         In the United States Court of Federal Claims
                                 OFFICE OF SPECIAL MASTERS
                                          No. 16-0731V
                                     Filed: March 13, 2018
                                         UNPUBLISHED

                                                     
    COURTNEY P. BINETTE,
                                                             Special Processing Unit (SPU);
                        Petitioner,                          Entitlement; Ruling on the Record;
    v.                                                       Decision Without a Hearing;
                                                             Causation-In-Fact; Influenza (“Flu”)
    SECRETARY OF HEALTH                                      Vaccine; Shoulder Injury Related to
    AND HUMAN SERVICES,                                      Vaccine Administration (SIRVA)

                       Respondent.


Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for
petitioner.
Robert Paul Coleman, III, U.S. Department of Justice, Washington, DC, for respondent.

                                   RULING ON ENTITLEMENT 1

Dorsey, Chief Special Master:

       On June 22, 2016, Courtney P. Binette (“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” or “Program”), alleging that as a result of
receiving an influenza (“flu”) vaccination on October 25, 2015, she suffered from a
shoulder injury related to vaccine administration (“SIRVA”). Petition at 1. The case was
assigned to the Special Processing Unit (“SPU”) of the Office of Special Masters. For
the reasons discussed herein, the undersigned finds that petitioner is entitled to
compensation.

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  Because this unpublished ruling contains a reasoned explanation for the action in this case, the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).
   I.     Procedural History

       Petitioner filed medical records in support of her June 22, 2016 petition. Pet.’s
Exs. 1-7 (Vaccination and Medical Records), ECF No. 6; Pet.’s Ex. 8 (Pet.’s Aff.), ECF
No. 10; Pet.’s Ex. 9 (Updated Medical Records), ECF No. 15; Pet.’s Exs. 10-11 (Dr.
Piscopo Records), ECF No. 31; Pet.’s Ex. 12 (JoAnn Lanoie Aff.), ECF No. 33; Pet.’s
Ex. 13 (Letter from Vocational Expert Roberta Hurley), ECF No. 34.

      An initial status conference was held on July 26, 2016. Order, ECF No. 9.
During that conference, a schedule was set for petitioner to file an affidavit and for
respondent to file initial feedback in the case. Id.

       On September 12, 2016, respondent filed a status report indicating he was
amenable to engaging in settlement discussions, ECF No. 11. Periodic status reports
were filed updating the undersigned on the progress of settlement. See ECF Nos. 13,
16, 18, 20, & 24.

       On March 1, 2017, respondent informed the court via email that the parties had
reached a tentative settlement agreement and requested that the undersigned issue a
15-week stipulation order. 15-Week Order, ECF No. 25 (withdrawn). A July 31, 2017
deadline was set for the filing of the parties’ stipulation of settlement. Id.

        On June 13, 2017, respondent reported that the authorized representative of the
Attorney General had declined to grant settlement approval for the parties’ proposed
tentative settlement. Resp.’s Status Report, ECF No. 26. As a result, the undersigned
convened a status conference on July 13, 2017. Order, ECF No. 27. During that
conference, the undersigned issued a preliminary finding that petitioner’s claim would
qualify as a SIRVA claim. Id. A schedule was set for briefing for a ruling on the record
and petitioner was directed to file her damages documentation. Id. Following the
conference, the undersigned also withdrew the March 1, 2017 15-Week Order. See
Order, ECF No. 27.

        Petitioner filed her motion for ruling on the record on September 18, 2017, ECF
No. 32. Respondent filed a memorandum in response on October 18, 2017, ECF No.
35. Petitioner did not file a reply. On December 20, 2017, the undersigned issued an
order introducing two medical articles discussing SIRVA as court exhibits: 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. See Order,
ECF No. 36. The parties were directed to file any responses by January 19, 2018. Id.
No responses were filed and the matter is now ripe for ruling.




                                             2
   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). § 11(c)(1)(C)(i). 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. § 14(a). If petitioner establishes that the vaccinee has suffered a
“Table Injury,” causation is presumed.

