Tenneson v. Secretary of Health and Human Services ( 2018 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-1664V
Filed: March 30, 2018
UNPUBLISHED
KELLI TENNESON,
Special Processing Unit (SPU);
Petitioner, Ruling on Entitlement; Causation-In-
v. Fact; Influenza (Flu) Vaccine;
Shoulder Injury Related to Vaccine
SECRETARY OF HEALTH AND Administration (SIRVA)
HUMAN SERVICES,
Respondent.
Ronald Craig Homer, Conway, Homer, P.C., Boston, MA, for petitioner.
Daniel Anthony Principato, U.S. Department of Justice, Washington, DC, for
respondent.
RULING ON ENTITLEMENT1
Dorsey, Chief Special Master:
On December 20, 2016, petitioner 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 her October 6, 2015 influenza (“flu”) vaccination.
Petition at 1. The case was assigned to the Special Processing Unit of the Office of
Special Masters. Petitioner now moves for a decision on the written record finding she
is entitled to compensation. (See ECF No. 28.) Respondent conversely moves for a
ruling on the record denying compensation to petitioner. (See ECF No. 27.) For the
1
Because this unpublished ruling contains a reasoned explanation for the action in this case, the
undersigned intends 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). 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, the undersigned agrees that the identified material fits
within this definition, the undersigned 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 “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
reasons described below, the undersigned finds that petitioner is entitled to
compensation.
I. Procedural History
Between December 23, 2016 and April 13, 2017, petitioner filed medical records
and affidavits from six individuals, including herself, in support of her claim. (ECF Nos.
7-8, 10-11, 16.)
On June 19, 2017 respondent filed his Rule 4(c) Report arguing that petitioner
failed to establish the onset of her left shoulder symptoms within a medically appropriate
time period, 48 hours, and thus failed to establish by preponderant evidence that she
developed SIRVA as a result of her October 6, 2015 flu vaccination. (ECF No. 18 at 5-
6)
Thereafter, on July 18, 2017 a status conference was convened by the OSM staff
attorney managing this claim on behalf of the undersigned to share the undersigned’s
impressions of the claim having reviewed petitioner’s medical records and affidavits, as
well as respondent’s Rule 4(c) Report. The undersigned issued a follow-up Order
indicating as follows:
[T]his claim generally meets the requirements for SIRVA. As an
initial matter, petitioner’s affidavit together with the records evidence onset
within 48 hours of petitioner’s vaccination. Accordingly, a fact hearing
should not be necessary. Specifically, both petitioner and her husband
aver in their affidavits that petitioner suffered pain the day after her
October 6, 2015 flu shot. Exs. 6 and 8. Further, at petitioner’s March 30,
2016 medical appointment she indicated she had “left arm pain since the
flu shot.” Ex. 2 at 89.
Additionally, the undersigned notes that petitioner’s clinical course
is consistent with SIRVA and that petitioner’s delay in reporting her injury
speaks to the severity and value of her injury. The undersigned does not
believe this is a claim that should go to hearing, but rather should be
resolved for a reasonable amount. Accordingly, the undersigned
encourages petitioner to make a reasonable demand upon respondent.
Order filed July 26, 2017. (ECF No. 19) To address concerns raised by respondent in
his Rule 4(c) Report and at the July 18, 2017 status conference petitioner agreed to file
a supplemental affidavit. (Id.) On August 22, 2017 petitioner filed supplemental
affidavits from three witnesses including herself. (ECF No. 21) Respondent filed a
status report on October 2, 2017 indicating that he was not willing to engage in
settlement discussions and intended to defend this case. (ECF No. 25)
Subsequently, the parties agreed the undersigned should issue a ruling on the
written record in lieu of a fact hearing and a briefing schedule was set. Additionally, the
undersigned filed the following two medical journal articles as evidence in regard to
SIRVA: B. Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA),
28 Vaccine 8049 (2010), filed as Court Exhibit I, and M. Bodor and E Montalvo,
Vaccination-related shoulder dysfunction, 25 Vaccine 585 (2007), filed as Court Exhibit
II. (ECF No. 26)
Petitioner and respondent each filed a motion for a ruling on the record on
November 20, 2017. (ECF Nos. 27-28) Petitioner filed response to respondent’s
motion on December 4, 2017 and respondent filed a reply to petitioner’s response on
December 5, 2017. (ECF Nos. 29-30)
Thus, this matter is ripe for a ruling on petitioner’s entitlement to compensation.
