Burroughs v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 21-84V

Filed: May 21, 2024

Special Master Horner

JUSTIN BURROUGHS,

Petitioner,

v.

SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

John Robert Howie, Jr., Howie Law, P.C., Dallas, TX, for petitioner.

Katherine Carr Esposito, U.S. Department of Justice, Washington, DC, for respondent.

RULING ON ENTITLEMENT 1

On January 5, 2021, petitioner, Justin Burroughs, filed a petition under the

National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), 2 alleging that

he suffered a Shoulder Injury Related to Vaccine Administration (“SIRVA”), a Table

Injury, resulting from adverse effects of a tetanus, diphtheria and acellular pertussis

(“Tdap”) vaccine he received on December 23, 2019. (ECF No. 1.) On December 7,

2022, he filed an amended petition adding an alternative cause-in-fact claim. (ECF No.

30.) For the reasons set forth below, I conclude that petitioner is entitled to

compensation for a Table SIRVA.

1

Because this document contains a reasoned explanation for the action taken in this case, it must be

made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or

at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government

Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic

Government Services). This means the document will be available to anyone with access to the

internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact

medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.

If, upon review, I agree that the identified material fits within this definition, I will redact such material from

public access.

2

Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.

§ 300aa-10-34.

1

I. Applicable Statutory Scheme

Under the National Vaccine Injury Compensation Program, compensation

awards are made to individuals who have suffered injuries after receiving vaccines. In

general, to gain an award, a petitioner must make a number of factual demonstrations,

including showing that an individual received a vaccination covered by the statute;

received it in the United States; suffered a serious, long-standing injury; and has

received no previous award or settlement on account of the injury. Finally – and the key

question in most cases under the Program – the petitioner must also establish a causal

link between the vaccination and the injury.

In some cases, the petitioner may simply demonstrate the occurrence of what

has been called a “Table Injury.” That is, it may be shown that the vaccine recipient

suffered an injury of the type enumerated in the “Vaccine Injury Table,” corresponding to

the vaccination in question, within an applicable time period following the vaccination

also specified in the Table. If so, the Table Injury is presumed to have been caused by

the vaccination, and the petitioner is automatically entitled to compensation, unless it is

affirmatively shown that the injury was caused by some factor other than the

vaccination. § 300aa-13(a)(1)(A); § 300 aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-

13(a)(1)(B).

As relevant here, the Vaccine Injury Table lists a Shoulder Injury Related to

Vaccine Administration or “SIRVA” as a compensable injury if it occurs within 48 hours

of vaccine administration. § 300aa-14(a) as amended by 42 CFR § 100.3. Table Injury

cases are guided by statutory “Qualifications and aids in interpretation” (“QAIs”), which

provide more detailed explanation of what should be considered when determining

whether a petitioner has suffered an injury listed on the Vaccine Injury Table. 42 CFR

§ 100.3(c). To be considered a “Table SIRVA,” petitioner must show that his injury fits

within the following definition:

SIRVA manifests as shoulder pain and limited range of motion occurring

after the administration of a vaccine intended for intramuscular

administration in the upper arm. These symptoms are thought to occur as

a result of unintended injection of vaccine antigen or trauma from the needle

into and around the underlying bursa of the shoulder resulting in an

inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal

structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is

not a neurological injury and abnormalities on neurological examination or

nerve conduction studies (NCS) and/or electromyographic (EMG) studies

would not support SIRVA as a diagnosis . . . . A vaccine recipient shall be

considered to have suffered SIRVA if such recipient manifests all of the

following:

(i) No history of pain, inflammation or dysfunction of the affected shoulder

prior to intramuscular vaccine administration that would explain the alleged

signs, symptoms, examination findings, and/or diagnostic studies occurring

after vaccine injection;

(ii) Pain occurs within the specified time-frame;

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(iii) Pain and reduced range of motion are limited to the shoulder in which

the intramuscular vaccine was administered; and

(iv) No other condition or abnormality is present that would explain the

patient's symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,

brachial neuritis, mononeuropathies, or any other neuropathy).

42 CFR § 100.3(c)(10).

Alternatively, if no injury falling within the Table can be shown, the petitioner may

still demonstrate entitlement to an award by showing that the vaccine recipient’s injury

was caused-in-fact by the vaccination in question. § 300aa-13(a)(1)(A); § 300aa-

11(c)(1)(C)(ii). To so demonstrate, a petitioner must show that the vaccine was “not

only [the] but-for cause of the injury but also a substantial factor in bringing about the

injury.” Moberly ex rel. Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315,

1321-22 (Fed. Cir. 2010) (quoting Shyface v. Sec'y of Health & Human Servs., 165 F.3d

1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec'y of Health & Human Servs., 451 F.3d

1352, 1355 (Fed. Cir. 2006). In particular, a petitioner must show by preponderant

evidence: (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 in order to prove causation-in-fact. Althen v. Sec’y of Health & Human

Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).

For both Table and Non–Table claims, Vaccine Program petitioners must

establish their claim by a “preponderance of the evidence”. § 300aa-13(a). That is, a

petitioner must present evidence sufficient to show “that the existence of a fact is more

probable than its nonexistence . . . .” Moberly, 592 F.3d at 1322 n.2. Proof of medical

certainty is not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867,

872-73 (Fed. Cir. 1991). However, 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. § 300aa-11(c)(1). Once a

petitioner has established their prima facie case, the burden then shifts to respondent to

prove, also by preponderant evidence, that the alleged injury was caused by a factor

unrelated to vaccination. Althen, 418 F.3d at 1278 (citations omitted); § 300aa-

13(a)(1)(B).

In this case, petitioner stresses that he suffered an injury consistent with a SIRVA

Table Injury. Alternatively, petitioner asserts that the evidence supports a non-Table

shoulder injury caused-in-fact by his vaccination. (ECF No. 32, 50.)

II. Procedural History

After filing his petition, petitioner filed medical records and a sworn statement.

(ECF Nos. 10-11; Exs. 1-11.) He filed his Statement of Completion on May 25, 2021.

(ECF No. 14.) Initially, this case was assigned to the Chief Special Master as part of

the Special Processing Unit (“SPU”) based on the allegations in the petition. (ECF No.

17-18.)

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Before respondent had completed his medical review of the case, petitioner filed

a motion for a finding of fact regarding the site and route of administration of the

vaccination at issue. (ECF No. 28.) Along with his motion, petitioner filed medical

literature marked as Exhibits 12-17. (ECF No. 27.) However, respondent subsequently

filed his Rule 4(c) Report rather than a motion response. (ECF No. 29.) Respondent

disputed that petitioner had shown his alleged injury had persisted for at least six

months and further disputed that he had demonstrated either a Table Injury or

causation-in-fact; however, he did not raise any argument with respect to the site or

route of administration of petitioner’s vaccination. (Id.)

On December 7, 2022, petitioner filed a motion for a ruling on the written record

urging his entitlement to compensation. (ECF No. 32.) Along with his motion, he filed

the curriculum vitae of one of his treating physicians – Dr. Marko Bodor – along with

additional medical literature. (ECF No. 31; Exs. 18-22.) Dr. Bodor has served as an

expert in prior SIRVA cases.

Respondent moved for a stay of his response deadline, arguing that petitioner

should file an expert report (ECF No. 33); however, the Chief Special Master denied the

motion and required respondent to file a response to the motion (ECF No. 35.) On

March 6, 2023, respondent filed his response to petitioner’s motion along with an expert

report by orthopedist Julie Bishop, M.D. (ECF Nos. 38-39; Exs. A-B.) Respondent also

filed medical literature marked as Exhibits B1-B7. (ECF No. 40.)

Petitioner then filed his reply brief and a motion to exclude Dr. Bishop’s report on

April 5, 2023. (ECF No. 42.) He additionally filed further literature marked as Exhibits

23-30 and a motion to exclude Dr. Bishop’s report. (ECF Nos. 41.)

