VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-00200
Package ID: USCOURTS-cofc-1_15-vv-00200
Petitioner: Mario Caruso
Filed: 2017-10-18
Decided: 2018-04-06
Vaccine: influenza
Vaccination date: 2012-10-16
Condition: acute disseminated encephalomyelitis
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Mario Caruso, a 64-year-old adult, filed a petition for compensation under the National Vaccine Injury Compensation Program on October 18, 2017, alleging that he developed acute disseminated encephalomyelitis (ADEM) as a result of receiving a trivalent influenza vaccine on October 16, 2012. Petitioner's family reported noticing behavioral changes, fatigue, and vision difficulties starting around November 2012. Mr. Caruso sought medical attention in late January 2013 for gait problems, diagnosed as dizziness and a gait disorder. Subsequent MRIs in March 2013 revealed multifocal signal abnormalities consistent with demyelination, and ADEM became the confirmed diagnosis. The case proceeded to an entitlement hearing. Special Master Brian H. Corcoran issued a decision on October 18, 2017, denying entitlement. The Special Master found that Mr. Caruso failed to meet his burden of proof for causation. Specifically, the decision noted that the onset of symptoms, occurring approximately two months after vaccination (late December 2012), was too temporally distant to be medically acceptable for vaccine-induced ADEM, citing scientific literature suggesting a shorter onset window. Furthermore, the Special Master determined that Mr. Caruso's presentation was an atypical, halting form of ADEM, which differed from the acute onset typically associated with vaccine-induced cases, and that reliable science linking vaccines to ADEM did not apply to his circumstances. Petitioner Mario Caruso filed a motion for review of this decision. On April 6, 2018, Senior Judge Loren A. Smith of the U.S. Court of Federal Claims issued an opinion denying the motion for review. The court upheld the Special Master's findings, agreeing that Mr. Caruso had not met his burden of proof under the Althen criteria, particularly regarding the proximate temporal relationship and the logical sequence of cause and effect for an atypical presentation of ADEM. The court found no arbitrary or capricious action by the Special Master in weighing the evidence, including fact testimony and medical records, and affirmed the denial of compensation.

Theory of causation field:
Petitioner Mario Caruso, aged 64, received an influenza vaccine on October 16, 2012, and alleged developing acute disseminated encephalomyelitis (ADEM). The claim was for a "Non-Table Injury." Petitioner's counsel was Joseph Pepper and Ronald Craig Homer. Respondent's counsel was Darryl Wishard. Special Master Brian H. Corcoran denied entitlement on October 18, 2017. The court, Senior Judge Loren A. Smith, denied petitioner's motion for review on April 6, 2018. Petitioner's expert was Dr. Carlo Tornatore, who opined ADEM was triggered by the flu vaccine via molecular mimicry or B and T cell activation, suggesting onset within a month, and citing the Poser study for a longer onset window. Respondent's expert was Dr. Thomas Leist, who opined the symptoms were not ADEM or, if they were, not vaccine-caused, citing literature (Rowhani-Rahbar, Noorbakhsh, Tenembaum) supporting a 5-28 day, or at most 42-day, interval for vaccine-induced ADEM. The Special Master found the first Althen prong (medical theory) satisfied, acknowledging prior cases linking flu vaccines to ADEM. However, the Special Master found the second prong (logical sequence) not met due to Mr. Caruso's "atypical ADEM" with a halting, non-acute onset, distinguishing it from the acute form discussed in literature. The third prong (proximate temporal relationship) was also not met, as the earliest medically supported onset was late December 2012 (approx. 60 days post-vaccination), exceeding the 2-42 day window cited in Rowhani-Rahbar and other literature. The court affirmed the Special Master's denial, finding no arbitrary action in weighing evidence and upholding the conclusion that petitioner failed to meet the burden of proof, particularly regarding the temporal proximity and atypical presentation of the injury.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_15-vv-00200-2
Date issued/filed: 2017-11-14
Pages: 23
Docket text: PUBLIC DECISION (Originally filed: 10/18/2017) Regarding 57 DECISION of Special Master (Signed by Special Master Brian H. Corcoran). (cr) Copy to parties.
--------------------------------------------------------------------------------
Case 1:15-vv-00200-LAS Document 59 Filed 11/14/17 Page 1 of 23
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 15-200V
(not to be published)
* * * * * * * * * * * * * * * * * * * * * * * * *
*
MARIO CARUSO, *
*
Petitioner, *
* Filed: October 18, 2017
v. *
* Decision; Denial of Entitlement;
SECRETARY OF HEALTH * Acute Disseminated
AND HUMAN SERVICES, * Encephalomyelitis (“ADEM”);
* Influenza (“flu”) Vaccine; Onset;
Respondent. * Third Althen Prong
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Joseph Pepper, Conway Homer, P.C., Boston, MA, for Petitioner.
Darryl Wishard, U.S. Dep’t of Justice, Washington, DC, for Respondent.
DECISION DENYING ENTITLEMENT1
On March 2, 2015, Mario Caruso filed this action seeking compensation under the National
Vaccine Injury Compensation Program (the “Vaccine Program”2). Petition (“Pet.”) (ECF No. 1).
Petitioner alleges that he developed acute disseminated encephalomyelitis (“ADEM”) as a result
of the trivalent influenza “(flu”) vaccine he received on October 16, 2012. Pet. at 1. An entitlement
hearing was held in Washington, DC, on April 20-21, 2017.
1 Although this decision has not been designated for publication, it will nevertheless be posted on the United States
Court of Federal Claims’ website, and in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012).
This means the ruling will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-
12(d)(4)(B), however, the parties may object to the published ruling’s inclusion of certain kinds of confidential
information. Specifically, under Vaccine Rule 18(b), each party has fourteen (14) days within which to request
redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance
and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would
constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the entire decision will be
available in its current form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3755 (codified as amended at 42 U.S.C. § 300aa-10 through 34 (2012)) (hereinafter “Vaccine Act” or “the
Act”). All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. §
300aa.

Case 1:15-vv-00200-LAS Document 59 Filed 11/14/17 Page 2 of 23
After considering the record as a whole, and for the reasons explained below, I find that
Petitioner has not carried his burden of proof. The two-month gap between vaccination and the
December 2, 2012 onset of symptoms most credibly connected to Petitioner’s subsequently-
diagnosed ADEM is too attenuated temporally to establish a medically acceptable timeframe for
vaccine-induced ADEM. In addition, although ADEM is usually understood to be acute (especially
when a vaccine is most plausibly implicated in its development), Petitioner experienced an atypical
form of the disease which evolved over time, only becoming acute a month after onset – but
Petitioner did not establish that the same reliable science associating certain vaccines with the
classic form of ADEM would still apply under the facts of this case.
I. Factual Background
Vaccination and Alleged Initial Symptoms
Mr. Caruso received the flu vaccine on October 16, 2012, when he was 64 years old. Ex. 1
at 1. His pre-vaccination medical history included prostate enlargement, hypolipoproteinemia,3
varicose veins of the lower extremity with an ulcer, and sclerosis of the skin.4 Ex. 2 at 1; Ex. 5 at
9.
There are no medical records from the ensuing ten weeks establishing or suggesting that
Mr. Caruso experienced any immediate reaction to the vaccine. Thus, on October 23, 2012,
Petitioner visited his physician at Peachwood Medical Group (“PMG”), in Clovis, California, to
have his lipid levels checked, and he did not then report any neurological issues or other symptoms.
Ex. 2 at 7, 12.5 Nevertheless, Mr. Caruso has alleged that in this post-vaccination time period he
began to experience symptoms connected to his later-diagnosed neurologic injury. See generally
Petitioner’s Affidavit, dated March 5, 2015, filed as Ex. 17 (ECF No. 7). In support, Petitioner
offered not only his own prior written statements, but the live hearing testimony of his wife, Sylvia
Caruso, and daughter, Kristy Caruso. See generally Transcript (“Tr.”) at 6-69, 70-90.
Mrs. Caruso testified that in November 2012, she and her husband moved from Kingsburg,
California, to Clovis, California. See generally Ex 24. At that time, she began to notice some
changes in his behavior. Id. at 1-2. Specifically, during the first week of November 2012, Mrs.
Caruso and Ms. Kristy Caruso noticed Petitioner uncharacteristically struggling to move large
items, and becoming extremely fatigued when he did so. Ex. 25 at 1; Tr. at 73-75. Mrs. Caruso
3 Hypolipoproteinemia is a term used to note the presence of abnormally low levels of lipoproteins in the serum.
Dorland’s Illustrated Medical Dictionary 903 (32d ed. 2012) (hereinafter “Dorland’s”).
4 Sclerosis is evidenced by a hardening of the skin, an increased formation of connective tissue, or disease of the
interstitial substance. Dorland’s at 1680.
5 The lipid check that was performed showed high levels of glucose, triglycerides, and LDL cholesterol. Ex. 2 at 12.
2

