VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-00864
Package ID: USCOURTS-cofc-1_16-vv-00864
Petitioner: I.J.
Filed: 2016-07-21
Decided: 2026-01-05
Vaccine: Tdap
Vaccination date: 2013-07-22
Condition: transverse myelitis
Outcome: compensated
Award amount USD: 2078709.51

AI-assisted case summary:
I.J., a 34-year-old male, filed a petition on July 21, 2016, seeking compensation under the National Vaccine Injury Compensation Program. He alleged that he developed transverse myelitis (TM) as a result of a Tetanus Diphtheria acellular-Pertussis (Tdap) vaccine he received on July 22, 2013. Following an entitlement hearing, the Special Master initially denied the claim, finding that while I.J. likely suffered from TM, there was insufficient evidence that the Tdap vaccine could cause TM or did so in his case. The Court of Federal Claims vacated this decision and remanded the case, finding the Special Master had misapplied legal standards and made arbitrary and capricious factual determinations regarding the Baxter study and the evidence of inflammation. Upon remand, the Special Master found that I.J. had established a plausible "can cause" theory for TM following Tdap vaccination, consistent with the Court's guidance on the "biological plausibility" standard. The Special Master also found that the "did cause" prong was met, citing evidence of inflammation and treaters' consideration of vaccines as a potential cause, despite some inaccuracies in their records. Consequently, entitlement was granted. A subsequent damages decision on January 5, 2026, awarded I.J. a total of $2,078,709.51. This included a lump sum payment of $1,668,311.51 for life care expenses, lost earnings, and pain and suffering, a $639,898.43 payment to satisfy a Medicaid lien, and an amount to purchase an annuity for future life care expenses. The award also included $1,190,602.00 for lost earnings and $250,000.00 for pain and suffering.

Theory of causation field:
Tdap vaccine on July 22, 2013, age 34, followed by transverse myelitis about 17 days later. COMPENSATED after initial denial, Court of Federal Claims remand, entitlement on remand, and damages litigation. Petitioner relied on Dr. Scott Zamvil and molecular mimicry/biologic plausibility evidence; the reviewing court found legal and factual errors in the initial denial. On remand, Chief Special Master Corcoran found petitioner met Althen and later awarded damages including pain and suffering, lost earnings, life-care components, and Medicaid lien satisfaction. Damages decision January 5, 2026.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_16-vv-00864-2
Date issued/filed: 2021-04-02
Pages: 44
Docket text: PUBLIC ORDER/RULING (Originally filed: 01/04/2021) regarding 114 DECISION of Special Master Signed by Chief Special Master Brian H. Corcoran. (omg) Service on parties made.
--------------------------------------------------------------------------------
Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 1 of 44
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-864V
(to be published)
* * * * * * * * * * * * * * * * * * * * * * * * *
I.J.
*
* Filed: January 4, 2021
Petitioner, *
*
v. * Entitlement Decision; Transverse
* Myelitis; Spinal Cord Infarction;
SECRETARY OF HEALTH AND * Tetanus Diphtheria acellular
HUMAN SERVICES, * Pertussis; Causation; Althen
Prong One
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Robert J. Krakow, Law Office of Robert Krakow, P.C., New York, NY, for Petitioner.
Catherine Stolar, U.S. Dep’t of Justice, Washington, DC, for Respondent.
ENTITLEMENT DECISION1
I.J.
filed a petition on July 21, 2016, seeking compensation under the National
Vaccine Injury Compensation Program (“Vaccine Program”).2 Petition (“Pet.”) at 1 (ECF No. 1).
I.J.
Mr. has alleged that he developed transverse myelitis (“TM”) due to the Tetanus Diphtheria
acellular-Pertussis (“Tdap”) vaccine he received on July 22, 2013. Id.
An entitlement hearing was held in this matter on October 22-23, 2019. After consideration
of the record and testimony provided at hearing, I deny an entitlement award in this case. As
1 This Decision will 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 that 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
whole Decision will be available to the public in its current form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-
10–37 (2012) (hereinafter “Vaccine Act” or “the Act”). Individual section references hereafter shall refer to § 300aa
of the Act.

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 2 of 44
discussed in more detail below, Petitioner has preponderantly established that he likely
experienced TM, prevailing over Respondent’s proposed alternative diagnosis of a spinal cord
infarction. But insufficient preponderant evidence offered in this case stands for Petitioner’s
contention that the Tdap vaccine can cause TM, or that it did so in this case.
I. Factual Background
A. Medical History Prior to Vaccination
I.J.
Prior to his vaccination in July 2013, Mr. was a healthy and active thirty-four-year-
old man with no history of neurological problems or clotting disorders. Tr. at 22–24. Earlier that
I.J.
year, Mr. had undergone a surgical procedure to repair a torn anterior cruciate ligament
(“ACL”) in his left knee. Ex. 2, filed July 26, 2016 (ECF No. 8-2); Ex. 15, filed Apr. 3, 2017 (ECF
I.J.'s
No. 28-1). However (and relevant to the claim at hand), Mr. family history was significant
for thrombophilia.3 Ex. 2. at 18, 21, 225.
B. Onset of Injury
I.J.
On July 22, 2013, Mr. received the Tdap vaccine. Vaccination Record, filed July 26,
2016 as Ex. 1 (ECF No. 8-1); Tr. at 7. No immediate complication or reactions were documented.
I.J.
See Ex. 1. A little over two weeks later, on August 6-7, 2013, Mr. reported feeling ill with
what he believed was a minor cold, but he quickly recovered. Ex. 2 at 8. The following day (August
I.J.
8, 2013), however, Mr. was reaching into the back pocket of his pants (to retrieve a Metro
card needed for public transportation in New York City) when he experienced a “pinch” in his
shoulder, broadening to sudden sharp pain and burning sensation in the back of his neck that ran
down from both shoulders and arms into his left leg. Id. at 7; Tr. at 14–15. These symptoms
continued to worsen, and within minutes he began to experience pain, tingling, and numbness that
spread throughout his arms and legs. Ex. 2 at 7.
I.J.
Mr. walked to NYU Medical Center, where he was immediately admitted to the
I.J.
emergency department. Tr. at 14–15. Within hours, Mr. lost the ability to use his arms and
I.J.'s
legs and began to exhibit urinary retention. Id. at 20. An MRI of Mr. cervical spine revealed
increased signal “predominantly within the central gray matter of the cervicothoracic cord
extending from C3 to the T1-2 level, most prominent from the C6 to the T1 level.” Ex. 8B at 1,
filed Jan. 4, 2019 (ECF No. 50-2). These results were deemed to be compatible with a diagnosis
of TM. Id. at 1–2.
3 Thrombophilia is the tendency to form blood clots. Thrombophilia, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=49901&searchterm=thrombophilia (last visited Nov. 23,
2020); Thrombus, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=49919&searchterm=thrombus (last visited Nov. 23, 2020).
2

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 3 of 44
I.J.'s
On August 9, 2013, treating neurologist Dr. Stephen Galetta noted that Mr.
symptoms had developed over the course of six hours. Ex. 2 at 20. He also observed that the MRI
I.J.'s
of Mr. cervical spine showed “high signal extending down the anterior part of the cord,”
and the signal intensity seemed to be concentrated in the ventral horns of the spinal cord. Id. Based
I.J.'s
on Mr. presentation and MRI results, Dr. Galetta proposed several differential diagnoses,
including TM, West Nile Virus, Neuromyelitis Optica (“NMO”), and Acute Disseminated
Encephalomyelitis (“ADEM”). Id.
I.J.
From August 9 to 15, 2013 Mr. was treated with Solumedrol, intravenous
immunoglobulin (“IVIG”), and plasma exchange (“PLEX”), and he underwent a series of
diagnostic laboratory studies to refine his diagnosis. Ex. 2 at 183, 373–444. One such test was an
antinuclear antibodies (“ANA”) test, which was performed on August 9, 2013, and resulted in a
positive showing (thus suggesting the possible existence of an autoimmune process).4 Id. at 139.
I.J.
Because Mr. did not have a family history of rheumatologic disease, however, this result
was only deemed suggestive of the presence of primary rheumatologic disease. Id. at 50.
Mycoplasma pneumoniae5 antibody levels were also elevated, but the significance of these
findings was not immediately clear given the possibility that they were attributable to the IVIG
I.J. I.J.
treatment Mr. was receiving at the time. Id. at 167, 172. Mr. was also found to be
positive for other antibodies, but treaters concluded that such results did not likely explain his
condition. Id. at 55–56, 61, 139, 169–70, 172. Tests for Rhinovirus and enterovirus were also
I.J.
positive. Id. 2 at 49. Additionally, Thrombophilia studies revealed that Mr. had elevated
Factor VIII levels and an activated partial thromboplastin time6 of 23. Id. at 162, 166, 170, 392.
A repeat MRI was performed on August 17, 2013. Ex. 9F, filed Jan. 4, 2019 (ECF No. 51-
1). The results of this MRI showed
4 An ANA test is typically used to assess the presence of systemic lupus erythematosus, as well as other autoimmune
diseases (e.g., mixed connective tissue disease, scleroderma, rheumatoid arthritis, Sjögren’s syndrome, and
polymyositis). However, because otherwise-healthy individuals also often test positive for ANA, follow-up testing is
necessary to confirm the existence of an autoimmune condition. See K. Pagana, et al., Mosby’s: Manual of Diagnostic
and Laboratory Tests 80, 82 (6th ed. 2018) (“Mosby’s”).
5 Mycoplasma pneumoniae is a bacterial species responsible for mild respiratory tract disease. Mycoplasma
pneumoniae, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=91174&searchterm=Mycoplasma+pneumoniae (last visited
Nov. 23, 2020).
6 Activated partial thromboplastin time (“aPTT”) is the period required for clot formation in recalcified blood plasma
after contact activation and the addition of platelet substitutes (e.g. brain cephalin or similar phospholipids); used to
assess the intrinsic and common pathways of coagulation. Activated partial thromboplastin time, Dorland’s Medical
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=113783 (last visited Nov. 24, 2020). A
prolonged aPTT can indicate a deficiency of a number of factors, including prekallikrein, high-molecular-weight
kininogen, factors XII, XI, IX, VIII, I, V and II, and fibrinogen. Id. The PTT (partial thromboplastin time) test is used
to assess the intrinsic system and the common pathway of clot formation. See Mosby’s at 344–45. Normal findings
for aPTT are 30-40 seconds and 60-70 seconds for PTT. Id. at 344.
3

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 4 of 44
…a long segment of T2/FLAIR hyperintensity extending from C2 to T3, largest
between C4 and C7 where most of the transverse diameter of the cord is noted . . .
At T2 and T3, the inferior aspect of the lesion, the T2-bright signal involves
predominantly the central gray matter. Patchy enhancement is noted scattered
throughout portions of the spinal cord between C4 and T1, with conspicuous
enhancement of the anterior horns of the central gray matter at C4. The DWI pulse
sequence reveals some small foci of restricted diffusion.
I.J.'s
Ex. 9F at 1–2. Based on these results, Mr. differential diagnosis was narrowed to
encompass only TM and spinal cord infarction—though the diagnosis of TM was identified as
favored due to “the age of [Mr. I.J. the repeat occurrence, and the holocord7 involvement, and
the cervical location” of the lesion. Id. at 2.
I.J.
That same day, Mr. was evaluated by an infectious disease specialist, Dr. Eddie
I.J.
Louie, M.D., who (mistakenly believing Mr. had received the Hepatitis B rather than Tdap
vaccine) noted that a causal connection between the Hepatitis B vaccine and TM has been
identified. Ex. 2 at 61. Dr. Louie dismissed the possibility that the rhinovirus played in the onset
I.J.'s
of Mr. condition, noting that this sort of viral infection is not associated with
neuromuscular diseases in which there is damage to the anterior horn of the spinal cord. Id. He
also observed that Petitioner’s symptoms were improving with steroid and IVIG treatment. Id.
I.J.'s
Because there were some lingering concerns, however, that Mr. condition could partially
be the result of mycoplasma myelitis,8 he was started on intravenous azithromycin. Id. at 61, 213.
Dr. Albert Favate—a member of the hospital stroke team—provided a neurology
consultation on August 19, 2013, and his assessment differed from the prior proposals that TM
explained Petitioner’s condition. Instead, Dr. Favate noted that “[i]n view of presentation cord
signal on MRI vascular etiology-thrombosed anterior spinal artery origin with prese[r]vation of
posterior collu[m]n function. [A]s possible sources are Vertebral artery thrombotic formation
w/Hypercoagulable state…Note AVM may be compressed and not seen on cord MRI in initial
I.J.
phase of cord infarct.” Ex. 2 at 62. Dr. Favate recommended that Mr. undergo a coagulopathy
work-up with hematology, as well as an MRI and spinal angiogram to visualize spinal circulation.
I.J.'s
Id. He also recommended repeat serological testing to further refine Mr. diagnosis. Id.
7
Holocord presentation denotes involvement of the entire spinal cord, extending from the cervicomedullary junction
to the tip of the conus. Y. Sheikh et al., Holocord Presentation, Radiopaedia, https://radiopaedia.org/articles/holocord-
presentation?lang=us (last visited Dec. 14, 2020).
8 Mycoplasma myelitis is a rare form of TM resulting from a Mycoplasma pneumoniae infection. An M. pneumoniae
infection is an exclusionary criterion under the proposed diagnostic criteria for TM. See, e.g., Transverse Myelitis
Consortium Working Group, Proposed Diagnostic Criteria and Nosology of Acute Transverse Myelitis, 59 Neurology
499, 500 (2002), filed as Ex. 35 on July 21, 2019 (ECF No. 63-4) (“Working Group”).
4

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 5 of 44
Following Dr. Favate’s evaluation, and at his recommendation, Kenneth Hymes, M.D., a
I.J.
hematologist, evaluated Mr. for thrombophilia. Ex. 2 at 62–65. Dr. Hymes acknowledged
I.J.'s
that while Mr. first MRI was interpreted as being most consistent with TM, he also noted
I.J.'s
that a repeat MRI conducted a few days after Mr. admission appeared to be more consistent
with a spinal cord infarction. Id. at 62. Mr. I.J.'s family history of lethal pulmonary emboli9 was
also quite concerning to Dr. Hymes. Id. at 62, 65 (“[t]he positive family history of thrombophilia
is noteworthy, and a thrombophilic disorder with venous thrombosis and paradoxical embolization
I.J.
might explain clinical findings”). He concluded that Mr. had experienced “[a]cute onset of
back pain and extremity weakness, possibly due to vascular injury to the spinal cord. A spinal
artery dissection or embolic lesion might explain these symptoms.” Id. at 65. Thus, Dr. Hymes
I.J.
suggested Mr. undergo thrombophilia studies. Id. He allowed, however, that a diagnosis of
TM was still also a reasonable explanation for Petitioner’s condition. Id.
Dr. Stephanie Sterling also provided a follow-up infectious disease consultation with Mr.
I.J. I.J.
on August 19, 2013. Ex. 2 at 66–68. Mr. told Dr. Sterling at this time that he had
received “a bunch of vaccines” approximately two to three days prior to the onset of his condition.
Id. at 66. Based on such (incorrect) reporting, Dr. Sterling proposed that vaccination could be
related to Petitioner’s subsequent development of TM. Id. at 68. Dr. Sterling, however, reviewed
I.J.'s
Mr. most recent MRI results, noting that newly-recorded abnormalities were focused
predominantly in the anterior horns of the central gray matter of the spinal cord, and might
therefore be more consistent with a spinal cord infarction. Id. at 68. She also acknowledged that
Petitioner’s condition was improving with steroids, IVIG, and PLEX treatments. Id. Dr. Sterling
did agree with Dr. Louie’s decision to rule out a rhinovirus infection as causal, since existing
literature did not support such a relationship. Id. And she expressed some skepticism regarding the
I.J.'s
role mycoplasma pneumoniae might have played in Mr. condition, though she agreed to
continue treatment with azithromycin. Id.
I.J.
On August 20, 2013, Mr. was evaluated by yet another neurology specialist, Dr.
I.J.
Miguel Litao. Ex. 2 at 213. Mr. had now developed a fever, exhibited elevated white blood
cell counts, and was experiencing difficulty breathing. Id. He was prescribed Zosyn and
Vancomycin, but his azithromycin treatment was discontinued due to the low likelihood of
mycoplasma infection. Id. at 213–14. Dr. Litao also observed that the August 17th MRI results
were (in his view) most consistent with a spinal cord infarction in the anterior spinal artery area.
Id. at 213.
I.J.
Shortly thereafter, Mr. was transferred to the medical intensive care unit. Ex. 2 at
230–31. A progress note was prepared by critical care physician, Dr. Jessica Leland Taff, at the
I.J.'s I.J.'s
time of Mr. transfer. Id. Dr. Taff observed that Mr. age, holocord involvement,
9 A pulmonary embolism is the closure of the pulmonary artery or one of its branches by an embolism. Pulmonary
Embolism, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=72763&searchterm=pulmonary+embolism (last visited Nov.
23, 2020).
5

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 6 of 44
and cervical location of the spinal cord lesion favored a TM diagnosis. Id. She also expressed a
I.J.'s
desire to obtain Mr. immunization history due to reports of TM following receipt of the
Hepatitis B vaccine. Id. at 231. Dr. Taff acknowledged, however, that the restricted diffusion seen
in the August 17th MRI was suggestive of a spinal cord infarction. Id.
I.J.
At the recommendation of several treating physicians, Mr. underwent a spinal
angiogram10on August 21, 2013. Ex. 5 at 41 (filed on compact disc); Ex. 9D at 3, filed Jan. 4, 2019
(ECF No. 50-9). The angiogram demonstrated “a lower cervical watershed corresponding to the
region of maximum abnormality…on the spinal MRI.” Ex. 9D at 3. The anterior spinal artery was
also described as “segmentally narrowed,” though it was acknowledged that this narrowing could
be due to an earlier thrombotic event. Id. But given the extensive distribution of the lesion, passive
compression or active inflammation were also considered. Id.
A follow-up hematology consultation provided by Dr. Hymes noted evidence of spinal
I.J.'s
artery occlusion in the angiogram, but he indicated that the results of Mr. thrombophilia
studies could also be seen in inflammation and were not likely to have caused an aggressive
thrombotic event. Ex. 9D at 76. Additionally, an echocardiogram did not reveal a right-to-left
shunt—circumstances commonly associated with an increased risk of embolism. Id. at 75; see also
N. Gomperts et al., A Broken Heart: Right-to-Left Shunt in the Setting of Normal Cardiac
Pressures, 24 Can. J. Cardiology. 227, 227 (2008), filed on July 21, 2019 as Ex. 32 (ECF No. 63-
1). Though he could not yet identify the etiology for his findings, and despite the caveats previously
mentioned, Dr. Hymes remained confident that the most likely diagnosis was an embolic lesion.
Ex. 2 at 76.
I.J.
On August 23, 2013, Mr. was released from the medical intensive care unit and was
transferred back to the neurology department. Ex. 2 at 245. Efforts to conclusively diagnose Mr.
I.J.
were summarized by Dr. Taff, who noted:
Initial MRI C[ervical] and T[horacic] spine on 8/8 showed long segment, central
increased signal [within] cervicothoracic spinal cord [without] enhancement
compatible [with] transverse myelitis . . . Repeat MRI done on 8/17 showed
decreased diffusion thought to be [consistent with] a spinal cord infarction within
the Anterior Spinal Artery territory . . . On 8/22 he had a spinal angiograph showing
a mid-cervical filling defect of the Anterior Spinal artery congruent [with]
suspected spinal infarct in the cervical watershed region…Hematology was
consulted for concern of pro-thrombotic state, but felt that labs were not consistent
with Antiphospholipid Ab syndrome or another pro-coagulant state . . . clarify
patient’s immunizations at occupational health, as there are case reports of TM
10 A spinal angiogram is a diagnostic procedure in which a contrast dye is injected into the arteries supplying the spinal
cord and x-ray images are obtained in order to study blood flow to the area. NYU Langone Health, Spinal Angiogram,
https://med.nyu.edu/radiology/about-us/subspecialties/neuro-interventional/our-services/patient-information-spinal-
angiogram (last visited Dec. 14, 2020).
6

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 7 of 44
following Hep[atitis] B immunization, although this appears a much less likely
scenario given angio[gram] and MRI findings.
I.J.'s
Ex. 2 at 245–47. Dr. Taff thus acknowledged that the etiology of Mr. condition was still
unclear, and hematology specialists felt that the thrombophilia panel results were not likely to have
caused such an aggressive thrombotic event—even though she overall seemed to favor infarction
as the proper diagnosis. Id. at 248.
I.J.
On August 26, 2013, Mr. was again evaluated by neurology in anticipation of his
being discharged to a rehabilitation facility. Ex. 2 at 276. His active problem list at that time
I.J.
included TM and thrombophilia. Id. It was also noted that Mr. exhibited an Anterior Spinal
Artery blockage at the C5 level, but it was again observed that this occlusion could be due to
swelling within the spinal cord. Id. at 281. This conclusion was echoed the very next day during a
neurology follow-up. Id. at 291.
I.J.
Mr. was discharged from NYU Hospital on August 29, 2013, and was transferred to
I.J.'s
Rusk Rehabilitation for intensive physical therapy. Ex. 2 at 6, 13. Mr. discharge diagnoses
included tetraplegia, spinal cord infarction, and thrombophilia, but notably did not include a TM
I.J.'s
diagnosis. Id. at 7. Dr. Foo, a neurologist, mentioned Mr. recent vaccinations, and he
indicated that vaccination records should be obtained for further consideration. Id. at 8, 12. But he
also observed the overall conflict in the medical record between possible diagnoses, noting as
follows:
The differential diagnosis is between spinal cord infarct and transverse myelitis.
The age of the patient, the repeat occurrence, and the holocord involvement, and
the cervical location favor transverse myelitis. Spinal cord infarction is suggested
by the evidence of restricted diffusion in portions of the lesion, the focal gray matter
T2-bright lesions noted on the current examination as well as on the prior
examination, and the focal gray matter enhancement in portions of lesions.
Id. at 10.
C. Follow-up Treatment
I.J.
For the next several months, Mr. participated in intensive inpatient rehabilitation.
See generally Ex. 6, filed Nov. 30, 2016 (ECF No. 17-1); Ex. 11, filed on Feb. 23, 2017 (ECF No.
I.J.
22-1). Mr. was later transferred to Brandywine Nursing Home where he received
I.J.
rehabilitation therapy for approximately six months. Ex. 11 at 3–4. On August 22, 2014, Mr.
was again transferred—this time to Lindenwood Nursing facilities for continued nursing and
rehabilitative care. See Ex. 6. His diagnosis at the time of admission was described as “spinal cord
infarction vs. transverse myelitis, paraplegia, thrombophilia….” Id. at 380. After seven months at
Lindenwood, he was discharged home on March 20, 2015. Id. at 380–82. At the time of his
7

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 8 of 44
I.J.'s
discharge, Mr. diagnosis was characterized as an “unspecified spinal cord disease.” Id. at
380.There are no records documenting medical or rehabilitative services since March 2015.
II. Witness Testimony
I.J.
A.
I.J.
Mr. submitted an affidavit and provided testimony at the entitlement hearing.
Petitioner’s affidavit, filed as Ex. 4 on July 25, 2016 (ECF No. 6-1) (“Affidavit”); Tr. at 7–40. Mr.
I.J.
first described his past medical history as healthy with no significant problems—having only
experienced gall stones in 2006 or 2007 and an ACL tear in his left knee that required arthroscopic
surgery in early 2013. Affidavit at 1–2; Tr. at 11–12.
I.J.
Mr. explained that in 2013, he was offered a job as a patient advocate at NYU
Medical Center, and was required to receive the Tdap vaccine as a condition of his employment.
Affidavit at 2; Tr. at 13. He received the Tdap vaccine on July 22, 2013. Affidavit at 2; Tr. at 13.
I.J.
Approximately two weeks later, Mr. was boarding a bus when he reached into his back, right
pants pocket to retrieve his bus pass and felt a sharp, burning pain that ran from the back of his
neck to his right shoulder and arm. Affidavit at 2; Tr. at 14. The pain and burning sensation
progressed and spread to his left shoulder and arm and down his leg, and he began to experience a
tingling sensation and weakness in his limbs. Affidavit at 2; Tr. at 14–16. He reported that at one
point, while walking to the hospital, he collapsed to one knee and struggled to get up. Affidavit at
I.J.
3; Tr. at 17. When Mr. arrived at NYU Medical Center, he was admitted to the emergency
department where he continued to experience progressive weakness, numbness, and a needle-like
pain sensation that was predominantly focused in his back and extending into his left arm. Tr. at
20–21. He also experienced urinary retention that required catheterization. Id. at 29–30.
I.J.
Shortly after his emergency department admission, Mr. underwent an MRI scan. Tr.
I.J.
at 24. Prior to his scan, Mr. recalled being fully mobile. Id. Immediately following his MRI
I.J.
scan, however, Mr. lost all mobility from the neck down. Id. at 25–27. He also exhibited
urinary retention, for which he required catheterization, as well as difficulty regulating his body
I.J.
temperature. Id. at 28–30. Following treatment with IVIG and plasmapheresis, Mr. regained
some mobility in his arms. Id. at 28.
I.J.
Mr. then described his extended rehabilitation at Rusk Rehabilitation. Tr. at 31. He
was eventually able to push back with his arms and support his own bodyweight with his arms. Id.
He was then transferred to Brandywine Nursing Home for additional therapy. Affidavit at 3; Tr.
at 32. He emphasized that this facility was located two hours away from his home, which made it
I.J.
difficult for his family to visit him regularly. Tr. at 32. Mr. described his time at Brandywine
I.J.
as lonely and emotionally difficult. Id. After approximately six months, Mr. was again
transferred—this time to Lindenwood Nursing Facility. Affidavit at 3–4; Tr. at 33. He was
eventually discharged home, but he continues with physical therapy at Rusk Rehabilitation and a
8

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 9 of 44
community access program. Tr. at 35–37. He has recovered some strength in his legs and mobility
in his upper extremities, but he does not have the dexterity he possessed prior to the onset of his
injury. Id. at 35–36.
B. Petitioner’s Experts
1. Dr. Scott Zamvil, M.D., Ph.D.
Dr. Zamvil, a neuroimmunologist, provided testimony at the hearing and offered a single
expert report. Tr. at 41–160; Report, filed as Ex. 16 on Sept. 11, 2017 (ECF No. 31-1) (“Zamvil
Rep.”). Dr. Zamvil opined that the Tdap vaccine can cause TM and did so in Petitioner’s case.
Dr. Zamvil received his bachelor’s degree in chemistry from Claremont Men’s College.
Dr. Zamvil Curriculum Vitae, filed as Ex. 17 on Sept. 11, 2017 (ECF No. 35-1) (“Zamvil CV”) at
1. He then obtained a Ph.D. in medical microbiology along with a medical degree from Stanford
Medical School. Id. Dr. Zamvil completed an internship in internal medicine at Pacific
Presbyterian Medical Center before completing residencies in internal medicine and neurology at
Stanford University Medical Center and Brigham and Women’s Hospital respectively. Id. He is
board certified in neurology. Id. Dr. Zamvil has served as a professor of both neurology and
immunology at Harvard Medical School and the University of California, San Francisco, and he
has published numerous journal articles on these subjects. Id. at 1, 14–21.
Some of Dr. Zamvil’s research has specifically considered T cell recognition of
autoantigens on myelin and central nervous system demyelination. Tr. at 43–44. He does not,
however, have expertise in vascular medicine or neuroradiology. Id. at 108. Dr. Zamvil has clinical
duties at the Multiple Sclerosis clinic at the University of California, and he often sees patients
suffering from demyelinating conditions, including multiple sclerosis (“MS”) and NMO, but he
has only recently started seeing patients with TM when they are concurrently experiencing NMO.
Tr. at 42, 48, 107. He explained, however, that TM overlaps with other demyelinating conditions
with which he is more familiar. Id. at 42, 45, 106. Though he was not able to personally evaluate
I.J.
Mr. Dr. Zamvil relied on the submitted medical records—including the treating physician
opinions and diagnostic test results contained therein. Tr. at 50. He did not, however, review either
the MRI studies or angiogram in forming his opinion, and instead deferred to Petitioner’s
neuroradiology expert, Dr. Watanabe, for her interpretation of those studies. Id. at 109–10.
Based on the medical record and the reports contained therein, Dr. Zamvil concluded that
I.J.
Mr. more likely than not experienced TM. Tr. at 51, 90, 110. He supported this conclusion
I.J.'s
by noting that the initial onset of Mr. condition—which progressively worsened over the
course of six to eight hours—was “stuttering” rather than an acute onset with near immediate
maximal deficit. Tr. at 52. This, Dr. Zamvil opined, was consistent with the diagnostic criteria for
TM set forth by the Transverse Myelitis Consortium Working Group. Id. at 60; Working Group,
at 500.
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Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 10 of 44
Dr. Zamvil began his testimony with a discussion focused on the diagnostic criteria and
pathophysiology of TM, in light of the TM Working Group criteria. Tr. at 49–50, 76–84; Working
Group at 500. He described TM as an inflammatory autoimmune response within the spinal cord.
Tr. at 44–45. TM may follow an infectious disease process and its pathogenesis is likely the result
of specific autoantigens. Id. at 44–45, 123–24. In this vein, Dr. Zamvil acknowledged that TM is
diagnostically distinct from other demyelinating conditions such as ADEM. Id. at 116. Dr. Zamvil
next addressed the first inclusionary criterion outlined by the Working Group paper: the
development of sensory, motor, and autonomic dysfunction. Tr. at 51, 76–78 (referencing Working
Group at 500). Dr. Zamvil concluded that Mr.
I.J.
satisfied this criterion because the weakness
and paralysis he experienced was an obvious example of motor dysfunction. Tr. at 77. Petitioner
also had documented spinothalamic11 sensory dysfunction and autonomic dysfunction resulting in
urinary retention. Id. at 77–78.
The second criterion—bilateral signs and/or symptoms—was also satisfied in Dr. Zamvil’s
I.J.
estimation, because Mr. exhibited sensory and motor dysfunction bilaterally. Tr. at 78. Dr.
I.J.'s
Zamvil did acknowledge that these symptoms were worse on Mr. right side than on his
left, but noted that this diagnostic criterion did not require precisely symmetrical presentation, just
bilateral. Id.; Working Group at 500. The third criterion discussed was that of a defined sensory
level. Id. at 78–80. Based on the record alone, Dr. Zamvil was unable to conclude whether Mr.
I.J.'s
clinical presentation satisfied this criterion. Id. at 79–80. Some evidence, such as the loss
of sensory perception below the level of T4, favored it, but evidence like the loss of motor function
in Petitioner’s arms (a level greater than T4), did not. Id. at 79. Thus, Dr. Zamvil admitted that
additional information was required to determine if this diagnostic criterion had been established.
Id. at 79–80. But he expressed more confidence that the criterion requiring “the exclusion of extra-
axial compressive etiology by neuroimaging” was satisfied, since the MRI imaging in this case did
not reveal evidence of a compressive etiology such as spinal stenosis or blood. Id. at 80; Working
Group at 500.
Next, Dr. Zamvil addressed the criterion requiring evidence of inflammation, as established
by pleocytosis12 or elevated IgG index or Gadolinium enhancement. Tr. at 80–82. Mr. I.J.'s
cerebrospinal fluid (“CSF”) analysis, Dr. Zamvil admitted, was negative for pleocytosis—yet in
his opinion this was an insufficient reason to rule out a TM diagnosis. Id. at 68, 81. According to
Dr. Zamvil, only fifty-seven percent of patients experiencing TM will exhibit pleocytosis, meaning
nearly half do not. Id. at 67, 82; P. Barreras et al., Clinical Biomarkers Differentiate Myelitis from
11 The term “spinothalamic” refers to the region extending between the spinal cord and the thalamus. Spinothalamic,
Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=46603&searchterm=spinothalamic (last visited Nov. 23,
2020).
12 Pleocytosis describes an elevated white blood cell count in the cerebrospinal fluid. Pleocytosis, Dorland’s Medical
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=39556&searchterm=pleocytosis (last
visited Nov. 23, 2020).
10

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 11 of 44
Vascular and Other Causes of Myelopathy, 90 Neurology 12, 17 (2018), filed as Ex. 86 on Oct.
I.J.
21, 2019 (ECF No. 98-1) (“Barreras”). Dr. Zamvil also agreed that Mr. did not demonstrate
an elevate IgG index or Gadolinium enhancement on his initial August 8, 2013 MRI. Tr. at 81.
However, given such a presentation, the TM Working Group diagnostic criteria recommends the
performance of repeat MRI and lumbar punctures, between two to seven days following onset.
Working Group at 500. In this case, the repeat MRI performed on August 17, 2013 did reveal
enhancement consistent with TM, but a repeat CSF study was not performed (based on the filed
medical record). Tr. at 69–70. Thus, Dr. Zamvil allowed that this criterion was not technically
satisfied—though he speculated that pleocytosis would have been evident in subsequent CSF
studies had they been performed. Id. at 69–70, 80–82.
I.J.
The last inclusionary criterion to be addressed was the timeframe in which Mr.
experienced progression to nadir. Tr. at 59–60, 64–66, 82–83. This factor, according to Dr. Zamvil,
is the most important in differentiating between myelitis and vascular etiologies. Id. at 58 (citing
Barreras at 12). The TM Working Group criteria indicates that a patient with TM would be
expected to reach nadir no sooner than four hours after the initial onset of symptoms. Working
I.J.'s
Group at 500. Mr. symptoms progressed over the course of six hours, and Dr. Zamvil
concluded that he did not reach nadir until somewhere between eight to nine hours after the onset
of his symptoms. Tr. at 60. Thus, this time course was sufficient to meet the last inclusionary
criterion. Id. at 82–83.
Dr. Zamvil next discussed the exclusionary criteria set forth in the TM Working Group
paper—those factors that, if present, argue against a TM diagnosis. Tr. at 83–84. He easily
I.J.
concluded that Mr. did not satisfy most of the exclusionary criteria, but he ultimately
deferred to Dr. Watanabe, an expert in neuroradiology, regarding the second exclusionary
criterion—clear arterial distribution clinical deficit consistent with thrombosis of the anterior
spinal artery. Id. at 83–84. Based on his own preliminary review, however, he did not find evidence
of embolism or thrombosis despite the “standard” workup that was performed. Id. at 90.
Besides vouching for TM as the proper diagnosis, Dr. Zamvil expressed the opinion that
the spinal cord infarction diagnosis included in the differential did not accurately characterize the
I.J.
constellation of symptoms Mr. experienced. Tr. at 55–57. Because a spinal cord infarction
was a suspected cause of Mr. I.J.'s condition, he underwent a “bubble study.”13 Id. at 55. The
I.J.
results of that study showed that Mr. did not suffer from a right-to-left shunt—strong
evidence contradicting the conclusion that Petitioner’s injuries were vascular in nature. Id. at 56–
I.J.
57. Additionally, the prolonged, “stuttering” onset Mr. experienced was more consistent
I.J.
with TM than spinal cord infarction. Id. at 60. Mr. did not reach nadir until at least six hours
after the initial onset of his first symptom. Id. at 57. This, according to Dr. Zamvil, would be highly
13 A “bubble study” or a contrast echocardiography is performed most commonly to evaluate heart wall motion (a
measure of heart wall function) and to detect valvular disease, evaluate the heart during stress testing, and identify and
quantify pericardial fluid. Mosby’s at 820.
11

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 12 of 44
unusual for a spinal cord infarction, which more commonly presents in an “apoplectic” manner,
with patients reaching nadir within minutes of onset. Id. at 59–60, 64–66; Barreras at 12, 16
(finding that nearly ninety percent of study participants experiencing spinal cord infarction reached
nadir in less than six hours while only four percent of participants experiencing spinal cord
inflammation reached nadir within the same timeframe); Working Group at 500 (noting
progression to nadir between four hours and twenty-one days following onset of symptoms is an
inclusionary criterion for the diagnosis of TM). He acknowledged, however, that members of the
I.J.
stroke team who evaluated Mr. did characterize the onset of his symptoms as “apoplectic,”
and although he disagreed with this reading of the record, he acknowledged that he lacked expertise
in vascular medicine. Tr. at 141–42.
Dr. Zamvil further supported his opinion by distinguishing the effects TM has on dorsal14
spinal column function versus the impact of an anterior spinal artery infarction. Tr. at 71–72, 87–
88. As he explained, infarction in the anterior15 spinal artery (located on the front facing portion
of the spinal cord) will in turn impact the anterior and lateral portions of the cord itself, thereby
affecting motor function and spinothalamic perceptions while preserving dorsal column function.
Id. at 72. As a result, a patient experiencing an anterior spinal artery infarction would exhibit
problems with motor function, temperature, pain, and gross touch sensations, but would not
experience any changes to dorsal column functions such as proprioception, vibratory sense, and
fine touch perception. Id. Dr. Zamvil admitted that he could not definitively conclude whether Mr.
I.J.
retained dorsal column function because the clinical testing for these functions was either
not performed or was done but not recorded. Id. at 72–73, 88. Instead, Dr. Zamvil relied on MRI
findings indicating posterior cord involvement to exclude a spinal cord infarction diagnosis. Id. at
86.
I.J.
Similarly, Dr. Zamvil acknowledged that Mr. was diagnosed with a “longitudinally
extensive myelopathy”—a condition that he agreed is more often the result of a vascular myopathy
(such as ischemic stroke) than inflammatory myopathies. Tr. at 148–49 (citing Barreras at 15).
Further still, Barreras found that twenty percent of study participants were initially misdiagnosed
with TM and were later found to have vascular abnormalities. Tr. at 145–46; Barreras at 15.
Dr. Zamvil did, however, stress that other record evidence generally supported TM as the
more likely diagnosis. MRI results were consistent with TM, and treating physicians overall
I.J.
seemed to embrace the TM diagnosis. Tr. at 53–54. Additionally, Mr. experienced some
improvement following treatment with Solumedrol, IVIG, and plasmapheresis—common
14 The term “dorsal” refers to the back of or a position that is more towards the back surface than some other object of
reference. Dorsal, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=14794&searchterm=dorsal (last visited Nov. 23, 2020).
15 The term “anterior” refers to the front of or more forward position of an organ. Anterior, Dorland’s Medical
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=3163&searchterm=anterior (last visited
on Nov. 23, 2020).
12

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 13 of 44
treatments for neuroinflammatory conditions16—though Dr. Zamvil was unable to discern the
extent of that improvement. Tr. at 54. Dr. Zamvil also emphasized that in acute TM, both gray and
white matter may be involved, and thus the involvement of gray matter does not preclude a TM
diagnosis, further reducing the significance of MRI findings suggesting lesion involvement as
encompassing both. Id. at 74.
Dr. Zamvil next opined on the issue of causation. He testified to two potential mechanisms
by which the Tdap vaccine could theoretically cause TM: molecular mimicry and innate immune
activation through adjuvant activity. Tr. at 92, 101; Zamvil Rep. at 9–12. Dr. Zamvil explained
that while not all vaccines can cause TM, vaccines containing the tetanus toxoid, such as Tdap,
contain protein sequences that share structural homology with those of myelin-targeting
autoantigens, and have been the subject of epidemiological studies seeking to identify relationships
between vaccination and neurological conditions. Tr. at 92, 112–13 (citing R. Baxter et al., Acute
Demyelinating Events Following Vaccines: A Case Centered Analysis, 63 Clinical Infectious
Diseases 1456, 1456 (2016), filed as Ex. 16 Ref. 12 on Sept. 11, 2017 (ECF No. 32-3) (“Baxter”));
Zamvil Rep. at 9.
In the presence of sufficient homology, T cells and antibodies may (due to similarity
between vaccine components and myelin proteins) engage in cross-reactivity against central
nervous system myelin. Tr. at 92; Zamvil Rep. at 11. To ascertain if such homology existed, Dr.
Zamvil conducted his own BLAST search17 in which he reviewed the National Institutes of
Health’s protein sequence database, comparing protein sequences contained within the Tdap
vaccine with those commonly found in human myelin. Tr. at 92; Zamvil Rep. at 10–11. He found
that there was significant sequential homology between these sequences, supporting the possibility
of molecular mimicry as the pathogenic impetus. Zamvil Rep. at 11. However, though he described
how molecular mimicry can lead to the development of other conditions such as experimental
16 Solumedrol is an anti-inflammatory synthetic glucocorticoid. Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=89219 (last visited Dec. 14, 2020). Plasmapheresis is a
procedure in which plasma is removed from blood and is then transfused back into the body with added donor
components such as frozen plasma or albumin. Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=39455&searchterm=plasmapheresis (last visited Dec. 14,
2020). IVIG therapy is used to treat immune system disorders. During an IVIG treatment, immunoglobulin (a
combination of antibody proteins) is injected into the body to help the immune system fight off infections. See Primary
Immunodeficiency: Treatment, Mayo Clinic, https://wwwmayoclinic.org/diseases-conditions/primary-
immunodeficiency/diagnosis-treatment/drc-20376910 (last visited Dec. 14, 2020).
17 Basic Local Alignment Search Tool (“BLAST”) is a medical/scientific internet resource that assists researchers in
finding regions of similarity between biological sequences of amino acids. The program compares nucleotide or
protein sequences to sequence databases and calculates the statistical significance. BLAST, U.S. National Library of
Medicine, https://blastncbinlmnih.gov/Blast.cgi (last visited Nov. 19, 2020). Research undertaken to identify such
homology has been previously described as an “in silica” study—meaning that the research is conducted via a desktop
or personal computer, and access to scientific databases, to identify the comparable amino acid sequences that is
referenced to establish homology. See, e.g., Blackburn v. Sec. of Health & Hum. Servs., No. 10-410V, 2015 WL
425935, at *10 (Fed. Cl. Spec. Mstr. Jan. 9, 2015). This kind of research is clearly case-oriented, and is not equivalent
to lab or clinical research that an expert might perform and/or rely upon for an opinion.
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Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 14 of 44
autoimmune encephalomyelitis and narcolepsy, Dr. Zamvil admitted that he could not identify any
studies concluding that Tdap can cause TM via this proposed mechanism. Tr. at 97, 136–37, 139,
152.
To further bulwark his proposed causal theory, Dr. Zamvil offered a study in which the
incidence of TM and ADEM (a different neurologic disease with a likely autoimmune etiology or
mechanism) following vaccination was studied. Tr. at 113–16; Zamvil Rep. at 7 (citing Baxter at
1456). Baxter found that after nearly 64 million vaccine doses, only seven cases of TM and eight
cases of ADEM were reported within 5 to 28 days post-vaccination. Baxter at 1456. While a
relationship between vaccination and the development of TM could not be established, Baxter
concluded that there was a statistically significant association between the Tdap vaccine and the
subsequent development of ADEM. Id. at 1460. Dr. Zamvil opined that the causal relationship
between Tdap and ADEM would be parallel to the expected relationship between Tdap and TM—
Baxter’s express finding pertaining to TM to the contrary. Tr. at 116.
Dr. Zamvil also relied on a series of case reports documenting instances of TM following
vaccination. Tr. at 119–121; Zamvil Rep. at 7 (citing N. Agmon-Levin et al., Transverse Myelitis
and Vaccines: A Multi-Analysis, 18 Lupus 1198, 1198–1204 (2009), filed as Ex. 16 Ref. 9 on Sept.
11, 2017 (ECF No. 31-10) (“Agmon-Levin”)). Agmon-Levin highlighted forty-three case reports
of TM following vaccination. Agmon-Levin at 1199. Of these, only four involved TM after
receiving either the diphtheria-tetanus-pertussis vaccine or the diphtheria-tetanus vaccine. Id.
Agmon-Levin also found that seventy-three percent of TM cases were reported within one month
I.J.
of vaccination, consistent with the timeframe Ms. experienced. Id.
Another case report cited by Dr. Zamvil documented acute transverse myelitis in a seven-
month-old child following receipt of the DTaP vaccine (a slightly different formulation of the same
vaccine that is administered to children). R.M.S. Riel-Romero, Acute Transverse Myelitis in a 7-
Month-Old Boy After Diphtheria-Tetanus-Pertussis Immunization, 44 Spinal Cord 688, 688–91
(2006), filed as Ex. 16 Ref. 11 on Sept. 11, 2017 (ECF No. 32-2) (“Riel-Romero”). Though the
treating physicians discussed in Riel-Romero noted several documented instances of TM following
receipt of the Tdap or other diphtheria-tetanus containing vaccine, they found that the temporal
association was not sufficient to establish a causal association and noted the possibility of mere
coincidence. Riel-Romero at 690. In relying on case reports generally, Dr. Zamvil acknowledged
the inherent limitations of such evidence, accepting that they could at bottom only show a temporal
relationship between vaccination and injury rather than provide scientifically-reliable causal proof.
Tr. at 120.
I.J.
Regarding the timeframe in which Mr. experienced the onset of his condition, Dr.
Zamvil opined that an autoimmune reaction would be expected to occur two to three weeks
I.J.'s
following vaccination. Tr. at 98–100. Mr. symptoms began seventeen days after receipt of
I.J.'s
the Tdap vaccine. Id. at 98. Thus, Dr. Zamvil concluded that the onset of Mr. condition
was consistent with an autoimmune reaction to his Tdap vaccination. Id.
14

