VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-02130
Package ID: USCOURTS-cofc-1_21-vv-02130
Petitioner: Tandy Hamilton
Filed: 2021-11-03
Decided: 2025-09-15
Vaccine: influenza
Vaccination date: 2018-10-29
Condition: thrombocytopenic purpura
Outcome: denied
Award amount USD: 

AI-assisted case summary:
On November 3, 2021, Tandy Hamilton filed a petition under the National Vaccine Injury Compensation Program, alleging he suffered from thrombocytopenic purpura (ITP) after receiving an influenza vaccine on October 29, 2018. Mr. Hamilton, born November 23, 1951, had a history of ITP dating back to 2008 and also suffered from bleeding hemorrhoids, which were the likely source of an iron deficiency anemia. He had been recommended for a hemorrhoidectomy by Dr. Jason Weiss. Following his flu vaccination, Mr. Hamilton experienced mouth blisters and a significant drop in platelet count, leading to hospitalization and treatment with intravenous immunoglobulin (IVIG) and prednisone. His platelet count improved, but he later required another hospitalization for IVIG and rituximab therapy due to persistent thrombocytopenia. His rituximab therapy concluded on December 12, 2018. Mr. Hamilton's primary argument was that his ITP, or its complications, lasted more than six months post-vaccination, primarily due to a delay in his hemorrhoid surgery. He contended that his surgeon, Dr. Weiss, delayed the surgery because of his ITP and rituximab treatment, and that he continued to suffer from anemia and hemorrhoids during this delay. He also argued that his IVIG treatment constituted a surgical intervention. The respondent argued that Mr. Hamilton's ITP resolved within two months of vaccination, that rituximab was a treatment, not a complication, and that there was no reliable evidence he was advised to wait six months for surgery due to rituximab. The respondent also contended that IVIG treatment was not a surgical intervention. Special Master Herbrina D. S. Young reviewed medical records, physician statements, and medical literature. The Special Master found that Mr. Hamilton failed to provide preponderant evidence that his ITP or its alleged complications met the six-month severity requirement. The medical records indicated his platelet counts normalized by December 19, 2018, and remained normalized. While Dr. Choi's letter stated surgery had to be delayed until a higher platelet level was achieved, it did not specify a six-month delay post-vaccination or post-rituximab completion. The Special Master found no medical record evidence supporting a contraindication for surgery for several months after rituximab completion, nor did Dr. Choi's records indicate a six-month delay was advised. Mr. Hamilton's own statement about Dr. Choi advising him to wait "a few months" was found inconsistent with the medical records. Furthermore, the Special Master determined that Mr. Hamilton's IVIG treatment did not qualify as a surgical intervention under the Vaccine Act, referencing the Federal Circuit's decision in Leming v. Secretary of Health & Human Services, and noting that IVIG administration is typically performed by nurses and not considered surgical in nature. Consequently, Mr. Hamilton's petition was denied.

Theory of causation field:
Petitioner Tandy Hamilton, age 67, received an influenza vaccine on October 29, 2018, and alleged a Table injury of thrombocytopenic purpura (ITP). The core issue was whether Petitioner met the Vaccine Act's severity requirement of suffering residual effects or complications for more than six months post-vaccination. Petitioner argued that a delay in his hemorrhoid surgery, necessitated by his ITP and rituximab treatment, constituted a complication lasting over six months, and alternatively, that his IVIG treatment qualified as a surgical intervention during hospitalization. Medical records showed Petitioner's ITP resolved by December 19, 2018, with normalized platelet counts thereafter. The Special Master found no preponderant evidence that Petitioner's treaters advised a six-month delay for surgery due to ITP or rituximab, nor that the delay itself constituted a qualifying complication. Petitioner's argument that IVIG treatment was a surgical intervention was also rejected, as it was not of a surgical variety. Petitioner's claim was denied by Special Master Herbrina D. S. Young on September 15, 2025.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_21-vv-02130-0
Date issued/filed: 2025-09-15
Pages: 17
Docket text: PUBLIC DECISION (Originally filed: 8/21/2025) regarding 49 DECISION of Special Master Signed by Special Master Herbrina D S Young. (gf) Service on parties made.
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Case 1:21-vv-02130-UNJ Document 50 Filed 09/15/25 Page 1 of 17
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: August 21, 2025
* * * * * * * * * * * * * * *
TANDY HAMILTON, *
*
*
Petitioner, * No. 21-2130V
*
v. * Special Master Young
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * *
Courtney Christine Jorgenson, Siri & Glimstad, LLP, Phoenix, AZ, for Petitioner.
Ryan Nelson, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION ON ENTITLEMENT1
On November 3, 2021, Tandy Hamilton (“Petitioner”) filed a petition pursuant to the
National Vaccine Injury Compensation Program.2 Petitioner alleged that he “suffered a Table
[i]njury, specifically thrombocytopenic purpura”3 (“ITP”) after receiving the influenza (“flu”)
1Because this Decision 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 Decision 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 National Childhood Vaccine Injury Act of 1986, Pub L. No. 99-660, 100 Stat. 3755 (“the Vaccine Act”
or “Act”). Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent
subparagraph of 42 U.S.C. § 300aa (2018).
3 Thrombocytopenic purpura is “any form of purpura in which the platelet count is decreased.”
Thrombocytopenic Purpura, DORLAND’S MED. DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=101173&searchterm=thrombocytopenic+purpura.
Platelets are “disk-shaped structure[s] . . . found in the blood of all mammals and chiefly known for
[their] role in blood coagulation.” Platelets, DORLAND’S MED. DICTIONARY ONLINE. Purpura is “any of a
group of conditions characterized by ecchymoses or other small hemorrhages in the skin, mucous
membranes, or serosal surfaces; causes include blood disorders, vascular abnormalities, and trauma.”
Purpura, DORLAND’S MED. DICTIONARY ONLINE. It also refers to “any of several conditions similar to
the traditional purpura group, which may be caused by decreased platelet counts, platelet abnormalities,

Case 1:21-vv-02130-UNJ Document 50 Filed 09/15/25 Page 2 of 17
vaccine on October 29, 2018. Pet. at 1, ECF No. 1. After carefully analyzing and weighing all the
evidence presented in this case in accordance with the applicable legal standards,4 I find that
Petitioner has not provided preponderant evidence that he “suffered the residual effects or
complications of such illness, disability, injury, or condition for more than [six] months after the
administration of the vaccine,” pursuant to the Vaccine Act’s severity requirement. § 11(c)(1)(D).
Accordingly, Petitioner is not entitled to compensation.
I. Procedural History
Petitioner filed his petition and personal statement on November 3, 2021. Pet.; Pet’r’s Ex
1, ECF No. 1. He filed medical records on November 14, 2021, and a statement of completion on
January 12, 2022. Pet’r’s Exs. 1–11, ECF Nos. 6, 9. In response to a status report filed by
Respondent, Petitioner filed additional requested medical records on January 4, 2023. Pet’r’s Exs.
12–14, ECF No. 18.
On February 13, 2023, Respondent filed his Rule 4(c) report and argued that “there is not
preponderant evidence that [P]etitioner suffered the residual effects of his alleged vaccine injury
for more than six months after his vaccination on October 29, 2018.” Resp’t’s Report at 13, ECF
No. 21. Petitioner filed an affidavit of no records and a statement of completion on February 20,
2023, and February 21, 2023, respectively. ECF Nos. 22–23. In response to Respondent’s
arguments, Petitioner filed a letter from his treating hematologist on August 30, 2023. Pet’r’s Ex.
