determined that petitioner “failed to prove by
preponderant evidence that she developed ADEM.” Id. at 28. Rather, the CSM found that
petitioner “appear[s] to suffer from another, unspecified illness that has bewildered her
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physicians.” Stillwell I at 16. Relying on precedents set by the Court of Appeals for the Federal
Circuit (“Federal Circuit”) in Broekelschen and Lombardi, the CSM concluded that the failure of
petitioner to establish the alleged injury of ADEM precluded the CSM from finding that this
injury had been caused by petitioner’s flu vaccination. In light of this ADEM failure of proof,
the CSM determined that petitioner was not entitled to compensation under the Vaccine Act. Id.
Nonetheless, in “an abundance of caution,” the CSM proceeded to apply the Althen test for
causation, and concluded that petitioner failed to satisfy this test.
On July 9, 2013, petitioner filed a timely motion to review the CSM’s decision. This
matter is now ripe for decision.
II. STANDARD OF REVIEW FOR VACCINE ACT CASES
The Court of Federal Claims has jurisdiction to review the decision of a special master in
a Vaccine Act case upon a properly filed petition for review. 42 U.S.C. § 300aa—12(e)(1).
When reviewing a special master’s decision, the court must take one of the following three
courses of action:
(A) Uphold the findings of fact and conclusions of law of the
special master and sustain the special master’s decision,
(B) Set aside any findings of fact or conclusion of law of the
special master found to be arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law and issue
its own findings of fact and conclusions of law, or
(C) Remand the petition to the special master for further action in
accordance with the court’s decision.
42 U.S.C. § 300aa–12(e)(2).
In Vaccine Act cases, the court applies different standards of review to different aspects
of a special master’s decision: the court reviews conclusions of law under the “not in accordance
with law” standard, findings of fact under the deferential arbitrary and capricious standard, and
discretionary rulings under the abuse of discretion standard. Masias v. Sec’y of Health & Human
Servs., 634 F.3d 1283, 1287-88 (Fed. Cir. 2011) (construing 42 U.S.C. § 300aa–12(e)(2)(B)); see
also Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 871 no. 10 (Fed. Cir.
1992); Pafford v. Sec’y of Health and Human Servs., 64 Fed. Cl. 19, 27 (2005), aff’d, 451 F.3d
1352 (Fed. Cir. 2006).
With regard to a special master’s conclusions of law, such as conclusions regarding legal
standards and burdens of proof, the court applies the “not in accordance with law standard.” Doe
93 v. Sec'y of Health & Human Servs., 98 Fed. Cl. 553, 566 (2011). Under this legal standard, a
special master’s application of the law is not entitled to any deference. Jarvis v. Sec’y of Health
and Human Servs., 99 Fed. Cl. 47, 58 (2011); see also Althen, 418 F.3d at 1278–79 (observing
that this court's “not in accordance with law” review of a special master's decision in a Vaccine
Act case is de novo); Saunders v. Sec'y of Dep't of Health & Human Servs., 25 F.3d 1031, 1033
(Fed. Cir. 1994) (“Because [the special master’s award of attorneys’ fees] is a legal question, we
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apply the “not in accordance with law” standard. Thus, we review the special master's award de
novo . . .”).
In contrast, a special master’s findings of fact are reviewed under the arbitrary and
capricious standard, which is “well understood to be the most deferential possible.” Munn, 970
F.2d at 870. “Congress assigned to a group of specialists, the Special Masters within the Court
of Federal Claims, the unenviable job of sorting through these painful cases and, based upon
their accumulated expertise in the field, judging the merits of the individual claims.” Deribeaux
ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363, 1366 (Fed. Cir. 2013)
(quoting Hodges v. Sec’y of Dept. of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)
(internal citations omitted)).
Accordingly, it is not the role of this court to “reweigh the factual evidence,” “assess
whether the special master correctly evaluated the evidence,” or “examine the probative value of
the evidence or the credibility of the witnesses.” Lampe v. Sec’y of Health & Human Servs., 219
F.3d 1357, 1360 (Fed. Cir. 2010). “If the special master ‘has considered the relevant evidence of
record, drawn plausible inferences and articulated a rational basis for the decision, reversible
error will be extremely difficult to demonstrate.’” Hibbard v. Sec’y of Health & Human Servs.,
698 F.3d at 1363 (quoting Hines on Behalf of Sevier v. Sec’y of Dep’t of Health & Human Servs.,
940 F.2d 1518, 1528 (Fed. Cir. 1991)). In other words, the court is “not to second guess [a]
[s]pecial [m]aster’s fact-intensive conclusions; the standard of review is uniquely deferential for
what is essentially a judicial process.” Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958,
961 (Fed. Cir. 1993).
