VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-01257
Package ID: USCOURTS-cofc-1_17-vv-01257
Petitioner: Glenn Reinhardt
Filed: 2017-09-15
Decided: 2022-10-26
Vaccine: influenza
Vaccination date: 2016-10-11
Condition: bilateral optic neuritis
Outcome: compensated
Award amount USD: 2247225

AI-assisted case summary:
Glenn Reinhardt filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that he developed bilateral optic neuritis (ON) as a result of the influenza vaccine he received on October 11, 2016. The petition was filed on September 15, 2017. Mr. Reinhardt, a 44-year-old male with no significant prior medical history other than chronic sinusitis, received his first-ever influenza vaccination on October 11, 2016. Approximately 12 days later, on October 23, 2016, he began experiencing vision obstruction in his right eye, which progressed rapidly. He was admitted to the hospital for three weeks, during which extensive testing was performed to rule out various potential causes of his vision loss. Ultimately, all other etiologies were ruled out, and he was diagnosed with bilateral optic neuritis. His treating neuro-ophthalmologist, Dr. Martha Schatz, ultimately diagnosed his condition as post-vaccine autoimmune optic neuritis, citing the temporal association with the flu vaccine and the exclusion of other causes. The court's Ruling on Entitlement, issued on April 2, 2021, found that Mr. Reinhardt had met his burden of proof under the Althen standard and was entitled to compensation, accepting the theory of molecular mimicry as the causal link. On October 26, 2022, a Decision on Joint Stipulation was issued, awarding Mr. Reinhardt a total of $2,247,225.67 in damages, which included compensation for first-year life care expenses, past and future lost earnings, pain and suffering, and past unreimbursable expenses, with the remainder to be paid via an annuity.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_17-vv-01257-0
Date issued/filed: 2021-05-10
Pages: 25
Docket text: PUBLIC ORDER/RULING (Originally filed: 4/2/2021) regarding 122 Ruling on Entitlement. Signed by Special Master Katherine E. Oler. (sl) Service on parties made.
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Case 1:17-vv-01257-UNJ Document 130 Filed 05/10/21 Page 1 of 25
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1257V
Filed: April 2, 2021
* * * * * * * * * * * * * * * * * * * * * * * * * *
*
GLENN REINHARDT, *
*
* TO BE PUBLISHED
Petitioner, *
*
v. *
* Influenza Vaccine; Bilateral Optic
* Neuritis (“ON”)
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
*
Respondent.
*
*
* * * * * * * * * * * * * * * * * * * * * * * * * *
Michael A. Baseluos, Baseluos Law Firm PLLC, San Antonio, TX, for Petitioner
Julia Martin Collison, U.S. Department of Justice, Washington, DC, for Respondent
RULING ON ENTITLEMENT1
Oler, Special Master:
On September 15, 2017, Glenn Reinhardt (“Petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 (the
“Vaccine Act” or “Program”). The petition alleges that Petitioner developed optic neuritis (“ON”)
as a result of the influenza (“flu”) vaccine he received on October 11, 2016. Pet. at 1, ECF No. 1.
1 This Ruling will be posted on the United States Court of Federal Claims’ website, 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 in 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object
to the Ruling’s inclusion of certain kinds of confidential information. To do so, each party may, within 14
days, 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, this Ruling will be available to the public in its present form. Id.
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa
(2012).
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Case 1:17-vv-01257-UNJ Document 130 Filed 05/10/21 Page 2 of 25
Upon review of the evidence submitted in this case, I find that Petitioner has met his burden
in showing that the flu vaccination he received on October 11, 2016 caused him to develop ON.
He is therefore entitled to compensation under the Vaccine Act.
I. Procedural History
On September 15, 2017, Petitioner filed his petition (“Pet.”), an expert report from Dr.
Dean Cestari (Ex. 15) and Dr. Cestari’s curriculum vitae (Ex. 16). The petition alleges that
Petitioner developed bilateral optic neuritis after receiving the flu vaccine (specifically Afluria)
resulting in irreversible legal blindness. Pet. at 1. On October 3, 2017, Petitioner filed the medical
literature associated with Dr. Cestari’s report and a Statement of Completion. Ex. 14; Ref. Nos. 1-
54, ECF Nos.14-18; ECF No. 19.
On May 8, 2018, Respondent filed a Status Report acknowledging that the record was
complete and indicating a willingness to participate in informal settlement discussions. ECF No.
28.
On September 9, 2018, while informal settlement negotiations were ongoing, Petitioner
filed an expert report from Dr. Omid Akbari in support of his position. Ex. 2; ECF No. 32. On
September 26, 2018, Petitioner filed the medical literature referenced in Dr. Akbari’s expert report.
Ex. 14; Ref. Nos. 1-53; ECF Nos. 37-41.
On October 11, 2019, after 15 months of informal settlement negotiations, Petitioner filed
a status report stating, “Settlement negotiations have broken down and there is no value in
continued extensions.” ECF. No. 53. Petitioner requested that the matter be placed on the hearing
docket. Id.
On December 13, 2019, Respondent filed an expert report from Dr. Timothy Vartanian
(Ex. A) and Dr. Vartanian’s CV. Ex. B; ECF No. 54. Respondent filed the medical literature
referenced in Dr. Vartanian’s first report on December 31, 2019. Exs. C-G; ECF No. 56.
On January 17, 2020, the parties filed a Joint Status Report in which Petitioner formally
withdrew his theory of causation based on ASIA. ECF. No. 57. At the entitlement hearing,
Petitioner confirmed that he was strictly relying on molecular mimicry as his medical theory of
causation. Tr. at 66.
On March 26, 2020, I issued a Prehearing Order. ECF No. 60. An entitlement hearing was
scheduled for May 21 and 22, 2020. ECF No. 60. I asked the parties to file all documents on which
they intended to rely at the hearing no later than April 23, 2020. Id.
On March 31, 2020, Petitioner filed an expert report from Dr. Robert Turner, Dr. Turner’s
CV, and the medical literature cited in support of his findings. Exs. 27-28, ECF No. 61. On April
20, 2020, Petitioner filed a second expert report from Dr. Turner, the associated supplemental
literature and MRI images. Supp. Ex. 28; Ref. Nos. 1-4; ECF. No. 64; Ex. 29; Supp. Ex. 29; ECF
No. 64; Ex. 30; Supp. Exs. 1-17A; ECF No. 64-65.
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On April 23, 2020, Petitioner filed an expert report from Dr. Martha Schatz, Dr. Schatz’s
CV, associated MRI reports and medical literature. Ex. 31-33; ECF No. 66. Petitioner also filed
Power Point Presentations prepared by Dr. Akbari and Dr. Cestari. Exs. 34-35; ECF No. 66. On
May 2, 2020, Petitioner filed the medical literature associated with Dr. Cestari’s Power Point
Presentation. Ex. 35; Ref. Nos. 1-4; ECF No. 80. On May 20, 2020, Petitioner filed an updated
CV for Dr. Schatz. Ex. 1; ECF No. 102.
On April 24, 2020, Petitioner filed his prehearing memorandum, supplemental medical
literature, and highlighted copies of Dr. Akbari’s medical literature. Ex. 32; Supp. 1-2; ECF No.
69; Ex. 19; Ref. Nos. 1- 53; ECF Nos. 70-74. On April 30, 2020, Petitioner filed a second expert
report from Dr. Akbari addressing the issues raised in Dr. Vartanian’s first report along with
additional medical literature. Ex. 37; ECF No. 75; Supp. Ex. 37; Ref. Nos. 1-15; ECF No. 75. On
May 1, 2020, Petitioner filed a second expert report from Dr. Cestari and the related medical
literature. Ex. 38; ECF No. 76; Supp. Ex. 38; Ref. Nos. 1-27; ECF Nos. 77-79. On May 7, 2020,
Petitioner filed a Supplemental Brief and Prehearing Order. ECF No. 83.
On May 11, 2020, Respondent filed a Prehearing Brief, a Supplemental Report from Dr.
Vartanian and the related medical literature. ECF Nos. 85; Exs. H-T; ECF No. 86. On May 13,
2020, Petitioner filed a Motion to Strike Dr. Vartanian’s Report on the grounds that it was filed
fewer than 10 days prior to the entitlement hearing and raised new issues and arguments not
presented in his first report. ECF No. 88. On May 15, 2020, I issued an order denying Petitioner’s
Motion to Strike. ECF No. 98.
On May 19, 2020, Petitioner filed a Response to Respondent’s Prehearing Brief. ECF No.
99. On May 20, 2020, Petitioner filed third expert reports from Dr. Cestari, Dr, Akbari and Dr.
Turner including additional medical literature from Dr. Turner. Exs. 39-41; ECF No. 100; Supp.
Ex. 41; Ref. Nos. 1-2; ECF No. 100.
I held an entitlement hearing on May 21 and 22, 2020. Due to the COVID-19 pandemic,
the hearing was conducted via videoconference. On June 29, 2020, after the hearing, and with the
permission of the Court, Petitioner filed a fourth expert report from Dr. Akbari and the associated
medical literature. Ex. 43; ECF No. 107; Ex. 43; Ref. Nos. 1- 24; ECF Nos. 108-111. On July 10,
2020, Petitioner filed his Post-Hearing Brief specifically addressing Althen Prong One. ECF No.
115.
On August 26, 2020, Respondent filed a Post-Hearing Brief. ECF No. 119. On September
22, 2020, the parties filed a Joint Status Report stating that the record was complete. ECF No. 120.
This matter is now ripe for adjudication.
II. Medical Records
The parties agree that there are no medical facts in dispute with respect to Petitioner’s
medical records and Petitioner’s timeline of symptoms. Joint Submission at 8; ECF No. 83; see
also Ex. 11 (Petitioner Timeline of Symptoms).
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A. Relevant Pre-Vaccination History
Prior to October of 2016, with the exception of chronic sinusitis, Petitioner was a relatively
healthy 44-year-old male with no significant medical history. Ex. 5 at 35. Prior to his influenza
vaccination on October 11, 2016, Petitioner had no major issues with his eyes. Dr. Diana Gonzalez,
an optometrist, conducted a routine eye exam on December 11, 2013, and noted no history of
ocular surgery, trauma or injury, and an unremarkable ocular family history. Ex. 9 at 2. Petitioner
had no complaints of physical ocular symptoms, routine headaches, double vision, visual floaters,
light flashes, blurry vision, or uncomfortable vision. Id. Petitioner wore contact lenses for myopic
astigmatism but was otherwise experiencing good/acceptable contact lens comfort, vision and eye
health. Id. at 3.
Dr. Sebastian Mora, an ophthalmologist, conducted a routine eye exam on September 26,
2016. Ex. 3 at 3. The results of that exam were normal and demonstrated 20/15 visual acuity
bilaterally (with contact lens correction). Ex. 14 at 2.
Petitioner’s treating physician, Dr. Yoo, conducted routine physical examinations in
October 2013 and June 2015. Bloodwork was unremarkable and exams were otherwise normal
with the exception of symptoms of irritable bowel syndrome. Ex. 10 at 6.
B. Relevant Post-Vaccination History
On October 11, 2016, Petitioner had follow-up appointment with his ENT, Dr. Christine
Gilliam, in connection with a sinus infection. Ex. 1 at 4. Dr. Gilliam noted that Petitioner was
feeling well, with no fever, headache or runny nose. Id. At that visit, Petitioner received his first
ever influenza vaccination. Id.
On October 24, 2016, Petitioner saw Dr. Mora, complaining of obstructed vision in his
right eye starting on October 23, 2016, 12 days after his vaccination. Ex. 3 at 5. Dr. Mora diagnosed
Petitioner with serious maculopathy and referred Petitioner to a retina specialist, Dr. Thomas Oei,
for further examination. Id. Dr. Oei observed an abnormality in the optic nerve and diagnosed
Petitioner with ischemic optic neuropathy but noted that further testing was necessary. Ex. 4 at 4.
Dr. Oei referred Petitioner to Dr. Schatz, a neuro-ophthalmologist. Id. On October 26, 2016, prior
to seeing Dr. Schatz, Petitioner telephoned Dr. Oei to inform him that Petitioner’s vision had
further deteriorated. Id. Dr. Oei recommended that Petitioner go to the nearest emergency room.
Id. Petitioner was admitted to University Hospital that day and remained for a period of three
weeks. Id.
Upon his admission to University Health System, the differential diagnosis for Petitioner's
vision loss and bilateral optic disc swelling was broad, including vascular, infectious,
inflammatory, post infectious, post-vaccine, metabolic, hereditary, comprehensive, and neoplastic
causes. Ex. 5 at 28. Over the next few days, Petitioner underwent an extensive diagnostic work up
looking for an infectious or autoimmune etiology in order to formulate a treatment plan. Id. at 20-
28.
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Petitioner’s treating team performed a myriad of tests including, but not limited to, vision
screening, bilateral vision exams, field of view testing, carotid ultrasound, CT scan, multiple MRIs
of the brain and orbits, blood sample testing, cerebral spinal fluid (CSF) testing, chest x-ray, stool
sample testing, lumbar puncture, neurological exams, and infectious disease evaluations. Ex. 5 at
76-118. All testing and lab work were either negative or non-diagnostic, ruling out multiple
potential causes including viral infection, bacterial infection, fungal infection, structural issues,
parasites, medication responses, environmental factors, brain issues, and abnormal CSF pressure.
Id.; see also Joint Submission at 7.
Despite having no clinical symptoms or positive lab results, Petitioner was treated
empirically for several conditions in an effort to increase his chances of recovery. Ex 5. at 72.
Petitioner was started on IV steroids followed by oral steroids. Id. Petitioner was treated for
Bartonella Hensley IgG3 (cat scratch fever) with a course of antibiotics. Id. He was also treated for
neuromyelitis optica spectrum disease (“NMO”) with five days of plasma exchange. Id.