The case was reassigned to the undersigned on April 26, 2023, with all three of

petitioner’s motions pending. (ECF No. 28, 43-44.) I then issued a Rule 5 Order,

wherein I denied petitioner’s motion to exclude Dr. Bishop’s report. (ECF No. 45, p. 2.)

I provided the parties with preliminary guidance relating to the Vaccine Act’s severity

requirement, the fourth SIRVA QAI criterion, and petitioner’s alternative cause-in-fact

claim. (Id. at 2-4.) I advised that I would provided petitioner an opportunity to respond

to Dr. Bishop’s report, but that I otherwise felt petitioner’s motion for a ruling on the

record was ripe and that it would be appropriate to resolve entitlement based on that

motion practice. (Id. at 4.)

Petitioner then filed an expert report by Dr. Bodor with supporting literature.

(ECF No. 47; Exs. 31-38.) He filed a supplemental motion for a ruling on the record on

September 25, 2023. (ECF No. 50.) Respondent filed a response on October 23,

2023, and petitioner filed a reply on November 6, 2023. (ECF Nos. 51-52.)

In light of the above I have determined that the parties have had a full and fair

opportunity to present their cases and that it is appropriate to resolve this issue without

a hearing. See Vaccine Rule 8(d); Vaccine Rule 3(b)(2); Kreizenbeck v. Sec’y of Health

& Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (noting that “special masters

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must determine that the record is comprehensive and fully developed before ruling on

the record”). Accordingly, this matter is now ripe for resolution.

III. Factual History

a. Medical Records

On December 23, 2019, petitioner presented to urgent care with a history of a cut

on his left ring finger one week prior. (Ex. 3, p. 3.) He was diagnosed with cellulitis and

prescribed an antibiotic ointment. (Id.) He was administered a Tdap vaccination in his

left shoulder. 3 (Id. at 4.) The next day, he complained by telephone of diaphoresis,

nausea, and migraine. (Id. at 5.) His antibiotic prescription was therefore changed.

(Id.)

On January 3, 2020, eleven days post-vaccination, petitioner presented to his

primary care provider. (Ex. 6, pp. 12-13.) He complained of left shoulder pain “x 10

days since the Tdap vaccine admin.” (Id. at 12.) Petitioner reported that his Tdap

vaccine had been administered too high up on his left arm and he was concerned it may

have caused “SIRVA.” (Id.) His pain was noted to be “aching” and “dull.” (Id.) He was

diagnosed with stable left shoulder pain and prescribed Meloxicam (an NSAID),

Carisoprodol (a muscle relaxant), and a Medrol Dosepak (a steroid). (Id. at 13.) An x-

ray was ordered, and he was instructed to follow up in two weeks. (Id.) The x-rays

were completed on January 21, 2020, and did not identify any abnormalities. (Id. at 14.)

On February 26, 2020, petitioner had an initial evaluation with an orthopedist

Stephen Yacoubian, M.D. 4 (Ex. 7, p. 3.) He reported “pain in the shoulder [that] started

with a tetanus shot, which was administered to his left shoulder on 12/26/2019 [sic.] in

3

The documentation of petitioner’s Tdap vaccine as generated by the urgent care (a consent form only)

does not confirm petitioner’s vaccination to have been administered in his left shoulder or that the vaccine

was intramuscular. (Ex. 2, Ex. 3, p. 4.) Petitioner filed a motion for a finding of fact on these points,

stressing that his subsequent medical treatment records consistently attribute his left shoulder pain to his

documented Tdap vaccination. (ECF No. 28.) As discussed in the procedural history above, respondent

never filed a response to this motion and did not raise any issue as to the site or route of administration of

the subject vaccination in his Rule 4 Report. In any event, I agree with petitioner that on this record the

subsequent treatment records (and in particular Ex. 6, p. 12; Ex. 7, p. 3) are sufficient to evidence a left

shoulder administration. Accord Hanna v. Sec’y of Health & Human Servs., No. 18-1455V, 2021 WL

3486248, at *9 (Fed. Cl. Spec. Mstr. July 15, 2021) (discussing prior cases supporting the proposition that

a consistent pattern of attribution of a shoulder injury to vaccination within treatment records is probative

evidence regarding the site of injection). Therefore, petitioner’s unopposed motion for a finding of fact

that petitioner’s vaccination was administered intramuscularly in his left shoulder is GRANTED.

4

In the interim, petitioner had an appointment with another internist on January 28, 2020. (Ex. 5, pp. 46-

47.) However, the medical records reflect that over the course of four years petitioner only ever saw this

doctor with respect to his ADHD. (Ex. 5, passim.) Petitioner’s shoulder condition was never discussed

with this doctor. (Id.) Petitioner also had an encounter with this doctor on March 24, 2020. (Ex. 5, pp.

48-49.)

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Florida . . . The left shoulder has been hurting since.” 5 (Id.) Pain was noted to be 8 out

of 10, worse with function and overhead function, and also with weakness and stiffness.

(Id.) Physical exam was positive for impingement, crepitus, and pain with abduction

and external rotation. (Id. at 4.) Weakness was noted, but O’Brien’s, Hawking,

Speed’s, and Spurling tests were negative. (Id.) Petitioner had no acromioclavicular

joint tenderness and no scapular winging. (Id.) The assessment was “[l]eft shoulder

strain injury, possible injection related injury.” (Id.) An MRI was ordered. (Id. at 5.)

Petitioner had a left shoulder MRI on March 1, 2020. (Ex. 7, p. 7.) The MRI

findings were as follows:

• “[A] focus of 1x2 cm marrow contusion in posterior lateral aspect of the humeral

head” and “a subtle cortical deformity.” (Id. at 8.) This was noted to be

“worrisome for a Hill-Sachs deformity” for which clinical correlation was

recommended. (Id.) There were also “numerous subchondral degenerative

cystic changes in the anterior aspect of the glenoid with marked loss of cartilage.”

(Id.)

• “A low-grade partial articular surface tear of the supraspinatus tendon.” (Id.)

• “Abnormal increased signal intensity is noted in the superior and anterior labrum

consistent with a SLAP type II lesion.” (Id.)

• “[N]o evidence of subacromial or subdeltoid bursal fluid collection.” (Id.)

• “[M]ild acromioclavicular joint degenerative changes” and a “[m]ild to moderate

amount of joint effusion.” (Id.)

Petitioner followed up with Dr. Yacoubian on March 18, 2020, to discuss the MRI

results. (Ex. 7, p. 11.) (This record incorrectly indicates the appointment was relative to

the right shoulder.) Regarding the post-vaccination onset of symptoms, Dr. Yacoubian

indicated that “I told the patient that I do not see any lesions or any damage in the

deltoid region where I presume the shot may have been given. It is conceivable that the

shot did go into the subacromial space inadvertently and may have contributed to

rotator cuff issues.” (Id.) Physical exam showed mild impingement, clicking, and

weakness, and petitioner was diagnosed with “[r]otator cuff partial tear, SLAP tear,

impingement, and history of tetanus injection with lateral pain right [sic.] shoulder.” (Id.

at 12.) Physical therapy was ordered. (Id.)

Petitioner presented for physical therapy on May 13, 2020. (Ex. 9, p. 2.)

Petitioner gave a history consistent with the above. (Id.) It was noted that he had an

active lifestyle prior to his injury, with reported activities including weightlifting, climbing,

swimming, and volleyball. (Id. at 2, 4.) Upon evaluation, petitioner had impaired flexion,

abduction, external rotation, and internal rotation. (Id. at 3.) The assessment was that

5

Petitioner also reported having “some kind of an allergic reaction to the tetanus shot” (Ex. 7, p. 3), which

presumably refers to his above-referenced telephone encounter of December 24, 2019 (Ex. 3, p. 5.).

6

petitioner was presenting to physical therapy “with signs/symptoms of L RCRSP

[presumably, rotator cuff related shoulder pain] secondary to getting a tetanus shot in

Dec 2019 for a finger injury.” (Id. at 4.) It was noted that petitioner had a good rehab

potential and six weeks of twice weekly physical therapy was recommended. (Id.)

