Grossmann v. Secretary of Health and Human Services

In the United States Court of Federal Claims

f

OFFICE OF SPECIAL MASTERS

No. 18-00013V

Filed: February 15, 2022

PUBLISHED

Special Master Horner

SUSAN GROSSMANN,

Petitioner, Shoulder Injury Related to

v. Vaccine Administration

(“SIRVA”); Influenza (“Flu”)

SECRETARY OF HEALTH AND Vaccine; Table Injury; Ruling on

HUMAN SERVICES, the Record

Respondent.

Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for

petitioner.

Sarah Duncan, U.S. Department of Justice, Washington, DC, for respondent.

RULING ON ENTITLEMENT 1

On January 2, 2018, petitioner, Susan Grossman, filed a petition under the

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

her receipt of an influenza vaccination on October 21, 2016, caused a left shoulder

injury. (ECF No. 1.) For the reasons set forth below, I conclude that petitioner is

entitled to an award of compensation.

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,

1 Because this decision contains a reasoned explanation for the special master’s action in this case, it will

be posted on the United States Court of Federal Claims’ website in accordance with the E-Government

Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic

Government Services). This means the decision 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 the special master, upon review, agrees that the identified material fits within this definition, it will be

redacted from public access.

2All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa-

10-34.

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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 administration of an influenza vaccine. § 300aa-14(a) as amended by 42 CFR §

100.3. Table Injury cases are guided by statutory “Qualifications and aids in

interpretation” (“QAIs”), which provides more detailed explanation of what should be

considered when determining whether a petitioner has actually 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 description:

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;

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

the intramuscular vaccine was administered; and

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(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

or death 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 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 v. Sec’y of Health & Human Servs., 592 F.3d 1315,

1321 (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 at 1322 n.2. Proof of medical

certainty is not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867, 873

(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-13(a)(1).

II. Procedural History

This case was originally assigned to the Special Processing Unit (“SPU”). (ECF

No. 1.) Petitioner filed medical records between January 16, 2018, and July 30, 2019.

(ECF Nos. 7-8, 13, 31, 41, 45.) Respondent initially requested that his Rule 4(c) report

remain suspended while the parties pursued settlement negotiations. (ECF No. 23.)

However, the parties were unable to informally resolve the case and respondent filed

his Rule 4(c) report recommending against compensation on October 15, 2019. (ECF

No. 49.)

On April 2, 2020, petitioner filed an expert report authored by orthopedist Clifford

J. Colwell, Jr., M.D. (ECF No. 53.) This case was then reassigned from the Special

Processing Unit to Special Master Roth on May 11, 2020. (ECF No. 57.) On June 9,

2020, respondent filed a responsive expert report from Paul Cagle, M.D. (ECF No. 58.)

Thereafter, petitioner substituted a different expert (Uma Srikumaran, M.D.) and both

parties filed additional expert reports on October 8 and December 7, 2020. (ECF Nos.

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61, 65.) On January 21, 2021, petitioner filed a supplemental report from Uma

Srikumaran, M.D. (ECF No. 66.)

This case was reassigned to my docket on January 29, 2021. (ECF No. 68.) On

March 23, 2021, respondent filed a second supplemental expert report from Dr. Cagle.

(ECF No. 70.) The parties subsequently determined that the record was complete.

(ECF No. 71.) On June 2, 2021, petitioner filed a motion for a ruling on the record.

(ECF No. 73.) Respondent filed his response on July 2, 2021. (ECF No. 74.)

Petitioner filed her reply on July 19, 2021. (ECF No. 75.)

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 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. As reflected in the medical records

Petitioner’s prior medical history is significant for hyperlipidemia, obesity,

vestibular neuronitis, Lyme disease, temporomandibular joint dysfunction, varicose

veins, degenerative disc disease, right hip bursitis and osteoarthritis. 3 (Ex. 2, pp. 36-37;

Ex. 3, passim; Ex. 4, pp. 131-93; Ex. 11, pp. 1-5; Ex. 12, passim.) Respondent agrees,

however, that “[p]etitioner did not have a history of left shoulder pain or injury.” (ECF

No. 74, p. 4.)

On October 21, 2016, petitioner received an influenza vaccination at Rite Aid

Pharmacy in the left deltoid. (Ex. 1, p. 1.) On November 7, 2016, petitioner called her

primary care physician Kenneth Lubansky, M.D., reporting that she received a flu shot

in her left arm and “[t]he pharmacist hit a nerve, she has extreme pain in left arm all

across her left side and left upper back, she took an Aspacreme patch with lidocaine

and nothing will relieve it.” (Ex. 8, p. 1.)

On November 15, 2016, petitioner presented to orthopedic surgeon Robert

DeFalco, D.O., complaining of “left shoulder pain.” (Ex. 2, p. 1.) Petitioner stated that

“she has had pain for the past 3 weeks…after getting the flu shot.” (Id.) She

complained of “superior & posterior pain shoulder that radiates up into neck & down

arm.” (Id.) Petitioner further reported “numbness & tingling in left arm & hand.” (Id.)

Dr. DeFalco reviewed petitioner’s left shoulder x-rays which were noted to be negative.

3Petitioner’s physical therapy records further indicate that petitioner underwent an L4 L5 discectomy in

1992 and 1995. (Ex. 4, p. 189; see also Ex. 11, p. 1 (“diskectomies in the lower lumbar spine in 1993 and

1998”))

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(Id. at 1, 11.) Petitioner described pain that was aggravated with range of motion. (Id.

at 1.) Upon physical examination, “[t]enderness over the left tip of the acromion and

subacromial bursa” was noted. (Ex. 2, p. 2.) Petitioner’s “left forward flexion [wa]s 180

degrees with pain in the impingement zone.” (Id.) Hawkins-Kennedy and Neer

impingement tests were positive on the left; though “no tenderness of the left posterior

surface, left parascapular area or left trapezius” was reported. (Id.) Petitioner had full

range of motion in her neck with no pain. (Id.) She was given a steroid injection into

the left shoulder subacromial space. (Id.) Dr. DeFalco’s assessment was “Bursitis of

left shoulder” and petitioner was ordered to start physical therapy and return in three to

four weeks. (Ex. 2, p. 2.)

On November 18, 2016, petitioner presented to Skylands Medical Group Sports

and Physical Therapy where she was seen by Ann Riesenman, P.T., reporting pain in

the lateral left shoulder at the time of the exam, with a pain rating of 3/10. (Ex. 4, p.

127, 129.) Petitioner had an incoming diagnosis of “adhesive capsulitis of left shoulder”

and “impingement syndrome of left shoulder.” (Ex. 4, p. 130.) Petitioner’s range of

motion was 70 degrees external rotation with associated pain and “tenderness &

multiple trigger points” with positive impingement signs. (Ex. 4, pp. 128.) Petitioner’s

assessment included decreased shoulder range of motion with associated pain. (Ex. 4,

p. 129.)4

On December 9, 2016, petitioner presented to Kevin White, D.O., complaining of

right hip pain beginning on December 5, 2016. (Ex. 2, p. 12.) Petitioner “pivoted with

her right foot and she felt a sharp stabbing pain in her right hip which radiates down into

her groin.” (Id.) X-rays of petitioner’s hip revealed no fractures, no dislocations, and

mild degenerative joint disease. (Id. at 13.) Petitioner was diagnosed with right hip

osteoarthritis. (Id.) This record contained no mention of petitioner’s shoulder, arm, or

neck pain. (See id.)

On December 19, 2016, petitioner returned to Ann Riesenman for physical

therapy for continued left shoulder pain. (Ex. 4, p. 111-12.) Petitioner noted that the

“pain is less intense into the [left] upper arm but most of the day present in the [left]

cervical region – upper trap.” (Ex. 4, p. 111.) At the time of exam, petitioner reported

4/10 pain in the lateral left shoulder. (Id.) Petitioner’s range of motion for left abduction

was 165 degrees and “painful” and left external rotation was 70 degrees and “painful.”

(Id. at 112.) Petitioner’s continued diagnoses were cervicalgia, adhesive capsulitis of

the left shoulder, and impingement of the left shoulder. (Id. at 114.) Petitioner returned

for physical therapy again on January 30, March 8, and April 24, 2017. (Ex. 4, pp. 2-6;

57-61; 82-86.) Petitioner had continued diagnoses of cervicalgia, adhesive capsulitis of

the left shoulder, and impingement of the left shoulder. (Ex. 4, pp. 6, 61, 86.) On April

24, 2017 petitioner reported, “I am frustrated, for I feel like I am no longer improving.”

4Between November 18, 2016, and April 24, 2017, petitioner attended twenty-eight physical therapy

sessions as Skylands Medical Group and Sports Physical Therapy. (Ex. 4, pp. 1-130.)

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(Ex. 4, p. 2.) Petitioner reported “shoulder/Elbow pain and stiffness with reaching,

lifting” however, “I am consistent with the [home exercise program] that helps a lot, and

overall I would say I made a 70% improvement.” (Id.) At this time petitioner “requested

discharge due to not wanting to exhaust her insurance benefits.” (Ex. 4, p. 5.)

