Cooper v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-114V
Filed: August 3, 2018
PUBLISHED
TIFFANY COOPER,
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.
Diana Lynn Stadelnikas, Maglio Christopher & Toale, PA, Sarasota, FL, for petitioner.
Robert Paul Coleman, III, U.S. Department of Justice, Washington, DC, for respondent.
FINDING OF FACT AND RULING ON ENTITLEMENT 1
Dorsey, Chief Special Master:
On January 26, 2017, 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 left shoulder injury as a result of
her November 17, 2015 influenza (“flu”) vaccination. Petition at 1. The case was
assigned to the Special Processing Unit of the Office of Special Masters.
Petitioner has now moved for a ruling on the written record finding that her
shoulder injury and its sequela were the result of her vaccination. For the reasons
described below, the undersigned finds that petitioner’s alleged shoulder injury is
1 Because this unpublished ruling contains a reasoned explanation for the action in this case, the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.
2National 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).
1
consistent with a shoulder injury related to vaccine administration (“SIRVA”) and further
that petitioner is entitled to compensation for her SIRVA.
I. Procedural History
Initially, petitioner filed medical records marked as Exhibits 1 through 5 on
January 31, 2017. (ECF No. 6.) Following an initial status conference, additional
medical records marked as Exhibits 6 and 7 were filed on April 19, 2017, and an
affidavit by petitioner marked as Exhibit 8 was filed on May 1, 2017. (ECF Nos. 11, 13.)
Further medical records marked as Exhibit 9 were filed on July 13, 207. (ECF No. 17.)
On September 8, 2017, respondent filed his Rule 4 report recommending against
compensation in this case. (ECF No. 20.) The primary issue raised by respondent is
that any claim that petitioner’s injury is consistent with a SIRVA is undermined by the
fact that she waited more than six months before seeking any treatment. (Id. at 6.)
Respondent further argued that any medical opinion by petitioner’s doctor favoring
vaccine causation should carry little weight because it is based only on petitioner’s
representation that her pain began immediately after vaccination. (Id. at 6-7.)
Respondent also argued that petitioner’s affidavit describing the circumstances leading
to her delay in treatment is inadequate or not credible. (Id. at 7-8.)
The undersigned provided petitioner an opportunity to file additional evidence
responsive to the issues raised by respondent. (ECF No. 21.) Additional witness
affidavits marked as Exhibits 10 through 13 were filed on February 9, 2018, along with
an amended statement of completion. (ECF Nos. 27-28.)
Thereafter, a status conference was held with the staff attorney managing this
case. (ECF No. 29.) Respondent’s counsel confirmed that respondent’s position had
not changed following petitioner’s submission of further evidence. (Id.) At that time,
petitioner indicated that she was amenable to a ruling on the written record and
respondent did not object. (Id.) However, the undersigned instructed petitioner to file
additional evidence authenticating certain photographs filed in the case and addressing
petitioner’s statement that she had consulted her school’s nurse regarding her shoulder
pain. (Id.) The parties agreed to a briefing schedule to be set following petitioner’s filing
of a further amended statement of completion. (Id.)
Additional affidavits responsive to the undersigned’s order and marked as
Exhibits 14 and 15 were filed on April 30, 2018, along with an amended statement of
completion. (ECF Nos. 31-32.)
Petitioner filed a motion for a fact ruling on the written record on June 4, 2018.
(ECF No. 34.) Petitioner requested “a finding of fact that petitioner’s shoulder injury
occurred immediately following the vaccination on November 17, 2015, with ongoing
pain and decreased range of motion [and] that Ms. Cooper’s ongoing sequelae,
specifically frozen shoulder and partial supraspinatus tear was a result of the
vaccination . . .” (Id. at 5.)
2
Respondent filed his response on July 18, 2018. (ECF No. 35.) Respondent
requested that “the Court find that the evidence is insufficient to support petitioner’s
assertion that her shoulder condition occurred immediately following vaccination and
deny petitioner’s claim for entitlement to compensation.” (Id. at 1.) Respondent
requested that the case be dismissed. (Id. at 11.)
Petitioner was provided the opportunity to file a reply, but did not do so. Thus,
this case is now ripe for a fact ruling resolving the onset of petitioner’s shoulder injury.