Petitioner continued physical therapy through June 2, 2020. (Ex. 9, p. 14.)

During the course of his physical therapy, the therapist “discussed biopsychosocial

contributing factors to pain, discussed reasoning why it is unlikely that vaccine caused

imaging findings, [and] validated Pt feelings that the vaccine caused his pain.” (Id. at

13.) He was discharged on June 24, 2020, after multiple no shows. (Id. at 16.) At the

time of his last physical therapy session, he was still symptomatic. 6 (Id. at 14.)

Thereafter, there is a seven-month gap in petitioner’s medical records from any provider

for any medical problem.

On January 10, 2021, petitioner had an initial evaluation with a psychiatrist. (Ex.

10, pp. 2-3.) In pertinent part, the history indicated:

Pt is a 29 yo male with no psychiatric history. He presents with anxiety and

depression symptoms secondary to something he went through around a

year ago. In December 2019, he cut himself while cooking, and tried to self-

treat it, and got infected. Over the holidays, he saw someone in urgent care

and he got it treated and got a tetanus shot. He had some reaction where

he felt really awful, had lots of pain, etc. He later had significant problems,

and had to see his PCP and then a shoulder specialist, and they found that

the tetanus shot was injected into the wrong place, and it caused [sic.] his

rotator cuff to the point it got inflamed and torn. The doctor he saw was

ignoring/not acknowledging that it was caused by the shot. He has gone

through a lot, and is now going to see a lawyer and look into what he went

through/his situation[] [t]hrough this whole year. He has not gotten

treatment/surgery. There was a lot of “spin” in that they kept ignoring the

issue.

(Id. at 2.) The psychiatrist noted a differential diagnosis between anxiety not otherwise

specified or posttraumatic stress disorder. (Id. at 3.) The encounter purported to

include a musculoskeletal exam that was normal; however, it was a telehealth

encounter and there is no specific mention of petitioner’s upper extremities. (Id. at 2-3.)

Shortly thereafter, petitioner reported to Marko Bodor, M.D., on January 21,

2021. (Ex. 11, p. 3.) Petitioner provided a history consistent with the above and it was

further noted that the “pain remains, feels deeper in the shoulder. He has no history of

injury, but played football . . .” (Id.) Physical exam documented “full active range of

6

Specifically, the patient comments indicate “[s]houlder has been feeling about the same.” (Ex. 9, p. 14.)

In that regard, his prior encounter had indicated “[s]hld continues to bother him . . . Today, shoulder is

feeling about the same where it bothers him when he uses it, but doesn’t bother him when at rest.” (Id. at

12.) The day before his final physical therapy appointment, petitioner’s shoulder was “bothering him more

than usual.” (Id. at 14.) However, as of the day of the final encounter, he felt he was back to “just above

baseline.” (Id.)

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motion of the left shoulder, but has pain with greater than 100 degrees abduction, 120

degrees forward flexion, 80 degrees external rotation. Has positive Hawkins and

negative scarf sign. He can internally rotate up to the thoracic level.” (Id.) Dr. Bodor

reviewed petitioner’s prior March 1, 2020, MRI report. (Id.) He assessed a “suspected

left SIRVA” and planned to have petitioner return for a “Tenex procedure.” (Id. at 4.)

On March 4, 2021, petitioner returned to Dr. Bodor for a diagnostic ultrasound

and ultrasound guided teres minor tendon anesthetic injection. (Ex. 11, p. 5.) At this

time, petitioner reported for the first time that he had also been experiencing tingling

down his forearm and to his fingertips. (Id. at 6.) On ultrasound, petitioner’s biceps

tendon, subscapularis, rotator interval, and anterior leading edge of the supraspinatus

were all noted to be intact. (Id. at 5.) He had no other rotator cuff abnormalities, but

“there was focal sonopalpation tenderness overlaying the teres minor tendon over the

anatomical neck. There seem to be an irregularity at the anatomical neck.” (Id.) It was

noted that the injection provided complete resolution of petitioner’s symptoms. (Id.) Dr.

Bodor concluded that petitioner had been experiencing SIRVA. (Id. at 7.)

b. Petitioner’s Statements

In his first statement, petitioner described the circumstances of his December 23,

2019 Tdap vaccination, which he indicated was administered in his left (non-dominant)

arm. (Ex. 1, p. 1.) He denied having any prior joint or muscle problems or any prior

injury or trauma to his left shoulder. (Id.) He indicated that “I was a healthy individual

who enjoyed exercising seven days a week and living an active and healthy lifestyle.”

(Id.) Petitioner felt his vaccination was administered higher than normal but did not

otherwise recall experiencing anything unusual at the time of the vaccination. (Id. at 2.)

He states that he began experiencing some shoulder pain about four hours post-

vaccination; however, he believed it to be normal post-vaccination pain. (Id.) He also

experienced diaphoresis, nausea, migraine, and fever, which prompted his December

24, 2019 call to the urgent care clinic. (Id.) The post-vaccination shoulder pain

worsened significantly within 24 hours of his vaccination and by Christmas he felt it was

“unbearable” and he began to lose range of motion. (Id.) The remainder of this

statement recounts what is otherwise reflected in petitioner’s medical records.

In a second statement, petitioner recounts:

Concerning the cessation of my physical therapy in June 2020, I did not

stop attending sessions because my issues had been fully resolved.

Rather, I stopped due to two main reasons: firstly, after attending six

physical therapy sessions, I experienced no improvement in my symptoms.

The sessions were painful, time-consuming, and seemed futile as my

symptoms remained unchanged. Secondly, these sessions took place

during the Covid-19 pandemic, and I concluded that, given the lack of

progress, it was not worth risking exposure to a potentially life-threatening

virus.

8

(Ex. 25, p. 1.)

Petitioner also noted that as an actor he takes pride in his physique, which is why

the impact of his injury on his work out routine caused increased anxiety and

depression. (Ex. 25, p. 2.) Additionally, he clarified that “I never participated in

professional or college sports. I only played football through about the tenth grade, and

that was it.” (Id.)

IV. Expert Reports

a. Respondent’s Expert, Orthopedist Julie Bishop, M.D. 7

Dr. Bishop does not agree that petitioner suffered onset of his shoulder

symptoms within four hours of his vaccination, because shoulder pain was not

referenced in his December 24, 2019 call regarding his antibiotic reaction, though Dr.

Bishop stresses it was never confirmed that petitioner suffered an adverse reaction to

his antibiotic. 8 (Ex. B, p. 7.) Further, Dr. Bishop suggests that the fact that petitioner

waited three weeks from the date of his initial primary care appointment until he

presented for his recommended x-ray “is unusual as the typical concerned patient would

present immediately for radiographs if it was recommended.” 9 (Id.)

7

Dr. Bishop serves as a professor in the department of Orthopaedic Surgery at the Ohio State University,

Wexner Medical Center, as well as Chief of the Division of Shoulder surgery, and Vice Chair of Finance

for the Orthopaedic Department. (Ex. A, p. 1-2, 7.) As a shoulder specialist, all of Dr. Bishop’s research

interests, publications, book chapters, and presentations have been on the treatment of shoulder

pathology. (Id. at 9-41.) Dr. Bishop has treated multiple patients with SIRVA in her practice over the

years and has published in this area as well. (Ex. B, p. 1.) Dr. Bishop received her medical degree from

Cornell University Medical College in 1997. (Ex. A, p. 1.) She completed fellow training in 2003

specifically in shoulder surgery (fellowship at Mount Sinai Hospital in New York City) and Orthopaedic

sports medicine (visiting fellowship at the University of Pittsburg Medical Center). (Id.) She is board

certified in orthopedic surgery. (Id. at. 2.) Dr. Bishop is also a fellow of the American Academy of

Orthopaedic Surgeons, an active member of the American Shoulder and Elbow Surgeons, a member of

the American Orthopaedic Society for Sports Medicine as well as an elected member of the American

Orthopaedic Association. (Id. at 9.)

8

Discussing petitioner’s later physical therapy encounters during which he characterized this reaction as

an allergic reaction to the vaccine, Dr. Bishop stresses that there is no literature supporting that assertion.