On May 5, 2017 petitioner returned to Dr. DeFalco for continued “left shoulder

pain.” (Ex. 2, p. 19.) Petitioner reported “feeling about the same, compared to last

visit.” (Id.) She described “deep and dull throbbing pain” at a 7/10, and Dr. DeFalco

noted that “pain is superior that radiates down to elbow.” (Id.) Upon physical

examination, Dr. DeFalco observed “[left] shoulder – full [range of motion] and strength

[with] no impingement sign.” (Id. at 20.) Petitioner was given a steroid injection in the

left shoulder subacromial space. (Id.) She was diagnosed with left shoulder bursitis.

(Id.) Dr. DeFalco further noted that he “would like to see [petitioner] for her shoulder

next week. I believe her pain is coming from her cervical spine. Overall, motion and

strength in the [left] shoulder are good[.]” (Id.) Dr. DeFalco ordered an MRI of the

cervical spine and instructed petitioner to follow up with Dr. Salari. (Id.)

On June 2, 2017 petitioner presented to orthopedic surgeon Benham Salari,

D.O., for “neck pain / left arm.” (Ex. 2, p. 29.) Petitioner presented with “complaint of

neck & left arm pain that started in October 2016 following a Flu shot. Patient with left

sided [cervical spine] pain that extends to left shoulder & elbow.” (Id.) She also

reported upper arm spasms, left arm weakness and rated her pain at 5-10/10,

“aggravated by everything, mostly sleeping.” (Id.) Upon physical examination Dr. Salari

noted “bilateral upper and lower extremities have good range of motion and no

significant deformities.” (Id. at 30.) The cervical spine MRI performed on May 9, 2017,

revealed mild degenerative changes of the cervical spine; small right paracentral disc

protrusions at C5-C6 and C6-C7; and no significant spinal canal or neural foraminal

stenosis at any level. (Id. at 27-28, 30.) Dr. Salari’s assessment was left shoulder

bursitis. (Id. at 31.) Dr. Salari ordered a left shoulder MRI to assess for rotator cuff

pathology. (Id.) He further noted that “MRI findings do not suggest cervical spine

pathology or cervical spine radiculopathy.” (Id.)

On July 12, 2017, petitioner underwent an MRI of the left shoulder. (Ex. 2, pp.

41-42.) The MRI revealed minimal lateral humeral joint effusion, degenerative marrow

changes to the acromioclavicular joints, increased linear signal along the thickened

supraspinatus tendon “probably representing tendinopathy.” (Id. at 41.) It further

revealed mild interstitial tears, though the infraspinatus, subscapularis and teres minor

tendons were intact, “no definite labral tear” was identified, there was moderate AC joint

arthropathy and laterally sloping acromial process “which does demonstrate mild mass

effect on the superior surface of the proximal supraspinatus tendon.” (Id.) Accordingly,

the radiologist’s impression indicated supraspinatus tendinopathy with mild interstitial

tears; moderate AC joint arthropathy; and mild impingement with lateral sloping

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acromial process demonstrating a mild mass effect on the superior surface of the

proximal supraspinatus tendon. (Id.)

On August 1, 2017 petitioner returned to Dr. DeFalco for continued left shoulder

pain. (Ex. 2, p. 43.) Dr. DeFalco noted petitioner’s “[p]ain is superior that radiates down

arm” and “rated as 3/10 in severity right now and 8/10 in severity at its worst.” (Id.)

Upon physical examination, he noted “[t]enderness over the left tip of the acromion and

subacromial bursa.” (Id. at 44.) Petitioner demonstrated full forward elevation, full

external rotation, full internal rotation, and left forward flexion was noted at 180 degrees

with pain in the impingement zone. (Id.) Hawkins-Kennedy and Neer impingement

tests were positive on the left. (Id.) Dr. DeFalco noted that the left shoulder MRI

showed rotator cuff tendonitis, and no tears of the rotator cuff. (Id.) Petitioner was

assessed with left shoulder bursitis. (Id.) Dr. DeFalco further noted that petitioner “has

had pain for 9 mo[nths] – difficulty sleeping every night – has had PT and HEP / nsaids

without any improvement [in] l[eft] shoulder.” (Ex. 2, p. 44.) Dr. DeFalco concluded “at

this point would suggest arthroscopy l[eft] shoulder – subacromial decompression.” (Id.)

On August 14, 2017 Dr. DeFalco made a preoperative diagnosis of “impingement

syndrome, left shoulder” and “Labral tear, anterior-posterior superior labral complex.”

(Ex. 6, p. 85.) During surgery, Dr. DeFalco noted that there were no degenerative

changes in the joint itself, though he observed a “labral tear in the anterior-posterior

superior labral complex and a debridement was performed.” (Id. at 86.) The rotator cuff

and glenohumeral ligament were intact. (Id.) Dr. DeFalco further noted that the

subacromial space had “thick bursitis” where a “bursectomy was performed.” (Id.) He

also observed “a rather large anterolateral spur” and thus a “subacromial

decompression was performed.” (Id.) No complications were noted. (Id.)

On August 24, 2017, petitioner presented to Diane Niestepski, PA-C, for her first

post-operative appointment. 5 (Ex. 2, p. 50-52.) Petitioner complained of “constant achy

pain of left shoulder rated as a 3/10.” (Id. at 50.) The sutures were removed, a

cortisone injection to the subacromial space was performed, range of motion was

initiated, and physical therapy was recommended. (Id.) Petitioner’s diagnoses included

superior glenoid labrum lesion of the left shoulder, subsequent encounter; bursitis of the

left shoulder; and impingement syndrome of the left shoulder. (Id. at 51.) On

September 19, 2017, petitioner returned for another follow-up appointment with Dr.

DeFalco. (Id. at 53-55.) Dr. DeFalco noted that petitioner was “feeling better compared

to last visit.” (Id. at 53.) He documented left forward flexion at 180 degrees with pain in

the impingement zone; full left external and internal rotation at 90 degrees abduction.

(Id. at 54.) Petitioner’s Hawkins-Kennedy and Neer impingement tests were positive on

the left. (Id.) Petitioner’s diagnoses remained the same as her previous visit and Dr.

5Between August 28, 2017, and December 13, 2017, petitioner attended 27 physical therapy sessions at

Skyland Sports and Physical Therapy. (Ex. 4, pp. 194-225; Ex. 7.)

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DeFalco instructed her to follow-up in four weeks. (Id.) On December 12, 2017,

petitioner presented to Dr. DeFalco, again noting that she was “feeling better compared

to last visit.” (Ex. 2, p. 72.) She reported soreness at 3/10 in severity in the office and

4/10 severity at its worst. (Id.) Dr. DeFalco noted that petitioner’s “shoulder looks pretty

good.” 6 (Id. at 74.) Upon physical examination, he documented full forward flexion

bilaterally and full left external and internal rotation at 90 degrees abduction bilaterally.

(Id. at 73.) No signs of impingement pain were documented. (See id.)

Ten months later, on October 30, 2018, petitioner presented for a follow-up

appointment with Dr. DeFalco. (Ex. 15, pp. 1-2.) Petitioner complained of “superior

shoulder pain & lateral left elbow pain” that was aggravated “by reaching, lifting,

carrying, laying on left side.” (Id.) Her pain was “alleviated by Oxycodone that she just

weaned off, heat ice[.]” (Id.) Petitioner requested a prescription for aquatic physical

therapy for the left shoulder. (Id.) Petitioner reported her left shoulder pain was a 3/10.

(Id.) Her physical exam revealed tenderness over the left tip of the acromion and

subacromial bursa; left forward flexion at 180 degrees with pain in the impingement

zone; and Hawkins-Kennedy and Neer impingement tests were positive on the left. (Id.

at 2.) Petitioner was diagnosed with left shoulder bursitis. (Id.)

Between October 9, 2018, and December 27, 2018, petitioner attended nine

aquatic therapy sessions for treatment on her left shoulder. (Ex. 17, pp. 1-15.)

Subsequently, between April 18, and May 1, 2019, petitioner attended four aquatic

therapy sessions, during which time she reported shoulder pain. (Ex. 17, pp. 16-34.)

On May 31, 2019, petitioner presented to her physical therapist who recommended that

she return to the orthopedist for tenderness along the rotator cuff, hesitance to use the

left shoulder, and functional limitations. (Ex. 17, p. 38.)

On July 16, 2019, petitioner presented to Dr. DeFalco for a follow-up for left

shoulder pain. (Ex. 18, pp. 1-2.) Dr. DeFalco noted that “[p]ain is superior & down into

armpit,” reported “as sharp pain” at 2/10 severity at rest and 7/10 severity at its worst.

(Id.) Upon physical examination, petitioner’s Hawkins-Kennedy and Neer impingement

tests were positive on the left. (Id. at 2.) Petitioner was assessed with left shoulder

bursitis. (Id.) Dr. DeFalco ordered petitioner to continue physical therapy, icing, and

home exercises. (Id.) He offered petitioner a left shoulder injection, but petitioner

declined. (Ex. 18, p. 2.)

b. As reflected in petitioner’s affidavit

Petitioner filed her affidavit on February 27, 2018. (ECF No. 10.) Petitioner

states that she presented to Rite-Aid Pharmacy for a flu vaccine. (Ex. 9, p. 1.) After

6Dr. DeFalco also noted that petitioner was “scheduled for spine surgery next week.” (Ex. 2, p. 74; see

also Ex. 2, p. 68 (petitioner “is intending to have large multilevel spinal fusion surgery in the next few

weeks” (dated 11/30/2017)); Ex. 16, p. 1 (“lumbar decompression and fusion 12/20/1017”).)