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 15 of 44
Dr. Zamvil also testified to the role adjuvants, such as alum, have in promoting pro-
inflammatory responses. Tr. at 101. He explained that such a pro-inflammatory response may
exacerbate autoimmune responses already initiated through cross-reactivity. Id.; S. Eisenbarth,
Crucial Role for the Nalp3 Inflammasome in the Immunostimulatory Properties of Aluminum
Adjuvants, 453 Nature 1122, 1122–25 (2008), filed as Ex. 16 Ref. 29 on Sept. 11, 2017 (ECF No.
33-10) (“Eisenbarth”). This theory proposes that the alum adjuvant stimulates proinflammatory
cytokine production via the Nalp3 innate immune response system. Eisenbarth at 1122. The
proinflammatory cytokines such as interleukin-1β and interleukin-18 that are produced are
associated with various aspects of adaptive immunity and antibody production. Id. at 1125.
I.J.'s
Lastly, Dr. Zamvil addressed whether the onset of Mr. symptoms seventeen days
I.J.
post-vaccination was medically appropriate. He explained that the Tdap vaccine Mr.
received was a booster, and thus would have initiated a faster, amnestic response. Tr. at 98–100.
Thus, cellular and immune responses within one or two weeks would be expected. Id. He did not,
I.J.'s
however, reconcile this proposed timeline (7-14 days) with Mr. onset seventeen days post-
vaccination.18
2. Dr. Alyssa Watanabe
Dr. Watanabe, a neuroradiologist, provided testimony at the hearing and offered three
expert reports. Tr. at 161–225; Report, filed as Ex. 21 on Jan. 4, 2019 (ECF No. 52-1) (“Watanabe
Rep.”); Supplemental Report, filed as Ex. 63 on Oct. 10, 2019 (ECF No. 85-1) (“Watanabe Supp.
Rep.”); Supplemental Report, filed as Ex. 89 on April 24, 2020 (ECF No. 111-1) (“Third Watanabe
I.J.
Rep.”). Dr. Watanabe opined that Mr. more likely than not suffered from TM as a result of
his Tdap vaccination. Watanabe Rep. at 22.
Dr. Watanabe received her bachelor’s degree (biological sciences) from Stanford
University before receiving her medical degree from the University of California, San Francisco.
Curriculum Vitae of Dr. Watanabe, filed as Ex. 27 on Jan. 8, 2019 (ECF No. 53-1) (“Watanabe
CV”). She completed an internship in internal medicine at Huntington Memorial Hospital before
completing her residency in diagnostic radiology at the University of California, Los Angeles. Id.
at 1. Dr. Watanabe then completed several fellowships in neuroradiology and interventional
neuroradiology at the University of Washington and the University of Southern California, though
she elected to withdraw from her final fellowship in order to pursue a position in private practice.
Id.; Tr. at 203. She is board certified in radiology and has additional certifications in
neuroradiology. Watanabe CV at 1. Dr. Watanabe has held several positions as an instructor and
clinician in the fields of radiology and neuro imaging, although her most recent educational and
clinical activity at the University of Southern California has been in a volunteer capacity. Id. at 2;
18 In his report, Dr. Zamvil again relied on a comparison to ADEM (a neurological condition that he agrees is
diagnostically distinguishable from TM), noting that it can occur within the proposed seventeen-day timeframe
proposed by Petitioner. Zamvil Rep. at 13.
15

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 16 of 44
Tr. at 200–02.19 She has also published numerous articles regarding radiology. Watanabe CV at
4–11.
Dr. Watanabe began by discussing angiography and the results of the August 8, 2013
I.J.
angiogram Mr. underwent during his initial hospitalization. Tr. at 171. As she explained, the
process of angiography includes rapidly injecting contrast dye during a CT scan in order to
visualize the patient’s arteries. Id. Though some of the literature offered by Petitioner questioned
the efficacy and reliability of angiography in diagnosing ischemic events such as infarction, Dr.
Watanabe opined that such tools could still be helpful when the clinical picture is unclear. Id. at
216–18; M. Vargas et al., Spinal Cord Ischemia: Practical Imaging Tips, Pearls, and Pitfalls, 36
I.J.
Am. J. Neuroradiology 825, 828 (2015), filed as Ex. 24 on Jan. 4, 2019 (ECF No. 52-4). Mr.
underwent a CT angiogram on August 8, 2013, and according to Dr. Watanabe, its results did not
reveal any vascular abnormalities. Tr. at 171–72; Watanabe Rep.at 6–7. These findings thus
eliminated some of the most common etiologies of spinal cord infarction from consideration. Tr.
at 171–72.
Dr. Watanabe next addressed the MRI imaging results that were obtained throughout the
I.J.'s
three-week period of Mr. hospitalization. Tr. at 173. The first MRI image to be addressed
was obtained on August 8, 2013. Id.; Watanabe Rep. at 7–8; Ex. 8D, filed Jan. 4, 2019 (ECF No.
50-4). In Dr. Watanabe’s view, it revealed “a very long segment of abnormal signal enhancement
throughout his cervical and going down into the thoracic cord,” which was initially interpreted to
be compatible with a diagnosis of TM. Id. at 173. Dr. Watanabe agreed with this interpretation,
though she acknowledged that these results were also compatible with other disease processes such
as stroke and polio. Id. at 173, 175. She also agreed that there was no evidence of enhancement in
this initial MRI (which would have suggested the presence of an active inflammatory process). Id.
at 209, 218. She later noted, however, that up to forty percent of patients experiencing TM will
have no MRI findings with initial enhancement, diminishing the significance of its absence. Id. at
211; Watanabe Supp. Rep. at 2 (citing G. Scotti & S. Gerevini, Diagnosis and Differential
Diagnosis of Acute Transverse Myelopathy. The Role of Neuroradiological Investigations and
Review of the Literature, 22 Neurological Sci. Supp. 69, 69–73 (2001), filed as Ex. 64 on Oct. 10,
2019 (ECF No. 85-2).
The second MRI images reviewed by Dr. Watanabe were obtained on August 17, 2013. Id.
at 177; Ex. 9B, filed Jan. 4, 2019 (ECF No. 50-7). These follow-up images revealed Gadolinium
enhancement—consistent with an inflammatory process and a breakdown of the blood-brain-
19 Dr. Watanabe’s credibility was somewhat diminished during cross examination, when she revealed that she is not
a listed faculty member on the University of Southern California Medical School’s website despite identifying herself
as a USC “Clinical Instructor” on her CV. Tr. at 201; Watanabe CV at 2. She also admitted that the work she does
there is done primarily on a “volunteer” basis—a detail that was not included in either her CV or her direct testimony.
Tr. at 201; Watanabe CV at 2. While these admissions somewhat undermined the probative value of Dr. Watanabe’s
testimony, I do not find that they established a firm basis for questioning the honesty or accuracy of her testimony or
opinions, which (except for the points she attempted to make about causation) largely stemmed from her professional
radiologic expertise.
16

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 17 of 44
barrier—that had not been present in the initial August 8th MRI. Tr. at 177–78, 193. Dr. Watanabe
explained this absence from the initial MRI study as the likely result of the MRI being conducted
so close in time to the onset of the disease process. Id. at 178. She also noted that the abnormal
signal was limited to the posterior portion of the spinal cord—opposite from the location of the
anterior spinal artery.20 Id. at 178–79. In her view, an anterior spinal artery infarction would not
affect the posterior segment of the spinal cord. Id. In addition, TM often features signal
abnormalities distributed throughout both the anterior and posterior segments of the cord, in a
pattern of two round bright spots known as “owl eyes” or “snake eyes,” though similar features
may be present after a spinal cord infarction. Id. at 179–80, 194–95. This abnormality establishes
damage to the anterior horn cells. Id. at 194. In 2016, three years after the initial onset of his
I.J.'s
symptoms, follow-up MRI imaging continued to reveal this pattern of damage in Mr.
spinal cord, further supporting TM over infarction. Id.; Ex. J, filed Sept. 17, 2019 (ECF No. 78-1).
The MRI imaging studies overall also revealed holocord involvement and mild diffusion
restriction. Tr. at 182–84, 190; Ex. 9F at 2. As Dr. Watanabe explained, holocord involvement
means that both the gray and white matter of the spinal cord are affected. Tr. at 182–83. She opined
that this pattern of involvement is typical of TM. Id. at 181, 183–84. She also explained that
diffusion restriction is a process in which the diffusion of water between cell membranes of tissue
in the body becomes impaired. Id. at 190. Although diffusion restriction is associated with TM, it
can also be seen in other conditions such as tumors, and abscesses, and she further explained that
it is “one of the most distinctive findings that one would expect for a stroke.” Id. at 190, 219; Y.
Kim et al., The Role of Diffusion-Weighted MRI in Differentiation of Ideopathic Acute Transverse
Myelitis and Acute Spinal Cord Infarction, 65 J. Kor. Soc’y Radiology 101, 101–08 (2011), filed
as Ex. 25 on Jan. 4, 2019 (ECF No. 52-5).
Because mild restriction diffusion was noted in Petitioner’s August 17th MRI, a spinal
angiogram was ordered and was performed on August 21, 2013. Tr. at 184, 189. That angiogram,
Dr. Watanabe concluded, provided no evidence of vessel cutoff,21 with the anterior spinal artery
appearing to her to be intact. Id. at 185. Though she acknowledged treater documentation of a
“cutoff,” Dr. Watanabe attributed this misinterpretation to how the results of the angiogram were
communicated by the treating radiologist. Id. at 224. Thus, notes regarding a cutoff do not support
a diagnosis of spinal cord infarction, but they likely mislead treaters to that conclusion. Id. at 189.
Dr. Watanabe also noted that there was no evidence of a blood clot at the time the
angiogram was performed, but she acknowledged the possibility that a previously existing clot
20 Dr. Watanabe acknowledged, however, that dorsal column involvement was not documented by any of Mr. I.J.'s
treating physicians, but she nonetheless maintained that her review of the MRI images revealed posterior cord
involvement. Id. at 222–23.
21 Dr. Watanabe used the term “cutoff” to describe an occlusion within the anterior spinal artery—something that she
did not see in Mr. I.J.'s spinal angiogram. Tr. at 186–87. If an occlusion is present, the dye that is injected into the
artery will abruptly stop, or “cutoff,” within the vessel. Id. at 187.
17

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 18 of 44
(that could have precipitated Petitioner’s symptoms) had dissolved. Tr. at 188. The absence of a
clear cutoff or blood clot within the anterior spinal artery was further proof to Dr. Watanabe that
a spinal cord infarction was an unlikely explanation for the radiological findings. Id. She did
observe a narrowing of the anterior spinal artery in the angiogram, but attributed it to inflammation
of the cord. Id. at 192. This opinion was supported by evidence of patchy enhancement—a finding
consistent with inflammation—on the August 17th MRI. Id. at 193.
Based predominantly on the August 17th MRI imaging, Dr. Watanabe concluded that Mr.
I.J.
more likely than not experienced TM rather than a spinal cord infarction. Tr. at 197. Her
overall impression was that the subsequent imaging did not evidence an embolism or thrombotic
event. Id. She admitted, however that the Working Group diagnostic criteria requires that all
inclusionary criteria are met while all exclusionary criteria are eliminated before a TM diagnosis
can be accepted. Id. at 208 (citing Working Group at 500). She similarly acknowledged that Mr.
I.J.
did not strictly meet these criteria, given the absence of pleocytosis and the lack of
enhancement on his initial MRI—though she argued that the MRI performed nine22 days after the
onset of his symptoms did show evidence of the required enhancement. Tr. at 209–10. To
I.J.'s
substantiate her position in light of these criteria (and Mr. clinical picture), Dr. Watanabe
opined that clinical judgment is not bound by rigid restrictions set forth on paper. Tr. at 210. This
argument was undercut by the medical record itself, however, because treating physicians did not
I.J.
unequivocally conclude that Mr. suffered from TM. See, e.g., Ex. 2 at 7 (listing discharge
diagnoses as tetraplegia, spinal cord infarction, and thrombophilia).
On rebuttal, Dr. Watanabe explained her process for reviewing MRI images, including a
description of the computer program and monitors that allowed her to review the images obtained
I.J.'s
during Mr. initial hospitalization. Tr. at 390–91. Utilizing such technology, Dr. Watanabe
observed that the majority of slides showed posterior cord involvement—contrary to the
contentions of Respondent’s expert. Id. at 316–18, 391–92. She again reiterated that posterior cord
involvement is not consistent with the “well defined geographic distribution” seen in anterior
spinal artery infarcts. Id. at 393. Dr. Watanabe also noted that the initial MRI performed on Mr.
I.J.
on August 8, 2013 (approximately eight hours after onset) was conducted with diffusion-
weighted imaging (“DWI”)23, though she acknowledged that this was unusual, and she was unable
to explain why DWI had been performed. Id. at 394, 396. According to Dr. Watanabe, that August
8th study did not show diffusion restriction—a characteristic that both she and Respondent’s expert
I.J.
agreed would have been present if Mr. had in fact suffered a spinal cord infarction. Id. at
22 Dr. Watanabe did concede that the Working Group diagnostic criteria require that repeat imaging studies, such as
an MRI, be repeated 2-7 days following onset, and that Mr. I.J.'s second MRI was performed outside of this
recommended timeframe. Tr. at 210.
23 The DWI technique uses water movement within the body to create a diagnostic image. See M. Thurnher & R.
Bammer, Diffusion-Weighted MR Imaging (DWI) in Spinal Cord Ischemia, 48 Neuroradiology 795, 799 (2006), filed
as Ex. 70 on Oct. 10, 2019 (ECF No. 86-4).
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I.J.
394–96. These observations bulwarked Dr. Watanabe’s opinion that Mr. more likely than
not had experienced TM rather than a spinal cord infarction.
Dr. Watanabe’s reports and testimony also touched in part on whether the Tdap vaccine
can cause TM, and she offered some additional case reports to support the contention. See, e.g.,
Tr. at 214–15, 221 (citing N. Gregg et al., Tdap Vaccination and Acute Demyelinating Events, 88
Neurology 1, 1–6 (2017), filed as Ex. 66 on Oct. 10, 2019 (ECF No. 85-4) (“Gregg”)). However,
such opinions greatly exceeded her professional expertise or knowledge, and since Dr. Zamvil was
by contrast well qualified to offer testimony and opinions on these matters, I have not given the
opinions she offered on this aspect of Petitioner’s case much, if any, weight.
3. Dr. Mark Levin
Dr. Levin, a hematologist, provided testimony and submitted a single expert report. Tr. at
231–90; Report, filed as Ex. 39 on Aug. 22, 2019 (ECF No. 68-1) (“Levin Rep.”). Following a
review of the medical record and the reports filed by Drs. Zamvil, Watanabe, and Alexander, Dr.
I.J.'s
Levin concluded that Mr. overall hematologic condition was insufficient to support a
diagnosis of spinal cord infarction. Levin Rep. at 5; Tr. at 236.
Dr. Levin received his bachelor’s degree from Yeshiva University, followed by a medical
degree from SUNY – Downstate Medical College. Dr. Levin Curriculum Vitae, filed as Ex. 62 on
Sept. 26, 2019 (ECF No. 81-1) (“Levin CV”). He subsequently obtained his master’s in business
administration from Herriott-Watt University in Scotland. Id. at 1. After obtaining his medical
degree, Dr. Levin completed his internship and residency in internal medicine at New York
Downtown Hospital and Hahnemann University Medical Center. Id. He also completed post-
doctoral training in hematology and oncology at the Long Island Jewish Hillside Hospital Medical
Center. Id. Dr. Levin is board certified in internal medicine and oncology. Id. While he has
previously held board certification in hematology, he has not sought recertification since 2000. Id.;
Tr. at 232, 258. Throughout his career, Dr. Levin has served as an associate professor of medicine
at several academic institutions in addition to his role as an attending clinician. Levin CV at 2. On
average, Dr. Levin sees approximately 400 patients a year, and has experience in evaluating
patients for stroke, though he indicated that such evaluations only happened “on occasion.” Tr. at
234. Beyond his clinical duties, Dr. Levin has also published numerous journal articles and
abstracts on topics within the fields of oncology and hematology. Levin CV at 6–11.
I.J.'s
The first hematologic factor addressed by Dr. Levin was Mr. family history of
venous thromboembolism (“VTE”), and whether it was significant in this case for diagnostic
purposes. Tr. at 237–39, 263; Levin Rep. at 2–3. Dr. Levin opined that a family history of VTE
I.J.
alone was an insufficient basis for concluding that Mr. had an increased prothrombotic risk.
I.J.'s
Tr. at 237–38; Levin Rep. at 2. He explained that genetic risk alone is quite low—Mr.
records did not contain any evidence for genetic risk beyond the family history notation—and
environmental factors may play a large role in the development of VTE. Tr. at 237–39; Levin Rep.
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at 2–3 (citing F. Couturaud et al., Factors that Predict Thrombosis in Relatives of Patients with
Venous Thromboembolism, 124 Blood 2124, 2129 (2014), filed as Ex. 40 on Aug. 22, 2019 (ECF
No. 68-2)). In addition, Dr. Levin noted that he lacked background evidence regarding the
I.J.'s
circumstances and context in which Mr. relatives experienced VTE, making it impossible
I.J.
for him to determine whether Mr. was at an increased risk for a prothrombotic condition.
I.J.
Levin Rep. at 3. He also clarified that in his view Mr. did not suffer from VTE or a deep
vein thrombosis (“DVT”), adding that a venous clot such as VTE or DVT is “essentially the same
phenomenon” as an arterial clot such as what could be seen in an anterior spinal artery infarction.
Tr. at 264–45.
Dr. Levin next addressed clotting risk and its relationship to Factor VIII levels (given the
I.J.
findings of elevated Factor VIII levels for Mr. Tr. at 239. As he explained, Factor VIII is
one of several hematologic requirements for blood clotting. Id. at 239–40. Factor VIII levels
average at about 100—and if too low can result in hemophilia, or the inability to clot. Id. at 240.
By contrast, when Factor VIII levels are too high, dangerous excessive clotting can occur. Id.
I.J.
Mr. presented with an elevated Factor VIII level of 196, consistent with the risk
factors associated with greater clotting like thrombosis or infarction. Id.; Ex. 2 at 166. While
treating physicians found this clinically significant, Dr. Levin attributed this elevation to
Petitioner’s alleged TM (and hence consistent with the diagnosis favored in Petitioner’s overall
claim). As he noted, inflammation—such as that seen within the spinal cord of a patient suffering
from TM—commonly leads to a secondary increase in Factor VIII. Tr. at 240–42, 282; Levin Rep.
at 4. This explanation thus relies on the assumption that spinal cord inflammation would have
systemic effects, but Dr. Levin did not provide any medical literature to support this supposition,
and he conceded that elevated Factor VIII levels can also occur after an infarction (and hence be
evidence of a propensity for the circumstances leading to infarction). Tr. at 283–84, 288–90.
The next risk factor addressed by Dr. Levin was that of obesity. Tr. at 243–44; Levin Rep.
at 3. At the time of his hospital admission, Mr. I.J. had a body mass index (“BMI”)24 of 32.25
Ex. 2 at 942. Dr. Levin explained that while a BMI over 30 meets the clinical requirement for
I.J.
obesity, Mr. just barely met that criterion, and this (coupled with his relatively young age)
would reduce the significance of this finding. Tr. at 243–44. Thus, it was Dr. Levin’s opinion that
Petitioner’s at worst mild obesity did not make it any more likely that he suffered from a spinal
cord infarction despite acknowledging that obesity is typically associated with an increased risk of
24 An individual’s BMI is a measure of body fat that gives an indication of nutritional status. Body Mass Index,
Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=82333 (last visited
Nov. 23, 2020).
25 In his report, Dr. Zamvil noted that Mr. I.J.'s BMI at the time of admission was 31.6. Zamvil Rep. at 3. The
medical record indicates, however, that Mr. I.J.'s BMI on August 8, 2013 was actually 32. Ex. 2 at 942. The
distinction between the two numbers is not large enough to give it great evidentiary significance.
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stroke. Id. at 244, 276–78.
Dr. Levin also discussed the role marijuana use26 may have played in Mr. I.J.'s clinical
presentation. Tr. at 244–45; Levin Rep. at 3. He acknowledged that marijuana is a risk factor for a
number of cardiovascular problems, but he did not find it to be significant for an increased
prothrombotic risk. Id. at 244. His review of the relevant literature revealed only one report that
I.J.
described two cases of marijuana-induced VTE—a condition Mr. did not suffer from. Id. at
244; D. Salhan et al., Cannabis-Induced VTE: Is it a Safe Recreational Drug?, 150 Chest Supp.
909A, 909A (2016), filed as Ex. 41 on Aug. 22, 2019 (ECF No. 68-3) (“Salhan”). Dr. Levin
acknowledged, however, that Salhan cited marijuana consumption as a risk factor for ischemic
stroke. Tr. at 275–76. He concluded nonetheless that marijuana consumption did not increase the
I.J.
likelihood that Mr. had experienced a spinal cord infarction. Id. at 244–45.
Finally, Dr. Levin compared incidence rates between TM and spinal cord infarction,
finding that while both conditions are relatively rare, TM is more common, occurring in 3 per
100,000 person-years,27 while primary and secondary spinal cord infarction occurs at a rate of 1.5
and 1.6 per 100,000 person-years respectively.28 Tr. at 242; Levin Rep. at 3–4; A. Qureshi et al.,
A Population-Based Study of the Incidence of Acute Spinal Cord Infarction, 9 J. Vascular
Interventional Neurology 44, 44 (2017), filed as Ex. 43 on Aug. 22, 2019 (ECF No. 68-5); T. West
et al, Acute Transverse Myelitis: Demyelinating Inflammatory, and Infectious Myelopathies, 32
Seminars Neurology 97, 97 (2012), filed as Ex. 44 on Aug. 22, 2019 (ECF No. 68-6). This, he
I.J.'s
seemed to suggest, further made it more likely that Mr. injury was TM (although opining
on statistical/epidemiologic issues like illness risk exceeded Dr. Levin’s expert qualifications).
C. Respondent’s Expert - Dr. David Alexander
Dr. Alexander, a neurologist, acted as Respondent’s sole expert, providing testimony at the
entitlement hearing in addition to preparing three reports. Tr. at 291–389; Report, filed as Ex. A
on Feb. 28, 2018 (ECF No. 41-1) (“Alexander Rep.”); Supplemental Report, filed as Ex. N on
Sept. 20, 2019 (ECF No. 79-1) (“Alexander Supp. Rep.”); Supplemental Report, filed as Ex. O on
I.J.
Jan. 2, 2020 (ECF No. 107-1) (“Third Alexander Rep.”). Dr. Alexander opined that Mr.
26 Medical records from Mr. I.J.'s initial admission note marijuana use in his social history. Ex. 2 at 38, 64, 79, 312.
27 The person years metric identifies the actual amount of time—in years—that an individual is at risk. See L.
Alexander et al., Calculating Person-Time, ERIC Notebook – University of Chapel Hill Department of Epidemiology,
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwiSwcb1_c3tAhUlxVkKHt
AhUlxVkKHWlmCsoQFj&url=https%3A%2F%2Fsph.unc.edu%2Ffiles%2F2015%2F07%2Fnciph_ERIC4.pdf&us
u=AOvVaw0KRjpRECJsQZt-9DhcmkuQ (last visited Dec. 14, 2020).
28 At hearing, Dr. Levin represented that TM occurs at a rate of three percent while spinal cord infarction occurs at a
rate of 0.6 percent. Tr. at 242. This statement was likely made in error. Dr. Levin’s report, however, is consistent with
the literature, and accurately reflects that secondary spinal cord infarction occurred in 0.0016 percent of study
participants, while TM occurred in 0.003 percent of study participants. Levin Rep. at 3–4.
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more likely than not experienced an anterior spinal artery infarction, as opposed to TM, and that
his condition was caused by factors other than the Tdap vaccine. Tr. at 299.
Dr. Alexander received his bachelor’s degree (neuroscience) from Amherst College before
obtaining his medical degree from the University of Minnesota Medical School. Updated Dr.
Alexander Curriculum Vitae at 1, filed as Ex. Q on Jan. 2, 2020 (ECF No. 107-3) (“Alexander
CV”). He then completed an internship in internal medicine at Boston University Medical Center
followed by a residency in neurology at Columbia Presbyterian Medical Center’s Neurological
Institute of New York. Id.; Tr. at 292. Dr. Alexander is board certified in neurology with
subspecialties and certifications in vascular neurology, neurorehabilitation, and spinal cord
medicine. Alexander CV at 2. He has held several academic positions at the University of
California, Los Angeles Medical School’s department of neurology, and he has held the position
of full-professor there since 2008. Id. at 2–3; Tr. at 292.
Dr. Alexander presently serves as the medical director and vice chief of staff for the
California Rehabilitation Institute—an in-patient facility that is primarily focused on neurological
rehabilitation. Alexander CV at 3; Tr. at 293. Throughout his career, Dr. Alexander has treated
between twenty and fifty patients with TM, but has treated thousands of patients who suffered
from a stroke. Tr. at 294. In addition to his clinical and academic duties, Dr. Alexander has
published several articles on subjects within the field of neurology and neurorehabilitation, though
he primarily focuses on his clinical practice and academic responsibilities rather than research.
Alexander CV at 11–14; Tr. at 295–96.
Dr. Alexander began by reviewing relevant definitions and the TM diagnostic criteria set
forth in the TM Working Group paper. Tr. at 302–05. TM describes general spinal cord
inflammation, and can be secondary to other conditions such as NMO, MS, and/or Lupus. Id. at
301–02. If a pre-existing causal infection cannot be identified, then the TM is deemed idiopathic.
Id. He emphasized that, overall, “it is pretty easy to be wrong about [TM],” and agreed that
Barreras found that up to fifty percent of TM diagnoses are wrong, with a large number of those
misdiagnosed patients actually suffered from a vascular abnormalities. Id. at 341–42 (citing
Barreras at 15).
Dr. Alexander largely echoed the testimony of Dr. Zamvil regarding the proper criteria for
a TM diagnosis (as embraced by the TM Working Group), but differed drastically in how to
understand or apply those criteria. In particular, while Dr. Zamvil advocated for their flexible
application, Dr. Alexander proposed they be utilized in a more stringent manner. See Tr. at 300,
302–05, 375. He also took issue with Dr. Zamvil’s testimony regarding gray matter involvement.
Id. at 304. According to Dr. Alexander, TM primarily targets white matter, and will not typically
affect gray matter. Id. at 304.
Next, Dr. Alexander explained the process of diagnosing spinal cord infarction (in
connection with his overall contention that the record best supports that as the proper diagnosis
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Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 23 of 44
over TM). Tr. at 305–06. Spinal cord infarction—which accounts for only one percent of all
strokes—is characterized by sudden onset of bilateral signs and symptoms. Id. at 305, 313. These
symptoms may develop over the course of hours, but timely administration of treatment can
reverse ischemic damage. Id. at 329.
Dr. Alexander also focused on the extent of gray matter involvement, which he explained
tends to be more extensive following a spinal cord infarction, because it is more sensitive to
ischemia. Tr. at 305. Gray matter involvement in the anterior horn cell area following a spinal cord
infarction may manifest as snake or owl eyes sign on MRI imaging studies. Id. at 309–10;
Alexander Rep. at 8. He also disputed the efficacy of angiography in diagnosing spinal cord
infarction, noting that although it is an imaging test commonly used to diagnose vascular problems
(such as arteriovenous malformations or arteriovenous dural fistulas), it is rarely used for purposes
of diagnosing a suspected spinal cord infarction. Tr. at 312, 366. The usefulness of angiography is
further reduced by the fact that clots are often resorbed, broken down, or embolized before an
angiogram can be performed. Id. Dr. Alexander estimated that approximately seventy-five percent
of all spinal cord infarctions have no identified etiology, and he thus did not find it unusual that
I.J.'s
Mr. treating physicians did not propose an etiology for his suspected infarction—though
some documentation was made in the record regarding his procoagulant state. Id. at 313–14, 336–
37.
MRI imaging in a patient who has suffered a spinal cord infarction is typically negative for
enhancement, but DWI—what he deems the “gold standard” measure for stroke assessment—may
be positive within fifteen minutes of ischemic changes. Tr. at 307–08, 323, 379–80. DWI
positivity, however, will fade within a couple of days. Id. at 379–80. He also allowed that DWI
positivity can be seen in some instances of TM, though he disputed the probative value of case
studies documenting this phenomenon. Id. at 383–84 (citing Kim at 103). Similarly, the presence
of “watershed” abnormalities, which reflect and are attributable to reduced circulation and
diminished vascular supply, are also consistent with spinal cord infarction. Id. at 310–11. But Dr.
Alexander also noted that CSF and dorsal column function are not typically affected in the event
of an anterior spinal artery infarction. Id. at 305–06.
Another point of dispute raised by Dr. Alexander was Petitioner’s experts’ use of the term
“holocord” to describe transverse involvement of the spinal cord. Tr. at 308; Alexander Rep. at 8.
In his view, “holocord” more accurately defines longitudinal involvement of the spinal cord,
beginning at the cervicomedullary junction in the neck and extending all the way down to the
conus, or tail, of the spinal cord. Tr. at 308; Alexander Rep. at 8. Dr. Alexander’s review of the
record did not reveal evidence of the extensive longitudinal involvement contemplated by his
proposed definition. Tr. at 308.
I.J.
Based on his review of the medical record, Dr. Alexander concluded that Mr. more
likely than not suffered an acute spinal cord infarction in the cervical region. Tr. at 314. This
determination began with the discharge diagnosis, in which treating physicians who had attended
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to Petitioner throughout his illness documented tetraplegia, spinal cord infarction, and
thrombophilia, but shied away from TM in the final differential. Id. at 314, 340; Ex. 2 at 4, 7. He
I.J.'s
further bulwarked his conclusion by referring to the results of Mr. MRI studies. Dr.
Alexander noted that the “long linear white streak down . . . the more anterior portion of the cord”
seen in the MRI conducted on August 8, 2013, was consistent with the “typical pencil-shaped
lesion that you see in spinal cord infarction,” along with evidence of ventral cord preservation. Tr.
at 300–01, 316 (citing Ex. 87 at 2). More specifically, Dr. Alexander opined that in cases of TM,
one would expect to see “more involvement of the cord” (evidenced by enhancement) rather than
a discreet stripe or contained anterior horn involvement. Tr. at 318.
Though the MRI images obtained on August 17, 2013 showed some evidence of dorsal
column involvement, Dr. Alexander noted that this finding had only been emphasized during Dr.
Watanabe’s hearing testimony. Tr. at 321. But even if accurate, Dr. Alexander considered this
finding to be not particularly noteworthy, because the anterior horn cells of the central gray matter
remained the area of greatest involvement. Id. at 321–22, 361–63. Similarly, the patchy
enhancement seen in the second MRI, though admittedly a potential sign of TM -related
inflammation, can also evidence spinal cord infarction in thirty to forty percent of cases. Id. at 324,
382–83. Ultimately, while he did not dispute the finding of dorsal cord involvement, Dr. Alexander
concluded that the overall presentation was more consistent with a spinal cord infarction. Id. at
379.
Dr. Alexander also raised the possibility that the “enhancement” documented in the second
August 2013 MRI (but not seen in the first) may not actually have reflected enhancement
attributable to cord inflammation, but rather a phenomenon known as “luxury perfusion,” whereby
blood flow is increased to an area previously affected by an infarction. Tr. at 324–25. Additionally,
Dr. Alexander opined that the DWI positivity seen in the second MRI was further evidence of an
acute spinal cord infarction, given the importance of that finding in diagnosing infarction
generally. Id. at 323. He did acknowledge, however, that if viewing the August 17, 2013 MRI in
isolation, it could support a diagnosis of TM (although he still maintained the overall record leaned
against that conclusion). Id. at 322, 325. He furthered this contention by noting that the MRI study
I.J.'s
conducted on November 15, 2016—three years after the onset of Mr. condition —
evidenced a “primarily ventral change” (which he interpreted as a pencil-shaped lesion in the
anterior horn) and an owl’s eyes abnormality, both of which he argued supported a diagnosis of
spinal cord infarction. Id. at 323–24.
Besides the above, Dr. Alexander disputed Dr. Watanabe’s findings regarding the
watershed abnormality seen on the August 17, 2013 MRI. Tr. at 325–26. Whereas Dr. Watanabe
interpreted the abnormality to extend beyond the area of expected involvement following an
anterior spinal artery infarction, Dr. Alexander expressed the opinion that the longitudinal position
of the abnormality, plus its posterior cord involvement, were more consistent with an acute spinal
cord infarction, and the extent of these abnormalities actually evidenced the central area of
maximum infarction and ischemia. Id. at 196, 311–12, 325–26.
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Dr. Alexander also deemed the August 21, 2013 spinal angiogram as supportive of his
theory. Tr. at 333; Ex. 2 at 451–52. The attenuation, filling defect, and segmental narrowing of the
anterior spinal artery that Dr. Watanabe agreed it revealed were consistent with a thrombotic event
such as an ischemic stroke. Tr. at 333–34. Even though a clot was not visible in the angiogram, he
explained that clots often dissolve, leaving behind residual arteriole narrowing. Id. at 334–35. Dr.
Alexander also addressed the “cutoff” discussed by Dr. Watanabe. Id. at 333. After reviewing the
angiogram report, he highlighted the note regarding an abrupt attenuation and filling defect at the
C6 level. Id. at 334; Ex. 2 at 452. He admitted, however, that the term “cutoff” was not used in the
record. Tr. at 367. Nonetheless, he concluded that a vessel abnormality existed, and he agreed with
the radiological interpretation noting “discontinuity” within the vessel. Id. at 368. And even if Dr.
I.J.
Watanabe was correct that Mr. had not experienced a cutoff of the vessel, treating physicians
I.J.
on the stroke team still believed Mr. suffered an infarction. Id. at 334. Further still, Dr.
Alexander emphasized that strokes do not require complete vessel occlusion, and the same
treatment would likely be rendered regardless. Id. at 334, 369–70.
Ultimately, after applying the TM Working Group diagnostic criteria, Dr. Alexander
concluded that a diagnosis of TM was not supported by the medical record. Tr. at 317. The initial
August 2013 MRI study did not reveal enhancement, and neither the MRI nor CSF studies29
produced evidence of inflammation that would occur in the presence of a central nervous system
demyelinating event. Id. at 317–18, 331. Additionally, the total area of cord involvement was fairly
limited, and was confined to the anterior horn cells thus preserving posterior column functions—
I.J.
though the total area of involvement was sufficient to cause the neurological symptoms Mr.
experienced. Id. at 318, 335–36. Dr. Alexander found such limited cord involvement to be more
consistent with a spinal cord infarction than TM. Id. at 316.
The thrombophilia studies—and more specifically the finding of elevated Factor VIII
levels—also supported Dr. Alexander’s proposed diagnosis. Though Dr. Zamvil attributed this
finding to the inflammatory processes specific to TM, Dr. Alexander argued that the limited
amount of tissue involved in TM is not enough to provoke systemic inflammation. Tr. at 343. Dr.
Alexander’s argument was further substantiated by the lack of evidence showing either local or
I.J.
systemic inflammation. Id. at 343–44. Regardless of whether Mr. suffered from TM or spinal
cord infarction, Dr. Alexander believed that he would have exhibited elevated Factor VIII levels
given the overall nature of his physical condition. Id. at 344.
Dr. Alexander further distinguished the competing diagnoses based on the timeframe in
I.J.
which Mr. experienced the initial onset of his symptoms. He opined that a sudden onset and
I.J.
rapid deterioration like that experienced by Mr. when he was boarding the bus and reaching
for his wallet was indicative of an apoplectic event such as vascular infarction, and not consistent
29 Dr. Alexander did allow for the possibility that immediate steroid treatment could mask pleocytosis, but he did not
believe this point was applicable because his understanding was that Mr. I.J. did not receive steroid treatment until
after the CSF study was completed. Tr. at 358.
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with how an inflammatory myelitis, such as TM, would present. Id. at 306–07, 319, 326–31, 372.
I.J.
Dr. Alexander also articulated that if Mr. had been suffering from TM, and the inflammatory
process had started two weeks post-vaccination as proposed by Petitioner, then the acute nature of
his symptoms onset was made even less likely. Id. at 327, 372. But Dr. Alexander also pointed out
I.J.'s
that treaters characterized the onset of Mr. condition as “apoplectic,” thus undermining
Petitioner’s proposed timeline of events. Id. at 373.
I.J.'s
Further, the stepwise, stuttering progression of Mr. symptoms was consistent with
collateral circulation following the initial onset of a spinal cord infarction. Id. at 329–30. This is
due to the body’s attempt to compensate and avoid ischemic damage by increasing blood flow to
the spinal cord. Id. This process, however, is not sustainable, and the failure of this system results
in ischemic damage to the cord. Id. at 330. Dr. Alexander also explained that back pain like that
I.J.
experienced by Mr. at the initial onset of his symptoms is typical of a spinal cord infarction,
but not of TM. Id. at 319, 327. On cross examination, however, Dr. Alexander did admit that the
overall timeline of symptom progression did fit the accepted temporal period for onset of TM
(between four hours and twenty-one days), and that treaters seemed to recognize, consistent with
I.J.
Petitioner’s testimony, that Mr. had experienced progressive symptoms over the course of
six to eight hours. Id. at 375–76. He maintained, however, that patients suffering from a spinal
cord infarction could also reach nadir within the same timeframe. Id. at 342.
I.J.
Dr. Alexander next addressed how the treatments Mr. received factor into
I.J.
determining a proper diagnosis. While Dr. Zamvil emphasized the role of treatments Mr.
received and his subsequent improvement in forming his opinions, Dr. Alexander disputed the
I.J.
diagnostic significance of these points. Tr. at 338–39. He noted that the improvements Mr.
experienced were mostly sensory in nature, and he opined that those improvements could have
been spontaneous. Id. He further explained that steroid treatment is non-specific and is not
necessarily indicated when TM is suspected. Id. Similarly, Dr. Alexander argued that the IVIG
I.J.
treatment Mr. received is also non-specific and has not been demonstrated to be an effective
I.J.
treatment for TM—though it is widely administered to TM patients and Mr. was noted as
having “marked improvement” following IVIG treatment. Id. at 352–56. He did ultimately admit
I.J.'s
that Mr. improvement subsequent to his IVIG treatment could evidence an inflammatory
condition. Id. at 352–55, 357.
After the entitlement hearing, Dr. Alexander submitted a second supplemental report
addressing Dr. Watanabe’s interpretation of the DWI MRI obtained on August 8, 2013, as well as
her conclusion (based on a comprehensive review of all relevant images) that the MRI performed
on August 13, 2013 demonstrated dorsal/posterior cord involvement—a conclusion he notes did
not appear in any of Dr. Watanabe’s pre-hearing reports. See generally Third Alexander Rep.
In this report, Dr. Alexander took issue with Dr. Watanabe’s interpretation of the DWI
MRI obtained on August 8, 2013. Third Alexander Rep. at 1–2. Whereas Dr. Watanabe concluded
that the images were negative for indicia of a spinal cord infarction, Dr. Alexander noted that the
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DWI revealed increased signal intensity in the anterior portion of the spinal cord—the same area
that demonstrated signal intensity in the T2 weighted MRI—consistent with an acute ischemic
stroke. Id. at 2. He noted, however, that the quality of the images was not typical for diagnostic
purposes, and there was no accompanying radiologic report for these images within the medical
I.J.
record. Id. He nonetheless concluded that the DWI MRI obtained just a few hours after Mr.
first began experiencing symptoms was most consistent with a spinal cord infarction. Id.
Dr. Alexander did agree with Dr. Watanabe’s conclusion that Mr. I.J.'s August 17th MRI
showed posterior/dorsal spinal cord involvement. Third Alexander Rep. at 5. But unlike Dr.
Watanabe, Dr. Alexander attributed these findings to a spinal cord infarction rather than TM. Id.
at 6–7. As he explained, posterior cord involvement is not uncommon in patients who have
experienced an anterior spinal artery infarction because both the anterior and posterior spinal
arteries are fed by the radiculomedullary artery. Id. at 3–5. In support of this contention, Dr.
Alexander cited several items of literature, including a study in which more than half of all
participants who experienced an anterior spinal artery infarction exhibited posterior cord
involvement. Id. at 4 (citing C. Masson et al., Spinal Cord Infarction: Clinical and Magnetic
Resonance Imaging Findings and Short Term Outcome, 75 J. Neurology Neurosurgery Psychiatry
1431, 1434 (2004), filed as Ex. D on Aug. 2, 2019 (ECF No. 67-2)); see also J. Novy et al., Spinal
Cord Ischemia: Clinical and Imaging Patterns, Pathogenesis, and Outcome in 27 Patients, 63
Archives Neurology 1113, 1117 (2006), filed as Ex. F on Aug. 2, 2019 (ECF No. 67-4); S.
Weidauer et al., Spinal Cord Ischemia: Aetiology, Clinical Syndromes and Imaging Features, 57
Neuroradiology 241, 244 (2015), filed as Ex. H on Aug. 2, 2019 (ECF No. 67-6) (“Weidauer”).
Thus, Dr. Alexander maintained that a clot in the radiculomedullary artery can result in
ischemic changes to both the anterior and posterior spinal cord. Third Alexander Rep. at 5–6 (citing
Weidauer at 244). Dr. Alexander supported his proposed interpretation by noting that the signal
distribution within the posterior column was limited to the area surrounding the left posterior spinal
artery and did not cross the cord midline as would be expected in TM. Third Alexander Rep. at 7.
Lastly, he noted that these findings would not have appeared on the initial MRI obtained just hours
I.J.'s
after the onset of Mr. symptoms because ischemic changes to the tissue would have
developed over time and only after secondary blood supplies to the cord were exhausted. Id. at 7–
8.
III. Procedural History
This matter commenced with the filing of the Petition on July 21, 2016. Over the following
months, Petitioner filed medical records in support of her claim. Respondent thereafter filed a Rule
4(c) Report on April 24, 2017, asserting that compensation was not appropriate in this case.
Respondent’s Report, filed April 14, 2017 (ECF No. 29). Petitioner subsequently filed expert
reports from Drs. Zamvil, Watanabe, and Levin along with supporting literature between the
summer of 2017 and fall 2019. Respondent filed a responsive report by Dr. Alexander on February
28, 2018, along with literature in opposition to Petitioner’s position. The parties filed their
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respective pre-hearing briefs over the summer of 2019, and a two-day entitlement hearing took
place on October 22-23, 2019. The parties elected to file post-hearing briefs, doing so on April 24,
2020. Petitioner’s Brief (ECF No. 112) (“Petitioner’s Post-Hearing Br.”); Respondent’s Brief
(ECF No. 113). The matter is now fully ripe for resolution.
IV. Applicable Legal Standards
A. Petitioner’s Overall Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).30
In this case, Petitioner does not assert a Table claim.
For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344,
1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (2005): “(1) a medical
theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and
30 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121,
124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V,
2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
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effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate
temporal relationship between vaccination and injury.”
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must
only be “legally probable, not medically or scientifically certain.” Id. at 549.
Petitioners may satisfy the first Althen pr ong 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). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury.
In discussing the evidentiary standard applicable to the first Althen prong, the Federal
Circuit has consistently rejected the contention that it can be satisfied merely by establishing the
proposed causal theory’s scientific or medical plausibility. See Boatmon v. Sec’y of Health & Hum.
Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also LaLonde v. Sec’y of Health & Hum. Servs.,
746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply
identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of
proof.” (citing Moberly, 592 F.3d at 1322)). Petitioners otherwise always have the ultimate burden
of establishing their overall Vaccine Act claim with preponderant evidence, regardless of what
evidentiary level of evidence on the “can cause” prong is required. W.C. v. Sec’y of Health & Hum.
Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell v. United States, 133 Fed.
Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s overall burden of proving
causation-in-fact under the Vaccine Act” by a preponderance standard).
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
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‘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).
Medical records and statements of a treating physician, however, do not per se bind the
special master to adopt the conclusions of such an individual, even if they must be considered and
carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,
test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y
of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates
that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and
cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the
opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their
suppositions or bases. The views of treating physicians should be weighed against other, contrary
evidence also present in the record—including conflicting opinions among such individuals.
Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious
for special master to weigh competing treating physicians’ conclusions against each other), aff’d,
698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,
2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review denied, 100 Fed.
Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v.Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must align 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. denied after remand, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. Appx. 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 rev. denied (Fed. Cl. Dec. 3,
2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Legal Standards Governing Factual Determinations
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [] relevant medical and scientific evidence contained in the record,” including “any
diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,
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condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, such as oral testimony surrounding the
events in question that was given at a later date, provided that such determination is evidenced by
a rational determination).
Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed.
Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his
contemporaneous medical records, the special master’s decision to rely on petitioner’s medical
records was rational and consistent with applicable law”), aff’d sub nom. Rickett v. Sec’y of Health
& Hum. Servs., 468 F. Appx. 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption
is based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people
honestly report their health problems to those professionals; and (iii) medical professionals record
what they are told or observe when examining their patients in as accurate a manner as possible,
so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez
v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.
Apr. 10, 2013); Cucuras v. Sec’y of Health & Hum. Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993
F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to
accurately report the onset of their daughter’s symptoms”).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005 WL
6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are generally found to be deserving of greater evidentiary weight than oral testimony—especially
where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec’y of Dep’t of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991) (citing United States
v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).
There are, however, situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“’[w]ritten
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records which are, themselves, inconsistent, should be accorded less deference than those which
are internally consistent’”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination
regarding a witness’s credibility is needed when determining the weight that such testimony should
be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs.,
No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional’s failure to document everything
reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;
or (4) a person’s purposeful recounting of symptoms that did not exist. Lalonde v. Sec’y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & 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 Pharmaceuticals,
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 (such as the district courts). Daubert factors are usually
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors
are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health
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& 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”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts 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)); see also Isaac v. Sec’y of Health &
Hum. Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot.
for rev. denied, 108 Fed. Cl. 743 (2013), aff’d, 540 F. Appx. 999 (Fed. Cir. 2013) (citing Cedillo,
617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on
a particular expert’s credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26
(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);
see also Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this
court has unambiguously explained that special masters are expected to consider the credibility of
expert witnesses in evaluating petitions for compensation under the Vaccine Act”).
Expert opinions based on unsupported facts may be given relatively little weight. See
Dobrydnev v. Sec’y of Health & Hum. Servs., 556 F. Appx. 976, 992–93 (Fed. Cir. 2014) (“[a]
doctor’s conclusion is only as good as the facts upon which it is based”) (citing Brooke Group Ltd.
v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993) (“[w]hen an expert assumes
facts that are not supported by a preponderance of the evidence, a finder of fact may properly reject
the expert’s opinion”)). Expert opinions that fail to address or are at odds with contemporaneous
medical records may therefore be less persuasive than those which correspond to such records. See
Gerami v. Sec’y of Health & Hum. Servs., No. 12-442V, 2013 WL 5998109, at *4 (Fed. Cl. Spec.
Mstr. Oct. 11, 2013), aff’d, 127 Fed. Cl. 299 (2014).
D. Consideration of Medical Literature
Both parties filed medical and scientific literature in this case, but not every filed item
factors into the outcome of this decision. While I have reviewed all the medical literature submitted
in this case, I discuss only those articles that are most relevant to my determination and/or are
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central to Petitioner’s case—just as I have not exhaustively discussed every individual medical
record filed. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016)
(“[w]e generally presume that a special master considered the relevant record evidence even
though he does not explicitly reference such evidence in his decision”) (citation omitted); see also
Paterek v. Sec’y of Health & Hum. Servs., 527 F. Appx. 875, 884 (Fed. Cir. 2013) (“[f]inding
certain information not relevant does not lead to—and likely undermines—the conclusion that it
was not considered”).
E. Consideration of Comparable Special Master Decisions
In reaching a decision in this case, I have considered other decisions issued by special
masters (including my own) involving similar injuries, vaccines, or circumstances. I also reference
some of those cases in this Decision, in an effort to establish common themes, as well as
demonstrate how prior determinations impact my thinking on the present case.
There is no error in doing so. It is certainly correct that prior decisions from different cases
do not control the outcome herein.31 Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351,
1358–59 (Fed. Cir. 2019); Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998).
Thus, the fact that another special master reasonably determined elsewhere, on the basis of facts
not in evidence in this case, that preponderant evidence supported the conclusion that vaccine X
caused petitioner’s injury Y does not compel me to reach the same conclusion in this case.
Different actions present different background medical histories, different experts, and different
items of medical literature, and therefore can reasonably result in contrary determinations.
However, it is equally the case that special masters reasonably draw upon their experience
in resolving Vaccine Act claims. Doe v. Sec’y of Health & Hum. Servs., 76 Fed. Cl. 328, 338–39
(2007) (“[o]ne reason that proceedings are more expeditious in the hands of special masters is that
the special masters have the expertise and experience to know the type of information that is most
probative of a claim”) (emphasis added). They would therefore be remiss in ignoring prior cases
presenting similar theories or factual circumstances, along with the reasoning employed in
reaching such decisions. This is especially so given that special masters not only routinely hear
from the same experts in comparable cases but are also repeatedly offered the same items of
medical literature regarding certain common causation theories. It defies reason and logic to
obligate special masters to “reinvent the wheel”, so to speak, in each new case before them, paying
no heed at all to how their colleagues past and present have addressed similar causation theories
or fact patterns. It is for this reason that prior decisions can have high persuasive value—and why
31 By contrast, Federal Circuit rulings concerning legal issues are binding on special masters. Guillory v. Sec’y of
Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y
of Health & Hum. Servs., No. 13-159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014). Special
masters are also bound within a specific case by determinations made by judges of the Court of Federal Claims after
a motion for review is resolved.
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special masters often explain how a new determination relates to such past decisions.32 Even if the
Federal Circuit does not require special masters to distinguish other relevant cases (Boatmon, 941
F.3d at 1358), it is still wise to do so.
ANALYSIS
I. Petitioner Has Established TM as His Likely Injury
In many Vaccine Program claims, prior to applying the Althen analytic framework it is
proper first to determine the nature of the petitioner’s injury, especially if the claimant’s causal
theory is dependent on the establishment of a specific injury. Broekelschen, 618 F.3d at 1345;
LaPierre v. Sec’y of Health & Hum. Servs., No. 17-227V, 2019 WL 6490730, at *16–17 (Fed. Cl.
Spec. Mstr. Oct. 18, 2019). That is the case here, since the parties strenuously dispute the proper
diagnosis—TM or spinal cord infarction—and since Petitioner’s causation theory wholly assumes
that the former is the correct one. Petitioner has not alleged that a spinal cord infarction could be
vaccine-caused, so a determination that this best characterized his injury would be fatal to his
claim.
Resolving this question is difficult. Both sides offered credible, reliably-bulwarked points
for their respective positions, supported in turn by fair and persuasive expert testimony. In addition,
I.J.'s
the medical record is ultimately equivocal on the matter. Unquestionably Mr. initial
treaters included both TM and infarction in their preliminary diagnostic differentials, noting the
testing and imaging results that supported both. Although by the time of Petitioner’s discharge it
could reasonably be concluded that treaters were leaning against TM as a final diagnosis, the record
I.J.'s
is ambiguous enough on the subject to leave more than a little room for doubt, and Mr.
post-hospitalization record offers no clarification of the matter. Dr. Watanabe’s reading of the
MRIs in this case also provided perspectives on the nature of Petitioner’s injury that were not fully
rebutted by Respondent (even after being provided the opportunity post-trial to do so).
The parties seemed to agree that the TM Working Group criteria were a good general
yardstick for evaluating if TM was present in this case—and it appears that not all were met fully.
Yet Petitioner successfully established either that certain of the criteria (for example, proof of
inflammation) had not completely been eliminated, or more generally that a TM diagnosis should
not be held to the literal standard set by the criteria. Tr. at 77–78, 80–83. And it is not my function
as special master to propose a “correct” diagnosis. Rather, my task is to weigh whether the
32 Consideration of prior determinations is a two-way street that does not only inure to the benefit of one party. Thus,
I would likely take into account the numerous decisions finding no association between vaccination and autism when
confronted with a new claim asserting autism as an injury and have informed such claimants early in the life of their
case that the claim was not viable for just that reason. But I would also deem a non-Table claim asserting GBS after
receipt of the flu vaccine as not requiring extensive proof on Althen prong one “can cause” matters, for the simple
reason that the Program has repeatedly litigated the issue in favor of petitioners.
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evidence preponderantly supports one conclusion over another—an analysis that leaves ample
room for doubt to remain in either direction, regardless of the final determination.
Petitioner did persuasively establish that he experienced sensory, motor, and autonomic
dysfunction consistent with TM. Tr. at 77. Similarly, he presented evidence that established the
bilateral nature of his symptoms despite the initial unilateral presentation. Id. at 78. Petitioner’s
position was further bulwarked by the absence of connective tissue disease, infectious disease,
abnormal void flows, and spinal radiation. Id. at 83–84. Other etiologies, such as optic neuritis and
I.J.'s
MS were also eliminated as potential causes for Mr. condition. Id. at 84. The progression
of Petitioner’s symptoms over the course of approximately eight or nine hours satisfied the
Working Group’s proposed diagnostic criteria and further distinguished Petitioner’s course from
that which is typical of spinal cord infarction. Id. at 57, 63, 83. And there is treater support for his
proposed diagnosis, and (unlike in other cases) a review of the medical record beyond his initial
onset does not suggest, based on the accumulation of additional information over time, that treaters
later abandoned TM as an explanation. On the other hand, Respondent’s expert Dr. Alexander
provided a number of reasonable points for why an infarction was more likely.
Overall, this issue is close, with the evidence largely in equipoise. The experts were equally
credible, making some points that were unrebutted while ceding others. Under such circumstances,
persuasive Vaccine Program caselaw counsels me to decide the matter in the Petitioner’s favor.
See Purtill v. Sec’y of Health & Hum. Servs., No. 18-832V, 2019 WL 7212162, at *6 (Fed. Cl.
Spec. Mstr. Nov. 12, 2019) (citing Roberts v. Sec’y of Health & Hum. Servs., No. 09-427V, 2013
WL 5314698 (Fed. Cl. Spec. Mstr. Aug. 29, 2013)). I do so here, and thus find that preponderant
evidence has been offered to establish that Petitioner more likely than not suffered from TM.
II. Petitioner Has Not Demonstrated that the Tdap Vaccine “Can Cause” TM
A. Relevant Case Law Regarding Vaccine Causality of TM
Claims alleging acute, nerve-demyelinating conditions like TM following vaccination are
common in the Vaccine Program. While some petitioners have obtained damages based on a
successful showing that TM was caused by the Tdap vaccine, most such cases have been resolved
through stipulations and proffers, leaving very few reasoned decisions addressing the issue of
causation—and even those that exist are not particularly recent. See, e.g., Raymo v. Sec’y of Health
& Hum. Servs., 11-654V, 2014 WL 1092274 (Fed. Cl. Spec. Mstr. Feb. 24, 2014) (petitioner
established entitlement to compensation for a claim alleging TM following receipt of the HPV,
Hepatitis A, meningococcal, and Tdap vaccines); Roberts, 2013 WL 5314698 (petitioner was
entitled to compensation for a claim alleging TM following receipt of the Tdap vaccine); Helman
v. Sec’y of Health & Hum. Servs., No. 10-813V, 2012 WL 1607142 (Fed. Cl. Spec. Mstr. Apr. 5,
36