II. Factual History
Petitioner, an elementary school teacher, received a flu vaccine on November
17, 2015. Ex. 1, p. 1; Ex. 8. She received her vaccination at her school through the
Long County Health Department. Ex. 15. Petitioner filed a record from the Georgia
Registry of Immunization Transactions and Services (“GRITS”) as evidence of the fact
of her vaccination.
The GRITS record does not indicate the site of administration. Id. However,
petitioner has additionally filed an affidavit by Katie Golden, the school’s nurse, averring
that petitioner received her vaccination in her left arm. 3 Ex. 15. In addition, petitioner
has filed photographs taken by her daughter, Sophie Cooper, approximately ten days
after the vaccination. Ex. 8, pp.3-4; Ex. 14. The photographs show petitioner’s left
shoulder and have a red circle marking the location of petitioner’s injection. Ex. 8, pp. 3-
4. Sophie Cooper avers that she placed the red circles on the photographs to show the
injection site. Ex. 14.
In her affidavit, petitioner averred that when she received her November 2015 flu
vaccination she felt immediate, severe pain at the injection site and that she had limited
range of motion of her left shoulder within 24 hours. Ex. 8, p. 1. Petitioner has also filed
affidavits from her school principal, her mother, and her husband. Exs. 10-12. Each of
these witnesses avers that petitioner experienced immediate pain following her
vaccination. Id.
Most significantly, petitioner also filed an affidavit by a coworker, Teri Martin. Ex.
13. Ms. Martin indicates that she was with petitioner when the vaccination was
administered. Id., p. 1. Ms. Martin avers that she observed petitioner receive her
vaccination and that the nurse was standing over her while administering the injection.
Id. Ms. Martin further indicates that petitioner commented immediately that her arm was
in severe pain. Id. Ms. Martin observed that the bandage over petitioner’s injection site
was higher on her shoulder than the other teachers who had also been vaccinated at
3There is no evidence to suggest that Ms. Golden was directly involved in the administration of
petitioner’s vaccination; however, as described below, petitioner conferred with Ms. Golden in her
capacity as the school nurse about her vaccination and shoulder injury less than one month after the
vaccination.
3
that time. Id. Ms. Martin recalls that petitioner continued to complain about her shoulder
pain for days and weeks. Id., pp. 1-2.
Petitioner first sought treatment of her shoulder pain from the school’s nurse.
She complained to the school nurse in early December of 2015 that she had trouble
lifting her left arm and had pain with movement. Ex. 8, 15. The nurse recommended
that Ms. Cooper contact the Long County Health Department. Id. Ms. Cooper reports
that a nurse from the health department told her to take ibuprofen and use a hot
compress. Ex. 8, p. 1. There is no record of either of these encounters filed in the
record of this case.
Petitioner avers that she followed the nurse’s advice and used a hot compress
and ibuprofen with no relief. Ex. 8, p. 1. Despite this, she indicates that she did not
seek medical care until the end of the school year, because she wanted to be present
for her students. Id. She did not indicate that absences were forbidden, but that as a
matter of professional responsibility they are “frowned upon and highly discouraged.” Id.
Petitioner’s principal, Ms. Wells, has provided an affidavit which confirms she was
aware of petitioner’s difficulties with her shoulder and also that it was a “critical period in
the academic year.” Ex. 10. Ms. Wells indicated that she asked Ms. Cooper why she
waited to see the doctor and was told that Ms. Cooper hoped her condition would
improve. Id. Petitioner’s mother also indicates that “Tiffany never complains about
anything and does not go to the doctor unless necessary.” Ex. 11.
Following her vaccination, petitioner’s next medical appointment was on April 5,
2016. Ex. 9. She was seen by her OBGYN for a yearly gynecologic evaluation and
there was no mention of her shoulder pain. 4 Id. There was no notation of any
abnormality on physical exam; however, the record does not indicate that any
musculoskeletal exam was performed. Id.