Ultimately, there was no noticeable improvement and Petitioner’s vision worsened. Id.
Petitioner was discharged from the hospital on November 14, 2016, with a diagnosis of
bilateral optic neuritis. Ex. 8 at 10. He completed his oral steroid treatment on January 4, 2017,
and although his disk swelling slowly receded, his visual field never fully returned. See Ex. 9 at
10. On February 15, 2017, Dr. Chan, a low vision specialist, determined that Petitioner was legally
blind and issued a certificate a legal blindness. Id.; Ex. 12. On February 16, 2017, Dr. Schatz
assessed Petitioner with post vaccine autoimmune optic neuritis based on the exclusion of other
possible etiologies and the temporal association with the flu vaccine administered two weeks prior.
Ex. 9 at 22. At the time of the entitlement hearing, he had not had a recurrence of symptoms. Tr.
at 124.
III. Expert Reports and Testimony
Petitioner filed a total of 11 expert reports authored by four experts: Dr. Dean Cestari, Dr.
Omid Akbari, Dr. Martha Schatz and Dr. Robert Turner. See Ex. 14 (“First Cestari Rep.”); Ex. 38
(“Second Cestari Rep.”); Ex. 39 (“Third Cestari Rep.”); Ex. 19 (“First Akbari Rep.”); Ex. 37
(“Second Akbari Rep.”); Ex. 40 (“Third Akbari Rep.”); Ex. 37 (“Fourth Akbari Rep.”); Ex. 32
(“Schatz Rep.”); Ex. 28 (“First Turner Rep.”); Ex. 29 (“Second Turner Report”); Ex. 41 (“Third
Turner Rep.”).
Respondent filed two expert reports, both authored by Dr. Timothy Vartanian. See Ex. A
(“First Vartanian Rep.”); Ex. H (“Second Vartanian Rep.).
For the sake of clarity, my summary of the expert reports and testimony will be divided as
follows: (1) those portions of the reports and testimony that address Petitioner’s medical theory of
causation, and (2) those portions of the reports and testimony that address Althen prongs two and
three.
3 Petitioner’s initial lab work came back borderline positive for Bartonella Hensley IgG. His subsequent
PCR amplification test, a more precise test for Bartonella came back negative, and Bartonella was ruled out
as the cause of Petitioner’s vision loss. Tr. at 119-22.
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A. Expert Reports re: Medical Theory of Causation
1. Dr. Akbari’s First Report
Dr. Akbari has a B.S. and a M.S. in general and medical microbiology, and a Ph.D. in
molecular and cellular immunology. Ex. 18 at 1. (hereinafter “Akbari CV”). He is a Professor of
Medicine and a Professor of Immunology at University of Southern California, USC, Keck School
of Medicine. Tr at. 12. Dr. Akbari is actively involved in researching the role immune tolerance
plays in triggering an autoimmune disease. Tr. at 14. Dr. Akbari has specifically studied immune
regulation/dysregulation after influenza infection and vaccination. Id. Several years ago, his lab
designed a new universal vaccine against the influenza virus for which they won several awards.
Id. at 15-16. Dr. Akbari’s lab has also conducted studies of viral-induced autoimmunity and
immune-mediated diseases that cause blindness. Id. at 15. Dr. Akbari has been the recipient of the
Henning Loewenstein Award for best practice and research in immunology and the Pharmacia
Award for the best immunology research. Id. The results of his research have been published in
several high impact journals such as New England Journal of Medicine, Journal of Clinical
Investigation, Journal of Experimental Medicine, Nature Immunology, Nature Medicine, and
Journal of Immunology. Id. at 16.
In Dr. Akbari’s first report, having reviewed Petitioner’s medical records, he concluded “to
a high degree of certainty, and by a preponderance of the scientific evidence, had it not been for
the flu vaccination, particularly the first exposure to flu vaccine, [Petitioner] would not have
developed symptoms such as optical neuritis, blurred vision and vision loss.” First Akbari Rep. at
17. Dr. Akbari’s report referenced 53 pieces of medical literature in support of his opinion.
Dr. Akbari’s research revealed that “the theory of molecular mimicry and vaccine
homology support that influenza immunization can plausibly4 cause an adverse immune cross
reaction and result in the onset of local optic neuro-degeneration observed in this case.” First
Akbari Rep. at 4. First, Dr. Akbari found that the Afluria vaccine is partially composed of the
H1N1 vaccine, a vaccine which has been widely studied and has been shown to contain two
separate six amino acid sequences that mimic those found in components of the myelin sheath. Id.
at 10-11; see also Markovic–Plese, et al., High level of cross-reactivity in influenza virus
hemagglutinin-specific CD4+ T-cell response: Implications for the initiation of autoimmune
response in multiple sclerosis, 169 J NEUROIMMUNOL 31-38 (2005) (filed as Ex. 19, Ref. No. 27),
KW Wucherpfennig & JL Strominger, Molecular mimicry in T cell-mediated autoimmunity: viral
peptides activate human T cell clones specific for myelin basic protein. 80 CELL 5, 695- 705 (1995)
(filed as Ex. 28) (hereinafter “Wucherpfennig1”). Dr. Akbari has also located research showing
that the H1N1 vaccine is capable of triggering an autoimmune response resulting in a
demyelinating disease. First Akbari Rep. at 12; see also Nachamkin, et al., Anti ganglioside
antibody induction by swine (A/NJ/1976 /1-Il Nl) and other influenza vaccines: insights into
4 During the entitlement hearing, Dr. Akbari clarified his use of the terms “plausible” and “reasonable” as
being “our language in science. . . . but that doesn’t mean that we are not sure.” Tr. at 21-22. “Whenever
the possibility of something is anything greater than 51 percent or 60 percent, we say it is plausible or it is
believed.” Tr. at 22.
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vaccine-associated Guillain-Barre syndrome, 198 J INFECT DIS. 2, 226-33 (2008) (filed as Supp.
Ex. 19, Ref. No. 34) (hereinafter “Nachamkin”).
Dr. Akbari cited two studies showing that cross-reactive T cells created in response to the
H1N1 vaccine have been shown to cause ON in both rat models and rhesus monkeys. First Akbari
Rep. at 11; see also Weilbach, et al., T-cell receptor V beta element expression in peripheral
nerves of Lewis rats suffering from experimental autoimmune neuritis, 79 J NEUROIMMUNOL 1,
69-75 (1997) (filed as Ex. 19, Ref No. 29) (hereinafter “Weilbach”); Bajramovic, et al.,
Oligodendrocyte-specific protein is encephalitogenic in rhesus macaques and induces specific
demyelination of the optic nerve, 38 EUR J IMMUNOL. 5, 1452-64 (2008) (filed as Ex. 19, Ref. No.
30) (hereinafter “Bajramovic”). Similarly, Dr. Akbari presented research suggesting that T cells
targeted to attack myelin basic protein (“MBP”) share a peptide sequence with the flu virus. First
Akbari Rep. at 11; see also Wucherpfennig1; Wucherpfennig, et al., Recognition of the
Immunodominant Myelin Basic Protein Peptide by Autoantibodies and HLA-DR2- restricted T
Cell Clones from Multiple Sclerosis Patients, 100 J CLIN INVEST 5, 1114-22 (1997) (filed as Ex.
19, Ref. No. 31) (hereinafter “Wucherpfennig2”).
To show that it is medically likely for the flu vaccine to cause ON in humans, Dr. Akbari
cited to the Karussis study which identified 21 patients who reported having an adverse reaction
to the flu vaccine within approximately 14 days of vaccination. First Akbari Rep. at 10; see also
D. Karussis & P. Petrou, The spectrum of post-vaccination inflammatory CNS demyelinating
syndromes, 13 AUTOIMMUNITY REVIEWS 215-24 (2014) (filed as Ex. 19, Ref. No. 26) (hereinafter
“Karussis”). Of those 21 cases, “optic neuritis was the prominent clinical presentation.”5 Id. Based
on all of the medical literature, Dr. Akbari concluded that “the scientific research supports the
assertion that stimulation of the immune system following vaccination, followed by the
production of antibodies in response to the vaccine is a plausible6 medical theory causally
linking the flu vaccination with the development of Petitioner’s symptoms including optical
neuritis and vision loss.” Id. at 18.
Dr. Akbari opined that the potential for molecular mimicry is high given that T cells need
only recognize a few amino acids of an antigenic peptide to induce an autoimmune response. First
Akbari Rep. at 6. Yet, the incidence of autoimmune disease “is only estimated to develop in
approximately 3-8% of the population.” Id. at 9. Dr. Akbari explained that the immune system has
many checkpoints which likely prevent a high incidence of autoreactive T cells from multiplying
and establishing pathology in the majority of individuals. Id.; Tr. at 54-55. With respect to the
remaining 3-8%, Dr. Akbari stated that certain individuals may be more susceptible or
genetically predisposed to developing an autoimmune disease. First Akbari Rep. at 16.
Dr. Akbari explained that the scientific community now believes that the immune
system’s inability to control an autoimmune response, rather than molecular mimicry alone, is the
main reason certain individuals develop an autoimmune disease. First Akbari Rep. at 10. The
immune system’s effector T cells are known to help eliminate different types of pathogens. Id. at
5 Two other demyelinating diseases were also reported in relation to the influenza vaccine: myelitis and
encephalitis. Tr. at 82.
6 See supra note 4.
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7. Regulatory T lymphocytes (Tregs) express cytokines which actively suppress the T effectors
and prevent them from getting out of control, i.e. otherwise attacking healthy cells due to molecular
mimicry. Id. at 7, 10. When Tregs are either insufficient or overwhelmed by T effectors, this results
in an “adverse autoimmune reaction upon stimulation of the immune system from infection or
vaccination.” Id. at 8. Notably, research has shown that the number of Tregs in patients with ON
is significantly decreased. Id. at 7; see also Kebir, et al., Human TH17 lymphocytes promote
blood-brain barrier disruption and central nervous system inflammation, 2007 NAT MED 13,
1173-75 (2007) (filed as Ex. 19, Ref. No. 11); Cong, et al., Change of Th17 Lymphocytes and
Treg/Th17 in Typical and Atypical Optic Neuritis, 11 PLOS ONE 1, e0146270 (2016) (filed as Ex.
19, Ref. No. 15); G Chen, et al., mTOR regulates neuroprotective effect of immunized
CD4+Foxp3+ T cells in optic nerve ischemia, 2016 SCI REP. 6, 37805 (2016) (filed as Ex. 19, Ref.
No 16); Y Liu, et al., Roles of Treg/Th17 Cell Imbalance and Neuronal Damage in the Visual
Dysfunction Observed in Experimental Autoimmune Optic Neuritis Chronologically, 17
NEUROMOLECULAR MED. 4, 391-403 (2015) (filed as Ex. 19, Ref. No. 22).
2. Dr. Vartanian’s First Report
Dr. Vartanian is a board-certified neurologist who subspecializes in the research and care
of patients with inflammatory demyelinating diseases. Ex. B at 1 (hereinafter “Vartanian CV”).
Dr. Vartanian taught at Harvard Medical School from 1992-2009 and is currently a Professor of
Neurology and Neuroscience at Weill Cornell Medical College of Cornell University. Id. at 2. He
is the attending neurologist at New York Presbyterian Hospital; Chief Scientist at Neurogen
Research Foundation; and Director of the Judith Jaffe Multiple Sclerosis Center at Beth Israel
Deaconess Medical Center. Id. at 2-3,7. Dr. Vartanian has published over 60 peer-reviewed papers
and is a peer editor for many publications, some of which include Journal of Cell Biology, Journal
of Neuroscience, Brain, Developmental Neuroscience, and Annals of Neurology. Id. at 11-19.
Dr. Vartanian’s first report challenged Dr. Akbari’s medical theory of causation on the
grounds that there is no convincing evidence of an association between the flu vaccine and ON
(bilateral or unilateral). First Vartanian Rep. at 12. Particularly, Dr. Vartanian stated that Dr.
Akbari failed to provide evidence showing that the flu vaccine can stimulate autoantibody
production resulting in optic neuritis; failed to show how a peptide without much homology can
bind and activate the immune system (with or without vaccination); failed to explain why the
majority of people receiving the flu vaccine fail to develop an autoimmune disease; and finally,
failed to provide evidence of a molecular or cellular mechanism that reduces Tregs following
vaccination. Id. at 11. With respect to Karussis, Dr. Vartanian noted that inflammatory disease
following vaccination does not prove that the vaccination caused the disease. Id. at 12.
3. Dr. Akbari’s Second Report
Dr. Akbari wrote his second report in response to Dr. Vartanian’s first expert report. In it,
he stated that Dr. Vartanian requires specific evidence of an occurrence “that has evaded
researchers for over 30 years. This narrow view of requiring scientific certainty ignores the
plethora of evidence that supports causation, [and] overlooks current emerging concepts involving
the complex induction of immune-mediated diseases.” Second Akbari Rep. at 1. A great deal of
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Dr. Akbari’s second report restated the findings in his first report that specifically address the
issues raised by Dr. Vartanian. See generally, Second Akbari Rep.
4. Dr. Vartanian’s Second Report
Dr. Vartanian reiterated that Petitioner has not established an epidemiological association
between the flu vaccine and optic neuritis. Second Vartanian Rep. at 5. He argued that Dr. Akbari
failed to identify the T cells or antibodies directed against Petitioner’s target antigens and the
molecular mimics of those antigens. Id. Dr. Vartanian also pointed to the absence of any study
replicating Dr. Akbari’s theory in animal models. Id.
