# T. v. Secretary of Health and Human Services

> United States Court of Federal Claims · December 4, 2024

URL: https://www.frixlaw.com/law-library/cases/10754475

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** December 4, 2024
- **Precedential status:** Unpublished
- **Opinion:** Opinion
- **Judges:** Brian H. Corcoran
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10754475

## How later opinions describe it (automated extraction)

- noting that Moberly “addresses the petitioner’s overall burden of proving causation-in-fact under the Vaccine Act” by a preponderance standard

## Opinion text

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In the Gnited States Court of Federal Claims

OFFICE OF SPECIAL MASTERS
No. 21-1213V

*eKKEKKEKKEKKEKEKEKHKEKKEKREKEK EK EK

Rn 8.1. Chief Special Master Corcoran

Petitioner, Filed: November 8, 2024
v.

SECRETARY OF HEALTH AND
HUMAN SERVICES,

Respondent.

+ & & He HH HE He EH

*eEREKKEKKEKKEKKEKKEKKEKKEKEK KEKE KEK

Jessica A. Wallace, Siri & Glimstad, LLP, Aventura, FL, for Petitioner.
Benjamin P. Warder, U.S. Department of Justice, Washington, DC, for Respondent.

ENTITLEMENT DECISION!

On April 15, 2021, (MM B.T. filed a petition for compensation under the
National Vaccine Injury Compensation Program (the “Vaccine Program”). ? Petitioner
alleges that he developed an ulnar neuropathy in his right upper extremity from receipt of an
influenza (“flu”) vaccine administered to him on September 19, 2018. Petition (ECF No. 1) at 1,
3.The parties have submitted expert reports and offered briefs so thatthe matter can be resolved
via a ruling on the record. See Petitioner’s Motion, dated Mar. 26, 2024 (ECF No. 42)
(“Mot.”); Respondent’s Opposition, dated May 14, 2024 (ECF No. 44) (“Opp.”); Petitioner’s
Reply, dated May 29, 2024(ECF No. 45). For the reasons stated in more detail below, I deny
entitlement.

" Under Vaccine Rule 18(b), each party has fourteen (14)days within which torequest redaction “ofany mfomation
furnished by that party: (1) that is a trade secret or commercal or fmancial m substance and is privileged or
con fidentia 1; ar (2) that mcludes m edical fils or similar fies, the disclosure of which would constitute a clearly
unwa Iranted mvasionof privacy.” Vaccme Rule 1 8(b). Otherwise, the whole Decsion will be a vaih bleto the pubic

in its present form. fd.

? The Vaccme Program comprises Part2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No.99-660,
100 Stat. 3758, codified asa mended at42 U.S.C. § §300aa-1 Othrough34 (2012)[heremafter“Vaccme Act” or “the
Act”). Individua | section references herea fter wil be to § 300aa of the Act (but willomit that statutory prefix).
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I. Factual Background

Pre-Vaccination Evidence of Limb and Shoulder Issues

Petitioner’s pre-vaccination medicalhistory bears on the alleged injury. He had previously
experienced several issues relating to his hands and right shoulder that are somewhat consistent
with the alleged injury,seeingsome of the same treaters who provided assistanceafter vaccination.
(His history ako reveals a propensity to seek treatment regularly, and the advice ofa large nutnber
of different providers).

For example, six years before the vaccination at issue (in October 2012), a magnetic
resonance imaging scan (“MRI”) of (I B-T.’s right elbow revealed the presence of
a large anconeus epitrochlearis accessory muscle, creating a mass effect on the ulnar nerveat the
level of the cubital tunnel, and resulting m elbow pain. Ex. 2 at 180. Then, m December 2016,
Petitioner had another MRI—this time of his right hand, occasioned by an accidentto it thathad
caused pam. Ex. 17 at 43-16. Thissecond MRI revealed a finger bone contusion plus a likely
related muscle sprain. Jd. Mr. Tacher underwent a third MRI in June 2017 of his nght shoulder
(and also due to reported pain), and which revealed tendinopathy. /d. at 39.

In addition, during the spring and early summer of 2018, (J B-T. had several
visits to chiropractor Cole Streets, D.C., of Sports & Spine Chiropractic & Rehabilitation
Solutions (“SSCRS”). Ex. 6 at 31-3 7. He sought chiropractic care to treat “symptoms in the
cervical spme described as intermittent aching discomfort that radiates to the head and
radiates to the right shoulder.” /d.at 31. Dr. Street’s impressions included cervical
dysfunction, impingement syndrome of the right shoulder, cervical gia, and right-hand pain. Jd.
Petitioner obtained additional chiropractic treatment at SSCRS that summer, complaining of
right shoulder pain, left-side cervical spine discomfort, and radiating pain from his
temporomandibular joint (“TMJ”) thatradiated to his head. /d. at 25~29, 31.

That same summer, (J BT. also visited a different chiropractor, Scott Weiland,
D.C, at Gulf Coast Spine & Sport (“GCSS”) for TMJ and persistent right shoulder pain. Ex.7 at
3-6. Testing revealed normal strength but pain on some movement with tendemess to
palpitation (“TTP”) of certain right shoulder muscles. /d. at 4, 5. Dr. Weiland provided
chiropractic physical adjustments but also proposedhome exercises. /d. at 5—6. His pain
remained over the summer, however./d. at 7-9, 10-12. He retumed to SSCRS in August-
September 2018to see Dr. Streets, also reporting right shoulder pain, and receiving treatment
comparable to what Dr. Weiland provided. Ex. 6 at 25-27.

September 20) 8 Vaccination

GS BT. (then 44-years old) received the flu vaccine in his right deltoid on
September 19, 2018, at a Cape Coral, Florida CVS Pharmacy. Ex. 1 at 2. Two days later
(September 21, 2018), Petitioner visited Dr. Streets at SSCRS complaining of constant, bilateral

shoulder pain at 5
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a 7/10 level. Ex. 6 at 24. The record from this visit (the first post-vaccination) makes no reference
to the vaccination event two days prior, and does not contain any representations from Petitioner
that the recent vaccination had caused pain or any other immediate symptoms. Jd. Dr. Streets
treated Petitioner with chiropractic manipulation and laser therapy, among other things. /d.

One-week post-vaccination, on September 27, 2018, 3) B.T. contacted
Neuroscience & Spine Associates (“NSA”) to schedule an appointment with neurologist Dr.
Igor Levy-Reis, based on a reported referral from another treater. Ex. 2 at 247. At this time,
Petitioner reported tingling in his feet and hands for one week—although no reference is made
in this intake form as to the prior vaccination. Jd. Then, in early October, he went to Jaffe
Sports Medicine (“JSM”) to see physical medicine and rehabilitation specialist, Peter Jaffe,
D.O. Ex. 3 at 10-13. J B.T. now noted his September vaccination, adding that after
receiving it he had developed bilateral upper extremity paresthesias, and reported
experiencing numbness and pain in his right forearm and hand, all of which were worsening. Jd.
at 10. Petitioner did also acknowledge his prior PT and hand-related treatments. /d. at 12.

A neurologic exam performed at Dr. Jaffe’s office revealed bilateral upper and lower
paresthesias, but normal reflexes and strength. Ex. 3 at 11. Petitioner underwent an EMG of his
upper right extremity at this time which demonstrated evidence ofa mild-to-moderate right ulnar
compression across the elbow, but no likely cervical radiculopathy. Ex. 8 at 46. Dr. Jaffe
proposed that (J B.T. was experiencing “worsening nerve dysfunction sequelae”
and possibly “Vaccine[-]induced [Guillam-Barré syndrome].” Ex. 3 at 11, 12 (noting a
diagnosis of “nerve dysfunction, right arm”). He prescribed gabapentin, PT, and home
treatments, including exercises. /d. at 12.

Later that same October and November, Petitioner returned to Dr. Streets, now
complaining of right wrist and elbow pain, plus left cervical spine pain. Ex. 6 at 22, 23. Dr. Streets
referred him to an orthopedic specialist, but also proposed an MRI to look for evidence ofnerve
entrapment. Jd. Petitioner saw that specialist—Dr. David Eichten of Joint Implant Surgeons of
Florida (“JISF”)—on November 7, 2018. Ex. 4 at 27-30. J B.T. reported pain in his
right elbow and wrist, radiating down his arm to his hands and beginning six weeks after the
September vaccination (meaning later October or early November), due, in his estimation, to
the vaccine’s misadministration. Jd. at 27. Dr. Eichten proposed Petitioner follow up with his
practice partner, Dennis Sagini, M.D., for “in[]situ decompression vs transposition of the ulnar
nerve.” Id. at 30.

