Lang v. Secretary of Health and Human Services ( 2021 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-995V
Filed: December 11, 2020
PUBLISHED
CHERI LANG, Special Master Horner
Petitioner, Table Injury; Shoulder Injury
v. Related to Vaccine
Administration (SIRVA);
SECRETARY OF HEALTH AND Influenza Vaccine
HUMAN SERVICES,
Respondent.
Leah Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for petitioner.
Colleen Clemons Hartley, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT 1
On July 24, 2017, petitioner, Cheri Lang, filed a petition under the National
Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10-34 (2018) 2 (“the Act” or “the
program”). (ECF No. 1.) Petitioner alleges that she suffered a Table Injury of shoulder
injury related to vaccine administration (“SIRVA”), resulting from an influenza (“flu”)
vaccine she received on October 11, 2016. (Id.) For the reasons set forth below, I find
that petitioner is entitled to compensation for a Table Injury of SIRVA.
I. Procedural History
Petitioner filed her petition on July 24, 2017. (ECF No. 1.) The case was initially
assigned to the Special Processing Unit. (ECF No. 4.) Petitioner filed medical records
between August 7, 2017 and March 13, 2019. (ECF Nos. 7, 12, 14, 19, 24, 25, 27, 36,
1
Because this decision contains a reasoned explanation for the special master’s action in this case, it will
be posted on the United States Court of Federal Claims’ website in accordance with the E-Government
Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the decision will be available to anyone with access to the
Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information the disclosure of which would constitute an unwarranted invasion of privacy.
If the special master, upon review, agrees that the identified material fits within this definition, it will be
redacted from public access.
2
Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.
§ 300aa-10-34.
1
47, 48.) Respondent filed his Rule 4 Report on May 30, 2019, identifying additional
outstanding records, but also recommending against compensation. (ECF No. 53.)
Petitioner’s outstanding medical records were filed on September 11, 2019. (ECF No.
58.) Petitioner later filed an expert report by Dr. Lesley J. Anderson on November 8,
2019. (ECF Nos. 59, 60.) This case was subsequently assigned to my docket on
January 14, 2020. (ECF No. 63.)
Respondent filed an expert report by Dr. Jennifer Winell on March 23, 2020.
(ECF Nos. 66.) Petitioner filed a supplemental expert report by Dr. Uma Srikumaran on
April 27, 2020. (ECF No. 68.) On May 14, 2020, respondent filed a supplemental
expert report by Dr. Winell. (ECF No. 71.) Petitioner’s final supplemental expert report
from Dr. Srikumaran was filed on June 8, 2020. (ECF No. 72.)
On July 8, 2020, the parties advised that, despite prior efforts, they are unable to
resolve the case informally. (ECF No. 73.) I advised that I intend to resolve the issue of
entitlement in this case on the written record and directed the parties to file briefs in
support of their respective positions. (ECF No. 74.) Respondent filed his brief on
September 14, 2020. (ECF No. 76.) Petitioner filed her initial brief on September 17,
2020, and a reply to respondent’s brief on October 19, 2020. (ECF Nos. 81, 84.)
Upon my review, the parties have had a full and fair opportunity to present their
cases and it is appropriate to resolve this case without a hearing. See Vaccine Rule
8(d); Vaccine Rule 3(b)(2); Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d
1362, 1366 (Fed. Cir. 2020) (noting that “special masters must determine that the
record is comprehensive and fully developed before ruling on the record.”).
Accordingly, this case is now ripe for a ruling on the record.
II. Factual History
a. As reflected in petitioner’s medical records
Prior to her October 11, 2016 vaccination, petitioner was a relatively healthy 45-
year old woman with no significant medical history. She was capable of lifting over fifty
pounds, and had received the flu vaccine for years without issue. (Ex. 2, p. 6.) On
October 11, 2016, petitioner received a flu vaccine at her place of employment, Dawn
Food Products. (Ex. 1, p. 1.)
Petitioner presented to Dr. Rebecca Kelley at SSM Family Healthcare (“SSM”) on
December 28, 2016. (Ex. 2, p. 5.) Petitioner’s chief complaint was “pain in her right
deltoid.” (Id.) She reported that she had experienced this pain “since receiving flu shot
on 10-11-16” and that her “pain is worse if [she] raises the arm.” (Id.) Petitioner
described her pain as gradually worsening, dull, and constant. (Id. at 6.) Petitioner
reported that her pain was 2/10 while resting, and 6/10 when raising her arm. (Id.) Dr.
Kelley noted that petitioner’s symptoms were “in her upper arm near the shoulder joint,”
while gesturing to her acromioclavicular (“AC”) joint. (Id. at 7.) Dr. Kelley’s exam
revealed decreased abduction, flexion, extension, internal rotation, and external rotation
2
in petitioner’s right shoulder. (Ex. 2, p. 8.) Although petitioner reported pain in her right
shoulder, her muscle strength was only somewhat diminished, showing 4/5 strength in
her flexion, extension, adduction, abduction, external rotation, and internal rotation, and
5/5 strength in her scapula elevation, retraction, and protraction. (Id.) Petitioner’s
supraspinatus and impingement tests were both positive. (Id.) Dr. Kelley diagnosed
petitioner with SIRVA and ordered shoulder x-rays with a potential MRI pending the x-
ray results. 3 (Id. at 9.) Petitioner’s shoulder x-ray was negative. (Id.)
Following her initial visit to SSM, petitioner filed a VAERS report on January 12,
2017. (Ex. 23, pp. 7-11.) Petitioner was next seen by radiologist Dr. George Cyriac for
an MRI at St. Mary’s Hospital on January 16, 2017. (Ex. 4, p. 19.) Petitioner’s MRI
revealed a mild interstitial tear and small subchondral cyst in the humeral head, but
nothing remarkable in her AC joint. (Id.)
On January 19, 2017, petitioner was evaluated for physical therapy at Peak Sport
and Spine. (Ex. 3, p. 7.) During this evaluation, petitioner again reported that her
shoulder pain began immediately after her flu vaccination. (Id.) She described her pain
as 2/10 at best and 7/10 at worst. (Id. at 7, 8.) Petitioner was scheduled for four weeks
of physical therapy with two sessions per week. (Id. at 9.) By January 24, 2017,
petitioner indicated that she was improving, and by February 14, she was tolerating her
physical therapy without pain or difficulty. (Id. at 12, 28.)
Petitioner received an orthopedic evaluation at SSM from Nurse Practitioner
(“NP”) Carrie Lucas and Dr. Richard White on February 21, 2017. (Ex. 6, p. 1.) During
this evaluation, petitioner reported that her physical therapy had “helped a little,” but that
she still experienced daily pain, specifically when lifting. (Id.) Petitioner exam revealed
tenderness to palpation over her lateral shoulder with a “deep pain,” mild tenderness of
the AC joint and biceps tendon, full active range of motion, pain with abduction, normal
strength, and a positive impingement test. (Id. at 2.) Reviewing petitioner’s MRI, NP
Lucas noted a subtle abnormality in the supraspinatus consistent with tendinopathy and
in the humeral head consistent with impingement. (Id.) Petitioner was diagnosed with
rotator cuff impingement syndrome and received a steroid injection in her subacromial
space. (Id. at 3.)
Petitioner was again seen by NP Lucas on April 4, 2017. (Id. at 10.) During this
visit petitioner reported that the steroid injection she received during her previous visit
reduced her pain for approximately two weeks, but that it had since returned. (Id.)
