Pitts v. Secretary of Health and Human Services ( 2023 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-1512V
PUBLISHED
Special Master Horner
TERRY PITTS,
Filed: March 10, 2023
Petitioner,
v. Reissued for Public Availability: April
4, 2023
SECRETARY OF HEALTH AND
HUMAN SERVICES, Shoulder Injury Related to Vaccine
Administration (“SIRVA”); Table
Respondent. Injury; Cause-in-fact; Influenza (“flu”)
vaccine; Denial; Onset
Terry Pitts, Evanston, IL, pro se petitioner.
Camille Michelle Collett, U.S. Department of Justice, Washington, DC, for respondent.
DECISION 1
On September 28, 2018, petitioner, Terry Pitts, filed a petition under the National
Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), 2 alleging that he
suffered “injuries, including Shoulder Injury Related to Vaccine Administration
(“SIRVA”)” resulting from adverse effects of his October 8, 2016 influenza (“flu”)
vaccination. (ECF No. 1.) For the reasons set forth below, I conclude that petitioner is
not entitled to compensation. The key issue is the timing of onset of petitioner’s alleged
post-vaccination shoulder injury.
1
Because this document 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 document will be available to anyone with access
to the Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to
redact medical or other information the disclosure of which would constitute an unwarranted invasion of
privacy. If 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
I. Applicable Statutory Scheme
Under the National Vaccine Injury Compensation Program, compensation
awards are made to individuals who have suffered injuries after receiving vaccines. In
general, to gain an award, a petitioner must make a number of factual demonstrations,
including showing that an individual received a vaccination covered by the statute;
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. Finally – and the key
question in most cases under the Program – the petitioner must also establish a causal
link between the vaccination and the injury. In some cases, the petitioner may simply
demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
shown that the vaccine recipient suffered an injury of the type enumerated in the
“Vaccine Injury Table,” corresponding to the vaccination in question, within an
applicable time period following the vaccination also specified in the Table. If so, the
Table Injury is presumed to have been caused by the vaccination, and the petitioner is
automatically entitled to compensation, unless it is affirmatively shown that the injury
was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A); § 300 aa-
11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).
As relevant here, the Vaccine Injury Table lists a Shoulder Injury Related to
Vaccine Administration or “SIRVA” as a compensable injury if it occurs within 48 hours
of administration of a vaccination. § 300aa-14(a) as amended by 42 CFR § 100.3.
Table Injury cases are guided by statutory “Qualifications and aids in interpretation”
(“QAIs”), which provide more detailed explanation of what should be considered when
determining whether a petitioner has actually suffered an injury listed on the Vaccine
Injury Table. 42 CFR § 100.3(c). To be considered a “Table SIRVA,” petitioner must
show that his injury fits within the following definition:
SIRVA manifests as shoulder pain and limited range of motion occurring
after the administration of a vaccine intended for intramuscular
administration in the upper arm. These symptoms are thought to occur as a
result of unintended injection of vaccine antigen or trauma from the needle
into and around the underlying bursa of the shoulder resulting in an
inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal
structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is
not a neurological injury and abnormalities on neurological examination or
nerve conduction studies (NCS) and/or electromyographic (EMG) studies
would not support SIRVA as a diagnosis . . . . A vaccine recipient shall be
considered to have suffered SIRVA if such recipient manifests all of the
following:
(i) No history of pain, inflammation or dysfunction of the affected shoulder
prior to intramuscular vaccine administration that would explain the alleged
signs, symptoms, examination findings, and/or diagnostic studies occurring
after vaccine injection;
(ii) Pain occurs within the specified time-frame;
2
(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 CFR § 100.3(c)(10).
Alternatively, if no injury falling within the Table can be shown, the petitioner may
still demonstrate entitlement to an award by showing that the vaccine recipient’s injury
or death was caused-in-fact by the vaccination in question. § 300aa-13(a)(1)(A);
§ 300aa-11(c)(1)(C)(ii). To so demonstrate, a petitioner must show that the vaccine
was “not only [the] but-for cause of the injury but also a substantial factor in bringing
about the injury.” Moberly ex rel. Moberly v. Sec'y of Health & Human Servs., 592 F.3d
1315, 1322 n.2 (Fed. Cir. 2010) (quoting Shyface v. Sec'y of Health & Human Servs.,
165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec'y of Health & Human Servs.,
451 F.3d 1352, 1355 (Fed. Cir. 2006). In particular, a petitioner must show by
preponderant evidence: (1) a medical theory causally connecting the vaccination and
the injury; (2) a logical sequence of cause and effect showing that the vaccination was
the reason for the injury; and (3) a showing of proximate temporal relationship between
vaccination and injury in order to prove causation-in-fact. Althen v. Sec’y of Health &
Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
For both Table and Non–Table claims, Vaccine Program petitioners must
establish their claim by a “preponderance of the evidence”. § 300aa-13(a). That is, a
petitioner must present evidence sufficient to show “that the existence of a fact is more
probable than its nonexistence . . . .” Moberly, 592 F.3d at 1322 n.2. Proof of medical
certainty is not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867, 873
(Fed. Cir. 1991). However, a petitioner may not receive a Vaccine Program award
based solely on his assertions; rather, the petition must be supported by either medical
records or by the opinion of a competent physician. § 300aa-13(a)(1). Once a
petitioner has established their prima facie case, the burden then shifts to respondent to
prove, also by preponderant evidence, that the alleged injury was caused by a factor
unrelated to vaccination. Althen, 418 F.3d at 1278 (citations omitted); § 300aa-
13(a)(1)(B).
In this case, petitioner stresses that he suffered a left-sided shoulder injury
consistent with a SIRVA Table Injury. (ECF No. 43, p. 1.) Alternatively, petitioner
asserts that reliable medical evidence supports a non-Table shoulder injury caused-in-
fact by his vaccination. (Id. at 6.)
II. Procedural History
At the time the case was filed, petitioner was represented by counsel. He did not
become a pro se petitioner until January 25, 2023. (ECF No. 55.) This case was
initially assigned to the Special Processing Unit (“SPU”) for expedited resolution based
on the allegations of the petition. (ECF No. 5.) Over several months, petitioner filed
evidence, including medical records, affidavits, and a letter by a treating physician,
3
marked as Exhibits 1-9. (ECF Nos. 7, 9, 11.) Respondent then advised as of August 5,
2019, that he intended to defend the case and later filed his Rule 4(c) Report setting
forth his view of the case on October 4, 2019. (ECF Nos. 17, 20.) Respondent
primarily raised the issue that petitioner’s medical records did not support a timing of
onset compatible with a Table injury of SIRVA. He additionally raised that without an
expert report the medical records were inadequate to support a cause-in-fact shoulder
injury claim. (ECF No. 20, pp. 6-9.)
Subsequently, the Chief Special Master issued an order advising that “I intend to
issue a fact finding as to the onset of petitioner’s alleged injury after providing the
parties an opportunity to file any further evidence they wish to have considered.
Because this ruling relates to a discrete factual issue, party briefs are not necessary.”
(ECF No. 21.) However, the Chief Special Master allowed the parties time to file either
additional evidence and/or memoranda regarding onset. (Id.) Petitioner subsequently
filed a Statement of Completion without filing any additional evidence and neither party
filed any brief. The Chief Special Master issued his finding of fact on April 29, 2020.
(ECF No. 25.) The Chief Special Master concluded there is evidence to support onset
occurring one week post-vaccination, but not preponderant evidence of onset occurring
within 48-hours of vaccination. (Id. at 8.)
Following the finding of fact, petitioner filed an amended petition to explicitly
assert an alternative claim based in causation-in-fact (ECF No. 29), along with an expert
report by orthopedist Uma Srikumaran, M.D. (ECF No. 28; Exs. 10-17.) At that point,
the Chief Special Master removed the case from the SPU and it was reassigned to
Special Master Roth. (ECF Nos. 30-31.) Respondent advised that he would continue
to defend the case (ECF No. 35) and he filed a responsive expert report by orthopedist
Paul Cagle, M.D., on February 3, 2021 (ECF No. 36; Ex. A-B). Petitioner then filed a
further report by Dr. Srikumaran responding to Dr. Cagle’s report. (ECF No. 37; Exs.
