Forrest v. Secretary of Health and Human Services

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); §

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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.)

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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.)

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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

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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.

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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).)

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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

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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

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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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