Fitzgerald v. Secretary of Health and Human Services ( 2020 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 19-282V
UNPUBLISHED
Chief Special Master Corcoran
CLARA FITZGERALD,
Filed: November 3, 2020
Petitioner,
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Findings of Fact; Intramuscular
HUMAN SERVICES, Route of Administration; Influenza
(Flu) Vaccine; Shoulder Injury
Respondent. Related to Vaccine Administration
(SIRVA)
Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for
petitioner.
Mollie Danielle Gorney, U.S. Department of Justice, Washington, DC, for respondent.
FINDING OF FACT1
On February 22, 2019, Clara Fitzgerald 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 left shoulder injury related to vaccine
administration (“SIRVA”) as a result of an influenza (“flu”) vaccine she received on
October 31, 2017. Petition at 1. The case was assigned to the Special Processing Unit of
the Office of Special Masters.
1 Because this unpublished ruling contains a reasoned explanation for the action in this case, I am required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 it 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.
2National 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).
For the reasons discussed below, I find that Petitioner’s October 31, 2017 flu
vaccine was administered intramuscularly into Petitioner’s left deltoid.
I. Relevant Procedural History
On March 7, 2019, Petitioner filed medical records, an affidavit, and a Statement
of Completion. ECF Nos. 7-8. Following an initial status conference, Respondent was
directed to file a status report indicating how he intended to proceed in this case. ECF
No. 10. On April 23, 2020, Respondent did so, stating that he had completed a medical
review and was opposed to settlement discussions. ECF No. 20. Respondent thereafter
filed a Rule 4(c) Report on June 8, 2020. ECF No. 21.
In the Report, Respondent noted that, to establish a presumptive SIRVA injury,
Petitioner must specifically show that the vaccine was administered intramuscularly—i.e.,
injected into a muscle. Res. Report at 5. Petitioner’s vaccination record indicated that the
vaccine “was administered into [P]etitioner’s left deltoid,” but did not specify the route of
administration or otherwise provide information signifying whether the vaccine was given
intramuscularly. Id. Respondent therefore maintained that Petitioner could not establish
a presumptive SIRVA under the Vaccine Injury Table. Id.
On July 17, 2020, I issued a Scheduling Order noting that I had reviewed
Respondent’s Rule 4(c) Report as well as the evidence filed to date. ECF No. 22. I
permitted the parties to file briefing as well as any other relevant evidence pertaining to
the route of administration of Petitioner’s October 31, 2017 flu vaccination. Id. The parties
were informed that I would thereafter issue a factual ruling regarding this issue. Id.
Respondent filed his brief on August 31, 2020, reiterating that Petitioner’s
vaccination record does not specify the route of administration or manufacturer. Res. Brief
at 2 (ECF No. 23). Respondent deemed this lack of specificity significant because Sanofi
Pasteur (a vaccine manufacturer) produced a flu vaccine that could be administered
intradermally during the 2017-2018 flu season—the season Petitioner received the
vaccination at issue. Id. at 2-3.
Respondent further noted that Vaccine Program cases have made fact findings
regarding the route of vaccine administration in some recent cases. See, e.g., Dorris v.
Sec’y of Health & Human Servs., No. 18-1265V, 2019 WL 7212165 (Fed. Cl. Spec. Mstr.
Nov. 13, 2019); Porzio v. Sec’y of Health & Human Servs., No. 17-1996V, 2019 WL
5290837 (Fed. Cl. Spec. Mstr. July 12, 2019). Res. Brief at 3. In both cases, intramuscular
administration was found to have occurred, partially because the vaccination records
recorded the vaccines as being administered into the deltoid, a muscle. Id. Respondent
argued, however, that such evidence is not dispositive regarding the route of
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administration, since intradermal vaccines are also administered in the “region of the
deltoid.”3 Id.Petitioner filed her own brief on August 31, 2020.4 ECF No. 25. In it, she cited the
Centers for Disease Control and Prevention website, which states that most flu vaccines
are administered in an arm muscle with a needle, with the deltoid muscle specifically
recommended for routine adult intramuscular vaccination. Pet. Brief at 2. Petitioner
asserted that “the Vaccine Administration Record in this case makes clear that [P]etitioner
received the vaccination in her deltoid muscle.” Id. Petitioner also cited to the Food and
Drug Administration (“FDA”) website, observing that none of the FDA-approved flu
vaccines during the 2017-2018 season were meant for intradermal use. Id. at 3-4.
The disputed issue of the route of administration of Petitioner’s October 31, 2017
flu vaccine is now ripe for resolution.
II. Medical Records
I have reviewed all the records filed to date. This ruling, however, is limited to
determining the route of administration of Petitioner’s October 31, 2017 flu vaccination.
Accordingly, I will only summarize or discuss evidence that directly pertains to this issue.
On October 31, 2017, Petitioner received a flu vaccine. Ex. 1 at 1. The vaccination
consent form lists Petitioner’s name and date of birth, and indicates she was administered
a quadrivalent form of the vaccine. Id. The form is signed and dated by Petitioner. Id. At
the bottom of the form there is a section marked “To be completed by person
administering vaccine.” Id. This section lists the date, lot number, and expiration date of
the vaccine, along with the name of the person who administered the vaccine. Id. This
section also contains the following text: “Site of Injection (Circle One): R Deltoid / L
Deltoid.” Id. “L Deltoid” (most likely meaning left deltoid) is circled. Id.Three weeks post-vaccination, on November 21, 2017, Petitioner presented to
Sonita Singh, M.D., at George Washington University Medical Faculty Associates. Ex. 2
at 1. Petitioner reported that she had received a flu vaccine on October 31st, and then
started experiencing left arm pain two hours later that persisted. Id. Petitioner stated that
she thought the “nurse put the flu shot too high on her arm resulting in SIRVA.” Id.Approximately a week later, on November 27, 2017, Petitioner underwent an initial
physical therapy evaluation. Ex. 3 at 14. Petitioner reported that she had received a flu
3 Respondent cited a vaccine administration instruction form from the “Immunization Action Coalition”
indicating that intradermal flu vaccines are administered in the “region of the deltoid.” Res. Brief at 3 n.2.
