In the United States Court of Federal Claims
)
VICTORIA LEMING and KEVIN LEMING, )
Parents and Natural Guardians of A.L., )
A Minor, )
) No. 18-232V
Petitioners, ) (Filed Under Seal: August 12, 2022;
) Reissued for Publication: August 29,
v. ) 2022)*
)
SECRETARY OF HEALTH AND HUMAN )
SERVICES, )
)
Respondent. )
)
Robert J. Krakow, Law Office of Robert J. Krakow, P.C., New York, NY, for Petitioner.
Julia M. Collison, Trial Attorney, Torts Branch, Civil Division, U.S. Department of Justice,
Washington, DC, with whom were Alexis B. Babcock, Assistant Director, Heather L. Pearlman,
Deputy Director, C. Salvatore D’Alessio, Acting Director, and Brian M. Boynton, Principal
Deputy Assistant Attorney General, for Respondent.
OPINION AND ORDER
KAPLAN, Chief Judge.
This case, brought under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.
§§ 300aa-1 to -34 (“Vaccine Act” or “the Act”), is before the Court for the second time. The first
time the Court heard the case was on a motion for review filed by respondent, the Secretary of
Health and Human Services (“the Secretary”). See Leming v. Sec’y of Health & Hum. Servs.,
154 Fed. Cl. 325 (2021) (“Leming I”). He sought review of the decision of then-Chief Special
Master Nora Beth Dorsey that Petitioners’ daughter, A.L., who experienced immune
thrombocytopenic purpura (“ITP”) within a few weeks of receiving the
measles-mumps-rubella-varicella (“MMRV”) vaccine, was eligible for compensation under the
Act. Specifically, he argued that the then-Chief Special Master erred when she found that A.L.’s
vaccine-related injury “resulted in inpatient hospitalization and surgical intervention” and so met
the severity requirement set forth in 42 U.S.C. § 300aa-11(c)(1)(D)(iii). Id. at 329–30.
*
Pursuant to Vaccine Rule 18(b), this opinion was initially filed on August 12, 2022, and the
parties were afforded fourteen days to propose redactions. The parties did not propose any
redactions and, accordingly, this Opinion is reissued in its original form for publication.
This Court granted the Secretary’s motion for review and reversed the then-Chief Special
Master’s decision. It held that the bone marrow aspiration that A.L. had undergone before
beginning a regimen of steroid treatment for her ITP was not a “surgical intervention” within the
meaning of 42 U.S.C. § 300aa-11(c)(1)(D)(iii). Id. at 335.
The Court remanded the case to the Office of Special Masters. On remand, Petitioners
resurrected an alternative argument that then-Chief Special Master Dorsey had rejected. They
contended that A.L. suffered the residual effects of her ITP more than six months post
vaccination and so satisfied the alternative severity criterion prescribed by 42 U.S.C.
§ 300aa-11(c)(1)(D)(i). Chief Special Master Corcoran, to whom the case had since been
reassigned, ruled against Petitioners. They then filed a motion for reconsideration, which he
denied.
Petitioners have now requested review of the Chief Special Master’s decision on remand
and his denial of their motion for reconsideration. They argue that he ignored or improperly
rejected evidence in the record showing that “Giant platelets” were present in A.L.’s blood more
than six months after she received the MMRV vaccine. According to Petitioners, these platelets,
which they allege caused her to bruise easily, were a residual effect of the episode of ITP she
suffered after her vaccination.
Alternatively, Petitioners argue that the Chief Special Master erred when he rejected their
contention that one of A.L.’s treating physicians directed that she not receive any additional
childhood vaccinations until the age of six, in light of her episode of ITP. This restriction, they
allege, constituted another residual effect of her vaccine injury that lasted more than six months
post vaccination as prescribed by 42 U.S.C. § 300aa-11(c)(1)(D)(i).
For the reasons set forth below, the Court concludes that the Chief Special Master’s
decision on remand and his decision denying reconsideration are neither arbitrary and capricious,
an abuse of discretion, nor contrary to law. Petitioners’ Motion for Review, ECF No. 102, must
therefore be DENIED.
BACKGROUND
I. A.L.’s September 2016 Vaccination, Development of ITP, and Subsequent
Successful Treatment
On September 6, 2016, during a scheduled well-child visit, fifteen-month-old A.L.
received the MMRV vaccine, the diphtheria-tetanus-acellular pertussis vaccine, and the
Haemophilus influenzae type b vaccine. Pet’rs’ Ex. 1 at 37–39, ECF No. 5-1. Within the next
week, A.L. developed a rash and fever. Pet’rs’ Ex. 13 at 3, ECF No. 24-1.
A.L.’s mother reported the rash to the pediatrician on September 16, 2016. Id. By this
time, A.L. no longer had a fever, and she was sleeping and eating normally. Id. The pediatrician
told A.L.’s mother that the rash was likely roseola and that no treatment was needed. Id.; see also
Pet’rs’ Ex. 8 at 214, ECF No. 5-8.
2
By September 29, 2016, however, A.L. had developed a petechial1 rash on her body and
tongue, and was experiencing bleeding gums, prompting her parents to take her to the emergency
room. Pet’rs’ Ex. 8 at 214–15. A blood test was administered, and it revealed a platelet count of
3,000/mm3. Id. at 211, 215. As a result, A.L. was diagnosed with ITP, id. at 215, “a disorder that
can lead to easy or excessive bruising and bleeding . . . result[ing] from unusually low levels of
platelets,” Immune thrombocytopenia (ITP), Mayo Clinic, https://www.mayoclinic.org/diseases-
conditions/idiopathic-thrombocytopenicpurpura/symptoms-causes/syc-20352325; see also 42
C.F.R. § 100.3(c)(7) (stating that thrombocytopenic purpura “is defined by the presence of
clinical manifestations, such as petechiae, significant bruising, or spontaneous bleeding, and by a
serum platelet count less than 50,000/mm3”).
A.L. was treated with one dose of intravenous (“IV”) immunoglobulin. Pet’rs’ Ex. 8 at
215. Nonetheless, she continued to exhibit bruising and petechia, and her platelet count in fact
decreased. Pet’rs’ Ex. 4 at 16, 19 (noting that A.L.’s platelet count was 1,000/mm3 on September
30), ECF No. 5-4. The next day, she was transferred to Children’s Hospital in Omaha, Pet’rs’ Ex.
8 at 215, where she received a second dose of IV immunoglobulin but still showed no
improvement, Pet’rs’ Ex. 4 at 16, 19.
As described in greater detail in the Court’s Opinion and Order on the first Motion for
Review, see Leming I, 154 Fed. Cl. at 327–29, A.L. began receiving IV steroid treatments for
her ITP on October 4, 2016, Pet’rs’ Ex. 4 at 52, 153. This time, the treatment was successful.
A.L.’s platelet count improved, id. at 4, and she was discharged from the hospital on October 12,
2016, id. at 3–5; see also id. at 4 (noting that A.L.’s platelet count at discharge was 19,000/mm3
and that she “had no active bleeding and all petechiae and bruising were resolving”); Pet’rs’ Ex.
9 at 11, ECF No. 5-9.
At A.L.’s first outpatient follow-up appointment on October 14, 2016, Dr. Amanda
Grimes, a hematologist, noted that A.L.’s mother had reported “no significant further bruising,”
and that A.L.’s petechiae and oral purpura had resolved. Pet’rs’ Ex. 9 at 11; see also id. at 13
(“Purpura . . . and rash noted. No petechiae noted.”). A.L.’s platelet count was now 25,000/mm3,
a “minimal[] improve[ment]” over the level present two days earlier when she was discharged
from the hospital. Id. at 14–15. She was reported to have “no further symptoms/active bleeding.”
Id. at 15.
Two weeks later, on October 28, 2016, A.L. underwent another round of blood tests
which revealed that her platelet count had continued to improve. Id. at 33–34. Dr. Grimes
directed that A.L. be weaned from steroid therapy “rapidly” over the following ten days, id. at
34, and the therapy ended by November 7, 2016, “with no symptom recurrence,” id. at 46.
