Bishop v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 18-0027V

UNPUBLISHED

MELISSA BISHOP, Chief Special Master Corcoran

Petitioner, Filed: November 20, 2020

v.

Special Processing Unit (SPU);

SECRETARY OF HEALTH AND Ruling on Entitlement; Causation-In-

HUMAN SERVICES, Fact; Influenza (Flu) Vaccine;

Shoulder Injury Related to Vaccine

Respondent. Administration (SIRVA)

Shealene Priscilla Mancuso, Muller Brazil, LLP, Dresher, PA, for petitioner.

Traci R. Patton, U.S. Department of Justice, Washington, DC, for respondent.

RULING ON ENTITLEMENT1

On January 4, 2018, Melissa Bishop filed a petition for compensation under the

National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the

“Vaccine Act”). Petitioner alleges that she suffered left shoulder injuries related to vaccine

administration (“SIRVA”) as a result of an influenza (“flu”) vaccine received on December

1, 2016. Petition at 1. The case was assigned to the Special Processing Unit of the Office

of Special Masters.

I. Relevant Procedural History

On January 4, 2018, Petitioner filed her petition and medical records (ECF No. 1).

Petitioner filed additional medical records on April 5, 2018 (ECF No. 9). On December 7,

1

Because this unpublished ruling contains a reasoned explanation for the action in this case, I am required

to post it on the United States Court of Federal Claims' website in accordance with the E-Government Act

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

Services). This means the ruling 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

National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease

of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C.

§ 300aa (2012).

2018, Respondent filed his Rule 4(c) Report asserting that Petitioner had failed to

establish entitlement to compensation for either a Table SIRVA claim or a non-Table,

causation-in-fact version of the same claim (ECF No. 20).

Petitioner subsequently filed Exhibits 13-18 containing additional evidence,

including an expert report and affidavits (ECF Nos. 22, 23, 27-28). Respondent then filed

an expert report, Exhibit A (ECF No. 29). On September 20, 2019, a Finding of Fact was

issued determining that the onset of Petitioner’s shoulder injury likely occurred within 48

hours of vaccination. Finding of Fact, issued Sept. 20, 2019 (ECF No. 32).

On December 18, 2019, Respondent filed an Amended Rule 4(c) Report (ECF No.

37). In it, Respondent acknowledged the onset finding, and further advised that he would

no longer defend the matter. Respondent’s Amended Rule 4(c) Report, at *2. Respondent

added that he “reserves his right to a potential appeal of this factual ruling and maintains

that a finding of entitlement to compensation cannot be sustained if the Findings of Fact

are vacated or overturned on appeal.” Id. at *2, n.1. Respondent accordingly requested

“a ruling based on the existing record regarding petitioner’s entitlement to compensation.”

Id.

On April 21, 2020, Petitioner filed a status report indicating that on that date,

Petitioner had forwarded a demand to Respondent (ECF No. 38). On June 22, 2020, the

court directed Petitioner to file a status report with an update on the parties’ discussions,

including whether Petitioner had received a response to her demand (Non PDF

Scheduling Order, issued June 22, 2020). On July 14, 2020, Petitioner filed additional

medical records as Exhibit 19 (ECF No. 39). On July 29, 2020, Petitioner filed a status

report stating that the parties had conferred on July 23 and 24, 2020 (ECF No. 40).

Petitioner reported that Respondent stated he expected to respond to Petitioner’s

demand within ten days of the issuance of a decision on entitlement. Id. Accordingly,

issuance of such a decision will help move the matter toward resolution.

II. Relevant Factual History

A. Pre-Vaccination Medical Records

Prior to the vaccination at issue in this case, Petitioner’s medical history

documented several health conditions, including fibromyalgia, hypertension, back pain,

migraine, anemia, and gastroesophageal reflux. Ex. 7 at 4; Exs. 10, 12. In particular, on

November 23, 2009, Petitioner was seen by Dr. Richard Brandon for back pain and knee

swelling, and also reported pain in her upper back, shoulders, and lower back. Ex. 12 at

1. Dr. Brandon assessed her with “[d]iffuse musculoskeletal pain-probable fibromyalgia.”

Id.

A few months later, on January 19, 2010, Petitioner saw Dr. Brandon for a follow

up. Among other concerns, she reported “pain in her chest that radiated to her left

shoulder” occurring in conjunction with an episode of extreme anxiety. Ex. 12 at 2. On

March 16, 2010, Petitioner returned to Dr. Brandon complaining of fibromyalgia, knee

2

pain, low back pain, migraines, and “some muscle pain in her neck and shoulder girdle

area.” Id.

B. December 1, 2016 Flu Vaccine and Post-Vaccination Medical Records

On December 1, 2016, Petitioner, then age 44, received the flu vaccine that is at

issue in this claim. Ex. 1 at 1. The vaccine was administered intramuscularly in Petitioner’s

left deltoid. Id. She received the flu vaccine during an appointment with Dr. Sam Sadeghi,

who was then her primary care physician. Ex. 7 at 96-101. During this appointment,

Petitioner reported back pain, which was a chronic problem, but no other musculoskeletal

issues. Id. at 99.

Just over a month later, in January 2017, Petitioner was seen by Nurse Practitioner

(“NP”) Dewayne Steffey. Ex. 2 at 16-18. The record indicated that she was a new patient

and was previously a patient of Dr. Sherri Rajoo and Dr. Sam Sadeghi. Id. at 17. Petitioner

reported having migraines and low back pain since her teens, being diagnosed with

fibromyalgia in 2007, and that she had “a lot of joint pain which comes and goes.” Id. On

examination, NP Steffey observed “joint pain with rom [range of motion] pain with

palpation lumbar spine.” Id. The record includes a pain medication, Norco, in the

medication list. Id. at 18.