18-24.) Respondent was provided an opportunity to file a further expert report but
declined. (ECF No. 38.)
Initially, petitioner requested a hearing (ECF No. 39); however, petitioner
subsequently filed a joint status report on behalf of the parties opting instead to proceed
to a ruling on the existing record without a hearing (ECF No. 40). Petitioner filed his
motion for a ruling on the record on July 30, 2021. (ECF No. 43.) Respondent filed a
response on September 28, 2021. (ECF No. 46.) Petitioner filed his reply on October
5, 2021. (ECF No. 47.) In his motion, petitioner argued both that his claim can prevail
based on a one-week onset under a causation-in-fact theory and that the Chief Special
Master’s prior fact finding should be revisited by the presiding special master such that
a Table SIRVA claim may still be viable. (ECF No. 43.)
Subsequently, however, on May 2, 2022, petitioner’s counsel filed a motion for
an award of interim attorneys’ fees and costs as well as a motion to withdraw as
attorney of record. (ECF Nos. 49-50.) In the motion to withdraw, petitioner’s counsel
represented that “petitioner and his counsel have developed irreconcilable differences
as to how to best advance the prosecution of his petition.” (ECF No. 50, p. 1.) Special
4
Master Roth granted counsel’s motion to withdraw on January 25, 2023, and petitioner
became a pro se petitioner. 3 (ECF No. 55.)
Shortly thereafter, this case was reassigned to the undersigned on February 2,
2023. (ECF Nos. 58-59.) On February 3, 2023, I issued a scheduling order setting forth
the procedural history of the case and explaining the case has “since been reassigned
to the undersigned and I intend to resolve the case expeditiously. However, although
the case has already been briefed for a ruling on the existing record, petitioner’s
counsel’s withdrawal based on irreconcilable differences with petitioner raises a
question as to whether the case remains ripe for resolution.” (ECF No. 62, pp. 1-2.) I
advised the parties that I intend to rule on petitioner’s pending motion for a ruling on the
record as soon as practicable, but afforded the parties a period of two weeks to notify
me of any objection to my acting on the pending motion. (Id. at 2.) No objection was
raised by either party.
I have determined that the parties have had a full and fair opportunity to present
their cases and that it is appropriate to resolve this issue without a hearing. See
Vaccine Rule 8(d); Vaccine Rule 3(b)(2); 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 matter is now ripe for resolution.
III. Factual History
Petitioner was 42 years old at the time of the vaccination at issue. There is no
indication that he had any prior contributory medical history. (ECF No. 46, p. 2 (citing
Ex. 1, p. 1; Ex. 2, pp. 25-26; Ex. 3, pp. 18-19).) Petitioner presented to his primary care
physician, Kyong Christopher Oh, M.D., on October 8, 2016, for a general adult exam
and, it appears, to establish care. 4 He received the flu vaccination at issue at this
encounter. It was administered in his left deltoid. (Ex. 1; Ex. 3, p. 19.) Petitioner was
directed to follow up in four weeks regarding his prescriptions. (Ex. 3, pp. 18-19.)
In his affidavit, petitioner states that he experienced immediate upper arm pain
after being vaccinated. (Ex. 7, p. 1.) He indicates he called Dr. Oh’s office later that
day to complain of his ongoing pain. (Id.) He also indicates that during the same call
he requested that an unrelated prescription be sent to Sam’s Club Pharmacy. (Id.) Dr.
Oh’s medical records do not include any record of a call from petitioner, though the
body of records does otherwise have telephone encounter records. There is a record of
a call from Sam’s Club Pharmacy on October 14, 2016, indicating that they had not
received necessary prescriptions. (Ex. 3, p. 17.) Petitioner’s wife also signed an
affidavit stating that she recalled discussing petitioner’s arm pain with him as of the
morning after the vaccination. (Ex. 6.) She states that the pain began the day of the
vaccination. (Id.)
3
Former counsel’s motion for an award of attorneys’ fees and costs remains pending.
4
The record indicates petitioner had recently moved to the area from Alabama. (Ex. 3, p. 18.)
5
Petitioner’s medical records suggest that he returned to Dr. Oh approximately
one month later. However, the records present a confusing picture of when exactly that
follow up occurred, because the records purport to show that he followed up on both
November 5, 2016, and November 7, 2016, which is highly unlikely. Based on the
record as a whole, it appears most likely that petitioner had only one check up with Dr.
Oh in early November of 2016, most likely on November 7. A medical record of
November 7, 2016, indicates petitioner is “[d]oing well here for checkup – medications
going well without side effect . . . Due for Rx today.” (Ex. 3, p. 13.) This is consistent
with what his prior October 8 record suggested was the purpose of his follow up. The
encounter record for November 5, 2016, indicates more vaguely that the reason for
appointment was “1 month f/u.” (Id. at 15-16.) That record is also identified as a
checkup. (Id.) The November 5 record contains no instruction for petitioner to follow up
again in two days and the November 7 record includes no notation to suggest petitioner
had been seen just two days prior. (Id. at 13-16.) Nothing in either medical record
otherwise indicates any reason why petitioner would be seen twice in the span of two
days for a routine follow up regarding his ongoing medications. Whereas the record of
the November 7, 2016, encounter has an electronic signature by Dr. Oh matching the
date of the encounter (Id. at 14), Dr. Oh’s electronic signature on the November 5,
2016, encounter record is dated March 14, 2018 (Id. at 15). Both records confirm
petitioner should continue his medications; however, there is more detailed discussion
regarding petitioner’s conversations with Dr. Oh in the November 7 record. (Compare,
Ex. 3, p. 13 and, id. at 15.) In any event, both records include the same physical
examination and review of systems notations, though only the November 7 encounter
recorded petitioner’s vital signs. (Ex. 3, pp. 13, 15.) Physical exam of the extremities
was limited to noting no edema. The review of systems for musculoskeletal is limited to
noting “joint pain denies” in both records. (Id. at 13, 16.)
There is no indication within either record that petitioner’s shoulder was
discussed. Petitioner’s affidavit indicates, however, that he discussed his shoulder pain
with Dr. Oh at the November 7 encounter. (Ex. 7, p. 1). Additionally, two later letters by
Dr. Oh have been filed in this case. (Exs. 5, 9.) The first letter dated October 4, 2018,
indicates that Dr. Oh does recall that on November 7, 2016, petitioner reported to him
that he had been having left shoulder pains. (Ex. 5.) In a later letter dated January 24,
2019, Dr. Oh clarifies that “[d]uring an appointment in early November 2016, [petitioner]
mentioned to me that he was having shoulder pain that began immediately after he
received his flu vaccine on 10/08/2016.” (Ex. 9.) Neither Dr. Oh nor petitioner ever
reference an appointment occurring November 5, 2016. (Exs. 5, 7, 9.)
Petitioner did not seek care again until February 21, 2017. (Ex. 3, pp. 10-11.) A
telephone record of February 20, 2017, suggests that the appointment was prompted by
the need to renew one of his prescriptions, which as a controlled substance required a
follow up appointment; however, when petitioner presented the next day the history of
present illness indicated that he complained of “some pains in the left arm,” further
noting that “he does total gym but is finding it difficult to do much exercise.” (Compare
Ex. 3, p. 10 and, id. at 12.) Despite presenting with a complaint of shoulder pain,
petitioner’s documented physical exam was still limited to noting that he had no edema
6
in his extremities and his review of systems still recorded “joint pain denies” under
musculoskeletal. (Ex. 3, p. 10.) Petitioner was assessed with “left shoulder pain” and
referred to an orthopedist. (Id. at 10-11.)
Petitioner then saw orthopedist Steven Levin, M.D., the next day. (Ex. 4, p. 8.)