16, ECF No. 24. On September 6, 2023, Petitioner filed additional medical records. Pet’r’s Ex. 17,
ECF No. 25. Petitioner also filed a direct rebuttal to Respondent’s assertion on September 21,
2023. Pet’r’s Br., ECF No. 26. On December 28, 2023, I issued an order noting that “the evidence
in the record is insufficient to support by preponderant evidence that residual effects or
complications of Petitioner’s ITP lasted for more than six months.” Order at 2, ECF No. 28.
Petitioner continued to file medical literature along with a statement from Dr. Thomas
Zizac and his own supplemental statement on January 29, 2024. Pet’r’s Exs. 18–21, ECF No. 30.
Petitioner also filed a response to my order on February 12, 2024. Pet’r’s Response, ECF No. 34.
Respondent filed a response on March 15, 2024, and Petitioner filed his reply on April 2, 2024.
Resp’t’s Response, ECF No. 36; Pet’r’s Reply, ECF No. 37. The parties filed another round of
responses due to the emergence of additional authority with Petitioner filing on May 7, 2024, and
Respondent filing his response on May 21, 2024. Pet’r’s Supp. Reply, ECF No 40; Resp’t’s Supp.
Reply, ECF No. 41. Petitioner filed a final reply on June 5, 2024. ECF No. 42. This matter is now
ripe for consideration.
vascular defects, or reactions to drugs.” Id. An ecchymosis is “a small hemorrhagic spot[] . . . in the skin
or mucous membrane forming a nonelevated, rounded or irregular, blue or purplish patch.” Ecchymosis,
DORLAND’S MED. DICTIONARY ONLINE.
4 While I have reviewed all of the information filed in this case, only those filings and records that are
most relevant to the decision will be discussed. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d
1322, 1328 (Fed. Cir. 2016) (“We generally presume that a special master considered the relevant record
evidence even though he does not explicitly reference such evidence in his decision.”) (citation omitted);
see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (“Finding
certain information not relevant does not lead to—and likely undermines—the conclusion that it was not
considered.”).
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Case 1:21-vv-02130-UNJ Document 50 Filed 09/15/25 Page 3 of 17
II. Summary of Relevant Evidence
a. Medical Records
Petitioner was born on November 23, 1951. Pet’r’s Ex. 12 at 2. His medical history prior
to the 2018 flu vaccination includes bilateral knee osteoarthritis. See Pet’r’s Ex. 7 at 43. Medical
records also indicate that Petitioner had a prior history of ITP as early as 2008. See Pet’r’s Ex. 11
at 285. On September 4, 2018, Petitioner saw Dr. James Y. Choi, a hematologist at the Virginia
Piper Cancer Center, for evaluation of normocytic anemia.5 Pet’r’s Ex. 3 at 4. Petitioner’s
bloodwork, dated August 15, 2018, revealed a normal white blood cell count and platelet level. Id.
Petitioner returned to Dr. Choi on September 19, 2018, and his lab results showed both an iron
deficiency and low vitamin B12. Pet’r’s Ex. 3 at 35. Records from this appointment also noted a
past medical history of ITP. Pet’r’s Ex. 10 at 6. Dr. Choi recommended that Petitioner undergo
total IV iron replacement therapy and start oral vitamin B12 supplements. Pet’r’s Ex. 3 at 35. Dr.
Choi also noted that Petitioner had bleeding hemorrhoids6 which were likely the source of his iron
deficiency and referred him to a colorectal surgeon. Id. Petitioner underwent total IV iron
replacement therapy on September 24, 2018. Id. at 64.
On October 10, 2018, Petitioner saw a colorectal surgeon, Dr. Jason Weiss. Pet’r’s Ex. 10
at 9. Petitioner reported that he had been dealing with hemorrhoids for several years and an
examination revealed prolapsing left lateral and right posterior mixed hemorrhoids and weak
sphincter tone. Id. at 9–10. Dr. Weiss recommended a hemorrhoidectomy7 due to the large size of
the hemorrhoids. Id. at 11.
Petitioner received an intramuscular flu vaccination on October 29, 2018. Pet’r’s Ex. 2 at
2.
On November 6, 2018, Petitioner had a follow-up appointment with Dr. Choi. Pet’r’s Ex.
3 at 63–64. Labs from November 1, 2018, showed improved iron levels, low vitamin B12 levels,
and normal platelets. Id. at 64–69. Petitioner went to Banner Urgent Care on November 10, 2018,
with a complaint of blood blisters in his mouth. Pet’r’s Ex. 9 at 13. He was directed to follow up
with his primary care provider (“PCP”) and hematologist. Id. at 15. Two days later, on November
12, 2018, Petitioner saw nurse practitioner (“N.P”), Krista Hawkins, at his PCP’s office. Pet’r’s
5 Normocytic anemia is “anemia with erythrocytes of normal size but a proportionate decrease in
hemoglobin content, packed red cell volume, and a number of erythrocytes per cubic millimeter of blood.
Normocytic Anemia, DORLAND’S MED. DICTIONARY ONLINE. Anemia is “a reduction below normal in
the concentration of erythrocytes or hemoglobin in the blood, . . . it occurs when the equilibrium is
disturbed between blood loss . . . and blood production.” Anemia, DORLAND’S MED. DICTIONARY
ONLINE. An erythrocyte is “one of the elements found in peripheral blood.” Erythrocyte, DORLAND’S
MED. DICTIONARY ONLINE. Hemoglobin is “the red oxygen-carrying pigment of erythrocytes.”
Hemoglobin, DORLAND’S MED. DICTIONARY ONLINE.
6 A hemorrhoid is a “prolapse of an anal cushion, resulting in pleading and painful swelling in the anal
canal.” Hemorrhoid, DORLAND’S MED. DICTIONARY ONLINE.
7 A hemorrhoidectomy is the “excision of hemorrhoids.” Hemorrhoidectomy DORLAND’S MED.
DICTIONARY ONLINE.
3

Case 1:21-vv-02130-UNJ Document 50 Filed 09/15/25 Page 4 of 17
Ex. 3 at 274. Petitioner reported a three-day history of a bleeding mouth ulcer. Id. Petitioner
declined a blood draw at his PCP’s office and planned to see his hematologist or seek emergency
care. Id. at 276. Later that same day, Petitioner presented to the Banner Thunderbird Medical
Center Emergency Department (“ED”). Pet’r’s Ex. 11 at 285. His chief complaint was a three-day
history of mouth blisters. Id. Petitioner also reported that he had ITP after a knee surgery in 2008,
and that “he went to his hematologist [two] weeks ago because his platelets were low.” Id. On
examination, multiple hemorrhagic bullae8 were noted inside his mouth. Id. at 286. His platelet
count was low at 1 K/MM3. Id. at 287. Petitioner was admitted to the hospital to start intravenous
immunoglobulin9 (“IVIG”) and an oral prednisone course. Id.
Dr. Choi enlisted his associate, hematologist and oncologist Dr. Joan M. Dahmer, for a
consultation with Petitioner on November 12, 2018. Pet’r’s Ex. 11 at 275. Dr. Dahmer wrote that
Petitioner’s ITP “was possibly triggered by the flu shot, but I am keeping an open mind.” Id. at
276. Dr. Dahmer also noted that Petitioner’s hemoglobin levels were not low enough to explain
fatigue, and suspected Petitioner’s low iron levels to be a contributor. Id. A November 14, 2018
progress note from Dr. Dahmer noted that Petitioner was “[a]sking about banding ‘since they can’t
do surgery.’ I think unless there is substantial bleeding from those hemorrhoids, that any procedure
should wait for stabilization [sic] of his [platelet] count.” Pet’r’s Ex. 11 at 257–58. Petitioner was
discharged on November 16, 2018. Pet’r’s Ex. 11 at 271. His mucosal bleeding was resolved, and
his platelet count had increased to 18,000. Id. at 271, 274.