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also recalled that during this general time frame (November-December 2012), Petitioner seemed
to be having difficulty with his vision, often closing one eye to focus when he drove or watched
television. Ex. 24 at 1-2; Tr. at 13. Mr. Caruso’s symptoms became progressively worse until the
end of December, when his family noticed (during a birthday celebration for his other daughter,
Gina) that he was walking in an unstable way, as he if were drunk (although the testifying fact
witnesses all maintained that he had not been inebriated at the time).6 Ex. 24 at 1-2, Ex. 25 at 1-2;
Tr. at 16-17, 76-77. Around this time, Mrs. Caruso shared her concerns about Petitioner’s health
with Ms. Kristy Caruso. Id. at 76-77.
January 2013 Incident and Initial Treatment
In late January 2013, Petitioner experienced a more acute incident that encouraged him to
seek medical intervention. As Mrs. Caruso related at the entitlement hearing, she and Petitioner
were shopping on a Friday, and as they were walking through a Walmart parking lot, Mr. Caruso
“suddenly” was “just walking totally weird.” Tr. at 18. His feet dragged, and he appeared to display
an uneven gait like a “drunken sailor.” Id. Mrs. Caruso used a shopping cart to stabilize Mr. Caruso,
and when they returned home she expressed to him her concern that his symptoms warranted a
doctor’s visit as soon as possible. Id. at 19.
Mr. Caruso made an appointment with his primary caregiver at PMG, nurse practitioner
Cynthia Baer, for January 28, 2013. See Ex. 16 at 1. The Carusos informed Nurse Practitioner Baer
that Petitioner was “walking funny,” and that his gait problems had begun the month before
(meaning December 2012), ebbing then recurring on the prior Friday (January 25th), at which time
he had experienced “really wobbling” legs. Id. at 1, 8. Mr. Caruso denied any paresthesias, but felt
off balance. Id. at 8. He also had been falling asleep in the evenings for the past month. Id.
These initial medical records do not mention any symptoms occurring prior to December
2012. Indeed, in the “review of systems” section of the medical record from this January 28th visit,
Petitioner denied experiencing blurred vision, double vision, photophobia, headaches, and
weakness (several of which would be included in the symptoms that Mrs. Caruso and Ms. Kristy
Caruso claim Petitioner had experienced in November 2012). Ex. 16 at 8. The results of a complete
exam were deemed normal, but Nurse Practitioner Baer noted that Mr. Caruso seemed “to slightly
drag right tow [sic]. No specific abnormality but gait does not seem totally normal.” Id. at 9.
Ultimately Petitioner was diagnosed with dizziness and a gait disorder, and diagnostic tests were
ordered. Id. at 12. A CT scan performed on Petitioner’s brain on February 1, 2013 found no
significant abnormalities, with the technician deeming the results “unremarkable.” Ex. 11 at 1.
6 It appears that in the gap in medical records from October 2012 - January 2013 Mr. Caruso had his appendix removed.
This is noted in his surgical history at his January 28, 2013 visit, but not at either of his visits to PMG in October 2012.
Ex. 16 at 2. No records involving this procedure were filed.
3

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Treater Consensus on ADEM Diagnosis
On February 8, 2013, Mr. Caruso returned to PMG complaining of dizziness, diplopia, and
gait difficulty, and was seen by Dr. Lee Copeland. Ex. 2 at 15. At that visit, and with his wife again
present, Petitioner repeated his representation from January that he had first experienced such
symptoms for a period of time of slightly greater than one month, and the Carusos expressed their
concerns about the nature of his symptoms. Id. at 20. Dr. Copeland included multiple sclerosis
(“MS”) or “other progressive neuro deficit” in the differential diagnosis and referred the Carusos
to a neurologist. Id.
A few days later, on February 11, 2013, Mr. Caruso saw neurologist Dr. Loveneet Singh.
Ex. 5 at 9-10. The Carusos again reported that Petitioner’s symptoms had been ongoing for
“approximately a month,” but had become progressively worse. Id. at 9. Mr. Caruso now
complained of fatigue, vision changes with diplopia, and gait problems with stumbling and
dragging of his left foot. Id. Mrs. Caruso reported that Petitioner was slower to respond verbally
to her, and that his voice had become softer. Id. At this visit, Mr. Caruso displayed impaired
coordination and diplopia, as well as an inability to perform rapid alternating movements. Id. His
gait was slow, and he required support when walking. Id.
Based upon the physical examination, Dr. Singh opined that Mr. Caruso demonstrated
evidence of upper motor neuron dysfunction, including cerebellar signs and gait ataxia.7 Ex. 5 at
10. Subsequent testing confirmed Dr. Singh’s impressions. Thus, brain and cervical spine MRIs
performed on March 2, 2013, showed multifocal signal abnormalities in the midbrain, brainstem,
brachium pontis, cerebellum, and spinal cord. Id. at 42. Some of the lesions enhanced,8 and some
cerebral volume loss was noted. These imaging studies also showed both enhancing and non-
enhancing signal abnormalities. Id. at 40, 42; Ex. 11 at 2-3, 5-6; see also Ex. 14 at 41. Evidence
of what appeared to be active inflammation in Petitioner’s spine suggested “active demyelinated
plaques with breakdown of the blood brain barrier.” Ex. 11 at 2-3.
Mr. Caruso saw Dr. Singh again on March 11, 2013. By this time, ADEM and MS were
both included in the differential diagnosis. Ex. 5 at 8. Dr. Singh also noted that Petitioner’s
symptoms had been preceded by a vaccination. Id. In an attempt to home in on the correct
explanation for Petitioner’s symptoms, Dr. Singh ordered more testing, including lab work to show
glucose and protein levels, a cell count, and an MS panel. Id. The results of this testing were largely
7 Gait ataxia is characterized by irregular muscular action when walking. Dorland’s at 170.
8 Lesion enhancement on MRI occurs after the uptake in the lesion of a Gadolinium-based contrast agent injected into
a subject’s blood. W.C. v. Sec’y of Health & Human Servs., 100 Fed. Cl. 440, 444 (2011). It reveals a breakdown of
the blood-brain barrier (since the contrast agent is able to go into the brain). Such a breakdown can trigger neurological
injury, by allowing infectious or inflammatory agents into the brain and central nervous system, causing damage. Tr.
at 110-12.
4

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normal, however, including no evidence of oligoclonal bands (commonly associated with MS),
and a negative MS panel otherwise. Id. at 26.
On March 11, 2013, Mr. Caruso obtained treatment from an ophthalmologist, Dr. Gary
Walters, at Eye Medical Center in Fresno, California. Dr. Walters informed Dr. Singh of his
findings on March 19, 2013, noting Petitioner’s sudden onset of double vision and walking
difficulties were reported to have begun to two months earlier (thus again placing onset of
symptoms no earlier than January 2013). Ex. 2 at 82, see also Ex. 7 at 25 (“pt’s wife states she
noticed he began to close one eye or the other when watching TV or driving around 2 mths ago
and then began to notice he was having problems walking”). Mr. Caruso displayed decreased
vision (right eye 20/200; left eye 20/70), although some of these symptoms showed improvement
later in 2013. Ex. 7 at 27.9
Thereafter, Petitioner continued to obtain treatment, and to seek an explanation for his
condition. An autosomal dominant ataxia evaluation ordered by Dr. Singh in February 2013 to
identify any pathogenic mutations that might explain the ataxia Petitioner was suffering came back
negative on March 26, 2013. Ex. 5 at 11-33. Mr. Caruso had a follow-up appointment on April 22,
2013, and was seen by Gloria Lovering, a nurse practitioner working with Dr. Singh. Id. at 7. The
handwritten record from that visit again referenced his October 2012 flu vaccination, and the
diagnostic assessment now included only ADEM and Balint Syndrome.10 Id. Petitioner was
instructed to seek physical therapy for his gait problems.
Subsequent Treatment Efforts
Mr. Caruso returned to Dr. Singh in July 2013. By this point, the ADEM diagnosis was
deemed confirmed, although no reference is made in these records to the flu vaccine having played
a role in its development. Ex. 5 at 5. Mr. Caruso has since continued to obtain treatment for his
ADEM/neurologic symptoms. After about a year of ongoing symptoms with no real signs of
progression in severity and no evidence of additional developing lesions, Mr. Caruso sought a
second neurological opinion on June 23, 2014. Ex. 14 at 49. At that time, he saw Dr. Leslie
Dorfman at the Stanford Hospital in Redwood City, California.
Dr. Dorfman discussed Mr. Caruso’s medical history up to that point, demonstrating a
desire to reevaluate Petitioner’s diagnosis in light of the entire medical record generated to that
date. Ex. 14 at 49-52. Some of his characterizations of the facts are not consistent with the
aforementioned records, however; thus, Dr. Dorfman places onset of Petitioner’s symptoms in
9 Thus, Petitioner’s vision improved to 20/100 on the right and 20/50 on the left by May 3, 2013, 20/70 on the right
20/40 on the left by June 3, 2013, and 20/50 on the right and 20/30 on the left by August 5, 2013. Ex. 7 at 7, 13, 1.
10 Balint Syndrome includes gaze paralysis, ataxia of eye movements, and other vision disturbances usually caused by
bilateral lesions in the parietooccipital region. Dorland’s at 1822.
5

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December 2012, but then indicates that symptoms “came on about a month after he received a [flu]
immunization,” when in fact the vaccine had been received more than two months prior. Id. at 49.
Dr. Dorfman otherwise noted that Petitioner had received at some point a “provisional diagnosis”
of ADEM, and that his condition had not significantly worsened but also had not improved. Id. at
49-50. Dr. Dorfman reviewed the MRIs ordered in 2013 by Dr. Singh, agreeing that they were not
indicative of MS. Id. at 51.
After a physical examination and consideration of Petitioner’s history, Dr. Dorfman
proposed that ADEM was an “acceptable working diagnosis,” but that he ultimately felt the true
classification for his symptoms remained unidentified. Ex. 14 at 51. He therefore proposed some
additional diagnostic testing aimed at arriving at a treatment that (if properly targeted at the actual
cause of Petitioner’s symptoms) would be more effective. Id.
A month later, Petitioner returned to Dr. Dorfman on July 25, 2014. See Ex. 14 at 47-48.
Dr. Dorfman noted that the testing he had requested had produced negative or normal results, and
that additional review of his 2013 MRIs by other neuro-radiologists had produced no novel
insights. Id. at 47. Dr. Dorfman thus opined that Mr. Caruso likely was suffering from an “atypical
form” of ADEM, offering no views as to its etiology, and recommended a steroid treatment,
followed by IVIG11 if the steroids proved ineffective. Id. at 47-48. By August (when Petitioner
sought treatment for pneumonia secondary to an incident of acid reflux), Mr. Caruso reported some
improvement from the steroid treatment, leading Dr. Dorfman to propose its continuation (while
still allowing for possible IVIG). Ex. 34 at 4-5.
Additional medical records indicate that Mr. Caruso has since continued to experience
sequelae from his 2012-2013 symptoms. See, e.g., Ex. 29 at 22-24, Ex. 33 at 1-2. Some of these
records suggest a relationship between the flu vaccine and Petitioner’s symptoms, but it appears
from those same records that the memorialized associations represent less the conclusions of
treaters and more the recitation of Mr. Caruso’s medical history made to them by Petitioner or his
spouse – recitations which differ from the contemporaneous information provided to treaters in
January 2013, after his initial gait problems led him to seek treatment. See, e.g., Ex. 33 at 1-2
(notes from August 3, 2015, visit with neurologist identifying gait problems as beginning in
November 2012, and an onset of other symptoms on January 1, 2013). MRIs performed in April
2015 appear to have confirmed that no additional lesions had appeared since 2013, thus further
corroborating the accuracy of the ADEM diagnosis (Ex. 22 at 1-5).
11 Intravenous immunoglobulin (“IVIG”) is a blood product used to treat patients with antibody deficiencies, including
neurological disorders. Clinical Uses of Intravenous Immunoglobulin, NCBI (2005),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1809480/ (lasted visited on Aug. 28, 2017). It is commonly
prescribed to treat diseases believed to be autoimmune in nature, increasing the effectiveness of an individual’s
immune response.
6