Finally, the court reviews a special master’s discretionary rulings for “abuse of
discretion.” Munn, 970 F.2d at 870 n. 10. Such rulings typically include review of evidentiary
rulings. See, e.g. Piscopo v. Sec’y of Health & Human Servs. 66 Fed. Cl. 49, 53 (2005). “An
abuse of discretion may be found when (1) the court's decision is clearly unreasonable, arbitrary,
or fanciful; (2) the decision is based on an erroneous conclusion of the law; (3) the court's
findings are clearly erroneous; or (4) the record contains no evidence upon which the court
rationally could have based its decision.” Hendler v. United States, 952 F.2d 1364, 1380 (Fed.
Cir. 1991); Woods v. Sec'y of Health & Human Servs., 105 Fed. Cl. 148, 151 (2012).
III. DISCUSSION
A. Vaccine Act Standards
The Vaccine Act, 42 U.S.C. §§ 300aa–1 to –34, established the National Vaccine Injury
Compensation Program to compensate individuals injured by vaccines “quickly, easily, and with
certainty and generosity.” H.R. Rep. No. 99–908, at 6 (1986), 1986 U.S.C.C.A.N. at 6344. The
Vaccine Act allows petitioners to seek compensation if they have “sustained, or ha[ve]
significantly aggravated” any “vaccine-related” “illness, disability, injury, or condition” caused
by a vaccine. 42 U.S.C. § 300a-11(c)(1)(C).
The Act provides petitioners two avenues for obtaining compensation: “table” and “off-
table” claims. W.C. Sec’y of Health & Human Servs., 704 F.3d 1352, 1355 (Fed. Cir. 2013). In
a table claim, if the petitioner can demonstrate that they received a vaccine listed in the Vaccine
Injury Table and that they suffered an injury within the time period defined by the table, the
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petitioner “benefits from a statutory presumption of causation.” Id. But if the injury is not listed
in the table, the petitioner must establish actual causation “by a preponderance of the evidence.”
Id.; 42 U.S.C. § 300aa-13(a)(1). Stated another way, a petitioner making an off-table claim must
present evidence showing that the vaccine “more likely than not” caused the injury. Capizzano
v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). Since ADEM is not
an injury listed on the Vaccine Injury Table, see 42 C.F.R. § 100.3, this case presents an off-table
claim.
In order to meet the preponderance of the evidence requirement for successfully bringing
an off-table claim, the petitioner has the burden of satisfying the following three-prong test set
forth in Althen v. Sec’y of Health & Human Servs.:
Concisely stated, [petitioner’s] burden is to show by preponderant
evidence that the vaccination brought about her injury by
providing: (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
showing of a proximate temporal relationship between vaccination
and injury. If [petitioner] satisfies this burden, she is entitled to
recover unless the [government] shows, also by a preponderance of
evidence, that the injury was in fact caused by factors unrelated to
the vaccine.
418 F.3d 1274, 1278 (Fed. Cir. 2005).
In Althen, the Federal Circuit emphasized that the Vaccine Act does not require exact or
conclusive evidence of causation, but a medically credible theory coupled with evidence of a
proximate temporal and causal relationship between the injury and the vaccination. See Althen,
418 F.3d at 1281-1282 (stating that “the purpose of the Vaccine Act's preponderance standard is
to allow the finding of causation in a field bereft of complete and direct proof of how vaccines
affect the human body”).
Generally speaking, this standard simply requires the special master to consider whether
there is preponderant evidence showing that the vaccine caused the alleged injury. “The function
of a special master is not to ‘diagnose’ vaccine-related injuries, but instead to determine based on
the record evidence as a whole and the totality of the case, whether it has been shown by a
preponderance of the evidence that a vaccine caused [petitioner’s] injury.” Lombardi, 656 F.3d
at 1352-53 (quoting Andreu ex rel. Andreu v. Sec'y of Dep't of Health & Human Servs., 569 F.3d
1367, 1382 (Fed. Cir. 2009)).
Although the Vaccine Act does not require absolute precision, it does require the
petitioner to establish an injury—the Act specifically creates a claim for compensation for
“vaccine-related injury or death.” 42 U.S.C. § 300aa-11(c) (emphasis added). Accordingly, the
Federal Circuit has held, in a series of recent decisions beginning with Broekelschen v. Sec’y of
Health and Human Servs., 618 F.3d 1339 (Fed. Cir. 2010), that if the special master finds, as a
preliminary matter, that petitioner has failed to substantiate the alleged injury, the special master
need not apply the Althen test for causality.