On February 9, 2017, Petitioner was seen by NP Steffey for a follow up

appointment. Ex. 2 at 11-14. The record of the visit states that she “continues to complain

of multiple myalgias. She now has the other complaints.” Id. at 14. The musculoskeletal

examination notes were identical to the prior visit: “joint pain with rom pain with palpation

lumbar spine.” Id.

On March 9, 2017, Petitioner returned to NP Steffey. Ex. 2 at 10-13. She

complained about her “left arm triceps where she had flu shot. She never had pain in it

prior to the shot. She received shot 12-1-2016.” Id. at 11. The musculoskeletal

examination notes were identical to the two prior visits: “joint pain with rom pain with

palpation lumbar spine.” Id. In addition, the neurological examination section documented

“limited rom left ac [acromioclavicular, i.e. shoulder] joint.” Id. Petitioner was given a

Medrol dose pak. Id. at 12. On March 28, 2017, Petitioner’s left shoulder was x-rayed due

to “[l]eft shoulder pain after flu shot.” Ex. 3 at 1. Mild calcifications and minimal joint spurs

were seen, with no fracture or dislocation. Id.

On April 6, 2017, Petitioner followed up with NP Steffey. Ex. 3 at 7-9. She reported

“significant worsening pain related to pain in her back and generalized joint pain . . . . She

is also having difficulty with lifting her left arm since she had a flu shot last December.

The arm is painful and cannot be lifted very high.” Id. at 8. On examination, her left

shoulder joint was found to be unable to flex past 45 degrees, and Petitioner stated that

she was unable to shave her underarm or fasten her bra. Id. An MRI and physical therapy

were recommended for her shoulder. Id.

3

On April 14, 2017, Petitioner underwent an MRI of her left shoulder. Exs. 4 at 1; 2

at 25. The findings indicated that “[m]inimal fluid is seen in the shoulder joint and

subacromial subdeltoid bursa . . . . Findings suggest adhesive capsulitis . . . . There is

minimal tendinopathy of the supraspinatus tendon centrally.” Id. On May 4, 2017,

Petitioner returned to NP Steffey, continuing to report difficulty lifting her left arm since

her flu shot in December and complaining of “pain in the left arm over the triceps.” Ex. 2

at 5. The MRI was noted to reveal adhesive capsulitis. Id. Petitioner was referred to an

orthopedist and for physical therapy. Id.

On May 23, 2017, Petitioner was seen by Dr. Linda Pearson for back pain. Ex. 8

at 2. Petitioner reported that she had a frozen left shoulder and that “she had the flu

injection in December 2016 and had complications since then with the left shoulder and

arm,” although her primary issue was her back pain. Id. In the history section of the record

under back pain, the record adds “[a]ssociated symptoms include headaches and tingling

(left hand).” Id. at 3. On the same page, four paragraphs below, the paragraph about

Petitioner’s left shoulder pain notes that she “[r]eports her left fingers go numb along the

finger tips and pain goes down from her left shoulder to her arm. Denies any issues with

her left shoulder before the flu shot.” Id.

On examination, Petitioner’s left shoulder was noted to have abnormal range of

motion in active and passive abduction, extension, and forward flexion. Ex. 8. at 11. Dr.

Pearson was unable to assess her left shoulder strength due to limited range of motion.

Id. Petitioner had positive impingement signs and tenderness in the acromion,

acromioclavicular joint, and deltoid. Id. She was assessed with “more recent left shoulder

adhesive capsulitis as well after a flu shot.” Id. at 14. Dr. Pearson noted that Petitioner

was scheduled to start physical therapy and be seen by an orthopedist for her shoulder

problem. Id. at 16.

On May 24, 2017, Petitioner was seen at Results Physiotherapy for an initial

evaluation of her shoulder. Ex. 5 at 35. The record stated:

PATIENT IS A 44 YEAR OLD FEMALE WHO PRESENTS WITH A 5

MONTH HISTORY OF CONSTANT LEFT SHOULDER PAIN AND

STIFFNESS OF VARYING INTENSITIES FOLLOWING HER FLU SHOT

IN DECEMBER. PATIENT IS LIMITED WITH ANY SHOULDER

MOVEMENTS WHICH IS LIMITING HER WITH HER ABILITY TO

[PERFORM] HER NORMAL DAILY ACTIVITIES.

Ex. 5 at 35. Petitioner reported a pain level of 7/10 at the time of the appointment, ranging

from 4/10 to 9/10. Id. at 35. The pain was noted to radiate from her shoulder to her

wrist/hand and fingers and thumb. Id. The mechanism of injury was recorded as “FLU

SHOT Stair Climbing.”3 Id. The Date of Injury stated “Month(s) Ago 5.” Id.

On examination, Petitioner demonstrated reduced range of motion in all planes.

Ex. 5 at 36. Her active range of motion was 25% of normal and limited by pain. Id. It was

3

The reference to stair climbing is not explained further.

4

recommended that Petitioner attend physical therapy three times a week for four weeks.

Id. at 38. A patient detail report signed by Petitioner on May 24, 2017, the date of her

initial physical therapy evaluation, listed a date of injury of “12-1-2016.” Id. at 90. A patient

medical history from the same date listed the problem as having begun on 12/1/16. Id. at

102. In response to a question about her expectations of physical therapy, Petitioner

wrote “To get my shoulder back to normal, the way it was before I got a flu shot.” Id. at

103. She reported that “more or less anything the more I do aggravates my shoulder; my

fingers are getting to where they are getting numb now.” Id.

Petitioner attended an additional 15 physical therapy sessions between May 25

and June 30, 2017. Ex. 5 at 41-88. By June 1, 2017, her active range of motion had

improved to 50%. Id. at 48. The physical therapist noted that Petitioner complained of

pain going down from her left shoulder into the wrist. Id. at 49. On June 14, 2017, her left

shoulder active range of motion had improved to 75% and passive range of motion was

90% in flexion and scaption and 50% in external rotation. Id. at 69. At her June 28, 2017

session, Petitioner reported that over the weekend she experienced a loud “pop” in her

left shoulder and her range of motion improved thereafter. Id. at 85. At her June 30, 2017

session, Petitioner’s left shoulder active range of motion was recorded as within normal

limits. Id. at 87. She was assessed as having progressed well with strengthening and

stabilization, and ready to continue on her own with a home exercise program. Id. at 88.