On November 20, 2018, follow-up bloodwork at the ED recorded Petitioner’s platelets had
decreased to 2,000 with no present bleeding. Pet’r’s Ex. 11 at 415, 622. Petitioner was admitted to
the hospital for another round of IVIG and ordered to start Rituxan.10 Id. at 621. Due to his
hemorrhoidal bleeding, Petitioner received one unit of platelets on November 22, 2018. Id. at 617.
Petitioner was discharged on November 24, 2018, with a platelet count of 29, 000. Id. at 381, 620.
Following this hospitalization, Petitioner saw Dr. Choi on November 27, 2018. Pet’r’s Ex.
3 at 89. Dr. Choi described Petitioner as having “now steroid refractory ITP” and recommended
that Petitioner receive rituximab weekly for four weeks. Id. at 90. Dr. Choi also noted that
Petitioner, “ha[d] bleeding hemorrhoids and will require treatment with his colorectal surgeon once
the thrombocytopenia issue is resolved.” Id. Petitioner’s rituximab therapy began on November
21, 2018, and was completed on December 12, 2018. Pet’r’s Ex. 3 at 150. Records from a follow-
up with Dr. Choi on December 19, 2018, documented that Petitioner’s platelet counts were “now
normalized,” at 173,000. Id. at 158. Dr. Choi’s office faxed a copy of this December 19, 2018
record to Petitioner’s colorectal surgeon, Dr. James Weiss, later that day. See Pet’r’s Ex. 14 at 23–
8 A bulla is “a large blister.” Bulla, DORLAND’S MED. DICTIONARY ONLINE.
9 Immunoglobulin refers to “any of the structurally related glycoproteins that function as antibodies.”
Immunoglobulin, DORLAND’S MED. DICTIONARY ONLINE.
10 Rituxan is a “trademark for a preparation of rituximab.” Rituxan, DORLAND’S MED. DICTIONARY
ONLINE. Rituximab is “a chimeric murine/human monoclonal antibody that binds the CD 20 antigen.”
Rituximab, DORLAND’S MED. DICTIONARY ONLINE. Hereinafter, I will refer to Petitioner’s course of
treatment as “rituximab” unless specifically quoting a source that references Rituxan.
4

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25. Dr. Choi requested Petitioner return in two months, and Petitioner was directed to call if he
developed any bruising, rashes, bleeding or petechiae.11 Id. at 150.
The next day, on December 20, 2018, Petitioner received a call and voicemail from Dr.
Weiss’s office to schedule an appointment. Pet’r’s Ex. 14 at 8. The following day, on December
21, 2018, Petitioner saw N.P. Hawkins. Pet’r’s Ex. 3 at 272. N.P. Hawkins noted Petitioner’s recent
hospitalization and that a “specialist [was] concerned that [the flu] vaccine led to these events.” Id.
On February 20, 2019, Petitioner returned to see Dr. Choi with a platelet count that had
“remain[ed] normalized” at 275,000. Pet’r’s Ex. 3 at 186–88. Dr. Choi noted that Petitioner “ha[d]
bleeding hemorrhoids and will require treatment with his colorectal surgeon. [Petitioner] state[d]
he will contact the surgeon when he is ready.” Id. at 187. Petitioner’s ITP history was documented
in PCP visit records on March 13, 2019, and he denied easy bruising or excessive bleeding. Id. at
269. This visit, along with others in May, was not related to Petitioner’s ITP, although it was
always similarly noted in his medical history. Id. at 270, 271; Pet’r’s Ex. 4 at 6.
On August 19, 2019, Petitioner called his hematologist’s office to report that he “is going
to schedule his hemorrhoid surgery.” Pet’r’s Ex. 12 at 2. Petitioner wanted “to know if he should
get his blood checked and if any other special precautions should be taken before he schedules.”
Id. Dr. Choi ordered a comprehensive metabolic panel, iron, total iron binding capacity, and iron
saturation labs. Id. at 6–9. Petitioner saw Dr. Choi on August 20, 2019, who noted that Petitioner’s
platelet count “remain[ed] normalized.” Pet’r’s Ex. 14 at 16–17.
Petitioner underwent a left lateral hemorrhoidectomy on September 4, 2019. Pet’r’s Ex. 14
at 14. Dr. Weiss noted Petitioner’s ITP and that his platelet count was at “219[,000] on August 19,
2019.” Id. at 6. On September 17, 2019, Petitioner presented for a post-hemorrhoidectomy
appointment with Dr. Weiss. Pet’r’s Ex. 4 at 199. Dr. Weiss noted that Petitioner’s bleeding post-
surgery had resolved, and that his platelets and hemoglobin were higher than before surgery. Id.
An October 22, 2019, “phone note” indicated that Petitioner called Dr. Weiss to report some
discomfort and rectal bleeding. Pet’r’s Ex. 14 at 4. Petitioner was advised this could be because
the wounds had not completely healed, and he deferred an in-person appointment. Id.
On February 6, 2020, Petitioner saw Dr. Kevin Houlihan for an annual examination. Pet’r’s
Ex. 13 at 34. Under his history of present illness, Dr. Houlihan recorded that Petitioner “developed
a flare of ITP after receiving this season’s flu vaccine. Would like to hold off on other vaccines at
this time until he speaks with his Hematologist, Dr. Choi.” Id. Dr. Houlihan further noted that
Petitioner “presents with a diagnosis of thrombocytopenic purpura. This was diagnosed years ago.
The course has been episodic. It is of severe intensity. Platelet counts dropped to 1[,000] with this
season’s flu vaccine.” Id. Routine labs, taken at Dr. Houlihan’s direction, were collected on
February 6, 2020. Pet’r’s Ex. 13 at 86. Petitioner’s platelet count was normal at 253,000. Id.
Petitioner also sought unrelated treatment for his left shoulder through April of 2020. Id. at 107.
A note from Petitioner’s August 17, 2020 telehealth appointment with Dr. Houlihan recorded
Petitioner’s ITP history and listed his status as “uncertain.” Id. at 28–29. This call was also
unrelated. Id.
11 Petechia is “a pinpoint, nonraised, perfectly round, purplish red spot caused by intradermal or
submucous hemorrhage.” Petechia, DORLAND’S MED. DICTIONARY ONLINE.
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About six months later, on February 8, 2021, Petitioner presented for a follow-up visit with
Dr. Houlihan. Pet’r’s Ex. 13 at 21. His ITP was again listed in his “Past Medical History.” Id.
Routine labs, which were collected on February 8, 2021, revealed that Petitioner’s platelet count
was normal at 182,000. Id. at 79. Labs were repeated on December 6, 2021, and Petitioner’s
platelet count remained normal at 227,000. Id. at 76. Repeat labs were completed on March 4,
2022, and Petitioner’s platelet count remained in normal range at 189,000. Id. at 72. Petitioner’s
most recently filed platelet count is from September 28, 2022, and it recorded a normal platelet
count at 195,000. Id. at 67.
b. Petitioner’s Sworn Statement
Petitioner submitted a sworn statement, dated November 2, 2021. See generally Pet’r’s Ex.
1. Petitioner averred that his “surgeon continued to delay [his] surgery for [his] hemorrhoids
because of the potential complications due to ITP.” Id. at 3. Petitioner also averred that he
“continued to suffer from anemia due to the bleeding,” and that even after concluding his
medication, he had stiff and painful joints “for probably another six months after the infusions.”
