Daugherty v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 19-1519V

MARYANN DAUGHERTY, Chief Special Master Corcoran

Petitioner,

v. Filed: June 5, 2024

SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

Daniel James Leeper, St. Petersburg, FL, for Petitioner.

Jennifer Leigh Reynaud, U.S. Department of Justice, Washington, DC, for Respondent.

FINDINGS OF FACT AND CONCLUSIONS OF LAW DISMISSING TABLE CLAIM1

On October 1, 2019, Maryann Daugherty filed a Petition for compensation under

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

“Vaccine Act”), alleging that she suffered a right-sided shoulder injury related to vaccine

administration (“SIRVA”) as the result of an influenza (“flu”) vaccine received on October

6, 2016. Petition (ECF No. 1). The case was assigned to the Special Processing Unit of

the Office of Special Masters (the “SPU”). Based on Respondent’s opposition and an

independent review of the evidence, I conclude that Petitioner has not established the

1 Because this unpublished decision contains a reasoned explanation for the action in this case, I am

required to post it on the United States Court of Federal Claims' website in accordance with the E-

Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic

Government Services). This means the decision will be available to anyone with access to the

internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact

medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.

If, 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).

alleged vaccine administration site. Therefore, her Table SIRVA claim is not tenable, and

must be dismissed.

I. Procedural History

Over 18 months after the claim’s initiation, Petitioner obtained and filed a required

record which reflected a contemporaneous, handwritten notation of her left (non-injured,

non-dominant) arm as the vaccine administration site. Ex. 11 (ECF No. 20). Respondent

subsequently objected that Petitioner could not preponderantly establish her alleged site

(and secondarily, onset within the 48-hour timeframe required for a Table SIRVA). Resp.

Status Report filed July 8, 2021 (ECF No. 24) (signaling his opposition); Rule 4(c) Report

filed Mar. 1, 2022 (ECF No. 25).

The parties were afforded a final opportunity to file “briefs and any additional

evidence they wished to have considered.” Scheduling Order filed July 26, 2022 (ECF

No. 26) (emphasis added). Only briefing was received. Pet. Response filed Sept. 12, 2022

(ECF No. 27) (hereinafter “Brief”); Respondent’s Response filed Nov. 15, 2022 (ECF No.

29) (hereinafter “Response”). The matter is now ripe for adjudication.

II. Authority

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 his 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.

To resolve factual issues, the special master must weigh the evidence presented,

which may include contemporaneous medical records and testimony. See Burns v. Sec'y

of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special

master must decide what weight to give evidence including oral testimony and

contemporaneous medical records). Contemporaneous medical records are presumed to

be accurate. See Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed.

Cir. 1993). To overcome the presumptive accuracy of medical records testimony, a

petitioner may present testimony which is “consistent, clear, cogent, and compelling.”

Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V, 2013 WL 1880825, at *3 (Fed.

Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec'y of Health & Hum. Servs., No. 90–

2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)).

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In addition to requirements concerning the vaccination received, the duration and

severity of petitioner’s injury, and the lack of other award or settlement,3 a petitioner must

establish that she suffered an injury meeting the Table criteria, in which case causation

is presumed, or an injury shown to be caused-in-fact by the vaccination she received.

Section 11(c)(1)(C).

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 a flu vaccine. 42 C.F. R. § 100.3(a)(XIV)(B). The criteria

establishing a SIRVA under the accompanying QAI are as follows:

Shoulder injury related to vaccine administration (SIRVA). SIRVA manifests

as shoulder pain and limited range of motion occurring after the

administration of a vaccine intended for intramuscular administration in the

upper arm. These symptoms are thought to occur as a result of unintended

injection of vaccine antigen or trauma from the needle into and around the

underlying bursa of the shoulder resulting in an inflammatory reaction.

SIRVA is caused by an injury to the musculoskeletal structures of the

shoulder (e.g., tendons, ligaments, bursae, etc.). SIRVA is not a

neurological injury and abnormalities on neurological examination or nerve

conduction studies (NCS) and/or electromyographic (EMG) studies would

not support SIRVA as a diagnosis (even if the condition causing the

neurological abnormality is not known). 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;

3 In summary, a petitioner must establish that he 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 his injury for more than six months, died from his 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 Section 11(c)(1)(A)(B)(D)(E).