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In Broekelschen, the petitioner experienced symptoms attributable to either transverse
myelitis (“TM”) or anterior spinal artery syndrome, and had received differential diagnoses for
those two conditions. Petitioner argued that his flu vaccination caused him to suffer TM, a
neurological disorder that has been causally connected with the flu vaccine. Respondent
disputed this assertion, and argued that petitioner had suffered anterior spinal artery syndrome, a
vascular disorder that is not caused by the flu vaccine. See id. at 1342-44. The Special Master
found that the record supported respondent’s position, and denied the petition without applying
the Althen test.
The Broekelschen court observed that “the instant action is atypical because the injury
itself is in dispute, the proposed injuries differ significantly in their pathology, and the question
of causation turns on which injury [petitioner] suffered.” Id. at 1346 (emphasis added). The
court, in a 2-1 opinion, upheld the Special Master’s approach, stating that “[m]edical recognition
of the injury claimed is critical and by definition a ‘vaccine-related injury’ . . . has to be more
than just a symptom or manifestation of an unknown injury.” Id. at 1349. The court
distinguished the case from Andreu,
"where the parties agreed that the petitioner suffered from a seizure
disorder . . . or Kelley, where the competing diagnoses were
variants of the same disorder . . . . Here, nearly all of the evidence
on causation was dependent on the diagnosis of [petitioner’s]
injury. Therefore, it was appropriate for the special master to first
find which of [petitioner’s] diagnoses was best supported by the
evidence presented in the record before applying the Althen test.”
Id. at 1346 (discussing Andreu, 569 F.3d at 1378 and Kelley Sec’y of Health and Human Servs.,
68 Fed. Cl. 84, 100-01 (2005)).
In Lombardi, the Federal Circuit also affirmed a special master assessing the injury
claimed by petitioner without applying the Althen test. Lombardi, 656 F.3d at 1352-53. The
petitioner in that case was afflicted with pain radiating into her right chest and with chronic
fatigue, beginning shortly after she had received a third dose of the hepatitis B vaccine. The
petitioner visited a number of doctors, who struggled to identify the etiology of her condition.
The petition itself “did not identify any injuries, but claimed that [petitioner] had sought frequent
medical treatment following the vaccination.” Id. at 1348. The petitioner’s expert witnesses
suggested several possible conditions that had been causally associated with the hepatitis B
vaccine but were not listed on the Vaccine Injury Table. Respondent’s witnesses argued that
petitioner did not suffer from any of these conditions, but suggested several alternatives not
causally associated with the vaccine. See id. at 1345-49.
The Special Master in Lombardi analyzed the evidence in the record and concluded that
petitioner had “not established that she suffers from any of the three conditions that provide the
basis for her experts’ opinions.” Id. at 1349 (quoting Doe 60 v. Sec’y of Health & Human Servs.,
No. 99–VV–523, 2010 WL 1506010 (Fed. Cl. Mar. 26, 2010)). The Special Master found the
cause of petitioner’s condition elusive and denied compensation under the Vaccine Act, without
reaching the Althen test. Id. The Federal Circuit affirmed the Special Master’s approach,
holding that “[i]n the face of such extreme disagreement among well-qualified medical experts,
each of whom had evaluated the petitioner, it was appropriate for the Special Master to first
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determine what injury, if any, was supported by the evidence in the record before applying the
Althen test to determine causation. In the absence of any specific injury of which petitioner
complains, the question of causation is not reached.” Lombardi, 656 F.3d at 1352-53 (emphasis
added) (internal citations removed).
Initially, the scope of the Broekelschen and Lombardi opinions was subject to dispute.
Previous opinions on this court, for instance, have narrowly characterized Broekelschen and
Lombardi as “exceptions to the general rule” that “a special master should not conduct a
differential diagnosis, at the outset of the causation analysis, to choose one diagnosis over
another, or over a combination of diagnoses.” Contreras v. Sec’y of Health and Human Servs.,
107 Fed. Cl. 280, 293 (2012). The court, in Contreras, argued that Broekelschen only applied in
cases where “two competing diagnoses of dissimilar diseases” are presented. Id. at 293. That
opinion characterized the injury analysis from Broekelschen and Lombardi “as a first step in the
causation analysis.” Id. The Contreras court construed Lombardi narrowly, limiting it to “an
unusual case where: (1) the petitioner presents conflicting diagnoses of her alleged vaccine
injury; (2) the experts have ‘extreme disagreement’ as to the malady suffered; and (3) the
diagnoses are not along a continuum of similar conditions.” Id. at 294-95.