Case 1:16-vv-00864-RTH Document 125 Filed 04/02/21 Page 37 of 44
2012) (petitioner was entitled to compensation for a claim alleging TM and NMO following receipt
of the Tdap vaccine).33
By contrast, several more recent, well-reasoned decisions have found that petitioners failed
in their effort to establish that the flu vaccine “can cause” TM, as required by the first Althen prong.
See Pearson v. Sec’y of Health & Hum. Servs., No. 16-09V, 2019 WL 3852633, at *13–14 (Fed.
Cl. Spec. Mstr. July 31, 2019); Forrest v. Sec’y of Health & Hum. Servs., No. 14-1046V, 2019
WL 925485 (Fed. Cl. Spec. Mstr. Jan. 28, 2019). Although such determinations are somewhat less
on point given the different vaccine at issue, they cast light on deficiencies in the reasoning that
led prior special masters to conclude that the Tdap vaccine could be causal of the same injury (and
also the theories offered in this particular case).
In Pearson, for example, an adult petitioner alleged that his receipt of the flu vaccine in
October 2012 precipitated TM, with onset within three months (although it took treaters
considerably longer to arrive at the diagnosis, which was not wholly supported by the record).
Pearson, 2019 WL 3852633, at *3–4. The Pearson petitioner made many arguments parallel to
those advanced in this case, e.g., that TM has an autoimmune-driven pathogenesis with molecular
mimicry as its mechanism. Id. at *6. Molecular mimicry was also relied upon in the Tdap-TM
cases mentioned above. See Roberts, 2013 WL 5314698, at *6; Helman, 2012 WL 1607142, at *3.
And the Pearson Petitioner relied specifically on Agmon-Levin’s review of post-vaccine TM cases
to support his causation showing. Pearson, 2019 WL 3852633, at *7. In reaction, Respondent’s
expert pointed out that Agmon-Levin in totality identified only two instances of TM post-flu
vaccine, and then only after a review of more than 35 years of literature to cull possible examples—
thus implicitly demonstrating how little evidence existed for an association. Id. at *9. The special
master denied compensation, observing (among other things) the low probative value of case
reports generally, as well as the error in overreliance on Agmon-Levin, given the facial limitations
of its findings. Id. at *14.
Forrest also featured an adult petitioner arguing that the flu vaccine caused TM, albeit with
a far shorter onset timeframe (within a day or more of vaccination). Forrest, 2019 WL 925495, at
*1. But there (as here) the petitioner also proposed molecular mimicry as the mechanism. Id. at
33
I issued a decision approximately two years ago denying entitlement for a claim alleging TM following receipt of
the DTaP vaccine (among others) in an infant child who experienced onset between thirty and thirty-six hours after
vaccination. Palattao v. Sec’y of Health & Hum. Servs., No. 13-591V, 2019 WL 989380 (Fed. Cl. Spec. Mstr. Feb. 4,
2019). The DTaP vaccine is the variant of the Tdap administered to infants and children. Notably, however, the
petitioners in Palattao expressly rejected the theory of molecular mimicry espoused in this case, and instead relied
solely on an aberrant proinflammatory cytokine response as the vaccine-instigated disease driver. Id. at *8. I found
that the onset had occurred too close in time to the vaccination, and that the petitioners had failed to “demonstrate that
cytokine upregulation in the periphery attributable to a vaccine can also trigger TM.” Id. at *36 (emphasis in original).
Thus, because of the difference in causation theory and overall circumstances, I find Pallattao to be less useful as a
guide to resolution of this matter.
37

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*3. In addition, Respondent (not Petitioner, as in this case) offered Baxter to undermine
Petitioner’s causation theory, highlighting that the very large-scale study saw no increased
incidence of TM after administration of the flu vaccine—parallel to the same finding Baxter
reached with respect to the Tdap vaccine (a finding Dr. Zamvil acknowledged at trial of this
matter). Id. at *5. Although the special master’s denial of entitlement in Forrest turned partially
on some matters not relevant herein (in particular, the short onset timeframe and its inconsistency
with the causal theory), the decision took special note of Baxter, observing the extent to which the
study undermined the claimant’s case (while acknowledging the “general rule” that petitioners are
not required to submit affirmative epidemiologic evidence as part of their prima facie case). Id. at
*5.
As I have already stated in my overview of the applicable legal standards to this case, none
of these prior decisions control the outcome herein. However, they do provide guidance in
evaluating the strength of the evidence offered by Petitioner herein in attempting to show that TM
can be vaccine-caused—and the evidentiary weakness of certain items relied upon to do so.
B. Petitioner’s Althen One Showing was Insufficient
Petitioner’s showing for the first Althen prong was only credibly supported by the
testimony and report of Dr. Zamvil (since neither Drs. Watanabe or Levin possessed the necessary
training or background to offer a reliable opinion on the “can cause”/causation prong).
Unquestionably, Petitioner has offered a variety of evidence in addition to Dr. Zamvil’s report to
support this prong. And, as noted above, there are reasoned decisions from the Program’s past that
support Petitioner’s case. I nevertheless find (based on consideration of Dr. Zamvil’s report,
testimony, the filed literature, and other, more recent decisions) that it has not been preponderantly
established that the Tdap vaccine can cause TM—and this determination, unlike my resolution of
the disputed injury question, is not close at all.
As a threshold matter, I note that Petitioner has mischaracterized the evidentiary standard
that is applied to the first Althen prong. See generally Petitioner’s Post-Hearing Br. at 46. Thus,
Petitioner incorrectly maintains that “reliable scientific evidence” is not required to meet his
preponderant burden—although perhaps in so asserting he confuses the fact that no particular class
of evidence (i.e. medical literature; research studies; expert reports; peer-reviewed articles; etc.)
need be offered with the overall obligation of Program petitioners to offer a reliable theory,
regardless of what specific items of evidence are gathered to support it. Knudsen, 35 F.3d at 548.
If certain individual components of evidence critical to a theory’s success are not themselves
reliable, that finding reasonably impacts the overall theory’s evidentiary preponderance. Petitioner
also erroneously suggests a theory’s mere plausibility is enough to meet the preponderant
standard—a contention that the Federal Circuit clearly rejected in the recent Boatmon decision.
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Boatmon, 941 F.3d at 1359.34 Petitioner thus fashions evidentiary standards for evaluating his
claim that are far easier to meet than the actual preponderant standard governing the claim.
Beyond this, the primary elements of Petitioner’s theory have several deficiencies. First,
scientific evidence not previously available when the TM/Tdap cases I mention above (and which
Petitioner references favorably) were decided six or more years ago does not support a causal
association between the Tdap vaccine and the development of TM. Compare Baxter
(epidemiologic study published in 2017) with Raymo, 2014 WL 1092274, at *19 (“[t]here are no
epidemiologic studies . . . linking or refuting a link between [TM] and vaccination”). Baxter is a
large-scale, comprehensive epidemiological study aimed at examining the risk of demyelinating
event following vaccination generally, and evaluated instances of the occurrence of two acute
demyelinating diseases (TM and ADEM) within a field of nearly 64 million vaccinations
(including almost six million Tdap recipients) derived from data maintained by the Vaccine Safety
Datalink. Baxter at 1456–57. Only seven cases of TM were reported between 5-28 days post-
vaccination—the very timeframe applicable herein. Id. at 1456–57. Baxter concluded that there
was no reliably-demonstrated association between vaccination and the subsequent development of
TM. Id. at 1456, 1461 (“[i]n conclusion, TM and ADEM are rarely, if ever, associated with
vaccines”).
Although it is unquestionably the case that Vaccine Program litigants are not required to
offer epidemiological evidence to prevail, special masters may take note of its existence and
consider it when determining if a claimant has met his burden of proof. See Palattao, 2019 WL
989380, at *37 (citing D’Toile v. Sec’y of Health & Hum. Servs., 726 F App’x 809, 811–12 (Fed.
Cir. 2018)). While I cannot state whether pre-Baxter decisions more favorable to Petitioner’s
theory, like Raymo or Roberts, would have been decided differently had the article existed when
they were issued, I can take Baxter into account in this unquestionably later case—and find that it
greatly damages Petitioner’s causation theory.
Ironically, in this case Baxter was offered by the Petitioner as an exhibit to Dr. Zamvil’s
report—making it difficult for Petitioner to argue herein (as many petitioners do when attempting
to rebut damaging epidemiologic proof) that my consideration of it amounts to “requiring”
Petitioner to have found positive epidemiologic evidence to prevail. Indeed, Dr. Zamvil expressly
relied on the Baxter article to support an association between TM and receipt of the Tdap vaccine.
34 Petitioner also maintains that special masters need not “apply gatekeeping standards of reliability pursuant to
Daubert,” citing Boatmon for this proposition as well. Petitioner’s Post-Hearing Brief at 46, citing Boatmon, 941 F.3d
at 1359. This is correct—but only in the narrow sense that it would not be legal error if a special master fails to apply
those standards. As I have already noted above, however, there is ample Federal Circuit support (cited even in
Boatmon) for embracing and applying the Daubert standards in Vaccine Act cases, for purposes of evaluating the
reliability of scientific and medical evidence (and thus what weight to give it). In the Program (unlike a federal district
court), Daubert does not function to limit what evidence is considered by a special master—but it does provide a way
to assess the trustworthiness of medical and scientific evidence, and hence the weight to give such evidence. I
consistently follow Daubert in this manner when I decide Vaccine Act cases—and it is my conclusion that I would
not be performing my function adequately if I did not do so.
39

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Tr. at 113–16; Zamvil Rep. at 7. But his assertions regarding its findings essentially ignored what
is so glaringly unfavorable about them. Thus, Dr. Zamvil attempted to redirect attention to the fact
that Baxter’s authors did find a slightly increased risk of ADEM following vaccination. Baxter at
1456 (noting eight reported cases of ADEM within 5-28 days of receiving the Tdap vaccine); Tr.
at 116. But ADEM is not the claimed injury (and Petitioner could not establish it on the present
record even if he so alleged). TM is the relevant injury—and therefore the findings in Baxter
specific to TM cannot simply be ignored.
Second, the applicability of prior decisions like Raymo, Roberts, and Helman—all of which
rely on literature similar to that offered herein, or more broadly involve theories parallel with
Petitioner’s theory of autoimmunity attributable to molecular mimicry—is limited by other
specific aspects of their respective holdings, or diminished by more recent determinations
involving the same causal theories producing TM. See Forrest, 2019 WL 925495, at *3 (citing
Caves v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 119, 135 (2011), aff’d without opinion, 463
F. App’x 932 (Fed. Cir. 2012)). In Raymo, for example, the petitioners prevailed based on a theory
that the tetanus toxoid component of the Tdap vaccine can cause TM via molecular mimicry and
bystander activation of IL-6—a proinflammatory cytokine which is associated with the
development of TM. Raymo, 2014 WL 1092274, at *18, 20. The special master noted, however,
that although molecular mimicry was an accepted medical/scientific explanation for many
autoimmune diseases, in acute TM “homology has not been demonstrated between any suspected
precipitating agent and the spinal cord nerve sheaths or axons.” Id. at *20. The special master thus
based her liability determination on the finding that the theory of bystander activation—a
mechanism not proposed by Petitioner’s experts in this case—was also a reasonable causal
explanation under the circumstances. Id. at *20; see also Dr. Zamvil Rep. at 9.
The petitioners in Roberts similarly relied on the theory of molecular mimicry to explain
how the Tdap vaccine could cause TM. Roberts, 2013 WL 5314698, at *6. The special master
deciding that case acknowledged that petitioners’ theory was supported by an expert opinion, but
included no further analysis to explain why the theory was persuasive. Id. And in Helman, only
two sentences of the special master’s analysis in total are dedicated at all to the first Althen prong.
Helman, 2012 WL 1607142, at *3. The special master concluded therein that the petitioner had
met his burden merely by providing expert testimony referencing causal mechanisms such as
molecular mimicry in addition to substantiating literature, though the special master did not
explain what literature was provided. Id. No analysis explained how the Tdap vaccine can cause
TM, thus greatly limiting the persuasive quality of such a determination. By contrast, and despite
the fact that the decisions do not involve Tdap, more recent determinations like Forrest and
Pearson constitute far more reliable guidance. These decisions in particular note the comparative
weakness of case study-oriented literature like Agmon-Levin, especially when weighed against
the value of Baxter.
Finally, and with the above as framework, I do not conclude that Petitioner’s specific
showing on the association between Tdap vaccine and TM was itself and on its own terms reliable
40

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or robust enough to preponderantly establish the first Althen prong.35 Thus, Dr. Zamvil relied on
molecular mimicry—a generally accepted scientific explanation for many autoimmune diseases,
to be sure, but one that cannot simply be invoked in every Vaccine Act claim to support causation.
Forrest, 2019 WL 925495, at *3 (citing Caves, 100 Fed. Cl. at 135). Rather, petitioners must
demonstrate (where they raise molecular mimicry as a possible mechanism) that it likely does link
the vaccine in question to the relevant injury. See Yalacki v. Sec’y of Health & Hum. Servs., No.
14-278V, 2019 WL 1061429, at *34 (Fed. Cl. Spec. Mstr. Jan. 31, 2019), mot. for review den’d,
146 Fed. Cl. 80 (2019). No such showing was made in this matter. Moreover, merely
demonstrating some homology between vaccine components and relevant self-structures based on
computer database searches does not carry the day. See Pek v. Sec’y of Health & Hum. Servs., No.
16-736V, 2020 WL 1062959, at *16 (Fed. Cl. Spec. Mstr. Jan. 31, 2020) (citing Blackburn, 2015
WL 425935, at *7 n.14)).
Dr. Zamvil’s assertions about the role the vaccine’s alum adjuvant could play in activation
of an aberrant innate response were even less reliable or persuasive. This argument relies mostly
on what is known as a general matter about the performance of adjuvants in promoting an immune
response—a noncontroversial assertion as far as it goes. But he has not shown, nor offered
evidence in addition to his testimony, that reliably suggests or establishes that vaccines containing
an aluminum adjuvant can, independent of anything else, cause a pathologic response not
otherwise shown to be vaccine-attributable. I have previously criticized similar arguments in other
cases, where petitioners try to convert what is known about a functioning immune process into
something pathologic. See, e.g., Olson v. Sec’y of Health & Hum. Servs., No. 13-439V, 2017 WL
3624085, at *20–21 (Fed. Cl. Spec. Mstr. July 14, 2017), mot. for review den’d, 135 Fed. Cl. 670
(2017), aff’d, 758 Fed. App’x 919 (2018). The argument is no better structured or advanced in this
case.
Petitioner also offered a few case reports, either collated in Agmon-Levin or contained in
independent items of literature, to bulwark his causal showing. But these too also were ultimately
of limited probative value—and not just for the reason that case reports generally are not given
significant weight when deciding Program cases, since they do not establish causation per se. See
Knorr v. Sec’y of Health & Hum. Servs., No. 15-1169V, 2018 WL 6991548, at *30 (Fed. Cl. Spec.
Mstr. Dec. 7, 2018) (citing W.C. v. Sec’y of Health & Hum. Servs., No. 07-456V, 2011 WL
4537887, at *13 (Fed. Cl. Spec. Mstr. Feb. 22, 2011), aff’d, 704 F.3d 1352 (Fed. Cir. 2013)). Riel-
35 Petitioner has argued that Respondent’s expert, Dr. Alexander did not himself rebut Dr. Zamvil’s theory, taking
specific issue with Dr. Alexander’s invocation of an Institute of Medicine report that purports to find no evidence
associating TM with tetanus toxoid-containing vaccines like Tdap. Petitioner’s Post-Hearing Br. at 49–50; Ex. A Ref.
1.My finding on the first Althen prong, however, is derived from a determination that Petitioner’s showing was itself
not preponderant—and that showing included especially damaging evidence like Baxter. I thus do not devote time
herein to weighing the competing strengths and weaknesses of each side’s expert contributions on this prong.
Petitioners must themselves meet their preponderant burden, no matter the relative strength of Respondent’s counter-
efforts—and this was not a case where a robust showing by the Petitioner merited consideration of Respondent’s
success in rebutting it.
41

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I.J.
Romero, for example, not only involved a young child rather than adult like Mr. but also
acknowledged that its observation of an association could simply be coincidental. Riel-Romero at
690. Agmon-Levin provided only four instances of association, and the weight this piece of
literature should receive overall has reasonably been questioned. Pearson, 2019 WL 3852633, at
*14. Other articles similarly offered limited numbers of case study instances. See, e.g., Gregg at 1
(describing two case reports of TM post-vaccination); F.S. Pidcock et al., Acute Transverse
Myelitis in Childhood, 68 Neurology 1474, 1476, 1479 (2007), filed as Ex. 55 on Sept. 13, 2019
(ECF No. 74-6) (“Pidcock”) (documenting thirteen instances of TM post-vaccination). But both
Pidcock and Gregg emphasize that the documented reports of post-vaccination TM could be
coincidental, and neither article claims to establish a causal relationship between vaccination and
the subsequent development of TM. Gregg at 4 (noting a possible association, but not
distinguishing between temporal and causal association types); Pidcock at 1479. These case reports
overall had some evidentiary value, and I have taken them into account (as my analysis should
demonstrate). But they are not enough to meet the preponderant burden, especially given the far
more comprehensive, contrary evidence provided by Baxter.36
All in all, the theory that the Tdap vaccine could cause TM was reasonably advanced in
this case, as the theory has found some success in the past—but it was not preponderantly
supported herein by sufficient reliable evidence, whatever the form, to find the first Althen prong
was met.
III. Althen Prongs Two and Three
Petitioner’s claim cannot succeed, given his failure to meet at least one of the three Althen
prongs. See Deshler v. Sec’y of Health & Hum. Servs., No. 16-1070V, 2020 WL 4593162, at *21
(Fed. Cl. Spec. Mstr. July 1, 2020) (citing W.C., 704 F.3d at 1356)). However, for purposes of
completion of my overall analysis, I will also discuss his success in meeting the other two.
Regarding the second, “did cause” prong, I find an absence of evidence that would allow
me to conclude that the Tdap vaccine likely produced Petitioner’s TM. Here, the inability to satisfy
certain of the TM Working Group criteria (acknowledged expressly by Dr. Zamvil), while not fatal
to Petitioner’s diagnosis contentions, was much more harmful to this Althen prong showing. Thus,
not only is there little evidence that Petitioner had experienced something amiss in the two week
post-vaccination period, but there was hardly any testing evidence (whether from serologic
sampling or MRI imaging) that would establish the existence of inflammation—a telltale sign
confirming the presence of the autoimmune process that Petitioner’s causation theory proposes
36 The fact that TM specifically, or vaccine injuries generally, are rare occurrences also is no defense to the insufficient
preponderant evidence offered in this case on causation. As a general matter, the Program is premised on the policy
consideration that vaccination is safe for the majority of individuals, but that in order to encourage use of vaccines
compensation for injuries should be permitted under specific defined circumstances. The Act thus inherently accepts
that vaccine injuries are uncommon—but their rarity is not a shield protecting petitioners from their evidentiary
obligations. Were it otherwise, claimants could prevail merely by pointing to their own individual “case study.”
42

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would have been instigated by the Tdap vaccine. The aspect of Dr. Zamvil’s opinion relying on
the pro-inflammatory characteristics of the alum adjuvant especially required some record
confirmation of excessive or unusual inflammation post-vaccination—evidence not found in this
record. There was also no evidence of any autoantibodies that might arguably be associated with
the asserted TM cross-reaction. And no treaters ever proposed that Petitioner’s injury, however
defined, was likely caused by his prior Tdap vaccine. At most, the record reveals instances in
which treaters assumed Petitioner had received a different vaccine (Hepatitis B) that they believed
could be associated with TM—but in some of these instances went on to opine that vaccine
causation was less likely than infarction given the diagnostic study results. See, e.g., Ex. 2 at 8, 61,
92, 230–31, 245–47. There is thus insufficient support in the record for the conclusion that the
Tdap vaccine could have caused Petitioner’s TM.
I additionally observe that the medical record suggests the existence of a pre-onset
intercurrent respiratory infection. Ex. 2 at 8. It is recognized that infection can be the instigating
cause of TM—and the presence of such an infection has in other cases been held to possibly
explain various demyelinating conditions. See, e.g., Deshler, 2020 WL 4593162, at *18 (two-thirds
of GBS cases follow an antecedent infection); Palattao, 2019 WL 989380, at *38 (evidence that
infant had upper respiratory infection prior to onset of TM undercut vaccine causality). The
evidence to support this alternative explanation is not itself particularly robust (certainly no
infectious agent was identified in testing), and I do not propose that it establishes a stronger
explanatory case than what Petitioner offered, or that (had the burden shifted to Respondent) it
was preponderantly established as an alternative cause. But it is additional evidence that was not
fully explained or distinguished by Petitioner, and thus it also undermined somewhat Petitioner’s
claim. See Deshler, 2020 WL 4593162, at *22.
By contrast, I find the record and evidence offered in this matter does support the
conclusion that Petitioner’s TM occurred in a medically acceptable timeframe, consistent with his
causation theory. As noted above, Petitioner asserts that his symptoms began just over two weeks
after his receipt of the Tdap vaccine—a timeframe which has consistently been deemed medically
appropriate in cases involving demyelinating conditions, including TM, following vaccination.
See, e.g., Raymo, 2014 WL 1092274, at *23 (onset of TM three to four days after receipt of the
Tdap vaccine); Schmidt v. Sec’y of Health & Hum. Servs., No. 07-020V, 2009 WL 5196169, at
*14 (Fed. Cl. Spec. Mstr. Dec. 17, 2009) (onset of TM one month after receiving the flu vaccine
falls within a medically acceptable timeframe). The onset timeframe was also consistent with Dr.
Zamvil’s persuasive testimony about the time it would take for a molecular mimicry-driven
process to manifest neurologic harm. But because Petitioner’s causation theory in this case was
not sufficiently supported with preponderant evidence, the consistency of the onset timing in this
case with Petitioner’s theory does not aid Petitioner.
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CONCLUSION
I.J.
Mr. was an engaging and highly sympathetic witness, and he plainly brought this
case in the good-faith belief that the Tdap vaccine he had received might be related to his
subsequent and sudden debilitating symptoms. He deserves praise for his aplomb in handling the
deficits his condition has imposed on him. Petitioner unquestionably has marshalled credible
support for his claim. And although it remains uncertain what his actual diagnosis should be, he
has carried his burden (albeit in a close case) of establishing that he more likely than not
experienced TM.
But the Vaccine Act permits me to award compensation to a petitioner alleging a “non-
Table Injury” only if he can show by medical records or competent medical opinion that the injury
could be, or was, vaccine-caused. And on these matters, the evidence is far less close, as even some
of the proof Petitioner himself offered undercuts his Althen prong one showing. Thus, there is
insufficient evidence to support an award of compensation, leaving me no choice but to hereby
DENY this claim.
In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the
court SHALL ENTER JUDGMENT in accordance with the terms of this decision.37
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
37 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices
renouncing their right to seek review.
44

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_16-vv-00864-3
Date issued/filed: 2021-07-20
Pages: 41
Docket text: **RE-DOCKETED 132 FOR POSTING TO THE COURT'S WEBSITE.** JUDGE VACCINE REPORTED OPINION re: granting 116 Motion for Review; granting 117 Motion for Leave to File Excess Pages. Signed by Judge Ryan T. Holte. (tb) Service on parties made. Modified on 8/16/2021 to correct date. (tb).
--------------------------------------------------------------------------------
Case 1:16-vv-00864-RTH Document 133 Filed 07/20/21 Page 1 of 41
In the United States Court of Federal Claims
No. 16-864
(Filed: 20 July 2021*)
***************************************
J., *
*
Petitioner, * Vaccine Act; Tdap Vaccine;
* Transverse Myelitis (“TM”); Molecular
v. * Mimicry.
*
SECRETARY OF HEALTH AND HUMAN *
SERVICES, *
*
Respondent. *
*
***************************************
Robert J. Krakow, Law Office of Robert Krakow, P.C., New York, NY, for petitioner.
Catherine Stolar, Trial Attorney, with whom were Gabrielle M. Fielding, Assistant
Director, Heather L. Pearlman, Acting Deputy Director, C. Salvatore D’Alessio, Acting
Director, and Brian M. Boynton, Acting Assistant Attorney General, Torts Branch, Civil
Division, Department of Justice, Washington, D.C., for respondent.
OPINION AND ORDER
Petitioner I.J. (“petitioner” or “I.J.”) moved for review of Chief Special Master
Corcoran’s decision that petitioner is not entitled to compensation under the National Vaccine
Injury Compensation Program, 42 U.S.C. §§ 300aa-1–300aa-34 (“Vaccine Act”). Petitioner
claims the tetanus-diphtheria-acellular pertussis (“Tdap”) vaccine he received on 22 July 2013
caused him to suffer transverse myelitis (“TM”). The Chief Special Master denied compensation
and found “insufficient preponderant evidence offered in this case stands for [p]etitioner’s
contention that the Tdap vaccine can cause TM, or that it did so in this case.” J. v. Sec’y of
Health & Human Servs., No. 16-864, ECF No. 125, at 2 (Fed. Cl. Spec. Mstr. Apr. 2, 2021)
(“Decision”) (emphasis omitted). Petitioner filed a motion for review of the Chief Special
Master’s decision, contending the decision was arbitrary and capricious, constituted an abuse of
discretion, and was contrary to law. For the following reasons, the Court GRANTS petitioner’s
motion and REMANDS this case to the Chief Special Master for further proceedings consistent
* This opinion was initially filed under seal pursuant to Vaccine Rule 18(b) of the Rules of the Court of Federal
Claims. The Court provided the parties 14 days to submit proposed redactions, if any, before the opinion was
released for publication. Neither party proposed redactions. This opinion is now reissued for publication in its
original form.