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II. Hearing Testimony
A. Fact Witnesses
As already noted, Mr. Caruso’s wife and daughter both testified at the entitlement hearing.
Their testimony was largely consistent with the factual summary above. Tr. at 6-90. Thus, they
attempted to corroborate Petitioner’s claim that onset of his symptoms began in November 2012,
two months before he sought formal medical treatment. Mrs. Caruso recalled that the most
noticeable symptom after Petitioner’s receipt of the flu vaccine was that he squinted one eye to
drive causing him to drive erratically. Tr. at 10. She remembered this pattern of driving occurring
around the first week of November. Id. In addition, both fact witnesses testified to noticing his
fatigue during the first week of November when Petitioner and his wife were moving to a new
house. Tr. at 11, 75. Thereafter, Mrs. Caruso observed changes in his daily routine due to sleepiness
and fatigue. Id. at 12, 76.12
Mrs. Caruso also described the worsening of Petitioner’s symptoms and the concern
expressed by Dr. Singh about the lesions observed from MRIs. In addition, Mrs. Caruso recalled
that Dr. Singh suggested at Petitioner’s March 11, 2013, visit that whatever was going on could
have been related to the flu vaccine (although there is no medical record corroborating this alleged
statement). Tr. at 27. Around this time, Mrs. Caruso began maintaining a journal documenting the
symptoms she noticed as well as the various doctors’ visits. See generally Ex. 39. The journal
(filed right before the hearing in April 2017) contains an entry from March 2013 stating that Mr.
Caruso’s squinting at the TV and while driving had begun “about November and into December.”
Id. at 1 (March 9, 2013 entry). However, Mrs. Caruso conceded on cross examination that at most
initial treater visits she identified onset as occurring after the shopping incident in late January,
explaining that she had not realized at the time that there might be a correlation between his gait
issues and other symptoms. Tr. at 47.
B. Petitioner’s Expert – Dr. Carlo Tornatore
Dr. Tornatore provided an initial report as well as a supplemental report reacting to
objections raised by Respondent about the onset of Petitioner’s symptoms, and testified at hearing.
See e.g., Exhibit 26, filed Nov. 24, 2015 (ECF No. 22) (“Tornatore Rep.”); Exhibit 28, filed Mar.
29, 2016 (ECF No. 29) (“Tornatore Supp. Rep.”); Tr. 97-187, 249-258.
Dr. Tornatore is a board-certified neurologist. See Exhibit 27, dated Nov. 24, 2015
(“Tornatore CV”). He graduated from Cornell University with Bachelor of Arts in Neurobiology,
and then attended Georgetown University Medical Center where he received a Master of Science
12 Kristy Caruso acknowledged that she had less day-to-day insight into the course of her father’s symptoms than Mrs.
Caruso, stating that outside of the moving event and birthday celebration, she had not noticed her father’s symptoms
despite spending the holidays with Petitioner and Mrs. Caruso. Tr. at 85.
7

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in Physiology. Id. at 2; Tr. at 98. He subsequently graduated from medical school at Georgetown
University School of Medicine, completed a residency in the Department of Neurology at
Georgetown University Hospital, and completed a fellowship in molecular virology at the National
Institutes of Health in Bethesda, Maryland. Tornatore CV at 2; Tr. at 98. Id. He has published
articles addressing cell biology and pathology of demyelinating disorders. Tornatore CV at 7-14.
Currently, he serves as Vice Chairman in the Department of Neurology at MedStar Georgetown
University Hospital and as a Professor of Neurology at Georgetown University Medical Center.
Tornatore CV at 3; Tr. at 98-99. At hearing, Dr. Tornatore represented that he is an immunologist
as well – but, although he plainly has training in the field and was competent to testify about it,
this is not his specialty, and his CV does not reflect a learned focus on the subject. Tr. at 98.
Dr. Tornatore opined that Mr. Caruso’s ADEM was triggered by his October 2012 flu
vaccination through the process of molecular mimicry. Tornatore Rep. at 12. He explained that
vaccination creates an immune response causing self-antigens contained in the brain to be
mistakenly destroyed by the immune system because they are homologous to antigens contained
in the vaccine. Id. According to Dr. Tornatore, these self-antigens can cause an “inflammation
cascade” that can damage organs, resulting in a variety of symptoms including motor, sensory,
gait, and bladder dysfunction. Id. at 13.
Dr. Tornatore could not identify a specific target antigen in the nervous system for the
pathogenesis of ADEM. Tornatore Rep. at 12-13. He did, however posit that it was highly
probable, given the vast amount of potential antigens in the nervous system, that homology could
be found between a nervous system peptide sequence and a vaccine antigen. Id. at 13.
Alternatively, he proposed that B and T cells could be activated by a vaccine antigen even in the
absence of homology. Id. Those B and T cells would then mount an autoimmune response leading
to ADEM. Id.
Dr. Tornatore proposed that Mr. Caruso’s ADEM most likely began within a month after
receipt of the flu vaccine (or November 2012). Tr. at 175. In so maintaining, however, he relied
solely on the affidavit of Mr. Caruso, rather than the contemporaneous medical records. Tornatore
Rep. at 13. In his supplemental report, Dr. Tornatore proposed a medical/scientific basis for the
acceptability of an ADEM onset that extended beyond 30 days. See Tornatore Supp. Rep. at 1,
citing C.M. Poser, Neurological Complications of Swine Influenza Vaccination, 66 Acta
Neurology Scandinavia 4:413‐31 (1982), filed as Ex. 28, Tab A (ECF No. 29-1) (“Poser”). Poser
was a 1982 study of the swine flu vaccine that found onset of autoimmune neurological
complications in patients who had received the vaccine occurring between one and 63 days. Poser
at 416-21. Dr. Tornatore testified that Poser supported his opinion that a two-month “lag” from
date of vaccination to onset had biologic plausibility. Tornatore Supp. Rep. at 1; see also Poser at
415. In fact, however, the mean interval set forth in Poser was actually 16.5 days, or a little more
than two weeks, with only one case falling outside the proposed two-month timeframe. Poser at
421.
8

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C. Respondent’s Expert – Dr. Thomas Leist
Respondent’s expert, Thomas Leist, M.D., Ph.D., submitted one expert report in this case
and testified at the hearing. See Ex. A, dated June 16, 2016 (ECF No. 30) (“Leist Rep.”); Tr. at
188-248.
Dr. Leist attended the University of Zurich, where he obtained his Ph.D. in immunology
and biochemistry as well as a post-doctorate degree in experimental pathologies. Tr. at 188-89;
see also Ex. B (Leist CV). He also completed a post-doctorate at the University of California, Los
Angeles and attended medical school in the United States at the University of Miami. Id. He then
completed a residency in neurology at Cornell University before becoming a fellow at the National
Institute of Health. Tr. at 189. Dr. Leist is board certified in neurology and currently serves as a
professor of neurology at Thomas Jefferson University in Philadelphia, Pennsylvania as well as
directing the MS center and guiding the MS or the neuro-immunology fellowship program. Id. As
a part of this role, he sees patients diagnosed with MS (whether solely or as part of a differential
diagnosis), as well as seeing patients in tertiary care hospitals affiliated with Thomas Jefferson
University Hospital. Id. Dr. Leist also treats patients with ADEM. Id. at 190-91.
Although Respondent had (as of the time of the filing of the Rule 4(c) Report) initially
accepted the accuracy of Mr. Caruso’s ADEM diagnosis, Dr. Leist disagreed (and Respondent
subsequently revised his formal position in the case in reaction). See Tr. at 230; Leist Rep. at 7.
Instead, Dr. Leist proposed that Mr. Caruso had first developed unspecified neurological
symptoms in late December 2012, experiencing some improvement in January 2013, followed by
worsening symptoms in late January/early February 2013. Id. at 194. He did not deem this
symptoms course to constitute ADEM – although regardless of what Mr. Caruso’s illness was, Dr.
Leist maintained, it was not vaccine-caused. Tr. at 194-96, Leist Rep. at 7.
In support of his argument, Dr. Leist referenced imaging studies of Mr. Caruso’s brain
performed in March 2013 showing both enhancing and non-enhancing signal abnormalities -
suggesting non-simultaneous accrual of lesions in the central nervous system, with some older
than others. Tr. at 194-95; Leist Rep. at 5-6. In ADEM, by contrast, lesions usually appeared
abruptly and at the same time. Leist Rep. at 5-6; S. Tenembaum, et al., Acute Disseminated
Encephalomyelitis: A Long Term Follow-Up Study of 84 Pediatric Patients, 59 Neurology 8:1224-
31, at 1224-26 (2002), filed as Ex. 26C (ECF No. 25-1) (“Tenembaum”). Thus, Dr. Leist
maintained, the non-enhancing lesions that had also been observed could have occurred prior to
the vaccination, and might have been caused instead by a longer-standing process of deterioration
consistent with aging or another remote injury. Tr. at 195-96. Dr. Leist further noted that Mr.
Caruso’s worsening vision, followed by an improvement from March to August 2013, was just as
compatible with optic neuritis as ADEM, further diminishing the accuracy of the diagnosis. Leist
Rep. at 6; Tr. at 211; Ex. 7 at 6.
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Dr. Leist further opined that, even if Mr. Caruso had properly been diagnosed with ADEM,
the disease could not have been caused by the flu vaccine. This opinion was largely based on the
timing of Petitioner’s symptoms. In Dr. Leist’s understanding, existing reliable literature only
supports a 5 to 28 day interval for causality between any kind of vaccine and ADEM. Leist Rep.
at 5, 7; Ex. C at 4. An article offered by Respondent, Rowhani–Rahbar, et al., Biologically
Plausible and Evidence–Based Risk Intervals in Immunization Safety Research, 31 Vaccine 271–
77 (2012), filed as Ex. C (ECF No. 30-3) (“Rowhani-Rahbar”) goes a bit further, noting that an
interval of 2 to 42 days “remains biologically plausible,” but expressing uncertainty as to the
trustworthiness of that conclusion. Rowhani-Rahbar at 274. Regardless, even 42 days, or six
weeks, was beyond the onset period in this case, which exceeded 60 days if measured from the
October 2012 vaccination to the earliest onset corroborated by the medical records (late December
2012). See Tr. at 28, 155, 194; Ex. 16 at 15.
Dr. Leist also questioned the timing of onset in light of the specific features of ADEM as
accepted in the medical and scientific community. An article filed by Petitioner - F. Noorbakhsh,
et al., Acute Disseminated Encephalomyelitis: Clinical and Pathogenesis Features, 29 Neurologic
Clinics 759-780 (2008), filed as Ex. 26B (ECF No. 25-1) (hereinafter, “Noorbakhsh”) - stated that
“ADEM typically appears with an abrupt onset of neurological symptoms 2 to 30 days” after
vaccination. Noorbakhsh at 761. But, Dr. Leist maintained, the medical record did not corroborate
such an abrupt onset under any fact pattern embraced by Petitioner to explain his course of
symptoms. Tr. at 220-21, Leist Rep. at 5-6. Dr. Leist also attacked Poser as unreliable support for
Petitioner’s onset argument, noting that it involved the swine flu vaccine, cited only case reports,
and that it was not referenced in more recent and widely-embraced articles discussing the
timeframe for ADEM like Noorbakhsh or Rowhani-Rahbar. Leist Rep. at 4. In addition, although
the authors in Tenembaum noted that ADEM was observed as being preceded by vaccination or
viral illness in 74 percent of cases, the mean onset stated in the article was 12.1 days – much shorter
than in this case. Id. at 3.
III. Procedural Background
After initiating this action in March 2015, Mr. Caruso began filing medical records in
support of his claim, completing the process three months later. Respondent’s Rule 4(c) Report
was then filed almost immediately thereafter, on June 3, 2015 (ECF No. 14). Initially, Respondent
accepted Petitioner’s allegation that he had in fact experienced “atypical” ADEM. Rule 4(c) Report
at 10. But Respondent maintained that compensation was not appropriate for Petitioner’s injury,
questioning both the strength of the evidence supporting the causation theory as well as the
appropriateness of the several-month timeframe between vaccination and onset. Id. at 11-12.
Petitioner was thereafter ordered to file an expert report, and after obtaining several
extensions of time did so on November 24, 2015, with the filing of Dr. Tornatore’s first report.
See ECF No. 22. Respondent raised questions in reaction to Dr. Tornatore’s opinion, noting that
10

