Robinson v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 21-32V

Filed: August 19, 2024

Special Master Horner

BRUCE ROBINSON,

Petitioner,

v.

SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

David John Carney, Green & Schafle, LLC, Philadelphia, PA, for petitioner.

Alexa Roggenkamp, U.S. Department of Justice, Washington, DC, for respondent.

DECISION 1

On January 4, 2021, petitioner filed a petition under the National Childhood

Vaccine Injury Act, 42 U.S.C. § 300aa-10, et seq. (2012), 2 alleging that he a left

shoulder injury resulting from his January 23, 2019 tetanus vaccination. (ECF No. 1.)

For the reasons discussed below, I now find that petitioner is not entitled to

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,

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

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

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

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

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

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

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

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

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

public access.

2

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

§ 300aa-10, et seq.

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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. § 300aa-11(c).

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)-(B); § 300 aa-11(c)(1)(C)(i); § 300aa-14(a).

The Vaccine Injury Table lists a Shoulder Injury Related to Vaccine

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

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

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

provide more detailed explanation of what should be considered when determining

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

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

within the following definition:

SIRVA manifests as shoulder pain and limited range of motion occurring

after the administration of a vaccine intended for intramuscular

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

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

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

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

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

not a neurological injury and abnormalities on neurological examination or

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

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

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

following:

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

prior to intramuscular vaccine administration that would explain the alleged

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

after vaccine injection;

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

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

the intramuscular vaccine was administered; and

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

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

brachial neuritis, mononeuropathies, or any other neuropathy).

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42 CFR § 100.3(c)(10).

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

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

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

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

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

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

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

1344, 1352 (Fed. Cir. 1999)); Pafford ex rel. 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). A petitioner may also

demonstrate that a vaccine caused a significant aggravation of a pre-existing condition.

See Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144 (2009) (combining

the first three Whitecotton factors for claims regarding aggravation of a Table injury with

the three Althen factors for off table injury claims to create a six-part test for off-Table

aggravation claims); see also W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352,

1357 (Fed. Cir. 2013) (applying the six-part Loving test.).

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

establish their claim by a “preponderance of the evidence”. § 300aa-13(a)(1)(A). That

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

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

medical certainty is not required. Bunting ex rel. Bunting v. Sec'y of Health & Human

Servs., 931 F.2d 867, 872-73 (Fed. Cir. 1991). However, a petitioner may not receive a

Vaccine Program award based solely on his assertions; rather, the petition must be

supported by either medical records or by the opinion of a competent physician.

§ 300aa-13(a)(1). Once a petitioner has established their prima facie case, the burden

then shifts to respondent to prove, also by preponderant evidence, that the alleged

injury was caused by a factor unrelated to vaccination. Althen, 418 F.3d at 1278

(citations omitted); § 300aa-13(a)(1)(B).

II. Procedural History

Based on the allegations in the petition, this case was initially assigned to the

Chief Special Master as part of the Special Processing Unit (“SPU”). (ECF No. 9-10.)

Petitioner filed an affidavit and medical records marked as Exhibits P1-P10. (ECF Nos.

6, 17.) In November of 2022, respondent filed his Rule 4 Report recommending against

compensation. (ECF No. 26.) Respondent argued that petitioner’s injury was

inconsistent with a Table SIRVA and further that he had demonstrated neither

causation-in-fact or any significant aggravation of his condition. (Id. at 15-23.)

Thereafter, the case was reassigned to the undersigned. (ECF Nos. 27-28.)

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Petitioner then filed an expert report by physical medicine and rehabilitation

specialist Naveed Natanzi, D.O., with supporting materials. (ECF Nos. 29-31; Exs. P11-

P13.) Respondent responded with a report by orthopedic surgeon Geoffrey Abrams,

M.D., accompanied by supporting materials. (ECF Nos. 33, 40; Exs. A-B.) Petitioner

subsequently filed a supplemental report by Dr. Natanzi. (ECF No. 34; Ex. P14.) I then

directed the parties to propose a briefing schedule for a ruling on the written record (or

to otherwise object to proceeding in that manner). Petitioner filed a motion for a ruling

on the written record on September 27, 2023. (ECF No. 37.) Respondent filed his

response on December 5, 2023, and petitioner filed a reply on December 19, 2023.

(ECF Nos. 39, 41.)

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

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

a hearing. See Vaccine Rule 8(d); Vaccine Rule 3(b)(2); see also Kreizenbeck ex rel.