Id. He continued that his doctor “indicated this was a side effect of the medications.” Id. Finally,
Petitioner averred that he was “not able to have the corrective surgery on [his] hemorrhoids until
October 2019 – the delay of which and [his] continuing symptoms were directly attributable to
[his] ITP.” Id. at 3.
On February 12, 2024, Petitioner filed a supplemental statement to clarify the
circumstances surrounding his delayed colorectal surgery. See generally Pet’r’s Supp. Statement,
ECF No. 34. Petitioner explained that although as of February 20, 2019, his “platelets were above
the bottom line for normal, they were still fluctuating.” Id. at 3. He recounted the two issues that
Dr. Choi identified with Petitioner “having [his] prior scheduled surgery.” Id. Due to Petitioner’s
platelet fluctuation, Dr. Choi “said he thought [Petitioner] should wait a few months before getting
the surgery just to be safe.” Id. Additionally, “the surgery was contraindicated within six months
of concluding [r]ituximab therapy.” Id. Petitioner averred that as a direct consequence of his ITP,
he “waited over six months after the conclusion of [his] [r]ituximab therapy before [he] started the
process to have [] surgery.” Id. He concluded that his bloodwork on August 19, 2019, six months
after the conclusion of his rituximab, showed a platelet count within normal range; and his surgery
was performed on September 4, 2019. Id.
c. Physician Letters
On August 30, 2023, Petitioner filed a letter dated August 28, 2023, from his treating
hematologist, Dr. Choi. Pet’r’s Ex. 16. Dr. Choi’s one page statement explained that “[d]ue to the
persistent thrombocytopenia, [Petitioner] had hemorrhoidal surgery that had to be delayed until a
higher level was achieved.” Id. Dr. Choi continued that Petitioner’s rituximab therapy, “was
completed on 12/12/2018 with subsequent resolution of the thrombocytopenia.” Id.
Petitioner also filed a statement from Dr. Thomas Zizac.12 Pet’r’s Ex. 21. Dr. Zizic is an
Associate Professor of Medicine at Johns Hopkins University. Id. at 1. He was previously their
12 Petitioner did not file Dr. Zizac’s CV; however, his sworn statement details his relevant experience and
authority.
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Case 1:21-vv-02130-UNJ Document 50 Filed 09/15/25 Page 7 of 17
Associate Director of Rheumatic Disease. Id. Dr. Zizac is also “a founding fellow of the American
College of Rheumatology.” Id. He received his medical degree from Johns Hopkins and completed
his internship and residency there in internal medicine. Id. Dr. Zizac was a rheumatology post-
doctoral fellow at Johns Hopkins before serving “as a flight surgeon at the School of Aerospace
Medicine at Brooks Airforce Base, San Antonio, Texas.” Id. He had a private practice in
rheumatology for fifteen years before joining academia full time. Id. Dr. Zizac is a past President
of the Maryland Society of Rheumatic Disease, and he has “published approximately 100 articles
and abstracts in peer reviewed journals as well as several dozen chapters in textbooks of medicine.”
Id.
Dr. Zizac conceded that “he has not reviewed [Petitioner’s] medical chart,” and noted that
his statement is not offered to “give an expert opinion” on causation. Pet’r’s’ Ex. 21 at 2. Dr. Zizac
did review Petitioner’s supplemental statement and asserted that “the American College of
Rheumatology guidelines recommend a six-month waiting period after the last Rituximab dosage
prior to undergoing elective surgery.” Id. In support of this contention, Dr. Zizac relied on an
article discussing perioperative immunosuppressive use, and guidelines for perioperative
management of antirheumatic medication. Id. He argued that “surgery in close proximity to
completion of [r]ituximab therapy is contraindicated.” Id. (emphasis omitted).
d. Medical Literature
The Micheal & Auron13 article filed by Petitioner, “highlight[s] the peri-operative
immunosuppressive management and doses suggested for patients with rheumatic diseases.”
Pet’r’s Ex. 19 at 1. The authors explain that rituximab is a monoclonal antibody that is used to
treat many conditions, including the chronic diseases: rheumatoid arthritis, lupus, and vasculitis.
Id. at 4. One side effect of the therapy is “B cell depletion within [two] to [three] weeks after a
dose.” Id. at 4. While B cell levels will eventually normalize after treatment, “[p]atients may
experience a significant drop in immunoglobulin levels, which remains for up to six months after
initiating rituximab.” Id. This could potentially leave rituximab patients more susceptible to
infection during this period if they undergo an operation. Id. Noting the “scant data about the use
of rituximab in the perioperative period,” the authors referenced the Goodman et al.14 article’s
suggestion to monitor “IgG levels, at least 100 days after rituximab dose, and if levels normalize,
then proceed further with elective surgery.” Id. at 5; see generally Pet’r’s Ex. 20. The authors
caution that “[i]f levels remain abnormal, then administration of [IVIG] is advised prior to
surgery.” Pet’r’s Ex. 19 at 5.
The Micheal & Auron article referenced “the American College of Rheumatology 2017
Guideline, recommend[ing] a [six]-month wait period after the last rituximab dose, to schedule
elective hip or knee surgery.” Pet’r’s Ex. 19 at 5. Likewise filed by Petitioner, the evidence-based
guideline is for “management of antirheumatic drug therapy for adults with rheumatoid arthritis
13 Madonna Michael & Moises Auron, Perioperative Immunosuppressive Use in Patients with
Rheumatologic Diseases, 3 J. XIANGYA MED. 38 (2018).
14 Susan M. Goodman et al., 2017 American College of Rheumatology/American Association of Hip and
Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients
with Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty, 69 ARTHRITIS CARE
& RESEARCH 1111 (2017).
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(“RA”), spondyloarthritis [“SpA”], juvenile idiopathic arthritis (“JIA”), or systemic lupus
erythematosus (“SLE”).” Pet’r’s Ex. 20 at 2. The authors specify that the “guideline is to be used
for those who have elected and have been deemed appropriate candidates for [hip or knee surgery].
We would caution against extrapolation of this guideline to other orthopedic procedures until
further data are available.” Id. at 3. Furthermore, “[t]his guideline does not address . . . medical
decisions unrelated to antirheumatic drug therapy . . . or perioperative evaluation and management
of concurrent disease.” Id. The authors explain that “[p]atients with rheumatic diseases undergoing
total hip arthroplasty and total knee arthroplasty are at increased risk for periprosthetic joint
infection.” Id. “Biologic medications[, including rituximab,] should be withheld as close to [one]
dosing cycle as scheduling permits prior to the elective [surgeries] and restarted after evidence of
wound healing, typically 14 days, for all patients with rheumatic disease.” Id. at 6. For example,
“[p]atients treated with rituximab every [six] months would schedule their surgery, when possible,
at the week after the first withheld dose during month [seven]. Id. at 7. In making this
recommendation, the Goodman et al. explained:
[A] systematic review, meta-analysis, and network meta-analysis revealed that
infection risk for biologic agents is strongly associated with high-dose therapy
(higher dose than the standard) and may not be associated with low-dose biologic
agents, so serum half-life may not correspond to the duration of the
immunosuppressant effect. The dosing cycle was therefore chosen as more relevant
in determining the withholding interval and timing the surgery at the end of the
dosing interval at the nadir of the drug effect.
Id. at 6.