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he opined that onset of vaccine-induced ADEM was most likely within 30 days of vaccine, but the
medical records unquestionably indicated onset no sooner than 60 days from the October 2012
vaccination (although Petitioner and other family members were alleging that they observed
neurologic symptoms in November 2012). See Status Report, dated November 30, 2015 (ECF No.
24). I subsequently held a status conference, ordering Petitioner to obtain a supplemental report
from Dr. Tornatore addressing the onset discrepancy and its impact on his theory. Order, dated
December 15, 2015 (ECF No. 26). Petitioner filed that supplemental report on March 29, 2016
(ECF No. 29).
In reaction, Respondent filed Dr. Leist’s sole report on June 16, 2016 (ECF No. 30). As
noted above, and contrary to Respondent’s earlier position, Dr. Leist opined that Mr. Caruso had
not experienced ADEM. Leist Rep. at 7; Tr. at 194. The parties thereafter agreed that the matter
was appropriate for resolution, and a hearing was set for April 2017. The hearing went forward as
scheduled, after which the parties requested an opportunity to file simultaneous post-hearing
briefs, doing so on July 28, 2017 (ECF Nos. 49-50). This matter is now ripe for a decision.
IV. Applicable Law
A. Petitioner’s Overall Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table –
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).13
In this case, Petitioner does not assert a Table claim.
For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d
13 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121,
124 (2003), aff’d 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-
159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
11

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867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344,
1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(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
proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278.
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory
must only be “legally probable, not medically or scientifically certain.” Id. at 549.
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325-26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of
Health & Human Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility . . . in many cases may be
enough to satisfy Althen prong one” (emphasis in original)), vacated on other grounds, 844 F.3d
1363 (Fed. Cir. 2017). But this does not negate or reduce a petitioner’s ultimate burden to establish
his overall entitlement to damages by preponderant evidence. W.C. v. Sec’y of Health & Human
Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).14
14 Although decisions like Contreras suggest that the burden of proof required to satisfy the first Althen prong is less
stringent than the other two, there is ample contrary authority for the more straightforward proposition that when
considering the first prong, the same preponderance standard used overall is also applied when evaluating if a reliable
and plausible causal theory has been established. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339,
1350 (Fed. Cir. 2010).
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The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is
nothing . . . that mandates that the testimony of a treating physician is sacrosanct – that it must be
accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record – including conflicting opinions
among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742, 749 (2011)
(not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions
against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Dept. of Health &
Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.
for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed.
Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for
what is a medically acceptable timeframe must also coincide with the theory of how the relevant
vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of
Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl.
353 (2012), aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human
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Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review
den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Law Governing Analysis of Fact Evidence
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [] relevant medical and scientific evidence contained in the record,” including “any
diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,
condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, such as oral testimony surrounding the
events in question that was given at a later date, provided that such determination is evidenced by
a rational determination).
Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed.
Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his
contemporaneous medical records, the special master’s decision to rely on petitioner’s medical
records was rational and consistent with applicable law”), aff’d, Rickett v. Sec’y of Health &
Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is
based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people
honestly report their health problems to those professionals; and (iii) medical professionals record
what they are told or observe when examining their patients in as accurate a manner as possible,
so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez
v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.
Apr. 10, 2013); Cucuras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993
F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to
accurately report the onset of their daughter’s symptoms.”).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical
records are generally found to be deserving of greater evidentiary weight than oral testimony –
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
14

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see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,
968 F.2d 1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United
States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that
oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).
However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon
common sense and experience, this rule should not be treated as an absolute and must yield where
the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19
(“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than
those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human
Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human
Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In
determining the accuracy and completeness of medical records, the Court of Federal Claims has
listed four possible explanations for inconsistencies between contemporaneously created medical
records and later testimony: (1) a person’s failure to recount to the medical professional everything
that happened during the relevant time period; (2) the medical professional’s failure to document
everything reported to her or him; (3) a person’s faulty recollection of the events when presenting
testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v.
Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir.
2014). In making a determination regarding whether to afford greater weight to contemporaneous
medical records or other evidence, such as testimony at hearing, there must be evidence that this
decision was the result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & Human Servs., 219 F.3d
1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to
the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339
(Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir.
15

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1999). “The Daubert factors for analyzing the reliability of testimony are: (1) whether a theory or
technique can be (and has been) tested; (2) whether the theory or technique has been subjected to
peer review and publication; (3) whether there is a known or potential rate of error and whether
there are standards for controlling the error; and (4) whether the theory or technique enjoys general
acceptance within a relevant scientific community.” Terran, 195 F.3d at 1316 n.2 (citing Daubert,
509 U.S. at 592-95).
The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial for a (such as the district courts). Daubert factors are usually
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors
are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health
& Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742-45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 91997)); see also Isaac v. Sec’y of Health &
Human Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot.
for review den’d, 108 Fed. Cl. 743 (2013), aff’d, 540 Fed. App’x 999 (Fed. Cir. 2013) (citing
Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony,
based on a particular expert’s credibility, is part of the overall reliability analysis to which special
masters must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325-26
(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);
see also Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this
court has unambiguously explained that special masters are expected to consider the credibility of
expert witnesses in evaluating petitions for compensation under the Vaccine Act”).
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D. Consideration of Medical Literature
Both parties filed medical and scientific literature in this case, but not every filed item
factors into the outcome of this decision. While I have reviewed all of the medical literature
submitted in this case, I discuss only those articles that are most relevant to my determination
and/or are central to Petitioner’s case – just as I have not exhaustively discussed every individual
medical record filed. Moriarty v. Sec’y of Health & Human Servs., No. 2015-5072, 2016 WL
1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special master considered
the relevant record evidence even though he does not explicitly reference such evidence in his
decision”) (citation omitted); see also Paterek v. Sec’y of Health & Human Servs., 527 F. App’x
875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead to – and likely
undermines – the conclusion that it was not considered”).
ANALYSIS
I. Brief Overview of ADEM
ADEM is formally defined as an inflammatory demyelinating disease of the central
nervous system characterized by an acute onset and a monophasic course. Tenembaum at 1224. It
features an autoimmune attack on the myelin sheath of the central nervous system, resulting in
inflammation and swelling in the brain and spinal cord.15 When the myelin is damaged, nerve
impulses can slow or stop, causing a range of neurological problems.16 Symptoms can include
fever, headache, vomiting, tremors, seizures, and paralysis.17 The incidence of ADEM is more
common in children or young adults.
The signature of ADEM is an abrupt onset typically following (in two to 30 days) an
infection, although vaccination has also been associated with the illness. Noorbakhsh at 761. Upon
MRI testing, lesions are found in the brain of patients suffering from ADEM, but these lesions
resolve, true to the monophasic nature of the disease. Id. In very rare instances a patient can have
a relapse of ADEM symptoms, but such patients have usually already experienced the abrupt initial
onset, and the later symptoms are not accompanied by new or worsened lesions. Id.
15 Dorland’s at 613; ADEM Overview, Nat’l MS Soc’y, http://www.nationalmssociety.org/What-is-MS/Related-
Conditions/Acute-Disseminated-Encephalomyelitis-(ADEM) (lasted visited on Aug. 29, 2017).
16 Demyelinating Disease: What Can You Do About It?, Mayo (2017), http://www.mayoclinic.org/diseases-
conditions/multiple-sclerosis/expert-answers/demyelinating-disease/faq-20058521 (last visited Aug. 29, 2017).
17 Dorland’s at 613.
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II. Onset of Mr. Caruso’s ADEM Most Likely Occurred in December 2012
Before determining whether Petitioner has carried his overall burden in this case, I must
make a fact determination regarding the onset of Petitioner’s first ADEM-related symptoms.
Petitioner argues for an onset beginning sometime in November 2012 (although Dr. Tornatore
allowed for the possibility of a later onset as well as also consistent with his causation theory). Tr.
at 114; Ex. 28 at 2. In support, Petitioner offered the testimony of his wife and daughter, both of
whom provided anecdotal recollection of incidents that could reflect neurologic problems (e.g.
weakness, sleepiness, blurred vision) that they witnessed affecting Petitioner as early as November
2012.
Both fact witnesses were credible individuals, and I have no doubt that they made an honest
effort to recall experiences or observations that might in retrospect seem connected to Mr. Caruso’s
later and more obvious neurologic symptoms. But the instances they described are too anecdotal
and inconclusive to deem significant (especially without any additional corroborative proof). This
is especially the case when their oral recollections are compared with Petitioner’s more precisely-
documented, medically-tested symptoms referenced in the January and February 2013 medical
records. Those records strongly support the conclusion that onset of his symptoms began in
December 2012 – as there are several instances in which Petitioner or Mrs. Caruso directly so
informed treaters. See, e.g., Ex. 16 at 15; Tr. at 28. Program precedent counsels giving such
contemporaneous evidence more weight than after-the-fact witness statements about a prior
occurrence. See Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per
curiam, 968 F.2d 1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992)
(citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally
been held that oral testimony which is in conflict with contemporaneous documents is entitled to
little evidentiary weight.”)).
The fact witnesses’ testimony about a November onset, by contrast, was not sufficiently
corroborated by other circumstantial evidence to elevate it over contemporaneous record proof that
clearly establishes a later onset date.18 The only overlap between the two was the contention that
Mr. Caruso first began to experience symptoms in December 2012. I therefore find that Petitioner’s
ADEM-related symptoms began no earlier than late December 2012 (approximately two months
after vaccination), as confirmed by witness testimony and corroborated by medical records from
around the time Petitioner first sought treatment for his gait problems in late January 2013.
18 The best corroborative evidence in this regard was Mrs. Caruso’s journal, which she began in March 2013. As noted
above, the journal does have an entry from early March referencing symptoms beginning in the November-December
continuum, and therefore is evidence supporting an earlier onset. Ex. 39 at 1, dated Apr. 18, 2017 (ECF No. 42) Yet
the relevant entry, dated March 9, 2013, must be evaluated against other medical records from March 2013 in which
onset is again anchored around the time of Petitioner’s January incident or December at the earliest. See, e.g., Ex. 7 at
25. This, plus the existence of several records from January 2013 also pinpointing that same period, preponderantly
supports a later onset than alleged by Petitioner.
18