Case 1:16-vv-00864-RTH Document 133 Filed 07/20/21 Page 2 of 41
with this opinion. Additionally, the Court GRANTS petitioner’s motion for leave to exceed the
page limit.1
I. Background
On 2 April 2021, the Chief Special Master reissued a public version of his sealed 4
January 2021 decision in this case. See Decision at 1. As the basic facts of this case have not
changed significantly since the Chief Special Master’s 4 January 2021 decision, the Court’s
recitation of the background facts draws from the Chief Special Master’s decision.
A. Petitioner’s Medical History Prior to Tdap Vaccine and Onset of Symptoms
I.J. was a healthy and active thirty-four-year-old male with no significant past medical
history. Medical Records, ECF No. 8-2 (“Med. Recs. 8-2”) at 8 (NYU hospital records). I.J. has
a family history significant for thrombophilia. Id. at 65. I.J. received a Tdap vaccination on 22
July 2013. Medical Records, ECF No. 8-1 (“Med. Recs. 8-1”) at 1 (Vaccination and related
records). The administering nurse noted no complications or immediate reactions to the vaccine.
Id. at 1–2.
Two weeks after vaccination, on 6 August 2013, I.J. reported “minor cold” symptoms but
felt he quickly recovered from the symptoms. Med. Recs. 8-2 at 8. On 8 August 2013, I.J.
experienced the symptoms leading to hospitalization. Id. at 7. I.J. first experienced a “fire-like”
sensation that started in the right side of his upper back around the shoulder blade. Id. The pain
quickly radiated to his chest and down both arms. Id. On top of the pain, he began experiencing
a persistent tingling in both of his arms. Id. The symptoms continued to worsen and eventually
the pain and tingling spread to both of his legs. Id. at 8. When I.J. started experiencing
weakness in his arms and legs, he decided to go to a hospital. Transcript, ECF No. 103-104
(“2019 Tr.”) at 15:19–17:20 (Transcript of oral argument in front of Special Master on 23
October 2019). I.J. walked to the NYU Medical Center, where he was immediately admitted to
the emergency department. Id. Within hours of being admitted, I.J. lost the ability to use his
extremities and developed urinary retention. Id. at 27:10–13, 29:1–4.
B. Diagnostic Testing, Initial Treatment, and Follow-up Treatment
On 8 August 2013, I.J. received his first magnetic resonance imaging (“MRI”) in the
emergency department. Medical Records, ECF No. 50-2 (“Med. Recs. 50-2”) at 1–2 (Report
printed from DVD for MRI cervical spine with and without IV contrast bone performed on 8
August 2013). The MRI revealed increased T2/STIR signal “predominantly within the central
gray matter of the cervicothoracic cord extending from C3 to T1-2 level, most prominent from
the C6 to T1 level.” Id. at 1. The radiologist’s impression of the MRI, which the ER physician
agreed, was of a “long segment, central increased signal within the cervicothoracic spinal cord
1 Petitioner filed a motion for leave to exceed the page limit contemporaneously with filing his motion for review.
See Mot. for Leave to File a Mem. Exceeding 20 Pages Accompanying a Mot. for Review, ECF No. 117.
Respondent indicated at oral argument the government does not oppose the motion. See Transcript, ECF No. 128 at
5:8–10.
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without enhancement compatible with transverse myelitis.”2 Id. at 1–2. I.J. also received a CT
angiogram during his workup, which revealed no vascular abnormalities and was characterized
by the doctor as an “unremarkable CT of the abdomen and pelvis.” Medical Records, ECF No.
50-1 (“Med. Recs. 50-1”) at 1–2 (Report printed from DVD for CT angiograph abdomen with IV
contrast performed on 8 August 2013).
On 9 August 2013, I.J.’s treating neurologist, Dr. Stephen Galletta, observed the timeline
of I.J.’s symptoms developing over the course of six hours, as well as I.J.’s MRI findings, the
extremity weakness, and the loss of reflexes, were all consistent with a TM diagnosis. Med.
Recs. 8-2 at 20. Dr. Galletta nevertheless proposed several additional differential diagnoses,
including West Nile Virus (“WNV”), Neuromyelitis Optica (“NMO”)3, and Acute Disseminated
Encephalomyelitis (“ADEM”)4. Id. He believed the “high signal extending down the anterior
part of the cord” and the signal concentration in the ventral horns further supported his suspected
TM diagnosis. Id. Dr. Galletta recommended a spinal tap (lumbar puncture) to rule out
varicella-zoster virus5 (“VZV” or more commonly known as shingles) and WNV, oligoclonal
bands to rule out multiple sclerosis, a brain MRI, vasculitis screen, and a Lyme and Syphilis
serology to rule out differential diagnoses of each virus. Id. While being tested for differential
diagnoses, I.J. received five days of IV solumedrol and started a treatment of intravenous
immunoglobulin (“IVIG”) to treat TM. Id. The lumbar puncture revealed I.J.’s cerebrospinal
fluid had normal red and white blood cells, indicating no pleocytosis, and normal glucose and
protein levels, which ruled out meningitis or encephalitis. Id. at 38. Dr. Galletta “[d]oubt[ed]”
I.J. had contracted botulism,6 tetanus,7 bacteremia8 or other bacterial infection, or listeria.9 Id. at
40. The consult record by Dr. Galletta listed diagnoses of TM and acute TM. Id. at 38.
On 10 August 2013, I.J. was examined by an infectious disease specialist, who ordered a
number of tests to rule out several suspected infectious diseases. Id. at 40. The infectious
disease specialist believed the presence of pathogen gram-positive rods (“GPR”) in a portion of
2 Transverse Myelitis is inflammation of the spinal cord in which the functional effect of the lesions spans the width
of the entire cord at a given level. W.A. Newman Dorland, Dorland’s Illustrated Medical Dictionary at 1201 (33rd
ed. 2020).
3 Neuromyelitis Optica is combined, but not usually clinically simultaneous, demyelination of the optic nerve and
the spinal cord; it is marked by diminution of vision and possibly blindness, flaccid paralysis of the extremities, and
sensory and genitourinary disturbances. See Dorland, supra note 2, at 1249.
4 Acute Disseminated Encephalomyelitis is characterized by perivascular lymphocyte and mononuclear cell
infiltration and demyelination; it occurs most often after an acute viral infection, especially measles, but may occur
without a recognizable antecedent. It is believed to be a manifestation of an autoimmune attack on the myelin of the
central nervous system. See Dorland, supra note 2, at 607.
5
Varicella-zoster virus is human herpesvirus 3. See Dorland, supra note 2, at 2035.
6
Botulism is food poisoning with neurotoxicity resulting from the eating of spoiled food contaminated with
Clostridium Bacterium. See Dorland, supra note 2, at 238.
7
Tetanus is an acute infectious disease caused by Clostridium tetani, which produces the exotoxins tetanospasmin
and tetanolysin; it usually enters the body through a contaminated puncture wound or insect bite. See Dorland,
supra note 2, at 1875.
8
Bacteremia is the presence of bacteria in the blood. See Dorland, supra note 2, at 188.
9
Listeria is a genus of bacteria of the family Listeriaceae, made up of small, coccoid, gram-positive rods that have a
tendency to form chains and palisades; they are found in animal feces, on vegetation, and in silage. See Dorland,
supra note 2, at 1052.
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the test results represented contamination of the samples not due to bacterial infection. Id. The
specialist also noted I.J.’s improvement with steroids and IVIG. Id.
The follow-up evaluations on 11 August 2013 and 12 August 2013 noted I.J. was
continuing to improve with the steroid and IVIG treatments, specifically in upper extremity
function. Id. at 131. The record states I.J. received a “5 day course of steroids (Solumedrol) and
a 5 day course of IVIG,” and he had “marked improvement on his upper extremity strength
though still not at baseline.” Id. at 139. The lack of leg movements was “still a concern,”
although his sensation had “improved markedly since admission.” Id. The plan following this
evaluation was to start a five-day course of plasmapheresis (“PLEX”)10 on 13 August 2013. Id.
I.J. was evaluated by a rheumatologist on 13 August 2013 who reviewed all of his blood
work and studies. Id. at 146. The blood work revealed signs of mildly elevated Anti-Ro but the
rheumatologist felt that the level present was not high enough to cause TM. Id. at 50. I.J. also
had a central line placed and received his first PLEX treatment on the same day. Id. at 146.
I.J. continued to show improvement with IVIG, IVMP, and PLEX treatments, but the
improvement was limited to his upper extremities. Id. at 176. The treating physicians raised
concern for a possible anterior spinal artery (“ASA”) occlusion. Id. at 177. On 17 August 2013
I.J. was examined by an infectious disease specialist, Dr. Louie. Id. at 61. Dr. Louie stated I.J.
had received a Hepatitis B vaccination11, and Dr. Louie raised the concern of TM being
associated with vaccines. Id. Dr. Louie also noted the low probability of I.J. having an infection
based on I.J.’s improvement from the steroid and IVIG treatments and all tests being negative for
infection. Id. The doctor agreed with the plan of evaluating I.J. for possible ASA and
recommended a respiratory virus culture to rule out all possible infections as the cause for the
symptoms. Id.
I.J. received another MRI on 17 August 2013.12 Id. at 10. This MRI was conducted for
differential diagnoses between TM and spinal cord infarction. Id. Evidence supporting the
diagnosis of TM included I.J.’s age, the repeat occurrence, holocord involvement, and cervical
location. Id. Evidence supporting the diagnosis of spinal cord infarction included “restricted
diffusion in portions of lesion, the focal gray matter T-2 bright lesions noted on the current
examination as well as the prior examination, and the focal gray matter enhancement in portions
of lesions.” Id. A hematologist noted I.J.’s symptoms were consistent with a vascular event in
the spinal cord (embolization or venous thrombosis), highlighted I.J.’s family history of
thrombophilia, and recommended thrombophilia studies. Id. at 63–65.
10 Plasmapheresis is the removal of plasma from withdrawn blood, with re-transfusion of the formed elements into
the donor; this may be done for therapeutic purposes. See Dorland, supra note 2, at 1434.
11 Dr. Louie wrongly noted that I.J. received a Hepatitis B vaccination in the medical record. Id. at 61; Med. Recs.
8-2 at 38. I.J. actually received a DTaP vaccination in preparation for his new job as noted supra. Med. Recs. 8-2 at
38.
12 The medical record states that the MRI was done on 16 August 2013 for a differential diagnosis between spinal
cord infarction and transverse myelitis. Id. at 10. All parties refer to this MRI as the 17 August 2013 MRI. See Mot.
for Review at 18; HHS Alexander Expert Report, ECF No. 79-1 (“Alex. Exp. Rep.”) at 2 (HHS Expert Alexander’s
Opinion); Decision at 3. The medical record later refers to this MRI as the 17 August 2013 MRI. See Med. Recs. 8-
2 at 10.
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On 20 August 2013, I.J.’s treating physicians reviewed the 17 August 2013 MRI imaging
and interpreted the abnormalities to be “now more concerning for spinal cord infarct[ion] than
transverse myelitis.” Id. at 71. On 21 August 2013, I.J. was examined by a hematologist, Dr.
Hymes, who noted I.J. had an “acute onset of paraplegia with angiographic evidence of a spinal
artery occlusion,” but stated “the findings on the thrombophilia panel can be seen in
inflammation, and by themselves would not be responsible for the aggressive thrombotic process
as evident here.” Id. at 76. Dr. Hymes further noted the hematology panel was negative for a
“lupus anticoagulant,” which, if positive, “would be the most likely explanation of a spinal cord
infarction.” Id. Dr. Hymes stated an embolic lesion “remain[ed] the most likely diagnoses,”
even though the site of the embolus remained “cryptic.” Id.
I.J. was also examined on 21 August 2013 by an internist, Dr. Taff, who examined the
differential diagnoses of TM and spinal cord infarct based on the most recent MRIs. Medical
Records, ECF No. 8-3 (“Med. Recs. 8-3”) at 230 (Additional NYU Medical Records). Dr. Taff
noted the “[p]atient age, holocord involvement and cervical location favor[ed] transverse
myelitis,” but a “spinal cord infarct [was] suggested by restricted diffusion in portions of [the]
lesion.” Id. at 230–31. Dr. Taff also raised the concern of I.J.’s immunization record because of
the concern TM could happen after Hepatitis B vaccinations. Id. at 231. Dr. Taff recommended
a CT angiogram for “further evaluation of spinal arterial supply.” Id.
Dr. Ahn, a physician specializing in spinal cord rehabilitation, provided an opinion
regarding I.J.’s spinal cord angiogram results from 22 August 2013.13 Petitioner’s Memorandum
in Supp. of Mot. for Review of the Special Master’s Dec. Filed on Jan. 4, 2021, ECF No. 118
(“Mot. for Review”) at 15–16 (Petitioner’s Memorandum in Support of Motion for Review of the
Special Master’s Decision). Dr. Ahn suggested the inflammatory process as shown in the
radiographic studies was associated with TM. Id. Dr. Ahn noted the etiology of the findings was
unclear and the subacute changes could be related to “an earlier thrombotic event,” but the “more
extensive distribution of the lesion present on MRI[] could represent passive compressive or
active perivascular inflammatory changes arising from the associated cervical spinal pathology
swelling.” Id. Dr. Ahn accepted I.J. to be transferred to the rehabilitation center and noted the
admitting diagnosis as “transverse myelitis with C5 tetraplegia, sensory incomplete.” Med.
Recs. 8-3 at 326.
On 26 August 2013, I.J.’s attending neurologist, Dr. Sanger, opined the ASA blockage at
C5 could have been due to spinal cord swelling and provided his clinical opinion of I.J. being
diagnosed with TM. Id. at 281. He noted in the medical record that I.J. was “found to have
transverse myelitis.” Id. Prior to I.J.’s transfer to the rehabilitation center, his neurologist, Dr.
Foo, noted a diagnosis of acute TM, TM, thrombophilia, and tetraplegia. Med. Recs. 8-3 at 286.
Dr. Foo also noted an “ASA blockage at C5 level,” but felt the “stenosis, occlusion could be due
13 Petitioner cited this medical record as “Ex. 5 at 41” but the only exhibit in the record labeled as “Ex. 5” is Exhibit
5a. See Mot. for Review at 16. This exhibit is only one page in length and is a letter explaining that two pages were
omitted from the medical record production filed as Exhibit 5. There is no Exhibit 5 in the record. See Medical
Records, ECF No. 15 at 1 (Notice of Filing of Medical Records by ECF – Exhibit 5a). Since the exhibit was not
submitted by the petitioner, the Court must cite from the Petitioner’s Motion for Review.
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to cord swelling.” Id. at 291. I.J.’s immunologist, Dr. Sterling, noted I.J.’s “acute progressive
weakness” and stated the diagnosis is “less likely spinal infarct per neuro[logist].” Id. at 92. Dr.
Sterling also noted “recent vaccinations could be related with transverse myelitis.” Id. Dr.
Sterling recommended another consult with neurology to determine what pre-employment
vaccines I.J. received and the dates of the vaccines as they may be associated with the TM
diagnosis. Id. In I.J.’s discharge summary, Dr. Foo noted that I.J. was improving with the
treatment of the steroids and IVIG for TM. Id. at 9.
I.J. was discharged but continued to receive rehabilitation for several months in intensive
inpatient rehabilitation. Medical Records, ECF No. 22-1 (“Med. Recs. 22-1”) at 3–4 (Medical
Records from Brandywine Nursing Home). I.J. was first transferred to Brandywine Nursing
Home, where he was in therapy for approximately six months. Id. He was then transferred to
Lindenwood Nursing Facility on 22 August 2014 for continued nursing and rehabilitative care.
Medical Records, ECF No. 17-1 (“Med. Recs. 17-1”) at 4 (Medical Records from Linden Center
for Nursing and Rehabilitation). I.J. was admitted to the Lindenwood facility with a diagnosis of
“spinal cord infarction versus transverse myelitis, paraplegia, and thrombophilia.” Id. I.J. spent
seven months at Lindenwood before being discharged on 20 March 2015. Id. at 1. His diagnosis
at the time of discharge was “unspecified spinal cord diseases.” Med. Recs. 17-1 at 380. The
record does not contain documentation of I.J.’s current medical or rehabilitative services since
his discharge in March 2015. Decision at 8.
II. The Vaccine Petition and Hearing Before the Special Master
Petitioner filed his vaccine petition against the Secretary of Health and Human Services
(“respondent”) on 21 July 2016. See Pet. for Vaccine Compensation, ECF No. 1. Petitioner
requested compensation for injuries he suffered from flaccid paraplegia and tetraplegia related to
transverse myelitis he allegedly developed after receipt of a Tdap vaccination on 22 July 2013.
See id. at 1. Respondent filed a response to petitioner’s motion for review on 4 March 2021. See
Respondent’s Mem. in Resp. to Pet’r’s Mot. for Review, ECF No. 122 (“Resp. to Mot. for
Review”).
A. Declarations and Testimonies Presented Before the Chief Special Master
1. Petitioner’s Testimony
I.J. submitted an affidavit and provided testimony in front of the Chief Special Master at
an entitlement hearing. Petitioner’s Affidavit, ECF No. 6-1 (“Affidavit”) (Declaration of I.J.
seeking compensation for injuries sustained after receiving a Tdap vaccination); 2019 Tr. at
7:18–40:14. I.J. stated in the affidavit and at the hearing the only health problems he
experienced throughout childhood and adulthood were gallstones and a torn anterior crucial
ligament (“ACL”). Affidavit at 2–3; 2019 Tr. at 11:9–12:4. The ACL tear required arthroscopic
surgery, and at pre-surgery testing I.J. was declared healthy and cleared for surgery. Affidavit at
2–3; 2019 Tr. at 12:5–12.
I.J. explained he was offered a job as a patient advocate at NYU Medical Center in 2013.
Affidavit at 2; 2019 Tr. at 12:13–23. As a prerequisite to employment as a patient advocate, I.J.
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had to receive a Tdap vaccination. Affidavit at 2; 2019 Tr. at 13:5–13:13. I.J. received the Tdap
vaccination on 22 July 2013. Affidavit at 2; 2019 Tr. at 13:11–13. Approximately two weeks
after receiving the Tdap vaccine, I.J. began experiencing various symptoms. Affidavit at 2–3;
2019 Tr. at 14:5–15:11. The symptoms quickly worsened, causing him to walk to NYU Medical
Center for evaluation. Affidavit at 2–3; 2019 Tr. at 15:11–17:20. Upon arrival at NYU Medical
Center, I.J. was admitted to the emergency room with worsening symptoms, including
progressive weakness, numbness, and “needle-like” sensations. 2019 Tr. at 20:9–21:9.
Shortly after admission to the emergency department, I.J. underwent an MRI. Id. at
24:5–7. I.J. recalls being fully mobile prior to the MRI, but states he lost all mobility from the
neck down immediately following the MRI. Id. at 24:8–27:13. I.J. also exhibited urinary
retention, requiring catheterization, and difficulty regulating his body temperature. Id. at 28:20–
30:4. While in the hospital, I.J. received IVIG and plasmapheresis treatments, which led to a
regaining of some mobility in his arms. Id. at 28:5–15.
Going through rehabilitation after leaving the hospital, I.J. was eventually able to support
his own body weight with his arms. Id. at 31:19–25. After I.J.’s extended time at Rusk
Rehabilitation, he was transferred to Brandywine Nursing Home for additional therapy and
rehabilitation. Id. at 32:1–3. I.J. spent six months at Brandywine before being transferred to
Lindenwood Nursing Facility. Affidavit at 3–4; 2019 Tr. at 33:23–25. I.J. was eventually
discharged from Lindenwood but continues physical therapy at Rusk Rehabilitation and through
a community access program. 2019 Tr. at 34:22–37:4. I.J. has recovered some strength in his
legs and mobility in his arms, but he does not have the same dexterity he had prior to the onset of
his injury. Id. at 35:20–36:12.
2. Petitioner’s Experts
a. Dr. Zamvil, M.D., Ph.D.
Dr. Zamvil, a neuroimmunologist, testified before the Chief Special Master and offered a
single expert report. See 2019 Tr. at 40:15–160:17; Expert Report of Scott S. Zamvil, M.D.,
Ph.D., ECF No. 31-1 (“Zamvil Ex. Rep.”) (The expert report of petitioner’s expert witness, Dr.
Zamvil). Dr. Zamvil stated the time frame of I.J.’s vaccination “corresponds to both the
expected cellular and humoral response to a vaccination” and opined both that Tdap vaccinations
can cause TM generally and the vaccine did specifically cause Petitioner’s TM. Zamvil Ex. Rep.
at 6–7. Dr. Zamvil described the inflammation criterion set by the Transverse Myelitis Working
Group and explained whether he believed “that criterion is met by the evidence in this case.” Id.
at 80:24–82:15 (citing Transverse Myelitis Consortium Working Group, Proposed Diagnostic
Criteria and Nosology of Acute Transverse Myelitis, 59 NEUROLOGY 499 (2002), ECF No. 63-4
(“the Working Group”)). He addressed the issue of inflammation being established by
pleocytosis,14 elevated immunoglobin G (“IgG”) index, or gadolinium15 enhancement. Id. at
81:4–15. Dr. Zamvil noted I.J.’s cerebrospinal fluid16 (“CSF”) analysis was negative for
14 Pleocytosis is the presence of a greater than normal number of cells in the cerebrospinal fluid. See Dorland, supra
note 2, at 1438.
15 Gadolinium is a silvery white, malleable, ductile, heavy metal, rare earth element. See Dorland, supra note 2, at
745.
16 Cerebrospinal fluid is fluid from the brain and spinal cord. See Dorland, supra note 2, at 328.
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pleocytosis, but he opined this was an insufficient reason to rule out TM as a diagnosis because
only fifty-seven percent of patients experiencing TM will exhibit pleocytosis. Id. at 81:16–
82:21. Dr. Zamvil also agreed I.J. did not have an elevated IgG index or gadolinium
enhancement on his initial MRI test performed on 8 August 2013. Id. at 81:8–15. The MRI
performed on 17 August 2013 revealed inflammation, but a repeat CSF study was not performed.
Id. at 68:22–69:17. Dr. Zamvil opined if the physicians had repeated the CSF testing, “it’s
possible and . . . maybe more likely” the repeated CSF would have shown inflammation given
“enhancement on the [17 August 2013] MRI in that manner.” Id. at 69:18–22.
Additionally, Dr. Zamvil opined the “bubble study” did not support spinal cord
infarction17 (“SCI”) as a proper diagnosis. Id. at 55:13–24. The study did not reveal a right-to-
left shunt, and Dr. Zamil opined the lack of a right-to-left shunt is strong evidence against a SCI
diagnosis. Id. at 56:6–57:3 (testifying the lack of right-to-left shunt “would pretty much
eliminate that particular possible etiology if a patient has a stroke”). Dr. Zamvil also opined
I.J.’s prolonged “stuttering” onset of symptoms was more consistent with TM than SCI. Id. at
60:5–20 (“[H]e had a symptom. He developed another symptom. Then it may have progressed
again . . . a stuttering course that occurs for more than six hours is consistent with a myelitis.”).
I.J. reached nadir at least six hours after his initial onset of symptoms. Id. at 57:10–13 (“The
time period from onset of symptoms, from the pinch or whatever upper sensory type symptoms
in the neck, to maximal deficit here was at least six hours.”). Dr. Zamvil stated SCI more
commonly presents as “apoplectic” and causes patients to reach nadir within minutes of onset,
while TM generally causes patients to reach nadir over the course of several hours. Id. at 60:17–
20 (“[A]poplectic onset, maximal deficit at onset, is very consistent with an infarct. A stuttering
course that occurs for more than six hours is consistent with a myelitis.”).
Dr. Zamvil proposed molecular mimicry as a potential mechanism of Tdap causing TM.
Zamvil Ex. Rep. at 9 (“Through molecular mimicry, vaccination with TDaP could lead to
amplification of pathogenic T cell or B cell (antibody) immune response causing inflammation in
the spinal cord.”). Dr. Zamvil conducted a BLAST search18 to find homology between Tetanus
toxoid (“TT”), “one of the three component protein antigens in TDaP[,] . . . with human myelin
proteins.” Id. at 10. Dr. Zamvil first evaluated the entire tetanus sequence and identified “[t]wo
clear positive examples of homology”: “The TT amino acid sequence 264-274 shared 64% (7 of
11) identity with myelin regulatory factor-like protein amino acids 671-681 . . . , and TT
sequence 366-375 shared 60% (6 of 10) identity with myelin-associated neurite-outgrowth factor
inhibitor amino acids 180-189.” Id. Dr. Zamvil then focused on “TT amino acid sequence 830-
844, . . . [b]ecause TT p830-844, like intact TT, elicits a strong response in TT vaccinated
individuals.” Id. at 10–11. Dr. Zamvil found “[r]emarkably, there was an 83% [sic] (5 of 6
amino acids) between sequence 887-892 and amino acids 151-156 of proteolipid protein (PLP) . .
. , the most abundant encephalitogenic protein in myelin tissue.” Id. at 11. Accordingly, Dr.
17 Spinal Cord Infarction is the formation of an area of coagulation necrosis in a tissue due to local ischemia
resulting from obstruction of circulation to the vessel within the spinal cord. See Dorland, supra note 2, at 922–23.
18 BLAST is an acronym for the “Basic Local Alignment Search Tool,” a tool which finds regions of similarity
between biological sequences. The program compares nucleotide or protein sequences to sequence databases and
calculates the statistical significance. NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION,
https://blast.ncbi.nlm.nih.gov/Blast.cgi (last visited June 9, 2021).
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Zamvil concluded “it is plausible that TDaP vaccination elicited T cells from [I.J.] could have
responded to a CNS autoantigen like PLP.” Id.
Dr. Zamvil further reviewed medical literature to support the position “[t]he association
of transverse myelitis and Tetanus toxoid (TT)-containing vaccination was clear.” Id. at 7 (“In a
systematic review of the literature, between 1970 and 2009 there were 37 cases of transverse
myelitis associated with vaccination, including four that occurred after DTP [(diphtheria–
tetanus–pertussis)] (this includes cellular (killed) and acellular vaccines) or DT [(diphtheria–
tetanus)].”) Dr. Zamvil noted “as transverse myelitis following TDaP is a rare event, one should
recognize that it has been challenging for epidemiologists to establish a relative risk.” Id. (citing
Roger Baxter et al., Acute Demyelinating Events Following Vaccines: A Case-Centered Analysis,
63 CLIN. INFECT. DIS. 1456 (2016)).
b. Dr. Alyssa Watanabe
Dr. Watanabe examined I.J.’s medical record and imaging studies and rendered an
opinion on the diagnosis of TM versus stroke. Expert Report, ECF No. 52-1 (“Watanabe Ex.
Rep.”) at 1 (Dr. Watanabe’s expert report concerning Tdap causing I.J.’s TM based on medical
imaging tests). Dr. Watanabe testified the CT angiogram I.J. underwent on 8 August 2013
revealed no vascular abnormalities, which did not support a finding of infarct or stroke. 2019 Tr.
at 171:12–14, 172:15–22 (“[T]he most common . . . underlying factor in getting a stroke in your
spinal cord is having arthrosclerotic disease or some sort of plaque or disease involving your
aorta or the arteries leading up.”). Dr. Watanabe then discussed the MRI test I.J. underwent on 8
August 2013 MRI. Id. at 172:7–10. Dr. Wanatabe agreed with I.J.’s treating physicians’
interpretation of the imaging “as compatible with transverse myelitis.” Id. at 172:14–16 (“[The 8
August 2013 MRI] was interpreted by the radiologist at NYU as compatible with transverse
myelitis, and I would have read it the same way.”). She noted the 8 August 2013 scan showed
no enhancement. Id. at 218:16–19.
Dr. Watanabe noted I.J.’s 17 August 2013 MRI showed gadolinium enhancement
consistent with an inflammatory process. Id. at 178:10–19. Dr. Watanabe opined “the patchy
enhancement throughout the area of the spinal cord” in the 17 August 2013 MRI “indicates that
there was a blood-brain barrier breakdown, inflammation, and development of necrosis and cell
death, which can be part of what occurs in transverse myelitis.” Id. at 193:14–22. Dr. Wanatabe
noticed the “contrast enhancement” seen in the 17 August 2013 MRI but not in the 8 August
MRI was “not unexpected,” due to the earlier MRI being performed “so early in the onset of
[I.J.’s] disease.” Id. at 177:23–178:6 (“In the literature, in a series of cases where patients were
imaged within 14 hours of onset, 80 percent of those patients did not show anything lighting up .
. . in that very early phase.”). Dr. Watanabe also pointed out the “abnormal cord signal in the
posterior part of the cord” in the 17 August 2013 MRI does not support a SCI diagnosis, because
“if the patient were to have had an anterior spinal artery infarct, you’d expect the infarct on the
spinal cord images to be seen in the distribution pattern of the anterior spinal artery itself.” Id. at
179:8–22. Dr. Wanatabe cited two additional pieces of support for the 17 August 2013 MRI
being “more likely than not more compatible with acute transverse myelitis than an infarct of the
anterior spinal artery”: “The lesion [in MRI imaging] extends into the white matter, and it's not
isolated just to the gray matter tracts, which is another hallmark of myelitis rather than an
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anterior spinal artery infarct”; Id. at 183:14–25; and “th[e] very extensive holocord experience . .
. [as] the white stuff almost entirely replacing the cord, except . . . some of the perimeter, . . . are
all signs that are indicative, more likely than not, of a transverse myelitis rather than an anterior
spinal artery infarct.” Id. at 184:1–7.
Dr. Watanabe noted the “mild diffusion restriction” shown by the 17 August 2013 MRI—
“something that can be seen with both [TM and SCI]”—“led to a consultation with the stroke
team, who then recommended [an] angiogram [test].” Id. at 184:16–21. Dr. Watanabe testified
the angiogram did not reveal evidence of a blood clot or a “cutoff.” Id. at 185:20–23 (“[T]he
neuroradiologist who performed and interpreted this angiogram never said “cutoff,” and he never
said he saw a clot.”), 188:15–16 (“[W]hat the angiogram shows is that we don’t see a clot in the
vessel that may have caused a stroke.”). Nevertheless, she acknowledged the possibility “that
there could have been a clot that could have disappeared, and now the vessel had recanalized.”
Id. at 188:2–6.
Dr. Watanabe acknowledged I.J.’s symptoms did not strictly meet all the Working Group
Diagnostic criteria. Id. at 209:25–210:10. Dr. Watanabe, however, disagreed the missing of
certain criterion meant “one cannot reach a diagnosis of TM.” Id. at 210:13–18. Dr. Watanabe
explained “in a clinical setting [doctors] make their own judgments, and [they are] not restricted
by this paper [of the Working Group].” Id. at 210:19–20.
c. Dr. Mark Levin
Dr. Levin, a hematologist, offered an expert report and testimony stating I.J.’s overall
hematologic condition was insufficient to support a SCI diagnosis. 2019 Tr. at 236:3–17; Expert
Report, ECF No. 68-1 (“Levin Ex. Rep.”) (Dr. Levin’s report concluding a diagnosis of SCI was
not supported). Dr. Levin addressed I.J.’s family history of venous thromboembolism
(“VTE”),19 and whether it was significant for diagnostic purposes. Levin Ex. Rep. at 2–3. Dr.
Levin noted, while there are a number of questions in the normal medical practice a doctor
should ask to understand if there is a genetic component, “[a]side from the mention of a history
of pulmonary embolism in two [of I.J.’s] relatives, there really was nothing else that [treating
physicians] looked into, tried to understand if there is a genetic component.” 2019 Tr. at
238:12–20 (Dr. Levin testifying “when you look at the family history, you really need specifics,
what age and what circumstances. For example, we’re always trained to ask questions . . . [(a
long list of questions are omitted)]. None of this was available in the record.”). Dr. Levin
opined the two factors respondent’s expert testified as abnormal—Factor VIII and protein S
laboratory data—do not indicate a genetic condition. 2019 Tr. at 239:16–19; Levin Ex. Rep. at
4.
Dr. Levin testified I.J.’s elevated factor VIII level is “the effect of inflammation that
happened from myelitis.” 2019 Tr. at 240:15–24. Dr. Levin opined “findings of inflammation
in the blood are the cause of the elevated Factor VIII level and not the opposite.” Levin Ex. Rep.
at 4. Dr. Levin further noted “[t]he elevated Factor VIII is completely consistent with a
diagnosis of transverse myelitis,” and “even had [respondent’s expert] been correct that a spinal
19 Venous Thromboembolism is obstruction of a vein with thrombotic material carried by the bloodstream from the
site of origin to plug another vessel. See Dorland, supra note 2, at 1892, 2016.
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cord infarction occurred, it would have most likely have been caused by the vaccine-caused
inflammation.” Id.
3. Respondent’s Expert – Dr. David Alexander
Dr. Alexander, a neurologist and Respondent’s sole expert provided testimony with three
reports. 2019 Tr. at 291–389; Expert Report, ECF No. 41-1 (“Alexander Ex. Rep. 1”) (Dr.
Alexander’s first expert report); Expert Report, ECF No. 79-1 (“Alexander Ex. Rep. 2”) (Dr.
Alexander’s second expert report); Expert Report, ECF No. 107-1 (“Alexander Ex. Rep. 3”) (Dr.
Alexander’s third expert report). Dr. Alexander opined I.J.’s Tdap vaccine “is not related to his
injury, which . . . is a spinal cord infarction.” 2019 Tr. at 299:16–25.
Dr. Alexander’s basis for his opinion that I.J. does not have TM is “[I.J.] doesn’t fit . . .
the Transverse Myelitis Consortium Working Group definition.” 2019 Tr. at 300:5–12. In
particular, Dr. Alexander found I.J. “didn’t have any evidence of inflammation,” as “[t]here was
no [g]adolinium enhancement on his initial MRI scan, and he didn’t have a CSF that showed any
inflammatory pleocytosis,” while “[b]oth of those are criteria . . . for [TM] diagnosis.” Id. at
300:13–17. Dr. Alexander further noticed “[I.J.’s] abrupt onset of symptoms that then evolved
over a bit of time . . . is much more consistent with acute ischemic stroke to the spinal cord.” Id.
at 300:18–21. Dr. Alexander opined “[t]he imaging shows very characteristic findings of spinal
cord infarction.” Id. at 300:23–24.
Regarding I.J’s MRI studies, Dr. Alexander testified the first MRI on 8 August 2013
shows “the typical pencil-shaped lesion that you see in spinal cord infarction, ventral cord and
preservation of the posterior elements there on the sagittal scan.” Id. at 317:21–24. Dr.
Alexander opined, if I.J. had TM, “in an MRI scan obtained hours after onset of symptoms,” one
would “expect to see more involvement of the cord rather than a simple stripes,” and “[i]t could
be the whole cord . . . , and you would expect to see enhancement.” Id. at 318:4–14. Dr.
Alexander concluded “even on this [8 August 2013 MRI] scan I would say that this is entirely
consistent with acute spinal cord infarction.” Id. at 317:11–12. Dr. Alexander acknowledged, if
the treating physicians had suspected SCI on I.J.’s admission, they would have asked for a
diffusion-weighted imaging (“DWI”)20 sequence for the 8 August 2013 MRI imaging, but the
doctors did not. Id. at 363:12–16. Dr. Alexander explained “the gold standard for acute stroke
in the brain or the spinal cord at this point and day and age [of I.J.’s onset] is diffusion-weighted
imaging,” which is “the most important single test [doctors] do when looking at acute stroke,”
and it has to be performed shortly after the onset of symptoms. Id. at 307:11–18, 308:3–9.
(“That DWI positivity comes on and peaks . . . relatively soon and decays after that. So it’s not a
long-lasting—it’s a measure of acute infarction and, in the brain, the most important single test
we do when looking at acute stroke.”).
20 DWI is a form of magnetic resonance imaging based upon measuring the random Brownian motion of water
molecules within a voxel tissue. Highly cellular tissues or those with cellular swelling exhibit lower diffusion
coefficients and diffusion is particularly useful in characterization of cerebral ischemia. Ayush Goel et al, Diffusion-
weighted Imaging, RADIOPAEDIA (last visited June 10, 2021), https://radiopaedia.org/articles/diffusion-weighted-
imaging-2?lang=us.
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Dr. Alexander then reviewed the findings from the second MRI test I.J. underwent on 17
August 2013. Id. at 320:23–321:6. Dr. Alexander acknowledged the MRI imaging “could be
[indicative of] transverse myelitis.” Id. at 323:19–23 (When asked “[c]an anything on this [MRI]
scan be indicative of transverse myelitis,” Dr. Alexander testified “I couldn’t tell exactly what
that is. It could be transverse myelitis.”). Dr. Alexander commented Dr. Watanabe’s opinion of
“an area of involvement of some kind of the dorsal columns” as “not being noteworthy,” and
“the treating physicians did not comment on this dorsal column because the predominant finding
was that of ventral cord involvement.” Id. at 321:15–322:18. Dr. Alexander acknowledged,
“[a]lthough the predominant infarction in [I.J.] is in the distribution of the ASA [(anterior spinal
arteries)], I agree there is also ischemia in the posterior PSA [(posterior spinal arteries)]
distribution.” Alexander Ex. Rep. 3 at 5. Dr. Alexander opined “this finding is not uncommon,
and supports, rather than undermines, the idea that [I.J.] had a SCI and not TM,” because both
the anterior and posterior spinal arteries are fed by the radiculomedullary artery.21 Id. Dr.
Alexander further noticed “the sharp medial edge of the signal intensity brightness” supported
the reading of SCI, because “TM would not respect the midline . . . , whereas a spinal cord
infarction would have a sharp demarcation corresponding to a vascular territory.” Id. at 6–7.
Dr. Alexander also addressed the 21 August 2013 Angiogram, which he opined as
supporting his conclusion of a SCI diagnosis. See Alexander Ex. Rep. 3 at 2 (“The correct
interpretation is that this angiogram is entirely consistent with an acute stroke thirteen days
ago.”). Dr. Alexander explained the absence of blood clots on the angiogram was not conclusive
because clots often dissolve and leave behind residual arteriole narrowing. Id. (“One would not
expect to find embolus or thrombus thirteen days after an infarct.”), see also 2019 Tr. at 333:25–
334:8. Dr. Alexander agreed with Dr. Watanabe that the angiogram does not show a cutoff, but
Dr. Alexander opined “mini-strokes are not 100 percent occlusions,” and “[on] 11 days post-
event . . . [doctors] wouldn’t expect . . . to see a residual cutoff or clot in the vessel.” Id. at
335:9–21.
Dr. Alexander disagreed with Dr. Levin’s testimony that I.J.’s elevated Factor VIII level
“was a systemic change in that 24 hours based on inflammation within the cord of myelitis.” Id.
at 343:9–13. Dr. Alexander opined, due to the small amount of tissue involved in TM, the
inflammation cannot trigger a systematic reaction like elevation in Factor VIII level. Id. at
343:14–19. Dr. Alexander found “there’s no local inflammation,” and “with no local reaction,”
he found “it hard to believe . . . a small degree of myelitis . . . create[ed] a systemic response
with changes in . . . factor levels.” Id. at 343:20–344:2. Dr. Alexander noted the elevated Factor
VIII level could be to due to I.J. being “a sick ICU guy” who was “developing infections,
possible aspiration pneumonia, being treated with antibiotics, and having hypotension.” Id. at
344:3–10.
Dr. Alexander opined the sudden onset time frame of I.J.’s symptom does not support a
diagnosis of TM. Id. at 372:9–23 (“It’s a typical course for a gradually progressive inflammation
that's been building up over . . . two weeks or so.”). Nevertheless, Dr. Alexander acknowledged
“timeline in terms of maximal deficit” noted in the Working Group is “between four hours and
21 days,” which is “what happened in [I.J.’s] case.” Id. at 375:8–14. Dr. Alexander also noted
I.J.’s improvements with treatments was not indicative of him having TM, because there is no
21 The radiculomedullary artery is an artery of the spinal cord. See Dorland, supra note 2, at 1547.
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valid scientific evidence supporting the treatments I.J. received actually work for TM, and I.J.’s
improvements, if there are any, are “spontaneous improvement in the sensory symptoms . . .
[that] indicate more spinal cord infarction.” Id. at 111:17–112:14.
B. The Special Master’s Decision Denying Compensation
On 4 January 2021, Chief Special Master Corcoran issued his decision denying
petitioner’s claim and denying compensation, concluding although “[p]etitioner has
preponderantly established that he likely experienced TM, prevailing over [r]espondent’s
proposed alternative diagnosis of a spinal cord infarction,” “insufficient preponderant evidence
offered in this case stands for [p]etitioner’s contention that the Tdap vaccine can cause TM, or
that it did so in this case.” J., No. 16-864, ECF No. 125, at 2 (emphasis omitted).
The Chief Special Master began the analysis by determining whether petitioner’s injury
was likely either TM or a spinal cord infarction. Id. at 35. As petitioner’s causal theory was
dependent on the establishment of his injury as TM, and petitioner did not allege a spinal cord
infarction could be vaccine-caused, “a determination that [a spinal cord infarction] best
characterized his injury would be fatal to his claim.” Id. The Chief Special Master found “this
issue is close, with the evidence largely in equipoise,” as “both sides offered credible, reliably-
bulwarked points for their respective positions, supported in turn by fair and persuasive expert
testimony,” and “the medical record is ultimately equivocal on the matter.” Id. at 35–36. While
“it is not [the Chief Special Master’s] function . . . to propose a ‘correct’ diagnosis,” the Chief
Special Master carried out his duty to “weigh whether the evidence preponderantly supports one
conclusion over another.” Id. The Chief Special Master “found preponderant evidence has been
offered to establish that [p]etitioner more likely than not suffered from TM” based on the
following fact findings: “Petitioner . . . experienced sensory, motor, and autonomic dysfunction
consistent with TM”; a number of other etiologies such as “connective tissue disease, infectious
disease, abnormal void flows, and spinal radiation . . . optic neuritis and MS” were absent or
eliminated; “[t]he progression of [p]etitioner’s symptoms over the course of approximately eight
or nine hours satisfied the Working Group’s proposed diagnostic criteria and further
distinguished [p]etitioner’s course from that which is typical of spinal cord infarction”; “there is
treater support for his proposed diagnosis”; and “a review of the medical record beyond
[petitioner’s] initial onset does not suggest, based on the accumulation of additional information
over time, that treaters later abandoned TM as an explanation.” Id. at 36.
The Chief Special Master next reviewed relevant case law regarding vaccine causality of
TM. The Chief Special Master noted “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,
1278 (2005): ‘(1) a medical theory causally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that the vaccination was the reason for the injury;
and (3) a showing of proximate temporal relationship between vaccination and injury’” to
establish entitlement of compensation for a non-table claim. Id. at 28. The Chief Special Master
further noted “several more recent, well-reasoned decisions have found that petitioners failed in
their effort to establish that the flu vaccine ‘can cause’ TM, as required by the first Althen
prong.” Id. at 37. While acknowledging “such determinations are somewhat less on point given
the different vaccine at issue,” the Chief Special Master found the cases “cast light on identifying
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deficiencies in the reasonings” of causality. Id. In Pearson, an adult petitioner alleged his
receipt of the flu vaccine precipitated the onset on TM within three months, relying on molecular
mimicry and Agmon-Levin’s review of post-vaccine TM cases to support causation. Id. (citing
Pearson v. Sec’y of Health & Human Servs., No. 16-09V, 2019 WL 3852633, at *3–4, *6–7
(Fed. Cl. Spec. Mstr. July 31, 2019)). The respondent in Forrest, another case of a petitioner
alleging the flu vaccine caused TM, offered Baxter to undermine causation and argue “the very
large-scale study saw no increased incidence of TM after administration of the flu vaccine.” Id.
at 38 (citing Forrest v. Sec’y of Health and Human Servs., No. 14-1046, 2019 WL 925495, *5
(Fed. Cl. Spec. Mstr. Jan. 29, 2019)). Although denying compensation based on “the short onset
timeframe and its inconsistency with the casual theory,” the special master in Forrest “took
special note of Baxter, observing the extent to which the study undermined the claimant’s case
(while acknowledging the ‘general rule’ that petitioners are not required to submit affirmative
epidemiologic evidence as part of their prima facie case).” Id. (citing Forrest, 2019WL 925485,
at *5).
With this background, the Chief Special Master considered petitioner’s Althen prong one
showing of whether Tdap vaccine can cause TM. Id. at 38. The Chief Special Master first
noted, “[a]s a threshold matter,” “[p]etitioner incorrectly maintains that ‘reliable scientific
evidence’ is not required to meet his preponderant burden.” Id. (emphasis omitted). According
to the Chief Special Master, while “no particular class of evidence (i.e. medical literature;
research studies; expert reports; peer-reviewed articles; etc.) need be offered with the overall
obligation of Program petitioners to offer a reliable theory, . . . [i]f certain individual components
of evidence critical to a theory’s success are not themselves reliable, that finding reasonably
impacts the overall theory’s evidentiary preponderance.” Id. (citing Knudsen ex rel. Knudsen v.
Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994)). The Chief Special Master
further pointed out petitioner “erroneously suggest[ed] a theory’s mere plausibility is enough to
meet the preponderant standard—a contention that the Federal Circuit clearly rejected in the
recent Boatmon decision.” Id. at 38–39 (citing Boatmon v. Sec’y of Health & Human Servs., 941
F.3d 1351, 1359 (Fed. Cir. 2019)).
The Chief Special Master found “several deficiencies” in petitioner’s causation theory.
Id. at 39. First, the Chief Special Master stated “scientific evidence not previously available
when [previous Tdap cases] were decided,” the 2017 Baxter study, failed to serve in plaintiff’s
favor. Id. The Chief Special Master characterized Baxter as “a large-scale, comprehensive
epidemiological study aimed at examining the risk of demyelinating event following vaccination
. . . within a field of nearly 64 million vaccinations (including almost six million Tdap recipients)
derived from data maintained by the Vaccine Safety Datalink.” Id. (citing Baxter at 1456–57)
(emphasis omitted). Baxter reported only seven cases of TM between 5-28 days post-
vaccination—the very timeframe applicable to petitioner’s claim—and “concluded that there was
no reliably-demonstrated association between vaccination and the subsequent development of
TM.” Id. (citing Baxter at 1456–57, 1561 (“In conclusion, TM and ADEM are rarely, if ever,
associated with vaccines.”)). The Chief Special Master acknowledged, “[a]lthough it is
unquestionably the case that Vaccine Program litigants are not required to offer epidemiological
evidence to prevail, special masters may take note of its existence and consider it when
determining if a claimant has met his burden of proof.” Id. (citing Palattao v. Sec’y of Health &
Human Servs., No. 13-591V, 2019 WL 989380, at *37 (Fed. Cl. Spec. Mstr. Feb. 4, 2019))
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(emphasis omitted). Accordingly, the Chief Special Master “[took] Baxter into account . . . and
[found] that it greatly damages Petitioner’s causation theory.” Id. The Chief Special Master
further noted, although petitioner’s expert Dr. Zamvil “expressly relied on the Baxter article to
support an association between TM and receipt of the Tdap vaccine,” “[Dr. Zamvil’s references
to Baxter] essentially ignored what is so glaringly unfavorable about them.” Id. at 39–40.
The second deficiency the Chief Special Master identified in petitioner’s causation theory
was petitioner’s reliance on molecular mimicry. Id. at 40–41. The Chief Special Master first
found “prior decisions like Raymo, Roberts, and Helman,” cases where petitioners successfully
relied on molecular mimicry to obtain compensation for TM caused by the Tdap vaccine, were
not applicable here because the cases are “limited by other specific aspects of their respective
holdings, or diminished by more recent determinations involving the same causal theories
producing TM.” Id. at 40. According to the Chief Special Master, the special master in Raymo
determined “in acute TM ‘homology has not been demonstrated between any suspected
precipitating agent and the spinal cord nerve sheaths or axons,’” and the Raymo special master
“based her liability determination on the finding that the theory of bystander activation—a
mechanism not proposed by Petitioner’s experts in this case—was also a reasonable causal
explanation under the circumstances.” Id. (citing Raymo v. Sec’y of Health & Human Servs., 11-
654V, 2014 WL 1092274, at *18, *20 (Fed. Cl. Spec. Mstr. Feb. 24, 2014)). The Chief Special
Master stated the special master in Roberts “acknowledged that petitioners’ theory was supported
by an expert opinion but included no further analysis to explain why the theory was persuasive.”
Id. (citing Roberts v. Sec’y of Health & Human Servs., No. 09-427V, 2013 WL 5314698, at *6
(Fed. Cl. Spec. Mstr. Aug. 29, 2013)) (emphasis omitted). And in Helman, “only two sentences
of the special master’s analysis in total are dedicated at all to the first Althen prong,” with “[n]o
analysis explain[ing] how the Tdap vaccine can cause TM, thus greatly limiting the persuasive
quality of such a determination.” Id. (citing Helman v. Sec’y of Health & Human Servs., No. 10-
813V, 2012 WL 1607142 at *3 (Fed. Cl. Spec. Mstr. Apr. 5, 2012)).
The Chief Special Master next specifically addressed the shortcomings of petitioner’s
reliance on molecular mimicry in the present case. Id. at 40–41. Petitioners’ relying on
molecular mimicry to establish causation “must demonstrate . . . that it likely does link the
vaccine in question to the relevant injury,” and the Chief Special Master concluded “[n]o such
showing was made in this matter.” Id. at 41 (citing Yalacki v. Sec’y of Health & Human Servs.,
No. 14-278V, 2019 WL 1061429, at *34 (Fed. Cl. Spec. Mstr. Jan. 31, 2019), mot. for review
den’d, 146 Fed. Cl. 80 (2019)). The Chief Special Master found “merely demonstrating some
homology between vaccine components and relevant self-structures based on computer database
searches does not carry the day.” Id. (citing Pek v. Sec’y of Health & Human Servs., No. 16-
736V, 2020 WL 1062959, at *16 (Fed. Cl. Spec. Mstr. Jan. 31, 2020)). The Chief Special
Master further noted “Dr. Zamvil’s assertions about the role the vaccine’s alum adjuvant could
play in activation of an aberrant innate response were even less reliable or persuasive,” as “he
has not shown, nor offered evidence in addition to his testimony, that reliably suggests or
establishes that vaccines containing an aluminum adjuvant can, independent of anything else,
cause a pathologic response not otherwise shown to be vaccine-attributable.” Id. (emphasis
omitted).
The Chief Special Master also considered the case reports offered by petitioner and found
them “of limited probative value—and not just for the reason that case reports generally are not
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given significant weight when deciding Program cases, since they do not establish causation per
se.” Id. (citing Knorr v. Sec’y of Health & Human Servs., No. 15-1169V, 2018 WL 6991548, at
*30 (Fed. Cl. Spec. Mstr. Dec. 7, 2018)). The Riel-Romeo case report, as noted by the Chief
Special Master, “not only involved a young child rather than adult like [petitioner], but also
acknowledged that its observation of an association could simply be coincidental.” Id. at 42
(citing Riel-Romero at 690). Agmon-Levin “provided only four instances of association,” and
Pearson already questioned “the weight this piece of literature should receive overall.” Id.
(citing Pearson, 2019 WL 3852633, at *14). Moreover, other articles such as “Pidcock and
Gregg emphasize that the documented reports of post-vaccination TM could be coincidental, and
neither article claims to establish a causal relationship between vaccination and the subsequent
development of TM.” Id. The Chief Special Master concluded: “[t]hese case reports overall
had some evidentiary value, and I have taken them into account . . . [b]ut they are not enough to
meet the preponderant burden, especially given the far more comprehensive, contrary evidence
provided by Baxter.” Id.
After concluding petitioner’s claim failed to meet the first Althen prong—whether the
Tdap vaccine can cause TM—and therefore “cannot succeed,” the Chief Special Master went on
to discuss Althen prongs two and three “for purposes of completion of [his] overall analysis.” Id.
The Chief Special Master found “an absence of evidence” to “conclude that the Tdap vaccine
likely produced [p]etitioner’s TM,” and therefore found petitioner failed to establish the second
Althen prong. Id. The Chief Special Master first noted “there was hardly any testing evidence
(whether from serologic sampling or MRI imaging) that would establish the existence of
inflammation—a telltale sign confirming the presence of the autoimmune process that
[p]etitioner’s causation theory proposes would have been instigated by the Tdap vaccine.” Id. at
42–43. Additionally, “[t]here was . . . no evidence of any autoantibodies that might arguably be
associated with the asserted TM cross-reaction,” and “no treaters ever proposed that
[p]etitioner’s injury, however defined, was likely caused by his prior Tdap vaccine.” Id. at 43.
The Chief Special Master also observed the existence of a pre-onset intercurrent respiratory
infection in petitioner’s medical record and noted “such an infection has in other cases been held
to possibly explain various demyelinating conditions.” Id. (citing Deshler v. Sec’y of Health &
Human Servs., No. 16-1070V, 2020 WL 4593162, at *18). The Chief Special Master concluded
this alternative explanation, though not dispositive, “undermined somewhat [p]etitioner’s claim”
as “additional evidence that was not fully explained or distinguished by [p]etitioner.” Id.
Although the Chief Special Master was not persuaded that petitioner had established by a
preponderance of the evidence the Tdap vaccine caused petitioner’s TM, he nevertheless found
“the record and evidence offered in this matter does support the conclusion that [p]etitioner’s TM
occurred in a medically acceptable timeframe, consistent with his causation theory.” Id. (citation
omitted). “But because [p]etitioner’s causation theory in this case was not sufficiently supported
with preponderant evidence, the consistency of the onset timing in this case with [p]etitioner’s
theory does not aid [p]etitioner.” Id.
III. Petitioner’s Motion for Review and Respondent’s Arguments
On 3 February 2021, petitioner filed a motion for review of the Chief Special Master’s
decision. See Mot. for Review. Petitioner argues “the [Chief] Special Master’s holdings [on
whether petitioner met Althen prong one] were arbitrary and capricious, constituted an abuse of
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discretion, and were contrary to law,” and “the [Chief] Special Master thereby heightened
[p]etitioner’s burden of proof, contrary to law.” Id. at 2. Petitioner further argues the Chief
Special Master’s decision on the second Althen prong “was internally inconsistent, and thus
contrary to law, and unsupported by the facts, and thus arbitrary and capricious.” Id.
A. Petitioner’s Objection 1 Regarding the Special Master’s Althen Prong One
Decision
Petitioner’s Objection 1 is:
Given the specificity of the demonstrated homologies between
tetanus toxoid constituents of the vaccine and myelin components
of the central nervous system, as well as the proximity of the time
frame from vaccination to onset of the transverse myelitis
(supporting evidence from Althen Prong 3, which was deemed to
have been proven), the Special Master’s holding that Petitioner had
failed to establish by a preponderance Althen Prong 1 (a “can it
cause” medical theory causally connecting the vaccination and the
injury) due largely to the Special Master's consideration of an
epidemiological study that simply did not rule out causation
between vaccination and the rare incidence of acute transverse
myelitis, was arbitrary and capricious, an abuse of discretion,
contrary to law and violative of due process of law.
Furthermore, the Special Master thereby improperly heightened the
burden of proof required of Petitioner, contrary to law, in particular
by requiring an improper and impossible to reach level
of specificity in connection with Petitioner's showing of the well-
established theory of molecular mimicry.
Mot. for Review at 28.
Petitioner objects to the Chief Special Master’s reliance on the Baxter study as “greatly
damag[ing] [p]etitioner’s medical theory,” arguing “[t]he elevation of this particular
epidemiological studyto a case-breaking status is arbitrary and capricious, an abuse of discretion,
and contrary to law.” Id. Petitioner contends “the absence of expert testimony on this issue [of
epidemiology] or any meaningful discussion of [Baxter’s] significance in the hearing or virtually
anywhere else in the record . . . constitutes a violation of due process.” Id. at 28–29. Although
the Baxter study was offered by petitioner, petitioner emphasizes it has “statistical limitations”
and is “of little significance in the rare case of Tdap-induced TM.” Id. at 29. Petitioner relies on
Baxter “not for its statistical epidemiology and conclusions,” “but for the data it reported . . . to
show that while TM is exceedingly rare, there were 7 instances shown in which TM occurred
after Tdap vaccination within the relevant time frame.” Id. at 31.
Petitioner compares this case to a prior case remanding a decision by the Chief Special
Master, Bender v. Sec’y of Health & Human Servs., in which the Court of Federal Claims noted
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“the Baxter study did not play a major role in [the Chief Special Master’s] determination . . . and
the [Chief] Special Master specifically acknowledged that no epidemiologists had been offered
as experts.” Id. at 29 (citing Bender v. Sec’y of Health & Human Servs., 138 Fed. Cl. 197
(2018)). In Bender, petitioner notes, the Chief Special Master “acknowledged that Baxter was
not a ‘randomized’ study and therefore could not be cited as definite proof that the vaccines at
issue could never be associated with the TM in the studied time periods.” Id. (citing Bender,
2018 WL 3679637 at *17).
Petitioner further argues the Chief Special Master unduly heightened petitioner’s burden
for the specificity “required upon a showing of the well-established theory of molecular
mimicry.” Id. at 32. According to petitioner, “greater specificity than a high degree of
homology to myelin components of the central nervous system (“CNS”) is not required in the
Vaccine Program” to establish the first Althen prong, and “[t]o hold otherwise is to unduly raise
the burden to be met by petitioners and impair the use of circumstantial evidence envisioned by
the Program’s requirement of preponderant proof.” Id. (citing Capizzano v. Sec’y of Health &
Human Servs., 440 F.3d 1317, 1325–26 (Fed. Cir. 2006)). Petitioner urges the Court to consider
current case law, in which “the special master found BLAST searches (such as those conducted
by Dr. Zamvil in the case at bar) reveal[ing] amino acid homologies between antigen
components of the HPV vaccine Gardasil and [myelin components of the CNS]” were sufficient
to establish “the proffered theory of molecular mimicry.” Id. at 33 (citing White v. Sec’y of
Health & Human Servs., 15-1521V, 2019 WL 7563239 at *21–22 (Dec. 19, 2019)).
Petitioner also argues the Chief Special Master’s “post-hoc devaluation of the causal role
of molecular mimicry is contrary to the long line of medical literature . . . and case law . . . that
supports this well-established theory in the context of vaccines containing tetanus toxoid.” Id. at
35 (citing Raymo v. Sec’y of Health & Human Servs., No. 11-0654V, 2014 WL 1092274, at *19
(Fed. Cl. Spec. Mstr. Feb. 24, 2014); Roberts v. Sec’y of Health and Human Servs., No. 09-
427V, 2013 WL 5314698 (Fed. Cl. Spec. Mstr. Aug. 29, 2013); Helman v. Sec’y of Health and
Human Servs., No. 10-813V, 2012 WL 1607142 (Fed. Cl. Spec. Mstr. Apr. 5, 2012); Hargrove
ex rel. Wise v. Sec’y of Health & Human Servs., No. 05-694V, 2009 WL 1220986 (Fed. Cl. Spec.
Mstr. Apr. 14, 2009); Bowes v. Sec’y of Health & Human Servs., No. 01-481V, 2006 WL
2849816 (Fed. Cl. Spec. Mstr. Sep. 8, 2006)). Petitioner contends the Chief Special Master
“essentially required a showing of a specific biological mechanism that cannot be proven” and
amounts to “unreachable, unrealistic level of evidence.” Id. at 36. According to petitioner,
“[w]hether a case is analyzed under Althen or the ‘Can it cause?’ formulation, petitioners are not
required to establish identification and proof of specific biological mechanisms, as the purpose of
the Vaccine Act’s preponderance standard is to allow the finding of causation in a field bereft of
complete and direct proof of how vaccines affect the human body.” Id. (citing Raymo, 2014 WL
1092274, at *12 (quoting Althen, 418 F.3d at 1280)) (some internal quotation marks omitted).
Petitioner thus argues the Chief Special Master’s approach to petitioner’s molecular mimicry
argument is “contrary to law.” Id.
In response to petitioner’s Baxter arguments, respondent argues “the Chief Special
Master is required to take into consideration all of the ‘relevant and reliable’ evidence
presented,” rather than “only those parts of the [Baxter] study [(e.g., the data)] that petitioner
believes were worth noting.” Resp. to Mot. for Review at 8 (citing Vaccine Rule 8(b)(1))
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(emphasis omitted). Respondent contends the special master “appropriately weighed the Baxter
study” because he “considered all of the evidence and made findings based on the record that are
not ‘wholly implausible.’” Id. at 8–9 (citing Cedillo v. Sec’y of Health & Human Servs., 617
F.3d 1328, 1338 (Fed. Cir. 2010) (findings of fact must be upheld if they are “based on evidence
in the record that [is] not wholly implausible”)). Respondent further argues the Chief Special
Master did not improperly heighten petitioner’s burden of proof by giving the Baxter study
greater weight than the other evidence offered by petitioner, as the Chief Special Master
considered all of the other evidence presented, including the case reports, in determining that
petitioner had failed to provide sufficient evidence to meet Althen prong one. Id. at 12–13.
Additionally, as the Baxter study was offered by petitioner’s expert and was repeatedly discussed
at the hearing, “the fact that petitioner repeatedly failed to develop testimony from Dr. Zamvil
that was more favorable to his position does not mean that petitioner was prevented from doing
so in violation of his due process rights.” Id. at 14.
In response to petitioner’s argument the Chief Special Master improperly heightened
petitioner’s burden of proof with respect to molecular mimicry, respondent argues a
determination by the Chief Special Master that “molecular mimicry ‘likely does link the vaccine
in question to the relevant injury’ . . . is necessary to prevail on a causation-in-fact claim.” Id. at
15 (citing W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1360 (Fed. Cir. 2013)
(quoting Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010)
(“a petitioner must provide a reputable medical or scientific explanation that pertains specifically
to the petitioner’s case”))) (emphasis omitted). Respondent notes Dr. Zamvil “could not identify
any studies concluding that Tdap can cause TM via [Dr. Zamvil’s] proposed mechanism,” and
Dr. Zamvil’s BLAST test, as noted by the Chief Special Master, is “clearly case-oriented, and is
not equivalent to lab or clinical research that an expert might perform and/or rely upon for an
opinion.” Id. (internal quotation marks omitted). Respondent opines the Special Master did not
raise petitioner’s burden of proof; to the contrary, petitioner simply failed the preponderance
standard by providing evidence that “fell far short of the mark.” Id. at 16.
B. Petitioner’s Objection 2 Regarding the Special Master’s Althen Prong Two
Decision
Petitioner’s Objection 2 is:
The Special Master's holding that Petitioner had failed to establish
Althen Prong 2 (“did it cause” evidence) was rendered irrational
by its internal inconsistency with his threshold determination that
Petitioner had established that his injuries included acute
transverse myelitis.
Additionally, the Special Master's interpretation of the medical
record regarding inflammation and other signs of TM was arbitrary
and capricious.
Mot. for Review at 36 (emphasis in original).
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Petitioner objects to the Chief Special Master’s reliance “upon a purported absence of
inflammation as undermining the diagnosis of TM.” Id. at 37. Petitioner argues he has
addressed “the question of inflammation” in several ways, including by providing statements
from petitioner’s expert, Dr. Watanabe. Id. at 37–38.
Petitioner also argues the Chief Special Master’s Althen prong two decision suffers from
a conflict “between the [Chief] Special Master’s determination that TM had been established as
threshold issue and his later conclusion that TM was not established for purposes of satisfying
Althen prong 2.” Id. at 39. Petitioner opines the special master had “already resolved the
specific issue of the significance of inflammation in connection with his threshold
determination” by finding “[p]etitioner successfully established either that certain of the criteria
[of the TM Working Group] (for example, proof of inflammation) had not completely been
eliminated, or more generally that a TM diagnosis should not be held to the literal standard set by
the criteria.” Id. (internal citation and quotation marks omitted). Petitioner thus contends
“[such] an internal inconsistency, . . . [which led to] an entire category of proof (Althen prong 2)
[being] deemed non-preponderant, is contrary to law and requires reversal.” Id.
In its response to petitioner’s Althen prong two arguments, respondent notes “because
the Chief Special Master found that petitioner did not satisfy Althen prong one, he was under no
obligation to even address petitioner’s evidence, or the lack thereof, under the other Althen
prongs.” Id. at 18 (citing W.C., 704 F.3d at 1358 (special master was not required to analyze
evidence under Althen prong one, where the court already determined a petitioner had failed to
meet preponderance standard under Althen prongs two and three)). Regarding petitioner’s
allegation the Chief Special Master’s Althen prong two decision suffers internal inconsistency,
respondent argues “[t]he Chief Special Master’s finding that petitioner had TM most certainly
does not equate to a finding that petitioner’s TM was caused by his vaccination.” Id. at 18–19
(emphasis in original). Respondent maintains petitioner’s disagreement with the Chief Special
Master’s “interpretation of the medical record regarding inflammation and other signs of TM” is
“not justification to overturn the Chief Special Master’s well-reasoned finding” that there was
“insufficient support in the record for the conclusion that the Tdap vaccine could have caused
petitioner’s TM.” Id. at 19–20.
The Court held oral argument on petitioner’s motion for review of the Chief Special
Master’s decision on 15 June 2021. Order, ECF No. 126.
IV. Legal Standards
A. The Court’s Standard of Review of a Special Master’s Decision
The Vaccine Act provides this Court jurisdiction to review a Special Master’s decision
upon timely motion of either party. See 42 U.S.C. § 300aa-12(e)(1)–(2). In reviewing the record
of the proceedings before the Special Master, the Court may: (1) “uphold the findings of fact
and conclusions of law of the special master and sustain the special master’s decision;” (2) “set
aside any findings of fact or conclusion of law of the special master found to be arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own
findings of fact and conclusions of law;” or (3) “remand the petition to the special master for
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further action in accordance with the court’s direction.” Id. § 300aa-12(e)(2). “Fact findings are
reviewed . . . under the arbitrary and capricious standard; legal questions under the ‘not in
accordance with law’ standard; and discretionary rulings under the abuse of discretion standard.”
Saunders v. Sec’y of Dept. of Health & Human Servs., 25 F.3d 1031, 1033 (Fed. Cir. 1994)
(quoting Munn v. Sec’y of Dept. of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir.
1992)).
It is not the Court’s role “to reweigh the factual evidence, or to assess whether the special
master correctly evaluated the evidence.” Lampe v. Sec’y of Health & Human Servs., 219 F.3d
1357, 1360 (Fed. Cir. 2000) (quoting Munn, 970 F.2d at 871). The Court also does “not examine
the probative value of the evidence or the credibility of the witnesses. These are all matters
within the purview of the fact finder.” Id. (quoting Munn, 970 F.2d at 871). “Reversal is
appropriate only when the special master’s decision is arbitrary, capricious, an abuse of
discretion, or not in accordance with the law.” Snyder ex rel. Snyder v. Sec’y of Health &
Human Servs., 88 Fed. Cl. 706, 718 (2009). The arbitrary and capricious standard “is a highly
deferential standard of review:” “[i]f the special master has considered the relevant evidence of
record, drawn plausible inferences and articulated a rational basis for the decision, reversible
error will be extremely difficult to demonstrate.” Hines ex rel. Sevier v. Sec’y of Dept. of Health
& Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991).
B. The Standard of Causation in Vaccine Cases
“A petitioner seeking compensation under the Vaccine Act must prove by a
preponderance of the evidence that the injury or death at issue was caused by a vaccine.”
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1341 (Fed. Cir. 2010) (citing
42 U.S.C. §§ 300aa-11(c)(1), -13(a)(1)). “A petitioner can show causation under the Vaccine
Act in one of two ways”: (1) “by showing that she sustained an injury in association with a
vaccine listed in the Vaccine Injury Table,” in which case “causation is presumed”; or (2) “if the
complained-of injury is not listed in the Vaccine Injury Table . . . the petitioner may seek
compensation by proving causation in fact.” Id. at 1341–42 (internal citations omitted). Vaccine
cases employ a burden shifting standard: “[o]nce the petitioner has demonstrated causation, she
is entitled to compensation unless the government can show by a preponderance of the evidence
that the injury is due to factors unrelated to the vaccine.” Id. at 1342 (citing Doe v. Sec’y of
Health & Human Servs., 601 F.3d 1349, 1351 (Fed. Cir. 2010); 42 U.S.C. § 300aa-13(a)(1)(B)).
“When a petitioner has suffered an off-Table injury . . . [the Federal Circuit] has
established the following test for showing causation in fact under the Vaccine Act:”
[The petitioner’s] burden is to show by preponderant evidence that the vaccination
brought about her injury by providing: (1) a medical theory causally connecting
the vaccination and the injury; (2) a logical sequence of cause and effect showing
that the vaccination was the reason for the injury; and (3) a showing of a proximate
temporal relationship between vaccination and injury.
Broekelschen, 618 F.3d at 1345 (quoting Althen v. Sec’y of Health & Human Servs., 418 F.3d
1274, 1278 (Fed. Cir. 2005)). Under the first prong of Althen, “[a] petitioner must provide a
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‘reputable medical or scientific explanation’ for its theory.” Boatmon v. Sec’y of Health &
Human Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019) (quoting Moberly ex rel. Moberly v. Sec’y
of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)). “While it does not require
medical or scientific certainty, [the explanation] must still be ‘sound and reliable.’” Id. (quoting
Knudsen ex rel. Knudsen v. Sec’y of Dept. of Health & Human Servs., 35 F.3d 543, 548–49 (Fed.
Cir. 1994)). Petitioners “need not produce medical literature or epidemiological evidence to
establish causation under the Vaccine Act.” Andreu ex rel. Andreu v. Sec’y of Dept. of Health &
Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009). Where such evidence is introduced, it
must not be viewed “through the lens of the laboratorian, but instead from the vantage point of
the Vaccine Act’s preponderant evidence standard.” Id. at 1380. For satisfying the second
Althen prong, “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.’” Capizzano v.
Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (quoting Althen, 418
F.3d at 1280). Lastly, “the proximate temporal relationship prong requires preponderant proof
that the onset of symptoms occurred within a timeframe for which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation-in-fact.” de
Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).
V. Respondent’s Disputes with the Chief Special Master’s Decision
In its brief, respondent urges the Court to leave the Chief Special Master’s decision
undisturbed because the decision was not “arbitrary, capricious, an abuse of discretion, or not in
accordance with law,” and because the petitioner fails to show any “reversible error.” Resp. to
Mot. for Review at 1. Nevertheless, during oral argument, respondent revealed it does not fully
agree with the Chief Special Master’s decision. See Transcript, ECF No. 128 at 52:2–7 (“Tr.”)
(government counsel responding to the Court’s observation that “it sounds like the [g]overnment
does dispute certain aspects of the Chief Special Master’s decision,” by stating: “Yes. . . . I am
not sure how this affects the outcome of the decision, but that is perhaps a different topic of
discussion.”)
Respondent disputes the Chief Special Master’s conclusion that petitioner’s injury is TM.
Id. at 14:3–9 (Respondent’s counsel stating, “[w]e disagree [with the Chief Special Master's
conclusion that petitioner experienced TM]. We think that SCI was the proper finding, but that’s
not the decision he reached.”). Respondent maintains it preserves the argument in its responsive
brief, where it discusses the Chief Special Master’s standard as applied to the “largely in
equipoise” evidence in this case. Id. at 11:15–22, 12:5–9, 12:21–8. Respondent’s counsel
emphasized during oral argument, “If the topic for discussion [at oral argument] was the
diagnosis of transverse myelitis, [r]espondent still believes that stroke was the proper diagnosis.”
Id. at 12:9–12.
On the Chief Special Master’s conclusions surrounding Althen element one, respondent
identifies a few aspects in the Baxter study where the Chief Special Master may have
misconstrued the results due to lack of supporting information. Respondent recognizes the Chief
Special Master’s characterization of the Baxter study—“within a field of nearly 64 million
vaccinations (including almost six million Tdap recipients) derived from data maintained by the
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Vaccine Safety Datalink . . . [o]nly seven cases of TM were reported between 5-28 days post-
vaccination”—is not a correct conclusion based on the data detailed in the study. Tr. at 79:9–4,
83:7–14 (respondent agreeing “that the [Chief] Special Master’s language [on Baxter] . . . of
seven cases of TM doesn’t seem to be a correct conclusion based on the data that’s detailed in
the Baxter discussion.”). According to respondent, “the supplementary data [of the Baxter study]
. . . would perhaps be informative on this point,” but the Chief Special Master did not “have the
supplementary data and/or cite the supplementary data.” Id. at 82:20–24, 83:15–17. Respondent
also describes the Chief Special Master’s statistical discussion of the Baxter study as “on his own
provid[ing] more details about the statistical analysis that was conducted in Baxter [than] Dr.
Zamvil testified about.” Id. at 87:8–11.
Regarding Althen element two, respondent disagrees with the Chief Special Master’s
finding of I.J.’s symptom onset time. According to respondent, I.J.’s testimony during
entitlement hearing does not support the Chief Special Master’s finding that “prior to [I.J.’s first
MRI scan on 8 August 2013], I.J. recalled being fully mobile,” and “[i]mmediately following his
MRI scan, however, I.J. lost all mobility from the neck down.” See Tr. at 49:15–50:22; Decision
at 8. Respondent contends I.J. referred to the timing of the CT scan as the point he started to lose
mobility, not the MRI scan. Tr. at 42:22–43:8 (Respondent’s counsel stated “[it] was the CT
scan, not the MRI” “when I.J. was able to move his extremities [going in] and when he came out
of the [scan] or immediately thereafter, he was not.”). Respondent acknowledges the timing of
I.J.’s loss of mobility is critical because such timing marked the onset of I.J.’s symptoms, but
disputes whether the timing of the onset was the time the CT scan or the first MRI was taken. Id.
at 42:2–4, 43:19–22 (Respondent’s counsel stated “the goal here is to figure out when the MRI
occurred.”).
Respondent further disputes the Chief Special Master’s Althen element 3 decision. The
Chief Special Master decided “the record and evidence offered in this matter does support the
conclusion that [p]etitioner’s TM occurred in a medically acceptable timeframe, consistent with
his causation theory.” Decision at 43 (emphasis omitted). Respondent clarified at oral
argument, “[r]espondent’s position was that Petitioner did not meet Althen prong 3.” Tr. at 7:7–
8. Respondent is not contesting this issue simply because petitioner “did not raise this issue on
appeal.” Id. at 7:9–15. “[T]o the extent it wasn’t raised on appeal,” however, respondent
expressed at oral argument it “does not provide any sort of objection.” Id. at 7:10–12.
VI. The Chief Special Master’s Althen Element One Decision
To prove causation in fact in an off-Table vaccine case, the petitioner must “show by
preponderant evidence that the vaccination brought about [the] 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.” Althen v. Sec’y of Health
& Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). The first element in Althen concerns
whether a vaccine can cause petitioner’s injury. Id. at 1279. Here, the Chief Special Master
noted, “[a]s a threshold matter, . . . [p]etitioner has mischaracterized the evidentiary standard that
is applied to the first Althen prong.” Decision at 38. The Chief Special Master found petitioner
erroneously “maintains that ‘reliable scientific evidence’ is not required to meet his preponderant
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burden” and “suggests a theory’s mere plausibility is enough to meet the preponderant
standard—a contention that the Federal Circuit clearly rejected in the recent Boatmon decision.”
Id. (citing Boatmon v. Sec’y of Health & Human Services, 941 F.3d 1351, 1359 (Fed. Cir.
2019)). The Chief Special Master further found the Baxter study attached in Dr. Zamvil’s report
“greatly damages [p]etitioner’s causation theory,” because Baxter reported “[o]nly seven cases of
TM . . . between 5-28 days post-vaccination” in “nearly 64 million vaccinations (including
almost six million Tdap recipients)” and concluded “there was no reliably-demonstrated
association between vaccination and the subsequent development of TM.” Id. at 39 (emphasis
omitted). Regarding petitioner’s causation theory based on molecular mimicry, the Chief Special
Master found, while molecular mimicry “is a generally accepted scientific explanation for many
autoimmune diseases,” petitioner’s evidence failed to demonstrate molecular mimicry “likely
does link the vaccine in question to the relevant injury.” Id. at 41. The Chief Special Master
recognized “prior decisions like Raymo, Roberts, and Helman [holding Tdap vaccine can cause
TM injury] rely on literature similar to that offered [by petitioner in this case], or more broadly
involve theories parallel with [p]etitioner’s theory of autoimmunity attributable to molecular
mimicry.” Id. at 40 (internal citations omitted). Nevertheless, the Chief Special Master found
these decisions are “diminished by more recent determinations involving the same causal
theories producing TM.” Id. (citing Forrest v. Sec’y of Health & Human Servs., 14-1046V, 2019
WL 925495 at *3 (Fed. Cl. Spec. Mstr. Jan. 28, 2019)).
A. Petitioner’s Burden of Proof in Althen Element One
To satisfy the first Althen factor, the petitioner must provide “a medical theory causally
connecting the vaccination and the injury.” Althen, 418 F.3d at 1278. The theory need not be
corroborated by medical literature or epidemiological evidence. Capizzano v. Sec’y of Health &
Human Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). The Federal Circuit’s instruction in
Andreu is “[t]he first prong [of Althen] was satisfied . . . [when petitioner’s expert] presented a
‘biologically plausible’ theory establishing that toxins in the whole-cell pertussis vaccine can
cause seizures.” Andreu ex rel. Andreu v. Sec’y of Dept. of Health & Human Servs., 569 F.3d
1367, 1375 (Fed. Cir. 2009); see also Knudsen ex. rel. Knudsen v. Sec’y of Health & Human
Servs., 35 F.3d 543, 550 (Fed. Cir. 1994) (finding “it is entirely plausible, and contemplated by
the statute, that DTP may cause an encephalopathy”).
In his opinion, the Chief Special Master suggested the later Federal Circuit decision of
Boatmon overruled Andreu’s biological plausibility standard for Althen element one. Decision at
38 (“Petitioner also erroneously suggests a theory’s mere plausibility is enough to meet the
preponderant standard—a contention that the Federal Circuit clearly rejected in the recent
Boatmon decision.”). In its 2019 Boatmon decision, the Federal Circuit stated: “we have
consistently . . . reiterated that a ‘plausible’ or ‘possible’ causal theory does not satisfy the
standard.” Boatmon, 941 F.3d at 1360 (citing Moberly ex rel. Moberly v. Sec’y of Health &
Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010), LaLonde v. Sec’y of Health & Human
Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (quoting Moberly, 592 F.3d at 1322)). It is
noteworthy that the Boatmon court’s holding specifies “a ‘plausible’ or ‘possible’ causal theory
does not satisfy the standard.” Id. (emphasis added). Althen articulates causation in fact in an
off-table vaccine case has three elements: (1) a medical theory causally connecting the
vaccination and the injury; (2) a logical sequence of cause and effect showing that the
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vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship
between vaccination and injury. Althen, 418 F.3d at 1278. In the section of the Boatmon
opinion where the Federal Circuit rejected a merely “plausible” theory as sufficient to establish
causation, the Federal Circuit was specifically analyzing the overall standard for “petitioners’
burden to prove actual causation by a preponderance of the evidence in off-table cases,” not a
standard for Althen element one. Boatmon, 941 F.3d at 1360. The Boatmon court reserved a
separate section to discuss Althen element one, where the court used “a sound and reliable
medical theory of [causation]” as the legal standard to review the special master’s decision. See
id. at 1360–62.
A further reading into the Moberly and LaLonde decisions cited by the Boatmon court
confirms the Federal Circuit did not overrule the “biological plausibility” standard for Althen
element one. In Moberly, the Federal Circuit held petitioner erroneously characterized the
standard for causation as “whether [petitioner’s] condition was ‘likely caused’ by the DPT
vaccine,” and the Federal Circuit criticized the “likely caused” formulation being “something
closer to proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and the injury,
which is not the statutory standard.” Moberly, 592 F.3d at 1322. The Moberly court cited
Andreu in discussing Althen element one, where the court distinguished Moberly from Andreu
because “in Andreu . . . the government’s expert witness did not dispute the biological
plausibility of the theory . . . . In this case, by contrast, the government’s expert witness did not
concede the biological plausibility of the . . . theory, and in fact testified that people in the field
don’t think it’s biologically plausible.” Id. at 1325 (citing Andreu, 569 F.3d at 1377) (internal
quotation marks omitted). Similarly, in LaLonde, the Federal Circuit held “a ‘plausible’ theory
of causation is insufficient for a petitioner to meet [the] burden of proof” necessary for the
petitioner to receive her requested relief in off-table vaccine case. LaLonde, 746 F.3d at 1339
(quoting Moberly, 592 F.3d at 1322). The Federal Circuit did not reject outright the
“plausibility” standard for a medical theory in LaLonde, but instead said the petitioner must
“show both the medical plausibility of her theory of causation and that the injury was consistent
with that theory.” Id. at 1340 (citing Hibbard v. Sec’y of Health & Human Servs., 698 F.3d
1355, 1365 (Fed. Cir. 2012)).
In Kottenstette v. Sec’y of Health & Human Servs, an unpublished Federal Circuit
opinion issued on 15 June 2021 overruling the Court of Federal Claims for applying an incorrect
legal standard, the Federal Circuit clarified the issue of the appropriate standard since Boatmon.
Kottenstette v. Sec'y of Health & Human Servs., No. 2020-2282, 2021 WL 2434329, at *1 (Fed.
Cir. June 15, 2021). In Kottenstette, the special master summarized the Althen element one
standard as “a search for ‘medical probability rather than certainty’” and explained “‘medical
probability means biologic credibility rather than specification of an exact biologic mechanism.’”
Id. at *6 (citing Kottenstette v. Sec’y of Health & Human Servs. (Kottenstette I), No. 15-1016V,
2020 WL 953484, at *2–3 (Fed. Cl. Feb. 12, 2020)). The Court of Federal Claims held the
special master applied an incorrect legal standard, stating “biologic credibility is not sufficiently
distinguishable from the ‘plausible’ or ‘reasonable’ standard that the Federal Circuit rejected in
Boatmon.” Id. (internal quotation marks omitted) (citing Kottenstette I at *3). The Federal
Circuit in Kottenstette held “the . . . special master applied the correct legal standard. Thus, the .
. . Court of Federal Claims decision vacating and remanding her decision is in error.” Id. The
court stated the special master’s standard correctly follows the Federal Circuit’s precedents “that
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proof of causation does not ‘require identification and proof of specific biological mechanisms.’”
Id. at *7 (quoting Knudsen, 35 F.3d at 549). The Federal Circuit explicitly stated “Boatmon did
not, and indeed, could not, overrule these previous articulations of the standard for causation.”
Id.
During oral argument, petitioner characterizes the Althen element one standard as: “a
claimant’s theory of causation must be supported by a reputable medical and scientific
explanation.” Tr. at 71:20–22. Respondent agrees with this standard and adds Andreu requires
the explanation must be supported by “a simple preponderance of the evidence.” Id. at 71:25–
72:2, 71:4–7. Petitioner “absolutely” agrees the preponderant standard is applicable, but
expresses the concern that “to apply [the preponderant standard] to the requirement of evidence
for prong 1 . . . is not exactly correct,” as “there’s a conflict of concepts with [Althen element
one and the evidential standard],” and “that may be where the confusion is.” Id. at 67:25–68:3.
The Federal Circuit’s Kottenstette decision came out after oral argument in this case, and
therefore the Court did not have the opportunity to solicit the parties’ opinions on the Althen
element one standard in view of Kottenstette. Nevertheless, the Federal Circuit’s clarification in
Kottenstette resolves petitioner’s confusion in applying the preponderant standard to Althen
element one: “proof of causation does not ‘require identification and proof of specific biological
mechanisms,’” and “Boatmon did not, and indeed, could not, overrule these previous
articulations of the standard for causation.” Kottenstette, 2021 WL 2434329, at *7 (quoting
Knudsen, 35 F.3d at 549). Accordingly, the Court finds the Chief Special Master erroneously
suggested Boatmon overruled Andreu’s biological plausibility standard for Althen element one.
Andreu, 569 F.3d at 1375 (“The first prong was satisfied . . . [when petitioner’s expert] presented
a ‘biologically plausible’ theory establishing that toxins in the whole-cell pertussis vaccine can
cause seizures.”); Decision at 38.
B. The Chief Special Master’s Reliance on the Baxter Study as Providing
“Comprehensive, Contrary Evidence”
Roger Baxter et al., Acute Demyelinating Events Following Vaccines: A Case-Centered
Analysis, 63 CLIN. INFECT. DIS. 1456 (2016), referred by the Chief Special Master as the Baxter
study, is Reference 12 in petitioner’s expert Dr. Zamvil’s report. ECF No. 32-3. Dr. Zamvil
cited the Baxter study only once in his report, as a reference for his opinion that “[t]he
association of transverse myelitis and Tetanus toxoid (TT)-containing vaccination was clear. As
transverse myelitis following TDaP is a rare event, however, one should recognize that it has
been challenging for epidemiologists to establish a relative risk.” See ECF No. 31-1 at 7 (Dr.
Zamvil’s expert report); see also Decision at 13.
The Chief Special Master described Baxter as:
“[A] large-scale, comprehensive epidemiological study aimed at examining the risk
of demyelinating event following vaccination generally, and evaluated instances of
the occurrence of two acute demyelinating diseases (TM and ADEM) within a field
of nearly 64 million vaccinations (including almost six million Tdap recipients)
derived from data maintained by the Vaccine Safety Datalink . . . [o]nly seven cases
of TM were reported between 5-28 days post-vaccination—the very timeframe
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applicable herein. . . . Baxter concluded that there was no reliably-demonstrated
association between vaccination and the subsequent development of TM.”
Decision at 39 (emphasis and internal citations omitted). The Chief Special Master took special
note that, while “Dr. Zamvil expressly relied on the Baxter article to support an association
between TM and receipt of the Tdap vaccine,” “his assertions regarding its findings essentially
ignored what is so glaringly unfavorable about them.” Id. at 39–40. The Chief Special Master
acknowledged “Dr. Zamvil also relied on a series of case reports documenting instances of TM
following vaccination,” such as the Agmon-Levin reports, to support the association of TM and
Tdap vaccines. Decision at 14. According to the Chief Special Master, Agmon-Levin reported
four “TM [incidences] after receiving either the diphtheria-tetanus-pertussis vaccine or the
diphtheria-tetanus vaccine” and “found seventy-three percent of TM cases were reported within
one month of vaccination, consistent with the timeframe [I.J.] experienced.” Id. The Chief
Special Master found “[t]hese case reports overall had some evidentiary value . . . . But they are
not enough to meet the preponderant burden, especially given the far more comprehensive,
contrary evidence provided by Baxter.” Id. at 42.
Petitioner strongly objects to the Chief Special Master’s reliance on the Baxter study,
maintaining “[t]he record is completely insufficient for the Chief Special Master to have placed
the weight that he placed on Baxter . . . and that was the case breaker. . . . And there just was
insufficient data, insufficient discussion, insufficient analysis for the Chief Special Master to
draw the conclusions that he did.” Tr. at 98:6–14. In particular, petitioner directs the Court to
consider that “[t]he underlying data [in Baxter] was not filed,” and “Dr. Zamvil’s reliance on
Baxter was for a very different purpose than what the Chief Special Master focused on.” Id. at
98:17–19.
Respondent agrees with petitioner in many aspects. Respondent agrees “Dr. Zamvil
used Baxter as a case summary report, and the [Chief] Special Master used Baxter as an
epidemiological study.” Id. at 101:24–102:2. Respondent further notes “the Chief Special
Master on his own provided more details about the statistical analysis that was conducted in
Baxter that Dr. Zamvil testified about.” Id. at 87:8–11. Respondent notes the Chief Special
Master’s findings on the Baxter study are not supported by a close reading of the article and,
while supplementary data is needed to understand the Baxter study, the Chief Special Master did
not “have the supplementary data and/or cite the supplementary data.” Id. at 82:19–83:17. In
response to a question of why the Court should still uphold the Chief Special Master’s decision
with all these shortcomings, the respondent argues, “even if we were to ignore Baxter, the
outcome would still be the same.” Id. at 92:18–21.
1. The Data and Statistical Analysis in the Baxter Study
The Chief Special Master found “within a field of nearly 64 million vaccinations
(including almost six million Tdap recipients) derived from data maintained by the Vaccine
Safety Datalink . . . [o]nly seven cases of TM were reported between 5-28 days post-
vaccination—the very timeframe applicable herein.” Decision at 39. During oral argument,
respondent helped the Court understand the correct reading of the Baxter study, based on the data
reported in Table 1 and Table 4 of the article, should be “there was one total risk case per one
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million doses of each vaccine,” and respondent does not “see where that seven number comes
from except in the results section [of the article’s Abstract].” Tr. at 82:5–7, 82:19–22, 83:21–24
(When the Court asked respondent’s counsel whether “the Court’s assessment that Table 4 read
together with Table 1 details that the total risk cases, the explanation is one TM case per 1
million vaccines administered,” respondent’s counsel replied “that’s what Table 4 would
suggest.”). The Court therefore notes the Chief Special Master’s reading of the Baxter study—
seven cases of TM reported in 64 million vaccinations—does not accurately reflect the data in
the article.
Respondent nevertheless suggested the Chief Special Master’s mistaken reading of the
numbers would not change the outcome, because the Baxter study noted “no increased risk was
found for TM following Tdap and that . . . was a statistically significant conclusion.” Tr. at
83:2–4; see also Decision at 39. On the Baxter study’s statistical analysis, respondent agrees
with the Court’s suggestion that one important number in Table 4 of the study is the P value for
each vaccine, because “[t]o reach a conclusion that a certain vaccine statistically increases the
risk of TM, the P value would have to be lower than something similar to .05.” Tr. 84:4–9. To
calculate a P value for the purpose of rejecting or admitting an association, there must be a study
group and a control group. 22 See Richard C. Dicker, The CDC Field Epidemiology Manual,
EPIDEMIC INTELLIGENCE SERVICE, ANALYZING AND INTERPRETING DATA (Dec. 13, 2018),
https://www.cdc.gov/eis/field-epi-manual/chapters/analyze-Interpret-
Data.html#anchor_1543585004 (describing an alternative hypothesis will be adopted if the null
hypothesis, the assumption being made, proves to be implausible). The Court struggles to
understand from the Chief Special Master’s decision what the control group is in the Baxter
study, and respondent could not lend help except for speculating the information might be in the
supplemental data which neither the Chief Special Master nor respondent had access to.23 Tr. at
83:15–17, 85:3–7. Respondent further comments the Chief Special Master “on his own provided
more details about the statistical analysis” than what was provided by Dr. Zamvil. Id. at 87:8–
12. In conclusion, the Court finds both parties at least agree the Chief Special Master made
important factual findings regarding the Baxter study without being presented with sufficient
evidence to support the findings.
Respondent suggests the Court focuses on Dr. Zamvil’s testimony regarding the Baxter
study, where Dr. Zamvil testified “the case control study was a fairly reliable type of evidence”
that revealed no statistically significant increased risk of immunization for TM. Id. at 90:1–6.
22 Basic statistics books, including Gary L. Tietjen, A Topical Dictionary of Statistics at 37–38, and the CDC
website, Richard C. Dicker, The CDC Field Epidemiology Manual, EPIDEMIC INTELLIGENCE SERVICE, ANALYZING
AND INTERPRETING DATA (Dec. 13, 2018), https://www.cdc.gov/eis/field-epi-manual/chapters/analyze-Interpret-
Data.html#anchor_1543585004, can help understand the Chief Special Master’s statistical findings in reference to
the Baxter Study. A p-value is the probability of finding an association as strong as, or stronger than, the one
observed if the null hypothesis were true. A small p-value means the null hypothesis is implausible. If p-value is
smaller that a predetermined cutoff, the null hypothesis is rejected in favor of the alternative hypothesis. A rejection
of the null hypothesis means the association is statistically significant.
23 On page 21 of the Chief Special Master’s decision, he wrote “Dr. Levin compared incidence rates between TM
and spinal cord infarction, finding that . . . TM is . . . occurring in 3 per 100,000 person-years.” This is the only
possible, though seemingly remote, information about the Baxter study’s control group the Court could identify
throughout the Chief Special Master’s decision. Tr. at 85:8–14. Respondent’s counsel explained to the Court the
question is beyond her level of statistical knowledge, and Dr. Levin, who supplied the “TM occurring in 3 per
100,000 person-years” statement, did not testify about the Baxter study. Id. at 86:7–22.
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The Court notes, and respondent agrees, Dr. Zamvil relied on the Baxter study for a different
purpose than the Chief Special Master did. Id. at 90:7–9; see also id. at 101:24–102:2
(Respondent’s counsel agreeing “Dr. Zamvil used Baxter as a case summary report, and the
Special Master used Baxter as an epidemiological study.”). Respondent suggests “for what the
Chief Special Master understood the holdings of Baxter to be,” he assigned correct weight to the
Baxter study in his decision, but at oral argument before the Court “shed some additional light on
what Baxter stands for more.” Id. at 106:8–16. Respondent specially notes the discussion of
lack of supplementary data and what Table 4 of the Baxter study shows. Id. at 101:18–20.
Given the “additional light” oral argument shed on the Baxter study, respondent maintains “the
Baxter study has some value in terms of its conclusions regarding no association between TM
and [Tdap vaccine].” Id. at 101:21–23.
Respondent agrees it is a “fair statement” that “a large-scale statistical study . . . has a
whole lot of data in it that stands for a variety of things” and “that the statistical value that Dr.
Zamvil, as an expert who probably also had access to all of the underlying data used in one
calculation, is far different than the statistical analysis used to describe a conclusion related [to]
something else, especially without a statistical background and review of the underlying data and
regressions and calculations.” Tr. at 90:16–91:2. In this case, the record is too incomplete for
the Chief Special Master to draw plausible inferences from the simple statistical conclusion
presented by the Baxter study. Furthermore, the Chief Special Master relied on the Baxter study
as “far more comprehensive, contrary evidence” to counter the probative value of other evidence
by the petitioner, such as the Agmon-Levin case reports, and “the far more comprehensive
contrary evidence provided by Baxter” is connected with the numbers the Chief Special Master
discussed as related to Baxter. Decision at 42; see also Tr. at 88:2–13. As discussed above, the
Chief Special Master’s findings of the numbers in Baxter, including a plain reading of the data
and the statistical analysis, is not supported by the record.
Accordingly, the Court finds the Chief Special Master’s decision that the Baxter study
provides “far more comprehensive, contrary evidence” is not supported by the record, and thus is
arbitrary and capricious. Saunders v. Sec’y of Dept. of Health & Human Servs., 25 F.3d 1031,
1033 (Fed. Cir. 1994) (quoting Munn v. Sec’y of Dept. of Health & Human Servs., 970 F.2d 863,
870 n.10 (Fed. Cir. 1992)) (“Fact findings are reviewed . . . under the arbitrary and capricious
standard.”); see also Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1380 (Fed. Cir.
2015) (“Where, as here, a special master . . . misconstrues [a petitioner’s] medical records, and
makes factual inferences wholly unsupported by the record, the Court of Federal Claims is not
only authorized, but obliged, to set aside the special master's findings of fact and conclusions of
law.”).
2. The Chief Special Master’s Consideration of the Baxter Study in
Other Cases
The 2016 Baxter study collected and analyzed data for 18 types of vaccines from the
CDC’s Vaccine Safety Datalink, and concluded “[f]or TM, we found no evidence of a safety
concern, or any association with subsequent illness [for any of the 18 vaccines]. If there is any
association, it is <1 per million doses for vaccines other than live zoster and live attenuated
influenza vaccines, and <2 per million doses of these 2 vaccines.” Baxter study at 1461. For
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some vaccines including Hepatitis B, the Baxter study concluded there is zero risk case per one
million vaccine receivers. Id. at 1460. The Chief Special Master considered the Baxter study in
other cases since the study’s publication, including Bender v. Sec’y of Health & Human Servs.,
11-693V, 2018 WL 3679637 (Fed. Cl. Spec. Mstr. Jul. 2, 2018) and McGrail v. Sec’y of Health
& Human Servs., 17-926V, 2021 WL 1728706 (Fed. Cl. Spec. Mstr. Apr. 23, 2021).
In Bender, the Chief Special Master denied compensation for TM the petitioner alleged
was caused by the Hepatitis A and meningococcal vaccines. Bender, 2018 WL 3679637 at *1–2.
The respondent in Bender offered the Baxter study to undermine petitioner’s causation theory for
TM. Id. at *30. The Chief Special Master considered the Baxter study but concluded it did not
“stand as [his] primary basis for finding the [p]etitioner did not establish a plausible causation
theory.” Id. Petitioner’s Althen element one demonstration in Bender failed for many reasons,
including petitioner providing no evidence linking the particular vaccines to her injury and her
experts “being significantly less persuasive” than respondent’s. Id. at *29, 31.
In McGrail, the Chief Special Master awarded compensation for TM the petitioner was
able to show—by a preponderance of evidence—was caused by the Hepatitis B vaccine.
McGrail, 2021 WL 1728706 at *1. As with Bender, the respondent offered Baxter to undercut
petitioner’s causation theory. Id. at *26. The Chief Special Master considered Baxter and found
it “does undercut [p]etitioner’s showing.” Id. The Chief Special Master nevertheless found the
petitioners successfully met the Althen element one burden for the following reasons:
petitioners’ experts “offered enough reliable scientific and medical evidence [including
molecular mimicry and case studies] . . . to provide a preponderant ‘can cause’ theory relating
the Hepatitis B vaccine to TM”; “existing [Vaccine] Program decisions [finding causation
between Hepatitis B and TM] also helped [p]etitioners”; and treaters’ opinions pointing out
Hepatitis B as the likely cause of the disease. Id. at 25. The Chief Special Master concluded
petitioners “barely met their preponderant burden on this first element,” and “well-reasoned and
controlling precedent in the Vaccine Program requires” the Chief Special Master “in such close
cases to decide the matter for the petitioner.” Id. at 26.
Petitioner argues the Chief Special Master’s reliance on the Baxter study in this case is
“undue and burden-heightening” compared to his discussion of Baxter in Bender. Mot. for
Review at 32. Petitioner was not aware of McGrail at oral argument, but respondent brought it
to the Court’s attention to demonstrate the Baxter study does not block every vaccine
compensation claim. Tr. at 96:24–97:13, 102:3–7. Respondent argues McGrail is
distinguishable from the present case because the respondent, rather than the petitioners, was the
party in McGrail which offered Baxter to support its position, but respondent could not offer a
legal explanation to justify different interpretations of evidence when offered by different parties.
Id. at 104:5–105:9. Respondent does not dispute the Chief Special Master read Baxter in a more
favorable light for petitioner in McGrail, regardless of Baxter finding zero increased risk for
Hepatitis B per one million doses. Id. at 105:9–20 (respondent stating “all [she] can say [on
Baxter being read in a more favorable light in McGrail] is that each case is very specific to the
facts and the evidence and findings of the Chief Special Master, and one decision is not binding
on another.”). Respondent nevertheless maintains, “to the extent that the Chief Special Master
reached a different decision about Baxter in a different case with different evidence and a
different vaccine, . . . that’s something that he is allowed to do as a Chief Special Master.” Id. at
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106:1–6. Respondent further noted, in McGrail, the Chief Special Master credited a previous
omnibus proceeding which found Hepatitis B was causal of TM. Id. at 106:21–24. In the
present case, the Chief Special Master acknowledged several previous decisions finding Tdap
being causal of TM, but refused to credit these decisions. Decision at 40 (citing Roberts v. Sec’y
of Health and Human Servs., No. 09-427V, 2013 WL 5314698 (Fed. Cl. Spec. Mstr. Aug. 29,
2013); Raymo v. Sec’y of Health & Human Servs., No. 11-0654V, 2014 WL 1092274 (Fed. Cl.
Spec. Mstr. Feb. 24, 2014); Helman v. Sec’y of Health and Human Servs., No. 10-813V, 2012
WL 1607142 (Fed. Cl. Spec. Mstr. Apr. 5, 2012)). Respondent explained the Chief Special
Master’s contrasting treatment of previous decisions in McGrail, as compared to this case, is due
to the factual and procedural differences linking vaccines to TM. Tr. at 107:17–108:23.
The Chief Special Master assigned consistent weight to the Baxter study in Bender and
McGrail: The Chief Special Master found the Baxter study “does undercut [p]etitioner’s
showing,” but he either decided it was not sufficient to rebut petitioner’s Althen element one
showing or it did not “stand as [the] primary basis for finding the [p]etitioner did not establish a
plausible causation theory.” McGrail, 2021 WL 1728706 at *26; Bender, 2018 WL 3679637 at
*30. In this case, the Chief Special Master found the Baxter study provided “far more
comprehensive, contrary evidence” against petitioner’s Althen element one showings. Decision
at 42. Petitioner complains the Chief Special Master elevated the Baxter study to “not the tie-
breaker, but the case-breaker” weight in this case despite the record being “completely
insufficient for the Chief Special Master to have placed the weight that he placed.” Tr. at 98:5–
11. Respondent describes the Baxter study in McGrail as “just one element,” and “in and of
itself, . . . not a tie-breaker.” Id. at 97:9–10.
Regarding the Baxter study itself, the only difference in the weight of the study between
this case and in Bender and McGrail is the fact Baxter was offered as petitioner’s evidence in
this case, and I.J. offered the Baxter study to show possible association between Tdap vaccine
and TM. The Chief Special Master read the Baxter study differently than petitioner’s expert,
finding the expert “essentially ignored what is so glaringly unfavorable” to petitioner in Baxter.
Decision at 40. The Court understands special masters are not required to distinguish other
relevant cases. Boatmon, 941 F.3d at 1358. The Chief Special Master cannot, however, read the
exact same evidence differently in different cases solely because it is offered by a different party.
Here, the Court finds the Chief Special Master’s conclusion that the Baxter study provided “far
more comprehensive, contrary evidence” in this case troublesome because of the stark contrast in
the weight the Special Master’s assigned to the Baxter study in this case versus Bender and
McGrail.24
24 The Baxter study does not completely disavow the association of TM and vaccines, but rather claimed “[i]f there
is any association, it is <1 per million doses for vaccines other than live zoster and live attenuated influenza
vaccines, and <2 per million doses of these 2 vaccines.” Baxter study at 1461. An extremely low rate of association
does not preclude the possibility of compensation, especially in view of the statutory purpose of the Vaccine Act.
See Boatmon, 941 F.3d at 1364 (Newman, P., dissenting) (quoting National Childhood Vaccine-Injury
Compensation Act: Hearing on S.2117 Before the S. Comm. on Labor & Human Res., 98th Cong. 3–4 (1984)
(“These few but important injuries create doubts and fears in our National Childhood Vaccination Programs. . . . We
must be able to assure parents that when their children are the victims of an appropriate and rational national policy,
a compassionate Government will assist them in their hour of need.”)). Respondent maintains vaccine compensation
is not predicated upon any particular rate of association between the injury and the vaccine. Tr. at 95:22–96:3
(When asked if “the rate of one in a million [is] too low for vaccine compensation,” respondent’s counsel stated “I
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C. The Chief Special Master’s Finding Related to Petitioner’s Burden of Proof for
Molecular Mimicry Theory
Petitioner relied on molecular mimicry to show the Tdap vaccine can cause TM. Mot. to
Review at 32. Petitioner’s expert found homologies between a protein antigen in Tdap and
human myelin proteins as “supporting the principle that TDaP has potential to activate the
immune response to CNS autoantigens.” Id. The Chief Special Master acknowledged molecular
mimicry is a “generally accepted scientific explanation for many autoimmune diseases.”
Decision at 41. The Chief Special Master also acknowledges previous cases, including Raymo,
Roberts, and Helman, found Tdap vaccines can cause TM, but concluded “the applicability of
prior decisions like Raymo, Roberts, and Helman—all of which rely on literature similar to that
offered herein, or more broadly involve theories parallel with [p]etitioner’s theory of
autoimmunity attributable to molecular mimicry—is . . . diminished by more recent
determinations involving the same causal theories producing TM.” Decision at 40 (citing
Forrest, 2019 WL 925495, at *3).
Petitioner argues Forrest was wrongly decided because it “runs afoul of the principle that
petitioners in the Vaccine Program need not prove their cases with scientific certainty.” Mot. to
Review at 34 (citing Moberly, 592 F.3d at 1322). Respondent agrees “Forrest is not consistent
with Raymo, Roberts, and Helman.” Tr. at 116:14–21. Respondent further argues Forrest is
significantly distinguishable from Raymo, Roberts, and Helman because Forrest addressed a
petitioner seeking compensation under the claim the flu vaccine caused their TM. Id. at 117:7–
17. Respondent also argues Raymo, Roberts, and Helman were wrongly decided, because “if the
Forrest standard was held to those cases, those petitioners would not have established molecular
mimicry.” Id. at 115:23–116:21 (“I don't think that Raymo and Roberts were correctly decided
or that the appropriate standard was used there. . . . I agree the Forrest decision is not consistent
with Roberts, Raymo, . . . [and] Helman.”). Respondent explains “in Roberts, the Special Master
discusses how molecular mimicry is plausible,” but “Boatmon made very clear that plausib[ility]
is insufficient.” Id. at 116:4–10.
As discussed in Section VI(A), the Federal Circuit warned “Boatmon did not, and indeed,
could not, overrule these previous articulations of the standard for causation.” Kottenstette, 2021
WL 2434329, at *7. The “biological plausibility” standard still applies for Althen element one.
Andreu, 569 F.3d at 1375 (“The first prong was satisfied . . . [when petitioner’s expert] presented
a ‘biologically plausible’ theory establishing that toxins in the whole-cell pertussis vaccine can
cause seizures.”). Accordingly, to the extent the Chief Special Master found Forrest discredited
Raymo, Roberts, and Helman because Boatmon abolished the plausibility standard of Andreu, the
Chief Special Master’s decision is “not in accordance with law.” Saunders, 25 F.3d at 1033
don’t think that vaccine compensation is predicated upon any particular rate.”). As respondent notes, a zero rate of
association between Hepatitis B and TM reported by Baxter did not preclude the Chief Special Master from
awarding award compensation in McGrail. Id. at 96:24–97:13; Baxter study at 1460. Respondent further notes “the
Baxter study— like all epidemiological studies—can never prove definitively that Factor A never causes Condition
B.” Resp. to Mot. for Review at 12 (internal quotation marks omitted) (citing Bender, 2018 WL 3679637, at *30
(quoting Crutchfield v. Sec’y of Health & Human Servs., No. 09-0039V, 2014 WL 1665227, at *15 (Fed. Cl. Spec.
Mstr. Apr. 7, 2014))); see also Tr. 100:10–16 (“[N]o study can say that a vaccine can’t cause a particular injury . . . .
That's just an impossible thing for any epidemiological study to establish.”).
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(quoting Munn, 970 F.2d 870 n.10) (“[L]egal questions [are reviewed] under the ‘not in
accordance with law’ standard.”); Decision at 40 (citing Forrest in support of the prospect “the
applicability of prior decisions . . . [is] diminished by more recent determinations involving the
same causal theories producing TM.”). On remand, the Chief Special Master should review
petitioner’s molecular mimicry showings under the correct legal standard.25
D. Conclusion Regarding Althen Element One
The Court does not address the question of whether petitioner offered sufficient evidence
to establish Althen element I through the molecular mimicry standard. Lampe v. Sec’y of Health
& Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000) (quoting Munn, 970 F.2d at 871) (noting
it is not the reviewing court’s role “to reweigh the factual evidence, or to assess whether the
special master correctly evaluated the evidence.”).26 Rather, the Court finds the Chief Special
Master applied an incorrect legal standard to weigh the evidence and that such a decision was
arbitrary, capricious, and not in accordance with law. See supra. On remand, the Chief Special
Master should reweigh the parties’ arguments under the correct legal standard.
VII. The Chief Special Master’s Althen Element Two Decision
The second Althen element concerns whether the vaccine did cause petitioner’s injury.
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). The Chief
Special Master discussed Althen element two and element three after he decided petitioner failed
to prove Althen element one. Decision at 42 (“Petitioner’s claim cannot succeed, given his
failure to meet at least one of the three Althen prongs. . . . However, for purposes of completion
of my overall analysis, I will also discuss his success in meeting the other two.”). The Chief
Special Master found petitioner failed to meet Althen element two due primarily to two
evidentiary shortcomings: (1) “there was hardly any testing evidence (whether from serologic
sampling or MRI imaging) that would establish the existence of inflammation—a telltale sign
confirming the presence of the autoimmune process that [p]etitioner’s causation theory
proposes”; and (2) “no treaters ever proposed that [p]etitioner’s injury, however defined, was
likely caused by his prior Tdap vaccine.” Id. at 41–42.
25 The Forrest decision was not reviewed by this court or the Federal Circuit. Therefore, the Forrest standard has no
precedential value.
26 Petitioner relied on BLAST search results to find homologies between a protein antigen in Tdap to human
myeline proteins, which supports petitioner’s molecular mimicry theory. Mot. to Review at 26. Respondent
criticizes the use of BLAST as “a case-oriented search and therefore . . . less reliable and persuasive.” Tr. at
112:13–16. Respondent further maintains Dr. Zamvil “kind of stopped with the homology,” and argues “those
sequences alone are [not] enough to establish that they would be biologically meaningful and would actually result
in autoantibodies.” Id. at 114:2–10; see also Decision at 41 (“[M]erely demonstrating some homology between
vaccine components and relevant self-structures based on computer database searches does not carry the day.”).
Petitioner directs the Court to look at Dr. Zamvil’s report beyond only the BLAST search, noting “he went on to
explain in detail the mechanisms supported by the medical literature, how it could cause this injury.” Tr. at 118:14–
20. Petitioner characterizes the BLAST search as “just one confirmatory tool based on a government database that
was used to support the theory, conforming with the requirement that there be an explanation that’s reliable and
reputable.” Id. at 118:22–1. Whether Dr. Zamvil’s approach is sufficiently reliable and persuasive to meet the
preponderance of evidence standard is a question best addressed by the Chief Special Master on remand. Lampe,
219 F.3d at 1360.
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A. Testing Evidence of Inflammation
The medical definition of transverse myelitis is inflammation of the spinal cord in which
the functional effect of the lesions spans the width of the entire cord at a given level. W.A.
Newman Dorland, DORLAND’S ILLUSTRATED MEDICAL DICTIONARY 1201 (33rd ed. 2020).
Respondent’s expert, Dr. Alexander, provided the same definition of TM to the Chief Special
Master: “Transverse myelitis . . . is defined by finding evidence of inflammation, seen either by
gadolinium enhancement on MRI or CSF pleocytosis, or both.” Alexander Ex. Rep. 1 at 9; see
also Decision at 22 (citing 2019 Tr. at 301:10–11 (Dr. Alexander testifying, “[t]ransverse
myelitis describes, you know, an inflammation of the cord.”)). According to the TM Working
Group criteria, the application of which both parties agreed with before the Chief Special Master,
inflammation is one inclusion criteria for diagnosing TM. Decision at 35 (“The parties seemed
to agree that the TM Working Group criteria were a good general yardstick for evaluating if TM
was present in this case.”); Proposed Diagnostic Criteria and Nosology of Acute Transverse
Myelitis, ECF No. 63-4 at 500 (Diagnosis criteria established by the Transverse Myelitis
Consortium Working Group). During oral argument, respondent again confirms, “[t]o the extent
that Dr. Alexander testified that transverse myelitis is inflammation of the spinal cord, in many
cases that’s correct. . . . [M]yelitis literally means inflammation of the spinal cord.” Tr. at
21:16–19.
Petitioner argues the Chief Special Master’s conclusion petitioner suffered from TM
internally contradicts the finding of no inflammation. Mot. for Review at 37 (“The [Chief]
Special Master relied upon a purported absence of inflammation as undermining the diagnosis of
TM. The [Chief] Special Master himself also suggested the possibility that the TM . . . might
have been prompted by a respiratory infection.”). At oral argument, respondent tried to defend
the Chief Special Master’s decision by arguing it is the petitioner’s burden, not respondent’s, “to
prove whether or not there’s inflammation.” Tr. at 25:23–25. At oral argument, respondent told
the Court inflammation is “an essential piece . . . to have transverse myelitis, and especially
vaccine-induced transverse myelitis,” and the Chief Special Master’s decision “was not faithful
to the transverse myelitis working group.” Id. at 23:3–5, 23:24–24:2. Respondent further stated
it is “essentially correct” to summarize the government’s position as: “there was no
inflammation of the [p]etitioner's spinal cord[,] and that a lack of inflammation of the spinal cord
should have resulted in the [Chief] Special Master concluding that there was not TM[,] and that
the conclusion that there was TM was inconsistent with the finding of no inflammation of the
spinal cord.” Id. at 24:11–18. The discussion with respondent on the relationship of
inflammation and TM reveals both petitioner and respondent hold the position that the Chief
Special Master’s decision on TM is inconsistent with his finding of no inflammation.
Petitioner maintains the Chief Special Master’s statement that “there was hardly any
testing [to support inflammation]” and his “dismissal of the testing” is arbitrary and capricious.
Id. at 35:20–21; see also Mot. for Review at 37 (“The [Chief] Special Master’s interpretation of
the medical record was arbitrary and capricious, requiring reversal. Moreover, the Decision by
the Special Master was rendered irrational by an internal inconsistency fundamental to
[p]etitioner’s case”) (emphasis omitted). The government agrees “[I.J.] underwent a number of
tests. It’s [respondent’s argument] that those tests didn’t show inflammation.” Tr. at 36:20–21.
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Petitioner first cites to the MRI testing done on 17 August 2013 (“17 August MRI”) as
supporting inflammation. Mot. for Review at 37–38. I.J.’s medical record shows he underwent
two rounds of MRI testing, one on 8 August 2013 (“8 August MRI”), and the other on 17
August 2013. Med. Recs. 50-2 at 1–2; Med. Recs. 8-2 at 10; see also Tr. at 28:6–8, 29:2–4
(Petitioner’s counsel stating, “I don't think there were more than two MRIs,” and respondent’s
counsel stating, “I agree with [petitioner’s counsel], there was only one second MRI
conducted.”). The parties do not dispute the 8 August MRI did not show inflammation, and
petitioner explained this is because “TM typically shows a lack of inflammation early in the
disease process.” Mot. for Review at 37; see also Tr. at 37:22–24 (“Respondent’s expert opined
that only the second MRI, the 8/17 showed any sort of enhancement.”); Mot. for Review at 37
(“[W]hile there was no gadolinium enhancement on the initial MRI, the follow up just a few
days later did so reflect gadolinium enhancement.”). The parties do not dispute the 17 August
MRI showed enhancement that was not in the 8 August MRI, but disagree on whether the
enhancement is inflammation. Tr. at 29:19–22 (Petitioner arguing “that the August 17th MRI . . .
show[s] inflammation.”), 37:24–38:2 (Respondent’s counsel arguing “8/17 is like nine days post
onset. That’s much too late to show evidence of inflammation if we are going to decide that this
is transverse myelitis.”). Respondent argues, because the 17 August MRI was taken outside the
2–7 day post-onset window, “it’s difficult to relate that back . . . to a vaccine or an immune-
mediated event.” Id. at 41:14–21. Nevertheless, respondent could not identify the exact onset
time of I.J.’s symptoms—whether at the CT scan or the first MRI—and disputes the Chief
Special Master’s finding. See supra Section V.27 Petitioner argues, whether or not the 8 August
MRI marked the onset of I.J.’s symptoms, “[the 17 August MRI] was not so widely outside [the
2–7 day post onset window] that it’s not relevant. It’s highly relevant and reflected the change in
I.J.’s condition and reflected the change in the presences of inflammation, which was a key point
on this logical sequence of cause and effect.” Tr. at 54:4–9.
When presented with the 17 August MRI imaging during oral argument, petitioner’s
counsel was not able to explain to the Court how the enhanced signals are indicative of
inflammation and stated he would defer this issue to the expert report of Dr. Watanabe, who
“was credited in the hearing.” Id. at 30:24–31:25. Respondent’s counsel did not offer to explain
how the imaging does not support an interpretation of inflammation, but at a later stage of the
oral argument counsel returned to the point to argue the enhanced signals “supported a spinal
cord infarct” based on the findings on diffusion-weighted imaging of the 17 August MRI. Id. at
27 During oral argument, respondent’s counsel for the first time questioned the Chief Special Master’s finding of
I.J.’s symptom onset time. See Tr. at 51:1–10 (Respondent agreeing “[t]he [g]overnment disputes the [Chief]
Special Master’s conclusion that prior to his scan, I.J. testified to being . . . fully mobile.”); Decision at 8 (“Prior to
his scan, [I.J.] recalled being fully mobile. Immediately following his MRI scan, however, [I.J.] lost all mobility
from the neck down.”) (internal citations omitted). Respondent contends I.J. referred to the timing of the CT scan
when he started to lose mobility, not the MRI scan. Tr. at 42:22–43:8 (Respondent’s counsel stated “that was the
CT scan, not the MRI” “when I.J. was able to move his extremities and when he came out of the [scan] or
immediately thereafter, he was not.”). Respondent acknowledges the timing of I.J. losing mobility is critical
because such timing marked I.J.’s symptom onset, id. at 42:2–4, but respondent disputes the timing of the onset. Id.
at 43:15–22 (Respondent’s counsel stating, “the goal here is to figure out when the MRI occurred. And so I don't
want to hold up the discussion by having a dispute about whether it was the CT scan or the MRI.”).
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63:1–15.28 I.J.’s medical record shows his treating physicians considered the differential
diagnosis between TM and SCI after the 17 August 2013 MRI and ordered CT angiogram for
“further evaluation of spinal arterial supply.” Med. Recs. 8-3 at 230–231; see also Decision at 4
(“Based on these results [of the 17 August MRI], I.J.’s differential diagnosis was narrowed to
encompass only TM and spinal cord infarction—though the diagnosis of TM was identified as
favored due to ‘the age of [I.J.], the repeat occurrence, and the holocord involvement, and the
cervical location’ of the lesion.”). Regarding the results of the CT angiogram, petitioner explains
“there was no cutoff of the artery . . . be[ing] seen in [the CT] angiogram . . . which is
inconsistent with there being an infarct.” Tr. at 33:2–5. Respondent does not dispute the CT
angiogram did not show an embolus or thrombus, but respondent’s expert states “[o]ne would
not expect to find embolus or thrombus thirteen days after an infarct.” Alexander Ex. Rep. 2 at
2.
Respondent does not offer specific evidence to directly negate the interpretation of the 17
August MRI as indicating inflammation. Respondent’s argument regarding the 17 August MRI
rather primarily concerns on it being taken outside the 2–7 day post onset window and the
enhancement possibly being indicative of an infarction. Tr. at 41:14–21, 63:1–15. Nevertheless,
the government disputes the onset time and could not reconcile the different outcomes of the 17
August MRI and the CT angiogram, despite these two tests being taken in a close timeframe.
See supra. The Chief Special Master acknowledges the 17 August MRI narrowed I.J.’s
differential diagnosis “to encompass only TM and spinal cord infarction—though the diagnosis
of TM was identified as favored.” Decision at 4.
Regarding the serologic sampling test, respondent suggested “testing of the cerebrospinal
fluid . . . show[ing] an elevated white blood cell count” can point to inflammation and noted
I.J.’s medical record does not contain such evidence. Tr. at 41:7–11. I.J. underwent a CSF test
around the same time as the first 8 August MRI test. See Mot. for Review at 22 n. 17. Petitioner
does not dispute “the CSF came back negative for pleocytosis (elevated white blood cell count).”
Id. at 38. Petitioner explains however, consistent with the 8 August MRI showing no
inflammation, “this is common and is seen to occur in 43% of patients diagnosed with TM.” Id.
There was no repeat CSF test done after the 17 August MRI. Tr. at 55:9–12. Respondent agrees,
“for the purpose of finding inflammation,” it is significant that there was no repeat CSF test done
when “[t]he first MRI . . . shows something different than the second MRI.” Tr at 55:19–24.
Respondent argues the fact no CSF test was repeated supports the finding of no inflammation,
because “if [the physicians] had suspected ongoing inflammation [they] would have conducted
another CSF exam.” Tr. at 56:7–9. Respondent’s argument regarding the CSF test, as best, finds
no support in the medical record, if not being completely speculative. The fact that a CSF test
was not properly repeated after the 17 August MRI test possibly captured inflammation should
not be construed as evidence against the finding of inflammation. Accordingly, the Courts finds
the record does not support the Chief Special Master’s finding that “there was hardly any testing
evidence (whether from serologic sampling or MRI imaging) that would establish the existence
of inflammation.” Decision at 42 (emphasis added).
28 Respondent emphasized during oral argument Dr. Alexander filed a supplemental expert report explaining how
apparent diffusion coefficient and diffusion-weighted imaging supports reading the enhanced signals in the 17
August MRI as spinal cord infarction. Tr. at 63:3–11.
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Petitioner further argues I.J.’s positive response to treatment addressing inflammation is
indicative of him having inflammation. Mot. to Review at 38 (“The TM diagnosis, and an
attempt by the treating physicians to address inflammation, was further supported by the course
of treatment provided . . . and the fact that he responded positively to these efforts, showing
‘some improvement’ strongly suggesting the presence of inflammation.”). Respondent agreed
“the positive response [I.J.] experienced from that treatment evidence can support
inflammation,” but insisted “[r]espondent’s expert did not feel that [p]etitioner’s improvement
was as drastic as [p]etitioner testified.” Tr. at 56:24–57:5 (emphasis added). The Chief Special
Master acknowledged I.J.’s positive response to anti-inflammatory treatment in numerous places
throughout the decision, but he did not consider the positive response as evidence supporting
existence of inflammation. Decision at 3 (“From August 9 to 15, 2013 [I.J.] was treated with
Solumedrol, intravenous immunoglobulin (“IVIG”), and plasma exchange (“PLEX”).”); id. at 13
n.16 (“Solumedrol is an anti-inflammatory synthetic glucocorticoid.” “IVIG therapy is used to
treat immune system disorders.”) (citations omitted); id. at 4 (Dr. Eddie Louie “observed that
[p]etitioner’s symptoms were improving with steroid and IVIG treatment.”); id. at 5 (Dr.
Stephanie Sterling “acknowledged that [p]etitioner’s condition was improving with steroids,
IVIG, and PLEX treatments.”); id. at 8 (I.J. testified “[f]ollowing treatment with IVIG and
plasmapheresis, [I.J.] regained some mobility in his arms.”).
In view of the inherent inconsistency of a TM diagnosis and absence of inflammation, the
result of I.J.’s 17 August MRI test, and I.J.’s positive response to anti-inflammatory treatment,
the Court finds the Chief Special Master’s factual finding—“there was hardly any testing
evidence (whether from serologic sampling or MRI imaging) that would establish the existence
of inflammation”—is arbitrary and capricious. Saunders v. Sec’y of Dept. of Health & Human
Servs., 25 F.3d 1031, 1033 (Fed. Cir. 1994) (quoting Munn v. Sec’y of Dept. of Health & Human
Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992)) (“Fact findings are reviewed . . . under the
arbitrary and capricious standard.”); see also Paluck v. Sec’y of Health & Human Servs., 786
F.3d 1373, 1380 (2015) (“Where, as here, a special master . . . misconstrues his medical records,
and makes factual inferences wholly unsupported by the record, the Court of Federal Claims is
not only authorized, but obliged, to set aside the special master's findings of fact and conclusions
of law.”); Andreu v. Sec’y of Dept. of Health & Human Servs., 569 F.3d 1367, 1375 (2009)
(concluding that a special master erred in disregarding probative testimony from a petitioner's
treating physicians); Mondello v. Sec’y of Dept. of Health & Human Servs., 132 Fed.Cl. 316,
323–25 (2017) (finding the special master “erred in her conclusion that petitioner’s claim had to
be dismissed for not providing any evidence of a theory of causation” when “there are [doctor’s
notes and records] and other pieces of evidence submitted by petitioner that arguably lend some
support to his claim”). The Court does not address whether the evidence petitioner presented
ought to have changed the Chief Special Master’s decision, nor does the Court consider whether
the evidence is sufficient to establish Althen element two. Lampe v. Sec’y of Health & Human
Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000) (quoting Munn, 970 F.2d at 871) (finding it is not
the reviewing court’s role “to reweigh the factual evidence, or to assess whether the special
master correctly evaluated the evidence.”). That is left to the Chief Special Master on remand.
B. Treater’s Opinions
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In deciding petitioner failed to meet Althen element two, the Chief Special Master found
“no treaters ever proposed that [p]etitioner’s injury, however defined, was likely caused by his
prior Tdap vaccine.” Decision at 43. The Chief Special Master identified two occasions in the
medical records where I.J.’s treating physicians mentioned a possible association between his
injury and his vaccine record: “Dr. Eddie Louie, M.D., who (mistakenly believing [I.J.] had
received the Hepatitis B rather than Tdap vaccine) noted that a causal connection between the
Hepatitis B vaccine and TM has been identified,” and Dr. Jessica Taff, who “also expressed a
desire to obtain [I.J.’s] immunization history due to reports of TM following receipt of the
Hepatitis B vaccine.” Id. at 4, 6. The Chief Special Master considered the treaters’ opinions,
and he drew the inference that “[a]t most, the record reveals instances in which treaters assumed
[p]etitioner had received a different vaccine (Hepatitis B) that they believed could be associated
with TM.” Id. at 43.
Petitioner emphasized at oral argument the fact “that the treaters did consider vaccines.”
Tr. at 61:20–21. Petitioner acknowledges “there was some error” in the treaters’ beliefs, but
since the treaters were “just trying to figure out what happened,” “to say . . . no treaters ever
proposed [p]etitioner’s injury . . . was likely caused by his prior Tdap vaccine is not exactly
accurate.” Id. at 61:21–62:3. Petitioner contends “to focus on [the treaters’ errors] in the . . .
element [two] analysis is not appropriate.” Id. at 62:7–9. Respondent agrees “the Chief Special
Master does note that treating physicians did discuss vaccines.” Id. at 59:24–60:1. Respondent
contends, however, “to the extent [treaters’ opinion over a vaccine-related injury] was
confounding with [treaters’ mistakenly tracking the type of vaccine that was received], . . . it’s
not particularly persuasive evidence.” Id. at 60:17–19. Respondent further informs the Court “if
a medical provider provides a causation opinion about a particular vaccine causing an injury,
that’s particularly . . . deserving of great weight.” Id. at 60:20–23. “But here, if we have a
statement about vaccines generally, . . . it’s less informed than a statement about a particular
vaccine causing a particular reaction.” Id. at 60:23–61:1.
Opinions of treating physicians are “quite probative,” because “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.’” Capizzano v. Sec’y of Health &
Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (quoting Althen, 418 F.3d at 1280).
Treaters’ opinions in the medical records “warrant consideration as trustworthy evidence,”
because these records are “generally contemporaneous to the medical events,” and the “accuracy
has an extra premium.” Cucuras v. Sec’y of Dept. of Health & Human Servs., 993 F.2d 1525,
1528 (Fed. Cir. 1993); see also Andreu, 569 F.3d at 1375 (“[T]reating 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.”) (citations and internal quotation marks omitted).
Here, the Chief Special Master considered the opinions of Drs. Louie and Taff but found them
“[a]t most . . . [revealing] instances in which treaters assumed [p]etitioner had received a
different vaccine (Hepatitis B) that they believed could be associated with TM.” Decision at 43.
The Chief Special Master further concluded “no treaters ever proposed that [p]etitioner’s injury .
. . was likely caused by his prior Tdap vaccine.” Id.
Petitioner argues the Chief Special Master’s focus on the treaters’ mistake in the type of
vaccine, while ignoring the evidence that the treaters did consider vaccines as the cause of
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petitioner’s TM, “is not appropriate.” Tr. at 62:7–9. As acknowledged by the Chief Special
Master, Drs. Louie and Taff both mentioned I.J.’s injury possibly being associated with vaccines.
Decision at 4, 6. Dr. Taff’s note shows the treaters were not certain about what type of vaccine
I.J. received, so Dr. Taff suggested “clarify[ing] I.J.’s immunization history,” instead of
“assuming” petitioner received a Hepatitis B vaccine. Med. Recs. 8-3 at 230 (“Will need to
clarify patient’s immunizations at occupational health, as there are case reports of TM following
Hep B immunization.”). Thus, the Chief Special Master’s inference that “[a]t most, the record
reveals . . . treaters assumed [p]etitioner had received a different vaccine (Hepatitis B) that they
believed could be associated with TM” is not supported by the record. Decision at 43.
In reaching the conclusion “no treaters ever proposed that [p]etitioner’s injury . . . was
likely caused by his prior Tdap vaccine,” the Chief Special Master disregarded I.J.’s treating
physicians’ opinions because the physicians either mistakenly recorded, or, in at least one
instance, was not sure about, the type of vaccine I.J. received. In Paluck, petitioner’s treating
physician noted petitioner’s neurodegeneration could have a “hereditary, toxic or metabolic
etiolog[y].” Paluck, 786 F.3d at 1385. The special master “acknowledged the term ‘toxic’ is
broad enough to include an injury caused by a vaccine” but disregarded the physician’s opinion,
because “[petitioner] ha[s] not addressed the other possible causes listed by [the physician].” Id.
at 1385–86 (internal quotation marks omitted). The Federal Circuit found the special master
“erred in disregarding contemporaneous statements from [petitioner’s] treating physicians
regarding the cause of his neurodegeneration,” and “[i]t was arbitrary and capricious for the
special master to wholly discount the probative value of [treaters’] statements simply because
[the treaters] suggested that his condition could also potentially be due to alternative causes.” Id.
Here, the treaters’ uncertainty about what type of vaccine I.J. received does not completely
negate the probative value of the treaters’ consideration of I.J.’s symptoms being related to his
immunization history, especially given the “quite probative” value of treaters’ opinions in Althen
element two. Capizzano, 440 F.3d at 1326. Accordingly, it was arbitrary and capricious for the
Chief Special Master to wholly discount the probative value of the treaters’ statements simply
because the treaters did not clarify I.J.’s immunization history. Paluck, 786 F.3d at 1386.
The Court makes no finding on whether the evidence of treaters’ opinions ought to have
changed the Chief Special Master’s decision, nor is the Court trying to consider whether such
evidence is sufficient to establish Althen element two. Lampe, 219 F.3d at 1360 (finding it is not
the reviewing court’s role “to reweigh the factual evidence”). As suggested by respondent, “if a
medical provider provides a causation opinion about a particular vaccine causing an injury, that’s
particularly . . . deserving of great weight . . . . But here, . . . [what is before the Court is] less
informed than a statement about a particular vaccine causing a particular reaction.” Tr. at 60:20–
61:1. The Court leaves the question to the Chief Special Master on remand.
C. Conclusion of Althen Element Two
The Court finds the Chief Special Master’s factual findings supporting his Althen element
two decision—“there was hardly any testing evidence (whether from serologic sampling or MRI
imaging) that would establish the existence of inflammation” and “no treaters ever proposed that
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[p]etitioner’s injury . . . was likely caused by his prior Tdap vaccine”—were arbitrary and
capricious. Saunders, 25 F.3d at 1033 (quoting Munn, 970 F.2d at 870 n.10) (“Fact findings are
reviewed . . . under the arbitrary and capricious standard.”); Paluck, 786 F.3d at 1380 (“Where,
as here, a special master . . . misconstrues [petitioner’s] medical records, and makes factual
inferences wholly unsupported by the record, the Court of Federal Claims is not only authorized,
but obliged, to set aside the special master’s findings of fact and conclusions of law.”); Andreu,
569 F.3d at 1375 (concluding that the special master erred in disregarding probative testimony
from a petitioner's treating physicians); Mondello, 132 Fed.Cl. at 323 (finding the special master
“erred in her conclusion that petitioner’s claim had to be dismissed for not providing any
evidence of a theory of causation” when “there are [doctor’s notes and records] and other pieces
of evidence submitted by petitioner that arguably lend some support to his claim”). As the
record contains at least some evidence suggesting “a logical sequence of cause and effect
show[s] that the vaccination was the reason for the injury,” the Chief Special Master’s Althen
element two is not supported by the record and the Court must remand the case.29 See id.
VIII. The Chief Special Master’s Althen Element Three Decision
The third element in Althen concerns temporal relationship between the vaccine and
petitioner’s injury. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir.
2005). The Chief Special Master found “the record and evidence offered in this matter does
support the conclusion that Petitioner’s TM occurred in a medically acceptable timeframe,
consistent with his causation theory.” Decision at 43 (emphasis omitted). The Chief Special
Master further noted “the onset timeframe was also consistent with Dr. Zamvil’s persuasive
testimony about the time it would take for a molecular mimicry-driven process to manifest
29 The Chief Special Master also considered the existence of “pre-onset intercurrent respiratory infection” as a
possible instigation cause of TM. Decision at 43. The Chief Special Master viewed the respiratory infection as
“additional evidence that was not fully explained or distinguished by [p]etitioner, and thus it also undermined
somewhat [p]etitioner’s claim.” Id. During oral argument, respondent explained to the Court “[r]espondent didn’t
set forth the respiratory infection as an alternate cause. That’s something the Chief Special Master pointed out sua
sponte.” Tr. at 57:21–24. The Chief Special Master stated in full: “The evidence to support this alternative
explanation is not itself particularly robust (certainly no infectious agent was identified in testing), and I do not
propose that it establishes a stronger explanatory case than what [p]etitioner offered, or that (had the burden shifted
to [r]espondent) it was preponderantly established as an alternative cause. But it is additional evidence that was not
fully explained or distinguished by [p]etitioner, and thus it also undermined somewhat [p]etitioner’s claim. But it is
additional evidence that was not fully explained or distinguished by [p]etitioner, and thus it also undermined
somewhat [p]etitioner’s claim.” Decision at 43 (emphasis original). It is unclear to the Court whether the Chief
Special Master was shifting the burden to petitioner to rule out an alternative cause, or he was simply describing the
record as being insufficient to review such an alternative cause. To the extent the Chief Special Master shifted the
burden of ruling out an alternative cause onto petitioner in Althen element two, such shifting is permitted only
“when evidence as to the Althen requirements is insufficient.” de Bazan v. Sec’y of Health & Human Servs., 539
F.3d 1347, 1352 n.3 (Fed. Cir. 2008) (citing Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146, 1149–50
(Fed. Cir. 2007)); see also Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1357–59 (Fed. Cir. 2006)
(holding the petitioner's failure to eliminate other potential causes was fatal to the petition when she had not
provided evidence of a proximate temporal relationship between the vaccine and her injury). Once the petitioner has
established a prima facie case for entitlement to compensation and thus met the burden to prove causation-in-fact,
the burden shifts to the government to prove “[b]y a preponderance of the evidence that the [petitioner’s injury] is
due to factors unrelated to the administration of the vaccine described in the petition.” de Bazan, 539 F.3d at 1352
(citing 42 U.S.C. § 300aa–13(a)(1)(B); Walther, 485 F.3d at 1150). On remand, there may be reason for the Chief
Special Master to further clarify his findings regarding the pre-onset respiratory infection.
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neurologic harm.” Id. Nevertheless, “because [p]etitioner’s causation theory in this case was not
sufficiently supported with preponderant evidence, the consistency of the onset timing in this
case with [p]etitioner’s theory does not aid [p]etitioner.” Id.
Petitioner did not raise any issue on appeal regarding the Chief Special Master’s Althen
element three decision. See Mot. to Review. Respondent disagrees with the Chief Special
Master’s Althen element three decision, but does not contest this issue because petitioner “did
not raise this issue on appeal.” Tr. at 7:7–15 (“Respondent’s position was that [p]etitioner did
not meet Althen prong 3. However, the Chief Special Master found that [p]etitioner met prong 3
and did not raise that issue on appeal. So to the extent it wasn’t raised on appeal, [r]espondent
does not provide any sort of objection.”). As the Chief Special Master’s Althen element three
decision is not a contested issue before the Court, the Court will not review it.
IX. Conclusion
As explained in greater detail supra, the Chief Special Master was arbitrary and
capricious in deciding the Baxter study provided “far more comprehensive, contrary evidence”
against petitioner’s element one showing, finding “there was hardly any testing evidence
(whether from serologic sampling or MRI imaging) that would establish the existence of
inflammation,” and finding “no treaters ever proposed that [p]etitioner’s injury . . . was likely
caused by his prior Tdap vaccine.” Based on very recent Federal Circuit clarification, the Chief
Special Master also erred in holding Boatmon abolished Andreu’s plausibility standard for Althen
element one.
Accordingly, the following is ordered:
1. Petitioner’s motion for review of the Special Master’s 4 January 2021 decision is GRANTED;
2. This case is hereby REMANDED to the Chief Special Master for further proceedings
consistent with this opinion.
IT IS SO ORDERED.
s/ Ryan T. Holte
RYAN T. HOLTE
Judge
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================================================================================
DOCUMENT 3: USCOURTS-cofc-1_16-vv-00864-4
Date issued/filed: 2022-01-31
Pages: 10
Docket text: PUBLIC ORDER/RULING (Originally filed: 01/04/2022) regarding 143 Ruling on Entitlement. Signed by Chief Special Master Brian H. Corcoran. (kav) Service on parties made.
--------------------------------------------------------------------------------
Case 1:16-vv-00864-RTH Document 144 Filed 01/31/22 Page 1 of 10
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-864V
(to be published)
* * * * * * * * * * * * * * * * * * * * * * * * *
I.J., *
* Chief Special Master Corcoran
Petitioner, *
*
v. * Filed: January 4, 2022
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Robert J. Krakow, Law Office of Robert Krakow, P.C., New York, NY, for Petitioner.
Catherine Stolar, U.S. Dep’t of Justice, Washington, DC, for Respondent.
RULING ON REMAND GRANTING ENTITLEMENT1
Isaac Jones filed a petition on July 21, 2016, seeking compensation under the National
Vaccine Injury Compensation Program (“Vaccine Program”).2 ECF No. 1. Mr. Jones alleged that
he developed transverse myelitis (“TM”) due to the Tetanus-Diphtheria-acellular-Pertussis
(“Tdap”) vaccine he received on July 22, 2013.
A two-day hearing was held in this matter on October 22–23, 2019. Initially I denied
entitlement, finding that although Petitioner had preponderantly established that he likely
experienced TM, insufficient evidence supported the conclusion that the Tdap vaccine can cause
1 This Decision will 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 that 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
whole Decision will be available to the public in its current form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-
10–37 (2012) (hereinafter “Vaccine Act” or “the Act”). Individual section references hereafter shall refer to § 300aa
of the Act.