III. Parties’ Arguments
a. Petitioner’s Six-Month Severity Requirement Brief
On September 21, 2023, Petitioner filed his brief to respond to Respondent’s contention
that the six-month severity requirement had not be met in this case. Pet’r’s Br. Petitioner argued
that generally, the six-month requirement can be met in one of multiple ways because, “residual
effects or complications and symptomatic are not synonymous.” Id. at 2 (citing Faup v. Sec’y of
Health & Hum. Servs., No. 12-78V, 2015 WL 443802 (Fed. Cl. Spec. Mstr. Jan. 13, 2015)). He
explained that his case involves complications that lasted at least six months, due to an inability to
undergo elective surgery for an unrelated symptomatic condition. Id. The recommended treatment
for Petitioner’s pre-existing hemorrhoids and anemia included elective surgery. Id. However, “[a]s
a result of his vaccine-induced ITP, his surgery was delayed for several months beyond what it
would have been.” Id. Petitioner likened this to an injury suffered by an individual who fainted
after an allergic reaction to a vaccine. Id. In both instances, the petitioner is “hurt[], requiring six
or more months of treatment,” not due to the immediate adverse effect of the vaccine, “but for the
consequential injury.” Id.
Petitioner argued that he suffered from hemorrhoids, and “[t]he surgery that would have
fixed that underlying medical issue was cancelled because his platelet levels had fallen below the
safe level for surgery.” Pet’r’s Br. at 3. Petitioner also continued “to suffer from anemia due to the
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bleeding.” Id. at 4. Petitioner stated that his hemorrhoid surgery had to be delayed until September
17, 2019, due to his ITP and treatment regimen, and thus, “he continued suffering complications
directly attributable to his ITP well beyond the six-month mark” following his October 29, 2018
flu vaccination. Id. at 3. Petitioner acknowledged that his platelet counts “started to normalize
between December 2018 and February 2019, although they continued to fluctuate.” Id. He argued
that “his surgeon continued to delay the surgery for hemorrhoids because of the potential
complications due to ITP.” Id.
On February 12, 2024, Petitioner filed a second brief in response to the Court’s December
29, 2023 order. Pet’r’s Response. In my order, I noted that in addition to his September 21, 2023
brief, Petitioner also filed a letter authored by his hematologist, Dr. James Choi, dated August 28,
2023. I concluded that although this letter supports that Petitioner’s surgery initially needed to be
delayed following his ITP onset, it does not address whether the surgery was ultimately delayed
for more than six months post vaccination because of Petitioner’s ITP. I then “allow[ed] Petitioner
an opportunity to submit evidence in support of his contention that his surgery was delayed for
more than six months as a result of his ITP.” Order at 2. Petitioner recounted his sworn statement
detailing a conversation he had with Dr. Choi. Specifically, Petitioner stated that Dr. Choi “thought
[he] should wait a few months before getting the surgery just to be safe.” Pet’r’s Response at 3.
Petitioner stated that Dr. Choi also “told [him] that surgery was contraindicated within six months
of concluding rituximab therapy.” Id. at 3. Lastly, Petitioner referred to Dr. Zizac’s statement that
asserted, “[a]s a result of his vaccine-induced ITP, his surgery was delayed for several months
beyond what it would have been, based not only on doctor’s recommendation, but on American
College of Rheumatology guidelines as to elective surgeries following receipt of [r]ituximab.” Id.
b. Respondent’s Six-Month Severity Requirement Brief
Respondent summarized his rebuttal to Petitioner in his March 15, 2024 response:
[First], in the instant case, there is no evidence that ITP caused a permanent or
ongoing injury in [P]etitioner lasting at least six months. Second, rituximab therapy
is not a complication of ITP; it is a treatment. Third, there is no reliable evidence
that [P]etitioner was ever advised that he needed to wait six months for surgery due
to the administration of rituximab, and [P]etitioner instead relies solely on evidence
that some types of surgery could be delayed due to chronic rituximab use in patients
with autoimmune diseases that does not appear to be applicable to this case.
Resp’t’s Response at 8–9.
Petitioner’s vaccination occurred on October 29, 2018, and the six-month severity
requirement would be satisfied by symptomology through at least April 29, 2019. Respondent
noted that “Petitioner’s platelets normalized by December 19, 2018,” and “remained normal with
repeat testing on February 20, 2019.” Resp’t’s Response at 10. Respondent argued that his ITP
“resolved by December 19, 2018, within two months of the subject ITP diagnosis, and repeat
testing at four months post vaccination shows that his condition did not return.” Id.
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Furthermore, Respondent argued that “there is no medical record evidence that [P]etitioner
was advised, at any time after December 19, 2018, that surgery would be contraindicated due to
his ITP, low platelet levels, or based on the fact that he received one course of rituximab.” Resp’t’s
Response at 10. Respondent referred to Dr. Dahmer’s note that “surgery was only contraindicated
‘given [Petitioner’s] severe thrombocytopenia’ documented at 5,000 on November 14, 2018, and
explained that Petitioner should wait until his platelets stabilized.” Id. (citing Pet’r’s Ex. 11 at 263).
Dr. Zizic’s opinion should be entirely discounted, according to Respondent, for several
reasons. As an initial matter, Dr. Zizac stated that he has “not reviewed [P]etitioner’s medical
chart,” and he instead relies solely on Petitioner’s statement. Resp’t’s Response at 10 (citing Pet’r’s
Ex. 21 at 2). Respondent noted that the medical records from Dr. Choi’s office do not mention any
needed delay due to Petitioner’s treatment, that rituximab played any role in the surgery’s delay,
nor did any records from Dr. Weiss indicate a delay in the surgery was necessary due to Petitioner’s
ITP treatment. Id. at 11.
Respondent also discussed Petitioner’s filed medical literature cited by Dr. Zizac. He noted
that the article filed by Petitioner “cautions that it is limited to patients with RA, SpA, JIA, or SLE
who take these medications and nothing in the article references ITP or acute periods of treatment
with rituximab, lasting only one month.” Resp’t’s Response at 14. The article “does not state that
[P]etitioner was required to wait six months before he could have surgery.” Id. The Goodman et
al. article “recommended a patient-specific and dose-specific withholding cycle prior to surgery
that is consistent with their recommendations for all other biologic agents, timing surgery at the
end of the dosing interval at the nadir of the drug effect.” Id. at 15. The Michael & Auron article
referred to the Goodman et al. article for the six-month wait period, but Respondent noted that this
“recommendation does not appear anywhere in Goodman et al.” Id.
Respondent contended that “if [P]etitioner was advised that he was at serious risk for an
infection, or that surgery was contraindicated for some other reason as a result of his rituximab
exposure, it belies credibility that Dr. Choi would have failed to note that in his records.” Resp’t’s
Response at 19. It is also noteworthy to Respondent that Petitioner told Dr. Choi during his
February 20, 2019 follow-up appointment that “he will contact the surgeon when he is ready.” Id.
c. Petitioner’s Reply Brief
Petitioner reiterated in his reply filed on April 2, 2024, that he does not claim to have
suffered from residual symptoms for six months. Pet’r’s Reply. “Instead, Petitioner maintains that
the delay in colorectal surgery and continued symptoms are a clear complication that arises directly
from the ITP.” Id. at 2. Conceding that the medical record does not document the relevant
conversation between him and Dr. Choi, Petitioner argued that the “[a]bsence of evidence is not
evidence.” Id. He noted “that any perceived inconsistencies between the testimony and the
contemporaneous medical records can be overcome by clear, cogent and consistent testimony
explaining the discrepancies. Id.
There is almost exactly six months between Petitioner’s follow-up appointment with Dr.
Choi on February 20, 2019, that revealed his platelet count was stable and his surgical
preoperational visit on August 19, 2019. Pet’r’s Reply at 3. Petitioner asserted that the only
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reasonable explanation for why he would wait that specific length of time is because that is what
he was told to do. Id. Therefore, he should not now be penalized and precluded from compensation
for taking his treater’s advice. Id. at 5.