C.J.K 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

Prior to the vaccination at issue, petitioner had a ten-year history of left shoulder

problems. In January of 2011, he underwent a left shoulder arthroscopy with labral

debridement, subacromial decompression, and rotator cuff repair. (Ex. 9, p. 50.) On

October 1, 2018, he underwent a complete left shoulder replacement and bicep

tenodesis. (Ex. P7, p. 109.) Petitioner argues that the October 2018 surgery had no

complications and that he had “no issues” following the surgery. (ECF No. 37, p. 3.)

As of a December 20, 2018, follow up, petitioner was noted to be doing “much

better,” though his orthopedist, Dr. Williams of Rothman Orthopedics, felt he continued

to have some reduced range of motion. (Ex. P1, p. 38.) X-rays showed his shoulder

implant to be in good condition and petitioner estimated he had 70% of his normal

function, with pain ranging from 0 at rest to a maximum of 3. (Id.) Petitioner was

assessed with recurrent dislocation, primary osteoarthritis, and bicipital tendinitis of the

left shoulder. (Id.) Petitioner wanted to resume playing golf and the orthopedist agreed

he could try, noting that it usually takes about three months to resume such activity

post-surgery. (Id.)

On January 23, 2019, petitioner received the tetanus vaccination at issue. (Ex.

P1, p. 33.) He avers in his written statement that he was pain free at the time of the

vaccination, but that he

felt pain and soreness at the injection site in my left shoulder. As the day

progressed the pain worsened and over the following two days, the pain

increased in intensity to the point where I began to think I was not

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experiencing routine vaccination discomfort. Throughout the following two

weeks, the soreness increased.

(Ex. P2, ¶¶ 9-10.) Petitioner further indicates that “while completing my physical

therapy from my previous operation, my strength decreased drastically and

immediately.” (Id. at ¶ 10.) However, I cannot locate any confirmation within petitioner’s

physical therapy records that he was continuing physical therapy for his shoulder during

this period. (See Ex. P8.)

Petitioner returned to Rothman Orthopedics on January 29, 2019, presenting to

Dr. Ross with a new complaint of right hamstring pain that had begun about six months

prior. (Ex. P1, p. 35.) Petitioner did not report any shoulder pain. (Id.) The physical

examination recorded that “Neck, back, and bilateral upper and lower extremities all

move well with normal range of motion, normal strength, no asymmetry, atrophy,

deformity, tenderness or instability.” (Id.) Petitioner then had a physical therapy

appointment for his hamstring the next day with no mention of shoulder pain. (Ex. P8,

pp. 66-68.)

Petitioner avers that he called Dr. Williams to report his post-vaccination shoulder

pain on February 8, 2019, and was told to wait a further week to see if the pain

persisted. (Ex. P2, ¶ 11.) The Rothman Orthopedics records confirm the call, but do

not corroborate petitioner’s account of his shoulder pain. (Ex. P10, p. 57.) Although the

record confirms that petitioner associated his shoulder pain with his tetanus vaccination,

it specifies that he reported that the pain had begun five days prior and that it had been

intermittent. (Id.)

Petitioner had a follow up appointment with Dr. Williams on February 19, 2019.

(Ex. P1, p. 32.) The history of present illness indicates that “[h]e was doing great. He

was actually full speed ahead. He was wonderfully happy with his shoulder until about

two or three weeks ago. He spontaneously began to experience more pain and he also

noted weakness along with decreased range of motion.” (Id.) Dr. Williams remarked on

physical exam “the thing that bothers me is that he definitely has weakness in external

rotation.” (Id.) In further notes, he explained that “[t]his really was not brought on by an

injury. It sounds like it was spontaneous rupture of his rotator cuff and I am concerned

that that is what happened . . . Given his degree of weakness, I suspect that it may be a

relatively large tear.” (Id.)

A follow up ultrasound confirmed a full-thickness tear of the left infraspinatus

tendon. (Ex. P3, pp. 54-55.) In his motion, petitioner confirms this represented a new

tear. (ECF No. 37, pp. 4-5 (citing Ex. P4, p. 4-14 and noting the tear had not been

documented prior to the October 2018 surgery).) After reviewing the ultrasound, Dr.

Williams further explained:

That is a very unusual tear pattern especially after shoulder replacement,

but even in general. Most of the time, an infraspinatus gets torn in an

isolated fashion, it is associated with some form of traumatic event. It is

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hard for me to understand how it could be associated with a tetanus shot.

It seems unlikely to me that the needle could have been put into the

infraspinatus and had an injection. It was not severely painful. However,

the bottom line is it looks like he has a tear of the infraspinatus . . .

