T. v. Secretary of Health and Human Services

]n t{Je U4niteb �tates Qtourt of jfeberal ctlai1ns

OFFICE OF SPECIAL MASTERS

No.21-1213V

*************************

*

B.T., * Chief Special Master Corcoran

*

Petitioner, * Filed: November 8, 2024

*

v. *

*

SECRETARY OF HEALTH AND *

HUMAN SERVICES, *

*

Respondent *

*

********************** ***

Jessica A. Wallace, Siri & Glimstad, LLP, Aventura, FL, for Petitioner.

Benjamin P. Warder, U.S. Department of Justice, Washington, DC, for Respondent

ENTITLEMENT DECISION 1

On April 15, 2021, B.T. filed a petition for compensation under the

National Vaccine Injury Compensation Program (the "Vaccine Program"). 2 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 l ,

3. The parties have submitted expert reports and offered briefs so that the 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) ('4Opp."); Petitioner's

Reply, dated May 29, 2024(ECF No. 45). For the reasons stated in more detail below, l deny

entitlement

1

Under Vaccine Rule l 8(b),eachparty bas fourteen. (14 )days within whi:b to requestredaction "ofany infOUDatilo

furnished by that party. (1) that is a trade SECret or commeicill or fmancill il substance atd is privileged er

confidential; er (2) that includes mcdral fits or simihr fies, the d isclosure of which wouli const:itutea clearly

unwammted invasionofprivacy ."Vaa::ineRule l 8(b). Othenvise, thewhole Decision willbeavaihbletothepubi:

in its present form. Id.

2

TheVaccine Prognnncompri;cs Part2 of theNatiooal ChildhoodVaa::ine Injury Act of 1986, Pub.L. :No. 99.«iO,

100 S tat.3758,codilied asamcoded at42 U.S.C. §§300a•l Othrough34 (2012)[hereioafter"Vaa::ineAct" or"lhe

Act"].Indivilual seaion references hereafter wilbe to§ 300aa of the Act (but v..Domit that statutory prefix).

I. Factual Background

Pre- Vaccination Evidence oflimb and Shoulder Issues

Petitioner's pre-vaccination medical history 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,seeing some of the same treaters who providedassistanceaftervaccinaticn.

(His history also reveals a propensity to seek treatment regularly, and the advice ofa large nwnber

of different providers).

For example, six years before the vaccination at issue (in October 2012), a magnetic

resonance imaging scan ("MRI") of- B.T.'s right elbow revealed the presence of

a lar� anconeus epitrochlearis accessory muscle, creating a mass effect on the ulnar nerve at the

level of the cubital tunnel, and resulting in elbow pain. Ex. 2 .t 180. Then, in December 2016,

Petitioner had another MRI-this time of his right hand, occasioned by an accident to it thathad

caused pain. Ex. 17 at 43-16. This second MRI revealed a finger bone contusion plus a likely

related muscle sprain. Id. Mr. Tac her underwent a third MRI in June 2017 of his right shoulder

(and also due to reported pain), and which revealed tendinopathy. Id. at 39.

In addition, during the spring and early summer of 2018, - 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 spine described as intermittent aching discomfort that radiates to the head and

radiates to the right shoulder." Id.at 31. Dr. Street's impressions included cervical

dysfunction, impingement syndrome of the right shoulder, cervicalgia, and right-hand pain. Id.

Petitioner obtained additional chiropractic treatment at SSCRS that summer, complaining of

right shoulder pain, left-srle cervical spine discomfort, and radiating pain from his

temporomandibular joint ("TMJ") that radiated to his head. Id. at 25-29, 31.

That same summer, - B.T. also visited a different chiropractor, Scott Weiland,

D. C., at Gulf Coast Spine & Sport ("GCSS") fa: TMJ and persistent right shoulder pain. Ex. 7 at

3-6. Testing revealed normal strength but pain on some movement with tenderness to

palpitation ("TIP") of certain right shoulder muscles. Id. at 4, 5. Dr. Weiland provided

chiropractic physw::al adjustments but also proposedhome exercises. Id. at 5-6. His pain

remained over the summer, however.Id. at 7-9, 10-12. He returned 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 2 0 I 8 Vaccination

-8.T. (then 44-years old) received the flu vaccine in his right deltoid on

September 19, 2018, at a Cape Coral, Florida CVS Pharmacy. Ex. l at 2. Two days later

(September 21, 2018), Petitioner visited Dr. Streets at SSCRS complaining of constant,bilateral

shoulder pain .t

2

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. Id. Dr. Streets

treated Petitioner with chiropractic manipulation and laser therapy, among other things. Id.

