Nicholson v. Secretary of Health and Human Services ( 2022 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1416V
Filed: September 22, 2022
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JULIE NICHOLSON, *
*
* TO BE PUBLISHED
Petitioner, *
*
v. *
* Influenza (“flu”) Vaccine; Shoulder Injury
* Related to Vaccine Administration
SECRETARY OF HEALTH AND * (“SIRVA”); Dismissal Decision
HUMAN SERVICES, *
*
*
Respondent. *
*
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Isiah R. Kalinowski, Maglio Christopher & Toale, Seattle, WA, for Petitioner
Debra A. Filteau Begley, U.S. Department of Justice, Washington, DC, for Respondent
DECISION ON ENTITLEMENT 1
Oler, Special Master:
On October 3, 2017, Petitioner Julie Nicholson filed a petition for compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq. 2 (the “Vaccine
Act” or “Program”) alleging that she suffered from a Shoulder Injury Related to Vaccine
Administration (“SIRVA”) as a result of the influenza (“flu”) vaccine she received on October 3,
2016. Pet. at 2, ECF No. 1.
1
This Decision will be posted on the United States Court of Federal Claims’ website, in accordance with
the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to
anyone with access to the internet. As provided in 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties
may object to the Decision’s inclusion of certain kinds of confidential information. To do so, each party
may, within 14 days, request redaction “of any information furnished by that party: (1) that is a trade secret
or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files
or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.”
Vaccine Rule 18(b). Otherwise, this Decision will be available to the public in its present form. Id.
2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa
(2012).
1
Upon review of the evidence in this case, I find that Petitioner has failed to preponderantly
demonstrate that the vaccine she received caused her condition. The petition is accordingly
dismissed.
I. Procedural History
Petitioner filed her petition on October 3, 2017. Pet. at 1. She filed medical records in
support of her claim on October 5, 2017 (Exs. 1-10), and an affidavit on December 26, 2017. ECF
Nos. 7, 8, 11. Respondent then filed his Rule 4 Report on October 2, 2018, recommending that
entitlement be denied. Resp’t’s Rep. at 1; ECF No. 22.
Petitioner filed a second affidavit (Ex. 12) and additional medical records on February 7,
2019 (Ex. 13). ECF No. 25.
I held a status conference February 28, 2019, where I asked the parties whether a ruling
addressing the issue of onset of Petitioner’s symptoms would help to move the case forward.
Respondent indicated that it would not, since Respondent believed there were several issues
besides onset with Petitioner’s case. ECF No. 26 at 1. I asked Petitioner’s counsel if any additional
objective evidence existed that may assist in pinpointing the date of onset. Specifically, I asked
whether Petitioner had confirmed that there was no record of the phone call she allegedly made to
her doctor the day after her flu vaccination. Petitioner’s counsel stated that he would search for a
record of that phone call, or any additional evidence that may clarify the date of onset. Id. at 2.
ECF No. 26.
Petitioner filed a third affidavit (Ex. 14) and additional medical records on April 15, 2019
(Exs. 15-18).
Petitioner filed an expert report from Dr. Naveed Natanzi (Ex. 20) along with supporting
medical literature on February 20, 2020. Exs. 21-41. Respondent filed a responsive expert report
from Dr. Geoffrey Abrams (Ex. A) and supporting medical literature on July 17, 2020 (Ex. A,
Tabs 1 – 13, Ex. B). Petitioner filed a second expert report on September 15, 2020 (Ex. 43).
Respondent filed a second responsive expert report on April 30, 2021, along with supporting
medical literature.
On May 25, 2021, I held a second status conference. ECF No. 55. I informed the parties
that I believed that Petitioner was unlikely to succeed in her claim, given 1) timing, 2) prior left
shoulder pain, and 3) alternative causation. Id. at 1. Each of these issues standing alone would
make it difficult for Petitioner to prevail in this case, but when taken together, they effectively
eliminate any path for Petitioner to receive compensation. Id. Accordingly, I ordered Mr.
Kalinowski to file a status report indicating whether Petitioner would like to file a motion to
dismiss or a motion for a ruling on the record.
On June 30, 2021, Petitioner filed a motion for a ruling on the record. Pet’r’s Mot., ECF
No 57. Respondent filed his response on September 7, 2021. Resp’t’s Resp. ECF No. 59. On
September 8, 2021, my law clerk reached out to Petitioner’s counsel via email to inquire if
2
Petitioner intended to file a reply brief. Counsel responded that Petitioner did not. See Informal
Communication (Remark) of September 13, 2021.
On September 21, 2021, the parties filed a joint status report indicating that the record was
complete for a ruling on the record. ECF No. 60. This matter is now ripe for an adjudication.
II. Relevant Medical Records
A. Petitioner’s Pre-Vaccination History
Petitioner was born on October 16, 1960. Ex. 1 at 1. She was diagnosed with multiple
sclerosis in 1999. Ex. 2 at 167.
Petitioner had previously received flu vaccinations on November 13, 2014 and October 13,
2015. Ex. 1 at 4. She received a Tdap vaccine on November 18, 2015. Id.
On September 26, 2012, Petitioner visited Dr. Michael Will at Lynchburg General Hospital
for several complaints, including “pain about her left arm, also some pain about the chest.” Ex. 2
at 198. X-rays taken on September 28, 2012 showed no damage to the left arm. Ex. 5 at 43. A
doppler ultrasound of her left upper arm was likewise negative. Id. Dr. Will stated that he suspected
the chest pain was “more GI in origin.” Ex. 2 at 200. Dr. Will emphasized that Petitioner needed
to be consistently taking her insulin, as her diabetes was uncontrolled and poorly managed. Id.
On September 28, 2012, while still in the hospital, Petitioner was seen by Dr. Nathan
Williams. Ex. 4 at 419. Dr. Williams noted that Petitioner was “complaining bitterly of her left
arm and shoulder hurting, which she said is the reason she came in.” Id. at 420. Dr. Williams noted
that her “range of motion is a little bit limited by pain.” Id. His notes state that the left arm pain
“sounds musculoskeletal.” Id. Dr. Williams ordered an x-ray of Petitioner’s left shoulder. Ex. 2 at
192. During the x-ray, Petitioner stated that she had been feeling “pain x 3 wks, no injury.” Id.
Petitioner was also noted to be suffering from “left arm pain and swelling.” Id. X-rays found no
evidence of an acute fracture or glenohumeral dislocation. Id. Petitioner was diagnosed with a
cervical strain after a CT scan of the C-Spine showed degenerative changes. Ex. 4 at 420.
On November 21, 2012, Petitioner “tripped on a rug while leaving Petsmart and fell
forwards to the ground.” Ex. 4 at 208. Petitioner complained of “lower back, left and right arm
pain, left and right knee pain, hip pain, and shoulder area/neck pain” after she was loaded into the
medic unit. Id. Petitioner had good PMS [pulse, motor, sensory] in all extremities, an abrasion to
her left knee, and some swelling/bruising to her right knee. Id. Petitioner’s pain was characterized
as moderate but aching. Id. at 217. X-rays of her left hand showed “a ring around the thumb that
apparently could not be removed. No fracture or other bony abnormality [was] seen. Id. at 222.
Petitioner was eventually diagnosed with a cervical strain and discharged home. Id. at 230.
On February 22, 2013, Petitioner was seen by Dr. Michael Okin for management of
diabetes. Ex. 2 at 99. Petitioner’s diabetes was eventually characterized as uncontrolled, as she did
not take her insulin consistently. Id. at 101.
3
On July 16, 2013, Petitioner visited Dr. Okin in the emergency room for a follow up
regarding her back pain. Ex. 2 at 96. Her glucose value was noted to be 521 at this visit. Id.
On March 17, 2015, Petitioner was seen at Centra Lynchburg General Hospital for neck,
back, left shoulder, left hip, and right wrist pain following a motor vehicle accident. Ex. 4 at 158.
Petitioner complained of left shoulder pain radiating to her neck. Id. at 154. X-Rays were ordered
of Petitioner’s pelvis and right hip. No fracture or misalignment was found. Id. at 158, 161.
Petitioner was discharged home the same day with pain medication and was instructed not to drive.
Id. at 163.
On April 3, 2015, Petitioner presented to Dr. Michael Okin for a follow up of pain “all
over” following a motor vehicle accident on March 17, 2015. Ex. 2 at 63. Petitioner complained
of “total body aches and pains including her low back without radiation. She ha[d] knee pain as
well as upper back pain.” Id. Upon examination, Dr. Okin noted “back pain, joint pain, myalgia
and swelling of extremities.”, as well as a headache. Id. Petitioner was given an x-ray and was
noted to have “mild degenerative disc disease.” Id. at 134.
On May 4, 2015, Petitioner presented to Rehab Associates of Central Virginia. Ex. 2 at
169. She presented with complaints of lower back pain related to her motor vehicle accident
occurring on March 17, 2015. Id. Petitioner was suffering from “increased pain, decreased ROM,
and decreased BLE strength.” Id. She was noted to suffer from “functional deficits of prolonged
standing, walking, squatting, bending, and lifting.” Petitioner was noted to have “extreme”
difficulty lifting or carrying groceries. Ex. 5 at 13.
On June 9, 2015, Petitioner presented again to Rehab Associates of Central Virginia. Ex.
5 at 13. Petitioner presented “with rounded shoulder posture and noted having to change positions
frequently and holding L arm throughout entire evaluation.” Id. Physical Therapist Matthew Nolen
documented that Petitioner presented with “tenderness to touch to the PSIS [posterior superior iliac
spine] and to the Lumbar paraspinals. [Petitioner] presents tenderness to touch to the piriformis
on [both] sides, more [left] than [right].” Id. at 17. Petitioner attended a total of nine physical
therapy appointments between May 4, 2015 and June 9, 2015. 3 Id. at 16. On the same day,
Petitioner was discharged from physical therapy. Mr. Nolen’s notes indicate that Petitioner
demonstrated a “13 percent improvement” over the course of her physical therapy. Id.
On December 11, 2015, Petitioner visited the emergency department with complaints of
right foot pain for four days. Ex. 4 at 7. Petitioner reported redness, drainage, and chills. Id.
Petitioner was diagnosed with a diabetic foot ulcer and was discharged home with care
instructions. Id. at 22.
On January 4, 2016, Petitioner was seen for an MRI of her right knee and her left ribs. Ex.
5 at 2, 3. In the provider notes, Dr. Michael Rowland stated that Petitioner had “right patellar and
elbow pain, left sided rib pain.” Ex. 5 at 2. Petitioner’s rib exam showed no displaced rib fractures.
Id. at 3.
3
The medical record does not appear to contain physical therapy records from any visit aside from May 4,
2015, or June 9, 2015.