(Ex. P3, p. 28.) 3 Dr. Williams recommended an arthroscopic procedure to confirm the

injury is limited to the infraspinatus and to potentially suture it. (Id. at 29.) He further

explained that

I also checked his motion today and passively I can get him up to 160

degrees very easily. Therefore, his shoulder is not stiff, just weak. With

any luck, this is an acute event, we can get the infraspinatus back where it

came from, fix it and have it healed.

(Id.)

On March 6, 2019, petitioner underwent an arthroscopic rotator cuff repair. (Ex.

P3, pp. 77-78.) Dr. Williams confirmed that petitioner had full range of motion and that

the subscapularis and supraspinatus were both healed, but that the infraspinatus was

torn off the humerus. (Id. at 77.) During a follow up appointment on March 19, 2019,

Dr. Williams felt that the procedure was successful in fixing the infraspinatus and he

stated, “I am hoping that if this heals, he will wind up getting a better shoulder.” (Ex. P1,

p. 30.) However, petitioner was not ultimately satisfied with the progress of his

recovery. (ECF No. 37, p. 5 (citing Ex. P5, p. 29; Ex. P2, ¶ 14); see also Ex. P3, p. 22

(report pain levels of 5 out of 10 and April 8, 2019 post-surgical follow up).)

Nonetheless, as of May 21, 2019, Dr. Williams was optimistic that the rotator cuff repair

had been helpful. (Ex. P1, p. 28.)

On July 23, 2019, petitioner had a further post-surgical follow up with Dr.

Williams. (Ex. P3, p. 18.) Petitioner complained of some pain, but primarily a lack of

function in his shoulder. (Id.) Dr. Williams continued to believe that his symptoms were

stemming from rotator cuff insufficiency but indicated that his pain and level of function

suggested that a revision of his prior shoulder replacement to a reverse shoulder

replacement would be appropriate. (Id. at 19.) At a further follow up on September 17,

2019, Dr. Williams maintained his recommendation. (Id. at 16-17.)

Shortly thereafter, petitioner sought a second opinion from orthopedist Lawrence

Miller, M.D., regarding the proposed reverse shoulder revision. (Ex. P6, p. 10.)

Petitioner reported that he had been doing well after his October 2018 shoulder surgery

until he received a vaccination (incorrectly noted as a flu shot) in that shoulder “which

caused him a lot of pain and weakness in the arm.” (Id.) He specified that he had no

fall or trauma when the pain began. (Id.) Dr. Miller reviewed petitioner’s prior reports

from Rothman Orthopedics but did not have imaging available. (Id. at 11-12.) Dr. Miller

3

Contrary to Dr. Williams’s opinion that a vaccination needle would not come into contact with the

infraspinatus tendon, petitioner later reported to his physical therapist that the tetanus vaccination had

caused his rotator cuff tear. (Ex. P8, p. 61.)

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opined that “[i]t is not clear why the shoulder failed,” but agreed that the reverse

shoulder replacement was the only option. (Id. at 12.)

Petitioner had a shoulder revision surgery on October 7, 2019. (Ex. P7, p. 7.)

Petitioner continued to seek further treatment as he recovered from this surgery;

however, the remainder of his medical records are not informative with respect to the

underlying cause of his condition.

IV. Expert Reports

a. Naveed Natanzi, D.O. 4

Dr. Natanzi opines that petitioner’s injury was due to overpenetration of his

vaccination needle into his rotator cuff, resulting in a SIRVA. (Ex. P11, p. 8-10.) This

opinion is based on three factors (1) accepting petitioner’s account of a post-vaccination

onset; (2) the lack of any other injury during the period of onset; and (3) the available

objective findings. (Id.) Dr. Natanzi stresses that he believes petitioner’s rotator cuff

was likely intact following his October 2018 surgery. (Id. at 8-9.) Dr. Natanzi

acknowledges petitioner had an isolated infraspinatus tendon tear but opines that such

tears are well documented in the SIRVA literature. (Id. at 9 (citing S. Atanasoff et al.,

Shoulder Injury Related to Vaccine Administration (SIRVA), 28 VACCINE 8049 (2010)

(Ex. P13, Tab b); Matthew G. Barnes et al., A “Needling” Problem: Shoulder Injury

Related to Vaccine Administration, 25 J. AM. BD. FAM. MED. 919 (2012) (Ex. P13, Tab c);

Soshi Uchida et al., Subacromial Bursitis Following Human Papilloma Virus Vaccine

Misinjection, 31 VACCINE 27 (2012) (Ex. P13, Tab l); Maj Sofia Szari et al., Shoulder

Injury Related to Vaccine Administration: A Rare Reaction, 36 FED. PRAC. 380 (2019)

(Ex. P13, Tab o); Michael Shahbaz et al., Shoulder Injury Related to Vaccine

Administration (SIRVA): An Occupational Case Report, 67 WORKPLACE HEALTH &

SAFETY 501 (2019) (Ex. P13, Tab p); 42 CFR § 100.3(c)(10)).)