Petitioner did not return to any physician until May 23, 2016, when she first
sought orthopedic care for her left shoulder. At that time, petitioner was seen by
orthopedist James Wilson, Jr., M.D. Ex. 4, p. 4. Petitioner reported that she had been
experiencing six months of left shoulder pain and stiffness since receiving a flu shot in
November of 2015. Id. Petitioner showed Dr. Wilson the photographs taken by her
daughter and Dr. Wilson agreed that the injection site was elevated and right below the
acromion. Id.
On physical exam, Dr. Wilson recorded a stiff shoulder with forward flexion about
50 to 60 degrees actively and passively and less on abduction. He estimated external
rotation of about 10 degrees. Ex. 4, p. 4. Dr. Wilson diagnoses petitioner as having
adhesive capsulitis (or frozen shoulder) and attributed it to petitioner’s flu vaccination,
noting that “it would appear to me that this for all intent and purpose is the causative
factor that set off this adhesive capsulitis.” Based on the photograph provided by
petitioner, Dr. Wilson believed that the vaccine “probably was given into the subacromial
4 Petitioner does not have a primary care physician. Ex. 6, p. 3.
4
space if not into the joint itself.” Id. Dr. Wilson recommended physical therapy and an x-
ray. 5 Id.
Petitioner began physical therapy on June 8, 2016. Ex. 3, p. 2. She reported
seven months of left shoulder pain and decreased range of motion beginning the day
after a flu vaccination. Id. Petitioner reported no pain at rest, but severe pain (10/10)
when performing quick movements. It was noted that her pain and limitations caused
difficulty with her activities of daily life. Id. Petitioner continued physical therapy through
July 27, 2016. Ex. 3, p. 13.
On July 11, 2016, petitioner returned to Dr. Wilson. Ex. 4, p. 3. He noted that she
was still stiff and that her frozen shoulder was “significantly frozen.” Id. Dr. Wilson
ordered an MRI to rule out any other problems. That MRI study, conducted on July 15,
2016, showed a longitudinal partial tear of the supraspinatus insertion, though the
majority of the supraspinatus was intact. Ex. 2, p. 2. It also showed a moderate
subchondral bone contusion and a small glenohumeral joint effusion. Id. Following the
MRI, Dr. Wilson maintained his assessment of frozen shoulder, noting that the MRI
“does show the listed problems with a little bit of impingement spur, a little bone marrow
edema on the superior humeral head just medial to the rotator cuff tendon” and no
rotator cuff tear or avascular necrosis. Ex. 4, p. 2. Dr. Wilson recommended continued
physical therapy and noted that petitioner would return for further follow up, and
possible arthroscopy, when her teaching scheduled permits. Id.
Petitioner returned to Dr. Wilson on February 20, 2017. Ex. 6, p. 7. Petitioner
reported that her pain had resolved but that she still had stiffness. Dr. Wilson recorded
that “forward flexion is 100, abduction is 90, external rotation is 34, internal rotation is 10
on the left shoulder.” Id. He maintained his assessment of left shoulder adhesive
capsulitis “apparently related to a flu vaccination” and recommended manipulation with
arthroscopic capsular release. Id.
No further records have been filed, though later dated affidavits suggest that
petitioner remained symptomatic with no indication that she pursued the recommended
shoulder surgery. Ex. 8; Ex. 12.
III. Party Contentions
In her motion, petitioner stresses that pursuant to Vaccine Rule 8 the
undersigned has the authority to make a finding of fact without a hearing based on the
record evidence. (ECF No. 34, p. 1.) Petitioner contends that the factual record –
including both medical records and witness affidavits as described above –
demonstrates that petitioner experienced a SIRVA which occurred immediately
following her November 17, 2015 influenza vaccination. (ECF No. 34, pp. 1, 5.)
Petitioner further contends that there is no evidence for an alternative cause for
petitioner’s injury, noting that her treating physicians ruled out any structural or
traumatic etiology. (ECF No. 34, p. 5.)
5 That x-ray showed no abnormality. Ex. 5, p. 4.
5
Respondent contends, however, that petitioner has not provided preponderant
evidence that onset of her injury occurred within 48 hours of her flu vaccination, noting
that petitioner did not seek treatment until approximately six months after receiving the
vaccine. (ECF No. 35, p. 8.) Respondent also stresses that petitioner presented for a
gynecological exam during the intervening period without referencing her shoulder pain.
(Id.)