II. Factual History3
On October 6, 2015, petitioner received an intramuscular flu vaccination from
Kaiser Permanente – Colorado, her primary care provider, which was administered in
her left deltoid. (Ex. 1 at 1) At the time of her vaccination, petitioner was 58 years old.
(Ex. 1 at 1.) Her prior medical history was significant for low back pain, osteoporosis,
and irritable bowel syndrome. (Ex. 2 at 46-48)
Petitioner, a recently retired director of a preschool, provided testimony in her
affidavits that the vaccine was administered “very high up on my left arm.” (Ex. 6 at 1;
Ex. 14 at 1.) Petitioner explained that the “next day, I woke up with extreme pain in my
shoulder. The pain started in the exact area where the shot was given and by the end
of the evening I was having sharp pains all the way down my left arm. I thought the
pain would go away eventually, so I tried to wait it out.” (Ex. 6 at 1-2; Ex. 14 at 1.)
Petitioner further testified that she is not someone “who easily goes to the doctor, so
despite my ongoing pain as time progressed, I did not immediately seek care for my
symptoms.” (Ex. 14 at 1; Ex. 6 at 2). Petitioner further explained that she was busy
watching her granddaughter and “had never heard of the flu vaccine causing this type of
sustained pain, so I continued to tough it out.” (Ex. 6 at 2; Ex. 14 at 1). Petitioner’s
husband, Michael Tenneson, likewise testified by affidavit that the day after she
received her flu vaccine petitioner told him that “where she received the flu shot, really
hurt. She also told me that she could not lift her left arm above her shoulder without
being in pain.” (Ex. 8 at 1) Mr. Tenneson testified that he told petitioner it was “probably
normal to feel pain the day after receiving a flu shot.” (Id.)
On December 17, 2015, primary care records indicate that petitioner called her
primary care provider requesting “a form faxed to her employer, please asap” indicating
that “she has been seen in the last year and is in good health.” (Ex. 2 at 78) Petitioner
averred in her affidavit that this phone call related to a form that was required by the
State of Colorado in order for her to serve as a Substitute Director at the preschool from
where she recently retired. (Ex. 14 at 2) Petitioner testified that the form was a one
3
While the undersigned has reviewed and considered all of the filed evidence in this claim, this factual
history is condensed for brevity.
page document indicating she had no communicable diseases that her doctor had seen
her within the year, and that she was able to work with children. (Id.) Petitioner stated
the form was based on a physical examination which took place prior to her October 6,
2015 flu vaccination. Petitioner did not undergo a physical examination on December
17, 2015. Petitioner explained that at that time she requested the form be completed
“my shoulder was painful, but because I did not know that the flu vaccine could cause
such a sustained injury, I continued to have the mindset it would get better with time.”
(Ex. 14 at 2) As the pain continued, petitioner testified in her affidavit that she made an
appointment in January of 2016 to see her primary care provider. (Id. at 3) The
appointment was scheduled for March 30, 2016.4 (Id.)
On January 22, 2016, petitioner’s medical records reflect that she placed a
phone call to Kaiser, her primary care provider, regarding a possible UTI. (Ex. 2 at 80)
That same day petitioner presented to the emergency room (“ER”), at which time the
following symptoms were recorded: right flank/abdominal pain, low back pain, blood in
urine, discomfort with urination, pain and vomiting. (Ex. 3 at 1) The level of petitioner’s
symptoms were documented by the ER as “severe.” (Id.) The physical exam section
of petitioner’s ER record includes an “extremities” section with the following descriptions
checked: “non-tender,” “nml ROM,” and “no pedal edema.” (Id. at 2) Ultimately,
petitioner was found to be suffering an acute urinary tract infection and kidney stones.