       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. § 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. § 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 Circuit Court 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.



                                              3
Id. All three prongs of Althen must be satisfied. Id.

       Section 11(c)(1) also contains requirements concerning the type of vaccination
received and where it was administered, the duration or significance of the injury, and
the lack of any other award or settlement. See § 11(c)(1)(A),(B),(D) and (E). With
regard to duration, a petitioner must establish she

              (i) suffered the residual effects or complications of such
              illness, disability, injury, or condition for more than 6 months
              after the administration of the vaccine, or (ii) died from the
              administration of the vaccine, or (iii) suffered such illness,
              disability, injury, or condition from the vaccine which resulted
              in inpatient hospitalization and surgical intervention.

§ 11(c)(1)(D) (emphasis added).

   III.   Analysis - Althen Prongs

          a. A Medical Theory Causally Connecting the Vaccination and Injury

        To satisfy the first Althen prong, the petitioner must show that the vaccination in
question can cause the injury alleged. See Pafford v. Sec’y of Health & Human Servs.,
2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff’d, 64 Fed. Cl. 19
(2005), aff’d, 451 F.3d 1352 (Fed. Cir. 2006). The petitioner must offer a medical theory
which is reputable and reliable. See, e.g., Pafford, 451 F.3d at 1355 (reputable);
Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1324 (Fed. Cir. 2010)
(reliable). The petitioner must prove this prong by preponderant evidence.
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir.
2010).

                  i. SIRVA Injury

        Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed
on the Vaccine Injury Table (“Table”). See Vaccine Injury Table: Qualifications and aids
to interpretation. 42 C.F.R. § 100.3(c)(10). Although petitioner’s claim was filed before
SIRVA was added to the Table, and thus cannot be found to be a SIRVA Table injury,
the undersigned’s findings are informed by the Qualifications and Aids to Interpretation
for SIRVA criteria used to evaluate such claims. The criteria 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

                                             4
neuritis, mononeuropathies, or any other neuropathy). Id.; see also 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).

                         1. The elements of petitioner’s SIRVA claim

       The undersigned’s findings and conclusions are as follows:

   a. Petitioner did not have a history of pain, inflammation or dysfunction of the
      affected shoulder prior to vaccine intramuscular administration.

        The undersigned reviewed Ms. Binette’s medical history prior to her October
2015 flu vaccination. Petitioner did not have a history of pain, inflammation or
dysfunction of her left shoulder prior to vaccination. Thus, petitioner satisfies this
criterion.

   b. Onset occurred within the specified time frame.

       Respondent argues that petitioner has not established that her left shoulder pain
began within 48 hours from her October 25, 2015 flu vaccination. Resp.’s Resp. at 7.
Respondent’s further asserts that petitioner’s recollection as to the onset of her shoulder
pain is inconsistent and thus, unreliable. Id. at 8. The undersigned disagrees.

       On October 25, 2015, petitioner received a flu vaccination intramuscularly in her
left upper arm. Pet.’s Ex. 1 at 1. Although petitioner often reported to her providers
thereafter that she received the flu shot on October 22, 2015 instead of October 25,
2015, she consistently reports that her pain began directly following the vaccination.
See Pet.’s Ex. 3 at 18 (dated 11/9/2015, “states limited ROM since 10/22/2015 flu shot
via her employer, left side, having trouble with all activity and sleeping); Pet.’s Ex. 4 at
48 (dated 11/19/2015, “P[atient] reports history of l[eft] [shoulder] pain since flu shot
received 10-22-15.”); Pet.’s Ex. 2 at 1-2 (dated 1/5/2016, “Here for left shoulder pain
since 10/22/15 when she had the flu vaccine.”); Pet.’s Ex. 2 at 3 (dated 1/5/2016,
“Symptoms started 10/22/15 when she received her flu shot.”); Pet.’s Ex. 6 at 7 (dated
2/26/2016, “She reports within a day or 2 she was having significant pain in her
shoulder and difficulty with use of her arm.”).

