Pendleton v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

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

KIMBERLY PENDLETON, *

* No. 22-39V

*

Petitioner, * Special Master Christian J. Moran

*

v. * Filed: November 14, 2024

*

SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

*

Respondent. *

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Ying Zhou, Law Office of Ying Zhou, Philadelphia, PA, for petitioner;

Emily Hanson, United States Dep’t of Justice, Washington, D.C., for respondent.

UNPUBLISHED DECISION DENYING COMPENSATION 1

Kimberly Pendleton alleges that the tetanus-diphtheria-acellular-pertussis

(“Tdap”) vaccine she received on July 31, 2019, caused her to suffer from an on-

Table Shoulder Injury Related to Vaccine Administration (“SIRVA”). Am. Pet.,

filed Oct. 4, 2024, at 4. Alternatively, Ms. Pendleton claims that her shoulder

injuries were caused-in-fact by the vaccine. Id. However, Ms. Pendleton has not

presented a theory to support her allegation that the vaccine was the cause-in-fact

1

Because this Decision 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 Decision will

be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the

parties have 14 days to identify and move to redact medical or other information, the disclosure

of which would constitute an unwarranted invasion of privacy. Any changes will appear in the

document posted in the website.

of her shoulder injury. Ms. Pendleton also has not established her claim alleging

an on-Table SIRVA.

I. Medical History

Ms. Pendleton was born in 1970. Exhibit 8 at 5. On July 31, 2019, when

Ms. Pendleton was 49 years old, she visited her primary care provider (“PCP”),

Norriton Family Medicine, for an annual exam. Id. at 1. Her ongoing problem list

included obesity, foot calluses, hot flashes, IBS, perimenopausal symptoms, and

tobacco use. Id. She had no acute complaints, and there is no mention in the

record of arm pain. Id. Ms. Pendleton received the Tdap vaccination. Id. at 5.

Thirty-four days later, on September 3, 2019, Ms. Pendleton returned to her

PCP with a chief complaint of left arm pain going up her neck. Exhibit 2 at 34.

(This appears to be an error, as most other records, including further notes from

this same visit, report right arm pain). She stated that, “since the day of the shot,”

she had pain that was shooting in nature from the site of injection to the top of her

shoulder in neck. She had not had any neck, shoulder, or arm issues prior to the

vaccine. Id. Dr. Aysha Jilani recorded that Ms. Pendleton had “Pain from cervical

spine to upper right arm with range of motion limited due to pain line.” Id. She

assessed Ms. Pendleton as having brachial neuritis and started her on a trial of

baclofen, steroids, and physical therapy. If Ms. Pendleton did not respond to this

treatment, Dr. Jilani planned to refer her to a physical medicine & rehabilitation

(“PMR”) specialist for an electromyography (“EMG”) study and treatment. Id. at

35.

Ms. Pendleton returned to Dr. Jilani on September 17, 2019. Exhibit 2 at 37.

Her chief complaint was right arm pain, and she reported that her arm had not “felt

right” since her vaccination six weeks prior. Id. She had not improved with

treatment, and stated that she felt worse. She had not been able to set up a physical

therapy appointment. Ms. Pendleton described the pain as going down her

shoulder to her neck, down to the right scapula, and now completely down her

right arm. She also reported weakness in her arm. Id. Dr. Jilani’s assessment was

cervical radiculopathy with a possible brachial plexus injury. She wrote that Ms.

Pendleton needed physical therapy to prevent a frozen joint, and that she should

get a PMR evaluation for a definitive diagnosis. Id. at 38. She prescribed

cyclobenzaprine and referred her to physical therapy and a PMR evaluation. Id.

2

On September 19, 2019, Ms. Pendleton had a physical therapy evaluation.

Exhibit 2 at 56. Ms. Pendleton recounted that she did not have pain immediately

following her vaccination, but “by the next day she was having severe [right] arm

pain.” Id. The pain worsened over time, and her symptoms were worse with

movement of her right upper extremity or neck. She had taken to holding her right

upper extremity at her chest, and she avoided turning her head to drive or talk to

people. The pain began at the base of her neck and spread into her right upper

extremity and down to her fingers and down her scapula. She described the pain

as shooting, burning, tingling, and throbbing, and pain medications did not help.