Three weeks later, on November 21, 2016, Dr. Grimes saw A.L. again. Id. at 45–53. Dr.
Grimes reported that A.L. was “asymptomatic” and that her platelet count had “normalized” at
1
Petechiae are small pinpoint skin rashes that can arise due to insufficient platelets. See
Dorland’s Illustrated Medical Dictionary 1401 (33d ed. 2020) (explaining that petechiae are
“purplish red spot[s] caused by intradermal or submucous hemorrhage”).
3
160,000/mm3. See id. at 51. She noted that A.L.’s mother still believed that A.L. bruised and
bled more easily than other children, id. at 45, but also observed that A.L. was
“SIGNIFICANTLY improved,” id. at 46; see also id. at 48 (“No petechiae and no rash noted.
Purpura: few scattered evolving ecchymoses – but overall improved.”). Dr. Grimes also recorded
that A.L.’s mother was “still . . . concern[ed]” about “immune dysfunction, and hesitant to
consider further immunizations for [A.L.].” Id. at 51 (noting that A.L. would be “refer[red] for
Immunology evaluation”).
Five weeks later, on December 30, 2016, A.L. had another follow-up examination, this
time with a different hematologist, Dr. Michelle Ting. See id. at 60–69. Dr. Ting reported that
A.L. “ha[d] been doing very well,” and that she “continue[d] to remain free of bleeding
symptomatology,” with “[n]o easy bruising or petechiae.” Id. at 61 (“Bruises/bleeds easily (now
resolved).”); id. at 63 (“Purpura: few scattered evolving ecchymoses, but only on shins.”). Dr.
Ting also noted that A.L. was no longer receiving treatment and had a normal platelet count. Id.
at 61–63, 66–67. She concluded that A.L.’s ITP “has likely resolved at this time, and is unlikely
to recur.” Id. at 66.
II. Follow-Up Exams in April and June 2017
On April 13, 2017, more than seven months after her MMRV vaccine, A.L. saw Dr.
Grimes for a follow-up appointment, including blood tests. See Pet’rs’ Ex. 9 at 94–97, 100–01.
Dr. Grimes reported that A.L. was “asymptomatic . . . with normalized platelet count . . . and
normalized platelet size/variance.” Id. at 100. She concluded that A.L.’s “ITP [was] resolved,”
stated that she had “counseled [A.L.’s] family regarding possibility of [ITP] recurrence (<5%),”
and opined that there was “no need for routine follow-up/surveillance (unless indicated by the
development of signs/symptoms of bleeding).” Id. She again noted, as she had in her November
2016 report, that A.L.’s mother was “concern[ed]” about “immune disfunction, and hesitant to
consider further immunizations for [A.L.].” Id.; see also id. at 51.
On the same day that she saw Dr. Grimes, A.L. was also seen by Dr. Lisa Forbes, a
pediatric immunologist. Id. at 78–81. Dr. Forbes noted that A.L. had been referred for
“consultation for ITP and concern for immunodeficiency,” and that A.L.’s mother was
“concerned that [A.L.’s] vaccination might have triggered the ITP.” Id. at 78. She noted that A.L.
had been “doing well with normal platelet count” since the conclusion of steroid therapy the
previous December, id. at 79, and observed that A.L. had no “bruising [or] bleeding
abnormalities,” id. at 80.
At A.L.’s next follow-up appointment ten weeks later (on June 29, 2017), Dr. Forbes
recorded that A.L.’s mother was expressing concerns “that [A.L.] is still bruising more easily
than other children,” but she also observed that “overall [she is] doing better.” Pet’rs’ Ex. 10 at 1,
ECF No. 5-10; but see id. at 2 (noting that A.L.’s mother “denies . . . bruising [or] bleeding
abnormalities”). Dr. Forbes also reported that A.L.’s mother was “concerned that [A.L.’s]
vaccination might have triggered the ITP.” Id. at 2.
During this appointment, Dr. Forbes recorded that A.L. had a bruise on her cheek and on
her ear. Id. at 4. She stated, however, that A.L.’s “ITP episode” had “now resolved.” Id. at 9.
4
In her report, Dr. Forbes observed that the blood tests that had been conducted in April,
discussed above, had revealed the presence of “mildly elevated transitional B cells on B cell
subset typing.” Id. at 9 (“Immune work-up otherwise reassuring.”). Therefore, Dr. Forbes stated,
she would recheck B cell subsets that day. Id.; see also Pet’rs’ Ex. 9 at 91 (documenting a
platelet count of 321,000/mm3 and a mean platelet volume of 9.0 femtoliters in April 2017). If
the B cells were “trending toward normal,” she opined, then the mild elevation was “likely due to
the immature immune system at [A.L.’s] age and new B cell differentiation following the ITP
episode now resolved.” Pet’rs’ Ex. 10 at 9. On the other hand, she observed, “[i]f the level
continues to increase, there will be concern for immune dysfunction with potential for recurrence
of autoimmune disease.” Id.
The blood tests Dr. Forbes ordered that day revealed that A.L.’s platelet count was
normal, id. at 6 (documenting a platelet count of 375,000/mm3), and that her mean platelet
volume was within the reference range (at 9.3 femtoliters), id. At the same time, in a box set
aside for “comments” concerning platelets, the report stated that “Giant platelets” had been
“noted on smear review.” Id. at 7.2
Dr. Forbes reviewed the results and concluded that they were “reassuring for normal B
cell differentiation.” Id. at 9. In fact, the results were so reassuring that she cancelled any further
testing and follow-up appointments with A.L. See Pet’rs’ Ex. 12 at 2 (“Per Dr. Forbes, all of
[A.L.]’s [June 29, 2017] labs were good so we can cancel her appointment for September.”),
ECF No. 19-1; see also Pet’rs’ Ex. 23, ¶ 6 (“Dr. Forbes contacted me again by telephone to
provide further advice regarding [A.L.]’s care and to report the June 2017 test results.”), ECF
No. 88-1. Dr. Forbes made no comments regarding the giant platelets present on the blood smear
review.
III. The Vaccine Claim and the Special Master’s Ruling on Facts
On February 14, 2018, A.L.’s parents, Petitioners Victoria and Kevin Leming, filed a
petition for compensation pursuant to the National Vaccine Injury Compensation Program, 42
U.S.C. §§ 300aa-1 to -34. Pet. for Comp. Under the Vaccine Act at 1, ECF No. 1. In their
Petition, the Lemings alleged that the vaccines A.L. received on September 6, 2016, caused her
to experience ITP, immune dysfunction, and immunodeficiency. See id. at 1.
The case was assigned to then-Chief Special Master Dorsey on February 15, 2018. ECF
No. 4. On December 21, 2018, the Secretary filed a Vaccine Rule 4(c) report. ECF No. 34. In it,
he asserted that Petitioners were not eligible for compensation because they could not satisfy the
Act’s severity requirement, codified at 42 U.S.C. § 300aa-11(c)(1)(D). Id. at 5–6. That provision
requires a petitioner to prove that her alleged vaccine-related illness, disability, injury, or
2
“Giant platelets” are “platelets the size of red blood cells.” Pet’rs’ Ex. 27 at 11 (David S.
Rosenthal, Evaluation of the peripheral blood smear (Robert A. Brodsky & Jennifer S. Tirnauer,
eds., Jan. 19, 2022), https://www.uptodate.com/contents/evaluation-of-the-peripheral-blood-
smear), ECF No. 98-4. They “may be seen in patients with increased platelet turnover or a
myeloproliferative neoplasm,” as well as “a variety of congenital bleeding disorders.” Id.
5
condition either: lasted longer than six months, 42 U.S.C. § 300aa-11(c)(1)(D)(i); resulted in
death, id. § 300aa-11(c)(1)(D)(ii); or “resulted in inpatient hospitalization and surgical
intervention,” id. § 300aa-11(c)(1)(D)(iii).