In the meantime, the Federal Circuit has taken a different approach. Several months after
Contreras was decided, the Federal Circuit issued Hibbard v. Sec’y of Health and Human
Services, 698 F.3d 1355 (2012), a case that expanded the scope of the Broekelschen and
Lombardi rulings. Hibbard, unlike Broekelschen and Lombardi, did not feature dueling theories
of the nature of the injury afflicting the petitioner. In Hibbard, it was uncontroverted that
petitioner suffered from dysautonomia, a dysfunction of the automatic nervous system. Id. The
only dispute was whether a flu vaccination caused petitioner to suffer postural orthostatic
tachycardia syndrome (“POTS”), a limited form of autonomic neuropathy that manifests itself as
dysautonomia, or whether petitioner’s dysauonomia was caused by some other factor. Id.
Respondent challenged whether petitioner could prove by a preponderance of the evidence that
petitioner had suffered POTS, but in contrast to Broekelschen and Lombardi, did not offer any
alternate theory of causation. Id. The Special Master found the evidence for POTS inconclusive,
and denied compensation without applying Althen. Id. Petitioner, in response, argued that this
approach conflicted with the burden-sharing test set forth in Althen. Id.
The Federal Circuit, in Hibbard, upheld the Special Master’s decision, without any of the
qualifying language used in Broekelschen and Lombardi. The court held that:
“[i]f a special master can determine that a petitioner did not suffer
the injury that she claims was caused by the vaccine, there is no
reason why the special master should be required to undertake and
answer the separate (and frequently more difficult) question
whether there is a medical theory, supported by ‘reputable medical
or scientific explanation,’ by which a vaccine can cause the kind of
injury that the petitioner claims to have suffered.”
Hibbard, 698 F.3d at 1365. The court explicitly expanded the scope of the injury inquiry by
contrasting the facts of the case with “previous cases” like Lombardi and Broekelschen, in which
there was an actual dispute as to which injury afflicted the petitioner. See also Hibbard, 698
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F.3d at 1370-71 (O’Malley, J., dissenting) (criticizing the majority for extending Broekelschen
“well beyond its facts”).
This approach also differs markedly from the “general rule” that a special master should
avoid selecting among differential diagnoses—the court held that “even assuming the medical
plausibility of [petitioner’s] theory of causation—that the vaccine triggered an immune response
that damaged her autonomic nerves—her failure to show that she had autonomic neuropathy
would be fatal to her case” because “whether [petitioner] suffers from autonomic neuropathy . . .
was a necessary component to her theory of vaccine-induced injury.” Id. at 1365. C.f. Andreu,
569 F.3d at 1378 (holding that petitioner was not required to prove whether petitioner had
suffered a febrile or afebrile seizure because the parties agreed that toxins in the TBT vaccine
can cause seizures, even if there was disagreement in the scientific literature as to whether the
vaccine could cause afebrile seizures); Kelley, 68 Fed. Cl. at 100-01 (2005) (holding that
petitioner was not required to precisely categorize his injury where the two possible diagnoses
were “variants of the same disorder”).
B. Review of the Special Master’s Decision
1. The Special Master Correctly Applied the Law
Petitioner argues that “the Chief Special Master erred as a matter of law in applying the
Lombardi approach to the present case” because this case “involv[ed] a question as to the
classification of a disease within an identified disease process, rather than whether an
unidentified disease process exists.” Id. at 14. In essence, petitioner contends that the CSM
errantly treated the uncertainty as to the sub-type of petitioner’s demyelinating encephalomyelitis
(ADEM, MS, or other) as if the cause of petitioner’s injuries was unknown. Id. Petitioner
argues that “the sub-classification . . . is of assistance [solely] for medical purposes, in the
treatment of the disease process.” Id. at 5. Petitioner asserts that she undisputedly “suffers from
an acquired demyelinating encephalomyelitis involving lesions at the pons and mid-areas of her
brain.” Pet’r’s Mot. at 4.
As explained above, the court reviews legal conclusions, such as the CSM’s decision to
apply Lombardi, under the “not in accordance with law” standard. Masias, 634 F.3d at 1287-88
(construing 42 U.S.C. § 300aa–12(e)(2)(B)).