On May 7, 2024, Petitioner filed a supplemental brief to address the Federal Circuit’s
decision in Leming v. Sec’y of Health & Hum. Servs. Pet’r’s Supp. Reply (citing 98 F.4th 1107
(Fed. Cir. 2024)). He argued that “[l]ike a biopsy, an IVIG infusion is a ‘surgical act or measure
for diagnostic or therapeutic purposes taken to prevent harm of a patient or to improve the health
of a patient.’” Id. at 3. While “maintain[ing] that the delay in colorectal surgery and ongoing
complaints due to delay following his ITP and Rituximab satisfy the severity requirement of 42
U.S.C. § 300aa–11(c)(1)(D)(i),” Petitioner also argued that Petitioner’s IVIG treatment satisfies §
11(c)(1)(D)(iii). Id. at 4.
Petitioner also addressed Spooner, a pre-Leming case where the special master found that
IVIG treatments were interventions because they were therapeutic, but not surgical because of the
nursing function of an IVIG. ECF No. 42 at 2; see Spooner v. Sec’y of Health & Hum. Servs., No.
13-159V, 2014 WL 504728 (Fed. Cl. Spec. Mstr. Jan. 16, 2014). In his final briefing, dated June
5, 2024, Petitioner asserted that the Spooner reasoning would not survive Leming because “[i]t is
now controlling law that that the phrase ‘surgical intervention’ . . . included surgical act or measure
for diagnostic or therapeutic purposes taken to prevent harm of a patient or to improve the health
of a patient[].” ECF No. 42 at 2. He concluded that the nursing function should not be a factor for
consideration. Id.
d. Respondent’s Reply Brief
On May 21, 2024, Respondent filed a reply to address Petitioner’s reliance on Leming.
Resp’t’s Supp. Reply. Respondent asserted that a piggyback administration of IVIG is not
analogous to a bone marrow biopsy as a surgical procedure. Id. at 2. The surgical nature of a biopsy
was not contested in Leming as “the procedure was performed by a surgeon, involved the insertion
of a specialized instrument to remove tissue, required general anesthesia and a surgical consent
form, resulted in a surgical report, and required recovery in the post-surgical care unit.” Id. at 3
(emphasis added). Conversely, Petitioner’s IVIG was administered bedside, by a nurse, and
without anesthesia. Id. In Leming, the issue was the therapeutic versus diagnostic nature of the
treatment. Id. Respondent asserted that the therapeutic purpose of Petitioner’s IVIG treatment is
not at issue presently. Id. Therefore, Leming is inapplicable. Id.
IV. Applicable Legal Standard
The Vaccine Act provides petitioners with two avenues to receive compensation for their
injuries resulting from vaccines or their administration. First, a petitioner may demonstrate that
she suffered a “Table” injury—i.e., an injury listed on the Vaccine Injury Table that occurred
within the provided time period. § 11(c)(1)(C)(i). The Vaccine Injury Table lists thrombocytopenic
purpura as a compensable injury if it occurs within seven to thirty days after administration of a
rubella-containing vaccine. § 300aa-14(a), as amended by 42 C.F.R. § 100.3. To establish that he
suffered a Table injury of thrombocytopenic purpura, a petitioner must show that his injury is
consistent with the Table’s qualifications and aids to interpretation (“QAIs”) for thrombocytopenic
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purpura. See 42 C.F.R. § 100.3(c). The QAIs state that thrombocytopenic purpura “is defined by
the presence of clinical manifestations, such as petechiae, significant bruising, or spontaneous
bleeding, and by a serum platelet count less than 50,000/mm3.” 42 C.F.R. § 100.3(c)(7).
Alternatively, a petitioner may receive compensation by demonstrating that he suffered an “off-
Table injury,” one not listed on the Table, as a result of his receiving a covered vaccine. See §
11(c)(1)(C); Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010);
Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1319–20 (Fed. Cir. 2006). This would
include a petitioner alleging that any other covered vaccine, e.g. flu, caused him to suffer from
thrombocytopenic purpura, even within the seven-to-thirty-day Table period.
Under either method, however, a petitioner must also show that the injured person
(i) suffered the residual effects or complications of his illness, disability, injury, or
condition for more than six months after the administration of the vaccine, or (ii)
died from the administration of the vaccine, or (iii) suffered such illness, disability,
injury, or condition from the vaccine which resulted in inpatient hospitalization and
surgical intervention[.]
§§ 11(c)(1)(D)(i)–(iii). Cases may appropriately be dismissed for failure to substantiate the
severity requirement. See, e.g., Hinnefeld v. Secy of Health & Hum. Servs., No. 11-328V, 2012
WL 1608839, at *4–5 (Fed. Cl. Spec. Mstr. Mar. 30, 2012) (dismissing case where medical history
revealed that petitioner’s Guillain–Barré Syndrome resolved less than two months after onset).
Petitioner has not alleged, and the record does not support, that death resulted from vaccination.
Thus, Petitioner must establish either that he “suffered the residual effects or complications of his
illness, disability, injury, or condition for more than six months after the administration of the
vaccine,” or that he “suffered such illness, disability, injury, or condition from the vaccine which
resulted in inpatient hospitalization and surgical intervention.” See §§ 11(c)(1)(D)(i), (iii).
It is Petitioner’s burden to prove his case, including the six-month requirement, by a
preponderance of the evidence. See § 13(a)(1)(A). To satisfy the six-month requirement, “[a]
potential petitioner must do something more than merely submit a petition and an affidavit
parroting the words of the statute.” Faup v. Sec’y of Health & Hum. Servs., No. 12-87V, 2015 WL
443802, at *3 (Fed. Cl. Spec. Mstr. Jan. 13, 2015) (quoting Black v. Sec’y of Health & Hum. Servs.,
33 Fed. Cl. 546, 550 (1995), aff’d, 93 F.3d 784, 792 (Fed. Cir. 1996)). A petitioner cannot establish
the length or ongoing nature of an injury merely through his or her own statements, but rather is
required to “submit supporting documentation which reasonably demonstrates that the alleged
injury or its sequelae lasted more than six months.” Black, 33 Fed. Cl. at 550 (internal quotations
omitted); see also Lett v. Sec’y of Health & Hum. Servs., 39 Fed. Cl. 259, 260–61 (1997) (“Section
300–aa13(a)(1) provides that a special master may not award compensation ‘based on the claims
of [a] petitioner alone, unsubstantiated by medical records or by medical opinion’”).
In Program cases, contemporaneous medical records and the opinions of treating
physicians are favored. Capizzano, 440 F.3d at 1326 (citing Althen v. Sec’y of Health & Hum.
Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005)). Indeed, when reviewing the record, a special master
must consider the opinions of treating physicians. Id. In addition, “[m]edical records, in general,
warrant consideration as trustworthy evidence. The records contain information supplied to or by
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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 & Hum. Servs., 993 F.2d
1525, 1528 (Fed. Cir. 1993). While a special master must consider these opinions and records,
they are not “binding on the special master or court.” 42 U.S.C. § 300aa-13(b)(1); see also
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1346–49 (Fed. Cir. 2010)
(affirming the special master’s finding that the petitioner suffered from one disease even though
the petitioner’s treating doctor had diagnosed the petitioner with a different disease). Rather, when
“evaluating the weight to be afforded to any such . . . [evidence], the special master . . . shall
consider the entire record.” § 13(b)(1).
