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

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1905V
Filed: February 15, 2023
PUBLISHED
Special Master Horner
JEANNE MICHELLE FORREST, as
special administrator of the estate of
JOANN FORREST, Shoulder Injury Related to
Vaccine Administration
Petitioner, (“SIRVA”); Influenza (“Flu”)
v. Vaccine; Ruling on the Record;
Significant Aggravation
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner.
Jennifer A. Shah, U.S. Department of Justice, Washington, DC, for respondent.
Ruling on Entitlement 1
On December 8, 2017, Joan Forrest filed a petition under the National Childhood
Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), 2 alleging that her receipt of an
influenza (“flu”) vaccination on December 16, 2014, caused a right shoulder injury,
specifically a Table Injury of “SIRVA.” (ECF No. 1.) On June 25, 2020, the current
petitioner, Jeanne Michelle Forrest, was substituted as petitioner in her capacity as legal
representative for the estate of Joann Forrest. 3 (ECF No. 58.) An amended petition
was subsequently filed to additionally plead significant aggravation as an alternate
theory. (ECF No. 63.) For the reasons set forth below, I conclude that petitioner is
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.
2All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa-
10-34.
3Throughout this decision, Jeanne Michelle Forrest will be referred to exclusively as “petitioner” and Joan
Forrest will be referred to as “Ms. Forrest.”
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entitled to an award of compensation for a significant aggravation of the Ms. Forrest’s
pre-existing shoulder injury.
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 flu vaccine. § 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 proven the existence an injury listed on the
Vaccine Injury Table. 42 CFR § 100.3(c). To be considered a “Table SIRVA,” petitioner
must show that the injury at issue meets the following four criteria:
(i) No history of pain, inflammation or dysfunction of the affected shoulder
prior to intramuscular vaccine administration that would explain the alleged
signs, symptoms, examination findings, and/or diagnostic studies occurring
after vaccine injection;
(ii) Pain occurs within the specified time-frame;
(iii) Pain and reduced range of motion are limited to the shoulder in which
the intramuscular vaccine was administered; and
(iv) No other condition or abnormality is present that would explain the
patient's symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,
brachial neuritis, mononeuropathies, or any other neuropathy).
42 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); §
2
300aa-11(c)(1)(C)(ii). To so demonstrate, a petitioner must prove 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 demonstrate: (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. 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 her assertions; rather, the petition must be supported by either medical
records or by the opinion of a competent physician. § 300aa-13(a)(1).
A petitioner may also allege that the vaccine at issue caused a “significant
aggravation” of a preexisting injury. The Vaccine Act defines significant aggravation as
“any change for the worse in a preexisting condition which results in markedly greater
disability, pain, or illness accompanied by substantial deterioration of health.” § 300aa-
33(4). Where a petitioner in an off-Table case is seeking to prove that a vaccination
aggravated a pre-existing injury, she must establish three additional factors. See
Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144 (Fed. Cl. 2009)
(combining the first three Whitecotton factors for claims regarding aggravation of a
Table injury with the three Althen factors for off table injury claims to create a six-part
test for off-Table aggravation claims); see also W.C. v. Sec’y of Health & Human Servs.,
704 F.3d 1352, 1357 (Fed. Cir. 2013) (applying the six-part Loving test.). The additional
Loving factors require petitioners to demonstrate aggravation by showing: (1) the
vaccinee’s condition prior to the administration of the vaccine, (2) the vaccinee’s current
condition, and (3) whether the vaccinee’s current condition constitutes a “significant
aggravation” of the condition prior to the vaccination. Id.II. Procedural History
As noted above, this case was initially filed on December 8, 2017. Based on the
allegations contained in the petition it was originally assigned to the Special Processing
Unit or “SPU” for possible information resolution. (ECF No. 5.) Through her counsel,
Ms. Forrest developed the record between March of 2018 and June of 2019. (ECF Nos.
9, 15, 25, 32, 35, 37, 39; Exs. 1-22.) Respondent then filed his Rule 4 Report on
September 24, 2019. (ECF No. 44.) Respondent contended that Ms. Forrest could not
establish a Table Injury of SIRVA and had not filed any expert medical opinion to
support a cause-in-fact claim. (Id. at 9-12.) Respondent suggested that Ms. Forrest
had a preexisting shoulder injury and that her symptoms were not limited to her
shoulder. (Id.)
3
After respondent filed his report, the case was reassigned out of the SPU and to
the undersigned and I ordered Ms. Forrest to file an expert report. (ECF No. 46-48.)
She filed a report by Marco Bodor, M.D., and supporting material on March 12, 2020.
(ECF No. 53; Exs. 24-29.) Respondent filed a responsive report by Julie Bishop, M.D.,
with supporting material on July 21, 2020. (ECF No. 59; Exs. A-B.) During this period,
Ms. Forrest passed away due to conditions unrelated to her injury claim and Jean
Michelle Forrest became petitioner as legal representative of the estate. (ECF Nos. 52,
56-58; Exs. 23, 30.) On August 31, 2020, petitioner filed a supplemental report by Dr.
Bodor responding to Dr. Bishop’s report. (ECF Nos. 60-61; Exs. 31-34.)
On September 2, 2020, I held a status conference during which I urged the
parties to consider litigative risk settlement and also noted that I felt the case is
appropriate for resolution on the written record. (ECF No. 62.) I discussed petitioner’s
claim as more likely to represent a claim for significant aggravation. (Id.) Specifically, I
explained that my review of the medical records suggested three arcs of shoulder
symptoms – the first predating the vaccination, the second immediately after
vaccination, and a third subsequent to a later series of falls. (Id. at 2.) Respondent’s
expert, Dr. Bishop, opined this was the natural course of Ms. Forrest’s degenerative
conditions; however, both Ms. Forrest’s primary care physician and Dr. Bodor opined
the second arc of symptoms constituted a vaccine-related aggravation of Ms. Forrest’s
shoulder condition. (Id.) Subsequently, on September 14, 2020, petitioner amended
her petition to include a claim for significant aggravation. (ECF No. 63.)
Thereafter, the parties exchanged several more expert reports. Respondent filed
a supplemental report by Dr. Bishop on April 28, 2021. (ECF No. 71; Ex. C.) Petitioner
filed a further report by Dr. Bodor on August 4, 2021. (ECF No. 74; Ex. 35.)
Respondent then filed a report by Dr. Bishop on September 30, 2021, and petitioner
responded with a report by Dr. Bodor on October 8, 2021. (ECF Nos. 76-77; Exs. D, 36-
38.) Respondent filed a report by Dr. Bishop on January 5, 2022, and petitioner filed a
report by Dr. Bodor on January 19, 2022. (ECF Nos. 79-80; Exs. E, 39-40.)
Respondent filed a final report by Dr. Bishop on March 7, 2022. (ECF No. 83; Ex. F.)
On March 8, 2022, I ordered petitioner to file a motion for a ruling on the record
and also permitted petitioner to simultaneously file a report by Dr. Bodor responding to
respondent’s final report by Dr. Bishop. Petitioner filed a final report by Dr. Bodor on
March 10, 2022, and her motion for a ruling on the record on May 9, 2022. (ECF Nos.
84-85; Exs. 41-43.) Respondent filed his response on June 22, 2022, and petitioner
filed a reply on July 6, 2022. (ECF Nos. 87-88.)
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.
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III. Factual History
a. As reflected in the medical records
i. Pre-vaccination
Ms. Forrest presented to her primary care physician on December 27, 2011, with
a complaint of right shoulder pain. (Ex. 4, p. 1.) On physical exam she had crepitus4
and impaired range of motion. (Id. at 2.) She followed up with an orthopedist (Dr.
Johnson) on January 13, 2012. 5 (Ex. 2, p. 1.) She complained of “persistent,” but
“waxing and waning” shoulder pain for approximately eight years. 6 (Id.) The pain had
worsened in the last few months. (Id.) She had previously tried physical therapy but felt
it had made her symptoms worse. By the time she sought treatment from Dr. Johnson,
the pain was interfering with her sleep. (Id.) On physical exam she had reduced range
of motion and signs of impingement (Hawkins and Neer’s testing were positive). 7 Ms.