On November 9, 2018, J B.T. had a previously-scheduled appointment at
NSA with Dr. Levy-Reis. Ex. 2 at 126—28. He again reported numbness in his right hand
beginning at the time of vaccination, due © purported misadministration. /d. at 126. And it was
claimed that the EMG performed by Dr. Jaffe at an earlier October visit demonstrated ulnar
neuropathy. Jd. Dr. Levy-Reis prescribed a Medrol Dosepak and gabapentin, and ordered an
MRI of Petitioner's right upper extremity and an EMG of his upper extremities. Jd. at 127.
Petitioner also saw Dr. Weiss that same day, reporting right elbow and hand pain in the
wake of vaccination and due to 3
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misadministration, with paresthesias beginning two days after vaccination and worsening pain
over time. Ex. 7 at 13-15.

On November 14, 2018, J B.T. returned to GCSS for a visit with Dr.
Weiland for treatment of persistent nerve pain in his nght arm that he associated with
his September vaccination. Ex. 7 at 16-17. The next day, he had an appointment at JISF with
orthopedic surgeon and hand specialist Dr. Sagini, at which time he reported symptoms and
vaccine associations comparable to what he was providing to other treaters at the time. Ex. 4 at
10—15. On examination, Petitioner’s Tinel’s sign3 was negative in the right radial tunnel but
positive in the right ulnar groove, and he displayed some pain and weakness with right wrist
flexion. /d. at 12-13. Dr. Sagini opined that gg B.T. might be experiencing a triangular
fibrocartilage complex (“TFCC”) sprain of the right wrist and a healing ulnar nerve neuritis, and
provided a direct injection into Petitioner’s hand and wrist which provided some prompt relief.

Id. at 13-14.
Treatment in 2019 and Beyond

Petitioner has filed medical records memorializing treatment he received in the ensuing
three years (2019-21). He continued to seek medical assistance from the same providers he had
seen in the months immediately following vaccination, reporting chronic symptoms he associated
with his September 2018 vaccination.

In the winter of 2019, for example, 9 QJ B.T. saw Dr. Weiland again,
complaining of unrelated neck and upper back pain, but also ongoing nerve pain he deemed
associated with his vaccination that prior fall. Ex. 7 at 18-20, 21-22, 23-24. He also had
several appointments into the spring of 2019 with Dr. Streets at SSCRS, during which he
consistently reported right elbow pain. Ex. 6 at 11-19.

In mid-March 2019, SR B.T. went back to Dr. Sagini but saw his physician’s
assistant (“PA”), Maria Rienzi, reporting more right hand/wrist/elbow pain. Ex. 4 at 66-70. PA
Rienzi noted some wrist range of motion issues and other hand concems, but did not deem
surgery necessary, and recommended that Petitioner undergo an MRI of his right wrist (to rule
out a TFCC tear) and right elbow (to rule out a biceps tendon tear versus brachialis tear). Jd. at
69-70. He saw a new treater at JSM in April 2019, now claiming that the
post-vaccination paresthesias he first experienced in his right upper extremity had migrated to
his feet (if more moderate in sensation). Ex. 3 at 14-16. The treater confirmed the possibility
of a vaccine reaction, and proposed (J B.T follow up with a PCP to confirm whether
he had some kind of flu vaccine sensitivity. Id.

The right elbow MRI recommended by PA Rienzi occurred in mid-April, and it
revealed an abnormal signal at the biceps tendon insertion that could represent tendinopathy
ertendon_bursitis Ex—$-at-45. On April 17, 2019, Petitioner underwent an MRI of his right
wrist, and its

3

“Tinel Sign” is defined as “a tingling sensation in the distal end of a limb whenpercussion is made over the site of
a divided nerve. It indicates a partial lesion or the becinine regeneration of the nerve.” Tin el Sign, Dorland’s
Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition 7id=1 06510 (last visited Nov.
8, 2024).
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findings seemed consistent with prior trauma of some kind (but also showed effusion assoc iated
with capsulitis/capsulosynovitis or TFCC thinning). /d. at 51. Another EMG, performed in early
May by Dr. Levy-Reis of NSA, demonstrated a right ulnar sensory neuropathy and isolated
decreased recruitment of the hypothenar muscles. Ex. 2 at 214-19. Dr. Levy-Reis also saw J.
GH BT. thereafter, on May 9, 2019. Jd. at 123-25. Based on his reported history and the
exam findings and testing, Dr. Levy-Reis opined that Petitioner had experienced a
vaccine-induced ulnar neuropathy (adding that there was a lack of clear evidence of right elbow
nerve entrapment). /d.

That same May, J B.T. returned to Dr. Sagini for consideration of his on-going
right wrist and elbow pain. Ex. 4 at 45-50. An examination of his right wrist was positive for
TTP over the ECU tendon sheath, and there was paresthesias related to ulnar nerve distribution.
Id. at 48. Dr. Sagini deemed Petitioner’s presentation to constitute evidence of distal biceps
tendinitis of the right elbow and sprain of the right wrist, and prescribingadditional medication and
pain injections. /d. at 49. Toward the end of the month, Petitioner began seeking treatment
from the Pain Management Center of Naples, due to his hand and shoulder pain (although his
ulnar neuropathy was noted as well). Ex. 13 at 5-8. An MRI performed that month of
Petitioner’s cervical spine revealed a numberof problems, including bulging discs and stenosis. Jd.
at 12. SM B.T. returned to Dr. Levy-Reis in June 2019, repeating his diagnosis of ulnar
neuropathy, and adding that “[i]t seems it was triggered by the [flu] injection.” Ex. 2 at 109-11.

Throughout that summer, Petitioner received occupational therapy (“OT”). Ex. 3 at 89—
108. A left shoulder MRI performed in August revealed intact rotator cuff tendons, mild
peritendinobursitis, and a small effusion. Ex. 8 at 47. Issues with back and shoulder pain also
led SJ B.T. to return to Dr. Levy-Reis in September 2019. Ex. 2 at 83-85. At this time,
however, Dr. Levy-Reis declared that the ulnar neuropathy in Petitioner’s right arm had
“pretty much resolved.” Jd. at 83-84.

By the fall, Petitioner continued to complain of left shoulder and right elbow pain, and
he received steroid or platelet-rich plasma injections mn his bilateral upper extremities. Ex. 2 at
80— 82. He followed up with Dr. Sagini at JISF in November, at which time he complained of
right wrist and elbow pain (but without right shoulder numbness or tingling). Ex. 4 at 54-58.
GH B.T. was assessed with right shoulder tendinitis, but Dr. Sagini also noted that OT
appeared to have helped Petitioner’s wrist pain and range of motion issues. Jd. at 57—58. Dr.
Sagini also proposed further consultation with a rheumatologist. Jd. at 58.

At an early December 2019 visit to NSA, Petitioner’s focus was on his difficulties
coping with left shoulder pain, and he complained that prior pain treatments had worn off. Ex. 2 at
76-78. He was now assessed with right cubital tunnel syndrome, nght distal biceps tendinitis,
left AC joint osteoarthritis, and left subacromial impingement with rotator cuff tendinitis. Jd. at
77,78. It was proposed that QM B.T. consider more invasive treatment, such as
ulnar nerve decompression with transposition surgery. Jd. That same month, Petitioner
obtained more pain management treatment at PMCN, and his ulnar nerve injury was
addressed, as well as many 5
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possible causes of it. Ex. 13 at 2—4. Petitioner continued to repeat his contention about his elbow-
related issues due to vaccine misadministrationat a visit to orthopedic hand specialist, Dr. Stephen
Helgemo, atthe Florida Hand Center(“FHC”) in mid-December 201 9. Ex. 10 at 3—5. Dr. Helgemo,
however, observed that Petitioner’s right elbow pain might “be coming from the biceps or the
brachioradialis [as] both are somewhat obscure problems that really do not have a readymade
solution,” and therefore, more invasive treatment was likely unwarranted. Jd. at 5.

2020 featured the same efforts by J B.T. to obtain treatment (both for the
injury at issue as well as other conditions) froma wide vaniety of medical providers. For example,
Petitioner returned to Dr. Helgemo in January 2020, and it was now recommended that he
undergo decompression surgery. Ex. 10 at6—7. He
subsequently receivedacupuncturetreatmentthat winter as well. Ex. 15 at 4.

In the early spring, Petitioner saw physiatrist Sebastian Klisiewicz, D.O., at Integrative
Rehab Medicine (“IRM”). Ex. 8 at 61-62. B.T. was assessed with right arm pain
and numbness, ulnar neuropathy, radial neuritis, right lateral wrist instability, and thinning of
the TFCC. /d. at 61. It was proposed that Petitioner undergo nerve hydrodissection 4 of the right
radial nerve and right ulnar nerve, along with a prolotherapy? injection of the right lateral wrist.
Id. Both procedures were performed at IRM on March 23, 2020. Jd. at 38-41.