Case 1:16-vv-00864-RTH Document 144 Filed 01/31/22 Page 2 of 10
TM, or that it did so in this case. I.J. v. Sec’y of Health & Hum. Servs., No. 16-864V, 2021 WL
1232733 (Fed. Cl. Spec. Mstr. Jan. 4, 2021) (the “Entitlement Decision”). However, Petitioner
sought review of the Entitlement Decision, and the Court subsequently vacated my prior
determination, remanding the matter for my determination a second time. J. v. Sec’y of Health &
Hum. Servs, 155 Fed. Cl. 20 (2021) (the “Remand Decision”).
I thereafter ordered Respondent to Show Cause why, in light of the Remand Decision’s
findings, entitlement should not be found for Petitioner, and both parties have briefed the issue.
Respondent’s Brief, dated September 20, 2021 (ECF No. 136) (“Resp. Show Cause”); Petitioner’s
Response, dated Oct. 14, 2021 (ECF No. 138) (“Pet. Response”); Respondent’s Reply, dated Nov.
12, 2021 (ECF No. 140) (“Reply”).3 Now, for the reasons stated below, I find that Petitioner has
carried his burden of proof, and is therefore entitled to damages.
BRIEF PROCEDURAL HISTORY
The January 2021 Entitlement Decision
As noted, this matter was tried over a two-day period in the fall of 2019. At trial, I heard
testimony from the Petitioner himself plus a total of four medical experts. My Entitlement Decision
observed that the parties primarily disputed the classification of Petitioner’s injury. Entitlement
Decision, 2021 WL 1232733, at *28. Indeed, Petitioner’s three experts all focused on this subject.
I found, however, that although there was evidence on both sides of the question, and resolution
of the matter presented a close call, Petitioner’s showing was ultimately preponderant, establishing
that TM was the diagnosis best supported by the record. Id. at *29.
Regarding the Althen prongs, however, I found that Petitioner had not preponderantly
established that the Tdap vaccine likely caused his TM, since only one of the three prongs had
been satisfied. Petitioner demonstrated that he experienced onset of his TM in a medically-
acceptable timeframe (measured from the date of vaccination) consistent with his causation theory
for how long it would take an autoimmune, vaccine-driven process to occur. Entitlement Decision,
3 The filing date for this Ruling admittedly falls outside the 90 days set by the Vaccine Rules for a special master to
act on a remanded matter (since the action was remanded to me on July 6, 2021—meaning acting on the remand
should have occurred on or before October 4, 2021). See Vaccine Rule 28(b). However, the Court of Federal Claims
has previously observed that “the Vaccine Act does not identify any consequences for a special master’s failure to
complete the task directed by the court on review within the statutory ninety-day remand period.” Greene v. Sec’y of
Health & Human Servs., No. 11-631V, slip. op., at 3 (Fed. Cl. May 30, 2018). In addition, even if my ruling (now in
Petitioner’s favor) had been issued within that 90-day timeframe, the case’s final and complete disposition would still
remain for a later date, since the parties must now undergo the meticulous process of determining damages in a case
involving a plainly-catastrophic injury—and experience tells that the damages calculation process will surely take far
longer than 90 days. Otherwise, my show cause order that prompted briefing on the remand issue was published in
July 2021, with both parties subsequently requesting (and receiving) extensions of time to file their respective briefs.
As a result, delay in issuance of this ruling prejudices neither party.
2