At that time he provided a history “complaining of left shoulder pain for 4 months after
he got a flu shot in October. He said it specifically started after he got a flu shot.” (Id.)
Petitioner complained of “discomfort in and around the biceps area and into the
shoulder, pain with overhead activity, pain at night.” (Id.) Additionally, “he had some
instances of mild numbness and tingling, but that since dissipated, no weakness in the
arm.” (Id.) Physical exam indicated his neck was non-tender and with full range of
motion. (Id. at 9.) Spurling’s and Lhermitte’s tests were both negative. 5 Physical exam
of the shoulder indicated “basically full painless range of motion” with mild pain at the
extremes of forward flexion along with “mildly positive” Neer and Hawkins tests. 6 (Id.)
Several additional tests were negative. (Ex. 4, p. 9.) X-rays were negative. (Id.) Dr.
Levin’s impression was bursitis. (Id.) He further indicated that he has had prior patients
he believed to have had inflammatory bursitis due to flu vaccinations penetrating the
bursa. (Id.) He then added “that is my diagnosis at this juncture in time.” (Id.) Dr.
Levin recommended conservative treatment, including physical therapy. (Id.)
Petitioner subsequently presented for a physical therapy evaluation on March 14,
2017. (Ex. 4, pp. 71-74.) At that time he reported that he “[r]ecieved flu shot in fall 2016
and about 1 week later noticed soreness in L lateral arm . . . Progressively has been
worsening and increased area of pain.” (Id. at 71.) The pain was characterized as
intermittent and sharp, 7/10 at worst, and aggravated by several activities involving the
lifting of the arm as well as working out. The pain was described as lateral shoulder
5
A Spurling test tests for the presence of cervical radiculopathy where “the examiner presses down on
the top of the head while the patient rotates the head laterally and into hyperextension; pain radiating into
the upper limb ipsilateral to a rotation position of the head indicates radiculopathy.” Spurling test,
D ORLAND’S MEDICAL D ICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=112983&searchterm=Spurling%20test (last
accessed Mar. 1, 2023). The Lhermitte sign is “the development of sudden, transient, electric-like shocks
spreading down the body when the patient flexes the head forward; seen mainly in multiple sclerosis but
also in compression and other disorders of the cervical cord.” Lhermitte sign, DORLAND’S MEDICAL
D ICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=106344&searchterm=Lhermitte%20sign (last
accessed Mar. 1, 2023).
6
A Hawkins-Kennedy test is a test used in the evaluation of orthopedic shoulder injury. “A positive
Hawkins-Kennedy test is indicative of an impingement of all structures that are located between the
greater tubercle of the humerus and the coracohumeral ligament.” Hawkins-Kennedy test, WIKIPEDIA,
https://en.wikipedia.org/wiki/Hawkins%E2%80%93Kennedy_test (last accessed Mar. 1, 2023). A Neer
impingement test is a test designed to reproduce symptoms of rotator cuff impingement “through flexing
the shoulder and pressure application.” Neer Impingement Test, WIKIPEDIA,
https://en.wikipedia.org/wiki/Neer_Impingement_Test (last accessed Mar. 1, 2023). In a Neer’s test,
symptoms should be reproduced “if there is a problem with the supraspinatus or biceps brachii.” Id.7
pain initially that spread to the top of the shoulder and into axilla. 7 Petitioner reported
that he had been able to use 50-pound dumbbells on his Total Gym system, but was
currently unable to use that system for working out. (Id.) The objective assessment
showed normal cervical range of motion without exacerbation when tested, although
petitioner reported left side tightness with some maneuvers. (Id. at 72.) Petitioner had
reduced range of shoulder movement and his Hawkins test was positive. (Id.) Six
weeks of physical therapy was recommended. (Id. at 73.)
Petitioner attended five further physical therapy sessions during March of 2017.
(Ex. 4, pp. 75-85.) During that time, petitioner reached out to Dr. Oh by telephone on
March 22, 2017, to discuss his shoulder pain. (Ex. 3, p. 9.) He indicated that he was
still having pain despite his therapy. (Id. at 8.) Dr. Oh sent a message to Dr. Levin
recommending that petitioner follow up with him for further recommendation. Dr. Oh
included an addendum in his record that “I also made it clear to patient that his shoulder
pain is not the result of the flu shot he received on 10/8/16.” (Id.) Subsequently, on
March 30, 2017, petitioner’s physical therapist likewise concluded that petitioner had
made no significant progress and that the referring physician should reevaluate the
need for further physical therapy. (Ex. 4, pp. 84-85.)
Petitioner returned to Dr. Levin on April 3, 2017. (Ex. 4, p. 25.) In addition to
findings relative to his shoulder, Dr. Levin also observed that:
he has numbness and tingling going down his arm as well as radicular type
pain. This all started after a flu injection. He may have developed some
adhesive capsulitis due to protecting his shoulder from the pain of a flu shot
and/or he might have developed some radiculopathy, it is difficult to discern.
(Id.) Dr. Levin recommended an EMG as well as an MRI of both the neck and shoulder.
(Id. at 26.)
An EMG/NCV study was conducted on April 6, 2017, to rule out cervical
radiculopathy, plexopathy, and/or carpal tunnel syndrome. (Ex. 4, pp. 21-23.) The
study was interpreted as “essentially normal.” (Id. at 22.) The cervical spinal MRI was
conducted on April 13, 2017. It found disc protrusion at C5-C6, but without evidence of
extrinsic compression of the cervical spinal cord. (Id. at 24.) Petitioner’s left shoulder
MRI of the same date showed no rotator cuff or labral tear, but edema around the
glenohumeral ligament and rotator cuff interval consistent with adhesive capsulitis. (Id.
at 20.) Petitioner returned to Dr. Levin on April 17, 2017, to review his results. (Id. at
33-34.) Based on his review of the test results, Dr. Levin recommended that petitioner
7
“[T]he pyramidal region of the upper limb between the upper thoracic wall and the shoulder, its base
f ormed by the skin and apex bounded by the approximation of the clavicle, coracoid process, and first
rib[.]” Axilla, DORLAND’S MEDICAL D ICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=5152&searchterm=axilla (last accessed Mar. 1,
2023).
8
follow up with a cervical spine specialist, but also recommended a steroid injection for
his shoulder and that he continue “aggressive” therapy for adhesive capsulitis. 8 (Id.)
Petitioner had one further encounter with Dr. Oh on May 20, 2017, before
establishing care with a new primary care provider, Emily Andrew, M.D., on July 15,
2017. (Ex. 3, pp. 5-6; Ex. 4, p. 41-42.) The May 20th encounter with Dr. Oh was a
three-month checkup. The record documents petitioner’s left shoulder pain in the
assessments but is otherwise uninformative. (Ex. 3, p. 5.) (As with the November 5,
2016 encounter, this record is electronically signed as of March 14, 2018.) When
petitioner presented to Dr. Andrew, the fact of his ongoing orthopedic treatment for left
shoulder pain was documented, but the appointment appears to have focused more
heavily on his diabetes management. (Ex. 4, pp. 41-42.) Petitioner declined a physical
therapy referral. (Id. at 42.)
On August 31, 2017, petitioner underwent an employment related health
screening. (Ex. 8.) He completed a questionnaire that marked “no” for any prior neck
or back problems and “no” for any “[b]one, muscle, joint, or nerve problems.” (Id. at 3.)
A physical examination checked “normal.” (Id. at 4.) However, the extent of the
physical exam is not indicated. (Id.) No further records were filed. Both petitioner and
his wife indicate in their affidavits, both signed in December of 2018, that petitioner has
experienced ongoing symptoms up to that point. (Ex. 7, p. 2 (“[t]hroughout this whole
ordeal I have been in tremendous pain . . . .”); Ex. 6, p. 1 (“[t]o this day, [petitioner] has
yet to fully recover from receiving the vaccine”).