Forrest was diagnosed with right shoulder subacromial impingement and a suspected
rotator cuff tear. (Id. at 3.)
Ms. Forrest returned to Dr. Johnson on February 9, 2012. A diagnostic
ultrasound showed “a chronic right shoulder full-thickness tear of the anterior medial
fibers of the supraspinatus with minimal tendon retraction” and acromioclavicular joint
osteoarthritis. (Ex. 2, p. 5.) She declined a steroid injection and was referred for a
surgical consultation that she apparently did not pursue. 8 (Ex. 15, p. 9.)
Ms. Forrest did not seek care again until about a year and a half later, when she
sought care from her primary care provider on July 12, 2013, following a fall in her
garden. (Ex. 4, p. 20.) She reported that about two weeks prior she fell down a slope in
her garden and fell onto her knees and right shoulder. She complained of right shoulder
4”The grating sensation caused by the rubbing together of the dry synovial surfaces of joints; called also
articular c.” Joint crepitus, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=67378&searchterm=joint%20crepitus (last
accessed Feb. 13, 2023).
5In addition to her shoulder complaint, petitioner also had bilateral hand pain and weakness that was
separately diagnosed as arthritis. (Ex. 2, p. 3.)
6Petitioner would later report to Dr. Johnson that she recalled a prior fall occurring about eight to ten
years prior. (Ex. 2, p. 4.)
7 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 Feb. 13, 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 Feb. 13, 2023). In a Neer’s test,
symptoms should be reproduced “if there is a problem with he supraspinatus or biceps brachii.” Id.8 Petitioner was referred to Dr. Benjamin Widmer but there is no indication from the records that she saw
Dr. Widmer at that time. (Ex. 15.) Petitioner’s first visit to Dr. Widmer appears to be on July 6, 2015. (Id.
at 11-16.)
5
and right knee pain as well as fatigue. (Id.) However, the fatigue was reportedly more
concerning at this particular visit. Ms. Forrest reported that she was still experiencing
shoulder pain, worse at night, that she felt was slowly improving and that her shoulder
pain “is not overly concerning.” (Id.) However, she did state that she could not cross
her arm across her chest. (Id.) On examination, she had no crepitus and no
tenderness to palpation, but reported some pain with resisted abduction and rotation.
Apart from her cross-body movement, her range of motion was normal. Neer’s test
demonstrated “some tightness” but Hawkins test was negative. (Id. at 21.) No
treatment was recommended.
However, Ms. Forrest returned to her primary care provider on August 5, 2013,
reporting that her right shoulder pain had worsened due to attempting to pull a vine out
of her garden. (Ex. 4, p. 24.) She now had mild tenderness to palpation in the inferior
to the acromion, limited external rotation, and abduction limited to 90 degrees. For the
first time she had pain with an empty can test. 9 (Id.) However, it was noted that her
passive range of motion was good. Accordingly, the injury was considered “probably
more consistent with rotator cuff tendinitis rather than tear” with an additional baseline of
osteoarthritis. (Id. at 25.) Ms. Forrest was referred to physical therapy. (Id.) However,
there is no evidence to suggest she acted on that referral.
On January 21, 2014, Ms. Forrest was hospitalized after a car accident. (Ex. 3,
pp. 1, 66.) She suffered a fractured rib, a left scapula fracture, facial lacerations, and a
pulmonary contusion. (Id.) There is no indication that the accident affected her right
shoulder.
On November 4, 2014, Ms. Forrest returned to her primary care physician with a
chief complaint of a rash on her face. (Ex. 4, p. 40.) Her history of osteoarthritis
affecting her hands, knees, and shoulder was referenced; however, she was managing
her pain with home exercises and herbal remedies. (Id.) Examination of Ms. Forrest’s
extremities provided only a cursory notation that she had no peripheral edema. (Id. at
41.) It was recommended that petitioner continue her home exercises, but no other
treatment was indicated for her osteoarthritis. (Id.)
ii. Vaccination and subsequent treatment
Ms. Forrest received the flu vaccination at issue in this case in her right deltoid
on December 16, 2014. (Ex. 16, p. 3; Ex. 1.) About a month later, on January 19,
2015, she sought treatment from her primary care provider “to evaluate right shoulder
pain after receiving her flu shot.” (Ex. 4, p. 46.) The following history was provided:
She presents with right upper extremity pain that began after receiving her
flu shot at Walgreens on 12/16/2014. She reports severe pain and difficulty
9 The empty can test (Jobe’s test) and full can tests are used to diagnose shoulder injuries. “Specifically,
these physical examination maneuvers examine the integrity of the supraspinatus muscle and tendon.”
Empty can/ Full can tests, WIKIPEDIA, https://en.wikipedia.org/wiki/Empty_can/Full_can_tests (last
accessed Feb. 13, 2023). In the empty can test, “the arm is rotated to full internal rotation (thumb down)
and in the full can test, the arm is rotated to 45° external rotation, thumb up.” Id. The test is considered
positive “if weakness, pain or both are present during resistance. A positive test result suggests a tear to
the supraspinatus tendon or muscle, or neuropathy of the suprascapular nerve.” Id.6
lifting her right should[er] during the 2 days following her flu shot . . . The
pain has caused multiple sleepless nights . . . Pain duration lasts from
minutes to hours in some instances . . . She denies any recent trauma, but
does report numbness, tingling, and weakness in the right arm.
(Id.) Ms. Forrest’s prior rotator cuff tear was noted, but “she has not had many
problems with the shoulder until after receiving the flu shot.” (Id.) Physical exam
showed impingement, with Neers and Hawkins tests producing pain. (Id. at 47.) Empty
can test showed weakness and she had significant weakness with a push off test.
Range of motion was full except for limited and “visibly painful” abduction. (Id.) The
assessment was that this “may represent progression of the tear that was exacerbated
by the inflammatory process [elicited] by the flu shot. Other thoughts include a bursitis
directly from the shot itself vs. a nerve injury from the injection.” (Ex. 4, p. 47.) Ms.
Forrest was referred to her orthopedist for further evaluation. (Id.)
On May 15, 2015, Ms. Forrest returned to her primary care provider and reported
that her shoulder pain “has slowly been improving.” (Ex. 4, p. 50.) She was having
difficulty securing an appointment with an orthopedist but reported that “the pain has
almost resolved.” (Id.) There is no indication of any relevant physical examination
findings at this encounter. (Id. at 50-51.)
On July 6, 2015, Ms. Forrest saw an orthopedic surgeon (Dr. Widmer). (Ex. 2, p.
31.) Her “long history” of right shoulder dysfunction was noted, but Ms. Forrest reported
that it “was not bothering her much but she had a flu shot in the fall and had pain and
dysfunction with increasing stiffness and pain thereafter.” (Id.) Petitioner reported a
“waxing and waning” of her condition but indicated that “she is not remotely back to
having as functional a shoulder as she would like.” (Id.) The pain reportedly extended
down to her hand at times. (Id.) She reported pain with internal and external rotation,
but no issue with forward elevation. (Id.) Physical exam confirmed her reduced range
of motion and an x-ray showed degenerative changes. She was diagnosed with
adhesive capsulitis in addition to her ongoing rotator cuff disease. (Id. at 33.) An MRI
was recommended. (Id.) Dr. Widmer did not specifically address whether Ms. Forrest’s
reported vaccination had any causal role in her condition.
Ms. Forrest opted not to undergo the MRI imaging recommended by Dr. Widmer.
(Ex. 15, p. 17.) However, she agreed to a diagnostic ultrasound. (Id. at 18.)
iii. Subsequent treatment and falls
Before Ms. Forrest was able to present for her diagnostic ultrasound, she
reported that she had experienced a fall while walking up steps. She “lost balance and
grabbed the railing so she wouldn’t fall, and she felt a pop in the middle of her forearm,
and she is having pain there now.” (Ex. 15, p. 20.) Ms. Forrest declined the
recommendation to get an x-ray and indicated she would maintain her upcoming
appointment for her diagnostic ultrasound. (Id.)