4
On January 21, 2016, Petitioner visited Dr. Kimberly Combs for chest pain. Petitioner
described the injury as occurring on January 12, 2016, where she “fell and hit chest, both knees
and right elbow.” Ex. 2 at 37. Petitioner was diagnosed with “decreased range of motion of the left
chest wall, difficulty taking a deep breath, hurts with palpitation, large bruise over the left breast,
painful to take a deep breath in, somewhat panting.” Id. at 40. On February 23, 2016, Petitioner
received an injection to help relieve the pain in her right elbow. Id. at 36.
On September 2, 2016, Petitioner presented to Dr. Combs with complaints of myalgia and
warts on her right hand. Ex. 2 at 24. Dr. Combs’ notes state that “the onset of myalgia has been
gradual and has been occurring for years (Worse this time [of] year, Has MS). Id. Petitioner’s pain
was described as a “moderate dull aching” located over the entire body. Id. Dr. Combs noted that
the symptoms have been associated with arthralgia. Id.
On September 9, 2016, Petitioner presented to nurse practitioner Shauntell Kline for back
pain. Ex. 2 at 19. Petitioner’s pain was described as “being located in the upper back (left side)”.
Id. It was characterized as “stabbing” and did not radiate. Petitioner’s symptoms were noted to be
aggravated by exertion. Id. Petitioner also complained of leg cramping at this visit. Id. The onset
of leg cramping was approximately one week prior. Id. Ms. Kline’s notes indicate that “there is
involvement of the left lower extremity, right lower extremity, left calf, right calf, left foot and
right foot.” Id. Upon examination, Ms. Kline noted that the “left side of back in lower rib area
[was] tender to touch” and Petitioner had “normal and symmetric movement” of all her extremities.
Id. at 22.
On October 3, 2016, Petitioner presented to Dr. Combs for a recheck of her back pain. Ex.
2 at 14. Petitioner’s pain was described as “being located in the upper back (left side)”. Id. It was
characterized as “stabbing” and did not radiate. Id. Dr. Combs noted that the pain had begun
approximately one month prior. Id. Upon examination, Petitioner was noted to have “joint pain,
joint swelling, joint stiffness and muscle spasm.” Id. at 16. Dr. Combs noted that Petitioner was
diagnosed with fibromyalgia and prescribed Lyrica. Id. at 16. Petitioner received her flu
vaccination at this visit. Id. at 17.
B. Petitioner’s Post-Vaccination History
On November 3, 2016, Petitioner presented to Dr. Peter Konieczny at CMG Neurology for
a follow up of her multiple sclerosis. Ex. 6 at 18. Petitioner complained that “I hurt, my muscles
hurt, feel like spiders are crawling on me, little tingly things.” Id. Dr. Konieczny’s notes indicate
that Petitioner had not seen a neurologist since 2011 because she “didn’t feel [as if she] needed
to.” Id. Petitioner complained of “fatigue, muscle pain, and paresthesias which have been
problematic now for 2-3 months.” Id. Upon performing a neurologic exam, Dr. Konieczny noted
that Petitioner’s shoulder shrug was “5/5 strength.” Id. at 18. A musculoskeletal exam revealed
that “strength and tone in all major muscle groups WNL for age and [d]emonstrates symmetrical
movements.” Id. Dr. Konieczny stated that “I’m not enti[r]ely sure how her symptoms of diffuse
pain and paresthesias are related to MS, if in any way. Repeat MRIs are warranted.” Id. at 19.
Petitioner was prescribed physical therapy.
5
On November 16, 2016, Petitioner was seen for an MRI of her cervical spine. Ex. 6 at 23.
The MRI revealed several degenerative findings, which Dr. Konieczny characterized as “mild
diffuse atrophy.” Id. at 24.
On November 22, 2016, Petitioner presented to Dr. Kimberly Combs with complaints of
arm pain “occurring in a persistent pattern for 1 month.” Ex. 2 at 10. Petitioner described the pain
as “moderate.” Dr. Combs noted that “since 10/3/16 flu shot she has had left arm/shoulder pain.”
Id. An examination revealed that Petitioner’s pain radiated “from the le[ft] shoulder down into
forearm.” Id. at 13. Petitioner was also noted to be suffering from depression at this visit. Id.
On December 14, 2016, Petitioner was seen at OrthoVirginia by Dr. Ian Smithson. Ex. 7
at 56. Under “history of present illness”, Dr. Smithson’s notes indicate that
for the past 2 months, [Petitioner] has had shooting pain radiate from her anterior
shoulder down her forearm. She believes the flu shot stemmed her pain that she
received on 10/3/16. Pain interrupts her sleep because she likes to sleep on her left
side. Pain is also aggravated with driving and lifting items. Denies symptoms of
numbness and tingling. Does not have radicular pain in hand.
Id. Dr. Smithson noted that Petitioner suffered from both fibromyalgia and MS. Id. Upon
examination, Petitioner had no swelling, ecchymosis, erythema, or induration. Id. at 57. Her
shoulder was tender to “palpitation at [the] anterior shoulder,” and her range of motion exam
revealed she had a loss of internal and external rotation. Id. Dr. Smithson explained to Petitioner
that he did not believe her symptoms were related to her flu shot, but instead were consistent with
adhesive capsulitis. Id. at 56. Dr. Smithson noted that Petitioner was seeking information “because
she has been consulting a lawyer regarding flu shot being administered incorrectly. She was
advised for home exercise program and steroid injection. Did not wish to proceed with steroid
injection. She admitted she will not do at home exercise program but did request more information
regarding adhesive capsulitis.” Id. Petitioner was prescribed physical therapy. Id.
On January 13, 2017, Petitioner was seen by physical therapist Kristine Lee. Ex. 7 at 60.
Ms. Lee’s notes indicated that Petitioner “developed left shoulder pain [anterior] [s]houlder which
goes down arm and stiffness since getting fl[u] shot 10/3/2016…Patient feels like the pain has
gotten worse since she saw the [d]octor. Pain is 7-8/10 today during therapy with movement.” Id.
Petitioner’s current level of function was noted as “basically reports keeps the left arm at side with
walking.” Id.
Petitioner saw Ms. Lee for physical therapy again on January 17, 2017. Ex. 7 at 62.
Petitioner noted that her arm felt better “after the heat.” Id. Following the session, Petitioner was
able to let her arm “hang at side after PROM.” Id. Ms. Lee noted that Petitioner “still walks with
it adducted to side with elbow flexion.” Id.
Petitioner had another physical therapy session on January 20, 2017. Ex. 7 at 64. Petitioner
noted that “my left shoulder feels so much better after heat that I can use the arm a little. Otherwise
I have to keep it at my side.” Id. Ms. Lee noted that “Patient did better with PROM left shoulder
ER today, but still quite painful with elevation.” Id. at 65. On January 23, 2017, Ms. Lee noted
6
that Petitioner was “still with pain with PROM shoulder and axilla. Needed verbal cues for correct
technique with [swiss ball] roll outs which she also does at home.” Id. at 67. On January 27, 2017,
Ms. Lee noted that Petitioner “continues to have pain with PROM and AROM left shoulder. Still
braces left arm at side with walking.” Id. at 72.
On January 31, 2017, Petitioner again presented for physical therapy with Ms. Lee. Ex. 7
at 73. Ms. Lee’s notes indicate that “Patient states she can’t pick up a coffee cup with Left UE.
The only thing that has improved since starting therapy is that she can raise [her] arm to the side a
little to put deodorant on. [She is] keeping [her] arm at [her] side all the time otherwise.” Id. Ms.
Lee’s assessment was that “Petitioner has not made progress with AROM Left shoulder since SOC.
Actually has less IR and ER. Still diffusely tender around scapula. Significant pain with all PROM.
Elbow extension has improved.” Id. at 74.
On February 3, 2017, Petitioner had her last physical therapy appointment with Ms. Lee.
Petitioner stated that her left shoulder was “feeling about the same” and that it was “still very sore
and she couldn’t use her arm for anything.” Ex. 7 at 75. Ms. Lee’s notes from February 3, 2017
indicate that she was treating Petitioner for “adhesive capsulitis of the left shoulder.” Id.
On April 21, 2017, Petitioner presented to Dr. Smithson for evaluation of left shoulder
pain. Ex. 8 at 6. Petitioner’s history indicates that “for the past 5 months, she has had shooting pain
radiate from her anterior shoulder down her forearm. She believes the flu [shot] she received on
10/3/16, incited the pain.” Id. Dr. Smithson noted that Petitioner’s range of motion had “worsened
because she has been apprehensive in working through her pain.” Id. at 9.
On June 9, 2017, Petitioner suffered a fall while carrying boxes from her living room to
her car. Ex. 10 at 13. Petitioner landed on her right hip and was unable to bear weight on her right
leg. Id. Petitioner was eventually diagnosed with fractures in her pelvis and was mostly confined
to a wheelchair. Id. at 11.
On August 30, 2017, Petitioner visited Dr. John Prahinski for pain in her right shoulder
and right pelvis. Ex. 10 at 5. Petitioner was described as being “mostly in the wheelchair” and
using a “walker in the house to get around to the refrigerator.” Id. Dr. Prahinski noted that
Petitioner had sustained a fall in early June which resulted in a sacral ala fracture and right pubic
rami fractures. Id. Dr. Prahinski diagnosed Petitioner with glenohumeral arthritis of the right
shoulder, and “unspecified chronicity” of right shoulder pain. Id. at 6. Petitioner made no mention
of left shoulder pain at this visit. Petitioner received a glenohumeral injection to her right shoulder
on September 7, 2017 to relieve her symptoms. Id. at 2.
On October 17, 2017, Petitioner visited Dr. Prahinski for a follow up on pain in her pelvis
and right shoulder. Ex. 13 at 5. Petitioner stated that her shoulder pain had improved significantly
with a glenohumeral injection. Id. at 6. Petitioner’s left shoulder was not mentioned at this visit,
and left shoulder pain was not listed in Petitioner’s problem list. Id. at 9-10.
On February 16, 2018, Petitioner visited Dr. Omar Elkhamra for pelvis pain. Ex. 13 at 11.
Petitioner complained of right sided pelvis pain and left ankle pain “for the past few months with
no inciting injury.” Id. Petitioner made no mention of either left or right shoulder pain at this visit.
7
On August 17, 2018, Petitioner visited Dr. Ian Smithson for chronic left shoulder pain. Ex.
13 at 18. Petitioner reported that she believed that the flu vaccine she received on October 3, 2016
incited her pain. Id. Petitioner reported persistent pain of her left shoulder, “localized over the
anterolateral aspect of the shoulder with limited motion.” Id. Petitioner was given a glenohumeral
injection in her left shoulder. Id. X-rays of the left shoulder demonstrated a “type 1 acromion with
moderate genohumeral joint space narrowing without fracture, dislocation, or subluxation.” Id. at
26.