One-week post-vaccination, on September 27, 2018, - 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 24 7. 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. Id. 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. - 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. Id.

at 10. Petitioner did also acknowledge his prior PT and hand-related treatments. Id. 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 B.T. was experiencing "worsening nerve dysfunction sequelae"

and possibly "Vaccine[-]induced [Guillain-Barre syndrome]." Ex. 3 at 11, 12 (noting a

diagnosis of "nerve dysfunction, right arm"). He prescribed gabapentin, PT, and home

treatments, including exercises. Id. 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. Id. Petitioner saw that specialist-Dr. David Eichten of Joint Implant Surgeons of

Florida ("flSF")-on November 7, 2018. Ex. 4 at 27-30.- 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. Id. at 27. Dr. Eich ten 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, - 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 1o purported misadministration. Id. at 126. And it was

claimed that the EMG performed by Dr. Jaffe at an earlier October visit demonstrated ulnar

neuropathy. Id. 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. Id. 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

misadministration, with paresthesias beginning two days after vaccination and worsening pain

over time. Ex. 7 at 13-15.

On November 14, 2018, - B.T. returned to GCSS for a visit with Dr.

Weiland for treatment of persistent nerve pain in his right arm that he associated with

his September vaccination. Ex. 7 at 16 -17. The next day, he had an appointment at JISF with

orthopedic sur� 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 examinatioo, Petitioner's Tinel's sign 3 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. Id. at 12-13. Dr. Sagini opined that- 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, • - 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, - 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 concerns, 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). Id. 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 - 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

or teadoa barsitis. E:ic 8 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 thed�tal endofalimb whenpercussionis madeoverthesie of

a di vided nerve. It indicates a pa rtial lesion or the begfuning regeneration of the nerve." Tin el Sign, Dorla nd's

Medral Dictiona ry Online,https://www .dorla ndsonline.com/dorla nd/de1mition ?id=l 06510 (last visited Nov .

8,2024).

findings seemed consistent with prior trauma of some kind (but also showed effusion associated

with capsulitis/capsulosynovitis or TFCC thinning). Id. 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

- B.T. thereafter, on May 9, 2019. Id. 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). Id.

That same May,_ 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 prescribing additional medication and

pain injections. Id. 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 neuropafuy was noted as well). Ex. 13 at 5-8. An MRI performed that month of

Petitioner's cervical spine revealed a number of problems, including bulging discs and stenosis. Id.

at 12.-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 4 7. Issues with back and shoulder pain also

led-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." Id. at 83-84.

By the fal� Petitioner continued to complain of left shoulder and right elbow pain, and

he received steroid or platelet-rich plasma injections in 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.•

- 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. Id. at 57-58. Dr.

Sagini also proposed further consultation with a rheumatologist. Id. 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, right distal biceps tendinitis,

left AC joint osteoarthritis, and left subacromial impingement with rotator cuff tendinitis. Id. at

77, 78. It was proposed that -B.T. consider more invasive treatment, such as

ulnar nerve decompression with transposition surgery. Id. That same month, Petitioner

obtained more pain management treatment at PMCN, and his ulnar nerve injury was

addressed, as well as many 5

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 ha nd specialist, Dr. Stephen

Helgemo,attheFlorida HandCenter("FHC') in mid-December 2019. Ex. 10 at3-5. 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. ld. at 5.

2020 featured the same efforts by- B.T. to obtain treatment (both for the

injury at issue as well as other conditions) from a wide variety of medical providers. For example,

Petitionerretumed to Dr. Helgemo in January 2020, and it was now recommended that he

undergo decompression surgery. Ex. 10 at6-7. He

subsequently receivedacupuncturetreatmen tthatwinter 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 latera l wrist instability, and thinning of

the TFCC. Id. at 61. It was propose d that Petitioner undergo nerve hydrodissection 4 of the right

radial nerve and right ulnar nerve, along with a prolotherapy 5 injection of the right lateral wrist.