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2021 WL 1232733, at *34. But in my determination Petitioner had not preponderantly
demonstrated that the Tdap vaccine had caused his injury, since there was very little evidence of
an aberrant immune-driven reaction. Id. at *32. Suspicion by treaters that a different vaccine, not
received by Petitioner, was causal was not in my estimation strong treater support. Id. at *33.
More importantly, I did not find that the first, “can cause” prong was satisfied. Entitlement
Decision, 2021 WL 1232733, at *29–33. In so determining, I focused on the limited showing made
by Petitioner’s primary expert, Dr. Scott Zamvil, observing that he relied on evidentiary categories
not subject to great weight (e.g., case reports, or the discredited theory that adjuvants in the vaccine
prompt an aberrant immune response), and also placed emphasis on molecular mimicry—a reliable
scientific theory by itself, but one which did not automatically carry the day for claimants simply
in its invocation. Id. at *32. I also noted that although many prior Program decisions found a Tdap-
TM association, more recent determinations might reflect a change in the scientific view on the
subject. Id. at *31. Finally, I gave weight to a scientific case series study offered by Dr. Zamvil,
Baxter,4 in which no association was observed between the Tdap vaccine and TM, based on
numerous vaccination events specific to the Tdap vaccine. Id. Dr. Zamvil emphasized that Baxter
observed a greater risk between Tdap and a different, but related, neurologic demyelinating injury,
but attempted to downplay Baxter’s Tdap-specific finding, and I faulted his opinion for ignoring
the facial and negative implications of this item of literature he otherwise highlighted. Id.
The Remand Decision
The Court’s Remand Decision made a number of legal and factual findings that resulted in
granting the motion for review and remanding the matter to me. First, the Court held that I
misapplied the legal standard applicable to the first Althen prong. Remand Decision, 155 Fed. Cl.
at 43. The Federal Circuit had characterized that standard over ten years ago, in Andreu v. Sec’y
of Health & Hum. Servs., 569 F.3d 1367, 1375 (Fed. Cir. 2009), as only requiring a showing of
“biological plausibility.” Id. A more recent Circuit decision seemed to emphasize that this framing
no longer held sway, noting that “a ‘plausible’ or ‘possible’ causal theory does not satisfy the
standard.” Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019). But
then, in a nonprecedential decision issued earlier this year, a different Circuit panel indirectly
addressed Boatmon—and in the view of the Court herein held that Boatmon had not rejected the
view that proof of an “exact biologic mechanism” was never required in establishing the first
Althen prong. Kottenstette v. Sec’y of Health & Hum. Servs., No. 2020-2282, 2021 WL 2434329,
at *6 (Fed. Cir. June 15, 2021). The Court interpreted this to mean that Boatmon’s articulation of
preponderance as governing the prong one evidentiary standard had not, in fact, rejected or
overturned the prior statement of mere plausibility in Andreu—and therefore I applied
preponderance to the first prong in error. Remand Decision, 155 Fed. Cl. at 44.
4 Baxter’s full cite is set forth in the Entitlement Decision.
3

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Second, the Court determined that several of my fact determinations were arbitrary and
capricious. Regarding evidence offered for the first prong, the Court addressed in great detail the
findings in the Baxter study. It determined that I misread Baxter’s findings regarding the
association between TM and the Tdap vaccine, and also that I overvalued Baxter’s weight
generally (especially to the extent I cited other decisions relying on it, but which had in the Court’s
view also relied on the Boatmon standard for the first Althen prong), or had given it different
weight in other cases. Remand Decision, 155 Fed. Cl. at 46–47. I otherwise was ordered to re-
evaluate the weight of Petitioner’s showing on the “can cause” prong (including how I evaluated
molecular mimicry as a mechanistic explanation for vaccine causation) in light of the Andreu
plausibility standard. Id. at 50.
Finally, the Court ruled that I erred in determining that the second Althen prong was not
met. Despite my finding that there was little in the medical record leading up to Petitioner’s
presenting symptoms seventeen days post-vaccination (see Entitlement Decision at *1–2, 33), the
Court emphasized the record of evidence of inflammation thereafter (around the time of
Petitioner’s initial treatment) as supportive of the Petitioner’s claim, and thus contrary to my more
blanket statement that “hardly any” testing evidence established pre-onset inflammation. Remand
Decision, 155 Fed. Cl. at 54. The Court also found that even if treaters had mischaracterized the
specific identity of the purportedly-causal vaccination at issue, the fact they suspected some prior
vaccination could be causal was still worthy of weight, although it left resolution of how much
weight to give this evidence to remand. Id. at 55–56.
PARTIES’ ARGUMENTS
Respondent
After the Court’s issuance of the Remand Decision, I ordered Respondent to Show Cause
why entitlement should not now be entered for Petitioner. Order, dated July 8, 2021 (ECF No.
131). Respondent contested the Court’s reliance on Kottenstette as stating the proper evidentiary
standard under the Althen test, emphasizing that this specific Circuit opinion was by its own terms
nonprecedential. Resp. Show Cause at *3. Thus, Respondent maintained that I had correctly
determined that the “causal theory was neither sound nor reliable.” Id. But Respondent then argued
that despite the Court’s determinations about the proper weight to be given to certain evidence,
there remained insufficient proof upon which to find that Petitioner had satisfied the first two
Althen prongs. Id. at *4.
Regarding the first Althen prong, Respondent argued that mere mention of molecular
mimicry generally could not amount to preponderant evidence in a specific case. Resp. Show
Cause, at *4–5. Otherwise, Petitioner’s expert, Dr. Zamvil, had failed to provide a sound and
4