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receiving the vaccine, “immediately [she] felt an odd sensation traveling down [her] arm

to [her] elbow.” (Id.) Petitioner was not concerned and “thought it was the fluid from the

vaccine.” (Id.) By the time she arrived home, petitioner avers that “the pain had

increased and gave [her] an intense headache.” (Id.) She speculated that this could be

“symptoms of the flu injection that would likely resolve on its own.” (Id.)

Five days later, on October 26, 2016, petitioner contacted the Rite-Aid pharmacy

to discuss her symptoms. (Ex. 9, p. 1.) By this time, petitioner describes her symptoms

of “deep throbbing pain” in her left arm that “immobilized [her] arm.” (Id.) She avers

that the range of motion in her neck and head were impacted, she had difficulty

sleeping, and experienced frequent headaches. (Id.) Petitioner states that her primary

care physician, Kenneth Lubansky, recommended that she see an orthopedic doctor.

(Id.) On November 15, 2016, petitioner presented to Dr. Robert DeFalco at the

Orthopedic Institute of New Jersey. (Id.) Petitioner states that Dr. DeFalco took x-rays,

gave her a cortisone injection and medication, and prescribed physical therapy. (Id.)

Petitioner avers that she began physical therapy at the Skylands Medical Group

on November 17, 2016. (Ex. 9, p. 1.) Her physical therapy continued through

December 13, 2017. (Id.) Petitioner states that during this time she was under the care

of Dr. DeFalco who attempted a conservative approach involving physical therapy, MRI,

medication, and cortisone injections. (Id.) After these conservative treatments failed,

petitioner states that it was decided that surgery was the best course of action. (Id.)

Subsequently Dr. DeFalco performed surgery on petitioner’s left shoulder on August 14,

2017. (Id.)

Petitioner states completing basic daily functions have become very difficult,

including grooming, dressing, cleaning, lifting, shopping, and driving. (Ex. 9, p. 2.)

According to petitioner, travel, hobbies, and other social activities are no longer

possible. (Id.) She further states that her work managing the bath showroom division at

Hamburg Supply has been affected by her pain. (Id.) Petitioner avers that her job

requires pulling and packing orders and carrying and showing product samples. (Id.)

She further avers that although co-workers assisted her with helping customers, she

lost commissions, she used all of her personal and vacation time when she was unable

to work due to her pain, and she was concerned about losing her job. (Id.) Lastly,

petitioner states that this event caused her to suffer exhaustion, frustration, weight gain

and depression; and she has suffered significant financial hardships related to her

medical expenses. (Id.)

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IV. Summary of Expert Opinions

a. Petitioner’s Initial Expert Clifford Cowell, Jr., M.D.

Initially, petitioner presented an expert opinion by orthopedist Clifford Cowell Jr.,

M.D. 7 Dr. Cowell opines that petitioner meets the requirements for a SIRVA injury. (Ex.

19, p. 1.) Specifically, Dr. Cowell opines that there was no indication that petitioner had

any previous history of pain, inflammation, or dysfunction of the affected shoulder prior

to her flu vaccination. (Id.) Furthermore, he stresses that petitioner’s symptoms began

immediately following the injection. (Id.) Dr. Cowell emphasizes that “all of [petitioner’s]

medical records that discuss the issue of onset…consistently indicate that her pain

occurred within the specific time frame outlined in the SIRVA requirements.” (Id. at 2.)

Dr. Cowell explains that it is “extremely common” for patients with shoulder

injuries to report pain in the neck and arm. (Ex. 19, p. 2.) For support Dr. Cowell cites

Gorski and Schwartz, who reported on thirty-four patients with neck pain who met the

criteria for shoulder impingement syndrome. (Id. (citing Jerrold M. Gorski & Lawrence

H. Schwartz, Shoulder Impingement Presenting as Neck Pain, 85(A) J. OF BONE & JOINT

SURGERY 635 (2003) (Ex. 22).) In that study, Dr. Cowell explains, thirty of thirty-four

patients had immediate relief of neck pain and the remaining four reported substantial

relief three weeks later. (Ex. 19, p. 2.) Dr. Cowell highlights the authors’ conclusion

that, in some patients, neck pain may be caused by shoulder impingement. (Id.)

Shoulder bursitis, Dr. Cowell notes, “doesn’t discriminate between neck and shoulders,

which means pain may occur in either area.” (Id. (citing Anne Asher, Common Causes

of Neck and Shoulder Pain, VERYWELLHEALTH, https://www.verywellhealth.com/common-

causes-of-neck-and-shoulder-pain-4126559 (last updated Nov. 22, 2019) (Ex. 23).)

Three weeks after vaccination, Dr. Cowell observes that petitioner reported

tenderness over the left tip of the acromion and subacromial bursa, petitioner had left

forward flexion at 180 degrees with pain in the impingement zone, and her Hawkins-

Kennedy and Neer tests were positive on the left—all findings consistent with SIRVA.

(Ex. 19, p. 2.) Petitioner’s incoming diagnoses listed in her physical therapy records

include “Adhesive capsulitis of left shoulder” and “Impingement syndrome of left

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Dr. Cowell serves as the medical director of the Shiley Center for Orthopaedic Research and Education

at Scripps Clinic where he acts as the Donald and Darlene Shiley Chair in Orthopaedic Research. (Ex.

19, p. 1.) He is also a clinical professor in the Department of Orthopaedics and Rehabilitation at the

University of California, San Diego, School of Medicine, and an adjunct clinical professor at the

Department of Basic Science and Clinical Research at the Scripps Research Institute. (Id.) Dr. Cowell

served as the chief of the Orthopaedic Division at Scripps Clinic and Director of the Lower Extremity

Reconstruction Fellowship Program for twenty years. (Id.) Dr. Cowell received his medical degree from

the University of Michigan in 1962. (Ex. 20, p. 1.) He completed his orthopaedic residency at the

Hospital for Special Surgery in New York City, and completed a trauma fellowship at Los Angeles County

Hospital. (Id.) Dr. Colwell is board certified in orthopaedic surgery. (Id. at 3.) Between 1968-1970 Dr.

Cowell served in the military as an orthopaedic surgeon at Carswell Air Force Base in Fort Worth, Texas.

(Id. at 1.) Dr. Colwell has authored over 260 peer-reviewed papers, as well as 19 book chapters,

including work related to total shoulder arthroplasty. (Id. at pp. 7-21.) He currently serves at the editor for

Bone and Joint Disease: Index and Review journal and The Journal of Arthroplasty. (Id. at 6.)

10

shoulder,” which Dr. Cowell explains are also consistent with SIRVA. (Id. (citing Ex. 4,

p. 130.)) Though Dr. DeFalco initially suspected petitioner’s shoulder pain came from

the cervical spine, Dr. Cowell observes that her MRI taken on June 2, 2017, did not

support a cervical spine cause for her symptoms. (Id. (citing Ex. 2, pp. 20, 31.)) In fact,

Dr. Cowell observes that orthopedist Dr. Salari ordered an MRI which revealed a

preliminary finding of “Supraspinatus tendinopathy with mild interstitial tears,” which Dr.

Cowell stresses is more consistent with SIRVA than a cervical cause for petitioner’s

pain. (Id.) Dr. Cowell suggests that petitioner’s surgery performed on August 14, 2017,

reduced but did not eliminate her pain, concluding that the surgery “must be considered

a successful procedure, and would indicate an injury to the shoulder consistent with

SIRVA.”8 (Id. at 2-3.)

b. Respondent’s Expert, Paul J. Cagle, M.D., initial report (Ex. A)

Respondent relies on the expert opinion of Paul J. Cagle, M.D. 9 Dr. Cagle

opines that petitioner’s subjective findings do not support the claim of a SIRVA. (Ex. A,

p. 3.) Petitioner described shoulder pain for three weeks after a shoulder vaccination,

but Dr. Cagle states that her pain was “vaguely described as involving her neck and

arm.” (Id.) Her pain was “nonspecific enough” that Dr. DeFalco suggested that he

believed the pain was coming from her neck. (Id.) Dr. Cagle concludes that Dr.

8 Though Dr. Cowell believes that petitioner meets the elements of a SIRVA Table Injury, he also briefly

addresses the elements of causation-in-fact. (Ex. 19, p. 3.) Citing an article by Atanasoff et al., Dr.

Cowell stresses that the theory behind SIRVA has been “well established medically” and has been

described in several well-respected peer reviewed journals. (Id. (citing Sarah Atanasoff et al., Shoulder

injury related to vaccine administration (SIRVA), 28 VACCINE 8049 (2010) (Ex. 24.)) According to Dr.

Cowell, this article provides support for the theory that antigenic material from the vaccine is injected into

synovial tissues resulting in an immune-mediated inflammatory pain reaction. (Id. (citing Atanasoff et al.,

supra, at Ex. 24.) The Arias et al. study in 2017 “adds to the reliability of the theory.” (Id. (citing Martin

Arias et al., Risk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations, 35

VACCINE 4870 (2017) (Ex. 25.)) That petitioner’s pain began on the day of her vaccination is consistent

with Atanasoff and Arias articles. (Id.) Dr. Cowell opines that the influenza vaccine, containing antigenic

material, “caused [petitioner] to suffer shoulder inflammation and pain caused by an immune-mediated

reaction.” (Id.)