Thereafter, however, Petitioner continued to experience elbow pain, and Dr. Klisiewicz
assessed him in April with right arm pain and numbness since Petitioner’s receipt of the flu
vaccine, plus right-sided ulnar neuropathy, right-sided radial neuritis, right-sided distal biceps
peritendinitis/bursitis, right-sided lateral wrist instability, and thinning of the right-side TFCC. Ex
8 at35—38. SY B.T. was instructed to focus on a home exercise program. /d. He retumed
to Dr. Klisiewicz in early May, reporting that the pain in his right arm had decreased, and he
received a steroid injection directed at the right radial and ulnar nerves. /d. at 2—5. Later that
month, Dr. Klisiewicz again saw 9) «B.T., and performed elbow laser therapy on his
right ulnarnerve. dd. at 11-13. Dr. Klisiewicz also that month administered PRP prolotherapy and
perineural injectons into Petitioner’s bilateral AC joints and the radial collateral ligament of his
right wrist. Id. at 6-7, 14-26.

At an appointment with Dr. Helgemo of FHC in July, Petitioner noted he continued to
experience elbow pain,among other things, and ulnarnerve decompression surgery was discussed.

* “Nerve hydrodissection” is defined as “a technique used when treating nerve entrapments, [and] involved the
injection ofan anesthetic, saline, or5% dextrose in waterto separate thenerve from the surrounding tissue, fascia, or
adjacent structures.” NIH National Library of Medicine, Ultrasound-Guided Nerve Hydrodissection for Pain
Management: Rationale, Methods, Current Literature, and Theoretical Mechanisms,
https://www.ncbi.nlm nih.gov/pmc/articles/PMC74 14936/ (last visited Nov. 8, 2024).

*“Prolotherapy” is defined as “an injection-basedcomplementary anda ltemativemedical(C AM) therapyfor chronic
musculoskeletal pain.” NIH National Library of Medicine, Prolotherapy in Primary Care Practice,
https://www ncbinlm.nih.gov/pmc/articles/PMC2831229/ (last visited Nov. 8, 2024).

6
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Ex. 10 at 8—9. It was noted, however, that nerve tests had “not shown anything except maybe
neuropathy on one [test],” and there was no “real area of tenderness” in Petitioner’s right elbow,
although Dr. Helgemo was able to palpate the ulnar nerve, which was sensitive above the elbow.
Id. at 8—9. Dr. Helgemo stated that he did not believe that surgery was “really clearly indicated,”
recommending instead right hand-oriented OT. Jd. at 9. Dr. Helgemo added that because the
tingling and numbness in Petitioner’s right had had largely stopped, the “primary impetus” to
perform an ulnar nerve decompression surgery was no longer present. Jd. Additional EMG testing
of B.T.’s right upper extremity performed by Dr. Jaffe in August 2020 revealed
moderate- to-severe ulnar compression across the right elbow, but no evidence of cervical
radiculopathy. Ex. 16 at 21.

Petitioner sought a second opinion on the propriety of surgery that same August, at the
University of Miami Hospital and Clinics (“‘UMHC”) with neurosurgeon Ian Cote, M.D. Ex. 9 at
8-11. Dr. Cote noted that J B.T. had previously undergone EMGs confirming a
diagnosis of compressive ulnar neuropathy at the elbow, and his exam revealed right-hand sensory
deficiencies. Jd. He deemed Petitioner’s ulnar neuropathy to be likely “secondary to a congenital
abnormality in the form of an accessory anconeus muscle belly.” Jd. at 10. But Dr. Cote did
recommend a surgical procedure—“an ulnar nerve neurolysis and decompression at the
elbow”—to which J B.T. expressed a willingness to undergo. Jd.

Toward the end of August, Petitioner saw yet another orthopedic surgeon and hand
specialist, Dr. Elizabeth Ouellette, again complaining of right elbow pain. Ex. 11 at 12—16. After
an extensive physical examination, Dr. Ouellette opined that I B.T. was suffering
from compartment syndrome of the right upper arm (secondary to the vaccination event from
2018), ulnar nerve entrapment at the right elbow, tear of the TFCC of the wrist, brachial
plexopathy without trauma, and injury of the radial nerve in the upper night arm. /d. Dr. Oullette
proposed a surgical plan for release of the plexus at the axilla and radial nerve at the triangular
space of the right upper extremity—the procedure was performed on September 18, 2020. Id.
at 16, 18-19. Petitioner experienced some post-surgical shoulder pain, but otherwise recovered
well from the procedure.

Records filed with respect to treatment gg B.T. received in 2021 (which cease
that spring) underscore his continued efforts to seek relief for the panoply of shoulder/
arm/hand symptoms he had experienced, but do not provide illumination as to causation.
Petitioner did, however, continue to inform treaters that his discomfort began at the time of his
September 2018 vaccination. See, e.g., Ex. 17 at 55-60 (documenting March 2021
visit to sports medicine/regenerative orthopedic specialist); Ex. 16 at 8-13 (documenting
visit to physical medicine and rehabilitation specialist). Despite some lingering symptoms,
Petitioner’s condition was generally deemed improved, and treaters largely recommended
medication or non-invasive treatments to manage any continued pain or sensory issues. See,
e.g., Ex. 16 at 30 (documenting follow-up EMG performed in April 2021, which revealed mild
ulnar neuropathy at Petitioner’s right elbow with new evidence of denervation, peripheral

neuropathy, myopathy, radiculopathy, 7
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radial neuropathy, brachial plexopathy, or carpal tunnel syndrome); Ex. 18 at 15—18 (noting
follow-up examination performed by Dr. Ouellette in April 2021 revealed full range ofmotion and
strength, plus resolution of compartment syndrome, and other than some mild wrist discomfort,
GE 3.1. reported decrease in numbness and overall improvement).

II. Expert Reports

A. Petitioner’s Expert — Dr. Carlo Tornatore

Dr. Tomatore, a board-certified neurologist, prepared two written reports for Petitioner in
support of the contention that his ulnar neuropathy was vaccine-caused. Report, dated Dec. 15,
2022 (ECF No. 31-1) (“Tomatore First Rep.”); Report, dated Aug. 26, 2023 (ECF No. 36-1)

(“Tomatore Supp. Rep.”).

Dr. Tomatore graduated from Comell University with a Bachelor of Arts and Sciences in
Neurobiology, and attended Georgetown University Medical Center, where he received a Master
of Science in Physiology. Curriculum Vitae, filed as Ex. 21 (ECF No. 39-1) (“Tomatore CV”) at
1. He subsequently graduated from medical school at Georgetown University School of Medicine,
completing a residency in the Department of Neurology at Georgetown University Hospital.
Tomatore CV 1-2. Dr. Tomatore also completed a fellowship in Molecular Virology at the
National Institute of Health in Bethesda, Maryland. /d. at 2. He has published multiple articles
addressing cell biology and pathology of demyelinating disorders. /d. at 6-15. Currently, Dr.
Tornatore serves as Professor and Chairman of the Department of Neurology at Georgetown
University Medical Center, Chairman and Neurologist-in-Chief of the Department of Neurology
at Medstar Georgetown University Hospital in Washington, D.C., and Executive Director of the
Multiple Sclerosis Patient Centered Specialty Home. Tomatore First Rep. at 1. Currently, Dr.
Tomatore follows approximately 124 patients with inflammatory neuropathies, myopathies and
disorders of the neuromuscular junction. Tomatore CV at3. Over the course of his career, he has
been involved with the care of approximately thousands of patients who present with
mononeuropathies and polyneuropathies. /d.

First Report

Dr. Tomatore first provided a detailed summary of Petitioner’s prior medical history and
the pertinent facts as they relate to the alleged vaccine-related injury before setting forth his
opinion. See generally Tomatore First Rep. at2—14. Dr. Tomatore opined that Petitioner’s “onset
of symptoms [is] consistent with a right ulnar injury at the level of the elbow two days after
receiving an influenza vaccination in the vicinity of the right ulnarnerve.” /d. at 14. He further
explained that Petitioner had a pseudocyst of the distal scaphoid as a result of a pre-vaccinaton
wrist injury, in addition to a congenital abnormality of theaccessoryanconeus muscle at the elbow,
which according to Dr. Tomatore, “may have made {J [B.T.] more susceptible to

an ulnar neuropathy due to a mis-administered vaccination.” /d. at 14-15.
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To support the conclusion that a mis-administered vaccination can result in an ulnar
neuropathy, Dr. Tornatore relied upon several items of literature. Tornatore First Rep. at 15; H.
Kim et al., Upper Limb Nerve injuries Caused by Intramuscular Injection or Routine
Venipuncture, 12 Anesthesia & Pain Medicine 103 (2017), filed as Ex. 19, Tab 1 (ECF No. 31-2)
(“Kim”); S. Geiringer & J. Leonard, /njection-Related Ulnar Neuropathy, 70 Arch Phys Med
Rehabili 705 (1989), filed as Ex. 19, Tab 2 (ECF No. 31-3) (“Geiringer”); V. Salanga & J. Hahn,
Traumatic Ulnar Neuropathy from Jet Injection: Case Report, 19 J Trauma 283 (1979), filed as
Ex. 19, Tab 3 (ECF No. 31-4) (“Salanga”).

