Shoemaker v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 20-0625V
UNPUBLISHED
KATHERINE SHOEMAKER, Chief Special Master Corcoran
Petitioner, Filed: January 18, 2022
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Dismissal; Onset; Influenza (Flu)
HUMAN SERVICES, Vaccine; Shoulder Injury Related to
Vaccine Administration (SIRVA)
Respondent.
David A. Kulwicki, Mishkind Kulwicki Law CO LPA, Cleveland, OH, for Petitioner.
Christine Mary Becer, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION1
On May 20, 2020, Katherine Shoemaker 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 right shoulder injury related to
vaccine administration (“SIRVA”) caused-in-fact by the influenza (“flu”) vaccine she
received on September 24, 2018. Petition at ¶¶ 2-3.
For the reasons set forth below, I hereby DENY entitlement in this case. Petitioner
has failed to provide any evidence to support her assertions. She has failed to establish
that her injury meets the definition for a Table SIRVA, and cannot otherwise make a
sufficient preponderant showing for non-Table vaccine causation.
1
Because this unpublished Decision contains a reasoned explanation f or the action in this case, I am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 ref erences to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
I. Procedural History
Along with her petition, Ms. Shoemaker filed her affidavit, PAR questionnaire listing
all medical providers seen, vaccine record, and some of the medical records required
under the Vaccine Act. Exhibits 1-7; Section 11(c) (regarding the medical records required
under the Act). In her affidavit, Petitioner further asserted that after receiving this
vaccination, she “immediately started having a deep ache in [her] right deltoid muscle
which continues to this day.” Exhibit 1 at ¶ 5. However, the medical records show
Petitioner did not seek treatment for her right shoulder pain until July 15, 2019, almost ten
months post-vaccination. Exhibit 3 at 8. Additionally, the vaccine record did not indicate
the site or method of vaccination. Exhibit 2.
After being ordered to provide a vaccine record which specified the site of
vaccination, Petitioner filed a supplemental affidavit indicating that she had “obtained and
reviewed records from the subject Meijer Pharmacy . . . [which] do not document in which
arm the vaccine was administered.” Exhibit 8 at ¶ 3. However, she did not provide these
records. She added that she “contacted the subject Meijer Pharmacy and was informed
that the store does not have a set policy as to which arm vaccines are administered . . .
[and that] the location is left to customer preference.” Id. at ¶ 4. The case was assigned
to the Special Processing Unit of the Office of Special Masters (the “SPU”).
During the initial status conference held on July 21, 2020, the parties discussed
the lack of documentation showing the site of vaccination and the approximately ten-
month delay between vaccination and when Petitioner first sought treatment for her right
shoulder pain. ECF No. 13. Petitioner was ordered to file additional evidence to address
these deficiencies. Id.
More than six months later, on February 10, 2021, Petitioner filed a third affidavit
providing reasons for the delay and detailing her efforts to obtain further vaccine
documentation and medical records from her gynecologist. Exhibits 9-10. She attributed
the delay to her reaching the age where she was no longer able to see her pediatrician –
along with her inability to obtain a new primary care provider, her schedule as a nursing
student, and her concern that reporting her injury would affect any future employment as
a nurse. Exhibit 9 at 3-4, 6-10. The medical records do show Petitioner failed to mention
her right shoulder pain during an October 17, 2018 visit to her gynecologist, approximately
three weeks post-vaccination. Exhibit 10 at 7-10.
On June 1, 2021, Respondent filed his Rule 4(c) Report opposing compensation.
ECF No. 19. He indicated that his position was based upon the fact that “[P]etitioner’s first
report of pain was ten months after vaccination.” Id. at 4 (emphasis in the original).
2
Thereafter, Petitioner was granted subpoena authority to obtain the complete
vaccine record from Meijer Pharmacy. ECF No. 21. On July 14, 2021, Petitioner filed the
documentation obtained through subpoena, which included a consent form that failed to
indicate the site of vaccination. Exhibit 11 at 18.3
On August 10, 2021, I issued an order to show cause. ECF No. 23. Petitioner filed
a response on September 9, 2021. ECF No. 24. The matter is now ripe for adjudication.