III. Affidavits
A. Petitioner’s First Affidavit
Petitioner submitted her first affidavit on December 26, 2017. Ex. 11. Petitioner stated that
“she mentioned to the vaccine administrator that it seemed she was injecting the vaccination too
high, but she assured me that it was in the correct location. I felt pain within two hours from the
vaccination.” Id. at 1. Petitioner further stated that “The next day I had trouble moving my left
arm. I remember taking note that it was impossible for me to use my left arm to turn my steering
wheel when driving. Soon I could hardly move my left arm because of this injury.” Id.
Petitioner also averred that she was unable to book a doctor’s appointment until
approximately one month after her vaccination. Ex. 11 at 2. At the primary care provider’s office,
Petitioner’s doctor referred her to an orthopedist for additional evaluation and treatment. Id. The
orthopedist speculated that Petitioner might be developing fibromyalgia and prescribed Lyrica as
treatment. Id.
B. Petitioner’s Second Affidavit
On February 7, 2019, Petitioner submitted a second affidavit in response to Respondent’s
Report. Ex. 12. Petitioner stated that “the place on my shoulder where [the nurse] injected the
vaccine immediately hurt.” Id. at 1. She further stated that the next day she “called the doctor’s
office where [she] had received the vaccination to complain that my left arm hurt ever since the
vaccination was administered, but was told the pain was normal, that my muscle was just sore
from the needle prick and [would] get better.” Id.
Petitioner then stated that she noticed “more pain on the morning of 4 October 2016” which
she assumed was a sore muscle from the vaccination, but the pain “got worse as that day wore on
and into the next day, 5 October.” Ex. 12 at 2. Petitioner stated that by October 5, 2016, she had
trouble “even moving [her] shoulder.” Id. Petitioner stated that “within 24 hours of the vaccination
I knew something was definitely wrong because I could not hold so much as a coffee cup with my
left hand” and that “within a few days from the vaccination…it was hard to drive because of the
difficulty in turning the steering wheel with my affected arm.” She further stated that she could
not sleep on her left side without it hurting her. Id.
Petitioner stated she was unable to book a doctor’s appointment until nearly two months
after she had received the vaccination. Ex. 12 at 2. In the interim, she was seen by a neurologist
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for her MS. Petitioner stated that she did not mention her shoulder pain at this visit because “the
problem with my shoulder was not related to my MS.” Id. Petitioner stated she was eventually
diagnosed with “frozen shoulder” by an orthopedist and referred to physical therapy, which did
not “substantially improve [her] situation.” Id. at 2-3.
Petitioner further denied suffering chronic problems in her neck, stating that she suffers
from “lower back pain at times.” Ex. 12 at 3. Petitioner stated that on June 9, 2015, she was “noted
to have ‘moderate limitation’ with tasks such as ‘lifting or carrying items like groceries’ but that
does not mean I was unable to lift or carry groceries.” Id. Petitioner noted that she “had been in a
car wreck two months earlier, which caused a lot of pain and limitations.” Id.
Petitioner also denied that her reports of pain in 2015 and 2016 were related to her left
shoulder. Ex. 12 at 3. Petitioner stated that she had never suffered from an injury to her shoulder
that would cause her ongoing pain or limitation to her range of motion, an injury or systemic
condition that would cause adhesive capsulitis, or that chronic problems in her back and neck
caused adhesive capsulitis in her shoulder. Id.
C. Petitioner’s Third Affidavit
On March 1, 2019, I issued an order instructing Petitioner to file any additional objective
evidence which may assist me in pinpointing the date of onset of Petitioner’s shoulder injury. ECF
No. 26.
In response, Petitioner filed a third affidavit on April 14, 2019. Ex. 14. Petitioner denied
ever engaging in email correspondence with her doctors, or filing a VAERS report regarding her
injury. Id. at 1. Petitioner denied undergoing chiropractic treatments, non-traditional treatments,
or psychological treatment. Id. Petitioner also stated she had been unemployed since she suffered
her injury. Id. at 2.
Petitioner also stated that she did not maintain a written journal, a calendar, or agenda at
the time of her injury. Ex. 14 at 1. She did not exercise at the time of her injury. Id. She did not
maintain telephone billing records and “did not believe telephone records would prove or disprove
the facts at issue herein.” Id. Petitioner also stated that her “financial records would not contain
useful information regarding the purchase of items that would help resolve the factual disputes in
this case.” Id. Finally, Petitioner averred that she did not post on social media regarding her injury
at any point. Id.
D. Petitioner’s Fourth Affidavit
Petitioner filed a fourth affidavit on February 20, 2020. Ex. 19, ECF No. 36. Petitioner
stated that she was standing while the vaccine was administered, and that her left arm was “lying
at rest, roughly parallel” with her torso. Id. at 1.
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IV. Expert Qualifications and Reports
A. Petitioner’s Expert: Naveed Natanzi, DO
Petitioner submitted two expert reports from Naveed Natanzi, DO. Ex. 20 (hereinafter
“First Natanzi Rep.”), Ex. 43 (hereinafter “Second Natanzi Rep.”).
Dr. Natanzi is board certified by the American Academy of Physical Medicine and
Rehabilitation and is board-eligible by the American Board of Pain Management. Ex. 21 at 1
(hereinafter “Natanzi CV”). Dr. Natanzi received a Bachelor of Arts in Biological Studies at the
University of California, Santa Barbara in 2007, and attended medical school at Western
University of Health Sciences, where he received a Doctor of Osteopathy in June 2012. Id. at 2.
Dr. Natanzi completed an internship at Downey Regional Medical Center from 2012-2013, then
completed his residency in physical medicine and rehabilitation at the University of California,
Irvine from 2013-2016. Id. at 1. Dr. Natanzi completed a fellowship at the Bodor Clinic in Napa,
California from January 2017-August 2017. Id.
From 2017-2018, Dr. Natanzi worked at the Pasadena Rehab Institute as an attending
physician specializing in interventional pain management. Natanzi CV at 1. In November 2017,
Dr. Natanzi founded the Regenerative Sports and Spine Institute, and since April 2018, Dr. Natanzi
has been a staff physician at the VA Long Beach Healthcare System. Id. Dr. Natanzi has served as
a witness in several SIRVA cases in the Program since 2017. Id.; see e.g., Taylor v. Sec’y of Health
& Hum. Servs., 2020 U.S. Claims LEXIS 2298 (Fed. Cl. Spec. Mstr. Oct. 20, 2020). He has
authored seven publications and has conducted a large double-blind research study. Id. at 3.
B. Respondent’s Expert: Dr. Geoffrey Abrams
Respondent filed two expert reports from Dr. Geoffrey D. Abrams. Ex A (hereinafter “First
Abrams Rep.”), Ex. C (hereinafter “Second Abrams Rep.”).
Dr. Abrams received a Bachelor of Arts in Human Biology with a concentration in
Neuroscience from Stanford University in 2000. Ex. B at 1 (hereinafter “Abrams CV”). He
received his medical degree from the University of California, San Diego in 2007. Id. He
completed a surgical internship at Stanford University in 2008. Id. Dr. Abrams completed his
residency at Stanford University Hospital and Clinics in 2012, and a fellowship at Rush University
Medical Center in 2013. Id.Dr. Abrams is board certified in Orthopedic Surgery, with a subspeciality in Orthopedic
Sports Medicine. Abrams CV at 2. He is licensed to practice medicine in Illinois and California
and is a California Fluoroscopy Supervisor and Operator. Id. He holds academic appointments at
the Stanford University School of Medicine and the Veterans Administration Hospital of Palo
Alto. Id. at 1.
Dr. Abrams has published seventy-two peer-reviewed publications as well as a number of
peer-reviewed short communications. Abrams CV at 2-22. He serves as the head team physician
for several of Stanford University’s varsity teams and is an assistant team physician for the Golden
10
State Warriors and the San Francisco 49ers. He has given numerous lectures on the topic of
orthopedics. Id. at 22-28.
C. Dr. Natanzi’s First Expert Report
Petitioner filed Dr. Natanzi’s first expert report on February 20, 2020. Dr. Natanzi stated
his theory of the case as follows: (1) an inadvertent overpenetration of the vaccine needle resulted
in (2) bursal rotator cuff and/or capsular penetration, which caused (3) immediate pain, limited
range of motion and discomfort. Petitioner’s vaccine then (4) interacted with naturally-occurring
antibodies from a prior vaccination, which resulted in an exaggerated, robust, and prolonged
inflammatory response resulting in (5) adhesive capsulitis and rotator cuff mediated pain. 4 First
Natanzi Rep. at 11.
Dr. Natanzi stated that “at the time of vaccination, [Petitioner’s] left arm was in a resting,
non-abducted position by her side. Both Ms. Nicholson and the injector were standing. The exact
injection location on her left deltoid muscle was not recorded.” Id. at 8.
Dr. Natanzi acknowledged that Petitioner’s medical providers do not correlate her
symptoms with her vaccination. First Natanzi Rep. at 8. He explained this by stating that “most
people are unaware that a vaccination can cause significant shoulder dysfunction, and they often
do not inherently associate adverse symptoms with a vaccination. This lack of knowledge and
understanding of SIRVA oftentimes results in discrediting vaccines as sources of post-vaccination
shoulder pain.” Id.Based on Dr. Natanzi’s review of the medical records, he believed that Petitioner’s
shoulder pain began “immediately post vaccination and that this presentation meets the temporal
relationship requirements (onset of pain within 48 hours) of a SIRVA injury.” First Natanzi Rep.
at 9. Dr. Natanzi’s belief stems from the fact that there is no “alternative etiology for the acute
development of shoulder pain in the peri-vaccination time period.” Id.Dr. Natanzi opined that Petitioner’s adhesive capsulitis was due to the fact that her flu
vaccination was improperly administered. First Natanzi Rep. at 9. Dr. Natanzi stated that the “risk
of adverse reactions and overpenetration is least when both the patient and administering provider
are seated and the arm is fully exposed, abducted, and flexed to 60 degrees with the hand resting
on the ipsilateral hip.” Id. Dr. Natanzi compared this optimal position with Petitioner’s vaccination,
stating that both Petitioner and the injector were standing, the vaccine was administered higher
than normal (per Petitioner’s first affidavit), and Petitioner’s arm was non-abducted at the time of
vaccination. Id. Dr. Natanzi stated that this sub-optimal vaccination procedure made it
“increasingly likely” that inadvertent overpenetration of the needle caused a SIRVA injury in
Petitioner. Id.4
Dr. Natanzi also opined that Petitioner’s August 30, 2017 right shoulder injury was “at least in part” the
result of overcompensation, “given [Petitioner’s] left shoulder dysfunction since vaccination.” First Natanzi
Rep. at 10. Because I have found that Petitioner’s left shoulder pain was not caused by her flu vaccine, I
similarly conclude that her right shoulder dysfunction was not attributable to vaccination.