(Ex. B, p. 8.) Thus, she indicates that “this is a connection/correlation that has only been made by the

petitioner.” (Id.) However, both petitioner’s statements and medical records are sufficiently clear in

distinguishing petitioner’s initial systemic complaints from his shoulder complaints as two separate issues.

Therefore, it is not necessary to resolve whether petitioner’s systemic symptoms were related to his

vaccine, his antibiotics, or some other unknown cause.

9

To the extent Dr. Bishop appears to raise this as a reason to be skeptical of the credibility of petitioner’s

subjective complaints, it is not persuasive. Nothing in the record indicates why petitioner’s x-ray study

was done on January 21, 2020. However, it is apparent from the medical records that petitioner went to a

different facility for the x-rays (Renaissance Imaging Centers vs. Burns Medical Group). (Ex. 6, p. 14.)

There is no basis for assuming that an immediate appointment would have been available to petitioner or

that petitioner didn’t select the earliest practicable appointment. Moreover, the record of petitioner’s

January 3, 2020 encounter confirms he was instructed to follow up in two weeks. (Id. at 13.) Accordingly,

petitioner would have been aware that “immediate” x-rays were not necessary. Considering the record as

a whole, I cannot agree that there is anything suspect in the timing of petitioner’s initial x-ray imaging.

9

By Dr. Bishop’s interpretation of the medical records, neither petitioner’s first

orthopedist, Dr. Yacoubian, nor his physical therapist, accepted that petitioner was

suffering any vaccine-related shoulder pain. (Ex. B, pp. 7-8.) Instead, she opines that it

was appropriate, following recommendations of the American Academy of Orthopaedic

Surgeons (AAOS), for Dr. Yacoubian to acknowledge that onset of petitioner’s shoulder

pain started after vaccination, but to explain that current evidence does not support

vaccine causation of common shoulder pathologies. (Id. at 8.) She further stresses that

the physical therapist expressed that a SIRVA was unlikely in favor of biopsychosocial

contributing factors. 10 (Id.) Dr. Bishop stresses that petitioner’s x-rays were negative,

and she interprets his MRI as having findings “consistent with the potential sequela of

shoulder instability.” (Id. at 7.) She states that “this is not uncommon for a prior football

player with a very active workout/gym reported history.” (Id.) She also stresses the

absence of findings of bursitis, rotator cuff edema, adhesive capsulitis, or lytic lesions of

the bone, which would be expected in SIRVA. (Id.) Thus, Dr. Bishop opines the MRI

findings are more consistent with a history of athletic injury rather than acute

inflammation due to vaccine reaction. (Id. at 8.)

Dr. Bishop further opines that petitioner’s injury likely resolved after physical

therapy:

[T]he petitioner then no-shows for any further PT sessions and seeks no

treatment for his shoulder until 7 months later, and therefore, it is

reasonable to conclude, his shoulder pain resolved, and ultimately

conservative treatment resolves his complaints. Typically, in the medical

field, if a patient no-shows for further PT sessions it is either due to 1) the

condition being resolved and no need to go back or 2) they are not getting

better and thus they return to their physician for further treatment

10

Later in her report, Dr. Bishop discusses petitioner’s psychology encounter during which he expressed

that his physicians were “ignoring/not acknowledging” that his shoulder problems were related to his

vaccination. (Ex. B, p. 9.) Dr. Bishop states that “the tone of this visit is very concerning” and that it is

“clearly a mischaracterization of what truly occurred as his physician and the PT clearly acknowledged his

concerns about the vaccine and provided him with appropriate treatment.” (Id.) Dr. Bishop goes on to

note that Dr. Bodor subsequently documented petitioner’s complaint that his prior orthopedist “refused to

acknowledge that his injury was related to the vaccine.” (Id.) She states that “this is the perception of the

petitioner, claiming he was not helped appropriately by other health care providers, when the records

clearly indicate this was not the case.” (Id.) Again, Dr. Bishop expresses skepticism regarding

petitioner’s credibility within his treatment history that is not persuasive. (See also n. 9, supra.) It is not

clear how Dr. Bishop squares this criticism of petitioner with her own assessment of the medical records

from which she opines that, though they purported to validate his concerns, both Dr. Yacoubian and the

physical therapist told petitioner his condition was not vaccine related. Whether the care petitioner

received was medically appropriate for the pathology he suffered is irrelevant to whether he subjectively

felt heard by his treaters as to the cause of his condition. And, regardless of whether Dr. Bishop agrees

with petitioner’s course of care, she cites evidence from the medical records to confirm the basis for

petitioner’s subjective experience of his prior medical treatment. In any event, as a layperson, petitioner

cannot be faulted for suspecting his prior medical care had been lacking when he felt he remained

symptomatic despite that care. Patients often seek second opinions for precisely this reason.

10

recommendations. Given that the petitioner did not return to any physician

for further treatment, one can again reasonably conclude, his symptoms

resolved.

(Ex. B, p. 8.)

Regarding petitioner’s subsequent treatment with Dr. Bodor, Dr. Bishop agrees

that the Tenex procedure recommended by Dr. Bodor, though “relatively new,” “is an

accepted technique to address chronic tendinopathies,” though much less commonly for

shoulder tendons. (Ex. B, p. 9.) Dr. Bishop asserts it should be viewed as an

experimental treatment for SIRVA and should not be viewed as confirmatory of

diagnosis. (Id.) Dr. Bishop indicates that Dr. Bodor’s actual surgical report does not

indicate he did any actual aspiration of a vaccine deposit and that his prior experience

with 9 patients is anecdotal. (Id.) Dr. Bishop stresses the limited value of case reports.

(Id.)

Dr. Bishop indicates that petitioner’s first encounter with Dr. Bodor did not include

any tenderness to palpation and petitioner had full range of motion at that time. (Ex. B,

p. 11.) It was only upon his return that petitioner was noted to have tenderness over the

teres minor and pain with cross chest abduction, which is also not consistent with his

prior treatment history. (Id.) Dr. Bishop also indicates that Dr. Bodor’s interpretation of

petitioner’s MRI changed from one visit to the next. (Id.) Thus, Dr. Bishop questions

whether petitioner’s history is actually consistent with Dr. Bodor’s prior experience using

Tenex to treat the shoulder and further suggests that the findings Dr. Bodor observed

were new and unrelated findings. (Id.)

In sum, Dr. Bishop opines:

There is significant evidence from the MRI that petitioner had many other

abnormalities in his shoulder clearly related to wear and tear and a very

likely history of anterior shoulder instability, that would explain his symptoms

and therefore, SIRVA is not the only plausible diagnosis for his

symptomology. The most consistent physical examination finding prior to

the petitioner seeing Dr. Bodor was a positive impingement sign noted

several times in the records, which can be seen with a “low-grade” partial

articular supraspinatus tear. Low-grade is a very mild, slight tear and

nothing on the MRI was consistent with any acute inflammatory reaction to

a vaccination.

Therefore, I conclude with a reasonable degree of medical certainty

that there is no objective evidence or documentation to support the shoulder

symptoms of [petitioner] were caused by his tetanus vaccination on

12/23/2019. There is insufficient support for this in the records and there is

instead evidence to support that his left shoulder findings were more likely

than not, due to chronic, degenerative, wear and tear types of pathology

that can be seen in a former football player and avid athlete.

11

(Id. at 12-13.)

b. Petitioner’s Expert, Orthopedist Marko Bodor, M.D. 11

In his report, Dr. Bodor largely focuses on the success of the treatment he

administered to petitioner. He asserts that petitioner’s response to this particular

treatment is consistent with a case series that he asserts provides proof of concept

evidence that for SIRVA cases involving the teres minor and infraspinatus tendon

insertions. (Ex. 32, pp. 2-3.) Dr. Bodor opines that, even if a Hill-Sach deformity was

present, it would not explain the edema he observed in the teres minor tendon and

would not respond to the ultrasonic aspiration and debridement procedure her

successfully performed on petitioner. (Id. at 3.) Dr. Bodor suggests that it is reasonable

that he was the first to detect the teres minor abnormality upon ultrasound. (Id.) He

indicates that ultrasound is more sensitive to the type of cortical abnormality he

observed on the teres minor and the abnormality is small enough to have potentially

been overlooked by the radiologist. (Id.) Dr. Bodor opines that petitioner “sustained a

classic SIRVA injury with no history of prior shoulder problems, onset of pain within 48

hours, symptoms for more than 6 months, concordant physical examination and MRI

findings, and fortunately near-complete resolution of his pain and disability following

treatment tarted to the areas of his disease.” (Id.)

