VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-01534
Package ID: USCOURTS-cofc-1_19-vv-01534
Petitioner: Christina Mitchell
Filed: 2019-10-02
Decided: 2025-04-22
Vaccine: influenza
Vaccination date: 2016-10-09
Condition: chronic immune thrombocytopenic purpura (ITP)
Outcome: compensated
Award amount USD: 310181.42

AI-assisted case summary:
Christina Mitchell filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that she suffered chronic immune thrombocytopenia purpura (ITP) as a result of an influenza vaccination she received on October 9, 2016. The respondent argued against compensation. The court found that Ms. Mitchell provided sufficient evidence that her flu vaccine caused her ITP, satisfying the requirements for an off-Table claim. The medical records indicated that prior to the vaccination, Ms. Mitchell was generally healthy, though a 2013 record showed a slightly low platelet count. Following the vaccination, she experienced symptoms consistent with ITP, including bruising and heavy menstruation, leading to a diagnosis of severe thrombocytopenia. Her condition was treated with various medications, including prednisone, Rituxan, IVIG, Nplate, and Promacta, and was ultimately classified as chronic ITP. Petitioner's experts, Dr. Abhimanyu Ghose and Dr. Marc Serota, opined that molecular mimicry was the likely mechanism by which the flu vaccine caused Ms. Mitchell's ITP, citing various studies and case reports. Respondent's experts, Dr. Lisa Baumann Kreuziger and Dr. Neil Romberg, disagreed, suggesting alternative causes such as a prior viral infection or a history of thrombocytopenia, and questioning the link between the flu vaccine and ITP. The court weighed the evidence and expert opinions, ultimately finding in favor of Ms. Mitchell. A Ruling on Entitlement was issued on January 11, 2023, granting her compensation. Subsequently, a Decision Awarding Damages was issued on April 22, 2025, awarding Ms. Mitchell a total of $310,181.42. This amount included $180,000.00 for pain and suffering, $7,676.42 for past unreimbursed expenses, $15,150.00 for past lost earnings, and $107,355.00 for future lost earnings.

Theory of causation field:
Influenza vaccine (Fluarix) on October 9, 2016, adult exact age not stated, followed about 35 days later by chronic ITP with bruising, heavy menstruation/bleeding symptoms, severe thrombocytopenia, steroid dependence, IVIG, Rituxan, Nplate, and Promacta. COMPENSATED. Petitioner's Dr. Abhimanyu Ghose and Dr. Marc Serota supported molecular mimicry/immune platelet destruction; respondent's Dr. Lisa Baumann Kreuziger and Dr. Neil Romberg proposed alternative viral or preexisting thrombocytopenia explanations. Special Master Dorsey granted entitlement January 11, 2023 and awarded $310,181.42 on April 22, 2025 ($180,000 pain/suffering + $7,676.42 expenses + $15,150 lost earnings + $107,355 future lost earnings).

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_19-vv-01534-0
Date issued/filed: 2023-07-11
Pages: 39
Docket text: PUBLIC DECISION (Originally filed: 1/11/2023) regarding 78 Ruling on Entitlement. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made.
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Case 1:19-vv-01534-UNJ Document 94 Filed 07/11/23 Page 1 of 39
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: January 11, 2023
* * * * * * * * * * * * * * * * * * * * * * * * *
CHRISTINA MITCHELL, * PUBLISHED
*
Petitioner, * No. 19-1534V
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Ruling on Entitlement; Influenza (“Flu”)
AND HUMAN SERVICES, * Vaccine; Immune Thrombocytopenia
* Purpura (“ITP”).
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
David John Carney, Green & Schafle LLC, Philadelphia, PA, for Petitioner.
Andrew Henning, U.S. Department of Justice, Washington, DC, for Respondent.