IV. Expert Reports
a. Petitioner’s Initial Expert Report by Orthopedist Uma Srikumaran,
M.D., MBA, MPH 9
8
The same day petitioner once again contacted Dr. Oh’s office by phone and requested information
regarding the vaccine had head received on October 8, 2016. (Ex. 3, p. 7.) The office reportedly told
petitioner that his vaccination had been administered correctly and “had nothing to do” with his shoulder
pain. (Id.)
9
Dr. Srikumaran serves as an associate professor in the Shoulder Division at the Johns Hopkins School
of Medicine and serves as the Shoulder Fellowship Director and Chair of Orthopaedic Surgery for the
Howard County General Hospital. (Ex. 10, p. 1.) He also serves as the Medical Director of the Johns
Hopkins Musculoskeletal Service Line in Columbia, Maryland. (Id.) Each year Dr. Srikumaran sees
approximately 2500-3000 patients for shoulder issues and performs 400-500 shoulder surgeries annually.
(Id.) He has treated approximately ten to twelve patients with shoulder dysfunction after vaccination in
the past five years. (Id.) Dr. Sr kumaran received his medical degree from Johns Hopkins School of
Medicine in 2005. (Ex. 11, p. 1.) He completed his orthopaedic residency at Johns Hopkins Hospital and
completed a shoulder surgery fellowship at Massachusetts General Hospital. (Id.) Dr. Srikumaran is
board certified in orthopaedic surgery. (Id. at 10.) He peer reviews journal articles for several
orthopaedic journals including The Journal of Bone & Joint Surgery, Orthopedics, Clinical Orthopedics
and Related Research, and The Journal of Shoulder and Elbow Surgery. (Ex. 10, pp. 1-2.) Dr.
Srikumaran was selected to serve on the Shoulder and Elbow Content Committee for the American
Academy of Orthopaedic Surgery. (Id.)
9
Dr. Srikumaran indicates that there is scientific literature available to demonstrate
that “injection of a vaccine antigen into the subacromial bursa [can lead] to a ‘robust
local immune and inflammatory response’ leading to pathology of the subacromial
space, biceps tendon, glenohumeral joint, and capsulitis.” (Ex. 10, p. 5 (citing Marko
Bodor & Enoch Montalvo, Vaccination-related shoulder dysfunction, 25 VACCINE 585
(2007) (Ex. 14); S. Atanasoff et al., Shoulder injury related to vaccine administration
(SIRVA), 28 VACCINE 8049 (2010) (Ex. 12)).) Further to this he cites experimental
evidence that he indicates shows the plausibility of inflammation caused by immune
mediated response to antigenic material. (Id. (citing D.C. Dumonde & L.E. Glynn, The
production of arthritis in rabbits by an immunological reaction to fibrin, 43(4) BRIT. J.
EXP. PATHOL. 373 (1962) (Ex. 15); C. Trollmo et al., Intra-articular immunization induces
strong systemic immune response in humans, 82 CLIN. EXP. IMMUNOL. 384 (1990) (Ex.
17)).) In that regard, Dr. Srikumaran stresses that petitioner “consistently and reliably”
reported post-vaccination shoulder pain to his treating physicians culminating in a
diagnosis of bursitis. (Id. at 6-7.) To the extent petitioner was later diagnosed with
adhesive capsulitis after failing physical therapy, he further opines that adhesive
capsulitis is also consistent with SIRVA. (Id. at 7.) Dr. Srikumaran feels confident that
cervical radiculopathy was ruled out by the treating physicians after a normal EMG/NCS
and that there are no reports to suggest that petitioner had any history of other shoulder
conditions that would explain his symptoms. (Ex. 10, pp. 6-7.) Noting that petitioner
reported onset of his shoulder pain occurring within one week of vaccination, he opines
that this is appropriate timing. (Id.) Dr. Srikumaran cites a review paper that he
indicates provides support for a latency for SIRVA-like shoulder injuries of up to two
months post-vaccination. (Id. at 5 (citing L.H. Martin Arias, Risk of bursitis and other
injuries and dysfunctions of the shoulder following vaccinations, 35 VACCINE 4870
(2017) (Ex. 13)).)
b. Respondent’s Expert Report by Orthopedist Paul J. Cagle, M.D. 10
Dr. Cagle stresses that when petitioner first sought care from Dr. Levin on April 3,
2017, he presented with a mixed picture of “signs of bursitis as well as signs of radicular
pain.” (Ex. A, p. 4.) He noted that Dr. Levin felt the clinical picture was unclear,
recommending both further evaluation of the cervical spine and a steroid injection to the
shoulder. (Id.) Further to this, Dr. Cagle does not view petitioner’s shoulder MRI results
10
Dr. Cagle serves an as assistant professor and Associate Program Director in the Department of
Orthopaedic Surgery at the Icahn School of Medicine at Mount Sinai. (Ex. A, p. 1.) He is a member of
the American Shoulder and Elbow Surgeons, and a faculty member of an internationally recognized
shoulder surgery fellowship. (Id.) His current practice focuses on the shoulder, representing 95% or
more of the patients and pathology he treats. (Id.) Dr. Cagle conducts clinical, biomechanical, and basic
science research. (Id.) He has presented scientific work nationally and internationally; and has published
over twenty articles related to shoulder injuries and surgery. (Ex. B, pp. 11-12.) Dr. Cagle is a peer
reviewer f or the Journal of Orthopaedic Research, Techniques in Shoulder and Elbow Surgery, and the
Journal of Shoulder and Elbow Surgery. (Id. at 13.) He received his medical degree from Loyola
University Chicago Stritch School of Medicine in 2008. (Id. at 2.) Dr. Cagle completed his orthopaedic
residency at the University of Minnesota Academic Health center and Medical School. (Id.) He also
completed a shoulder and elbow fellowship at Mount Sinai Hospital in New York and is board certified in
orthopaedic surgery. (Id.)
10
as supporting SIRVA because they do not show an increase in bursal fluid. (Id.)
Moreover, Dr. Cagle indicates that the MRI results and physical exam are in contrast
regarding the shoulder pathology at issue. He suggests that the MRI shows
inflammation of the inferior glenohumeral ligament, which is consistent with adhesive
capsulitis, while the physical exam of February 22, 2017, demonstrated no loss of
motion, which is incompatible with adhesive capsulitis. (Id.) In contrast, he stresses
that the cervical spine MRI showed protrusion of the neural foramen of the left C5-6
nerve. Thus, Dr. Cagle appears to suggest that it is the cervical spine MRI rather than
the shoulder MRI that evidences an acute explanation for petitioner’s condition. Dr.
Cagle charges that Dr. Srikumaran’s explanation of the MRI findings is selective. (Id. at
4-5.) Dr. Cagle contends that the literature cited by Dr. Srikumaran is inapposite due to
the lack of evidence of a shoulder-based etiology for petitioner’s condition and also that
the literature is unpersuasive in itself because it does not establish a mechanism to
support the association it seeks to present between vaccination and shoulder
dysfunction. (Id. at 5-6.)
c. Petitioner’s Supplemental Expert Report by Dr. Srikumaran
In response to Dr. Cagle’s assessment of the clinical history, Dr. Srikumaran
stresses that the April 3, 2017, encounter discussed by Dr. Cagle was not Dr. Levin’s
first examination of petitioner and that on February 22, 2017, Dr. Levin opined after
physical examination that petitioner had bursitis that he attributed to the vaccination.
(Ex. 18, p. 1.) Dr. Srikumaran agrees that cervical radiculopathy was within the
differential diagnosis, but disagrees regarding Dr. Cagle’s assessment that the cervical
etiology is more likely. He stresses that the April 3, 2017, physical examination
demonstrated reduced range of motion, crepitus, and positive Neer and Hawkins tests.
These are consistent with shoulder pathology whereas the same exam shoed a non-
tender neck exam with full range of motion and a negative Spurling’s test, all of which
are inconsistent with cervical radiculopathy. (Id. at 2.) Dr. Srikumaran notes that Dr.