Respondent argues that petitioner’s stated reason for delaying treatment is not
credible. Respondent notes that notwithstanding her assertion that absences are
frowned upon and that she felt it is “imperative” that she be present for her students,
petitioner was able to attend the April 5, 2016 gynecological appointment. (ECF No. 35,
p. 8.) Respondent also stresses that petitioner’s affidavit did not address petitioner’s
ability to secure an appointment outside of school hours. (Id.) Respondent further
argues that petitioner’s claim of immediate onset is uncorroborated because there are
no contemporaneous medical records and all of the fact witness affidavits filed in this
case are dated two or more years after the vaccination in question. (ECF No. 35, p. 9.)
Finally, respondent argues that Dr. Wilson’s causation opinion should carry little
weight. Respondent argues that Dr. Wilson “did not see petitioner until more than six
months after vaccination, and the basis for this conclusion rests entirely upon
petitioner’s representation to him that her left arm pain developed immediately post-
vaccination. See ex. 4 at 4. However, because the medical and scientific basis
underlying any attribution of causation must be thoroughly examined, Dr. Wilson’s
opinions hold little-to-no weight as a physician’s conclusions ‘are only as good as the
reasons and evidence that support them.’” (ECF No. 35, p. 9. (quoting Davis v. HHS, 20
Cl. Ct. 168, 173 (1990).) In that regard, respondent is critical of Dr. Wilson’s reliance on
petitioner’s photographs of her injection site, arguing that the photographs are undated
and unverified and inadequate to determine the details of petitioner’s injection. (ECF
No. 35, pp. 9-10.)
In light of these arguments, respondent requests that petitioner’s claim be
dismissed. (ECF No. 35, p. 11.)
IV. Findings of Fact
There is no dispute that petitioner had a left shoulder injury. Nor is there any
dispute that petitioner’s injury is limited to her left shoulder. The question at issue is
whether petitioner’s left shoulder injury as reflected in the medical records was vaccine-
caused. In order to reach that question on this record, the undersigned will resolve
three factual issues: (1) the location of petitioner’s alleged injury-causing vaccination;
(2) whether petitioner experienced immediate pain following that vaccination; and (3)
whether any alternative explanation exists for petitioner’s shoulder pain.
6
A. Injection Site
The undersigned finds that petitioner’s November 17, 2015 influenza vaccine
was administered in her left shoulder. As described above, the injection site is not
included in petitioner’s vaccination record as filed in this case. Ex. 1. However,
petitioner has filed additional evidence supporting her contention that the injection was
administered into her left shoulder. First, petitioner has sworn that this is so. Ex. 8.
Additionally, petitioner’s statement is corroborated by a statement from the school
nurse, who indicated that petitioner was given an injection by the Long County Health
Department in her left arm. Ex. 15. Petitioner’s sworn statement is still further
corroborated by photographs taken days after the injection. Ex. 8, pp. 3-4. These
photographs were contemporaneously marked by petitioner’s daughter to show the site
of injection. Ex. 14. Although respondent disputes the authenticity of the photographs
based on the fact that they are not dated, respondent has not addressed the affidavit by
Sophie Cooper authenticating the photographs and averring as to the date that they
were taken. Moreover, the undersigned takes note of the fact that petitioner’s
orthopedist documented the fact that petitioner showed him photographs of her injection
site the first time she saw him for her shoulder injury, lending further credibility to Sophie
Cooper’s affidavit. Ex. 4, p. 4. Additionally, petitioner explicitly and consistently linked
her left shoulder injury to her vaccination when presenting to multiple medical providers.
See, e.g. Ex. 4, p. 4; Ex. 3, p. 13.
B. Whether petitioner experienced immediate pain
The undersigned finds based upon the record as a whole that there is
preponderant evidence that petitioner experienced pain immediately following her
vaccination and reduced range of motion within 24 hours. This is sworn to by petitioner
(Ex. 8), but is also supported by significant corroborating evidence.
First, petitioner’s contemporaneous medical records indicate that when she first
sought formal care for her shoulder injury, she reported that her pain began in
November of 2015 when she was given the flu shot. Ex. 4, p. 4. At that time, petitioner
presented her orthopedist photographs demonstrating that her injection was unusually
high. Id. This underscores the fact that at the time of her first orthopedic appointment,
petitioner firmly linked the onset of her pain to her vaccination. Her orthopedist further
noted that “[s]he has had no injury that set this off, by her report, other than the flu shot.”