On June 1, 2017, Petitioner returned to NP Steffey. Ex. 2 at 1-3. She reported that

she had been to pain management and that “[h]er pain in the arm has no[t] changed much

with pain along her triceps . . . . She still does not have much motion in left arm. She

states physical therapy has been painful as expected. She is to see orthopedist in a

couple of weeks.” Id. at 2.

On June 6, 2017, Petitioner was seen by orthopedist Dr. Jeffrey France. Ex. 6 at

2. Dr. France noted that Petitioner “had an injection in her left shoulder for flu in December

2016. It hurt and she kind of held it still and it has gotten stiff.” Id. She had an MRI, which

confirms some adhesive capsulitis and she is stiff with abduction, external rotation,

forward flexion.” Id. On examination, Dr. France found that Petitioner’s left shoulder had

“greatly decreased abduction, external rotation.” Id. Dr. France assessed Petitioner with

left frozen shoulder and adhesive capsulitis. Id. He concluded that “[t]he important thing

is to get motion started. I think the shot probably just hurt and then she held it still and it

got significantly stiff and inflamed. Hopefully, we can reverse all this with motion.” Id. He

noted that she was already in physical therapy and that if that was unsuccessful, a closed

manipulation (surgical procedure) may be needed. Id.

On June 27, 2017, Petitioner returned to Dr. Pearson for a follow up concerning

her back pain. Ex. 8 at 29. Her left shoulder range of motion was assessed as 100

degrees in active abduction and 70 degrees in forward flexion. Id. at 33. Dr. Pearson

noted a “[g]reat improvement with range of motion.” Id. at 34. Dr. Pearson determined

that no procedures were needed given her significant improvement with physical therapy.

Id. at 35.

5

On July 11, 2017, Petitioner returned to Dr. France. Ex. 6 at 1. She reported that

her shoulder was doing much better with good motion, strength, and stability, and that

she had worked hard to reestablish motion. Id. On examination, her left shoulder had

“good extension, flexion, stability.” Id. Dr. France indicated that he would see Petitioner

as needed, and that both Petitioner and he were pleased with her progress in physical

therapy. Id.

On July 13, 2017, Petitioner had medial branch blocks placed to help with her back

pain. Ex. 8 at 61. Petitioner was seen for back pain by NP Brenda Friend, on July 26,

August 24, and October 19, 2017. Id. at 37-56. There is no indication in the record that

Petitioner’s left shoulder was discussed or examined. Id.

On January 18, 2018, Petitioner was seen by NP Friend. Ex. 19 at 223. The record

noted that she had done physical therapy resulting in improved range of motion. Id. She

continued to have tenderness in the posterior left upper extremity and shoulder region,

but that her orthopedist, Dr. France, did not recommend any further treatment. Id. At

Petitioner’s February 15, 2018 appointment, Dr. Pearson noted that Petitioner’s left

shoulder pain was “stable – worse with weather but tolerable. Doing her exercises.” Id. at

244.

On September 11, 2018, Petitioner returned to Dr. France complaining of left

shoulder pain. Ex. 11 at 1. She reported that the pain radiated down into her lateral bicep

to the level of her elbow. Id. at 2. On examination, she exhibited tenderness of the

supraspinatus, infraspinatus, subacromial bursa, subdeltoid bursa, and lateral cuff

insertion, as well as subjective tenderness of the lateral acromion. Id. at 3. On

examination, Dr. France found positive impingement signs, recording “Neer’s test

positive, Hawkin’s test positive, and cross chest maneuver (impingement) positive.” Id.

Her range of motion was noted to be normal. Id. The record stated that she had “done

well with her range of motion and strengthening today seems to be just impingement.” Id.

Dr. France administered a steroid injection into her subacromial space. Id.

On September 12, 2018, Petitioner was seen by NP Rebekah Ragan. Ex. 19 at

369. Petitioner reported “increased L shoulder pain. She states this started after a flu shot.

She saw orthopedics for this yesterday and they gave her a steroid injection. She states

they also ordered an xray of this advised that if injection does not help she will need

surgery.” Id.

On October 23, 2018, Petitioner returned to Dr. France. Ex. 11 at 6. On

examination, he found her range of motion in her left shoulder to be “limited and painful.”

Id. at 7. She again displayed positive impingement signs as well as positive results on the

O’Brien’s test, Speed’s test, Yergason’s test, and subscapularis lift off test, and the empty

can sign was positive. Id. Dr. France noted:

[H]er left shoulder pain seems to be a combination of adhesive capsulitis

and sub acromial impingement. she has been doing home PT for a long

time without any success and her exam and HPI are concerning for

6

something more going on than can be fixed with a CSI [corticosteroid

injection] so we will get an MRI to further assess.

Ex. 11 at 7.

On November 7, 2018, Petitioner was seen by NP Ragan. Ex. 19 at 390. She

reported “increased L shoulder pain s/t rotator cuff tear.” Id. A November 1, 2018 MRI

was noted as pending. Id.

A second left shoulder MRI was performed. Ex. 11 at 11. The record is undated

but has a fax date of November 19, 2018. Id. The MRI showed “[n]o appreciable fluid in

subacromial/subdeltoid bursa . . . . Infraspinatus tendinosis with a small intrasubstance

tear of the posterior fibers at the insertion” as well as mild degenerative changes. Id.

