Court Opinion

ID: 4637664
Source: CourtListenerOpinion
Date Created: 2020-11-25 22:01:41.551565+00
Date Added: 2024-06-11T07:59:06.934888
License: Public Domain

In the United States Court of Federal Claims
                                 OFFICE OF SPECIAL MASTERS
                                         No. 18-0759V
                                      TO BE PUBLISHED

    SARAH FLORES and RYAN C.                                 Chief Special Master Corcoran
    FLORES, on behalf of M.F., a Minor
    Child,                                                   Filed: October 26, 2020

                        Petitioner,                          Special Processing Unit (SPU);
    v.                                                       Findings of Fact; Statutory Six Month
                                                             Requirement; Severity Requirement;
    SECRETARY OF HEALTH AND                                  Surgical Intervention; Measles
    HUMAN SERVICES,                                          Mumps Rubella (MMR) Vaccine;
                                                             Thrombocytopenic Purpura (ITP)
                        Respondent.

Diana Lynn Stadelnikas, Maglio Christopher & Toale, PA, Sarasota, FL, for Petitioner.

Kyle Edward Pozza, U.S. Department of Justice, Washington, DC, for Respondent.

                                         FINDINGS OF FACT1

       On May 30, 2018, Sarah and Ryan C. Flores filed a petition for compensation
under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2
(the “Vaccine Act”), on behalf of their minor daughter, M.F. Petitioners allege that
following the June 23, 2016 administration of a measles, mumps and rubella (“MMR”)
vaccine, M.F. experienced immune thrombocytopenic purpura (“ITP”). See generally
Petition. The case was assigned to the Special Processing Unit of the Office of Special
Masters.

1  Because this fact ruling contains a reasoned explanation for the action in this case, I am required 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).
This means the fact ruling will be available to anyone with access to the internet. 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, I agree that the
identified material fits within this definition, I 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 section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
      For the reasons set forth below, and as I announced during the October 2, 2020
motions hearing,3 I find that Petitioners have succeeded in producing preponderant
evidence to satisfy the Vaccine Act’s severity requirement. Accordingly, Respondent’s
request for dismissal of the petition is denied.

    I.      Relevant Procedural History

       As noted above, the case was initiated in May 2018. After reviewing Petitioners’
medical records and affidavit, Respondent filed a status report stating that he was not
amenable to engaging in settlement discussions and requesting 60 days in which to file
his status report pursuant to Vaccine Rule 4(c). ECF No. 26. This request was granted.

       On July 19, 2019, Respondent filed the Rule 4(c) Report maintaining that the case
was not appropriate for compensation under the terms of the Vaccine Act. ECF No. 29.
Respondent specifically argued that “M.F.’s condition resolved around early November
2016, about three months after the July 2016 onset, and about four months after her June
2016 vaccination.” Id. at 5. Respondent further argued that Petitioners “failed to establish
that M.F. underwent a ‘surgical intervention’ as understood in the context of the Vaccine
Act” and requested dismissal of the petition. Id.

       Petitioners filed a response to Respondent’s Rule 4(c) Report on January 20,
2020. Petitioners asserted that the Vaccine Act’s severity requirement had been satisfied
because M.F.’s bone marrow aspiration and biopsy constituted a “surgical intervention”
(which, as discussed in greater detail below, is an alternative basis for finding severity).
ECF No. 36. Nevertheless, on February 28, 2020 Respondent filed a status report
indicating that he would continue to defend this claim. ECF No. 38.

        The parties’ arguments on the disputed severity requirement issue were based on
briefing completed prior to the motions day hearing. Thus, on March 5, 2020, Petitioners
filed a Motion for Findings of Fact and Conclusions of Law Regarding Entitlement. ECF
No. 42. Respondent filed his response (“Response”) on April 6, 2020. ECF No. 44.
Petitioners filed a reply on April 13, 2020. ECF No. 45.