Petitioner reported that she had pain even at rest, but no pain past her elbow, no
numbness, and occasional neck stiffness related to the way she postured her shoulder
to account for her pain. (Id.) Petitioner showed full range of motion and did not appear
3
Interestingly, respondent argues that because SIRVA is a concept developed “by administrative
rulemaking” it cannot serve as the basis for a cause-in-fact claim in lieu of the diagnosis of a specific
shoulder injury. (ECF No. 76, n.18.) As noted here, petitioner’s medical records show that at least one of
her physicians specifically used the term SIRVA in her assessment. (Ex. 2, p. 9.) This may suggest that,
regardless of its origin, the SIRVA concept is beginning to make inroads into the medical lexicon as a
diagnostic entity. However, since this claim does resolve on the basis of the Vaccine Injury Table it is not
necessary to reach that question.
3
to have tenderness to palpation at the AC joint, but did show tenderness in the bicipital
groove. (Id.) NP Lucas noted that physical therapy, home exercises, and subacromial
steroid injections all failed to resolve petitioner’s pain and scheduled an MRI arthrogram
to evaluate for a labral pathology. (Id. at 11.)
Petitioner received an MRI arthrogram on April 14, 2017, which showed no
rotator cuff tears, mild increased signal in the supraspinatus consistent with tendinosis,
minimal fluid in the subacromial and subdeltoid bursa, mild deformity of the superior
labrum, and a small subchondral cyst near the supraspinatus insertion. (Ex. 4, p. 42.) It
was noted that it was uncertain whether petitioner’s mild labrum deformity was due to a
“normal variation” or labral injury. (Id.)
Petitioner returned to Peak Sport and Spine for her final appointment on April 14,
2017. (Ex. 3, p. 33.) During this visit, petitioner reported that her pain had decreased to
a 2/10 at worst, and that she was able to perform daily activities and work activities with
little or no pain. Petitioner’s discharge assessment noted that she exhibited “an
excellent prognosis at time of discharge from skilled rehabilitative therapy in conjunction
with a home exercise program.” (Id.)
On April 18, 2017, petitioner returned to NP Lucas and Dr. White reporting the
same symptoms that she had on April 14, now with occasional pain in her right shoulder
radiating to her neck and right elbow. (Ex. 6, p. 12.) NP Lucas noted that petitioner’s
prior MRI arthrogram demonstrated “some supraspinatus tendinopathy and some cystic
changes of the humeral head consistent with impingement.” (Id.) There were “no
obvious findings” in petitioner’s right shoulder, but NP Lucas did note that “[t]here are
symptoms that point to her cervical spine as the source of her pathology.” (Id.) NP
Lucas ordered cervical spine x-rays to evaluate a possible spinal pathology for
petitioner’s injury; however, no such x-ray report is included in petitioner’s records. (Id.)
Petitioner was seen on April 27, 2017 by orthopedic surgeon Dr. Tameem
Yehyawi of Columbia Orthopedic Group. (Ex. 5, p. 7.) Petitioner again reported that
onset of her pain began immediately after receiving the flu shot in October 2016. (Id.)
She explained to Dr. Yehyawi the medical treatment she had received up to that point
and indicated that she did not believe the steroids or physical therapy had worked due
to the fact that her pain persisted. (Id.) Petitioner described her pain as a “constant dull
ache that feels deep within the joint.” (Id.) Dr. Yehyawi noted some localization of
petitioner’s pain over the lateral aspect of her shoulder that worsened with overhead
activity and external rotation. (Id.) Petitioner denied any weakness, stiffness,
numbness, or paresthesias. (Id.) During this exam, petitioner described her pain as
4/10 and characterized the sensation as aching and shooting. (Ex. 5, p. 7-8.) Dr.
Yehyawi noted that petitioner had “an excellent range of motion” but showed painful
Hawkins and Neer impingement tests. (Id. at 8.) Dr. Yehyawi believed that the majority
of petitioner’s pain was coming from her rotator cuff and bursitis that was “triggered by a
flu shot with inflammation there.” (Id. at 9.) Dr. Yehyawi believed that, due to the failure
of other conservative treatments, surgery was the best option for petitioner. (Id.)
4
Petitioner received arthroscopic shoulder surgery including rotator cuff
debridement, subacromial decompression with acromioplasty, labrum debridement, and
a bursectomy on June 19, 2017. (Ex. 7, pp. 1, 4.) Dr. Yehyawi’s operative report notes
a degenerative right shoulder partial-thickness supraspinatus rotator cuff tear,
subacromial impingement, and a degenerative superior labrum tear, anterior to
posterior. (Id. at 1.) Following the surgery, Dr. Yehyawi recorded in addition to his
initial diagnosis findings of “anterolateral acromial spurring and CA ligament fraying and
bursitis of the subacromial space suggestive of impingement . . . .” (Id. at 2.)
On a June 29 follow-up, Dr. Yehyawi again noted that petitioner’s October 2016
flu vaccine “very likely could’ve caused an inflammatory response in the tendon and the
bursa that persisted . . . .” (Id.) Following her surgery, petitioner began a new round of
physical therapy on July 5, 2017 with therapist Calvin Canine at Peak Sport and Spine.
(Ex. 28, p. 5.)
On July 25, 2017, petitioner was again seen by Dr. Yehyawi, and reported that
physical therapy had mildly improved her range of motion, but that her lateral shoulder
discomfort persisted. (Ex. 11, p. 1.) Dr. Yehyawi believed that this would resolve with
time. (Id.) Petitioner completed her post-operation physical therapy on August 30,
2017. (Ex. 28, p. 53.) Petitioner’s final physical therapy record notes that she was able
to tolerate all exercises with mild pain and recommended continued home exercise. (Id.
at 51.)
Petitioner saw Dr. Yehyawi for several post-surgery follow-up exams between
September and December of 2017. (Ex. 13, p. 1, 2-3, 4-5, 6-8.) On September 5, Dr.
Yehyawi observed that petitioner only felt pain at the extremes of flexion and abduction,
but was otherwise pain free. (Id. at 1.) On October 17, petitioner reported that her pain
was improving and that she was making progress, but still experienced some pain with
certain movements. (Id. at 2.) Dr. Yehyawi administered a cortisone injection into
petitioner’s subacromial space without complication. (Id. at 3.) On November 21,
petitioner indicated that the October 17 cortisone injection provided temporary relief but
that her pain returned within a week. (Id. at 4.) Dr. Yehyawi noted that petitioner
experienced some pain as a result of her rotator cuff tendinopathy, but believed that the
primary pain she complained of was coming from the AC joint. (Id. at 5-6.) He
recommended an ultrasound-guided AC joint injection for diagnostic and therapeutic
purposes. (Ex. 13, p.6.) Dr. Yehyawi believed that if the injection did not cause any
significant relief, it would mean that petitioner’s discomfort was due to her rotator cuff
tendinopathy. (Id.) Petitioner received this injection from Dr. Farmer on November 29,
2017. (Ex. 26, pp. 4-6.) Petitioner’s final post-surgery follow-up with Dr. Yehyawi was
on December 28, 2017. (Ex. 13, p. 6-8.) During this visit, Dr. Yehyawi reported that
petitioner had “developed symptoms over the [AC] joint that were not necessarily
present prior to her first surgery. Her pain is localized there.” (Id. at 7.) Further, Dr.