Id. Both procedures were performed at IRM on March 23, 2020. Id. 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-side d lateral wrist instability, and thinning of the right-side TFCC. Ex.

8 at35-38. - B.T. was instructed to focus on a home exercise program. Id. He returned

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. Id. at 2-5. Later that

month, Dr. Klisiewicz again saw - B.T., and performed elbow laser therapy on his

right ulnar nerve. Id. at 11-13. Dr. Klisiewicz also that month administered PRP prolotherapy and

perineural injecoons 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 ulnar nerve decompression surgery was discussed.

4

"Nerve hydrodissection" is defined as "a technique used when treatingneive entrapments, [and] involved the

injection ofan anesthetic, saline, or5% dextrose n waterto separate thenerve from the surrounding tissue, fascn, or

adjacent structures." NIH National Library of Medicile, Ultrasound-Guided Nerve Hydrodissectionfor Pain

Management: Rationale. Methods, Current Literature, and Theoretical Mechanisms,

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC74 l4936/ (last visited Nov. 8, 2024).

s "Prolo therapy" is defmed as "an injection-basedcomplementary anda ltemativemedical (C AM)thera pyfor chroni:

musculoskeletal pain." NIH National Library of Medicine, Prolotherapy in Prima,y Care Practice,

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC283 l 229/ (last visited Nov. 8, 2024).

6

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. Id. 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. Id. Additional EMG testing

of B.T.'s right upper extremity performed by Dr. Jaffe in August 2020 revealed

moderater 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 - B.T. had previously undergone EMGs confirming a

diagnosis of compressive ulnar neuropathy at the elbow, and his exam revealed right-hand sensory

deficiencies. Id. He deemed Petitioner's ulnar neuropathy to be likely "secondary to a congenital

abnormality in the form of an accessory anconeus muscle belly." Id. at 10. But Dr. Cote did

recommend a surgical procedure-''an ulnar nerve neurolysis and decompression at the

elbow"-to which-B.T. expressed a willingness to undergo. Id.

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 - 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 right arm. Id. 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- B.T. received in 2021 (which cease

that spring) underscore his continued efforts to seek relief for the panoply of shoulder/

amvhand 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

radial neuropathy, brachia! plexopathy, or carpal tunnel syndrome); Ex. 18 at 15-18 (noting

follow-up examination performed by Dr. Ouellette in April 2021 revealed full range of motion and

strength, plus resolution of compartment syndrome, and other than some mild wrist discomfort,

- B.T. reported decrease in numbness and overall improvement).

II. Expert Reports

A. Petitioner's Expert -Dr. Carlo Tornatore

Dr. Tornatore, 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) ("Tornatore First Rep."); Report, dated Aug. 26, 2023 (ECF No. 36-1)

("Tornatore Supp. Rep.").

Dr. Tornatore graduated from Cornell 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) ("Tornatore 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

Tornatore CV 1-2. Dr. Tornatore also completed a fellowship in Molecular Virology at the

National Institute of Health in Bethesda, Maryland. Id. at 2. He has published multiple articles

addressing cell biology and pathology of demyelinating disorders. Id. 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. Tornatore First Rep. at 1. Currently, Dr.

Tornatore follows approximately 1 24 patients with inflammatory neuropathies, myopathies and

disorders of the neuromuscular junction. Tornatore CV at 3. Over the course of his career, he has

been involved with the care of approximately thousands of patients who present with

mononeuropathies and polyneuropathies. Id.

First Report

Dr. Tornatore 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 Tornatore First Rep. at 2-14. Dr. Tornatore 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 vaccinationin the vicinity of the right ulnar nerve."ld. at 14. He further

explained that Petitioner had a pseudocyst of the distal scaphoid as a result of a pre-vaccination

wrist injury, in addition to a congenital abnormality of the accessoryanconeus muscle at the elbow,

which according to Dr. Tornatore, ''may have made- [B.T.] more susceptible to

an ulnar neuropathy due to a mis-administered vaccination." Id. at 14-15.

8

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., Upp er 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, Injection-Related Ulnar Neuropathy, 10 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 mechanisms that 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 oo

surrounding tissues, leading to fibrosis or small vessel thrombosis, with a delayed secondary effect

on nerve." Kim at l 03. As Dr. Tornatore pointed out, both patients discussed in Kim had been

injected on the left by a right-handed nurse, and thus "[c ]ombined with a 'sidearm' delivery, [such]

positioning likely facilitated missing the deltoid completely, skirting medial to the triceps long

head, and entering the medial-lyingneurovascular bundle." Tornatore First Rep. at 17; Kim at 106.