On March 26, 2019, both parties filed motions for a ruling on the facts. ECF Nos. 38, 39.
Then-Chief Special Master Dorsey issued such a ruling on July 12, 2019. See Ruling on Facts,
ECF No. 41. As pertinent to the current motion for review, she agreed with the Secretary that
Petitioners had failed to demonstrate that A.L. had suffered ITP-related sequelae for more than
six months post vaccination as required to be eligible for compensation pursuant to clause (i) of
42 U.S.C. § 300aa-11(c)(1)(D). See id. at 5–7. Specifically, she found that the evidence did not
support Petitioners’ contentions that A.L. continued for more than six months to experience the
adverse effects of immune dysfunction and/or bruising attributable to ITP. Id. at 6–7.
Then-Chief Special Master Dorsey observed that Petitioners’ allegations that A.L.’s
immune system “remained ‘abnormal’ for more than six months after vaccination” were based
on Dr. Forbes’ June 29, 2017 report. Id. at 6–7. As described above, Dr. Forbes had noted “mild
elevation” in A.L.’s “transitional B cells,” based on her April 2017 blood tests, Pet’rs’ Ex. 10 at
9, and stated that—should the level continue to increase—it would create concerns about
immune dysfunction with the “potential for recurrence of autoimmune disease,” id.; see also
Pet’rs’ Ex. 9 at 91. But the June 29, 2017 tests Dr. Forbes conducted alleviated any potential
concerns. As then-Chief Special Master Dorsey observed, Dr. Forbes characterized the results of
the June 29, 2017 blood tests as “good,” and she cancelled A.L.’s follow-up appointment without
ordering any further treatment. Ruling on Facts at 6 (citing Pet’rs’ Ex. 10 at 8–9; Pet’rs’ Ex. 12
at 2). Relying on Dr. Forbes’ observations, and the rest of the record, then-Chief Special Master
Dorsey concluded that “A.L. did not suffer immune dysfunction or dysregulation persisting for
more than six months after her September 6, 2016 vaccinations.” Id. at 6–7.
Then-Chief Special Master Dorsey similarly rejected Petitioners’ contention that A.L.
“suffered continued ITP-related bruising more than six months after vaccination.” Id. at 7. She
acknowledged that, in the notes regarding the June 29, 2017 appointment, Dr. Forbes recorded
that A.L.’s mother “fe[lt] that [A.L.] [was] still bruising easier than other children” and had also
noted bruising on A.L.’s cheek and ear. Id. (citing Pet’rs’ Ex. 10 at 1, 4). However, she
explained, Dr. Forbes “did not attribute any . . . bruising to A.L.[’s] previous ITP diagnosis.” Id.
She agreed with the Secretary that Petitioners had not proven that the bruising A.L.’s mother had
observed was attributable to her vaccine injury, and therefore concluded that A.L. had not
“suffered the residual effects or complications of [her] illness, disability, injury, or condition for
more than 6 months after the administration of the vaccine” as required for compensation under
clause (i) of the Vaccine Act’s severity requirement. See id.
IV. Proceedings on Remand
Order to Show Cause
On June 28, 2021, Chief Special Master Brian H. Corcoran, to whom the case had since
been reassigned, issued an Order directing Petitioners to show cause why the case should not be
dismissed given: (1) this Court’s decision that A.L. had not undergone a surgical intervention
6
within the meaning of 42 U.S.C. § 300aa-11(c)(1)(D)(iii); and (2) then-Chief Special Master
Dorsey’s undisturbed finding that they “ha[d] not established by preponderant evidence that A.L.
suffered residual effects of her ITP for six months after her vaccination” within the meaning of
42 U.S.C. § 300aa-11(c)(1)(D)(i). Order to Show Cause at 2 (quoting Ruling on Facts at 7), ECF
No. 84.
Petitioners responded that the Chief Special Master should not dismiss the case given
certain “new facts” set forth in an affidavit Petitioner Victoria Leming executed on August 30,
2021, Pet’rs’ Resp. to Order to Show Cause at 1, ECF No. 88, as well as an upcoming
appointment the Lemings had scheduled with Dr. Forbes for October, id. at 2. In the affidavit,
Ms. Leming asserted that A.L. “continues to bruise easily” and “has suffered the effects and
complications of her ITP until the present.” Pet’rs’ Ex. 23, ¶ 12. In addition, Ms. Leming stated
that “[s]ometime” before June 2017 Dr. Forbes had informed her by phone “that [A.L.]’s B cell
counts were high, consistent with the adverse effects of ITP,” and that, while “the titers from
[A.L.]’s earlier vaccinations came back in the normal range,” “a second round of testing was
necessary.” Id. ¶ 4. Following that second round of testing on June 29, 2017, Ms. Leming
asserted, “Dr. Forbes said that [A.L.]’s B cell count was still high” although lower than the first
test conducted in April 2017. Id. ¶ 6. She stated that Dr. Forbes told her in June 2017 that, “based
on the tests, [A.L.] was still experiencing the effects of the ITP but was nearing [the] end of the
ITP healing process.” Id.
“During the same June telephone conversation,” Ms. Leming continued, “Dr. Forbes told
[her] that because of [A.L.]’s vaccine reaction and resulting immune dysfunction, [Dr. Forbes]
was ordering [A.L.] to avoid vaccinations until at least the age of six,” allegedly citing “the risk,
due to her ITP, of an adverse effect from vaccination.” Id. ¶ 7. According to Ms. Leming, Dr.
Forbes had told her that, “before [A.L.] resumed receiving vaccines, she would need to return for
another round of testing.” Id. (“Dr. Forbes recommended that we defer vaccination . . . .”). As a
result, Ms. Leming stated, A.L. “ha[d] not had any vaccines since June 2017.” Id. ¶ 9.
Citing these representations in Ms. Leming’s affidavit, Petitioners argued that “Dr.
Forbes believes that [A.L.]’s ITP and related immunodeficiency has continued through the age of
six, requiring further testing.” Pet’rs’ Resp. to Order to Show Cause at 3. They further observed
that A.L.’s upcoming October 22, 2021 appointment with Dr. Forbes “promises to yield further
information confirming these facts.” Id. In addition, in a footnote, Petitioners noted that the
Federal Circuit had taken under consideration an appeal concerning “the interpretation by the
Court of Federal Claims of the statutory meaning of the Vaccine Act’s ‘residual effects’
requirement” in the context of ITP, and argued that “the outcome of the appeal will likely have
some bearing on the determination of the issues in the present case.” Id. at 2 n.1 (citing Wright v.
Sec’y of Health & Hum. Servs., 146 Fed. Cl. 608, 614–15 (2019)).
Decision on Remand
Given the pendency of the appeal in the Federal Circuit in Wright, Chief Special Master
Corcoran deferred his decision regarding the disposition of the case on remand. See Decision on
Remand at 4, ECF No. 96. The court of appeals issued its decision on January 5, 2022. See
Wright v. Sec’y of Health & Hum. Servs., 22 F.4th 999 (Fed. Cir. 2022). Three weeks later, and
7
without requesting additional briefs from the parties, the Chief Special Master dismissed the
case. See Decision on Remand. He concluded that Petitioners had not proven that A.L. suffered
from the residual effects or complications of her vaccine injury for longer than six months as
required to establish severity under 42 U.S.C. § 300aa-11(c)(1)(D)(i). Id. at 7–11.
The Chief Special Master found that the “factual history contained in section II of Special
Master Dorsey’s [Ruling on Facts] represent[ed] an accurate summary of the relevant facts in
this matter,” and he adopted and incorporated that section into his decision. Id. at 4 (explaining
that he agreed with “that aspect of her ruling (which was not contested or disturbed on review) in
its entirety”). He also adopted section IV(a) of the Ruling on Facts (“Six Month Sequela”). Id. at
9 (explaining that section IV(a) “remains undisturbed by” Leming I and that he “concur[s] with
the reasoning behind it”).