Yehyawi noted that petitioner’s AC joint injection alleviated her pain for around nine
days, but that it had returned. (Id.) Dr. Yehyawi again felt that the best course of action
was surgery, and petitioner agreed. (Id. at 8.)
5
Petitioner underwent a right shoulder arthroscopy with distal right clavicle
resection on January 29, 2018 to treat “right shoulder [AC] joint arthritis.” (Ex. 14, p. 1.)
On March 13, 2018, Dr. Yehyawi indicated that petitioner had no pain at rest, but that
she may continue to experience occasional soreness due to her mild rotator cuff
tendinopathy. (Ex. 15, p. 3.) On April 24, 2018, petitioner indicated that she was “much
better than before surgery.” (Ex. 20, p. 1.)
Petitioner returned to Dr. Yehyawi on August 2, 2018, complaining of continued
discomfort in her anterolateral shoulder and AC joint. (Ex. 22, p. 1.) Dr. Yehyawi
believed that petitioner was suffering from an AC arthritis flare up and planned for an
ultrasound guided steroid injection. (Id.) Petitioner’s physical examination revealed
decreased range of motion, 130 degrees flexion, and minimal discomfort with Hawkins
and Neer testing. (Id. at 2.) Dr. Yehyawi concluded that petitioner now presented “with
some inflammation potentially from some scar tissue in the [AC] joint with some crepitus
and discomfort there as well as rotator cuff tendinopathy.” (Id. at 2.)
By August 30, 2018, Dr. Yehyawi could no longer explain petitioner’s discomfort.
(Ex. 26, pp. 1-2.) Instead, he ordered anti-inflammatories and an MRI. (Id.) Several
days later, on September 5, 2018, Dr. Yehyawi noted that petitioner still had an
insertional cyst in her infraspinatus. (Id. at 3.) He also believed that petitioner’s
“primary pain generator” was a persistent rotator cuff tendinopathy and some bursitis
that had reformed. (Id.) Dr. Yehyawi’s conclusion notes that petitioner had suffered
“months and months of significant pain and inflammation as she had a flu shot which set
off an inflammatory storm throughout her rotator cuff and significant pain that persisted
for several months.” (Id.) Dr. Yehyawi recommended physical therapy, an MRI, and a
course of anti-inflammatories to manage petitioner’s pain. (Id. at 2.)
Petitioner began another round of physical therapy on September 12, 2018 at
Peak Sport and Spine. (Ex. 27, p. 75.) Although the physical therapist indicated
January 29, 2018 as the date of onset for petitioner’s pain, they also noted “a long
history of initial onset [from] 10-11-16 after a flu shot in the right shoulder. . . .’” (Id.)
Petitioner’s physical therapist noted “popping, crunching with elevation” and some right
shoulder weakness. (Id. at 76-77.)
On December 3, 2018, petitioner was examined by orthopedist Dr. Christopher
Farmer. (Ex. 26, p. 9.) Petitioner’s exam revealed a mildly flared AC joint and mild
rotator cuff tendinopathy. (Id.) He discussed potential treatment options including oral
and injectable medications, therapy, additional imaging, and surgery. (Id. at 10.)
Petitioner chose to receive an injection Autologous Conditioned Plasma into her right
shoulder. (Id.) Petitioner was seen again by Dr. Farmer on December 31, 2018. (Id. at
12.) At that time, Dr. Farmer believed petitioner was suffering from adhesive capsulitis
based on her complaints of stiffness. (Id.) He prescribed an oral steroid and
encouraged continued home exercise. (Id.)
Dr. Farmer followed up with petitioner one month later, on January 31, 2019.
(Ex. 26, p. 14.) Petitioner reported that the oral steroid provided relief for her shoulder
6
pain and that her symptoms had not worsened. (Id.) On April 16, 2019, Dr. Farmer
noted that petitioner had almost full abduction and flexion with a “much better” range of
motion in her right shoulder. (Ex. 29, p. 1.) Petitioner’s internal rotation was mildly
painful, but without weakness. (Id.) Dr. Farmer believed that petitioner was suffering
from a mildly flared AC joint and mild rotator cuff tendinopathy. (Id. at 2.) He
recommended a glenohumeral injection and home exercise. (Id.)
Dr. Farmer saw petitioner for the last time on June 13, 2019. (Ex. 29, p. 4.)
During this visit, he indicated that the only option left to diagnose petitioner’s shoulder
pain was to check for underlying neurogenic causes. (Id.) Consequently, Dr. Farmer
ordered a nerve conduction test which showed no abnormalities. (Id.) He concluded
that petitioner was simply suffering from a chronic impingement syndrome in the AC
joint and that “we may just have to consider her to be at maximal medical improvement.”
(Id.)
Following treatment from Dr. Farmer, petitioner sought another evaluation of her
shoulder, this time from Dr. Matthew Smith. (Ex. 38, p. 1.) Petitioner rated her pain as
a 3/10 at this visit and described it as a “deep aching.” (Id.) She related a medical
history of two shoulder surgeries, and pain following her flu shot. (Id.) Dr. Smith
observed good rotator cuff strength, but deltoid atrophy and mid-arm pain. (Id. at 2.)
Dr. Smith ordered an MRI, which revealed mild infraspinatus and subscapularis
tendinosis and mild glenohumeral osteoarthritis. (Id. at 2, 4.)
Petitioner had an ultrasound-guided right suprascapular nerve block procedure
on November 27, 2019. (Ex. 38, p. 9.) She was seen by Dr. Smith for a follow-up on
December 23, 2019. (Id. at 5.) Petitioner reported that the nerve block did not help her
pain at all. (Id.) Dr. Smith noted that petitioner’s pain was “potentially the result of a
post vaccine inflammatory neuropathy” and referred her to pain management for further
evaluation. (Id.)
Petitioner’s medical record concludes with a report from Dr. Ebby George
Varghese on January 13, 2020. (Ex. 48, p. 1.) Dr. Varghese explained that it is unlikely
petitioner will ever be pain free, prescribed Neurontin, a nerve-pain management drug,
and noted that “her shoulder is not the same shoulder she had prior to her flu shot.” (Id.
at 2-3.) Petitioner has not filed any other medical records.
b. As reflected in the Affidavits
In addition to the above medical records, petitioner filed affidavits of her husband,
sister, and coworker to support her claim. (Exs. 31-33.) She also filed a letter to the
court explaining why she chose to postpone medical treatment for her shoulder. (Ex.
47.) These materials all purport to provide specific recollections that demonstrate
petitioner’s shoulder pain began immediately after her vaccination and in some
instances also seek to explain petitioner’s delay in seeking treatment. Comparing these
written submissions to each other and to the medical records, I do not find any obvious
7
inconsistencies. Nonetheless, for the reasons discussed in section IV(b), below, it is not
necessary to address the specific recollections described.
III. Expert opinions
a. Petitioner’s Initial Expert Report - Dr. Lesley J. Anderson
Petitioner initially filed an expert report by orthopedist Dr. Lesley J. Anderson to
support her claim. 4 (Ex. 34.) Dr. Anderson does not believe petitioner’s condition is
due to arthritis because “arthritis is extremely unlikely to have an acute onset causing
significant pain the day after vaccination with the pain and the new onset of decreased
range of motion requiring treatment for a long period thereafter.” (Ex. 34, p. 3.) Dr.
Anderson notes that petitioner had no history of shoulder issues, onset of pain within 48
hours of vaccination, that petitioner’s primary pain and injury were confined to her right
shoulder, and that there is no evidence of any alternative cause of her pain. (Id.)