Id. Ms. Pendleton reported that she had no prior issues with her right upper

extremity or neck, but was now unable to grip, lift, carry, reach, clean, do dishes,

or cook. Id. at 57. She rated her pain as an 8 out of 10. Id.

The examination found that Ms. Pendleton’s right upper extremity active

range and passive range were limited, and that there was significant muscle

guarding in her right shoulder. Exhibit 2 at 57. Her right upper extremity strength

was within functional limits. Id. at 58. The assessment stated that her presentation

was most consistent with cervical radiculopathy, although there were “no hard

neuro[logical] signs present.” Id. at 59. It was also noted that Ms. Pendleton had

impairments in her cervical range of motion and motor control, and muscle

guarding and limited neural/soft tissue mobility throughout the cervical and

thoracic spine and right upper extremity. Her rehabilitation prognosis was fair,

and it was predicted that she would benefit from skilled physical therapy with an

eventual discharge to a home exercise program. Id.

On October 2, 2019, Ms. Pendleton had an EMG on her right arm. Exhibit 5

at 367. Ms. Pendleton recounted that after her vaccine, she had increased pain in

her right arm, fever, and difficulty moving her arm. Id. It was now better, but she

still had pain into her scapula and difficulty moving her neck and shoulder. She

also reported tingling down her arm and into her fingers, migrating from her elbow

to her hand. She reported that she sometimes had throbbing pain that could last

15-20 minutes and was worse at night in her shoulder and arm. She did not have

symptoms on her left side, and she did not have previous injuries to her arm or

neck.

The EMG study was abnormal. Exhibit 5 at 367. The impression noted

evidence of right median neuropathy of the wrist of mild to moderate severity,

with similar findings on the left.

3

After four visits, Ms. Pendleton was discharged from physical therapy on

January 20, 2020. Exhibit 4 at 323. The reason given was: “because the patient

did not return / dropped out.” The Secretary notes that this discharge was five

months and 20 days post-vaccination. Resp’t’s Rep. at 3.

Ms. Pendleton saw Dr. Abim Esrick at her PCP office on June 16, 2020 with

a primary complaint of back pain that had started three days prior. Exhibit 2b at

403. The symptoms had started after work with no particular inciting or

aggravating event. It was located in her right lower thoracic back. She described

the pain as moderate-severe intensity, constant, and aggravated by prolonged

standing, rotation, and using the stairs. Dr. Esrick assessed her as having a spasm

of the thoracic back muscle. He and advised her to continue gabapentin and

Tylenol, to do home exercises, to take time off work/return with restrictions, and to

refrain from bending, twisting, lifting weights over 20 pounds, and standing from

more than ten minutes at a time. Id. at 404.

A follow-up appointment with Dr. Esrick took place ten days later. Exhibit

2b at 408. Ms. Pendleton’s symptoms had greatly improved, but not yet fully

resolved. She could stand for longer than ten minutes, twist, and bend, but did not

think she could lift more than 20 pounds. She was taking gabapentin and Advil

but was not doing home exercises. Id. Ms. Pendleton was advised to continue her

treatments and to return to work on light duty. Id. at 409. On July 15, 2020, Ms.

Pendleton advised Dr. Mahalakshmi Srinivasan at her PCP office that her lower

back pain had resolved a week prior, and she returned to full duty at work. Id. at

413-14.

Ms. Pendleton had another appointment with her PCP on September 5, 2020.

Exhibit 2b at 418. Her chief complaint was “recurrent right arm

pain/numbness/tingling” beginning “after a vaccine.” It was noted that she

improved after a lot of physical therapy. Gabapentin helped, but she had run out.

Id. Dr. Srinivasan assessed her as having radiculopathy and right arm pain, and

referred her to physical therapy and restarted the gabapentin. Id. at 419.

Ms. Pendleton went to Moss Rehab for physical therapy on October 7, 2020.

Exhibit 4 at 324. Her history of present illness listed a one-month history of right

neck, scapular, and upper extremity pain “that began when temperatures dropped.”

Id. at 327. It was noted that she was first seen nine months prior for the same

condition “which she states began after receiving a tetanus shot.” Id. She had no

complaints during the summer, but now her pain was worse with use of her upper

4

right extremity. It had been diagnosed as radiculopathy. The assessment found

that she had “impairments in CT mobility, CT soft tissue pain, and mild upper limb

tension.” Id. at 329. 2 The plan was for her to do one session per week for three

weeks. Id. at 330.