(Id. at 3-8) Petitioner explained in her affidavit that she was enroute to a trip to the
mountains with her family on January 22, 2016 when she started to experience
“excruciating back pain” and that by the time they reached their destination she was “in
horrible pain, and could not stop urinating and vomiting.” (Ex. 14 at 3) Petitioner
indicated due to her severe symptoms her husband and son took her to the ER where
she spent several hours, but was only seen by a doctor for two to three minutes. (Id. at
3-4) Petitioner testified that no examination of her upper extremities was conducted
while she was at the ER, to include that no examination of her left shoulder for
tenderness or range of motion. (Id. at 4)5 Petitioner testified that only her back and
abdomen were touched. (Id.) Petitioner explained subsequent to her visit she spoke to
the billing department in regard to her visit and after describing her experience at the
ER they reduced the cost billed to her and apologized for the care she received. (Id.)
The affidavits of petitioner’s son and husband, both who stayed with her in the ER
examination room, are consistent with petitioner’s recollection of January 22, 2016.
(Exs. 15-16)
Thereafter, the medical records reflect that petitioner placed phone calls to
Kaiser on January 25 and 26, 2016 in follow-up to her ER visit due to concerns about
4
The undersigned notes petitioner’s affidavit contains a typographical error indicating that the
appointment was scheduled for March 31, 2016.
5
However, petitioner did aver that she noted to the CT scan technician at the ER that she could not raise
both of her arms overhead because she had very minimal range of motion as a result of her flu vaccine in
October. (Ex. 14 at 5) He indicated she should let a doctor know what occurred and she told him she had
a physical scheduled for March. (Id.)
leaving town in a few weeks. (Ex. 2 at 84-85) Petitioner described her kidney stone,
and “[d]enied pain, blood in her urine and fever.” (Id. at 84) Deja Vandeloo, MD, noted
that pain medication was “not really need(ed) right now unless absolutely has to” and
that petitioner indicated she was feeling better. (Id. at 85) Dr. Vandeloo stated urology
indicated the stone should pass and to follow-up in two weeks if it does not. (Id.)
Subsequently, petitioner first received medical treatment for her shoulder pain on
March 30, 2016. (Ex. 2 at 89) Petitioner testified in her affidavit this was the first time
she had seen her primary care doctor, Dr. Vandeloo, since prior to her flu shot. (Ex. 14
at 6) According to Dr. Vandeloo’s record, petitioner reported she experienced
left arm pain since flu shot 10/15, pain all the way down arm. Can barely
move arm now. Just hasn't gotten better. Wakes her up at night. Does
watch her grand-baby and can lift her but hard time getting seat belt, etc.
No other trauma. No prior shoulder problems. Wondering if they hit a
nerve or something as they gave the flu shot kind of high up she thinks.
(Ex. 2 at 89) Dr. Vandeloo’s muscoskeletal examination of petitioner found “limited ROM
left shoulder—can only abduct/extend to approx 80-90 degrees and can only get a few
more degrees passively.” (Id. at 90 ) Dr. Vandeloo diagnosed petitioner with adhesive
capsulitis of the left shoulder. (Id.at 91) Dr. Vandeloo followed up with the “shot line
who said [petitioner’s shoulder injury] was not due to vaccine by they can’t comment on
administration.” (Id.) An orthopedist was also consulted who “also felt unlikely this is all
related to flu shot.” (Id.) However, the orthopedist did note that petitioner “certainly
could have developed a frozen shoulder if she hasn’t moved it [for] 5 mo[nths] [since the
flu vaccination].” (Id. at 97) Dr. Vandeloo ordered a left shoulder xray and referred
petitioner to physical therapy and an orthopedist. (Id. at 91) Petitioner’s orthopedist
referral notes as follows:
Kelli Tenneson is a 58 year old female. Please see this patient and send
me a copy of your note including your opinion and recommendations for
the following left shoulder problem: frozen shoulder--pt has had pain ever
since flu shot 10/15 w/ no injury. Worsening ROM over last 5 months. No
trauma.
(Id. at 89)
Petitioner followed up with physical therapist, Robert Webers, on April 13, 2016.
(Id. at 99) Mr. Webers recorded the following history: “Pt got a flu shot in Oct. 2015, and
since then she has had pain as above [right lateral humerus pain].” (Id.) Mr. Webers
performed an exam and found petitioner’s range of motion to be limited. (Id.) Mr.