         Furthermore, petitioner’s coworker, JoAnn Lanoie, recalls petitioner having
difficulty performing aspects of her job due to shoulder pain immediately following her
October 25, 2015 flu shot. Pet.’s Ex. 12 at 1; see also Pet.’s Ex. 8 at 1 (Pet.’s Aff.).

       Based upon the totality of the evidence set forth in the medical records and
affidavits, the undersigned finds that the onset of petitioner’s shoulder pain was within
48 hours of her October 25, 2015 flu vaccination, and therefore, is within the Vaccine
Table specified time frame of <48 hours. § 13(a)(1)(A) (preponderant standard).


                                              5
   c. Pain and reduced range of motion are limited to the shoulder in which the
      intramuscular vaccine was administered.

       The evidence submitted by petitioner includes medical records detailing the
treatment which she sought for pain in her left shoulder since her October 2015 flu
vaccination. See e.g., Pet.’s Ex. 2 at 4, 8; Pet.’s Ex. 3 at 18; Pet.’s Ex. 4 at 48; Pet.’s
Ex. 6 at 7-8. A summary of these records follows.

        Following her October 25, 2015 flu vaccination, petitioner presented to her
primary care physician on November 9, 2015. Pet.’s Ex. 3 at 18. The record from that
visit provides:

       The incident occurred at work (Pt states at work on 10/22/2015 she received
       [sic] a flu shot to the left shoulder and a few days after the shot she has had
       pain, decreased range of motion and midl [sic] swelling without redness. . .
       The left shoulder is affected. The incident occurred more than 1 week ago.
       Injury mechanism: flu shot.

Id. at 19. Petitioner was diagnosed with acute bursitis of the left shoulder. Id. at 21.

       On December 11, 2015 petitioner’s primary care physician referred her to an
orthopedic surgeon for an evaluation of her left shoulder pain. Pet.’s Ex. 3 at 16. On
January 5, 2016, petitioner was seen by a physician’s assistant at Elliot Orthopaedic
Surgery for treatment of left shoulder pain. The assessment from that visit was “left
rotator cuff tendonitis s/p flu shot” and petitioner was given a steroid injection and an x-
ray of her left shoulder was ordered. Pet.’s Ex. 2 at 4-5.

       From November 19, 2015 to February 11, 2016, petitioner attended ten physical
therapy sessions for her left shoulder. Pet.’s Ex. 4, passim. Petitioner returned to her
primary care physician on February 15, 2016 reporting ongoing pain and reduced range
of motion in her left shoulder. Pet.’s Ex. 3 at 3.

        Petitioner underwent an MRI of her left shoulder at Elliot Orthopaedic Surgery on
February 21, 2016, the results of which were reviewed by Dr. Mark Piscopo at Elliot
Hospital on February 26, 2016 Pet.’s Ex. 2 at 8; Pet.’s Ex. 6 at 7-8. At that visit, Dr.
Piscopo explained to petitioner the MRI findings were consistent with rotator cuff
tendinosis caused, in his opinion, by petitioner’s October 2015 flu vaccination. Pet.’s
Ex. 6 at 8. Dr. Piscopo advised petitioner that her diagnosis fell “into the category of
shoulder injury related to vaccine administration (SIRVA)” and that “beyond the
treatment measures that she has received there does not appear to be any other
intervention that is indicated at this time.” Id. He recommended that additional steroid
injections and physical therapy may be considered as needed in the future. Id.

      Petitioner thereafter continued to seek treatment for her left shoulder pain. On
March 31, 2016, petitioner sought a second opinion from orthopedic surgeon, Dr.


                                              6
Douglas Goumas at New Hampshire Orthopaedic Center. Pet.’s Ex. 5 at 15. Petitioner
returned to Dr. Goumas for steroid injection for left shoulder pain on April 1, 2016. Id. at
13. During an April 22, 2016 follow-up, Dr. Goumas referred petitioner to additional
physical therapy and prescribed Meloxicam for her left shoulder pain. Id. at 12.