The Federal Circuit has clarified the meaning of “residual effects and complications” to
satisfy the six-month severity requirement in the context of ITP. See Wright v. Sec’y of Health &
Hum. Servs., 22 F.4th 999 (Fed. Cir. 2022). The Circuit held that a petitioner failed to satisfy the
six-month requirement when her child, B.W.’s, platelet count normalized less than three months
post ITP onset because his “relatively non-invasive ongoing [platelet] monitoring” was not a
“residual effect” pursuant to § 300aa–11(c)(1)(D)(i). Id. at 1001, 1003, 1006–07. The Circuit noted
that the child experienced later bruising that was not related to his vaccine injury and that his
ongoing testing “did not reveal, constitute, or cause any somatic change.” Id. at 1001. Defining the
language in § 300aa–11(c)(1)(D)(i), the Federal Circuit determined that “[t]he term ‘residual
effects[]’ . . . requires a change within the patient that is caused by the vaccine injury.” Id. at 1004.
It continued that “‘[r]esidual’ suggests something remaining or left behind from a vaccine injury .
. . . Because vaccine injuries are somatic conditions defined by their signs and symptoms within
the patient, . . . their residues are similarly defined.” Id. at 1005–06.
The Federal Circuit stated that the use of the words “suffered” and “complication” in
association with “residual effects” in § 300aa–11(c)(1)(D)(i) “suggest that Congress contemplated
residual effects to be detrimental conditions within the patient, such as lingering or recurring signs
and symptoms.”15 Wright, 22 F.4th at 1006. Complication is also defined as “[a] morbid process
or event occurring during a disease which is not an essential part of the disease, although it may
result from it.” Id. (internal citations omitted); see also Complication, DORLAND’S ONLINE MED.
DICTIONARY (“1. a disease or diseases concurrent with another diseases. 2. The concurrence of
two or more diseases in the same patient.”). It concluded that “[r]ead together, ‘residual effects’
and ‘complications’ appear to both refer to conditions within the patient, with ‘residual effects’
focused on lingering signs, symptoms, or sequelae characteristic of the court of the original vaccine
injury, and ‘complications’ encompassing conditions that may not be ‘essential part[s] of the
disease’ or may be outside the ordinary progression of the vaccine injury.” Wright, 22 F.4th at
1006.
A more recent decision by the Circuit addressed the meaning of “inpatient hospitalization
and surgical intervention.” Leming, 98 F.4th 1107. The statute is silent as to the definition of
surgical and relying on Dorland’s Medical Dictionary, the Circuit understood “surgical
intervention to require an act or measure taken to prevent harming of a patient or to improve the
health of a patient, and is of the surgical variety, for either diagnostic or therapeutic purposes. Id.
15 The Federal Circuit clarified that its decision “do[es] not disturb existing case law holding that a course
of treatment lasting longer than six months can be a ‘residual effect.’” Wright, 22 F.4th at 1006.
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at 1111 (emphasis added). The legislative intent behind a 2000 amendment also provided a
cosponsor quote that was cited in the case: “the modified program makes compensation available
if the injury requires a hospital stay or surgery.” Id. (citing 146 Cong. Rec. H8206 (daily ed. Sep.
27, 2000) (statement of Rep. Gilman)).
V. Discussion
Petitioner received the vaccine at issue on October 29, 2018. Thus, in order to fulfill the
severity requirement, Petitioner must establish by preponderant evidence that he: (1) suffered the
residual effects or complications for more than six months after the administration of the vaccine,
until at least April 29, 2018; or (2) suffered such illness, disability, injury, or condition from the
vaccine which resulted in inpatient hospitalization and surgical intervention. See §§ 11(c)(1)(D)(i)
and (iii). There is no dispute that Petitioner’s ITP fully resolved prior to April 29, 2018. In his
reply brief, Petitioner reiterated that he satisfies the six-month threshold, not due to residual effects
of ITP, but because his ITP treatment necessitated a delay in his colorectal surgery and the
continued symptoms qualify as a complication that lasted six months. Alternatively, Petitioner
argued that his IVIG treatment qualifies as a surgical intervention that occurred while he was
hospitalized. However, Petitioner has failed to present preponderant evidence of either prong to
satisfy the severity requirement.
a. Residual Effects or Complications
Petitioner argued that based on his treater’s advice, he delayed his colorectal surgery for
six months after the conclusion of his rituximab treatment and continued to suffer from anemia
and hemorrhoids during that time. This suffering, he contended, qualifies as a complication.
Respondent does not address whether the delay in Petitioner’s surgery or the symptoms that he
continued to suffer would qualify as a morbid process or event that resulted from his ITP, i.e. a
complication. Also, Respondent does not address generally if a delay in treatment for an unrelated
disease is a morbid event that is not essential to the vaccine injury but is nonetheless a result of it.
In this case, Respondent argued that the delay was not on advice of a treating medical professional,
not necessary, and therefore not relevant to his claim. Setting aside the issue of whether this type
of event could ever qualify as a complication, I find in this case that Petitioner has not provided
preponderant evidence that it does at present.
Petitioner asserted that he waited to schedule his surgery at the behest of his treater, Dr.
Choi, and offered in support of said assertion the six-month time frame between his February
follow-up and his August call scheduling of the surgery. However, nothing in the records from Dr.
Choi, nor the letter that he submitted suggests that he told Petitioner to wait until September for
his surgery. The medical records provide the following timeline:
Date Event Pet’r’s Ex.
November 21, 2018 Petitioner begins rituximab. 3 at 150.
December 12, 2018 Petitioner ends rituximab. 3 at 150.
December 19, 2018 Dr. Choi characterized Petitioner’s platelet count as “now 14 at 23.
normalized” at 173,000.
Dr. Choi faxed a record of Petitioner’s count to Dr. Weiss.
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December 20, 2018 Dr. Weiss called Petitioner and left voicemail for him to 14 at 8.
schedule an appointment.
February 20, 2019 Dr. Choi noted that Petitioner’s platelet count has “remained 3 at 187.
normalized” at 275,000.
Dr. Choi noted that Petitioner will require treatment with his
surgeon.
Petitioner stated to Dr. Choi, “he will contact the surgeon
when he is ready.”
August 19, 2019 Petitioner called Dr. Weiss office to ask if “he should get his 12 at 2.
blood checked,” because he is going to schedule his surgery.
August 20, 2019 Petitioner’s count “remained normalized.” 14 at 16.
September 4, 2019 Petitioner underwent surgery. 14 at 14.
The letter that Dr. Choi submitted stated that “[d]ue to the persistent thrombocytopenia,
the patient had hemorrhoidal surgery that had to be delayed until a higher [platelet] level was
achieved. The patient underwent rituximab therapy for [four] doses which was completed on
12/12/2018 with subsequent resolution of the thrombocytopenia.” Pet’r’s Ex. 16 at 1. As
Respondent has noted, there is nothing in Petitioner’s medical record that suggests a
contraindication for Petitioner’s surgery for a period of several months after the conclusion of his
therapy. Furthermore, when given the opportunity to clarify the effect that ITP and corresponding
treatment would have on Petitioner’s ability to have colorectal surgery, Dr. Choi’s letter only stated
that the surgery had to be delayed until a higher level was achieved. Dr. Choi first described
Petitioner’s platelet levels as normalized in December of 2018. Assuming Petitioner’s argument,
it is unclear why the six-month delay would not have started on the day that Petitioner concluded
his therapy, which would have been December 12, 2018. Furthermore, the “higher level” that Dr.