Id. Additionally, petitioner repeated similar reports to her physical therapist. Ex. 3, p. 2.
At that time, she specifically identified her reduced range of motion as beginning “the
day after a flu vaccination.” Id.Medical records generally “warrant consideration as trustworthy evidence.”
Cucuras v.HHS, 993 F.2d 1525, 1528 (Fed.Cir.1993). Greater weight is typically given
to contemporaneous records. Vergara v. HHS, 08-882V, 2014 WL 2795491,*4 (Fed. Cl.
Spec. Mstr. May 15, 2014) (“Special Masters frequently accord more weight to
contemporaneously-recorded medical symptoms than those recorded in later medical
histories, affidavits, or trial testimony.”) To the extent respondent argues in effect that
7
these medical records are not credible because they are not contemporaneous to the
onset of petitioner’s injury, the undersigned is not persuaded.
As the undersigned has previously noted, a delay of several months before
seeking treatment does not necessarily defeat a SIRVA claim. See, e.g. Cooper v HHS,
16-1387V, 2018 WL 1835179, *6 (Fed. Cl. Spec. Mstr. Jan. 18, 2018) (holding that “the
undersigned does not find a delay in treatment of several months to be dispositive in
and of itself regarding the question of onset in a SIRVA case such as this.”) Although
these records are about six months removed from the onset of petitioner’s injury, they
represent the first time she was formally evaluated by a medical professional for her
injury and her injury was still ongoing at that time with active treatment continuing for
several months after. They are therefore contemporaneous treatment records and are
entitled to significant weight as they “contain information supplied to or by health
professionals to facilitate diagnosis and treatment of medical conditions.” Cucuras, 993
F.2d at 1528. As the Federal Circuit has previously noted, treatment records are
considered trustworthy at least in part because“[w]ith proper treatment hanging in the
balance, accuracy has an extra premium.” Id. This remains true regardless of whether
there is some delay in seeking treatment.
In any event, these medical records are not the sole evidence bearing on the
onset of petitioner’s injury. In this case, petitioner has secured an affidavit from an eye
witness who was with her at the time of her injection. That witness, Teri Martin,
indicated that she observed that petitioner’s vaccination was awkwardly administered,
that petitioner complained of severe pain immediately thereafter, and that she observed
this pain continuing over time. Ex. 13. Other witnesses have similarly averred that
petitioner’s pain began following her vaccination and continued during the months that
she delayed formal treatment. Exs. 10-12. Although respondent argues that these
affidavits should generally be discounted based on the fact that they were drafted two
years after the events at issue, respondent has not raised any specific issue calling into
question the veracity or accuracy of these recollections. Moreover, the undersigned
finds that they are cogent and consistent with the contemporaneous medical records
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); Cucuras, 993 F.2d at 1528 (noting that “the Supreme
Court counsels that oral testimony in conflict with contemporaneous documentary
evidence deserves little weight.”).
Additionally, petitioner has provided an affidavit from her school nurse, who
verifies that petitioner sought medical advice from her regarding her shoulder injury
approximately one month after her injurious vaccination. Ex. 15. Crediting this affidavit,
it is not accurate to say that petitioner delayed in seeking any treatment for six months.
This also diminishes the significance of the fact that petitioner saw her OBGYN in April
of 2016 without mentioning her shoulder pain. An intervening medical appointment
without mention of the ongoing shoulder injury could cast doubt on petitioner’s claim. In
this context, however, this is of little concern. The evidence shows that petitioner had
already sought medical advice regarding her shoulder from the school nurse and health
8
department prior to the OBGYN appointment and was hoping the pain would resolve on
its own. Exs. 8, 11, 15. Moreover, the appointment was not with a primary care
physician, but with a specialist unrelated to orthopedics or any other relevant specialty,
and there is no evidence to suggest any musculoskeletal exam was conducted.