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(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) (2017).

III. Finding of Fact and Conclusions of Law – Vaccine Administration Site

I have reviewed all of the filings submitted by both parties to date. The below

summary focuses on the vaccine administration site.

• Medical records from three years prior to the date of vaccination reflect that

Petitioner’s medical history was non-contributory, and that she is right-handed.

See generally Exs. 2, 6.

• Petitioner was 75 years old upon receiving the subject Fluzone vaccine on October

6, 2016, at a local Walgreens pharmacy location. The Walgreens “Vaccine

Administration Record (VAR) – Informed Consent for Vaccination” form, includes

the following section, which indicates a left-sided vaccine administration site. Ex.

11 at 2.

• On an insurance “payment notice” dated October 17, 2016, a handwritten notation

indicates that on October 21, 2016, Petitioner called the insurance provider

“questioning overpayment to Walgreens for flu shot,” and was informed that the

apparent overpayment instead represented an “administration fee for giving shot.”

Ex. 1 at 4.4

4 Petitioner filed the payment notice as initial proof of receiving the vaccination, Ex. 1, prior to obtaining and

filing the contemporaneous vaccine administration record including site, Ex. 11.

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• On October 24, 2016, Petitioner followed up with an established orthopedist for

her chronic hip and foot pain. No complaints or findings relating to the above

vaccination, or the shoulders, were noted. Ex. 6 at 21 – 24.

• Thirty-four (34) days post-vaccination, on November 9, 2016, Petitioner saw her

primary care provider (“PCP”) Dr. Minnix for a routine six-month follow-up

evaluation, and discussed subjects including her right ear, right hip, and

hypothyroidism. Ex. 2 at 10. A physical exam was positive for hip tenderness. Id.

at 11. No complaints or findings relevant to the right shoulder were noted. But Dr.

Minnix recorded: “Immunization: Flu3V (Fluzone High Dose), 65 YRS+, NO PRES

– ALL PAYORS: 0.5 ML (Dose No:1) on Right Deltoid.” Id. 5

• On December 12, 2016, and January 17, 2017, Petitioner attended orthopedics

evaluations for her lower extremity complaints. Ex. 6 at 18 – 19, 14 – 17 (ordered

chronologically).6

• On February 9, 2017 – now four months post-vaccination – Dr. Minnix recorded

that Petitioner’s complaints included chronic right shoulder pain since “around the

time of a flu shot in October of last year.” Ex. 2 at 7. The pain was “not in the

shoulder joint, but in the proximal humerus near the insertion of the deltoid

muscle.” Id. An exam of the shoulder was unremarkable (specifically noting normal

range of motion), except for tenderness at the reported site of vaccination. Id. Dr.

Minnix assessed non-specific “right arm pain,” and planned an x-ray. Id.

• On February 15, 2017, an x-ray of the right shoulder visualized a down-sloping

acromion” and degenerative changes in the acromioclavicular joint. Ex. 3 at 1. The

x-ray indication was “pain in upper third of humerus since flu shot 10/2016.” Id.

• On May 9, 2017, Dr. Minnix recorded Petitioner’s report of ongoing “arm pain which

she relates to a flu shot,” and her waiver of an orthopedic referral. Ex. 2 at 4 – 5.

• On June 5, 2017, an examiner at Sedgwick Claims Management Services Inc.,

emailed that based on Petitioner’s report of injury persisting for over six months,

5 Petitioner has not addressed this notation. However, no other evidence suggests that Dr. Minnix

administered a repeat administration of Fluzone – which involves only one dose. Ex. 2 at 10 – 11; see also

Food & Drug Administration, Fluzone Intradermal Quadrivalent 2016 – 2017 Package Insert, available at

https://www.fda.gov/media/90251/download&ved=2ahUKEwj3z6eKlLGGAxV3M1kFHdm3AQcQFnoECB

wQAQ&usg=AOvVaw0-Gr6zUif05npiuCFHFQY1 (last accessed May 28, 2024).

6 Subsequent orthopedics records have been reviewed but are omitted from this factual summary.

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she would “need to file a claim with the National Vaccine Injury Compensation

Program.” Ex. 7 at 1.