V. Discussion

Petitioner argues that he is entitled to compensation for his shoulder injury, either

as a Table SIRVA or on the basis of a shoulder injury caused-in-fact by his vaccination.

(ECF No. 50, pp. 7-13; see also ECF No. 32, pp. 22-38.) Respondent disputes as a

threshold matter that petitioner has met the statutory severity requirement under the

Vaccine Act. (ECF No. 51, pp. 7-11; see also ECF No. 29, pp. 7-9; ECF No. 38, pp. 7-

11.) Regarding a Table SIRVA, respondent contends that petitioner’s injury is explained

by prior shoulder dysfunction that predated his vaccination, implicating the first and

fourth of the SIRVA QAI criteria. (ECF No. 51, pp. 9-11; see also ECF No. 32, pp. 8-9;

ECF No. 38, pp. 8-11.) Respondent also dispute that petitioner has demonstrated

causation-in-fact. (ECF No. 51, pp. 11-14; see also ECF No. 32, pp. 38-41; ECF No.

38, pp. 11-13.) Because I have concluded that petitioner has demonstrated the

presence of a Table SIRVA, it is not necessary to address the parties’ arguments with

respect to causation-in-fact.

11

Dr. Bodor received his medical degree from the University of Cincinnati in 1987 and completed a

surgery internship at the University of California, San Diego, in 1988. (Ex. 18, p. 1.) He completed his

physical medicine and rehabilitation residency at the University of Michigan in 1993. (Id.) Along with

three fellows, he sees approximately 28 patients per day, where he performs diagnostic and therapeutic

procedures. (Id. at 2.) Dr. Bodor is affiliated with the UCSF Department of Neurological Surgery and the

UC Davis Department of Physical Medicine and Rehabilitation, collaborating in the care of patients and

teaching visiting faculty, fellows, residents, medical and pre-medical students. (Id.) He also serves as the

medical director of the Napa Medical Research Foundation, spending approximately 10-20 hours per

week supervising research assistants and PhD students. (Id.)

12

a. Severity Requirement

In order to state a claim for a vaccine-related injury under the Vaccine Act, a

vaccinee must have either:

(i) suffered the residual effects or complications of such illness, disability,

injury, or condition for more than 6 months after the administration of the

vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered

such illness, disability, injury or condition from the vaccine which resulted

in inpatient hospitalization and surgical intervention.

§ 300aa-11(c)(1)(D); see also Black v. Sec’y of Health & Human Servs., 33 Fed. Cl.

546, 550 (1995) (reasoning that the “potential petitioner” must not only make a prima

facie case, but clear a jurisdictional threshold, by “submit[ting] supporting

documentation which reasonably demonstrates that a special master has jurisdiction to

hear the merits of the case”), aff’d, 93 F.3d 781 (Fed. Cir. 1996) (internal citations

omitted). In this case, only the first of these conditions is potentially met. 12

The Vaccine Act prohibits a special master from ruling for petitioner based solely

on his allegations unsubstantiated by medical records or medical opinion. § 300aa-

13(a)(1). However, “the function of a special master is not to ‘diagnose’ vaccine-related

injuries, but instead to determine ‘based on the record evidence as a whole and the

totality of the case,’” whether causation has been demonstrated. Andreu ex rel. Andreu

v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1382 (Fed. Cir. 2009) (quoting

Knudsen ex rel. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549 (Fed.

Cir. 1994)). Special masters are not bound by the reports, summaries, or conclusions

contained in the medical records. § 300aa-13(b)(1). Rather, the special master must

consider the entire record. Id.

12

Neither “residual effects” nor “complication” is defined within the Vaccine Act itself. See § 300aa-33.

However, in Wright v. Secretary of Health & Human Services, the Federal Circuit described these terms

as follows: “‘Residual’ suggests something remaining or left behind from a vaccine injury. An effect that is

‘residual’ or ‘left behind’ is one that never goes away or that recurs after the original illness.” 22 F.4th

999, 1005 (Fed. Cir. 2022) (internal citation omitted). A “complication,” however, is a “morbid process or

event occurring during a disease which is not an essential part of the disease, although it may result from

it.” Id. at 1006. (internal citation omitted).

Read together, “residual effects” and “complications” appear to both refer to conditions

within the patient, with “residual effects” focused on lingering signs, symptoms, or sequalae

characteristic of the course of the original vaccine injury, and “complications”

encompassing conditions that may not be “essential part[s] of the disease” or may be

outside the ordinary progression of the vaccine injury.

Id. (alteration in original). Because the complication or residual effect must be “of such illness, disability,

injury, or condition,” the traditional tort concepts of causation apply, and the vaccine injury must be both a

but-for cause and substantial contributing factor to the complication or residual effects at issue. Id. at

1004-05.

13

A petitioner must prove by a preponderance of the evidence the factual

circumstances surrounding his claim. See § 300aa-13(a)(1)(A). However, not every

element of petitioner’s claim needs to be specifically supported by medical records or

opinion. For example, onset of an injury may be determined to be consistent with the

Vaccine Injury Table even when the first symptom or manifestation “was not recorded or

was incorrectly recorded as having occurred outside such period.” § 300aa-13(b)(2).

The fact of a vaccination also need not itself be proven by medical records or medical

opinion. See, e.g., Wonish ex rel. Wonish v. Sec’y of Health & Human Servs., No. 90-

667V, 1991 WL 83959, at *4 (Cl. Ct. Spec. Mstr. May 6, 1991) (stating, with regard to §

300aa-13(a)(1), that “it seems obvious then that not all elements must be established by

medical evidence” and that “[v]accination is an event that in ordinary litigation could be

established by lay testimony” as “[m]edical expertise is not typically required”);

Centmehaiey v. Sec’y of Health & Human Servs., 32 Fed. Cl. 612, 621 (1995) (noting

that the “lack of contemporaneous, documentary proof of vaccination, however, does

not necessarily bar recovery”), aff’d, 73 F.3d 381 (Fed. Cir. 1995). The Federal Circuit

has also observed, albeit in the context of attorneys’ fees and costs, that

[w]hile lay opinions as to causation or medical diagnosis may be properly

characterized as mere “subjective belief” when the witness is not competent

to testify on those subjects, the same is not true for sworn testimony as to

facts within the witness’s personal knowledge, such as the receipt of a

vaccine and the timing and severity of symptoms.

James-Cornelius ex rel. E.J. v. Sec’y of Health & Human Servs., 984 F.3d 1374, 1380

(Fed. Cir. 2021).

However, medical records do ordinarily “warrant consideration as trustworthy

evidence.” Cucuras ex rel. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525,

1528 (Fed. Cir. 1993). Thus, where subsequent testimony conflicts with

contemporaneous medical records, special masters frequently accord more weight to

the medical records. See, e.g., Reusser ex rel. Reusser v. Sec’y of Health & Human

Servs., 28 Fed. Cl. 516, 523 (1993) (“written documentation recorded by a disinterested

person at or soon after the event at issue is generally more reliable than the recollection

of a party to a lawsuit many years later”); see also Vergara ex rel. J.A.V. v. Sec’y of

Health & Human Servs., No. 08-882V, 2014 WL 2795491, *4 (Fed. Cl. Spec. Mstr. May

15, 2014) (“Special Masters frequently accord more weight to contemporaneously-

recorded medical symptoms than those recounted in later medical histories, affidavits,

or trial testimony.”).

