Dawson v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 19-278V
UNPUBLISHED
CHRISTOPHER DAWSON, Chief Special Master Corcoran
Petitioner, Filed: November 4, 2021
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Entitlement to Compensation; Table
HUMAN SERVICES, Injury; Influneza (“Flu”) Vaccine;
Shoulder Injury Related to Vaccine
Respondent. Administration (SIRVA)
Jerome A. Konkel, Samster Konkel and Safran, Wauwatosa, WI, for Petitioner.
Claudia Barnes Gangi, U.S. Department of Justice, Washington, DC, for Respondent.
RULING ON ENTITLEMENT
On February 21, 2019, Christopher Dawson filed a petition for compensation under
the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq. 1 (the
“Vaccine Act”), alleging that he suffered a Shoulder Injury Related to Vaccine
Administration (“SIRVA”) as a result of an influenza (“flu”) vaccine administered to him on
December 28, 2016. Petition, ECF No. 1 at ¶¶13-14. The case was assigned to the
Special Processing Unit of the Office of Special Masters (the “SPU”).
For the reasons described below, I find that Petitioner is entitled compensation for
his SIRVA.
I. Relevant Procedural History
As noted above, the case was initiated in February 2019. On September 8, 2020,
Respondent filed his Rule 4(c) Report. ECF No. 25. Respondent specifically maintained
that Petitioner had not established that he suffered limited range of motion after the
administration of the flu vaccine on December 28, 2016, and thus does not meet the
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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).
criteria to establish a Table SIRVA case. Id. at 6 (citing 42 C.F.R. § 100.3(c)(10)).
Respondent further asserted that Petitioner had not provided evidence sufficient to
establish causation-in-fact under the relevant standard. Id. at 4-6.
On October 9, 2020, I ordered to Petitioner to file a Response the Rule 4(c) Report,
and Show Cause why his SIRVA Table case should not be dismissed (ECF No. 26), and
he did so on November 20, 2020. ECF No. 27. On November 24, 2020, Respondent filed
a reply to Petitioner’s response. ECF No. 28. This matter is now ripe for my ruling on
Petitioner’s entitlement to compensation.
II. Factual Findings and Ruling on Entitlement
A. Legal Standards
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.
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)).
In addition to requirements concerning the vaccination received, the duration and
severity of petitioner’s injury, and the lack of other award or settlement, 2 a petitioner must
establish that she suffered an injury meeting the Table criteria, in which case causation
2
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 qualif ying f or a limited
exception; suffered the residual effects of her injury f or 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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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 an influenza vaccine. 42 C.F.R. § 100.3(a)(XIV)(B). The
Vaccine Injury Table’s qualifications and aids to interpretation (“QAI”) for SIRVA provide
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;
(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)(emphasis added).
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B. Findings of Fact Regarding Reduced Range of Motion
Respondent’s sole objection in this case is that Petitioner cannot establish he
suffered reduced or limited range of motion as part of his SIRVA - a Table QAI
requirement.
As a preliminary matter, I find that it is not readily apparent that the QAI to establish
a Table SIRVA injury requires that a petitioner establish that he suffered limited or
reduced range of motion. The QAI for SIRVA discusses reduced or limited range of motion
in two places. In the first instance, it states that “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.” 42 C.F.R. § 100.3(c)(10) (emphasis
added). This phrasing supports Respondent’s argument that range of motion limits must
be demonstrated (although there is some ambiguity in the language). Next, the SIRVA
QAI provides that “[a] vaccine recipient shall be considered to have suffered SIRVA if
such recipient manifests all of the following: . . . . (iii) Pain and reduced range of motion
are limited to the shoulder in which the intramuscular vaccine was administered; . . . .” Id.This subsection arguably could be understood only to define the locus of range of motion
issues (“the shoulder in which the intramuscular vaccine was administered”), and not that
proof of range of motion limits is a specific injury element.