In response to Dr. Abrams, Dr. Natanzi acknowledges that post-shoulder

replacement rotator cuff tearing is “an unfortunate but known phenomenon,” though he

asserts it is rarer than Dr. Abrams suggests and typically is not acute absent trauma.

(Ex. 14, p. 2.) Dr. Natanzi also suggests that the literature Dr. Abrams cites would not

account for this happening as soon as four and a half months following the surgery.

(Id.) Dr. Natanzi acknowledges that rotator cuff tears can result from post-surgical

4

Dr. Naveed Mayer Natanzi received his bachelor’s degree from the University of California, Santa

Barbara and his Doctor of Osteopathy from Western University of Health Sciences. (Ex. P12, p. 2.) He

completed an internship at Downey Regional Medical Center and a residency in physical medicine and

rehabilitation at the University of California, Irvine. (Id. at 1-2.) He also completed a fellowship at Bodor

Clinic in Interventional Regenerative Sports and Spine Medicine. (Id. at 1.) He is board certified in both

physical medicine and rehabilitation, and pain management. (Id.) He founded the Interventional

Regenerative Sports and Spine Medicine branch of Regenerative Sports and Spine Institute and currently

works as a staff physician at VA Long Beach Healthcare System and a medical director at Tova Surgical

Center. (Id.) He has authored eight publications. (Id. at 3.)

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physiotherapy but believes this is “almost always” associated with a traumatic and

painful event.” (Id. at 3.) Dr. Natanzi asserts that

[a]lthough the findings of a full-thickness cuff tear (as opposed to a partial

tear) are uncommon in the setting of a SIRVA injury, the fact that Mr.

Robinson had an intact cuff coming out of surgery and the acuity of pain

that he presented with after vaccination just a few months after surgery

makes the vaccine the only reasonable culprit.

(Id. at 2.) Although Dr. Natanzi stresses that petitioner’s rotator cuff was likely intact

following his surgery, he does agree that his prior history likely left his infraspinatus

tendon “relatively weaker” and susceptible to a full thickness tear from the vaccination.

(Id.)

b. Geoffrey Abrams, M.D. 5

Dr. Abrams opines that petitioner’s condition can be explained by rotator cuff

tearing alone. (Ex. A, p. 6.) Given that petitioner’s medical records confirm his

infraspinatus tear as the cause of his symptoms, the key question is what caused the

tear. (Id.) In that regard, he indicates rotator cuff tears are a well-known post-surgical

phenomenon. (Id. (citing Alvarho Guzman et al., Arthroscopic Repair of Traumatic

Rotator Cuff Tear Following Total Shoulder Arthroplasty: A Case Report and Review of

Literature, 11 CLINICAL CASE REPS. e07210 (2023) (Ex. A, Tab 1); Steven J. Hattrup et

al., Rotator Cuff Repair After Shoulder Replacement, 15 J. SHOULDER & ELBOW SURGERY

78 (2006) (Ex. A, Tab 2); David M. Levy et al., Rotator Cuff Tears After Total Shoulder

Arthroplasty in Primary Osteoarthritis: A Systematic Review, 10 INT’L J. SHOULDER

SURGERY 78 (2016) (Ex. A, Tab 3); Allan A. Young et al., Secondary Rotator Cuff

Dysfunction Following Total Shoulder Arthroplasty for Primary Glenohumeral

Osteoarthritis: Results of a Multicenter Study with More than Five Years of Follow-Up,

94 J. BONE & JOINT SURGERY 685 (2012) (Ex. A, Tab 4); Filippo Familiari et al.,

Supraspinatus Tears After Total Shoulder Arthroplasty: A Review of Diagnosis and

Treatment, 25 SEMINARS ARTHROPLASTY 64 (2014) (Ex. A, Tab 5)).) Further, Dr. Abrams

indicates that petitioner’s MRI prior to his first surgery in 2011 confirmed that he was

suffering severe atrophy of his infraspinatus muscle, likely due to tendon tearing. (Id.