Applying this standard, the court affirms the CSM’s application of Lombardi. Petitioner
simply misstates the law as it currently stands. Although the Federal Circuit has continued to
recite the general principle that it is not the role of a special master to engage in differential
diagnosis, the Federal Circuit has increasingly emphasized that a petitioner must, as a
preliminary matter, establish a specific injury in order for the Althen test to come into play.
Critically, Federal Circuit precedent dictates that the petitioner has the burden of proving, by the
preponderance of the evidence, that they are actually afflicted by the injury which, under their
theory of vaccine-induced injury, was caused by the vaccine. See Hibbard, 698 F.3d at 1365. A
“vaccine-related injury” must be “more than just a symptom or manifestation of an unknown
injury[;]” “[m]edical recognition of the injury claimed is critical.” Broekelschen, 618 F.3d at
1349.
The court is not persuaded by petitioner’s argument that a precise ADEM diagnosis is not
necessary. Petitioner’s ADEM diagnosis is clearly a “necessary component to her theory of
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vaccine-induced injury.” Hibbard, 698 F.3d at 1365. This is demonstrated by the fact that the
evidence presented before the CSM related to ADEM, not demyelinating diseases generally or
other demyelinating diseases. Petitioner’s expert witness specifically alleged that petitioner
suffered from “an atypical example of the subacute onset of demyelinating brain stem
encephalitis, a variant of ADEM.” Pet’r’s Ex. 8 at 3. Moreover, petitioner cited studies by Poser
(1982), Saito et al. (1980), Shoji and Kaji (2003), Miyamoto et al. (1996), Ravaglia et al. (2004),
etc. in support of the proposition that ADEM, in particular, can be triggered by the flu vaccine.
Id. at 4-5. As respondent notes, “[t]he theories put forth by petitioner’s expert all relied on a
diagnosis of ADEM, and thus this particular diagnosis lies at the very crux of petitioner’s case-
in-chief.” Res. at 9. Thus, Hibbard dictates that petitioner’s failure to establish that she has
ADEM is fatal to her case.
For these reasons, the court finds that the CSM did not err by considering whether
petitioner had demonstrated she suffered from a vaccine-caused ADEM injury by a
preponderance of the evidence in the record, as a predicate to applying the Althen test. Because
petitioner’s arguments and expert testimony centered on a diagnosis of ADEM, the CSM did not
err in applying Lombardi once she determined that petitioner had not carried her burden of
establishing that she suffered from ADEM.
2. The Special Master’s Factual Findings Were Not Arbitrary or Capricious
Petitioner also argues that the CSM acted arbitrarily and capriciously in finding that
petitioner had failed to prove, by a preponderance of the evidence, that she was suffering from
ADEM. Pet’r’s Mot. at 1. Petitioner insists that the CSM erroneously focused on whether
petitioner was actually suffering from ADEM, “rather than whether [p]etitioner’s disease was
within the medically accepted guidelines of ADEM.” Pet’r’s Mot. at 14. Petitioner
acknowledges that her symptoms do not match those typically exhibited by ADEM patients, but
insists that she suffers from an “atypical” variant of ADEM. Id. at 1.
As explained above, the CSM cited the following six reasons for finding that petitioner
was not suffering from ADEM, or even an “atypical” variant thereof: (1) the statistical
probability that petitioner suffers from ADEM, (2) the absence of an ADEM diagnosis from her
treating physicians; (3) the appearance of her brain lesion in the MRI; (4) the slow onset of her
symptoms; (5) the nature and severity of her symptoms; and (6) the protracted course of her
illness and her limited recovery. Stillwell I at 16-28. In short, the CSM found that “petitioner’s
onset, symptoms, and the course of her illness diverge in too many respects and by too great a
degree from the presentation of ADEM to even be deemed an atypical form of ADEM.” Id
(emphasis added).
Petitioner disputes the CSM’s finding that Ms. Stillwell was not suffering from ADEM.
Petitioner argues that it was improper for the CSM to consider that most victims of ADEM are
young children or adolescents because Dr. Kinsbourne introduced evidence that it is possible for
ADEM to afflict adults. Pet’r’s Mot. at 5-6. Petitioner also argues that the absence of an ADEM
diagnosis by any of petitioner’s treating physicians is irrelevant because “a physician’s purpose
in classifying a disease process is to determine a course of medical treatment and prognosis – and
not to establish a causative factor which may be necessary in a legal proceeding.” Id. at 6.
