VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00503
Package ID: USCOURTS-cofc-1_20-vv-00503
Petitioner: M.R.
Filed: 2020-07-29
Decided: 2025-08-25
Vaccine: MMR
Vaccination date: 2017-11-07
Condition: immune thrombocytopenic purpura (ITP)
Outcome: entitlement_granted_pending_damages
Award amount USD: 

AI-assisted case summary:
On April 27, 2020, Mayra Del Bosque, as the parent and natural guardian of M.R., a minor, filed a petition under the National Childhood Vaccine Injury Act. The petition alleged that M.R. suffered immune thrombocytopenic purpura (ITP) caused-in-fact by vaccinations received on November 7, 2017, including the measles, mumps, and rubella (MMR) vaccine. Petitioner counsel was David John Carney of Green & Schafle LLC, and respondent counsel was Benjamin Patrick Warder of the U.S. Department of Justice. Special Master Daniel T. Horner presided over the case. The parties did not dispute that M.R. suffered ITP, but they disagreed on the timing of symptom onset. In a prior ruling on October 12, 2023, the Special Master found that abnormal bruising was the first symptom of M.R.'s ITP, with onset occurring no earlier than 31 days and within 42 days post-vaccination. This timing meant the case did not qualify for the Vaccine Injury Table's presumption for ITP, which requires onset between 7-30 days post-vaccination for the MMR vaccine. Consequently, the case proceeded under the "causation-in-fact" standard, requiring petitioner to prove a medical theory connecting the vaccine and injury, a logical sequence of cause and effect, and a proximate temporal relationship (the Althen analysis). Respondent conceded that the MMR vaccine can cause ITP and that the elevated risk persists for up to 42 days, satisfying the first and third Althen prongs. The dispute centered on the second prong: whether there was a logical sequence of cause and effect implicating the MMR vaccine. Respondent argued that M.R.'s ITP was atypical for vaccine-caused ITP, citing an insidious and gradual decrease in platelet levels, chronicity, and the presence of pharyngitis diagnosed on December 8, 2017, as a more likely cause. Respondent's expert, Dr. Strouse, suggested that vaccine-caused ITP typically involves a sudden decrease in platelets and is usually self-limiting, resolving within weeks to months. Dr. Strouse also pointed to the pharyngitis as a potential cause, noting that short-term decreases in neutrophils and platelets can be seen with viral suppression. Petitioner argued that M.R.'s clinical course supported a logical sequence of cause and effect, supported by her expert, Dr. Ghose, who opined that the MMR vaccine caused M.R.'s ITP and that no other triggering event was documented. Petitioner contended that respondent's arguments regarding gradual onset and chronicity were not persuasive, noting that respondent acknowledged that 10% of ITP patients have chronic disease and that the six-month severity requirement for compensation does not preclude chronic cases. Petitioner also argued that the pharyngitis diagnosis was vaguely described and not attributed to M.R.'s ITP by treating physicians. The Special Master found that respondent's arguments regarding the onset and chronicity of M.R.'s ITP were not persuasive. The Special Master noted that the medical records did not clearly indicate the speed of M.R.'s platelet drop and that the Rajantie study cited by respondent had limitations. The Special Master also found that the chronicity of M.R.'s ITP did not distinguish it from vaccine-related ITP, citing respondent's own expert's acknowledgment of chronic ITP after MMR vaccination in some cases. Regarding the pharyngitis, the Special Master found that it was not sufficiently established as a sole cause, noting that "pharyngitis" simply indicates a sore throat and that respondent's expert relied on a syllogism that viral infections often cause ITP. The Special Master concluded that petitioner proved by a preponderance of the evidence that M.R.'s ITP was caused-in-fact by the MMR vaccination. A separate order for damages will be issued.

Theory of causation field:
Petitioner M.R., a minor, received an MMR vaccine on November 7, 2017. The petition alleged Immune Thrombocytopenic Purpura (ITP) caused-in-fact by the vaccine. The Special Master previously found ITP onset between 31-42 days post-vaccination, precluding a Table presumption. The case turned on the "causation-in-fact" standard (Althen analysis). Respondent conceded Althen prongs one (medical theory) and three (proximate temporal relationship) based on expert Dr. Strouse's acknowledgment that MMR can cause ITP and elevated risk persists up to 42 days. The dispute focused on Althen prong two (logical sequence of cause and effect). Respondent argued M.R.'s ITP was atypical due to insidious/gradual onset, chronicity, and a concurrent pharyngitis diagnosis on December 8, 2017, suggesting viral infection as a more likely cause. Petitioner countered with expert Dr. Ghose, who opined the MMR vaccine caused M.R.'s ITP and no other trigger was documented. The Special Master found respondent's arguments regarding gradual onset and chronicity unpersuasive, noting fluctuations in platelet counts and that chronicity does not preclude vaccine causation. The Special Master found the pharyngitis diagnosis insufficient to establish it as the sole cause, rejecting statistical likelihood alone and noting no treating physician linked it to the ITP. The Special Master concluded petitioner proved by a preponderance of the evidence that the MMR vaccine caused M.R.'s ITP. Entitlement was granted pending damages. Attorneys: David John Carney (Petitioner), Benjamin Patrick Warder (Respondent). Special Master: Daniel T. Horner. Decision Date: August 25, 2025.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_20-vv-00503-0
Date issued/filed: 2023-11-06
Pages: 16
Docket text: PUBLIC ORDER/RULING (Originally filed: 10/12/2023) regarding 47 Findings of Fact & Conclusions of Law. Signed by Special Master Daniel T. Horner. (sh) Service on parties made.
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Case 1:20-vv-00503-UNJ Document 48 Filed 11/06/23 Page 1 of 16
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 20-503V
Filed: October 12, 2023
MAYRA DEL BOSQUE, as parent and
Special Master Horner
natural guardian of M.R., a minor,
Petitioner,
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
David John Carney, Green & Schafle, LLC, Philadelphia, PA, for petitioner.
Benjamin Patrick Warder, U.S. Department of Justice, Washington, DC, for respondent.
Findings of Fact and Conclusions of Law1
On April 27, 2020, the above captioned petitioner, Mayra Del Bosque, filed a
petition on behalf of her minor child, M.R., under the National Childhood Vaccine Injury
Act, 42 U.S.C. § 300aa, et seq. (2012),2 alleging that M.R.’s receipt of pneumococcal
conjugate (“PCV”); Haemophilus influenzae type b (“Hib”); hepatitis A (“hep A”);
measles, mumps, and rubella (“MMR”); and varicella vaccinations on November 7,
2017, caused M.R. to suffer immune thrombocytopenic purpura (“ITP”). (ECF No. 1,
p.1.) For the reasons discussed below, I now find that there is preponderant evidence
that onset of M.R.’s ITP occurred within 42 days of vaccination, but there is not
preponderant evidence that onset occurred within 30 days of vaccination.
1 Because this document contains a reasoned explanation for the action taken in this case, it must be
made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or
at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic
Government Services). This means the document will be available to anyone with access to the
internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.
If, upon review, I agree that the identified material fits within this definition, I will redact such material from
public access.
2 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.
§ 300aa-10-34.
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Case 1:20-vv-00503-UNJ Document 48 Filed 11/06/23 Page 2 of 16
I. Procedural History
Petitioner initially submitted medical records, marked Exhibits P1, P3, and P4.
(ECF No. 6.) In addition, petitioner submitted an affidavit, marked Exhibit P2. (ECF No.
6.) Petitioner later filed additional medical records, marked Exhibits P5 through P8.
(ECF Nos. 10, 13, 18, 22.) On April 13, 2021, respondent filed his Rule 4(c) Report and
concluded that the case is not appropriate for compensation, raising issues relative to
the timing of onset as well as evidence of an antecedent infection. (ECF No. 25.)
Thereafter, petitioner filed an expert report by Abhimanyu Ghose, M.D., a hematologist
and oncologist, marked Exhibit P9, with accompanying medical literature, marked
Exhibit P11 through P11. (ECF Nos. 28-29.) Dr. Ghose opined that M.R. developed
ITP as a result of the vaccinations he received on November 7, 2017. (Ex. P9, pp. 8-9.)
Respondent filed a report by John Strouse, M.D., Ph.D., a pediatric hematologist and
oncologist, marked Exhibit A, with accompanying medical literature, marked Exhibits A-
1 through A-12. (ECF No. 32.) Dr. Strouse opined that M.R.’s vaccination was not the
cause of his ITP. (Ex. A, p. 4.)
A Rule 5 status conference was held on January 4, 2022. (ECF No. 33.) During
this conference, I noted that a Table claim of ITP following MMR vaccination requires an
onset within 30 days post-vaccination; however, respondent’s expert, Dr. Strouse,
indicated that an onset period of up to 42 days post-vaccination could be medically
appropriate to infer causation. (Id. at 1.) My preliminary view was that “petitioner’s
testimony, the medical records, and expert opinions, can very likely be harmonized to
place onset of M.R.’s ITP within 42 days of his MMR vaccination, timing that is
consistent with a causal inference.” (Id. at 2.) That is, petitioner could potentially meet
her prima facie burden under Althen and thereby shift the burden of proof to respondent
with respect to demonstrating any factor unrelated to vaccination as the cause of M.R.’s
ITP. (Id.)
On February 28, 2022, petitioner filed a supplemental report by Dr. Ghose,
marked Exhibit P13. (ECF No. 34.) Petitioner then filed additional medical records
marked Exhibits P14 through P15. (ECF Nos. 35.) On May 26, 2022, respondent filed
a supplemental report by Dr. Strouse, marked Exhibit C, with accompanying medical
literature marked Exhibit C-2. (ECF No. 38.) Thereafter, petitioner filed further medical
records marked Exhibits P16 through P18. (ECF No. 39.) The parties then proposed
proceeding with a mutually agreeable briefing schedule for written submissions, but
ultimately disagreed on the scope of the issue presented. (ECF Nos. 40, 41.)
On July 1, 2022, petitioner filed a Motion for a Ruling on the Record. (ECF No.
42.) In her motion, petitioner requested a finding as to her entitlement to compensation,
but also requested an opportunity to seek a hearing should the parties’ briefs raise any
issue that would warrant a hearing. (Id. at 4.) Respondent filed a response to this
motion on September 13, 2022. (ECF No. 45.) In his response, respondent requested
that my ruling be limited to onset only and not reach the question of entitlement.
Respondent sought to reserve the right to provide additional briefing on entitlement at a
later date. (Id. at 3.) Petitioner replied to this response on September 27, 2022, in
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Case 1:20-vv-00503-UNJ Document 48 Filed 11/06/23 Page 3 of 16
which she urged that I disregard respondent’s objection and rule as to all issues. (ECF
No. 46.)