Webers found that petitioner presented with signs and symptoms consistent with
adhesive capsulitis and recommended treatment every 10 days for four weeks with a
goal to increase petitioner’s range of motion. (Id.)
Subsequently, petitioner was evaluated by orthopedist, Tracy Frombach, DO, on
April 27, 2016. Dr. Frombach recorded the following history,
patient is a 58-year-old female who in October received her flu shot. The
patient states that the day following her flu shot she had significant pain in
the left shoulder and had limited range of motion. The patient states that
she is unable to lift her arms above her head, but her strength close to the
body and lower than the shoulder is adequate.
(Id. at 109) Dr. Frombach’s exam found petitioner suffered limited range of motion and
mild tenderness through petitioner’s mid deltoid. (Id. at 110) Dr. Frombach assessed
petitioner’s injury as follows: “1. Adhesive capsulitis of the left shoulder following a flu
injection in October 2015. 2. Left rotator cuff syndrome.” (Id.) Dr. Frombach
administered a left subacromial injection to treat petitioner’s left shoulder and
recommended petitioner strictly adhere to her home exercise program through physical
therapy. (Id. at 110-111) Thereafter, petitioner continued to follow-up with Dr. Frombach
through October 2016 at which time Dr. Frombach noted in her history that “[t]his
started in October of 2015 and is resolving” and found specifically that petitioner’s “[l]eft
adhesive capsulitis [was] almost completely resolved.” (Ex. 4 at 44-45) Petitioner
continued to pursue physical therapy through at least March of 2017. (Ex. 13 at 33)
III. Party Contentions
In sum,6 petitioner argues she has satisfied the criteria, as detailed by Vaccine
Injury Table’s Qualifications and Aids to Interpretation (“QAI”), to establish a Table claim
for SIRVA. (ECF No. 28 at 16-20) Alternatively, petitioner argues that she has met the
burden for establishing entitlement to compensation in an “Off-Table” claim by
demonstrating the Althen v. HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005) criteria to
establish petitioner more likely than not suffered a SIRVA. (Id. at 24-26)
Respondent argues that petitioner’s contemporaneous records do not establish
that her injury manifested within a medically appropriate time frame. (ECF No. 27 at 6.)
Respondent argues that petitioner’s contemporaneous records indicate that petitioner’s
shoulder pain began approximately three to six months subsequent to her October 6,
2015 vaccination. (Id. at 7) Respondent asserts that the literature submitted by the
court establishes that most SIRVA injuries begin within two days, and all occur within
four days of vaccination. (Id. at 6) Accordingly, respondent argues petitioner’s claim
should be denied. (Id. at 7-10)
IV. Finding of Fact
The first issue to be addressed is when the onset of petitioner’s shoulder injury
occurred. Petitioner has the burden of demonstrating the facts necessary for
entitlement to an award by a “preponderance of the evidence.” § 300aa-12(a)(1)(A).
Under that standard, the existence of a fact must be shown to be “more probable than
6
The undersigned has fully reviewed and considered the parties’ briefing in this matter, however for the
purpose of brevity does not summarize and/or address each argument put forward.
its nonexistence.” In re Winship, 397 U.S. 358, 371 (1970) (Harlan, J., concurring). In
light of all of the above record evidence and for the reasons described below, the
undersigned finds that there is preponderant evidence that the onset of petitioner’s
alleged shoulder pain occurred within 48 hours of petitioner’s October 6, 2015 flu
vaccination.
As described above, petitioner’s medical records demonstrate that petitioner
repeatedly and consistently placed the onset of her condition within 48 hours of her
vaccination. Respondent argues that there is no corroborating evidence that petitioner
experienced the onset of symptoms during the six months after the vaccination and
before seeking treatment for her injury. (ECF No. 27 at 9) However, respondent
unreasonably dismisses petitioner’s contemporaneous treatment records since the
records were not created contemporaneously with the onset of petitioner’s shoulder
pain. (ECF No. 30 at 1-2) The fact that petitioner delayed seeking treatment for her
shoulder symptoms does not negate the value of her treatment records or render this
evidence not credible, although it may speak to the severity of her injury.7 The
undersigned does not find petitioner’s delay in treatment of nearly six months to be
dispositive regarding the question given the facts and circumstances of this case.