RULING ON ENTITLEMENT1
I. INTRODUCTION
On October 2, 2019, Christina Mitchell (“Petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42
U.S.C. § 300aa-10 et seq. (2012).2 Petitioner alleges that she suffered chronic immune
thrombocytopenia purpura (“ITP”) as the result of an influenza (“flu”) vaccination administered
on October 9, 2016. Petition at Preamble (ECF No. 1). Respondent argued against
1 Because this Ruling contains a reasoned explanation for the action in this case, the undersigned
is required to post it on the United States Court of Federal Claims’ website in accordance with
the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services). This means the Ruling 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, the undersigned agrees that the
identified material fits within this definition, the undersigned will redact such material from
public access.
2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§ 300aa-10 to -34 (2012). All citations in this Ruling to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.

Case 1:19-vv-01534-UNJ Document 94 Filed 07/11/23 Page 2 of 39
compensation, stating that “an award of compensation under the [Vaccine] Act is not
appropriate.” Respondent’s Report (“Resp. Rept.”) at 1 (ECF No. 25).
After carefully analyzing and weighing the evidence presented in this case in accordance
with the applicable legal standards, the undersigned finds that Petitioner has provided
preponderant evidence that her flu vaccine caused her ITP, satisfying Petitioner’s burden of
proof under Althen v. Secretary of Health & Human Services, 418 F.3d 1274, 1280 (Fed. Cir.
2005). Accordingly, Petitioner is entitled to compensation.
II. ISSUES TO BE DECIDED
Diagnosis is not at issue. The parties’ experts agree that the proper diagnosis is ITP.
Joint Pre-Hearing Submission (“Joint Submission”), filed May 6, 2022, at 1 (ECF No. 68). More
specifically, the parties agree Petitioner has been diagnosed with chronic ITP. Id. The parties do
not dispute that Petitioner received a flu vaccine on October 9, 2016. Id. However, the parties
dispute the onset of Petitioner’s ITP. Id.
Petitioner does not allege a Table injury, and thus, Petitioner must prove causation-in-fact
in accordance with Althen by preponderant evidence. Petitioner submitted two expert reports
and supporting medical literature as evidence that molecular mimicry is the mechanism by which
the flu vaccine can cause ITP. Petitioner’s Motion for Ruling on the Record (“Pet. Mot.”), filed
May 6, 2022, at 27-40 (ECF No. 71). Petitioner’s expert, Dr. Marc Serota, opines that the flu
vaccine Petitioner received on October 9, 2016 caused her ITP. Id. at 43. Petitioner argues that
because “there were no other causal agents that preceded the onset of ITP except for the [flu]
vaccination, there exists a logical sequence of cause and effect that is supported by expert
opinion.” Id. Lastly, Petitioner alleges she developed ITP within 35 days of receiving her flu
vaccination. Id. at 41-42. “Based on the evidence that exists in this case and the medical
literature that currently exists, Petitioner has more than carried her burden of proof and should be
entitled to compensation under the Vaccine Act.” Id. at 48.
Respondent disagrees with Petitioner and argues Petitioner has not proven the Althen
prongs by preponderant evidence. Resp. Response to Pet. Mot. (“Resp. Response”), filed June
24, 2022, at 10-20 (ECF No. 76). Respondent argues that Petitioner (1) “has [] not established a
persuasive medical theory causally connecting the flu vaccine to ITP,” (2) “has not established a
logical sequence of cause and effect showing that the flu vaccine was the reason for her ITP,”
and (3) “has not demonstrated a proximate temporal relationship between the flu vaccine and her
alleged injury.” Id.