II. Scope of this Fact Finding and Party Contentions
In light of the above, I have concluded that the parties have had a full and fair
opportunity to develop the record with respect to onset only. See Vaccine Rule 8(d);
Vaccine Rule 3(b)(2); see also Kreizenbeck v. Sec’y of Health & Human Servs., 945
F.3d 1362, 1366 (Fed. Cir. 2020) (explaining that the Vaccine Act requires special
masters to determine whether hearings or witness testimony are reasonable and
necessary before ruling on the record). Petitioner’s arguments regarding the sufficiency
of the record for a ruling as to entitlement are significantly undercut by her own stated
interest in maintaining the right to request an entitlement hearing. (ECF No. 42, p. 4).
Moreover, petitioner heavily emphasizes my prior Rule 5 Order, but as respondent
urges, that was a preliminary discussion only and I noted that the timing of onset was
significant to Dr. Strouse’s opinion in particular. (Id.; ECF Nos. 33, p. 1; 45, p. 3; 46.)
Because the parties’ experts reasonably came to differing assessments of onset based
on the limitations of the evidence, I will provide the parties an opportunity to have their
experts present supplemental reports setting forth their opinions based on the facts as I
have now found them.3 Thereafter, I anticipate resolving entitlement expeditiously and
likely based on the written record.
Regarding onset, petitioner argues that onset of ITP was evidenced by M.R.’s
history of easy bruising which she contends began two weeks post-vaccination. (ECF
No. 42, pp. 35.) She further contends that, even accounting for respondent’s expert’s
assessment of when the bruising began, onset of ITP was still within 42 days of M.R.’s
vaccinations. (Id. at 37-38.) Respondent disputes that M.R.’s ITP was the cause of his
bruising. (ECF No. 45, p. 24.) Accordingly, respondent asserts there is no evidence
M.R. suffered ITP prior to the date of his first blood test on January 2, 2018, which was
56 days post-vaccination. (Id. at 23-26.) Additionally, respondent contends petitioner’s
description of M.R.’s bruising within her affidavit is uncorroborated and contradicted by
the medical records. (Id. at 18, 22, 24-25.)
3 See Burns ex rel. Burnes v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding
that “[t]he special master concluded that the expert based his opinion on facts not substantiated by the
record,” and “[a]s a result, the special master properly rejected the testimony of petitioner's medical
expert”); see also Rickett v. Sec’y of Health & Human Servs., 468 Fed. App’x 952, 958 (Fed. Cir. 2011)
(holding that “it was not error for the Special Master to assign less weight to Dr. Bellanti’s conclusion
regarding challenge-rechallenge to the extent it hinged upon Mr. Rickett’s testimony that was inconsistent
with the medical records”); Dobrydnev v. Sec’y of Health & Human Servs., 566 Fed. App’x 976, 982-83
(Fed. Cir. 2014) (holding that the special master was correct in noting that “[w]hen an expert assumes
facts that are not supported by a preponderance of the evidence, a finder of fact may properly reject the
expert’s opinion” (alteration in original) (quoting Dobrydnev v. Sec’y of Health & Human Servs., No. 04-
1593V, 2010 WL 8106881, at *9 n.12 (Fed. Cl. Spec. Mstr. Oct. 27, 2010), aff’d, 556 Fed. App’x 976
(Fed. Cir. 2014))).
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Case 1:20-vv-00503-UNJ Document 48 Filed 11/06/23 Page 4 of 16
III. Factual History
a. As reflected in medical records
M.R. was born on October 31, 2016. (Ex. P5, p. 125.) M.R.’s mother had a
typical pregnancy and gave birth to twins by a Cesarean section. (Id.; Ex. P7, p. 79.)
M.R.’s newborn screening was normal. (Ex. P6, pp. 521-804.) On the day he was
born, M.R. received the newborn hepatitis B vaccine with no adverse reaction. (Id. at
537, 741.)
M.R. was a relatively healthy newborn. He was seen for a cough on November
22, 2016, and January 3, 2017. (Ex. P1, pp. 9, 10.) M.R. experienced some formula
intolerance along with other gastrointestinal problems and was eventually diagnosed
with gastroesophageal reflux disease (“GERD”). (Id. at 13.) At his six-month wellness
check on May 30, 2017, M.R. received his hepatitis B; diphtheria, tetanus, acellular
pertussis (“DTaP”); Hib; polio (“IPV”); PCV; and rotavirus vaccinations. (Id. at 19.) At
his nine-month wellness check on August 14, 2017, M.R. received his influenza (“flu”),
rotavirus, PCV, and IPV vaccinations. (Id. at 24.)
On September 8, 2017, M.R. was diagnosed with bronchiolitis. (Id. at 25.) On
October 2, 2017, M.R. was diagnosed with an upper respiratory infection. (Id. at 29.) At
his 12-month wellness check on November 7, 2017, M.R. received the set of
vaccinations at issue in this case, which included the Hib, PCV, varicella, hep A, and
MMR vaccines. (Id. at 26.)
Later that same month, on November 22, 2017, M.R. was brought to his
pediatrician with complaints of cough, fever, and a swollen groin area, although he had
no fever at the time he was seen. (Id. at 30.) He was again diagnosed with an upper
respiratory infection. (Id.) Although petitioner’s affidavit suggests M.R. had bruising at
that time, this was not reported in the medical record. (Compare Ex. P2, p. 3, with Ex.
P1, p. 30.)
M.R. returned to his pediatrician with a chief complaint of fever on December 8,
2017, but with a normal temperature upon presentation. He had redness in his throat
and was diagnosed with pharyngitis. (Ex. P1, p. 31.) A three-day course of Zithromax
was prescribed. (Id.) Again, although petitioner’s affidavit indicates M.R. was
experiencing bruising at this point in time, bruising is not documented in the December
8, 2017 medical record. (Compare Ex. P2, p. 3, with Ex. P1, p. 30.)
On January 3, 2018, M.R. was seen by his pediatrician with a history of present
illness concerning “bruising mainly on legs.” (Ex. P1, p. 32.) In advance of the
appointment, blood was drawn on January 2, 2018. M.R.’s platelet count was 51,000,
significantly below the reference range of 200,000-550,000/mcL. (Ex. P6, p. 472.) In
seeking the bloodwork, M.R.’s pediatrician suspected anemia (Id. at 457); however,
after the testing and examination M.R. was diagnosed with leukopenia and
“thrombocytopenia, unspecified” (Ex. P1, p. 32.). Repeat bloodwork was ordered and
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M.R. was referred to hematology. (Id.) On January 4, 2018, M.R.’s repeat platelet
count was higher, but again lower than the reference range, at 97,000. (Ex. P6, p. 450.)
On January 14, 2018, M.R.’s mother noticed M.R. was bleeding from the mouth.
(Ex. P6, pp. 367, 370, 380-81.) She took him to the hospital where he was first triaged
at around 11:00pm and was observed to have torn upper lip and small hematoma, but
no active bleeding. (Id.) He also had mild petechiae of his forehead, upper torso, and
neck.4 His platelet count was 4,000. (Id.) M.R. was transferred to the children’s
hospital on January 15, 2018. (Ex. P3, p. 6.) Petitioner reported that M.R. had been
undergoing evaluation since early January for easily bruising, but the history is not
explicit regarding when the bruising began. (Id. at 10.) Specifically, a history provided
by petitioner recorded that
In early January, patient was evaluated by his pediatrician due to a concern
for bruising, per mother. Mother was confused because the patient seemed
to bruise easily, however his twin sister had never experienced similar
bruising. His pediatrician did a workup on 1/2, revealing a low white blood
cell count, low platelets of 51k, high monocytic ratio, with a PT/PTT/INR that
was normal. He underwent follow-up blood work on 1/4 and was noted to
have an increased RBC count, a normal WBC count, and platelet that had
increased from 51k to 97k. . . . The patient was scheduled to undergo follow-
up lab work 3 weeks later, however P [sic] patient experienced this incident
with bleeding of the mouth last night was brought to the Laredo ER and
subsequently transferred to us for further management.
(Id.)
A separate history recorded the same morning further indicated that “[m]om
states that on 1/1/18 she noticed red ‘pinpoint perfect circles’ over his skin, and could
feel a [sic] little balls and lumps under some of them. . . . Mom states rash on skin and
bruises that were noted at beginning of the month had resolved until last night.” (Id. at
24.) This history further indicated that “[m]om states patient has not cried or shown that
he was hurting prior to seeing his mouth bleeding. No increased irritability or fussiness.
No prior abnormal bleeding or bruising.” (Id.)
M.R. was assessed as having “a past medical history and current presentation
consistent with immune thrombocytopenia of childhood.” (Id. at 22.) Based on the
presentation and increase in platelet counts on January 4, 2018, the treaters suggested
that M.R.’s ITP initially self-resolved before recurring more severely. (Id. at 22, 26.)
This was noted to be “slightly atypical.” (Id. at 26.) The differential diagnoses included
malignancy, bone marrow failure, acute viral infection, and autoimmune condition(s);
however, these were all considered less likely given M.R.’s normal white and red blood
4 Bruising was not documented as part of M.R.’s initial January 14, 2018 presentation at Doctor’s Hospital
of Laredo (Ex. P6, p. 370); however, it was documented the next day by Children’s Hospital of San
Antonio (Ex. P3, p. 12). He had scattered bruising over his upper extremities, trunk, and lower
extremities. (Id.)
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cell counts, lack of a clear viral prodrome, and lack of systemic symptoms. (Id. at 26-
27.) It was noted, however, that “[s]ometimes in the setting of recent viral infections or
other immune system triggers, ITP can be provoked” with about 15-20% of patients
going on to have the chronic form of ITP. (Id. at 32.) M.R. was given 1 g/kg of IVIG
treatment and his platelet count rose to 37,000. (Id. at 6.) He was eventually released
on January 16, 2018. (Id. at 3.) While he was in the hospital, M.R. was given a flu shot.
(Id. at 159.)
One week later, on January 26, 2018, M.R. had a follow up appointment with a
hematology/oncology team. (Id. at 180.) It was noted that his platelets had again
dropped below 10,000. (Id.) He was prescribed both 15 mg/5 mL prednisone and 15
mg/mL ranitidine. (Id. at 183.) On January 30, 2018, M.R. followed up with his
pediatrician who requested bloodwork and recommended a follow up with the
hematologist/oncologist in a week. (Ex. P1, p. 35.) M.R.’s platelet count was 154,000
on February 1, 2018. (Ex. P6, p. 359.) On February 8, 2018, M.R.’s dose of
prednisone was decreased to 5 mL per day. (Ex. P3, p. 196.) His platelet count at this
appointment was 64,000. (Id. at 195, 206.)