Levin was concerned regarding radicular pain as well as numbness and tingling down
the arm but suggests that radiating pain is not incompatible with SIRVA or adhesive
capsulitis. (Id.) Dr. Srikumaran again stresses that petitioner’s shoulder MRI was
consistent with adhesive capsulitis and disagrees that the February 22, 2017, physical
exam is in conflict with that finding, suggesting the “mild pain on extremes of forward
flexion” is consistent with early signs of adhesive capsulitis while more advanced signs
of adhesive capsulitis are documented in later records. (Id.) Dr. Srikumaran also
provided an expanded discussion of his opinion with regard to general causation,
adding citations to a number of additional publications. (Id. at 3-7.) Among those
additional citations, Dr. Srikumaran added a discussion of a study by Hesse, et al., that
demonstrates a statistically significant risk of bursitis following vaccination. (Id. at 6
(citing Elisabeth Hesse et al., Risk for subdeltoid bursitis after influenza vaccination, 173
ANN. INTERN. M ED. 253 (2020) (Ex. 21).)
V. Discussion
a. Timing of Onset
11
As a threshold matter, petitioner has specifically requested in his motion that the
presiding special master revisit the Chief Special Master’s finding of fact regarding
onset. (ECF No. 43, p. 3 (requesting that the currently presiding special master
independently evaluate onset).) Respondent offered no competing argument in his
motion response. Although I ultimately have reached the same result as the Chief
Special Master, revisiting the basis for my finding of fact in the interest of completeness
is advisable for three reasons.
First, the fact finding of a previously assigned special master is not binding upon
a subsequently presiding special master. Godfrey v. Sec’y of Health & Human Servs.,
2015 WL 10710961, at *9 (Fed. Cl. Spec. Mstr. Oct. 27, 2015) (noting that “[g]enerally,
special masters may change or revisit any ruling until judgment enters, even if the case
has been transferred.”); see also Hanlon v. Sec’y of Health & Human Servs., 40 Fed.Cl.
625, 630 (1998), aff’d, 191 F.3d 1344 (Fed. Cir. 1999) (special masters are not bound
by their own or other special masters’ decisions). Second, petitioner correctly notes that
subsequent Federal Circuit authority at least raises a question as to elements of the
Chief Special Master’s analysis. (ECF No. 43, p. 4.) In particular, the Chief Special
Master cited Sanchez v. Secretary of Health and Human Services, for the proposition
that a series of three linked propositions regarding the manner in which people seek
healthcare favors a presumption in favor of contemporaneous medical records. (ECF
No. 25 (citing 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013),
vacated on other grounds, Sanchez by & through Sanchez v. Sec’y of Health & Human
Servs., 809 Fed.Appx. 843 (Fed. Cir. 2020).) Subsequent to the issuance of this fact
finding, however, the Federal Circuit in Kirby v. Secretary of Health & Human Services,
specifically rejected these propositions as a misreading of prior precedent. 11 997 F.3d
1378, 1383 (Fed. Cir. 2021). And, third, based on my evaluation of the record as a
whole, I do not necessarily agree that petitioner sought care twice in November of 2016,
a point that partly underlies the fact finding.
As petitioner suggests in his motion, the Federal Circuit has observed that
“[a]lthough a patient has a ‘strong motivation to be truthful’ when speaking to his
physician, that does not mean he will report every ailment he is experiencing, or that the
physician will accurately record everything he observes.” Kirby, 997 F.3d at 1383.
Furthermore, it has also previously been observed that “[m]edical records are only as
accurate as the person providing the information.” Parcells v. Sec’y of Health & Human
Servs., No. 03-1192V, 2006 WL 2252749, at *2 (Fed. Cl. Spec. Mstr. July 18, 2006).
And, importantly, “the absence of a reference to a condition or circumstance is much
less significant than a reference which negates the existence of the condition or
11
In Kirby the Federal Circuit discussed a different decision, Robi versus Secretary of Health & Human
Services, that relied on the same series of propositions in evaluating contemporaneous medical records.
As the Federal Circuit discussed it in Kirby, the Robi decision concluded that these propositions
supported a presumption that contemporaneous medical records are both complete and accurate. Kirby,
997 F.3d at 1382-83. It is that presumption that the Federal Circuit ultimately rejected as going beyond
the prior suggestion in Curcuras that contemporaneous medical records can carry significant weight. Id.
Here, the Chief Special Master did not explicitly rely on a presumption that the contemporaneous medical
records were complete.
12
circumstance.” Murphy v. Sec’y of Health & Human Servs., 23 Cl.Ct. 726, 733 (1991)
(quoting the decision below), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992). The
Murphy Court also observed that “[i]f a record was prepared by a disinterested person
who later acknowledged that the entry was incorrect in some respect, the later
correction must be taken into account.” Murphy, 23 Cl.Ct. at 733.
I perhaps find less significance than did the Chief Special Master in the fact that
petitioner’s complaint of shoulder pain was not documented during his treatment with
Dr. Oh in November of 2016. (See Ex. 3, pp. 13-16.) For the reasons discussed in the
factual history above, I conclude it is more likely that the medical records reflect only
one encounter at that time, rather than the two encounters discussed in the Chief
Special Master’s fact finding. Thus, this was not likely a repeated omission. Moreover,
Dr. Oh has indicated, albeit much more remotely, that his original record was not
complete with respect to petitioner’s complaint of shoulder pain. (Exs. 5, 9.) Although
the November encounter records also purported to indicate in a review of systems that
petitioner denied any musculoskeletal complaints, this same notation was also included
in Dr. Oh’s February 21, 2017, record wherein petitioner specifically presented with a
complaint of left shoulder pain. (Compare Ex. 3, p. 10 with, Ex. 3, p. 13 and, Ex. 3, p.
16.) Thus, I am not persuaded it is a reliable notation. Accordingly, I do not consider
Dr. Oh’s November 2016 body of medical records to be strong evidence regarding
whether petitioner was experiencing shoulder pain at that time.
Significantly, however, the one time during his course of treatment when the
onset of petitioner’s shoulder pain was reported with specificity, petitioner told his
physical therapist on March 14, 2017, that he experienced pain “about 1 week” after his
vaccination. (Ex. 4, p. 71.) Petitioner also associated his pain to his vaccination on
other occasions, but none of these records include enough specificity to contradict his
specific report of pain beginning one-week post-vaccination. (Ex. 4, p. 8 (noting onset
four months prior and “after” flu vaccine); Ex. 4, p. 41 (“started after flu injection.”). Nor
is there any contemporaneous record to support petitioner’s recollection that he called
Dr. Oh’s office the day of his vaccination despite the fact that Dr. Oh’s office otherwise
regularly created records of his calls. Although Dr. Oh’s later letter provides some
evidence to suggest petitioner reported the onset of his pain as occurring “immediately”
after his vaccination (Ex. 9), the March 14, 2017, history provided to the physical
therapist remains the earliest recollection in evidence on this record regarding the
specific onset of petitioner’s shoulder pain. When a treating physician offers a
statement that is not contemporaneous to events and is not within the context of
diagnosis and treatment, a special master may conclude that it is not entitled to the
same weight as contemporaneous medical records. See Milik v. Sec’y of Health &
Human Servs., 822 F.3d 1367, 1381-82 (Fed. Cir. 2016).
Based on my own independent review of the complete record, I conclude that
there is not preponderant evidence that onset of petitioner’s shoulder pain began within
48-hours of vaccination. Further to this finding, I also conclude that the evidence
preponderates in favor of onset occurring within one-week post-vaccination.
