Brennom v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 21-51V

UNPUBLISHED

JANE BRENNOM, Chief Special Master Corcoran

Petitioner, Filed: October 6, 2023

v.

Special Processing Unit (SPU);

SECRETARY OF HEALTH AND Influenza (Flu) Vaccine; Shoulder

HUMAN SERVICES, Injury Related to Vaccine

Administration (SIRVA); Six Month

Respondent. Severity Requirement

Jessica Anne Olins, Maglio Christopher & Toale, PA, Seattle, WA, for Petitioner.

Christine Mary Becer, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION DISMISSING CASE 1

On January 5, 2021, Jane Brennom filed a petition for compensation under the

National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq. 2 (the

“Vaccine Act”). Petitioner alleges that she suffered a shoulder injury related to vaccine

administration (“SIRVA”) as a result of an influenza (“flu”) vaccine administered on

January 16, 2019. Petition at 1-2.

On June 14, 2022, Respondent filed Rule 4(c) Report opposing compensation,

arguing (among other things) that Petitioner cannot meet the Vaccine Act’s “severity”

requirement. An Order was issued requiring Petitioner to show cause why this claim

should not be dismissed for failure to establish injury severity. Order to Show Cause, ECF

No. 33. Petitioner responded on October 11, 2022. Petitioner’s Response to Order to

1 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, upon

review, I agree that the identified material fits within this definition, I will redact such material from public

access..

2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease

of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §

300aa (2012).

Show Cause and Motion for Findings of Fact and Conclusions of Law Regarding Severity

(“Response”), ECF No. 39.

For the reasons discussed below, I find Petitioner has not established that she

suffered the residual effects of her injury for more than six months, and therefore dismissal

of the claim is warranted.

I. Procedural History

Shortly after filing her Petition, Ms. Brennom filed declarations from herself and her

husband, plus the medical records required by the Vaccine Act. Exhibits 1-16, ECF Nos.

6-8, 10; see Section 11(c). On March 18, 2021, the case was activated and assigned to

the Special Processing Unit. ECF No. 11.

Respondent filed his Rule 4(c) Report a year later, opposing compensation

because of an inability to show severity. Rule 4(c) Report at 1-2 (citing Section

11(c)(1)(D)). In particular, given an intervening left arm injury from a blood draw and a

year-long gap in treatment from early June 2019 (less than five months post-vaccination)

until late June 2020 (more than one year later), “[i]t cannot be assumed that the shoulder

pain reported on June 30, 2020, was related to her flu vaccine on January 16, 2019.” Id.

at 5. Petitioner maintains in reaction that she can establish severity. Response at 21.

II. Factual Background

The medical records reveal that Petitioner was sixty seven years old at the time of

vaccination, and had previously suffered from conditions including osteoarthritis involving

multiple joints, herpes zoster without complication, type 2 diabetes, psoriasis, basal cell

carcinoma, obesity, cervical stenosis, frozen shoulder, and shoulder bursitis. See, e.g.,

Ex. 6 at 23-24; Ex. 16 at 49; Ex. 11 at 5. She underwent multiple surgeries including three

right shoulder arthroscopic surgeries in 2011 through 2013. Ex. 6 at 24; Ex. 11 at 6.

Petitioner was regularly seen by a rheumatologist for her osteoarthritis, the symptoms of

which included fatigue, swelling in the knees and fingers, and pain in the lower back,

knee, toes, neck, and shoulders. Ex. 6 at 5 (August 6, 2018 rheumatology visit). In her

affidavit,

On January 16, 2019, Petitioner received a flu vaccine in her left arm. Ex. 17 at 7.

Twice later that winter - on January 22, 2019, and February 4, 2019 - Petitioner saw her

rheumatologist, but did not report shoulder pain. Ex. 6 at 30-37, 49- 51. But she reported

the pain at a subsequent rheumatology visit on February 21, 2019.

An MRI of Petitioner’s left shoulder performed on March 4, 2019, revealed a partial

thickness supraspinatus tear, moderate infraspinatus and teres minor muscle edema, a

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SLAP tear that was “likely degenerative”, mild osteoarthritis, mild subacromial and

subdeltoid bursitis, and “severe infraspinatus tendinopathy”. Ex. 6 at 57. The muscle

edema and bursitis were noted as possibly related to the injection. Id. There were also

signs of severe infraspinatus tendinopathy, moderate infraspinatus and teres minor

muscle edema. Id.

On March 25, 2019, Petitioner returned to her rheumatologist who noted that the

MRI showed inflammation and bursitis “possibl[y] related to the injection site” or early

brachial plexus neuropathy. Ex. 6 at 40-45.

Petitioner was next seen by Dr. Mark Frankle at the Florida Orthopaedic Institute

on April 10, 2019, for left shoulder pain, which she reported had begun at the time of her

January vaccination. Ex. 2 at 8. A physical exam showed mild to moderate range of motion

restrictions but full strength. Ex. 2 at 10-12. She was diagnosed with a SIRVA and a

cortisone injection was administered. Id. at 12.