On November 20, 2018, Petitioner returned to Dr. France to review her MRI

results. Ex. 11 at 8. On examination, her left shoulder range of motion was “full but slightly

painful, specifically with abduction.” Id. at 10. She continued to exhibit positive

impingement signs. Id. Dr. France noted that the MRI showed findings of impingement

and a partial thickness rotator cuff lesion. Id. In light of Petitioner’s “good but painful

function of the shoulder,” he recommended conservative treatment including physical

therapy, injection therapy, and anti-inflammatory medication. Id. If that was not

successful, surgical options could be discussed. Id. Petitioner indicated that she wanted

to do the exercises on her own rather than returning to formal physical therapy. Id.

On February 4, 2019, Petitioner returned to Dr. Pearson for back pain. Ex. 19 at

449. Petitioner reported that she was still working on her exercises to keep her left

shoulder mobile, and that she experienced increased pain after her exercises. Id. On

examination, her left shoulder range of motion was found to be abnormal and she

exhibited tenderness, positive impingement signs, and positive results on the cross arm

test. Id. at 452. Dr. Pearson noted that strengthening, and not surgery, had been

recommended for her left shoulder. Id. at 454.

On February 27, 2020, Petitioner was seen by NP Rebekah Weaver for back pain.

Ex. 19 at 640. She also reported “increase intermittent in the left shoulder pain; reports

she was given a flu shot wrong about 4 yrs ago.” Id. Petitioner reported that “colder

weather exacerbates her left shoulder pain which she reports began after flu shot 4 years

ago.” Id. at 644.

On April 23, 2020 and May 21, 2020, Petitioner was seen by video by NP Shawna

Smith for back pain and shoulder pain. Id. at 667-68, 690. She reported an increase in

left shoulder pain, and that her pain increased with rainy weather. Id. at 668. She reported

a severity level of 6/10 and that the problem had been waxing and waning and was

associated with limited range of motion and stiffness, but no joint swelling, numbness, or

tingling. Id. at 669, 690.

7

C. Expert Reports

1. Petitioner’s Expert Report

Petitioner provided an expert report from Naveed Natanzi, D.O., a board-certified

specialist in physical medicine and rehabilitation with fellowship training in interventional

sports and spine medicine. Ex. 14 at 1. Dr. Natanzi stated that he was trained by Marko

Bodor, M.D., the first medical professional to describe SIRVA in literature from 2006. Id.

In his expert report, Dr. Natanzi summarized the records he had reviewed and

relevant medical literature. Ex. 14 at 1-7. He found no evidence that Petitioner had a

native left shoulder dysfunction prior to vaccination. Id. at 1-2. He noted that her pre-

vaccination medical history included “complaints of vague myofascial pain but no native

shoulder pathology” or dysfunction. Id. Following the December 1, 2016 flu shot, however,

her records repeatedly indicated that she reported pain in her left shoulder since her flu

shot. Id. at 2-4.

Dr. Natanzi opined that Petitioner’s left shoulder pain was “a direct result of the

influenza vaccine she received on 12/1/16.” Ex. 14 at 1. He noted that Petitioner described

atypical severe pain in her left arm immediately after vaccination. Id. at 8. Petitioner

reported that when the vaccine was administered, Petitioner was seated with her left arm

in a resting, non-abducted position by her side, and the injector was standing. Id.

Dr. Natanzi acknowledged Petitioner’s “long history of fibromyalgia (FM) with

chronic diffuse body aches stemming back to 2009-2010” that included “diffuse

myofascial pains in the upper back, lower back, and shoulders.” Ex. 14 at 8. However, he

explained that fibromyalgia is “markedly different in clinical presentation than symptoms

related to a structural shoulder injury.” Id. FM symptoms are diffuse and throughout the

body, while Petitioner’s shoulder pains were focal and isolated. Id. He added that it would

be “extremely unlikely to see left shoulder adhesive capsulitis with FM alone . . . . [while]

in the context of SIRVA, adhesive capsulitis is a very common finding.” Id.

Dr. Natanzi discussed Petitioner’s limitations, and stated that “[t]he inability to

perform behind the back movements such as putting on and off a bra are further

suggestive of rotator cuff dysfunction, and again generally unlikely in the context of FM

alone.” Ex. 14 at 8. He added:

In summary, although it is likely that Ms. Bishop experienced a heightened

response to the dysfunction associated with vaccine overpenetration as a

result of underlying FM, this does not change the fact that the vaccine did

over-penetrate causing SIRVA. In other words, had a vaccination been

properly administered, as in previous vaccinations (i.e. 11/18/15), it is

extremely unlikely that these symptoms develop despite the presence of

FM. As such, I opine that the presence of FM does not negate the fact that

Ms. Bishop was in fact injured by her vaccination.

8

Id. at 8-9.

Dr. Natanzi acknowledged that Petitioner’s history included chronic pain and

multiple doctor visits, but found convincing that there were “never complaints of structural

left shoulder dysfunction until post-vaccination” and that the first record of shoulder

dysfunction was on March 9, 2017, when Petitioner reported left shoulder pain since

December 1, 2016. Ex. 14 at 9. He described that record as “limited and poorly described”

but noted that it documented joint pain and range of motion pain. Id. He added that

Petitioner averred that she mentioned her shoulder symptoms to the nurse practitioner

on February 9, 2017 “which may be referred to in the again incomplete note where it was

written, ‘she now has the other complaints.’ ” Id. He concluded:

Given the lack of structural left shoulder dysfunction preceding the

vaccination, coupled with the lack of any other injury or accident to explain

the shoulder symptoms, all in conjunction with Ms. Bishop’s affidavit

outlining immediate onset of symptoms, I opine to a reasonable degree of

medical certainty that Ms. Bishop’s symptoms developed immediately after

the vaccination. As such, this clinical scenario falls well in line within the

generally accepted timeframe of symptoms in SIRVA cases (pain within 48

hours).

Id.