II. Applicable Legal Standards
Under Section 13(a)(1)(A) of the Act, a petitioner must demonstrate, by a
preponderance of the evidence, that all requirements for a petition set forth in section
11(c)(1) have been satisfied. A petitioner may prevail on her claim if the vaccinee for
whom she seeks compensation has “sustained, or endured the significant aggravation of
any illness, disability, injury, or condition” set forth in the Vaccine Injury Table (the Table).
Section 11(c)(1)(C)(i). The most recent version of the Table 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). The Table injury of SIRVA
following receipt of an influenza vaccine was added in 2017. 4 If a petitioner establishes
that the vaccinee has suffered a “Table Injury,” causation is presumed.
3
It appears Petitioner mistakenly dated her signature as provided on September 7, 2018. E xhibit 11 at
18. However, other entries, including the signature of the vaccine administrator, use the correct date of
September 24, 2018. Id. at 17-18.
4
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) (2017). The criteria establishing a
SIRVA under the accompanying Qualification and Aids to Interpretation (“QAI”) are as f ollows:
Shoulder injury related to vaccine administration (SIRVA). SIRVA manifests as shoulder
pain and limited range of motion occurring af ter the administration of a vaccine intended
f or intramuscular administration in the upper arm. These symptoms are thought to occur
as a result of unintended injection of vaccine antigen or trauma f rom the needle into and
around the underlying bursa of the shoulder resulting in an inf lammatory 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
suf fered SIRVA if such recipient manifests all of the following:
(i) No history of pain, inf lammation or dysfunction of the af f ected 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
3
If, however, the vaccinee suffered an injury that either is not listed in the Table or
did not occur within the prescribed time frame, petitioner must prove that the administered
vaccine caused injury to receive Program compensation on behalf of the vaccinee.
Section 11(c)(1)(C)(ii) and (iii). In such circumstances, petitioner asserts a “non-Table or
[an] off-Table” claim and to prevail, petitioner must prove her claim by preponderant
evidence. Section 13(a)(1)(A). This standard is “one of . . . simple preponderance, or
‘more probable than not’ causation.” Althen v. Sec’y of Health & Human Servs., 418 F.3d
1274, 1279-80 (Fed. Cir. 2005) (referencing Hellebrand v. Sec’y of Health & Human
Servs., 999 F.2d 1565, 1572-73 (Fed. Cir. 1993). The Federal Circuit has held that to
establish an off-Table injury, petitioners must “prove . . . that the vaccine was not only a
but-for cause of the injury but also a substantial factor in bringing about the injury.”
Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1351 (Fed. Cir 1999). Id. at
1352. The received vaccine, however, need not be the predominant cause of the injury.
Id. at 1351.
The Federal Circuit has indicated that petitioners “must show ‘a medical theory
causally connecting the vaccination and the injury’” to establish that the vaccine was a
substantial factor in bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting
Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). The
Circuit Court added that "[t]here must be a ‘logical sequence of cause and effect showing
that the vaccination was the reason for the injury.’” Id. The Federal Circuit subsequently
reiterated these requirements in its Althen decision. See 418 F.3d at 1278. Althen
requires a petitioner
to show by preponderant evidence that the vaccination
brought about her injury by providing: (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 a proximate temporal relationship between vaccination and
injury.
Id. All three prongs of Althen must be satisfied. Id.(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).
4
Finding a petitioner is entitled to compensation must not be “based on the claims
of a petitioner alone, unsubstantiated by medical records or by medical opinion.” Section
13(a)(1). Further, contemporaneous medical records are presumed to be accurate and
complete in their recording of all relevant information as to petitioner’s medical issues.
Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
Testimony offered after the events in questions is considered less reliable than
contemporaneous reports because the need for accurate explanation of symptoms is
more immediate. Cucuras, 993 F.2d at 1528 (noting that “the Supreme Court counsels
that oral testimony in conflict with contemporaneous documentary evidence deserves little
weight”); Reusser v. Sec’y of Health & Human Servs., 28 Fed. Cl. 516, 523 (1993);
Vergara v. Sec’y of Health & Human Servs., No. 08-882V, 2014 WL 2795491, at *4 (Fed.
Cl. Spec. Mstr. July 17, 2014) (“Special Masters frequently accord more weight to
contemporaneously-recorded medical symptoms than those recounted in later medical
histories, affidavits, or trial testimony.”).
III. Analysis
As I informed Petitioner in the Order to Show Cause, the record lacks evidence
needed to support her claims. ECF No. 23. Specifically, she has failed to provide evidence
to counter the inferences derived from her ten-month delay in seeking treatment, or to
show her condition during that time. Id. Petitioner in reaction has filed barely two pages
that reiterate the evidence already contained in the record of the case, and otherwise
arguing that an expert report is not needed for causation. Response, filed Sept. 9, 2021,
ECF No. 24. She maintains that she “has shown that her claim should not be dismissed .
. . and that [her] claim should be maintained within SPU.” Id. at 2.
The record in this case still shows that Petitioner did not seek medical care for her
alleged SIRVA until almost ten months post-vaccination, on July 15, 2019. Exhibit 3 at 8.
The purpose of the visit was to establish care and undergo an annual physical. While
noting at the time of this visit that Petitioner complained of right shoulder pain which she
attributed to the flu vaccine she received in September 2018, her primary care provider
(“PCP”) appeared to question that conclusion, given the length of time which had passed
between vaccination and when Petitioner sought care. It was also noted that Petitioner
was offered formal physical therapy which she refused in favor of a home exercise
program. Id.Other than this record and later-provided histories, plus the allegations made in
the Petition and her affidavit, Petitioner has provided no evidence to support her claim,
such as affidavits from family, friends, or co-workers or other documentation. Additionally,
she offered no explanation of her condition during the ten-month period from September
2018 until she sought care or evidence in July 2019.
5
Narratives of post-vaccination pain provided closer in time to the vaccine’s
administration date would typically be afforded more weight than assertions made when
filing the Petition. See Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528
(Fed. Cir. 1993). And it is not uncommon for claimants alleging a SIRVA injury to delay
care a bit, and/or to first recount a history of pain even a month or two after vaccination.
Here, however, Petitioner first provided this information to her PCP almost ten months
post-vaccination, and only four months before the medical records were requested to
support Petitioner’s claim. Thus, it is more properly characterized as a current assertion
made by Petitioner contemporaneously with the advancement of this claim – and
therefore the kind of assertion not typically given much weight, if any . See Section
13(a)(1) (instructing that a special master may not find compensation appropriate “based
on the claims of a petitioner alone, unsubstantiated by medical records or by medical
opinion”).
In order, to prevail in this case, Petitioner needed to provide preponderant
evidence to support her assertion that she suffered a SIRVA as alleged. Petitioner’s ten-
month delay in seeking treatment, and lack of evidence regarding the onset of her pain
and alleged symptoms during this ten-month period, suggest the claim cannot succeed. I
provided Petitioner the opportunity to provide the evidence to establish a vaccine-related
injury as she alleges. Petitioner has failed to do so.
IV. Conclusion
To date, and despite ample opportunity, Petitioner has failed to file preponderant
evidence to support her allegations of a right SIRVA injury following receipt of the flu
vaccine on September 24, 2018. Petitioner was informed that failure to file sufficient
evidence, to support her claim would be treated as either a failure to prosecute this claim
or as an inability to provide supporting documentation for this claim. Accordingly, this case
is DISMISSED. The clerk shall enter judgment accordingly. 5
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
5
Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice
renouncing the right to seek review.
6