Because of these language ambiguities, whether petitioners are in fact expressly
required to establish reduced range of motion has been questioned. See, Portee v. Sec'y
of Health & Hum. Servs., No. 16-1552V, 2018 WL 5284599, at *11 (Fed. Cl. Sept. 14,
2018) (finding the “medical records show that, in this case, petitioner suffered from both
pain and limited ROM. There is preponderant evidence to show petitioner has satisfied
what could be deemed an additional requirement in the QAI”)(emphasis added). To
be sure, if a petitioner does exhibit reduced or limited range of motion under the QAI to
establish a Table SIRVA any reduced range of motion must be “limited to the shoulder in
which the intramuscular vaccine was administered.” Id.Despite the above, I find that Petitioner did manifest reduced or limited range of
motion in his left shoulder. I make these findings after a complete review of the record to
include all medical records, affidavits, testimony, Respondent’s Rule 4 report, the parties
briefing, and additional evidence filed. Specifically, I note:
• On December 28, 2016, Petitioner received an intramuscular flu vaccination in
his left deltoid. Ex. 3 at 5, 14, 194-95. At that time Petitioner resided in the
Waupan Correctional Institute in Waupan, Wisconsin.
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• On January 6, 2017, Petitioner was seen in the Health Services Unit (“HSU”)
following a health service request (“HSR”) made on January 1, 2017 for “pain
to L[eft] deltoid [following] flu shot.” Ex. 3 at 14. On examination, Petitioner
exhibited full range of motion and was assessed with “altered comforted
[related to] musculoskeletal pain.” Id. Petitioner was advised to treat with a hot
compress and to continue to use arm as “nonuse can potentially cause more
‘tightness’ in muscle.” Id.• On January 20, 2017, Petitioner was seen at the HSU for “[left] shoulder pain,”
he reported that his shoulder was not improving despite using heat and
exercising. Id. On examination, Petitioner exhibited full range of motion of his
left shoulder and arm and was again assessed with “altered comforted [related
to] musculoskeletal pain.” Id. Petitioner was advised to continue his treatment
plan of utilizing “heat” and “ROM” exercises until “MD” follow-up. Id.• On April 20, 2017, Petitioner was seen again at the HSU for complaints of “pain
and ‘fatigue’ in deltoid area [of his] L[eft] shoulder since getting flu shot [on]
12/28.” Id. at 13. It was noted that petitioner had full range of motion, and that
he was able to perform pushups and play handball. On examination Petitioner’s
left shoulder was tender over the mid-deltoid and at the AC joint, he was found
to have “good” range of motion. Id. Physical therapy (“PT”) and an x-ray was
for Petitioner’s left shoulder was ordered. Id. at 40.
• On June 29, 2017, Petitioner was seen at the HSU and reported his left
shoulder “unchanged,” that he had not begun PT, and that naproxen was “not
helping.” Id. at 10. On examination he was found to have full range of motion
and to be “tender” in the subacromial space. Id. He was assessed with bursitis
of the left shoulder and a steroid injection was planned. Id. The steroid injection
was administered on July 13, 2017. Id.
• On September 29, 2017, Petitioner reported to HSU for left shoulder pain.
“Objective” findings included “[f]ull ROM bilateral arms + R[ight] shoulder” with
complaints of “pain + limited ROM [with] L[eft] shoulder in upward mot[ion].” Ex.
3 at 11. A musculoskeletal assessment indicated his “problem location” was
noted to be his left shoulder and a box was checked indicating “ROM
limitations.” Id. at 12.
• On October 31, 2017, Petitioner was seen again at HSU and reported that his
left shoulder was “now better” and on exam he was found to have “good ROM.”
Ex. 3 at 9.
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• On November 8, 2017, Petitioner received a steroid injection in his left shoulder
“for SIRVA.” Ex. 3 at 9.
• On December 12, 2017, Petitioner was seen at HSU and reported his left
shoulder was “much improved” and that he had full “ROM again, but [his
shoulder] still hurts [with] certain movements.” Id. On exam he was found to
have “good ROM and strength.” Id.