Dr. Natanzi then addressed the “tingling” noted as a symptom of pre-existing

chronic back pain. Ex. 14 at 9. He stated that “there is no neuro-anatomic association

where any low back dysfunction would present with upper extremity symptoms, namely

[tingling]. Assuming that Ms. Bishop was experiencing tingling and the note erroneously

listed it under the low back paragraph, the presence of isolated tingling is extremely non-

specific and would certainly have no bearing on this claim.” Id.

With respect to the records indicating that Petitioner’s pain extended to her fingers

and thumb, Dr. Natanzi stated:

Radiating pains associated with tingling are common findings in cases of

SIRVA. In fact, altered sensation in the ipsilateral [same side] limb after

SIRVA was recorded by Atanasoff et al. in four patients out of a cohort of

thirteen. Similarly, Okur et al. describe a cool, numb, and heavy sensation

with radiating pains along the affected limb in a SIRVA patient immediately

after vaccination. As such, in light of no history of other diagnoses (i.e.,

cervical radiculopathy, peripheral mononeuropathy, etc.) to suggest

otherwise, I believe the hand symptoms experienced by Ms. Bishop were

directly related to SIRVA.”

Id. at 9-10.

Dr. Natanzi then reviewed the temporal course of events in this case and found

that they “are consistent with SIRVA.” Ex. 14 at 11. He described the sequence of events

9

as inadvertent over-penetration of the vaccination needle, resulting in bursal, capsular,

and/or tendinous penetration, causing immediate sharp radiating pain, numbness, and

discomfort associated with limited range of motion on the day of vaccination. Id. This

resulted in the vaccine interacting with antibodies from prior vaccination and an

exaggerated robust and prolonged inflammatory response. Ultimately, he opined that this

sequence of events resulted in inflammation of the joint capsule and development of

impingement, adhesive capsulitis, and reduced range of motion. Id.

Dr. Natanzi stated that for the reasons set forth in his report, he did not believe that

Petitioner’s fibromyalgia was a condition or abnormality that would explain Petitioner’s

symptoms. Ex. 14 at 11. Dr. Natanzi concluded:

Ms. Bishop’s symptoms closely mimic those of the SIRVA cases described

in medical literature. Given the outlined temporal relationship of symptoms

to the vaccine, evidence of improper vaccination technique, and the

absence of any pre-vaccination shoulder dysfunction, it is more likely than

not that the influenza vaccination on 12/1/16 caused Ms. Bishop’s left

shoulder dysfunction . . . . I see nothing in this case to preclude a SIRVA

diagnosis.

Id. at 12.

2. Respondent’s Expert Report

Respondent provided an expert report from Paul J. Cagle, M.D., Assistant

Professor and Associate Program Director in the Department of Orthopaedic Surgery at

the Icahn School of Medicine at Mount Sinai. Ex. A at 1. Dr. Cagle states that he is a

Board Certified Orthopaedic Surgeon with fellowship training in shoulder surgery. Id. He

is a member of the American Shoulder and Elbow Surgeons, the American Academy of

Orthopaedic Surgeons, and the American Orthopaedic Association. Id. He states that his

current practice focuses on shoulder problems, which represent approximately 95% or

more of the patients and pathology he treats. Id.

Dr. Cagle’s curriculum vitae (“CV”) shows that he earned his medical degree at

Loyola University Stritch School of Medicine. Ex. B at 1. He then did an orthopaedic

residency at the University of Minnesota, followed by a Shoulder and Elbow Fellowship

at Mount Sinai in New York and a Shoulder Fellowship at a private hospital in Lyon,

France. Id. His CV lists grant funding, a patent, honors and publications, presentations,

research, and other professional activities. Id. at 2-17.

In his expert report, Dr. Cagle focused on the two medical appointments between

the December 1, 2016 vaccination and the March 9, 2017 record showing that Petitioner

reported shoulder pain. Ex. A at 2. He noted that Petitioner was seen on January 10, 2017

and February 9, 2017, and that “[t]hese two visits demonstrate a pattern of diffuse muscle

and joint pain involving multiple areas of her body.” Id. The first record of shoulder pain,

on March 9, 2017, indicated that Petitioner reported pain in her left triceps. Id. He noted

10

that the April 14, 2017 MRI showed minimal fluid in the shoulder joint and subacromial

subdeltoid bursa. Id.

Dr. Cagle then discussed the proposed mechanism of injury. He noted that current

Centers for Disease Control and Prevention guidelines would call for a 1-inch needle for

Petitioner. Ex. A at 3. He added that studies have found this to be a safe needle length,

and thus “it can be presumed that . . . the risk of ‘overpenetration’ was quite low.” Id.

Dr. Cagle then noted that Petitioner’s medical records do not reflect any report of

shoulder pain until over three months after vaccination. Ex. A at 3. In the interim, Petitioner

was seen and treated twice for pain in her muscular skeletal system, noted as back pain

and joint pain. Id. As Dr. Cagle noted:

This finding is of significance. Had she been evaluated for a completely

unrelated event, it could be conceivable that new onset shoulder pain would

not have been discussed, but as she was presenting for treatment of back

and joint pain, pains in the muscular skeletal system were clearly assessed

and discussed during the visit. Thus for over 3 months, there was no

mention or record of shoulder pain, even though Ms. Bishop had two visits

for joint and back pain. Shortly after Ms. Bishop reported her shoulder pain,

an MRI was performed and showed minimal fluid in the shoulder joint and

subacromial subdeltoid bursa. This is again of significance as an injection

into either the capsule or the bursa capable of causing adhesive capsulitis

would cause inflammation and a fluid response. A fluid reaction to an

influenza injection has been documented in the literature and a lack of fluid

response on the MRI from 4/14/2017 speaks against a claim of acute

reaction from the vaccination.

Id. at 4.

Dr. Cagle then critiqued Dr. Natanzi’s report by asserting that Dr. Natanzi

“incorrectly assessed or [did] not read” Ex. 14.10, a medical journal report by Arias et al.,4

and, as a result, miscalculated the number of SIRVA cases reported in the literature. Ex.