Three different health care providers documented consistently as to onset. The
first time petitioner sought medical treatment for her injury from her primary care
provider, Dr. Vandeloo on March 30, 2016, she placed the onset of her pain as since
her October 2015 flu shot. (Ex. 2 at 89) Her subsequent physical therapy evaluation by
physical therapist, Robert Webers on April 13, 2016 noted that “[patient] got a flu shot in
Oct. 2015, and since then she has had pain.” (Id. at 99) Petitioner again linked her
shoulder pain to her October 6, 2015 flu vaccination at her April 27, 2016 evaluation by
orthopedist, Dr. Frombach. Dr. Frombach noted “patient is a 58-year-old female who in
October received her flu shot. The patient states that the day following her flu shot she
had significant pain in the left shoulder and had limited range of motion.” (Id. at 109)
Additionally, the undersigned finds petitioner’s affidavits explaining her pattern of
treatment and reports to her physicians as reasonable and credible. See, e.g. Stevens
v. HHS, 90-221V, 1990 WL 608693, *3 (Cl. Ct. Spec. Mstr. 1990)(noting that clear
cogent, and consistent testimony can overcome missing or contradictory medical
records). Petitioner’s account is detailed, cogent and corroborates the statements she
made to her health care providers. Moreover, in the undersigned’s experience,
petitioner’s affidavits and medical records together reflect a pattern of treatment
consistent with and similar to many other SIRVA claims.8 Likewise, petitioner’s
affidavits are consistent with the affidavits filed from petitioner’s family members.
7
The undersigned further rejects respondent’s argument that her finding of onset in these circumstances
opens up the Vaccine Program to fraud and abuse. (ECF No. 27 at fn 6; ECF No. 30 at 1-2) The
undersigned has carefully reviewed all evidence filed in this matter and finds no evidence of fraud.
8
The undersigned disagrees with respondent’s characterization of petitioner’s affidavit as internally
inconsistent. (ECF No. 27 at 9-10) The undersigned finds that petitioner’s lack of awareness that a flu
Respondent argues petitioner’s earlier visit to the ER on January 22, 2016, and
follow-up phone calls to Kaiser, establish that petitioner’s shoulder pain approximately
began three to six months subsequent to her October 6, 2015 flu vaccination. (ECF No.
27 at 7-9) In particular, respondent relies upon checkmarks next to “non-tender,” “nml
ROM,” and “no pedal edema” under the “extremities” portion of the physical exam
section of petitioner’s ER record (Ex. 3 at 2) as evidence that the onset of petitioner’s
injury did not commence until three to six months after the flu vaccine. (Id.) Given the
context of these records the undersigned disagrees with respondent’s assertion. The
undersigned notes that petitioner was seen at the ER on January 22, 2016 for a UTI
and kidney stones which are extremely painful conditions for which petitioner was
seeking urgent medical attention. Additionally, in the undersigned’s experience
thorough physical examinations are not conducted in the ER setting for issues beyond
or unrelated to the reason for the visit. The undersigned notes this is in contrast to a
general or physical examination conducted by a primary care physician or orthopedist.
The undersigned finds that petitioner’s subsequent phone calls to Kaiser on January 25
and 26, 2016 are clearly in follow-up to petitioner’s emergency room visit for her UTI
and kidney stones, and the description of lack of pain relates accordingly to those
issues, as opposed to a lack of pain in her left shoulder. Additionally, petitioner, her
husband, and son in their testimony by affidavit offer consistent, cogent, and reasonable
descriptions of the events leading to petitioner’s ER visit and the ER visit itself. (See
Ex. 14-16)
The undersigned finds that the affidavits submitted by and on behalf of petitioner
and the medical records work in tandem to provide preponderant evidence that
petitioner’s shoulder pain began within 48 hours of her October 6, 2015 flu vaccination.