Several months later, on June 4, 2019, Petitioner returned to Dr. Frankle and

reported 75% improvement. Ex. 2 at 6. Dr. Frankle now noted that Petitioner “has made

excellent gains both subjective[ly] and objectively since her last visit”, but that she wanted

to try another injection. Id. A second cortisone injection was administered at that time. Id.

at 6-7.

After a three-month gap in treatment, Petitioner saw her primary care provider, Dr.

Beth Belof-Jasko, on August 6, 2019. Ex. 16 at 91. The record notes that Petitioner had

“complication of flu shot- bursitis of left shoulder this past winter,” but includes no mention

of ongoing or existing pain. Id. Then, after a lengthier gap, Petitioner returned to her

primary care physician in February 2020 - but for left elbow pain. Ex. 16 at 139. She now

reported that she had blood drawn three weeks prior and her left elbow has been sore

and tender since that time. She again made no mention of her prior SIRVA concerns.

After yet another treatment gap (and now and 18 months post-vaccination),

Petitioner returned to Dr. Frankle on June 30, 2020, complaining of left shoulder pain and

seeking another steroid injection. Ex. 2 at 14. She now reported her pain as eight out of

ten at that time, and another cortisone injection was administered. Id. at 15-16. She was

assessed with an inflamed rotator cuff with a history of an underlying vaccination causing

the need to treat.

A year later (June 2, 2021), she returned to orthopedist for a follow-up regarding

her left shoulder. Ex. 18 at 8-10. She reported that she was still experiencing shoulder

pain, and rated it as eight out of ten. Id. at 9. Further, Petitioner gave “a history of having

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had a vaccine Administration into her left arm” and “feels she is currently having a flare

up.” Id. An examination showed impingement symptomatology, but no reduced range of

motion. Id. at 10.

Petitioner was again seen for shoulder pain on August 3, 2022. Ex. 23 at 12-14.

The record notes that Petitioner “has been having pain in her shoulder for a couple of

years.” Id. at 14. She was diagnosed with tendinitis and mild-to-moderate degenerative

changes. Petitioner had a follow-up for her shoulder pain on September 14, 2022. Ex. 23

at 7. The record notes that Petitioner’s shoulder pain was “secondary to a flu vaccine

given in her left deltoid in 1/2019 resulting in post vaccine bursitis vs post vaccine

tendonitis.” Id. at 9.

Petitioner returned to Florida Orthopaedic Institute on September 14, 2022, with

complaints of pain in her left shoulder and tendinitis of the left rotator cuff. Ex. 23 at 13.

The record states on set of the left shoulder pain was June 4, 2019, and tendinitis onset

was August 5, 2022. Id.

Petitioner has submitted three affidavits in support of her petition. Ex. 12, 14, 20.

She states that her arm pain started immediately after the injection. Ex. 14 at 1. Petitioner

further described how the pain has affected her life and her course of treatment. Id. at 1-

3. She also described how Covid impacted her ability to seek treatment, indicating that

the gaps in treatment were due in part to a desire to avoid Covid exposure. Ex. 20 at 2.

Stephen Brennom, Petitioner’s husband, also submitted an affidavit in this case.

Ex. 13. Mr. Brennom states that Petitioner first complained of shoulder pain the day after

she got vaccinated, and that she became frustrated when local providers could not

identify a reason for her pain. Id.

Petitioner also submitted an expert report addressing causation and sequela. Ex.

24.

III. Legal Standard

Before compensation can be awarded under the Vaccine Act, a petitioner must

demonstrate, by a preponderance of evidence, all matters required under Section

11(c)(1), including the factual circumstances surrounding her claim. Section 13(a)(1)(A).

In making this determination, the special master or court should consider the record as a

whole. Section 13(a)(1). Petitioner’s allegations must be supported by medical records or

by medical opinion. Id.

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In particular, a petitioner must establish that she suffered an injury meeting the

Table criteria (i.e. a Table injury), in which case causation is presumed, or an injury

shown to be caused-in-fact by the vaccination she received. If a petitioner establishes

a Table injury the burden shifts to respondent to establish a more likely alternative

cause. Section 13(a)(1)(A), 11(c)(1)(C)(i), 14(a). If a petitioner cannot establish a Table

injury, she or she may pursue causation-in-fact under the legal standard set forth in

Althen v. Sec'y of Health & Hum. Servs., 418 F. 3d 1274, 1278 (Fed. Cir. 2005).

The most recent version of the Table, which can be found at 42 C.F.R. § 100.3,

identifies the vaccines covered under the Program, the corresponding injuries, and the

time period in which the particular injuries must occur after vaccination. Section 14(a).