Chief Special Master Corcoran was not persuaded by the “new evidence” Petitioners had
submitted, id. at 7, 9, including Ms. Leming’s affidavit, in which she represented that Dr. Forbes
was of the view that A.L.’s “ITP and related immunodeficiency has continued through the age of
six, requiring further testing,” id. at 9 (quoting Pet’rs’ Resp. to Order to Show Cause at 3). The
Chief Special Master found this contention “utterly contra[dicted]” by the medical record. Id. He
explained that “A.L. has never been diagnosed with the chronic form of ITP that would be
expected to persist,” and that “Dr. Forbes’s contemporaneous treatment records demonstrate that
after reviewing the bloodwork ordered on June 29, 2017, she had no concerns that A.L.’s ITP
and/or any related immunodeficiency persisted, and recommended only follow-up as needed.”
Id. at 9–10 (discussing Pet’rs’ Ex. 10 at 9). Further, he explained, no additional medical records
had been provided to demonstrate that A.L.’s platelet count had been abnormal after 2016,
despite the fact that several months had passed “since A.L.’s purported appointment with Dr.
Forbes [in October 2021].” Id. at 10 (noting that “no updated medical records or other evidence
has been filed that alter this analysis”).
The Chief Special Master also found unpersuasive Petitioners’ contention “that A.L.
continues to bruise easily,” noting that this assertion had been addressed in Special Master
Dorsey’s Ruling on Facts, where she observed that Dr. Forbes “did not attribute any June 29,
2017 bruising to A.L.[’s] previous ITP diagnosis.” Id. (quoting Ruling on Facts at 7). In the two
years since that ruling, he continued, “no other proof (such as evidence of platelet drops or
bleeding) has been offered to corroborate Petitioners ‘new’ contention that A.L.’s current
propensity to bruise easily is caused by her ITP or is evidence that her ITP persists.” Id. In any
event, Chief Special Master Corcoran went on, “[b]ruising per se is simply too nonspecific, even
in the context of ITP, to amount to evidence of ongoing sequelae, in the absence of proof of
accompanying platelet count drops.” Id. at 10–11 (citing Wright, 22 F.4th at 1005)).
“Finally,” Chief Special Master Corcoran found, “Petitioners’ assertion that Dr. Forbes
recommended that A.L. receive no further vaccines until age six (and then only after further
testing), due to an increased risk of an adverse event,” could not support a finding “that A.L.’s
ITP and/or any related immunodeficiency persisted for more than six months.” Id. at 11 (citing
Pet’rs’ Resp. to Order to Show Cause at 2; Pet’rs’ Suppl. Resp. to Order to Show Cause at 2,
ECF No. 90; Pet’rs’ Ex. 23, ¶¶ 7, 9). “[T]he mere risk of a future associated problem that could
be triggered a second time by vaccination,” he concluded, “cannot satisfy severity.” Id. (citing
8
Parsley v. Sec’y of Health & Hum. Servs., 08-781V, 2011 WL 2463539, at *5 (Fed. Cl. Spec.
Mstr., May 27, 2011)).
Petitioners’ Motion for Reconsideration
On February 10, 2022, Petitioners filed a motion for reconsideration of the Chief Special
Master’s Decision on Remand pursuant to Vaccine Rule 10(e). See Pet’rs’ Mot. for Recons. of
the Decision on Remand Filed on Jan. 26, 2022 (“Pet’rs’ Mot. for Recons.”), ECF No. 97.3
Along with their motion, Petitioners submitted additional medical records, including blood test
results from October 2021 and a new November 2021 report from Dr. Forbes. Pet’rs’ Ex. 38,
ECF No. 99-1. They also submitted an expert report from Dr. Mark Levin, Pet’rs’ Ex. 24, ECF
No. 98-1, along with a number of items of medical literature, Pet’rs’ Exs. 25–36, ECF Nos. 98-2
to -13.
In their Motion for Reconsideration, Petitioners complained throughout that the Chief
Special Master had not solicited their views regarding the impact of the Federal Circuit’s
decision in Wright before he dismissed their case. See, e.g., Pet’rs’ Mot. for Recons. at 2
(arguing that Petitioners were not given an opportunity “to show how their case meets the
six-month severity statute, taking into consideration the Federal Circuit’s new statutory
construction [in Wright]”).4 They noted that, under Wright, the term “residual effects” in
§ 300aa-11(c)(1)(D)(i) of the Vaccine Act “is focused on effects within the patient, particularly
lingering signs and symptoms of the original vaccine injury.” Id. at 14 (emphasis in original)
(quoting Wright, 22 F.4th at 1006). They argued that the evidence showed that A.L.
“experienced a demonstrable change within her body caused by the vaccine injury that persisted
well past six months post vaccination.” Id. at 3. That change was the presence of “Giant
platelets” noted in her June 2017 blood test report. Id. Petitioners argued that the presence of
giant platelets is “an abnormality—a ‘residual effect or complication’—that was caused by her
vaccine injury, immune thrombocytopenia purpura.” Id.
3
Vaccine Rule 10(e)(1) provides that “[e]ither party may file a motion for reconsideration of the
special master’s decision within 21 days after the issuance of the decision, if a judgment has not
been entered and no motion for review under Vaccine Rule 23 has been filed.” And Vaccine
Rule 10(e)(3) gives the special master “the discretion to grant or deny the motion, in the interest
of justice.”
4
See also Pet’rs’ Mot. for Recons. at 3 (arguing that their claim “was not yet ripe for
adjudication because the Petitioners had not had an opportunity to present their case considering
the Federal Circuit’s seminal Opinion in Wright”); id. at 4 (arguing that the Chief Special Master
had issued his Decision on Remand “without the benefit of the Petitioners’ input to consider the
Wright Opinion’s bearing . . . on their case”); id. at 16–17 (arguing that the Chief Special Master
“did not give Petitioners a chance to present their case post-Wright”); id. at 17 (criticizing the
Chief Special Master’s issuance of his “Decision on Remand twenty-three days after the Federal
Circuit issued its Opinion in Wright, without providing the Petitioners with an opportunity to
present how the Federal Circuit’s Opinion in Wright might bear on their case”).
9
While the notation regarding giant platelets was not new evidence, and was not
commented upon by any of A.L.’s treating physicians, Petitioners cited the newly submitted
report of Dr. Levin in an effort to explain its significance. See id. at 10–12, 19–22. They noted
his observation that “large platelets were present during the acute phase of [A.L.’s ITP] in
October 2016,” and that a blood test performed in June 2017 indicated elevated B cell levels plus
“[t]he presence of large or Giant platelets.” Id. at 11 (quoting Pet’rs’ Ex. 24 at 8). Dr. Levin
opined that “[t]he presence of large platelets in [A.L.]’s blood in June 2017 shows that she was
continuing to experience the effects of her vaccine-caused ITP.” Pet’rs’ Ex. 24 at 8. (“The
presence of Giant platelets in [A.L.]’s June 29, 2017, blood sample, is evidence of such a
continuing thrombocytopenic process, the source of which is her ITP that began in September
2016.”). Moreover, he observed, “Giant platelets are associated with detrimental effects on the
patient” and “can result in certain kinds of excessive bleeding.” Id.
Petitioners also argued that another residual effect of A.L.’s ITP was that she had not
been able to receive any of her routine childhood vaccinations since 2016. Pet’rs’ Mot. for
Recons. at 24–29. They cited Dr. Forbes’ purported “recommendation” to that effect in June
2017, and represented that she was “currently evaluating A.L. to determine an appropriate
vaccination schedule, due to an increased risk of an adverse event.” Id. at 27.