Consequently, Dr. Anderson believes that petitioner has satisfied the four elements for a
Table SIRVA. (Id.)
Although petitioner reported pain in her neck and upper arm, she described it as
radiating to those areas from her shoulder. (Id.) Per Dr. Anderson: “[i]t is extremely
common in patients with shoulder impairment . . . to use other muscles . . . to lift their
arm and therefore develop pain in the posterior and lateral neck muscles.” (Id.) In Dr.
Anderson’s experience, roughly 50% of patients with shoulder injuries report pain
radiating to the elbow due to “the anatomy of the subdeltoid bursa which is contiguous
with the subacromial bursa.” (Ex. 34, p. 2.) Dr. Anderson reviewed petitioner’s medical
imaging records and found no alternative explanation for her pain other than an
anatomic shoulder injury. (Id.) Studies have shown a link between shoulder
impingement and neck pain, meaning that petitioner’s neck pain does not rule out the
fact that her injury was confined to her shoulder. (Jerrold M. Gorski & Lawrence H.
Schwartz, Shoulder Impingement Presenting as Neck Pain, 85-A J. OF BONE & J OINT
SURGERY 635 (2003) (Ex. 36).) Dr. Anderson concludes that these facts suggest
petitioner’s condition is consistent with a Table SIRVA. (Ex. 34, p. 3.)
b. Respondent’s Initial Expert Report - Dr. Jennifer Winell
Respondent relied upon the opinion of orthopedist Jennifer Winell, M.D. 5 (Ex. A.)
Dr. Winell concedes that nothing in the record suggests that petitioner had any history
4
Dr. Anderson received her medical degree from Hershey Medical School in 1976 and completed her
residency at UCLA’s Department of Orthopaedic Surgery. (Ex. 35, p. 1.) She is board certified by the
American Board of Orthopedic Surgery. (Id. at 2.) Dr. Anderson currently runs her own practice as an
orthopedic surgeon, specializing in arthroscopy and knee and shoulder surgery. (Id. at 1.) She has
authored fourteen publications and presented over one hundred times on subjects involving arthroscopy,
orthopedics, and diagnosis of various shoulder and knee injuries. (Id. at 3-8.)
5
Dr. Winell received her medical degree from New York University School of Medicine in 1996 and
completed her residency in orthopedic surgery at New York Orthopaedic Hospital in 2007. (Ex. B, p. 1.)
She is board certified by the American Board of Orthopaedic Surgery. (Id.) Dr. Winell is currently
8
of pain or dysfunction affecting her shoulder prior to her vaccination and therefore, she
has met the first element of a SIRVA claim. (Ex. A, p. 5.) However, because petitioner
offered no objective evidence of onset and waited two and a half months to seek
treatment for her injury, Dr. Winell believes that petitioner has failed to establish onset of
pain within 48 hours. (Id.) Dr. Winell also suggests that, although the record fails to
rule out that petitioner’s pain was confined to her shoulder, it likewise fails to confirm
that fact. (Id. at 5.) According to Dr. Winell, it is possible petitioner was suffering from
an alternative pathology because her initial orthopedist suspected her symptoms
caused by a cervical spine issue. (Id.) Additionally, Dr. Winell notes several underlying
degenerative conditions that could cause petitioner’s injury including a “degenerative
tear of the superior labrum, [a] partial thickness articular sided tear of [the]
supraspinatus tendon, anterolateral acromial spurring, and CA ligament fraying.” (Id.)
According to Dr. Winell, “these are well known common causes of shoulder pathology
cited in hundreds of scientific papers regarding shoulder impingement and were
documented by Dr. Yehyawi in his operative report.” (Ex. A, p. 6.)
Dr. Winell believes that the subacromial bursitis noted in Dr. Yehyawi’s operative
report “likely resulted from an anatomic degenerative pathology rather than an
unintentional injection of the subacromial space.” (Id. at 6.) This is because, according
to Dr. Winell, “if there was only bursitis of the subacromial space from an inflammatory
reaction to the injection, then one could expect improvement from a bursectomy alone.”
(Id.) However, because petitioner’s surgeon “chose to also address the abnormal
anatomic pathology that was found intra-operatively,” it follows that the surgeon
believed petitioner’s pain was caused by the anatomic degeneration. (Id.) Because
neither of these operations alleviated petitioner’s pain, and even required additional
surgeries, Dr. Winell believes that petitioner suffered from an anatomic degenerative
process and not SIRVA. (Id.)
c. Petitioner’s Supplemental Expert Report - Dr. Uma Srikumaran
Petitioner later filed a supplemental report by shoulder specialist Uma
Srikumaran, M.D., M.B.A., M.P.H. 6 (Ex. 39.) Dr. Srikumaran agrees with Dr. Anderson
that patients with shoulder injuries will often develop neck pain when they use other
muscles to account for their lack of shoulder function. (Ex. 39, p. 8.) He suggests this
is the case with petitioner, considering the fact that her April 4, 2017 medical records
specifically state that she suffers occasional neck pain because of “the way she
postures her shoulder due to the pain.” (Id.) Dr. Srikumaran notes, petitioner’s pain
employed by the University of Pennsylvania – School of Medicine. (Id.) She has published several peer
reviewed reports on pediatric orthopedics, and several chapters in pediatric textbooks. (Id. at 4.)
6
Dr. Srikumaran received his medical degree from Johns Hopkins University School of Medicine in 2005
and completed his residency in orthopedic surgery at Johns Hopkins Hospital in 2010. (Ex. 40, p. 1.)
He is board certified by the American Board of Orthopaedic Surgery. (Ex. 39, p. 1.) Dr. Srikumaran is
currently Chair of the Department of Orthopaedic Surgery at Howard County General Hospital and an
attending physician at Johns Hopkins Hospital in Bayview Medical Center at Howard County General
Hospital. (Ex. 40, p. 1.) He has published over one hundred articles, reports, chapters, and editorials on
orthopedics and shoulder injuries. (Id. at 2-6.)
9
stopped at her elbow and that her nerve conduction test ruled out any cervical spine
issues. (Id.) Further, petitioner experienced substantial pain relief following
subacromial cortisone and steroid injections which suggests that her pain was
anatomical and not neurologic. (Id.) Based on these facts, Dr. Srikumaran concludes
that petitioner’s injury was confined to her shoulder and that her neck and arm pain
were secondary to that injury. (Id.)
Dr. Srikumaran disagrees with the suggestion that AC joint arthritis is a more
likely explanation of petitioner’s symptoms. (Ex. 39, p.8.) He explains that neither the
medical records nor the timeline of events supports this conclusion. (Id.) According to
Dr. Srikumaran, AC joint arthritis would not be so acute following a vaccination, nor
would it be expected to cause the substantial loss of shoulder function that petitioner
experienced. (Id.) Dr. Srikumaran notes that petitioner’s primary care physician and
two orthopedic surgeons each diagnosed petitioner with either general SIRVA, rotator
cuff impingement, rotator tendinopathy, subacromial impingement, or bursitis, which are
“all diagnoses consistent with SRIVA.” (Id.) He believes that the AC joint pain petitioner
experienced was likely a result of diffuse inflammation of the AC joint which can be
triggered by vaccinations. (Id.) Dr. Srikumaran opines that Dr. Winell’s conclusion that
petitioner’s condition was most likely due to a degenerative condition is “not logical and
directly refuted by the operative surgeon as he believed . . . the bursitis was triggered by
a flu shot [causing inflammation].” (Id.) Dr. Srikumaran explains that petitioner had no
history of shoulder issues, and that her anatomy could not suddenly change within 48
hours to cause her shoulder pain. (Ex. 39, p. 8.) Consequently, Dr. Srikumaran
believes that petitioner’s vaccination was a clear trigger causing an inflammatory
response involving the AC joint. (Id.)