Special masters are cautioned against favoring contemporaneous records

“reflexively” and must not overemphasize individual records at the expense of a

comprehensive evaluation of the entire record. Shapiro v. Sec’y of Health & Human

Servs., 101 Fed. Cl. 532, 539-41 (2011). “[M]edical records are only as accurate as the

person providing the information.” Parcells ex rel. Parcells v. Sec’y of Health & Human

Servs., No. 03-1192V, 2006 WL 2252749, at *2 (Fed. Cl. Spec. Mstr. July 18, 2006).

Moreover, “the absence of a reference to a condition or circumstance is much less

14

significant than a reference which negates the existence of the condition or

circumstance.” Murphy ex rel. Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct.

726, 733 (1991) (quoting Murphy ex rel. Murphy v. Sec’y of Health & Human Servs., No.

90-882V, 1991 WL 74931, at *4 (Cl. Ct. Spec. Mstr. Apr. 25, 1991)), aff’d, 968 F.2d

1226 (Fed. Cir.), cert. denied, Murphy v. Sullivan, 506 U.S. 974 (1992).

In Kirby v. Secretary of Health & Human Services, the Federal Circuit confirmed

that it is not an error for a special master to find the severity requirement met where that

finding is based on a collection of “plausible evidence.” 997 F.3d 1378, 1381 (Fed. Cir.

2021). In that case, petitioner’s medical records reflected active treatment of her

condition for only a few months before she was released as having reached maximum

medical improvement, though not entirely symptom free. Id. at 1380. Thereafter, the

medical records were silent as to her alleged residual effects for the remaining duration

of the six-month post-vaccination period. Id. However, petitioner testified that she

continued a home exercise plan for more than a year. Id. at 1381. Her testimony was

corroborated by documentation in the form of her retained home exercise sheet, a more

remote return visit where the relevant symptoms were again reported, and an expert

opinion confirming her reported symptoms were consistent with her injury. Id. The

Federal Circuit concluded that where the medical records are silent, rather than

contradictory, it was not error for the special master to credit the petitioner’s

corroborated testimony as evidence satisfying the six-month severity requirement. Id. at

1384.

Here, the medical records are clear. Petitioner began treatment for his alleged

shoulder condition on January 3, 2020, approximately 11 days post-vaccination. (Ex. 6,

pp. 12-13.) Thereafter, he continued seeking regular treatment until June 2, 2020,

approximately five months and ten days post-vaccination. (Ex. 9, p. 14.) At that time,

petitioner was still symptomatic and further physical therapy was anticipated; however,

he began to “no show” for his physical therapy appointments. (Id. at 16.) After that,

there is an undisputed seven-month gap in petitioner’s treatment records. However,

when petitioner returned to care, he provided histories indicating that his symptoms had

persisted. (Ex. 10, p. 2; Ex. 11, p. 3.) Ultimately, Dr. Bodor’s physical examination

confirmed shoulder impingement (positive Hawkins test), which had been a feature of

his condition during his original course of treatment. (Compare Ex. 11, pp. 3, 7 and Ex.

7, pp. 4, 12.) In and of itself, a seven-month gap in treatment is not necessarily

informative of whether a SIRVA or SIRVA-like injury persisted. For example, in Ratzlaff

v. Secretary of Health & Human Services, I awarded damages to a SIRVA petitioner

who had several extended gaps in her treatment history, including an 11-month gap, a

16-month gap, a 13-month gap, and a six-month gap. 18-1017V, 2023 WL 4072909

(Fed. Cl. Spec. Mstr. May 24, 2023). While the parties disputed the significance of the

treatment gaps vis-à-vis the severity of the petitioner’s ongoing symptoms, it was

undisputed that the petitioner had an overall six-year history of symptoms sequela to

her SIRVA. Id. at *7.

Nonetheless, respondent raises three points of concern. First, respondent

contends that petitioner’s premature departure from physical therapy implies his injury

15

had resolved. (ECF No. 51, pp. 7-8; Ex. B, p. 8.) Second, respondent contends that

petitioner’s subsequent medical records should be given less weight because he

resumed treatment after he filed his petition for compensation. (ECF No. 51, pp. 8-9

(citing Kohl v. Sec’y of Health & Human Servs., No. 16-748V, 2022 WL 4127217, at *24

(Fed Cl. Spec. Mstr. Aug. 18, 2022); Gerami v. Sec’y of Health & Human Servs., No.

12-442V, 2013 WL 5998109, at *4 (Fed Cl. Spec. Mstr. Oct. 11, 2013), mot. rev. den’d,

127 Fed. Cl. 299 (2014); Goodgame v. Sec’y of Health & Human Servs., 157 Fed. Cl.

62 (2021)).) And, third, respondent contends through his expert that the physical

findings included in his medical records following the 7-month gap in treatment are not

supportive of SIRVA. (Id. at 8.)

Respondent’s suggestion that petitioner discontinued physical therapy because

his condition had resolved is speculative and not well supported by the record of this

case. It is clear from petitioner’s final physical therapy encounter, which was just about

20 days shy of the six-month mark, that he was still symptomatic (Ex. 9, p. 14) and

nothing in any of the medical records suggests he had recovered. Respondent’s own

expert identifies two primary reasons a person will discontinue physical therapy – either

the patient feels the condition resolved and further physical therapy is not needed or the

patient feels the physical therapy is not helping and they feel the need for further

evaluation. (Ex. B, p. 8.) While Dr. Bishop assesses the former to be a more likely

explanation in this case, this conclusion is inseparable from her broader skepticism of

petitioner’s treatment history that I do not find persuasive. (See n. 9, 10, supra.) In

effect, Dr. Bishop opines that petitioner was not frustrated by his treatment because, in

her view, he should not have been frustrated by his treatment. (See n. 10, supra.)

However, this conclusion is directly contradicted by petitioner’s subsequent psychology

encounter in which he explicitly explained that he had been frustrated with his prior

treatment. (Ex. 10, p. 2.) Furthermore, neither Dr. Bishop’s report nor respondent’s

motion response acknowledges that petitioner’s gap in treatment correlates to the rise

of the Covid-19 pandemic. (Ex. B; ECF No. 51.) Petitioner has provided a sworn

statement specifically indicating that the pandemic factored into his decision regarding

ongoing treatment. (Ex. 25, p. 1.) I find this explanation to be facially reasonable and

compatible with the medical records. Moreover, respondent has offered no specific

challenge to it.

Regarding respondent’s second point, it must be stressed that each of the cases

cited by respondent supports the proposition that medical encounters specifically

arranged for purposes of litigation are entitled to less weight. Kohl, 2022 WL 4127217,

at *24 (discussing a medical record that stated “[n]eeds a statement for her attorney . .

.”); Gerami v. Sec’y of Health & Human Servs., No. 12-442V, 2013 WL 5998109, at *4

(Fed. Cl. Spec. Mstr. Oct. 11, 2013) (discussing a treating physician opinion letter filed

after petitioner was ordered to file medical records); Goodgame, 157 Fed. Cl. at 70

(discussing a medical record “arranged ‘at the recommendation of her lawyer.’”). It is

not the case that bona fide treatment records receive less weight simply by virtue of

having been created after the petition was filed. When an ongoing treatment

relationship is present, such medical records still contain “information supplied to or by

health professionals to facilitate diagnosis and treatment of medical conditions. With

16

proper treating hanging in the balance, accuracy has an extra premium.” Cucuras, 993

F.2d at 1528. In this case, even granting that Dr. Bodor’s dual role as treating physician

and expert has the potential to blur these distinctions within the most recent records,

respondent has not come forward with any reason – apart from timing – to suspect that

petitioner’s telehealth psychology encounter was for purposes of litigation. Although the

medical record does state that petitioner “is now going to see a lawyer and look into

what he went though/his situation,” this is referenced only as part of petitioner’s overall

history, not as any indication of the purpose of the encounter. (Ex. 10, p. 2.)

Petitioner’s medical record supports that his ongoing shoulder symptoms and frustration

with what he viewed as ineffective prior treatment were the underlying foundation for the

anxiety and depression he was seeking to treat at that time. (Id. at 2-3.)

