 



              In the United States Court of Federal Claims
                                                          OFFICE OF SPECIAL MASTERS
                                                                   No. 16-1116V
                                                               Filed: June 19, 2018
                                                                  UNPUBLISHED

                                                                      
    BEVERLY TOWNE,                                                    
                                                                          Special Processing Unit (SPU); Fact
                                           Petitioner,                    Hearing; Findings of Fact; Onset;
    v.                                                                    Tetanus Diphtheria acellular
                                                                          Pertussis (Tdap) Vaccine; Shoulder
    SECRETARY OF HEALTH                                                   Injury Related to Vaccine
    AND HUMAN SERVICES,                                                   Administration (SIRVA)

                                         Respondent.

                                                                      
Verne E. Paradie, Jr., Paradie, Sherman, et al., Lewiston, ME, for petitioner.
Jennifer Leigh Reynaud, U.S. Department of Justice, Washington, DC, for respondent.
 
                                                                FACT RULING1
Dorsey, Chief Special Master:
       On September 9, 2016, Dr. Beverly Towne (“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 left
shoulder injuries caused by a Tetanus Diphtheria acellular Pertussis (“Tdap”) vaccine
she received on December 23, 2015. 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 left shoulder injuries was
within 48 hours of her December 23, 2015 Tdap 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  Because this unpublished ruling contains a reasoned explanation for the action in this case, the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 September 8, 2016, Dr. Towne filed her petition and medical records marked
as exhibits 1-3. (ECF No. 1.) On January 26, 2017, she filed exhibits 4-9 with a
Statement of Completion. (ECF Nos.11, 13.)
        On May 1, 2017, respondent filed a status report stating that medical personnel
at the Division of Injury Compensation at the Department of Health and Human Services
had completed a preliminary review of petitioner’s claim and determined that
“petitioner’s symptoms [did] not appear to be within a feasible timeframe to infer a
causal relationship with the vaccination.” (ECF No. 17). Respondent also noted that
when petitioner first reported her shoulder pain, approximately 19 weeks after
vaccination, petitioner advised that it could be related to her exercises involving kettle
bells. Id. Respondent proposed filing his report pursuant to Vaccine Rule 4(c) within 60
days. This request was granted. (See Non-PDF Order dated 05/02/2017).

        On July 6, 2017, respondent filed his Rule 4(c) Report. (ECF No. 20.)
Respondent recommended against awarding compensation to petitioner in this case,
arguing, inter alia, that the record is insufficient to substantiate that the onset of
petitioner’s left shoulder symptoms began within forty-eight hours of vaccination. Id. at
3. Respondent reiterated her argument that petitioner first reported her shoulder
symptomatology to a medical professional more than four months after vaccination, and
even then she thought it may be related to kettle ball exercises. Id. citing Pet. Ex. 1 at
3-6. Respondent states that when petitioner ultimately did associate her pain with
vaccination, the record is deficient in demonstrating that the onset was specifically
within 48 hours and as such, “the current record does not establish by preponderant
evidence that petitioner developed SIRVA as a result of her December 23, 2015 Tdap
vaccination.” Id. Respondent argues that the Vaccine Act prohibits a finding of
entitlement “based on the claims of a petitioner alone, unsubstantiated by medical
records or by medical opinion.” Id.; 42 U.S.C. § 300aa-13(a)(1).
       Thereafter, the undersigned issued an order directing petitioner to file affidavits
from any fact witnesses that would be able to support her position regarding the onset
of her shoulder injury. (ECF No. 21). On October 23, 2017, petitioner filed the affidavit
of the nurse who administered the vaccination, as well as an affidavit from the doctor for
whom she was employed. See Pet. Exs. 10-11 (ECF Nos. 22-23).

        On November 14, 2017, the parties filed a joint status report stating that they
have been unable to resolve the matter and requested a fact hearing. On January 11,
2018, a status conference was held by the staff attorney managing this case and a fact
hearing was scheduled. (ECF No. 26.) In preparation for the fact hearing, petitioner
filed a pre-hearing submission. (ECF No. 28). Respondent filed no additional pre-
hearing submissions.

      II.    Fact Hearing and Ruling

       A fact hearing was held in Washington, D.C., on May 1, 2018. Dr. Towne was
the sole witness and she appeared in-person 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
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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,
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:
       [A]s I understand the Rule 4 in this case that . . . one of the issues in the case is
       onset, and that is whether or not Dr. Towne experienced the onset within 48
       hours as required by the Table. After having reviewed all of the exhibits, the
       medical records, the affidavits of the witnesses and after hearing Dr. Towne's
       testimony today, I find that onset of her pain occurred within the specified time
       frame of less than or equal to 48 hours.

       My findings are based on a number of key pieces of evidence, including Dr.
       Towne's affidavit and her testimony here today; the affidavit of the nurse who
       administered the vaccine; as well as the affidavit of the physician she worked for
       who was also her PCP, Dr. Brian Knighton; the history documented by Dr.
       Knighton on May 6th, 2016 that Dr. Towne had left shoulder pain which initially
       began four to five months earlier; the history by Dr. Knighton when he
       documented that the Petitioner attributed the pain to getting a DTaP vaccination
       on 12/23/2015 when he notes she developed deltoid pain after the injection,
       since then she has had varying degrees of shoulder pain; as well as the
       evaluation by Dr. Sara Shubert on June 8th, 2016, when she documented that

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      petitioner also developed pain in the deltoid and lateral shoulder which persisted
      up until the current time after the Tdap injection.

      Moreover, the initial physical therapy evaluation performed by Denise Bluhm,
      physical therapist, on June 27th, 2006, notes that Dr. Towne received a tetanus
      shot in her left shoulder December 2015, and the day after the injection had
      significant left upper trapezius and neck pain, which was still present after one
      week. It is also noted on the MRI report dated June 12th, 2016, that Petitioner's
      symptoms started 12/'15 at the time of the Tdap injection. Thus, I find that
      petitioner's pain began within 48 hours of the vaccine.

      As for Dr. Towne's delay in seeking treatment until May of 2016, I find the
      reasons for her delay set forth in her affidavit and her testimony here today to be
      credible and reasonable. Specifically, because Dr. Towne is a physician, and it is
      typical for many medical professionals to self-treat or seek out informal advice
      about their own medical ailments, they often wait before seeking formal medical
      treatment. That is what I find happened in these circumstances, and I find the
      delay in seeking treatment to be reasonable given the facts and circumstances of
      this case. That is the end of my ruling.

      Transcript at 46-48.

      III.   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 December 23, 2015 Tdap vaccination.
IT IS SO ORDERED.
                                 s/Nora Beth Dorsey
                                 Nora Beth Dorsey
                                 Chief Special Master
 




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