• In a July 17, 2017, letter addressed to the Vaccine Program, Petitioner reported a

right-sided vaccine administration on October 6, 2016, followed by right shoulder

pain and weakness. Ex. 8 at 1. Petitioner reported that she had followed up

repeatedly with the pharmacy until she was referred to Sedgwick and notified of

the Program. Id. Petitioner asked the Vaccine Program to “loo[k] into this situation

and advis[e] her how to proceed,” specifically noting concern about how long the

injury would last and potential long-term effects. Id.

• In October 2017, upon establishing care with a new PCP, Lauren Natoli, D.O.,7

Petitioner’s complaints included right shoulder pain since her receipt of a flu shot

at Walgreens the previous year. Ex. 5 at 21. Dr. Natoli did not record a physical

exam or any specific assessment of the shoulder, but recorded that an unnamed

lawyer had requested MRIs before proceeding with Petitioner’s case. Id.

• In November 2017, Dr. Natoli ordered MRIs of the right shoulder and humerus,

which visualized a large partial tear of the undersurface of the anterior

supraspinatus tendon; a small labrum tear; and moderate subacromial bursitis. Ex.

5 at 31 – 34; see also id. at 6 (Dr. Natoli’s subsequent note that Petitioner was

scheduled for an orthopedic evaluation of her shoulder).

• At a November 14, 2017, initial evaluation, orthopedist David Braun, M.D.,

recorded Petitioner’s history of injury stemming from a flu shot. Ex. 9 at 5; see also

id. at 7 – 9 (new patient form). On exam, the right shoulder had full ROM, normal

strength, and no muscle atrophy – only point tenderness to palpation over the

inferior lateral deltoid. Id. at 5. In Dr. Braun’s view, the MRIs revealed only “slight

degenerative changes” and no fracture, dislocation, or structural abnormalities. Id.

Dr. Braun discussed that he had seen previous cases of flu shots associated with

“severe subacromial bursitis,” but Petitioner’s case was more suggestive of a nerve

injury. Id. Thus, Dr. Braun referred Petitioner to a colleague specializing in

neurology. Id.

• On November 28, 2017, the neurologist, Adam DiDio, M.D., recorded a similar

history from Petitioner, and an unremarkable exam with the exception of right

supraspinatus weakness. Ex. 9 at 2 – 3. Dr. DiDio found no current evidence of

brachial neuritis/plexopathy, injury to the axillary nerve (running underneath the

7 Petitioner’s last encounter with Dr. Minnix was in September 2017. It does not address shoulder pain, or

any information regarding Petitioner’s subsequent switch to a new PCP. Ex. 2 at 1 – 2.

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deltoid), or complex regional pain syndrome. Id. at 3. He provided a trial of

Lidoderm patches and also offered neuropathic pain medications, while deferring

to Dr. Braun regarding further orthopedic work-up, such as for a rotator cuff tear.

Id. But there are no further records from Drs. Braun and DiDio’s practice.8

• In her October 2019 affidavit, Petitioner attests that that a Walgreens employee

administered the subject flu vaccine into her right shoulder. Ex. 10 at ¶ 6. She

recalls developing right shoulder pain and difficulty with movement “the same day,”

which she initially “assumed to be a normal after effect of the vaccine.” Id. at ¶ 7.

After these symptoms persisted for some unspecified period, she “returned to

Walgreens on multiple occasions, and made them put it in their records,” but the

staff instructed Petitioner to “expect pain and discomfort,” apply ice, and rub the

painful areas. Id. at ¶ 8. After those measures did not alleviate her injury, she

presented to her PCP Dr. Minnix in February 2017. Id. at ¶ 9. Petitioner also attests

that her complaints to Walgreens led to her discovery of the Vaccine Program, and

to her letter written in July 2017. Id. at ¶¶ 8, 21.

• Petitioner avers that there is no additional evidence of her communications with

Walgreens, Sedgwick, and/or the Vaccine Program. Pet. Status Report filed Apr.

19, 2021 (ECF No. 21).

The most contemporaneous record – the initial vaccination administration record

(Ex. 11 at 2) - is not in Petitioner’s favor. In reaction, Petitioner avers that in general,

“pharmacy employees are not perfect, and mistakes happen when entering information

into a record.” Brief at 1. However, she does not offer any case-specific arguments, or

reference any evidence beyond her own affidavit. Id. at 1 – 2. In contrast, Respondent

contends that the contemporaneous record should receive a high presumption of

accuracy, especially as it contains a handwritten notation. Rule 4(c) Report at 6 – 7.