On August 7, 2015, Ms. Forrest underwent a right shoulder ultrasound which
showed: (1) “right subscapularis partial tearing versus tendinosis. No evidence of a full
7
thickness tear”; (2) “atrophic appearing long head of the biceps tendon, likely indicating
a chronic tear/rupture”; and (3) “right supraspinatus full thickness tendon tear with
probable retraction of the anteromedial fibers. No evidence of an acute tear.” (Ex. 2, p.
42.)
On August 20, 2015, Ms. Forrest saw a different orthopedic surgeon (Dr.
Gardiner). (Ex. 20, pp. 17-19.) Ms. Forrest reported her history of chronic shoulder
pain with additional persistent shoulder pain following her December 2014 flu
vaccination. (Id. at 17.) Dr. Gardiner reviewed the ultrasound report and recommended
a rotator cuff repair surgery given the severity of petitioner’s reported symptoms. (Id. at
18-19.)
Subsequently, on September 10, 2015, Ms. Forrest returned to her primary care
provider reporting that she had experienced another fall on August 31, 2015. She had
landed on her chest and had ongoing chest pain. (Ex. 4, p. 63.) On September 29,
2015, Ms. Forrest reported that she had another fall that caused her to hit her head. (Id.
at 66.) She had no residual symptoms of head trauma, apart from a resolving
hematoma, but reported worsened right shoulder pain over time as her “bigger
concern.” (Id.) She reportedly had a shoulder exam “consistent with rotator cuff strain,
not consistent with full-thickness tear.” (Id. at 67.) There was no indication for imaging,
but petitioner was referred to physical therapy. (Id.) Ms. Forrest presented for a
physical therapy evaluation on October 22, 2018. (Ex. 20, p. 9.) She was given
instructions for a home exercise program but did not otherwise return for further
physical therapy sessions. (Id.) However, her primary care provider subsequently
noted on November 4, 2015, that her shoulder was improving with physical therapy.
(Ex. 4, p. 77.)
iv. Further records
Ms. Forrest did not seek any care for the next four months. Then, on March 9,
2016, she established care with a new primary care provider. (Ex. 7, p. 20.) At that
time Ms. Forrest reported a history of her post-vaccination injury that suggested she had
nerve damage caused by her vaccination in addition to her previously diagnosed rotator
cuff tear. (Id.) The Review of Systems recorded right arm neuropathy and shoulder
pain, but physical examination was only cursory with no indication of range of motion or
any specific testing maneuvers. (Id. at 21.) She was referred for both orthopedic and
neurologic evaluation. (Id. at 23.) Ms. Forrest’s neurology follow up was unrevealing.
Her neurologist felt it was “[d]ifficult to separate symptoms from rotator cuff problems.”
(Ex. 9, p. 15.) A subsequent electrodiagnostic study was normal. (Id. at 6-12.)
On August 16, 2016, Ms. Forrest saw a new orthopedist. (Ex. 10, p. 9.) The
orthopedist felt Ms. Forrest was a “poor historian” and recorded no history of any of the
prior inciting events reflected in her prior medical history. (Id.) She reported severe
pain localized to the lateral aspect of the shoulder, worse with activities. (Id.) On
physical exam, Ms. Forrest had reduced range of motion and positive Neer, Hawkins,
and empty can tests. (Id. at 11.) She was diagnosed with mild to moderate
glenohumeral osteoarthritis and a suspected rotator cuff tear. She was referred for an
MRI study. (Id. at 12.) That MRI, conducted October 3, 2016, showed “[m]oderate
degenerative changes [at the] humeral head [as well as] [d]egenerative changes in the
8
acromioclavicular joint with undersurface spurring impress[ing] upon the supraspinatus
musculotendinous junction region.” (Ex. 10, pp. 6-7.) It also showed “[f]ull thickness
tearing of the supraspinatus and infraspinatus tendons with retraction beneath the
acromioclavicular joint and abutment of the humeral head and acromion. The
supraspinatus and infraspinatus muscles are retracted and appear small/atrophic.” (Id.
at 7.) There was also “[m]oderate joint effusion with suspected debri[s].” (Id.) Upon
review of the MRI, the orthopedist advised Ms. Forrest she had a chronic irreparable
rotator cuff tear and recommended a reverse total shoulder arthroplasty as a last resort.
(Id. at 5.) Ms. Forrest declined a subacromial steroid injection and the orthopedist
referred her to physical therapy. (Id.) Ms. Forrest attended physical therapy from
February through July of 2017, seeing improvement in her pain but not a resolution of
her limited function. (Ex. 5.)
Ms. Forrest subsequently sought a fourth orthopedic opinion on August 2, 2017.
(Ex. 8, pp. 1-4.) Ms. Forrest reported history that included her post-vaccination pain as
well as a fall in April of 2016 that she felt improved her symptoms. She reported that
she had been told by her doctor that the fall broke up some of her scar tissue. She
reported numbness and tingling down her arm in addition to her shoulder pain. (Id. at
1.) Ms. Forrest was diagnosed with an unspecified rotator cuff tear or other rupture of
the right shoulder along with bursitis, impingement, and cervical radiculopathy. (Id. at
4.) Ms. Forrest deferred on a recommended cervical MRI study because her symptoms
were improving. She was to continue physical therapy and undergo a shoulder MRI to
further evaluate her rotator cuff. (Id.) The MRI showed complete tears of the
supraspinatus and infraspinatus tendons with five centimeters of retraction and
moderate to severe muscle atrophy as well as mild subscapular tendinosis, a complete
stable tear of the biceps tendon, subluxation of the humeral head, mild to moderate
glenohumeral and acromioclavicular osteoarthritis, and a small glenohumeral joint
effusion. (Id. at 9.) A capsular reconstruction was recommended. (Id.) Initially, Ms.
Forrest deferred because she felt she had “functional range of motion,” but she returned
about a month later and indicated she would proceed with surgery. (Id. at 9, 15.)
Ms. Forrest never pursued the recommended surgery. She passed away on
November 8, 2019.
b. As reflected in Ms. Forrest’s affidavits
Ms. Forrest filed two affidavits in this case. (ECF Nos. 1. 15.) I have reviewed
these affidavits and they are consistent with the history reflected in the above-discussed
medical records. The affidavits do not contain any additional details that would affect
the resolution of entitlement in this case.
9
IV. Summary of Expert Opinions
a. Initial Report by Petitioner’s Expert, Marco Bodor, M.D. 10
Dr. Bodor opines that Ms. Forrest sustained a significant aggravation of
preexisting shoulder dysfunction caused by her December 16, 2014 influenza
vaccination. (Ex. 24, p. 3.) He explains that “[p]rior to this vaccination, she had
intermittent pain but little disability, whereas afterwards she had considerable disability.
This is a key distinction.” (Id. at 3-4.)
Dr. Bodor explains that the likely mechanism of injury is injection of the vaccine
into the subacromial bursa and adjacent rotator cuff. (Ex. 24, p. 4 (citing Marko Bodor &
Enoch Montalvo, Vaccination-related shoulder dysfunction, 25 VACCINE 585 (2007) (Ex.
26); Brian P. McColgan & Frank A. Borschke, Pseudoseptic arthritis after accidental
intra-articular deposition of the pneumococcal polyvalent vaccine: a case report, 25(7)
AM. J. EMERG. MED. 1 (2007) (Ex. 27); S. Atanasoff et al., Shoulder injury related to
vaccine administration (SIRVA), 28 VACCINE 8049 (2010) (Ex. 28) (as filed as Ex. A, Tab
3)).) Further to this, he cites a case report to demonstrate that a preexisting full
thickness rotator cuff tear may make it more likely that the substance of the vaccine
would pass through the tear into the joint. (Id. (citing Andrew Neviaser & Jo A.
Hannafin, Adhesive Capsulitis: A review of current treatment, 38(11) Am. J. Spots Med.
2346 (2010) (Ex. 29)).) Dr. Bodor opines that vaccine deposition into the infraspinatus
and teres minor insertions is common in cases of SIRVA and that this would be
consistent with Dr. Widner’s finding of painful external rotation in Ms. Forrest’s case.