11
Dr. Natanzi then proceeded to rule out other causes of Petitioner’s shoulder pain. He noted
that in September 2012, Petitioner was seen in the emergency department for chest pain, nausea,
vomiting, and left shoulder pain. First Natanzi Rep. at 9. While in the hospital, Petitioner was
found to suffer from “mild shoulder restriction with some bicipital tenderness” and “atraumatic
left shoulder pain.” Id. Dr. Natanzi noted that following this emergency room visit, Petitioner’s
medical records did not mention left shoulder pain “for a few years.” Id. at 10. Dr. Natanzi
therefore attributed Petitioner’s shoulder pain to her “fear of having a heart attack and not a
structural shoulder injury.” Id.Dr. Natanzi then addressed Petitioner’s March 2015 motor vehicle accident. First Natanzi
Rep. at 10. Dr. Natanzi noted that the ambulance records indicated that Petitioner experienced “left
shoulder pain that radiated to her neck” but that hospital records from the same day describe
Petitioner with hip, neck, and wrist pain, with no mention of shoulder pain; he further noted that
the medical records from April 3, 2015 describe “multiple joint complaints” but make no mention
of shoulder-specific complaints. Id. Dr. Natanzi acknowledged that Petitioner’s physical therapy
notes from June 9, 2015, stated that Petitioner “was holding her left arm and had difficulty carrying
groceries” but he noted that “there is not a description of why [Petitioner] was having this
difficulty.” Id. Furthermore, Dr. Natanzi noted that none of Petitioner’s other physical therapy
records from this time period mention shoulder pain, “which further lends likelihood to the theory
that there was no significant shoulder injury in the post-motor vehicle accident period.” 5 Id.Finally, Dr. Natanzi stated that if Petitioner’s shoulder was a “true pain generator and limiting
factor, [Petitioner] would have made mention of it as she did with regard to her left shoulder post-
vaccination.” Id.Given Dr. Natanzi’s interpretation of the medical records, he opined that “as a result of the
motor vehicle accident, [Petitioner] experienced multiple joint strains and whiplash, which may or
may not have involved the shoulder joint” and that Petitioner “did not experience a significant
shoulder injury and that her symptoms were likely related to a strain which is common in the
context of motor vehicle collisions.” First Natanzi Rep. at 10. Dr. Natanzi stated that Petitioner’s
post-motor vehicle collision symptoms were “markedly different in intensity, frequency, and
quality in comparison to her post-vaccination symptoms.” Id.Finally, Dr. Natanzi discussed Petitioner’s fibromyalgia diagnosis. First Natanzi Rep. at
11. Dr. Natanzi stated that he is not convinced that Petitioner suffered from fibromyalgia, but even
if she did, fibromyalgia symptoms are typically “diffuse and present throughout the body” whereas
the symptoms experienced by Petitioner in the shoulder were “focal and isolated.” Id. As a result,
Dr. Natanzi opined that the presence or absence of fibromyalgia has “no bearing” on the fact that
Petitioner was injured by her vaccination. Id.5
The medical records from Rehab Associates from Central Virginia do not contain any notes from the visits
between May 4, 2015 and June 9, 2015. However, notes from May 4, 2015 indicate that Petitioner had
“extreme difficulty” “lifting or carrying items like groceries.” Ex. 2 at 164. By June 9, 2015, the records
indicate that Petitioner had a “moderate limitation” “lifting or carrying items like groceries.” Id. at 163-64.
12
D. Dr. Abrams’ First Expert Report
Respondent filed an expert report from Dr. Abrams on July 17, 2020, responding to
Petitioner’s expert report. First Abrams Rep.
Dr. Abrams stated that there were “a number of factors” which would preclude ascribing
Petitioner’s left shoulder pain to her vaccination, including: (1) “a history of severe and
uncontrolled diabetes, which is a well-known cause of adhesive capsulitis and shoulder pain”; (2)
“the literature reporting on adhesive capsulitis following vaccine administration almost
exclusively describes healthy patients”; (3) “the lack of any objective evidence (imaging) of a
SIRVA-related injury”; (4) “A diagnosis of arthritis of the left shoulder, also a well-known source
of waxing and waning shoulder pain”; (5) “numerous medical events and accidents associated with
left shoulder pain prior to the index vaccination”; and (6) “No report of shoulder pain until almost
two months after vaccination, including no mention of any shoulder pain during a visit with a
neurologist approximately one month following the vaccination in question.” First Abrams Rep.
at 5.
Dr. Abrams opined that, without an MRI of Petitioner’s shoulder, it was impossible to tell
if Petitioner suffered a SIRVA injury, as an MRI would show symptoms of a SIRVA such as
inflammation in the subacromial space. First Abrams Rep. at 7. He also noted that Petitioner did
not report any ongoing left shoulder pain from April 2017 to August 17, 2018, which led him to
believe that Petitioner “did not have ongoing pain at that time.” Id. at 9. Dr. Abrams opined that
this lack of ongoing pain, coupled with radiographs in August 2018 showing “moderate
osteoarthritis of the shoulder”, strongly suggested a non-SIRVA related cause of shoulder pain. Id.Dr. Abrams stated that “There is a significant and profound effect on the petitioner’s
diagnosis of uncontrolled diabetes (and subsequent predisposition to inflammation and shoulder
pathology) on the overall pain, function, and structure of her shoulder.” He opined that because
Petitioner’s A1c values and blood sugar values were significantly elevated from May 2011 “up to
and including the day of vaccination”, Petitioner was suffering from hyperglycemia. First Abrams
Rep. at 6. Dr. Abrams stated that “diabetes is the single greatest risk factor” for the development
of adhesive capsulitis. Id.Dr. Abrams then explained the method by which hyperglycemia causes adhesive capsulitis,
stating that “hyperglycemia permanently alters tissue macromolecules through accelerated
advanced glycation end-products (AGEs) formation.” First Abrams Rep. at 7. Dr. Abrams noted
that these AGEs have been found in cases of frozen shoulder, and that clinically, the changes
caused by AGE formation can “change the biological properties of the shoulder joint capsule to
decrease its elasticity (makes the shoulder stiff) and increase intrinsic inflammation (make it
painful). Id. Dr. Abrams conceded that case reports exist of adhesive capsulitis following vaccine
administration but stated that these injuries occur almost entirely in patients who are otherwise
healthy prior to vaccine administration and none of the reported cases include patients with a
“diagnosis of uncontrolled diabetes and prior shoulder pain.” Id.Dr. Abrams also differentiated between an injury to the subacromial space, and an injury
to the joint capsule of an injured person’s arm, stating that adhesive capsulitis is an “inflammatory
13
condition” of the joint capsule. First Abrams Rep. at 6. Dr. Abrams stated that the American
Academy of Orthopedic Surgeons holds the position that “vaccine administration to the shoulder
cannot cause or contribute to common shoulder pathologies such as…adhesive capsulitis.” Id.Dr. Abrams then discussed other alternative causes of Petitioner’s shoulder pain. Dr.
Abrams stated that Petitioner suffered from left shoulder arthritis, pointing to a radiograph from
December 2016 which revealed “joint space narrowing of the glenohumeral…joint
(osteoarthritis).” First Abrams Rep. at 8 (omitting internal quotations). He opined that “some of
the petitioner’s symptoms match th[ose] experienced by patients with mild to moderate arthritis of
the shoulder. Vaccines are not known to cause arthritis of the shoulder and therefore have no
etiologic factor in this condition.” Id.Dr. Abrams also noted that Petitioner had suffered from numerous medical events and
accidents, some of which involved her left shoulder, any one of which could have led to her
shoulder pain. First Abrams Rep. at 8. This included Petitioner’s September 2012 admission to the
hospital for “nausea, vomiting, and chest pain” which included “reported left shoulder pain” and
Petitioner’s March 17, 2015 motor vehicle accident in which she complained of left shoulder pain.
Id.Dr. Abrams then addressed Dr. Natanzi’s assertion that Petitioner’s right shoulder pain was
caused by overcompensation due to her alleged left SIRVA injury. First Abrams Rep. at 9. Dr.
Abrams disputed this assertion, noting that Petitioner “first reported right shoulder pain…on
August 25, 2017, and stated that her pain had been present for over one month. Petitioner herself
stated it was “possibly from [a] recent fall back in June.” Id. Dr. Abrams further noted that on
August 30, 2017, Petitioner saw Dr. Prahinski and made no mention of left shoulder pain or a need
to compensate for her left shoulder at this visit. Id. Dr. Abrams concluded that Petitioner’s right
shoulder pain was likely due to her use of a wheelchair and walker following a fractured hip in
June 2017, as wheelchairs and walkers place considerable stress on the shoulders. Id.Dr. Abrams concluded his report by stating that Petitioner did not meet the criteria for a
SIRVA injury because (1) Petitioner had a history of pain and dysfunction of the affected shoulder;
(2) Petitioner’s pain did not occur within 48 hours of vaccination; and (3) Petitioner’s uncontrolled
diabetes was a much more logical explanation for Petitioner’s symptoms. First Abrams Rep. at 10.
E. Dr. Natanzi’s Second Expert Report
Petitioner submitted a rebuttal report from Dr. Natanzi on September 15, 2020. Second
Natanzi Rep.