Additionally, Dr. Bodor’s subsequent medical records confirm on physical

examination that petitioner presented with full, but painful, range of motion and signs of

impingement. (Ex. 11, pp. 3, 7.) Dr. Bishop raises a concern that the findings of

tenderness over the teres minor and pain with cross chest abduction that informed Dr.

Bodor’s specific use of Tenex treatment in March of 2021 were not present at his earlier

January encounter. (Ex. B, p. 11.) However, she agrees that “a positive impingement

sign [was] noted several times in the records.” (Id. at 12.) Thus, it is not necessary to

resolve whether the additional findings of teres minor tenderness and cross abduction

pain were sequela to petitioner’s original injury or whether the resulting Tenex treatment

is supportive of Dr. Bodor’s opinion. Dr. Bishop has not called into question that painful

range of motion and signs of impingement are consistent with petitioner’s prior history

and consistent with sequela of SIRVA.

For all of these reasons, I find that there is preponderant evidence that symptoms

attributable to petitioner’s post-vaccination shoulder injury persisted for at least six

months. This conclusion does not turn on the significance (if any) of Dr. Bodor’s use of

a Tenex treatment.

b. Table SIRVA

i. QAI criteria (ii) and (iii) are undisputed

In his motion, petitioner asserts that onset of his alleged shoulder pain arose

within 48 hours of his vaccination, as required by the second SIRVA QAI criterion, and

that his pain and reduced range of motion were limited to his affected shoulder, as

required by the third SIRVA QAI criterion. (ECF No. 32, pp. 25-30.) In his Rule 4

Report and two motion responses, respondent has only ever challenged petitioner’s

Table SIRVA allegation based on QAI criteria (i) and (iv), which are discussed below.

(ECF No. 29, pp. 8-9; ECF No. 38, pp. 8-11; ECF No. 51, pp. 9-11.) Thus, petitioner’s

satisfaction of the second and third SIRVA criteria is undisputed.

I do note, however, that Dr. Bishop herself disputed that onset of petitioner’s

shoulder pain arose within 48 hours of vaccination. (Ex. B, p. 12.) However, I do not

find Dr. Bishop’s reasoning to be persuasive. Dr. Bishop focuses merely on the fact that

17

petitioner did not report shoulder pain when, about 24 hours post-vaccination, he

reported a broader reaction that was attributed to his antibiotic. (Id.) Considering the

records as a whole, the treatment records for the shoulder condition provide

preponderant evidence of onset of shoulder pain within 48 hours of vaccination. Dr.

Bishop also appears to dispute that petitioner met the third SIRVA criterion because he

did not have reduced range of motion (Id.); however, she indicates only that he never

lost passive range of motion (Id). The physical therapy evaluation confirmed that he did

have impaired active range of motion. (Ex. 9, p. 3.) There has been no suggestion that

his pain and reduced range of motion were not limited to the affected shoulder.

Based on the record as a whole, I find that petitioner has satisfied the second

and third SIRVA criteria by preponderant evidence.

ii. QAI criteria (i) and (iv)

Under the first SIRVA QAI criterion, petitioner must show that there is “[n]o

history of pain, inflammation or dysfunction of the affected shoulder prior to

intramuscular vaccine administration that would explain [his] alleged signs, symptoms,

examination findings, and/or diagnostic studies occurring after vaccine injection.” 42

C.F.R. 100.3(c)(10). Additionally, under the fourth criterion, he must show that “[n]o

other condition or abnormality is present that would explain the patient's symptoms (e.g.

NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or

any other neuropathy).” Id. In this case the first and fourth SIRVA criteria are best

addressed together, because respondent offers one argument that implicates both

criteria. That is, respondent argues that, despite first experiencing left shoulder

symptoms subsequent to vaccination, petitioner’s shoulder symptoms are explained by

findings consistent with a longstanding prior shoulder dysfunction. (ECF No. 29, p. 9;

ECF No. 38, pp. 9-10; ECF No. 51, p. 10.) Thus, respondent’s contentions with respect

to the first and fourth criteria rise or fall together.

Respondent’s expert opines (1) that petitioner’s cortical deformity in the humeral

head on MRI is consistent with a “Hill-Sachs deformity” which is indicative of a prior

shoulder dislocation, (2) that petitioner had other MRI findings consistent with

degenerative changes, and (3) that petitioner did not have any of the classic findings

associated with SIRVA. (Ex. B, pp. 3, 7-8.) Thus, combined with a reported history of

athletic activity, including football, she opines “with a reasonable degree of medical

certainty that there is no objective evidence or documentation to support the shoulder

symptoms of Mr. Burroughs were caused by his tetanus vaccination on 12/23/2019.[13]

13

To be clear, Dr. Bishop misstates petitioner’s burden of proof to the extent that she implies petitioner

has a burden of demonstrating that his tetanus vaccine caused his symptoms. Under the Vaccine Injury

Table, petitioner is entitled to a presumption of vaccine causation. § 300aa-13(a)(1); § 300aa-

11(c)(1)(C)(i); § 300aa-14(a). Pertinent to this discussion, petitioner’s burden of proof under the fourth

SIRVA criterion is to demonstrate either (a) that his history is entirely free of the alternative condition at

issue or (b) if not, that the condition would not explain his symptoms. 42 C.F.R. 100.3(c)(10)(iv); Durham

v. Sec’y of Health & Human Servs., No. 17-1899V, 2023 WL 3196229, at *14 (Fed. Cl. Spec. Mstr. May 2,

2023).

18

(Id. at 12.) There is insufficient support for this in the records and there is instead

evidence to support that his left shoulder findings were more likely than not, due to

chronic, degenerative, wear and tear types of pathology that can be seen in a former

football player and avid athlete.” (Id. at 12-13.)

Importantly, however, although SIRVA criterion four requires the petitioner to

show that “[n]o other condition or abnormality” would explain petitioner’s symptoms,

SIRVA itself is not limited to any specific finding or diagnosis. The QAI definition of

SIRVA was specifically drafted to encompass unspecified musculoskeletal shoulder

dysfunction. The proposed rulemaking explained that it was intended to capture

“several diagnoses, beyond deltoid bursitis, that resulted in shoulder pain following

vaccination, including tendonitis, impingement syndrome, frozen shoulder syndrome,

and adhesive capsulitis.” National Vaccine Injury Compensation Program: Revisions to

the Vaccine Injury Table, 80 Fed. Reg. 45132-01 (proposed July 29, 2015) (to be

codified at 42 CFR pt. 100). In that regard, the QAI defines SIRVA broadly as “an injury

to the musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae,

etc.).” 42 C.F.R. 100.3(c)(10). Thus, SIRVA is in effect a clinical syndrome and

petitioner does not bear any burden to demonstrate a specific diagnosis or MRI finding

that would support its presence. Therefore, when respondent contends that intrinsic

shoulder pathology constitutes a condition that would otherwise explain petitioner’s

symptoms, “the question raised by respondent’s argument is whether petitioner’s own

clinical history indicates that [his] shoulder pathology wholly explains [his] symptoms

independent of vaccination.” Lang v. Sec’y of Health & Human Servs., No. 17-995V,

2020 WL 7873272, at *13 (Fed. Cl. Spec. Mstr. Dec. 11, 2020); see also Quantie v.

Sec’y of Health & Human Servs., No. 18-610V, 2023 WL 2234271, at *20 (Fed. Cl.

Spec. Mstr. Feb. 27, 2023) (observing that “[t]he findings on petitioner’s MRI are not

indicative of ‘whether any other condition could explain petitioner’s symptoms’ . . .”)