Additionally, petitioner acknowledges that ADEM usually produces separate, or multifocal,
lesions that are visible in MRIs, but insists that several studies cited by Dr. Kinsbourne support
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the possibility that some cases of ADEM may exhibit unifocal lesions. Id. at 6-8. Petitioner also
acknowledges that the onset of ADEM symptoms is usually rapid, but argues that an onset of
four weeks after the vaccination is nevertheless “within the generally acceptable onset.” Id. at 9-
10. Additionally, petitioner disputes respondent’s argument that the severity of petitioner’s
symptoms was inconsistent with symptoms typically caused by ADEM. Id. at 10-12. Finally,
petitioner argues that even if petitioner’s protracted course of injury was atypical, it was still
within the acceptable range for ADEM. Id. at 12-13.
As explained in the preceding section, petitioner has the burden of establishing, by the
preponderance of the evidence, that she actually suffers from the specific injury she alleges was
caused by the vaccination. Hibbard, 698 F.3d at 1365; see also Broekelschen, 618 F.3d at 1349
(holding that petitioner must establish that she suffers from a “vaccine-related injury,” not
merely “a symptom or manifestation of an unknown injury”); Lombardi, 656 F.3d at 1553
(holding that petitioner must successfully establish a “specific injury”). Whether petitioner has
successfully satisfied this burden is clearly a factual question, which is reviewed under the
arbitrary and capricious standard. See Hibbard, 698 F.3d at 1363, 1365. Under this deferential
standard, the court must uphold factual findings if the special master has considered the record
and made plausible inferences. Id. at 1363 (quoting Hines on Behalf of Sevier, 940 F.2d at
1528).
Plainly, petitioner disagrees with the CSM’s assessment of the evidence. Nevertheless,
the court finds that the CSM’s factual findings are clearly supported by the record and therefore
are not arbitrary and capricious. As explained above, there is no specific marker for ADEM.
Rather, in identifying ADEM, both clinical findings and laboratory evidence must be taken into
account. Thus, in considering whether petitioner was suffering from ADEM or some other
malady, the court finds that it was reasonable for the CSM to consider a number of probabilistic
factors, such as the typical age of individuals afflicted by ADEM, the typical course of illness,
severity of symptoms, and others.
The CSM summarized the typical characteristics of ADEM, and carefully elucidated six
factors that weighed against a finding that petitioner was suffering from ADEM. In light of the
fact that petitioner’s symptoms were undisputedly “atypical,” not just in one respect but on
multiple levels, the court concludes that the CSM’s finding is substantially supported by the
record on the whole.
Finally, petitioner’s argument that the CSM should have focused on whether her “disease
was within the medically accepted guidelines of ADEM” rather than whether petitioner actually
suffered ADEM plainly misstates the law. As explained in the preceding section, petitioner has
an affirmative burden of showing, by the preponderance of the evidence, that she actually suffers
from the specific injury she alleges was caused by the vaccination. Hibbard, 698 F.3d at 1365.
For the foregoing reasons, the court finds that the CSM did not act arbitrarily or
capriciously in finding that petitioner does not suffer ADEM.
***********
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The ratio decidendi of the CSM’s decision is that petitioner “failed to prove by
preponderant evidence that she developed ADEM.” Stillwell I at 28-29. As the CSM noted, this
determination “precludes a finding of causation” and thus obviates any need to apply the Althen
test for causation. Id. (citing Lombardi, 656 F.3d at 1352-53).
But, in “an abundance of caution” the CSM evaluated petitioner’s claim under the Althen
test’s prongs. Stillwell I at 29. Because the CSM decided the case on Lombardi grounds, the
CSM’s Althen evaluation is dicta. See e.g. Cohens v. State of Virginia, 19 U.S. 264, 399-400
(1821) (remarking that, with regard to dicta, “[i]t is a maxim not to be disregarded, that general
expressions . . . are to be taken in connection with the case in which those expressions are used . . .
The reason of this maxim is obvious. The question actually before the Court is investigated with
care, and considered in its full extent. . . .”). Accordingly, the court does not reach the question
of whether the CSM’s determination that petitioner did not satisfy the Althen test was arbitrary or
capricious.
IV. CONCLUSION
In sum, the court affirms the Chief Special Master’s determination that petitioner’s claim
fails under Lombardi. Petitioner has not carried the burden of proving she suffers from a
vaccine-related injury. Accordingly, the Special Master’s DECISION is AFFIRMED and
petitioner’s MOTION for review of that decision is DENIED.
IT IS SO ORDERED.
s/ Lawrence J. Block
Lawrence J. Block
Judge
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