On October 14, 2020, Ms. Pendleton had an appointment at her PCP office

with Dr. Tejaswi Venigalla to follow-up after an ER visit for back pain. She was

in significant pain after running out of cyclobenzaprine. Exhibit 2b at 424. She

had “left” arm pain from vaccination (this appears to be an error). Id. She was

ordered to continue cyclobenzaprine for her back spasm and continue gabapentin

for her arm pain, and was referred to physical therapy. Id. at 425-26.

Ms. Pendleton returned to Moss Rehab on October 21, 2020 for another

physical therapy session. Exhibit 4 at 334. She tolerated the session well but

needed cueing to minimize guarding of her upper right extremity. Id. at 336. Her

next session was on October 29, 2020. Id. at 338. She was described as doing

well, and requiring cueing to avoid compensation and shrugging. Id. at 340.

On November 12, 2020, Ms. Pendleton had another physical therapy

session. Exhibit 4 at 342. She again tolerated the session well, and was improving

her right shoulder mobility and tolerance. Id. at 344.

Ms. Pendleton went to Dr. Srinivasan on June 23, 2021 for an employment

physical. She reported that she had not worked for two years due to long hours

and flair ups of pain in her back, but she was starting a new job soon. Exhibit 2b at

427. Her right arm pain was improving with gabapentin. Id. at 429. She was

diagnosed with pain in her right arm, but there were no abnormal findings. Her

gabapentin was refilled. Id.

On October 11, 2021, Ms. Pendleton went to her PCP office and saw Dr.

Charles Cutler for low back pain. She rated it at a 7/10, and stated that it had

started two days prior. She noted that she had pain like this “every time of this

year.” It was “shocklike,” aggravated by movement, and relieved by sitting still

and taking muscle relaxant or Tylenol. Exhibit 2b at 431. Ms. Pendleton was

prescribed more gabapentin and was referred to physical therapy. Id. at 432.

2

Given the context, “CT” may be an abbreviation for “cervicothoracic.”

5

II. Procedural History

Ms. Pendleton filed her petition on January 11, 2022, alleging that the Tdap

vaccine she received on July 31, 2019 caused her to suffer from a form of SIRVA

known as shoulder impingement syndrome. She noted that she had previously

received a Tdap vaccination in 2013 with no incident. Ms. Pendleton stated that

“started to experience severe pain from the site of injection in her right arm to the

top of her right shoulder and neck” approximately 24 hours after receiving the

vaccine in July 2019. She described the pain as shooting in nature, limiting her

right arm’s range of motion, and putting her in moderate distress.

Along with her petition, Ms. Pendleton filed a Vocational Economic

Evaluation from Gary and Katherine Young. Exhibit 6. The Youngs interviewed

Ms. Pendleton on October 7, 2021 for the evaluation. Id. at 1. The Youngs

explain that the Social Security Administration considers age, education,

occupations, and transferable skills when adjudicating disability claims. In

combination with the Social Security Administration’s standards, the Youngs

utilized the RAPEL methodology: Rehabilitation Plan, Access to the Labor

Market, Placeability, Earnings Capacity, and Labor Force Participation. Id. at 1-2.

The Youngs reviewed Ms. Pendleton’s medical history, noting that she had

severe right arm pain following a tetanus shot, and stated that she was diagnosed

with “a shoulder impingement injury.” Exhibit 6 at 3. They opined that Ms.

Pendleton’s restrictions are permanent. Id. at 13. They noted that she was

working towards furthering her education and becoming a Licensed Practical

Nurse and then a Registered Nurse. However, the Youngs stated that she does not

have enough stamina for a full day of work, and that she has lost dexterity in her

right hand. These interfere with her aspirations. Id. The Youngs estimated past

and future wage loss between $239,219 and $787,418. Id. at 19.

The case remained pending in the Special Processing Unit (“SPU”) as the

parties entered into litigative risk settlement discussions. See Resp’t’s Status Rep.,

filed Sept. 19, 2023. After the parties reached an impasse in their settlement

negotiations, the Secretary filed his Rule 4(c) Report on January 17, 2024. The

Secretary argued that compensation should be denied, as Ms. Pendleton’s pain and

reduced range of motion were not limited to her right shoulder, and therefore she

did not satisfy the third requirement of the Qualifications and Aids to

Interpretation. Resp’t’s Rep. at 6-7. Additionally, the Secretary argued that Ms.