4 Petitioner has also filed an affidavit describing her previous efforts to obtain a more detailed vaccination
record. Ex. 9 (ECF No. 24).
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vaccination that was “incorrectly placed and injected in the [left] shoulder bursa,” which
caused shoulder pain and associated symptoms. Id.III. Analysis
A petitioner must prove, by a preponderance of the evidence, the factual
circumstances surrounding her claim. Section 13(a)(1)(A). Under that standard, the
existence of a fact must be shown to be “more probable than its nonexistence.” In re
Winship, 397 U.S. 358, 371 (1970) (Harlan, J., concurring).
To establish a presumptive Table SIRVA injury, Petitioner must show that the
vaccine she received was administered intramuscularly—i.e., injected into a muscle. See
42 CFR § 100.3(c)(10) (“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” (emphasis added)).
As noted by Respondent, the recent Porzio and Dorris rulings involved factual
disputes regarding the route of vaccine administration. In Porzio, Respondent argued (as
here) that there was insufficient evidence that the petitioner’s flu vaccine was
administered intramuscularly, but the special master found otherwise. Porzio, 2019 WL
5290837, at *1. The vaccine administration record in that case stated that the vaccine
had been injected into the petitioner’s left deltoid. Id. at *3. In addition, the prescribing
information for the vaccine indicated that it was for intramuscular use (and thus should
not be administered intravenously, intradermally, or subcutaneously). Id. In addition, the
petitioner (a nurse practitioner) averred that she was sitting when the vaccine was
administered despite asking to stand, which makes it easier to correctly place an
intramuscular injection. Id. All such evidence was deemed preponderantly supportive of
Petitioner’s side of the dispute.
The outcome was the same in Dorris (a case I decided). There, the petitioner’s
vaccination record listed the site of injection as “left deltoid” but did not specifically indicate
whether the vaccine was administered intramuscularly. Dorris, 2019 WL 7212165, at *1.
At a post-vaccination medical appointment, however, the petitioner stated that the vaccine
was improperly administered in the upper shoulder area instead of the lateral, or side,
deltoid. Id. at *2. The petitioner also averred that the vaccine was administered unusually
high on the shoulder. Id. After Respondent requested a ruling regarding the route of
administration, I found that there was preponderant evidence of intramuscular
administration based on the information above. Id. at *1, 3.
The facts of this case are analogous to those in Porzio and Dorris. As already
noted, Petitioner’s vaccine administration record indicates that Petitioner’s vaccine was
administered into her left deltoid, a muscle. Ex. 1 at 1; see, e.g., Dorland’s Illustrated
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Medical Dictionary (32nd ed. 2012) at 484 (defining deltoid as “triangular in outline, as the
deltoid muscle”). In addition, and like Porzio and Dorris, Petitioner later reported to her
medical providers that the vaccine had been administered high on her left arm, and she
believed the improper administration had resulted in injection of the vaccine into the
bursa. Taken together, these records support that Petitioner’s October 31, 2017 flu
vaccine was administered intramuscularly into her left deltoid.
Respondent has cited evidence suggesting that an intradermally-administered
version of the flu vaccine was in use during the period Petitioner received the vaccination
at issue. Respondent also notes that intradermal vaccines are administered in the “region
of the deltoid,” thus allowing for the possibility that (despite Petitioner’s allegations) a
version of the vaccine not literally covered by the Table SIRVA claim requirements was
at issue in this case. Res. Brief at 2-3.
These arguments are not, however, ultimately persuasive. Apart from the evidence
already discussed, I have observed through my work on other cases that the majority of
flu vaccines are administered intramuscularly into the deltoid muscle. 5 It is also the case
that vaccination records produced in the Program frequently fail to identify the specific
form of administration deemed in this case dispositive by Respondent (meaning that huge
numbers of otherwise-meritorious Table SIRVA claims would require dismissal simply
because the record did not specify this issue). Under a preponderant standard, these
deficiencies are not a bar to entitlement where—like here—the overall evidence
preponderates in favor of the claim.6
IV. Conclusion
In light of the evidence supporting the conclusion that the flu vaccine Petitioner
received was administered intramuscularly, and lacking persuasive evidence supporting
any other route of administration, I find that it is more likely than not that Petitioner’s
October 31, 2017 flu vaccine was administered intramuscularly into her left deltoid.
Respondent shall file a status report, by no later than Friday, December 04, 2020,
indicating whether he is interested in exploring an informal resolution of Petitioner’s claim.
5 Respondent has suggested that an intradermally-administered version of the flu vaccine was in use during
the period Petitioner received the vaccination at issue. However, the mere possibility of an intradermally-
administered version does not defeat Petitioner’s preponderant showing in light of the other evidence
supporting her claim.
6 I have relied upon the available record evidence in addition to my accumulated experience adjudicating
Vaccine Act claims. See Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)
(“Congress assigned to a group of specialists, the Special Masters within the Court of Federal Claims, the
unenviable job of sorting through these painful cases and, based upon their accumulated expertise in the
field, judging the merits of the individual claims”).
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IT IS SO ORDERED.
s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
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