2

Case 1:19-vv-01534-UNJ Document 94 Filed 07/11/23 Page 3 of 39
III. BACKGROUND
A. Medical Terminology
Immune thrombocytopenia,3 also referred to as immune thrombocytopenia purpura or
idiopathic thrombocytopenia purpura,4 “is an acquired thrombocytopenia caused by
autoantibodies against platelet antigens.” Pet. Exhibit (“Ex.”) 20(aa) at 1.5
“Adult chronic [ITP] is an autoimmune disorder manifested by immune-mediated
thrombocytopenia. It manifests clinically by varying degrees of purpura[6] and mucosal bleeding
depending in large part on the severity of the thrombocytopenia.” Pet. Ex. 17(a) at 1.7
Additional manifestations include petechiae,8 epistaxis,9 and severe hemorrhage. Pet. Ex. 20(aa)
3 Thrombocytopenia is a “decrease in the number of platelets.” Thrombocytopenia, Dorland’s
Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=49875 (last
visited Dec. 27, 2022).
4 To avoid confusion, the undersigned will refer to immune thrombocytopenia, idiopathic
thrombocytopenia purpura, and immune thrombocytopenia purpura as ITP throughout this
Ruling.
5 Donald M. Arnold & Adam Cuker, Immune Thrombocytopenia (ITP) in Adults: Clinical
Manifestations and Diagnosis, UpToDate, https://www.uptodate.com/contents/immune-
thrombocytopenia-itp-in-adults-clinical-manifestations-and-diagnosis (last updated July 2, 2020).
6 Purpura is “any of a group of conditions characterized by ecchymoses or other small
hemorrhages in the skin, mucous membranes, or serosal surfaces,” or “any of several conditions
similar to the traditional purpura group, which may be caused by decreased platelet counts[] [or]
platelet abnormalities.” Purpura, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=42170 (last visited Dec. 27, 2022).
7 Robert McMillan et al., Self-Reported Health-Related Quality of Life in Adults with Chronic
Immune Thrombocytopenic Purpura, 83 Am. J. Hematology 150 (2008).
8 Petechia is “a pinpoint, nonraised, perfectly round, purplish red spot caused by intradermal or
submucous hemorrhage.” Petechia, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=38200 (last visited Dec. 27, 2022).
9 Epistaxis is a nosebleed or “hemorrhage from the nose.” Epistaxis, Dorland’s Med. Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=16952 (last visited Dec. 27,
2022).
3

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at 7-9. “The clinical presentation of ITP is defined [as] less than 100,000 platelets per μl . . . .”
Pet. Ex. 17(d) at 1;10 see also Resp. Ex. H at 2.11
ITP can be classified as either primary or secondary. Resp. Ex. H at 2. Primary ITP is
defined as “an autoimmune disorder characterized by isolated thrombocytopenia (peripheral
blood platelet count < 100 ×109/L) in the absence of other causes or disorders that may be
associated with thrombocytopenia.” Id. Secondary ITP is all other forms of immune-mediated
thrombocytopenia that are due to underlying diseases such as systemic lupus erythematosus. Id.;
Pet. Ex. 20(aa) at 2.
“[A]n ITP diagnosis . . . should be regarded as persistent if it lasts between three and 12
months, including patients without a spontaneous recovery or those lacking a complete response
to treatment.” Pet. Ex. 17(d) at 2; see also Resp. Ex. H at 3. After 12 months from the diagnosis,
ITP is considered chronic. Pet. Ex. 17(d) at 2. ITP is considered “severe” if “bleeding occurs at
the onset or later, requiring treatment adjustment and additional medical care.” Id.
Both infections and vaccinations have been associated with the development of ITP. See,
e.g., Pet. Ex. 17(d) at 3-9; Pet. Ex. 17(e) at 4-7;12 Pet. Ex. 33 at 6;13 Resp. Ex. K at 3;14 Resp. Ex.
Q at 3-4.15 Associated infections include Helicobacter pylori (“H. pylori”), hepatitis C virus,
human immunodeficiency virus (“HIV”), Epstein-Barr virus (“EBV”), cytomegalovirus, upper
respiratory infections, sinusitis, tonsillitis, and chickenpox. Pet. Ex. 17(d) at 3-9; Pet. Ex. 33 at
6; Resp. Ex. K at 3; Resp. Ex. Q at 3. There is also an increased risk of ITP following the
10 M. Rinaldi et al., Immune Thrombocytopaenic Purpura: An Autoimmune Cross-Link Between
Infections and Vaccines, 23 Lupus 554 (2014).
