Leming v. Secretary of Health and Human Services

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

18

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.

19

s/ Elaine D. Kaplan

ELAINE D. KAPLAN

Chief Judge

20