Dr. Natanzi began his report by noting that both he and Dr. Abrams agree that Petitioner
suffers from adhesive capsulitis but disagree as to the etiology of Petitioner’s condition. Second
Natanzi Rep. at 1. He also noted that Petitioner “never experienced a sustained shoulder injury
prior to her vaccination in October 2016.” Id. at 3. He supported this statement by noting that pre-
vaccination, Petitioner logged “sparse, infrequent, and inconsistent complaints” regarding her left
shoulder, but post-vaccination, Petitioner’s complaints of shoulder pain were “sustained.” Id.14
Dr. Natanzi conceded that those patients who suffer from “uncontrolled [diabetes mellitus]
have an increased chance of developing adhesive capsulitis.” Second Natanzi Rep. at 1. Citing
Chan, Dr. Natanzi stated that “for each unit that the HbA1c level was greater than 7, the risk of
developing [adhesive capsulitis] increased 2.7%.” Id. Using this formula, Dr. Natanzi calculated
that the chance of Petitioner developing spontaneous adhesive capsulitis was anywhere from 20-
46%. Id. He therefore concluded that “mathematically, even in light of [Petitioner’s] uncontrolled
[diabetes mellitus], it is more likely than not that [diabetes mellitus mediated adhesive capsulitis]
does not develop.” Id.Dr. Natanzi disagreed with Dr. Abrams’ assertion that Petitioner did not develop pain
within 48 hours of her vaccination, stating that Petitioner developed pain “within hours after her
vaccination”. First Natanzi Rep. at 1. To support this point, Dr. Natanzi referred to Petitioner’s
first affidavit, in which she discussed feeling pain immediately after her shot; he also noted the
medical record from November 22, 2016, in which Petitioner stated to Dr. Combs that she had
pain in her shoulder for approximately one month. Id., see also Ex. 2 at 10. Dr. Natanzi concluded
that, based upon this timeline, Petitioner’s injury was “more in line with a SIRVA mediated injury
rather than a spontaneously occurring underlying disease”. Id.Dr. Natanzi then addressed Dr. Abrams’ assertion that reports of SIRVA-mediated
adhesive capsulitis “are in generally healthy patients.” Second Natanzi Rep. at 2. He opined that
“this statement is not supported by the literature” (noting one patient who was described to have
underlying hypertension and chronic obstructive pulmonary disease) and that Dr. Abrams’
assertion had no relevance. Id. Dr. Natanzi opined that if adhesive capsulitis “can happen to a
healthy person without medical conditions it is even more likely to happen to someone with
multiple medical conditions.” Id.Finally, Dr. Natanzi addressed Dr. Abrams’ alternative diagnosis of osteoarthritis. Second
Natanzi Rep. at 2. Dr Natanzi noted that both osteoarthritis and SIRVA “present with shoulder
pain and limited range of motion; therefore, they can be challenging to distinguish based on
physical exam alone. As with [adhesive capsulitis], the clinical history/context is key in
differentiating whether or not osteoarthritis could be a source of [Petitioner’s] pain.” Id. Dr.
Natanzi stated that osteoarthritis is a “degenerative issue with a development of pain that is
characteristically slow, gradual, indolent, waxing and waning, and oftentimes progressive” as
opposed to a SIRVA injury, which is “acute, sudden, and immediate.” Id. He therefore concluded
that, because Petitioner’s symptoms were “acute and severe”, the clinical picture was “much more
in line with an acute process which is exactly what SIRVA is.” Id.Dr. Natanzi concluded his report by stating that “if one were to accept it as fact that
Petitioner’s pain began immediately (within hours) after her vaccination as she describes in her
affidavit and as described by multiple medical providers” and “given the temporal relationship of
symptoms to the accident coupled with physical exam findings of limited range of motion and pain
– a SIRVA injury is the only reasonable diagnosis.” Second Natanzi Rep. at 2.
15
F. Dr. Abrams’ Second Expert Report
Respondent submitted a rebuttal expert report from Dr. Abrams on April 30, 2021. Second
Abrams Rep.
Dr. Abrams disagreed with Dr. Natanzi’s characterization of Petitioner’s risk for shoulder
pain due to her uncontrolled diabetes. Second Abrams Rep. at 1. Dr. Abrams noted that in a group
of participants with type 2 diabetes, 63% had shoulder pain or a shoulder disability. Id., citing
Shah.
Dr. Abrams also disagreed with Dr. Natanzi’s interpretation of the Chan article. Dr. Natanzi
stated that “for each unit that the HbA1c level was greater than 7, the risk of developing [adhesive
capsulitis] increased 2.7%.” Second Abrams Rep. at 1; citing Second Natanzi Rep. at 1. Dr.
Abrams stated that Dr. Natanzi failed “to recognize [that] the risk for developing adhesive
capsulitis is cumulative over time, and if one reads from the article itself…the article states that
“(f)or each unit of time (emphasis added) that HbA1c was greater than 7, there was a 3% increase
in the risk of adhesive capsulitis.” Id, citing Chan (emphasis in original). Dr. Abrams noted that
Petitioner’s blood sugar (HbA1c) was significantly elevated for at least six years prior to her
vaccination. Second Abrams Rep. at 1. Dr. Abrams opined that “because of this history of elevated
blood glucose over such a long time period, her risk of developing adhesive capsulitis was much
greater than 20-46%, as the petitioner’s expert states.” Id.Dr. Abrams disagreed with Dr. Natanzi that adhesive capsulitis can occur in patients with
underlying conditions. Second Abrams Rep. at 2. Dr. Abrams noted that, although Dr. Natanzi
pointed to a single report of “suspected SIRVA in a patient with hypertension and chronic
pulmonary disease”, these are conditions that have no known association with shoulder pain or
pathology, “unlike diabetes, cervical pathology, [or] fibromyalgia.” Id. Dr. Abrams therefore
opined that “in patients with conditions like diabetes, or other medical diagnoses known to cause
shoulder pathology, this would be a significant confounder and calls into question the accuracy of
a SIRVA diagnosis.” Id.Dr. Abrams also disagreed with Dr. Natanzi’s characterization of shoulder pain related to
arthritis. Second Abrams Rep. at 2. Dr. Natanzi stated that pain linked to shoulder arthritis is “slow
and gradual” rather than acute. Second Natanzi Rep. at 2. Dr. Abrams disagreed with this assertion,
stating that shoulder arthritis often presents with acute complaints, and “the most common
presentation for a person with shoulder arthritis is a statement that ‘it just started hurting one day’
and they do not recognize an inciting event.” Id.Dr. Abrams then turned to Petitioner’s history of cervical spine disease/arthritis. Second
Abrams Rep. at 3. He noted that a CT scan in November 2012 showed “multilevel degenerative
changes” in her cervical spine and on an MRI taken “just after the vaccination in question, she was
found to have C4/5 severe left foraminal narrowing and degenerative changes.” Id., citing Ex. 4 at
217, Ex. 6 at 23. Dr. Abrams stated that cervical disease has “well known overlap with shoulder
pain, and in many cases, can be the cause of perceived shoulder pain.” Id.16
Dr. Abrams disagreed with Dr. Natanzi that Petitioner’s shoulder pain began “within
hours” of her vaccination. Second Abrams Rep. at 3. In support of his assertion, Dr. Abrams stated
that (1) Petitioner “did not report shoulder pain until almost two months after the vaccination”; (2)
that she “had spoken to legal counsel prior to this first report of shoulder pain”; (3) her medical
visit with her neurologist on November 3, 2016 yielded no “documentation of any shoulder pain
or weakness/pain on physical exam”; (4) Petitioner described her pain to Dr. Combs on November
22, 2016 as “radiating pain”; and (5) In September 2016, Petitioner was diagnosed with
fibromyalgia, “a chronic pain condition and…another potential reason for musculoskeletal pain.”
Id.Dr. Abrams concluded his report by restating his opinion that Petitioner’s shoulder pain
was likely not present when she was seen by her neurologist on November 3, 2016 and started at
some point after that date. Second Abrams Rep. at 4.
V. Applicable Law
A. Petitioner’s Burden in Vaccine Program Cases
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),
including the factual circumstances surrounding his claim. § 13(a)(1)(A). In making this
determination, the special master or court should consider the record as a whole. § 13(a)(1).
Petitioner’s allegations must be supported by medical records or by medical opinion. Id.
To resolve factual issues, the special master must weigh the evidence presented, which may
include contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum.
Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special master must decide what weight
to give evidence including oral testimony and contemporaneous medical records).
Contemporaneous medical records are presumed to be accurate. See Cucuras v. Sec’y of Health &
Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). To overcome the presumptive accuracy of
medical records testimony, a petitioner may present testimony which is “consistent, clear, cogent,
and compelling.” Sanchez v. Sec’y of Health & Hum. Servs., No. 11–685V, 2013 WL 1880825, at
3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec’y of Health & Hum. Servs., No. 90–
2808V, 1998 WL 408611, at 5 (Fed. Cl. Spec. Mstr. June 30, 1998)).
In addition to requirements concerning the vaccination received, the duration and severity
of petitioner’s injury, and the lack of other award or settlement, a petitioner must establish that he
suffered an injury meeting the Table criteria, in which case causation is presumed, or an injury
shown to be caused-in-fact by the vaccination he received. § 11(c)(1)(C).
The most recent version of the Table identifies the vaccines covered under the Program,
the corresponding injuries, and the time period in which the particular injuries must occur after
vaccination. § 14(a). Pursuant to the Vaccine Injury Table, a SIRVA is compensable if it manifests
within 48 hours of the administration of an influenza vaccine. 42 C.F.R. § 100.3(a)(XIV)(B).
Pursuant to the Table, SIRVA is defined as:
17
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 (even if the condition causing the neurological
abnormality is not known).
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).
42 C.F.R. § 100.3.
If, however, a petitioner suffered an injury that either is not listed in the Table or did not
occur within the prescribed time frame, she must prove that the administered vaccine caused her
injury to receive Program compensation. § 11(c)(1)(C)(ii) and (iii). In such circumstances,
petitioner asserts a “non-Table or [an] off-Table” claim and to prevail, petitioner must prove her
claim by preponderant evidence. § 13(a)(1)(A).
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 & Hum.
Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). The Federal Circuit added that “[t]here must be a
‘logical sequence of cause and effect showing that the vaccination was the reason for the injury.’”
Id. The Federal Circuit subsequently reiterated these requirements in a three-pronged test set forth
in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Under this test,
a petitioner is required 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
18
(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. Id. at
1280.
B. Law Governing Analysis of Fact Evidence
The process for making factual determinations in Vaccine Program cases begins with
analyzing the medical records, which are required to be filed with the petition. Section 11(c)(2).
The special master is required to consider “all [] relevant medical and scientific evidence contained
in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s
report which is contained in the record regarding the nature, causation, and aggravation of the
petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic
or evaluative test which are contained in the record and the summaries and conclusions.” Section
13(b)(1)(A). The special master is then required to weigh the evidence presented, including
contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3
F.3d 413, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to
afford greater weight to contemporaneous medical records than to other evidence, such as oral
testimony surrounding the events in question that was given at a later date, provided that such
determination is evidenced by a rational determination).
Medical records created contemporaneously with the events they describe are generally
trustworthy because they “contain information supplied to or by health professionals to facilitate
diagnosis and treatment of medical conditions,” where “accuracy has an extra premium.” Kirby v.
Sec’y of Health & Hum. Servs., 997 F.3d 1378 (Fed. Cir. 2021) citing Cucuras, 993 F.2d at 1528.
This presumption is based on the linked proposition that (i) sick people visit medical professionals;
(ii) sick people honestly report their health problems to those professionals; and (iii) medical
professionals record what they are told or observe when examining their patients in as accurate a
manner as possible, so that they are aware of enough relevant facts to make appropriate treatment
decisions. Sanchez v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825 at *2 (Fed.
Cl. Spec. Mstr. Apr. 10, 2013) mot. for rev. denied, 142 Fed. Cl. 247, 251-52 (2019), vacated on
other grounds and remanded, 809 Fed. Appx. 843 (Fed. Cir. Apr. 7, 2020).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005 WL
6117475 at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are generally found to be deserving of greater evidentiary weight than oral testimony -- especially
where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
19
v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony
which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)).