Case 1:15-vv-00200-LAS Document 59 Filed 11/14/17 Page 19 of 23
III. Petitioner Has Not Carried His Burden of Proof
A. Althen Prong One
Of the three Althen prongs relevant herein, the first bears the least on this claim’s
resolution. Petitioner proposed that the flu vaccine can, via the mechanism of molecular mimicry,
cause an autoimmune reaction resulting in ADEM. First Tornatore Rep. at 13; Tr. at 104.
Respondent largely ignored this aspect of Mr. Caruso’s case – and for good reason, as there is
ample existing Program authority (backed up by reliable scientific and medical evidence) that
certain vaccines, including the flu vaccine, are reasonably associated with ADEM.19 Such cases
have been litigated fully, and the science offered to support the theory found to be reliable. I am
persuaded by such prior decisions, and therefore find that the first Althen prong was satisfied in
this case.
B. Althen Prong Two
Respondent (likely in the hope of establishing an injury that is less associated with the flu
vaccine than ADEM), attempted to poke holes in the conclusion that Mr. Caruso suffered from
ADEM, arguing that his overall course of illness – a steady progression over a month, beginning
more likely than not in late December 2012, a lapse, and then a round of more obviously alarming
symptoms sufficiently severe for him to seek treatment – was inconsistent with the commonly-
understood acute nature of ADEM. Tr. at 194-99; Leist Rep. at 5. Further, Dr. Leist attributed
Petitioner’s vision impairment to an optic neuritis diagnosis rather than as further evidence of
ADEM. Leist Rep. at 6.
Despite these efforts, preponderant evidence better supports the ADEM diagnosis, at least
in a general sense. There is ample record evidence supporting the diagnosis of ADEM over other
central nervous system demyelinating diseases like MS (i.e. nature of lesions, lack of oligoclonal
bands), and the lack of recurrent or new lesions later further supports ADEM. More importantly,
Mr. Caruso’s treaters embraced ADEM as the proper diagnosis, and it does not appear that any
treaters ever adopted an interpretation of the record consistent with what Dr. Leist proposed. Just
as the records in this case did not corroborate fact witness testimony about onset, they also do not
corroborate Respondent’s preferred alternative diagnosis.
19 See, e.g., Brown v. Sec’y of Health & Human Servs., No. 09-426V, 2011 WL 5029865, at *41 (Fed. Cl. Spec. Mstr.
Sept. 30, 2011) (flu vaccine caused petitioner’s ADEM injury); Daniels v. Sec’y of Health & Human Servs., No. 07-
462V, 2012 WL 763175 (Fed. Cl. Spec. Mstr. Feb. 16, 2012) (awarding damages after a ruling on entitlement linked
ADEM to a flu vaccination); Hawkins v. Sec’y of Health & Human Servs., No. 99-405V, 2009 WL 711931 (Fed. Cl.
Spec. Mstr. Feb. 27, 2009) (awarding compensation for ADEM linked to hepatitis B vaccine); Banks v. Sec’y of Health
& Human Servs., No. 02-0738V, 2007 WL 2296047 (Fed. Cl. Spec. Mstr. July 20, 2007) (awarding compensation for
ADEM linked to MMR vaccine); Camerlin v. Sec’y of Health & Human Servs., No. 99-615V, 2003 WL 22853070
(Fed. Cl. Spec. Mstr. Oct. 29, 2003) (awarding compensation, finding HiB vaccine was a substantial factor related to
ADEM); Kuperus v. Sec’y of Health & Human Servs., No. 01-0060V, 2003 WL 22912885 (Fed. Cl. Spec. Mstr. Oct.
23, 2003) (awarding compensation for ADEM linked to DTaP vaccine).
19

Case 1:15-vv-00200-LAS Document 59 Filed 11/14/17 Page 20 of 23
But my Althen prong two analysis does not end with the conclusion that Respondent failed
in challenging that diagnosis’s evidentiary basis – because the most reliable evidence concerning
Petitioner’s diagnosis is not supportive of the causation theory he has (successfully) presented.
As Dr. Tornatore acknowledged, and as the record confirms, Petitioner’s illness is best
characterized as “atypical ADEM.” Tr. at 113-16. Not only was Petitioner outside the usual
demographic group experiencing the disease (the very young), but his symptoms did not manifest
acutely or suddenly, but instead unfolded more slowly and haltingly. Thus, almost a month passed
between the first time Mr. Caruso’s wife and daughter observed him displaying an unsteady gait
in December 2012 to his performance of the “drunken sailor” walk while shopping on January
25th. Indeed, had I accepted Petitioner’s allegation that onset of ADEM occurred in November
(and thus closer in time to vaccination), the progression of his symptoms would appear even less
like classic ADEM, since his medical history would then constitute a series of somewhat mild
neurologic symptoms (some weakness, vision difficulty), later leading to more concerning gait
dysfunction that slightly improved before progressively worsening a month later.
The above poses a dilemma for evaluating the success of Petitioner’s “did cause”
evidentiary showing. On the one hand, Mr. Caruso’s combination of symptoms, imaging evidence,
and other test results led skilled treaters to adopt ADEM as the proper diagnosis, and I find
sufficient preponderant evidence supports that conclusion (especially in light of Dr. Dorfman’s
views expressed in the summer of 2014, which had the benefit of a more expansive record to
review than what had been available to initial treaters). But because Petitioner’s symptoms were
inconsistent with ADEM as it is most commonly understood, it becomes more difficult to simply
assume that the same vaccine association applicable to “normal” cases of the disease applies here.
Indeed, the literature offered to explain a vaccine’s role in causing ADEM largely if not exclusively
discusses the acute form of the disease, beginning within a month of infection or vaccination – not
what the facts show Mr. Caruso experienced. See, e.g., Tenembaum at 1224, Noorbakhsh at 761.
Other special masters have denied compensation on such grounds. Thus, as observed by
former Chief Special Master Campbell-Porter in Stillwell v. Sec’y of Health & Human Servs., No.
11-77V, 2013 WL 4540013, at *16 (Fed. Cl. Spec. Mstr. June 17, 2013), mot. for review den’d,
118 Fed. Cl. 47 (2014):
the symptoms of ADEM appear abruptly—that is, between one and two week after the
triggering event—in the overwhelming majority of cases . . . Petitioner’s symptom onset
occurred slowly and well beyond the typical time frame for the vast majority of subjects
afflicted with ADEM.
Given the undisputed facts about both ADEM as it is commonly understood and the
progression of Mr. Caruso’s symptoms, I do not find in favor of Petitioner on this second prong.
20