       Petitioner received a third steroid injection for continued left shoulder pain from
Dr. Piscopo on September 28, 2016. Pet.’s Ex. 9 at 1-3. Petitioner returned to Dr.
Piscopo on January 13, 2017 for ongoing left shoulder pain. Pet.’s Ex. 10 at 1. Dr.
Piscopo noted petitioner’s left shoulder “continues to show some functional restriction,”
ordered an MRI of petitioner’s left shoulder and advised petitioner that surgery may
need to be considered. Id. at 2. Petitioner returned to Dr. Piscopo on April 27, 2017
reporting ongoing pain and limited range of motion of her left shoulder and was
administered a fourth steroid injection. Pet.’s Ex. 11 at 3.

       Based on the records of petitioner’s ongoing treatment summarized above, the
undersigned finds that the pain and decreased range of motion petitioner experienced
are limited to her left shoulder in which she received the flu vaccine. Thus, petitioner
has satisfied this criteria.

   d. 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).

      There is no evidence in the record that demonstrates any type of condition or
abnormality that would explain petitioner’s symptoms.

                 ii. Logical sequence of cause and effect showing the vaccine was
                     the reason for the injury

        Guided by the criteria for evaluating a Table SIRVA injury, the undersigned finds
that petitioner has shown, by a preponderance of the evidence, a logical sequence of
cause and effect showing that her October 25, 2015 flu vaccine was the reason for her
shoulder injury. The SIRVA criteria provides a perfectly logical sequence of cause and
effect including (1) 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). The undersigned has found,
infra, that petitioner has satisfied all these requirements and thus has satisfied Althen
prong two.

       Moreover, based on the undersigned’s knowledge and experience reviewing a
large number of SIRVA claims, petitioner’s clinical course is consistent with SIRVA.


                                             7
The undersigned further bases this finding on the previously filed articles, Court Exhibit I
(B. Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA), 28
Vaccine 8049 (2010)) and Court Exhibit II (M. Bodor and E Montalvo, Vaccination
Related Shoulder Dysfunction, 25 Vaccine 585 (2007)).

                iii. Proximate temporal relationship between vaccination and
                     injury

    “The proximate temporal relationship prong [under Althen] requires preponderant
proof that the onset of symptoms occurred within a timeframe for which, given the
medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352
(Fed. Cir. 2008). This analysis involves two inquiries: (1) considering the medical basis
of the proffered theory, how long after vaccination would onset or worsening of the
disease occur; and (2) did onset or worsening of the disease actually occur in the
expected timeframe. The first inquiry necessarily intersects with the prong one
analysis. See Langland v. Sec’y of Health & Human Servs., 109 Fed. Cl. 421, 443
(2013); Veryzer v. HHS, 100 Fed. Cl. 344, 356 (2011).

        As discussed above, under the SIRVA criteria, the onset of the symptoms of
petitioner’s shoulder injury must begin within 48 hours or less of the vaccination. The
undersigned has found that the onset of petitioner’s shoulder injury began within 48
hours of the vaccination, and thus, petitioner has satisfied Althen prong two.

   IV.    Conclusion

        A cause-in-fact injury is established when petitioner demonstrates by a
preponderance of the evidence: (1) She received a vaccine set forth on the Vaccine
Injury Table; (2) She received the vaccine in the United States; (3) She sustained or had
significantly aggravated an illness, disease, disability, or condition caused by the
vaccine; and (4) the condition has persisted for more than six months. § 13(a)(1)(A).
To satisfy the burden of proving causation in fact, petitioner must establish each of three
factors announced by the Federal Circuit in Althen v. Sec’y of Health & Human Servs.
by preponderant evidence: (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 proximate temporal relationship between vaccination
and injury. 418 F.3d 1274, 1278 (Fed. Cir. 2005). Proof of medical certainty is not
required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir.
1991).

       In light of all of the above, and in view of the submitted evidence, including
the medical records and the parties’ respective motions, the undersigned finds
petitioner entitled to Vaccine Act compensation.

IT IS SO ORDERED.
                                                 s/ Nora Beth Dorsey
                                                 Nora Beth Dorsey

                                             8
    Chief Special Master




9