(Id.) He also opines that petitioner’s subsequent development of adhesive capsulitis as
diagnosed by Dr. Widner is also consistent with SIRVA. He explains that adhesive
capsulitis is a “true inflammatory disorder” and that SIRVA patients are at increased risk
of adhesive capsulitis compared to the general population. (Id.) Dr. Bodor
acknowledges that Ms. Forrest also reported some symptoms consistent with nerve
involvement but noted that after she was referred to a neurologist her EMG and
neurologic exam were normal. (Id.)
10 Dr. Bodor received his medical degree from the University of Cincinnati in 1987 and completed a
surgery internship at the University of California, San Diego, in 1988. (Ex. 25, p. 1.) He completed his
physical medicine and rehabilitation residency at the University of Michigan in 1993. (Id.) Along with
three fellows, he sees approximately 28 patients per day, where he performs diagnostic and therapeutic
procedures. (Id. at 2.) Dr. Bodor is affiliated with the UCSF Department of Neurological Surgery and the
UC Davis Department of Physical Medicine and Rehabilitation, collaborating in the care of patients and
teaching visiting faculty, fellows, residents, medical and pre-medical students. (Id.) He also serves as the
medical director of the Napa Medical Research Foundation, spending approximately 10-20 hours per
week supervising research assistants and PhD students. (Id.) Dr. Bodor was the first person to describe
vaccination-related shoulder dysfunction in the journal Vaccine in 2007, which was subsequently
renamed SIRVA by Atanasoff et al. in 2010. (Ex. 24, p. 1.) He has treated 15 patients with SIRVA in his
practice since 2007 and has reviewed over 35 SIRVA petitions for the VICP. (Id.)
10
b. Initial Report by Respondent’s Expert, Julie Y Bishop, M.D. 11
Although Dr. Bishop disagrees with Dr. Bodor’s assessment of Ms. Forrest’s own
clinical history, she does not offer any specific challenge to his explanation of how a
vaccine could, in general, significantly aggravate a preexisting shoulder condition. Dr.
Bishop opines that Ms. Forrest’s course both before and after the vaccination at issue is
consistent with a “waxing and waning” course of mild osteoarthritis and rotator cuff tear.
(Ex. A, p. 7.) She disagrees with Dr. Bodor’s assessment that her condition was
substantially worse post-vaccination and instead indicates that it was not until the
summer of 2015, when Ms. Forrest began experiencing falls and noted feeling a
popping in her arm, that the tempo of her care increased. (Id.) Dr. Bishop charges that
Dr. Bodor does not account for the “known and expected course of someone with Ms.
Forrest’s pre-vaccine shoulder condition.” (Id.)
Dr. Bishop agrees that Ms. Forrest may have experienced two days of mild post-
vaccination irritation of her shoulder as she reported, but also notes that this was noted
to have improved and that Ms. Forrest’s pain was otherwise documented as
intermittent, which is more consistent with osteoarthritis and rotator cuff disease. (Ex.
A, p. 8.) Dr. Bishop also acknowledges there was progression of Ms. Forrest’s
condition but opines that this progression cannot be explained by her vaccination. (Id.)
Dr. Bishop contends that Ms. Forrest’s objective imaging over time confirms the
progression of her preexisting shoulder dysfunction as the explanation of her clinical
course. (Id.) In particular, she stresses that the imaging shows the worsening of
petitioner’s rotator cuff tears over time. (Id.)
Further to this, Dr. Bishop explains that glenohumeral osteoarthritis is itself a
progressive condition with no treatment that can reverse or slow its natural progression.
Decreased function generally occurs over months to years. (Ex. A, p. 8.) Over time,
osteoarthritis results in pain and stiffness resulting in functional imitations, especially
with overhead activities and external rotation. (Id.) “The loss of motion is due to
capsular thickening and contraction and is a hallmark of the disease.” (Id.) Dr. Bishop
opines that Ms. Forrest’s condition, as documented by Dr. Widner, “clearly matches” the
course of osteoarthritis. (Id. at 9.) Dr. Bishop agrees with Dr. Widner’s diagnosis of
adhesive capsulitis but disagrees with Dr. Bodor’s attribution of that adhesive capsulitis
11 Dr. Bishop serves as a professor in the department of Orthopaedic Surgery at the Ohio State
University, Wexner Medical Center, as well as Chief of the Division of Shoulder surgery, and Vice Chair of
Finance for the Orthopaedic Department. (Ex. A, p. 1.) As a shoulder specialist, all of Dr. Bishop’s
research interests, publications, book chapters, and presentations have been on the treatment of
shoulder pathology. (Id.; Ex. B pp. 9-41.) Dr. Bishop has treated multiple patients with SIRVA in her
practice over the years and has published in this area as well. (Id.) Dr. Bishop received her medical
degree from Cornell University Medical College in 1997. (Ex. B, p. 1.) She completed fellow training in
2003 specifically in shoulder surgery (fellowship at Mount Sinai Hospital in New York City) and
Orthopaedic sports medicine (visiting fellowship at the University of Pittsburg Medical Center). (Ex. A, p.
1.) She is board certified in orthopedic surgery. (Ex. B, p. 2.) Dr. Bishop is also a fellow of the American
Academy of Orthopaedic Surgeons, an active member of the American Shoulder and Elbow Surgeons, a
member of the American Orthopaedic Society for Sports Medicine as well as an elected member of the
American Orthopaedic Association. (Ex. A, p. 1.)
11
to vaccination. (Id.) Whereas Dr. Bishop agrees that primary idiopathic adhesive
capsulitis may be associated with SIRVA, she asserts that Ms. Forrest had secondary
adhesive capsulitis related to her underlying osteoarthritis. (Id.)
According to Dr. Bishop, “[a]nother hallmark finding of [glenohumeral
osteoarthritis] is that the pain is often intermittent and can be aggravated by various
activities, thus there are times when it flares up and times when it calms down.” (Ex. A,
p. 9.) This, she concludes, “is in step with [Ms. Forrest’s] statements that her symptoms
were intermittent and when aggravated, the pain was present for a short period of time.”
(Id.) Dr. Bishop further indicates that Ms. Forrest’s documented falls may also have
contributed to the progression of her rotator cuff tear and also aggravated her
underlying osteoarthritis. (Id. at 10.)
With regard to neurologic symptoms, Dr. Bishop disagrees that these symptoms
could be referred from the shoulder. (Ex. A, p. 10.) Rather, Dr. Bishop stresses that
Ms. Forrest had documented degenerative disc disease that likely explains her
neurologic symptoms. (Id.) Nonetheless, Dr. Bishop characterizes the neurologic
symptoms as “nonspecific” and explains that while the neurologic condition may explain
Ms. Forrest’s difficulty with fine skills, her pain and reduced range of motion in her
shoulder are related to her rotator cuff and arthritic changes. (Id.)
c. Subsequent Reports by the Parties’ Experts
After providing their initial opinions, both parties’ experts filed multiple
supplemental reports. (Exs. 31, 35, 41, C-F.) I have carefully reviewed all of these
reports; however, it is not necessary to summarize each report. A substantial portion of
the analysis contained in these reports relates to the question of whether neurologic
symptoms of numbness and tingling can be seen among patients experiencing shoulder
conditions. However, as explained above, even though the experts differ on their
interpretation of the neurologic symptoms at issue in this case, they both nonetheless
also opine that Ms. Forrest’s clinical history is largely explained by her shoulder
pathology. Whether Ms. Forrest’s numbness and tingling into her hand is consistent
with the shoulder pathology itself or separately explained by an additional condition is
immaterial to resolving whether that agreed upon shoulder pathology was aggravated
by her vaccination.
V. Party Contentions
a. Petitioner’s Motion
In her motion for a ruling on the record, petitioner focuses exclusively on the
significant aggravation claim included in her amended petition. (ECF No. 85.)
Petitioner argues that while Ms. Forrest had a history of osteoarthritis and a rotator cuff
tear, “[t]he difference in symptomology in the right shoulder from before to after the
vaccine administration was dramatic” and constitutes a significant aggravation of Ms.
Forrest’s condition inclusive of adhesive capsulitis, severe pain, and loss of range of
motion. (Id. at 1.)