9

Dr. Cagle serves an as assistant professor and Associate Program Director in the Department of

Orthopaedic Surgery at the Icahn School of Medicine at Mount Sinai. (Ex. A, p. 1.) He is a member of

the American Shoulder and Elbow Surgeons, and a faculty member of an internationally recognized

shoulder surgery fellowship. (Id.) His current practice focuses on the shoulder, representing 95% or

more of the patients and pathology he treats. (Id.) Dr. Cagle conducts clinical, biomechanical, and basic

science research. (Id.) He has presented scientific work nationally and internationally; and has published

over twenty articles related to shoulder injuries and surgery. (Ex. B, pp. 11-12.) Dr. Cagle is a peer

reviewer for the Journal of Orthopaedic Research, Techniques in Shoulder and Elbow Surgery, and the

Journal of Shoulder and Elbow Surgery. (Id. at 13.) He received his medical degree from Loyola

University Chicago Stritch School of Medicine in 2008. (Id. at 2.) Dr. Cagle completed his orthopaedic

residency at the University of Minnesota Academic Health center and Medical School. (Id.) He also

completed a shoulder and elbow fellowship at Mount Sinai Hospital in New York and is board certified in

orthopaedic surgery. (Id.)

11

DeFalco “took this belief quite seriously as this prompted a referral for an evaluation and

an MRI of her cervical spine.” (Id.)

Upon review of objective findings, Dr. Cagle opines that petitioner’s physical

exam is inconsistent. (Ex. A, p. 3.) Dr. Cagle points to petitioner’s first visit with Dr.

DeFalco November 11, 2016, where she was noted to have impingement pain. (Id.; Ex.

2, pp. 1-3.) However, in petitioner’s visit on May 5, 2017, Dr. Cagle stresses that

petitioner’s physical exam of her left shoulder noted full range of motion and strength

with no signs of impingement. (Id.; Ex. 2, pp. 19-21.) “[T]here is nothing” in the physical

exam from this visit, according to Dr. Cagle, that supports continued bursitis. (Id.)

Again, on October 30, 2018, Dr. Cagle notes that petitioner had the same physical

exam findings, despite an extended time period, multiple cortisone injections, physical

therapy and surgery. (Id.) Yet, Dr. Cagle observes that in an earlier record from

December 13, 2017, petitioner reported to her physical therapist that she had 90%

relief. (Id. (citing Ex. 7, p. 2.)) Overall, Dr. Cagle opines, that “this demonstrates either

an unreliable physical exam or a physical exam pointing away from a diagnosis of

bursitis” and towards “another pathology that could cause the same exam findings on

the first and last visit with Dr. DeFalco.” (Id.)

Dr. Cagle opines that the imaging findings are also not consistent with SIRVA.

(Ex. A, p. 3.) The MRI findings, he explains, demonstrated no signs of bursitis, the most

common finding associated with SIRVA. (Id.) According to the medical literature,

patients with SIRVA have increased fluid signal and bursal fluid on MRI presentation.

(Id.) 10 Furthermore, Dr. Cagle notes that the additional finding of rotator cuff

tendinopathy is also inconsistent with SIRVA. (Id.) Rotator cuff tendinopathy is

consistent with chronic rotator cuff degenerative pathology. (Id.) Multiple studies,

according to Dr. Cagle, have demonstrated through ultrasound and MRI assessments

that people over the age of 50 years old can have asymptomatic rotator cuff pathology.

(Id. at 4.)11 Over fifty percent of individuals who have asymptomatic rotator cuff

10 Citing Jean-Hugues Salmon et al., Bone erosion and subacromial bursitis caused by diphtheria-

tetanus-poliomyelitis vaccine, 33 VACCINE 6152 (2015) (Ex. A, Tab. 1); Patrick Messerschmitt et al.,

Progressive osteolysis and surface chondrolysis of the proximal humerus following influenza vaccination,

35 ORTHOPEDICS e283 (2012) (Ex. A, Tab. 2); Matthew G. Barnes et al., A “needling” problem: shoulder

injury related to vaccine administration, 25 J. AM. BOARD FAM. MED. 919 (2012) (Ex. A, Tab. 3); Gerald

Kuether et al., Atraumatic osteonecrosis of the humeral head after influenza A-(H1N1) v-2009

vaccination, 29 VACCINE 6830 (2011) (Ex. A, Tab. 4); Gokean Okur et al., Magnetic resonance imaging of

abnormal shoulder pain following influenza vaccination, 43 SKELETAL RADIOOGY 1325 (2014) (Ex. A, Tab.

5); Neeti A. Bathia & Todd Stitik, “Influenza vaccine shoulder” –vaccination related traumatic injury to the

infraspinatus: a case report, 43 AM. J. OF PHYSICAL MED. & REHABILITATION S118 (2009) (Ex. A, Tab. 6.);

Soshi Uchida et al., Subacromial bursitis following human papilloma virus vaccine misinjection, 31

VACCINE 27 (2012) (Ex. A, Tab 7.)

11

Citing Jerry S. Sher et al., Abnormal findings on magnetic resonance images of asymptomatic

shoulders, 77 J. OF BONE & JOINT SURGERY 10 (1995) (Ex. A, Tab. 8); Siegbert Tempelhof et al., Age-

related prevalence of rotator cuff tears in asymptomatic shoulders, 8(4) J. OF SHOULDER & ELBOW Surgery

296 (1999) (Ex. A, Tab. 9); Hiroshi Minagawa et al., Prevalence of symptomatic and asymptomatic rotator

12

pathology will become symptomatic in an average of 2.8 years. (Id. (citing Ken

Yamaguchi et al., Natural history of asymptomatic rotator cuff tears: a longitudinal

analysis of asymptomatic tears detected sonographically, 10 J. OF SHOULDER ELBOW

SURG. 199 (2001) (Ex. A, Tab. 11.)) Thus, Dr. Cagle explains, the findings of

tendinopathy represent chronic rotator cuff pathology, “and the natural history of the

diagnosis is over a fifty percent chance of progression to painful symptoms.” 12 (Ex. A,

p. 4.)

c. Uma Srikumaran, M.D., M.B.A., M.P.H., Initial Report (Ex. 26)

After respondent filed his initial expert report, petitioner substituted a different

orthopedic expert, Uma Srikumaran, M.D., M.B.A., M.P.H. 13 Dr. Srikumaran opines that

petitioner’s records indicate that her left shoulder condition was caused by the October

21, 2016, flu vaccination. (Ex. 26, p. 6.) He further opines that there are no records

suggesting a prior history of left shoulder pain or pathology. (Id.)

Dr. Srikumaran emphasizes that petitioner consistently and reliably reported

“immediate shoulder pain (same day) with intensification over time after vaccination” to

cuff tears in the general population: From mass-screening in one village, 10 J. OF ORTHOPAEDICS 8 (2013)

(Ex. A, Tab. 10.)

12 Regarding injection of the vaccine, Dr. Cagle also notes that improper penetration into the bursal layer

is a commonly proposed mechanism in SIRVA cases. (Ex. A, p. 4.) However, for this to occur, an

inappropriate technique and / or an overly long needle would have to have been used. (Id.) Based on

current CDC guidelines and studies testing the appropriate needle length, administration of a vaccine in

petitioner’s case would require a needle over one inch in length in order to penetrate the bursa (based on

someone within petitioner’s weigh and GMI range). (Id. (citing Dose route site and needle size, CENTERS

FOR DISEASE CONTROL AND PREVENTION, www.immunize.org/catg.d/p3085.pdf. (last accessed Mar. 22,

2019) (Ex. A, Tab. 13); Gregory A. Poland et al., Determination of deltoid fat pad thickness: implications

for needle length in adult immunizations, 277(21) J. AM. MED. ASSN. 1709 (1997) (Ex. A, Tab. 14); Michael

Phillip Koster et al., Needle length for immunization of early adolescents as determined by ultrasound,

124 PEDIATRICS 666 (2009) (Ex. A, Tab. 15.)) Based on this data, Dr. Cagle explains that it is highly

unlikely that a standard needle would have penetrated past the deltoid. (Id.) While this may be

potentially relevant regarding a cause-in-fact claim, as long as petitioner demonstrates her injury to be

consistent with a Table Injury, she enjoys a presumption that her injury was caused by her vaccination so

long as respondent does not prove it was caused by a factor unrelated to vaccination.

13 Dr. Srikumaran serves as an associate professor in the Shoulder Division at the Johns Hopkins School

of Medicine and serves as the Shoulder Fellowship Director and Chair of Orthopaedic Surgery for the

Howard County General Hospital. (Ex. 26, p. 1.) He also serves as the Medical Director of the Johns

Hopkins Musculoskeletal Service Line in Columbia, Maryland. (Id.) Each year Dr. Srikumaran sees

approximately 2500-3000 patients for shoulder issues and performs 400-500 shoulder surgeries annually.

(Id.) He has treated approximately ten to twelve patients with shoulder dysfunction after vaccination in

the past five years. (Id.) Dr. Srikumaran received his medical degree from Johns Hopkins School of

Medicine in 2005. (Ex. 27, p. 1.) He completed his orthopaedic residency at Johns Hopkins Hospital and

completed a shoulder surgery fellowship at Massachusetts General Hospital. (Id.) Dr. Srikumaran is

board certified in orthopaedic surgery. (Id. at 10.) He has published numerous articles in the field of

shoulder surgery, though none specifically related to SIRVA. (Ex. 26, p. 1.) He also peer reviews journal

articles for several orthopaedic journals including The Journal of Bone & Joint Surgery, Orthopedics,

Clinical Orthopedics and Related Research, and The Journal of Shoulder and Elbow Surgery. (Id.)