Pursuant to the Vaccine Injury Table, a SIRVA is compensable if it manifests within 48

hours of the administration of an influenza vaccine. 42 C.F.R. § 100.3(a)(XIV)(B). A

vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests

all of the following:

(i) No history of pain, inflammation or dysfunction of the affected shoulder

prior to intramuscular vaccine administration that would explain the alleged

signs, symptoms, examination findings, and/or diagnostic studies occurring

after vaccine injection;

(ii) Pain occurs within the specified time frame;

(iii) Pain and reduced range of motion are limited to the shoulder in which

the intramuscular vaccine was administered; and

(iv) No other condition or abnormality is present that would explain the

patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,

brachial neuritis, mononeuropathies, or any other neuropathy).

42 C.F.R. § 100.3(c)(10).

In addition to causation, a petitioner must also meet the requirements

establishing that the vaccine received is “covered” by the Program, the duration and

severity of petitioner’s injury, and the lack of other award or settlement. 3 With regard to

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In summary, a petitioner must establish that she received a vaccine covered by the Program, administered

either in the United States and its territories or in another geographical area but qualifying for a limited

exception; suffered the residual effects of her injury for more than six months, died from her injury, or

underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or collected

an award or settlement for her injury. See § 11(c)(1)(A)(B)(D)(E).

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severity, a petitioner must show that she suffered the residual effects or complications

of her injury or condition for more than six months after the administration of the vaccine.

§ 11(c)(1)(D)(i); see Song v. Sec'y of Health & Hum. Servs., 31 Fed. Cl. 61, 65-66

(1994), aff'd, 41 F.3d 1520 (Fed. Cir. 2014) (noting that a petitioner must demonstrate

the six-month severity requirement by a preponderance of the evidence). Finding that

petitioner has met the severity requirement cannot be based on petitioner's word alone,

though a special master need not base their finding solely on medical records. Section

13(a)(1); see Colon v. Sec'y of Health & Hum. Servs., 156 Fed. Cl. 534, 541 (2021).

Severity must be established regardless of whether the claim arises under the Table or

is a causation-in-fact claim.

IV. Petitioner Does Not Meet the Severity Requirement

Petitioner received her vaccine on January 16, 2019, and alleges pain that same

day. To meet the severity requirement, she must establish that she suffered the effects

of her injury through July 16, 2019 (six months after onset). The record in this case,

however, establishes pain only through early June 2019, less than five months post-

vaccination. Ex. 2 at 6. Thereafter it is silent for over one year – or until June 30, 2020.

Id. at 13-14. Thus, the record supports only the premise that Petitioner’s left shoulder

injury lasted through early June 2019 – less than five months post- vaccination.

Other record evidence corroborates the conclusion that Petitioner’s injury more likely

than not had resolved within the six month post-onset period. After receiving her first

steroid injection in early April 2019, Petitioner reported 75 percent improvement. Thus, it

is reasonable to believe that the second steroid injection administered in early June 2019

likely offered a complete resolution of any remaining vaccine induced pain.

There is other evidence suggesting a recurrence of pain – but it occurs too long after

the six-month severity timeframe to conclude it was “more likely than not” related to the

SIRVA, as opposed to some other intervening event. Thus, although Petitioner again

reported left shoulder pain in June 2020, she has not provided sufficient evidence to link

this later pain to her January 2019 injury. The MRI, performed in March 2019, showed

multiple conditions which could account for Petitioner’s later pain – such as the SLAP tear

attributed to degenerative changes. And the record clearly establishes that Petitioner

suffered prior shoulder problems - including a frozen left shoulder in 2000 and

osteoarthritis and pain in multiple locations – including her shoulders.

Petitioner also argues that the gap in treatment was due to the effectiveness of the

cortisone injections. Response at 10-12. The gaps in this case, however, are not short or

only occurring after receipt of a cortisone shot. Rather, there are three between

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treatments, with each lasting months to a year. 4 Based upon my experience adjudicating

thousands of SIRVA claims, it would be unusual for a steroid injections to provide such

lengthy periods of otherwise-temporary relief for a SIRVA injury that was persisting.

Given the above, I cannot conclude that the record preponderantly establishes

Petitioner’s injury persisted for the six months required by the Act. Such lengthy treatment

gaps are too large to ignore in this case given the facts, and allows for the possibility of

other intervening factors as more likely explanatory of Petitioner’s subsequent shoulder

complaints than her winter 2019 injury.

Conclusion

Because Petitioner has failed to meet the severity requirement set forth in Section

11(c)(1)(D)(i), Petitioner cannot establish entitlement, and therefore I must DISMISS

his claim in its entirety. In the absence of a timely-filed motion for review (see Appendix

B to the Rules of the Court), the Clerk of Court shall enter judgment in accord with this

Decision. 5

IT IS SO ORDERED.

s/Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

4

Petitioner did not seek treatment or report shoulder problems during the following periods: June 4, 2019 to June

30, 2020; June 30, 2020 to June 2, 2021; and June 2, 2021 to August 3, 2022.

5

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their

right to seek review.

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