Dr. Tornatore also proposed that Kim provided additional support for B.T.'s

onset of symptoms beginning forty-eight hours post-vaccination, since the "[m]igration 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." Id.

Dr. Tornatore further opined that if Petitioner were suffering from a congenital abnormality

of the accessory anconeus muscle atthe elbow, "then the migration of the injected material/vaccine

and[/]or 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 result in an ulnarneuropathy

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." Id. Based on the medical records and facts herein,

Dr. Tornatore opined that 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." Id.

9

Supp lemental 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 from the misplaced vaccination,"

and this second injury likely exacerbated the existing injury at the elbow. Id. at 4. Double crush

syndrome can be defined as "the coexistence of dual compressive lesions along the course of a

nerve," and can be further demonstrated via an animal model described in an item ofliterature. /d.

at 5; K. Nemoto et al., An Experimental Study on the "Double Crush" HypothesiY, 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 was reduced 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 that the damage of the dual compression exceeds the

expected additive damage caused by each isolated compression." Tornatore Supp. Rep. at 5.

Moreover, Dr. Tornatore maintained that N emoto supports the notion that"[compressioo]

can result in permanent symptomatic injury to the nerve distal to the proximal point ofinjury long

after the proximal injury has resolved." Tornatore 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 Afechanisms Underlying Dual Nerve Diwrders, 16 Manual Therapy 557

(2011), filed as Ex. 20, Tab 5 (ECFNo. 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 futther

elaboration of the double crush concept, Dr. Callaghan also cited, but did not discuss in detail, four

cases discussing ulnar double crush. Tornatore Supp.Rep. at5; M. Akyuzetal.,Electromyography

and Ultrasonography in the Diagnosis of a Rare Double-Crnsh Ulnar Nerve Injury, 92 Arch Phys

Med Rehabil 1914(2011), filed as Ex. 20, Tab 6(ECFNo. 36-7); B. Corder et al.,Subacute Ulnar

Nerve Compression Neuropathy following Hand Crush lnjwy in the Setting of lntracanal

Accessory Abductor Digiti Afinimi: 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 principlesthatexist to support

a double crush scenario as explanatory herein of Petitioner's injury. Tornatore Supp. Rep. at 6.

As he detailed, ''l. .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 ulnar nerve dysfunction at the

elbow, became evident due to the disruption of the axoplasmic flow proximally from the

vaccine site." Tornatore Supp. Rep. at 6.

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 revealed the 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. Id. 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. Id. He further addressedDr. Callaghan's asserti:m

that an injection in the deltoid, and/or other areas of the upper arm would be incapable of causing

an ulnar nerve injury elsewhere. Id. Dr. Tornatore argued that not only had Dr. Callaghan

"ignore[ d] the fact that- 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." Id.; see

also Geirin� at 705 (Fig. 1), 706 (Figs. 2, 3).

In response to Dr. Callaghan's comment that "[v]accination 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.'' Id.

Dr. Tornatore then brieflyaddressedDr. Callaghan's criticisms ofreferenced case reports.

Tornatore Supp. Rep. at 8. Dr. Callaghan argued that the case reports documenting traumatic injwy

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 compressionas a result of the accessory anconeus

muscle injury (i.e., the first incident in a double crush scenario) could occur. Id. He further opined

that such a scenario was illustrated in Nemoto. Id. 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 first report do-illustrate a vaccine/injection-related ulnar injury from misplaced injectbns.

Tornatore Supp. Rep. at 9.

11

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 (ECFNo. 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. Id. 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 andNeurology, respectively.