12
Petitioner stresses that under a Loving analysis for significant aggravation,
respondent is incorrect to suggest (through his expert) that Ms. Forrest’s preexisting
condition should be evaluated by looking to the expected course of the underlying
conditions. (ECF No. 85, p. 15.) Rather, petitioner indicates that under the legal
standard at issue only petitioner’s pre- and post-vaccination conditions may be
compared and petitioner is not obligated to prove that her post-vaccination condition is
worse than her expected outcome. (Id. at 15-16) (quoting Sharpe v. Sec’y of Health &
Human Servs., 964 F.3d 1072, 1082 (Fed. Cir. 2020).)
Petitioner argues that through Dr. Bodor she has set forth a mechanism of
significant aggravation that is “essentially the same as any SIRVA injury.” (ECF No. 85,
p. 16.) That is, petitioner argues that the significant aggravation in this case was
caused by injection of a vaccine into the subacromial bursa and adjacent rotator cuff.
(Id.) She further argues that this is consistent both with Ms. Forrest’s treating
physician’s assessment and the medical literature filed in this case. (Id. at 16-18.)
Further to this, petitioner argues that the medical records are clear in attributing Ms.
Forrest’s worsened condition to her vaccination, both in terms of the history she
provided and the treating physician’s assessment, and that the timing is medically
appropriate for vaccine-causation. (Id. at 18-20.) Thus, petitioner argues that she has
proven Loving prongs four through six. (Id.)
b. Respondent’s Response
Respondent agrees that a Loving analysis is the relevant legal framework. (ECF
No. 87, p. 10.) However, respondent counters that nothing in the Sharpe decision cited
by petitioner “prohibits respondent from introducing, or the special master from
considering, evidence that petitioner’s post-vaccination clinical course is consistent with
the expected clinical course of the condition, and that the vaccine was therefore not a
‘substantial factor’ in aggravating that condition.” (Id. at 11.) Respondent contends that
petitioner has failed to demonstrate by preponderant evidence that Ms. Forrest’s
vaccination was a substantial factor in causing a significant aggravation of her
preexisting condition as opposed to her condition having evolved “in a manner wholly
consistent with the natural progression of her diagnoses, perhaps with accelerations
caused by falls and other incidents.” (Id. at 12.)
Regarding petitioner’s theory of causation, respondent contends that Dr. Bodor’s
theory is not supported by any medical literature and further that petitioner is engaged in
conflation when she equates a primary de novo shoulder injury and the worsening of a
pre-existing shoulder injury. (ECF No. 87, p. 13.) Respondent stresses that none of the
cited literature supports vaccines as the cause of a progression of a rotator cuff tear and
asserts that the literature is inapposite. (Id.) In contrast to the evidence petitioner has
cited regarding Ms. Forrest’s own history, respondent stresses the evidence Dr. Bishop
has brought forward regarding the fact that glenohumeral arthritis and rotator cuff tears
naturally progress over time, arguing that Ms. Forrest’s history is consistent with this
type of progression. (Id. at 13-19.) Further to this, respondent disputes that Ms. Forrest
had primary adhesive capsulitis caused by her vaccination. (Id. at 19-20.) Finally,
because respondent distinguishes the two days of post-vaccination petitioner
experienced as temporary irritation separate from her broader condition, respondent
13
contends that petitioner has not demonstrated a medically acceptable temporal
relationship between Ms. Forrest’s vaccination and her worsened condition. (Id. at 21-
22.)
c. Petitioner’s Reply
In her reply, petitioner contends that respondent is seeking to “complicate” this
case. Petitioner stresses several aspects of the medical records to illustrate why she
believes the significant aggravation in this case is clear cut. She contends that “[t]here
is significant, credible evidence that the flu vaccination Ms. Forrest received on
December 16, 2014, either directly caused, or significantly aggravated, Ms. Forrest’s
increased shoulder symptomology.” (ECF No. 88, p. 3.) Petitioner further stresses that
because she has presented a prima facie case of vaccine-caused significant
aggravation, she is not required to eliminate alternative causes of her injury. She
contends that respondent has not, in turn, presented preponderant evidence that Ms.
Forrest’s injury was due to a factor unrelated to vaccination (namely the natural
progression of her pre-existing shoulder conditions). (Id.) That is, respondent has not
presented preponderant evidence satisfying his own burden of proof that eliminates Ms.
Forrest’s vaccination as a substantial factor in her subsequent symptomology. (Id. at 4.)
In that regard, petitioner stresses that respondent has conceded that Ms. Forrest
suffered a post-vaccination inflammatory response and that his expert has failed to
address the fact that Ms. Forrest’s own treating physician concluded that this
inflammatory reaction caused a significant aggravation of her shoulder prior shoulder
condition. (Id. at 3.)
VI. Analysis
a. Petitioner’s Table Injury claim
Although the parties focus on significant aggravation in their briefing, I first note
in the interest of completion that petitioner has not demonstrated a Table Injury of
SIRVA as pleaded in the original petition. The first SIRVA QAI prong requires “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.” 42
CFR §100.3(c)(10). The Table SIRVA criteria does not necessarily require a spotless
prior health history of the affected shoulder. Compare, O’Leary, M.D. v. Sec’y of Health
& Human Servs., 18-584V, 2021 WL 3046617, at *8 (Fed. Cl. Spec. Mstr. June 24,
2021) (finding petitioner suffered a Table SIRVA despite an “old history of trauma to his
shoulder” that had previously resolved); and, Clark v. Sec’y of Health & Human Servs.,
18-813V, 2022 WL 16635681 (Fed. Cl. Spec. Mstr. Feb. 7, 2022) (finding that
“[a]lthough a total shoulder replacement relieved much of petitioner’s earlier severe
shoulder pain, it appears, contrary to petitioner’s contention, that it never fully
resolved.”). However, as discussed further below, I find that this case represents a
significant aggravation of Ms. Forrest’s preexisting shoulder condition. In short, Ms.
Forrest’s medical records confirmed she had preexisting shoulder dysfunction confirmed
by objective imaging and medical records created shortly before vaccination indicated
14
her shoulder complaints were still symptomatic. Further, when she presented for care
post-vaccination, her treating physicians understood her symptoms as an exacerbation
of her preexisting shoulder dysfunction. And, indeed, this is also how petitioner’s expert
approaches his causal opinion. Therefore, petitioner cannot demonstrate that Ms.
Forrest’s history is compatible with the first SIRVA criterion. Accord Kelly v. Sec’y of
Health & Human Servs., No. 17-1918V, 2022 WL 1144997 (Fed. Cl. Spec. Mstr. Mar.
24, 2022).
b. Petitioner’s Significant Aggravation Claim
i. Petitioner’s condition prior to administration of the vaccine
(Loving prong one)
In light of all of the above, and upon consideration of the record as a whole, I find
that the following is supported by preponderant evidence: Prior to the vaccination at
issue Ms. Forrest had right shoulder rotator cuff disease and glenohumeral joint
osteoarthritis. (See, e.g. Ex. A, p. 7; Ex. 31, p. 1.) Ms. Forrest had a confirmed rotator
cuff tear with only “minimal”/”no significant” tendon retraction. (Ex. 2, p. 5.) Prior to
vaccination, symptoms associated with these conditions were occasionally exacerbated
by isolated events (Ex. 4, pp. 20, 24); however, Ms. Forrest was not experiencing
continuous disability. She had a baseline of ongoing pain and reduced range of motion
that was “not overly concerning.” (E.g. Ex. 4, p. 20.) The medical records confirm that
shortly before the vaccination at issue, on November 4, 2014, Ms. Forrest was
experiencing only mild pain that she was satisfied managing with home exercise and
herbal remedies. (Ex. 4, pp. 20, 40.)
ii. Petitioner’s current condition/condition after administration of the
vaccine (Loving prong two)
In light of all of the above, and upon consideration of the record as a whole, I find
that the following is supported by preponderant evidence: After vaccination, Ms. Forrest
suffered an “exacerbation” of her prior shoulder pain along with reduced range of motion
that both she and her primary care provider attributed to her vaccination. (Ex. 4, p. 47;
Ex. 2, p. 31.) Her primary care physician initially focused on her reported severe pain
for the two days following her vaccination followed by continued, but intermittent, pain,
the pattern of which was generally consistent with symptoms of her prior shoulder
dysfunction, but the severity of which was worse than she had been experiencing prior
to vaccination. (Id. at 46; Ex. A, p. 8.) Eventually, her treating orthopedist diagnosed
adhesive capsulitis in addition to her prior rotator cuff tear as explanation for her
stiffness and reduced range of motion. (Ex. 2, pp. 31, 33.) By the time of her
orthopedic presentation in early July of 2015, Ms. Forrest’s post-vaccination pain and
reduced range of motion had improved but not completely resolved. (Ex. 2, p. 31.)