M.R. saw his pediatrician for his 15-month wellness check on February 13, 2018.
(Ex. P1, p. 36.) He received his flu, DTaP, hep A, Hib, MMR, varicella, and PCV
vaccinations. (Id. at 37.) On February 15, 2018, M.R. had a follow up with his
hematologist. (Ex. P3, p. 202.) M.R.’s prednisone prescription was further tapered from
5mL per day to 3mL per day given that his platelet count had increased to 72,000
despite the prior reduction of his prednisone prescription to 5mL per day. (Id. at 200.)
M.R. was seen again on February 22, 2018, and his platelets had increased to 337,000.
(Id. at 202-05.) His prednisone was further tapered to 1mL per day. (Id. at 204.)
M.R. was seen again by his hematologist on March 8, 2023. (Id. at 211.) The
hematologist recommended continuing M.R. on 1 mL of prednisone a day. (Id. at 212.)
The plan was to wean off if M.R. could maintain a platelet count of greater than 30,000.
(Id.) However, M.R.’s blood was drawn again on March 14, 2018, and platelet count
had dropped to 12,000. (Ex. P6, p. 342.) M.R. was admitted to the hospital on March
16, 2018, and was given 1 gm/kg of IVIG treatment. (Ex. P3, p. 218.) M.R.’s blood was
drawn again on March 21, 2018. (Ex. P6, p. 324.) After the IVIG treatment, M.R.’s
platelet count was up to 50,000. (Id.)
On March 22, 2018, M.R. was seen by his pediatrician for a cough and
congestion and to follow up on his labs. (Ex. P1, p. 39.) M.R. was diagnosed with
sinusitis and rhinitis. (Id.) The next week, on March 29, 2018, M.R. was seen by Nurse
Practitioner Jennifer Hemmeger. (Ex. P3, p. 323.) She noted that M.R. had completed
his prednisone wean on March 26, 2018. (Id. at 324.) At this appointment, M.R. was
showing symptoms, such as easy bruising and petechiae. (Id.) His platelet count was
below 10,000. (Id.) M.R. was prescribed Win-Rho. (Id.)
On April 5, 2018, M.R. went to see his pediatrician for a follow up on his sinusitis
and rhinitis. (Ex. P1, p. 40.) M.R.’s platelet count was 11,000. (Id.) On April 6, 2018,
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M.R. was seen by hematology. (Ex. P3, p. 350.) M.R.’s ITP flare was not responding to
Win-Rho and was thought to be a good candidate for Promacta. (Id. at 351.) On April
12, 2018, M.R.’s platelet count was still extremely low at 12,000. (Ex. P6, p. 291.)
M.R.’s platelet count was slightly higher, but still low, at 46,000, on April 19, 2018. (Id.
at 274.) M.R.’s platelet count dropped even lower, to 9,000, on April 30, 2018. (Id. at
257.)
Thereafter, Promatcta continued to be M.R.’s long term treatment plan. His
platelet levels continued to fluctuate and he had additional periods where bruising was
again reported as an issue. Although I have reviewed all of M.R.’s medical records, the
further course of M.R.’s ITP is not illuminating as to the onset issue discussed herein.
As of March 3, 2022, M.R.’s platelet count was 150,000 and he was doing well on 12.5
mg of Promacta per day. (Ex. P18, pp. 6, 14.)
b. As reflected in petitioner’s affidavit
On May 8, 2020, petitioner submitted an affidavit, as the natural parent and legal
guardian of M.R. (Ex. P2, ¶ 1.) Petitioner notes that M.R. was “healthy, active, and had
no history of any conditions, diseases or disorders affecting his platelet counts or
resulting in any bruising.” (Id. ¶ 4.) Petitioner states that M.R. received PCV, Hib, hep
A, MMR, and varicella vaccinations on November 7, 2017. (Id. ¶¶ 5 (citing Ex. P1, p.
27), 11.) According to the affidavit, approximately two weeks later, M.R. “started to
develop bruising on his lower extremities, particularly on his calves.” (Id. ¶ 12.) M.R.
subsequently developed a cough and some congestion and petitioner took him to the
doctor on November 22, 2017. (Id.) At this appointment, M.R.’s bruises were not
discussed because petitioner believed these bruises were the result of M.R. falling
when trying to walk. (Id.) (Petitioner’s affidavit did not specifically address the
December 8, 2017 encounter.)
In the middle of December 2017, petitioner noticed that M.R.’s bruising started to
progress to his legs, armpits, arms, back of knees, and along his spine. (Id. ¶ 13.)
Petitioner described the bruises as “very dark in color” and noted that some bruises had
lumps associated with them. (Id.) Petitioner observed, “I could not figure out why my
son was getting bruises in random spots of his body.” (Id.) She explained that she
“decided to keep a closer eye on any additional bruising in his body,” further indicating
that “[b]oth he and his sister were in the same walking and stumbling stage, both would
be clumsy and fall quite often, and both would hit edges of furniture frequently.
However, only my son, [M.R.], was getting more bruises than his twin sister.” (Id.)
On January 3, 2018, petitioner took M.R. to be evaluated by his pediatrician. (Id.
¶ 14.) Subsequently, petitioner noticed excessive bleeding from M.R.’s mouth. (Id. ¶
15.) Petitioner took M.R. to the emergency room on January 15, 2018. (Id. ¶ 16.) (The
medical records reflect it was actually late on the 14th.) Blood results at the hospital
confirmed that M.R. had a low platelet count and needed to be evaluated by a pediatric
hematologist. (Id.) M.R. was transferred to a Children’s Hospital via ambulance and
was started on IVIG treatment. (Id.)
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Over the next year, M.R. was readmitted to the hospital for a low platelet count.
(Id. ¶ 18.) M.R. did not respond well to the treatments and would often pull his hair,
bang his head, and hit or bite petitioner. (Id.) During this time, M.R. was treated with
IVIG, WinRho, steroids, and platelet transfusions. (Id. ¶ 19.) In the summer of 2019,
petitioner went to another physician who recommended chemotherapy if medication
stopped working. (Id.)
Currently, M.R. continues to treat with Promacta, but he still bruises. (Id. ¶ 21.)
He gets sick “frequently due to his compromised immune system and his fluctuating
platelet count.” (Id.)
IV. Expert Opinions
a. Petitioner’s Hematology/Oncology Expert, Dr. Ghose 5
Dr. Ghose provided two reports for this case. (Exs. P9, P13.) In his first report,
Dr. Ghose began by summarizing M.R.’s medical history. (Ex. P9, p. 3-4.) He agrees
with M.R.’s diagnosis of chronic ITP. (Id. at 7.)
In his first report, Dr. Ghose assumed that M.R. first experienced onset of
bruising about two weeks post-vaccination as indicated in petitioner’s affidavit. (Id. at 3,
7.) He opines that this is well within the timeframe for developing ITP post-vaccination.
(Id. at 7.) He states that, generally, in cases of Secondary ITP due to vaccination, kids
develop symptoms of ITP an average of 18 days following vaccination. (Id. (citing K.
Ikegame et al., Letter to the Editor, Idiopathic Thrombocytopenic Purpura After Influenza
Vaccination in a Bone Marrow Transplantation Recipient, 38 BONE MARROW
TRANSPLANTATION 323 (2006) (Ex. P11(y)); Satoshi Mamori et al., Letter to the Editor,
Thrombocytopenic Purpura After the Administration of an Influenza Vaccine in a Patient
with Autoimmune Liver Disease, 77 DIGESTION 159 (2008) (Ex. P11(z))).) However, he
also explained that cases of ITP following the MMR vaccine can develop within six
weeks of vaccination. (Id. at 8.)6 He opines that the early bruising that M.R. developed
5 Abhimanyu Ghose, M.D., FACP, is a board certified hematologist and oncologist. (Ex. P10, p. 1.) He
attended medical school at the University of Cincinnati, completed his residency in internal medicine at
the University of Toledo Medical Center, and completed a fellowship in hematology and oncology at the
University of Cincinnati. (Id.) He is currently employed at the Arizona Center for Cancer Care/Honor
Health, and he both sees patients and participates in clinical research. (Id.) He has published 21 peer-
reviewed articles. (Ex. P13, p.1; Ex. P10, p. 3-5.)
6 In support of this conclusion, Dr. Ghose cites exhibits that he has labeled “32 and 33,” however, this
appears to be an error. His expert report only lists 28 exhibits and petitioner has only provided 28
exhibits to the court. Nonetheless, several other exhibits provided by petitioner support this conclusion,
including: Valerio Cecinati et al., Vaccine Administration and the Development of Immune
Thrombocytopenic Purpura in Children, 9 HUMAN VACCINES & IMMUNOTHERAPEUTICS 1158 (2013) (Ex.
P12(b)); Annie P. Jonville-Bera et al., Thrombocytopenic Purpura After Measles, Mumps, and Rubella
Vaccination: A Retrospective Study by the French Regional Pharmacovigilance Centres and Pasteur-
Merieux Serums et Vaccins, 15 PEDIATRIC INFECTIOUS DISEASE J. 44 (1996) (Ex. P11(o)); and Corri Black
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two weeks after vaccination is a “classic sign of ITP” and is “well within the time frame
when symptoms of ITP develop following vaccination.” (Id.) He opined that since
M.R.’s ITP was untreated in November 2017, M.R.’s symptoms continued to worsen
until his ITP was diagnosed and he began treatment on January 3, 2018. (Id.)
Dr. Ghose also places the drop in M.R.’s platelet count as occurring by mid-
December, which correlates to the time when petitioner indicates she observed a wider
progression of M.R.’s bruising. (Id.) He explained that “[t]he chronology of events in
this situation supports what we typically see in a case of vaccine associated ITP. It
would take a matter of weeks for M.R.’s platelets to go from normal down to 51,000 as
confirmed on January 3, 2018. It would logically and medically flow that M.R.’s onset of
ITP was at least several weeks prior to January 3, 2018.” (Id.)
In his second report, Dr. Ghose addresses three topics in response to Dr.