The Chief Special Master’s Order Denying Reconsideration
On February 18, 2022, Chief Special Master Corcoran denied Petitioners’ Motion for
Reconsideration. See Order Den. Mot. for Recons. (“Recons. Order”), ECF No. 101. He
observed that, while there was little case law interpreting the “interests of justice” standard, id. at
3, his practice was to “permit[] reconsideration when the movant provided new, relevant
evidence that would have borne on [his] initial decision had it been previously available,” id. at
4. Here, however, Petitioners had not supplied any “new medical findings or evidence.” Id. at 5.
Instead, he explained, they had relied almost entirely upon existing record evidence, in particular
the June 2017 blood test findings. Id. at 5–6. The Chief Special Master noted that, while
Petitioners were focusing for the first time on two particular aspects of A.L.’s test results, the
blood test evidence itself had already been considered multiple times and been deemed
insufficient to establish severity under § 300aa-11(c)(1)(D)(i) “by two special masters.” Id. at 5
(noting that Petitioners were “emphasizing for the first time ‘the giant platelets noted on smear
review’ in conjunction with [A.L.]’s bruising and B cell findings from this timeframe,” but that
Special Master Dorsey had already rejected a severity finding after considering these facts (citing
Ruling on Facts at 4–5)).
The Chief Special Master further concluded that the new medical records documenting
A.L.’s October 2021 blood test and follow-up visit with Dr. Forbes in November did not yield
evidence that A.L. suffered from the residual effects or complications of her ITP more than six
months after her vaccination. Id. at 5–6. He observed that A.L.’s October 2021 blood test results
“were not interpreted by Dr. Forbes as suggesting A.L. was at risk for ITP or immune
dysfunction.” Id. at 5 (citing Pet’rs’ Ex. 38). At best, Petitioners were “highlight[ing] a different
aspect of the record (the giant platelets and/or B cell levels) that they did not previously
reference.” Id. at 6. But the medical studies submitted by Petitioners, he explained, did not
demonstrate any “legitimate changes in the scientific understanding of ITP . . . [which] would
10
render this aspect of the record more significant today than it was in 2019.” Id. It continued to be
the case, he said, that “ITP is not present if a serum platelet count is normal” and that “bruising
alone (and whatever might cause that) is not enough to prove [ITP-related] injury.” Id. (citing
Wright, 22 F.4th at 1002–03).
Finally, the Chief Special Master acknowledged that “[i]ntervening precedent can . . .
provide grounds for reconsideration, if it in fact has the potential for altering a matter’s prior
resolution.” Id. at 4. But he had already explicitly considered the impact of Wright on
Petitioners’ claim in his Decision on Remand. Id. at 6–7; see also Decision on Remand at 4, 6,
10. He acknowledged that he had not previously “invite[d] Petitioners to offer their parsing of
Wright,” but concluded that, even with “the benefit of their reading of it,” their arguments were
“wholly unpersuasive.” Recons. Order at 6–7.
V. Petitioners’ Motion for Review
On February 25, 2022, Petitioners filed the present Motion for Review of Chief Special
Master Corcoran’s Decision on Remand and his Reconsideration Order pursuant to 42 U.S.C.
§ 300aa-12(e)(1). See Pet’r’s Mot. for Review of the Special Master’s Decision Filed on Jan. 26,
2022, and Denial of Mot. for Recons. (“Pet’rs’ Mot.”), ECF No. 102; Pet’rs’ Mem. of Numbered
Objs. to the Decision on Remand Filed on January 26, 2022, and in Supp. of Pet’r’s Mot. for
Review (“Pet’rs’ Mem.”), ECF No. 104; see also Vaccine Rule 24 (“Memorandum of
Objections”).
The Secretary filed a response to Petitioners’ Motion on March 28, 2022, in which he
urged the Court to affirm the Chief Special Master’s determination. Resp. to Mot. for Review
(“Sec’y’s Resp.”), ECF No. 106. The Court held oral argument on Petitioners’ Motion via
videoconference on August 4, 2022.
DISCUSSION
I. Jurisdiction and Standard of Review
Congress established the National Vaccine Injury Compensation Program in 1986 to
provide a no-fault compensation system for vaccine-related injuries and deaths. Figueroa v.
Sec’y of Health & Hum. Servs., 715 F.3d 1314, 1316–17 (Fed. Cir. 2013). The Act is
“[r]emedial legislation” which “should be construed in a manner that effectuates its underlying
spirit and purpose.” Id. at 1317 (alteration in original) (citing Cloer v. Sec’y of Health & Hum.
Servs., 675 F.3d 1358, 1362 (Fed. Cir. 2012)).
A petition seeking compensation under the Vaccine Act must be filed in the Court of
Federal Claims, after which the Clerk of Court forwards it to the Office of Special Masters for
assignment. 42 U.S.C. § 300aa-11(a)(1). The special master to whom the petition is assigned
“issue[s] decision on such petition with respect to whether compensation is to be provided under
the [Vaccine Act] and the amount of such compensation.” Id. § 300aa-12(d)(3)(A).
11
The Vaccine Act grants the Court of Federal Claims jurisdiction to review the decisions
of special masters (subject to further review in the Federal Circuit). Mahaffey v. Sec’y of Health
& Hum. Servs., 368 F.3d 1378, 1383 (Fed. Cir. 2004) (citing 42 U.S.C. § 300aa-12(d)(3)(A)).
On review, the Court has several options. It may:
(A) uphold the findings of fact and conclusions of law of the special master and
sustain the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the special master found
to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with law and issue its own findings of fact and conclusions of law, or
(C) remand the petition to the special master for further action in accordance with
the court’s direction.
42 U.S.C. § 300aa-12(e)(2); see also Vaccine Rule 27.
The Court reviews a special master’s legal determinations de novo, applying the “not in
accordance with law” standard. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321
(Fed. Cir. 2010); Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278–79 (Fed. Cir.
2005); see also Carson v. Sec’y of Health & Hum. Servs., 727 F.3d 1365, 1368 (Fed. Cir. 2013)
(instructing the reviewing court to “give no deference to the . . . Special Master’s determinations
of law”).
By contrast, review of a special master’s factual determinations is limited to whether such
determinations are arbitrary, capricious, and/or reflect an abuse of discretion, Moberly, 592 F.3d
at 1321, which is a “uniquely deferential” standard, Milik v. Sec’y of Health & Hum. Servs., 822
F.3d 1367, 1376 (Fed. Cir. 2016) (quoting Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d
958, 961 (Fed. Cir. 1993)). The Court does not reweigh the evidence nor examine its probative
value or the credibility of the witnesses; those “are all matters within the purview of the fact
finder.” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011) (citing
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1349 (Fed. Cir. 2010)).
Therefore, if a special master “‘has considered the relevant evidence of record, drawn plausible
inferences and articulated a rational basis for the decision,’ then reversible error is ‘extremely
difficult to demonstrate.’” Milik, 822 F.3d at 1376 (quoting Hines v. Sec’y of Health & Hum.
Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).
II. Merits
Under the Vaccine Act, “[a] petitioner seeking compensation must establish by a
preponderance of the evidence that the injury or death was caused by a vaccine.” Wright, 22
F.4th at 1001 (citing 42 U.S.C. §§ 300aa-11(c)(1)(C), -13(a)(1)). There are two ways a petitioner
may make this showing. “First, the petitioner may prove that the injury is one listed in the
Vaccine Injury Table, 42 U.S.C. § 300aa-14(a); 42 C.F.R. § 100.3(a) (2020), and occurred within
the time provided within the Table, establishing a presumption of causation.” Id. (citing
Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1319–20 (Fed. Cir. 2006)).
Second, where an injury is not listed in the Vaccine Injury Table, the petitioner must prove
causation in fact. Id. at 1001–02.
12
Whether the case involves a Table Injury (as here) or requires specific proof of causation,
compensation is only available for injuries that reach a specified threshold of severity. A
petitioner seeking compensation under the Act must therefore also prove that she: (1) suffered
the residual effects of her vaccine-related illness, disability, injury, or condition for more than six
months, 42 U.S.C. § 300aa-11(c)(1)(D)(i); (2) suffered a vaccine-related illness, disability, injury
or condition that resulted in death, id. § 300aa-11(c)(1)(D)(ii); or (3) suffered a vaccine-related
illness, disability, injury or condition that “resulted in inpatient hospitalization and surgical
intervention,” id. § 300aa-11(c)(1)(D)(iii).