Callaghan CV at 1. He also completed fellowships inNeuromuscular and the Center for Healthcare

Research and Transformation Policy at the University of Michigan. Id. Dr. Callaghan is board

certified by the American Board of Psychiatry and the American Board of Electrodiagnosti.c

Medicine. Id. He has published more than 130 articles and medical book chapters, with a majori1y

focusing on neuropathy, and including the appropriate diagnostic evaluation and treatment of

neuropathy. Id. at 14-24. Currently, Dr. Callaghan serves as an Associate Professor ofNeurology

at the University of Michigan. Id.; 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. Id. at 7. Of note, Dr. Callaghan emphasized that Petitioner

underwent five EMG/NCS studies, three of which revealed "clear localization of the elbow." Id.;

Ex. 2 at 214; Ex. 3 at 14, 21. WhilePetitioner'sMRJ of his right elbow did not reveal 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 susceptJ.ble

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, I 07 Orthopaedics & Traumatology: Surgery and Research

1 (2021), filed as Ex. A, Tabl (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 fuat

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

12

criticized Dr. Tomatore's opinion that the flu vaccine could have aggravated

B.Ts "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." Id. at 8. All case reports offered for this proposition involved specific injuries occurring

at places on

the arm well above the elbow. Id.; 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. Id.; Kim at l 03, 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 "mis1eading" for Dr. Tornatore to c1aim contemporaneous

treaters supported causation, noting that Petitioner's orthopedist, hand specialist physician, and

neurosurgeon all embraced the diagnosis of an ulnar mononeuropathy attributable to compression

at the elbow. Id. Moreover, Dr. Callaghan stressed that "the many flares of(Petitioner' s] symptoms

over the years" undermined vaccine causation further. Id. He deemed the recurrence of flarn-ups

"clearly" due to existing compression at the right elbow. Id.

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 "not compatible" with a vaccination-triggered traumatic

injury at the ulnar nerve. Id. Instead, such an injury would typically occur almost immediately

following injection, and associated symptoms would be more likely to present as persistent. Id. 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. Id.

Geirin�r & Leonard at 705.

III. -Procedural 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.

13

IV. Parties' Arguments

Petitioner

Petitioner argues that he has presented sufficient evidence-medical records and a medical

opinion from an expert in the field of neurology-as to how the flu vaccine he received on

September19,2018, caused him to suffer from ulnar neuropathy. Mot at27 . 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 �.T.'s complaints of bilateral extremity

pain and cervical pain, none of these records referenced the presence ofright elbow pain. Id. at29.

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 -B.T. had an anatomical predisposition to ulnar compression across the

elbow-making him susceptible to a vaccine-caused injury. Id. at 30; Tornatore First Rep. at

13-14. In addition, Petitioner emphasized the significance of evidence of misadministration,

citing medical literature discussing 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

evidenceto satisfy his burden under A/then prong one. Mot at 34.

Next, Petitioner argued that he established a logical sequence of cause and effect that the

flu vaccine did cause his ulnar neuropathy. Id. 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 ofhis right ulnar neuropathy. Id.; Ex. 3 at29; Ex.2 at14-16, 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. Id. at 37 .

Finally, Petitioner contends that he has established a proximate temporal relationship

between his receipt of the flu vaccine and his right ulnar neuropath y. Id. at 3 8. Here, Petitioner

explains that his medical records provide support for an onset of approximately two days post­

vaccination. Id.; Ex. 3 at10-13; Ex. 6 at23; Ex.4 at27-30; Ex. 2 at126-28. Petitioner also relies

on several items of medical literature cited by Dr. Tornatore to further demonstrate the various

mechanisms by which a vaccine-related ulnar neuropathy can occur, as well as why a two-day

onset would be medically acceptable. Mot. at 38. While Respondent argues that the 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 B.T.'s

medical records

14

include reports of immediate pain when he received his flu vaccine. Id. 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 [B.T.] received on September 19, 2018, was

administered improperly." Id. at 29. 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 evideoce to substantiate this supposition. Id.; Tornatore First Rep. at 14-15.

Respondent also criticizes Dr. Tornatore's reliance on the concept of "double crush syndrome"

as an explanation for Petitioners 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 \WS 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. Id 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 do not 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

"[i]nstead of providing instances in the medical literature and in his opinions that supported his

[ overall] theory," therefore, failing t> produce preponderant evidence that the flu vaccine can cause

ulnar neuropathy. Id. at 3 3.

15

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. Id. at 35. Respondent

acknowledges that- B. T., throughout his clinical course, consistently stated his belief

lhat his vaccination was mis-administered. Id. at 36; see also Ex. 4 at 27 (reporting that the flu

vaccine was given "the wrong way" at 11n /18 visit with orthopedic surgeon, Dr. Eichten); Ex.

