Ivanchuk v. Secretary of Health and Human Services ( 2015 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 15-357V
Filed: September 18, 2015
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VERA IVANCHUK, as mother and *
Natural guardian, and ANDREY *
IVANCHUK, as father and natural *
Guardian of Y.I., *
*
Petitioners, * Finding of Fact; Surgical Intervention;
v. * Special Processing Unit (“SPU”)
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
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Jeffrey Pop, Pop & Associates, Beverly Hills, CA, for petitioners.
Christine Becer, U.S. Department of Justice, Washington, D.C., for respondent.
RULING ON FACTS 1
On April 9, 2015, Vera and Andrey Ivanchuk [“petitioners”] filed a petition for
compensation under the National Vaccine Injury Compensation Program, 42 U.S.C.
§300aa-10, et seq, [the “Vaccine Act” or “Program”] on behalf of their minor daughter,
Y.I. The petition alleges that following the April 17, 2012 administration of a number of
vaccinations, including Measles Mumps and Rubella (“MMR”), Y.I. experienced
Thrombocytopenic Purpura (“ITP”). Petition at 1. The case was assigned to the Special
Processing Unit [“SPU”].
I. Procedural History
An initial status conference was held with the staff attorney managing this case
on June 22, 2015. During the status conference, petitioners’ counsel confirmed that
petitioners were alleging that Y.I.’s spinal tap and bone marrow biopsy, conducted
1 Because this unpublished ruling contains a reasoned explanation for the action in this case, it will be
posted on the United States Court of Federal Claims' website, in accordance with the E-Government Act
of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). In accordance with Vaccine Rule
18(b), petitioners have 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.
under anesthesia, constituted a “surgical intervention” in satisfaction of the Vaccine
Act’s severity requirement at §300aa-11(c)(1)(D). See Scheduling Order, June 22,
2015 (ECF No. 9). In a status report of July 27, 2015, respondent’s counsel indicated
that upon review of the case, her client wished to file a Rule 4(c) report. See Status
Report, July 27, 2015 (ECF No. 10). In subsequent e-mail communication with the
court’s staff attorney, respondent’s counsel confirmed that her client was opposed to
settlement and wished to have a status conference with the Chief Special Master to
discuss petitioner’s contention that Y.I.’s bone marrow biopsy constituted a surgical
intervention. 2
On September 17, 2015, I held a status conference with the parties. During the
call I indicated that I intended to rule on the question of whether Y.I.’s bone marrow
biopsy constitutes a surgical intervention for Program purposes. Respondent’s counsel
raised and preserved respondent’s objection to my ruling.
II. Facts
Y.I. was born on December 29, 2008. Ex. 1, p. 1. On April 17, 2012, she was seen
for her 3 year well child check-up at which she received the following vaccinations:
DTap-HIB-IPV, Hepatitis A, Pneumococcal Conjugate, MMR, and Varicella. Ex. 2; Ex. 5,
pp. 1-3.
Approximately one week later, on April 28, 2012, Y.I.’s mother reported unusual
bruising following a “minor bump.” Ex. 1, p. 2; Ex. 7, p. 18. The bruise worsened the
following day, and Y.I. also developed petechia, gingival bleeding, and bloody urine. Id.
On April 29, 2012, Y.I. was admitted to the emergency department on stretcher via
EMS and her case was classified as “urgent.” Ex. 7, pp. 127-28. She was diagnosed
with “severe” thrombocytopenia, having a platelet count of 2,000. Ex. 7, p. 19. She
remained hospitalized for 10 days. Ex. 7, p. 18-20.
Initially, Y.I. was given two rounds of IVIG. 3 Ex. 7, p. 19. She experienced clinical
improvement, but no change in her platelet count. Id. She was later given
prednisolone, an oral steroid, beginning May 3, 2012, which improved her
thrombocytopenia by May 8, 2012, her discharge date. Id. During her hospitalization,
Y.I. underwent a bone marrow aspiration and biopsy “to rule out myeloprofliferative
disease prior to starting oral steroids.” Id.
Although Y.I. continued to have follow-up appointments to monitor her platelet
counts in the several months following discharge, petitioners do not contend that Y.I.’s
ITP persisted for at least six months. Petition at 3.
2 At the time of respondent’s counsel’s request, this case was on the docket of then Chief Special Master
Vowell. The case was transferred to my docket on August 7, 2015. See Notice of Reassignment, August
7, 2015 (ECF No. 12).
3 Petitioners have not alleged that Y.I.’s IVIG treatments constituted a surgical intervention.
III. Discussion
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.
§300aa-11(c)(1)(D).