Pendleton did not meet the six-month severity requirement, as she did not report

any pain for ten months. Id. at 7.

6

After reviewing the Secretary’s assessment, the Chief Special Master

commented:

Petitioner may be successful in establishing the six-month sequela

needed to satisfy the Vaccine Act’s severity requirement. More

problematic is the conflicting evidence regarding the nature and cause

of Petitioner’s symptoms, and I agree expert reports will likely be

needed in this case to pursue either a Table or causation-in-fact SIRVA.

Order, issued March 22, 2024. The Chief Special Master further noted that there

was “some evidence supporting a potential brachial neuritis Table injury,” but that

“substantial deficiencies” would need to be addressed, specifically the too-soon

onset and the lack of EMG evidence. Additionally, Ms. Pendleton maintained that

the brachial neuritis diagnosis was incorrect, and expressed no desire to pursue this

claim. Id. The Chief Special Master authorized Ms. Pendleton to retain an expert,

and the case was transferred out of SPU and reassigned to the undersigned. Id.

Ms. Pendleton filed an expert report from Dr. Asif M. Ilyas, a board-

certified orthopedic surgeon who is also certified in hand surgery. Exhibit 11 at 5.

Dr. Ilyas examined Ms. Pendleton and had the impression that she had “Right

shoulder impingement/bursitis, caused by ‘shoulder injury related to vaccine

administration.’” Id. at 4. He based this on a review of her history and medical

records, an evaluation of diagnostic studies, and on his own examination. Id. He

stated that her shoulder pain had “continued unimproved since the date of

vaccination.” Id. at 5.

The undersigned then issued a template affidavit regarding onset, which Ms.

Pendleton completed and filed on June 21, 2024. Exhibit 12. On July 22, 2024,

the Secretary filed an expert report from Dr. Paul J. Cagle, a board-certified

orthopedic surgeon with training in shoulder surgery. Exhibit A at 1.

Dr. Cagle opined that Ms. Pendleton’s case was not a demonstration of

SIRVA, stating that she did not meet the Table criteria. First, he noted that the

first evidence of shoulder pain was dated more than a month after the vaccination

and does not state that pain occurred within 48 hours. This record also references

pain in the neck with concern for a neurologic origin rather than a shoulder origin.

Exhibit A at 4. Next, Dr. Cagle stated that “there is a lack of definitive evidence

demonstrating a true loss of range of motion in the shoulder.” Id. at 5. Dr. Cagle

7

also highlighted that Ms. Pendleton’s symptoms were frequently attributed to

radiculopathy and/or neck/cervical pathology, and that there was no attempt to

separate the shoulder from the neck symptoms. Id. Finally, Dr. Cagle saw no

evidence of an objective shoulder injury to constitute a SIRVA, noting that there

was no shoulder-specific examination or treatment. Id.

Dr. Cagle next addressed the Youngs’ vocational report. He disagreed with

their use of the term “impingement injury,” stating that the correct diagnostic term

is “impingement syndrome.” Exhibit A at 5. He saw no objective evidence of

impingement syndrome in the medical history, and believed it was unsupported.

Id. at 5-6. He agreed with the Youngs about several diagnoses—allergic rhinitis,

alopecia, elevated blood pressure, irritable bowel syndrome, low back pain,

radiculopathy, and radiculopathy of arm—but noted that these are evidence of pain

outside of the shoulder. Id. at 6. Dr. Cagle stated that he was “unaware of any

scientific reference that supports impingement syndrome being a permanent

condition,” even as he has treated thousands of patients with the diagnosis. He

saw no support for the Youngs’ statement that hand dexterity was a reason for the

limitations. Id.

Dr. Cagle noted that the first record mentioning the “impingement

syndrome” was in the October 2, 2019 EMG report, which he stated was “a very

strange place to make a diagnosis.” Exhibit A at 6. He opined that the

“impingement syndrome” came into the record after an EMG was performed when

the treating provider “wanted to suggest that the EMG was not positive for a

brachial plexus/nerve injury, and that perhaps an inflammatory pathology, such as

impingement syndrome was possible.” Id. at 6-7. The diagnosis was then

propagated through the rest of the medical records.