It must be noted that it is very common for SIRVA petitioners to have findings on

an MRI that are potentially consistent with preexisting degenerative changes. For

example, petitioner has filed a review conducted by the Department of Health and

Human Services and Centers for Disease Control wherein 476 conceded SIRVA claims

were examined for their clinical features. (Elizabeth M. Hesse et al., Shoulder Injury

Related to Vaccine Administration (SIRVA): Petitioner Claims to the National Injury

Compensation Program, 2010-2016, 38 VACCINE 1076 (2020) (Ex. 27).) They observed

degenerative changes, including rotator cuff degeneration and/or tendinopathy and

acromioclavicular arthritis, in a significant number of SIRVA claimants. (Id. at 5 (Table

5).) Among these compensated claims, 16.2% had evidence on MRI of

acromioclavicular arthritis, a further 16.2% had labral tears, and over 40% had either

complete or partial rotator cuff tears. (Id.)

Moreover, Atanasoff, et al., which was specifically cited in the proposed

rulemaking for SIRVA, accounts for post-vaccination aggravation of preexisting shoulder

dysfunction as a potential explanation for at least some SIRVA cases. Consistent with

Dr. Yacoubian’s suggestion that the vaccination could have contributed to petitioner’s

rotator cuff issues (Ex. 7, p. 11), Atanasoff, et al., state:

19

In general, chronic shoulder pain with or without reduced shoulder joint

function can be caused by a number of common conditions including

impingement syndrome, rotator cuff tear, biceps tendonitis, osteoarthritis

and adhesive capsulitis. In many cases, these conditions may cause no

symptoms until provoked by trauma or other events. Reilly et al., reviewed

a series of shoulder ultrasound and MRI studies obtained in asymptomatic

persons past middle age and found partial or complete rotator cuff tears in

39% of those individuals. Therefore, some of the MRI finding in our case

series, such as rotator cuff tears, may have been present prior to

vaccination and became symptomatic as a result of vaccination-associated

synovial inflammation.

(S. Atanasoff et al., Shoulder Injury Related to Vaccine Administration (SIRVA), 28

VACCINE 8049, 8051 (2010) (Ex. 20, p. 3).)

Thus, respondent’s argument against a Table SIRVA ultimately turns not merely

on whether petitioner had any degenerative changes on MRI, but on whether Dr. Bishop

is persuasive in correlating petitioner’s symptoms to a Hill-Sachs deformity that would

otherwise point to a prior shoulder dislocation as the source of his symptoms regardless

of vaccination.

Petitioner’s medical records do not clearly support Dr. Bishop’s opinion regarding

a prior shoulder dislocation. Dr. Bishop opines that a shoulder dislocation is likely

because “a Hill-Sachs [] is something that only occurs from shoulder

instability/dislocations/or subluxations.” (Ex. B, p. 11 (emphasis original).) However,

petitioner’s MRI was equivocal in noting a cortical deformity with marrow contusion on

the humeral head that was “worrisome” for a Hill-Sachs deformity and recommended

clinical correlation for a “possible history of anterior dislocation of the shoulder.” (Ex. 8,

p. 2.) The MRI report notes the cortical deformity at issue to be “subtle.” (Id. at 3.) Dr.

Bishop reviewed only the MRI report and not the underlying imaging. Accordingly, she

has no basis for urging a more definitive conclusion regarding the possible Hill-Sachs

deformity. Moreover, petitioner’s treatment records never provided the clinical

correlation recommended by the radiologist. Petitioner returned to his orthopedist on

March 18, 2020, specifically to discuss his MRI results. (Ex. 7, p. 11.) Dr. Yacoubian

noted the evidence of a Hill-Sachs lesion in particular but did not elicit any history of

prior shoulder dislocation. (Id.) Moreover, he also documented that it remained

“conceivable” that petitioner’s symptoms were caused by his vaccination and assessed

impingement with a “history of tetanus injection with lateral pain right shoulder.” (Id. at

12.) Dr. Bishop believes Dr. Yacoubian’s record expresses doubt on the whole that

petitioner’s symptoms were vaccine caused, but regardless, Dr. Yacoubian’s record

provides no support for the idea that petitioner’s symptoms are better explained by any

history of shoulder dislocation, instead emphasizing that onset was correlated to the

vaccination.

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Dr. Bishop also overstates the degree to which the medical records implicate

petitioner’s athleticism as a cause of his injury. Based on several notations in the

medical records, Dr. Bishop opines that petitioner was an “avid” athlete. (Ex. B, p. 13.)

However, nothing in the medical records supports this as a cause of petitioner’s

symptoms. When petitioner first presented for orthopedic care, Dr. Yacoubian simply

recorded as part of petitioner’s history that “[t]he patient is very physically active and

enjoys going to the gym and working out and keeping in good shape.” (Ex. 7, p. 3.)

However, his assessment was nonetheless “left shoulder strain injury, possible injection

related injury.” (Id. at 4.) And, as explained above, Dr. Yacoubian maintained this

assessment even after being prompted by radiology to clinically correlate for a prior

dislocated shoulder. Although petitioner subsequently reported to Dr. Bodor that he had

played football, this was accompanied by a notation explicitly confirming that petitioner

had no history of injury to the shoulder. (Ex. 11, p. 3.) After receiving this history, and

reviewing the MRI report, Dr. Bodor suspected that petitioner had suffered SIRVA rather

than suffering consequences of an old football injury. (Id. at 4.) Despite being aware

that petitioner enjoyed keeping physically fit, none of his treating physicians opined that

either his shoulder symptoms or his MRI findings were caused by his athletic pursuits.

Moreover, as Dr. Bishop acknowledged, the treating physicians repeatedly validated

petitioner’s concern that the symptoms arose post-vaccination. (Ex. B, p. 8.) Without

supporting evidence from the medical records, respondent does not cast doubt on

petitioner’s alleged SIRVA merely by noting that the petitioner enjoys exercise. Accord

Stiller v. Sec’y of Health & Human Servs., No. 20-1841V, 2023 WL 8539387, at *9-11

(Fed. Cl. Spec. Mstr. Nov. 13, 2023).

In sum, petitioner had a distinct onset of shoulder symptoms post-vaccination.

Although his MRI demonstrated some degenerative changes, there is insufficient

evidence to conclude that petitioner’s clinical course is explained by preexisting

shoulder pathology alone and activation of preexisting pathology, including of the rotator

cuff, is consistent with the SIRVA concept. Though petitioner’s treating physicians did

not reach any firm conclusion regarding the cause of his pain, the resulting medical

records show distinct suspicion of a vaccine-related injury and little to no concern of a

prior sports injury as respondent has suggested. The specific MRI finding respondent’s

expert stressed (a Hill-Sach deformity) was only noted by the radiologist equivocally and

that finding was never validated by clinical correlation. For all of these reasons,

petitioner has met SIRVA criteria one and four by preponderant evidence. In reaching

this conclusion, it is not necessary to address the further question of whether Dr.

Bodor’s use of Tenex and findings relative to the teres minor would further confirm the

presence of a SIRVA.

c. Factor unrelated to vaccination

Once petitioner has satisfied his own prima facie burden, respondent has the

opportunity to demonstrate, also by a preponderance of the evidence, that petitioner’s

injury was nonetheless caused by a factor unrelated to vaccination. §§ 300aa-

13(a)(1)(B), (a)(2); Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717

F.3d 1363, 1367 (Fed. Cir. 2013). Although respondent argued that preexisting

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shoulder pathology was present and would defeat petitioner’s Table claim under SIRVA

criterion four, he has not explicitly argued that he could meet his own burden of proof to

establish that the pathology at issue actually more likely than not caused petitioner’s

shoulder injury. And, indeed, for the reasons discussed above, I found that the

evidence preponderates against such a conclusion. Thus, even additionally considering

respondent’s arguments as endorsing factors unrelated to vaccination as the cause of

petitioner’s injury, those arguments would still fail for all the same reasons discussed

above.

VI. Conclusion

After weighing the evidence of record within the context of this program, I find by

preponderant evidence that petitioner suffered a Table Injury of SIRVA resulting from

his December 23, 2019 Tdap vaccination and that the injury persisted for at least six

months. Accordingly, petitioner is entitled to compensation for his SIRVA. A separate

damages order will be issued.

IT IS SO ORDERED.

s/Daniel T. Horner

Daniel T. Horner

Special Master

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