Case 1:15-vv-00200-LAS Document 59 Filed 11/14/17 Page 21 of 23
Petitioner has not demonstrated that reliable science linking vaccines like the flu vaccine to ADEM
applies to his own circumstances, which present a more halting form of the condition.
C. Althen Prong Three
Petitioner has offered insufficient evidence, whether in the form of recorded medical
documents or literature, supporting his assertion that the timeframe in which his symptoms
developed was medically acceptable.
As Respondent has pointed out, the most reliable scientific evidence relating to ADEM’s
connection to vaccines suggests a far shorter timeframe for onset of the disease than is present
under the facts of this case.20 As noted above, Rowhani-Rahbar stated that the most medically
reliable onset between vaccination and ADEM was from 9-30 days. Rowhani-Rahbar at 273. This
article allows the possibility of a somewhat longer timeframe—up to 42 days, or six weeks – but
is frank in acknowledging that such a time period is less reliable scientifically. Rowhani-Rahbar
at 274. But for present purposes, either of these timeframes are shorter than what I have found
herein to be Petitioner’s earliest possible onset in December 2012 (about sixty days post-
vaccination).
Rowhani-Rahbar is particularly persuasive with regard to the expected onset for vaccine-
induced ADEM. Indeed, it was explicitly relied upon in another case involving both Drs. Tornatore
and Leist as experts. In Day v. Sec’y of Health & Human Servs., No. 12-630V, 2015 WL 8028393,
at *19-20 (Fed. Cl. Spec. Mstr. Nov. 13, 2015), a case involving neuromyelitis optica occurring
three days after a flu vaccine, Dr. Tornatore invoked Rowhani-Rahbar, Noorbakhsh, and
Tenembaum in establishing the reliability of a three-day onset based on a molecular mimicry-
mediated autoimmune reaction to a vaccine. Day, 2015 WL 8028393, at *19. In finding for the
Day petitioner, Chief Special Master Dorsey characterized the Rowhani-Rahbar intervals as
“persuasive.” Id. at *22. If such a timeframe was deemed reliable for purposes of finding causation
when onset fell within it, then it should also have evidentiary heft when applied to a timeframe
that falls well outside it – as here.
The greater reliability of shorter onset timeframes for vaccine-induced ADEM finds
support in the decisions of other special masters. See, e.g., Daniels v. Sec’y of Health & Human
Servs., No. 07-462V, 2012 WL 763175 (Fed. Cl. Spec. Mstr. Feb. 16, 2012) (ADEM onset
occurring eight days post-vaccination found to be medically acceptable). By contrast, excessively
long timeframes have been rejected for many kinds of allegedly vaccine-caused autoimmune
processes. See, e.g., Sullivan v. Sec’y of Health & Human Servs., No. 10-398V, 2015 WL 1404957,
20 I do not find that Poser is as reliable in supporting a longer timeframe, as it involved a different vaccine and was
based upon a single instance of onset beyond two months.
21

Case 1:15-vv-00200-LAS Document 59 Filed 11/14/17 Page 22 of 23
at *21 (Fed. Cl. Spec. Mstr. Feb. 13, 2015) (in a claim involving Gardasil vaccine and rheumatoid
arthritis where petitioner relied on molecular mimicry as the theory, three months was “too long a
timeframe in which onset could have occurred.”).
I acknowledge there are reasoned decisions concluding that a two-month onset for ADEM
induced by the flu vaccine is medically acceptable. See, e.g., Brown v. Secretary of Health and
Human Services, No. 09-426V, 2011 WL 5029865, at *42-44 (Fed. Cl. Spec. Mstr. Sept. 30, 2011).
However (and putting aside the fact that I am not bound by the decisions of other special masters),
two considerations persuade me not to endorse that timeframe in this case. First, Brown’s findings
about timeframe relied on comparing ADEM to other demyelinating diseases like Guillain-Barré
syndrome, but (as noted in Stillwell) there are sound medical reasons for differentiating the two
with respect to onset and timeframe despite their common demyelinating features. Stillwell, 2013
WL 4540013, at *21-22 (reliable medical evidence “suggests that ADEM has a much shorter
latency period than GBS”).21
Second, and discussed above in connection with Petitioner’s Althen prong two showing,
the atypical, halting form of ADEM that Mr. Caruso experienced further erodes Petitioner’s
preponderant showing that a two-month onset (which even Brown characterizes as an “outermost
time period” (Brown, 2011 WL 5029865, at *44)) is in this case medically acceptable. ADEM is
most commonly and reliably understood to have an abrupt onset. Noorbakhsh at 761. But here,
Petitioner’s initial symptoms in December 2012 were mild, with several weeks passing thereafter
before his condition became sufficiently acute to impel him to seek medical intervention. The
weaknesses of his third prong showing are magnified by the atypical course of his ADEM.
CONCLUSION
The Vaccine Act permits me to award compensation only if a Petitioner alleging a “non-
Table Injury” can show by medical records or competent medical opinion that the injury was more
likely than not vaccine-caused. Here, Petitioner’s causation theory depends upon my finding that
she experienced a particular injury, but the weight of the evidence does not support that conclusion.
Thus—and even if the theory itself has plausibility—there is insufficient evidence to support an
award of compensation, leaving me no choice but to hereby DENY this claim.
21 Other special masters have addressed the appropriate timeframe for onset of vaccine-induced ADEM based upon
the location of the inflammatory damage in the central nervous system. See e.g., Kuperus, 2003 WL 22912885;
Johnson v. Sec’y of Health & Human Servs., No. 99-0219V, 2000 WL 1141582 (Fed. Cl. Spec. Mstr. July 27, 2000).
In both Kuperus and Johnson, the relevant onset period was said to be dependent upon the location of the lesions—in
the brain (slower onset of no more than 42 days) or in the spinal cord (faster onset of no more than 21 days). Kuperus,
2003 WL 22912885, at *10 (awarding compensation by emphasizing that Petitioner’s onset did not exceed the 42 day
outermost limit for causation), Johnson, 2000 WL 1141582, at *6 (“with any infection or immunization, Dr. Weig
would look at what occurred 10-21 days before onset. Beyond that there would be no causal relationship.”). In this
case Mr. Caruso had lesions in both his brain and spinal cord, but even under the longer timeframe applicable to brain
lesions his onset would still be too long to satisfy the third Althen prong. Ex. 5 at 39-43
22

Case 1:15-vv-00200-LAS Document 59 Filed 11/14/17 Page 23 of 23
In the absence of a timely-filed motion for review (see Appendix B to the Rules of Court),
the Clerk shall enter judgment in accord with this decision.22
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Special Master
22 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their
right to seek review.
23

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_15-vv-00200-3
Date issued/filed: 2018-04-06
Pages: 10
Docket text: PUBLIC DECISION (Originally filed: 3/19/2018) regarding 57 DECISION of Special Master. Signed by Senior Judge Loren A. Smith. (ae) Service on parties made. Modified on 6/21/2018 - corrected typographical error (jt1).
--------------------------------------------------------------------------------
Case 1:15-vv-00200-LAS Document 70 Filed 04/06/18 Page 1 of 10
United States Court of Federal Claims
No. 15-200V
(Filed Under Seal: March 19, 2018)
Reissued: April 6, 20181
)
MARIO CARUSO, )
)
Petitioner, )
)
Vaccine Case; Motion for Review;
v. )
Influenza Vaccine; Althen; Burden of
)
Proof
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
OPINION
Ronald Craig Homer, Conway, Homer, P.C., Boston, MA, for petitioner.
Darryl R. Wishard, Vaccine/Torts Branch, Civil Division, United States Department of Justice,
Washington, DC, for respondent.
SMITH, Senior Judge:
Petitioner, Mario Caruso, seeks review of a decision issued by Special Master Brian H.
Corcoran denying his petition for vaccine injury compensation. Petitioner brought this action
pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 et seq.
(2012), alleging that petitioner developed acute disseminated encephalomyelitis (“ADEM”) as a
result of the trivalent influenza vaccine he received on October 16, 2012. The Special Master
denied compensation, finding that petitioner had not met his burden of proof. Caruso v. Sec’y of
Health & Human Servs., 2017 WL 5381154 (Fed. Cl. Spec. Mstr. Oct. 18, 2017) (Caruso).
Petitioner now moves for review of this decision. For the reasons that follow, the Court
DENIES his motion.
1 An unredacted version of this opinion was issued under seal on March 19, 2018. The
parties were given an opportunity to propose redactions, but no such proposals were made.

