 



              In the United States Court of Federal Claims
                                                          OFFICE OF SPECIAL MASTERS
                                                                   No. 16-0340V
                                                            Filed: December 21, 2017
                                                                 UNPUBLISHED

                                                                      
    HILDA ALMANZAR,                                                   
                                                                          Special Processing Unit (SPU); Fact
                                           Petitioner,                    Hearing; Findings of Fact; Onset;
    v.                                                                    Influenza (Flu) Vaccine; Shoulder
                                                                          Injury Related to Vaccine
    SECRETARY OF HEALTH                                                   Administration (SIRVA)
    AND HUMAN SERVICES,

                                         Respondent.

                                                                      
Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for petitioner.
Sarah Christina Duncan, U.S. Department of Justice, Washington, DC, for respondent.
 
                                                                FACT RULING1
Dorsey, Chief Special Master:
        On March 16, 2016, Hilda Almanzar (“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 right
shoulder injuries caused by an October 9, 2014 influenza (“flu”) vaccination. Petition at
1-2. The case was assigned to the Special Processing Unit of the Office of Special
Masters. For the reasons discussed below, the undersigned finds that the onset of
petitioner’s right shoulder injuries was within 48 hours of her October 9, 2014 influenza
vaccination.



                                                            
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  Because this unpublished ruling contains a reasoned explanation for the action in this case, the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 Prior to Hearing
       On March 16, 2016, Ms. Almanzar filed her petition and medical records marked
as exhibits 1-4. (ECF No. 1.) She also filed a Statement of Completion. (ECF No. 2.)
Subsequently, during the initial status conference held on April 20, 2016, additional
outstanding medical records were identified. (ECF No. 8.) Additional records and an
amended Statement of Completion were filed on June 20, 2016 and October 5-6, 2016.
(ECF Nos. 9-10, 15-16.)
       On November 7, 2016, respondent filed a status report stating respondent was
interested in pursuing settlement discussions and requested that the deadline for the
Rule 4(c) report be suspended. (ECF No. 17). Respondent also requested additional
information from petitioner to facilitate settlement discussions. The deadline for
respondent to file the Rule 4(c) report was suspended and petitioner was ordered to file
a status report in 30 days updating the undersigned on the status of the parties’
settlement discussions. (ECF No. 18).
        Over the next six months, the parties attempted to informally resolve this matter.
On May 8, 2017, petitioner filed a status report stating that the parties had reached an
impasse and were requesting a fact hearing. (ECF No. 34). Respondent proposed
filing a Rule 4(c) report by June 30, 2017. This request was granted. (ECF No. 35).
       On June 30, 2017, respondent filed his Rule 4(c) Report. (ECF No. 36.)
Respondent recommended against awarding compensation to petitioner in this case.
Id. Respondent argued, inter alia, that the evidence was insufficient to show a logical
sequence of cause and effect or a temporal relationship between vaccination and injury
because petitioner did not seek medical attention for her shoulder injury until four
months after her vaccination. Id. at 7. Respondent argued that the record was unclear
regarding the timing of onset of petitioner’s injury and as such, petitioner had failed to
established causation-in-fact by a preponderance of the evidence. Id.
       Thereafter, following a status conference held by the staff attorney managing this
case, the undersigned concluded that the case was ripe for a fact hearing. (ECF No.
37.) In preparation for the hearing, petitioner filed additional information requested by
respondent in her Rule 4(c) report and another Statement of Completion on August 30,
2017. (ECF No. 39-40.)
       II.    Fact Hearing and Ruling
       A fact hearing was held in Washington, D.C., on December 5, 2017. Ms.
Almanzar was the sole witness and she appeared via video-conferencing from New
Jersey with her attorney. At the conclusion of the hearing, the undersigned informed
the parties that she intended to issue a ruling from the bench. The parties consented.
The undersigned stated that her ruling would resolve whether the onset of petitioner’s
symptoms occurred within 48 hours of vaccination.
        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,


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the undersigned’s findings were 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 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).