A at 4. Dr. Cagle added that there is “no documentation at all of the technique utilized for

the vaccination, this [that an improper technique was used for the vaccination at issue] is

only speculative and I do not understand where the assertion is being derived from.” Id.

at 5. Dr. Cagle otherwise had “concerns about relying on [statements in Petitioner’s

affidavit] as they do not coincide with the lack of reported shoulder pain demonstrated in

the medical records.” Id. Dr. Cagle concluded that there was no definitive evidence of

inappropriate vaccination technique, no documentation of appropriate timing of onset of

symptoms, and thus “it is highly unlikely that the influenza vaccination which occurred on

12/1/2016 and any subsequent shoulder pain or injury experienced by Marie Bishop are

correlated.” Id.

4

L.H. Martin Arias et al., Risk of bursitis and other injuries and dysfunctions of the shoulder following

vaccinations, 35 Vaccine 4870 (2017), filed as Petitioner’s Exhibit 14.10, Respondent’s Exhibit A15.

11

D. Affidavit Evidence

Petitioner has filed an affidavit explaining the administration of the December 1,

2016 flu vaccine, the symptoms she experienced thereafter, and her subsequent seeking

of medical care. Ex. 13. She was seated on the exam table while the nurse who

administered the vaccine was standing. Id. at ¶ 2. The nurse “jabbed [the needle] into my

upper left arm . . . . [and] it burned and hurt. Immediately following vaccination, I felt pain

in my left shoulder. The pain and burning continued to hurt after she administered the

shot. It was the worst pain that I have ever had when receiving a flu vaccine . . . . When I

first received my injection, my range of motion was affected. . . . Later on that night my

left arm and shoulder [were] still sore.” Id.

Petitioner further explained that the pain continued through December 2016 and

January 2017. Ex. 13 at ¶ 3. This pain was intermittent, and thus she did not think much

of it. Id. However, over time, the condition progressed to where she could no longer lift

her arm in front of her or over her head. Id. She explained that she did an internet search

of her symptoms in February or March 2017, and found a person describing symptoms

similar to hers that resulted from a flu vaccine. Id. at ¶ 5. Until then, she had not realized

that the flu vaccine could cause this kind of injury. Id.

Regarding her January 10, 2017 appointment, Petitioner stated that she was a new

patient, and was trying to focus on remembering what to discuss/mention, while NP

Steffey had a lot of questions. Id. at ¶ 8. As a result, and due to her desire to end the

appointment quickly, she neglected to mention her shoulder/arm pain at this time. Id. At

the February 9, 2017 appointment, however, Petitioner recalled saying something to NP

Steffey about her arm at the end of the appointment. Id. at ¶ 9. In response, Petitioner

recalls, NP Steffey told her that if her arm was still hurting at her next appointment, he

would order x-rays, which he in fact did after the March 9, 2017 appointment. Id.

Petitioner has also submitted an affidavit from her husband, David Bishop. Ex. 16.

He avers that he took her to the December 1, 2016 appointment at which she received

the flu shot. Id. at ¶ 2. He stated that he waited for her in the lobby and that when she

came out, she told him that “the shot they gave her didn’t feel like the other Flu shots she

had gotten before. She told me that it hurt and burned immediately when the nurse had

given it to her, and she had felt pain in her left shoulder afterwards.” Id. In particular:

She took her bandaid off when she got home and it was up high toward the

back of her arm in the back of her shoulder. She was very sore and she

began to swell after a few days and it got harder for her to raise her arm up

in front of her even above her head. I was there when she took her bandaid

off. I remember she wouldn’t let me take it off because she was in so much

pain.

Id. at ¶ 4. Mr. Bishop adds that “I would have to help my wife for awhile with getting her

bra on.” Id. at ¶ 5. He explained that the pain continued through Christmas and “she had

a hard time doing some things with her arm such as picking up plates.” Id. at ¶ 7.

12

In addition, Petitioner submitted an affidavit from her mother in law, Leala Bishop.

Ex. 17. This affidavit averred that Petitioner “never complained about pain in her shoulder

until she had the flu vaccination in December of 2016.” Id. at ¶ 2. However, around

Christmas of 2016, “I remember her telling me of the flu shot and how her arm had swollen

as the days went by . . . . I remember her arm hurting her and seeing her having difficulty

in putting her arm around to the front of her and to the side, she was in pain . . . . she

couldn’t hardly raise her arm.” Id. at ¶ 3. As this affiant explained:

She had told me over several different times about when she went and got

the vaccine shot and the pain afterwards. She had talked about it had

burned and hurt afterwards . . . . she would hold her shoulder when she

would come over to visit and complain of pain . . . Melissa would complain

or favor her left shoulder . . . . She can only put her arm/hand, not very far

in the back of her back . . . . She still has pain.

Id. at ¶¶ 4-6.

Petitioner’s mother, Paula Trent, also submitted an affidavit. Ex. 18. She averred

that “my daughter has never had a prior injury to her left arm/shoulder ever before

December 1, 2016.” Id. at ¶ 2. After the December 1, 2016 vaccination, however, Ms.

Trent stated:

3. . . . I remember her complaining to me the day she received her

vaccination on December 1, 2016, that when she went to the doctor that

she got a Flu shot earlier that day and that when the nurse gave it to her it

felt different . . . .

4. I remember a few days went by that when I had talked to her again she

had told me it was swollen . . . . and it was kind of hard to put her arm in

front of her and to the side of her, and she could barely extend her arm

outward.

5. I had talked to her again about a week following the vaccination and her

pain had not gotten any better. It had gotten harder for her to put her arm

up in front of her and above her head. She couldn’t get plates out of the

cabinet . . . .

6. At Christmas that year, I remember as we gathered for family time that

my daughter was holding her left arm and rubbing her shoulder a lot. I

remember asking her what was wrong and she had reminded me of the Flu

shot she had got and I couldn’t believe that she was still hurting from that. I

had told her she might should get it looked at. But my daughter, as I know,

my daughter puts off going to the doctor until the last minute, she is that

much like her dad.