• On January 23, 2018, an MRI was ordered of Petitioner’s left shoulder for “pain
and ↓ ROM > 1 year.” Ex. 3 at 37.
• On May 30, 2018, an MRI was conducted on Petitioner’s left shoulder, the
reason provided for the MRI exam was “left shoulder pain and decreased range
of motion.” Ex. 5 at 9. The MRI impression was “no internal derangement of the
left shoulder.” Id.
• On June 28, 2018, Petitioner was seen by Dr. Jeffrey C. Manlove. Dr. Manlove
indicated that Petitioner’s left shoulder pain began after “he received a flu
vaccination and initially he had extremely limited range of motion due to pain.”
Ex. 4 at 45. However, Petitioner reported “he can now manage full range of
motion” and Dr. Manlove noted “I was confident that it’s on its way back to
normal.” Id. On examination, Dr. Manlove found that Petitioner has “full range
of motion of left shoulder” with “no tenderness on palpitation.” Id. Dr. Manlove
assessed Petitioner with “SIRVA left shoulder following flu shot one [and a] half
years ago. This now appears to be resolving and he no longer has any
functional impairment.” Id.
The aforementioned medical records preponderantly establish that Petitioner
manifested both pain and reduced range of motion in his left shoulder, and that this pain
and reduced range of motion were limited to his left shoulder.
Admittedly, it is the case that on numerous occasions Petitioner manifested good
or full range of motion of the left shoulder. However, the contemporaneous medical
records (cited above) also document both subjective and objective evidence to the
contrary. In particular, on September 29, 2017, Petitioner subjectively reported to HSU
complaints of “pain + limited ROM [with] L[eft] shoulder in upward mot[ion].” Ex. 3 at 11.
HSU reported that Petitioner had “[f]ull ROM bilateral arms + R[ight] shoulder.” Id.
(emphasis added). This same record contains an objective “musculoskeletal” assessment
which indicated that Petitioner’s “problem location” was noted to be his left shoulder and
a box was checked indicating “ROM limitations.” Id. at 12.
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Further, objective evidence is found in Petitioner’s MRI order and report, both of
which document that Petitioner required a left shoulder MRI due to his left shoulder pain
and decreased range of motion. Ex. 3 at 37, Ex. 5 at 9. Respondent apparently dismisses
this evidence because it is contained in records generated more than one year after
Petitioner’s vaccination. ECF No. 27 at 3. However, assuming that there is a requirement
that a Petitioner must manifest reduced range of motion to meet the Table criteria for
SIRVA, no time period is set forth in which Petitioner must manifest reduced range of
motion.
C. Ruling on Entitlement
As discussed above, Respondent’s only objection to Petitioner’s Table SIRVA
claim is that Petitioner did not establish that he suffered reduced or limited range of motion
as required by the Table QAI for SIRVA. However, as further discussed above, I have
found that Petitioner has established that he manifested reduced or limited range of
motion of the left shoulder.
Further, I find based upon my complete review of the record in this case, that
Petitioner has established fully satisfied all Table requirements to establish SIRVA
pursuant to 42 C.F.R. § 100.3(c)(10) (the QAI) and 42 C.F.R. § 100.3(a)(XIV)(B) (listing
a time frame of 48 hours for a Table SIRVA following receipt of the flu vaccine). Therefore,
Petitioner has satisfied all requirements for a Table SIRVA and is entitled to a presumption
of causation.
Additionally, I find based upon my review of the record, and Respondent’s lack of
objection, that Petitioner has provided preponderant evidence to establish the additional
requirements of Vaccine Act under Section 11(c), i.e. receipt of a covered vaccine,
residual effects of injury lasting six months, etc. See generally § 11(c)(1)(A)(B)(D)(E).
Accordingly, I find that Petitioner is entitled to compensation for his injury.
III. Conclusion
As indicated above, I have specifically found that Petitioner has demonstrated
preponderant evidence of entitlement to compensation under the Vaccine Act. I therefore
find that Petitioner is entitled to compensation in this case.
A Damages Order will follow.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
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