Dr. Srikumaran also questions the significance of the fact that petitioner’s pain
did not resolve after her first surgery. (Id.) He notes that petitioner’s general shoulder
pain substantially improved after her first surgery, and that it only persisted in her AC
joint. (Ex. 39, p. 9.) According to Dr. Srikumaran, petitioner’s initial surgery
substantially improved her lateral shoulder pain while the subsequent surgery improved
her AC joint pain. Dr. Srikumaran explains that this is not unusual and, in fact,
appropriate care. (Id.) He ultimately concludes that based on the above analysis,
petitioner’s pain cannot be explained by a degenerative process, and is much more
likely a result of an inflammatory response caused by petitioner’s flu vaccination. (Id.)
d. Respondent’s Supplemental Expert Report – Dr. Jennifer Winell
In response to Dr. Srikumaran’s opinion, Dr. Winell notes that petitioner’s MRI
findings show a shoulder pathology caused by a degenerative condition; not a vaccine-
mediated immune regulated inflammatory response. (Ex. C, p. 1.) She also reiterates
that because there is no imaging to rule out cervical spine involvement, there remains a
possibility that petitioner’s pain localized in her neck and referred to her shoulder. (Id.)
Dr. Winell concludes that at best, it is unclear whether petitioner’s primary pain was
localized in her shoulder, and therefore, she cannot prove that she has met this element
of a Table SIRVA. (Id.)
10
In her supplemental report, Dr. Winell clarifies that she only opines that petitioner
did not have resolution of her shoulder pain following her initial surgery, and that the
additional surgery was required, which suggests that her pain was the result of an
ongoing degenerative process. (Ex. C, p. 2.) She explains that her only conclusion
regarding AC arthritis was that “petitioner’s AC arthritis would not have been caused by
the vaccine.” (Id.) Instead Dr. Winell indicates that “it was clear that petitioner had
generalized shoulder pain consistent with impingement as well as AC joint pain, both of
which are commonly seen together in this age group and many times addressed with
one surgery.” (Id.)
However, Dr. Winell takes issue with Dr. Srikumaran’s opinion that petitioner’s
vaccination initiated a biological mechanism resulting in petitioner’s AC joint
inflammation. (Id.) She indicates that “it is unclear how an unintentional injection of this
area would cause a synovitis of the AC joint,” because “the subacromial space is
enclosed by the bursa which does not have a direct connection to the synovium of the
AC joint other than being adjacent to it.” (Id.) Dr. Winell also points out that Dr.
Yehyawi’s second report explicitly states that petitioner’s AC joint was “very arthritic with
minimal to no joint space remaining.” (Ex. C, p. 3.) According to Dr. Winell, this finding
does not indicate a “simple synovitis” but instead “almost complete joint obliteration,
consistent with an advanced degenerative process.” (Id.) Dr. Winell stresses that there
are “hundreds of scientific peer reviewed articles in orthopedic literature discussing this
exact pathology as the cause of her type of symptoms, some of which were cited in my
original report.” (Id.) Dr. Winell reiterates that the degenerative condition she cites as
the cause of petitioner’s symptoms is “extremely common in petitioner’s age group.”
(Id.)
Dr. Winell disagrees with Dr. Srikumaran’s assertion that petitioner’s pain
substantially improved after her first surgery. (Id. at 3-4.) She cites several medical
records created after petitioner’s first surgery, each noting that petitioner continued to
suffer some mild pain or discomfort. (Id. at 4 (citing Ex. 7, pp. 1-4; Ex. 7, p. 5; Ex. 11, p.
1; Ex. 13, pp. 2-3).) Dr. Winell suggests that based on this documentation, petitioner’s
pain did not resolve after her surgery. (Ex. C, p. 4.)
e. Petitioner’s Final Expert Report – Dr. Uma Srikumaran
Dr. Srikumaran notes that petitioner’s anatomy did not abruptly change and
degenerate to the extent that it suddenly became painful. (Ex. 46, p. 2.) Based on
petitioner’s medical history and imaging, Dr. Srikumaran believes that petitioner had this
degenerative condition for a significant period of time without pain. Instead, Dr.
Srikumaran suggests that, “[c]onsidering the time course of events, no prior issues with
that shoulder, and objective evidence on MRI of inflammation as well as during surgery
(“extensive bursitis”) noted by the operative surgeon, the most logical and likely cause
was the vaccination eliciting an inflammatory response in the shoulder.” (Id.) Dr.
Srikumaran says that Dr. Winell’s conclusion that the inflammation in petitioner’s
11
shoulder is caused by a degenerative process “completely ignores the time course of
events.” (Id.)
Dr. Srikumaran clarified that he does not believe petitioner’s injection was
directed into the AC joint, but he opines that inflammation from the injection site spread
to the AC joint from the subacromial bursa. (Ex. 46, p. 2.) According to Dr. Srikumaran,
degeneration of AC joint ligaments is common, and when this happens, it makes the
subacromial bursa continuous with the AC joint synovium. (Id.) Thus, Dr. Srikumaran
points out, direct connections of the AC joint to the subacromial space are common in
patients like petitioner who suffer from AC joint arthrosis. (Id.) Dr. Srikumaran explains
that this is consistent with Dr. Winell’s conclusion that petitioner’s AC joint was
“completely obliterated” due to her arthrosis. (Id.) Consequently, Dr. Srikumaran
indicates that Dr. Winell is incorrect to conclude that petitioner could not have
developed a synovitis in her AC joint from inflammation in the subacromial space.
Dr. Srikumaran questions the reliability of the “hundreds of articles” that Dr.
Winell cites to support the theory that abnormal acromial pathology can cause
petitioner’s shoulder pain symptoms. (Ex. 46, p. 2.) According to Dr. Srikumaran, the
articles that Dr. Winell cites “1) do not state abnormal pathology as the only cause of
pain and 2) are refuted by many other articles suggesting acromial morphology does not
play a role in typical shoulder pathology.” (Id.) Dr. Srikumaran points out that the time
course of events suggest that petitioner’s shoulder degeneration was not the cause of
her pain. (Ex. 46, p. 3.) Petitioner’s pain began immediately following the vaccination,
inflammation was observed following her vaccination, and her degeneration was of a
degree that indicates it had been occurred prior to her vaccination. (Id.) There are
many things that can trigger inflammation and cause a pre-existing degenerative
condition to become symptomatic, vaccination is shown to have a “strong, reliably and
consistently, temporal association” with this condition and petitioner was vaccinated
immediately before her pain began. (Id.)
IV. Analysis
In this case, petitioner has alleged a so called “Table Injury.” That is, petitioner
alleges that she suffered an injury of the type enumerated in the “Vaccine Injury Table,”
corresponding to the vaccination in question, within an applicable time period following
the vaccination also specified in the Table. If the presence of a Table Injury is proven, it
is presumed to have been caused by the vaccination. § 300aa-13(a)(1)(A); § 300 aa-
11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).