13

several medical providers in various clinical settings. (Id. at 7.) Although petitioner’s

records indicate that her first report of shoulder pain occurred seventeen days post-

vaccination, Dr. Srikumaran explains that “[t]he vast majority of patients do not have

their pain (outside of acute traumas/emergency room situations) evaluated within 48

hours.” (Id.) In fact, he explains that it is “quite normal for someone to wait weeks or

even longer prior to formal evaluation as in [petitioner’s] case.” (Id.)

Dr Srikumaran opines that petitioner’s pain in her shoulder and arm were

consistently reported with reduced range of motion in the shoulder, weakness, and

positive exam tests extending beyond six months. (Ex. 26, p. 7.) Petitioner’s MRI

findings showed rotator cuff partial tears and supraspinatus tendinopathy, both common

conditions associated with SIRVA. (Id. (citing Ex. 2, p. 42.)) Dr. Srikumaran agrees

with Dr. Colwell’s conclusion that petitioner’s clinical course, exam findings, diagnoses,

and medical care (including the arthroscopic surgery) are all appropriate and consistent

with the management of SIRVA. (Id. at 7-8.)

Dr. Srikumaran disagrees with Dr. Cagle regarding the significance of petitioner’s

reports of pain radiating into her neck and down her arm. (Ex. 26, p. 8 (citing Ex. 8; Ex.

2, pp. 1-6, 22, 29-31, 43-45; Ex. 4, p. 246.)) Dr. Srikumaran stresses that “it is

important to recognize ‘radiation’ of the pain is quite different from pain originating at

these other sites (neck/arm).” (Id.) Radiation, he explains, “is simply another way

medical professionals describe the pain, much like severity, quality (sharp, ache), or

associated symptoms (burning, tingling).” (Id.) Furthermore, he stresses that shoulder

pain is well-known to radiate, or extend to, adjacent areas such as the neck or down the

arm. (Id.) At petitioner’s May 5, 2017, visit with Dr. DeFalco, Dr. Srikumaran highlights

the chief complaint of continued left shoulder pain with a final diagnosis of bursitis of the

left shoulder. (Id. (citing Ex. 2, p. 20.)) It was “very appropriate for DeFalco to have

considered potential other sources of shoulder pain” when other treatment methods

were not providing relief, according to Dr. Srikumaran. (Id.) Like Dr. Colwell, Dr.

Srikumaran notes that Dr. DeFalco ruled out a cervical cause for petitioner’s pain based

on petitioner’s MRI and evaluation. (Id. (citing Ex. 2, p. 31.)) Even still, Dr. Srikumaran

stresses that no other conditions, “such as neuropathies or radiculopathies,” can explain

petitioner’s symptoms. (Id.)

In response to Dr. Cagle’s report, Dr. Srikumaran explains that the various

physical findings in petitioner’s visits are quite typical because shoulder pain can

present in different ways and can change over time. (Ex. 26, p. 8.) Dr. Srikumaran

maintains that petitioner was correctly diagnosed with bursitis and that neither Dr. Cagle

nor the medical records suggest any other pathology likely to explain petitioner’s

symptoms. (Id. at 8-9.) While Dr. Cagle suggests that the lack of bursitis in the MRI is

inconsistent with SIRVA, Dr. Srikumaran explains that the operative record is in Exhibit

6, where a camera was directly placed into the subacromial space, noting that the

subacromial space “had ‘thick bursitis’ where a ‘bursectomy was performed.’” (Id. at 9

(citing Ex. 6, p. 86.)) Quoting the MRI, Dr. Srikumaran notes that “[t]here is increased

14

linear signal along the thickened supraspinatus tendon probably representing

tendinopathy with mild interstitial tears.” (Id.) Dr. Srikumaran explains that the finding

of “increased linear signal” could be interpreted as bursitis. (Id.) He stresses that in

petitioner’s case there was direct arthroscopic visualization of bursitis at the time of

surgery. (Id.) Moreover, Dr. Srikumaran notes that rotator cuff pathology is quite

common in individuals over the age of fifty, and the vast majority of cases are

asymptomatic. (Ex. 26, p. 9.) In petitioner’s case, the immediate and sudden pain

occurring soon after vaccination is not consistent with the “slow waxing and waning”

development of symptoms of this chronic condition. 14 (Id.)

d. First Supplemental Report, Dr. Cagle (Ex. C)

In his first supplemental expert report, Dr. Cagle disputes Dr. Srikumaran’s claim

that shoulder pain can present in different ways and change over time. (Ex. C, p. 1

(citing Ex. 23, p. 9.)) Suggesting that shoulder pathology can change from time to time,

without reason or course, suggests that the pathology is random, Dr. Cagle explains.

(Ex. C, p. 1.) Shoulder pathology, however, is not random; and Dr. Cagle further

stresses that Dr. Srikumaran has not provided any evidence documenting a change

over time with treatments and outcomes. (Id.) According to Dr. Cagle, Dr. Srikumaran

incorrectly interprets the radiating pain beyond the shoulder as consistent with a SIRVA.

(Id.) Dr. Cagle observes that petitioner described “symptoms outside of the shoulder

area at the first complaint and during a therapy visit 27 post-vaccination.” (Id.)

14 Nor, speaking to causation-in-fact, does Dr. Srikumaran expect there to have been a “description of an

inappropriate technique in the medical record” of petitioner’s vaccine administration. (Ex. 26, p. 9 (citing

Dr. Cagle’s report (Ex. A, p. 4).) A high position, less than ideal angle, and / or a thin deltoid muscle

could result in injection of antigenic material near the bursa. (Id.) Citing Bodor & Montalvo, Dr.

Srikumaran explains that a “high” position of injection into the deltoid can lead to a subacromial injection

rather than an intramuscular injection. (Id. at 10 (citing Marko Bodor & Enoch Montalvo, Vaccination-

related shoulder dysfunction, 25 VACCINE 585 (2007) (Ex. 30).) Moreover, Dr. Srikumaran likewise

agrees with Dr. Colwell that the medical literature supports the theory that vaccinations can cause

shoulder injuries. (Id. at 9-10.) In Atanasoff et al., Dr. Srikumaran stresses that all of the patients had a

rapid onset of symptoms isolated to the area of injection. (Id. (citing Atanasoff et al., supra, at Ex. 24.))

Furthermore Arias et al., in a large systematic review, established the time course of injury with a majority

of patients reporting pain within 48 hours, and many reporting a high injection location. (Id. (citing Martin

Arias et al., supra, at Ex. 25.)) Both authors propose an immune mediated response of inflammation

related to antigens injected into the bursal tissue, likely from poor administration technique. (Id.) Dr.

Srikumaran adds that both animal (Dumonde) and human (Trollmo) basic studies support this theory. (Id.

(citing D.C. Dumonde & L.E. Glynn, The Production of Arthritis in Rabbits by an immunological reaction to

Fibrin, 43(4) BRIT. J. OF EXPERIMENTAL PATHOLOGY 373 (1961) (Ex. 31); C. Trollmo et al., Intra-articular

immunization induces strong systemic immune response in humans, 82 IMMUNOLOGY 384 (1990) (Ex.

32.)) Dr. Srikumaran notes that the logical sequence of cause and effect established from the medical

theory in petitioner’s case suggests that the needle injection of vaccine antigen inadvertently near the

bursa or rotator cuff tendon led to a strong immune-mediated inflammatory reaction, causing bursitis and

tendinopathy. (Id.) In his experience as a shoulder surgeon, Dr. Srikumaran states that patients reliably

identify their trigger and can be trusted when they do so. (Id.) Ultimately, petitioner’s records show

consistent and reliable subjective reporting reinforced by objective diagnostic tests and surgical findings –

all which support vaccination as the cause of petitioner’s shoulder pain.

15

Therefore, “this radiating pain was specifically noted to have occurred immediately upon

vaccination.” (Id.) (emphasis added).

Regarding petitioner’s MRI, Dr. Cagle emphasizes that the MRI report does not

demonstrate the “classic” findings published in the SIRVA literature, nor does the

SIRVA literature correlate MRI findings with arthroscopy findings. (Ex. C, p. 1.)

Moreover, suggesting that another radiologist may have interpreted petitioner’s MRI

differently would be speculative. (Id.) According to Dr. Cagle, Dr. Srikumaran

selectively focuses on the MRI and the operative findings. (Id.) In the MRI, Dr. Cagle

notes that Dr. Srikumaran focuses on the rotator cuff pathology while disregarding the

AC joint arthropathy and mass effect of the acromion on the supraspinatus tendon. (Id.)

Both of these findings, according to Dr. Cagle, “can be a source of shoulder pain, and

the acromion is a well described source of impingement pain.” (Id.) Furthermore, “Dr.

Srikumaran disregards the SLAP lesion, not appreciated on the MRI, despite SLAP

lesions being a common cause of shoulder pain.” 15 (Id. at 2.)

e. First Supplemental Expert Report, Dr. Srikumaran (Ex. 34)

Dr. Srikumaran maintains that shoulder pain, as a symptom, can present in

different ways and change over time with various treatments. (Ex. 34, p. 1.) He

suggests that Dr. Cagle conflates the symptom of “pain” with physical findings or

shoulder pathology. (Id.) A rotator cuff tear, for example, can present with varying

degrees of pain or types of pain. (Id.) Quoting petitioner’s medical records, Dr.