However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475 at *19 (“[w]ritten
records which are, themselves, inconsistent, should be accorded less deference than those which
are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination
regarding a witness’s credibility is needed when determining the weight that such testimony should
be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent and
compelling.” Sanchez, 2013 WL 1880825 at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs.,
No. 90-2808V, 1998 WL 408611 at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional’s failure to document everything
reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;
or (4) a person’s purposeful recounting of symptoms that did not exist. LaLonde v. Sec’y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory connecting the vaccine to the injury often
requires a petitioner to present expert testimony in support of his or her claim. Lampe v. Sec’y of
Health & Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony
is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert
v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum.
Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195
F.3d 1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability of testimony
are: (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or
technique has been subjected to peer review and publication; (3) whether there is a known or
potential rate of error and whether there are standards for controlling the error; and (4) whether the
theory or technique enjoys general acceptance within a relevant scientific community.” Terran,
195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95).
The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora. Daubert factors are employed by judges to exclude
20
evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these
factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health
& Hum. Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 743. In this matter, (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to
require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592
F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a
particular expert’s credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the
reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y
of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously
explained that special masters are expected to consider the credibility of expert witnesses in
evaluating petitions for compensation under the Vaccine Act”).
D. Consideration of Medical Literature
Finally, although this decision discusses some but not all of the medical literature in detail,
I have reviewed and considered all of the medical records and literature submitted in this matter.
See Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We
generally presume that a special master considered the relevant record evidence even though [s]he
does not explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health &
Hum. Servs., 115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every
piece of evidence or testimony in her decision.’” (citation omitted)), aff’d, 601 F. App’x 982 (Fed.
Cir. 2015).
21
VI. Analysis
A. Table Claim
In the instant case, Petitioner alleges that she suffered a SIRVA Table injury following her
influenza vaccination on October 3, 2016. In order to prevail on her claim, Petitioner must show
each of the following by a preponderance of the evidence:
(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).
42 C.F.R. § 100.3.
For the reasons discussed below, I do not find that Petitioner has presented preponderant
evidence that she meets the criteria for a Table injury.
1. Petitioner’s History of Prior Left Shoulder Pain does not Explain her Post-
Vaccination Pain
Although Petitioner had a history of left shoulder pain in the years prior to her October 3,
2016 flu vaccination, there is not preponderant evidence that this prior pain explains her post-
vaccination symptoms.
On September 26, 2012, Petitioner was admitted to the hospital complaining of nausea,
vomiting, and chest pain. Ex. 2 at 190. During her hospital stay, Petitioner also complained of left
shoulder pain that she stated had been ongoing for three weeks with no known injury. Id. at 190,
192. She had a left shoulder x-ray, which was negative. Id. Left shoulder pain was included as one
of her discharge diagnoses. Id. at 191.
On March 17, 2015, Petitioner visited the ER after she was involved in a motor vehicle
accident. Ex. 4 at 159. Upon presentation, Petitioner complained of neck, back, right wrist, left
shoulder, and left hip pain. Id. She had digital x-rays performed of her pelvis and right wrist only,
suggesting that she was not experiencing sufficient left shoulder pain such that her doctor felt an
x-ray was appropriate. Id. at 161.
On June 15, 2015, Petitioner presented to physical therapy for lower back pain caused by
her MVA in March, 2015. Ex. 2 at 163. The PT Matthew Nolen added the following note to the
record: “Pt is a female with BMI of 26.6, presenting with rounded shoulder posture and noted
22
having to change positions frequently and holding L arm throughout entire evaluation.” Id. at 164.
The record does not elucidate why Petitioner was holding her left arm.
Although Petitioner’s medical records document that she was experiencing back pain in
2015 and 2016, none of these records suggest that Petitioner’s prior shoulder pain recurred. See
e.g., Ex. 2 at 19 (medical visit on September 9, 2016 where Petitioner complained of back pain).
In fact, on October 3, 2016, the day she received the allegedly causal flu vaccine, Petitioner
presented for a re-check of her back pain. Id. at 14-18. Dr. Combs performed a comprehensive
physical exam and did not document that Petitioner was experiencing left shoulder pain. See id.This medical visit, conducted on the day Petitioner received the vaccine at issue in this case,
suggests that any shoulder pain Petitioner had experienced in the past was not affecting her as of
the date of vaccination. Accordingly, Petitioner has presented preponderant evidence in support of
the first Table injury criterion.
2. Onset of Petitioner’s Shoulder Pain was between November 4, 2016 and
November 22, 2016, more than 48 Hours after Vaccination
Petitioner received her flu vaccine on October 3, 2016. She described experiencing intense
pain in her shoulder within one day of vaccination. Petitioner averred,
Within 24 hours of the vaccination I knew something was definitely wrong because
I could not hold so much as a coffee cup with my left hand. Within a few days from
the vaccination, I could not maneuver to put on a brassiere, and it was hard to drive
because of the difficulty in turning the steering wheel with my affected arm.
Ex. 12 at 2.
Petitioner claims that she called her PCP’s office the next day to report the pain she was
experiencing. Petitioner stated, “I called that doctor’s office where I had received the vaccination
to complain that my left arm hurt ever since the vaccination was administered, but was told the
pain was normal, that my muscle was just sore from the needle prick and [would] get better.” 6 Ex.
12 at 1.
Petitioner requested copies of the office telephone records from her PCP, presumably to
corroborate her account of calling the office on October 4, 2016. Ex. 18 at 3. The request returned
the following:
Id. at 7.
6
Petitioner did not mention this phone call in her first affidavit. Instead, she averred that she “waited a
week to see if the symptoms would resolve on their own, as residual pain from vaccinations usually do.
When the pain and limitation in movement did not resolve, I called my doctor's office to schedule an
appointment.” Ex. 11 at 2.
23
During a status conference on February 28, 2019, I asked Petitioner to attempt to find any
additional objective evidence that could assist her in pinpointing the date of onset of her shoulder
pain. See Scheduling Order dated March 1, 2019. ECF No. 26. Specifically, I asked Petitioner to
look for personal phone records which would document any call she may have made to her PCP.
Id. Petitioner filed her third affidavit on April 15, 2019, although the document was executed on
February 25, 2019, three days before the status conference where I asked for the information. See
Ex. 14 at 3. In her third affidavit, Petitioner averred as follows: “I have not maintained telephone
billing records that contain listings of numbers dialed, and I do not believe telephone records would
prove or disprove the facts at issue herein.” Id. at 1. Thus, there is no evidence in the record which
corroborates Petitioner’s statement that she called her PCP the day after vaccination to complain
of left arm pain.
Petitioner’s first medical visit after vaccination was with Dr. Konieczny, her neurologist,
on November 3, 2016. The purpose of the visit was to re-establish care for her MS. Ex. 6 at 17-19.
During this visit, Petitioner indicated that she had not been to a neurologist in five years. Id. at 17.
She complained of fatigue, muscle pain, and paresthesias that had been going on for two to three
months. Id. She stated, “I hurt, my muscles hurt, feel like spiders are crawling on me, little tingly
things.” Id. There is no indication that Petitioner told Dr. Konieczny she was experiencing left
shoulder pain.
The Review of Systems section documents that Petitioner was experiencing tingling, but
was negative for any other complaint. Ex. 6 at 17.
Upon performing a neurologic exam, Dr. Konieczny noted that Petitioner’s shoulder shrug
was “5/5 strength.” Ex. 6 at 18. Dr. Konieczny further documented “Give way weakness of both
deltoids, biceps, iliopsoas”. 7 Id. Petitioner was able to complete the finger-nose-finger testing
without any documented issues. Id.A musculoskeletal exam revealed “strength and tone in all major muscle groups WNL for
age.” Ex. 6 at 18. Dr. Konieczny described that Petitioner was experiencing “diffuse pain and
paresthesias”, and did not note any pain specific to her left shoulder. Id.Dr. Abrams persuasively opined as follows:
7
The iliopsoas musculotendinous unit (IPMU) is comprised of the major and minor psoas muscles and the
iliacus muscle. The IPMU is commonly referred to as the iliopsoas muscle. “The iliopsoas
musculotendinous unit (IPMU) is the primary flexor of the thigh with the ability to add and extra-rotate the
coxofemoral joint. … The muscles can act separately. The iliacus muscle stabilizes the pelvis and allows a
correct hip flexion during the run; the psoas major muscle stabilizes the lumbar spine during the sitting
position and the thigh flexion in a supine position or when standing. The psoas major acts as a stabilizer of
the femoral head in the hip acetabulum in the first 15 degrees of movement. The psoas minor muscle
participates in the flexion of the trunk and can stretch the iliac fascia.” NIH, National Library of Medicine,
Anatomy, Bony Pelvis and Lower Limb, Iliopsoas Muscle, www.ncbi.nlm.nih.gov/books/NBK531508/ (last
accessed Sept. 6, 2022).
24
The petitioner did not report any left shoulder pain when she saw [] Dr. Konieczny
on November 3, 201[6]. That was just one month after the index event, and there is
no mention of any left arm symptoms. Dr. Konieczny evaluated petitioner for any
signs of MS after a long break in care for that condition, and his record shows that
he tested every extremity, including the petitioner’s upper extremity, for which she
reported no pain with exam maneuvers.
First Abrams Rep. at 10. This failure to mention left shoulder pain was despite the fact that, as
stated in her affidavit, Petitioner was experiencing so much pain that she could not hold a coffee
cup with her left hand. Ex. 12 at 2.
Petitioner conceded that she did not mention shoulder pain to Dr. Konieczny at the
November 3, 2016 visit. See Ex. 12 at 2. 8 She averred that the reason for this omission was
“because the problem with my shoulder was not related to my MS.” Ex. 12 at 2. However,
Petitioner not only failed to mention shoulder pain to Dr. Konieczny, but she also did not exhibit
any pain during the comprehensive physical exam performed by her neurologist. The fact that
Petitioner did not mention left shoulder pain during this visit with her neurologist or exhibit any
left shoulder pain during the physical exam he performed is a significant fact which suggests that
she was not experiencing left shoulder pain at the time she presented to Dr. Konieczny.
Petitioner did not mention left shoulder pain until her next medical appointment, which
was on November 22, 2016. 9 Petitioner presented to Dr. Kimberly Combs complaining of
moderate left arm/shoulder pain which began after her 10/3/16 flu vaccine. Ex. 2 at 10. An
examination revealed that Petitioner’s pain radiated “from the le[ft] shoulder down into forearm.”