Dr. Vartanian argued that if the flu vaccine shares a meaningful sequence homology with
MBP, one would predict a much higher incidence of post-vaccination auto-immune demyelination
given the prevalence of seasonal flu vaccinations. Id. at 7. He cited to the Silvanovich study for
the proposition that “searches for short amino acid sequence matches of eight amino acids or fewer
to identify proteins as potential cross-reactive allergens is a product of chance and adds little value
to the allergy assessments for newly expressed proteins.” Id. at 7; see also Silvanovich, et al., The
value of short amino acid sequence matches for prediction of protein allergenicity, 90 TOXICOL
SCI. 1, 252-58 (2006) (filed as Ex. Q) (hereinafter “Silvanovich”); Trost, et al., Bacterial peptides
are intensively present throughout the human proteome, 1 SELF/NONSELF 1, 71-74 (2010) (filed
as Ex. R) (hereinafter “Trost”) (suggesting that about 50,000 perfect sequences, each 9 amino acids
long, are shared between 40 bacterial proteomes and about one third of the human proteome).
Based on his research, Dr. Vartanian concluded that there is no statistical association between the
flu vaccine and demyelinating diseases, “let alone a high incidence of CNS demyelinating disease
post-vaccination.” Id. at 6.
Finally, Dr. Vartanian opined that even assuming the flu vaccine were capable of triggering
a demyelinating autoimmune response, Dr. Akbari failed to show that the flu vaccine contains an
adjuvant capable of penetrating the blood brain barrier (“BBB”) of the CNS. Id. at 7.
5. Dr. Akbari’s Third Report
In response Dr. Vartanian’s references to Silvanovich and Trost, Dr. Akbari noted that
Silvanovich relates to pollens, and that allergens have no relevance to this case.7 Third Akbari Rep.
at 2. Similarly, Trost addresses bacterial sequences, none of which have any relevance to this case.
Id. at 1.
6. Dr. Akbari’s Fourth Report
Dr. Akbari’s fourth report, filed after the entitlement hearing, addressed two articles
concerning the BBB cited by Dr. Vartanian in his second report and discussed at length by Dr.
Vartanian at the entitlement hearing. Dr. Akbari agreed that penetrating the CNS is a requirement
7 Dr. Akbari also noted that both the Trost and Silvanovitch articles were published in low impact journals.
Third Akbari Rep. at 1-2. Trost has only been cited five times in the past ten years, Silvanovitch 13 times
in the past 14 years. Id.
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for inducing a demyelinating condition; however, he did not find the articles cited by Dr. Vartanian
to be relevant to Petitioner’s case.8 Fourth Akbari Rep. at 2. Dr. Akbari opined that it is important
to distinguish the BBB from the Blood Retina Barrier (“BRB”) and the Blood Ocular Barrier
(“BOB”). Id. at 3. The BRB and BOB surrounding the optic nerves are very delicate and many
studies have shown that they do not block complete access to the optic nerve. Id. at 3, citing
Hofman, et al., Lack of blood-brain barrier properties in microvessels of the prelaminar optic
nerve head, 2001 INVEST OPHTHALMOL VIS SCI 42, 895-901 (2001) (filed as Supp. Ex. 43, Ref.
No. 3); Diaz-Coranguez, et al., The inner blood-retinal barrier: Cellular basis and development,
2017 VISION RES 139, 123-37 (2017) (filed as Supp. Ex. 43, Ref. No. 4). Dr. Akbari reported that
the “[i]nfluenza vaccine is known to induce specific T cells that can disrupt BRB and cause optic
neuritis.” Fourth Akbari Rep. at 3, citing Kebir, et al., Human TH17 lymphocytes promote blood-
brain barrier disruption and central nervous system inflammation, 2007 NAT MED 13, 1173-75
(2007) (filed as Supp. Ex. 43, Ref. No. 5).
B. Expert Testimony re: Medical Theory of Causation
1. Dr. Akbari’s Expert Testimony
Dr. Akbari testified that molecular mimicry via the influenza vaccine was a substantial
factor in Petitioner’s development of optic neuritis. Tr. at 21, 23-24. Dr. Akbari presented the court
with a power point presentation thoroughly laying out his theory connecting the flu vaccine to
Petitioner’s ON via molecular mimicry. See Ex. 34.
First, Dr. Akbari discussed the Nachamkin article, which found that H1N1 vaccines contain
structures that can induce anti-ganglioside antibodies in mice. Tr. at 48-49. Nachamkin provides
evidence that the H1N1 vaccine is capable of triggering an autoimmune response resulting in a
demyelinating disease. Id.
Next, Dr. Akbari discussed the Weilbach article, which found that rats injected with T cells
targeted to attack MBP (a component of the myelin sheath) started to experience blindness due to
demyelination of the nervous system. Tr. at 49-51. Similarly, Bajramovic found that rhesus
monkeys injected with T cells targeted to attack oligodendrocyte-specific protein resulted in
inflammatory responses throughout the central nervous system, specifically causing demyelination
of the optic nerve resulting in blindness. Id. According to Dr. Akbari, both Weilbach and
Bajramovic provide evidence that autoreactive T cells are capable of damaging the central nervous
system (“CNS”) and causing blindness. Id.
Finally, Dr. Akbari discussed the two Wucherpfennig studies which found that T cells
isolated from the blood of patients with multiple sclerosis, based upon their reactivity to MBP,
share a peptide sequence with the flu virus. Tr. at 51-52. The Wucherpfennig studies provide an
example of molecular mimicry with influenza strains contained in the same vaccine that Petitioner
received. Tr. at 52.
8 Dr. Akbari’s Fourth Report was filed after the entitlement hearing, with permission of the court, given
that Dr. Vartanian’s Second Report and supporting literature was filed fewer than 10 days before the hearing
and raised new issues not presented in his first report.
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To tie all of this research together, Dr. Akbari discussed Karussis, which he explained is
not a single case study but a meta-analysis. Tr. at 53. Karussis collected all of the reported adverse
events related to vaccines in the United States from 1979-2003. Id. The search located a total of
71 reported cases, 21 of those specifically related to the flu vaccine. Id. Of those 21 cases, nine
reported optic neuritis as the adverse effect.9 Tr. at 54. According to Dr. Akbari, Karussis is
evidence of a real-world association between the flu vaccine and the development of ON in human
beings. Tr. at 55.
Dr. Akbari testified that the low rate of autoimmune responses following vaccination is a
testament to the safety of vaccines and the efficiency of the immune system. Tr. at 62-63. Yet,
“safety and rarity do not rule out the scientific plausibility10 of adverse immune responses.” Id. at
63. Dr. Akbari opined that in addition to a molecular mimic triggering an autoimmune response,
Petitioner did not have a sufficient level of regulatory T cells to contain that response, and that is
why he developed optic neuritis following his influenza vaccination. Id. at 79.
In the absence of a clinical lab test that can prove that the flu vaccine caused Petitioner’s
optic neuritis via molecular mimicry, Dr. Akbari testified that one must make a determination
based on many factors including the medical history of that particular patient, the timing of clinical
presentation of symptoms, the composition of the vaccine, and the existence of clinical factors to
support a diagnosis. Id. at 74. Having considered the totality of the circumstances in this case, Dr.
Akbari is of the opinion that it is more than 51% likely that the flu vaccine was a substantial factor
causing Petitioner’s condition. Id.
Highly relevant to this case, in Dr. Akbari’s opinion, is the fact that Petitioner developed
ON after receiving his first ever influenza vaccination. Tr. at 98. Many people get the flu vaccine
every year. Id. If something goes wrong after the 10th, 11th, or 12th vaccination, one needs “to look
at what were the difference between that particular influenza vaccine or situation of that day or
situation of patient at the time, and others.” Id. When a person develops a reaction to a vaccine
after the first one, that has to be one of the factors considered as playing an important role. Id. at
98-99.
According to Dr. Akbari, another highly relevant factor is that the Afluria package insert
warns that “Neurological disorders temporally associated with influenza vaccination, such as optic
neuritis, have been reported.” Tr. at 83; Ex. 2. Petitioner began to experience vision loss
approximately 12 days after receiving the Alfuria vaccine, consistent with the onset of symptoms
reported in Karussis. Tr. at 84-85.
2. Dr. Vartanian’s Expert Testimony
Dr. Vartanian testified that molecular mimicry, as it has been presented, is a nonviable
hypothesis, based on a lack of evidence. Tr. at 315, 333. Dr. Vartanian believes the theory is flawed
on the grounds that a six amino acid sequence is too short to be of any relevance. Id. at 331-33.
9 Two other demyelinating diseases were also reported in relation to the influenza virus: myelitis and
encephalitis. Tr. at 82.
10 See supra note 5.
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Dr. Vartanian quoted Trost which revealed that human proteins share thousands of matches with
bacterial and viral peptides suggesting “that autoimmune diseases should have a much higher
incidence than actually observed, both in the total number of individuals affected and the number
of autoimmune pathologies per individual.” Id. at 333, quoting Trost.
Dr. Vartanian testified at length regarding Dr. Akbari’s failure to show that the influenza
vaccine contains an adjuvant capable of penetrating the blood brain barrier of the CNS. Citing the
Brabb study, Dr. Vartanian listed two requirements for inducing a demyelinating autoimmune
disease: (1) exposure to an organism/bacteria/virus/vaccine that activates the immune response in
the periphery, and (2) penetration, via damage, to the CNS barriers. Tr. at 335, Brabb, et al.,
Triggers of autoimmune disease in a murine TCR-transgenic model for multiple sclerosis, 159 J
IMMUNOL 1, 497-507 (1997) (filed as Ex. J); see also Owens, et al., Perivascular spaces and the
two steps to neuroinflammation, 67 J NEUROPATHOL EXP NEUROL 12, 1113-21 (2008) (filed as Ex.
P). In animal models, for example, simply injecting an animal with MBP will not trigger a
demyelinating disease unless you add the pertussis toxin which targets and opens the BBB. Tr. at
335-37. Dr. Vartanian found nothing in the influenza vaccine that would allow it to breach the
BBB. Id. at 346.
C. Expert Reports re: Althen Prongs Two and Three
All of Petitioner’s experts agree with Petitioner’s diagnosis of vaccine-induced ON. Dr.
Cestari, Dr. Turner and Dr. Vartanian spent a great deal of time debating whether ON was the
proper diagnosis in their reports. At the entitlement hearing Dr. Vartanian agreed that bilateral
optic neuritis was the most likely diagnosis; however, he does not believe that it was vaccine-
induced. Tr. at 354. Instead, Dr. Vartanian suggested that Petitioner’s condition was anti-MOG11
induced. My discussion of the expert reports and testimony will be limited to that issue.
1. Dr. Schatz’s Report
On April 23, 2020, Petitioner filed an expert report authored by Dr. Martha Schatz. Ex. 32
(hereinafter “Schatz Rep.”). Dr. Schatz is a board-certified ophthalmologist specializing in neuro-
ophthalmology. Ex. 42 at 2 (hereinafter “Schatz CV”). She is a Professor of Clinical
Ophthalmology at University of Texas Health Science Center of San Antonio. Id. at 1. Dr. Schatz
has maintained a clinical practice since 1998 and is currently the Chief Ophthalmologist at
Pediatric Ophthalmologist Service. Id. at 14. She is published in a variety of peer reviewed journals
and is regularly invited to speak on topics related to neuro-ophthalmology. Id. at 9-11. Dr. Schatz
served as Petitioner’s treating physician during his stay at University Hospital.
Dr. Schatz’s report explains her reasons for ultimately diagnosing Petitioner with post-
vaccine ON: (1) the temporal association between the vaccination and his vision loss, and (2) his
11 MOG stands for myelin oligodendrocyte glycoprotein. Tr. at 193. MOG proteins provide structural
integrity to the myelin sheath. Tr. at 193. When anti-MOG antibodies attack the MOG proteins, they cause
demyelination. Tr. at 194.
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symptoms were more characteristic of other reported cases of post-vaccine ON, despite the fact
that those cases are rare. Id. at 5. Petitioner was not responsive to any treatments for other known
causes of bilateral optic neuritis, such as NMO-Spectrum and anti-MOG, and all other possible
etiologies had been ruled out. Id. at 4-5. “Some would suggest that [Petitioner] had simply
idiopathic optic neuritis, a diagnosis used when there is no other cause definitely found when a
patient presents with his first episode. However, [Petitioner] did have another probable etiology -
his first influenza vaccination two weeks prior to vision loss.” Id. at 5.
2. Dr. Cestari’s First Report
Petitioner filed Dr. Cestari’s first report as an exhibit accompanying his petition. Ex. 1
(hereinafter “First Cestari Rep.”). Dr. Cestari received his B.A. from Colgate University and his
M.D. from Tel Aviv University. Ex. 15 at 2 (hereinafter “Cestari CV”). He is board certified as a
neurologist and ophthalmologist. Id. He is one of roughly ten neuro-ophthalmology specialists in
the United States. Tr. at 166. Dr. Cestari subspecializes in optic nerve disease and in treating double
vision. Id. He is a professor of Ophthalmology at Harvard Medical School and an assistant clinical
professor of Optometry at the New England College of Optometry. Cestari CV at 3. Dr. Cestari
has had an active medical and surgical practice at Massachusetts Eye and Ear Infirmary since 2006,
where he also serves as the fellowship director of neuropathology. Id. at 35; Tr. at 168. He
performs clinical and translational research, is well published in many peer-reviewed publications,
and regularly gives local, regional, national and international talks. Cestari CV at 29-32; Tr. at
169-72.
Dr. Cestari reviewed Petitioner’s medical records and agreed with the diagnosis of vaccine-
induced bilateral optic neuritis. “Influenza vaccination-associated optic neuritis is a rare
occurrence and its diagnosis is one of exclusion and can only be made when all other possible
causes are ruled out.” First Cestari Rep. at 16. Dr. Cestari emphasized that he has rarely seen
“a more complete, thorough and exhaustive evaluation and work up looking for an etiology of a
bilateral optic neuropathy that included four MRIs of the brain and orbits as well as every
conceivable blood test and a spinal tap.” Id. at 17. It is Dr. Cestari’s opinion that, given the
extensive negative medical findings, the theory of how a vaccine can induce optic neuritis
presented by Dr. Akbari, and the temporal relationship between the onset of visual symptoms 12
to 14 days following flu vaccine, “the only possible explanation for Petitioner’s signs and
symptoms is a post vaccination optic neuritis.” Id.