    II.     Issue

       At issue is whether Petitioners have met the Vaccine Act’s severity requirement by
establishing either that M.F.’s bone marrow aspiration and biopsy constituted a surgical
intervention for purposes of the Vaccine Act, and/or that she continued to suffer the
residual effects or complications of ITP for more than six months.

3
 See Minute Entry dated October 2, 2020. The transcript of the hearing, which was not yet filed as of the
date of this Ruling, is hereby incorporated into my Findings of Fact by reference.

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   III.      Authority

          In order to state a claim under the Vaccine Act, a vacinee must have either:
          (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.
Section 11(c)(1)(D) (emphasis added).
        There is no definition of “surgical intervention” within the Vaccine Act. See Section
33 (Definitions). Nor is there any Federal Circuit decision interpreting that term. As
described in prior decisions by special masters, the “surgical intervention” language was
added to the Vaccine Act primarily to allow for recovery for the injury of intussusception
(a condition often experienced by infants in which a portion of the intestine telescopes
into itself), which can require surgery but does not typically “persist” (in terms of injury-
related sequelae) for six months. See, e.g., Spooner v. Sec’y of Health & Human Servs.,
No. 13-159V, 2014 WL 504728 (Fed. Cl. Spec. Mstr. Jan. 16, 2014); Stavridis v. Sec’y of
Health & Human Servs., No. 07-261V, 2009 WL 3837479 (Fed. Cl. Spec. Mstr. Oct. 29,
2009); Ivanchuck v. Sec’y of Health & Human Servs., No. 15-357V, 2015 WL 6157016
(Fed. Cl. Spec. Mstr. Sept. 18, 2015).
        Special masters interpreting the “surgical intervention” language have disagreed
somewhat as to its meaning, and have applied the term in different ways depending upon
the circumstances that the injury in question poses. Spooner, for example, involved a
petitioner who alleged that her minor child developed Guillain Barré syndrome (“GBS”)
after receiving a hepatitis A vaccine. 2014 WL 504278. The child was admitted to the
hospital’s neurological department five days after vaccination and, when concerns of GBS
were raised, the minor underwent a lumbar puncture and received IVIG treatment. Id. at
*1, 9. The special master (relying on medical dictionary definitions) interpreted the phrase
to mean “the treatment of a disease, injury and deformity with instruments or by the hands
of a surgeon to improve health or alter the course of a disease.” Id. at *10. Using this
definition, he determined that although a lumbar puncture conducted under general
anesthesia was clearly surgical in nature, it did not constitute an “intervention,” because
it was diagnostic and not necessary for treatment. Id. at *12. Conversely, he determined
that IVIG treatments were not surgical in nature. Id.
       Subsequent cases more factually on point to the current matter have
acknowledged Spooner’s holding, but have effectively applied a different interpretation of
the disputed language, justifying the distinction due to the nature of the injury in question.
Ivanchuck, for example, involved a minor who developed ITP after receiving several
vaccinations, including MMR. The special master found that a bone marrow aspiration

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and biopsy “to rule out myeloproliferative disease prior to starting oral steroids”
constituted a surgical intervention. Ivanchuck, 2015 WL 6157016, at *1. As in Spooner,
the Ivanchuck special master stressed that the procedure occurred in accordance with
hospital policies for a surgical procedure and occurred under general anesthesia, but
(unlike Spooner) was an intervention because it was performed as part of a protocol
bearing on future possible treatments. Id. at *2-3.
       A similar result, also involving bone marrow aspiration and biopsy in an ITP case,
was reached in Leming v. Sec’y of Health & Human Servs., No. 18-0232V, 2019 WL
5290838 (Fed. Cl. Spec. Mstr. July 12, 2019) – a case decided by the same special
master that adjudicated the Ivanchuck matter. The Leming petitioners argued that their
minor daughter developed ITP, immune dysfunction, and immunodeficiency after
receiving three different vaccines. Id. As in Ivanchuck, the biopsy was conducted under
general anesthesia, and the hospital followed surgical protocols involving consent and
post-operative recovery, thus suggesting it was “procedural” in nature. Id. at *6. But the
special master also noted that the procedure was conducted “to rule out bone marrow
disorders for which steroid treatment would be contraindicated,” and hence was also an
“intervention.” Id. The special master added that the medical record explicitly stated that
the procedure was required to institute treatment rather than diagnose the minor’s
condition. Id.
       Given the above, there is a slight divergence between the Spooner reading of the
phrase (which requires the intervention ultimately to be more directly aimed at treating
the underlying issue than in evaluating its nature) and Ivanchuck/Leming -- which, in a
more factually-apposite context to the present, read “intervention” a bit more broadly,
allowing procedures that are invasive but mainly aimed at making additional diagnostic
determinations that may later impact treatment to be deemed to satisfy the severity
requirement.