11 Francesco Rodeghiero et al., Standardization of Terminology, Definitions and Outcome
Criteria in Immune Thrombocytopenic Purpura of Adults and Children: Report from an
International Working Group, 113 Blood 2386 (2009).
12 Carlo Perricone et al., Immune Thrombocytopenic Purpura (ITP) Associated with
Vaccinations: A Review of Reported Cases, 60 Immunologic Rsch. 226 (2014).
13 Nichola Cooper & James Bussel, The Pathogenesis of Immune Thrombocytopaenic Purpura,
133 Brit. J. Haematology 364 (2006).
14 Maurice Swinkels et al., Emerging Concepts in Immune Thrombocytopenia, 9 Frontiers
Immunology 1 (2018).
15 Bernward Zeller et al., Childhood Idiopathic Thrombocytopenic Purpura in the Nordic
Countries: Epidemiology and Predictors of Chronic Disease, 94 Acta Paediatrica 178 (2005).
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measles-mumps-rubella (“MMR”) vaccination.16 Pet. Ex. 17(c) at 1;17 Pet. Ex. 17(d) at 2; Pet.
Ex. 17(q) at 1.18 ITP has also been reported following vaccination for hepatitis A and B,
diphtheria-tetanus-acellular pertussis (“DTaP”), varicella, and flu. Pet. Ex. 17(d) at 2; Pet. Ex.
17(e) at 4.
B. Procedural History
Petitioner filed her petition on October 2, 2019, followed by medical records on October
14, 2019. Petition; Pet. Exs. 1-8. This case was reassigned to the undersigned on October 23,
2019. Notice of Reassignment dated Oct. 23, 2019 (ECF No. 9). Petitioner filed additional
medical records from February 2020 to June 2020. Pet. Exs. 9-14. On June 25, 2020,
Respondent filed his Rule 4(c) Report, in which he recommended against compensation. Resp.
Rept. at 1.
Petitioner filed expert reports from Dr. Abhimanyu Ghose and Dr. Serota along with
supporting medical literature on December 24, 2020. Pet. Exs. 15-20. On April 27, 2021,
Respondent filed expert reports and medical literature from Dr. Lisa Baumann Kreuziger and Dr.
Neil Romberg. Resp. Exs. A-BB. Thereafter, the undersigned held a Rule 5 conference on
August 12, 2021. Order dated Aug. 12, 2021 (ECF No. 48). The undersigned preliminarily
found Petitioner’s onset to be 35 days following her vaccination and that Petitioner would be
able to satisfy all three Althen prongs. Id. at 2.
Petitioner filed additional medical records on October 12, 2021. Pet. Ex. 21. After the
parties were unable to resolve this case informally, a status conference was held on January 11,
2022, and Petitioner was directed to file additional records. Order dated Jan. 11, 2022 (ECF No.
58). In January and March 2022, Petitioner filed additional medical records and an affidavit.
Pet. Exs. 22-32. In May 2022, Petitioner filed additional medical literature. Pet. Exs. 33-35.
On March 12, 2022, Petitioner filed a joint status report, indicating both Petitioner and
Respondent would like to resolve entitlement through a ruling on the record, and a briefing
schedule was set. Joint Status Rept., filed Mar. 12, 2022, at 1 (ECF No. 65); Ruling on the
Record Order dated Mar. 14, 2022 (ECF No. 66). On May 6, 2022, Petitioner filed a motion for
a ruling on the record and Respondent filed the parties’ joint submission. Pet. Mot.; Joint
Submission. Respondent filed his response to Petitioner’s motion on June 24, 2022, and
Petitioner filed a reply on July 8, 2022. Resp. Response; Pet. Reply Brief in Support of Pet. Mot.