Dr. Cestari explained that proving causation of an extremely rare side effect can be
difficult, and that clinicians often rely on published case reports to lend support to a causal
relationship between a mediation and a side effect. First Cestari Rep. at 14. “The most convincing
support for a causal relationship between the influenza vaccine and optic neuritis comes from a
report of a challenge-rechallenge case in which a 59-year-old woman developed bilateral optic
neuritis on 2 separate occasions, 1 year apart, after consecutive annual influenza vaccinations.”
First Cestari Rep. at 16; see also, Id. at 14. T.P. Hull & J.H. Bates, Optic neuritis after influenza
vaccination, 124 AM J OPHTHALMOL 5, 703-04. (1997) (filed as Ex. 14, Ref. No. 39) (hereinafter
“Hull”).
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For proof of a temporal relationship, Dr. Cestari cited to the Stübgen article, showing that
as of 2013, there have been 38 reports of presumed post-vaccination optic neuritis, either bilateral
or unilateral, all occurring an average of two to three weeks after vaccination. First Cestari Rep. at
15; see also Stübgen, J.P., A literature review on optic neuritis following vaccination against virus
infections, 12 AUTOIMMUN REV 10, 990-97 (2013) (filed as Ex. 14, Ref. No. 14) (hereinafter
“Stübgen”).
3. Dr. Vartanian’s First Report
Dr. Vartanian’s first report mainly disputed Petitioner’s diagnosis on the grounds that optic
neuritis is almost always contrast-enhancing on MRI, and Petitioner’s MRIs were normal. First
Vartanian Rep. at 9.12
Dr. Vartanian does not agree that Petitioner’s work-up excluded all other known causes of
bilateral optic neuritis on the grounds that the empirical treatment for suspected NMO and anti-
MOG-related ON was neither sufficient nor diagnostically informative. First Vartanian Report at
10. He argued that case reports do not prove causation and concluded: “To a reasonable degree of
medical certainty, the visual loss experienced by petitioner is not due to vaccine-induced
inflammatory/autoimmune optic neuritis.” Id. at 13.
4. Dr. Turner’s First Report
Dr. Turner’s first report was limited to his review of Petitioner’s MRIs and his opinion that
the MRIs represent an inflammatory optic neuritis. See generally, First Tuner Rep.
5. Dr. Turner’s Second Report
In his second report, Dr. Turner opined that the “optimum timing for MRI enhancement of
the optic nerve is within 4 weeks of symptomatology.” Second Tuner Rep. at 1; see also Zhang, et
al., MRI texture heterogeneity in the optic nerve predicts visual recovery after optic neuritis, 2014
NEUROIMAGE CLIN. 4, 302-07 (2014) (filed as Supp Ex. 29, Ref. No. 1) (hereinafter “Zhang”).
Thus, in Dr. Turner’s opinion, the MRI studies conducted at University Hospital on October 27,
2016 are consistent with a vaccine injury. Id. at 2. He stated: “Although the MRI does not indicate
causality between the vaccine and Petitioner’s clinical state, it does support a temporal
relationship.” Id.
6. Dr. Cestari’s Second Report
In his second report, Dr. Cestari stated that Petitioner has atypical bilateral ON, and that
atypical bilateral ON can usually be attributed to one of three identifiable causes: NMO, anti-
MOG, or vaccination. Second Cestari Rep. at 9. Petitioner’s symptoms were inconsistent with a
diagnosis of either NMO or anti-MOG induced ON, leaving vaccine-induced ON as the only viable
etiology. Id. at 11.
12 This opinion was later retracted at the evidentiary hearing after Dr. Vartanian had an opportunity to
review Dr. Turner’s reports. Tr. at 354.
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Dr. Cestari reported that Petitioner did not and still does not fit the anti-MOG clinical
profile. See discussion of anti-MOG clinical characteristics infra at 16.
7. Dr. Vartanian’s Second Report
Dr. Vartanian argued that anti-MOG should not be ruled out, especially now that anti-MOG
testing is available. Second Vartanian Rep. at 8. Dr. Vartanian stressed that Petitioner should be
tested, and if the tests come back positive, Petitioner can be treated to avoid a relapse. Id. at 8.
Dr. Vartanian also stated that: “The distinguishing features of anti-MOG NMO are
dramatic swelling of the intro-ocular segment of the optic nerve, longitudinal twisting of the optic
nerve, and peri-neural enhancement, none of which I see in the [MRIs] taken from petitioner.”
Second Vartanian Rep. at 5.
8. Dr. Cestari’s Third Report
Dr. Cestari’s third report criticized Dr. Vartanian’s suggestion that Petitioner should
undergo anti-MOG testing on the grounds that “he DOCUMENTS IN HIS REPORT THAT MR.
REINHARDT'S MRI FINDINGS ARE INCONSISTENT WITH ANTI-MOG OPTIC NEURITIS
and I agree!!!” Third Cestari Rep. at 13 (emphasis in original). Consequently, “there is no reason
to obtain anti-MOG testing now. Mr. Reinhardt does not fit the clinical or radiologic profile of a
patient with anti-MOG optic neuritis. He has had no recurrences of optic neuritis.” Id.
9. Dr. Tuner’s Third Report
In his third report, Dr. Turner stated that his review of Petitioner’s MRIs did not reveal any
anti-MOG characteristics. Third Turner Rep. at 1. Dr. Turner also noted that Dr. Vartanian refuted
his own theory by admitting that Petitioner’s MRIs do not support an anti-MOG diagnosis. Id. at
2.
D. Expert Testimony re: Althen Prongs Two and Three
1. Dr. Schatz’s Testimony
Dr. Schatz’s testified that by empirically treating Petitioner with corticosteroids, the
treating team was able to rule out anti-MOG induced ON. After receiving IV steroids followed by
three months of oral steroids “[h]is disk swelling slowly receded, went down, and his vision -- and
his visual field never returned.” Tr. at 124; see also Ex. 5 at 72; Ex. 9 at 17. Furthermore, even had
anti-MOG testing been available in 2016, Petitioner did not fit the clinical profile, and testing
Petitioner now would not reveal anything about his immune status back in 2016. Tr. at 137, 158.
In addition to excluding other possible etiologies, Dr. Schatz testified that there “were
features of [Petitioner’s] case that stood out as specific for vaccine-related optic neuritis.” Tr. at
153. One was the temporal course of his presentation, 12 days after his first ever influenza vaccine.
Additionally, although there is no established medical literature discussing the clinical conditions
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of vaccine-induced ON, Dr. Schatz testified that anecdotal case reports do exist; and when
compared to case reports concerning anti-MOG related ON, Petitioner’s symptoms were more
consistent with the vaccine-related cases. Tr. at 154, 161.
2. Dr. Cestari’s Testimony
Dr. Cestari testified that although anti-MOG induced ON is a relatively new clinical entity,
it was once considered to be an extension of multiple sclerosis. Tr. at 134. Thus, researchers have
known about it and written about it for a long time. Id. Dr. Cestari testified that so much anti-MOG
research and literature exists that we can get a good sense of what does and does not fit the clinical
profile. Id.at 402. After considering the anti-MOG literature, Dr. Cestari opined that “the
preponderance of evidence does not support that diagnosis.” Id. at 395.
Anti-MOG associated optic neuritis has distinct clinical manifestations. Tr. at 195. It
typically occurs in young women. Id. at 395. It is usually unilateral, and it is usually associated
with a good prognosis. Id. In general, about half of patients will have complete recovery or
significant recovery if treated with corticosteroids. Id. at 195. But the “hallmark of patients with
anti-MOG antibodies and optic neuritis is recurrence.” Id. at 194. Autoimmune diseases naturally
have a tendency to recur because there is a chronic ongoing level of inflammation, and in anti-
MOG patients the rate of recurrence is 80-84% within one year. Id. at 197-98, 403, 404.
When compared to vaccine-induced ON, “there should not be recurrence if there was a
one-time trigger.” Tr. at 197. Petitioner has gone almost four years without any recurring
symptoms, and the proper diagnosis becomes clearer the longer you wait. Id. at 404. “I would
expect that within three and a half years, if this was anti-MOG optic neuritis, and he's not on
maintenance, therapy [for] immunosuppression, he should have another event, and he hasn’t.” Id.
Dr. Cestari also testified that Petitioner received a flu vaccination 12 days prior to the onset
of his symptoms, so that has to be a consideration. Tr. at 395. We know that the Afluria insert
warns that cases of optic neuritis have been reported post-vaccination. Id. As a neuro-
ophthalmologist, when a patient presents with some kind of vision loss, part of Dr. Cestari’s review
is to ask, “have you had any kind of immunization in the last 30 days, because we know that the
literature, medical literature, supports the possibility that this could happen.” Id. at 398. In Dr.
Cestari’s opinion “the preponderance of evidence makes it much more likely that the influenza
vaccination that Petitioner received substantially contributed to the development of his optic
neuritis.” Id. at 399.
3. Dr. Turner’s Testimony
Dr. Turner testified that his review of Petitioner’s MRIs revealed that they were 100 percent
abnormal. Tr. at 275. On October 27, 2016, both of Petitioner’s optic nerves were showing
enhancement. Id. at 275-76. “So, without question, the MRI study, you can take this to the bank
on this one image alone, shows enhancement.” Id.; see also Supp. Ex. 5 (Image 9 Series 13001).
Dr. Turner does not believe that Petitioner’s MRIs exhibited any of the radiological
features of anti-MOG ON. Tr. at 299-300. The Chen article found that the MRIs of anti-MOG
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patients show long segment (more than 50%) enhancement of the anterior segment of both optic
nerves, perioptic soft tissue involvement, and enhancement of the optic nerve sheath.” Id. at 297;
see also Chen, et al., Myelin Oligodendrocyte Glycoprotein Antibody (MOG-lgG)-Positive Optic
Neuritis: Clinical Characteristics, Radiologic Clues and Outcome, 2018 AM. J. OPTHALMOL. 195,
8-15 (2018) (filed as Ex. 38, Ref. No. 6). According to Dr. Turner, Petitioner’s MRIs did not show
involvement of the perioptic soft tissue or enhancement of the optic nerve sheath. Id. at 297.
Petitioner’s optic nerve enhancement was roughly 7 millimeters in a 5-centimeter structure –
certainly not more than 50%. Id. As referenced in Dr. Vartanian’s second report, Dr. Turner also
did not observe any longitudinal twisting of the optic nerve or paraneural enhancement.” Tr. at
299.
4. Dr. Vartanian’s Testimony
Dr. Vartanian does not believe that the evidence is sufficient to prove that Petitioner’s ON
was vaccine induced. Tr. at 324. According to Dr. Vartanian, everyone agrees that this is a complex
and unusual case, but “[n]o one can say, with authority, that this is vaccine related when there is
no vaccine related clinical syndrome that is well described.” Tr. at 326, 328. Dr. Vartanian testified
that case reports are completely unreliable in connection with vaccine-induced autoimmune
diseases “when you think of how frequent vaccines -- influenza vaccines are given to how many
people, the -- you know, pure chance of someone getting a vaccine and two weeks, three weeks, a
month later having some clinical event is actually quite high.” Id. at 345-46.
Dr. Vartanian is of the opinion that the most appropriate diagnosis for Petitioner is anti-
MOG induced ON. Tr. at 325. Dr. Vartanian testified that as an autoimmune condition, anti-MOG
fits nicely with Petitioner’s molecular mimicry theory. Id. at 328. Yet, Dr. Vartanian admitted that
Petitioner does not fit the classical clinical presentation of anti-MOG ON. In discussing this
apparent contradiction, Dr. Vartanian testified that not every patient presents with the same clinical
features, and that Petitioner has an atypical form of anti-MOG ON. Id. at 326, 377. “Unusual
presentations, uncommon presentations, partial, you know, phenotypes happen all the time.” Id. at
367.
IV. Applicable Law
A. Petitioner’s Burden in Vaccine Program Cases
Under the Vaccine Act, when a petitioner suffers an alleged injury that is not listed in the
Vaccine Injury Table, a petitioner may demonstrate that he suffered an “off-Table” injury.
§ 11(c)(1)(C)(ii).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
off-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit
in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005). Althen requires that
petitioner establish by preponderant evidence that the vaccination he received caused his 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.
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Under the first prong of Althen, 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 & Hum. Servs., 35 F.3d
543, 548 (Fed. Cir. 1994). Proof that the proffered medical theory is reasonable, plausible, or
possible does not satisfy a petitioner’s burden. Boatmon v. Sec’y of Health & Hum. Servs., 941
F.3d 1351, 1359-60 (Fed. Cir. Nov. 7, 2019).
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 & Hum. Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325-26). However, special masters are “entitled to require some indicia
of reliability to support the assertion of the expert witness.” Boatmon, 941 F.3d at 1360, quoting
Moberly, 592 F.3d at 1324. Special Masters, despite their expertise, are not empowered by statute
to conclusively resolve what are complex 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 & Hum.
Servs., 121 Fed. Cl. 230, 245 (2015), vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017);
see also Hock v. Sec’y of Health & Hum. Servs., No. 17-168V, 2020 U.S. Claims LEXIS 2202 at
*52 (Fed. Cl. Spec. Mstr. Sept. 30, 2020).
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 (“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 & Hum. 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”). 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. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011),
aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health & Hum. 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).
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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 & Hum. 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 &
Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012),
aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. 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 parties agree that there are no medical facts in dispute with respect to Petitioner’s
medical records and Petitioner’s timeline of symptoms. Joint Submission at 8, ECF No. 83; see
also Ex. 11 (Petitioner Timeline of Symptoms). Accordingly, Petitioner’s medical records are
presumed to accurate and complete and are afforded substantial weight. Cucuras, 993 F.2d at 1528;
Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed. Cl. 598, 608 (2010); Lowrie v. Sec’y of Health
& Hum. Servs., No. 03-1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005).