13
b. Table SIRVA
As explained above, there is not preponderant evidence that onset of petitioner’s
alleged shoulder injury occurred within 48 hours of his vaccination. This defeats
petitioner’s Table injury claim for the reasons discussed in Section I, above. See 42
CFR § 100.3(c)(10)(ii).
c. Causation-in-fact
For the reasons discussed below, the one-week post-vaccination onset in this
case is singularly fatal to petitioner’s claim on this record. As discussed under Althen
prong one below, petitioner is persuasive in establishing that the flu vaccine can in
general cause shoulder injuries of the type reflected in his medical records and, as
discussed under Althen prong two, Dr. Levin and Dr. Srikumaran demonstrate that
petitioner likely did suffer shoulder pathology in addition to his suspected cervical spinal
degeneration. However, as discussed under Althen prong three, Dr. Srikumaran is
unpersuasive on this record in seeking to extend the necessary causal inference as far
out as a full week post-vaccination.
i. Althen prong one
Petitioner is required to present a persuasive medical theory of causation
demonstrating that the influenza vaccine could have caused his shoulder condition.
Althen, 418 F.3d at 1278. It is well-established in the Vaccine Program that
compensation may be awarded for shoulder injuries on a cause-in-fact basis. See, e.g.,
A.P. v. Sec'y of Health & Human Servs., No. 17-784V, 2022 WL 275785 (Fed. Cl. Spec.
Mstr. Jan. 31, 2022); L.J. v. Sec'y of Health & Human Servs., No. 17-0059V, 2021 WL
6845593 (Fed. Cl. Spec. Mstr. Dec. 2, 2021); Tenneson v. Sec'y of Health & Human
Servs., No. 16-1664V, 2018 WL 3083140 (Fed. Cl. Spec. Mstr. Mar. 30, 2018), rev.
den., 142 Fed. Cl. 329 (2019). However, petitioner’s medical theory must be supported
by “reputable” scientific evidence and must “pertain[] specifically to the petitioner’s
case.” Moberly, 592 F.3d at 1322.
Petitioner may not merely rely on the fact that SIRVA was added to the Vaccine
Injury Table to establish a medical theory for a cause-in-fact claim. Grant v. Sec’y of
Health & Human Servs., 956 F.2d 1144, 1147-48 (Fed. Cir. 1992). 12 The government’s
12
In Grant, the Federal Circuit explained the distinction between Table and non-Table claims and quoted
the legislative history of the Vaccine Act as follows:
If the petitioner sustained or had significantly aggravated an injury not listed in the Table,
he or she may petition f or compensation. If the petitioner sustained or had signif icantly
aggravated an injury listed in the Table but not within the time period set forth in the Table,
he or she may petition for compensation. In both these cases, however, the petition must
affirmatively demonstrate that the injury or aggravation was caused by the vaccine. Simple
similarity to conditions or time periods listed in the Table is not suf ficient evidence of
causation; evidence in the f orm of scientific studies or expert medical testimony is
necessary to demonstrate causation f or such a petitioner. (Such a f inding of causation is
deemed to exist for those injuries listed in the Table which occur within the time period set
f orth in the Table.)
14
recognition of “SIRVA” as a vaccine-caused injury was limited by the accompanying QAI
criteria. In this case, I have already concluded for the reasons discussed above that
petitioner has not met those criteria. Thus, if petitioner’s medical theory under Althen
prong one was limited to taking judicial notice of the government’s recognition of
SIRVAs as occurring in some contexts, petitioner’s case would necessarily have to fail
under Althen prong two, because the facts of petitioner’s case do not fall within the
confines of that recognition. Accord L.J., 2021 WL 6845593 (taking judicial notice of the
Table Injury of SIRVA under Althen prong one and applying the Table SIRVA QAI as
the basis for assessing Althen prong two); Tenneson, 2018 WL 3083140 (same). To
hold otherwise would be to expand the causal presumption afforded by the Vaccine
Injury Table.
Here, Dr. Srikumaran opined that vaccine antigens injected into synovial tissue
can cause a “prolonged immune-mediated inflammatory reaction.” (Ex. 10, p. 5 (citing
Atanasoff et al., supra, at Ex. 12.) To support this contention, Dr. Srikumaran offered
several medical articles examining post-vaccination shoulder pain. In particular, the
Atanasoff study found an association between vaccination and shoulder injury based on
the subjects’ lack of prior shoulder symptoms and rapid onset of pain following
vaccination. (Atanasoff et al., supra, at Ex. 12, p. 8051.) The Atanasoff authors
surmised that an immune-mediated inflammatory reaction induced by the vaccine
caused the subjects’ shoulder symptoms. (Id.) Given that there is no diagnostic test
available to determine whether shoulder dysfunction is vaccine-caused, the Atanasoff
authors emphasized the importance of evaluating clinical presentation in identifying
post-vaccination shoulder injuries. (Id. at 8052.) Dr. Srikumaran’s theory is further
supported by the Bodor and Montalvo case reports that found that injection into the
subdeltoid bursa likely caused “a robust local immune and inflammatory response.”
(Bodor & Montalvo, supra, at Ex. 14, p. 586.) Bodor and Montalvo concluded that
“[g]iven that the subdeltoid bursa is contiguous with the subacromial bursa, [the
injection] led to a subacromial bursitis, bicipital tendonitis, and inflammation of the
shoulder capsule.” (Id.)
Further to this, Dr. Srikumaran also presented the Hesse et al., study which
confirms an epidemiological risk of post-vaccination bursitis. The study examined
nearly three million people who received the 2016-2017 seasonal flu vaccine and
looked for incidences of subdeltoid bursitis diagnosed within 180 days of vaccination.
(Hesse et al., supra, at Ex. 21, p. 253.) The Hesse et al. authors “identified a small risk
for subdeltoid bursitis with new symptom onset after injection of an influenza vaccine.”
(Id. at 259.) The Hesse et al. study specifically demonstrated bursitis as a statistically
significant epidemiological finding rather than simply a clinical observation. (See id.)
Grant, 956 F.2d at 1147-48 (quoting H.R.Rep. No. 908, 99th Cong., 2d Sess., pt. 1, at 15 (1986),
reprinted in 1988 U.S.C.C.A.N. 6344, 6356) (emphasis in Grant); see also Schick-Cowell v. Sec’y of
Health & Human Servs., 18-656V, 2022 WL 619839 (Fed. Cl. Spec. Mstr. Feb. 8, 2022); A.P., 2022 WL
275785; but see L.J., 2021 WL 6845593 (taking judicial notice of the Table Injury of SIRVA under Althen
prong one for case filed prior to inclusion of SIRVA on the Vaccine Injury Table, but decided after);
Tenneson, 2018 WL 3083140 (same).
15
Taken together, the literature offered by Dr. Srikumaran supports the theory that the flu
vaccine can cause bursitis via post-vaccination inflammation.
In general, primary adhesive capsulitis, as opposed to secondary adhesive
capsulitis, “is a specific pathologic entity in which chronic inflammation of the capsule
subsynovial layer produces capsular thickening, fibrosis, and adherence of the capsule
to itself and to the anatomic neck of the humerus.” (Andrew Neviaser & Robert
Neviaser, Adhesive Capsulitis of the shoulder, 19 J. AM. ACAD. ORTHROP. SURG. 536,
536 (2011) (Ex. A, Tab 9).) Thus, the SIRVA body of literature includes adhesive
capsulitis among the conditions encompassed by this framework of post-vaccination
shoulder injury phenomena. For example, one of the case report subjects in the above-
discussed Bodor & Montalvo article suffered adhesive capsulitis. (Bodor & Montalvo,
supra, at Ex. 14, p. 586.) Additionally, a study of the clinical characteristics of 476
SIRVA cases conceded by the government in this program showed that 5.5% of cases
carried an initial diagnosis of adhesive capsulitis. (Hesse et al., Shoulder Injury Related
to Vaccine Administration (SIRVA): Petitioner claims to the National Vaccine Injury
Compensation Program, 2010-2016, 38 VACCINE 1076, 1079 (Table 4) (2020) (Ex. 20)).)
Although respondent disputes that petitioner has satisfied Althen prong one, I
note that several petitioners in this Program have successfully relied upon on the same
body of literature where the undersigned has awarded compensation in cause-in-fact
shoulder claims. E.g., Kelly v. Sec'y of Health & Human Servs., No. 17-1918V, 2022
WL 1144997, at *22 (Fed. Cl. Spec. Mstr. Mar. 24, 2022); Colbert v. Sec'y of Health &
Human Servs., No. 18-166V, 2022 WL 2232210, at *18 (Fed. Cl. Spec. Mstr. May 27,
2022); Layne v. Sec'y of Health & Human Servs., No. 18-57V, 2022 WL 3225437, at *18
(Fed. Cl. Spec. Mstr. July 12, 2022).