As relevant here, Vaccine Injury Table lists SIRVA as a compensable injury if it
occurs within 48 hours of administration of a vaccine containing the influenza virus. §
300aa-14(a) as amended by 42 C.F.R. § 100.3(a). The Act’s “Qualifications and aids in
interpretation” (“QAI”) provide specific guidelines used to evaluate Table Injury SIRVA
claims. See 42 C.F.R. § 100.3(c)(10). To be considered a Table “SIRVA,” petitioner
must show: (i) there is “no history of pain, inflammation or dysfunction of the affected
shoulder prior to intramuscular vaccine administration that would explain the alleged
12
signs, symptoms, examination findings, and/or diagnostic studies occurring after
vaccine injection”; (ii) that “onset of pain occurred within the specified timeframe,” i.e.
within 48 hours; (iii) that “pain and reduced range of motion are limited to the shoulder in
which the intramuscular vaccine was administered”; and (iv) that “no other condition or
abnormality is present that would explain the patient's symptoms (e.g. NCS/EMG or
clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other
neuropathy).” 42 C.F.R. § 100.3(a); 42 C.F.R. § 100.3(c)(10).
If petitioner can prove that her alleged injury meets these four elements, she will
be entitled to compensation unless the government can show the injury was caused by
a factor unrelated to vaccination. § 300aa-13(a)(1)(B). Petitioner bears a
“preponderance of the evidence” burden of proof. § 300aa-13(a)(1).
a. No history of pain, inflammation or dysfunction of the affected
shoulder
Nothing in the medical record suggests that petitioner ever had any manifestation
of pain or dysfunction in her right shoulder prior to the vaccination at issue. Respondent
has made no argument on this point, and his expert, Dr. Winell, concedes this element
is met. (Ex. A, p.5.)
b. Pain occurs within the specified timeframe (48 hours)
Based on the record as a whole, I find that there is preponderant evidence that
the onset of petitioner’s shoulder pain was within 48 hours of her October 11, 2016 flu
vaccination. On this point, respondent argues only that:
Petitioner did not seek initial treatment for her right shoulder pain until more
than 11 weeks following the subject vaccination, on December 28, 2016.
Simply, preponderant evidence does not support the onset of petitioner’s
right shoulder complaints within 48 hours of the flu vaccination. Petitioner’s
statement, the affidavits submitted on her behalf, and the sweeping
conclusions of petitioner’s experts do not cure the evidentiary deficiencies
with respect to onset this case.
(ECF No. 76, p. 21 (internal citations omitted).)
However, absent additional factors, respondent’s suggestion that an 11-week
delay in seeking treatment in itself constitutes an evidentiary deficiency is not
persuasive. Respondent’s argument is inconsistent with the Vaccine Act insofar as the
statute instructs that the special master may find the time period for the first symptom or
manifestation of onset required for a Table Injury is satisfied “even though the
occurrence of such symptom or manifestation was not recorded or was incorrectly
recorded as having occurred outside such a period.” §300aa-13(b)(2). Moreover, prior
decisions by myself and other Special Masters have found that postponing treatment for
a limited number of months is not per se dispositive of whether onset of shoulder pain
13
occurred within the specified time period for a SIRVA. See e.g., Forman-Franco v.
Sec’y of Health & Human Servs., No. 15-1479V, 2018 WL 1835203 (Fed. Cl. Spec.
Mstr. Feb. 21, 2018); Tenneson v. Sec’y of Health & Human Servs., No. 16-1664V,
2018 WL 3083140 (Fed Cl. Spec. Mstr. Mar. 30, 2018), mot. rev. denied 142 Fed. Cl.
329 (2019); and Gurney v. Sec’y of Health & Human Servs., No. 17-481V, 2019 WL
2298790 (Fed. Cl. Spec. Mstr. Mar. 19, 2019).
For example, in Williams v. Secretary of Health & Human Services, I found that
the petitioner had established onset within 48 hours even though he had delayed
treatment for his shoulder injury by roughly five months, a period significantly longer
than the delay seen in this case. No. 17-1046V, 2020 WL 3579763, at *2 (Fed. Cl.
Spec. Mstr. Apr. 1, 2020). Typically, when delays in seeking treatment have contributed
to dismissal of prior SIRVA claims, it has been because the contemporaneous medical
records that do exist have otherwise been inconsistent with petitioner’s allegation of
immediate post-vaccination onset. See e.g., Small v. Sec’y of Health & Human Servs.,
No. 15-478V, 2019 WL 6463985, at *11 (Fed. Cl. Spec. Mstr. Nov. 1, 2019); Demitor v.
Sec’y of Health & Human Servs., No. 17-564V, 2019 WL 5688822, at *10 (Fed. Cl.
Spec. Mstr. Oct. 9, 2019).
Here, although the record for petitioner’s December 28, 2016 encounter was
made 11 weeks after her vaccination, it is nonetheless trustworthy as a medical record
contemporaneous to her treatment, having been created to facilitate diagnosis and care
for her shoulder pain. See e.g., Cooper v. Sec’y of Health & Human Servs., No. 16-
1378V, 2018 WL 1835179, at *6 (Fed. Cl. Spec. Mstr. Jan. 18, 2018); see also Cucuras
v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993); Doe v. Sec'y
of Health & Human Servs., 95 Fed. Cl. 598, 608 (2010). The history petitioner provided
at that time is consistent with an immediate post-vaccination onset (Ex. 2, p. 5) and
respondent has not identified any basis for questioning the accuracy and completeness
of the record itself. Moreover, despite her apparent skepticism regarding petitioner’s
own clinical history, respondent’s expert has conceded that there is no such thing as an
“appropriate” time to seek treatment. (Ex. C, p. 1.) Further, all of petitioner’s later
treatment records consistently associate onset to her vaccination. (Ex. 3, p. 7; Ex. 5, p.
7; Ex. 6, p. 1; Ex. 26, p. 7; Ex. 27, p. 75; Ex. 38, p. 1; Ex. 48, p.1) Apart from
petitioner’s initial delay in seeking treatment, respondent has not identified any piece of
evidence on this record that is inconsistent with onset occurring within 48 hours of
vaccination. Accordingly, there is no basis for questioning the time of onset accepted
by the treating physicians in the facially valid medical records.
c. Pain and reduced range of motion confined to the shoulder
With regard to the third SIRVA QAI prong, respondent argues that petitioner’s
injury was not confined to her shoulder based on a suspicion of a cervical etiology for
petitioner’s condition, evidenced by a record by Dr. White as well as petitioner’s
reported pain radiating from her shoulder to her neck and bicep. This is not persuasive.
14
Dr. White only preliminarily considered a possible cervical spine etiology as an
explanation for petitioner’s condition. (Ex. 6, p. 12.) Respondent himself acknowledges
that there was no further follow up or evaluation to suggest a cervical pathology of
petitioner’s condition. (ECF No. 76, p. 21.) Moreover, respondent’s expert
acknowledged that “[w]hile this was one area to explore and rule out, there is little to go
off of here . . .” (Ex. A, p. 5.) Ultimately, she characterized this issue as only
“questionable.” (Id.) In the context of the complete record, including petitioner’s
extensive orthopedic treatment, there is not preponderant evidence on this record that
petitioner suffered any cervical spinal condition. 7 Moreover, there is no evidence of any
reduced range of motion beyond petitioner’s shoulder. Nor are there any objective
findings that suggest any neck, elbow, or other etiology for petitioner’s injury, which was
consistently treated as a shoulder injury.