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory connecting the vaccine to the injury often
requires a petitioner to present expert testimony in support of her claim. Lampe v. Sec’y of Health
& Hum. 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 & Hum. Servs.,
617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d
1302, 1316 (Fed. Cir. 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 fora. Daubert factors are employed by judges to exclude
evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these
factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health
& Hum. 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”).
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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 & Hum. 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. 136, 146 (1997)). A “special master is entitled to
require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592
F.3d at 1324. 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. Id. at 1325-26 (“[a]ssessments as to the
reliability of expert testimony often turn on credibility determinations”).
D. Consideration of Medical Literature
Although this decision discusses some but not all of the medical literature in detail, I
reviewed and considered all of the medical records and literature submitted in this matter. See
Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally
presume that a special master considered the relevant record evidence even though [s]he does not
explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health & Hum. Servs.,
115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every piece of
evidence or testimony in her decision.’” (citation omitted)), aff’d, 601 F. App’x 982 (Fed. Cir.
2015).
V. Analysis
A. Preponderant Evidence Establishes that Petitioner Suffers from ON
Dr. Vartanian suggests that anti-MOG induced ON is the more appropriate diagnosis in
this case. Tr. at 325. Yet, Dr. Vartanian admits that Petitioner does not fit the clinical profile.
Second Vartanian Rep. at 5.; Tr. at 368-71. He claims that Petitioner has a rare or atypical form of
anti-MOG but did not provide any medical literature in support of his theory. Tr. at 372-73. The
lack of medical literature, he argues, is due to the fact that anti-MOG ON is a relatively new entity
and the medical research is evolving. Id. at 374.
Ultimately, Dr. Vartanian’s criticisms of the vaccine-induced diagnosis come down to a
disagreement concerning Petitioner’s clinical course of treatment: “regardless of the case and its
outcome,” if he were my patient he would be checked repeatedly for aquaporin-4 and anti-MOG
every few months, at least for a year or two. Tr. at 324, 375. The fact that Petitioner has not only
surpassed the two years of testing proposed by Dr. Vartanian without a relapse but has also gone
more than five years now without a relapse is sufficient to persuade me that Petitioner’s condition
was not anti-MOG induced. My finding is based on Dr. Cestari’s testimony that recurrence is the
hallmark of anti-MOG optic neuritis, and on the medical literature submitted by both Dr. Cestari
and Dr. Vartanian. See Cobo-Calvo, et al., MOG antibody-related disorders: common features and
uncommon presentations, 264 J NEUROL 9, 1945-55 (2017) (finding a relapsing course in 44–83%
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of patients more commonly involving the optic nerve) (filed as Ex. D); Jarius, et al., MOG-IgG in
NMO and related disorders: a multicenter study of 50 patients, Part 2: Epidemiology, clinical
presentation, radiological and laboratory features, treatment responses, and long-term outcome,
2016 13 J NEUROINFLAMMATION 279 (2016) (filed as Ex. 38, Supp. Ref. No. 12) (finding that of
the 50 MOG-IgG-positive patients studied, 80% first relapsed within a median of 5 months and
concluding MOG-IgG-related CNS autoimmunity requires consistent treatment and care);
Ramanathan, et al., Antibodies to myelin oligodendrocyte glycoprotein in bilateral and recurrent
optic neuritis, 1 NEUROIMMUNOL NEUROINFLAMM 4, (2014) (MOG antibody–associated BON is
a relapsing disorder that is frequently steroid responsive and often steroid dependent) (filed as Ex.
N).
I have also considered the relative strength of the expert opinions in this case. While Dr.
Vartanian is clearly qualified to opine on the matters before the court, Dr. Cestari is one of
approximately ten neuro-ophthalmology specialists in the United States. He subspecializes in optic
nerve disease and treats patients for these conditions. Because of this expertise, I have given greater
weight to his opinion than to that of Dr. Vartanian.
I will next address each of the Althen prongs in the order of their significance to this case.
B. Althen Prong One
In the context of the Program, “to establish causation, the standard of proof is
preponderance of evidence, not scientific certainty.” Langland v. Sec’y of Health & Human Serv.,
109 Fed. Cl. 421, 441 (2013). Petitioner’s burden under Althen’s first prong is to provide a medical
theory causally connecting the vaccination and the injury. Id. This theory must be sound and
reliable. Boatmon, 941 F.3d at 1359.
Petitioner has alleged an “off-Table” injury, and thus must prove by preponderant evidence
a medical theory causally connecting the flu vaccine to his bilateral optic neuritis. Petitioner
theorizes that the flu vaccine caused his ON by means of molecular mimicry. The theory of
molecular mimicry explains how an infection or vaccine can lead to an autoimmune disease. First
Akbari Rep. at 4. When a foreign antigen and an antigen produced by the body share certain
attributes, such as similar protein peptides or a similar structural architecture, the immune system
can mistakenly attack the self-produced antigen due to its similarities with the foreign “mimic.”
First Akbari Rep. at 5; Tr. at 25, 31. A demyelinating disease is an autoimmune disease that occurs
when the immune system attacks part of the body’s central nervous system. Tr. at 27.
The optic nerve is part of the CNS and is surrounded by a myelin sheath, similar to the
rubber coating around a copper wire. Tr. at 193. The myelin sheath insulates the optic nerve and
ensures that the electric impulses to and from the nerve are transmitted efficiently. Id. When the
myelin sheath is damaged due to an autoimmune disease, it results in a demyelinating disease, i.e.,
optic neuritis. Id. at 21.
At the outset, I note that the Vaccine Program generally recognizes that the flu vaccine is
capable of causing a demyelinating condition. Notably, Guillain-Barré syndrome is recognized as
an “on-Table” injury caused by seasonal influenza vaccines. 42 C.F.R. § 100.3(a)(XIV)(D). With
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respect to “off-Table” injuries, the following cases have held that the flu vaccine caused or
significantly aggravated a CNS demyelinating condition: Hitt v. Sec’y of Health & Hum. Servs.,
No. 15-1283V, 2020 WL 831822 (Fed. Cl. Spec. Mstr. Jan. 24, 2020) (finding the flu vaccine
caused the Petitioner’s MS); Calise v. Sec'y of Health & Hum. Servs., No. 08-865V, 2011 WL
1230155, at *27 (Fed. Cl. Spec. Mstr. March 14, 2011) (finding that the flu vaccine is capable of
breaching the blood-brain barrier and triggering NMO); Brown v. Sec'y of Health & Hum. Servs.,
No. 09-426V, 2011 WL 5029865, at *41 (Fed. Cl. Spec. Mstr. Sept. 30, 2011) (finding the flu
vaccine caused Petitioner's ADEM); Hayes v. Sec'y of Health & Hum. Servs., No. 06-738V, 2010
WL 2985632, at *3 (Fed. Cl. Spec. Mstr. July 12, 2010) (finding that, by the process of molecular
mimicry, the flu vaccine was a substantial cause of Petitioner’s transverse myelitis, ADEM,
bilateral optic neuritis, and developmental delay).
Molecular mimicry is also a well-established theory in the Vaccine Program and has been
persuasively linked to different immune-mediated conditions. See e.g. W.C. v. Sec'y of Health &
Hum. Servs., No. 07-456V, 2011 WL 4537877, at *11 (Fed. Cl. Spec. Mstr. Feb. 22, 2011),
(finding that molecular mimicry is a well-regarded theory in some contexts), mot. for rev. denied,
100 Fed. Cl. 440 (2011), aff'd, 704 F.3d 1352 (Fed. Cir. 2013); H.J. v. Sec’y of Health & Hum.
Servs., No. 011-0301V, 2015 WL 6848357 (Fed. Cl. Spec. Mstr. Nov. 6, 2015) (finding that
Petitioner’s Rheumatoid Arthritis was more likely than not caused by molecular mimicry
following the Tdap vaccine); Day v. Sec’y of Health & Hum. Servs, No. 12-630V, 2016 WL
6237236 (Fed. Cl. Spec. Mstr. Nov. 15, 2015) (finding that Gardasil and flu vaccine led Petitioner
to develop neuromyelitis optica via molecular mimicry); Salmins v. Sec’y of Health & Hum. Servs.,
No. 11–140V, 2014 WL 1569478 (Fed. Cl. Spec. Mstr. Mar. 31, 2014) (finding that HPV vaccine
caused Petitioner to develop GBS via molecular mimicry); Roberts v. Sec’y of Health & Hum.
Servs., No. 09-427V, 2013 WL 5314698 (Fed. Cl. Spec. Mstr. Aug. 29, 2013) (finding that Tdap
vaccine led Petitioner to develop transverse myelitis via molecular mimicry ); Hayes, 2010 WL
2985632, at *3 (finding that, by the process of molecular mimicry, the flu vaccine was a substantial
cause of Petitioner’s transverse myelitis, ADEM, bilateral optic neuritis, and developmental
delay).
Dr. Akbari testified that Petitioner’s first flu vaccination contained components that share
a similar structure or sequence with components of the myelin sheath, and more likely than not,
the flu vaccine triggered an autoimmune response that was capable of penetrating the CNS and
damaging Petitioner’s optic nerve. A central component of Dr. Akbari’s theory is that certain
people may be predisposed to autoimmunity, thus accounting for the low rate of autoimmune
responses following vaccination.
Several studies support Dr. Akbari’s theory in this case. The Wucherpfennig studies
demonstrate that T cells isolated from the blood of patients with multiple sclerosis share a peptide
sequence with the flu virus. Tr. at 51-52. These studies provide an example of molecular mimicry
with influenza strains contained in the same vaccine that Petitioner received. Id. at 52.
The Nachamkin article found that H1N1 vaccines contain structures that can induce anti-
ganglioside antibodies in mice. Tr. at 48-49. Nachamkin provides evidence that the H1N1 vaccine
(a component of which was included in Petitioner’s 2016 flu vaccine) is capable of triggering an
autoimmune response resulting in a demyelinating disease. Id.
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Additionally, the Karussis meta-analysis described nine reported cases of optic neuritis
following flu vaccine. See Ex. 19, Ref. No. 26. While case reports are not robust evidence, they do
constitute some evidence with which petitioners can meet their burden in the Vaccine Program.
See Contreras v. Sec’y of Health & Hum. Servs., 107 Fed. C. 280 (Fed. Cl. 2012); see also
Capizzano 440 F.3d at 1325-26.
Dr. Vartanian’s discussion of epidemiologic studies, animal models and identification of
specific peptide structure/sequences and molecular mimics before attributing causality to the flu
vaccine is contrary to Vaccine Program case law. Petitioners are not required to identify “specific
biological mechanisms” to establish causation, nor are they required to present “epidemiologic
studies, rechallenge, the presence of pathological markers or genetic disposition, or general
acceptance in the scientific or medical communities.” Capizzano, 440 F.3d at 1325 (quoting
Althen, 418 F.3d at 1280). It is not Petitioner’s burden to prove his theory with this level of
specificity. Knudsen, 35 F.3d at 549.
In evaluating the evidence that has been presented, I find that Dr. Akbari has provided a
sound and reliable medical theory demonstrating that the flu vaccine can cause bilateral optic
neuritis. Accordingly, I find that Petitioner has carried his burden of proof with respect to the first
Althen prong.
B. Althen Prong Three
Under Althen prong three, a petitioner must establish the “timeframe for which it is medically
acceptable to infer causation,” and he must demonstrate that the onset of his disease occurred
within that timeframe. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed. Cl. 532, 542-43 (2011),
recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012), aff’d without op., 503 F.
App’x 952 (Fed. Cir. 2013). Petitioner received the flu vaccine on October 11, 2016. On October
23, 2016, Petitioner first reported symptoms of ON, 12 days following his vaccination. Both sides
agree that Petitioner experienced his first clinical sign of ON on this date. Joint Submission at 8,
ECF No. 83; see also Ex. 11 (Petitioner Timeline of Symptoms).
Dr. Schatz testified that the onset of Petitioner’s disease 12 days after his flu vaccination
is a medically acceptable temporal interval and consistent with the theory of molecular mimicry.
Tr. at 143-44. Dr. Akbari explained that after immunization, it takes three to five days for the
antigen to get picked up by an antigen-presenting cell. Tr. at 97. Any adverse immune reaction
would generally begin around day five, peaking around days seven to ten. Id. Both Dr. Akbari and
Dr. Cestari provided evidence demonstrating that two to three weeks was the average timeframe
for the onset of ON following a flu vaccination. Dr. Akbari cited Karussis in which the meta-data
reflected the onset of ON following the flu vaccination occurred at an average of two to three
weeks. Id. at 54. Dr. Cestari discussed the Stübgen and Hull articles evidencing a two to three-
week temporal relationship. First Cestari Rep. at 14-15.
Petitioner also cited to Shindler in support of the third Althen prong. See Shindler, et al.,
Retinal ganglion cell loss induced by acute optic neuritis in a relapsing model of multiple sclerosis,
12 MULTIPLE SCLEROSIS 526-32 (2006) (filed as Ex. 43, Ref. No. 23) (hereinafter “Shindler”). In
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this study, the authors examined the relationship between inflammation and retinal ganglion cell
loss during acute optic neuritis. Shindler at 526. During the course of the study, the authors found
that “No optic neuritis was detected prior to day 9 following immunization. Incidence of optic
neuritis was 30% at day 9 and increased to over 70% by day 11, remaining high through day 18.”
Id. Although the mice in this study were immunized with proteolipid protein peptide 139_151 and
not the flu vaccine, this study does provide some support for Petitioner’s contention that the onset
of ON 12 days after vaccination was medically appropriate.
I also note that Dr. Vartanian testified he did not dispute any of the expert reports with
respect to the concept that 12-14 days “fits within our temporal understanding of when T cell and
antibody responses are generated.” Tr. at 356.