7 at 13 (documenting 11'9/2018 visit with chiropractor, Dr. Weiland, and noting Petitioner's

complaint 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 vaccine 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 F3d

13 78, 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

B.T.'s] treating physicians. Opp. at 37.

Regarding Dr. Tomatore's assertion that the compression of Petitioner's ulnar nerve at the

right elbow was asymptomatic prior to his receipt of the flu vaccine, Respondent maintains that

B.T.'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." Id.; Ex. 2 at 180 . Because the clinical indication for this MRI was

"[e]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 at the elbow is secondary to compression or extension

of the nerve within the cubital tunnel. Id.; 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 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. Id. 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." Id.; 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."' Id.

16

V. Applicable Legal Standards

A. Petitioner's Overall Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (I) 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)(l)(A), ll(c)(l), and 14(a), as amended by 42 C.F.R. § 100.3; §

1 l(c)(l)(C)(ii)(I); see also Moberly v. Sec 'yo/Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.

Cir. 2010); Capizzano v. Sec'y o/Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006). 6

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." 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 standrutl).

Proof of medical certainty is not required. Bunting v. Sec'y ofHealth & 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,

13 52-53 (Fed. Cir. 1999)); Pafford v. Sec'y ofHealth & Hum. Servs ., 451 F.3d 13 52, 13 55 (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)(l ).

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 A/then v. Sec'y ofHealth and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): "(I) 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."

6

Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authorty.

Han Ion v. Sec'y o_(Health & Hum. Servs., 40 Fed CL 625,630 ( 1998). By contrast, Federal Circuit rulings concemng

legal issues are binding on special masters. Guillory v. Sec'y ofHealth &Hum. Servs., 59 Fed. CL 121, 124 (2003}

aff'd 104 F. App 'x. 712 (Fed. Cir. 2004); see also Spooner v. Sec '.Y ofHea lth &Hum. Servs., No. l 3-l 59V, 2014 WL

504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

17

Each A/then prong requires a different showing. Under A/then 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 prong without resort to medical literature,

epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical

theory. Andreu v. Sec '.Yo.fHealth &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. Contreras, 121 Fed.

Cl. at 245("[p]lausibility . . . in many cases maybe enough to satisfy A/then 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'dNo. 2023-1321, 2024 WL 3064398, at

*2(Fed.Cir. June 20, 2024)(arguments "for a less than preponderance standard" deemed "plainly

inconsistent with our precedent" (citing Moberly, 592 F.3d at 1322)); Boatmon v. Sec '.Y ofHealth

&Hum. Servs., 941 F.3d 1351, 1359 (Fed.Cir. 2019); see alsoHoward v. Sec'y ofHealth &Hum.

Servs., 2023 WL 4117370, at *4(Fed.Cl. May 18, 2023)("[t]he standard has been preponderance

for nearly four decades"),ajf'd, 2024 WL 2873301(Fed.Cir. June 7, 2024)(unpublished). And

petitioners always have the ultimate burden of establishing their overall Vaccine Act claim with

preponderant evidence. WC. v. SecyofHealth &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 A/then prong requires proof of a logical sequence of cause and effect, usually

supported by facts derived from a petitioner's medical records. A/then , 418 F.3d at 1278; Andreu,

569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant v. SecyofHealth &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

18

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 A/then, 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)( l ) (providing that "[a]ny such diagnosis, conclusion,judgmen�

test result,report,or summary shall not be binding on the special master or court"); Snyder v. Secy

ofHealth & 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,contrazy

evidence also present in the record-including conflicting opinions among such individuals.

Hibbardv. Sec'yofHealth &Hum. Servs., l 00Fed. Cl. 742,749(20l l )(notarbitrary 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 ofDept. 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.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 (A/then prong one's requirement). Id. at 1352; Shapiro v. Sec'y of Health & Hum.

Servs., 101 Fed. Cl. 532, 542(2011), recons. den 'd after remand, 105 Fed. Cl. 353 (2012), 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), ajf'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. Secy

ofHealth & Hum. Servs., 86 Fed. Cl. 135, 144 (2009). In Loving, the Court of Federal Claims

19

combined the A/then test with the test from Whitecotton v. Secy ofHealth & 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;see also WC., 704 F.3d at 1357 (holding that"theLovingcase 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 ofHealth & 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

out a 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 of1he

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). Id. 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 11(c)(2). The special master is required

to consider "all [ ] relevant medical and scientific evidence contained in the record," including

"any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained

in the record regarding the nature, causation, and aggravation of the. petitioner's illness, disability,

injury, condition, or death," as well as the "results of any diagnostic or evaluative test which are

contained in the record and the summaries and conclusions." Section 13(b)(l )(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

20

surrounding the events in question that was given at a later date, provided that such determination

is evidenced by a rational determination).