   IV.       Finding of Fact

       I make the following finding regarding severity after a complete review of the record
to include all medical records, affidavits, Respondent’s Rule 4 report, Petitioner’s
response, and briefing by the parties. Specifically, I base the findings on the following
evidence:

         •   M.F., a minor, received an MMR vaccination on June 23, 2016. She was
             fourteen months old at the time of vaccine administration. Ex. 1 at 1;

         •   On July 20, 2020, M.F. was brought to her pediatrician after her mother noticed
             bruising and “a few small red spots” on her child’s body. M.F. was assessed
             with petechiae and was sent to the emergency room. Ex. 15 at 149-150;

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        •   Labs taken on July 20, 2020 revealed that M.F. had a platelet count of two.4
            M.F. was assessed with a scalp contusion and severe ITP and was transferred
            to Memorial Hermann Texas Medical Center (“Memorial”) for further evaluation
            and treatment. Ex. 9 at 33-34;

        •   M.F. underwent a hematology consultation on July 22, 2016. The medical note
            documenting this visit indicates that she received two doses of IVIG and that
            her platelet count had risen to seven. It was also noted that if there was no rise
            in M.F.’s platelet count, a bone marrow aspiration and biopsy would be the
            “next step in order to consider [her participation in a] steroid trial as long as
            bone marrow findings are consistent with ITP (increased megakaryocytes).”
            Ex. 10 at 9-13;

        •   M.F. was discharged home on July 23, 2016 with a platelet count of 23. Ex. 10
            at 15;

        •   M.F. was brought to her pediatrician on July 25, 2016 for a follow-up visit. After
            noting that M.F.’s platelet count had again dropped to two, her pediatrician
            recommended M.F.’s return to Memorial’s emergency department. Ex. 15 at
            164;

        •   On July 25, 2016, M.F. was readmitted to the hospital for “bone marrow
            aspiration and biopsy to confirm the diagnosis.” Ex. 10 at 216. After pre-surgery
            checklists were completed and M.F.’s mother signed surgical and anesthesia
            consent forms, M.F. underwent bone marrow aspiration and biopsy. The
            procedure was performed by Dr. Rodrick Zvavanjanja. Id. at 294-303, 312, 316-
            317;

        •   M.F. was transported to the post-anesthesia care unit (“PACU”) following the
            bone marrow aspiration and biopsy. Ex. 10 at 313. A consult note indicates that
            the treating team’s recommendations would be based upon the biopsy’s
            results. Id. at 219;

        •   M.F. was discharged from the hospital on July 28, 2016 with a platelet count of
            6. In addition to prescriptions for prednisone and Zantac, M.F.’s treatment plan
            included “weekly counts [and] weaning once platelets normalize-this could be
            weeks to months.” Ex. 10 at 219-220, 226, 240-241;

        •   An August 12, 2016 chart note indicates that M.F.’s platelet count had risen to
            10 and that she should “continue weekly labs.” Ex. 2 at 71. By August 25, 2016,
            M.F.’s platelet count was reported to have risen to 31. Ex. 2 at 55;

4
 The number listed in the platelet count results is representative of the number of platelets in the thousands,
e.g., an account of three represents three thousand platelets. For children, the normal range is typically
between 150-400, and for infants between 200-475. K. Pagana & T. Pagana, MOSBY’S MANUAL OF
DIAGNOSTIC AND LABORATORY TESTS (4th. ed. 2010) at 416.