Additionally, based on the pattern of treatment petitioner received over an
extended period from multiple physicians and the additional opinions of her experts, it
does not appear that petitioner’s subjective report of some radiating pain, without more,
provides any meaningful basis for questioning the etiology of petitioner’s shoulder pain
as stemming from her shoulder injury. Petitioner’s experts persuasively explain that
secondary neck and arm pain often occur in shoulder injuries because patients
compensate for their lack of shoulder function by using their arm and neck muscles to
conduct daily activities or support their injured shoulder. (Ex. 34, p. 2; Ex. 39, p. 8.) In
that regard, petitioner’s medical records do reflect that she related to Dr. White that she
felt her neck pain was related to postural changes due to her shoulder injury. (Ex. 6, p.
10.) Moreover, Dr. White specifically confirmed that petitioner’s pain did not radiate
below the elbow, a point stressed by the experts as distinguishing shoulder pain from
cervical pain. (Ex. 6, p. 15.) Although Dr. Winell interprets petitioner’s medical records
differently, she did not dispute Drs. Anderson’s and Srikumaran’s explanation of the
association between shoulder dysfunction and radiating pain. (Ex. C, pp. 1-2.)
d. No other condition or abnormality explains petitioner’s symptoms
Finally, relying on Dr. Winell’s assessment of petitioner’s presentation,
respondent argues that petitioner’s Table Injury allegation fails because she suffered a
degenerative shoulder condition unrelated to her vaccination that represents a more
likely cause of her pain. Specifically, Dr. Winell opined in her first report that “[t]he
pathology noted on Dr. Yehwahi’s operative reports are indicative of an underlying
degenerative condition. These included: degenerative tear of the superior labrum,
partial thickness articular sided tear of supraspinatus tendon, anterolateral acromial
spurring and CA ligament fraying.” (Ex. A, p. 5.) First, Dr. Winell opined that these
findings are well known causes of shoulder impingement and that they constitute a
more likely explanation of petitioner’s undisputed bursitis than does petitioner’s
vaccination. (Id. at 5-6.) Second, Dr. Winell discussed the acromioclavicular arthritis
7
For the same reasons discussed in this section, a cervical spinal condition also does not constitute a
condition or abnormality explaining petitioner’s symptoms as discussed relative to the fourth SIRVA QAI
prong discussed below.
15
evidenced in Dr. Yehwahi’s operative report and noted that it would not be vaccine-
caused. (Id. at 6.)
However, because SIRVA is by definition an unspecified “injury to the
musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae, etc.)” (see
42 C.F.R. §100.3(c)(10)), respondent does not defeat petitioner’s claim simply by noting
the presence of shoulder dysfunction beyond deltoid bursitis. Although deltoid bursitis
is the specific condition that has been most clearly associated with vaccine-related
shoulder injuries, the QAI definition of SIRVA was specifically drafted to encompass
shoulder dysfunction beyond that condition. 8 Proposed Rulemaking, 2015 WL
4538923, at *45136; See also Gurney v. Sec’y of Health & Human Servs., No.17-481V,
2019 WL 2865490, at *7 (Fed. Cl. Spec. Mstr. Apr. 24, 2019) (finding that “the timing
and course of petitioner’s adhesive capsulitis remains consistent with a post-vaccination
sequela to her SIRVA as described in the [Atanasoff study] and as envisioned by the
rulemaking which created SIRVA as a Table Injury.”). The Atanasoff article relied upon
in creating QAI for SIRVA (and filed in this case as Exhibit 41) in turn states that:
In general, chronic shoulder pain with or without reduced shoulder joint
function can be caused by a number of common conditions including
impingement syndrome, rotator cuff tear, biceps tendonitis, osteoarthritis
and adhesive capsulitis. In many cases these conditions may cause no
symptoms until provoked by trauma or other events. Reilly et al reviewed a
series of shoulder ultrasound and MRI studies obtained in asymptomatic
persons past middle age and found partial or complete rotator cuff tears in
39% of those individuals. Therefore, some of the MRI finding in our case
series, such as rotator cuff tears, may have been present prior to
vaccination and became symptomatic as a result of vaccination-associated
synovial inflammation.
(S. Atanasoff et al., Shoulder Injury Related to Vaccine Administration (SIRVA), 28
VACCINE 8049, 8051 (2010) (Ex. 41, p. 3).)
8
Specifically, respondent’s proposed rulemaking stated in relevant part:
The IOM reviewed the scientific and medical literature f inding evidence that convincingly
supports a causal relationship between vaccine injection (with a needle) into an arm and
deltoid bursitis. The report noted that the published VICP case series (Atanasoff et al.), as
described, were clinically consistent with deltoid bursitis. The VICP case series found that
93 percent of patients had the onset of shoulder pain within 24 hours of vaccine
administration and 54 percent had immediate pain f ollowing vaccine injection. The VICP
case series found several diagnoses, beyond deltoid bursitis, that resulted in shoulder pain
following vaccination, including tendonitis, impingement syndrome, frozen shoulder
syndrome, and adhesive capsulitis. Another case series reported two cases of shoulder
pain, weakness and reduced range of motion following vaccination with onset of symptoms
within 48 hours of vaccination. [Bodor M, Montalvo E, Vaccination related shoulder
dysfunction, Vaccine 25(2007) 585-587.] In order to capture the broader array of potential
injuries, the Secretary proposes to add SIRVA for [certain influenza] vaccines that are
administered intramuscularly through percutaneous injection into the upper arm.
Proposed Rulemaking, 2015 WL 4538923, at *45136 (emphasis added).
16
A further study by Hesse et al., conducted by the Department of Health and
Human Services and Centers for Disease Control, examined the characteristics of 476
SIRVA cases conceded by the government as meeting the regulatory definition of
SIRVA. (Elizabeth M. Hesse et al., Shoulder Injury Related to Vaccine Administration
(SIRVA): Petitioner Claims to the National Injury Compensation Program, 2010-2016,
38 Vaccine 1076 (2020) (Ct. Ex. I).) Consistent with both Atanasoff and the
respondent’s own rulemaking, the Hesse study observed SIRVA alongside or in
connection with degenerative changes, including rotator cuff degeneration and/or
tendinopathy and acromioclavicular arthritis, in a significant number of cases. For
example, among the compensated claims examined, 16.2% had evidence on MRI of
acromioclavicular arthritis, a further 16.2% had labral tears, and over 40% had either
complete or partial rotator cuff tears. 9 (Id. at 5 (Table 5).)
Accordingly, findings consistent with impingement, rotator cuff tears, or AC
arthritis do not per se preclude a finding that a Table SIRVA exists. Rather, the
question raised by respondent’s argument is whether petitioner’s own clinical history
indicates that her shoulder pathology wholly explains her symptoms independent of
vaccination. In that context, Dr. Winell’s opinion that petitioner did not suffer a SIRVA is
far less persuasive. In fact, Dr. Winell’s opinion is actually somewhat unclear in even
asserting the presence of any separate explanation for petitioner’s shoulder pain.
In her supplemental report, Dr. Winell clarified that, although petitioner’s AC
arthritis would not be vaccine caused, she does not opine that AC arthritis is a more
likely explanation for petitioner’s shoulder pain. (Ex. C, p. 2.) Rather, she explained
that “[i]t was clear that petitioner had generalized shoulder pain consistent with
impingement as well as AC joint pain, both of which are commonly seen together in this
age group . . .” (Id.) As explained above, however, to the extent Dr. Winell opines that
petitioner’s specific findings add up to a presentation of impingement syndrome as the
likely cause of her shoulder pain, that condition was explicitly included in respondent’s
regulatory rulemaking as among the conditions intended to fall within the scope of
SIRVA. 2015 WL 4538923, at *45136.