Strouse’s report: onset, cause, and diagnosis. (Ex. P13.) With regard to onset, he
reiterates his rationale that M.R.’s platelets would have dropped below normal range
well prior to January 3, 2018. (Id. at 1-2.) Given petitioner’s report of M.R. bruising first
in November, and then later more severely in December, as well as the amount of time
over which M.R.’s platelets would be expected to be dropping, Dr. Ghose confirms that
his opinion, stated to a reasonable degree of medical certainty, is that M.R. was
suffering ITP (i.e., having a platelet count under 100,000) by no later than 42 days post-
vaccination, which is consistent with the November 7, 2017 MMR vaccine being the
cause of his ITP. (Id.)
b. Respondent’s Hematology/Oncology Expert, Dr. Strouse7
Respondent’s expert, Dr. Strouse also submitted two reports in this case. (Ex. A;
Ex. C.) In his first report, Dr. Strouse summarizes M.R.’s medical record and ultimately
agrees with his diagnosis of chronic ITP. (Ex. A. pp. 1-2, 4.) However, he stresses that
M.R.’s initially mild presentation suggests his decrease in platelets was specifically due
to decreased platelet production, likely resulting from viral infection. (Id. at 3.) He
opines that, usually, ITP in children “presents with the rapid development of severe
thrombocytopenia without other decreases in white blood cells . . . or red blood cells.”
(Id.) Dr. Strouse noted that M.R.’s ITP was unusual in that he initially had only a minor
decrease in white and red blood cells. (Id.) However, Dr. Strouse notes that this short
term decrease in both white and red blood cells is seen with viral suppression. (Id.) He
attributed such viral suppression in M.R. to his pharyngitis, noting that “[v]iral infections
are the most common cause of pharyngitis” in younger children. (Id.)
et al., MMR Vaccine and Idiopathic Thrombocytopaenic Purpura, 55 BRIT. J. CLINICAL PHARMACOLOGY 107
(2003) (Ex. P11(n)).
7 John J. Strouse, M.D., Ph.D. is a board certified pediatric hematologist and oncologist. (Ex. B, p. 1.) He
is currently an Associate Professor of Medicine and Pediatrics and Director of the Adult Sickle Cell
Program at Duke University. (Ex. A, p. 1.) Throughout his clinical practice, he has treated both children
and adults with acute and chronic autoimmune thrombocytopenia. (Id.) He received both his M.D. and
Ph.D. from Johns Hopkins University, and he has published 95 refereed journals. (Ex. B, pp. 2-9.)
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Dr. Strouse agrees that the MMR vaccine can trigger ITP in young children up to
42 days post-vaccination. (Id.) However, he opines that onset of M.R.’s ITP is
“unclear.” (Id. at 4.) Dr. Strouse explains that mild thrombocytopenia (which he defines
as a platelet count over 50,000) is often asymptomatic. (Id. at 3.) Instead, he suggests
that the leg bruising petitioner described occurring in November 2017 may well have
been related to the type of bruising typically seen in toddlers learning to walk. (Id. at 4.)
And, although he acknowledges petitioner described increased bruising occurring about
five to six weeks post vaccination, he stresses that thrombocytopenia was not actually
documented until M.R.’s January 2, 2018 blood test showed low platelets with severe
thrombocytopenia not being evidenced until mid-January, about ten weeks post-
vaccination. (Id.) Therefore, he opines a viral infection (for which M.R. was seen on
December 8, 2017) occurring about four weeks prior to onset is a more likely cause of
the ITP. (Id.)
In his second report, Dr. Strouse discusses Dr. Ghose’s assessment of “kinetics
of changes in platelet count.” (Ex. C, p. 2.) He suggests that the type of gradual
decline in platelet counts that Dr. Ghose cites would be more likely seen in
thrombocytopenia following triggers such as cytotoxic chemotherapy or bone marrow
failure, rather than the immune mechanism at issue in ITP specifically. (Id.) Rather, in
young children with ITP, the drop in platelets is “usually sudden.” (Id.) Dr. Strouse
suggests that M.R. experienced bruising five to six weeks post-vaccination at the
earliest and then only mild thrombocytopenia about eight weeks post-vaccination. He
believes it is unlikely that the thrombocytopenia caused M.R.’s increased bruising. (Id.)
V. Legal Standard
Pursuant to section 13(a)(1)(A) of the Vaccine Act, a petitioner must prove their
claim by a preponderance of the evidence. A special master must consider the record
as a whole but is not bound by any diagnosis, conclusion, judgment, test result, report,
or summary concerning the nature, causation, and aggravation of petitioner’s injury or
illness that is contained in a medical record. § 300aa-13(b)(1). Thus, for example, the
Vaccine Act instructs that a special master may find the time period for the first
symptom or manifestation of onset required for a Table Injury is satisfied “even though
the occurrence of such symptom or manifestation was not recorded or was incorrectly
recorded as having occurred outside such period.” § 300aa-13(b)(2). However, the
Federal Circuit has held that contemporaneous medical records are ordinarily to be
given significant weight due to the fact that “[t]he records contain information supplied to
or by health professionals to facilitate diagnosis and treatment of medical conditions.
With proper treatment hanging in the balance, accuracy has an extra premium. These
records are also generally contemporaneous to the medical events.” Cucuras v. Sec’y
of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
Thus, where medical records are clear, consistent, and complete, they should be
afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V,
2005 WL 6117475, at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule is
not absolute. Afterall, “medical records are only as accurate as the person providing the
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information.” Parcells v. Sec’y of Health & Human Servs., No. 03-1192V, 2006 WL
2252749, at *2 (Fed. Cl. Spec. Mstr. July 18, 2006). In Lowrie, the special master wrote
that “written records which are, themselves, inconsistent, should be accorded less
deference than those which are internally consistent.” 2005 WL 6117475, at *19
(quoting Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d
per curiam, 968 F.2d 1226 (Fed. Cir. 1992)). Importantly, however, “the absence of a
reference to a condition or circumstance is much less significant than a reference which
negates the existence of the condition or circumstance.” Murphy, 23 Cl. Ct. at 733
(quoting the decision below).
When witness testimony is offered to overcome the weight afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent,
and compelling.” Camery v. Sec’y of Health & Human Servs., 42 Fed. Cl. 381, 391
(1998) (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808V, 1998 WL
408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). Further, a special master must
consider the credibility of the individual offering the testimony. See Andreu ex rel.
Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009);
Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). In
determining whether to afford greater weight to contemporaneous medical records or
other evidence, such as testimony, there must be evidence that this decision was the
result of a rational determination. Burns v. Sec’y of Health & Human Servs., 3 F.3d 415,
417 (Fed. Cir. 1993). The special master is obligated to consider and compare the
medical records, testimony, and all other “relevant and reliable evidence” contained in
the record. La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 204 (2013)
(citing § 300aa-12(d)(3); Vaccine Rule 8), aff’d, 746 F.3d 1334 (Fed. Cir. 2014); see
also Burns, 3 F.3d at 417 (concluding that the special master did not err by excluding
expert opinion based on facts not substantiated by the record).
VI. Finding as to Onset
There is no dispute that M.R. had confirmed thrombocytopenia, later diagnosed
as ITP, when he first presented for testing on January 2, 2018, 56 days post-
vaccination. (Ex. P6, p. 472.) However, the date of M.R.’s first presentation for
diagnosis and treatment is not the same as the onset of his condition. In particular,
M.R.’s January 2 blood test and January 3 follow up with his pediatrician were prompted
by a history of bruising. (Ex. P1, p. 32.) Resolving the disputed timing of onset of
M.R.’s ITP involves two questions. First, when was the onset of the bruising that
ultimately led to M.R.’s presentation for treatment of what was ultimately diagnosed as
ITP? Second, does that bruising identify the onset of the ITP? For the reasons
discussed below, I conclude that there is preponderant evidence that the bruising for
which M.R. was treated occurred within 42 days of vaccination, but not 30 days of
vaccination. I further conclude that Dr. Strouse is not persuasive in doubting that the
bruising at issue is indicative of the onset of ITP. Accordingly, there is preponderant
evidence that M.R. suffered onset of ITP within 42 days of his November 7, 2017
vaccinations.
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a. Onset of Bruising
Although petitioner indicates in her affidavit that M.R. began bruising on his lower
legs within two weeks of his vaccination, respondent stresses that M.R. had medical
encounters of November 22 and December 8, 2017, wherein the bruising was not
recorded. (Ex. P1, pp. 30-31.) The December 8 encounter in particular marks the 31st
day post-vaccination. Thus, respondent doubts the accuracy of the account. Citing
Kirby v. Secretary of Health and Human Services, 997 F.3d 1378 (Fed. Cir. 2021),
petitioner disagrees, arguing that the silence of these medical records is not dispositive.
(ECF No. 46, p. 5.) Petitioner is correct as a general matter that the silence of the
medical records is not necessarily dispositive; however, unlike the later bruising arising
in mid-December, petitioner herself distinguishes this earlier bruising, which was
confined to M.R.’s calves, as not concerning. (Ex. P2.)
Even without treating the medical records as definitive evidence that the bruising
did not occur, the absence of any notation of bruising in the contemporaneous medical
records would still tend to confirm petitioner’s recollection that it was not unusual or
concerning enough to be reported to M.R.’s physician. Relatedly, because the calf
bruises were not brought to medical attention, there is no treating physician opinion
available regarding the nature or extent of the bruising and whether it is medically
reasonable (even in hindsight) to attribute the bruises to the later-diagnosed ITP rather
than M.R.’s toddling. Petitioner’s affidavit is the only evidence suggesting that this calf
bruising was occurring at all during that time period and even that account doubts (albeit
as a lay person) that it was medically relevant. As both petitioner herself and
respondent’s expert suggest, leg bruising is not necessarily unexpected among toddlers
learning to walk. (Ex. A, p. 4.) Thus, even if some calf bruising did occur in the late
November to early December timeframe petitioner recalled, there is not preponderant
evidence that it was related to M.R.’s later diagnosed ITP.
There is, however, preponderant evidence that a subsequent onset of a more
concerning pattern of bruising occurred in “mid-December,” which would fall within 42
days of M.R.’s vaccinations, i.e., on or before December 19, 2017. Petitioner’s account
that a pattern of bruising over a wider area of M.R.’s body began in mid-December is
consistent with the medical records. Whereas the calf bruising in November 2017 was
not necessarily concerning and did not come to medical attention, petitioner explained
that “[i]n the middle of December 2017, [M.R.’s] bruising had started to progress to other
parts of his body, particularly his legs, armpits, arms, back of his knees, and along his
spine.” (Ex. P2, p. 3.) Petitioner explained that this bruising became concerning
because M.R.’s twin sister was not experiencing anything similar, despite also learning
to walk. (Id.) Thereafter, the medical records confirm that petitioner presented M.R. for
care on January 3, 2018, specifically due to a prior history of bruising. (Ex. P1, p. 32
(noting history concerning for “burising [sic] mainly on legs”).)8 Moreover, the same
8 Respondent suggests that bruising was not documented by the physical examination at that time (ECF
No. 45, p. 19) and it is true that bruising is not specifically noted within the physical exam portion of the
record; however, the pediatrician’s history of present illness clearly includes actual findings and not just
parental reports. In addition to noting bruising, it also reports the results of certain blood tests. (Ex. P1,
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pattern of bruising petitioner described in her affidavit was later confirmed as part of
M.R.’s subsequent presentation during his physical examination in mid-January. (Ex.