Subsequently, Ms. Forrest had imaging performed on multiple occasions that confirmed
progression of her rotator cuff tear, though her osteoarthritis was still only mild to
moderate (Ex. 2, p. 42; Ex. 10, pp. 6-7; Ex. 8, p. 9.); however, this imaging was
captured after Ms. Forrest experienced a separate exacerbation of her condition in that
she reported falls to which she had attributed a “pop” in her shoulder and increased
15
pain. (Ex. 15, p. 20; see also Ex. 4, pp. 63, 66.) Thus, Ms. Forrest’s subsequent history
after late July of 2015 is less informative of her condition during the months following
her vaccination.
iii. Whether the post-vaccination condition is a “significant
aggravation” of the prior condition (Loving prong three)
The Vaccine Act defines significant aggravation as “any change for the worse in
a preexisting condition which results in markedly greater disability, pain, or illness
accompanied by substantial deterioration of health.” § 300aa-33(4). Here, consistent
with the statutory definition, a comparison of the findings of fact under Loving prongs
one and two shows that Ms. Forrest’s post-vaccination condition reflects a change for
the worse in her pre-vaccination condition inclusive of pain and disability as well as a
physical deterioration in health during the months following her vaccination. Indeed,
respondent agrees that Ms. Forrest’s condition deteriorated in the three years following
her vaccination. (ECF No. 87, p. 12.) What respondent disputes is that this
deterioration was vaccine-caused. (Id.) This is addressed relative to Loving prongs
four through six below.
iv. Medical theory of causation (Loving prong four/Althen prong
one)
Petitioner is required to present a persuasive medical theory of causation
demonstrating that the influenza vaccine could have significantly aggravated Ms.
Forrest’s preexisting 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
12In 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 for compensation. If the petitioner sustained or had significantly
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 sufficient evidence of
causation; evidence in the form of scientific studies or expert medical testimony is
necessary to demonstrate causation for such a petitioner. (Such a finding of causation is
16
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/Loving prong four 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/Loving prong five, 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. Bodor’s theory is not explained in depth, but exists in the form of two
assertions. First, he opines that “[t]he mechanism of injury most likely involved injection
of vaccine into the subacromial bursa and adjacent rotator cuff.” (Ex. 24, p. 4.) Among
the accompanying citations, Dr. Bodor includes a publication of two case reports of
which he is coauthor. In that report, he explains that “[w]e hypothesize that in both of
our cases vaccine was injected into the subdeltoid bursa, causing a robust local
immune and inflammatory response” ultimately leading to inflammation of the shoulder
capsule due to the subdeltoid bursa being contiguous to the subacromial bursa. (Bodor
& Montalvo, supra, at Ex. 26, p. 2.) Second, he opines that “the misplaced injection
likely led to adhesive capsulitis.” (Ex. 24, p. 4.) This was the ultimate resulting
condition in one of Dr. Bodor’s own two case reports. (Bodor & Montalvo, supra, at Ex.
26, pp. 2-3.) Further to this, Dr. Bodor cites the Atanasoff article, which is well known in
SIRVA litigation. In pertinent part, the Atanasoff authors hypothesized 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 findings 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.
deemed to exist for those injuries listed in the Table which occur within the time period set
forth in the Table.)
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).
17
(Atanasoff et al., supra at Ex. 28, p. 3.)
For respondent, Dr. Bishop offers no critique that would challenge Dr. Bodor’s
first assertion. In fact, she agrees that “[a] vaccine could cause some irritation of the
shoulder joint . . . .” (Ex. A, p. 8.) Instead, Dr. Bishop contends with regard to Dr.
Bodor’s second assertion that his theory conflates primary adhesive capsulitis and
secondary adhesive capsulitis. (Ex. A, p. 9.) However, the distinction Dr. Bishop raises
constitutes a Loving prong five rather than Loving prong four question. Dr. Bishop
states in relevant part that “[p]rimary adhesive capsulitis, what Dr. Bodor is referring to
in his report, is a condition that affects 3-5% of the population between ages of 30 and
60, and only this type of adhesive capsulitis has been associated with SIRVA cases.” 13
(Id. (citing Atanasoff et al., supra, at Ex. A, Tab 3; Beth Hibbs et al., Reports of atypical
shoulder pain an dysfunction following inactivated influenza vaccines, Vaccine Adverse
Event Reporting System (VAERS), 2010-2017, 38 Vaccine 1137 (2020) (Ex. A, Tab
4)).) By Dr. Bishop’s description, primary adhesive capsulitis is idiopathic and
“associated with capsular inflammation in the absence of a known lesion.” (Ex. A, p. 9.)
In contrast, secondary adhesive capsulitis is a term used to describe “a constellation of
conditions that result in stiff shoulder” secondary to “an underlying condition/pathology.”
(Id.) Thus, Dr. Bishop is not actually challenging whether an inflammatory vaccine
response can cause adhesive capsulitis. She acknowledges that this association has
been observed. Rather, she is observing that some cases of what appears to be
adhesive capsulitis are otherwise explained by known shoulder dysfunction. 14
In his motion response, respondent stresses Dr. Bishop’s statement that “[t]here
is no literature at all to support that an influenza vaccine can cause progression of a
rotator cuff tear or influence the progress course of pre-existing arthritis.” (ECF No. 87,
pp. 12-13 (quoting Ex. A, p. 9.) Further to this, respondent argues in reference to both
Dr. Bodor’s above-discussed case report and the Atanasoff article that “[a]lthough the
Atanasoff article theorizes that vaccination could cause symptoms to manifest in
patients with pre-existing, asymptomatic RTC tears, neither of these articles mention the
possibility that a vaccination could actually cause progression of a pre-existing RTC tear
or pre-existing shoulder OA.” (Id. at 13 (emphasis original).) Importantly, however, these
assertions reflect respondent’s interpretation of Ms. Forrest’s clinical history rather than
petitioner’s. They do not directly refute the causal theory petitioner actually presented,
which is based on a vaccine-caused inflammatory irritation of the joint capsule and
ultimately adhesive capsulitis rather than progression of the underlying conditions
themselves. 15
13In his response, Dr. Bodor took this statement as agreement that primary adhesive capsulitis is, in fact,
associated with SIRVA without addressing the further contention that this would not extend to secondary
adhesive capsulitis. (Ex. 31, p. 1.) Dr. Bishop noted this in her responding report. (Ex. C, p. 2.) This
specific point was not addressed any further in any of the subsequent expert reports.
14 In fact, as discussed further with respect to Loving prong five, below, Dr. Bishop cites to literature that
actually contends that the term “secondary adhesive capsulitis” is effectively a misnomer when applied in
the manner Dr. Bishop invokes.
15In Kelly v. Secretary of Health & Human Services, I explained that a limitation of the Atanasoff article in
the context of significant aggravation is that it constitutes a descriptive analysis without comparison to
18
v. Logical sequence of cause and effect connecting the
vaccination and significant aggravation (Loving prong
five/Althen prong two)
The second Althen prong/fifth Loving 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”).
As discussed above, there is preponderant evidence that Ms. Forrest
experienced increased pain and reduced range of motion post-vaccination relative to
her prior baseline. Her primary care physician considered this an “exacerbation” of her
prior shoulder complaints likely caused by her vaccination 16 and her orthopedist
subsequently diagnosed a post-vaccination onset of adhesive capsulitis with capsular
background rates or controls and excludes subjects with preexisting shoulder conditions. 2022 WL
1144997 at *22. The Atanasoff authors further explain that there are no diagnostic tests available to
assess whether the shoulder dysfunction they observed was vaccine-caused, leaving only their ability to
clinically isolate the onset of symptoms to identify post-vaccination shoulder injuries as a distinct entity.