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      •   On September 1, 2016, M.F. had a platelet count of 131. M.F.’s mother was
          instructed to “cut the dose of [M.F.’s] prednisone in half . . . and repeat labs
          next Thursday 9/8/16.” Ex. 2 at 41;

      •   On September 13, 2016, M.F.’s mother was informed that her daughter’s
          platelet count had dropped to 31. The corresponding chart note indicates that
          M.F.’s pediatrician “wants [M.F.] to go back to twice a day on her medication
          and labs again this week.” Ex. 2 at 39-40;

      •   The results of M.F.’s labs from September 19 and September 27, 2016 reveal
          that she had normal platelet counts of 213 and 176, respectively. M.F.’s parents
          were instructed to decrease their daughter’s prednisone dosage. Ex. 2 at 33-
          35;

      •   On October 6, 2016, M.F.’s mother was informed that her daughter’s platelet
          count dropped to 131. It was noted that this number “is a little down from last
          time . . . but is OK to go down again on the [p]rednisone.” Ex. 2 at 28;

      •   Labs from October 26, 2016 showed that M.F. had a platelet count of 179,
          which was “completely within normal limits.” M.F.’s mother was instructed to
          “begin to alternate [prednisone] every other day for a week, then stop.” Ex. 2 at
          19;

      •   On November 14, 2016, M.F.’s mother reported that her daughter had
          “basically been fully off the medication for a couple of days.” Although a clinical
          staff note from this date indicates that M.F.’s physician believed it was “okay to
          ‘take a break’ from the lab,” M.F.’s platelet count on November 21, 2016 was
          218. Ex. 2 at 11-12;

      •   On February 10, 2017 (six months and 21 days after M.F. was first assessed
          with ITP), she had her final tests in the record, which showed a normal platelet
          count of 219. Ex. 2 at 6; and

      •   M.F. presented to a hematology clinic on August 10, 2017. The medical note
          documenting this appointment indicates that M.F. was “able to be weaned off
          steroids in the end of October and has been doing well since then.” Ex. 12 at
          7.

        The above items of evidence establish that M.F. experienced hospitalization and
surgical intervention within the meaning of Subsection 11(c)(1)(D)(iii) of the Vaccine Act.
First, there is no question that M.F. underwent a surgical procedure in a literal sense. In
order to perform the bone marrow aspiration and biopsy, M.F. was placed under general
anesthesia and the procedure was performed by a physician. Ex. 10 at 212, 294, 317. A
pre-surgery checklist was completed. Id. at 312. M.F.’s mother signed a consent for an
operative procedure, which identified possible risks of heart failure, fever and infection.
Id. at 296-303. Following the procedure, M.F. was transported to the PACU. Id. at 313.