The motion for review presently before the Court concerns the Chief Special Master’s
determination under clause (i) of the severity provision that A.L. did not “suffer[] the residual
effects or complications” of her ITP for more than six months after she received the MMRV
vaccine. Id. § 300aa-11(c)(1)(D)(i). Petitioners contend that this determination was arbitrary and
capricious and/or an abuse of discretion, alleging that there exist two alternative bases on which
the Chief Special Master could have and should have found 42 U.S.C. § 300aa-11(c)(1)(D)(i)
satisfied. Pet’rs’ Mem. at 1–2.
First, Petitioners rely on a June 29, 2017 laboratory report showing that on that day a
blood test revealed both elevated levels of B cells and the presence of “Giant platelets” in A.L.’s
blood. See id. at 24–36. Petitioners contend that A.L.’s ITP caused the formation of the giant
platelets and that they affected the ability of her blood to clot, which explained why A.L.
allegedly continued to bruise easily. Id. at 27, 33. Therefore, Petitioners argue, the giant platelets
were residual effects of A.L.’s ITP. Id. at 26, 29.
Alternatively, Petitioners argue that, at the direction of her doctor, and because of the risk
of adverse effects, A.L. did not receive routine childhood vaccinations for over four years. Id. at
37–43. They contend that the doctor’s direction was a course of treatment she prescribed for
A.L.’s vaccine injury and therefore a “residual effect” of that injury. Id. at 42.
The Chief Special Master rejected both arguments. See Recons. Order. For the reasons
set forth below, his determinations were neither arbitrary and capricious, an abuse of discretion,
nor contrary to law. Petitioners’ Motion for Review must therefore be denied.
Whether the “Giant Platelets” Noted in a June 2017 Blood Smear
Represented a Residual Effect of A.L.’s Vaccine Injury
Petitioners contend that the Chief Special Master did not give sufficient weight to the
results of a blood smear taken on June 29, 2017, which, as noted, revealed the presence of “Giant
platelets” in A.L.’s blood. Pet’rs’ Mem. at 26 (citing Pet’rs’ Ex. 10 at 7). They argue that the
medical literature and the report of their medical expert, Dr. Mark Levin, show that the giant
platelets were caused by and therefore were a residual effect of A.L.’s vaccine-injury—i.e., ITP.
Id. at 26–27, 30–31. Further, Petitioners observe, giant platelets interfere with the blood’s ability
to clot. Id. at 33 (citing Pet’rs’ Ex. 24 at 8). Therefore, they posit, the bruises Dr. Forbes recorded
in June 2017 were caused by “a continuing ITP process as revealed by the medical evidence of
the presence of giant platelets.” Id. at 30. They argue that when the Chief Special Master denied
their Motion for Reconsideration, he “improperly ignored or rejected [this] unambiguous
13
evidence of a detrimental somatic condition within A.L. that was medically caused by and a
‘residual effect’ of A.L.’s vaccine-caused ITP.” Id. at 2 (citing Wright, 22 F.4th at 1005–06).
These arguments lack merit.
First, there is ample support in the record for the finding of the Chief Special Master (and
that of his predecessor, former Chief Special Master Dorsey) that A.L. was not suffering from
ITP at the time she allegedly experienced unusual bruising in June 2017. Recons. Order at 5–6.
In fact, the great weight of the medical evidence, which both of them credited, showed that
A.L.’s vaccine injury—i.e., ITP—was resolved in December 2016. Id. at 2, 5–6; Ruling on Facts
at 5–7; see also Pet’rs’ Ex. 9 at 66 (hematologist’s December 30, 2016 statement that A.L.’s ITP
“has likely resolved at this time and is unlikely to recur”); id. at 45–46 (documenting that A.L.
was weaned off of steroids in November 2016 with “no symptom recurrence”); id. at 95 (April
13, 2017 report of hematologist stating that A.L. remained “completely free of bleeding
symptomatology”).
These conclusions are based on a series of blood tests, which showed a normal platelet
count. See Pet’rs’ Ex. 9 at 55, 79, 100; Pet’rs’ Ex. 10 at 6; Pet’rs’ Ex. 12 at 2. The blood test
results are dispositive because, as the Chief Special Master observed, and as is consistent with
the medical literature Petitioners themselves submitted, “platelet count drops” are “the sine qua
non for diagnosing ITP.” Recons. Order at 2; see also Pet’rs’ Ex. 36 at 2 (defining ITP as the
condition of having a platelet count of less than 50,000/mm3 or a higher count but “accompanied
by severe or mucosal bleeding”), ECF No. 98-13; Pet’rs’ Ex. 29 at 1 (defining ITP as a “platelet
count [of less than] 100,000/[mm3]”), ECF No. 98-6; Pet’rs’ Ex. 32 at 1 (noting that ITP “is
defined as a platelet count of <150,000/[mm3]”), ECF No. 98-9.
Petitioners argue nonetheless that, even if A.L.’s ITP had in some sense been “resolved”
in December 2016, in June 2017 she was still suffering from its “residual effects,” as the court of
appeals interpreted that term in Wright. Pet’rs’ Mem. at 25–28. In Wright, a two-year-old child
(B.W.) was diagnosed with ITP about two weeks after he received an MMRV vaccine. 22 F.4th
at 1003. Although his platelet count was normal within a few months, he continued to experience
bruising over the next two years and had to return for blood tests on several occasions. Id. at
1003–04. Each blood test revealed a normal platelet count, reflecting that B.W. no longer
suffered from ITP. See id. The petitioners in Wright argued nonetheless that the severity
requirement was met because the blood tests B.W. had been required to undergo were
themselves the residual effect of the now-resolved ITP. See id. at 1004.
The Federal Circuit rejected Petitioners’ argument. Id. at 1004–07. While it agreed that
the language of 42 U.S.C. § 300aa-11(c)(1)(D)(i) “dictates that a residual effect must be caused
by the vaccine injury,” id. at 1004–05, it observed that “vaccine injuries are somatic conditions
defined by their signs and symptoms within the patient,” and “their residues are similarly
defined,” id. at 1005–06 (citing 42 C.F.R. § 100.3(c)). The phrase “residual effects,” the court
said, “is focused on effects within the patient, particularly lingering signs and symptoms of the
original vaccine injury.” Id. at 1006. In addition, the court of appeals held, “[t]he words
‘suffered’ and ‘complication,’ used in association with ‘residual effects’ in
§ 300aa-11(c)(1)(D)(i),” indicate that “Congress contemplated residual effects to be detrimental
conditions within the patient, such as lingering or recurring signs and symptoms.” Id. Moreover,
14
the use of the word “suffered,” the court explained, “suggests something detrimental, especially
something painful.” Id.; see also id. at 1007 (observing that the legislative history showed that
Congress “intends the word ‘suffered’ to require painful or otherwise detrimental effects”).
The court concluded that the blood tests B.W. had undergone, which it characterized as
“relatively non-invasive,” had not been shown to be detrimental to his health. Id. Therefore, the
court of appeals held, they did not qualify as “residual effects” or “complications” of his
thrombocytopenia. Id.
The Chief Special Master’s decision is entirely consistent with the court of appeals’
approach in Wright. As noted above, Petitioners argued that the presence of giant platelets in
A.L.’s blood smear, noted in a comment in the June 29, 2017 blood test report, was—if not
evidence that she still suffered from ITP—at least evidence that she was suffering its residual
effects. Pet’rs’ Mem. at 28–31. According to Petitioners, “[t]he presence of large or Giant
platelets is abnormal,” id. at 17 (quoting Pet’rs’ Ex. 24 at 8), and constitutes the kind of “somatic
change” described in Wright, id. at 25. They contend that the giant platelets were a “direct
product of immune thrombocytopenia,” “have a detrimental effect on A.L.’s ability to clot,” and
“thus [are] likely related to A.L.’s continued bruising.” Id. at 33 (citing Pet’rs’ Ex. 24 at 8).