Case 1:15-vv-00200-LAS Document 70 Filed 04/06/18 Page 2 of 10
I. BACKGROUND
A brief recitation of the facts provides necessary context.2
Mr. Caruso received the flu vaccine on October 16, 2012, when he was 64-years-old.
Prior to receiving the vaccine, his medical history included prostate enlargement,
hypolipoproteinemia,3 varicose veins of the lower extremity with an ulcer, and sclerosis of the
skin.4 Subsequent to receiving the vaccine, Mr. Caruso’s medical evidence did not indicate any
immediate reaction to the vaccine for the 10 weeks following vaccination. On October 23, 2012,
Mr. Caruso visited a physician at the Peachwood Medical Group (“PMG”) to have his lipid
levels checked, at which point he did not report any neurological issues or other symptoms.
At trial, Mr. Caruso’s wife, Sylvia Caruso, testified that she noticed changes in Mr.
Caruso’s behavior around November 2012. Specifically, she stated that he struggled to move
large items and began having difficulty with his vision during that period. She then testified that
things progressively worsened and that petitioner started walking in an unstable way around the
end of December 2012.
In late January of 2013, Mr. Caruso began seeking medical attention after he experienced
a more acute incident, wherein he was shopping and his feet suddenly started to drag and he
displayed an uneven gait like a “drunken sailor.” On January 28, 2013, petitioner had an
appointment with his nurse practitioner at PMG, at which he stated that he had been sporadically
“walking funny,” falling asleep in the evenings, and felt off balance, but denied paresthesia.5
These medical records did not indicate that Mr. Caruso had been experiencing any symptoms
prior to December 2012. Additionally, he denied experiencing blurred vision, double vision,
photophobia,6 headaches, and weakness. His exam results were deemed normal, but the nurse
practitioner indicated that Mr. Caruso seemed “to slightly drag right tow [sic]. No specific
abnormality but gait does not seem totally normal.” Petitioner was diagnosed with dizziness and
2 As the basic facts here have not changed significantly, the Court’s recitation of the
background facts here draws from the Special Master’s earlier opinion in Caruso.
3 Hypolipoproteinemia is “the presence of abnormally low levels of lipoproteins in the
serum, as in hypobetalipoproteinemia and Tangier disease.” Dorland’s Illustrated Medical
Dictionary 903 (32nd ed. 2012) (“Dorland’s”).
4 A varicose vein is “a dilated tortuous vein, usually in the subcutaneous tissues of the leg,
often associated with incompetency of the venous valves.” Dorland’s at 2036. A varicose ulcer
is “an ulcer on the leg due to varicose veins, such as a stasis ulcer.” Id. at 1998. Sclerosis of the
skin is “an induration or hardening, such as hardening of a part from inflammation, increased
formation of connective tissue, or disease of the interstitial substance.” Id. at 1680.
5 Paresthesia is “an abnormal touch sensation, such as burning, prickling, or formication,
often in the absence of an external stimulus.” Dorland’s at 1383.
6 Photophobia is “abnormal visual intolerance of light.” Dorland’s at 1441.
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Case 1:15-vv-00200-LAS Document 70 Filed 04/06/18 Page 3 of 10
a gait disorder, and diagnostic tests were ordered. A CT scan from February 1, 2013 found no
significant abnormalities, and the results were deemed “unremarkable.”
Mr. Caruso was again seen at PMG on February 8, 2013, complaining of dizziness,
diplopia,7 and gait difficulty. He was referred to a neurologist. On February 11, 2013, petitioner
met with Dr. Loveneet Singh, at which point he complained of fatigue, vision changes, and gait
problems. During the visit he displayed impaired coordination and diplopia, an inability to
perform rapid alternating movements, a slow gait, and a need for support when walking. Dr.
Singh opined that Mr. Caruso demonstrated evidence of upper motor neuron dysfunction,
including cerebellar signs and gait ataxia.8 Brain and cervical spine MRIs performed on March
2, 2013, showed multifocal signal abnormalities in the midbrain, brainstem, brachium pontis,
cerebellum, and spinal cord. Some of the lesions enhanced,9 and some cerebral volume loss was
noted. The MRIs also showed both enhancing and non-enhancing signal abnormalities. There
also appeared to be evidence of active inflammation on petitioner’s spine, which suggested
“active demyelinated plaques with breakdown of the blood brain barrier.”
Mr. Caruso again met with Dr. Singh on March 11, 2013, at which point ADEM10 and
multiple sclerosis11 (“MS”) were included in his differential diagnosis. Dr. Singh ordered more
testing, including lab work of petitioner’s glucose and protein levels, a cell count, and an MS
panel. The results of the testing were relatively normal, with no evidence of oligoclonal bands12
and a negative MS panel.
7 Diplopia is “the perception of two images of a single object . . . .” Dorland’s at 525.
8 Ataxia is the “failure of muscular coordination; irregularity of muscular action.” Dorland’s
at 170.
9 A lesion is “any pathological or traumatic discontinuity of tissue or loss of function of a
part. Dorland’s at 1025.
10 Acute disseminated encephalomyelitis (“ADEM”) is “an acute or subacute
encephalomyelitis or myelitis characterized by perivascular lymphocyte and mononuclear cell
infiltration and demyelination; it occurs most often after an acute viral infection, especially
measles, but may occur without a recognizable antecedent. It is believed to be a manifestation of
an autoimmune attack on the myelin of the central nervous system. Symptoms include fever,
headache, and vomiting; sometimes tremor, seizures, and paralysis; and lethargy progressing to
coma that can be fatal. Many survivors have residual neurologic deficits.” Dorland’s at 613.
11 Multiple sclerosis is “a disease in which there are foci of demyelination throughout the
white matter of the central nervous system, sometimes extending into the gray matter; symptoms
usually include weakness, incoordination, paresthesias, speech disturbances, and visual
complaints. The course of the disease is usually prolonged, so that the term multiple also refers to
remissions and relapses that occur over a period of many years.” Dorland’s at 1680.
12 Oligoclonal means “pertaining to or derived from a few clones.” Dorland’s at 1317.
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Case 1:15-vv-00200-LAS Document 70 Filed 04/06/18 Page 4 of 10
Additionally on March 11, 2013, petitioner visited Dr. Gary Walters, an ophthalmologist,
at Eye Medical Center in Fresno, California. Dr. Walters noted in his records that petitioner’s
sudden onset of double vision and walking difficulties were reported to have begun two months
prior, in January 2013. At this appointment, Mr. Caruso showed decreased vision (right eye
20/200; left eye 20/70), but those symptoms showed improvement throughout 2013.
Petitioner again visited Dr. Singh in July 2013, at which point the ADEM diagnosis was
confirmed, but nothing in the medical records indicated that the flu vaccine played a part in its
development. After a year of ongoing symptoms with no signs of progression in severity or
evidence of additional developing lesions, Mr. Caruso sought a second neurological opinion. He
saw Dr. Leslie Dorfman at the Stanford Hospital in Redwood City, California on June 23, 2014.
Dr. Dorfman reviewed petitioner’s MRIs and agreed that they were not indicative of MS. Dr.
Dorfman also opined that ADEM was an “acceptable working diagnosis,” but that he ultimately
felt the true diagnosis for petitioner’s symptoms remained unidentified.
Petitioner returned to Dr. Dorfman on July 25, 2014, at which point Dr. Dorfman noted
that recent testing produced negative or normal results. Dr. Dorfman then opined that Mr.
Caruso was likely suffering from an “atypical form” of ADEM, offering no signs as to its
etiology, and he recommended that petitioner undergo steroid treatment, followed by IVIG13 if
the steroids proved ineffective. By August, petitioner reported improvement from the steroid
treatment, and Dr. Dorfman proposed its continuation.
Additional medical records indicate that Mr. Caruso has continued to experience
sequelae14 from his 2012-13 symptoms. Some records suggest a relationship between the flu
vaccine and petitioner’s symptoms, but those records memorialize representations made by
petitioner, rather than provide contemporaneous information provided to treaters when Mr.
Caruso began seeking treatment in January 2013. MRIs from April 2015 confirm that no
additional lesions have appeared since 2013, further corroborating the accuracy of the ADEM
diagnosis.
13 Intravenous immunoglobulin (“IVIG”) is a blood product used to treat patients with
antibody deficiencies, including neurological disorders. Decision, at 6 (citing Clinical Uses of
Intravenous Immunoglobulin, NCBI (2005),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1809480/ (last visited on Aug. 28, 2017)).
It is commonly prescribed to treat diseases believed to be autoimmune in nature, increasing the
effectiveness of an individual’s immune response. Id.
14 Sequelae are “any lesion[s] or affection[s] following or caused by an attack of disease.”
Dorland’s at 1696.
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Case 1:15-vv-00200-LAS Document 70 Filed 04/06/18 Page 5 of 10
On November 24, 2015, petitioner filed the expert report of Dr. Carlo Tornatore.15 On
June 16, 2016, respondent filed the expert report of Dr. Thomas Leist.16 An entitlement hearing
was held on April 21, 2017, and Special Master Corcoran denied petitioner’s claim on October
18, 2017, finding that there was insufficient evidence to support an award of compensation.
Decision of the Special Master (hereinafter “Dec.”) at 22. Petitioner filed his Motion for Review
(hereinafter “MFR”) on November 17, 2017. Respondent filed its Response to petitioner’s
Motion for Review (hereinafter “Resp. to MFR”) on December 18, 2017. Petitioner’s Motion is
fully briefed and ripe for review.
II. STANDARD OF REVIEW
Under the Vaccine Act, this Court may review a special master’s decision upon the
timely request of either party. See 42 U.S.C. § 300aa-12(e)(1)-(2). In that instance, the Court
may: “(A) uphold the findings of fact and conclusions of law. . . , (B) set aside any findings of
fact or conclusion of law. . . found to be arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law. . . , or, (C) remand the petition to the Special Master for
further action in accordance with the court’s direction.” Id. at § 300aa-12(e)(2)(A)-(C).
Findings of fact and discretionary rulings are reviewed under an “arbitrary and capricious”
standard, while legal conclusions are reviewed de novo. Munn v. Sec’y of Health & Human
Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992).
This Court cannot “substitute its judgment for that of the special master merely because it
might have reached a different conclusion.” Snyder ex rel. Snyder v. Sec’y of Dep’t of Health &
15 Dr. Tornatore is a board-certified neurologist. See Ex. 27, dated Nov. 24, 2015 (“Tornatore
CV”). He graduated from Cornell University with a Bachelor of Arts in Neurobiology, and then
attended Georgetown University Medical center where he received a Master of Science in
Physiology. See Tornatore CV at 2; Tr. at 98. He subsequently graduated from medical school at
Georgetown University School of Medicine, completed a residency in the Department of
Neurology at Georgetown University Hospital, and completed a fellowship in molecular virology
at the National Institutes of Health in Bethesda, Maryland. See id. Currently, he serves as Vice
Chairman in the Department of Neurology at MedStar Georgetown University Hospital and as a
Professor of Neurology at Georgetown University Medical Center. See Tornatore CV at 3; Tr. at
98-99.
16 Dr. Leist attended the University of Zurich, where he obtained his Ph.D. in immunology
and biochemistry as well as a post-doctorate degree in experimental pathologies. See Tr. at 188-
89; see also Ex. B (“Leist CV”). He also completed a post-doctorate at the University of
California, Los Angeles and attended medical school at the University of Miami. See id. He then
completed a residency in neurology at Cornell University before becoming a fellow at the National
Institutes of Health. See Tr. at 189. Dr. Leist is board certified in neurology and currently serves
as a professor of neurology at Thomas Jefferson University in Philadelphia, Pennsylvania as well
as directing the MS center and guiding the MS or the neuro-immunology fellowship program. See
id.
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Case 1:15-vv-00200-LAS Document 70 Filed 04/06/18 Page 6 of 10
Human Servs., 88 Fed. Cl. 706, 718 (2009). “Reversal is appropriate only when the special
master’s decision is arbitrary, capricious, an abuse of discretion, or not in accordance with the