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        Second, the circumstances of the present injury allow for the conclusion that M.F.’s
bone marrow aspiration and biopsy constituted an “intervention.” Admittedly, and as
Respondent correctly observes, the aspiration biopsy was somewhat diagnostic –
although not purely so, since (by the time a decision was made to perform it) M.F.’s
platelet counts had already been determined to suggest ITP, and she had also manifested
clinical indicia of the condition (bruising and petechiae). But the procedure also had a
treatment orientation as well. The record clearly indicates that treaters believed a bone
marrow aspiration might be necessary to guide further treatment (which had already
featured IVIG infusions) if platelet counts declined again. Ex. 10 at 13.5 Sure enough, they
did decline – and the aspiration was deemed necessary to determine if the ITP was in
fact symptomatic of a larger issue (in which case an alternative treatment involving
steroids would be tried). Ex. 10 at 216-219. Thus, and consistent with Ivanchuck and
Leming, the dual character of this invasive procedure supports a finding that it is a
“surgical intervention” serious enough to satisfy the severity requirement.
       In addition, other factors relevant to a claimed ITP Table injury after receipt of the
MMR vaccine counsel in favor of my determination. First, I observe that bone marrow
testing is recognized in the Vaccine Act’s Qualifications and Aids to Interpretation (the
“QAIs”) as an evaluative tool for ITP. In defining this condition, it is noted in the QAIs that
“[b]one marrow examination, if performed, must reveal a normal or an increased number
of megakaryocytes in an otherwise normal marrow.” 42 C.F.R § 100.3(b)(8). The inclusion
of bone marrow examination in its definition of ITP reveals that this procedure is
understood to be part of the reasonable standard of care (at least as of the time the Table
claim was established), supporting the conclusion that for ITP (somewhat akin to
intussusception), proof of an invasive procedure required as part of its treatment was
envisioned to establish severity.
        Second, I also note that (independent of whether a bone marrow aspiration and
biopsy fits the Act’s surgical intervention definition as construed in Spooner), Petitioners
arguably can satisfy the temporal severity requirement under the facts of this case. Prior
cases in the Program have found ongoing monitoring, or need for medication, to
constitute a residual effect. In Wright v. Sec’y of Health & Human Servs., 146 Fed. Cl.
608 (2019), a case with similar facts to the one at bar, it was found (in a Table ITP case)
that subsequent platelet testing of a minor child was a “residual effect” of a vaccine injury.
The court reasoned that “testing for a condition that could return ought to be compensated
under the Vaccine Act when the testing is causally connected to the underlying vaccine-
injury and triggered by subsequent symptoms of the conditions. The fact that those tests
did not reveal the presence of ITP is not controlling.” Wright, 146 Fed. Cl. at 614.

5 It is common when dealing with ITP for treaters to employ bone marrow biopsies to confirm the scope and
extent of the condition, since that impacts treatment choices. See, e.g., S. Gerald Sandler, M.D., Immune
Thrombocytopenic Purpura, at http://www.emedicine.com/med/topic1151.htm (last updated Jan. 11, 2020)
(“[b]ecause corticosteroid administration may change marrow morphology, performance of a bone marrow
aspiration and biopsy should be considered to confirm the diagnosis of ITP if the clinical presentation,
patient age, or other findings are atypical for acute ITP before the patient is treated with corticosteroids.”).

                                                       7
        Respondent has acknowledged that Petitioners could satisfy the six-month
severity requirement by demonstrating that “M.F. suffered the residual effects or
complications of her ITP through at least December 23, 2016 (i.e., more than six months
after the vaccine administration date of June 23, 2016).” Response at 7. Here, the medical
record establishes this. Testing performed throughout this timeframe reveal several
instances in which M.F.’s platelet count reached normal limits before dropping: Between
September 1 and September 13, 2016, M.F.’s platelet count dropped from 131 to 31. Ex.
2 at 39-41. Then, between September 19 and September 27, 2016, M.F.’s platelet
account dropped from 213 to 176. Id. at 33-35. Finally, on October 6, 2016, M.F.’s platelet
count dropped to 131. Id. at 28. Two of these fluctuations caused M.F.’s physician to
recommend an increase in her prednisone dosage. Id. at 33-35, 39-40. Testing
subsequently continued into February 2017 – and although further fluctuations were not
observed, M.F.’s pattern of platelet count drops had been inconsistent enough to be
deemed to warrant observation. This fact pattern is thus consistent with what the Wright
court deemed sufficient in an ITP case to establish severity.

   V.     Scheduling Order

      Given the above finding of fact – specifically that Petitioners have succeeded in
producing preponderant evidence to satisfy the Vaccine Act’s severity requirement –
Respondent’s Motion to Dismiss is DENIED. Respondent shall instead evaluate and
provide his current position regarding the merits of Petitioners’ case.
        Pursuant to my October 2, 2020 Docket Entry Order, Respondent shall file, by no
later than Friday, October 30, 2020, a status report indicating whether he intends to
defend this matter in any regard other than severity. Also by Friday, October 30, 2020,
Petitioners shall file a status report indicating whether they have provided their demand
to Respondent.

IT IS SO ORDERED.

                                  s/Brian H. Corcoran
                                  Brian H. Corcoran
                                  Chief Special Master

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