Accordingly, petitioner has offered a reputable causal theory sufficient to meet
his burden under Althen prong one.
ii. Althen prong two
The second Althen prong requires proof of a logical sequence of cause and
effect showing that the vaccine was the reason for the injury, usually supported by facts
derived from a petitioner's medical records. Althen, 418 F.3d at 1278; Andreu ex re.
Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1375–77 (Fed. Cir. 2009);
Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006);
Grant, 956 F.2d at 1148. However, medical records and/or statements of a treating
physician do not per se bind the special master to adopt the conclusions of such an
individual, even if they must be considered and carefully evaluated. See 42 U.S.C.
§300aa-13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result,
report, or summary shall not be binding on the special master or court”); Snyder v. Sec'y
of Health & Human Servs., 88 Fed.Cl. 706, 746 n.67 (2009) (“there is nothing . . . that
mandates that the testimony of a treating physician is sacrosanct—that it must be
accepted in its entirety and cannot be rebutted”).
16
Here, there is a significant issue with respect to Althen prong three that also
prevents petitioner from demonstrating a logical sequence of cause and effect under
Althen prong two. That issue is discussed separately below. Setting that issue aside
arguendo, there is otherwise no question that when petitioner first sought orthopedic
care, his treating orthopedist (Dr. Levin) felt he was suffering bursitis caused by an
inflammatory response to vaccination. (Ex. 4, p. 9.) He later added adhesive capsulitis
to his impression, which he further suggested could be related sequela. (Id. at 25.)
This opinion accounted for two physical examinations as well as subsequent MRI
findings. Moreover, Dr. Levin’s stated rationale is entirely consistent with Dr.
Srikumaran’s theory under Althen prong one. However, respondent raises two issues.
First, he contends that Dr. Cagle should be viewed as more persuasive in interpreting
petitioner’s history as consistent with a cervical spinal issue. (ECF No. 46, p. 17.)
Second, he suggests that Dr. Levin’s causal opinion was not definitive while petitioner’s
primary care provider repeatedly asserted that the vaccination had been administered
properly. (Id. at 19.) Neither of these arguments is persuasive.
While Dr. Cagle raises some reasonable points with respect to the possibility of a
cervical spinal condition being present, he is not persuasive in further suggesting that
this possibility renders petitioner’s diagnosed shoulder pathology unlikely. While a
cervical spinal issue can sometimes be the better explanation for a clinical presentation
that includes shoulder pain, the presence of cervical spinal degeneration does not
preclude the presence of an additional shoulder injury. Prior petitioners have
succeeded where their treating physicians diagnosed a shoulder injury in the presence
of unrelated cervical spinal degeneration. Compare Colbert v. Sec'y of Health & Human
Servs., No. 18-166V, 2022 WL 2232210 (Fed. Cl. Spec. Mstr. May 27, 2022) and,
Layne v. Sec’y of Health & Human Servs., 18-57V, 2022 WL 3225437 (Fed. Cl. Spec.
Mstr. July 12, 2022) with Truett v. Sec'y of Health & Hum. Servs., No. 17-1772V, 2022
WL 17348386 (Fed. Cl. Nov. 1, 2022). Here, Dr. Srikumaran is persuasive in noting
that Dr. Levin’s physical examinations provided sufficient evidence to support his
diagnosis of an orthopedic shoulder injury. Moreover, nothing in the medical records
suggests that Dr. Levin ever felt that petitioner had a cervical condition to the exclusion
of a shoulder pathology. Significant to this point is the fact that Dr. Levin continued to
recommend “aggressive” therapy for adhesive capsulitis even while simultaneously
recommending further investigation of petitioner’s cervical spine. (Ex. 4, pp. 9, 34-35.)
Thus, respondent is not persuasive in suggesting that Dr. Levin’s diagnostic opinion
was either tentative or rescinded following his review of the spinal MRI. Nor is the mere
presence of some numbness and tingling dispositive. (Hesse et al., supra, at Ex. 20, p.
1080 (Table 4) (indicating that 7.4% of conceded SIRVAs included tingling or
paresthesia).)
Nor is Dr. Oh’s skepticism that petitioner’s injury could have been vaccine-related
controlling. The only reason Dr. Oh indicated for skepticism is the assertion that
petitioner’s vaccine was correctly administered. (Ex. 3, p. 7.) However, that does not
preclude a SIRVA. Petitioner has filed a study by Hesse, et al., evaluating the clinical
characteristics of conceded SIRVA claims within this program. According to that paper,
less than half of SIRVA cases include any alleged error in vaccine administration.
17
(Hesse et al., supra, at Ex. 20, p. 1080.) Moreover, the literature cited by Dr. Cagle also
suggests that, to the extent overpenetration is suspected as a contributing factor in
SIRVA, needle penetration into the bursa may be attributable to needle length and
anatomical diversity without the need for improper technique, explaining
Current Centers for Disease Control and Prevention guidelines state that a
1-inch needle depth is appropriate for most patients (except for persons
>200 lbs or new-borns), which is a seemingly “one-size-fits-all” approach
for an increasingly diverse population. A study of MRI deltoid fat pads by
Lippert found that with using 5/8 inch, 7/8-inch, or 1/inch needles for
intramuscular deltoid injections would cause 11% (16 of 150), 55% (83 of
150), and 61% (92 of 150) of patients to experience overpenetration,
respectively.
(Matthew Barnes et al., A “Needling” Problem: Shoulder Injury Related to Vaccine
Administration, 25(9) J. AM. BOARD FAM. M ED. 919, 921 (2012) (Ex. A, Tab 2).) The
authors characterize the argument for changing vaccination technique as “compelling.”
(Id.) According to these authors, based on the 160 lbs documented during petitioner’s
October 8, 2016 encounter, petitioner would have to have had his vaccination
administered with a needle shorter than what the CDC typically recommends in order to
ensure there was no overpenetration. (Id.; see Ex. 3, p. 18.) Thus, it is not necessary
for petitioner to demonstrate any incorrect injection technique in order to demonstrate a
logical sequence of cause and effect between his vaccination and his injury.
Accordingly, if not for the timing of onset that is fatal to petitioner’s claim,
petitioner’s medical records coupled with Dr. Srikumaran’s additional supporting opinion
would otherwise preponderantly establish a logical sequence of cause and effect
between petitioner’s vaccination and his alleged shoulder injury.
iii. Althen prong three
The third Althen prong requires establishing a “proximate temporal relationship”
between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term
has been equated to the phrase “medically-acceptable temporal relationship.” Id. A
petitioner must offer “preponderant proof that the onset of symptoms occurred within a
timeframe which, given the medical understanding of the disorder's etiology, it is
medically acceptable to infer causation.” de Bazan v. Sec'y of Health & Human Servs.,
539 F.3d 1347, 1352 (Fed. Cir. 2008). In this case, Dr. Srikumaran is unpersuasive in
suggesting that the medically acceptable timeframe during which vaccine causation of a
shoulder injury can be inferred extends as far as two months post-vaccination. (Ex. 10,
p. 5; Ex. 18, p. 5.) He is further unpersuasive in suggesting that the one-week post-
vaccination onset present in this case supports any inference of causation.
The two-month timeframe referenced by Dr. Srikumaran is derived from two
outlier case reports in a study by Arias, et al., of prior reported cases of potential SIRVA.
The Arias authors undertook a review of 67 prior medical articles and 13,717 reports of
vaccine-related notifications from the Adverse Reaction Data of the Spanish
18
Pharmacovigilance System or “FEDRA” to assemble a case series of 45 subjects.