(citing Ex. P9, p. 46).) A slow worsening and increase in tearing over time is the known,

natural history of rotator cuff pathology. (Id.) Petitioner’s age and repeated treatment

with corticosteroid injections are further factors that can contribute to rotator cuff

deterioration. (Id. at 6-7 (citing Ken Yamaguchi et al., The Demographic and

5

Dr. Geoffrey D. Abrams received his bachelor’s degree from Stanford University and his medical degree

from the University of California, San Diego. (Ex. B, pp. 1-2.) He completed a surgical internship at the

Department of General Surgery and a residency in the Department of Orthopedic Surgery at Stanford

University Hospital and Clinics. (Id. at 1.) Additionally, he completed a fellowship in orthopedic sports

medicine at Rush University Medical Center. (Id.) He is board certified in orthopedic surgery. (Id. at 2.)

He currently works as an associate professor at Stanford University School of Medicine and as the

Director of Sports Medicine for Varsity Athletics Lacob Family Sports Center at Stanford University. (Id. at

1.) He has authored 140 peer reviewed publications, four peer reviewed short communications, 37 book

chapters, and 97 peer reviewed abstracts. (Id. at 2-18, 20-30.)

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Morphological Features of Rotator Cuff Disease: A Comparison of Asymptomatic and

Symptomatic Shoulders, 88 J. BONE & JOINT SURGERY 1699 (2006) (Ex. A, Tab 6);

Benjamin John Floyd Dean, et al., Glucocorticoids Induce Specific Ion-Channel-

Mediated Toxicity in Human Rotator Cuff Tendon: A Mechanism Underpinning the

Ultimately Deleterious Effect of Steroid Injection Tendinopathy?, 48 BRIT. J. SPORTS

MED. 1620 (2014) (Ex. A, Tab 7)).) Although petitioner’s August 2018 MRI confirmed

his rotator cuff tendons were intact, it did not otherwise indicate the condition of the

tendons. (Id. at 7.) Alternatively, with or without the tear being a pain generator,

petitioner’s presentation is also potentially consistent with his October 2018 surgery

simply having been less successful than initially thought. (Id. at 8.) Dr. Abrams notes

that his increased symptoms occurred about three to four months post-surgery, which

corresponds to the strengthening phase of rehabilitation. (Id.) It is common for

symptoms to increase during this phase of rehabilitation. (Id.) In either event, Dr.

Abrams also disputes Dr. Natanzi’s contention that rotator cuff tendon tears are

common in SIRVA. (Id.) Although Dr. Abrams agrees that many SIRVA patients have

pre-existing partial rotator cuff pathology at the time of their SIRVAs, “full thickness

tears – essentially acute ruptures of a rotator cuff tendon as is suspected in the

petitioner – is not a known or reported complication of SIRVA and also does not agree

with the accepted mechanism of SIRVA . . .” (Id.) Moreover, Dr. Abrams disagrees that

the timing of onset is appropriate to invoke SIRVA. (Id. at 8-9.)

V. Analysis

a. Onset of petitioner’s shoulder pain is incompatible with either a

Table SIRVA or any SIRVA-like injury caused-in-fact by vaccination

In his motion petitioner confirms that, whether approaching the case as a Table

Injury of SIRVA or as a shoulder injury caused (or aggravated) in fact by vaccination, his

claim is premised on a finding that the onset of his shoulder pain began within 48 hours

of his vaccination. (ECF No. 37, pp. 14-17, 32-33; ECF No. 41, pp. 2-3, 11-12.)

Moreover, based on my review of Dr. Natanzi’s reports, he bases his opinion on an

assumption that onset of petitioner’s shoulder pain began within 48 hours of vaccination

and does not set forth any other medically appropriate timeframe from which to infer

vaccine causation. (Ex. P11, p. 8, Ex. P14, p. 1.) Nor, even undertaking independent

review of the medical literature filed, would I conclude that such a showing has been

made. E.g. Pitts v. Sec’y of Health & Human Servs., No. 18-1512V, 2023 WL 2770943,

at *14 (Fed. Cl. Spec. Mstr. Mar. 10, 2023) (finding a one-week post-vaccination onset

is not supported by SIRVA medical literature and collecting cases with respect to timing

of onset for SIRVA-like injuries). Accordingly, petitioner’s failure to preponderantly

demonstrate this timing of onset is dispositive.

Pursuant to Vaccine Act § 300aa-13(a)(1)(A), a petitioner must prove their claim

by a preponderance of the evidence. A special master must consider the record as a

whole, but is not bound by any diagnosis, conclusion, judgment, test result, report, or

summary concerning the nature, causation, and aggravation of petitioner’s injury or

illness that is contained in a medical record. § 300aa-13(b)(1). However, the Federal

Circuit has held that contemporaneous medical records are ordinarily to be given

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significant weight due to the fact that “[t]he records contain information supplied to or by

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

proper treatment hanging in the balance, accuracy has an extra premium. These

records are also generally contemporaneous to the medical events.” Cucuras ex rel.

Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

Thus, where medical records are clear, consistent, and complete, they should be

afforded substantial weight. Lowrie ex rel. Lowrie v. Sec’y of Health & Human Servs.,

No. 03-1585V, 2005 WL 6117475, at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005).

However, this rule is not absolute. Kirby v. Sec’y of Health & Human Servs., 997 F.3d

1378, 1382 (Fed. Cir. 2021) (stating that “[w]e reject as incorrect the presumption that

medical records are accurate and complete as to all the patient’s physical conditions.”)

Afterall, “medical records are only as accurate as the person providing the information.”

Parcells ex rel. Parcells v. Sec’y of Health & Human Servs., No. 03-1192V, 2006 WL

2252749, at *2 (Fed. Cl. Spec. Mstr. July 18, 2006). In Lowrie, the special master wrote

that “written records which are, themselves, inconsistent, should be accorded less

deference than those which are internally consistent.” 2005 WL 6117475, at *19

(quoting Murphy ex rel. Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733

(1991), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992)). Importantly, however, “the

absence of a reference to a condition or circumstance is much less significant than a

reference which negates the existence of the condition or circumstance.” Murphy, 23

Cl. Ct. at 733 (quoting the decision below), aff’d per curiam, 968 F.2d 1226 (Fed. Cir.

1992).

When witness testimony is offered to overcome the weight afforded to

contemporaneous medical records, such testimony must be “consistent, clear, cogent,

and compelling.” Camery v. Sec’y of Health & Human Servs., 42 Fed. Cl. 381, 391

(1998) (citing Blutstein ex rel. Blutstein v. Sec’y of Health & Human Servs., No. 90-

2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). Further, the

Special Master must consider the credibility of the individual offering the testimony.

Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). In

determining whether to afford greater weight to contemporaneous medical records or

other evidence, such as testimony, there must be evidence that this decision was the

result of a rational determination. Burns ex rel. Burns v. Sec’y of Health & Human

Servs., 3 F.3d 415, 416-17 (Fed. Cir. 1993). The special master is obligated to consider

and compare the medical records, testimony, and all other “relevant and reliable

evidence” contained in the record. La Londe v. Sec’y Health & Human Servs., 110 Fed.

Cl. 184, 204 (2013) (citing § 300aa-12(d)(3); Vaccine Rule 8), aff’d sub nom. LaLonde

ex rel. L.M. v. Sec’y of Health & Human Servs., 746 F.3d 1334 (Fed. Cir. 2014); see

also Burns, 3 F.3d at 416.

As explained above, petitioner’s affidavit confirms that he first reported his new

shoulder pain to Dr. Williams by phone on February 8, 2019. (Ex. P2, ¶ 11.) However,

the contemporaneous record of that call documents that petitioner’s call resulted in a

voicemail in which he stated that “he noticed the pain about 5 days ago,” which

unambiguously places onset on or about February 3, 2019, approximately two weeks

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after his tetanus vaccination. (Ex. P10, p. 57.) Although the record documents a

subsequent conversation discussing that petitioner suspected that his pain was related

to the vaccination, that additional notation does not contradict the timing of onset

indicated by the voicemail. (Id.) When petitioner followed up with Dr. Williams in

person about ten days later, he reported as of February 19, 2019, that the condition had

been present for “two or three weeks.” (Id. at 54.) This places onset between about

January 29, 2019, and February 5, 2019, broadly consistent with the onset reported in

the prior voicemail. Nothing on this record suggests any reason to doubt the accuracy

of these initial, contemporaneous treatment records. Thus, they should be afforded

substantial weight. Dr. Natanzi reasons on petitioner’s behalf that these encounter

records are explained by the fact that SIRVA patients often do not initially associate

their symptoms to their vaccinations. (Ex. P11, p. 8.) However, this rationale cannot

explain the medical records in this case. The records confirm that petitioner reported

onset occurring about two weeks post-vaccination while also explicitly suspecting the

symptoms were vaccine-related. (Ex. P10, p. 57.) When petitioner subsequently

sought a second opinion, he again repeated that his felt his symptoms were vaccine-

caused, but the record does not address the timing of onset. (Ex. P6, p. 10.)