Based on the existing medical literature and expert testimony, I find that onset of ON 12
days after flu vaccination is an acceptable timeframe in which to infer causation. I further find that
Petitioner has established the onset of his symptoms occurred within that timeframe. Petitioner has
satisfied the third Althen prong.
C. Althen Prong Two
Under Althen’s second prong, a petitioner must “prove a logical sequence of cause and
effect showing that the vaccination was the reason for the injury.” Althen, 418 F.3d at 1278.
The fact that Petitioner has already established Althen prongs one and three bolsters his
ability to establish that the flu vaccination was in fact the cause of his condition. “Medical
opinions that explain how a vaccine can cause the injury alleged coupled with evidence
demonstrating a close temporal relationship “are quite probative” in proving actual causation.
Capizzano, 440 F.3d at 1358; see also Contreras, 107 Fed. Cl. at 295 (finding that there is a
“logical overlap between the three Althen prongs, and evidence that goes towards proving one
prong may also be probative for another”).
1. Petitioner’s Treating Physician
Dr. Schatz’s explained the exhaustive testing and treatment that Petitioner had undergone
prior to receiving the diagnosis of vaccine-induced ON. Schatz Rep. at 2. In addition to ruling out
all other possible etiologies for bilateral optic neuritis, she highlighted the importance of this being
Petitioner’s first flu vaccination. Id. at 5. “Some would suggest that [Petitioner] had simply
idiopathic optic neuritis, a diagnosis used when there is no other cause definitely found when a
patient presents with his first episode. However, [Petitioner] did have another probable etiology -
his first influenza vaccination two weeks prior to vision loss.” Id. Because she is Petitioner’s
treating physician, I find Dr. Schatz’s opinion to be especially probative. In weighing the evidence
in Vaccine Program cases, the opinions of treating physicians are favored “as they 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.” Althen, 418 F.3d at 1280.
Dr. Schatz’s diagnosis is supported by both Dr. Cestari and Dr. Turner. It is Dr. Cestari’s
opinion that, “Given the extensive negative work-up, the biologically plausible theory of how a
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vaccine can induce optic neuritis and the temporal relationship of the onset of visual symptoms 12
to 14 days following receiving the influenza vaccination, the only possible explanation for
Petitioner’s signs and symptoms is a post vaccination optic neuritis.” Id.
I find Dr. Schatz’s assessment of Petitioner’s condition to be reasonable and persuasive. I
find that the flu vaccine, more likely than not, did cause Petitioner’s ON. Thus, Petitioner has
satisfied the second Althen prong.
VI. Conclusion
Upon careful evaluation of all the evidence submitted in this matter, including the medical
records, the testimony, as well as the experts’ opinions and medical literature, I conclude that
Petitioner has met his burden of proof under Althen. Accordingly, Petitioner is entitled to
compensation. An order regarding damages will issue shortly.
IT IS SO ORDERED.
s/ Katherine E. Oler
Katherine E. Oler
Special Master
25

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DOCUMENT 2: USCOURTS-cofc-1_17-vv-01257-2
Date issued/filed: 2022-06-27
Pages: 11
Docket text: PUBLIC ORDER/RULING (Originally filed: 4/20/2022) regarding 190 CONCLUSIONS OF LAW regarding 185 Petitioner's Motion. Signed by Special Master Katherine E. Oler. (sl) Service on parties made.
--------------------------------------------------------------------------------
Case 1:17-vv-01257-UNJ Document 206 Filed 06/27/22 Page 1 of 11
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1257V
* * * * * * * * * * * * * * * * * * * * * * * * * *
*
*
GLENN REINHARDT
*
*
Petitioner, * Special Master Katherine E. Oler
*
*
v. Filed: April 20, 2022
*
*
SECRETARY OF HEALTH AND * Motion to Strike; Judiciary Estoppel;
HUMAN SERVICES, * Issue Preclusion; Judicial Notice
*
*
Respondent *
*
* * * * * * * * * * * * * * * * * * * * * * * * * *
OPINION AND ORDER REGARDING PETITIONER’S MOTION TO STRIKE1
On March 4, 2022, Petitioner filed a Motion entitled “Petitioner’s Motion to Strike Report
of Dr. Lee/Request for Judicial Notice and/or Declaratory Judgment on Issue of Legal/Statutory
Blindness and Vocational Rehabilitation (VR).” Petr’s Mot. to Strike, ECF No. 180 (hereinafter
“Petr’s Mot.”). Petitioner requests the following relief in his Motion:
1. That the Court “preclude the Government’s litigation of legal blindness by estoppel
and strike all aspects of Dr. Lee’s report that call into question an already adjudicated
disability”;
2. That the Court “reject opinions of Dr. Lee that fall under the expertise of an OT and/[or]
vocational rehabilitation expert”;
3. That the Court “preclude the Government’s claim via [Respondent’s vocational expert]
that [Petitioner] is a candidate for [vocational rehabilitation] by estoppel”;
1 Because this unpublished Decision contains a reasoned explanation for the action in this case, I intend to
post this Decision on the United States Court of Federal Claims’ website, in accordance with the E-
Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44
U.S.C. § 3501 note (2012)). This means the Decision 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 Decision’s
inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party
has fourteen 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 Decision in its present form will be available. Id.
1

Case 1:17-vv-01257-UNJ Document 206 Filed 06/27/22 Page 2 of 11
4. That the Court “take judicial notice of the prior adjudication of [Petitioner’s] statutory
blindness and judicial notice that [Petitioner] is not a candidate for [vocational
rehabilitation]”; and
5. To the extent that the Court “can issue a declaratory judgment” on the requested judicial
notice, that the Court do so.
Petr’s Mot. at 11. For the reasons discussed in this decision, Petitioner’s Motion is DENIED.
I. Procedural History
Petitioner filed his Motion on March 4, 2022. ECF No. 180.
I held a status conference in this case on March 8, 2022. See Scheduling Order of March
16, 2022, ECF No. 188. I addressed Petitioner’s instant motion regarding judicial estoppel and
judicial notice. Id. at 2. I informed the parties that I would like them to brief this issue and stated
that I would then issue a ruling on Petitioner’s motion. Id.
On March 16, 2022, Respondent filed his response. ECF No. 180 (hereinafter “Respt’s
Resp.”). Petitioner filed his reply on March 23, 2022. ECF No. 189 (hereinafter “Petr’s Reply”).
II. Parties’ Arguments
A. Issue Preclusion/Judicial Estoppel
In his Motion, Petitioner notes that there is a “general policy that the Government should
not be precluded from litigating issues of public importance which may have been decided in an
earlier action between private parties.” Petr’s Mot. at 6, citing United States v. Mendoza, 464 U.S.
154 (1984). However, Petitioner argues that the rule against applying the principles of issue
preclusion against the Government is “not absolute.” Id., citing United States v. Stauffer Chem.
Co., 464 U.S. 165 (1984) (holding that defensive use of issue preclusion against the Government
is available to a party which prevailed against the Government in a prior action).
Petitioner notes that in Montana v. United States, 440 U.S. 147 (1979), the federal
government was bound by a state court decision ruling against the State of Montana in a tax dispute
because the same issue had already been litigated before the state court. Petr’s Mot. at 7. Petitioner
argues that similarly, because the Social Security Administration has already found Mr. Reinhardt
to be statutorily blind, the Department of Health and Human Services is precluded from arguing
otherwise. Id. Petitioner argues that the “fact that there are two separate federal agencies
involved…makes no difference. Both agencies are part of the Government.” Id. (emphasis in
original). Petitioner did not cite any case law to support the proposition that sister agencies of the
federal government are bound by each other’s decisions.
In his Response, Respondent notes that under the doctrine of judicial estoppel, “where a
party successfully urges a particular position in a legal proceeding, it is estopped from taking a
contrary position in a subsequent proceeding where its interests have changed.” Respt’s Resp. at
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4. R.F. v. Sec’y of Health & Hum. Servs., No. 08-504V, 2015 WL 1396357 at *5 (Fed. Cl. Spec.
Mstr. Mar. 6, 2015). He notes that “the doctrine is intended to protect the integrity of the judicial
system rather than the individual parties to a case, and its application is left to a court’s discretion.
Id, citing R.F., 2015 WL 11396357 at *5. Respondent further notes that as a threshold matter,
judicial estoppel requires a final decision “on the merits.” Id. at 5, citing R.K. v. Sec’y of Health &
Hum. Servs., No. 03-0632V at *27 (Fed Cl. Spec. Mstr. Sept 28, 2015).
Respondent argues that the Social Security Administration is a “distinct agency” and its
positions cannot be imputed to the Secretary. Respt’s Resp. at 5, citing Perrin v. Sec’y of Health
& Hum. Servs., No. 99-562V, 2004 U.S. Claims LEXIS 328 at *6 (Fed. Cl. Spec. Mstr. Nov. 22,
2004) (“decisions of Social Security ALJ’s are not binding on the special masters or judges of this
federal court”). Respondent argues that the SSA and HHS are not interchangeable as parties to
litigation. Respt’s Resp. at 5. Respondent also argues that he is “not aware of any judicial action
with respect to petitioner’s arguments, nor any final decision on the merits,” and accordingly
judicial estoppel does not apply in this instance. Id.
In Petitioner’s Reply, he argues that Respondent’s reliance on Perrin is misplaced. Petr’s
Reply at 5. Petitioner argues that in Perrin, the central question was causation, not damages. Id.
Petitioner argues that the issue here is that the Social Security Administration (“SSA”) has “already
made a disability determination based on SSA standards that [Petitioner] was legally/statutorily
blind” and the Respondent is estopped from “challenging Petitioner’s classifications under the
SSA’s own delineated medical standards.” Id.
Finally, Petitioner argues that because the SSA did not deem Petitioner eligible for
vocational rehabilitation, Respondent’s vocational expert should be estopped from opining that
Petitioner is a candidate for vocational rehabilitation. Petr’s Mot. at 11.
In his response, Respondent states that he “reasonably disputes that Petitioner “is not a
candidate” for Vocational Rehabilitation (“VR”). Respt’s Resp. at 6. Respondent argues that
“whether petitioner is a candidate for VR for the purpose of receiving SSDI benefits is a piece of
evidence that can be considered by the court, but it is not the same as determining whether
petitioner would benefit from VR for the purpose of a lost wage claim in the Vaccine Program.”
Id. at 6-7. Respondent also notes that “even petitioner’s vocational expert has suggested that
Petitioner seek out vocational rehabilitation.” Id. at 7.
B. Judicial Notice
Petitioner further argues that it is within the Court’s power to take judicial notice of the
fact that Petitioner is legally blind and requests that I issue a declaratory judgment or something
similar to that effect. Petr’s Mot. at 11.
Respondent notes that “although the Federal Rules of Evidence do not apply in the Vaccine
Program, FRE 201(b) provides: The court may judicially notice a fact that is not subject to
reasonable dispute because it: (1) is generally known within the trial court’s territorial jurisdiction;
or (2) can be accurately and readily determined from sources whose accuracy cannot reasonably
questioned.” Respt’s Resp. at 6, citing Fed. R. Evid. 201. Respondent states that he “reasonably
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disputes” that “every doctor would agree that petitioner meets the definition of ‘statutory
blindness’” and that he “reasonably disputes that Petitioner “is not a candidate” for Vocational
Rehabilitation. Id. Accordingly, Respondent argues, judicial notice of Petitioner’s blindness is not
appropriate in this case. Id.
In his reply, Petitioner notes that he is requesting the Court to “recognize that [Petitioner]
is statutorily/legally blind under the SSA definition i.e. the widest diameter of [Petitioner’s] visual
field subtends an angle no greater than 20 degrees.” Petr’s Reply at 7. Petitioner states that “his
fear is that without a baseline determination from the Court on this issue, the [hearing] will delve
into a fruitless argument….” Id.
C. Motion to Strike Dr. Lee’s Expert Report
Petitioner urges me to “apply Daubert principles in excluding any opinions of Dr. Lee on
[Petitioner’s] ability to perform Activities of Daily Living (ADLs) or return to work in certain
occupations.” Petr’s Mot. at 10. Petitioner argues that Dr. Lee’s opinions, “as adopted and
expanded upon by Mr. Leslie and HHS, violate principles of issue preclusion and judicial
estoppel.” Id.
In his Response, Respondent agrees with Petitioner that “In the Vaccine Program, scientific
evidence is evaluated for reliability using the test set forth in Daubert v. Merrell Dow
Pharmaceuticals, 509 U.S. 579 (1993). Respt’s Resp. at 2, citing Terran v. Sec’y of Health & Hum.
Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999), cert. denied, 531 U.S. 812 (2000). However,
Respondent notes that application of the Daubert test in the Vaccine Program is “procedurally
different from its use in jury proceedings where there is stricter adherence to the Federal Rules of
Evidence.” Id. at 2. Respondent argues that the principle of Daubert is to “prevent scientifically
unsound evidence from being presented to the jury,” and in the Vaccine Program, the lack of a
jury reduces the need for a strict application of the Daubert test. Citing Veryzer v. Sec’y of Health
& Hum. Servs., Respondent argues that “there are two different, reasonable procedures that can be
applied in a non-jury setting to test scientific testimony for reliability. One method is for the
factfinder to exclude unreliable testimony prior to any sort of hearing. Alternatively, the factfinder
could consider the evidence and subsequently apply the reliability test to determine whether to
afford the evidence any weight. The choice to follow either of these approaches is completely
within the special master’s discretion.” No. 06-522V, 2010 U.S. Claims LEXIS 375, at *73 (Fed.
Cl. Spec. Mstr. June 15, 2010) (finding that a special master may exclude unreliable evidence, or
admit the evidence and “afford it but trifling probative weight”).