Srikumaran stresses that petitioner complained of “superior & posterior pain shoulder

[sic] that radiates up into neck & down arm.” (Id. (citing Ex. 2, p. 1.))

Dr. Srikumaran clarifies that he did consider both the MRI and arthroscopic

findings in petitioner’s records. (Ex. 34, p. 1.) He points to “direct visual evidence of

‘thick bursitis’ at the time of surgery.” (Id.) (emphasis in original). Dr. Srikumaran

acknowledges that he is “disregarding the AC joint arthropathy and mass effect of the

acromion, or SLAP tear found during surgery” because “these are chronic conditions

which did not develop suddenly after injection; they existed for years or decades prior.”

(Id.) Importantly, he stresses that “petitioner never sought treatment for any of them.” 16

(Id.)

15 Dr. Cagle also disputes petitioner’s medical theory of causation. (Ex. C, p. 2.) Dr. Cagle acknowledges

that the scientific literature supports a theory that vaccination events are “associated with shoulder

injuries but the literature does not support the mechanism for how this occurs.” (Id.) (emphasis in

original). Dr. Cagle stresses that the papers cited by Dr. Srikumaran “hypothesize that the injected

material (the vaccine and/or adjuvants) cause an inflammatory reaction.” (Id.) (emphasis in original).

However, Dr. Cagle maintains that there is very little supporting data for the mechanism of action theory.

(Id.) In fact, Trollmo et al., was published thirty years ago, and DuMonde & Glynn was an animal study

published fifty-eight years ago – demonstrating “just how little support exists.” (Id. at 2-3.)

16In this report, Dr. Srikumaran also further addresses causation-in-fact. Dr. Srikumaran maintains that

the articles from Bodor et al. (supra, at Ex. 30), Atanasoff et. al. (supra, at Ex. 24), Dumonde & Glynn

(supra, at Ex. 31), Trollmo et al. (supra, at Ex. 32), and Arias et al. (supra, at Ex. 25), add reliability to

16

f. Second Supplemental Expert Report, Dr. Cagle (Ex. D)

Concerning petitioner’s MRI data, Dr. Cagle expresses concern over Dr.

Srikumaran classification of petitioner’s “chronic conditions.” (Ex. D, p. 1.) In his final

report, Dr. Srikumaran classified petitioner’s AC joint arthropathy, mass effect of the

acromion and SLAP tear as chronic conditions. (Ex. D, p. 1; Ex. 34, p. 1.) Dr. Cagle

criticizes this classification because “Dr. Srikumaran doesn’t explain [] how he is

determining some findings to be new/acute and some findings to be old/chronic.” (Ex.

D, p. 1.) In contrast, Dr. Cagle believes that “all the findings on the MRI are chronic.”

(Id.) He concludes that “Dr. Srikumaran has not presented any evidence as to why

some findings in the MRI are new while others are chronic, but we are now in

agreement that the MRI demonstrates a clear history of chronic pathology.” (Id.)

Finally, Dr. Cagle maintains that SIRVA reports have demonstrated an association

between an injection of a vaccine and shoulder injury, but the literature has “not

established how shoulder injuries can occur.” (Id. at 2 (citing Paul J. Cagle, Shoulder

Injury after Vaccination: A Systematic Review, 56 REVISTA BRASILEIRA ORTOPEDIA. 299

(2021) (Ex. D, Tab. 1.))

V. Party Positions

a. Petitioner’s contentions

Petitioner contends that she suffered a left-sided shoulder injury meeting all four

elements demonstrating a SIRVA Table injury. (ECF No. 73, pp. 5-6.) Petitioner

stresses that her pain was limited to her left shoulder. (ECF No. 73, p. 6.) Quoting Dr.

Colwell, petitioner stresses that “[i]t is extremely common for patients with injuries to

their shoulders to report pain in the neck and arm.” (Id. at 7 (quoting Ex. 19, p. 2.)

Furthermore, “[p]etitioner’s SIRVA injury was responsible for the symptoms in her neck,

arm, etc.” (Id. at 7 (quoting Ex. 19, p. 2.)) Although respondent contends petitioner’s

pain was not limited to her shoulder, petitioner quotes Dr. Srikumaran’s report where he

explains that “[s]houlder pain is well-known to radiate (extend to) adjacent areas such

as the neck or down the arm.” (Id. at 7 (quoting Ex. 26, p. 8.)) Moreover, petitioner’s

petitioner’s causation theory, despite their age. (Ex. 34, p. 2-4.) Moreover, he suggests that this theory

has growing acceptance as evidenced by the vaccination guidelines from the CDC and the Journal of the

American Pharmacists Association. (Ex. 34, p. 5 (citing New Shingles Vaccine Fact Sheet for Healthcare

Providers, CDC.GOV, https://www.cdc.gov/shingles/multimedia/shingles-factsheet-

hcp.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fhcp%2Finfographics%2Fyc

ts-shingrix.html (last updated July 1, 2019); Foster & Davis, Vaccine administration: preventing serious

shoulder injuries, 53(1) J. AM. PHARM. ASSOC. 102-03 (2013)). Dr. Srikumaran stresses that new research

has provided epidemiologic evidence supporting the association of subdeltoid bursitis after influenza

vaccination. (Ex. 34, p. 5.) According to Dr. Srikumaran, Hesse et al. found an increased risk of 7.78

cases per 1 million vaccinations. (Id. (citing Hesse et al., Risk For Subdeltoid Bursitis After Influenza

Vaccination: A Population-Based Cohort Study, 173(4) ANN. INTERN. MED. 253061 (2020) (Ex. 36.)) This

epidemiologic evidence can now be “added to the growing observational clinical evidence making a

strong argument for the validity of shoulder injury related to vaccination.” (Ex. 34, p. 5 (citing Elisabeth M.

Hesse et al., Shoulder injury related to vaccine administrations (SIRVA): petitioner claims to the National

Vaccine Injury Compensation Program, 2010-2016, 38 VACCINE 1076 (2020) (Ex. 35.))

17

medical records indicate “that she did not experience cervical pathology.” (Id. at 8

(citing Ex. 26, p. 8.))

Petitioner further stresses that her medical record, as a whole, demonstrates that

petitioner’s pain and reduced range of motion were limited to the shoulder. (ECF No.

75, pp. 2-3.) Petitioner’s treating physicians, Dr. DeFalco (orthopedic surgeon), Diane

Niestpski (physician assistant), and Ann Riesenman (physical therapist), all provided

care and treatment “solely to petitioner’s shoulder.” (Id. at 3.)

Petitioner highlights language from the Secretary prior to adopting the Final Rule

adding SIRVA to the Vaccine Injury Table, indicating that “pain in the neck or back

without an injury to the shoulder in which an individual received a vaccine would not be

considered SIRVA.” (Id. at 8-9 (quoting 82 Fed. Reg. 6294 (Jan. 19, 2017).) Thus,

petitioner stresses that the opposite must also be true. (Id. at 9.) “[P]ain in the neck

with an injury to the shoulder in which an individual received a vaccine must be

considered SIRVA.” (Id.) (emphasis in original).

Petitioner further argues that petitioner’s symptoms were not caused by a factor

unrelated to vaccination and that respondent ignores the fact that petitioner’s shoulder

“was asymptomatic prior to her SIRVA injury.” (Id. at 4.) Petitioner stresses that her

treating physicians continued to assess her as suffering from bursitis, and that bursitis

was the primary post-surgical diagnosis. (Id. at 4-5 (citing Ex. 2, pp. 44; Ex. 6, p. 86.))

Furthermore, there are “no other conditions such as neuropathies or radiculopathies

that can explain [petitioner’s] symptoms.” (Id. (quoting Ex. 26, p. 8.).) Petitioner also

emphasizes that the QAI does not require petitioner to articulate a mechanism for injury

in an On-Table claim; and the lack of bursitis on a single MRI is not dipositive in an On-

Table claim. 17 (Id. at 10.)

b. Respondent’s contentions

Respondent argues that petitioner has not met the elements for an On-Table

SIRVA. (ECF No. 74, pp. 10, 14.) Specifically, respondent stresses that petitioner’s

17 Alternatively, petitioner asserts that reliable medical evidence supports a non-Table injury was caused-

in fact by her vaccination. (Id.) In support of her causation-in-fact claim, petitioner asserts that she has

satisfied all three Althen prongs. (ECF No. 73, p. 10.) Under Althen prong one, petitioner cites Atanasoff

et al. as well as epidemiologic evidence (Hesse et al.) supporting the association of subdeltoid bursitis

after influenza vaccination. (Id. at 10-11.) The “theory is that vaccine antigen injected into synovial tissue

has the potential for inducing a prolonged immune-mediated inflammatory reaction.” (Id.) Under Althen

prong two, petitioner suggests that the needle injection of the vaccine inadvertently near the bursa or

rotator cuff tendon led an immune-mediate inflammatory reaction causing bursitis and tendinitis. (Id. at

12.) Although “no treating physician attributed petitioner’s shoulder pain as being actually caused by her

vaccination,” petitioner maintains that several physicians noted the temporal association. (Id.) Finally,

under Althen prong three, petitioner asserts that petitioner’s medical records show that the onset of her

shoulder pain occurred within 48 hours of receiving her October 21, 2016 influenza vaccination. (Id. at

12-13.) Lastly, petitioner stresses that she need not prove a specific mechanism to prove causation, as

suggested by Dr. Cagle. (Id. at 13-15.)