Finally, Dr. Cagle addressed Dr. Ilyas’s report. Dr. Cagle stated that there

was a lack of evidence to support the diagnosis of right shoulder

impingement/bursitis, as it would be very unusual for such to last for years given

that it is a treatable condition. Exhibit A at 7. He also noted that Dr. Ilyas did not

explain the “new-found change in shoulder range of motion” despite there being a

full range of motion in numerous records post-vaccination. Dr. Ilyas also did not

advance a literature-supported viable mechanism to explain how the vaccine could

have caused these symptoms for five years. Id. Dr. Cagle concluded that this is

not a demonstration of SIRVA; there is no evidence of a shoulder injury; there is

no evidence of sustained loss of shoulder motion; and there is no evidence of a

structural shoulder injury. Id. at 8.

8

A status conference was held on August 5, 2024 to discuss the parties’

reports. Ms. Pendleton requested the opportunity to have Dr. Ilyas to file a rebuttal

report. The undersigned advised that this would be the last opportunity for Dr.

Ilyas to present a theory on causation-in-fact, and failure to do so would mean that

Ms. Pendleton could only proceed on a SIRVA claim. Order, issued Aug. 5, 2024.

The undersigned noted that Dr. Ilyas had examined Ms. Pendleton, and asked if the

Secretary wanted Dr. Cagle to examine her as well. The Secretary stated that he

was not requesting this at the time. Id.

Ms. Pendleton submitted Dr. Ilyas’s second report on October 4, 2024.

Exhibit 20. The majority of the report responds to Dr. Cagle’s report. Dr. Ilyas

reaffirmed his diagnosis and opinion. He stated that the records show that Ms.

Pendleton reported pain “since the day of the shot”. Id. at 1 (citing records from

September 3, 2019). Dr. Ilyas strongly disagreed with Dr. Cagle’s statement that

there was concern for a neurologic origin of the pain rather than a shoulder origin.

Id. at 2. He noted that the primary care physician who diagnosed Ms. Pendleton

with brachial neuritis was not an orthopedist. Furthermore, Dr. Ilyas explained

that brachial neuritis is the product of trauma to the arm or an inflammatory

process, and results in a combination of pain, numbness extending into the hand,

and isolated areas of muscular weakness. Dr. Ilyas opined that her symptomology

was inconsistent with brachial neuritis, but consistent with shoulder

impingement/bursitis related to vaccination. Id.

Dr. Ilyas also disagreed with Dr. Cagle’s opinion that there is no definitive

evidence of a true loss of range of motion in Ms. Pendleton’s shoulder. Exhibit 20

at 2. He disputed that the records indicate she ever regained a full range of motion.

He also opined that the treaters “were erroneously pursuing a neurological cause”

of the symptoms and that there was never evidence of a nerve injury. Id. at 3.

Rather, he stated that Ms. Pendleton’s reports of shoulder pain were consistent.

Dr. Ilyas maintained his diagnosis of vaccine-related shoulder

impingement/bursitis based on his exam and findings of a sore shoulder, decreased

active range of motion, positive Hawkin’s sign, and positive Neer sign. Exhibit 20

at 3. He also cited findings indicative of no radiculopathy, including lack of

numbness in the hand and arm, full range of motion in the neck, 5/5 strength in all

nerve distributions below the shoulder, and no radiation or pain distally. Id. He

affirmed that there was evidence of “impingement syndrome,” i.e., his own

examination and the lack of evidence of a neurologic problem. Id.

9

Dr. Ilyas contested Dr. Cagle’s reliance on the medical history provided by

the Youngs, who are not medical doctors but vocational experts. Exhibit 20 at 3.

He also opined that the diagnoses were inconsistent with the complaints of

shoulder pain, and furthermore, contended that their vocational analysis “had

nothing to do with [Ms. Pendleton’s] medical diagnosis and/or injury causality.”

As to Dr. Cagle’s contention that should impingement syndrome is not

permanent, Dr. Ilyas conceded that it is reversable when treated, but noted that Ms.

Pendleton’s injury was never formally treated by an orthopedist. Exhibit 20 at 4.

He agreed that shoulder impingement syndrome does not directly impede dexterity,

but “it can cause generalized upper extremity dysfunction limiting work ability.”

Id.

Dr. Ilyas also disagreed that the EMG being used to diagnose shoulder

impingement syndrome would be “strange.” Exhibit 20 at 4. The neurologist who

mentioned the possibility would be qualified to opine on such.