Petitioners charge that the Chief Special Master ignored these arguments because they
were raised for the first time in their Motion for Reconsideration. See, e.g., id. at 21–22, 35–37.
They note that he several times pointed out that the arguments were not based on new evidence
but rather on evidence that either was or could have been in the record before both Special
Master Dorsey and himself. Id. at 35 (arguing that he “presumably” rejected their claim “because
it is based on ‘evidence that existed at the time of the [Ruling on Facts]’” (quoting Recons. Order
at 4)); see also id. at 35–36.
In the Court’s view, the Chief Special Master would not have abused his discretion had
he in fact decided not to consider Petitioners’ arguments based on the presence of giant platelets.
As the Chief Special Master observed, the information that giant platelets were present on the
2017 blood smear was not “new” evidence for purposes of deciding whether to grant Petitioners’
Motion for Reconsideration. Recons. Order at 5. The underlying report that included the blood
smear results was part of the record before Special Master Dorsey in 2019 when she issued her
Ruling on Facts. Id. And, as the Chief Special Master observed, the opinions Dr. Levin expressed
were not based on changes in the scientific understanding of ITP. Id. at 6. All that was new was
Petitioners’ argument: that the results of the 2017 blood smear are relevant, indeed critical, to the
proof of their claim. And this argument could have been made as early as the time that Special
Master Dorsey issued her Ruling on Facts in July 2019.
In any event, the Chief Special Master did, in fact, address Petitioners’ argument
regarding the presence of giant platelets, including the observations in Dr. Levin’s report and
accompanying medical literature. See id. at 5–6. Dr. Levin was asked “to evaluate and provide
[his] medical opinion regarding the question of whether or not [A.L.] had recovered fully or
continued to experience residual effects of her ITP after the six-month mark after her MMR and
other vaccinations she received on September 6, 2016, which would have been after April 5,
201[7].” Pet’rs’ Ex. 24 at 1–2. Dr. Levin stated that, in his view, A.L. “had not fully recovered
15
after April 5, 201[7], although she had made good progress toward recovery.” Id. at 2.
“Specifically,” he stated, “there is clear medical evidence, based on the testing of her platelets
that [A.L.] still had the effects of her ITP after April 5, 201[7].” Id. That medical evidence,
according to Dr. Levin, consisted of the June 29, 2017 blood smear reflecting the presence of
giant platelets, which Dr. Levin opined “show[ed] that the effects of her ITP were present as of
6/29/17 and she had not fully recovered from her ITP.” Id. at 4.5
Moreover, he stated, the notation in the record that A.L. was “‘bruising more easily than
other children’ reported by [her] mother and documented in the Texas Children’s Hospital record
. . . was likely the clinical manifestation of the residual ITP process.” Id. at 8 (citing Pet’rs’ Ex.
10 at 1). “Large or Giant platelets,” he explained, “are associated with detrimental effects on the
patient because such large platelets do not adhere to the walls of injured blood vessels, and are
not as effective in clotting, which can result in certain kinds of excessive bleeding.” Id. “Thus,”
he concluded, “the presence of large platelets in [A.L.]’s body in June 2017 explains why [she]
continued to experience bruising at that time, even considering that the acute phase of her ITP
had passed, and she was recovering.” Id.
Dr. Levin’s report, of course, was drafted exclusively for purposes of this litigation. In
addition, Dr. Levin wrote the report some three years after Special Master Dorsey had already
found the existing record did not show that A.L. continued to suffer residual effects of her ITP
beyond the six-month threshold, and also after the Chief Special Master issued his decision on
remand. The focus of Dr. Levin’s report was the presence of giant platelets in the blood smear
results, a topic about which none of A.L.’s treating physicians—including Dr. Forbes, who
ordered the tests—thought worthy of even mentioning.
The Chief Special Master reasonably declined to give Dr. Levin’s views much weight,
finding that the medical literature cited in Dr. Levin’s report did not show that an acute episode
of ITP “lingers” in a patient after his or her platelet count increases to the normal range. See
Recons. Order at 6 (noting that Petitioners’ Exhibits “merely discuss the role that B cells or
platelet size play in ITP’s pathogenesis (and what in turn that says about treatment of ITP while
it is occurring) – not that B cells or giant platelets establish ITP’s lingering presence, in the
absence of evidence of platelet count drops” (citing Pet’rs’ Exs. 31, 34, ECF Nos. 98-8, 98-11)).
Equally significant, even if the giant platelets were a residual effect of A.L.’s ITP, there
is no evidence in the record that established that their presence was detrimental to her. Dr. Levin
5
Dr. Levin explained that “[t]he body can compensate for ITP (the autoimmune destruction of
peripheral platelets) for an extended period.” Pet’rs’ Ex. 24 at 8. It “responds to a low or
fluctuating level of platelets by the bone marrow producing platelets to compensate for increased
peripheral destruction of platelets, which occurs in the condition we call ITP,” and “does so by
breaking off fragments of megakaryocytes earlier than normal, resulting in immature and larger
platelets.” Id. “The presence of Giant platelets in [A.L.]’s June 29, 2017, blood sample,” he
opined, “is evidence of such a continuing thrombocytopenic process, the source of which is her
ITP that began in September 2016.” Id. And, he observed, “the finding of elevated immune
function subsets” in the June 2017 blood tests, “including elevated B cells,” also “points to and is
consistent with the ongoing effects of [her] ITP.” Id. at 9.
16
stated that the presence of the giant platelets in A.L.’s body in June 2017 “explains why [she]
continued to experience bruising at that time, even considering that the acute phase of her ITP
had passed.” Pet’rs’ Ex. 24 at 8. But Dr. Levin did not personally observe the bruises mentioned
in Dr. Forbes’ June 2017 report. See Pet’rs’ Ex. 10 at 4. And, as Special Master Dorsey
observed, although Dr. Forbes noted bruises on A.L.’s left cheek and left ear pinna (outer ear)
during her June 29, 2017 exam, she “did not attribute [that] bruising to A.L.’s previous ITP
diagnosis,” even as she noted that A.L.’s mother believed that A.L. was still bruising more easily
than other children. Ruling on Facts at 7.
The Chief Special Master was also not persuaded by Dr. Levin’s observation that the
presence of “elevated B cells[] points to and is consistent with the ongoing effects of [A.L.]’s
ITP.” Pet’rs’ Mem. at 28 (emphasis in original) (quoting Pet’rs’ Ex. 24 at 9); see also id. at 14
(observing that A.L.’s June 29, 2017 blood tests showed “immune dysregulation,” based on
“elevated B cell subset levels” (citing Pet’rs’ Ex. 10 at 4–6, 7)). Dr. Forbes ordered the June
2017 blood tests and, after reviewing the results, concluded that they were “reassuring for normal
B cell differentiation.” Pet’rs’ Ex. 10 at 9. For that reason, she cancelled any further testing and
follow-up appointments with A.L. See Pet’rs’ Ex. 12 at 2 (“Per Dr. Forbes, all of [A.L.’s] [June
29, 2017] labs were good so we can cancel her appointment for September.”).
The Chief Special Master, in short, concluded neither the presence of giant platelets
described in the June 2017 blood test report, nor the reported elevated B cell levels constituted
“residual effects” of ITP within the meaning of 42 U.S.C. § 300aa-11(c)(1)(D)(i), as interpreted
in Wright. His conclusion was based on a review of the record as a whole and on his
determination that the opinions expressed in Dr. Levin’s report were entitled to little weight.
Because it is his responsibility to weigh the evidence and assess its reliability, and because his
conclusions are supported by the record, the Court will not disturb the Chief Special Master’s
findings that neither the presence of giant platelets nor A.L.’s temporarily elevated B cell count
constituted residual effects of A.L.’s ITP.