Id. at 13. Dr. Combs referred Petitioner to an orthopedist. Id.On December 14, 2016, Petitioner was seen at OrthoVirginia by Dr. Ian Smithson. Ex. 7
at 56. Under “history of present illness”, Dr. Smithson’s notes indicate that “[f]or the past 2
months, [Petitioner] has had shooting pain radiate from her anterior shoulder down her forearm.
She believes the flu shot stemmed her pain that she received on 10/3/16.” Id.Petitioner’s shoulder was tender to “palpitation at [the] anterior shoulder,” and her range
of motion exam revealed she had a loss of internal and external rotation. Ex. 7 at 57. Dr. Smithson
explained to Petitioner that he did not believe her symptoms were related to her flu shot. Id. at 56.
He assessed her with adhesive capsulitis of the left shoulder. Id. Dr. Smithson further noted that
Petitioner was seeking information “because she has been consulting a lawyer regarding flu shot
being administered incorrectly.” Id.8
In her brief, Petitioner also conceded that the notes from this visit “are admittedly inconsistent with
Petitioner’s account of constant and debilitating pain with reduced range of motion in her left shoulder.”
Pet’r’s Mot. at 8.
9
On November 16, 2016, Petitioner was seen for an MRI of her cervical spine. She did not mention left
shoulder pain at this appointment either. Ex. 6 at 23.
25
Petitioner returned to Dr. Konieczny on January 5, 2017. Ex. 6 at 20. The purpose of this
visit was to discuss the results of her MRI, which revealed “at least 15 white matter lesions of both
cerebral hemispheres without enhancement and no intrinsic cord signal changes… The brain MRI
was judged to be stable from prior in 2011.” Id. Accordingly, like the last visit with Dr. Konieczny,
Petitioner visited her neurologist to discuss issues surrounding her MS. However, unlike her prior
visit with Dr. Konieczny, in the review of systems section from the January 5, 2017 appointment,
Dr. Konieczny documented:
Musculoskeletal Present- Arm or Leg Pain and Arm Weakness. Not Present- Muscle Pain and
Weakness.
Id. There is no indication from this record that Petitioner’s arm or leg pain and arm weakness
involved her MS. This fact further reduces the persuasiveness of her explanation that she did not
mention shoulder pain to Dr. Konieczny on November 3 because she was seeing him for MS.
In general, contemporaneous medical records are presumed to be accurate and
complete. Cucuras v. Sec'y of Health & Hum. Servs., 933 F.2d 1525, 1528 (Fed. Cir. 1993). In
assessing when Petitioner developed pain in her left shoulder/arm, I have credited the medical
records from November 3, 2016 over those from November 22, 2016.
By the time Petitioner presented to her December 14, 2016 medical appointment with Dr.
Smithson, she was actively pursuing her vaccine claim. This point further reduces the value of this
record, as it was created in anticipation of litigation. 10 See, e.g., Sheets v. Sec'y of Health & Hum.
Servs., No. 16-1173V, 2019 WL 2296212 at *19 (Fed. Cl. Spec. Mstr. Apr. 30, 2019) (finding that
later-in-time statements whether made to treaters or prepared for purposes of litigation do not
suffice to contradict contemporaneous records); Goodgame v. Sec'y of Health & Hum. Servs., No.
17-339V, 2019 WL 4165275 at *4 (Fed. Cl. Spec. Mstr. Jul. 30, 2019) (giving little weight to
medical records prepared after a doctor’s visit that petitioner attended “at the recommendation of
her lawyer.”).
I have also considered the Kirby case in arriving at my factual determination in the case at
bar. In Kirby, a portion of the petitioner’s medical records were silent regarding the persistence of
her symptoms. The Federal Circuit held that medical records are not presumptively accurate and
complete as to all [of a] patient’s physical conditions. Kirby v. Sec’y of Health & Hum. Servs, 997
F.3d 1378, 1382-83 (Fed. Cir. 2021). The Circuit held that a reasonable fact finder could find that
petitioner’s testimony of ongoing pain did not conflict with the records which were silent about
either the existence or the nonexistence of such symptoms. Id. at 1383. The Circuit noted that the
silence in the Kirby records could be explained by the fact that petitioner had “reached maximum
medical improvement and thus exhausted all available treatment.” Id. This final point is certainly
a difference between the petitioner in Kirby and the petitioner in this case. Petitioner had never
sought treatment for left arm pain that she associated with vaccination.
Based on the particular facts of this case, I find that Petitioner’s silence about left
arm/shoulder pain on November 3, 2016 raises substantial question about whether such pain
10
I find the medical records documenting Petitioner’s later medical visits to be unpersuasive for the same
reason. See e.g., Ex. 7 at 60. Ex. 8 at 6. Ex. 13 at 18.
26
existed at that time. Petitioner first mentioned shoulder pain to a medical provider on November
22, 2016, approximately 50 days after vaccination.
Ultimately, for the reasons discussed in this decision, I find there is not preponderant
evidence to support the onset of shoulder pain within 48 hours of vaccination. Instead,
preponderant evidence supports that Petitioner developed shoulder pain sometime between
November 4 and November 21, 2016, between 32 and 49 days after her October 3, 2016 flu
vaccine.
3. Pain and Reduced Range of Motion are not Limited to the Left Shoulder
Petitioner has not presented preponderant evidence that her “pain and reduced range of
motion are limited to the shoulder in which the intramuscular vaccine was administered” as
required by the QAI for SIRVA. 42 C.F.R. § 100.3(c)(10).
The medical records consistently document that Petitioner’s pain radiated from her
shoulder down her arm. See Ex. 2 at 13 (medical visit from November 22, 2016 documenting that
Petitioner’s pain radiated “from the le[ft] shoulder down into [the] forearm.”); Ex. 7 at 56
(appointment with orthopedist who noted Petitioner “has had shooting pain radiate from her
anterior shoulder down her forearm.”); Ex. 7 at 60 (physical therapy appointment which
documented that Petitioner “developed left shoulder pain … which goes down arm.”); Ex. 8 at 6
(appointment with orthopedist who documented “for the past 5 months, [Petitioner] has had
shooting pain radiate from her anterior shoulder down her forearm.”). Because Petitioner’s pain is
not limited to her shoulder, she does not meet this element required to establish a Table injury.
4. Petitioner has Other Conditions that Explain her Symptoms
I have conducted a thorough analysis of Petitioner’s other conditions in my discussion of
the second Althen prong. Ultimately, I find there is no reason to conclude that Petitioner’s shoulder
pain is separate and distinct from these other conditions.
Although Petitioner has presented preponderant evidence that she had no history of pain,
inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration
that would explain her signs and symptoms of left shoulder pain, she has not preponderantly
demonstrated that her pain began within 48 hours of vaccine administration, that her reduced range
of motion is limited to her left shoulder, or that she has no other condition or abnormality that
would explain her symptoms. Accordingly, she has not established the elements of a Table Injury.
B. Causation in Fact
Even though Petitioner has not demonstrated that she suffered from a Table Injury, she
may still be entitled to compensation if she can establish each element of the three part Althen test.
1. Althen Prong One
Under Althen’s first prong, the causation theory must relate to the alleged injury. Petitioner
27
must provide a “reputable” medical or scientific explanation, demonstrating that the vaccines
received can cause the type of injury alleged. Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d
1352, 1355-56 (Fed. Cir. 2006). The theory must be based on a “sound and reliable medical or
scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir.
1994). It must only be “legally probable, not medically or scientifically certain.” Id. at 549.
There is little question that a vaccine (to include the flu vaccine) can cause a SIRVA. The
Vaccine Injury Table indicates that a SIRVA can be presumed to be caused by the flu vaccine if
certain criteria are met. The Court of Federal Claims has noted that the existence of a Table injury
can help a petitioner to meet Althen’s first prong. See Doe 21 v. Sec'y of Health & Hum. Servs., 88
Fed. Cl. 178, 199 (2009), rev’d on other grounds, 527 Fed. Appx. 875 (Fed. Cir.
2013) (determining that a petitioner fulfilled Althen prong one, in part, because “the Table
recognizes that a vaccine containing pertussis can cause encephalopathy[ ]”). Additionally, the
Court of Federal Claims indicated that “a medical theory causally connecting” a given vaccine and
a given injury that has been “well recognized by the Office of Special Masters[ ]” can support a
petitioner’s fulfillment of the first prong. See id. Special masters have previously taken judicial
notice that the Table links SIRVA to certain vaccines and have also found that “there is a well-
established track record of awards of compensation for SIRVA being made on a cause-in-fact basis
in this program.” See, e.g., Porcello v. Sec’y of Health & Hum. Servs., No. 17-1255V, 2020 WL
4725507 at *6 (Fed. Cl. Spec. Mstr. June 22, 2020).
Dr. Natanzi opined that the overpenetration of the vaccine needle into the upper portion of
the deltoid can cause an inflammatory response leading to adhesive capsulitis. First Natanzi Rep.
at 11. This opinion is supported by the medical literature filed in this case. See e.g., Cross et al.,
Don’t aim too high: Avoiding shoulder injury related to vaccine administration, 45 AFP 5, 303-
06 (2016) (filed as Ex. 24); Bodor & Montalvo, Vaccination-related shoulder dysfunction, 25
VACCINE, 585-87 (2007) (filed as Ex. 25); Degreef & Debeer, Post-vaccination Frozen Shoulder
Syndrome. Report of 3 Cases, 112 ACTA CHIR BELG, 447-49 (2012) (filed as Ex. 28). I find this
theory to be sound and reliable. Accordingly, Petitioner has presented preponderant evidence in
support of the first Althen prong.
2. Althen Prong Two
Under Althen’s second prong, a petitioner must “prove a logical sequence of cause and
effect showing that the vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. The
sequence of cause and effect must be “'logical' and legally probable, not medically or scientifically
certain.” Id. A petitioner is not required to show “epidemiologic studies, rechallenge, the presence
of pathological markers or genetic disposition, or general acceptance in the scientific or medical
communities to establish a logical sequence of cause and effect.” Id. (omitting internal citations).
Capizzano, 440 F.3d at 1325. Instead, circumstantial evidence and reliable medical opinions may
be sufficient to satisfy the second Althen prong.
The evidence in this case suggests that Petitioner’s shoulder pain was likely caused by
28
either her uncontrolled diabetes or osteoarthritis of the left shoulder. 11 The existence of these other
medical conditions reduces the persuasiveness of Petitioner’s showing that the vaccine “did cause”
her condition. See K.L. v. Sec’y of Health & Hum. Servs., 134 Fed. Cl. 579, 598 (Fed. Cl. 2017)
(“regardless of whether the burden of proof ever shifts to the respondent, the special master may
consider the evidence presented by the respondent in determining whether the petitioner has
established a prima facie case”) (internal citations omitted).
a. Diabetes Mellitus
It is uncontested that Petitioner has a significant medical history of uncontrolled diabetes.