P3, p. 12 (physical exam documenting “scattered bruising noted to upper extremities,
trunk, and lower extremities”).)
The medical treatment records alone do not document a clear period of onset for
M.R.’s prior bruising; however, bruising was clearly the reason petitioner initially sought
care for M.R. for what was ultimately diagnosed as ITP, meaning that the bruising
necessarily predated M.R.’s January 2, 2018 blood test. Moreover, one of the histories
provided in the contemporaneous medical records during the course of M.R.’s
hospitalization at Children’s Hospital of San Antonio on January 15, 2018, explicitly
confirms the rationale underlying petitioner’s affidavit account. Specifically, that history
explained of M.R.’s bruising that “[i]n early January, patient was evaluated by his
pediatrician due to a concern for bruising, per mother. Mother was confused because
the patient seemed to bruise easily, however his twin sister had never experienced
similar bruising.” (Id. at 10.) This history exactly matches petitioner’s explanation in her
affidavit as to how she first observed M.R.’s abnormal bruising and then later sought
care for that bruising in early January 2018. (Ex. P2.) It therefore offers fairly strong
corroboration of petitioner’s affidavit regarding the history of bruising. Moreover, even
without the benefit of the additional affidavit account, it confirms observation of M.R.’s
bruising in comparison to his sister over time prior to his first presentation to the
pediatrician.9
To be sure, the medical records include some seeming inconsistencies and,
therefore, do not necessarily support petitioner’s recollection uniformly. In particular,
respondent stresses a different history provided during the same hospitalization which
recorded that “[m]om states that on 1/1/18 she noticed red ‘pinpoint perfect circles’ over
his skin. Patient was taken to his PCP and on 1/2 had blood work done . . . . Mom
states rash on skin and bruises that were noted at beginning of month had resolved until
last night.”10 (Ex. P3, p. 24.) This would seem to suggest, contrary to her affidavit, that
petitioner first noted abnormal bruising on January 1, just the day before seeking care.
Importantly, however, the focus of this particular history appears to be the separate rash
or rash-like presentation rather than the additionally referenced bruising, and only the
rash is explicitly noted as having been observed by petitioner herself on the first of the
p. 32.) Given that bruising is the only outward symptom discussed in the history of present illness, one
would likely expect a more explicit statement if that single presenting symptom were found to be absent
upon physical examination.
9 That is, it reflects petitioner observing (and being confused by) a difference between twin siblings in their
propensity to bruise. Naturally, this would suggest observation over the course of time, rather than being
consistent with any abrupt onset of abnormal bruising.
10 After noting that M.R.’s initial bruising had resolved until last night, the same history further notes in the
following paragraph that “[m]om states patient has not cried or shown that he was hurting prior to seeing
the mouth bleeding. No increased irritability or fussiness. No prior abnormal bleeding or bruising.” (Ex.
3, p. 24.) Although somewhat ambiguous, this reference to “no prior abnormal bleeding or bruising”
appears to refer to the period immediately prior to his presentation for mouth bleeding (subsequent to the
resolution of his prior bruising) rather than contradicting the preceding history within the same record.
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month. Otherwise, this history is less clear with respect to the sequence of events. In
particular, it is not necessarily clear whether “noted at the beginning of the month” refers
to petitioner’s own observation or the observation of M.R.’s pediatrician as of his first
medical encounter on January 3. In any event, even if the two histories are in tension,
the separate history discussed above, which recorded petitioner’s confusion that only
M.R., and not his sister, was bruising easily, was recorded on the same date at the
same facility and is an affirmative account too specific to have been entered merely in
error.
On the whole, the record preponderates in favor of a finding that onset of the
bruising that ultimately led to M.R.’s presentation on January 3, 2018, began in mid-
December of 2017. Onset of a wider pattern of concerning bruising first arising in mid-
December is not contradicted by the earlier November 22 and December 8 records and
is consistent with petitioner first seeking care for M.R. in very early January. Although
the subsequent treatment records are not completely clear with regard to onset, they
contain sufficient information to corroborate petitioner’s affidavit account.
b. Bruising as the Presenting Symptom of ITP
Both parties’ experts agree as a general matter that bruising is a symptom of ITP.
(Exs. A, p. 3; P9, p. 4.) Further to this, both M.R.’s treating physicians and petitioner’s
expert, Dr. Ghose, attribute M.R.’s own history of bruising to his ITP. (Exs. P9, p.7-8;
P1, p. 32; P3, pp. 12-13.) Additionally, Dr. Ghose reasons on petitioner’s behalf that it
would take “weeks” for platelet counts to drop from a normal level to the 51,000 level
documented on January 2, 2018. (Ex. P9, p. 8.) Therefore, he opines that it is
medically reasonable to conclude that the platelets had dropped below 100,000 (i.e.,
ITP range) by mid-December. (Id.; Ex. P13, pp. 1-2.) This also correlates to when the
abnormal bruising began.
Dr. Strouse disagrees with Dr. Ghose’s assessment of platelet kinetics, citing
Zeller et al. for the proposition that platelet counts in children with ITP “usually” drop
suddenly. (Ex. C, p. 2 (citing Bernward Zeller et al., Childhood Idiopathic
Thrombocytopenic Purpura in the Nordic Countries: Epidemiology and Predictors of
Chronic Disease, 94 ACTA PAEDIATRICA 178 (2005) (Ex. A, Tab 12)).) Dr. Strouse also
opines ITP is an unlikely cause of M.R.’s own bruising. (Id.) He stresses that
thrombocytopenia was not documented until January 2, 2018, about 8 weeks post-
vaccination. (Ex. A, p. 4.) He further stresses that severe thrombocytopenia was not
documented until mid-January of 2018, about 10 weeks post-vaccination. (Id.) Dr.
Strouse further notes that a platelet count of 51,000 can often be asymptomatic. (Id. at
3). There are several problems with Dr. Strouse’s line of reasoning.
Dr. Strouse’s opinion is in tension with the contemporaneous medical records.
Regardless of whether a platelet count of 51,000 can be asymptomatic, M.R. was
diagnosed with ITP by his pediatrician based on his initial presentation, which included
both a platelet count of 51,000 and a history of bruising. (E.g., Ex. P1, p. 32.)
Moreover, there is no indication any of his treating physicians doubted his bruising was
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related to his ITP or felt any other cause for the bruising was implicated. (Id.; Ex. 3, p.
12-13 (noting bruising and indicating M.R.’s “past medical history and current
presentation [are] consistent with immune thrombocytopenia of childhood”) Notably,
while Dr. Strouse attributes leg bruising to M.R.’s learning to walk, he offers no
alternative explanation for the wider pattern of bruising that occurred later. However, as
discussed above, that bruising was concerning enough to cause petitioner to seek
medical treatment for M.R. Thus, if M.R.’s bruising was not considered a symptom of
his ITP, another explanation would have been warranted as part of his medical
evaluations. In fact, M.R.’s medical records imply that it was only the fact of M.R.’s ITP
that gave his treaters comfort that there was no child abuse to report. (Ex. P3, p. 5.)
M.R.’s hospital records note of his initial ED presentation of January 14 that M.R. “was
noted to have petechiae on his neck and face, as well as bruising to areas on his
forehead arms, trunk, and lower extremities. The[y] initially questioned mom with
concern, however she reported that he has been seeing his pediatrician since early
January to evaluate the bruising.” (Id. (emphasis added); see also admission data at
pp. 83, 88 (identifying bruising under problems, but marking “no” for unexplained
bruising).)
Additionally, January 2, 2018, is merely the first time M.R.’s platelets happened
to be measured during the relevant period. Accordingly, even if one preferred Dr.
Strouse’s assessment of platelet kinetics over that of Dr. Ghose, the date of the test
result does not in itself imply the date of the drop in platelet counts. Regardless of
whether the initial drop occurred suddenly or over the course of weeks, Dr. Strouse
provides no rationale for divorcing the drop in platelets from the outward presentation of
symptoms consistent with ITP. Dr. Strouse offers a discussion that suggests M.R.’s
own initial pattern of mild platelet deficiency is better viewed as consistent with viral
suppression. (Ex. C, p. 2.) However, based on my review of that discussion, this point
speaks to the underlying cause of M.R.’s ITP more so than the timing of its onset.
Thus, while that may be a consideration in the ultimate causal analysis, it does not
suggest that the timing of onset is other than what is reflected in M.R.’s medical records
and petitioner’s affidavit.
Dr. Strouse stresses the difference between M.R.’s January 2 platelet count and
his mid-January platelet count to seemingly implicate a sudden platelet drop occurring
around that specific time that distinguishes M.R.’s later more severe thrombocytopenia
from his earlier mild presentation. (Ex. A, p. 3; Ex. C, p. 1.) However, the significance
of select platelet counts is not at all clear given the documented fluctuations in M.R.’s
platelet counts over time. After M.R.’s platelet count was initially measured at 51,000, it
was rechecked two days later and was higher at 97,000. (Ex. P6, pp. 450, 472.) Only
after that did it drop to 4,000 by January 14, 2018. (Ex. P3, p. 5.) Thereafter, as
discussed extensively in the factual summary above, M.R.’s platelet counts fluctuated
throughout his entire treatment history. Dr. Strouse has filed literature explaining that
“[a]lmost all patients have fluctuations in their platelet count” and that “[r]ecognition that
the platelet count is less important than overall bleeding symptoms” has improved care.
Nichola Cooper, State of the Art - How I Manage Immune Thrombocytopenia, 177 BRIT.
J. HAEMATOLOGY 39, 39, 48 (2017) (Ex. A, Tab 5, pp. 1, 10). Thus, it is difficult to see
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how the drop in platelets between January 2 and January 14 could be informative of the
initial onset of M.R.’s ITP given the overall fluctuations.
Finally, contrary to what Dr. Strouse suggests, the Zeller et al. study does not
actually address platelet kinetics upon condition onset. See Zeller et al., supra Ex. A,
Tab 12. The Zeller et al. study was a prospective study examining the clinical courses
of 423 children with ITP over six months. See id. at 1. Subjects were brought into the
study if they were diagnosed with ITP under conventional diagnostic criteria and had at
least one prior platelet measurement that indicated the need for therapy. See id. at 2.
Nothing in the study is readily identifiable as an analysis of pre-diagnosis platelet
trajectories. When the study refers to sudden versus insidious onset, it is referring to
symptom onset. Zeller et al. indicates that an “insidious” onset of symptoms (defined as
symptom duration of over two weeks prior to diagnosis) is “strongly associated” with the
chronic form of ITP, id. at 5-6, which both experts agree M.R. ultimately suffered. (Exs.