I have also considered petitioner’s competing narrative account. However, I do

not find that it outweighs the contemporaneous records for several reasons. First,

petitioner’s statement was not signed until January 27, 2021. (Ex. P2, p. 5.) By

contrast, his first report of increased shoulder pain occurred a mere five days after

onset. (Ex. P10, p. 57.) Thus, it reflects a much fresher recollection. Second,

petitioner’s statement associates the onset of his shoulder pain to a drastic decrease in

ability to complete his physical therapy; however, there do not appear to be any physical

therapy records available to corroborate that assertion. Third and relatedly, petitioner’s

recollection that onset of his shoulder pain and weakness occurred shortly after

vaccination is explicitly contradicted by physical examination findings from January 29,

2019. (Ex. P1, p. 35.) As of that date, Dr. Ross documented normal strength, normal

range of motion, and a lack of any tenderness or instability in petitioner’s bilateral upper

extremities. (Id.) Dr. Natanzi stresses that it would be common for a shoulder

complaint to go unmentioned at an appointment focused on petitioner’s hamstring

injury. (Ex. P11, p. 8.) If the medical record were limited to simply failing to record a

history of shoulder pain or failing to document any upper extremity exam, I might agree.

Cf. Kirby, 997 F.3d at 1383 (observing that a physical exam noting only “neurological:

not present – dizziness” does not confirm a complete absence of neurologic symptoms).

However, this reasoning cannot explain Dr. Ross’s explicit notation describing a normal

upper extremity exam. (Ex. P1, p. 35.) This is especially concerning because, although

the appointment was for a hamstring complaint, Dr. Ross is an orthopedist who would

otherwise be more likely to record an accurate musculoskeletal exam. Moreover, Dr.

Ross’s record is consistent with the other contemporaneous medical records which

place onset of shoulder pain by petitioner’s own report around January 29, 2019 at the

earliest.

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Considering all of the above, and based on the record as a whole, the evidence

preponderates in favor of a finding that petitioner’s shoulder pain began after January

29, 2019, at the earliest.

b. The evidence preponderates in favor of a finding that petitioner

suffered a tear of his infraspinatus tendon unrelated to his

vaccination

Regardless of whether petitioner was to meet the four QAI criteria of a Table

SIRVA or otherwise present a prima facie case based on causation-in-fact, respondent

would still be permitted to demonstrate that petitioner’s condition is otherwise explained

by a factor unrelated to vaccination. § 300aa-13(a)(1)(B). In that regard, respondent

argues (in the Table context), based on Dr. Abrams’s assessment, that petitioner’s

increased shoulder pain is likely explained by shoulder pathology unrelated to

vaccination. (ECF No. 39, pp. 16-17.) Consistent with respondent’s argument, my

conclusion is that the evidence preponderates in favor of petitioner’s shoulder

symptoms being caused by an infraspinatus tear unrelated to vaccination.

First and foremost, spontaneous rupture of the rotator cuff, rather than any

vaccine-related rotator cuff injury, was Dr. Williams’s initial impression. (Ex. P1, p. 32.)

That conclusion was later confirmed by ultrasound and during an arthroscopic

procedure. (Ex. P3, pp. 54-55, 77-78.) Further, Dr. Williams considered petitioner’s

report that he was suspicious that his symptoms were related to his vaccination but

concluded that vaccine-causation was unlikely. (Id. at 28.) Petitioner later reported his

symptoms to a second orthopedist, Dr. Miller, as a post-vaccination occurrence, but did

not receive any different assessment. (Ex. P6.) Although not binding, treating

physician opinions are “favored” because “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.” Capizzano v. Sec’y of Health & Human

Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (citations omitted).

Dr. Williams’s assessment is particularly compelling in this case for several

reasons. First, both experts agree with Dr. Williams’s diagnosis of an infraspinatus tear

as the likely source of petitioner’s symptoms. (Ex. 11, p. 9; Ex. A, p. 6.) Second, Dr.

Williams was the first physician to whom petitioner reported his symptoms and he was

already very familiar with petitioner’s prior condition, having been petitioner’s surgeon

for his October 2018 surgery and the physician attending to his post-surgical follow up.

(Ex. P10, p. 57; Ex. P7, p. 109; Ex. P1, pp. 35, 38.) Moreover, Dr. Williams himself

visualized the injury as limited to the infraspinatus during his arthroscopic follow up

procedure. See Nuttall v. Sec’y of Health & Human Servs., 122 Fed. Cl. 821, 832

(2015) (explaining that treating physician opinion is favored because they generally are

familiar with the patient before and after the injury and are witness to the condition

unfolding). Third, Dr. Williams is an orthopedic specialist. And, fourth, his records

reflect that in opining against vaccine causation, Dr. Williams specifically contemplated

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the causal theory (needle overpenetration into the cuff) raised by Dr. Natanzi. (See Ex.