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reliable explanation for how the Tdap vaccine could cause TM. Id. at *5. While Dr. Zamvil tried
to establish that the mechanism of molecular mimicry could instigate immune-mediated disease
processes, he had offered little in the way of evidence directly connecting the Tdap vaccine to TM
in this manner. Id. And online database searches showing homology between amino acid
sequences in the proteins found in the vaccine’s antigens and self protein structures was inadequate
to establish preponderance. Id.
Respondent next maintained that Petitioner had not met his burden as to Althen prong two,
observing the absence of evidence “of any autoantibodies that might arguably be associated with
the asserted TM cross-reaction.” Resp. Show Cause at *6 (citing Entitlement Decision, 2021 WL
1232733, at *43). He also emphasized the importance of my finding that there was not excessive
or unusual inflammation even with the little evidence of some post-vaccination. Resp. Show Cause
at *6–7. Respondent also questioned the value of treater speculation in this case, noting that
treating physician opinions “are not sacrosanct, and can be rebutted and found unreliable or not
dispositive by a special master based on the record as a whole.” Id. at *7; Section 13(b)(1); Snyder
v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (Fed. Cl. 2009) (citations omitted). In
this case particularly, treaters had not even properly identified the vaccine received by Petitioner.
Resp. Show Cause at *7.
On reply, Respondent reiterated prior arguments. Case reports purportedly associating the
Tdap vaccine with TM via molecular mimicry were in Respondent’s view distinguishable or
provided no detail as to a possible mechanism. Reply at *1–2. Otherwise, the acceptance of
molecular mimicry in different vaccine injury cases does not render the theory dispositive or
persuasive herein, absent evidence connecting TM to the mechanism, or a showing how the Tdap
vaccine could instigate a cross-reaction due to molecular mimicry. Id. Respondent further argued
that the lack of studies connecting Tdap and TM weighed against causation. Id. at *3. And even if
some of Petitioner’s treaters had referenced some vaccine as possibly causal, they did not implicate
the Tdap vaccine, and the basis for their conclusions was not otherwise evident in the medical
record, with no real explanation for Petitioner’s TM ever agreed upon or identified. Id. at *4.
Petitioner
Petitioner emphasizes the Court’s embrace of “biologically plausible” as the Althen prong
one standard, arguing that it has been met herein. Pet. Response at *3. A connection between the
Tdap vaccine and TM has been repeatedly linked in literature and prior cases, via molecular
mimicry, noting also that sufficient homology for a cross-reaction to occur was proven. Id. at *3,
7. Petitioner also restates the criticisms leveled against the Baxter study by the Court, and hence
why I erroneously viewed it as undercutting the strength of Petitioner’s Althen one showing. Id. at
*4. Petitioner otherwise tried to bulwark Dr. Zamvil’s theory and use of other scientific studies.
Id. at *5–6.
5

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ANALYSIS
In any remanded case, the special master is bound by the determinations of the Court on
matters of law and fact. Rickett v. Sec’y of Health & Hum. Servs., 468 F. App’x 952, 959 (Fed.
Cir. 2011) (quoting Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (Fed. Cl.
1998)). Given the notably extensive and painstaking nature of the Court’s Remand Decision, and
after consideration of the briefs filed in response to my Order to Show Cause, I find that
Respondent has not identified grounds for a second entitlement determination consistent with my
first.
First, the Court’s embrace of a plausibility evidentiary standard for Althen prong one—a
standard I am compelled to apply herein5—effectively obligates me to find on the present record
that Petitioner has offered in this case a plausible medical theory that the Tdap vaccine “can cause”
TM. Dr. Zamvil, a qualified expert, certainly proposed a reliable mechanism (molecular mimicry)
to explain how components of the vaccine could cross-react with homologous amino acid
sequences making up nerve myelin, and in turn cause an autoimmune attack leading to TM. He
also demonstrated how antigenic components of the vaccine could mimic self amino acid
5 I must accept the Court’s interpretation of the law on this matter and apply it in my remand determination. But having
reviewed Boatmon and Kottenstette in detail, I am far less certain than the Court that the two are actually in opposition,
with the latter rejecting the former (as the Court has concluded). Kottenstette’s discussion of Boatmon was limited to
the fact that the three-judge Boatmon panel found the deciding special master in that case had effectively applied the
wrong evidentiary burden. Boatmon, 941 F.3d at 1359 (“[t]he Special Master deviated from the correct “reputable,”
“sound and reliable” standard and articulated a lower “reasonable” standard. . . We have consistently rejected
theories that the vaccine only “likely caused” the injury and reiterated that a “plausible” or “possible” causal
theory does not satisfy the standard”) (emphasis added). The Kottenstette panel, by contrast, found that the special
master in question (whose initial decision in the claimant’s favor was overturned before the matter was remanded to
a different special master (because the prior special master had retired)), had articulated the proper overall
preponderant requirement—and thus in the Kottenstette panel’s view had not committed the error identified in
Boatmon. Kottenstette, 861 F. App’x at 440–41. The Kottenstette panel otherwise does not characterize the Boatmon
articulation of the first Althen prong standard to be erroneous. And merely noting, as Kottenstette does, that a specific
biologic mechanism need not be offered to establish causation, or that scientific certainty is not the evidentiary
standard overall, is not equivalent to finding that claimants need not prove the Althen one causation prong by a
preponderance of the evidence.
I urge the Court in future cases to reconsider whether in fact the Federal Circuit’s facially non-precedential Kottenstette
decision is controlling and/or eliminates what the Circuit has previously said about the first Althen prong (and what
the special masters have collectively understood the standard to be—now, for many years). Purely from the standpoint
of the Vaccine Program, a standard of mere plausibility would effectively mean that claimants could always satisfy
the first prong, simply by pointing out the plausibility of molecular mimicry instigated by the immune system as a
mechanism for autoimmunity—and thus the distinction between Table claims (in which the Government concedes
causation) and non-Table would be obliterated. I also note that holding claimants to a preponderant showing on the
“can cause” prong does not work an injustice, or elevate their burden unreasonably. There is no dispute that petitioners
may offer a variety of evidence to prove their claim—they are not required to offer epidemiologic proof, for example—
and thus the existing evidentiary system employed in the vast majority of vaccine claims takes into account the lack
of a requirement of medical certainty.
6

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structure/sequences. Although the theory was mostly provided in an outline form, without much
in the way of direct evidence establishing the actual capacity of the Tdap vaccine to prompt
demyelination in the manner proposed, I cannot dispute the plausibility of the contention. Indeed—
nearly any vaccine could plausibly cause demyelination by instigating a cross-reaction, assuming
a sufficient degree of sequential and structural homology.
I must also now give Baxter limited weight, if any, in contrast to my prior determination.
It remains the case that Dr. Zamvil specifically invoked Baxter even though it was facially at odds
with his very theory, since the article’s findings favorable to Petitioner involve a different injury,
acute disseminated encephalomyelitis (“ADEM”)—while Baxter’s authors plainly discount the
TM-Tdap association. Entitlement Decision, 2021 WL 1232733, at *31. However, the Court has
articulated a number of sound reasons for placing less faith in Baxter’s findings.6 In addition, no
epidemiologic study can ever “disprove” the possibility of causation (something I have myself
recognized repeatedly in the past),7 and the Court noted that the trial record did not evaluate
Baxter’s findings specifically enough from all sides to permit it being deemed wholly reliable or
persuasive. On remand, I determine that although Baxter still merits some evidentiary weight, in
the context of this case—where Petitioner’s prong one showing was overall a bit more all-inclusive
than Respondent’s—it was not by itself enough to rule against Petitioner on the “can cause” prong.
Baxter alone does not eliminate the plausibility (applying the Court’s Althen prong one standard)
of the causation theory.
Importantly, certain other items of evidence offered by Petitioner in support of his
causation theory remain in my estimation underserving of evidentiary weight, and I am
comfortable so finding despite the constraints of the Remand Decision. Thus, I do not find that the
case reports offered by Petitioner (such as those referenced in Agmon-Levin—an oft-criticized
review article summarizing a number of case reports) are persuasive evidence to any degree, and
therefore offer limited support for his contentions.8 Indeed, if I over-valued Baxter (which
certainly involved thousands of vaccinations, even if the precise number I cited was incorrect),
then it would have to be similarly erroneous for me to deem four documented case reports of post-
vaccination TM to be especially probative—since the same evidentiary criticisms raised against
6 The Court has also correctly observed that I myself have not deemed Baxter dispositive, or particularly persuasive,
on the subject of the TM-Tdap link, in every case. Remand Decision, 155 Fed. Cl. at 47–48, citing McGrail v. Sec’y
of Health & Hum. Servs., No. 17-926V, 2021 WL 1728706, at *1 (Fed. Cl. Spec. Mstr. Apr. 23, 2021).
7 See, e.g., Kelly v. Sec’y of Health & Hum. Servs., No. 16-878V, 2021 WL 5276373, at *26 n.24 (Fed. Cl. Spec. Mstr.
Oct. 10, 2021), appeal docketed, Nov. 17, 2021 (Fed. Cl.).
8 Entitlement Decision, 2021 WL 1232733, at *11 (Agmon-Levin referenced only four instances of post-Tdap-
comparable TM); see also Pearson v. Sec'y of Health & Hum. Servs., No. 16-9V, 2019 WL 3852633, at *14 (Fed. Cl.
Spec. Mstr. July 31, 2019) (giving low weight to Agmon-Levin in case alleging that flu vaccine caused TM, since
Agmon-Levin referenced only two post-flu vaccine TM cases—based on a review of 39 years of published case
reports).
7

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the reliability of Baxter’s findings go double for anecdotal reports of temporal associations
between vaccination and injury. And I am not at all persuaded by Dr. Zamvil’s adjuvant arguments
either, for reasons I previously articulated. Entitlement Decision, 2021 WL 1232733, at *32.
Nevertheless, Dr. Zamvil’s showing was still more comprehensive than Respondent’s
rebuttal. Petitioner in this case endeavored to offer proof for how the Tdap vaccine could be causal
of TM, and this coupled with the fact that the theory has been found persuasive in numerous prior
cases (even if those cases, like Raymo v. Sec'y of Health & Hum. Servs., 11-654V, 2014 WL
1092274 (Fed. Cl. Spec. Mstr. Feb. 24, 2014), were explicitly decided without the benefit of more
comprehensive studies like Baxter) is enough for me to find that a plausible “can cause” theory
was advanced. This is especially so since (a) both experts were roughly comparable in expertise,
and (b) I do not find that Respondent’s sole expert, Dr. Alexander, rebutted Dr. Zamvil’s overall
contentions, preferring instead simply to deny causation (to the extent he addressed it at all).9 I
have found in other cases that even a lackluster showing by Petitioner can establish causation
where Respondent chooses not to defend or does so ineffectually. See, e.g., Barone v. Sec'y of
Health & Hum. Servs., No. 11-707V, 2014 WL 6834557, at *9 (Fed. Cl. Spec. Mstr. Nov. 12,
2014) (petitioner prevailed on Althen one showing despite some thinness of contentions, since
Respondent offered no expert to rebut Petitioner’s showing).
Accordingly, I find sufficient evidence was offered herein by Petitioner to meet the
plausibility standard applied by the Court on the first Althen prong—and it was not rebutted by
Respondent. In a different case, where an immunologist (for example) testifying for the
Respondent made more specific rebuttal points (beyond Baxter) showing how the Tdap vaccine
likely could not cause TM, my conclusion could well be different. But here (especially since the
parties’ experts predominantly focused their testimony on the diagnostic debate), the fact that the
overall record was globally sparse on causation means that what Petitioner did offer ended up
being sufficient. I will remain open in future cases to find that the Tdap vaccine cannot likely cause
TM—but on this record I am comfortable concluding that Petitioner plausibly established it can.
Second, I find on this record that the “did cause” prong of Althen has also been established.
Here, there is no question raised by the parties (or the Court) that a preponderant showing is
required—and although Petitioner’s case was (again) not especially robust, it was enough to cross
the preponderant line. As the Remand Decision observes, there was evidence of post-vaccination
9 Indeed—Dr. Alexander’s first report said nothing about causation. See Report, dated February 28, 2018, filed as Ex.
A (ECF No. 41-1). His second report only contested the evidentiary value of Agmon-Levin (Report, dated September
20, 2019, filed as Ex. N (ECF No. 79-1) at 3)—a proposition I wholly embrace, but something that does not defeat
Petitioner’s “can cause” showing. And his final supplemental report (Report, dated December 26, 2019, and filed as
Ex. O (ECF No. 107-1)) was prepared post-hearing and intended only to comment on MRI findings discussed at
hearing by Dr. Watanabe.
8

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inflammation,10 and no other possible explanation for TM identified by treaters. This, plus Dr.
Zamvil’s reasoned opinion vouching for the vaccine’s causal role in propagating Petitioner’s TM,
was enough to establish that the vaccine likely caused the injury.
The overall brevity of my Remand Ruling is a product of my desire to bring this matter
(which is now more than five years old) to a conclusion. It is in the interests of the Program (and
its policy goals of swift resolution of vaccine injury claims) not to further delay resolution of this
case with even more detailed analysis of the success of the evidentiary showing made herein. As
my original Entitlement Decision set forth, the Petitioner unquestionably did succeed in carrying
several of his evidentiary burdens, despite the fact that the parties hotly disputed the nature of
Petitioner’s injury. Upon reflection, it appears that their joint zeal in debating the injury (the subject
that took up the majority of trial time, and which involved all four testifying experts) may have
distracted both from giving the same attention to the other Althen prongs—resulting in insufficient
attention being paid to these equally-vital issues, and opening the door to my initial determination
that important causation matters were not adequately established.
The Court has now performed its own exacting review and weighing of the evidence,
concluding that a different outcome is favored. There is, of course, still some room for a more
detailed explication of certain topics. I could, for example, order both sides to offer epidemiologic
expert testimony to delve into the intricacies of Baxter, with the goal of clearing up some of the
questions raised about the weight its findings should receive. A whole additional hearing day, or
more, could be devoted to the inquiry, and there are no doubt experts (whether or not their expertise
arises from epidemiologic matters) that could provide views on both sides of the topic.11
10 Of course, in any case alleging an auto-inflammatory neuronal illness, there will inherently be evidence of
inflammation specific to the injury (since this is an essential driver of the disease process)—suggesting that it is
somewhat circular to conclude that proof of the process directly resulting in injury alleged (and from the very time the
disease was first observed clinically) stands as weight-deserving proof of causation. It is for this very reason that I
typically look for other corroborative evidence that the vaccine caused the injury—evidence of autoantibodies
associated with the pathogenesis of the disease, for example, or some kind of testing result that suggests a process
leading to the injury was underway, even before onset’s outward manifestation. The Remand Decision found this
evidence of inflammation especially compelling herein, however, and so it binds my determination.
11 See, e.g., Smith v. Sec'y of Health & Hum. Servs., No. 14-848V, 2018 WL 3991386 (Fed. Cl. Spec. Mstr. July 5,
2018). In Smith, a special master determined that the Hepatitis B vaccine was not demonstrated to have likely caused
a claimant’s TM. There, the Respondent’s expert offered Baxter to contest Petitioner’s prong one arguments, and in
so doing he deemed Baxter “‘by far, the best’ of the papers that he looked at because ‘the [sample size] is the largest
and the analysis is really well done,’” along with the fact that the total number of vaccination incidents considered
was “‘less subject to underreporting than a typical study.’” Smith, 2018 WL 3991386, at *18. That expert also
considered Baxter deserving of weight despite the fact that no epidemiologic evidence could completely rule out
vaccine causation, given the total number of vaccination occurrences considered weighed against the handful of
instances of post-vaccination TM. Id. at *19. Of course, none of this vouching is in evidence herein—but I reference
it to underscore the fact that skepticism of Baxter is not necessarily well-founded, and certainly could be the subject
of reasoned disagreement.
9

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But rather than prolong the case with a second round of findings that, however well-
reasoned, would surely become fodder for additional appeal, judicial prudence—plus concern for
fairness to the Petitioner, who unquestionably did experience a post-vaccination injury, regardless
of how causation is resolved, and who has brought this claim in evident good faith—counsels me
to bring this matter to an end, if possible.
CONCLUSION
Petitioner has satisfied his burden in establishing that the Tdap vaccine caused his TM,
entitling him to damages. A damages order shall issue separately.
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
10

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DOCUMENT 4: USCOURTS-cofc-1_16-vv-00864-6
Date issued/filed: 2026-01-05
Pages: 24
Docket text: PUBLIC DECISION (Originally filed: 03/28/2024) regarding 225 Findings of Fact & Conclusions of Law. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made.
--------------------------------------------------------------------------------
Case 1:16-vv-00864-RTH Document 248 Filed 01/05/26 Page 1 of 24
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-864V
* * * * * * * * * * * * * * * * * * * * * * * * *
*
I.J., * Chief Special Master Corcoran
*
Petitioner, * Filed: March 28, 2024
*
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Robert J. Krakow, Law Office of Robert J. Krakow, P.C., New York, N.Y, for Petitioner.
Catherine E. Stolar, U.S. Dep’t of Justice, Washington, DC, Respondent.
FINDINGS OF FACT AND CONCLUSIONS OF LAW REGARDING DAMAGES1
On July 21, 2016, I.J. filed a petition seeking compensation under the National Vaccine
Injury Compensation Program (the “Vaccine Program”).2 Petitioner alleged that he suffered
transverse myelitis (“TM”) as a result of a Tetanus Diphtheria acellular-Pertussis vaccine he
received on July 22, 2013. Petition (ECF No. 1) (“Pet.”) at 1.
Although I granted entitlement to Petitioner in January 2022 (see Ruling, dated January 4,
2022 (ECF No. 143)), the parties have since that time been unable to resolve damages on their
own. Petitioner claims he is entitled to pain and suffering, lost earnings, future medical care, and
reimbursement of a Medicaid lien. Petitioner’s Prehearing Brief at 1 (ECF No. 211). Respondent
1 Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information
furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or
confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public
in its present form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”).
All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. §§ 300aa.