7. I remember seeing her range of motion in her left shoulder continue to go

down into March 2017.

Id. at ¶¶ 3-7.

13

III. Ruling on Entitlement

In this case, Respondent has represented that he no longer intends to defend this

case, but does not otherwise concede that Petitioner is entitled to compensation. In

similar circumstances, special masters have determined that it is appropriate to proceed

to decide entitlement. See, e.g., Davis v. Sec’y of Health & Human Servs., No. 09-295V,

2010 WL 3790178, at *3 (Fed. Cl. Spec. Mstr. Sept. 8, 2010) (noting that “respondent

does not concede liability in this case [but] has stated . . . that respondent will not expend

any further resources to defend this case” and proceeding to rule on entitlement).

Before compensation can be awarded under the Vaccine Act, a petitioner must

demonstrate, by a preponderance of evidence, all matters required under Section

11(c)(1). Section 13(a)(1)(A). In making this determination, the special master or court

should consider the record as a whole. Section 13(a)(1). Petitioner’s allegations must be

supported by medical records or by medical opinion. Id. In addition to requirements

concerning the vaccination received, the duration and severity of petitioner’s injury, and

the lack of other award or settlement,5 a petitioner must establish that she suffered an

injury shown to be caused-in-fact by the vaccination she received. Section 11(c)(1)(C). In

this case, the claim is analyzed as an off-Table, or causation in fact, claim based on the

allegations of the Petition. Petition at ¶ 14.

A petitioner must “prove . . . that the vaccine was not only a but-for cause of the

injury but also a substantial factor in bringing about the injury.” Shyface v. Sec’y of Health

& Human Servs., 165 F.3d 1344, 1351 (Fed. Cir 1999). Id. at 1352. The vaccine, however,

need not be the predominant cause of the injury. Id. at 1351. The Federal Circuit has

indicated that a petitioner “must show ‘a medical theory causally connecting the

vaccination and the injury’” to establish that the vaccine was a substantial factor in

bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting Grant v. Sec’y of Health

& Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). The Federal Circuit

subsequently reiterated these requirements in a three-pronged test. See Althen v. Sec’y

of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Under this test, a

petitioner is required:

5

In summary, a petitioner must establish that she received a vaccine covered by the Program, administered

either in the United States and its territories or in another geographical area but qualifying for a limited

exception; suffered the residual effects of her injury for more than six months, died from her injury, or

underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or collected

an award or settlement for her injury. See Section 11(c)(1)(A)(B)(D)(E). These requirements are not

contested in this case and I find that the medical records and other evidence establish that they are met.

14

to show by preponderant evidence that the vaccination brought about her

injury by providing: (1) a medical theory causally connecting the vaccination

and the injury; (2) a logical sequence of cause and effect showing that the

vaccination was the reason for the injury; and (3) a showing of a proximate

temporal relationship between vaccination and injury.

Id. All three prongs of Althen must be satisfied. Id. Circumstantial evidence may be

considered, and close calls regarding causation must be resolved in favor of the

petitioner. Althen, 418 F.3d at 1280.

Although the first and second prongs of Althen appear to be similar, these analyses

involve different inquiries. See Doe 93 v. Sec’y of Health & Human Servs., 98 Fed. Cl.

553, 566-67 (2011). The first prong focuses on general causation - whether the

administered vaccine can cause the particular injury suffered by the petitioner; while the

second prong focuses on specific causation - whether the administered vaccine did cause

the injury. Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352, 1355-56 (Fed. Cir.

2006).

In this matter, I find preponderant evidence exists with respect to all three Althen

prongs, thus entitling Petitioner to an award of damages. I discuss the bases for my

conclusion below.

A. Althen Prong One

Even though this case is a non-table claim, I take judicial notice of the fact that

Respondent has added SIRVA after receipt of an intramuscularly administered seasonal

flu vaccine to the Table.6 Thus, in proposing the Table addition of SIRVA, Respondent

discussed the scientific evidence regarding the means by which this injury is caused –

and in so doing specifically referenced two articles also offered in connection with both

expert reports in this case. See National Vaccine Injury Compensation Program:

Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132, 45136-37 (July 29, 2015); S.

Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA), 28 Vaccine

8049 (2010), filed as Petitioner’s Exhibit 14.5 and Respondent’s Exhibit A4 (ECF Nos.

23-7 and 29-5) (“Atanasoff”); M. Bodor and E. Montalvo, Vaccination Related Shoulder

Dysfunction, 25 Vaccine 585 (2007), filed as Petitioner’s Exhibit 14.2 and Respondent’s

Exhibit A4 (ECF Nos. 23-4, 29-12) (“Bodor”).

6

Although claimants may not rely expressly on the Table elements of a claim comparable to a non-Table claim to

meet their burden of proof, the fact that the Table has been amended to add a claim naturally suggests the existence

of reliable scientific or medical evidence in support of the “can cause” prong. See Doe 21 v. Sec'y of Health & Human

Servs., 88 Fed. Cl. 178, 193 (2009), rev’d on other grounds, 527 Fed. Appx. 875 (Fed. Cir. 2013).

15

These articles provide persuasive and reliable support for the conclusion that the

flu vaccine could cause a SIRVA injury. The mechanism set forth in Atanasoff is described

as “the unintentional injection of antigenic material into synovial tissues resulting in an

immune-mediated inflammatory reaction.” Atanasoff, Ex. 14.5 at 1. As its authors

indicated, this results in an inflammatory response which may be prolonged due to pre-

existing antibody in the synovial tissue from an earlier, naturally-occurring infection or

vaccination. Id. at 3. They also observed that bursitis and greater fluid in the bursa were

two of the findings often seen in MRI studies of vaccine injured shoulders. Atanasoff

further mentioned that many of the patients they studied may have had prior conditions

such as rotator cuff tears which only became symptomatic following the improper vaccine

injection. To distinguish this type of vaccine-related shoulder injury from conditions

caused by a mechanical injury or overuse, the authors pointed to “the rapid onset of pain

with limited range of motion following vaccination” which was seen in the patients they

studied. Id. Bodor provides additional support for this proposed mechanism.