(Martin Arias et al., supra, at Ex. 13.) The authors assessed 37 cases from the
published literature and 8 cases from FEDRA. Among the published cases, post-
vaccination onset ranged from immediate to three days. (Id. at 3 (Table 2).) Among the
FEDRA cases, 6 of the 8 were noted to have had onset occurring within 7 days of
vaccination. Out of all the cases reviewed by Arias, et al., only two cases from FEDRA
had latencies beyond one-week post-vaccination and only one case had a latency of
one week. (Id. at 3.) Moreover, nothing in the authors’ analysis specifically endorses a
view that the cases involving longer latencies were vaccine-caused. Instead, the
authors conclude that 48 hours is the likely relevant onset based on the majority of
cases falling within that timeframe. (Id. at 1 (abstract).)
In contrast, a statistical analysis also cited by Dr. Srikumaran examined cases of
bursitis occurring within 180 days of vaccination and used the 60 days post-vaccination
period as the background rate to find a statistically elevated risk of bursitis occurring
within 3 days post-vaccination. (Hesse et al., supra, at Ex. 21.) Indeed, the literature as
a whole suggests that a clear majority of vaccine-related shoulder injuries occur within
48 hours of vaccination with some anecdotal evidence potentially supporting that onset
may occur a few days later in a minority of cases. (See Atanasoff, et al., supra, at Ex.
12, p. 8050 (one out of 13 cases occurred 4 days post-vaccination; Martin Arias et al.,
supra, at Ex. 13, p. 4872 (noting “6 in 8 FEDRA patients complained of increasing
severity pain starting within the first 24 h or few days (4-7 days) post-vaccination.”);
Hesse et al., supra, at Ex. 21, p. 253 (statistically significant elevated risk of bursitis in
the first three days post-vaccination).
Nor does the experimental evidence Dr. Srikumaran cites persuasively address
the issue. While Trollmo, et al., sought to compare intra-articular injections to
subcutaneous injections, it is not clear how those findings regarding systemic immune
response would support the timing of onset in this case. (Trollmo et al., supra, at Ex.
17.) Regardless of the measurements taken, all six of the subjects receiving intra-
articular injections experienced temporary swelling and stiffness of the injected joint
within two to four hours of vaccination. (Id. at 386.) Dumonde & Glynn is a study
involving a rabbit model designed to examine rheumatoid arthritis. (Dumonde & Glynn,
supra, at Ex. 15.) On this record, Dr. Srikumaran has not substantiated its relevance on
the specific issue of timing of onset. While the study examined changes within injected
joints over a period of weeks, it was not equipped to detect the onset of pain symptoms.
Dr. Cagle was also somewhat unpersuasive in that he urged “the accepted 48
hour standard” without further explanation. (Ex. A, p. 6.) An issue that is evident in the
body of SIRVA literature is that some of the larger studies treat the 48-hour onset as a
threshold screening issue. For example, the 2019 study by Hesse, et al., examines 476
cases of SIRVA that were conceded within this program. (Hesse et al., supra, at Ex. 20,
p. 1076.) This provides valuable insight regarding variation in clinical characteristics
among confirmed SIRVAs, but does not provide evidence regarding the full scope of
what might reasonably constitute a SIRVA-like injury caused-in-fact by vaccination,
because it is limited to cases conceded by the government and those concessions are
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governed by the QAI criteria now included on the Vaccine Injury Table, including the
requirement of a 48 hour onset. Similarly, a study by Hibbs, et al., examined reports of
shoulder injuries reported to the Vaccine Adverse Event Reporting System (VAERS),
but only considered reports with onset occurring within 48 hours of vaccination. (Beth
F. Hibbs et al., reports of atypical shoulder pain and dysfunction following inactivated
influenza vaccine, Vaccine Adverse Event Reporting System (VAERS), 2010-2017, 38
VACCINE 1137 (2020) (Ex. 22).) Yet, strict adherence to a 48-hour onset as utilized by
these studies is refuted by the Hesse, et al., study, which found a statistically significant
elevation of risk for three days post-vaccination. (Hesse et al., supra, at Ex. 21.) In that
regard, the Federal Circuit holding in Paluck v. Secretary of Health & Human Services
cautions against setting “hard and fast deadline[s]” for onset. See 786 F.3d 1373, 1383-
84 (Fed. Cir. 2015) (stating that “[t]he special master further erred in setting a hard and
fast deadline” for onset and noting that the medical literature filed in the case “do not
purport to establish any definitive timeframe for onset of clinical symptoms.”).
Nonetheless, petitioner bears the burden of proof on this point and, even without
treating the 48-hour period as a bright line, there is little to no evidence on this record to
specifically support a one-week latency as medically reasonable.
Balancing all of the above, I conclude on this record that petitioner has not
satisfied Althen prong three based on a one-week post-vaccination onset. This is
consistent with prior cases which have generally fallen into two categories. Several
prior cases have denied entitlement to compensation where onset of shoulder pain
occurred months post-vaccination. Nicholson v. Sec'y of Health & Human Servs., No.
17-1416V, 2022 WL 14437541, at *25-26 (Fed. Cl. Spec. Mstr. Sept. 22, 2022) (denying
entitlement where onset of shoulder pain occurred between 32-49 days post-
vaccination); Clavio v. Sec'y of Health & Human Servs., No. 17-1179V, 2022 WL
1078175, at *8 (Fed. Cl. Spec. Mstr. Feb. 16, 2022) (denying entitlement where onset of
shoulder pain was 59 days post-vaccination); Mack v. Sec'y of Health & Human Servs.,
No. 15-0149V, 2016 WL 5746367, at * 10-11 (Fed. Cl. Spec. Mstr. July 14, 2016)
(explaining that the 48-hour onset required by the Vaccine Injury Table does not
preclude “a claim involving a later onset (even one that is substantially later)” but finding
petitioner failed to demonstrate a six-month post-vaccination onset is medically
reasonable to infer causation). On the other hand, several prior cases have suggested
that onset falling outside of the 48-hour Table window but within less than one week
post-vaccination can support a cause-in-fact shoulder injury claim. Kuczarski v. Sec'y of
Health & Human Servs., No. 20-0312V, 2023 WL 1777208, at *3-4 (Fed. Cl. Spec. Mstr.
Feb. 6, 2023) (dismissing Table SIRVA claim but noting that “a causation-in-fact injury
claim might still be tenable, based on an onset occurring a week after vaccination.”);
Murray v. Sec'y of Health & Human Servs., No. 17-1357V, 2022 WL 17829797 (Fed. Cl.
Spec. MStr. Oct. 27, 2022) (finding entitlement where onset of shoulder pain occurred
within “a few days” and less than seven days post-vaccination); Jewell v. Sec'y of
Health & Human Servs., No. 16-0670V, 2017 WL 7259139, at * 3 (Fed. Cl. Spec. Mstr.
Aug. 4, 2017) (finding entitlement for shoulder injury occurring 72 hours post-
vaccination); but see C.C. v. Sec'y of Health & Human Servs., No. 17-708V, 2021 WL
2182817 (Fed. Cl. Spec. Mstr. Mar. 31, 2021) (finding onset of shoulder pain one-week
post-vaccination did not satisfy Althen prong three because petitioner’s Althen prong
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one theory was based on the Vaccine Injury Table, which required a 48-hour onset);
Porcello v. Sec'y of Health & Human Servs., No. 17-1255V, 2020 WL 4725507, at *9
(Fed. Cl. Spec. Mstr. June 22, 2020) (denying entitlement where petitioner failed to
show onset “reasonably close” in time to vaccination where the only precise notation of
onset indicated an 11-day latency).
VI. Conclusion
Petitioner has my sympathy for what he has endured. However, considering the
record as a whole under the standards applicable in this Program, petitioner has not
preponderantly established either that his October 8, 2016 flu vaccination resulted in a
Table SIRVA or alternatively caused-in-fact a shoulder injury. Accordingly, petitioner is
not entitled to compensation. Therefore, this case is dismissed. 13
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
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In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter
judgment accordingly.
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