There is no definition of “surgical intervention” within the Vaccine Act. See
§300aa-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 to allow for recovery for intussusception, which often
requires surgery but does not typically persist for six months. See, e.g. Spooner v. HHS,
No. 13-159V, 2014 WL 504728 (Fed. Cl. Spec. Mstr. Jan. 16, 2014); Stavridis v. HHS,
No. 07-261V, 2009 WL 3837479 (Fed. Cl. Spec. Mstr. Oct. 29, 2009).
In Spooner, the special master interpreted surgical intervention as “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.” 2014 WL 504278, *10. In that case,
the special master based his definition of surgical intervention on entries from Dorland’s
Illustrated Medical Dictionary (29th Edition). 2014 WL 504278, *10. He noted that the
Federal Circuit has approved of the use of medical dictionaries to define medical terms.
Id. (citing Abbot v. HHS, 19 F.3d 39 (Fed. Cir. 1994)). I agree with the definition of
surgical intervention identified in Spooner. 4
In Spooner, utilizing the above definition, the special master determined that a
lumbar puncture conducted under general anesthesia was surgical in nature, but did not
constitute an “intervention,” because it was diagnostic and not necessary for treatment.
Id. at 12. Conversely, he determined that IVIG, though for treatment, was not surgical in
nature. Id.
4 I do note that in the earlier Stavridis decision, the chief special master rejected essentially the same
definition adopted in Spooner, contending that it was overly broad. 2009 WL 3837479, *4. In that case,
the chief special master accepted the unrebutted opinion of respondent’s medical expert that steroid
treatments and blood transfusions should not be understood as surgical interventions. Id. at *6. That
decision did acknowledge, however, that there is a “large gray area between treatments that are definitely
considered ‘surgical intervention’ and those that are not.” Id. at *6. In this case, I find that the medical
records offer sufficient detail to address this issue without the need for further medical opinion. I also
note that in this case respondent’s counsel cited approvingly to the Spooner decision during the status
conference.
In this case, there is no question that Y.I. underwent a surgical procedure. In
order to perform the bone marrow aspiration and biopsy, Y.I. was placed under
anesthesia and the procedure was performed by a physician. See, e.g. Ex. 7, p. 1, 190.
A preoperative checklist was completed. Ex. 7, pp. 130-31. Her mother signed a
consent for an operative procedure. 5 The authorization form identified possible risks of
pain, bleeding and infection. Ex. 7, pp. 5-6. Following the procedure, Y.I. was
monitored with Aldrete scoring to assess her recovery from anesthesia. Ex. 7, p. 4.
I also find that Y.I.’s bone marrow aspiration and biopsy constituted an
intervention. Although a bone marrow biopsy is in itself not a treatment that alters the
course of a disease or condition, under the facts of this case that is an incomplete
characterization. 6 Y.I.’s medical records indicate that "a bone marrow biopsy was
performed to rule out myeloproliferative disease prior to starting oral steroids . . ." Ex 7,
p. 19. The same record indicates that the oral steroid effectively improved Y.I.’s ITP. Id.
Because the medical record explicitly indicates that the bone marrow biopsy was
required in order to institute treatment, the bone marrow biopsy was a necessary and
integral part of the overall treatment protocol that ultimately cured Y.I.’s ITP. I also find
it significant that at three years of age at the time of the procedure, Y.I. was incredibly
young. It is highly unlikely that her treating physician would have subjected her to an
invasive procedure of this nature without sufficient need. 7
Finally, I note that this finding is narrowly tailored to the facts and circumstances
presented by this case. It is not a finding that bone marrow biopsy constitutes a surgical
intervention in all circumstances.
IV. Conclusion
For all these reasons, I find that Y.I. experienced hospitalization and surgical
intervention within the meaning of §300aa-11(c)(1)(D)(iii) of the Vaccine Act.
s/ Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
5
The authorization form used in Y.I.’s case is titled “Authorization for Administration of Anesthesia and for
Performance of Operations and Other Procedures.” Ex. 7, pp. 5-6.
6During the status conference, respondent’s counsel argued that a bone marrow biopsy is a diagnostic
procedure and that under the reasoning in Spooner, petitioners’ claim should be dismissed. I find,
however, that this case is factually distinct from Spooner. Of course, even if the facts of the two cases
were identical, I am not bound by the decision of another special master.
7 It is also worth noting that, as described above, Y.I.’s bone marrow biopsy was performed in the course
of a hospitalization following admission to the emergency department as an “urgent” case of “severe” ITP.
In addition to the definition described in Spooner, Dorland’s Illustrated Medical Dictionary also defines an
intervention as “the procedures involved in responding to an emergency.” Dorland’s (32nd Ed.), p. 952.
This suggests the need to identify appropriate treatment protocol on an urgent basis and provides
additional rationale for considering the treatment protocol as a whole an “intervention.”