V. Ruling on Entitlement
In light of the above finding of fact, the undersigned further finds that this case is
ripe for adjudication on the question of petitioner’s entitlement to compensation for her
alleged SIRVA. For the reasons described below, the undersigned finds that petitioner
is entitled to compensation.
a. Legal Standard
In this case, because petitioner’s claim predates the inclusion of SIRVA on the
Vaccine Injury Table,9 petitioner must prove her claim by showing that her injury was
“caused-in-fact” by the vaccination in question. § 300aa-13(a)(1)(B); § 300aa-
11(c)(1)(C)(ii). In such a situation, of course, the presumptions available under the
Vaccine Injury Table are inoperative. The burden is on the petitioner to introduce
vaccination can cause a sustained injury is not inconsistent with petitioner still believing or attributing her
left shoulder pain to her flu shot in the left shoulder.
9
Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed on the Vaccine Injury
Table (“Table”). See National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury
Table, Final Rule, 82 Fed. Reg. 6294, Jan. 19, 2017 (codified at 42 CFR Part 100.3(c)); National Vaccine
Injury Compensation Program: Revisions to the Vaccine Injury Table, Delay of Effective Date, 82 Fed.
Reg. 11321, Feb. 22, 2017 (delaying the effective date of the final rule until March 21, 2017).
evidence demonstrating that the vaccination actually caused the injury in question.
Althen v. HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. HHS, 940 F.2d 1518,
1525 (Fed. Cir. 1991). The showing of “causation-in-fact” must satisfy the
“preponderance of the evidence” standard, the same standard ordinarily used in tort
litigation. § 300aa-13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at
1525. Under that standard, the petitioner must show that it is “more probable than not”
that the vaccination was the cause of the injury. Althen, 418 F.3d at 1279.
The petitioner need not show that the vaccination was the sole cause or even the
predominant cause of the injury or condition, but must demonstrate that the vaccination
was at least a “substantial factor” in causing the condition, and was a “but for” cause.
Shyface v. HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999).
Under the leading Althen test, petitioner must satisfy three elements. The Althen
court explained this “causation-in-fact” standard, as follows:
Concisely stated, Althen’s burden is 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 proximate temporal relationship
between vaccination and injury. If Althen satisfies this burden, she is
“entitled to recover unless the [government] shows, also by a
preponderance of the evidence, that the injury was in fact caused by
factors unrelated to the vaccine.”
Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner
need not necessarily supply evidence from medical literature supporting petitioner’s
causation contention, so long as the petitioner supplies the medical opinion of an
expert. Id. at 1279-80. The court also indicated that, in finding causation, a Program
fact-finder may rely upon “circumstantial evidence,” which the court found to be
consistent with the “system created by Congress, in which close calls regarding
causation are resolved in favor of injured claimants.” Id. at 1280.
b. Analysis
The undersigned finds that petitioner satisfies the three prongs of Althen as
follows:
i. Althen Prong 1
Under Althen Prong One, there must be preponderant evidence of a medical
theory causally connecting petitioner’s vaccination to her injury. In satisfaction of Althen
Prong One, the undersigned takes judicial notice of the fact that respondent has added
SIRVA to the Vaccine Injury Table for the influenza vaccine. See National Vaccine
Injury Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg.
45132, Notice of Proposed Rulemaking, July 29, 2015 (citing Atanasoff S, Ryan T,
Lightfoot R, and Johann-Liang R, 2010, Shoulder injury related to vaccine
administration (SIRVA), Vaccine 28(51):8049-8052)10; see also Doe 21 v. HHS, 88 Fed.
Cl. 178 (July 30, 2009), rev’d on other grounds, 527 Fed. Appx. 875 (Fed. Cir.
2013)(holding that recognition of a link between vaccine and injury on the Vaccine Injury
Table supports petitioner’s burden under Althen Prong One.)
In any event, although it is petitioner’s burden to establish all Althen prongs by
preponderant evidence, respondent has not disputed that the flu vaccine can cause
SIRVA. In that regard, it is worth noting that there is a well-established track record of
awards of compensation for SIRVA being made on a cause-in-fact basis in this
program. See, e.g. Loeding v. HHS, No. 15-740V, 2015 WL 7253760 (Fed. Cl. Spec.