Respondent further argues that Dr. Lee’s conclusions are “extremely limited” and do not
fall under the purview of a different expert. Respt’s Resp. at 3. Respondent states that Dr. Lee’s
conclusions (e.g., Petitioner’s driving ability) are not out of the scope of his expertise and in fact,
“neither of the vocational experts in this case are qualified to interpret the visual testing in this
way.” Id. at 4. Respondent therefore argues that Dr. Lee’s report is “probative, and no part should
be stricken.” Id.
In his reply, Petitioner argues that Dr. Lee is opining on subject matter outside his expertise.
Petr’s Reply at 4. Petitioner urges me to consider only those opinions from Dr. Lee that he is
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qualified to give and to “be wary of allowing Dr. Lee to wade into areas that require the expertise
of an occupational and vocational therapist.” Id. at 5, 7.
III. Law Governing Judicial Estoppel and Judicial Notice in the Federal Circuit
A. Judicial Estoppel in the Federal Circuit
Under the doctrine of judicial estoppel, “where a party successfully urges a particular
position in a legal proceeding, it is estopped from taking a contrary position in a subsequent
proceeding where its interests have changed.” Cuyahoga Metropolitan Housing Auth. v. United
States, 65 Fed. Cl. 534, 554 (Fed. Cl. 2005), quoting Data Gen. Corp. v. Johnson, 78 F.3d 1556,
1565 (Fed. Cir. 1996); see also Davis v. Wakelee, 156 U.S. 680, 689 (1895); New Hampshire v.
Maine, 532 U.S. 742, 751 (2001); see further Pegram v. Herdich, 530 U.S. 211 (2000). The Court
of Federal Claims has identified three “necessary elements” to be considered when determining
whether application of judicial estoppel is appropriate: (1) whether a party's later position is
inconsistent with its earlier position; (2) whether a party had successfully persuaded a court to
accept the earlier position, such that judicial acceptance of the inconsistent position would suggest
that one of the courts had been misled; and (3) whether the party asserting the inconsistent position
would be unfairly advantaged (or the other party unfairly prejudiced) unless estopped. Moreland
Corp. v. United States, 76 Fed. Cl. 268, 294 (2007), citing Cuyahoga Metropolitan Housing Auth.,
65 Fed. Cl. at 554). Ultimately, the doctrine is intended to protect the integrity of the judicial
system rather than the individual parties to a case, and its application is left to a court's discretion.
Data Gen. Corp., 78 F.3d at 1565; Cuyahoga Metropolitan Housing Auth., 65 Fed. Cl. at 554.
The doctrine of judicial estoppel is intended to prevent a litigant from “‘playing fast and
loose with the courts,’ by assuming contrary positions in legal proceedings,” Def. Tech., Inc. v.
United States, 99 Fed. Cl. 103, 127 (2011); see also Housing Auth. of Slidell v. United States, 149
Fed. Cl. 614, 643 (2020), and applies “just as much when one of the tribunals is an administrative
agency.” Trustees in Bankr. of N. Am. Rubber Thread Co., Inc. v. United States, 593 F.3d 1346,
1354 (Fed. Cir. 2010); see also City of Wilmington v. United States, 152 Fed. Cl. 373 (Fed. Cl.
2021). Only when the statements made in the earlier proceeding involve the “truth-seeking
function of the court” (or administrative tribunal) does judicial estoppel apply. Egenera, Inc., 972
F.3d at 1379-80 (citation omitted). Judicial estoppel only applies to legal proceedings that are
adjudicatory in nature. City of Wilmington, 152 Fed. Cl. at 379 (omitting internal citations).
i. Effect of Social Security Disability Decisions on the Vaccine Program
In the Court of Federal Claims, “[d]ecisions of Social Security Administrative Law Judges
are not binding on the special masters or judges of this federal court.” See Gardner-Cook v. Sec’y
of Health & Hum. Servs., No. 99-884V, 2003 U.S. Claims LEXIS 396 at *11 (Fed. Cl. 2003)
(unpub.). Furthermore, decisions of Social Security ALJs regarding whether the petitioner is
"disabled" under the Social Security Act are appealed to the federal district courts. Judge Horn
noted that “[a]lthough this court certainly gives due regard, and often deference, to the decisions
issued by federal District Court judges, those decisions are not binding on judges of this court.”
See UMC Electronics Co. v. United States, 816 F.2d 647, 652 n.6 (Fed. Cir. 1987), citing South
Corp. v. United States, 690 F.2d 1368, 1371 (Fed. Cir. 1982), cert. denied, 484 U.S. 1025 (1988).
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As noted, the doctrines of res judicata and collateral estoppel operate to prevent the re-
litigation of claims and issues that have already had their day in court. Gardner-Cook, 2003 U.S.
LEXIS 396 at *19, see also Cuyahoga Metropolitan Housing Auth., 65 Fed. Cl. at 554. “The issues
in the two forums, stemming from different statutes with different purposes, and providing
exclusive jurisdiction in different forums, do not operate to foreclose a properly tailored inquiry in
the other forum.” Gardner-Cook, 2003 U.S. LEXIS 396 at *19. Given the different inquiries, “it
is not inconsistent for [a] petitioner to receive Social Security disability benefits, but no benefits
under the Vaccine Compensation Program….” Id.
B. Judicial Notice in the Federal Circuit
Under Federal Rule of Evidence 201(b), “The court may judicially notice a fact that is not
subject to reasonable dispute because it: (1) is generally known within the trial court's territorial
jurisdiction; or (2) can be accurately and readily determined from sources whose accuracy cannot
reasonably be questioned.” Fed. R. Evid. 201(b). “A courts' power to take judicial notice ‘is to be
exercised . . . with caution,’ that ‘[c]are must be taken that the requisite notoriety exists,’ and that
[e]very reasonable doubt upon the subject should be resolved promptly in the negative.’” Oliver v.
Sec’y of Health & Hum. Servs., 900 F.3d 1357, 1363 n.5 (Fed. Cir. 2018), quoting Brown v. Piper,
91 U.S. 37 (1875).
The Vaccine Act states that the procedural rules to be applied by special masters shall
"provide for a less-adversarial, expeditious, and informal proceeding for the resolution of
petitions," and specifically that they shall "include flexible and informal standards of admissibility
of evidence." See Hines on behalf of Servier v. Sec’y of Health & Hum. Servs., 940 F.2d 1518,
1525 (Fed. Cir. 1991), citing 42 U.S.C. § 300aa-12(d)(2)(A), (B). The Federal Circuit has
interpreted this provision to mean that “the Federal Rules of Evidence need not be followed in
proceedings under the Act.” Hines, 940 F.2d at 1525. Under the authority granted by 28 U.S.C. §
2071 (1988) and 42 U.S.C. § 300aa-12(d)(2), the Court of Federal Claims has promulgated rules
of procedure for use by special masters in vaccine cases. Id. Rule 8(b) states: "In receiving
evidence, the special master will not be bound by common law or statutory rules of evidence. The
special master will consider all relevant, reliable evidence, governed by principles of fundamental
fairness to both parties." Hines, 940 F.2d at 1525-26, citing Rule 8(b), Vaccine Rules of the Office
of Special Masters (Appendix J to the RUSCC).
Well-known medical facts are the types of matters of which judicial notice may be taken.
Compare Franklin Life Ins. Co. v. William J. Champion & Co., 350 F.2d 115, 130 (6th Cir. 1965),
cert. denied, 384 U.S. 928 (1966) (taking judicial notice of the fact that cancer does not manifest
itself quickly), with Hardy v. Johns-Manville Sales Corp., 681 F.2d 334, 347-48 (5th Cir. 1982)
("The proposition that asbestos causes cancer, because it is inextricably linked to a host of disputed
issues . . . is not at present so self-evident a proposition as to be subject to judicial notice."); see
also Hines, 940 F.2d at 1526.
IV. Analysis
A. Respondent is not Estopped from Presenting Evidence Regarding Petitioner’s
Visual Limitations
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i. Petitioner’s Social Security Application is not a Final Adjudication
on the Merits
In his Motion, Petitioner asserts that, because the SSA has already determined that
Petitioner is “legally/statutorily blind”, Respondent is estopped from presenting evidence from Dr.
Lee regarding Mr. Reinhardt’s visual limitations, namely, that Petitioner’s visual field does not
subtend an angle greater than 20 degrees. Petr’s Mot. at 11, see also Petr’s Reply at 6.
Respondent argues that the Social Security Administration is a “distinct agency” and its
positions cannot be imputed to the Secretary. Respt’s Resp. at 5, citing Perrin v. Sec’y of Health
& Hum. Servs., (“decisions of Social Security ALJ’s [sic] are not binding on the special masters
or judges of this federal court”). Respondent argues that the SSA and HHS are not interchangeable
as parties to litigation. Respt’s Rep. at 5. Respondent also argues that he is “not aware of any
judicial action with respect to petitioner’s arguments, nor any final decision on the merits,” and
accordingly judicial estoppel does not apply in this instance. Id. Petitioner counters this point by
noting that both Perrim and Gardner-Webb speak to causation, not damages.
I find Respondent’s position to be persuasive in this case. As a threshold manner, in order
to consider judicial estoppel, the previous action must have resolved with a final judgment on the
merits of a case. Only when the statements made in the earlier proceeding involve the “truth-
seeking function of the court” (or administrative tribunal) does judicial estoppel apply. Egenera,
Inc., 972 F.3d at 1379-80 (citation omitted). Judicial estoppel only applies to legal proceedings
that are adjudicatory in nature. City of Wilmington, 152 Fed. Cl. at 379 (omitting internal citations).
In order to apply for benefits from the SSA, a person must complete an application. See
https://www.ssa.gov/applyfordisability/. Following an application, the SSA will review and
process an application, then inform an applicant of a decision regarding eligibility. Id. If an
applicant’s request is denied, he may appeal the decision. See https://www.ssa.gov/benefit
s/disability/appeal.html. There are four levels of appeal: reconsideration, hearing by an
administrative law judge, review by an appeals court, and federal court review. Id.
In this case, Petitioner received SSDI benefits following his initial application to the SSA.
See Ex. 83, Benefits Planning Query. No appeal appears to have been undertaken. Petitioner has
filed no record of an appeal into the record.
Similar to Mohamed v. Marriott Int’l, here, the determination that Petitioner was eligible
for SSDI benefits was made pursuant to a paper application, without a formal hearing. 944 F. Supp.
277, 283-84 (S.D.N.Y. 1996). Petitioner was required to complete an application and provide a
medical certification that he was blind. Because blindness is a “listed disability”, SSA did not
inquire further into Petitioner’s capacity to work. See 20 CFR § 404.1520(d) (“If you have an
impairment(s) which meets the duration requirement and is listed in appendix 1 or is equal to a
listed impairment(s), we will find you disabled without considering your age, education, and work
experience.”); see also 20 CFR Part 404, Subpart P, App. I (last revised June 3, 2022). “The case
for application of the [judicial estoppel] doctrine is clearly strongest when the forum and its
procedures permit a judgment on the merits after the orderly presentation of evidence in adversarial
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litigation.” See Mohamed, 944 F. Supp at 283: Compare Cheatwood v. Roanoke Indus., 891 F.
Supp. 1528, 1534-38 (N.D. Ala. 1995) (applying estoppel where prior workers compensation
determination involved hearing with live sworn testimony by plaintiff) with Swineford v. Snyder
County, 15 F.3d 1258, 1268-69 (3d Cir. 1994) (declining to give preclusive effect to
unemployment compensation board finding in subsequent civil rights litigation, because, inter
alia, of the board's informal mechanisms of eligibility determination) and Dockery v. North Shore
Medical Ctr., 909 F. Supp. 1550, 1557 (S.D. Fa. 1995) (declining to apply collateral estoppel
where prior administrative procedure involved only filling out of application).
Here, there was no adversarial litigation involved in Petitioner’s SSDI application, and
Petitioner has filed no evidence of such litigation. Only when the statements made in the earlier
proceeding involve the “truth-seeking function of the court” (or administrative tribunal) does
judicial estoppel apply. Egenera, Inc., 972 F.3d at 1379-80 (citation omitted). Because Petitioner’s
SSDI claim was not adjudicated on the merits, I find that the doctrine of judicial estoppel does not
apply in this case.
Although I do not believe that the SSA’s grant of Petitioner’s SSDI application is a “final
adjudication on the merits”, for sake of completion, I have addressed Petitioner’s other points as
well.
ii. Decisions of the Social Security Administration are not Binding on
Respondent or the Office of Special Masters
Petitioner argues that because the SSA and HHS are sister agencies of the federal
government, positions taken by the SSA preclude HHS from taking a different position.
In Petitioner’s Reply, he argues that Respondent’s reliance on Perrin is misplaced. Petr’s
Reply at 5. Petitioner argues that in Perrin, the central question was causation, not damages. Id.
Petitioner argues that the central question here is that the SSA has “already made a disability
determination based on SSA standards that [Petitioner] was legally/statutorily blind” and the
Respondent is estopped from “challenging Petitioner’s classifications under the SSA’s own
delineated medical standards.” Id.
I find Petitioner’s position unpersuasive. Although it is true that both Perrin and Gardner-
Cook consider the causation aspect of the Vaccine Program, Judge Horn’s reasoning in Gardner-
Cook is applicable to damages as well. Perrin, 2004 U.S. Claims LEXIS 328; Gardner-Cook,
2003 U.S. Claims LEXIS 396. In particular, Judge Horn notes that “[t]he issues in the two forums,
stemming from different statutes with different purposes, and providing exclusive jurisdiction in
different forums, do not operate to foreclose a properly tailored inquiry in the other forum.”
Gardner-Cook, 2003 U.S. Claims LEXIS 396 at *18. When inquiring into an applicant’s condition,
the SSA does not inquire into the extent of a disability, only into whether one exists. See generally
CFR 20 § 404.1520. If an applicant suffers from a listed disability, the SSA does not inquire
whether the applicant can return to the workforce. See CFR 20 §§ 404.1520(a)(4)(i) – (v); see also
CFR 20 § 404.1520(d). Contrary to the SSA’s inquiry, I must determine the extent of Petitioner’s
injury to determine an award of damages under the Vaccine Program, not under the Social Security
Act.