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shoulder pain and reduced range of motion were not limited to her left shoulder. (Id. at

10-11.) From petitioner’s first complaint she described pain in her left arm “all across

the left side,” and her left upper back. (Id. at 11 (citing Ex. 8.)) Subsequently,

respondent emphasizes that petitioner complained of superior and posterior shoulder

pain that radiated up into her neck and down her arm and a constant headache, as well

as cervical spine pain. (Id. (citing Ex. 1, pp. 1-6, 22, 29-31, 43-45; Ex. 4, p. 246).)

Respondent suggests that though Dr. Colwell opines that shoulder injuries commonly

report pain in the neck and arm, that neither he nor the literature explains “how such

pain would occur immediately with shoulder pain, as reported by petitioner.” (Id. (citing

Ex. 19, p. 2.)) In addition, the language of the QAI “specifies that pain outside the

shoulder in which the vaccine was administered is sufficient to defeat a Table SIRVA

claim.” (ECF No. 74, p. 11.)

Respondent also argues that petitioner’s symptoms are caused by a factor

unrelated to vaccination. (ECF No. 74, p. 12.) Respondent stresses that petitioner’s

MRI showed no signs of bursitis, but did show rotator cuff tendinopathy, which “is more

consistent with chronic rotator cuff degenerative pathology.” (Id. (citing Ex. A, p. 3.)) In

addition, petitioner’s MRI showed AC joint arthropathy, a mass effect of the acromion on

the supraspinatus tendon, and a SLAP tear—all chronic conditions that predated

petitioner’s vaccination. 18 (Id. (citing Ex. C, p. 2; Ex. D, p. 2.))

VI. Discussion

As explained above, the Vaccine Injury Table lists SIRVA as a compensable

injury if it occurs within 48 hours of administration of a vaccine containing the influenza

virus. § 300aa-14(a) as amended by 42 C.F.R. § 100.3(a). To be considered a Table

“SIRVA,” petitioner must show: (i) there is “no history of pain, inflammation or

dysfunction of the affected shoulder prior to intramuscular vaccine administration that

18 Respondent also contends that petitioner has neither pled nor established a cause-in-fact claim. (ECF

No. 74, p. 14.) First, respondent argues that petitioner has not preponderantly established a medically

recognized injury. (Id. at 15.) Though petitioner contends that her “diagnoses of bursitis, adhesive

capsulitis, impingement, and tendinopathy are all associated with SIRVA,” respondent’s expert Dr. Cagle

stresses that petitioner’s MRI did not show bursitis, but instead revealed chronic conditions associated

with degenerative pathology. (Id. at 15-16 (quoting ECF No. 73, p. 12.)) Second, respondent argues that

petitioner has not set forth a reliable medical theory explaining how the influenza vaccine can cause

bursitis, adhesive capsulitis, impingement, or tendinopathy. (Id. at 16.) Atanasoff et al. proposed a

potential theory of antigenic material causing an immune response, though respondent suggests that this

was not the objective of the article. (Id.) Though the medical literature supports the proposition that

vaccination can be associated with shoulder injuries, the literature does not preponderantly establish a

mechanism for “how vaccinations can cause shoulder injuries.” (Id. at 17) (emphasis in original). A

“plausible” or “possible” causal link does not meet the preponderant standard. (Id.) Lastly, respondent

argues that petitioner fails to show a logical sequence of cause and effect because petitioner’s expert fails

to explain how he distinguishes between petitioner’s chronic conditions not caused by the vaccination and

the new, acute, conditions that he considers vaccine-related. (Id. at 18.) Nor does a proximate temporal

association between vaccination and injury satisfy petitioner’s burden to prove causation in fact. (Id.)

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would explain the alleged signs, symptoms, examination findings, and/or diagnostic

studies occurring after vaccine injection”; (ii) that “onset of pain occurred within the

specified timeframe,” i.e. within 48 hours; (iii) that “pain and reduced range of motion

are limited to the shoulder in which the intramuscular vaccine was administered”; and

(iv) that “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 C.F.R. § 100.3(a); 42 C.F.R. §

100.3(c)(10).

In this case there is no dispute as to the first and second QAI SIRVA criteria.

Respondent agrees that “[p]etitioner did not have a history of left shoulder pain or

injury.” (ECF No. 74.) Additionally, respondent raises no argument in either his Rule 4

report or his response to petitioner’s motion for a ruling on the record that petitioner’s

injury arose outside of the 48-hour timeframe identified by the Vaccine Injury Table.

(ECF Nos. 49, 74.) My own review of the record confirms these points. Based on the

record as a whole, petitioner has preponderantly established that she suffered onset of

new shoulder pain within 48 hours of the vaccination at issue in this case. Rather,

respondent’s defense against petitioner’s Table Injury claim hinges on the third and

fourth SIRVA QAI prongs. Respondent contends that petitioner’s pain was not limited to

the shoulder in which she received her vaccination and also that her condition is better

explained by chronic shoulder pathology that predated her vaccination. (ECF No. 74,

pp. 10-13.) However, neither argument is persuasive given the record of this case.

With regard to the third SIRVA criterion, which requires that the petitioner’s pain

and reduced range of motion be limited to the shoulder at issue, petitioner stresses

language included in the preamble to the final regulation placing SIRVA on the Vaccine

Injury Table. (ECF No. 73, pp. 8-9 (citing 82 Fed. Reg. 6294 (Jan. 19, 2017).)

Specifically, the government addressed this QAI criterion in response to public

comment. For clarity and context, the comment summary and response are worth

quoting in full:

Comment: A commenter suggested that shoulder injury related to vaccine

administration (SIRVA) as defined in the QAI is too restrictive because the

recipient's pain and reduced range of motion must be limited to the shoulder

in which the intramuscular vaccine was administered. The commenter

stated that such language was an artificial and unnecessary qualification,

and expressed concern that recipients who have other symptoms, such as

shoulder pain radiating to the neck or upper back, will not have the benefits

of a Table injury. The commenter suggested that the QAI be expanded to

include the shoulder and parts of the body attributed to that injury.

Response: SIRVA is a musculoskeletal condition caused by injection of a

vaccine intended for intramuscular administration into the shoulder, and, as

its name suggests, the condition is localized to the shoulder in which the

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vaccine was administered. In other words, pain in the neck or back without

an injury to the shoulder in which an individual received a vaccine would not

be considered SIRVA. Shoulder injuries that are not caused by injection

occur frequently in the population. Thus, it is important to have a definition

of SIRVA that is clearly associated with vaccine injection. The portion of the

QAI limiting the pain and reduced range of motion to the shoulder in which

the vaccine was administered is necessary to accurately reflect the vaccine-

associated condition.

82 Fed. Reg. 6294, 6296.

I am not persuaded by petitioner’s argument that, by including the example of

neck or back pain without shoulder injury, the above response language accepts

broadly that shoulder pain with accompanying neck pain necessarily falls under the

SIRVA rubric in all events. (ECF No. 73, p. 9.) However, the government’s comment

response reveals that the third SIRVA criterion is intended to ensure that SIRVA claims

are limited to instances in which “the condition is localized to the shoulder in which the

vaccine was administered” (emphasis added). Thus, it is clear that the gravamen of this

requirement is to guard against compensating claims involving patterns of pain or

reduced range of motion indicative of a contributing etiology beyond the confines of a

musculoskeletal injury to the affected shoulder. See Werning v. Sec'y of Health &

Human Servs., No. 18-0267V, 2020 WL 5051154, at *10 (Fed. Cl. Spec. Mstr. July 27,

2020) (finding that a petitioner satisfied the third SIRVA QIA criterion where there was a

complaint of radiating pain, but the petitioner was “diagnosed and treated solely for pain

and limited range of motion to her right shoulder.”)

In this case, it is true that there are subjective complaints by petitioner suggesting

that she experienced pain beyond the confines of her shoulder. Moreover, for a period

of time her treating physician suspected that her condition might be attributable to

cervical spine based on those complaints. However, despite these complaints,

petitioner’s first post-vaccination orthopedic assessment included multiple findings

suggestive of shoulder pathology while noting full range of motion without pain in her

neck. (Ex. 2, p. 2.) Moreover, despite some ongoing suspicion, a cervical origin for

petitioner’s complaints was later ruled out explicitly by her treating physician based on

MRI study. Specifically, MRI of petitioner’s cervical spine revealed only mild

degenerative changes that do “not suggest cervical spine pathology or cervical

radiculopathy,” (Ex. 2, p. 31) while MRI of the left shoulder revealed findings that led to

an arthroscopic surgery recommendation with a preoperative diagnosis of shoulder

impingement. (Id. at 41-44; Ex. 6, p. 85).

Although petitioner’s subjective complaints are probative as to the severity and

timing of her symptoms, she is not herself competent to speak to the medical

significance of her complaints. See James-Cornelius on Behalf of E. J. v. Sec'y of

Health & Human Servs., 984 F.3d 1374, 1380 (Fed. Cir. 2021) (“While lay opinions as to

causation or medical diagnosis may be properly characterized as mere ‘subjective

21

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. . . .”) In

that regard, petitioner’s experts are instead persuasive in opining for the reasons

discussed more fully above that petitioner’s own pain complaints are consistent with the

expected manifestations of the type of musculoskeletal injuries associated with SIRVA.