Mstr. Oct. 15, 2015)(noting that “respondent ‘has concluded that petitioner’s injury is
consistent with SIRVA; that a preponderance of evidence establishes that her SIRVA
was caused in fact by the flu vaccination she received on October 14, 2014; and that no
other causes for petitioner’s SIRVA were identified.”); see also Johnson v. HHS, No. 16-
165V, 2016 WL 3092002 (Fed. Cl. Spec. Mstr. April 13, 2016)(awarding compensation
for a SIRVA caused-in-fact by the influenza vaccine); Koenig v. HHS, No. 16-1496V,
2017 WL6206391 (Fed. Cl. Spec. Mstr. April 13, 2017)(same). Moreover, respondent
has conceded causation in many prior Hep A-caused SIRVA cases in particular. See,
e.g. Telonidis v. HHS, No. 15-450V, 2015 WL 5724746 (Fed. Cl. Spec. Mstr. Sept. 2,
2015); Salas v. HHS, No. 16-739V, 2016 WL 8459834 (Fed. Cl. Spec. Mstr. Nov. 7,
2016).
ii. Althen Prong 2
Under Althen Prong Two, petitioner must demonstrate a logical sequence of
cause and effect showing that the vaccination was the reason for the injury. Although
petitioner’s claim does not constitute a Table Injury, the undersigned finds the QAI
criteria for SIRVA to be persuasive regarding the factors necessary to demonstrate a
logical sequence of cause and effect. The criteria under the 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:
10
Codified at 42 CFR Part 100.3(c).
(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 CFR Part 100.3(c)(10) (Qualifications and Aids to Interpretation for SIRVA).
In light of the factual history described above, the undersigned finds that all four
of the criteria listed in the QAI for SIRVA are satisfied by preponderant evidence.
Based on petitioner’s medical records and affidavit, prior to petitioner’s flu
vaccination October 6, 2015 she had no history of pain, or other signs or symptoms in
her left shoulder consistent with SIRVA. The undersigned further notes that respondent
has not alleged that petitioner had any symptoms of SIRVA prior to her October 6, 2015
flu vaccine.
Additionally, petitioner’s post-vaccination medical records reveal no other
proffered explanation for her injury and her diagnostic evaluations are significant for
findings consistent with a SIRVA injury, including limited range of motion (Id. at 90-91,
99, 110) and a diagnosis of adhesive capsulitis (Id. at 90-91, 99, 110).
As discussed above, based upon petitioner’s medical records and affidavits, the
undersigned finds petitioner’s onset of her shoulder injury is within the specified time
frame of < 48 hours. The undersigned finds petitioner offers a reasonable and
persuasive explanation in her affidavits for her delay in reporting her shoulder injury,
and finds persuasive petitioner’s reports to both Drs. Vandeloo and Frombach, as well
as physical therapist, Mr. Webers regarding the onset of her shoulder pain. The
undersigned further finds that petitioner offers a reasonable and cogent explanation of
the limited nature of her examination at the ER on January 22, 2016 and the nature of
her follow-up phone calls with Kaiser.
For all these reasons, the undersigned finds that petitioner has presented
preponderant evidence pursuant to Althen Prong Two of a logical sequence of cause
and effect showing that her injury was vaccine-caused.
iii. Althen Prong 3
Under Althen Prong Three, there must be a proximate temporal relationship
between vaccination and injury. Respondent asserts that the relevant, medically
accepted, timeframe for onset of a SIRVA injury based upon the literature submitted by
the undersigned is within 4 days of vaccination. (ECF No. 27 at 6) Thus, in light of the
above finding of fact that petitioner’s shoulder pain began within 48 hours of her
October 6, 2015 flu vaccination, petitioner has satisfied Althen Prong Three.
iv. Factors Unrelated to Vaccination
Respondent has not asserted, nor has the undersigned identified any factor
unrelated to petitioner’s vaccination which would meet respondent’s burden of
establishing an alternative cause for petitioner’s injury unrelated to vaccination.
VI. Conclusion
Thus, for all the foregoing reasons, the undersigned finds petitioner’s has
established by preponderant evidence that her October 6, 2015 flu vaccination was the
cause-in-fact of her SIRVA. Accordingly, the undersigned DENIES respondent’s
request for a ruling denying compensation (ECF No. 27 at 10) and GRANTS petitioner’s
motion for a finding that petitioner is entitled to compensation for SIRVA (ECF No. 28 at
26).
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master