P3, p. 28.)

Additionally, Dr. Natanzi’s assessment that SIRVA is more likely is based on an

assumption regarding onset that is not preponderantly supported for the reasons

discussed in the preceding section. Accordingly, his ultimate conclusion as to vaccine

causation is not persuasive. See Burns, 3 F.3d at 417 (holding that “[t]he special

master concluded that the expert based his opinion on facts not substantiated by the

record. As a result, the special master properly rejected the testimony of petitioner's

medical expert.”); Rickett v. Sec’y of Health & Human Servs., 468 F. App’x 952, 958

(Fed. Cir. 2011) (holding that “it was not error for the Special Master to assign less

weight to Dr. Bellanti's conclusion regarding challenge-rechallenge to the extent it

hinged upon Mr. Rickett's testimony that was inconsistent with the medical records.”);

Dobrydnev v. Sec’y of Health & Human Servs., 566 F. App’x 976, 982–83 (Fed. Cir.

2014) (holding that the special master was correct in noting that “when an expert

assumes facts that are not supported by a preponderance of the evidence, a finder of

fact may properly reject the expert's opinion”) (citing Brooke Grp. Ltd. v. Brown &

Williamson Tobacco Corp., 509 U.S. 209, 242 (1993)); see also Bushnell ex rel. J.R.B.

v. Sec'y of Health & Human Servs., No. 02-1648V, 2015 WL 4099824, at *12 (Fed. Cl.

Spec. Mstr. June 12, 2015) (finding that “because Dr. Marks' opinion is based on a false

assumption regarding the onset of J.R.B.'s condition, and the incorrect assumption of a

‘stepwise regression’ after each vaccine administration, it should not be credited.”)

Absent that false assumption regarding onset, Dr. Natanzi does not otherwise dispute

that an infraspinatus tear can happen spontaneously as both Drs. Williams and Abrams

opined. In fact, he agrees that rotator cuff tears occurring post-surgery is a known

phenomenon and that petitioner’s prior history did leave him susceptible to such a tear.

(Ex. P14, p. 2.)

Finally, Dr. Natanzi is not persuasive in contending that needle overpenetration

can cause a complete tear of the infraspinatus tendon as seen in petitioner. (Ex. P11,

pp. 8-11.) Dr. Natanzi cites five references for the proposition that rotator cuff tendon

tears can be seen in SIRVA; however, these citations do not support needle

overpenetration as a cause of rotator cuff tearing. (Id. at 9 (citing Atanasoff et al.,

supra, at Ex. P13, Tab b); Barnes et al., supra, at Ex. P13, Tab c; Uchida et al., supra,

at Ex. P13, Tab l; Szari et al., supra, at Ex. P13, Tab o; Michael Shahbaz et al., supra,

at Ex. P13, Tab p).) On the whole, the sources cited by Dr. Natanzi support the

proposition that needle penetration into the subacromial space can result in an

inflammatory reaction that can lead to bursitis and shoulder dysfunction. However,

these sources do not establish that needle penetration into the rotator cuff occurs or can

lead to a full thickness tear of the infraspinatus. Instead, as Dr. Abrams alludes, the

Atanasoff paper hypothesizes that inflammation of the shoulder capsule can lead to the

activation of pre-existing, but previously asymptomatic, shoulder dysfunction.

(Atanasoff et al., supra, at Ex. 13, Tab b, pp. 2-3.) Here, however, Dr. Natanzi stresses

that his opinion is that petitioner’s infraspinatus tear was not preexisting. (Ex. P14, p. 2

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(“there is no reason to believe that [petitioner’s] rotator cuff was not completely intact

coming out of his surgier on 12/20/18.”) Moreover, Dr. Williams confirmed during the

subsequent arthroscopic tendon repair that the injury was limited to the infraspinatus.

(Ex. P3, p. 77.) Presumably if a broader inflammatory process was unfolding in the

shoulder capsule, it would have been observed at that time.

VI. Conclusion

Petitioner has my sympathy for the injury he suffered. However, for all the

reasons discussed above, I cannot conclude that he has preponderantly demonstrated

his injury to constitute a Table Injury of SIRVA or that it was either vaccine caused or

aggravated. Accordingly, this case is dismissed. 6

IT IS SO ORDERED.

s/Daniel T. Horner

Daniel T. Horner

Special Master

6

In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter

judgment accordingly.

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