To the extent explanation for the delay in seeking orthopedic treatment is helpful,
petitioner cites her work obligations as an explanation for her delay. Ex. 8. The
undersigned is not persuaded by respondent’s argument that petitioner has not
satisfactorily demonstrated that she was prevented by her work from pursuing
treatment. Petitioner has not averred that she was prevented from seeking treatment.
Nor would the record support such a claim. Rather, she only indicated that she
prioritized her work duties over her self-care. In the undersigned’s experience, such
prioritization is not unusual among individuals experiencing SIRVA. See, e.g. Cooper,
2018 WL 1835179, *2 (noting that petitioner described a delay in seeking treatment due
to an extended trip to Vietnam and care for her ailing mother); Marino v. HHS, 16-622V,
2018 WL 2224736, at *2 (Fed. Cl. Spec. Mstr. Mar. 26, 2018) (noting a delay in seeking
treatment due to a busy work schedule and difficulty making appointments); Almanzar v.
HHS, No. 16-340V, 2017 WL 8220616, at *3 (Fed. Cl. Spec. Mstr. Dec. 21, 2017)
(noting delay in treatment due to difficulty scheduling appointments and snow storms);
Knauss v. HHS, 16-1372V, 2018 WL 3432906 (Fed. Cl. Spec. Mstr. May 23,
2018)(noting three month delay in seeking treatment without a specified reason). That
petitioner appeared for a gynecological exam in the intervening period is not
discrediting. There is no evidence in the record that the exam interfered with her work
duties. As respondent notes, the record is silent as to the availability of appointments
outside of work hours. 6 Moreover, petitioner’s subsequent records noted that she
considered the academic year in considering if and when to undergo arthroscopy. Ex. 4,
p. 2.
C. Alternate Explanation for Shoulder Pain
Upon complete review of the record, the undersigned finds no basis for
concluding that there is any explanation for petitioner’s shoulder pain other than her
November 17, 2015 influenza vaccination. Prior to vaccination, petitioner was a
generally healthy individual and there is no evidence that she had any relevant pre-
6 Respondent’s argument on this point is speculative. Respondent suggests, in effect, that the OBGYN
appointment shows that it was possible for petitioner to balance her work schedule and medical
appointments. This argument assumes either that petitioner’s OBGYN appointment resulted in an
excused absence from work or that the OBGYN’s scheduling practices both allowed for after-work
appointments and are representative of other medical offices available to petitioner, such as Dr. Wilson’s
office. Nothing in the record supports either assumption. Respondent’s reference to other unspecified
providers, such as urgent care clinics, that may have been available is also speculative. Nothing in the
record speaks to what providers were available to petitioner or what limiting factors impacted her
selection of an orthopedist. In any event, the undersigned does not find that it is incumbent upon
petitioner to demonstrate that her delay in treatment resulted from completely insurmountable obstacles.
9
existing health concerns. 7 Moreover, petitioner’s contemporaneous orthopedic
treatment records are clear in stating that she reported no other injury, had no risk
factors for a fracture, and her orthopedist checked for scars or bruising. Ex. 4, p. 4.
Following that exam, the orthopedist concluded that the vaccine was the cause of
petitioner’s frozen shoulder. Id. A subsequent MRI study did not reveal any findings
interpreted as inconsistent with the orthopedists initial assessment. Ex. 4, p. 2; Ex. 6, p.
7.
V. Ruling on Entitlement
In light of the above findings of fact, the undersigned further finds that this case is
ripe for adjudication on the question of whether petitioner is entitled to compensation for
her alleged SIRVA. For the reasons described below, the undersigned finds that Ms.
Cooper is entitled to compensation.
A. Legal Standard
In this case, because petitioner’s claim predates the inclusion of SIRVA on the
Vaccine Injury Table, petitioner must prove his 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
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
7Petitioner did not have a primary care physician. Her only regular medical care was through her
OBGYN. There are no indications in the OBGYN records of any shoulder or musculoskeletal issues. Ex.
7.
10
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 notice of the fact that respondent has added SIRVA
to the Vaccine Injury Table for influenza vaccines intended for intramuscular
administration in the upper arm. 8 See 42 C.F.R. § 100.3; 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); 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 respondent stresses petitioner’s burden to establish a
medical theory, he has not disputed that the influenza 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
8 Although petitioner’s vaccine record is silent as to the route of administration, the record does indicate
that the vaccine petitioner received was a Fluarix-PF, which the undersigned understands to be
formulated for intramuscular use. Significantly, respondent has raised no issue as to the route of
administration in this case.