(“Pet. Reply”), filed July 8, 2022 (ECF No. 77).
16 A presumption of causation is afforded under the Vaccine Injury Table for cases of ITP
following MMR if onset is between 7 and 30 days. 42 C.F.R. § 100.3(a)(V)(A).
17 E. Miller et al., Idiopathic Thrombocytopenic Purpura and MMR Vaccine, 84 Archives
Diseases Childhood 227 (2001).
18 Corri Black et al., MMR Vaccine and Idiopathic Thrombocytopaenic Purpura, 55 Brit. J.
Clinical Pharmacology 107 (2003). This article was also cited by both of Petitioner’s experts.
See also Pet. Ex. 20(q).
5

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This matter is now ripe for adjudication.
C. Factual History
1. Medical History
Prior to the vaccination at issue, Petitioner had a medical history that included annual
examinations, acute pharyngitis, acute bronchitis, strep throat, and upper respiratory infections.
Pet. Ex. 8 at 2-13; Pet. Ex. 9 at 1-7. On September 12, 2013, Petitioner went in for an annual
appointment with her OB/GYN. Pet. Ex. 12 at 6. At this appointment, her platelet count was
below normal at 137,000 (range 155,000-379,000). Id. at 7.
On October 9, 2016, Petitioner received the flu vaccination at issue; the Fluarix vaccine,
a trivalent flu vaccine. Pet. Ex. 1 at 3. On October 21, 2016, Petitioner saw her OB/GYN for her
annual visit. Pet. Ex. 3 at 11-12. Petitioner reported she felt dizzy during her menstrual period
and headaches the week prior. Id. She reported no other abnormalities during this appointment.
Id.
Petitioner had an appointment on December 7, 2016 with her OB/GYN due to a
prolonged, heavy period. Pet. Ex. 3 at 8. She reported heavy bleeding for eight days, passing
clots, and feeling dizzy. Id. Nurse practitioner, Elizabeth Newsome, performed a general
examination and noted no abnormalities. Id. She sent Petitioner for blood work including a
complete blood count (“CBC”) to confirm anemia. Id. She advised Petitioner to take an over-
the-counter iron supplement. Id. During this visit, Petitioner also reported cold-like symptoms
and was prescribed a Z-Pak19 to treat sinusitis. Id. The following day, on December 8, 2016,
Petitioner’s lab results came back showing a platelet count of 12,000 (range 150,000-400,000).
Id. at 13-14. Petitioner was advised her platelet count was critically low and she needed to see a
hematologist immediately. Id. at 13.
Dr. Gautam Kishore Kale, a hematologist-oncologist, evaluated Petitioner on December
12, 2016. Pet. Ex. 4 at 5. Dr. Kale noted Petitioner’s recent sinus infection and diagnosed
Petitioner with “[s]evere thrombocytopenia likely immune thrombocytopenia versus
thrombocytopenia due to recent upper respiratory tract infection.” Id. at 12. He noted that her
ITP “[c]ould be from an acute viral upper respiratory infection which hopefully will improve
over time and not cause chronic ITP.” Id. During this appointment, Petitioner also complained
of increased clumsiness and cognitive slowing. Id. Dr. Kale sent Petitioner for a computerized
tomography (“CT”) that showed no evidence of bleeding, however there was a 12 mm area of
19 Z-pak, or Zithromax or azithromycin, is “an azalide antibiotic . . . used in the treatment of mild
to moderate infections caused by susceptible organisms.” Azithromycin, Dorland’s Med.
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=5244 (last visited
Dec. 27, 2022); see also Zithromax, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=54062 (last visited Dec. 27, 2022).
6

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high density that Dr. Kale postulated was calcium or a meningioma.20 Id. at 12, 24. He did not
find it to be of concern and determined her symptoms could be from her upper respiratory
infection. Id. An ultrasound of her abdomen showed increased spleen size. Id. at 12. Petitioner
was prescribed prednisone21 to increase her platelet count. Id.