P9, p. 7; A, p. 4.) Thus, I do not view the Zeller study as refuting Dr. Ghose’s opinion
with respect to onset.
VII. Conclusion
In light of all of the above, the evidence preponderates in favor of a finding that
abnormal bruising was the first symptom of M.R.’s ITP and that onset of the condition
occurred no earlier than 31 days post-vaccination but within 42 days post-vaccination.
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
16

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DOCUMENT 2: USCOURTS-cofc-1_20-vv-00503-1
Date issued/filed: 2025-08-25
Pages: 11
Docket text: PUBLIC ORDER/RULING (Originally filed: 7/29/2025) regarding 67 Ruling on Entitlement. Signed by Special Master Daniel T. Horner. (ksb) Service on parties made.
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Case 1:20-vv-00503-UNJ Document 69 Filed 08/25/25 Page 1 of 11
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 20-503V
Filed: July 29, 2025
Special Master Horner
MAYRA DEL BOSQUE as parent and
natural guardian of M.R., a minor,
Petitioner,
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
David John Carney, Green & Schafle LLC, Philadelphia, PA, for petitioner.
Benjamin Patrick Warder, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT1
On April 27, 2020, petitioner filed a petition under the National Childhood Vaccine
Injury Act, 42 U.S.C. § 300aa, et seq. (2012) (“Vaccine Act”),2 alleging that M.R.
suffered immune thrombocytopenic purpura (“ITP”) caused-in-fact by vaccination(s) he
received on November 7, 2017, including measles, mumps, and rubella (“MMR”)
vaccine. (ECF No. 1.) For the reasons set forth below, I conclude that petitioner is
entitled to compensation for M.R.’s injury.
I. Applicable Statutory Scheme
Under the National Vaccine Injury Compensation Program, compensation
awards are made to individuals who have suffered injuries after receiving vaccines. In
1 Because this document contains a reasoned explanation for the action taken in this case, it must be
made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or
at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic
Government Services). This means the document will be available to anyone with access to the
internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.
If, upon review, I agree that the identified material fits within this definition, I will redact such material from
public access.
2 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.
§ 300aa-10, et seq.
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general, to gain an award, a petitioner must make a number of factual demonstrations,
including showing that an individual received a vaccination covered by the statute;
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. Finally – and the key
question in most cases under the Program – the petitioner must also establish a causal
link between the vaccination and the injury. In some cases, the petitioner may simply
demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
shown that the vaccine recipient suffered an injury of the type enumerated in the
“Vaccine Injury Table,” corresponding to the vaccination in question, within an
applicable time period following the vaccination also specified in the Table. If so, the
Table Injury is presumed to have been caused by the vaccination, and the petitioner is
automatically entitled to compensation, unless it is affirmatively shown that the injury
was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A);
§ 300aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B). The Vaccine Injury Table
includes ITP as an injury associated with the MMR vaccine, but only if onset occurs
between 7-30 days post-vaccination. 42 C.F.R. § 100.3(a)(V)(A).
Alternatively, if no injury falling within the Table can be shown, a petitioner could
still demonstrate entitlement to an award by instead showing that the vaccine recipient’s
injury or death was caused-in-fact by the vaccination in question. § 300aa-13(a)(1)(A);
§ 300aa-11(c)(1)(C)(ii). In particular, a petitioner must demonstrate that the vaccine
was “not only [the] but-for cause of the injury but also a substantial factor in bringing
about the injury.” Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321-22
(Fed. Cir. 2010) (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344,
1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352,
1355 (Fed. Cir. 2006). To successfully demonstrate causation-in-fact, petitioner bears a
burden to show: (1) a medical theory causally connecting the vaccination and the injury;
(2) a logical sequence of cause and effect showing that the vaccination was the reason
for the injury; and (3) a showing of proximate temporal relationship between vaccination
and injury. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir.
2005).
For both Table and Non-Table claims, Vaccine Program petitioners bear a
“preponderance of the evidence” burden of proof. § 300aa-13(1)(a). That is, a petitioner
must offer evidence that leads the “trier of fact to believe that the existence of a fact is
more probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact’s existence.” Moberly, 592 F.3d at 1322
n.2 (alternation in original); see also Snowbank Enters., Inc. v. United States, 6 Cl. Ct.
476, 486 (1984) (explaining that mere conjecture or speculation is insufficient under a
preponderance standard). Proof of medical certainty is not required. Bunting v. Sec’y
of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). However, a petitioner
may not receive a Vaccine Program award based solely on her assertions; rather, the
petition must be supported by either medical records or by the opinion of a competent
physician. § 300aa-13(a)(1).
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Cases in the Vaccine Program are assigned to special masters who are
responsible for “conducting all proceedings, including taking such evidence as may be
appropriate, making the requisite findings of fact and conclusions of law, preparing a
decision, and determining the amount of compensation, if any, to be awarded.” Vaccine
Rule 3(b)(1). Special masters must ensure each party has had a “full and fair
opportunity” to develop the record. Vaccine Rule 3(b)(2). However, special masters are
empowered to determine the format for taking evidence based on the circumstances of
each case. Vaccine Rule 8(a); Vaccine Rule 8(d). Special masters are not bound by
common law or statutory rules of evidence but must consider all relevant and reliable
evidence in keeping with fundamental fairness to both parties. Vaccine Rule 8(b)(1).
The special master is required to consider “all [] relevant medical and scientific evidence
contained in the record,” including “any diagnosis, conclusion, medical judgment, or
autopsy or coroner’s report which is contained in the record regarding the nature,
causation, and aggravation of the petitioner’s illness, disability, injury, condition, or
death,” as well as the “results of any diagnostic or evaluative test which are contained in
the record and the summaries and conclusions.” § 300aa-13(b)(1)(A). The special
master is required to consider all the relevant evidence of record, draw plausible
inferences, and articulate a rational basis for the decision. Winkler v. Sec’y of Health &
Human Servs., 88 F.4th 958, 963 (Fed. Cir. 2023) (citing Hines ex rel. Sevier v. Sec’y of
Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).
II. Factual and Procedural History
On October 12, 2023, I issued Findings of Fact and Conclusions of Law in this
case. (ECF No. 47; 2023 WL 7299812 (Fed. Cl. Spec. Mstr. Oct. 12, 2023).) The
factual history of M.R.’s injury, as well as a summary of the expert opinions and the
procedural history of this case leading up to that point, are included in the finding of fact
and will not be repeated. There is no dispute that M.R. suffered ITP; however, the
parties disagree as to the timing of onset. After considering the record as a whole, I
concluded that “abnormal bruising was the first symptom of M.R.’s ITP and that onset of
the condition occurred no earlier than 31 days post-vaccination but within 42 days post-
vaccination.” (ECF No. 47, p. 16; 2023 WL 7299812, at *12.)
Thereafter, petitioner filed updated medical records marked as Exhibits P19-P23
and the parties filed briefs regarding petitioner’s entitlement to compensation.
Specifically, petitioner filed a motion for a ruling on the record on August 12, 2024,
respondent filed his response on October 31, 2024, and petitioner filed a reply on
December 2, 2024. (ECF Nos. 62, 64-65.)
I have determined that the parties have had a full and fair opportunity to present
their cases and that it is appropriate to resolve entitlement on the existing record. See
Vaccine Rule 8(d); Vaccine Rule 3(b)(2); see also Kreizenbeck v. Sec’y of Health &
Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (noting that “special masters must
determine that the record is comprehensive and fully developed before ruling on the
record”).
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III. Party Contentions
Given the finding that onset of M.R.’s ITP occurred between 31-42 days post-
vaccination, respondent notes that, of course, M.R.’s injury does not qualify for any
causal presumption under the Vaccine Injury Table. (ECF No. 64, n. 3.) Thus, this
case turns on the three-part Althen analysis for causation-in-fact. (Id. at 17.) However,
respondent acknowledged that his expert, Dr. Strouse, agreed that the MMR vaccine
can cause ITP and further acknowledged that Dr. Strouse agreed that the elevated risk
of post-MMR vaccine ITP persists for up to 42 days. (Id. at 21-23.) Therefore,
respondent conceded that, so long as the prior finding of fact controls, petitioner has
satisfied the first and third Althen prongs. (Id.) Regarding the second Althen prong,
which remains as the only disputed element of petitioner’s prima facie case, respondent
argues that there is no logical sequence of cause-and-effect implicating M.R.’s MMR
vaccine as a cause of his ITP, even after accounting for petitioner’s demonstration of a
theory of causation and appropriate timing. (Id. at 24.) Respondent contends that
petitioner has treated Althen prong two as “an ‘afterthought.’” (Id. at 29 (citing Randolph
v. Sec’y of Health & Human Servs., No. 15-146V, 2021 WL 5816271, at *22 (Fed. Cl.
Spec. Mstr. Nov. 12, 2021)).)
First, respondent argues that M.R.’s ITP “was not typical for vaccine-caused
ITP.” (ECF No. 64, p. 25.) Specifically, respondent contends that M.R. experienced an
insidious and gradual decrease in platelet levels, whereas post-vaccination ITP
generally includes a sudden decrease in platelet counts as autoantibodies bind to
platelets and are then rapidly cleared by the spleen or liver. (Id (citing Ex. C, p. 2;
Bernward Zeller et al., Childhood Idiopathic Thrombocytopenic Purpura in the Nordic
Countries: Epidemiology and Predictors of Chronic Disease, 94 ACTA PÆDIATRICA 178
(2005) (Ex. A, Tab 12, pp. 1-6).) Respondent cites a study by Rajantie et al., in which
no cases of insidious onset of ITP (defined as the presence of symptoms for more than
two weeks prior to diagnosis) followed MMR vaccine. (Id. at 25-26 (discussing J.
Rajantie et al., Vaccination Associated Thrombocytopenic Purpura in Children, 25
VACCINE 1383 (2007) (Ex. P11(j))).)
Second, the persistence of M.R.’s ITP is not consistent with the typical clinical
course of vaccine-caused ITP. Whereas M.R. suffered ITP chronically, vaccine-caused
ITP is usually self-limiting and resolves within weeks to months. (Id. at 26-27 (citing Eric
K. France et al., Risk of Immune Thrombocytopenic Purpura After Measles-Mumps-
Rubella Immunization in Children, 121 PEDIATRICS e687 (2008) (Ex. P11(m)); Corri
Black et al., MMR Vaccine and Idiopathic Thrombocytopenic Purpura, 55 BRIT. J.