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caused-in-fact by the influenza vaccine); Koenig v. HHS, No. 16-1496V, 2017
WL6206391 (Fed. Cl. Spec. Mstr. April 13, 2017)(same); 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
Qualifications and Aids to Interpretation (“QAI”) criteria for SIRVA to be persuasive
regarding the factors necessary to demonstrate a logical sequence of cause and effect. 9
The criteria under the QAI are as follows:
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) (Qualifications and Aids to Interpretation for SIRVA).
In light of the factual history and findings described above, the undersigned finds
that all four of the criteria listed in the QAI for SIRVA are satisfied by preponderant
evidence. As noted above, the undersigned finds no history of pain, inflammation or
dysfunction of petitioner’s left shoulder prior to her November 17, 2017 vaccination.
Additionally, the undersigned found that petitioner experienced pain and reduced range
of motion within 48 hours of receipt of her vaccination. There has been no suggestion
that petitioner experienced pain and reduced range of motion other than in the impacted
shoulder. Nor would the record of the case support such a contention. Further, the
undersigned found no evidence of any other condition or abnormality that would explain
petitioner’s condition.
Additionally, petitioner’s claim is supported by the medical opinion of her
orthopedist. Ex. 4, p. 4. Following a physical examination, Dr. Wilson concluded that
petitioner was experiencing adhesive capsulitis caused by her flu vaccine. Id.9 Of note, although respondent does not explicitly endorse the use of the QAI to guide a determination as
to causation-in-fact, he does cite the 48 hour requirement from the Vaccine Injury Table as a necessary
component of establishing Althen prongs 2 and 3. (ECF No. 35, p. 10.)
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Respondent argues that Dr. Wilson’s opinion should be discounted, because he
did not see petitioner until more than six months after vaccination and the basis of his
opinion is petitioner’s representation to him that her left arm pain developed immediately
post-vaccination. In that regard, respondent stresses that a physician’s conclusions
“are only as good as the reasons and evidence that support them.” (ECF No. 35, p. 9
(quoting Davis v. HHS, 20 Cl. Ct. 168, 173 (1990).)
Given the finding of fact above, the undersigned is not persuaded by
respondent’s argument. As noted above, petitioner’s assertion that her injury began
immediately after her vaccination is credible and supported by corroborating evidence.
Thus, the undersigned does not find that petitioner’s physician’s reliance on that history
was misplaced or suspect. Moreover, the orthopedist’s records reflect a physical
evaluation, including the ruling out of alternate traumas or injuries. Additionally, the
orthopedist subsequently ordered and reviewed MRI studies without changing his
assessment of petitioner’s injury and its cause. Ex. 6, p. 7 (characterizing petitioner’s
injury as apparently vaccine-related subsequent to interpretation of petitioner’s MRI).
Significantly, respondent raises no other concern about this orthopedist’s opinion, such
as challenging his qualifications or clinical skills.
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 supported by medical opinion 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. In this case, respondent agrees that the relevant,
medically accepted, timeframe for onset of a SIRVA injury is within 48 hours of
vaccination. (ECF No. 35, p. 10.) Thus, in light of the above finding of fact that
petitioner’s shoulder pain began immediately, with reduced range of motion within 24
hours, petitioner has necessarily satisfied Althen Prong Three.
iv. Factors Unrelated to Vaccination
Respondent has not asserted, nor would the undersigned find, that there is any
evidence in the record to support respondent’s burden of establishing an alternative
cause for petitioner’s injury unrelated to vaccination.
VI. Conclusion
In light of all of the above, the undersigned GRANTS petitioner’s motion and
DENIES respondent’s competing request that petitioner’s claim be dismissed. The
undersigned finds that there is preponderant evidence that petitioner suffered a left
shoulder injury consistent with a SIRVA and that petitioner’s SIRVA first manifested with
immediate pain and reduced range of motion within 24 hours.
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Thus, in view of the evidence of record, the undersigned finds that
petitioner is entitled to compensation.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
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