Alleged Restrictions on Further Vaccinations Until A.L. Turned Six
Petitioners’ second challenge to the Chief Special Master’s decision is based on his
rejection of their contention that another residual effect of A.L.’s ITP was that A.L. was
restricted from receiving any childhood immunizations until her sixth birthday. Pet’rs’ Mem. at
37–38. The Chief Special Master rejected this argument because, among other reasons, the
medical records in the case were inconsistent with Ms. Leming’s assertion in her affidavits that
Dr. Forbes told her that A.L.’s vaccinations should be delayed until after her sixth birthday. See
Recons. Order at 5 n.5. Petitioners contend that the Chief Special Master’s factual finding “is
erroneous and contrary to the totality of the record.” Pet’rs’ Mem. at 39 n.18. The Court
disagrees.
Petitioners’ proof that Dr. Forbes told them not to vaccinate A.L. is based entirely on Ms.
Leming’s several affidavits. See Pet’rs’ Mem. at 38, 38–39 n.18. In the first, which is dated
October 19, 2017, Ms. Leming states that, during a telephone call in June 2017, Dr. Forbes
“order[ed] [A.L.] to avoid vaccinations until the age of 6.” Pet’rs’ Ex. 15, ¶ 11, ECF No. 31-1.
Further, she asserted, Dr. Forbes also told her that, “before [A.L.] resumed receiving vaccines,
17
she would need to return for another round of testing and possibly follow a delayed schedule of
vaccination while being closely watched.” Id.
Similarly, in her subsequent affidavit, dated February 14, 2018, Ms. Leming stated that
Dr. Forbes informed her during this same June 2017 phone call that A.L. “will need further
testing down the road if she is to receive her booster vaccines,” that she “should not receive any
vaccines until she is at least 6 years of age,” and that she should only receive “one vaccine at a
time.” Pet’rs’ Ex. 11, ¶ 23, ECF No. 6-1. Ms. Leming states that she was “also advised that
during the next 4 years [A.L.] has a higher chance than other children of having ITP.” Id.
Finally, Ms. Leming referenced her June 2017 telephone call with Dr. Forbes in an
affidavit dated August 30, 2021, in which she again stated that Dr. Forbes “order[ed] [A.L.] to
avoid vaccinations until at least the age of six because of the risk, due to her ITP, of an adverse
effect from vaccination,” and that she had “said that before [A.L.] resumed receiving vaccines,
[A.L.] would need to return for another round of testing.” Pet’rs’ Ex. 23, ¶ 7. Dr. Forbes, she
said, “recommended that we defer vaccination and watch [A.L.] closely for any symptoms of
ITP or immune dysfunction.” Id.
Ms. Leming’s description of the advice she received in June 2017 is not supported by the
medical record. As the Chief Special Master observed, the comprehensive medical records that
document A.L.’s treatment for ITP, including the follow-up exams conducted after December
2016, do not reflect that Dr. Forbes or any other provider advised Ms. Leming to delay
vaccinating A.L. again until she was six years old (or for any period of time). In fact, the records
contain no mention of any restriction on vaccinations, which one might expect to find given that
Ms. Leming had on several occasions raised concerns about the risks of A.L. having an adverse
reaction to vaccines. See Pet’rs’ Ex. 9 at 51, 78, 100; Pet’rs’ Ex. 10 at 2. To the contrary, as
discussed above, the contemporaneous treatment records reflect that Dr. Forbes cancelled any
follow-up appointments after reviewing the results of A.L.’s June 2017 blood tests, without any
indication that there was need for any further testing. Pet’rs’ Ex. 12 at 2.
Petitioners argue that the records of A.L.’s November 2021 visit with Dr. Forbes support
their contention that Dr. Forbes had advised that A.L. not receive vaccines due to the risk of
another episode of ITP. Pet’rs’ Mem. at 39 (citing Pet’rs’ Ex. 38 at 29). The notes of that visit
state that Ms. Leming had been seen that day “to revisit vaccination and decide how to move
forward” and “to discuss [A.L.’s] reaction risks for vaccine reaction.” Pet’rs’ Ex. 38 at 26, 29.
They further reflect that Dr. Forbes recommended that A.L. begin a catch-up vaccination
schedule which would start with the COVID-19 vaccine, to be followed by “inactivated vaccines
including the flu shot,” with the “live vaccine[s]” to be “address[ed]” “separately,” by starting
with the Varicella vaccine and, three months later, the MMR vaccine. Id. at 29. The notes of the
visit also record that Dr. Forbes and Ms. Leming “discussed signs of ITP and that should [A.L.]
develop symptoms post vaccination she should be seen and a [complete blood count] obtained.”
Id.
Petitioners contend that it is significant that, during this visit, “Dr. Forbes recommended a
delayed catch-up schedule with the live vaccines delayed even further.” Pet’rs’ Mem. at 39.
According to Petitioners, this “shows that Dr. Forbes was in accord with the restriction on
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vaccination, with focus on the MMR vaccine that caused A.L.’s ITP.” Id. (citing Pet’rs’ Ex. 38 at
29).
The inference Petitioners would have had the Chief Special Master indulge is not an
especially compelling one. Dr. Forbes’ recommendation that A.L. begin a “catch-up schedule”
was an instruction that A.L. catch up on the vaccinations she had not received on schedule. See,
e.g., Catch-up Immunization Schedule for Children and Adolescents Who Start Late or Who Are
More than 1 Month Behind, Centers for Disease Control and Prevention (Feb. 17, 2022),
https://www.cdc.gov/vaccines/schedules/hcp/imz/catchup.html#table-catchup. The fact that the
recommendation was made does not suggest anything about why A.L. stopped getting her
vaccinations. It is entirely possible, given her mother’s concern about the risks of vaccination,
that A.L.’s parents made the decision to avoid them on their own.
It was not unreasonable for the Chief Special Master to give weight to the fact that the
medical record did not reflect the advice Dr. Forbes supposedly gave Ms. Leming not to have
A.L. vaccinated until she turned six. And doing so does not reflect any lack of sincerity or bad
faith on Ms. Leming’s part in reporting what she understood Dr. Forbes’ advice to be. Medical
records are afforded weight because they “contain information supplied to or by health
professionals to facilitate diagnosis and treatment of medical conditions,” and are “generally
contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d
1525, 1528 (Fed. Cir. 1993). With respect to the advice given by a physician, it is fair to assume
that medical records will generally be more reliable than the recollection of lay persons.
It was therefore not unreasonable for the Chief Special Master to conclude that, had Dr.
Forbes advised Petitioners that A.L. not receive any of her childhood immunizations for a period
of several years, she would have documented that advice in A.L.’s medical records. The Court
therefore declines to disturb his finding that A.L. was not restricted from receiving her childhood
vaccinations as a residual effect of her ITP.6
CONCLUSION
On the basis of the foregoing, Petitioners’ Motion for Review and Memorandum of
Numbered Objections to the Decision on Remand, ECF Nos. 102 and 104, are DENIED, and the
Decision of the Chief Special Master on Remand dismissing Petitioners’ claim, as well as his
Reconsideration Order, ECF Nos. 96 and 101, are SUSTAINED. The Clerk is directed to enter
judgment accordingly.
IT IS SO ORDERED.
6
The Chief Special Master also held that any alleged restriction on vaccination would not in any
event be a residual effect of A.L.’s ITP because “the mere risk of a future associated problem
that could be triggered a second time by vaccination cannot satisfy severity.” Remand Decision
at 11. Given the Court’s conclusion upholding the Chief Special Master’s factual finding that Dr.
Forbes never directed that A.L. pause her vaccinations, it is unnecessary to decide whether, had
she done so, the vaccine restriction would constitute a residual effect of A.L.’s ITP.
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s/ Elaine D. Kaplan
ELAINE D. KAPLAN
Chief Judge
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