(Atanasoff et al., supra, at Ex. 28, p. 4.) Thus, while the Atanasoff hypothesis is not wholly irrelevant to
the significant aggravation context, the article itself is not helpful in distinguishing under what
circumstances it would be reasonable to conclude that a vaccine can cause a worsening of the clinical
presentation of a preexisting condition that is already symptomatic. In Kelly, the petitioner overcame this
limitation by providing epidemiology that showed a statistically significant risk of post-vaccination bursitis
where the Kelly petitioner himself had evidence of bursitis. Kelly, 2022 WL 1144997 at *22-23. Here, the
specific expert presentations regarding adhesive capsulitis as discussed relative to both Loving prongs
four and five, and the diagnosis of adhesive capsulitis arising post-vaccination, play a similar role. Had
the contours of the expert opinions in this case been different, and had Dr. Bishop more directly
challenged Dr. Bodor’s theory as a matter of general rather than specific causation, it is not clear that the
literature Dr. Bodor relied upon would be persuasive without more.
16 To be clear, in identifying an “exacerbation” of Ms. Forrest’s condition, Dr. Allred does include a
reference to a possible “progression” of Ms. Forrest’s rotator cuff tear (Ex. 4, p. 47), which I explained
relative to Loving prong four is not petitioner’s medical theory of the case. However, considering his
impression as a whole, it is clear that this is not the sum total of Dr. Allred’s opinion. He also cites a post-
vaccination inflammatory process, bursitis, and nerve injury as possible mechanisms. On the whole it is
clear that his impression balances his knowledge of Ms. Forrest’s chronic conditions against her more
acute presentation to opine that the chronic conditions alone do not explain her presentation. Although
this ruling repeatedly references his use of the term “exacerbation” as a shorthand, the medical record as
a whole reflects a medical opinion consistent with significant aggravation regardless of the specific use of
that term.
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irritability as an additional overlay to her preexisting rotator cuff disease. (Ex. 4, p .47;
Ex. 2, pp. 32-33.) Based on his analysis of Ms. Forrest’s complete medical history and
his theory of causation, petitioner’s expert opines that this constitutes a significant
aggravation of her condition in the form of worsened symptoms and a vaccine-caused
adhesive capsulitis. (Ex. 31.) Respondent’s contrary view raises two overarching
questions: (1) whether Ms. Forrest’s adhesive capsulitis diagnosed post-vaccination
must be understood as secondary to her preexisting shoulder dysfunction; and (2)
whether Ms. Forrest’s post-vaccination presentation is explained by the natural
progression of her preexisting condition. Respondent asserts the answer to both
questions is yes, thereby defeating petitioner’s claim that Ms. Forrest’s vaccine did
substantially contribute to a worsening of her condition. However, this is not
persuasive.
There are significant limitations regarding Dr. Bishop’s opinion that Ms. Forrest’s
adhesive capsulitis must necessarily be understood as secondary to her preexisting
condition(s) to the exclusion of a vaccine-caused inflammatory process. First, the
literature Dr. Bishop cites explains that the question is one of clinical judgment. While
underlying shoulder pathology can be a cause of the symptoms of adhesive capsulitis,
these materials do not support any contention that preexisting shoulder pathology per
se explains adhesive capsulitis. Neviaser and Hannafin explain that “[d]iagnosis can be
challenging as factors both intrinsic and extrinsic to the shoulder can cause stiffness
and pain.” (Neviaser & Hannafin, supra, at Ex. 29, p. 1 (also filed as Ex. A, Tab 2).)
“Distinguishing between primary or idiopathic disease and pain due to other causes can
be difficult and there is frequent overlap.” (Id. at 2.) “Subtle clues in the history and
physical examination allow discrimination of primary adhesive capsulitis from these
other conditions.” (Id.)
Here, although the medical records are not robust, the expressed views of the
treating physicians are closer to petitioner’s view than respondent’s. Given his ongoing
treatment relationship with Ms. Forrest spanning both her pre- and post- vaccination
history, Dr. Allred was well positioned to exercise clinical judgment in determining
whether Ms. Forrest’s own preexisting shoulder pain was exacerbated by extrinsic
factors. 17 The Federal Circuit has recognized that “treating physicians are likely to be in
the best position to determine whether ‘a logical sequence of cause and effect show[s]
that the vaccination was the reason for the injury.’” Capizzano, 440 F.3d at 1326(quoting Althen, 418 F.3d at 1280); Nuttall v. Sec'y of Health & Human Servs., 122 Fed.
Cl. 821, 832 (2015) (noting the importance of the prior treatment relationship in giving
special weight to treating physician opinions), aff'd, 640 F. App'x 996 (Fed. Cir. 2016).
Second, the literature Dr. Bishop cites further explains that the term “secondary
adhesive capsulitis” is used in two distinct contexts. In some cases, it is used to refer to
17 Ms. Forrest’s primary care records show that a number of different physicians were involved in her care
in the years prior to her vaccination. (Ex. 4, passim.) However, Dr. Allred was the physician that saw Ms.
Forrest during her last encounter prior to vaccination. (Id. at 40-43.) He was also involved in her care in
an attending capacity during prior encounters where she had reported prior inciting events that had
aggravated her shoulder pain. (Id. at 20-27.) Thus, he was familiar with both her overall history and her
baseline just prior to vaccination.
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“extra-articular cause(s) of shoulder stiffness without involvement of the joint capsule.”
(Neviaser & Hannafin, supra, at Ex. 29, p. 2 (Ex. A, Tab 2).) This is the context in which
secondary adhesive capsulitis may be explained by conditions such as glenohumeral
arthritis and rotator cuff injury. (Id.) However, that use is effectively a misnomer. In
contrast, “secondary adhesive capsulitis” may also be used to refer to isolated areas of
capsular contracture that occur concurrently with other known injuries or diseases. (Id.)
In that context, secondary adhesive capsulitis may be “indistinguishable from idiopathic
adhesive capsulitis.” (Id.) “The differentiation between the stiff and painful shoulder
without any joint capsule involvement and with capsule involvement (true adhesive
capsulitis) must be established before a rational treatment can be prescribed.” (RJ
Neviaser & TJ Neviaser, The frozen shoulder: diagnosis and management, 2223 CLIN.
ORTHOP. RELAT. RES. 59 (1987) (Ex. A, Tab 5).) 18 “Although frozen shoulder and
adhesive capsulitis are frequently used interchangeably, recognition that many
conditions can cause a stiff and painful shoulder while adhesive capsulitis is a distinct
pathological entity is essential for evaluating both patients and the literature.” (Neviaser
& Hannafin, supra, at Ex. A, Tab 2, p. 1.) The cause of true adhesive capsulitis is not
known, but it has been linked to many preceding factors, including trauma and
autoimmune disease. (Id.) And importantly, as Dr. Bishop recognizes, it has also been
linked to vaccination. (Ex. A, p. 9.)
In this case, Dr. Widner’s treating orthopedic assessment does not use the
specific terminology of “primary” or “secondary” to describe Ms. Forrest’s adhesive
capsulitis; however, on physical examination he recorded “capsular irritability,” which
strongly suggests his opinion was that Ms. Forrest had capsule involvement, i.e. true
adhesive capsulitis. (Ex. 2, pp. 32-33.) Thus, Dr. Bishop is not persuasive with respect
to her suggestion that Ms. Forrest’s own adhesive capsulitis is readily distinguishable
from the type of primary or idiopathic adhesive capsulitis that is associated with
vaccination. Dr. Bishop’s opinion on this point is also less persuasive because she
acknowledges that Ms. Forrest did experience at least temporary irritation of the
shoulder joint caused by her vaccination and therefore relies on the notion that Ms.
Forrest’s subsequently diagnosed adhesive capsulitis is merely coincidental to this
irritation despite the fact that her other shoulder dysfunction had existed for years prior
and despite seeming to accept that vaccinations can lead to adhesive capsulitis. (Ex. A,
p. 8.)