Kim described two cases of an injection-related ulnar neuropathy following vaccination,
and noted several mechanismsthat might account for its development, including “1. Direct trauma
to nerve fibers from the needle; 2. Compression of nerve fibers by the injected material, either
intraneural or extraneural; 3. Hematoma caused by injection leading to nerve compression; 4.
Direct toxic effect ofinjected material on nerve fibers; [or] 5. Toxic effect of injected material on
surrounding tissues, leadingto fibrosis orsmall vessel thrombosis, with adelayed secondary effect
on nerve.” Kim at 103. As Dr. Tornatore pointed out, both paticnts discussed in Kim had becn
injected on the left by a right-handed nurse, and thus “[c Jombined with a ‘sidearm’ delivery, [such]
positioning likely facilitated missing the deltoid completely, skirting medial to the triceps long
head, and entering the medial-ly ingneurovascular bundle.” Tornatore First Rep. at 17; Kim at 106.
Dr. Tornatore also proposed that Kim provided additional support for J 8-T-‘s
onset of symptoms beginning forty-eight hours post-vaccination, since the “[mlJigration of the
injected material from its original location is one explanation for the delayed onset of
symptoms, 30 minutes in one case, several hours in the other.” Jd.

Dr. Tornatore further opined thatif Petitioner were suffering froma congenital abnormality
of the accessory anconeus muscle atthe elbow, “then the migration of the injected materia]/vaccine
and[/Jor a hematoma, could [have] indeed resulted in compression of an already compromised
ulnar nerve at the elbow.” Tornatore First Rep. at 18. In fact, several of Petitioner’s EMG/NCS
studies indicated “a significant aggravation of a pre-existing condition,” according to Dr.
Tornatore, thus corroborating this possibility. Tornatore First Rep. at 18.

To conclude his first report, Dr. Tornatore argued that “there are scientifically recognized
reasons why an improperly administered influenza vaccination could resultin an ulnar neuropathy
above the elbow.” Tornatore First Rep. at 19. He further emphasized the notion that such an injury
is more likely to occur in an individual who might present with an “anatomical predisposition to
developing ulnar neuropathy above the elbow.” Jd. Based on themedical records and facts herein,
Dr. Tornatore opined that J B.T-‘s receipt of the flu vaccine on September 19,
2018, was “improperly administered, [and thus] aggravating [his] congenital propensity for
development of ulnar neuropathy above the elbow.” Jd.
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Supplemental Report

Dr. Tornatore’s second report began by briefly describing the concept of “double crush
syndrome” as it relates to the case herein. Tornatore Supp. Rep. at 3. As he explained, “[i}n
[Petitioner’s] case, there was a second injury above the elbow fromthe misplaced vaccination,”
and this second injury likely exacerbated the existing injury at the elbow. Jd. at 4. Double crush
syndrome can be defined as “the coexistence of dual compressive lesions along the course of a
nerve,” and canbe further demonstrated via an animal model described in an item of literature.
at 5; K. Nemoto et al., An Experimental Study on the “Double Crush” Hypothesis, 12 J. Hand
Surgery 552, 558 (1987), filed as Ex. 20, Tab 4 (ECF No. 36-5) (“Nemoto”) (clamping sciatic
nerve of dogs at either a single or two sites, and finding that where the nerve was compressed at
proximal and distal sites, complete conduction block was seen in 50 percent of the nerves at six
weeks, and motor nerve conduction velocity wasreduced to 66 percent). Dr. Tornatore maintained
that Nemoto “emphasizes the point that two low grade compressions along the nerve trunk are
worse than one such compression[,] but also thatthe damage of the dual compression exceeds the
expected additive damage caused by cach isolated compression.” Tornatore Supp. Rep. at 5.

Moreover, Dr. Tornatore maintained that Nemoto supports the notion that “[compression]
can result in permanent symptomatic injury to the nerve distal to the proximal! point of injury long
after the proximal injury has resolved.” Tomatore Supp. Rep. at 5; Nemoto at 558; see also A.
Schmid & M. Coppieters, The Double Crush Syndrome Revisited—A Delphi Study to Reveal
Current Expert Views on Mechanisms Underlying Dual Nerve Disorders, 16 Manual Therapy 557
(2011), filed as Ex. 20, Tab 5 (ECF No. 36-6) (identifying fourteen mechanisms associated with a
first nerve disorder that may predispose to the development of another nerve disorder, four of
which were considered highly plausible (i.e., impaired axonal transport, ion channel up or
downregulation, inflammation in the dorsal root ganglia, and neuroma-in-continuity)). In further
elaboration of the double crush concept, Dr. Callaghan also cited, but did not discuss in detail, four
cases discussingulnar double crush. Tornatore Supp. Rep. at5;M. Akyuzetal., Electromyography
and Ultrasonography in the Diagnosis of a Rare Double-Crush Ulnar Nerve Injury, 92 Arch Phys
Med Rehabil 1914 (2011), filed as Ex. 20, Tab 6 (ECF No. 36-7); B. Corder et al., Subacute Ulnar
Nerve Compression Neuropathy following Hand Crush Injury in the Setting of Intracanal
Accessory Abductor Digiti Minimi: A Double Crush Phenomenon, J. Hand Surgery Global Online
1 (2023), filed as Ex. 20, Tab 7 (ECF No. 36-8).

Dr. Tornatore thus opined that there are recognized scientific principlesthat exist to support
a double crush scenario as explanatory herein of Petitioner’s injury. Tornatore Supp. Rep. at 6.
As he detailed, ‘1. FB T. had long standing compression of the ulnar nerve at the
elbow due to congenital accessory anconeus muscle (i.e., the first crush of a potential double
crush syndrome); and 2. Following the misplaced injection of the influenza vaccine in the
upper arm, the second component of the double crush,symptoms of ulnarnerve dysfunction at the
elbow, became evident due to the disruption of the axoplasmic flow proximally from the
vaccine site.” Tornatore Supp. Rep. at 6.

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The second part of the supplemental report was devoted to responding to comments made
by Respondent’s expert, Dr. Callaghan. Tornatore Supp. Rep. at 6—10. Dr. Tornatore noted that
Dr. Callaghan acknowledged that Petitioner’s October 2012 MRI results had revealedthe existence
of an accessory anconeus muscle, and he disputed Dr. Callaghan’s minimization of the role that
this kind of anatomical predisposition could have in the development of an ulnar neuropathy seen
two days post-vaccination. /d. at 6. Dr. Tornatore instead insisted that he had adequately
demonstrated, via the referenced literature, that an anatomical predisposition can become
symptomatic through a double crush scenario. /d. He further addressed Dr. Callaghan’s assertion
that an injection in the deltoid, and/or other areas of the upper arm would be incapable of causmng
an ulnar nerve injury elsewhere. /d. Dr. Tornatore argued that not only had Dr. Callaghan
“ignore[d] the fact that J B.T. reported receiving the vaccination below the deltoid,”
but that the diagrams referenced in Geiringer demonstrated “how anatomically it would be
possible to cause injury to the ulnar nerve in the upper arm from a misplaced injection.” /d.; see
also Geiringer at 705 (Fig. 1), 706 (Figs. 2, 3).

In response to Dr. Callaghan’s comment that “[v]Jaccination is [ ] unlikely a cause of
Petitioner’s ulnar neuropathy, given the many flares of his symptoms over the years,” Dr.
Tornatore argued instead that Dr. Callaghan “misse[d] the point that the [flu] vaccine led to the
significant aggravation of the ulnar neuropathy at the elbow via a double crush syndrome and
subsequent changes to the physiology of the ulnar nerve at the elbow.” Tornatore Supp. Rep. at 8.
He further explained that when the ulnar nerve undergoes such changes, “they will continue to be
periodically symptomatic[,] independent of any further injury proximally[,] given the ongoing
compression from the accessory anconeus muscle.” Jd.