Finally, Dr. Ilyas defended against Dr. Cagle’s critiques of his first report,

again citing his own examination as evidence of her shoulder

impingement/bursitis; pointing to the lack of treatment to explain the duration of

the symptoms; disputing that the records demonstrate a return to full range of

motion; and citing to two articles, which were not filed.3

Notably absent from Dr. Ilyas’s second report was an explanation of a theory

by which the Tdap vaccine could cause an impingement injury. In his conclusion,

he stated that Ms. Pendleton’s “injuries do satisfy the Althen prongs for an off-

table injury.” Exhibit 20 at 5. He stated summarily:

Althen Prong 1: A medical theory causally connecting the vaccine

and injury. The diagnosis of impingement syndrome is casually

connected to the Tdap vaccination of July 31, 2019.

3

C.T. Wood and A.M. Ilyas, Shoulder Injury Related to Vaccine Administration: Diagnosis and

Management, 4 J. Hand Surg. Glob. Online 111 (2022).

A.K. Harrison and E.L. Flatow, Subacromial impingement syndrome, 19 J. Am. Acad. Orthop.

Surg. 701 (2011).

10

Althen Prong 2: A logical sequence of cause and effect showing the

vaccine was the reason for the injury. The clinical data I reviewed

showed clear evidence of the onset of Ms. Pendleton’s right shoulder

complaints and symptoms triggered by the Tdap vaccine of July 31,

2019.

Althen Prong 3: A showing proximate temporal relationship

between the vaccination and the injury. The record does reflect Ms.

Pendleton’s complaints of pain and discomfort in the area of the vaccine

injection in the required temporal period.

Id. at 5-6. Despite the lack of a specific theory, Ms. Pendleton amended her

petition to add a claim “for cause-in-fact shoulder injuries resulting from the

subject vaccine.” Am. Pet., filed Oct. 1, 2024.

III. Standards for Adjudication

A petitioner is required to establish her case by a preponderance of the

evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence standard

requires a “trier of fact to believe that the existence of a fact is more probable than

its nonexistence before [he] may find in favor of the party who has the burden to

persuade the judge of the fact's existence.” Moberly v. Sec’y of Health & Hum.

Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted). Proof of

medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931

F.2d 867, 873 (Fed. Cir. 1991).

Distinguishing between “preponderant evidence” and “medical certainty” is

important because a special master should not impose an evidentiary burden that is

too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.

Cir. 2009) (reversing special master's decision that petitioners were not entitled to

compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357

(Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.

Cir. 1993) (disagreeing with dissenting judge's contention that the special master

confused preponderance of the evidence with medical certainty).

IV. Discussion

To receive compensation under the National Vaccine Injury Compensation

Program, petitioner must prove either (1) that she suffered a “Table Injury”—i.e.,

11

an injury falling within the Vaccine Injury Table—corresponding to her

vaccination, or (2) that she suffered an injury that was actually caused by a

vaccine. See 42 U.S.C. §§ 300aa-13(a)(1)(A) and 300aa-11(c)(1). Ms. Pendleton

asserts both an on-Table injury via her SIRVA claim and an off-Table shoulder

injury caused in fact by the vaccine. Am. Pet., filed Oct. 1, 2024.

A. Off-Table Claim

An off-Table claim requires a petitioner to present “(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.”

Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).

The source of this evidence must be “medical records” or “medical opinion.” 42

U.S.C. § 300aa–13(a)(1).

Under the first Althen prong, a petitioner must set forth a reliable theory to

explain how a particular vaccine can cause the alleged injury; scientific certainty is

not required. Althen, 418 F.3d at 1279-80. However, petitioners must propose a

theory or mechanism, supported by a sound and reliable medical or scientific

explanation. Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed.

Cir. 1994).

Here, although Dr. Ilyas’s report summarily states that Ms. Pendleton’s

impingement syndrome “is casually connected” to her Tdap vaccination, there is

no attempt to explain how the flu vaccine would be capable of causing the injury.

The Vaccine Act does not permit a petitioner to prevail based on her claims alone,

“unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa–

13(a)(1). Neither Dr. Ilyas nor the medical records explain how the vaccine could

have caused Ms. Pendleton’s impingement syndrome. Thus, Ms. Pendleton cannot

satisfy the first Althen prong. See Talbert v. Sec’y of Health & Hum. Servs., No.