9
Dr. Winell questioned the value of the Hesse study as a piece of medical literature. (Ex. C, p. 4.)
Specifically, she indicated that, while descriptive, studies such as Hesse, et al, are inadequate to assess
causation. (Id.) And, indeed, the Hesse article itself includes a similar disclaimer, indicating that “MRI
f indings in our cases should be interpreted with caution and not be equated with prima facie evidence of a
causally associated injury. Such findings are not uncommon among people in the age group of our
cases, independent of vaccination (i.e., shoulder pathology is common in middle age and old age).”
(Hesse et al., supra, at Ct. Ex. I, p. 6.) In presenting her prima facie case under the Vaccine Injury Table,
however, petitioner does not bear any burden of proving causation generally or to show that her shoulder
pathology can be directly related to her vaccination as causal. It would be incompatible with the very idea
of the Vaccine Injury Table to hold petitioner to a burden of proving causation to establish a Table Injury.
Accordingly, descriptive evidence from this medical literature relating to the nature of prior SIRVA claims
brought in this program need not represent evidence of causation in order to be relevant and valuable. In
any event, Dr. Srikumaran opined that the Hesse study constitutes valuable observational data. (Ex. 46,
p. 3.)
17
Moreover, while it may be true that certain of petitioner’s MRI and surgical
findings can be associated with impingement even in the absence of vaccination, Dr.
Winell appears to somewhat overstate or oversimplify the cause and effect relationship
among these findings in the presentation of impingement syndrome. Impingement
syndrome itself “consists of a spectrum of clinical findings, NOT injury to a specific
structure.” (Stephen M. Simons et al., Shoulder Impingement Syndrome, WOLTERS
KLUWER UPTODATE, https://www.uptodate.com/contents/shoulder-impingement-
syndrome (Dec. 8, 2020) (Ex. A, Tab 1, p. 14 (emphasis original)).) In her first report
Dr. Winell highlighted a report by Harrison and Flatow which found that intrinsic
degeneration, including tearing and fraying of rotator cuff tendons, and extrinsic
compression factors, such as acromial spurs, have been linked to shoulder
impingement syndrome. (Alicia Harrison & Evan Flatow, Subacromial Impingement
Syndrome, 19 J. OF THE AM. ACAD. OF ORTHOPAEDIC SURGEONS 701 (2011) (Ex. A, Tab
5).) However, those authors cautioned that “[t]he relationship between subacromial
impingement and rotator cuff disease in the etiology of rotator cuff injury is a matter of
debate.” (Harrison & Flatow, supra, at Ex. A, Tab 5, p. 1.) They further explained that
“the etiology of rotator cuff disease has long been debated and the cause is likely
multifactorial . . .” (Id. at 2.) Upon my review, Harrison and Flatow neither supports nor
refutes the understanding of SIRVA discussed above.
Additionally, Dr. Winell’s reliance material suggests that “[p]ain from shoulder
impingement syndrome (SIS) may result from injury to a number of involved structures,
including: the rotator cuff (RC), subacromial bursa, biceps tendon, and labrum. The
history and physical examination are used to identify the structures involved and direct
treatment.” (Simons et al., supra, at Ex A, Tab 1, p. 5). This is consistent both with the
concept of SIRVA generally and with Dr. Yehyawi’s initial opinion that petitioner’s
shoulder pain was specifically related to post-vaccination inflammation of the bursa and
rotator cuff. (Ex. 5, p. 9.) Dr. Srikumaran also contends that the acute inflammation
that was observed around petitioner’s AC joint would be unexpected for a degenerative
process, and that it is more likely the result of a vaccine-mediated inflammatory
response. (Ex. 39, p. 9.)
Significantly, Dr. Winell’s competing opinion that petitioner’s condition is better
explained as a degenerative condition is premised in part on her disbelief that onset of
petitioner’s condition was sudden and related to vaccination. (See, e.g., Ex. A, p. 6
(discounting petitioner’s recollection of any temporal association to vaccination and
explaining “[t]he natural histories of shoulder subacromial impingement/AC arthritis are
that they frequently occur in this age group (>40) and pain can be brought on by actions
of movements that may seem inconsequential or routine in activities of daily living.”).)
However, as described in section IV(b) above, there is preponderant evidence of a
temporal relationship between petitioner’s vaccination and the onset of her shoulder
pain. “When an expert assumes facts that are not supported by a preponderance of the
evidence, a finder of fact may properly reject the expert’s opinion.” Dobrydnev v. Sec’y
of Health & Human Servs., 566 Fed. Appx. 976, 982-83 (Fed. Cir. 2014) (citing Brooke
Group Ltd. v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993)). In
contrast to Dr. Winell, and consistent with my own fact finding, Drs. Anderson and
Srikumaran both concluded that the abrupt onset of post-vaccination shoulder pain
18
documented in the medical record is inconsistent with clinical onset of a degenerative
condition. (Ex. 34, p. 3; Ex. 39, p. 8.)
Finally, to the extent respondent may argue that Dr. Winell’s opinion supports the
position that the degree of dysfunction related to either a rotator cuff pathology or
arthritis must necessarily preclude vaccination as the cause, that represents a question
of clinical judgment. However, Dr. Winell’s assessment that it was more likely
petitioner’s degenerative findings explained her bursitis rather than her bursitis
explaining the clinical activation of her shoulder pain (Ex. A, pp. 5-6) is directly
contradicted by the clinical judgment of petitioner’s own treating orthopedic surgeon. In
his first post-operative report, Dr. Yehyawi specifically maintained his opinion “that the
injection that started all of her pain very likely could’ve caused an inflammatory
response in the tendon and the bursa that persisted . . .” (Ex. 7, p. 5.) Dr. Yehyawi
continued to maintain his opinion that petitioner’s pain was primarily due to rotator cuff
and bursal inflammation even after accounting for the presence of AC arthritis. (Ex. 26,
pp. 1-3.) Nothing in the record of this case calls into question Dr. Yehyawi’s clinical
care and, given his in-person treatment of petitioner and first-hand observation of her
shoulder during surgery, he is better positioned than Dr. Winell to make judgments as to
the clinical significance of his own post-operative findings. E.g., Capizzano v. Sec’y of
Health & Human Servs., 440 F.3d 1327, 1326 (Fed. Cir. 2006) (“medical records and
medical opinion testimony are favored in vaccine cases, as treating physicians are likely
to be in the best position to determine whether a ‘logical sequence of cause and effect
show [s] that the vaccination was the reason for the injury’”).
e. Factor unrelated
Pursuant to the Vaccine Act, once petitioner has met her prima facie burden of
demonstrating a Table Injury, respondent may still prove the condition is “due to factors
unrelated to the administration of the vaccine describe in the petition.” § 300aa-
13(a)(1)(B). In this case, apart from the cervical spinal condition and degenerative
shoulder pathology discussed above, respondent has not raised any issue as to any
factor unrelated to vaccination.
V. Conclusion
For all the reasons discussed above, after weighing the evidence of record within
the context of this program, I find by preponderant evidence that petitioner suffered a
Table Injury of SIRVA following her October 11, 2016 flu vaccination as alleged. A
separate damages order will be issued.
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
19