Dr. Tornatore then brieflyaddressed Dr. Callaghan’s criticisms of referenced case reports.
Tornatore Supp. Rep. at 8. Dr. Callaghan argued thatthe case reports documenting traumatic injury
of the ulnar nerve post-vaccination documented only injuries significantly higher than the elbow,
but Dr. Tornatore maintained that were such an injury the second incident in a double crush
scenario, then symptomsrelating to the previous compressionasa result of the accessory anconeus
muscle injury (i.e., the first incident in a double crush scenario) could occur. /d. He further opmed
that such a scenario was illustrated in Nemoto. /d. In addition, Dr. Tornatore also disagreed with
Dr. Callaghan’s statement that “[w ]hile case reports and series are valuable tools in flagging areas
for future study, they are anecdotal and provide low-level evidence compared to other study
designs.” Callaghan Rep. at 8; Tornatore Supp. Rep. 9. In fact, he maintained, “[t]he Institute of
Medicine was very clear about the value of case reports that demonstrate strong mechanistic
evidence” which according to Dr. Tornatore, is exactly what the three case reports he referenced
in his firstreport do— illustrate a vaccine/injection-related ulnar injury from misplaced injections.
Tornatore Supp. Rep. at 9.

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B. Respondent's Expert — Dr. Brian Callaghan

Dr. Callaghan, a neuromuscular specialist in treatment of neuropathies like ulnar
mononeuropathy, prepared one written report on behalf of Respondent. Report, dated Apr. 21,
2023 (ECF No. 33-1) (“Callaghan Rep.”). Dr. Callaghan opines that Petitioner’s clinical course is
consistent with a diagnosis of ulnar neuropathy at the right elbow caused by compression rather
than vaccination. Jd. at 9.

Dr. Callaghan graduated from the University of Michigan with a Bachelor of Science, and
attended the University of Pennsylvania Medical Center, where he received his medical degree.
He subsequently graduated from the University of Michigan with a Masters in Science in Clinical
Research Design and Statistical Analysis. Curriculum Vitae, filed as Ex. B (ECF No. 33-3)
(“Callaghan CV”) at 1. Thereafter, Dr. Callaghan completed an internship and residency at the
University of Pennsylvania Medical Center in Preliminary Medicine and Neurology, respectively.
Callaghan CV at 1. He also completed fellowships in Neuromuscular andthe Center for Healthcare
Research and Transformation Policy at the University of Michigan. Jd. Dr. Callaghan is board
certified by the American Board of Psychiatry and the American Board of Electrodiagnostic
Medicine. Jd. He has published more than 130 articles and medical book chapters, with a majority
focusing on neuropathy, and including the appropriate diagnostic evaluation and treatment of
neuropathy. Jd. at 14—24. Currently, Dr. Callaghan serves as an Associate Professor of Neurology
at the University of Michigan. /d.; Callaghan Rep. at 1.

Dr. Callaghan began his report summarizing the pertinent medical history and facts of
Petitioner’s case. See generally Callaghan Rep. at 1-6. He then opined on Petitioner’s overall
diagnosis—stating that based on Petitioner’s various test results, a clear diagnosis of right ulnar
neuropathy at the elbow was indicated. /d. at 7. Of note, Dr. Callaghan emphasized that Petitioner
underwent five EMG/NCS studies, three of which revealed “clear localization of the elbow.” Jd;
Ex. 2 at214;Ex.3 at 14,21. While Petitioner’s MRI of his right elbow did notreveal impingement,
Dr. Callaghan noted that Petitioner’s neurologist documented “mild impingement of the ulnar
nerve at the right elbow” in his report, and that Petitioner’s ultrasound demonstrated “clear
evidence of compression at the elbow.” Callaghan Rep. at 7; Ex. 2 at 59. Moreover, an MRI
performed in October 2012 (and thus years before the relevant vaccination) revealed the accessory
anconeus muscle, which according to Dr. Callaghan is known to make an individual susceptible
to compression of the ulnar nerve at the elbow. Callaghan Rep. at 7.

Ulnar neuropathy of the elbow, explained Dr. Callaghan, “is almost always secondary to
compression or stretch of the nerve within the cubital tunnel.” Callaghan Rep. at 7; A. Cambon-
Binder, Ulnar Neuropathy at the Elbow, 107 Orthopaedics & Traumatology: Surgery and Research
1 (2021), filed as Ex. A, Tab] (ECF No. 33-2) (“Cambon-Binder”). Although Dr. Callaghan
allowed for the possibility that an “injection into the elbow could cause an ulnar neuropathy at that
situs, [an] injection at the shoulder cannot,” because “[t]he deltoid, where vaccinations are
administered, and the elbow are anatomically far apart.” Callaghan Rep. at 7—8. Dr. Callaghan also

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criticized Dr. Tomatore’s opinion that the flu vaccine could have aggravated Pn
B.T’s “congenital propensity” to develop an ulnar neuropathy above the elbow—noting that
“[t]here is no evidence that the flu vaccine, or any vaccine, can cause an ulnar neuropathy at the
elbow.” /d. at 8. All case reports offered for this proposition involved specific injuries occurring
at places on

the arm well above the elbow. Jd.; Salanga at 2. In addition, Kim (which Dr. Tornatore highlighted)
not only affirmed the rarity of ulnar neuropathies caused by injection, but does not even specify
“vaccine-related” injection as a possible cause. /d.; Kim at 103, 106 (stating that “[i]njection-
related ulnar nerve injury seems to be relatively rare,” and finding that only 2 of 645 patients with
ulnar nerve injuries analyzed over a thirty year period were thought to possibly have incurred the
injury due to injection).

Dr. Callaghan then briefly addressed whether the medical record itself supported causation.
Callaghan Rep. at 8. While Petitioner’s neurologist had in fact considered a potential causal
relationship between his receipt of the flu vaccine and his subsequent development of ulnar
neuropathy, Dr. Callaghan deemed it “misleading” for Dr. Tornatore to claim contemporaneous
treatcrs supported causation, noting that Petitioncr’s orthopedist, hand specialist physician, and
neurosurgeon all embraced the diagnosis of an ulnar mononeuropathy attributable to compression
at the elbow. Jd. Moreover, Dr. Callaghan stressed that “the many flares of [Petitioner’ s] symptoms
over the years” undermined vaccine causation further. Jd. He deemed the recurrence of flare-ups
“clearly” due to existing compression at the right elbow. /d.

Finally, Dr. Callaghan addressed the medical acceptability of timing of onset in this case.
In his view, “an onset of symptoms [two] days after [Petitioner’s] receipt of the flu vaccination,
and intermittent symptoms initially” were “notcompatible” with a vaccination-triggered traumatic
injury at the ulnar nerve. Jd. Instead, such an injury would typically occur almost immediately
following injection, and associated symptoms would be more likely to present as persistent. /d. To
bulwark his opinion, Dr. Callaghan noted that even the medical literature relied upon by Dr.
Tornatore supported a symptom onset within several hours—not two days as the case herein. Je.

Geiringer & Leonard at 705.
Ill. rocedural History

As noted above, this case was initiated in April 2021, a little over three years ago, and
assigned to a different special master. Shortly thereafter, it was reassigned to me in February 2022.
Respondent filed his Rule 4(c) Report contesting entitlement in July 2022. Report, dated July 19,
2022 (ECF No. 25). The parties began the process of obtaining expert reports, with the final report
from Dr. Tornatore filed on November 1, 2023. I proposed a briefing schedule for a ruling on the
record, and the matter is ripe for resolution.

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IV. Parties’ Arguments

Petitioner

Petitioner argues that he has presented sufficient evidence—medical recordsand a medical
opinion from an expert in the field of neurology—as to how the flu vaccine he received on
September 19,2018, caused him to suffer from ulnar neuropathy. Mot. at 27. Prior to his receipt
of the flu vaccine on September 19, 2018, Petitioner had regularly received chiropractic care, and
while many of these visits documented a 1: complaints of bilateral extremity
pain and cervical pain, none of these records referenced the presence of right elbow pain. Jd. at 29.
Petitioner further notes that medical records suggest that he suffered from a congenital
abnormality in the form of an accessory anconeus muscle belly, which Dr. Tornatore opined
meant that ie 30. had an anatomical predisposition to ulnar compression across the
elbow—making him susceptible to a vaccine-caused injury. /d. at 30; Tornatore First Rep. at
13-14. In addition, Petitioner emphasized the significance of evidence of misadministration,
citing medical literature discussmg the mechanisms in which a mis-administered vaccination can
cause an ulnar neuropathy. Mot. at 31; Tornatore First Rep. at 15—17; Geiringer at 705 —06;
Kim at 106. Thus, based upon the filed medical records, Dr. Tornatore’s opinion, and the
associated medical literature, Petitioner maintains that he has provided preponderant
evidence to satisfy his burden under A/then prong one. Mot. at 34.