       With these factors in mind, the undersigned made the following preliminary
findings of fact:
      After having reviewed all of the exhibits, the medical records, the records of
      orthopedist, Dr. Mark Schwartz, the affidavits, and hearing testimony today, I
      issue the following findings of fact.
      Based on my review of Respondent’s Rule 4 report, it appears that the issues
      requiring this fact hearing today are whether the onset of petitioner’s symptoms
      occurred within 48 hours of the administration of the flu vaccine to Ms. Almanzar
      in light of the fact that the medical records do not show that she sought treatment
      until February 11, 2015, approximately four months later. The time period for the
      first symptom or manifestation of symptoms for a shoulder injury related to
      vaccine administration under the rules and regulations which govern the Vaccine
      Program is less than or equal to 48 hours.
      The second issue is whether petitioner has sustained a shoulder injury related to
      flu vaccine, or SIRVA, as a result of the flu vaccine administered to her on
      October 9, 2014. There is no issue as to the date of vaccination or the location
      where she received the vaccine, which was the right arm. (Pet. Ex. 5.)
      Shoulder injury related to vaccine administration manifests as shoulder pain and
      limited range of motion occurring after the administration of vaccine by
      intramuscular injection in the upper arm. These symptoms are thought to occur
      as a result of unintended injection of the vaccine or trauma from the needle into
      and around the underlying bursa of the shoulder resulting in an inflammatory

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    reaction. SIRVA is caused by an injury to the musculoskeletal structures of the
    shoulder to tendons, ligaments, bursa, etc. A vaccine recipient shall be
    considered to have suffered SIRVA if she/he manifests all of the following: first,
    no history of pain, inflammation or dysfunction of the affected shoulder prior to
    the intramuscular (IM) vaccine administration that would explain the alleged
    signs, symptoms, examination findings and/or diagnostic studies occurring after
    vaccine injection. With regard to this criteria, I find that Ms. Almanzar had no
    history of pain, inflammation or dysfunction of her right shoulder prior to her flu
    vaccine administration. The records of her primary care physician and
    orthopedic surgeon do not reveal a history of prior right shoulder problems.
    Additionally, the testimony here today is consistent with my finding on this point.
    The next criteria for a SIRVA injury is that onset of the pain occur within the
    specified timeframe of less than or equal to 48 hours. As to onset, based on
    petitioner’s affidavit, her testimony today, the history documented by Dr. Zenon
    Switenko on February 11, 2015, that petitioner had pain which began 4 months
    prior, Pet. Ex. 2 at 2, the history by Dr. Schwartz, when he documented that
    petitioner ‘attributed shoulder pain to flu’ shot, (Pet. Ex. 3-1), and the evaluation
    by physical therapist, Gary Harris, on December 28, 2015, when he documented
    ‘onset following flu vaccine to right shoulder’ on October 9, 2014, and ‘onset
    speed – Sudden,’ (Pet. Ex. 8 at 1), I find that petitioner’s pain began within 48
    hours of the vaccine. (See also Novacare Rehab records, Pet. Ex. 14 at 1 (dated
    3/25/2015) ‘Mechanism of Injury…patient reports onset of mid aspect of right
    humerus after receiving flu injection on October 9, 2014’).
    There is one conflicting piece of evidence, a note by physical therapist, Todd
    Updike, on June 17, 2015, stating that petitioner had an ‘insidious onset of pain.’
    (Pet. Ex. 4 at 1). The use of the word ‘insidious’ implies that the problem
    developed gradually. However, this entry can be explained by petitioner’s
    affidavit, paragraph three, where she states, ‘Immediately after the vaccination, I
    felt some pain in my right shoulder. Over the next two weeks, I developed more
    significant discomfort, pain and range of motion issues in the shoulder.’ Thus,
    the onset was immediate, and sudden, as documented by Mr. Harris, and the
    problem became gradually worse, and was insidious as documented by Mr.
    Updike. I find that the onset of pain occurred immediately after the flu vaccine
    was administered and that this was within the specified time frame of 48 hours.
    As for petitioner’s delay in seeking treatment until February, 2015, I find the
    reasons for the delay set forth in her affidavit and her testimony today to be
    credible and reasonable. Specifically, petitioner described that she tried to
    schedule an earlier appointment with her PCP, Dr. Sapna Jain, but she had no
    available appointments until January, 2015. An appointment was made for
    January 6, 2015, which was cancelled due to a snowstorm. A subsequent
    appointment set for January 26, 2015 was also cancelled due to a snowstorm.
    For these reasons, she was unable to see a doctor until February 11, 2015.
    Again, I find this delay in seeking treatment to be reasonable given the facts and
    circumstances.