18-699V, 2024 WL 1675338, at *19 (Fed. Cl. Spec. Mstr. Apr. 3, 2024).

Without a showing on each Althen element, a petitioner cannot receive

compensation; thus, when a petitioner fails to establish one Althen prong,

additional analysis is not required. Moreover, Ms. Pendleton has not set forth a

theory against which to compare the facts of her case and determine if the Tdap

vaccine actually did cause her injury. Nor is there a theory against which to

evaluate whether the onset occurred within an appropriate timeframe. As with the

first prong, Dr. Ilyas makes conclusory statements that there is “clear evidence”

12

that the Tdap vaccine “triggered” her symptoms, and that there was an onset “in

the required temporal timeframe,” but he does not elaborate. Exhibit 20 at 5-6. In

the absence of a theory, Ms. Pendleton’s claim fails under the remaining Althen

prongs as well. Ms. Pendleton’s off-Table claim is therefore dismissed.

B. On-Table SIRVA Claim

To satisfy the elements for an on-Table SIRVA claim, a petitioner must

show that (1) she had no history of shoulder pain prior to vaccination, (2) the onset

of pain occurred within 48 hours after vaccination, (3) the injury is confined to the

shoulder in which she received the vaccine, and (4) there is no evidence of any

alternative cause of her pain. 42 C.F.R. § 100.3(c)(10)(i)-(iv).

Ms. Pendleton has had sufficient notice of potential issues with her on-Table

SIRVA claim. The Secretary argued in his Rule 4(c) Report that she did not meet

the criteria for SIRVA. Resp’t’s Rep. at 5-7. Likewise, in the Order transferring

the case out of SPU, the Chief Special Master commented that Ms. Pendleton

would likely have trouble meeting the third criterion.

While Dr. Ilyas discusses Ms. Pendleton’s range of motion in her shoulder,

he does not discuss whether the injury is confined to the shoulder. The medical

records, however, consistently indicate that the injury was not confined to Ms.

Pendleton’s shoulder. See, e.g., Exhibit 2 at 37 (pain described as going down her

shoulder to her neck, down to the right scapula, and completely down the right

arm); id. at 56 (physical therapy record of pain radiating from the base of the neck

into the scapula and fingers); Exhibit 4 at 324 (history of right neck, scapular, and

upper extremity pain); Exhibit 5 at 1 (difficulty moving neck and shoulders, pain

into scapula, and tingling from right elbow into fingers); id. at 367 (pain into

scapula and tingling migrating from elbow to fingers).

These medical records, which memorialize Ms. Pendleton’s

contemporaneous problems, are presumptively accurate. Cucuras v. Sec’y of

Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). The Youngs’ report

also discusses neck pain and a loss of dexterity in Ms. Pendleton’s right hand.

Exhibit 6 at 3, 6. Although given an opportunity through the submission of reports

from Dr. Ilyas, Ms. Pendleton has not presented a persuasive basis for finding that

her pain was limited to her shoulder. Therefore, she cannot establish that she

fulfills the regulatory definition for SIRVA. See Scott v. Sec’y of Health & Hum.

Servs., No. 20-1982V, 2024 WL 4544335, at *19-20 (Fed. Cl. Spec. Mstr. Sep. 25,

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2024) (the presence of neck pain / cervical radiculopathy precludes a petitioner

from satisfying the third SIRVA criterion).

Accordingly, Ms. Pendleton is not entitled to compensation for her on-Table

claim. (Given this finding regarding the third criterion, evaluating the fourth

criterion is not required. It is also not required to assess whether any shoulder

injury lasted longer than six months).

V. Conclusion

Ms. Pendleton merits admiration for her perseverance through her difficult

course of pain. However, Ms. Pendleton has not shown that the Vaccine Program

can compensate her, as she has not presented sufficient evidence for her off-Table

claim, nor has she satisfied the elements for an on-Table SIRVA claim. Thus, the

case is dismissed for lack of persuasive evidence.

The Clerk’s Office is instructed to dismiss this case and to enter judgment in

accord with this decision unless a motion for review is filed. Information about

filing a motion for review, including the deadline for any such submission, is

available through the Vaccine Rules posted on the website for the Court of Federal

Claims.

IT IS SO ORDERED.

S/Christian J. Moran

Christian J. Moran

Special Master

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