Next, Petitioner argued that he established a logical sequence of cause and effect thatthe
flu vaccine did cause his ulnar neuropathy. /d. at 34. In so asserting, Petitioner notes several
instances where treating physicians andproviders documented a concern for his receipt of the flu
vaccine as causal of his right ulnar neuropathy. /d.; Ex. 3 at 29; Ex. 2 at 14—16, 110, 125, 128; Ex.
11 at 12. Moreover, Petitioner emphasizes that the treating physicians and providers who did
document the flu vaccine as likely causal were all specialists in the areas of physical medicine and
rehabilitation. Mot. at 36. Petitioner further disagrees with Respondent’s interpretation of Dr.
Cote’s August 2020 diagnosis and assessment of B.T.’s injury, arguing that
Petitioner’s congenital abnormality in the accessory anconeus muscle was asymptomatic prior to
his receipt of the vaccination, and that Dr. Cote noted this abnormality as not providing any
clarification as to what caused or triggered it becoming symptomatic. /d. at 37.

Finally, Petitioner contends that he has established a proximate temporal relationship
between his receipt of the flu vaccine and his nght ulnar neuropathy. Jd. at 38. Here, Petitioner
explains that his medical records provide support for an onset of approximately two days post-
vaccination. Jd.; Ex. 3 at 10—13; Ex. 6 at23; Ex. 4at27—30; Ex. 2 at 126—28. Petitioner also reles
on several items of medical literature cited by Dr. Tornatore to further demonstrate the various
mechanisms by which a vaccine-related ulnar neuropathy canoccur, as well as why a two-day
onset would be medically acceptable. Mot. at 38. While Respondent argues thatthe literature cited
to by Dr. Tornatore indicates “the greatest delay” in onset of symptoms as occurring no more
than several hours after an alleged trigger, Petitioner maintains that J] B.1.’s

medical records 14
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include reports of immediate pain when he received his flu vaccine. /d. at 39; Ex. 2 at 121. Such
immediate pain evidences “direct trauma to the nerve fibers from the needle and the worsening
pain, numbness, tingling, weakness and other symptoms may have resulted from any one of the
mechanisms that result from migration of the injured material.” Mot. at 39.

Respondent

Respondent first argues that Petitioner has not produced reliable evidence that the flu
vaccine can cause ulnar neuropathy. Opp. at 28. He maintains that Dr. Tornatore’s opinions are
not supported by a reputable scientific or medical explanation, but instead are “based on the
assumption that the flu vaccine JM [B.T.] received on September 19, 2018, was
administered improperly.” /d. at29. Moreover, Dr. Tornatore presumes that Petitioner’s alleged
pre-vaccination pseudocyst in his right distal scaphoid and a congenital abnormality of the
accessory anconeus muscle at the right elbow rendered Petitioner susceptible—but without
reliable scientific evidence to substantiate this supposition. /d.; Tornatore First Rep. at 14-15.
Respondent also criticizes Dr. Tornatore’s reliance on the concept of “double crush syndrome”
as an explanation for Petitioner's development of an ulnar neuropathy above the elbow—arguing
that Dr. Tornatore’s reasoning (as well as literature offered in support) is flawed and has “no
specific relevance to the facts presented in this case.” Opp. at 30.

For example, Geiringer discussed two patients who developed mild ulnar neuropathies
following “sidearm” vaccine administration in their upper arms. Yet 1) the vaccines used in the
Geiringer study were different than what Petitioner received; 2) there is no medical evidence to
suggest that Petitioner received the vaccine in question in a “sidearm” position; and 3) the onset
of Petitioner’s symptoms occurred much later (two days) than what was reported for the studied
individuals. Geiringer at 1-2; Opp. at 30-31. A different article, Salanga, discussed an injury to
the proximal portion of the ulnar nerve due to a jet injection. There, a thirty-year-old woman
received the swine flu vaccine, at which time she noted immediate onset of an “electrical” shock
from the site of vaccination. Salanga at 1. Salanga’s authors opined that the women’s injury was a
result of her arm being faultily held “with too much rotation” and due to a lock of protective
underlying subcutaneous tissue whichrendered her ulnar nerve more vulnerable to injury. /d. at 2.
But Salanga is not relevant herein, since Petitioner did not receive the vaccine in question via a jet
injection, and the medical records donot document Petitioner feeling any sort of sudden shock at
the site of vaccination—or that Petitioner developed any sort of palpable mass on his right upper
arm post-vaccination. Opp. at 32.

Otherwise, Respondent maintains, Dr. Tornatore only has provided irrelevant examples
“[ijnstead of providing instances in the medical literature and in his opinions that supported his
[overall] theory,” therefore, failing to produce preponderant evidence that the flu vaccine can cause
ulnar neuropathy. Jd. at 33.

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Next, Respondent argues that Petitioner has failed to demonstrate a logical sequence of
cause and effect that the flu vaccine did cause his ulnar neuropathy. /d. at 35. Respondent
acknowledges that {ij B.T., throughout his clinical course, consistently stated his belief
thathis vaccination was mis-administered. Jd. at 36; see also Ex. 4 at 27 (reporting that the flu
vaccine was given “the wrong way” at 11/7/18 visit with orthopedic surgeon, Dr. Eichten); Ex.
7 at 13 (documenting 11/9/2018 visit with chiropractor, Dr. Weiland, and noting Petitioner’s
complamt that his flu vaccine was placed “into his tricep[s] area instead of his deltoid area”).
Respondent also acknowledges that Petitioner’s statements regarding this mis-administration of
his flu vaccme were maintained in the medical records, which according to the Federal Circuit,
are considered generally “trustworthy” as they “contain information supplied to or by health
professionals to facilitate diagnosis and treatment of medical conditions,” where “accuracy has
an extra premium” Opp. at 36-37 (citing Kirby v. Sec’y of Health & Hum. Servs.,997 F.3d
1378, 1382 (Fed. Cir. 2021 ). However, Respondent contends, Petitioner is not medically
qualified to opine as to whether his flu vaccine, or any vaccine, was mis-administered, and the
medical records containing such representations do not arise from “the firsthand observations of

ae 8.7. ’s] treating physicians. Opp. at 37.

Regarding Dr. Tornatore’s assertion thatthe compression of Petitioner’s ulnarnerve at the
right elbow was asymptomatic prior to his receipt of the flu vaccine, Respondent maintains that
Me BT .’s October 2012 MRI results (six years prior to vaccination) revealed “a large
anconeus epitrochlearis accessory muscle creating a mass effect on the ulnar nerve at the level of
the cub ital tunnel.” /d.; Ex. 2 at 180. Because the clinical indication for this MRI was
“Te]lbow pain,’ Respondent argues that the compression of Petitioner’s ulnar nerve was not
likely “asymptomatic” prior to his receipt of the flu vaccine. Opp. at 38. Rather, as Dr. Callaghan
noted, “almost always” ulnar neuropathy atthe elbow is secondary to compression or extension
of the nerve within the cubital tunnel. /d.; Cambon-Binder at 1—3. Moreover, there was an
absence of any evidence indicating that Petitioner had an ulnar nerve injury above the
elbow—while QM B.T.’s four EMGs “precisely localized” an injury to his right elbow.
Opp. at 38; Ex. 8 at 46; Ex. 2 at 214-19; Ex. 16 at 21, 30. Accordingly, compression at the right
elbow alone was the most likely cause of Petitioner’s injury. Opp. at 41.

Lastly, Respondent argues that Petitioner has failed to offer preponderant evidence of a
medically acceptable timeframe between his receipt of the flu vaccine and the alleged onset of his
ulnar neuropathy. /d. at 43-44. A symptoms onset of two days post-vaccination, as well as
“intermittent symptoms initially,” is “not compatible with [P]etitioner’s receipt of the flu vaccine
causing traumatic injury to his right ulnar nerve.” /d.; Callaghan Rep. at 8. Rather, and as Dr.
Callaghan emphasized, a majority of occurrences for traumatic injury typically take place
immediately following vaccination, and thus “symptoms ‘would be expected to be constant.” /d.

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Vv. 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”—.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)(1)(); 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).®
There is no Table claim for an ulnar neuropathy injury, and therefore Petitioner can only advance
a causation-in-fact 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.” Moberiy, 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 and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1) a
medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause
and effect showing that the vaccination was the reason for the injury; and (3) a showing of
proximate temporal relationship between vaccination and injury.”

° Decisions of special masters (some of which! reference in this ruling) constitute persuasive butnot binding authority.
Hanlon v. Sec’y of Health & Hum. Servs.,40 Fed, CL. 625, 630(1998). By contrast, Federal Circuit rulings conceming
legal issues are binding on special masters. Guillory v. Sec 'y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003),
aff'd 104F. App’x. 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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Each Althen prong 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.” Jd. at 549.

Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec 'y of Health & 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 A/then 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.” Jd. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed.
Cl. at 245 (“[p]lausibility ... in many cases may be enough to satisfy Althen prong one” (emphasis
in original)).