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              The next criteria is that the pain and reduced range of motion are limited to the
              shoulder in which the vaccine was administered. This finding is based upon the
              petitioner’s testimony and the medical records that petitioner’s pain and reduced
              range of motion are limited to the right shoulder, in which the vaccine was
              administered. (Pet. Ex. 3 at 4 – ‘pain in limitation of motion…right shoulder
              appears to have restriction of motion…’ dated 04/16/2015).
              The next criteria is that there be no other condition or abnormality that would
              explain the patient’s symptoms. I find that there is no other condition or
              abnormality identified by Dr. Schwartz, or revealed in the testimony today which
              would explain petitioner’s symptoms.
              With regard to causation and the Althen3 prongs, I have covered the mechanism
              of injury as set forth in the rules and regulations. With regard to the logical
              sequence of cause and effect, I find that the totality of the facts and
              circumstances set forth in the medical records, other exhibits, and testimony
              today, that there is preponderant evidence of causation establishing that
              petitioner has proven a clinical course consistent with a SIRVA claim.
              Specifically petitioner presented to Dr. Switenko on February 11, 2015, and the
              records show that the signs and symptoms and a diagnosis of pain aggravated
              by daily activity (Pet. Ex. 2 at 2), reduced range of motion, impingement of the
              right shoulder (Pet. Ex. 2 at 4), with diagnosis of right shoulder tendonitis (Pet.
              Ex. 2 at 1). Subsequently, she underwent an MRI on February 18, 2015, which
              showed mild to moderate supraspinatus and infraspinatus tendinosis, and
              subdeltoid bursitis (Pet. Ex. 2 at 9). On March 19, 2015, Ms. Almanzar saw
              orthopedist, Dr. Schwartz, who diagnosed her with tendinitis of the right shoulder,
              and he administered a steroid injection. (Pet. Ex. 3 at 3-4). In April 2015, she
              continued to complain of right shoulder pain and she had limited range of motion
              (ROM). On May 5, 2015, her diagnosis was adhesive capsulitis, impingement
              syndrome, and rotator cuff tendinitis. She underwent surgery, manipulation of
              her right shoulder, arthroscopy and lysis of adhesions, and rotator cuff repair.
              (Pet. Ex. 3 at 12). She went on to attend physical therapy from June 2015
              thought December 2015, or longer. On April 7, 2016, eleven months post-op,
              she saw Dr. Schwartz and reported that in the last several months, she had
              noted an increase in her pain. A repeat steroid injection was administered. (Pet.
              Ex. 9 at 3).
              Petitioner described today that she has improved, but she still experiences pain
              and continues to take over-the-counter medication, particularly at night. Also, as
              demonstrated today, she still has some limitations with her range of motion,
              although again, she is much improved. In summary, Ms. Almanzar’s clinical
              course is consistent with a SIRVA injury. This is the end of my ruling.




                                                            
3
    Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).

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      III.   Closing of the Record Regarding Entitlement

        Following the hearing, the undersigned took judicial notice of two articles
pertaining to causation of vaccine-related shoulder injuries which were filed as court
exhibits. These articles are: 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. 42.) The parties have been provided 30 days to
provide any additional evidence regarding entitlement or any response to the court
exhibits. (Id.)
      IV.    Conclusion
      In light of all of the above, and in view of the submitted evidence, including
the medical records, credible witness testimony, and findings of fact, the
undersigned finds that the onset of petitioner’s right shoulder injuries was within
48 hours of her October 9, 2014 influenza vaccination.
       A scheduling order has been issued granting parties until January 19, 2018,
to submit any additional evidence on entitlement. (ECF No. 42). After the record
closes, the undersigned intends to issue a decision on entitlement based on all
the evidence submitted into the record, and consistent with the findings set forth
in this ruling.
IT IS SO ORDERED.
                                 s/Nora Beth Dorsey
                                 Nora Beth Dorsey
                                 Chief Special Master
 




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