Case 1:16-vv-00864-RTH Document 248 Filed 01/05/26 Page 2 of 24
does not contest the appropriateness of these categories of damages, and has reached agreement
with Petitioner on the pain and suffering amount to be awarded, but disputes some amounts or
proposed treatments included in Petitioner’s life care plan. Petitioner’s Prehearing Damages Brief,
filed September 20, 2023 (ECF No. 211) (“P. Br.”) at 15 (agreement on pain and suffering); see
also Respondent’s Prehearing Damages Brief, filed September 20, 2023 (ECF No. 210) (“R. Br.”).
A hearing on the disputed damages issues was held on October 16, 2023, in New York,
NY. Based on the testimony heard at that time plus the parties’ filings, and for the reasons set forth
below, I find that Petitioner is entitled to (a) $250,000.00 in actual pain and suffering, as previously
agreed by the parties, (b) $1,190,602.00 in actual lost wages, past and future, (c) a relocation/rent
differential lump sum of $74,804.60, and (d) $626,327.70 to satisfy the outstanding Medicaid lien
for previously-received medical care associated with the vaccine injury. Additionally, an award
for the life care expenses granted will be issued consistent with this ruling once the parties provide
a final life care plan.
I. Factual Background
A more complete summary of the relevant medical history and factual background is
contained in the entitlement decision. Entitlement Decision, dated January 4, 2021 (ECF No. 114).
I incorporate that history herein. In short, Petitioner has been found to have suffered TM due to
vaccination—and as the damages hearing revealed, he has experienced numerous life-altering
difficulties as a result.
II. Hearing Testimony
A. Fact Witnesses
1. I.J. - Petitioner testified as a fact witness in the hearing. See generally Tr. at
12–62. He stated that he has gained some mobile function back since the start of his injury in 2013,
but had interruptions in his therapy during the Pandemic. Id. at 13. Thus, he considers his condition
largely the same, with minor improvements. Id.
In particular, I.J. remains confined to a wheelchair due to loss of control of his lower limb
function. He can now move his right toes, and can sometimes move his left leg. Tr. at 13. But he
still cannot walk, stand, or turn himself in bed. Id. at 14. He has also lost dexterity in his hands,
which he cites as a safety issue - he cannot grab a doorknob or turn a key during an emergency.
Id. The most he can do in bed is hook his arm around a bedrail to turn himself, but he fears his arm
getting stuck in that situation. Id. at 15. Transfers (meaning moving between locations such as his
bed, chair, and shower or toilet) are particularly difficult. Id. at 16. In most such circumstances,
Petitioner requires a human aide to assist him in transfer, and even then falls can occur. Id. at 16,
36. He disputed contentions in Respondent’s life care plan that he is able to move himself without
assistance between his wheelchair and toilet. Id. at 17.
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I.J. has made some efforts to improve his mobility. For example, he underwent a knee
replacement surgery in 2017, after his physical therapist proposed that his knee issues would
prevent any improvement in stability to assist in his own transfers. Tr. at 29–32. The surgery
improved his ability to stabilize himself during transfers. Id. at 33. He remains unable to stand on
his own, but can put some weight in his legs when being transferred to a car. Id. at 33–34. He
believes that, with more therapy, he could improve his ability to put weight in his legs for a brief
period of time. Id.
Because of these drastic mobility limitations, I.J. relies on health care assistants—both
immediate family and outside professionals (although the primary such individual, as discussed
below, turns out to be his uncle). He noted that his parents and wife (with whom he lives) have
made significant accommodations to their personal schedules to assist in his care. Tr. at 24.
Although his uncle, James Moore, has specific expertise in caring for an individual with
Petitioner’s needs, and is physically able to assist, there are instances where the relevant care
agency sometimes sends caregivers who are older, and do not have the strength needed to move
him. Id. at 36. (He believes that a ceiling-mounted lift system could help with this issue. Id.). In
addition, there are times of the day when gaps in care lead to him being alone for significant
amounts of time. Id. at 20. He is alone for at least two hours each morning, between the time his
wife and daughter leave the house and when his caregiver arrives. Id. During this period, he cannot
physically make it to a bathroom, which can cause skin and hygiene issues. Id. at 21. Additionally,
he cannot make himself food or bathe. Id. at 22.
Petitioner’s living accommodations provide some related cause for concerns when
caregivers are absent. Tr. at 47. I.J. currently lives in a 16th floor apartment. Id. Recently, another
apartment in his hall had a fire, which activated the fire alarm. Id. When he heard the alarm and
tried to leave the building, he discovered that the elevators shut down in the event of a fire, leaving
no way for him to escape. Id. at 47, 48. He believes a ground floor unit would provide him with a
safer living environment. Id.
I.J. also provided testimony about other injury-related sequelae he experiences. He has
continuous pain, which he described as a “stinging sharp sensation.” Tr. at 25. He rates his pain as
a 5-7 out of 10 on a daily basis. Id. at 26. He often uses cannabis to ease his pain. Id. at 29. He has
had psychological counseling for coping with his limitations in the past, but does not have it now.
Id. at 24–25. He found it helpful to process the emotions about his injury. Id. He can no longer
work a regular job, but still makes a small amount of income selling music catalogs. Id. at 28.
However, in 2022, he made only $2,000 per year from this venture after accounting for business
expenses. Id.
Petitioner believes a number of therapy modalities would help improve his health and
overall condition. Tr. at 39. For example, he received acupuncture therapy in the past through a
program providing it to individuals with disabilities. Id. It helped his chronic pain so much that he
did not need to take pain pills. Id. He cited similar improvements with massage therapy, which he
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used to receive twice a week. Id. at 40. Though he has not yet had chiropractic care, one of his
doctors recommended it to prevent spinal curvature. Id. at 41. In addition, I.J. testified that he goes
to the gym regularly with his father or caregiver. Id. The strength that he gains through back
exercises improves his ability to sit up straight. Id. at 42. He also benefits from use of the steam
room for breathing issues. Id. He would like to start using the pool, and has spoken to gym
management about his adaptive needs to do so, but would need the assistance of a qualified aide.
Id. He believes the weightlessness of the pool environment would help him improve strength in
his legs, in the hopes of eventually taking steps on his own. Id. at 43.
There are also a number of items that Petitioner maintains would aid him if obtained (or
replaced more often). The existing bed he utilizes must be manually cranked to lower and lift—a
difficult endeavor for him alone to perform. Tr. at 37, 38. He maintained that an automatic bed
would be preferrable. Id. at 38. He has used for therapy a Functional Electric Stimulation (“FES”)
bicycle, which allows pedaling of a stationary bike while providing electronic stimulation to
muscles. Id. at 46. Access to such a device at home would strengthen his legs, and help him work
towards standing. Id. He also wants to use a standing wheelchair, which simulates standing for the
brain and muscles. Id. at 47. And Petitioner noted that a number of adaptive equipment he uses at
home (bedside urinals, a wooden sliding board, a shower chair) are all subject to wear and tear,
and therefore for hygienic reasons should be replaced more often. Id. at 43–45.3
2. Isaac Jones Sr. - Mr. Jones (Petitioner’s father) is 71 years old, and is a
retired city property manager. Tr. at 64. He retired early to help care for his son after his injury.
Id. When a care aide is unavailable, he goes to his son’s apartment and helps him with all basic
care needs, such as bathing, eating, and transferring between locations, providing these services
without payment. Id. at 65, 67. When care was significantly interrupted by the Pandemic, he and
his son contacted his brother-in-law, James Moore, to become Petitioner’s aide. Id. He agreed that
I.J. had made only small improvements in function since his 2013 injury. Id. at 67–68.
3. James Moore – Mr. Moore is Petitioner’s uncle. Tr. at 75. Although he acts
as Petitioner’s primary in-home caregiver, his testimony revealed that he was uniquely suited for
this position, because he has been employed as a care aide for over 20 years. Id. at 71. Although
he has worked with different populations of individuals with care needs, such as children with
special needs, adults with intellectual disabilities, and adults with physical disabilities, he is trained
to assist with all activities of daily living. Id. at 71–73.
When care facilities shut down during the Pandemic, he began caring for Petitioner
personally. Tr. at 75. He has now been working as Petitioner’s aide for approximately three and a
half years. Id. at 76. He is paid by Accent Care, through a program paying family members to
3 I also note that Petitioner appears to be a very positive, intelligent, and articulate individual, who copes with his
injury about as well as possible, and is to be commended for maintaining his spirits despite the debilitating setback he
experienced due to no fault of his own.
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provide care. Id. at 77. He works 40 hours per week, as allotted by the agency, and is paid $17.50
per hour. Id. at 77, 78.
When Mr. Moore arrives at Petitioner’s apartment around 9:00 AM, Petitioner is in bed.
Tr. at 78. He first helps Petitioner prepare for a shower by transferring him between his bed and
shower chair. Id. at 79. To lower the bed, he must crank the handle about 45 times. Id. After
Petitioner is in the shower chair, Mr. Moore wheels him to the bathroom. Id. His shower chair is
then connected to a base piece in the tub, which allows him to transfer over to be bathed. Id. at 81.
After bathing he is transferred back out of the tub, and taken into the bedroom. Id. Mr. Moore
cranks and lowers the bed again, and transfers Petitioner onto the bed. Id. Once he is dressed, Mr.
Moore transfers him back into the wheelchair and prepares breakfast for him. Id. at 82. After
eating, they go to various activities, such as doctor’s appointments or the gym. Id. they must drive
to doctor’s appointments, which requires Mr. Moore to transfer Petitioner into a car. Id. at 83.
Mr. Moore also noted that he performs many tasks for Petitioner, such as house cleaning,
laundry, and a variety of errands. Tr. at 84. He then reiterated some of the points made in
Petitioner’s testimony regarding Petitioner’s mobility limitations, and about several times where
Petitioner fell during transfers. Id. at 84–88. He agreed that items such as a ceiling-mounted lift
and an updated hospital bed would improve Petitioner’s safety and quality of life, and make his
care easier. Id. at 86–88.
B. Life Care Planners
Both sides retained life care planners, who prepared lengthy written assessments of the
specific care recommended for I.J. Petitioner’s Report, dated September 14, 2023 (ECF No. 204-
1) (“Lajterman Plan”); Respondent’s Report, dated September 14, 2023 (ECF Nos. 203-1 and 203-
2) (“Curtis Plan”).
1. Linda Lajterman - Ms. Lajterman received her nursing degree from the
Charles E. Gregory School of Nursing in 1979. CV of Linda Lajterman, RN, filed September 14,
2023, as Ex. 114 (ECF No. 204-4) (“Lajterman CV”). She received additional certifications in
medical-legal consulting, forensic medical fraud investigation, and life care planning for
catastrophic cases. Lajterman CV at 1. She is licensed as a Certified Disability Management
Specialist, Certified Case Manager, Certified Senior Disability Analyst and Fellow, and Certified
Life Care Planner. Id. After over a decade in clinical nursing, she began working in case
management at rehabilitation centers. Id. at 2. She later began working as a life care consultant,
and owns an independent consulting firm. Id. She is presently licensed to practice nursing in New
Jersey. Id. at 1.
Ms. Lajterman began her testimony by discussing the process of preparing the life care
plan in this case. Tr. at 102. She first reviewed Petitioner’s medical records to learn the nature of
his injury, then conducted an interview with Petitioner via “Zoom” remote software. Id. During
this interview, she asked him in detail about his abilities, and what assistance he needs throughout
the day. Id. at 103. She then supplemented this information with further review of medical records,
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including those from the rehabilitation facility. Id. She followed this with a second interview a few
months later, and estimates the total interview time to be around three and a half hours. Id. at 105.
Ms. Lajterman acknowledged she never performed an in-person site visit, nor did she physically
meet with Petitioner in connection with the drafting of her plan. Id. at 146–49.
When testifying about the contents of her report, Ms. Lajterman was asked about the
differences between her recommendations and those of the Respondent’s expert, Linda Curtis. Tr.
at 110. In many instances, their recommendations differed only in how the care was to be paid
for—with Ms. Lajterman including the direct cost in her plan, whereas Ms. Curtis would list the
item as covered by the insurance scheme she was proposing. Id. at 110.
Ms. Lajterman noted that she was not asked to comment on insurance coverage proposed
for Petitioner by Respondent. Tr. at 111. She otherwise did not dispute that many of the life care
plan items she provided for would be paid for entirely by insurance—and thus took no issue with
instances in which Ms. Curtis represented this to be the case (although as noted below Ms.
Lajterman did not agree in all circumstances that the extent of coverage of specific life care plan
components under insurance would be sufficient). Id. at 146. In addition, Ms. Lajterman admitted
that she applied a standard of attempting to maximize Petitioner’s overall life enjoyment in
ascertaining whether a life care plan item was proper, as opposed to what was medically sufficient
or necessary. Id. at 153. And she noted that her recommendations were not limited to care directly
associated with Petitioner’s injury—meaning, for example, she allowed for costs for care from an
audiologist, despite no demonstrated link to Petitioner’s TM—but instead included in her plan all
of the medical care he was currently receiving. Id. at 113, 150–51.
Overall, Ms. Lajterman determined that I.J. could do very little on his own—and she
specifically testified that her views were confirmed after listening to his testimony during the
damages hearing. Tr. at 104, 108. He requires assistance with toileting, bathing, meals, medical
care, and errands, needing assistance even when performing tasks that he has some minimal
capacity to attempt. Id. at 104. For example, I.J. may be able to call his pharmacy to renew a
prescription, but then needs someone else to pick up the prescription and help him take the
medication. Id. Petitioner is also at risk for falls in his home, and his fall risk score has not changed
since he was initially discharged from rehabilitation. Id. at 106.
Based on his health status, Ms. Lajterman made a number of care recommendations, both
for personal treatment and assistance as well as physical items or other accommodations. The
largest proposed allocation was for in-home care, with Ms. Lajterman recommending 24-7
assistance (hence far more than the present 70 hours per week he receives). Tr. at 140; Lajterman
Report at 10. She deemed his existing circumstances (in which he is frequently left alone for
several hours every day) to be extremely unsafe, since “[t]here’s a lot that could happen in two to
three hours that could leave this man significantly injured, dead, unable to get out of the building.”
Tr. at 141. She instead proposes a permanent, live-in assistant, provided by an agency and paid at
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a going hourly rate. Id. Working with an agency would ensure replacement aides are available (and
she estimated a team of two to three people would be needed for full coverage). Id.4
Ms. Lajterman then testified about her recommendations for therapeutic modalities to be
provided by treaters or care-giving professionals. Tr. at 113. She emphasized the need for
Petitioner to receive regular physical therapy, for example, in addition to engaging in home or
gym-based exercise program with the assistance of his aide. Id. She recommended twice-weekly
sessions in her report, contesting the sufficiency of Respondent’s recommendation of only once-
weekly sessions that decrease in subsequent years (and if insurance only covered once-per-week
sessions, she proposed an allocation of costs for a second weekly session). Id. at 115. She proposed
a comparable, twice-per-week regime for both psychologic counseling (so Petitioner could address
the mental health effects of his injury) and occupational therapy. Id. at 111, 122; Lajterman Plan
at 8. And she recommended visits with a nutritionist three times a year (more than what
Respondent proposed) where Ms. Curtis recommended only twice. Id. at 112.
While the parties disputed only the frequency of many of these components of personally-
performed therapeutic care, Ms. Lajterman made some recommendations that Respondent
questioned outright. For example, Ms. Lajterman proposed massage therapy, acupuncture, aqua
therapy, and chiropractic care, all of which she deemed necessary in addition to physical therapy
and gym sessions. Tr. at 121–22; Lajterman Plan at 8. She admitted that acupuncture, massage
therapy, nutritional advice, and chiropractic care had not been recommended for I.J. by a doctor,
but asserted that they were consistent with clinical practice guidelines. Id. at 154–55, 157.
Another potentially high-cost care item in Ms. Lajterman’s plan involved home living
modifications. Tr. at 131. In her view, Petitioner’s current apartment, located on the 17th floor of
his building, was “extremely unsafe”—making him a “sitting duck” in the event of a fire, since it
would be exceedingly difficult to move him rapidly (and since he would be unable to do so absent
personal assistance from a care-giver). Id. She proposed a $100,000.00 allocation, based on that
of the Paralyzed Veteran’s Association, and their estimation for modifications in the New York
Metro area, to permit Petitioner both to obtain a ground-floor apartment and to make modifications
to it (such as ramps or a ceiling-mounted lift system). Id. at 132; Lajterman Plan at 9. A lift system
would particularly be beneficial, since it would render transitions of Petitioner easier to perform
at home (even on his own), reducing the risk of an accident due to a fall. Id. at 127–28. The sling
utilized in such a system would also allow him to assume something close to a standing position
at a bathroom or kitchen counter. Id. at 128.
Ms. Lajterman then moved on to discuss some other specific aid equipment recommended
for Petitioner’s home. Tr. at 125. The three largest such items were the FES bicycle, an upgraded
4 Ms. Lajterman also included in her estimate the cost for residential care, in the event that home care is no longer an
option. Tr. at 143, Lajterman Plan at 10. However, Respondent’s life care planner disputed the need for such
contingency planning. Tr. at 238. I do not find that such a life care plan element is required under the circumstances,
and it is not therefore included in my damages determination.
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bed, and ramps. Id. at 126. An FES bicycle is only available in therapy environments, and not
found in a regular gym. Id. However, Ms. Lajterman represented that she had in the past
encountered instances in which individuals with spinal cord injury have home access to such a
piece of equipment. Id. Individuals use the bike with electrodes placed on the skin, which
stimulates muscle contraction and increase strength. She stated that this equipment would not wear
out quickly, would likely be a one-time purchase, and would greatly aid Petitioner. Id. at 127.
Ms. Lajterman also proposed that I.J. receive a bed from the “ProBed” line. Tr. at 129. This
bed aids in turning and repositioning immobile patients, to prevent them from having pressure
sores and skin breakdown. Id. She recalled Petitioner’s earlier testimony about a serious pressure
wound on his back, which required him to lay on his front for five months to treat. Id. She opined
that the cost of the bed (just under $50,000.00) equaled out to the cost of treating an open wound,
and was therefore both justified and cost-effective as well. Id. Further, such a bed moves up and
down manually, and does not need to be cranked by an aide. Id. at 130. When asked about the
Respondent’s argument that this bed should not be included because a bed frame and mattress is
deemed a routine expense, she said she did not understand that recommendation. Id. at 131. She
also clarified that this cost item was intended to cover a bed in a range of costs, rather than a
specific model. Id. at 178.
Ms. Lajterman testified about the need for replacement portable ramps. Tr. at 130. These
ramps could be taken to places that are not wheelchair-accessible, and set up so that Petitioner
could access them. Id. She recommended that these ramps be replaced every five years to ensure
safety and good working order, at a cost of $300. Id. at 130–131.
Next, Ms. Lajterman discussed her recommendation for wheelchairs and maintenance. Tr.
at 134. One proposal—a custom standing wheelchair for Petitioner—was accepted by Respondent,
and its cost would be covered by insurance. Id. But they disagreed on the cost allocation for
maintenance, with Ms. Lajterman recommending an allocation of at least $500 per year, regardless
of actual need, deeming Respondent’s allocation of $109.80 inadequate. Id. at 134, 135. In
addition, she recommended a specialized seat cushion to prevent skin breakdown, plus provision
of a manual light wheelchair in case the primary wheelchair malfunctioned or was not otherwise
accessible by a home care provider. Id. at 135, 136. Relatedly, Ms. Lajterman proposed cost
provisions for a new, wheelchair-accessible van for Petitioner’s transportation (to be driven by
home care aides), plus allocations for its maintenance. Tr. at 138–39.
Finally, Ms. Lajterman identified a number of lower-cost care components. Lajterman Plan
at 17. First, she recommended he be provided access to a medical alert system in case of
emergencies. Tr. at 125 She proposed that bedside urinals be replaced weekly, as they must be
cleaned carefully to prevent infection, and are relatively inexpensive. Id. She also testified that
items such as sliding boards and shower chairs be replaced periodically due to wear and tear. Id.
at 126. And she called for cost allocation for a number of miscellaneous small hygiene supplies
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and medications (acknowledging that Respondent did not contest the need for the medications,
and that almost all would likely be covered by insurance in any event). Tr. at 136, 138.
2. Linda Curtis – Ms. Curtis earned a Bachelor of Science in Nursing from
Florida State University in 1982, and a Master of Sciences in Health Services Management from
Florida Institute of Technology in 1991. Curriculum Vitae of Linda Curtis, R.N., filed September
14, 2023 (ECF No. 204-3). She is a Certified Nurse Life Care Planner and Certified Case Manager.
Id. She has over 40 years of nursing experience that has included caring for the ill and injured
across the continuum of life. Id. Her acute care experience includes the following fields: Critical
care, Medical-Surgical, Emergency, Cardiology, Rehabilitation, and Orthopedics as a staff nurse
and supervisor. Id. Her areas of expertise include physical rehabilitation, spinal cord injuries,
traumatic brain injuries, chronic pain, multi trauma, amputees, burn and orthopedic injuries. Id.
Since 1995, she has been the President of Medical Record Review LLC, and has been retained by
over 100 law firms and insurance carriers as a consulting expert. Id. She has prepared life care
plans in the Vaccine Program over 300 times before. Tr. at 214.
Ms. Curtis based her life care plan recommendations on a review of the medical records,
plus an in-person site visit with Petitioner. She visited Petitioner’s home in October 2022, and
spent slightly over two hours with him. Curtis Plan at 1; Tr. at 222. She also explained her overall
approach in preparing a plan for Respondent. Her goal was to provide “adequate coverage for basic
care needs,” rather than to optimize Petitioner’s quality of life. Id. at 218. Otherwise, she factored
in offsets to create a plan falling within the guidelines of the Vaccine Program (which both
functions as “payer of last resort,” and also, in Ms. Curtis’s understanding, does not aim for injury
compensation to maximize an individual’s possible quality of life overall, even if recommended
care will move a petitioner in that direction). Id. at 220.
Ms. Curtis began her testimony by providing her perception of Petitioner’s abilities—based
upon her personal evaluation of him as well as his testimony at hearing. She noted his overall drive
and high spirits, and that he was able to assist in his own transfers and simple tasks such as taking
medication, but that he did require an aide to complete most needed activities of daily living. Tr.
at 224, 216–17. Ms. Curtis also later acknowledged that, based on Petitioner’s testimony, she had
modified her position on some specific care issues. Tr. at 265. At the same time, she emphasized
over and over that many care items would be adequately covered by insurance—and that the
insurance regime she proposed (and which was not addressed in Ms. Lajterman’s life care plan)
was particularly comprehensive and reasonable. Id. at 220. Thus, her plan proposed funding for
Medicare insurance, a Medigap policy, and Medicare Part D for prescription coverage. Id. at 220.
In many cases, therefore, Ms. Curtis deemed Petitioner’s life care plan elements to exceed not only
what was medically reasonable, but to reflect costs that insurance would capture.
Regarding home care, Ms. Curtis denied the need for around-the-clock assistance. Tr. at
238. She noted that in her experience offering life care plan recommendation in Vaccine Program
cases, she had only seen the need for that degree of care in a few rare circumstances, involving the
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most severely-disabled individuals such as those in a coma and/or on a ventilator. Id. And her plan
was intended to help improve Petitioner’s functional abilities overall, allowing him to become
more independent and rely less on caregivers. Id. at 249.
Nevertheless, Ms. Curtis recommended six hours per day of attendant care, totaling 42
hours per week (and increasing to eight hours a day, or 46 hours a week, when Petitioner turned
65). Id. at 240. In this amount of time, a caregiver could help Petitioner get ready at the beginning
of the day, then leave him safely alone for independent activities in the middle of the day, returning
in the evening to prepare dinner and help him go to bed. Id. Later in her testimony, Ms. Curtis
allowed that Petitioner should not receive less than what he presently received, and that in fact she
would be comfortable with him receiving eight to ten hours per day (adding that it was likely the
insurance scheme she proposed would cover much of it). Id. at 253–54, 265.
Ms. Curtis was less supportive of many of the other proposed therapeutic treatments,
however. For example, she contested Ms. Lajterman’s recommendations for massage therapy,
chiropractic care, and acupuncture. Tr. at 230. She deemed massages to be a “routine expense”—
something that would typically be paid for by an individual but was not treatment-associated or
needed in connection with the vaccine injury at issue. Id. In addition, physical therapy Petitioner
would be entitled to receive through insurance would likely include some amount of massage. Id.
at 230–231. When discussing chiropractic care and acupuncture therapy, she pointed out that there
were no medical records of which she was aware recommending these therapies, rendering their
need “speculative,” and adding that she did not know of any scientific basis for their use in
treatment of transverse myelitis. Id. at 231. Similarly, while Ms. Curtis agreed aqua therapy might
be beneficial to Petitioner, she deemed it a care item that could be obtain in the context of
insurance-covered physical therapy. Tr. at 232. By contrast, Ms. Curtis agreed that nutrition
consultations might be beneficial, but deemed only four visits in total necessary. Id. at 231–32.
Other larger-scale items also were viewed by Ms. Curtis as unnecessary or not available in
the Program. Full home modification to a rental, she proposed, was not possible legally,5 and
Petitioner’s specific itemizations for it too speculative. Tr. at 234. And the danger of Petitioner’s
high-story apartment location (specifically in the event of a fire) was addressed by the lower-cost
option of a medical alert system, which she had included in her own life care plan. Id. at 229, 235.
In fact, this kind of system (which would permit Petitioner to obtain emergency assistance for a
number of issues or potentially dangerous incidents) was a reason why 24-7 home care was
unnecessary. Id. at 244.
Although she concurred for the need to modify any existing motor vehicle owned by
Petitioner for his own access, she denied that the Vaccine Program allowed injured parties the
purchase of a wholly-new vehicle. Id. at 227. (She also expressed the view that a vehicle modified
to allow Petitioner himself to drive might provide a good therapeutic goal. Id. at 228). Ms. Curtis
5 Later in her testimony, however, Ms. Curtis stated that if modifications could be made to a rental home, she would
recommend them in this case. Tr. at 261–62.
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accepted that access to an FES bicycle could be an effective therapy, but deemed Petitioner’s
ownership of such an expensive item an “over-the-top expense,” adding that it was the kind of
thing he likely could utilize elsewhere in the context of his physical therapy. Id. at 234; see
Lajterman Plan at 17 (listed cost of FES bike is $19,500).
Ms. Curtis acknowledged Petitioner should obtain an automatic/non-cranking bed, but
deemed the insurance scheme her plan established sufficient to obtain for him an excellent
upgrade, even if at a lower cost than what Ms. Lajterman proposed. Tr. at 230. And she agreed to
the need for the supplies, medications, and other sundries included in Petitioner’s plan, but noted
that she had proposed sums that she deemed most cost-effective, in keeping with the Vaccine
Program’s damages limitations. Id. at 236.
C. Vocational/Economic Experts
1. Andrew Gluck – Mr. Gluck prepared a single written report for Petitioner
and testified at hearing. Analysis of Loss of Earnings of I.J., dated September 14, 2023, filed as
Ex. 107 (ECF No. 34-2) (“Gluck Analysis”); Tr. at 182. Mr. Gluck maintained that Petitioner is
unable to work due to his physical limitations, noting in support that he receives Social Security
disability payments. Tr. at 183. Based upon this, he proposed to offer a calculation of Petitioner’s
total lost wages—actual as well as future—and provided an amount, although one he largely
acknowledged had not been adjusted in any regard (and which in fact he attempted to adjust in the
midst of testimony). Tr. at 192, 209.
Mr. Gluck received his undergraduate degree in Economics and Philosophy from the
University of Florida in 1965. CV of Andrew Gluck, filed on September 14, 2023 (ECF No. 204-
5). He went on to earn graduate degrees in Psychology and Vocational Rehabilitation, and worked
in various settings as a psychologist, vocational counselor, and rehabilitation specialist. Id. In
1990, he completed an M.S. with coursework in microeconomics, accounting, applied social
sciences, and administrative law. Id. He then earned his Ed.D. from Columbia University, through
interdisciplinary studies in philosophy, economics, psychology, and statistics. Id. Since then, he
has worked as a vocational economic analyst, in addition to teaching. Id.
To determine Petitioner’s total lost wages, Mr. Gluck relied on Petitioner’s tax returns and
his offer letter from NYU (his former employer at the time of injury).6 Tr. at 185. He then adjusted
Petitioner’s yearly earnings for inflation, and added on a 24.4% fringe benefit rate based on the
national average for fringe benefits (in order to include the value of non-direct salary compensation
benefits). Id. at 186. Mr. Gluck deemed this rate to be conservative, since an educational entity
like NYU can provide a wider array of benefits than other employers, such as tuition credits. Id.
On cross-examination, however, Mr. Gluck noted that his fringe benefits calculation came from
the Bureau of Labor Statistics average, and that he had not used a rate specific to the hospital
industry (a relevant consideration given Petitioner’s employment at the time of injury). Id. at 194–
6 Petitioner was then starting a job as a Patient Advocate at NYU Medical Center. Entitlement Decision at 8.
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95. But he deemed industry-specific calculations of little utility, unless the individual is a union
worker, municipal worker, or a very high earner. Id. at 197.
Mr. Gluck then used the Department of Labor’s American Community Survey to estimate
Petitioner’s remaining working years from the time of his injury. Tr. at 188. He concluded that
Petitioner had 26.3 working years left as August 2013 (the time of his injury), factoring in the
probability of death, job loss, or non-participation in the workforce. Id. Notably, Mr. Gluck
acknowledged at hearing that his initial report did not discount the lost wages sum for likely taxes
that would have been imposed on earnings. Id. at 189. But (and taking into account Respondent’s
expert’s analysis in his own written report) he proposed to do so in his testimony, and based upon
that (and as reflected in Petitioner’s pre-hearing submission) he offered a reduced sum, offset by
taxes, in the amount of $1,586,204. Id.; Petitioner’s Prehearing Brief at 34.
This was not the only reduction agreed to by Petitioner and Mr. Gluck at hearing. Mr.
Gluck also admitted that his calculations differed from those of Respondent’s expert in a number
of ways—and that many of the differences favored Respondent’s analysis. Tr. at 190. For example,
he did not deduct for Petitioner’s disability benefits, received starting in August 2013, which he is
eligible for through October 2023. Id.; see Kennedy Analysis (ECF No. 203-4) at 4 (explanation
of Petitioner’s disability benefits). On re-direct, Mr. Gluck clarified that deducting the disability
benefits was in fact necessary—and that doing so would further lower his estimate of lost past and
future wages to $1,432,704.00. Id. at 209.
In addition, Mr. Gluck applied a different net discount rate approach, relevant in reducing
the value to net present value of sums Petitioner was maintaining he would have earned in the
future. Rather than the 1.25 percent figure embraced by Dr. Kennedy, Mr. Gluck had used a half
point increase based on “long-term rates of wage growth and T-bill rates.” Tr. at 190. In so doing,
he believed the difference between a present value on a wage sum and future amounts effectively
zeroed out. Id. at 189. He also testified that this approach was often used in litigation in
Pennsylvania state court matters that he testified in—although he did not explain why that
approach would have utility or persuasive force in the Vaccine Program case. Id. at 198.
Ultimately, however, Mr. Gluck acknowledged that he did not fully understand why the
discounting methods were different, and he even seemed to concede that Dr. Kennedy’s reasoning
on the matter was persuasive. Tr. at 190–191. Regardless, he noted that the remaining gap between
the parties’ positions on total lost wage sums (applying the competing discount rate approaches)
was only $200,000-300,000. Id. at 191.
2. Dr. Patrick Kennedy - Dr. Kennedy is an economist, and he provided his
own calculation of lost wages for this matter. Respondent’s Loss of Earnings Analysis, dated
September 14, 2023 filed as Exhibit U (ECF No. 203-4) (“Kennedy Analysis”); Tr. at 270.
Dr. Kennedy holds a bachelor’s degree in Economics from the University of California,
San Diego and a Doctorate in Economics from Stanford University. Curriculum Vitae of Patrick
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Kennedy, filed on September 14, 2023 (ECF No. 203-5). He has been a managing director with
Torrey Partners, a managing director with LECG, a shareholder with Mack Barclay, Inc., a director
of economic research with International Securities Group and an economist with the Board of
Governors of the Federal Reserve System in Washington, D.C. Id. He is currently an economist
and Managing Director with Stout. Stout is a global investment bank and advisory firm
specializing in corporate finance, accounting and transaction advisory, valuation, financial
disputes, claims, and investigations. Id. Dr. Kennedy routinely analyzes loss of earnings in state
and federal court, including in Vaccine Program matters. Tr. at 270. He testifies in equal amounts
for plaintiffs and defendants. Id.
In this case, Dr. Kennedy estimated Petitioner’s lost wages, after offsets and discounts, to
be $1,190,602.00. Tr. at 271. To arrive at this figure, Dr. Kennedy (like Mr. Gluck) used records
of prior earnings, multiplied by a statistical work-life expectancy. Id. at 272. However, Dr.
Kennedy used a wage growth rate specialized to the hospital industry, given Petitioner’s
occupation at the time of injury. Id. As he explained, wage growth for hospital employment is
historically higher than national wage growth. Id. at 273. He also used a fringe benefit average
(19.89%) specific to hospital employees, a figure slightly lower than the one used by Mr. Gluck.
Id. He used a similar adjustment for income taxes. Id. Dr. Kennedy also came to a slightly different
figure for disability payments—a total of $185,326 after applying a present value calculation and
discount rate. Id. at 274–75.
Besides the above, Dr. Kennedy’s calculation also relied on a different net present value
discount rate. Kennedy Analysis at 5–9. In so doing, he took issue with Mr. Gluck’s use of the
“total offset method,” stating that “[i]t’s effectively a net zero discount rate.” Tr. at 274. Indeed,
Dr. Kennedy maintained that even if the alternative discount rate had been properly applied, he
would “have a material disagreement with that approach.” Id. His methodology uses both the
historical relationship between interest rates and inflation, and future projections “on things like
the Social Security Trust Fund, the OMB, Office of Management and Budget, and, importantly,
the Federal Reserve projections.” Id. at 276. Mr. Gluck’s figures, by contrast, relied on the use of
30 or 90-day Treasury bills, rather than five-year US Treasuries. Dr. Kennedy opined that five-
year Treasuries would be a more appropriate investment than T-bills, so he used that option in his
calculation. Id. at 278–279.
Dr. Kennedy also explained why he did not include employer contributions to Social
Security in his calculations. Tr. at 280. There is “significant uncertainty” as to whether Petitioner
would ever be able to receive Social Security benefits—he testified that the reserves are projected
to run out by 2037, before Petitioner reaches Social Security retirement age. Id. at 281. Further, a
calculation for Petitioner would need an offset to account for his receipt of SSDI benefits. Id. at
281–282. Factoring this in would reduce Petitioner’s total loss by nearly $400,000. Id. Thus, given
the uncertainty of Petitioner ever benefitting from these contributions, he chose not to subtract this
amount from his estimate. Id.
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III. Relevant Law on Damages Determinations
A. General Considerations
A petitioner may recover “actual unreimbursable expenses incurred before the date of
judgment awarding such expenses which (i) resulted from the vaccine-related injury for which the
petitioner seeks compensation, (ii) were incurred by or on behalf of the person who suffered such
injury, and (iii) were for diagnosis, medical or other remedial care, rehabilitation . . . determined
to be reasonably necessary.” Section 15(a)(1)(A)(i) –(iii). The petitioner bears the burden of proof
with respect to each element of compensation requested. Brewer v. Sec’y of Health & Hum. Servs.,
No. 93-0092V, 1996 WL 147722, at *22–23 (Fed. Cl. Spec. Mstr. Mar. 18, 1996).
As noted above, this provision of the Act permits recovery of costs to be incurred for future
care as well, although such costs must be shown to be “reasonably necessary.” Section
15(a)(1)(A)(iii)(I) –(II). The meaning of the phrase “reasonably necessary” is somewhat imprecise,
as I have recognized in other cases. Barone v. Sec’y of Health & Hum. Servs., No. 11-707V, 2016
WL 3577540 (Fed. CL. Spec. Mstr. May 12, 2016). But it encompasses the idea that additional
care aimed at maximizing an injured party’s overall well-being (not matter how personally
deserving the individual may be) is not in keeping with the scope of damages envisioned by the
Program. I.D. v. Sec’y of Health & Human Servs., No. 04-1593V, 2013 WL 2448135, at *6 (Fed.
Cl. Spec. Mstr. Apr. 19, 2013) (defining “reasonably necessary” to mean “that which is required
to meet the basic needs of the injured person . . . but short of that which may be required to optimize
the injured person’s quality of life”); see also Bedell v. Sec’y of Health & Hum. Servs., No. 90-
765V, 1992 WL 266285 (Cl. Ct. Spec. Mstr. Sept. 18, 1992) (defining the term to mean more than
merely barely adequate, but less than the most optimal imaginable). And it goes almost without
saying that such costs must also pertain to care associated with the alleged injury or its sequalae.
Medical care a petitioner might receive, even if needed, that is not aimed at treatment of the vaccine
injury at issue, or related to it, is not a reasonably necessary future care component.
B. Lost Wages – Past and Future
The Vaccine Act provides for recovery of “actual and anticipated loss of earnings
determined in accordance with generally recognized actuarial principles and projections,” where
the injured party’s “earning capacity is or has been impaired by reason of such person’s vaccine-
related injury.” Section 15(a)(3)(A). The calculation of lost earnings damages must be performed
in a “cautious manner ‘in accordance with generally recognized principles and projections.’”
Brown v. Sec’y of Health & Hum. Servs., No. 00-182V, 2005 WL 2659073, at *6 (Fed. Cl. Spec.
Mstr. Sept. 21, 2005) (citing Section 15(a)(3)(A)). Moreover, the Vaccine Act requires that any
award of compensation relating to future damages shall be reduced to its net present value. Section
15(f)(4)(A).
Compensation awarded for a petitioner’s anticipated loss of earnings may not be based on
speculation. J.T. v. Sec’y of Health & Hum. Servs., No. 12-618V, 2015 WL 5954352, at *7 (Fed.
Cl. Sept. 17, 2015) (indicating Section 15(a)(3)(A) “does not envision that ‘anticipated loss of
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earnings’ includes speculation” and thus refusing to allow lost wages on a planned business
venture that was too indefinite); Dillenbeck v. Sec’y of Health & Hum. Servs., 147 Fed. Cl. 131,
139 (2020 (citing J.T., 2015 WL 5954352, at *7). Accordingly, it is not enough to substantiate
such a request with some evidence, if the submissions offered ultimately rely on speculated (if
somewhat informed) “guesses” about what a claimant might have earned under optimal conditions.
See, e.g., Moreland v. Sec’y of Health & Hum. Servs., No. 18-1319V, 2022 WL 10469047 (Fed.
Cl. Spec. Mstr. Sept. 2, 2022) (denying injured real estate agent’s claim of lost commissions;
although petitioner substantiated her claim with evidence, she could not demonstrate her
expectation of commissions or other real estate-related income was more than a reasoned hope).
IV. Appropriate Compensation in this Matter – Disputed Components
A. Lost Wages – Past and Future
Petitioner requests a total award of $1,432,704.00, for past and future lost wages. To
support this component of his damages demand, Petitioner relies on a mix of earnings
documentation and expert input from Mr. Gluck. See generally Gluck Analysis; Petitioner’s Tax
Returns 2008-2013, filed on August 18, 2023 (ECF No. 200); Petitioner’s Employment and
Earning Records, filed on March 24, 2023 (ECF No. 106). Respondent agrees that Petitioner
cannot re-enter the workforce, and is entitled to past and future lost wages, but (relying on the
same background information about Petitioner’s prior earnings) estimates Petitioner’s total lost
earnings to be the lesser sum of $1,190,602.00. Kennedy Analysis at 11. And as noted above,
Respondent applies a 1.25% offset rate, along with a fringe benefits rate specific to the hospital
industry, where Mr. Gluck applies one based on more general labor statistics. Kennedy Analysis
at 10.
Respondent’s calculation was plainly better-defended and explained by Dr. Kennedy, and
was more persuasive than what Mr. Gluck proposed. Indeed, Mr. Gluck admitted at hearing that
his initial figure lacked numerous necessary discounts (in particular taxes), and then conceded he
could not rebut Dr. Kennedy’s discount rate reasoning. Tr. at 190–191. I also note that a discount
rate in the range proposed by Dr. Kennedy is far more in keeping with how that rate has been
calculated in prior Vaccine Program cases, over more than 20 years. See, e.g., Watkins v. Sec’y of
Health & Hum. Servs., No. 95-154V, 1999 WL 199057 (Fed. Cl. Spec. Mstr. Mar. 12, 1999)
(discussing in detail the calculation of net discount rates and agreeing with the method used by Dr.
Kennedy).
Accordingly, Respondent’s proposed figure was persuasively established, and calculated
“in accordance with generally recognized actuarial principles and projections.” Section
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15(a)(3)(A).7 And (again, by Mr. Gluck’s admission) the sum I will order does not reflect an
egregious drop in total lost wages to be paid, when compared against Petitioner’s demand.
Therefore, and based on the evidence filed, I shall award Petitioner $1,190,602.00 in lost wages,
both actual and future.
B. Medical Care Expenses
Overall, Respondent’s life care planner Linda Curtis offered a more persuasive evaluation
of Petitioner’s medically-established needs. Ms. Curtis visited Petitioner in person before making
her recommendations, giving her a more accurate perspective on his day-to-day activities and
limitations. She also did a better job taking into account Program guidelines for what kinds of costs
are allowable. At the same time, Petitioner’s own testimony (supplemented by the other fact
witnesses and Ms. Lajterman) confirmed his need for some cost categories exceeding what
Respondent was willing to accept. I provide a brief run-down of my findings on disputed categories
below.
1. Insurance
Ms. Curtis recommends comprehensive Medicare coverage as part of Petitioner’s award,
to cover many of the items Petitioner’s life care planner recommended - but at a lower cost to the
Program. She has also provided an interlocking system of coverage, to ensure no gaps occur. Curtis
Plan at 2. Petitioner has voiced no objection to Ms. Curtis’s insurance recommendation (and in
fact did not even attempt to take into account whether certain proposed life care plan items would
even be covered under such insurance).
Accordingly, damages in this case shall include the costs of this insurance package (to be
determined in connection with any annuity product that must be obtained to ensure future care
sums are available). As discussed below, only in instances in which a proposed care item is not
likely to be covered under such insurance are provisions included for the extra cost.
2. Wheelchair
Petitioner will be granted the cost of all of the wheelchair components requested, including
a custom standing power wheelchair, battery replacements, maintenance, a specialized seat
7 While the Federal Circuit has not interpreted what qualifies as “generally recognized actuarial principles and
projections,” there are several decisions that interpret “actuarial principles” in a broader sense from other federal and
state statutes, where actuarial data and expert opinions are required to substantiate damages. See, e.g., Chabner v.
United of Omaha Life Ins. Co., 994 F. Supp. 1185, 1194 (N.D. Cal. 1998), aff’d, 225 F.3d 1042 (9th Cir. 2000) (finding
that under the Americans with Disabilities Act, sound actuarial principles “must . . . include reference to some sort of
actuarial data either in the form of actuarial tables or clinical studies estimating mortality rates”); Fleisher v. Phoenix
Life Ins. Co., 18 F. Supp. 3d 456, 480 (S.D.N.Y. 2014) (taking into account conflicting expert testimony when
assessing “accepted actuarial principles” under a New York statute).
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cushion, and a manual backup wheelchair. This will amount to a total of $84,968.00. Lajterman
Plan at 19.
3. Ceiling-Mounted Lift System
Within 30 days of this Ruling, Petitioner shall inform me whether under City of New York
and other applicable rent and apartment law policies modification of a rental apartment may be
made for a disabled tenant to install the requested ceiling-mounted lift system, and the cost. If this
is permissible under law, the cost shall be included in the damages award, regardless of insurance
coverage. If impermissible, however, it shall not be included.
4. FES Bike
Petitioner has not shown that it is medically necessary for him to own an FES bike that
would be located in his home. He is instead encouraged to access a FES bike at a physical therapy
center, as part of any such sessions covered by the comprehensive insurance coverage proposed
by Respondent.
5. Home Care Assistance
Respondent’s expert made a compelling argument that Petitioner can be left alone for short
periods of time if provided with a medical alert system in case of emergency. In addition, Petitioner
has not demonstrated that the severity of his injury-related deficiencies merit round-the-clock
home care. As noted at hearing, however, Respondent concedes Petitioner should receive at least
8-10 hours a day of this care. Tr. at 265. And I find he should not receive less such care than is
presently provided to him—and he currently receives 70 hours per week of care. Id. at 140. Thus,
he will be provided with the cost of 10 hours per day of attendant care, at a rate of $29.00 per hour.
6. Physical and Occupational Therapy
Petitioner will not be separately awarded the cost of physical and occupational therapy, as
he can likely obtain any such needed care via the Respondent’s recommended insurance.
7. Audiology
Petitioner has not shown a specific link between any hearing issues he suffers and his
vaccine injury. Thus, the cost of audiology care will not be separately covered (although he may
otherwise seek any needed care that would otherwise be covered as a medical expense under
Respondent’s recommended insurance scheme).
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8. Cannabis
Cannabis cannot be a covered medical expense under the Vaccine Program, even if
prescribed by a treater, as it is a Schedule I controlled substance under the federal Controlled
Substances Act, 21 U.S.C. § 801, et seq. I therefore do not include the cost of this treatment in
damages.
9. Acupuncture
Petitioner will not be awarded the cost of acupuncture therapy, as he has not shown that it
was recommended by a doctor for his injury.
10. Nutritionist
Petitioner will not be awarded the cost of consults with a nutritionist. He may instead obtain
coverage for such advice via Respondent’s proposed insurance scheme.
11. Massage Therapy
Petitioner will not be awarded the cost of massage therapy, as he has not shown that it is
recommended by a doctor for his injury. He may instead obtain coverage for massage via
Respondent’s proposed insurance scheme (and specifically any physical therapy sought
thereunder).
12. Gym Membership/Aqua Therapy
Petitioner will be provided with the cost of an annual gym membership to work on his
mobility in his free time. Within 30 days of this Ruling, Petitioner will propose a sum to cover a
local gym membership. Petitioner will not be provided a separate award of costs to cover aqua-
therapy, but is encouraged to identify a gym that could provide pool access, and/or seek such
therapy in the context of any physical therapy obtained via insurance.
13. Psychological counseling
Petitioner will not be provided with the cost of psychological counseling, as this will be
covered by Respondent’s proposed insurance scheme.
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14. Medical Alert System
The parties agree on the need for a life alert system, to safeguard Petitioner when alone.
Both Petitioner and Respondent have listed the cost of this system as $300.00 per year to
Petitioner’s life end, and accordingly this sum shall be provided for as an ongoing medical costs.
15. Supplies
Petitioner will be provided with the cost of all hygiene supplies requested, including
incontinence products, gloves, wipes, bed pads, and condom catheters, for a total of $107,835.83.
He will also receive most of the larger care supplies he requested, such as bedside urinals (replaced
weekly), sliding boards, and rolling shower chairs and commode. Going by Petitioner’s estimate,
periodic replacement of these items will cost approximately $591.60 per year to Petitioner’s life
end.
16. Prescriptions
All necessary medications and prescriptions should be available under Respondent’s
proposed insurance scheme, and therefore no additional damages component is needed to account
for this expense. Although some prescriptions requested in Petitioner’s life care plan (i.e., Cialis)
have not been shown to be reasonably necessary for treatment of his transverse myelitis, it is likely
he can seek reimbursement for them under Respondent’s proposed comprehensive insurance
policy.
17. Wheelchair-Accessible Vehicle
The cost of a new wheelchair-accessible van is deemed a routine expense not compensable
under the Program (except in rare circumstances not present herein), and therefore I do not provide
for this in damages. See Petronelli v. Sec'y of Health & Hum. Servs., No. 12-285V, 2016 WL
3252082, at *2 (Fed. Cl. Spec. Mstr. May 12, 2016) (Petitioner not awarded cost of a wheelchair-
accessible van when she was capable of traveling in a standard vehicle for short distances).
However, Petitioner will be awarded the cost of wheelchair-accessible modifications to a vehicle,
and routine updates to these modifications, as recommended by Respondent’s expert. This will
total $29,000.00. Curtis Plan at 15–16.
18. Bed
Petitioner has made a compelling argument that he needs a semi-electric bed, rather than
one that must be manually cranked by a caregiver to move up and down. However, Ms. Curtis
established in her testimony that a semi-electric bed will be covered by proposed insurance, and
Petitioner did not otherwise establish that the specific model of bed requested would be the only
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reasonably adequate modality to aid his health. Accordingly, I do not provide herein for a separate
item of coverage for a new bed.
C. Apartment Relocation Expenses
Petitioner and Ms. Lajterman made compelling arguments at the hearing about Petitioner’s
safety concerns in the event of a fire. Petitioner currently resides on the 17th floor of his apartment
building. Because elevators normally shut down during a fire, his only route of escape would be
the building stairs. But the fact that he is wheelchair-bound means first responders not only would
have to carry him down seventeen flights of stairs, but also make it up to the 17th floor in the first
place. In the case of a serious fire emanating from the lower level of the building, there is a
significant chance emergency personnel would not be able to rescue Petitioner in time. Thus, due
to his injury, a first floor or very low floor apartment is a reasonable accommodation for
Petitioner’s overall safety.
As of the time of the hearing, the record lacked sufficient information about the cost of
Petitioner’s current apartment versus what sums would be needed to obtain an apartment on a
lower floor. Accordingly, after a status conference on January 31, 2024, I asked Petitioner to
propose a calculation for the cost of moving to a comparable, first-floor apartment, and he has
done so. Memorandum, dated February 29, 2024 (ECF No. 223) (“Memorandum”). Respondent
then filed his own brief on the topic. Response, dated March 15, 2024 (ECF No. 224)
(“Response”).
Petitioner’s memorandum includes an affidavit from Petitioner and information for
comparable apartments in Brooklyn, NY. See generally Memorandum. He provides the layout of
his current apartment for reference. Id. at 4–6. He also provides online listings for various
apartments, ranging in monthly rent costs from $8,995.00 to $2,180.00. Id. at 8–34. Petitioner’s
affidavit represents that he consulted several movers and received verbal estimates of
approximately $5,000.00 for his move. Id. at 152. He also explains that his current apartment
complex is rent-subsidized. Id. Once he receives damages in this case, he will exceed the asset
limits for the complex. Id. He then provides a list of prices and locations for the apartments he
found in internet searches, but notes that some of the apartments are not in safe areas. Id. at 154–
155.
Respondent has opposed the award of any relocation-related costs. First, he maintains that
the language of the Vaccine Act in Section 15(c) prohibits awarding the cost of a new rental unit,
stating that the amount for residential and custodial care must “be sufficient to enable the
compensated person to remain living at home.” Response at 3; 42 U.S.C. § 300aa-15(c). In support,
he offers legislative history evidence suggesting that this kind of damages award was not
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contemplated as reasonably covered by the Vaccine Act at the time of its promulgation. Response
at 4.
In addition, Respondent cites several cases in which Petitioners were denied the cost of
purchasing a new home entirely, or funds for building an addition onto their current home.
Response at 5–7; Marrero v. Sec'y of Dep't of Health & Hum. Servs., No. 88-12V, 1990 WL
293367 (Cl. Ct. Spec. Mstr. May 23, 1990); Gresh v. Sec'y of Dep't of Health & Hum. Servs., No.
89-91V, 1990 WL 270206 (Cl. Ct. Spec. Mstr. Oct. 26, 1990). And he contests that the risk to
Petitioner’s safety is sufficient to justify such expenses. He notes, for example, that Petitioner
testified at hearing that firefighters knocked on his door after another unit on the hall had a minor
fire- thus proving his accessibility to first responders. Response at 8; Tr. at 59–62. Respondent
instead deems security at the existing apartment complex adequate to protect Petitioner in an
emergency situation. Id. Respondent further argues that Petitioner could have moved by now were
this a real concern, since his injury occurred more than ten years ago. Id. at 9. Otherwise,
Respondent denies the probative value of the evidence Petitioner has offered to establish
comparable apartment costs, noting that several of the apartments listed were either inaccessible
or located on even higher floors than Petitioner’s current apartment. Id. at 9–11.
Although Respondent correctly observes several deficiencies in Petitioner’s justification
for a particular amount of award8 for this damages component, he is unpersuasive in his larger
argument that this kind of cost cannot be awarded in the Vaccine Program. First, most of the cases
cited involved the distinguishable circumstance in which a claimant sought damages sufficient to
purchase an entirely new home. See, e.g., Marrero, No. 88-12V, 1990 WL 293367. Here, by
contrast, the question is to what extent the differential between Petitioner’s existing rental property
and one that would pose less of a safety risk is justified. Petitioner is not requesting (nor would I
agree to award) total rental coverage for the remainder of his life.
Second, many of Respondent’s case citations actually involve circumstances in which
petitioners were provided with damages merely to alleviate housing issues posed by an existing
property (and are thus somewhat consistent with the current request). In one such case, for
example, petitioners were awarded $38,148.00 for the yearly cost of a group home for their
disabled son, rather than some amount to obtain a different apartment suitable for his needs. Kono
v. Sec'y of Dep't of Health & Hum. Servs., No. 93-123V, 1995 WL 774598, at *16 (Fed. Cl. Spec.
Mstr. Dec. 21, 1995). Notably, the Kono petitioners had failed to submit any documentation
supporting their request for rental costs into the record, and yet some provisions for this cost were
made.
Finally, there is some (albeit limited) case support for the propriety of damages components
aimed at shielding wheelchair-bound petitioners from the risk of fire. In Hale v. Sec'y of Dep't of
8 Indeed, Petitioner’s filing does not even attempt to propose a final figure.
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Health & Hum. Servs., No. 90-13V, 1990 WL 608696, at *7 (Cl. Ct. Spec. Mstr. Oct. 16, 1990),
mot. for review den’d, 22 Cl. Ct. 403 (1991), a petitioner was awarded $30,000.00 for home
modifications to accommodate their wheelchair-bound son. The special master in that case
specifically noted that “[i]n the event of fire or other emergency, additional smoke detectors and
an exit from Christopher's bedroom is needed.” (emphasis added).
Here, Petitioner faces some risk if he continues to live in a high-floor apartment. The minor
fire mentioned in his testimony that occurred on his hallway, during which firefighters knocked
on his door to alert him, is not at all comparable to the possibility of a severe, structure-destroying
fire that would put Petitioner in grave danger. Petitioner’s concerns about the reliability of
emergency services in a large city are also well-founded. And the contention that Petitioner could
have already made more effort to secure a lower-floor apartment fails to take into account the
housing difficulties faced by low-income individuals—especially those who already have rent-
subsidized apartments in New York City.
Thus, while Respondent is correct that the risk from fire or other natural disaster is not
certain, it is sufficiently realistic that some provision should be made herein for Petitioner to obtain
a more evidently-safe living situation. I thus find an award of damages to enable relocation is
warranted. However, the amount to be awarded remains to be calculated—and on this issue,
Petitioner’s evidentiary inputs are not especially helpful. Under such circumstances, I deem it in
the interests of justice (and to avoid awarding damages for too speculative a concern, or that
amount to windfall) to fashion a lump sum amount sufficient to cover moving expenses and some
amount of transitional rent costs for a lower floor apartment.
Prior cases in the Program, including some cited by Respondent, have awarded similar
lump sums for petitioners to use as they see fit in securing adequate housing for disabled
individuals. For example, in Anghel v. Sec'y of Dep't of Health & Hum. Servs., No. 90-210V, 1991
WL 211867, at *3 (Cl. Ct. Oct. 3, 1991), in lieu of home modifications not found to meet the Act’s
“reasonably necessary” standard, an award of $40,000.00 was permitted for house alterations “to
be spent as the Anghel family sees fit.” (emphasis added). This figure was based on the estimate
for the average cost of wheelchair-accessible home modifications as determined by the National
Spinal Cord Injury Research Center. Other cases have also provided for lump sum housing awards
that permit a petitioner discretion in their utilization. See, e.g., Gresh v. Sec'y of Dep't of Health &
Hum. Servs., No. 89-91V, 1990 WL 270206, at *7 (Cl. Ct. Spec. Mstr. Oct. 26, 1990) (awarding
$45,000 for home modifications, and stating “[t]his amount will provide for a wheelchair
accessible bathroom and permit petitioners to select among other proposed modifications. If
petitioners determine that modification of the present structure is not feasible, the amount may be
applied towards the purchase of a more appropriate home” (emphasis added)); see also
Marrero, 1990 WL 293367, at *11 (awarding $100,000.00 for home renovations, and stating that
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“[i]f zoning ordinances prohibit such construction at the Marrero's current residence, the amount
awarded would enable the Marrero's to make similar renovations to a comparable house”).
As noted, while Petitioner has offered some information that can be used to calculate a
relocation lump sum, it provides no total amount requested, and is not fully reliable. However, he
has offered sufficient evidence to establish not only a reasonable moving cost, but a range of
possible rent increase outcomes—and these sums are not specifically undermined by Respondent’s
broad-based contentions. I will therefore include a lump sum of $74,804.60, based upon estimates
of (a) $5,000.00 to move, and (b) an average rent increase9 of $13,960.92 per year ($1,163.41 x
12), with five years of this sum included. The increase is capped at five years to account for the
possibility that Petitioner ultimately opts not to move (or finds an apartment with a comparable
cost), so as not to grant him an unreasonable windfall, and also since the true risk of a catastrophe
attributable to his current higher floor circumstances cannot be predicted to any degree of certainty.
CONCLUSION
In light of all of the above, I find Petitioner is entitled to (a) $250,000.00 in actual pain and
suffering, as previously agreed by the parties, (b) $1,190,602.00 in actual lost wages, past and
future, and (c) a relocation/rent differential lump sum of $74,804.60. These figures will be
incorporated in the final damages decision to be issued in this case. The amount of $626,327.70
will also be specified in the Decision to satisfy the outstanding Medicaid lien for previously-
received medical care associated with the vaccine injury.
The parties shall prepare a joint final life care plan spreadsheet incorporating my rulings
herein on disputed categories of care that can be appended to the Decision. They shall file this
document on or before April 30, 2024.
9 To arrive at the $1,163.41 per month increase figure, the following calculation was employed: Petitioner’s list of
comparable apartment rents (Memorandum at 154–155) was evaluated for reasonableness, with several units listed
deemed to be luxury accommodations, and hence not fairly included in the calculation. In addition, relying on
Petitioner’s current housing situation, all rental prices in excess of $5,000.00 per month were removed from
consideration.
The twelve remaining amounts set forth in Petitioner’s submissions (ranging from $2,180.00 per month to $4,800.00
per month) were then averaged, resulting in the amount of $2,769.41. This sum was then compared against Petitioner’s
current rent. Notably, Petitioner did not specify in his affidavit what amount he pays per month currently, but his
apartment complex’s website shows two bedroom units starting at $1,606.00 (Spring Creek Towers,
https://www.springcreektowers.com/theapartments.html). This amount was subtracted from the average, showing a
monthly increase of $1,163.41 ($2,769.41-$1,606.00=$1,163.41). This figure was in turn multiplied by twelve to
determine a yearly amount ($1,163.41 x 12= $13,960.92), and then in turn multiplied by five to account for five years
($13,960.92 x 5= $69,804.60). This amount was added to the $5,000.00 moving cost estimated by Petitioner.
Memorandum at 152. Thus, adding the sums together ($69,804.60 + $5,000.00=$74,804.60) yields the amount to be
awarded.
23

Case 1:16-vv-00864-RTH Document 248 Filed 01/05/26 Page 24 of 24
IT IS SO ORDERED.
s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
24

================================================================================
DOCUMENT 5: USCOURTS-cofc-1_16-vv-00864-7
Date issued/filed: 2026-01-05
Pages: 7
Docket text: PUBLIC DECISION (Originally filed: 06/05/2024) regarding 238 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made.
--------------------------------------------------------------------------------
Case 1:16-vv-00864-RTH Document 249 Filed 01/05/26 Page 1 of 7
States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-864V
* * * * * * * * * * * * * * * * * * * * * * * * *
*
I.J., * Chief Special Master Corcoran
*
Petitioner, * Filed: June 5, 2024
*
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Robert J. Krakow, Law Office of Robert J. Krakow, P.C., New York, N.Y, for Petitioner.
Catherine E. Stolar, U.S. Dep’t of Justice, Washington, DC, Respondent.
FINAL DAMAGES DECISION1
On July 21, 2016, I.J. filed a petition seeking compensation under the National Vaccine Injury
Compensation Program (the “Vaccine Program”).2 Petitioner alleged that he suffered transverse
myelitis (“TM”) as a result of a Tetanus Diphtheria acellular-Pertussis vaccine he received on July
22, 2013. Petition (ECF No. 1) (“Pet.”) at 1.
After a trial and ensuing appellate practice, Petitioner was found entitled to damages in January
2022 (see Ruling, dated January 4, 2022 (ECF No. 143)), but the parties were unable to agree to a
final sum, despite some concurrence on individual damages components. A hearing was held in
October 2023, and although it resulted in some determinations (see March 28, 2024, Finding of
1 Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information
furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or
confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public
in its present form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (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.
1

Case 1:16-vv-00864-RTH Document 249 Filed 01/05/26 Page 2 of 7
Fact and Conclusions of Law (ECF No. 225) (the “March Damages Ruling”)), other disputes
persisted.
On May 1, 2024, I ordered that “the final proffer/stipulation on damages in this matter will be
filed on or before May 31, 2024.” ECF No. 230 at 2. The parties opted instead to file a Joint Status
Report containing the information needed for me to issue a final damages decision. ECF No. 237.
Accordingly, my final damages determination (which includes the rulings I issued in the March
Damages Ruling) are herein set forth.
I. Items of Compensation
A. Life Care Items
Respondent engaged life care planner Linda Curtis, RN, MS, CNLCP, CCM, and Petitioner
engaged Linda Lajterman, RN, CCM, CDMS, ABDA, CLCP, to provide an estimation of I.J.’s
future vaccine-injury-related needs, and each offered a life care plan. See ECF Nos. 203-1, 204-1.
Agreed-upon life care items, as well as life care items I determined after the October 2023 hearing,
are illustrated by the chart entitled “Appendix A: Items of Compensation for I.J.,” attached to this
Decision as Tab A. I incorporate by reference this document, as well as the determinations made
in my March Damages Ruling.
B. Lost Earnings
The parties agreed that based upon the evidence of record, I.J. has suffered a loss of
earnings under the Vaccine Act, but did not initially agree on the total amount. But after hearing,
I determined that Petitioner was entitled to $1,190,602.00 in actual lost wages, past and future. See
March Damages Ruling at 16.
C. Pain and Suffering
The parties agree that based on the evidence of record, I.J. is entitled to an award of $250,
000 in actual pain and suffering, the maximum amount allowed under the Vaccine Act. 42 U.S.C.
§300aa-15(a)(4).
D. Apartment Relocation Expenses
After disagreement by the parties on the compensability of apartment relocation expenses,
I decided that a final damages decision would award $70,804.23. This amount reflects $5,000.00
for expenses expected to be incurred in compensation year one, and the discounted present value
2

Case 1:16-vv-00864-RTH Document 249 Filed 01/05/26 Page 3 of 7
of annual expenses of $13,960.92 expected to be incurred in compensation years two through six,
consistent with 42 U.S.C. § 300aa-15(a)(1). See March Damages Ruling at 23.3
E. Medicaid Lien
Respondent proffers that Petitioner should be awarded funds to satisfy a New York City
Department of Social Services Medicaid lien in the amount of $639,898.43, which represents full
satisfaction of any right of subrogation, assignment, claim, lien, or cause of action the New York
City Department of Social Services may have against any individual as a result of any Medicaid
payments the New York City Department of Social Services has made to or on behalf of Petitioner
from the date of his eligibility for benefits through the date of judgment in this case as a result of
his vaccine-related injury suffered on or about August 1, 2013, under Title XIX of the Social
Security Act.
II. Form of the Award
The compensation provided to Petitioner will be made through a combination of a lump sum
payment and future annuity payments, as described below:
A. A lump sum payment of $1,668,311.51, representing compensation for life care
expenses expected to be incurred in the first year after judgment ($156,905.28), lost
earnings ($1,190,602.00), pain and suffering ($250,000.00), and apartment relocation
expenses ($70,804.23) in the form of a check payable to Petitioner;
B. A lump sum payment of $639,898.43, representing compensation for satisfaction of the
New York City Department of Social Services Medicaid Lien, payable jointly to
Petitioner and:
New York City Department of Social Services
ATTN: Evelyn Sylvester
Division of Liens and Recovery
375 Pearl Street
New York, NY 10038
CIN: NC98405Y
3 After an initial amount for rent costs ($74,804.60) was calculated and set forth in the March Damages Ruling, it
was determined after informal discussions with the parties that the net discount rate had not been applied to the
future portion of this damages component, as required by Section 15(f)(4)(A). After applying this discount, the
corrected amount came to $70,804.23. This recalculated sum was communicated to the parties, and neither disagreed
with this corrected figure.
3

Case 1:16-vv-00864-RTH Document 249 Filed 01/05/26 Page 4 of 7
Case Number: 1004628
C. An amount sufficient to purchase an annuity contract,4 subject to the conditions
described below, that will provide payments for the life care items contained in the life
care plan, as illustrated by the chart at Tab A, attached hereto, paid to the life insurance
company,5 from which the annuity will be purchased.6 Compensation for Year Two
(beginning on the first anniversary of the date of judgment) and all subsequent years
shall be provided through respondent’s purchase of an annuity, which annuity shall
make payments directly to petitioner, I.J., only so long as petitioner is alive at the time
a particular payment is due. At the Secretary’s sole discretion, the periodic payments
may be provided to petitioner in monthly, quarterly, annual, or other installments. The
“annual amounts” set forth in the chart at Tab A describe only the total yearly sum to
be paid to petitioner and do not require that the payment be made in one annual
installment.
a. Growth Rate
The parties agree that a four percent (4%) growth rate should be applied to all
non-medical life care items, and a five percent (5%) growth rate should be applied
to all medical life care items. Thus, the benefits illustrated in the chart at Tab A that
are to be paid through annuity payments should grow as follows: four percent (4%)
compounded annually from the date of judgment for non-medical items, and five
percent (5%) compounded annually from the date of judgment for medical items.
b. Life-Contingent Annuity
Petitioner will continue to receive the annuity payments from the life insurance
company only so long as he, I.J., is alive at the time that a particular payment is
4 At Respondent’s discretion, Respondent may purchase one or more annuity contracts from one or more life insurance
companies.
5 The Life Insurance Company must have a minimum of $250,000,000 capital and surplus, exclusive of any mandatory
security valuation reserve. The Life Insurance Company must 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.
6 Petitioner authorizes the disclosure of certain documents filed by the petitioner in this case consistent with the Privacy
Act and the routine uses described in the National Vaccine Injury Compensation Program System of Records, No. 09-
15-0056.
4

Case 1:16-vv-00864-RTH Document 249 Filed 01/05/26 Page 5 of 7
due. Written notice shall be provided to the Secretary of Health and Human
Services and the life insurance company within twenty (20) days of I.J.’s death.
III. Summary of Payments Following Judgment
A. Lump sum paid to Petitioner, I.J.: $1,668,311.51;
B. Medicaid lien: $639,898.43;
and
C. An amount sufficient to purchase the annuity contract described above in Section (II)(C).
These amounts represent compensation for all damages that would be available under Section
15(a) of the Vaccine Act. The Clerk of the Court is directed to enter judgment in accordance
with this Decision.7
IT IS SO ORDERED.
s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
7 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing
the right to seek review.
5

Case 1:16-vv-00864-RTH Document 249 Filed 01/05/26 Page 6 of 7
Appendix A: Items of Compensation for I.J. Page 1 of 2
Lump Sum
Compensation Compensation Compensation Compensation Compensation Compensation Compensation
ITEMS OF COMPENSATION G.R. * M Year 1 Years 2-5 Year 6 Years 7-10 Year 11 Years 12-19 Years 20-Life
2024 2025-2028 2029 2030-2033 2034 2035-2042 2043-Life
Medicare Part B Premium 5% M 2,096.40 2,096.40 2,096.40 2,096.40 2,096.40 2,096.40
Medicare Part B Deductible 5% 240.00 240.00 240.00 240.00 240.00 240.00 240.00
Medigap G 5% M 3,696.00 3,696.00 3,696.00 3,696.00 3,696.00 3,696.00 3,696.00
Medicare Part D 5% M 333.60 333.60 333.60 333.60 333.60 333.60 333.60
Primary Care Physician 5% *
Neurology 5% *
Urology 5% *
Physical Medicine & Rehabilitation 5% *
Podiatry 4% 280.00 280.00 280.00 280.00 280.00 280.00 280.00
Physical Therapy Evaluation 4% *
Occupational Therapy Evaluation 4% *
Diagnostic Testing 5% *
Physical Therapy 4% *
Men's Disposable Pull Ups 4% M 547.50 547.50 547.50 547.50 547.50 547.50 547.50
Gloves 4% M 146.00 146.00 146.00 146.00 146.00 146.00 146.00
Wipes 4% M 337.48 337.48 337.48 337.48 337.48 337.48 337.48
Chux 4% M 1,044.00 1,044.00 1,044.00 1,044.00 1,044.00 1,044.00 1,044.00
Condom Catheter 4% M 1,144.00 1,144.00 1,144.00 1,144.00 1,144.00 1,144.00 1,144.00
Medical Alert 4% 300.00 300.00 300.00 300.00 300.00 300.00 300.00
Bedside Urinal 4% M 416.00 416.00 416.00 416.00 416.00 416.00 416.00
Sliding Board 4% 39.00 15.60 15.60 15.60 15.60 15.60 15.60
Rolling Shower Chair/Commode 4% 800.00 800.00 800.00 160.00 160.00
Mattress Overlay 4% 579.00 579.00 57.90 57.90
Portable Ramp 4% 300.00 300.00 300.00 60.00 60.00
Power Wheelchair 4% 10,500.00 10,500.00 10,500.00 2,100.00 2,100.00
Wheelchair Battery 4% * 200.00 200.00 200.00 200.00 200.00 200.00 200.00
Wheelchair Maintenance 4% 500.00 500.00 500.00 500.00 500.00 500.00 500.00
Specialized Seat 4% 369.00 369.00 369.00 184.50 184.50
Manual Wheelchair 4% 549.00 549.00 549.00 91.50 91.50
Baclofen 5% *
Gabapentin 5% *

Case 1:16-vv-00864-RTH Document 249 Filed 01/05/26 Page 7 of 7
Appendix A: Items of Compensation for I.J. Page 2 of 2
Lump Sum
Compensation Compensation Compensation Compensation Compensation Compensation Compensation
ITEMS OF COMPENSATION G.R. * M Year 1 Years 2-5 Year 6 Years 7-10 Year 11 Years 12-19 Years 20-Life
2024 2025-2028 2029 2030-2033 2034 2035-2042 2043-Life
Senna 4% 51.10 51.10 51.10 51.10 51.10 51.10 51.10
Colace 4% 36.50 36.50 36.50 36.50 36.50 36.50 36.50
Aspirin 4% 65.70 65.70 65.70 65.70 65.70 65.70 65.70
Wheelchair Accessible Vehicle 4% 20,000.00 20,000.00 2,000.00 2,000.00
Vehicle Modification Maintenance 4% 900.00 900.00 900.00 900.00 900.00 900.00 900.00
Driver's Evaluation 0% 875.00
Live In Attendant 4% M 105,560.00 105,560.00 105,560.00 105,560.00 105,560.00 105,560.00 105,560.00
Ceiling Lift System 0% 5,000.00
Gym Membership 0% *
Lost Earnings 1,190,602.00
Pain and Suffering 250,000.00
Apartment Relocation Expenses 70,804.23
Medicaid Lien 639,898.43
Annual Totals 2,308,209.94 117,909.88 130,427.88 117,909.88 151,006.88 122,563.78 120,467.38
Note: Compensation Year 1 consists of the 12 month period following the date of judgment.
Compensation Year 2 consists of the 12 month period commencing on the first anniversary of the date of judgment.
As soon as practicable after entry of judgment, respondent shall make the following payment to petitioner for Yr 1 life care
expenses ($156,905.28), lost earnings ($1,190,602.00), pain and suffering ($250,000.00), and apartment relocation
expenses ($70,804.23): $1,668,311.51.
As soon as practicable after entry of judgment, respondent shall make the following payment jointly to
petitioner and the New York City Department of Social Services, as reimbursement of the state's Medicaid lien: $639,898.43.
Annual amounts payable through an annuity for future Compensation Years follow the anniversary of the date of judgment.
Annual amounts shall increase at the rates indicated above in column G.R., compounded annually from the date of judgment.
Items denoted with an asterisk (*) covered by health insurance and/or Medicare.
Items denoted with an "M" payable in twelve monthly installments totaling the annual amount indicated.