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 Kalajdzic v. Sec’y of Health &
Hum. Servs., No. 17-792V, 2022 WL 2678877 (Fed. Cl. Spec. Mstr. June 17, 2022), mot. for
review den ‘d, Dkt. No. 79 (Fed. Cl. Oct. 27, 2022), aff'd No. 2023-1321, 2024 WL 3064398, at
*2 (Fed. Cir. June 20, 2024) (arguments “for a less than preponderance standard” deemed “plamly
inconsistent with our precedent” (citing Moberly, 592 F.3d at 1322)); Boatmon v. Sec’y of Health
& Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also Howard v. Sec'y of Health & Hum.
Servs., 2023 WL 4117370, at *4 (Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance
for nearly four decades”), aff'd, 2024 WL 2873301 (Fed. Cir. June 7, 2024) (unpublished). And
petitioners always have the ultimate burden of establishing their overal/ Vaccine Act claim with
preponderant evidence. 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

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at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & 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, orsummary shall notbe bindingon the special master orcourt’); 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), affd,
698 F.3d 1355 (Fed. Cir. 2012); Veryzerv. 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 den ’d, 100 Fed.
Cl. 344, 356 (2011), aff'd without opinion, 475 F. Appx. 765 (Fed. Cir. 2012),

The third A/then prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. A/then, 418 F.3d at 1281. That term has been equated to the
phrase ““medically-acceptable temporal relationship.” /d. 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). /d. at 1352; Shapiro v. Sec’y of Health & Hum.
Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), affd
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. den’d (Fed. Cl. Dec. 3,
2013), aff'd, 773 F.3d 1239 (Fed. Cir. 2014).

B. Standard for Significant Aggravation Claim

Where a petitioner alleges significant aggravation of a preexisting condition, the A/then
test is expanded, and the petitioner has additional evidentiary burdens to satisfy. Loving v. Sec'y
of Health & Hum. Servs., 86 Fed. Cl. 135, 144 (2009). In Loving, the Court of Federal Claims

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combined the Althen test with the test from Whitecotton v. Sec’y of Health & Hum. Servs., 81 F.3d
1099, 1107 (Fed. Cir. 1996), which related to on-Table significant aggravation cases. The resultant
“significant aggravation” test has six counterparts, which require establishing:

(1) The person’s condition prior to administration of the vaccine, (2) the
person’s current condition (or the condition following the vaccination if that is
also pertinent), (3) whether the person’s current condition constitutes a
‘significant aggravation’ of the person’s condition prior to vaccination, (4) a
medical theory causally connecting such a significantly worsened condition to
the vaccination, (5) a logical sequence of cause and effect showing that the
vaccination was the reason for the significant aggravation, and (6) a showing of
a proximate temporal relationship between the vaccination and the significant
aggravation.

Loving, 86 Fed. Cl. at 144; seealso W.C., 704 F.3d at 1357 (holding that “the Loving case provides
the correct framework for evaluating off-table significant aggravation claims’). In effect, the last
three prongs of the Loving test correspond to the three Althen prongs.

In Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072 (Fed. Cir. 2020), the Federal
Circuit further elaborated on the Loving framework. Under Prong (3) of the Loving test, the
Petitioner need not demonstrate an expected outcome, but merely that her current-post vaccination
condition was worse than pre-vaccination. Sharpe, 964 F.3d at 1081. And a claimant may make
outa prima facie case of significant aggravation overall without eliminating a preexisting condition
as the potential cause of her significantly aggravated injury (although the Circuit’s recasting of the
significant aggravation standard still permits Respondent to attempt to establish a “factor
unrelated” cause, where a petitioner’s showing is enough to make out a prima facie case and
thereby shift the burden of proof to Respondent). /d. at 1083.

C. 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 1 1(c)(2). The special master is required
to consider “all [ ] relevant medical and scientific evidence contained in the record,” including
“any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained
in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability,
injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are
contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special
master is then required to weigh the evidence presented, including contemporaneous medical
records and testimony. See Burns v. Sec'y of Health & Hum. Servs.,3 F.3d 415,417 (Fed. Cir.
1993) (determining that 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

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surrounding the events in question that was given ata later date, provided that such determination
is evidenced by a rational determination).

As noted by the Federal Circuit, “[mJedical records, in general, warrant consideration as
trustworthy evidence.” 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, Rickett v. Sec'y of Health & Hum.
Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked
propositions explains why such records deserve some weight: (i) sick people visit medical
professionals; (ii) sick people attempt to honestly report their health problems to those
professionals; and (iii) medical professionals record whatthey are told orobserve 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), affd, 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 often 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 Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), affd per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary

weight.”’)).

However, the Federal Circuit has also noted that there is no formal “presumption” that
records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health
& Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which
compelling oral or written testimony (provided in the form of an affidavit or declaration) 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 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

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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. La Londe v. Sec'y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203—04 (2013), affd, 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.

D. 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 Pharm., Inc., 509
U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs.,617 F.3d 1328, 1339 (Fed.
Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).
Under Daubert, the 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).

In the Vaccine Program the Daubert factors play a slightly differentrole than they do when
applied in other federal judicial settings, like the district courts. Typically, Daubert factors are
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are

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used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &
Hum. Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). 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. 146 (1997)); see also Isaac v. Sec'y of Health & Hum.
Servs., No. 08-601 V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for
review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo,
617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on
a particular expert's credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325-26
(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations’);
see also Porter v. Sec'y of Health & 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’).

E. Consideration of Medical Literature

Both parties filed medical and scientific literature in this case, but not all such items factor
into the outcome of this decision. While I have reviewed all the medical literature submitted, I
discuss only those articles that are most relevant to my determination and/or are central to
Petitioner’s case—just as I have not exhaustively discussed every individual medical record filed.
Moriarty v. Sec’y of Health & Hum. Servs., No. 2015-5072, 2016 WL 1358616, at *5 (Fed. Cir.
Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record
evidence even though he does not explicitly reference such evidence in his decision”) (citation
omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 ¥F. App’x 875, 884 (Fed. Cir.
2013) (“[flinding certain information not relevant does not lead to—and likely undermines—the
conclusion that it was not considered”).

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E Resolution of Claim on Written Record

I am resolving Petitioner’s claim on the filed record. The Vaccine Act and Rules not only
contemplate but encourage special masters to decide petitions on the papers where (in the exercise of
their discretion) they conclude that doing so will properly and fairly resolve the case. Section
12(d)(2)(D); Vaccine Rule 8(d). The determination to rule on the record in lieu of hearing has been
affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir.
2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21
n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided case
on the papers in lieu of hearing and that decision was upheld). I am simply not required to hold a
hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health & Hum.
Servs., 38 Fed. Cl. 397, 402-03 (1997) (determining that special master acted within his discretion in
denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health & Hum. Servs., No. 90-
882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).

ANALYSIS

The parties agree on the diagnosis of an ulnarneuropathy to explain Petitioner’s symptoms,
See, e.g., Callaghan Rep. at 7. They therefore only dispute the cause of that injury—and
specifically its relationship to the demonstrated, preexisting accessory anconeus muscle condition
that Petitioner unquestionably possessed.

Although claimants have in the past sought compensation for alleged vaccine-caused ulnar
neuropathies, there are very few written reasoned decisions addressing causation in the context
But at least one petitioner successfully established entitlement under A/then for this kind of injury.
See Salazar v. Sec’y of Health & Hum. Servs., No. 15-817V, 2021 WL 319393 (Fed. Cl. Spec.
Mstr. Jan. 5, 2021) (finding that Petitioner established by preponderant evidence that she sustained
a right ulnar neuropathy caused by her October 2, 2014, receipt of the flu vaccine). That decision
provides good guidance herein—but it also underscores why entitlement is not appropriate in this
matter.

In Salazar, a petitioner with no relevant prior history of injury (unlike the present case)
received a right-sided vaccination. She experienced an immediate reaction and pain, evidence of
which was concretely memorialized in the relevant medical records. Salazar, 2021 WL 319393, at
*5. Relying on a theory comparable to what is offered herein, the Sa/azar petitioner maintained
that a pre-existing asymptomatic condition (cubital tunnel syndrome) had been “unmasked” by the
vaccine’s misadministration, resulting in nerve injury. /d. at *9—11. Importantly, the petitioner
submitted direct proof that she was asked to bend her arm 90 degrees at the elbow, place her hand
on her hip, and flex forward, at the time of vaccine administration. Id. at *5. Id. The special master
deemed all three Althen prongs met. Id. at *18—22.

Salazar provides helpful guidance, but is distinguishable from the present case in several
important regards. For example, the record in this case clearly establishes that Petitioner had a

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documented history of right limb pain and issues. Thus, as late as the same month as vaccination,
Petitioner was receiving treatment for these complaints. See Ex. 6 at 25—27 (discussing visit to
SSCRS with Dr. Streets on 9/7/2018, and documenting pain in Petitioner’s right shoulder in which
chiropractic manipulation, laser therapy, and release techniques and soft tissue mobilization were
provided).