With regard to the second question raised by respondent’s defense, while it is
undoubtedly true that rotator cuff tears and osteoarthritis can both progress over time
generally, both Dr. Bishop and respondent acknowledge that this is not Ms. Forrest’s
own history. Dr. Bishop stated that “[i]n addition to just the element of time, Ms. Forrest
had many documented falls over the years and [it] is certainly possible that any of her
falls, especially the ones that precipitated a call to see her doctor, could have led to
progression of her rotator cuff tear and would have certainly aggravated her significant
18 Respondent’s Exhibit A, Tab 5, appears to be only the abstract of the article by Neviaser & Neviaser.
This quote from the abstract simply underscores the differentiation of adhesive capsulitis with capsular
involvement specifically as “true” adhesive capsulitis, which is also consistent with the substance of the
Neviaser & Hannafin article. (See Neviaser & Hannafin, supra, at Ex. 29 (also filed as Ex. A, Tab 2).)
21
underlying osteoarthritis. (Ex. A, p. 10.) Thus, even by respondent’s own
characterization it is not the case that the progression of Ms. Forrest’s condition is
explained merely by the passage of time or the general nature of her degenerative
conditions as progressive. Indeed, while Dr. Bishop explains that it is a “hallmark” of
osteoarthritis that “there are times when it flares up and times when it clams down,” she
specifically couches these flares as constituting “aggravat[ions]” of the osteoarthritis.
(Ex. A, p. 9.) In that context, respondent offers little reason for his disbelief that Ms.
Forrest’s vaccination would constitute a further aggravating event occurring in the
course of a condition he acknowledges to have otherwise been aggravated multiple
times. As noted above, this is especially difficult to accept given that Dr. Bishop agrees
that Ms. Forrest likely did suffer at least a limited inflammatory reaction within her
shoulder joint. (Ex. A, p. 8.)
To the extent Dr. Bishop relies on Ms. Forrest’s objective imaging to confirm the
progression of Ms. Forrest’s preexisting conditions, the later imagining available for
comparison post-dates the falls that Dr. Bishop agrees were likely to have been
contributory. (Ex. A, p. 9 (citing Ex. 2, p. 42; Ex. 7, p. 36).) Thus, the imaging is not
evidence of a “natural” progression of the underlying conditions and is not suggestive of
the condition of Ms. Forrest’s shoulder between the time of her vaccination and the
subsequent falls. Further to this, it was the opinion of Ms. Forrest’s primary care
physician, who followed her shoulder condition both before and after the vaccination,
that the post-vaccination presentation constituted an “exacerbation” of her condition
rather than being explained as part of a waxing and waning course of the condition. In
any event, petitioner is not obligated to prove that Ms. Forrest’s ultimate outcome was
worse than the expected course of her condition. Sharpe, 964 F.3d at 1082. Rather,
petitioner is obligated to demonstrate that Ms. Forrest’s vaccination was a substantial
factor that affected her condition. Id. (citing Locane v. Sec’y of Health & Human Servs.,
685 F.3d 1375 (Fed. Cir. 2012). Thus, even if Ms. Forrest’s later falls obscured whether
her post-vaccination adhesive capsulitis meaningfully contributed to her later history,
this would not defeat a claim based on the arc of symptoms she experienced in the
months following her vaccination.
vi. Proximate temporal relationship between vaccination and
significant aggravation (Loving prong six/Althen prong three)
The third Althen prong/sixth Loving 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).
Here, petitioner argues that the medical records reflect an onset of Ms. Forrest’s
post-vaccination symptoms that was “almost immediate,” stressing Ms. Forrest’s initial
report to her primary care provider that she had severe pain during the two days
following her vaccination. (ECF No. 85, p. 19.) Petitioner argues this is appropriate
22
timing when compared against the 48-hour onset reflected on the Vaccine Injury Table
for SIRVA. (Id.) Although this is not a Table SIRVA claim, petitioner argues that she
has set forth a mechanism of significant aggravation that is “essentially the same as any
SIRVA injury.” (Id. at 16.) Thus, for example, the above-discussed Atanasoff article
likewise indicates that a clear majority of subjects experienced onset of shoulder pain
within 24 hours of vaccination. (Atanasoff et al., supra, at Ex. 28, p. 2 (Table 1).)
Respondent does not dispute any of these points but contends that the two days of
post-vaccination pain that Ms. Forrest reported are separate from her ongoing
symptoms that are better attributed to her osteoarthritis and her rotator cuff tear. (ECF
No. 87, p. 12.) In particular, respondent argues that “petitioner improperly conflates the
brief period of pain decedent reported in the days immediately following vaccination with
the ongoing progression of her RTC tear and OA” and further that “considering the
record as a whole, Dr. Bishop opines that any symptoms after May 15, 2015, were
unrelated and instead represented the natural course of her pre-existing shoulder
pathology.” (Id. at 21.) There are two issues with this line of reasoning.
First, to the extent respondent appears to contend Ms. Forrest suffered only a
couple days of distinct pain, this misinterprets Ms. Forrest’s initial encounter with her
primary care physician on January 19, 2015. (Ex. 4, p. 46.) Respondent is correct that
the history of present illness specifically reports that petitioner had “severe pain and
difficulty lifting her right should[er] during the 2 days following her flu shot.” (Id.)
However, it also states that “[t]he pain has caused multiple sleepless nights since that
time and persists until today.” (Id.) Thus, the medical records do not support any
contention that the reference to two days of severe post-vaccination pain represented
an isolated and unrelated phenomenon. Even accounting for Dr. Bishop’s opinion that
the intermittency of symptoms reported as part of this history is consistent with how
osteoarthritis and rotator cuff tears present, this has far less significance in the context
of significant aggravation. Dr. Allred, who had previously treated Ms. Forrest, was
aware of Ms. Forrest’s preexisting shoulder dysfunction and concluded that the history
she reported was consistent with an exacerbation of the symptoms of her own
condition. (Ex. 4, pp. 20, 24, 40, 47.) Inherent to that opinion would be an
understanding that the complained of symptoms are consistent with known
symptomology of the preceding condition only worse than they had been before.
Second, respondent’s reliance on the May 15, 2015, follow up encounter is also
misplaced. Respondent contends that the fact that Ms. Forrest’s condition was “almost
resolved” is evidence that it was more likely “associated with a mild irritation caused by
her vaccination.” (ECF No. 87, p. 21 (quoting Ex. A, p. 8).) While respondent is correct
that this record provides a history that Ms. Forrest’s pain “has slowly been improving”
and, in fact, reportedly was “almost resolved,” her medical records do not reflect this as
the termination of either the course of her condition or her relevant treatment of that
condition. (Ex. 4, p. 50.) Specifically, although Dr. Allred recorded “interval
improvement” in Ms. Forrest’s shoulder pain, he referred her to physical therapy at that
time. (Id. at 51.) Moreover, Ms. Forrest subsequently sought further follow up
treatment from an orthopedist where in July of 2015 she received her adhesive
23
capsulitis diagnosis based in part on a history of more severe symptoms over the prior
six months. (Ex. 2, p. 33.)
c. Factor Unrelated
Once petitioner has satisfied her own burden pursuant to the Loving test, the
burden shifts to respondent to demonstrate that the injury was caused by factors
unrelated to vaccination. § 300aa-13(a)(1)(B); Deribeaux v. Sec’y of Health & Human
Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013). In order to meet his burden, respondent
must demonstrate by preponderant evidence “that a particular agent or condition (or
multiple agents/conditions) unrelated to the vaccine was in fact the sole cause (thus
excluding the vaccine as a substantial factor).” de Bazan, 539 F.3d at 1354. In this
case, respondent has argued that Ms. Forrest’s vaccination was not a substantial factor
in bringing about her alleged injury. Respondent’s arguments have been considered in
the context of the above Loving analysis. Because his arguments were unpersuasive in
that context, they likewise fail to suggest he has met his own burden of proof.
VII. 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 has
demonstrated that Ms. Forrest suffered a significant aggravation of her pre-existing
shoulder injury caused-in-fact by her December 16, 2014, flu vaccination. A separate
damages order will be issued.
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
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