law.” Id. Under this standard, a special master’s decision “must articulate a rational connection
between the facts found and the choice made.” Cucuras v. Sec’y of Dep’t of Health & Human
Servs., 26 Cl. Ct. 537, 541–42 (1992), aff’d, 993 F.2d 1525 (Fed. Cir. 1993) (citing Burlington
Truck Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)). This standard is “highly
deferential.” Hines v. Sec’y of Dep’t of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir.
1991). “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.” Id.
III. DISCUSSION
Althen v. Secretary of Health & Human Services provides the evidentiary burden for
petitioners attempting to succeed in a vaccine petition based on causation. See generally Althen
v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). In order to prove causation-
in-fact, a petitioner must
show by preponderant evidence that the vaccination brought about [petitioner’s]
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.
Id. at 1278. In order to succeed, petitioners must provide a “reputable medical or scientific
explanation” for their claim. Id.
Within this framework, petitioner makes two numbered objections to the October 18,
2017 decision. See MFR at 10, 26. First, petitioner asserts that the Special Master’s decision to
discount the fact testimony in its entirety was arbitrary, capricious, and an abuse of discretion.
Id. at 10. Second, petitioner argues that the Special Master committed error in his Althen prong
two analysis by failing to consider relevant evidence and requiring evidence that does not exist.
Id. at 26.
A. Fact Testimony
In his Motion for Review, petitioner alleges that the Special Master’s decision to discount
the fact testimony in its entirety was arbitrary, capricious, and an abuse of discretion. MFR at
10. In making this argument, petitioner posits that the Special Master failed to address the La
Londe factors. MFR at 16. Petitioner further argues that the Special Master “did not clearly
explain his basis for affording no weight to [the] credible [fact witness] testimony.” Id. at 18.
At the outset, the Special Master is not bound to follow the analytical framework
articulated by this Court in La Londe. A decision of this Court only binds a special master in the
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same case on remand. Hanlon ex rel. Hanlon v. Sec’y of Dep’t of Health & Human Servs., 40
Fed. Cl. 625, 630 (1998), aff’d, 191 F.3d 1344 (Fed.Cir.1999)); Jones v. Sec’y of Dep’t of Health
& Human Servs., 78 Fed. Cl. 403 (2007); Snyder ex rel. Snyder, 88 Fed. Cl. at 719, n.23.
Further, petitioner is incorrect in asserting that Special Master Corcoran failed to discuss
the La Londe factors. The Special Master specifically cited to La Londe, stating the following:
In determining the accuracy and completeness of medical records, the Court of
Federal Claims has listed four possible explanations for inconsistencies between
contemporaneously created medical records and later testimony: (1) a person’s
failure to recount to the medical professional everything that happened during the
relevant time period; (2) the medical professional’s failure to document everything
reported to her or him; (3) a person’s faulty recollection of the events when
presenting testimony; or (4) a person’s purposeful recounting of symptoms that did
not exist.
Dec. at 15; La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d,
746 F.3d 1334 (Fed. Cir. 2014). The Special Master then goes on to state that “[i]n making a
determination regarding whether to afford greater weight to contemporaneous medical records or
other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination.” Dec. at 15 (citing Burns v. Sec’y of Health & Human Servs.,
3 F.3d 415, 417 (Fed. Cir. 1993)).
Special Master Corcoran ultimately determined that, while the fact witnesses were
credible individuals, “the instances they described are too anecdotal and inconclusive to deem
significant (especially without any additional corroborative proof),” particularly where “their
oral recollections are compared with Petitioner’s more precisely-documented, medically-tested
symptoms referenced in the January and February 2013 medical records.” Dec. at 18. The
Special Master expanded on this by stating that the fact witness testimony “was not sufficiently
corroborated by other circumstantial evidence to elevate it over contemporaneous record proof
that clearly establishes a later onset date.” Id. However, he did determine that there exists an
overlap between the contentions of the fact witnesses and the information in the medial records
in December 2012, thereby determining that the “ADEM-related symptoms began no earlier than
late December 2012. . . , as confirmed by witness testimony and corroborated by medical records
from around the time Petitioner first sought treatment for his gait problems in January 2013.” Id.
Petitioner specifically points to a journal entry dated March 9, 2013, in which petitioner’s
wife states that Mr. Caruso began having neurological symptoms in November 2012. MFR at
21-22. Petitioner takes issue with the fact that the Special Master did not afford this journal
entry more weight than he afforded to the contemporaneous medical records, which support a
late-December or early-January onset. MFR at 22; Dec. at 18, n.18. While petitioner might
prefer more weight be afforded to Mrs. Caruso’s March 9, 2013 journal entry, the Special Master
clearly evaluated its relevance in establishing an onset period.
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Determining what weight should be afforded to the testimony of a fact witness, expert
witness, or medical records is a finding well within the discretion of the Special Master, and this
Court will not endeavor to infringe upon that well-established discretion.
B. Althen Prong Two
In addition to arguing that the Special Master’s treatment of the fact testimony was
arbitrary, capricious, and an abuse of discretion, petitioner also asserts that the Special Master
erred as a matter of law by failing to consider relevant evidence and requiring evidence that does
not exist in his analysis of Althen prong two. Specifically, petitioner alleges that the Special
Master “failed to consider relevant evidence in determining whether the petitioner met his
burden of establishing a logical sequence of cause and effect between the vaccination and the
injury,” and that “in doing so the Special Master’s conclusion amounted to his own speculation
and, thus, was arbitrary, capricious, and an abuse of discretion.” MFR at 26-27. Petitioner also
asserts that, contrary to law, the Special Master “elevated petitioner’s burden of proof by
requiring medical literature specifically describing [Mr. Caruso’s] clinical picture—and not
ADEM generally—occurring as a result of vaccination.” Id. at 27.
As an initial matter, Althen prong two requires “a logical sequence of cause and effect
showing that the vaccination was the reason for the injury.” Capizzano v. Sec’y of Health &
Human Servs., 440 F.3d 1317, 1324 (Fed. Cir. 2006) (quoting Althen, 418 F.3d at 1278). “‘A
logical sequence of cause and effect’ means what it sounds like—the claimant’s theory of cause
and effect must be logical.” Id. at 1326. While a finding of causation “must be supported by a
sound and reliable medical or scientific explanation,” causation “can be found in vaccine
cases. . .without detailed medical and scientific exposition on the biological mechanisms.”
Knudsen v. Sec’y of the Dep't of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994).
However, petitioners must still provide a “reputable medical or scientific explanation” for their
claim. Althen, 418 F.3d. at 1278.
The Special Master acknowledged that “preponderant evidence better supports the
ADEM diagnosis,” and that “there is ample record evidence supporting the diagnosis of ADEM
over other central nervous system demyelinating diseases like MS (i.e. nature of lesions, lack of
oligoclonal bands), and the lack of recurrent or new lesions later further supports ADEM.” Dec.
at 19. However, the Special Master also found that “the most reliable evidence concerning
Petitioner’s diagnosis is not supportive of the causation theory he has (successfully) presented.”
Id. at 20 (emphasis in original). The Special Master expanded on this in the following way:
Mr. Caruso’s combination of symptoms, imaging evidence, and other test results
led skilled treaters to adopt ADEM as the proper diagnosis, and I find sufficient
preponderant evidence supports that conclusion (especially in light of Dr.
Dorfman’s views expressed in the summer of 2014, which had the benefit of a more
expansive record to review than what had been available to initial treaters). But
because Petitioner’s symptoms were inconsistent with ADEM as it is most
commonly understood, it becomes more difficult to simply assume that the same
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vaccine association applicable to “normal” cases of the disease applies here. Indeed,
the literature offered to explain a vaccine’s role in causing ADEM largely if not
exclusively discusses the acute form of the disease, beginning within a month of
infection or vaccination – not what the facts show Mr. Caruso experienced.
Id.; S. Tenembaum, et al., Acute Disseminated Encephalomyelitis: A Long Term Follow-Up
Study of 84 Pediatric Patients, 59 Neurology 8: 1224-31, at 1224 (2002), filed as Ex. 26C (ECF
No. 25-1); F. Noorbakhsh, et al., Acute Disseminated Encephalomyelitis: Clinical and
Pathogenesis Features, 29 Neurologic Clinics 759-780, at 761 (2008), filed as Ex. 26B (ECF
No. 25-1).
As the Special Master noted, “the symptoms of ADEM appear abruptly—that is, between
one and two week[s] after the triggering event—in the overwhelming majority of cases.” Dec. at
20 (citing Stillwell v. Sec’y of Health & Human Servs., No. 11-77V, 2013 WL 4540013, at *16
(Fed. Cl. Spec. Mstr. June 17, 2013), mot. for review den’d, 118 Fed. Cl. 47 (2014)). The
Special Master also noted that “[n]ot only was Petitioner outside the usual demographic group
experiencing the disease (the very young), but his symptoms did not manifest acutely or
suddenly, but instead unfolded more slowly and haltingly.” Id. Then, the Special Master
pointed out that even “had I accepted Petitioner’s allegation that onset of ADEM occurred in
November (and thus closer in time to vaccination), the progression of his symptoms would
appear even less like classic ADEM, since his medical history would then constitute a series of
somewhat mild neurologic symptoms (some weakness, vision difficulty), later leading to more
concerning gait dysfunction that slightly improved before progressively worsening a month
later.” Finally, the Special Master concluded that “[p]etitioner has not demonstrated that reliable
science linking vaccines like the flu vaccine to ADEM applies to his own circumstances, which
present a more halting form of the condition.” Id. at 21.
Traditionally, “Special Masters have broad authority in building a record for decision in
vaccine cases and enjoy ‘flexible and informal standards of admissibility of evidence.’” Hunt v.
Sec’y of Health & Human Servs., 123 Fed. Cl. 509, 519 (2015) (citing Davis v. Sec'y of Health &
Human Servs., 94 Fed. Cl. 53, 65 (2010), aff'd in part, rev'd on other grounds, 420 F. App’x. 973
(Fed. Cir. 2011) (quoting 42 U.S.C. § 300aa–12(d)(2)(B))). Special Masters need not discuss
every scintilla of evidence when issuing a decision. As such, “[t]his Court will not substitute its
judgment for that of the Special Master when the Special Master considered all of the pertinent
evidence, including many of the particulars cited by Petitioner.” Vaughan on Behalf of A.H. v.
United States, 107 Fed. Cl. 212, 220 (2012). While it is clear that petitioner takes issue with the
way that the Special Master weighed the evidence presented to him, Special Master Corcoran
clearly considered all of the pertinent evidence provided. This Court cannot reweigh the
evidence at hand to arrive at a new conclusion without infringing upon the great deference
afforded special masters in making compensation decisions.
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IV. CONCLUSION
This Court finds that petitioner has not met his burden of proof in alleging that his
October 16, 2012 influenza vaccine resulted in his acute disseminated encephalomyelitis. For
the foregoing reasons, the Court DENIES petitioner’s Motion for Review.17
IT IS SO ORDERED.
Loren A. Smith
s/
Loren A. Smith,
Senior Judge
17 This opinion shall be unsealed, as issued, after April 2, 2018 unless the parties, pursuant to
Vaccine Rule 18(b), identify protected and/or privileged materials subject to redaction prior to that
date. Said materials shall be identified with specificity, both in terms of the language to be redacted
and the reasons therefor.
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