As Dr. Abrams noted in his report, Petitioner’s A1c 12 and blood sugar values in the years prior to
vaccination were severely elevated and included the following: A1c of 15.0% on September 26,
2012 (Ex. 2 at 205); blood glucose of 521 on July 15, 2013 (Ex. 2 at 96); A1c of 10.65% on March
27, 2014 (Ex. 2 at 140); A1c of 10.6% on May 8, 2015 (Ex. 2 at 130); A1c of 10.6% on October
3, 2016 (Ex. 2 at 113). A normal A1c range is 4.50-5.70. Ex. 2 at 140.
As Dr. Abrams noted in his first expert report, “There is a significant and profound effect
of the petitioner’s diagnosis of uncontrolled diabetes (and subsequent predisposition to
inflammation and shoulder pathology) on the overall pain, function, and structure of her shoulder.”
First Abrams Rep. at 6. This position is supported by the medical literature.
Diabetes is the “single greatest risk factor” for the development of adhesive capsulitis. First
Abrams Rep. at 6; citing Jason Ramirez, Adhesive Capsulitis: Diagnosis and Management, 99 AM
FAM PHYSICIAN 5, 297-300 (2019) (filed as Ex. A, Tab 1) (hereinafter “Ramirez”); Redler &
Dennis, Treatment of Adhesive Capsulitis of the Shoulder, 27 J AM ACAD ORTHOP SURG, e544-54
(2019) (filed as Ex. A, Tab 2). The Ramirez article described a 2016 study, which concluded that
patients with diabetes “were five times more likely than the control group to have adhesive
capsulitis.” Ramirez at 297. Additionally, Shah et al., noted that 63% of a group of participants
with type 2 diabetes had shoulder pain or disability. Shah et al., Upper extremity impairments, pain
and disability in patients with diabetes mellitus, 101 PHYSIOTHERAPY 2, 147-54 (2015) (filed as
Ex. C, Tab 1).
Dr. Abrams described the biological process at play. He opined that “hyperglycemia
permanently alters tissue macromolecules through accelerated advanced glycation end-products
(AGEs) formation.” First Abrams Rep. at 7; citing Michael Brownlee, Glycation Products and the
Pathogenesis of Diabetic Complications, 15 DIABETES CARE 12, 1835-43 (1992) (filed as Ex. A,
11
I have not assessed whether Respondent has established alternate causation by preponderant evidence,
and instead have considered this evidence in so much as it reduces the strength of Petitioner’s Althen prong
two showing.
12
“The A1C test is a blood test that provides information about your average levels of blood glucose, also
called blood sugar, over the past 3 months. The A1C test can be used to diagnose type 2
diabetes and prediabetes. The A1C test is also the primary test used for diabetes management.” The A1C
Test & Diabetes, NIH, National Institute of Diabetes and Digestive and Kidney Diseases,
www.niddk.nih.gov/health-information/diagnostic-tests/a1c-test (last accessed Sept. 8, 2022).
29
Tab 6); Brownlee et al., Advanced Glycosylation End Products in Tissue and the Biochemical
Basis of Diabetic Complications, 318 N ENGL J MED. 20, 1315-21 (1988) (filed as Ex. A, Tab 7).
Dr. Abrams noted that AGEs have been found in cases of adhesive capsulitis. First Abrams Rep.
at 7; citing Hwang et al., Advanced glycation end products in idiopathic frozen shoulders, 25 J
SHOULDER ELBOW SURG. 6, 981-88 (2016) (filed as Ex. A, Tab 4). “Clinically, these factors change
the biological properties of the shoulder joint capsule to decrease its elasticity.” First Abrams Rep.
at 7; citing Wu et al., Elasticity of the Coracohumeral Ligament in Patients with Adhesive
Capsulitis of the Shoulder, 278 RADIOLOGY 2, 458-64 (2016) (filed as Ex. A, Tab 8).
In fact, Dr. Natanzi accepted this point in his expert report. He stated: “It is undeniable that
Ms. Nicholson has a history of uncontrolled DM. It is also equally undeniable that those with DM
and especially uncontrolled DM have an increased chance of developing adhesive capsulitis
(AC).” Second Natanzi Rep. at 1. 13 He went on to note that the Chan article stated that “for each
unit that the HbA1c level was greater than 7, the risk of developing AC increased 2.7%.” 14 Id. He
then concluded as follows:
Ms. Nicholson’s HbA1c in October 2016 was around 10.6%. Using this general
formula, the chance of Ms. Nicholson spontaneously developing AC related to DM
is approximately 20 – 46%. As such, mathematically, even in light of her
uncontrolled DM it is more likely than not that DM mediated AC does not develop.
In other words, just because on[e] may have DM or even uncontrolled DM - it may
increase your chance but does not guarantee development of DM mediated AC.
Id. As noted, Dr. Abrams disagreed and opined that because the risk of developing adhesive
capsulitis is cumulative over time, Petitioner’s risk was higher than 20-46%. Second Abrams Rep.
at 1-2.
Ultimately, it is clear that patients with uncontrolled diabetes have an increased risk of
developing adhesive capsulitis, and that Petitioner’s diabetes was uncontrolled for years before
she developed adhesive capsulitis. As such, a preponderance of the evidence demonstrates that
13
Petitioner also acknowledged this point in her brief. She stated: “Petitioner concedes that the prior history
of diabetes, and the worsening of symptoms from diabetes in the 18 months leading up to vaccination,
clearly do present a strong risk factor for Petitioner’s shoulder injury.” Pet’r’s Mot. at 27. Petitioner argues,
however, that this clinical picture “created a situation ripe for immune dysregulation” and that the vaccine
Petitioner received was a substantial causal factor in her development of a shoulder injury. Id. However,
this position is not persuasive. Petitioner has not presented any evidence that this happened in her case. In
fact, my findings that her pain began between 32 and 49 days after vaccination strongly suggests that this
theory is inapplicable to the specific facts of Petitioner’s case.
14
Petitioner never filed this article into the record, so I am unable to assess the merit of Dr. Natanzi’s
position. I do note that Dr. Abrams disagreed with this interpretation of the Chan article. See Second Abrams
Rep. at 1-2.
30
Petitioner’s uncontrolled diabetes is a likely explanation for her development of adhesive
capsulitis.
b. Osteoarthritis
Dr. Abrams noted that “[s]houlder arthritis in another leading cause of shoulder pain in the
general population.” First Abrams Rep. at 8; citing Millet et al., Shoulder Osteoarthritis: Diagnosis
and Management, 78 AM FAM PHYSICIAN 5, 605-11 (2008) (filed as Ex. A, Tab 10). Dr. Natanzi
acknowledged that “OA and SIRVA both present with shoulder pain and limited range of motion;
therefore, they can be challenging to distinguish based on physical exam alone.” Second Natanzi
Rep. at 2.
However, Petitioner did not only have a physical exam. Petitioner had an x-ray of her left
shoulder on December 14, 2016 which demonstrated “[j]oint space narrowing of glenohumeral
and AC joint.” Ex. 7 at 56-57. Dr. Abrams opined that these x-ray results demonstrate that
Petitioner has arthritis of the left shoulder, which he described as “a well known source of waxing
and waning shoulder pain.” First Abrams Rep. at 5. Accordingly, Petitioner’s osteoarthritis of the
left shoulder is also a condition that explains her shoulder pain.
c. Treating Physicians
I further note that none of Petitioner’s treating doctors linked her vaccination with her
shoulder pain. In fact, Dr. Smithson, Petitioner’s treating orthopedist, noted the following during
Petitioner’s December 14, 2016 medical appointment: “I advised Ms. Nicholson that I do not
believe her symptoms are related to her flu shot.” Ex. 7 at 56.
In weighing evidence, special masters are expected to consider the views of treating
doctors. Capizzano, 440 F.3d at 1326. The views of treating doctors about the appropriate
diagnosis are often persuasive because the doctors have direct experience with the patient whom
they are diagnosing. See McCulloch v. Sec’y of Health & Hum. Servs., No. 09-293V, 2015 WL
3640610, at *20 (Fed. Cl. Spec. Mstr. May 22, 2015). The fact that Dr. Smithson disavowed any
connection between Petitioner’s flu vaccine and her shoulder injury is persuasive evidence that the
vaccine did not play any role in her condition.
For these reasons, Petitioner has failed to establish the second Althen prong by
preponderant evidence.
3. Althen Prong Three
The timing prong contains two parts. First, a petitioner must establish the “timeframe for
which it is medically acceptable to infer causation” and second, she must demonstrate that the
onset of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed.
Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012),
aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013).
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As discussed in the analysis of her Table claim, I find that Petitioner developed shoulder
pain sometime between November 4 and November 21, 2016, between 32 and 49 days after her
October 3, 2016 flu vaccine. Petitioner has presented no persuasive evidence which suggests a
shoulder injury caused by vaccination can develop this long after vaccine administration. In fact,
her medical literature indicates onset of shoulder pain generally occurs within approximately two
days of vaccination. Significantly, Petitioner’s expert did not provide an opinion explaining how
shoulder pain could develop 32-49 days after vaccination.
Other special masters have considered this issue and have determined that a timeline
between vaccination and onset of pain such as the one in the present case does not constitute a
medically acceptable temporal interval. See, Clavio v. Sec’y of Health & Hum. Servs., No. 17-
1179V, 2022 WL 1078175 (Fed. Cl. Spec. Mstr. Feb. 16, 2022) (finding that 59 days between
vaccination and onset of shoulder pain fails to satisfy the third Althen prong); Mack v. Sec’y of
Health & Hum. Servs., No. 15-149V, 2016 WL 5746367 at *8 (Fed. Cl. Spec. Mstr. July 14, 2016)
(finding that a 42 day onset between vaccination and onset of shoulder pain is not a medically
acceptable timeframe to infer causation in a SIRVA case). C.C. v. Sec’y of Health & Hum. Servs.,
No. 17-708V, 2021 WL 2182817 at *20, 23 (Fed. Cl. Spec. Mstr. Mar. 31, 2021) (concluding that
a one week onset in a SIRVA case was not medically appropriate given the theory of causation).
For these reasons, I find that Petitioner has not presented preponderant evidence in support
of the third Althen prong.
VII. Conclusion
Upon careful evaluation of all the evidence submitted in this matter, including the medical
records, medical literature, the affidavits, as well as the experts’ opinions, I conclude that Petitioner
has not shown by preponderant evidence that she is entitled to compensation under the Vaccine
Act. Her petition is therefore DISMISSED. The clerk shall enter judgment accordingly. 15
IT IS SO ORDERED.
s/ Katherine E. Oler
Katherine E. Oler
Special Master
15
Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly
or separately) a notice renouncing their right to seek review.
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