(Ex. 19, p. 2 (Dr. Cowell); see also Asher, supra, at Ex. 23; Ex. 26, p. 8 (Dr.

Srikumaran).) And, in any event, the government’s own expert in effect disclaims

petitioner’s subjective pain complaints as vague and non-specific, suggesting they may

not have been diagnostically useful. (Ex. A, p. 3.)

Thus, the evidence does not preponderate in favor of any finding that petitioner

had diagnostically meaningful complaints of pain or reduced range of motion beyond

her left shoulder. Nor does the evidence preponderate in favor of any finding that

petitioner’s reported pattern of pain is otherwise suggestive of an etiology for that pain

beyond her diagnosed musculoskeletal shoulder injury. Accordingly, petitioner has

satisfied the third SIRVA QAI criterion.

The remaining question is whether any other condition could explain petitioner’s

symptoms. Respondent, and Dr. Cagle, contend based on imaging and operative

findings that petitioner’s condition is more consistent with chronic degeneration. (ECF

No. 73, p. 12.) Respondent stresses Dr. Cagle’s observation that petitioner did not

show the “classic” signs of bursitis typical of SIRVA (a point disputed by Dr. Srikumaran)

while also demonstrating pathology such as rotator cuff tendinopathy that Dr. Cagle

suggests is more consistent with degeneration. (Id.) However, there is an inherent

tension in respondent’s position. On the one hand, respondent agrees that “[p]etitioner

did not have a history of left shoulder pain or injury” (ECF No. 74) and further does not

dispute that petitioner’s symptoms began abruptly within 48 hours of her vaccination.

On the other hand, respondent contends that petitioner’s post-vaccination presentation

is nonetheless explained by chronic, degenerative, pre-existing shoulder dysfunction

despite all outward appearances of petitioner’s clinical history suggesting, consistent

with SIRVA, a temporal association with petitioner’s vaccination. Respondent’s

argument is ultimately unpersuasive.

Because SIRVA is by definition an unspecified “injury to the musculoskeletal

structures of the shoulder (e.g. tendons, ligaments, bursae, etc.)” (see 42 C.F.R.

§100.3(c)(10)), respondent does not defeat petitioner’s claim simply by noting the

presence of shoulder dysfunction beyond deltoid bursitis. Nor, alternatively, does

respondent defeat petitioner’s claim by asserting a lack of evidence of bursitis.

Although deltoid bursitis is the specific condition that has been most clearly associated

with vaccine-related shoulder injuries, the QAI definition of SIRVA was specifically

drafted to encompass shoulder dysfunction beyond that condition. 19 Proposed

19 Specifically, respondent’s proposed rulemaking stated in relevant part:

The IOM reviewed the scientific and medical literature finding evidence that convincingly

supports a causal relationship between vaccine injection (with a needle) into an arm and

22

Rulemaking, 2015 WL 4538923, at *45136; See also Gurney v. Sec’y of Health &

Human Servs., No.17-481V, 2019 WL 2865490, at *7 (Fed. Cl. Spec. Mstr. Apr. 24,

2019) (finding that “the timing and course of petitioner’s adhesive capsulitis remains

consistent with a post-vaccination sequela to her SIRVA as described in the [Atanasoff

study] and as envisioned by the rulemaking which created SIRVA as a Table Injury.”).

The Atanasoff article relied upon in creating QAI for SIRVA (and filed in this case as

Exhibit 24) in turn states that:

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.

(Atanasoff et al., supra at Ex. 24, p. 3.)

Here, the specific diagnoses explored by petitioner’s treating physicians –

bursitis, impingement, and adhesive capsulitis – fall under the umbrella of SIRVA. 20

Moreover, Atanasoff shows that pre-vaccination subclinical degenerative changes, even

including rotator cuff tears, are not in themselves incompatible with SIRVA or with the

deltoid bursitis. The report noted that the published VICP case series (Atanasoff et al.), as

described, were clinically consistent with deltoid bursitis. The VICP case series found that

93 percent of patients had the onset of shoulder pain within 24 hours of vaccine

administration and 54 percent had immediate pain following vaccine injection. The VICP

case series found several diagnoses, beyond deltoid bursitis, that resulted in shoulder pain

following vaccination, including tendonitis, impingement syndrome, frozen shoulder

syndrome, and adhesive capsulitis. Another case series reported two cases of shoulder

pain, weakness and reduced range of motion following vaccination with onset of symptoms

within 48 hours of vaccination. [Bodor M, Montalvo E, Vaccination related shoulder

dysfunction, Vaccine 25(2007) 585-587.] In order to capture the broader array of potential

injuries, the Secretary proposes to add SIRVA for [certain influenza] vaccines that are

administered intramuscularly through percutaneous injection into the upper arm.

Proposed Rulemaking, 2015 WL 4538923, at *45136 (emphasis added).

20Compare and Ex. 2, p. 2 (initial orthopedic assessment of bursitis on November 15, 2016); Ex. 4, p.

127, 130 (presenting to physical therapy on November 18, 2016, with diagnoses of impingement

syndrome and adhesive capsulitis); Ex. 2, p. 41 (radiologists interpreting MRI as showing, inter alia,

tendinopathy, mild interstitial tears, and mild impingement); Ex. 6, p. 85-86 (pre- and post-operative

diagnoses of impingement syndrome and labral tear along with operative finding of thick bursitis) and

Proposed Rulemaking, 2015 WL 4538923, at *45136 (explaining that SIRVA encompasses tendonitis,

impingement syndrome, frozen shoulder syndrome, and adhesive capsulitis).

23

suspected mechanism by which SIRVA manifests. 21 Additionally, under the first three

SIRVA criteria, petitioner’s clinical history is consistent with a temporally appropriate

post-vaccination onset of new shoulder pain.

It would not be in keeping with intention of the Vaccine Injury Table to require

petitioner to further prove mechanistically how her vaccination could have caused the

specific musculoskeletal condition constituting her own SIRVA. Thus, without more,

respondent is unpersuasive in asserting that previously asymptomatic degenerative

changes otherwise explain petitioner’s post-vaccination clinical history to the exclusion

of a SIRVA. See Lang v. Sec'y of Health & Human Servs., No. 17-995V, 2020 WL

7873272, at *13 (Fed. Cl. Spec. Mstr. Dec. 11, 2020) (explaining that “findings

consistent with impingement, rotator cuff tears, or AC arthritis do not per se preclude a

finding that a Table SIRVA exists. Rather, the question raised by respondent's argument

is whether petitioner's own clinical history indicates that her shoulder pathology wholly

explains her symptoms independent of vaccination.”); Yost v. Sec'y of Health & Human

Servs., No. 18-288V, 2021 WL 2326403, at *15 (Fed. Cl. Spec. Mstr. May 6, 2021)

(rejecting Dr. Cagle’s opinion that post-vaccination bursitis was more likely explained by

overuse and a history of vigorous exercise, noting that that the Atanasoff study

considered and rejected mechanical overuse as an explanation); see also O'Leary v.

Sec'y of Health & Human Servs., No. 18-584V, 2021 WL 3046617, at *12 (Fed. Cl.

Spec. Mstr. June 24, 2021) (finding that respondent’s argument that petitioner’s

adhesive capsulitis was “coincidental” to vaccination was contrary to the causal

presumption made available under the Vaccine Injury Table).

Once petitioner has made a prima facie showing of a Table Injury, respondent

may still present evidence that the injury was nonetheless caused by a factor unrelated

to vaccination. § 300aa-13(a)(1)(B); Deribeaux v. Sec’y of Health & Human Servs., 717

F.3d 1363, 1367 (Fed. Cir. 2013). In that context the burden of proof shifts to

respondent to make such a claim by preponderant evidence. In order to meet his

burden, respondent must demonstrate “that a particular agent or condition (or multiple

agents/conditions) unrelated to the vaccine was in fact the sole cause (thus excluding

the vaccine as a substantial factor).” de Bazan v. Sec’y of Health & Human Servs., 539

F.3d 1347, 1354 (Fed. Cir. 2008). In that regard respondent remains unpersuasive for

the same reasons discussed above. Petitioner’s overall clinical course is more

consistent with onset of SIRVA than with any inevitable clinical manifestation of chronic

degeneration.

VII. Conclusion

For all the reasons discussed above, after weighing the evidence of record as a

whole, I find by preponderant evidence that petitioner suffered a Table Injury of SIRVA

21

Notably, the SIRVA QAI includes a list of examples of the “other condition[s] or abnormalit[ies]” that

may be incompatible with a SIRVA claim – “e.g. NCS/EMG or clinical evidence of radiculopathy, brachial

neuritis, mononeuropathies, or any other neuropathy.” 42 C.F.R. § 100.3(c)(10). All of the listed

examples relate to neurological conditions that may affect the shoulder and none of these examples are

applicable to petitioner’s own case or Dr. Cagle’s proffered opinion regarding degenerative changes such

as tendinopathy.

24

following her October 21, 2016 influenza vaccination as alleged. She is therefore

entitled to compensation. Because I have found the presence of a Table Injury in this

case, it is not necessary to address whether petitioner has presented a cause-in-fact

claim. A separate damages order will be issued.

IT IS SO ORDERED.

s/Daniel T. Horner

Daniel T. Horner

Special Master

25