CLINICAL PHARMACOLOGY 107 (2003) (Ex. P11(n)); Valerio Cecinati et al., Vaccine
Administration and the Development of Immune Thrombocytopenic Purpura in Children,
9 HUM. VACCINES & IMMUNOTHERAPEUTICS 1158 (2013) (Ex. P12(b))).)
Third, respondent’s expert presents M.R.’s prior pharyngitis, documented at
M.R.’s December 8, 2017 pediatric visit, as a more likely cause of his ITP. (Id. at 27
(citing Ex. P1, p. 31).) In particular, whereas M.R.’s presentation was atypical in initially
demonstrating only mild thrombocytopenia and neutropenia (Id. at 28 (citing Ex. P1, p.
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32; Ex. P6, pp. 213-14), Dr. Strouse explained that “short-term decreases in neutrophils
and platelets can be seen with viral suppression for up to several weeks.” (Id.)
Pharyngitis in toddlers is commonly caused by viral infection and even petitioner’s
expert agreed that ITP can be caused by viral infection. (Id.) Respondent does not
address whether there is sufficient evidence for respondent to affirmatively prove that
M.R.’s pharyngitis constitutes a factor unrelated to vaccination under his own shifted
burden of proof. Instead, he argues that he is permitted to present evidence of an
independent, non-vaccine cause for M.R.’s ITP to contradict or weaken petitioner’s
prima facie showing. (ECF No. 64, pp. 27-28 (citing Stone v. Sec’y of Health & Human
Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012)).)
Petitioner argues, however, that M.R.’s clinical course, as described in his
medical records, does support a logical sequence of cause-and-effect implicating M.R.’s
vaccination as a but for cause of his condition. (ECF No. 65, p. 5.) Specifically, M.R.
demonstrated an onset of symptoms of ITP within an appropriate timeframe from which
to infer causation and his ITP was diagnosed and confirmed by laboratory results at the
time of diagnosis that showed a white blood cell count of 3.62 and platelets of 51,000.
(Id. at 6 (citing Ex. P1, p. 32).) Petitioner maintains that the logical sequence of cause
and effect is further supported by her expert’s causal opinion, which set forth a theory of
causation and also noted that no other triggering event was documented as a
precipitating event for M.R.’s ITP. (Id. at 8.)
Petitioner argues that respondent’s contention that vaccine-caused ITP must
resolve within weeks to months would mean that no petitioner would ever be
compensated for this injury in the Vaccine Program given the six-month statutory
severity requirement.3 (Id. at 11.) Moreover, petitioner stresses that respondent
acknowledges that 10% of ITP patients will have chronic disease. (Id. (citing ECF No.
64, p. 27).) Petitioner argues that respondent cannot reasonably contend that there is a
meaningful difference between a gradual and sudden drop in platelets when his expert
has opined that onset of ITP can occur up to 42 days post-vaccination. (Id.)
Petitioner stresses that M.R.’s purported viral antecedent is only “vaguely
described” and that no treating physician attributed M.R.’s ITP to any viral illness or to
pharyngitis. (ECF No. 65, pp. 8-9.) Petitioner further argues that, even if M.R.’s
vaccination and pharyngitis both represented potential causes of his ITP, petitioner
would not bear a burden of eliminating the other cause. (Id. at 9 (citing Walther v. Sec’y
of Health & Human Servs., 485 F.3d 1146, 1149 (Fed. Cir. 2007)).) Petitioner argues
that respondent cannot meet his own shifted burden of proof to demonstrate the
pharyngitis as the sole cause of the ITP. (Id. at 13-14.)
3 This argument does not actually present the full picture in that petitioners suffering ITP may alternatively
demonstrate that they experienced inpatient hospitalization and surgical intervention. Leming v. Sec’y of
Health & Human Servs., 98 F.4th 1107 (Fed. Cir. 2024). Prior petitioners have, in fact, struggled to
demonstrate greater than six months of sequela related to ITP. E.g., Crabbe v. Sec’y of Health & Human
Servs., No. 10-762V, 2011 WL 4436724 (Fed. Cl. Spec. Mstr. Aug. 26, 2011).
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IV. Analysis
The second Althen prong requires preponderant proof of a logical sequence of
cause and effect, which is usually supported by facts derived from petitioner’s medical
records.4 Althen, 418 F.3d 1278; Andreu v. Sec’y of Health & Human Servs., 569 F.3d
1367, 1375-77 (Fed. Cir. 2009); Capizzano v. Sec’y of Health & Human Servs., 440
F.3d 1317, 1326 (Fed. Cir. 2006); Grant v. Sec’y of Health & Human Servs., 956 F.2d
1144, 1148 (Fed. Cir. 1992). In this case, the contemporaneous medical records
establish the fact of M.R.’s ITP and I have determined that the onset of the symptoms of
his ITP occurred within a time period from which a causal inference can be drawn.
However, the medical records lack an explicit medical opinion addressing the underlying
cause of M.R.’s ITP. In that regard, while the opinions of treating physicians are often
favored, Capizzano, 440 F. 3d at 1326, a petitioner may support a cause-in-fact claim
through presentation of either medical records or an expert medical opinion. See
§ 300aa-13(a). Absent any explicit opinion in the medical records favoring either party’s
preferred explanation for M.R.’s ITP, analysis of Althen prong two becomes a weighing
of the competing expert opinions.
Even where, as here, Althen prongs one and three have been satisfied, the
Federal Circuit has cautioned that Althen prong two “is not without meaning.”
Capizzano, 440 F.3d at 1327. Indeed, the Althen court held that “neither a mere
showing of a proximate temporal relationship between vaccination and injury, nor a
simplistic elimination of other potential causes of the injury suffices, without more, to
meet the burden of showing actual causation.” 418 F.3d at 1278. Ultimately, a
petitioner bears an affirmative burden of proof to establish that the vaccine did cause
the injury at issue. Pafford, 451 F.3d at 1357-58. However, the Federal Circuit has also
explained that satisfaction of Althen prongs one and three is probative regarding the
presence of a logical sequence of cause and effect. Capizzano, 440 F.3d at 1326. The
Court described the circumstances in which Althen prong two may be a stumbling block
as follows:
There may well be a circumstance where it is found that a vaccine can
cause the injury at issue and where the injury was temporally proximate to
the vaccination, but it is illogical to conclude that the injury was actually
caused by the vaccine. A claimant could satisfy the first and third prongs
without satisfying the second prong when medical records and medical
opinions do not suggest that the vaccine caused the injury, or where the
4 Medical records are generally viewed as trustworthy evidence. Cucuras v. Sec’y of Health & Human
Servs., 993 F.2d 1525, 1528 (Fed. Cie. 1993). These records are generally contemporaneous to the
medical events and “contain information supplied to or by health professionals to facilitate diagnosis and
treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an extra
premium.” Id. However, medical records and/or statements of a treating physician’s views do not per se
bind the special master. § 300aa-13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,
test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y of
Health & Human Servs., 88 Fed. Cl. 706, 745 n.67 (2009) (reasoning that “nothing . . . mandates that the
testimony of a treating physician is sacrosanct—that is must be accepted in its entirety and cannot be
rebutted”).
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probability of coincidence or another cause prevents the claimant from
proving that the vaccine caused the injury by preponderant evidence.
Id. at 1327.
Here, as in Capizzano, it is established that M.R.’s MMR vaccine can cause ITP
and that the injury was temporally proximate to the vaccine. And, further to that,
petitioner has come forward with an affirmative medical opinion by a qualified specialist,
Dr. Ghose, who opines, based on a review of M.R.’s own clinical history and the
relevant medical literature, that M.R.’s MMR vaccine did cause his ITP. (Ex. 9, pp. 7-8.)
However, respondent seeks to raise two considerations, like those referenced in
Capizzano, as confounding. First, respondent raises several arguments regarding the
clinical presentation of M.R.’s own ITP that he contends disfavor the vaccine as a cause
of the condition. Second, he argues that he has presented evidence indicating that
another cause, namely a viral infection evidenced by pharyngitis, prevents a finding that
M.R.’s ITP was caused by his vaccination.
Respondent argues that the nature of the onset of M.R.’s ITP, which he contends
included a gradual decrease in platelet counts, is not typical of vaccine causation.
Respondent’s argument includes two distinct points. Respondent contends (1) that
vaccine-related ITP includes an abrupt or rapid decrease in platelets and (2) that a
study by Rajantie et al. shows that no instance of post-MMR ITP had an insidious onset
of symptoms, by which they meant symptoms arising more than two weeks prior to
diagnosis. (Rajantie et al., supra, at Ex. P11(j), p. 2.) However, these points are not
persuasive in light of the facts as I have found them. In the finding of fact, I explained
that M.R.’s platelet count was diagnostic of ITP the first time it was measured on
January 2, 2018, and fluctuated thereafter. (ECF No. 47, p. 15; 2023 WL 7299812, at
*11 (explaining that “January 2, 2018, is merely the first time M.R.’s platelets happened
to be measured during the relevant period . . . . [and] the date of the test result does not
in itself imply the date of the drop in platelet counts”).) Therefore, respondent’s
argument that platelets declined gradually prior to January 2, 2018, is speculative.5
5 In the finding of fact, I further explained that:
Dr. Strouse stresses the difference between M.R.’s January 2 platelet count and his mid-
January platelet count to seemingly implicate a sudden platelet drop occurring around that
specific time that distinguishes M.R.’s later more severe thrombocytopenia from his earlier
mild presentation. (Ex. A, p. 3; Ex. C, p. 1.) However, the significance of select platelet
counts is not at all clear given the documented fluctuations in M.R.’s platelet counts over
time. After M.R.’s platelet count was initially measured at 51,000, it was rechecked two
days later and was higher at 97,000. (Ex. P6, pp. 450, 472.) Only after that did it drop to
4,000 by January 14, 2018. (Ex. P3, p. 5.) Thereafter, as discussed extensively in the
factual summary above, M.R.’s platelet counts fluctuated throughout his entire treatment
history. Dr. Strouse has filed literature explaining that “[a]lmost all patients have
fluctuations in their platelet count” and that “[r]ecognition that the platelet count is less
important than overall bleeding symptoms” has improved care. Nichola Cooper, State of
the Art - How I Manage Immune Thrombocytopenia, 177 BRIT. J. HAEMATOLOGY 39, 39, 48
(2017) (Ex. A, Tab 5, pp. 1, 10).
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Moreover, Dr. Strouse’s opinion that platelets drop “suddenly” in post-vaccination ITP is
based on citation to a study by Zeller et al., which did not actually measure how quickly
platelets dropped prior to diagnosis. (Ex. C, p. 2 (citing Zeller et al., supra, at Ex. A, Tab
12).) Dr. Strouse has not explained what would constitute a “sudden” drop in platelets
or how such a requirement would square with his opinion that there is an elevated risk
of post-vaccination ITP for up to six weeks post-vaccination.