In addition, the Salazar petitioner was easily able to substantiate independent medical
record evidence that the vaccine had been mis-administered. Salazar, 2021 WL 319393, at *18.
Here, by contrast, although Petitioner may have reported misadministration, these contentions are
not well-substantiated even if contemporaneous records contain evidence of Petitioner’s
representations. See, e.g., Exs. 2 at 126 and 4 at 27. Salazar also involved documented immediate
pain—again, somewhat unlike this case, where Petitioner (an individual who readily sought
treatment for comparable issues) had at least two medical treater visits in the immediate post-
vaccination timeframe, but without complaining of any vaccine administration-related sequela.
See Exs. 2 at 247 and 6 at 24. Finally— and perhaps most importantly—Petitioner herein clearly
possessed a preexisting condition at his elbow that even Petitioner’s expert agrees played a role in
his injury (as opposed to a subclinical condition that was unmasked by vaccination).

Althen Analysis

Taking the above into account, I cannot find entitlement established under Althen. Salazar
certainly supports the conclusion that a misadministered flu vaccine “can cause” an ulnar
neuropathy, whether or not due to the downstream impact of vaccination or directly as a result—
and since Petitioner’s theory seems consistent with what was offered in that case, I can find the
first prong to have been preponderantly satisfied. But a claimant must satisfy all three prongs to
obtain entitlement, and he cannot do so on this record. Dobrydnev v. Sec’y of Health & Hum.
Servs., 566 Fed. Appx. 976, 980 (Fed. Cir. 2014).

First, Petitioner cannot demonstrate that the flu vaccine “did cause” his ulnarneuropathy—
i.e., that it was likely a substantial factor in his injury. Here, the preexisting muscle injury (first
observed in 2012) is the obstacle. Ex. 2 at 180. Dr. Callaghan (who clearly possesses more first-
hand expertise in evaluating this specific sort of neuropathy than Dr. Tornatore) provided a
persuasive reading of the medical record, and in so doing demonstrated a lack of evidence that the
initial vaccination likely produced the kind of injury that could impact the preexisting issue,
consistent with the theory Dr. Tornatore proposed. Callaghan Rep. at 8. As a result, although there
is some record evidence suggesting that several of Mr. Tacher’s treating physicians considered his
receiptof the flu vaccine to have caused his right ulnar neuropathy, the medical records themselves
simply do not establish the presence of a separate, above-the-elbow injury due to a mis-
administered vaccine. Indeed, and as pointed out in Dr. Callaghan’s report, Petitioner underwent
five EMG studies—four of which “precisely localized” Mr. Tacher’s injury at the elbow, not
above. See Ex. 2 at 134; Ex. 3 at 14, 21; Ex. 16 at 30. AndI do not give great weight to Petitioner’s
subjective contentions that the vaccination was itself injurious—especially since he did not

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immediately report this to be the case (and this matter involves an individual who regularly sought
treatment for any limb-related concerns he had).

It is thus instead more likely that Petitioner’s post-vaccination elbow symptoms related
solely to his preexisting elbow-specific muscle problem. While it is no doubt the case that a
Vaccine Act claimant need not disprove an alternative explanation for an injury, he must address
evidence in the record undermining the conclusion that the vaccine played a substantial role in his
injury. Exum v. Sec’y of Health & Hum. Servs., No. 21-1513V,2024 WL 4291116, at *14 (Fed.
Cl. Spec. Mstr. Aug. 29, 2024) (citing Strone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373,
1380 (Fed. Cir. 2012) (“[t]he special master is entitled to consider the record as a whole... and
no evidence should be embargoed from the special master’s consideration simply because itis also
relevant to another inquiry under the statute.”)). That has not been successfully done here. Even if
Dr. Tornatore’s “double crush scenario” theory has some scientific reliability, I cannot conclude
on this record that the vaccination constituted a second intervening instance of a “crush” leading
to exacerbation of Petitioner’s preexisting condition.

The timing of Petitioner’s injury under A/then prong three has also not been shown to be
medically acceptable. Case reports relied upon by Dr. Tornatore to support his causation theory
involved instances of more obvious and immediate vaccine-related pain (i.e., within thirty minutes
to several hours), whereas Mr. Tacher’s alleged injury most likely occurred approximately forty-
eight hours post-vaccination, in Dr. Tornatore’s estimation. First Tornatore Rep. at 17; See
Geiringer at 705. But Dr. Callaghan persuasively established that a traumatic injury due to
vaccination sufficient to result in a downstream neuropathy of the kind asserted herein would
typically occur immediately following receipt of a vaccine, and that associated symptoms would
also be expected to mirror that timeline.

Loving Analysis

My determination is the same under a Loving analysis—which could arguably be applied
herein, based ona construction of the claim in which Petitioner’s preexisting accessory anconeous
muscle injury is alleged to have been worsened due to vaccination. First, the record does not fully
support the conclusion that Petitioner’s condition actually worsened post-vaccination. The third
Loving prong requires an examination of Petitioner’s pre- and post-vaccination conditions, and a
determination of whether Petitioner’s current condition constitutes a “significant aggravation” of
his pre-vaccination condition. Loving, 86 Fed. Cl. at 144. Under the Vaccine Act, a “significant
aggravation” is “any change for the worse in a preexisting condition which results in markedly
greater disability, pain, or illness accompanied by substantial deterioration of health.” Section
33(4).

Medical records filed herein, however, clearly demonstrate Petitioner’s frequent visits
regarding bilateral shoulder and right limb issues to multiple treating physicians over the span of
several years prior to receiving the flu vaccine—and many more thereafter. Petitioner regularly

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complained of limb-related pain andneuropathic issues, pre- and post-vaccination, and the tempo
of these complaints was consistent throughout (even though he identified the vagginat

an inflection point). Thus, on September 21, 2018 (two days sadist
B.T. saw Dr. Streets at SSCRS reporting “constant, throbbing, non-radiating pain in his left and
right shoulders” but noting further that he had no significant changes in his health history since
his last visit on September 7, 2018, and with respect to his “overall health symptoms.” Ex. 6 at24.
And Dr. Streets employed the same treatment methods (i.e., chiropractic manipulation, laser
therapy, and release technique and instrument assisted soft tissue mobilization) from prior
appointments to address Petitioner’s current concerns. Id.

Similarly, B.1. underwentEMGINCS testing on October 2, 2018, during a
visit with Dr. Jaffe at JSM—the results of which revealed only a mild to moderate right ulnar
neuropathy. Ex. 3 at 21. As noted in Dr. Callaghan’s report, subsequent EMG/NCS testing
several years later, on April 7, 2021, also demonstrated a mild right ulnar neuropathy at the
elbow but with noted improvement from previous testing done on August 10, 2020. Callaghan
Rep. at 6; Ex. 16 at 30 (documenting EMG/NCS results revealing a moderate to severe right
ulnar neuropathy at the elbow); see also Ex. 2 at 86 (documenting visit with Dr. Reis on
September 5, 2019, which noted Petitioner’s right ulnar mononeuropathy was resolving, with
only some tenderness of the right elbow) (emphasis added). These intermittent flare ups, as
persuasively explained by Dr. Callaghan, reflect the effects of the existing compression at his
right elbow, but do not largely support the conclusion that overall Petitioner was in fact
suffering from a worsened condition post-vaccination.

Of course, as a general matter it is not especially difficult for a claimant to prove the first
three Loving prongs, given the Circuit’s treatment of them in Sharpe. And therefore, the mere fact
that Petitioner’s pre-vaccinationaccessory anconeus muscle injury was not givinghim trouble, but
clearly did post-vaccination, might be sufficient to meetthis prong, despite my overall view of the
record. But the same flaws discussed above with respect to Althen prongs two and three would
also apply to their Loving counterparts (Loving prongs five and six). For even if Salazar’s
reasoningsupports the determination that a vaccine that was improperly administered could(via
Dr. Tornatore’s embrace ofthe double crush theory) worsen his elbow-associated pre-vaccination
muscle condition, it has not been preponderantly demonstrated that in this case the vaccine did
worsen it, or that this occurred in a medically acceptable timeframe. Petitioner’s overall
presentation, pre-existing health issues, non-specific nature of early complaints, and the lack of
preponderant evidence of a first “hit” caused by the vaccine all undermine the conclusion that his
subsequent ulnar neuropathy was worsened by vaccination.

CONCLUSION

Claimants must carry their burden of proof. Because Petitioner cannot show by
preponderant evidence that his injury was caused by the vaccination preceding it, I deny
entitlement.

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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.’

IT ISSO ORDERED.

/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master

7 Pursuant to Vaccine Rule | 1(a), the parties may expedite entry of judgment if (jointly or separately) they file notices
renouncing their right to seek review.

28

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10754475. Public record. Not legal advice.