This scientific/medical evidence comprises preponderant evidence supporting the

conclusion that the seasonal flu vaccine, when administered intramuscularly but

improperly injected in the synovial space, can cause an inflammatory response resulting

in shoulder injury. Petitioner has therefore satisfied the first Althen prong.

B. Althen Prong Two

The second Althen prong requires proof of a logical sequence of cause and effect,

usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d

at 1278; Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1375-77 (Fed. Cir.

2009)); Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir.

2006); Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992).

In establishing that a vaccine “did cause” an injury, the opinions and views of the injured

party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367;

Capizzano, 440 F.3d at 1326 (“treating physicians are likely to be in the best position to

determine whether a ‘logical sequence of cause and effect show[s] that the vaccination

was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280).

In his expert report, Dr. Natanzi opined that the following sequence of events,

consistent with SIRVA, explained Petitioner’s injury. He theorized that inadvertent over-

penetration of the vaccination needle resulted in bursal, capsular and/or tendinous

penetration, causing Petitioner to experience immediate sharp radiating pain, numbness,

and discomfort associated with limited range of motion on the day of vaccination. Then,

he suggested, the vaccine interacted with naturally occurring antibodies from a prior

vaccination, resulting in an exaggerated robust and prolonged inflammatory response.

16

This, he proposed, resulted in inflammation of the joint capsule and development of

impingement, adhesive capsulitis, and reduced range of motion. Ex. 14 at 11.

The medical records contain evidence corroborating Petitioner’s contention that

the flu vaccine caused Petitioner’s shoulder injury in the manner described by Dr. Natanzi.

At the appointment when Petitioner received the vaccine, she reported back pain but no

other musculoskeletal issues. Ex. 7 at 99. Shortly thereafter, however, she developed

pain within 48 hours that persisted and worsened over time. After three months, Petitioner

sought care for her shoulder pain and reduced range of motion. Her symptoms persisted,

and an MRI showed fluid in her shoulder joint and subacromial subdeltoid bursa, as well

as tendinopathy.

Dr. Cagle focuses on the MRI noting “minimal” fluid, and finds this significant. Ex.

A at 4. He argues that an injection capable of causing adhesive capsulitis would cause

inflammation and a fluid response, and that “a lack of fluid response on the MRI from

4/14/2017 speaks against a claim of acute reaction from the vaccination.” Id. Dr. Cagle

seems to wrongly interpret “minimal fluid” to mean no fluid at all. He inaccurately

discusses the April 2017 MRI as showing a lack of fluid response; instead, the MRI does

show a fluid response, which Dr. Cagle agrees would be present with an injection that led

to adhesive capsulitis.

I find that the preponderance of the evidence demonstrates that Petitioner’s

December 1, 2016 flu vaccine likely caused her left shoulder injury.

C. Althen Prong Three

The third Althen prong “requires preponderant proof that the onset of symptoms

occurred within a timeframe for which, given the medical understanding of the disorder’s

etiology, it is medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y of Health

& Human Servs., 539. F.3d 1347, 1352 (Fed. Cir. 2008).

On September 20, 2019, a fact ruling was issued finding that the onset of

Petitioner’s left shoulder pain occurred within 48 hours of vaccination, which is the

required timing for a Table SIRVA.7 This fact finding is also sufficient to satisfy the third

7

Respondent’s amended Rule 4(c) Report asserts in a footnote that the September 20, 2019 fact ruling

acknowledged that expert reports were filed but did not address the experts’ opinions regarding onset.

Respondent’s Amended Rule 4(c) Report, at *8, n.3.

While the onset ruling did not expressly discuss the experts’ opinions on onset, I have reviewed those

opinions and find that they do not cast doubt on the onset ruling. I acknowledge that Dr. Cagle emphasized

the significance of the fact that the January 10 and February 9, 2017 appointments involved Petitioner’s

muscular skeletal system but not her shoulder injury. However, I note that Petitioner did report non-specific

17

Althen prong here, since that timeframe has been shown by the evidence offered by

Petitioner to be medically acceptable.

IV. Conclusion

Having reviewed the affidavits, medical records, expert reports, and

documentation in this case, I find that Petitioner has provided preponderant evidence to

establish that the flu vaccine she received on December 1, 2016, likely caused her to

suffer pain and reduced range of motion in her left shoulder. Petitioner is therefore entitled

to compensation under the Vaccine Act. A damages order will be issued setting the next

deadline in this case.

IT IS SO ORDERED.

s/Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

“joint pain” at these visits. Dr. Cagle implies that the lack of specifically-identified shoulder pain means that

Petitioner did not have shoulder pain at the time of those appointments. However, Petitioner explained that

she did not discuss her shoulder pain with her care provider at the January appointment because the

appointment was long and she was tired, and that she did mention it at the end of the February appointment.

I find Petitioner’s explanation to be consistent with the medical records. Moreover, I note that at the time of

the January and February 2017 appointments, Petitioner was taking prescription pain medication which,

even if not prescribed for her shoulder pain, likely alleviated that pain at least somewhat. Finally, Petitioner

explained that the pain following vaccination initially was intermittent and thus she did not think much of it,

but she became concerned when it worsened over time. In addition, she explained that she was unaware

that a flu vaccine could cause a shoulder injury until February or March of 2017.

Reviewing the record as a whole, I find that a preponderance of the evidence supports the finding that the

onset of Petitioner’s shoulder pain began within 48 hours of vaccination. Therefore, I affirm the September

20, 2019 fact ruling.

18