Based upon my experience with SIRVA cases (over 2,000 within SPU since my

appointment as Chief Special Master, additional cases handled within chambers, and

review of opinions issued by other special masters), I observe that it is not unusual for

information regarding the vaccine administration site to be incorrect – especially

information contained in computerized records, which may feature a ‘dropdown’ menu

which may not be updated each time a separate vaccine is administered.9 Thus, although

8 I have also considered, but find less relevant to the situs determination, further medical records from the

PCP Dr. Natoli. See generally Ex. 5.

9 See, e.g., Mezzacapo v. Sec’y of Health Servs., No. 18-1977, 2021 WL 1940435, at *2 (Fed. Cl. Spec.

Mstr. Apr. 19, 2021); Desai v. Sec’y of Health & Human Servs., No 14-0811V, 2020 WL 4919777, at *14

(Fed. Cl. Spec. Mstr. July 30, 2020); Rodgers v. Sec’y of Health & Human Servs., No. 18-0559V, 2020 WL

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such records are unquestionably the first-generated documents bearing on issues

pertaining to situs, they are not per se reliable simply because they come first – and in

fact the nature of their creation provides some basis for not accepting them at face value.

But information which requires specific action on the part of the vaccine administrator

(often at the very time of administration), such as a handwritten notation on a printed form,

generally warrants more significant weight.10

Such handwritten notations can be rebutted of course, by additional, case-specific

evidence and circumstances. For instance, in one case a petitioner’s history of

vaccination and subsequent injury in the same shoulder was medically documented just

13 days post-vaccination, and consistently thereafter. That petitioner also explained that

she requested vaccination in her non-dominant arm. Rizvi v. Sec’y of Health & Hum.

Servs., No. 21-0881V, 2022 WL 2284311 at * 3 (Fed. Cl. Spec. Mstr. May 13, 2022). In

another more recent matter, the petitioner’s history was medically documented 23 days

post-vaccination, and in numerous later records. And the site notation was found on “an

otherwise haphazardly-completed form (containing entries listed diagonally and not in the

allotted space)” – constituting a specific reason to doubt its reliability. Toothman v. Sec’y

of Health & Hum. Servs., No. 22-0207V, 2024 WL 2698520, at *4 (Fed. Cl. Spec. Mstr.

Apr. 19, 2024).

Here, Petitioner has not raised any specific reason to question the accuracy of the

handwritten notation on the initial vaccination record – and it appears to have been

completed correctly (rather than “haphazardly,” as in Toothman, 2024 WL 2698520, at

*4). Moreover, the record is consistent with avoidance of Petitioner’s dominant right arm

(recognized in prior cases as a “reasonable request that vaccinated individuals often

make.” Rizvi, 2022 WL 2284311, at *4; see also Ex. 6 at 5 (indicating that Petitioner is

right-handed). Thus, the contemporaneous, handwritten vaccine administration record in

this case has some facial reliability that Petitioner has not undermined.

While a subsequent, PCP computerized record indicates a right-sided vaccine

administration, that was not based on any medical provider’s personal knowledge of what

transpired at the retail pharmacy location. Rather, it was created later in time, and likely

represents either the PCP’s assumption, or Petitioner’s own report of situs. It also lacks

any context – such as Petitioner’s complaints or any findings of a shoulder injury

potentially attributable to vaccination at that time.

1870268, at *5 (Fed. Cl. Spec. Mstr. Mar. 11, 2020); Stoliker v. Sec’y of Health & Human Servs., No. 17-

0990V, 2018 WL 6718629, at *4 (Fed. Cl. Spec. Mstr. Nov. 9, 2018).

10 See, e.g., Schmidt v. Sec’y of Health & Hum. Servs., No. 17-1530V, 2021 WL 5226494, at *8 (Fed. Cl.

Spec. Mstr. Oct. 7, 2021); Marion v. Sec’y of Health & Hum. Servs., No. 19-0495V, 2020 WL 7054414 at

*8 (Fed. Cl. Spec. Mstr. Oct. 27, 2020).