And, while respondent’s argument as to insidious onset may have had some
bearing on petitioner’s argument that symptom onset of ITP had been much earlier than
I ultimately found, the finding of fact concluded that onset of ITP in this case occurred in
mid-December, heralded by a distinct onset of wider spread bruising, and diagnosis
occurred at the beginning of January. This is very close to the two-week demarcation
identified by Rajantie et al. and Zeller et al. In that regard, it is important to note the
following limitations of the Rajantie study: the authors do not explain why two weeks to
diagnosis is an important cut off; they do not explain how the timing of the first
symptoms was ascertained among the subjects; and, of the 506 total children in the
study, only 35 of the subjects were post-vaccination subjects. But, in any event, even if
I did agree that onset of M.R.’s ITP was insidious, respondent has otherwise pointed to
literature – Zeller et al. – that indicates that sudden onset is also more common among
cases of ITP following infection, which is what respondent’s expert opines was the
cause of M.R.’s ITP. (Ex. C, pp. 2-3; Zeller et al., supra, at Ex. A, Tab 12, p. 4 tbl. II.)
Thus, even if onset of M.R.’s ITP was insidious, this issue would not necessarily favor
one party’s proffered explanation over another.
Additionally, and relatedly, respondent stresses that Dr. Strouse explained that
short-term decreases in neutrophils and platelets can be seen with viral suppression for
up to several weeks. (Ex. A, p. 3.) Specifically, Dr. Strouse indicates that “M.R.’s initial
presentation with mild thrombocytopenia and neutropenia is typically seen with
decreased production.” (Id.) Decreased production is one of three mechanisms of
thrombocytopenia, with the others being increased consumption/destruction and
sequestration. (Id.) However, in M.R.’s case, Dr. Strouse indicated that he “then
developed increased bleeding and bruising and severe thrombocytopenia without other
cytopenias.” (Id.) Apart from the “short term” decreases in platelet and neutrophil
counts, Dr. Strouse otherwise suggests that ITP related to either vaccination or infection
is generally related to increased consumption/destruction of platelets. (Id.) Both Dr.
Strouse’s report and the literature he cites suggest that decreased platelet production
and increased consumption/destruction of platelets are distinct “classes” of ITP. (Ex. A,
p. 3; Jenny M. Despotovic, Causes of Thrombocytopenia in Children, UPTODATE (2021)
(Ex. A, Tab. 1, pp. 1-2).) Given that Dr. Strouse has identified a more severe course of
chronic ITP in M.R.’s case that could not be explained by a “short term” or “several
(ECF No. 47, p. 15; 2023 WL 7299812, at *12.) In the instant motion response, respondent
acknowledged this aspect of the fact finding, but urged that “a fluctuation in the platelet level is not the
same thing as a gradual decrease in platelet level with which M.R. initially presented. Respondent
reiterates that a gradual decrease in platelet level is not typical of vaccine-caused ITP.” (ECF No. 64, n.
10.) However, the point remains that nothing on this record indicates how quickly M.R.’s platelets
dropped from normal to diagnostic of ITP. All we know is that the first time he was tested, a little over two
weeks after onset of symptoms, he already had a diagnostically significant reduction in platelets.
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weeks” long viral suppression of platelets, he has not adequately explained why it is
reasonable to invoke multiple different classes of ITP to explain M.R.’s overall clinical
history when he otherwise suggests that infection – like vaccination – would typically
result in the class of ITP resulting from platelet consumption/destruction. Moreover, Dr.
Strouse’s invocation of viral suppression was premised on his understanding that the
onset of M.R.’s ITP occurred in January of 2018, rather than December of 2017.
However, for reasons explained in the finding of fact, I rejected that contention. (ECF
No. 47, pp. 12-16; 2023 WL 7299812, at *9-12.)
Respondent further suggests that M.R.’s ITP is atypical of vaccine caused ITP
because it was long-lasting. Thus, for example, in Wright v. Secretary of Health &
Human Services, the Federal Circuit noted that “the Secretary recognized when adding
[ITP] to the Table, thrombocytopenic purpura is rarely chronic, i.e., lasting more than 6
months, and chronic cases are thought to be the result of an autoimmune disorder
rather than viral vaccination or viral infection.” 22 F.4th 999, 1003 (Fed. Cir. 2022)
(citing National Vaccine Injury Compensation Program: Revisions and Additions to the
Vaccine Injury Table—II, 60 Fed. Reg. 56,289, 56,295 (Nov. 8, 1995)). Here, however,
respondent’s own expert, Dr. Strouse, though noting M.R. to have had a chronic
presentation, explicitly opined that M.R.’s ITP was likely related to a prior viral infection,
which, as noted above, represents the same class of ITP as vaccine-caused ITP. (Ex.
C, pp. 2-3). Dr. Strouse stated that “[c]hronic ITP is uncommon after MMR vaccination
as most children (93%) have resolution of thrombocytopenia within 6 months based on
a meta-analysis of ITP associated with MMR vaccination.” (Ex. A, p. 3 (citing Elpis
Mantadakis et al., Thrombocytopenic Purpura After Measles-Mumps-Rubella
Vaccination: A Systematic Review of the Literature and Guidance for Management, 156
J. PEDIATRICS 623 (2010) (Ex. A, Tab 6)).) On its face, this is not a statement that
disclaims the potential for vaccine-related ITP to become chronic. Yet, looking closer at
Mantadakis et al., as cited by Dr. Strouse, the authors note that while only 7% of post-
MMR cases became chronic and, hence, overall “MMR-associated ITP is less likely to
become chronic compared with the more common non-vaccine-associated disease,”
“the percentage of children who have development of chronic non-vaccine-associated
ITP appears similar to that of MMR-related cases in children aged 12 to 18 months of
age alone.” (Mantadakis et al., supra, at Ex. A, Tab 6, pp. 4-5.) M.R. received the
MMR vaccination at issue at his 12-month well visit. (Ex. P1, pp. 26-27.) Thus, the
chronicity of M.R.’s ITP does not distinguish his case from vaccine-related ITP.
Finally, respondent argues that M.R.’s pharyngitis, diagnosed on December 8,
2017, is a more likely cause of his ITP. On this point, the parties cite different Federal
Circuit precedents. Petitioner focuses on Walther, in which, citing the Restatement
(Second) of Torts, the Federal Circuit explained that “in cases involving multiple
independent potential causes, if it is clear ‘that harm has been caused to the plaintiff by
only of them, but there is uncertainty as to which one has caused it, the burden is upon
each such actor to prove that he has not caused the harm.’” Walther, 485 F.3d at 1151
(quoting RESTATEMENT (SECOND) OF TORTS § 433B(3) (AM. L. INST. 1965)). Thus, in this
Program “the petitioner generally has the burden on causation, but when there are
multiple independent potential causes, the government has the burden to prove that the
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covered vaccine did not cause the harm.” Id. Citing Stone, 676 F.3d at 1379,
respondent argues that he is entitled to present M.R.’s pharyngitis as confounding
petitioner’s prima facie showing without assuming the burden of proof. However, while
Stone explains as “commonsense” the proposition that no evidence is embargoed from
a special master’s analysis of petitioner’s prima facie case, the Stone court explained
that the special master nonetheless “may not require the petitioner to shoulder the
burden of eliminating all possible alternative causes in order [to] establish a prima facie
case” and that the special master may conclude an injury is due to a factor unrelated to
vaccination “only if that finding is supported by a preponderance of the evidence.” 676
F.3d at 1379-80.
Whereas Dr. Ghose opined on petitioner’s behalf that no other immunologic
trigger was documented, respondent argues via Dr. Strouse that M.R.’s pharyngitis of
December 8, 2017, is a more likely cause of his ITP. (ECF No. 64, p. 29.) However,
although Dr. Ghose does not dispute that M.R. was seen for a fever on December 8 and
diagnosed with pharyngitis, he stresses that this is inadequate to confirm a viral
infection in particular. (Ex. P13, p. 2.) A diagnosis of “pharyngitis” simply indicates
M.R. had a sore throat. Pharyngitis, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=38409 (last visited July 28, 2025).
In that regard, Dr. Strouse merely relies on the syllogism that pharyngitis among young
children is often explained by viral infections and that viral infection, in turn, is the cause
of many cases of ITP. (Ex. C, p. 2.) Importantly, however, the Federal Circuit has
“rejected statistical likelihood alone as proof of actual causation.” Boatmon v. Sec’y of
Health & Human Servs., 941 F.3d 1351, 1363 (Fed. Cir. 2019) (citing Knudsen v. Sec’y
of Health & Human Servs., 35 F.3d 543, 550 (Fed. Cir. 1994)). As explained above,
M.R. was not actually diagnosed with a viral illness, none of M.R.’s treating physicians
attributed his ITP to his prior presentation with pharyngitis in particular or an infectious
illness more generally, and Dr. Strouse was not persuasive in contending that the
clinical characteristics of M.R.’s own ITP can distinguish an infectious cause. Thus,
having considered the evidence raised by respondent with respect to pharyngitis as a
potential cause of M.R.’s ITP (accord Stone), I cannot conclude that respondent’s
argument in favor of pharyngitis as the cause of M.R.’s ITP confounds petitioner’s prima
facie showing under the Althen test.
Once petitioner has satisfied her own burden pursuant to the Althen test, the
burden shifts to respondent to demonstrate that the injury was caused by factors
unrelated to vaccination. § 300aa-13(a)(1)(B); Deribeaux v. Sec’y of Health & Human
Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013). In this case, respondent has not argued
that he can satisfy his own burden of proof with respect to the idea that M.R.’s ITP was
caused by his pharyngitis. But in any event, the Federal Circuit has rejected the
contention that the presence of a viral infection can per se be considered a factor
unrelated to vaccination. Knudsen, 35 F.3d at 548-50. Rather, respondent bears a
burden of proving not only that there was a viral infection, but also that the infection was
principally responsible for causing petitioner’s injury. Id. Thus, any argument by
respondent that he had preponderantly established such an infection as the cause of
M.R.’s ITP would fail for the same reasons discussed above. Accord Knudsen, 35 F.3d
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at 550 (stating that “[t]his conflicting record evidence does not in our view either compel
a finding of viral alternative causation nor preclude one. If the evidence is seen in
equipoise, then the government has failed in its burden of persuasion and
compensation must be awarded.”).
V. Conclusion
After weighing the evidence of record within the context of this Program, I find by
preponderant evidence that petitioner has demonstrated that M.R. suffered ITP caused-
in-fact by the MMR vaccination he received on November 7, 2017. A separate
damages order will be issued.
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
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