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Furthermore, the SSA has promulgated guidance stating that decisions by other
governmental agencies and nongovernmental entities are not binding on the SSA. See CFR 20 §
404.1504 (stating, in part: “Other governmental agencies and nongovernmental entities…make
disability, blindness, employability, Medicaid, workers' compensation, and other benefits
decisions for their own programs using their own rules. Because a decision by any other
governmental agency or a nongovernmental entity about whether you are disabled, blind,
employable, or entitled to any benefits is based on its rules, it is not binding on us and is not
our decision about whether you are disabled or blind under our rules.”) (emphasis added). It
therefore stands to reason that decisions by the SSA are likewise not binding on Respondent or
this court. See generally Gardner-Cook, 2003 U.S. Claims LEXIS 396, see also Washington v
Ameritech Sickness & Accident Disability Benefit Plan, 66 Fed. Appx. 656 (7th Cir. 2003) (finding
SSA determinations not binding on EIRSA plans); Combs v. Reliance Std. Life Ins. Co., No. 2:08-
cv-102, 2009 U.S. Dist. LEXIS 82602 (S.D. Ohio 2009) (finding SSA determination not binding
on defendant insurance company for purposes of disability eligibility); see further Fields v. Wilkie,
No. 20-5197, 2020 U.S. App. Vet. Claims LEXIS 2361 (App. Ct. Va. Claims December 30, 2020)
(finding that SSA determinations are not binding upon the Department of Veterans Affairs).
I also note that Petitioner’s proposed relief would frustrate the purpose of the Vaccine
Program. In essence, Petitioner requests that judicial estoppel be invoked to avoid the presentation
of any evidence contrary to the SSA’s grant of Petitioner’s disability application. The Vaccine
Program is not governed by the Federal Rules of Evidence. See RCFC App. B, Rule 8 (b)(1) (“In
receiving evidence, the special master will not be bound by common law or statutory rules of
evidence but must consider all relevant and reliable evidence governed by principles of
fundamental fairness to both parties.”). Principles of fairness require “flexible and informal
standards of admissibility of evidence.” 42 US.C. §§ 300aa-12(d)(2)(B). To grant Petitioner’s
motion would mean that I am limited to only considering the opinion of the SSA-affiliated doctor
who deemed Petitioner disabled. Such an interpretation would prevent me from effectively
assessing damages in this case.
Respondent’s experts are well-qualified, as evidenced by their CVs that have been filed
into the record. See, e.g., Ex. EE, CV of Dr. Lee. Petitioner has not demonstrated that Dr. Lee’s
report is “so unreliable, it forfeits every trace of being helpful.” Veryzer, 2010 U.S. Claims LEXIS
375 at *69 - *70. Their testimony will be helpful to me, the factfinder, in appropriately determining
the extent of Petitioner’s injury and the appropriate award of damages. To not consider
Respondent’s expert testimony would be a violation of the principles upon which the Vaccine
Program is based. RCFC App. B, Rule 8 (b)(1).
iii. Consideration of Dr. Lee’s Expert Opinion
Petitioner requests that the Court “reject opinions of Dr. Lee that fall under the expertise
of an OT and/[or] vocational rehabilitation expert.” Petr’s Mot. at 11. Petitioner urges me to “apply
Daubert principles in excluding any opinions of Dr. Lee on [Petitioner’s] ability to perform
Activities of Daily Living (ADLs) or return to work in certain occupations.” Petr’s Mot. at 10.
Petitioner argues that Dr. Lee’s opinions, “as adopted and expanded upon by Mr. Leslie and HHS,
violate principles of issue preclusion and judicial estoppel.” Id.
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Petitioner’s position is unpersuasive. While it is true that in the Vaccine Program,
“scientific evidence is evaluated for reliability using the test set forth in Daubert v. Merrell Dow
Pharmaceuticals,” application of the Daubert test in the Vaccine Program is “procedurally
different from its use in jury proceedings where there is stricter adherence to the Federal Rules of
Evidence. Terran v. Sec’y of Health and Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999), cert.
denied, 531 U.S. 812 (2000), citing Daubert, 509 U.S. 579 (1993).
In determining whether a particular expert's testimony was reliable or credible, I may
consider whether the expert is offering an opinion that exceeds the expert's training or competence.
Walton v. Sec'y of Health & Hum. Servs., No. 04-503V, 2007 U.S. Claims LEXIS 150, at *17-18
(Fed. Cl. Spec. Mstr. Apr. 30, 2007) (otolaryngologist not well suited to testify about disciplines
other than her own specialty). While hearing testimony from an expert, I may properly evaluate,
and give appropriate weight to, whether certain testimony is beyond a particular expert's purview.
See e.g., King v. Sec'y of Health & Hum. Servs., No. 03-584V, 2010 U.S. Claims LEXIS 87, at
*78-79 (Fed. Cl. Spec. Mstr. Mar. 12, 2010) (petitioner's expert far less qualified to offer opinion
on general causation issues pertaining to autism than specific issues pertaining to the petitioner's
actual medical history, given the nature of the expert's qualifications). An opinion “does not obtain
legitimacy in the Program simply because it comes out of the mouth of a medical doctor —
especially if that opinion concerns matters outside the doctor's expertise.” Murphy v. Sec’y of
Health & Hum. Servs., No. 05-1063V, 2016 U.S. Claims LEXIS 677 at *108-*109 (Fed. Cl. Spec.
Mstr. Apr. 25, 2016).
Accordingly, I am tasked with determining the relative weight to afford opinions from
experts – be they from Petitioner or Respondent. In the Vaccine Program, Daubert serves not so
much as a bar to expert testimony, but rather as a guiding tool to assess the weight I should grant
an expert’s opinion. See Garcia v. Sec’y of Health & Hum. Servs., No. 05-0720V, 2010 U.S.
Claims LEXIS 390 at *26 (Fed. Cl. Spec. Mstr. May 19, 2010) (“As a rule, [Special Masters] are
supposed to state their analysis of expert testimony, including their analysis regarding its
reliability. When the Court checks the expert's opinion against the medical records (and/or fact
witness affidavits) in the ‘did it’ phase of causation analysis, or compares the expert's theory to the
medical literature filed in the case, that is to determine the level, if any, of reliability in that expert's
proffered opinion. It is to establish the reliability to see if the Court may afford it sufficient weight
to a preponderance.”). Accordingly, I will assess the relative weight that I afford to Dr. Lee’s
opinion (as I will with the other experts in this case). I decline to conduct that analysis at this point
in time, before I have heard his testimony.
iv. Judicial Notice of Petitioner’s Disability and Eligibility for Vocational
Rehabilitation
Petitioner requests that the Court “take judicial notice of the prior adjudication of
[Petitioner’s] statutory blindness and judicial notice that [Petitioner] is not a candidate for
[vocational rehabilitation].” Petr’s Mot. at 11.
The taking of judicial notice is governed by Federal Rule of Evidence 201. Although the
Federal Rules of Evidence are not formally applied in Vaccine Act proceedings, the Federal Circuit
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has approved the taking of judicial notice in a case arising under the Vaccine Act. See 42 U.S.C.
§ 300aa-12(d)(2)(B); Vaccine Rule 8(b)(1); see also Munn v. Sec'y of Health & Hum. Servs., 970
F.2d 863, 873 (Fed. Cir. 1992); Hines ex rel. Sevier v. Sec'y of Health & Hum. Servs., 940 F.2d
1518, 1525-26 (Fed. Cir. 1991). “A judicially noticed fact must be one not subject to reasonable
dispute in that it is either (1) generally known within the territorial jurisdiction of the trial court or
(2) capable of accurate and ready determination by resort to sources whose accuracy cannot
reasonably be questioned.” Fed. R. Evid 201(a).
Respondent states that he “reasonably disputes” that “every doctor would agree that
petitioner meets the definition of ‘statutory blindness’” and that he “reasonably disputes that
Petitioner “is not a candidate” for Vocational Rehabilitation. Respt’s Resp. at 6. Accordingly,
Respondent argues, judicial notice of Petitioner’s blindness or lack of suitability for vocational
rehabilitation is not appropriate in this case. Id.
I find Respondent’s argument persuasive on this point. Dr. Lee has provided an opinion as
to the extent of Petitioner’s injury. Additionally, both Petitioner and Respondent have submitted
expert reports regarding Petitioner’s ability to re-enter the workforce. The issue of Petitioner’s
statutory blindness2 and suitability for vocational rehabilitation are therefore both “reasonably
disputed” by Respondent. I therefore find that judicial notice is inappropriate in this case.
V. Conclusion
Accordingly, based on the foregoing, Petitioner’s Motion is DENIED.
Any questions regarding this Order may be directed to my law clerk, Neil Bhargava, by
telephone at 202-357-6351, or by email at neil_bhargava@cfc.uscourts.gov.
IT IS SO ORDERED.
s/ Katherine E. Oler
Katherine E. Oler
Special Master
2 I note for the parties that the overarching issue in this case is not the label of statutory blindness. The goal
of the damages hearing is to assess the extent to which Petitioner’s injury affects his daily life. To that end,
at the hearing, the experts should focus their testimony on what Petitioner can and cannot do.
11

================================================================================
DOCUMENT 3: USCOURTS-cofc-1_17-vv-01257-3
Date issued/filed: 2022-10-26
Pages: 11
Docket text: PUBLIC DECISION (Originally filed: 10/4/2022) regarding 211 DECISION of Special Master - Stipulation. Signed by Special Master Katherine E. Oler. (sl) Service on parties made.
--------------------------------------------------------------------------------
Case 1:17-vv-01257-UNJ Document 215 Filed 10/26/22 Page 1 of 11
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1257V
(not to be published)
* * * * * * * * * * * * * * * * * * * * * * * * * *
*
*
GLENN REINHARDT,
*
* Filed: October 4, 2022
Petitioner, *
*
*
v. * Decision by Stipulation; Damages;
* Influenza (“Flu”) Vaccine; Optic Neuritis
SECRETARY OF HEALTH AND * (“ON”).
HUMAN SERVICES, *
*
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * * *
Michael Baseluos, Baseluos Law Firm, PLLC, San Antonio, TX, for Petitioner
Julia Collison, U.S. Department of Justice, Washington, DC, for Respondent
DECISION ON JOINT STIPULATION1
On September 15, 2017, Glenn Reinhardt (“Petitioner”) filed a petition, seeking
compensation under the National Vaccine Injury Compensation Program (“the Vaccine
Program”).2 Pet., ECF No. 1. Petitioner alleges he suffered from optic neuritis (“ON”) as a result
of the influenza (“flu”) vaccination he received on October 11, 2016. See Stipulation ¶ 2, dated
October 4, 2022 (ECF No. 210); see also Pet. at 1. On April 2, 2021, I issued a Ruling on
Entitlement finding that Petitioner was entitled to compensation. ECF No. 122.
1 Although this Decision has been formally designated “not to be published,” it will nevertheless be posted
on the Court of Federal Claims’ website in accordance with the E-Government Act of 2002, 44 U.S.C. §
3501 (2012). This means the Decision 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 Decision’s inclusion of
certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen
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 Decision in its present form will be available. 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-10–34 (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.

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Respondent “continues to maintain his contrary position, but will not seek review of the
Special Master’s determination of entitlement upon its memorialization as a reviewable decision.”
See Stipulation ¶ 4. Nonetheless, both parties, while maintaining their above-stated positions,
agreed in a stipulation filed October 4, 2022 that the issues before them can be settled and that a
decision should be entered awarding Petitioner compensation.
I have reviewed the file, and based upon that review, I conclude that the parties’ stipulation
is reasonable. I therefore adopt it as my decision in awarding damages on the terms set forth
therein.
The stipulation awards:
1. A Lump Sum
A lump sum of $2,247,225.67, which amount represents compensation for first-year
life care expenses ($27,954.01), past lost earnings ($453,427.00), future lost earnings
($1,510,689.00), pain and suffering ($250,000.00), and past unreimbursable expenses
($5,155.66) in the form of a check payable to Petitioner.
2. An Annuity
The remainder of damages shall be paid in the form of an annuity contract, which shall be
purchased as soon as practicable after entry of judgment. Accordingly, pursuant to 42 U.S.C. §
300aa-15(f)(4), I order Respondent to purchase, and take ownership of, an annuity contract as
described below:
Each Life Insurance Company must meet the following criteria:
1. Have a minimum of $250,000,000 of capital and surplus, exclusive of any mandatory
security valuation reserve; and
2. have one of the following ratings from two of the following rating organizations:
a) A.M. Best Company: A++, A+, A+g, A+p, A+r, or A+s;
b) Moody’s Investor Service Claims Paying Rating: Aa3, Aa2, Aa1, or Aaa;
c) Standard and Poor’s Corporation Insurer Claims-Paying Ability Rating: AA-, AA,
AA+, or AAA;
d) Fitch Credit Rating Company, Insurance Company Claims-Paying Ability Rating:
AA-, AA, AA+, or AAA.
The Secretary of Health and Human Services shall purchase an annuity contract from the Life
Insurance Company for the benefit of Glenn Reinhardt, pursuant to which the Life Insurance
Company will agree to make payments periodically to Glenn Reinhardt as described in paragraph
9 of the attached Stipulation. This award represents compensation for all damages that would be
available under 42 U.S.C. § 300aa-15(a).

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I approve a Vaccine Program award in the requested amount set forth above to be made to
Petitioner. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of
the Court is directed to enter judgment herewith.3
IT IS SO ORDERED.
s/ Katherine E. Oler
Katherine E. Oler
Special Master
3 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by jointly filing notice
renouncing their right to seek review.

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