8

The subsequent medical records, beginning roughly four months post-vaccination,

are consistent with Petitioner’s contentions that the vaccine was administered in her right

shoulder. But that belief is weakly supported by the available non-medical documentation,

which indicates that Petitioner complained to Walgreens and was referred to its claims

examiner by eight months post-vaccination, leading to her discovery of the Vaccine

Program by nine and one-half months post-vaccination.11 Such evidence, “no matter how

sincere, is not sufficient to meet her burden of proof,” Response at 11, particularly in the

face of the contemporaneous handwritten record compelling a different result. I therefore

find that the vaccine was more likely than not administered in Petitioner’s left deltoid.12

Conclusion and Order to Show Cause

The factual finding of a left-sided vaccine administration renders the claim of a

right-sided SIRVA untenable. See 42 C.F.R. § 100.3(c)(10)(iii) (providing that a SIRVA is

limited to “the shoulder in which the intramuscular vaccine was administered”).

Petitioner’s Table SIRVA claim is therefore DISMISSED.

It is therefore unnecessary to resolve whether Petitioner’s shoulder pain began

within the 48-hour post-vaccination timeframe that would be required for a Table SIRVA

claim. 42 C.F.R. §§ 100.3(a), (c)(10)(ii); Rule 4(c) Report at 7, Response at 10 - 14

(challenging this criteria).

Instead at this stage, the remaining question is whether any off-Table, causation-

in-fact claim might be feasible. See generally Petition (alleging only a Table SIRVA); but

see Brief at 3 (requesting the opportunity to pursue causation-in-fact); but see Rule 4(c)

Report at 7 – 8, Response at 15 - 17 (averring that Petitioner’s treating providers did not

endorse a vaccine injury). Respondent’s briefing and my preliminary review of the

evidence has not identified any obvious onset date, or alternative cause, for the injury

11 But the available non-medical evidence is notably sparse – in particular, lacking any contemporaneous

documentation or later recollections of the timing, or substance, of Petitioner’s complaints directly to

Walgreens prior to being referred to its claims administrator Sedgwick. This stands in contrast to Petitioner’s

contemporaneous documentation of concern, and prompt action, regarding her insurance provider’s

potential overpayment to Walgreens for the vaccination.

12 Petitioner (and Respondent) received a full and fair opportunity to present her case – including an

opportunity to file any additional evidence in conjunction with the briefing. Scheduling Order filed July 26,

2022 (ECF No. 26).

It is also recognized that Petitioner had “no objection” to a hearing. Brief at 1. But Petitioner herself

seemingly would have been the only witness to testify, based on the lack of affidavits from any other

witnesses. Thus, I find it appropriate to resolve the claim on the filed record. Section 12(d)(2)(D); Vaccine

Rule 8(d); Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (affirming

the decision to rule on the record in lieu of hearing).

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discussed herein. Therefore, Petitioner will be afforded one brief and final opportunity to

determine whether she would like to pursue any remaining causation-in-fact claim

centering on an injury in the non-vaccinated shoulder/arm. However, it is reiterated that

Petitioner may not formally retain an expert, or order any expert’s written report, without

prior consultation with Respondent and the Court. Any request for experts, when

combined with this case’s age, would likely support the case’s transfer out of SPU for

further proceedings.

Petitioner’s failure to respond to this or other orders issued in this action, as well

as failure to file evidence required to support his claim, will be interpreted as a failure to

prosecute resulting in dismissal of Petitioner’s claim. Tsekouras v. Sec’y of Health & Hum.

Servs., 26 Cl. Ct. 439 (1992), aff’d, 991 F.2d 810 (Fed. Cir. 1993) (per curiam); Sapharas

v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 503 (1996); Vaccine Rule 21(b).

Accordingly, within 30 days, by no later than Monday, July 8, 2024, Petitioner

shall show cause why her claim should not be dismissed for insufficient proof of

causation-in-fact.

In the alternative, if Petitioner wishes to exit the Vaccine Program, counsel shall

file the appropriate motion, Stipulation, or Notice. See

http://www.uscfc.uscourts.gov/sites/default/files/autism/EXITING GUIDANCE TO PRO

SES.pdf.

IT IS SO ORDERED.

s/Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

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