Choi described was first indicated in the medical record on December 19, 2018. Indeed, it was
following the appointment on this date that Dr. Weiss was contacted and his office reached out to
Petitioner. It is unclear why the six-month delay would not have started on the day Dr. Choi
documented Petitioner’s normalized platelet count and alerted his surgeon. Either of these starting
points would have placed potential dates for Petitioner’s surgery in June, three months sooner than
the realized surgery date. Records from February 20, 2019, do not indicate Petitioner entered a
new status in terms of his diagnosis. Dr. Choi noted that his platelet count remained as it was in
December: normalized. Indeed, Petitioner’s count had “remained normalized” for two months. It
is unclear why this date would be appropriate to begin the six-month delay.
In my December 29, 2023 order, I alerted Petitioner to the lack of preponderant evidence
that explains the delay, even after considering Dr. Choi’s August 28, 2023 letter. In response,
Petitioner submitted a statement that Dr. Choi told him to wait “a few months” before scheduling
this surgery. As Respondent noted, this is inconsistent with Dr. Choi’s repeated notations in
Petitioner’s medical record that he should undergo surgery once his platelet levels are higher, i.e.
normalized. It is inconsistent with Dr. Choi immediately alerting Dr. Weiss of Petitioner’s lab
results, and Dr. Weiss’s response in contacting Petitioner for an appointment. It is also inconsistent
with Dr. Choi’s record keeping of his interactions with Petitioner, including their conversations.
See Pet’r’s Ex. 3 at 187 (Petitioner stating that “he will contact the surgeon when he is ready”).
Petitioner correctly noted that clear, cogent, and consistent testimony can explain inconsistencies
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between a layperson’s recollection and medical records. In this case, Petitioner’s explanation
leaves additional questions unresolved.
Lastly, Dr. Zizac’s statement and accompanying medical literature are not particularly
helpful given the facts in this case. It is true that Dr. Zizac did not need to review Petitioner’s
medical record to opine generally that rituximab therapy is a contraindication to colorectal surgery
within six months. However, his reliance on Petitioner’s statement and admitted unreview of
Petitioner’s medical record casts doubt on the applicability of his statements to the present case.
For example. Dr. Zizac cited to the American College of Rheumatology guideline to conclude that
a six-month waiting period should follow rituximab therapy prior to elective surgery. The literature
that was filed in support of this contraindication is in the context of rheumatology patients suffering
from chronic illnesses: RA, SpA, JIA or SLE, that typically affect the joints, who then undergo
hip or knee (joint) surgery. The literature cautioned against expanding the guideline beyond these
parameters and also note that increased infection may only be associated with high-dose treatment
regiments. ITP was not mentioned in any of these articles, and Dr. Zizac did not explain how
Petitioner’s rituximab treatment for ITP prior to hemorrhoidal surgery is appropriately analogous
to an RA patient undergoing knee surgery. Furthermore, he does not reconcile the discrepancy
over whether and why the six-month delay should start at treatment conclusion, platelet
normalization, or some period of time after platelet normalization. Lastly, he does not address the
doctor’s vague statement, according to Petitioner, to wait several months, if indeed six months is
the appropriate amount of time despite Dr. Choi’s less specific contraindication, notwithstanding.
After a review of all the evidence, including but not limited to Petitioner’s medical records,
his statements, the opinion of his expert, and filed literature, I do not find that the record contains
preponderant evidence that Petitioner’s treaters advised Petitioner to wait six months following his
February 20, 2019 follow-up appointment with Dr. Choi to schedule his colorectal surgery. Nor is
there preponderant evidence that Dr. Choi’s actual recommendation—for Petitioner to wait to
schedule his surgery until his platelet counts had returned to normal—resulted in Petitioner’s
hemorrhoid surgery being scheduled for greater than six months post vaccination. Accordingly, I
do not find preponderant evidence that Petitioner’s extended suffering from hemorrhoids and
anemia due to his delayed surgery is a direct result of his ITP and treatment. Petitioner has not
satisfied the severity requirement by establishing he suffered a residual effect or complication
pursuant to the Act.
b. Surgical Intervention
Alternatively, Petitioner argued that his IVIG treatment qualifies as a surgical intervention
undertaken during an inpatient hospitalization and thereby satisfies the severity requirement.
Petitioner cited the Circuit’s decision in Leming to assert that “[i]t is now controlling law that the
phrase ‘surgical intervention,’ as used in the Act included surgical act or measure for diagnostic
or therapeutic purposes taken to prevent harm of a patient or to improve the health of a patient,
which was required to be conducted as a result of the vaccine injury, so long as the vaccine
recipient was also hospitalized as an inpatient.” Pet’r’s Reply at 2 (emphasis added). Petitioner
sought to characterize IVIG as “a measure for diagnostic or therapeutic purposes” and focus on
the Circuit’s rejection of previous case law that discounted medical treatments performing a
nursing function. Pet’r’s Supp. Reply at 3. That line of reasoning is misplaced here, however.
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Petitioner’s fatal error is the failure to consider that the Circuit intended “surgical” to apply to both
act and measure. Petitioner is correct that the Leming analysis included the requirement of a
surgical act or measure, but the analysis does not stop there. Petitioner extracted this requirement
from a more comprehensive discussion of what constitutes a surgical intervention. Additional
context reveals the Circuit ultimately concluded that “[r]elying on these Dorland’s dictionary
definitions taken together, we understand ‘surgical intervention’ to require an act or measure
taken to prevent harming of a patient or to improve the health of a patient, and is of the surgical
variety, for either diagnostic or therapeutic purposes.” Leming, 98 F.4th at 1111 (emphasis added).
The significance and placement of “surgical” is determinative. Assuming that Petitioner’s IVIG is
a measure taken to improve the health of a patient, and is for a therapeutic purpose, it must still be
of a surgical variety. The Circuit noted “the hospitalization and the surgery must both be casually
related to the recipient’s negative reaction to the vaccine.” Id. at 1113. Surgery is defined by
Dorland’s as treatment done “by manual or operative means,” and “work performed by a surgeon.”
Surgery, DORLAND’S MED. DICTIONARY ONLINE.
As noted by Respondent, in Leming, the procedure in question was performed by a surgeon,
in a hospital room, under anesthesia, and entailed the manual removal of tissue. While all of those
factors need not be present for an operation, IVIG administration requires none. In Elvira v. Sec’y
of Health & Hum. Servs., the special master noted that the Circuit left “unaddressed the question
of what factors or circumstances would allow for the conclusion that a given act or measure is of
the surgical variety.” No. 17-531V, 2024 WL 4966035 at *15 (Fed. Cl. Spec. Mstr. Nov. 6, 2024)
(internal citations omitted). Historically, “special masters have typically examined in each instance
whether a needle-based procedure was considered by the treating hospital to have been a surgical
procedure.” Id. Notably, the special master in Elvira specifically cited to the conclusion in Spooner
that IVIG is not surgical when framing his analysis of Leming. Id. (citing Spooner, 2014 WL
504728 at *12–13). Here, there is no evidence that the hospital considered Petitioner’s IVIG
therapy to be of the surgical variety. Further, the Spooner analysis continues to provide guidance
related to the surgical nature of an act or measure, specifically in relation to IVIG treatments. See
generally 2014 WL 504728. After consideration of the parties’ arguments and applicable case law
(cited and reviewed), Petitioner has not presented preponderant evidence that his IVIG therapy
qualifies as a surgical intervention in satisfaction of the Act’s severity requirement.
VI. Conclusion
After a careful review of the record, Petitioner has failed to prove by preponderant evidence
that his injury lasted for six months after his October 29, 2018 vaccination, pursuant to the Vaccine
Act’s severity requirement. Accordingly, I DENY Petitioner’s claim and DISMISS his petition.16
IT IS SO ORDERED.
s/Herbrina D. S. Young
Herbrina D. S. Young
Special Master
16 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of a notice
renouncing the right to seek review.
17