As noted by the Federal Circuit, "[m]edical records, in general, warrant consideration as

trustworthy evidence." Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y ofHealth & 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"), affd,Rickett v. Sec'y ofHealth &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 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 ofHealth &Hum. Servs., No. 11-685V,

2013 WL 1880825,at *2 (Fed. Cl. Spec.Mstr. Apr. 10, 2013); Cucuras v. Sec'y ofHealth &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 shoukl

o

be aff rdedsubstantial weight.Lowriev. Sec'y ofHealth&Hum. Servs.,No. 03-1585V,2005WL

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 ofHealth &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 evidentiruy

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 ofHealth

& 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 ofHealth & 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

21

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 l 880825,at*3 (citingBlutstein v. Sec'y ofHealth & Hum. Servs.,

No. 90-2808V, 1998 WL 408611, at* 5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the

accuracy and completeness ofmedical 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 ofHealth

& Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), ajfd, 746F.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 ofHealth & 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 'yo/Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.

Cir. 2010) (citing Terran v. Sec'y ofHealth & 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 different role 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

22

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

La,mpe, 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. 08-601V, 2012 WL 3609993, at* 17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot.for

review den 'd, 108 Fed. Cl. 7 43 (2013), ajJ'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 tum on credibility determinations");

see alsoPorter 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) ("[ f]inding certain information not relevant does not lead to-and likely undermines----the

conclusion that it was not considered").

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F. 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 cas e

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 ofHealth & 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 ulnar neuropathy to explainPetitioner'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 ofHealth & Hum. Servs., No. 15-817V, 2021WL319393 (Fed. Cl. Spec.

Mstr. Jan. 5, 2021) (finding thatPetitioner 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 WL319393, at

* 5. Relying on a theory comparable to what is offered herein, the Salazar petitioner maintained

that a pre-existing asymptomatic condition (cubital tunnel syndrome) had been "unmasked"by the

vaccine's misadministration, resulting in nerve injury. Id. 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 ofvaccine administration. Id. at* 5. Id. The special master

deemed all three A/then 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

24

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 9/7/20 18, 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).

A/then Analysis

Taking the above into account, I cannot find entitlement established under A/then. Sa/az,a,r

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 thatthe flu vaccine "did cause" his ulnar neuropa1hy­

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 1he

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 1here

is some record evidence suggesting that several of Mr. Tacher' s treating physicians considered his

receipt of 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. And I do not give great weight to Petitioner's

subjective contentions that the vaccination was itself injurious-especially since he did not

25

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 addres.s

evidence in the record undermining the conclusion that the vaccine played a substantial role in his

injury. Exum v. Sec'y ofHealth & Hum. Servs., No. 21-1513V,2024 WL4291116,at *14 (Fed.

Cl. Spec. Mstr. Aug. 29, 2024) (citing Strone v. Sec'y ofHealth & Hum. Servs., 6 76 F.3d 13 73,

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 it is also

relevant to another inquiry under the statute.")). That has not been successfully done here. Even if

Dr. Tomatore'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 Althen 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. Tomatore'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 on a 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 thitd

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

3 3(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

26

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 va I • I I I •

an inflection point). Thus, on September 21, 2018 (two days post-vaccination),

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 at 24.

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.T. underwentEMG/NCS 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 giving him trouble,but

clearly did post-vaccination, might be sufficient to meet this prong, despite my overall view of 1he

record. But the same flaws discussed above with respect to A/then prongs two and three woukl

also apply to their Loving counterparts (Loving prongs five and six). For even if Salazar's

reasoning supports the determination that a vaccine that was improperly administered could(via

Dr. Tornatore's embrace ofthe double crush theory) worsenhis 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.

27

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. 7

IT IS SO ORDERED.

Isl Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

7

Pursuant to Vaccine Rule 11 (a), the parties may expediteentryofjudgmentif Gointly orseparately)theyfile notces

renouncing their right to seek review.

28