On December 19, 2016, Petitioner was seen for a follow up appointment. Pet. Ex. 4 at
18. Her platelet count had increased to 126,000. Id. at 24. Dr. Kale’s assessment was again
“severe thrombocytopenia likely immune thrombocytopenia versus thrombocytopenia due to
recent viral upper respiratory tract infection.” Id. He decided to taper her prednisone and
monitor her platelet count weekly with the hope that her ITP was not chronic and would improve
over time. Id. at 25.
After beginning the taper, Petitioner was seen for a follow up visit on December 27,
2016. Pet. Ex. 4 at 27, 30. Her platelet count had dropped to 32,000. Id. at 30, 33. Dr. Kale
increased her prednisone to 40 mg per day. Id. at 34.
On January 3, 2017, Petitioner was seen for another follow up appointment. Pet. Ex. 4 at
35. Her platelet count was stable at 42,000 on 40 mg of prednisone. Id. at 38, 42. Based on this,
Dr. Kale opined that Petitioner’s thrombocytopenia appeared to be steroid dependent. Id. at 42.
Dr. Kale and Petitioner discussed other treatment options including high dose dexamethasone22
and a slow prednisone taper, Rituxan,23 or a splenectomy.24 Id. Petitioner wanted to stop taking
steroids because they made her feel “a little edgy” and gain weight. Id. Petitioner decided to
consider these options and continue taking prednisone. Id. On January 10, 2017, Petitioner was
seen for another follow up appointment. Id. at 45. Petitioner had decided to start Rituxan and
continue taking prednisone until Rituxan became effective. Id. at 51.
20 Meningioma is “a benign, slow-growing tumor of the meninges.” Meningioma, Dorland’s
Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=30336 (last
visited Dec. 27, 2022).
21 Prednisone is “a synthetic glucocorticoid derived from cortisone, administered orally as an
anti-inflammatory and immunosuppressant in a wide variety of disorders.” Prednisone,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=
40742 (last visited Dec. 27, 2022).
22 Dexamethasone is administered as “an antiinflammatory and immunosuppressant in a wide
variety of disorders.” Dexamethasone, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=13599 (last visited Dec. 27, 2022).
23 Rituxan is used “in the treatment of CD20-positive, B-cell noon-Hodgkin lymphoma;
administered intravenously.” Rituximab, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=43977 (last visited Dec. 27, 2022).
24 Splenectomy is the “excision . . . of the spleen.” Splenectomy, Dorland’s Med. Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=46675 (last visited on Dec. 27,
2022).
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Petitioner was seen again on February 6, 2017. Pet. Ex. 4 at 53. Her diagnosis was
“isolated thrombocytopenia likely ITP.” Id. at 56. Petitioner was tapering off prednisone and
was taking 30 mg and reducing by five mg every five to seven days. Id. She had received three
of her four doses of Rituxan and was receiving her final dose that day. Id. Her platelet count
had dropped to 11,000 the previous week. Id. at 57. She had then received high dose
dexamethasone and her platelet count had increased to 183,000. Id. She had another follow up
appointment on February 13, 2017. Id. at 62. After tapering her prednisone to 20 mg per day,
Petitioner’s platelet count dropped to 9,000 and she experienced epistaxis (nosebleed). Id. at 68.
Her prednisone was increased to 60 mg per day. Id. at 69. She agreed to be admitted to the
hospital for intravenous immune globulin (“IVIG”)25 and to start Nplate.26 Id.
The next follow up appointment was March 1, 2017. Pet. Ex. 4 at 71. Petitioner had
responded well to IVIG and Nplate. Id. at 77. Her platelet count was up to 191,000. Id. Dr.
Kale explained to Petitioner that IVIG may remain effective for two-to-four weeks and since she
was two weeks post-treatment, he would continue to monitor her platelets closely. Id. at 77-78.
Dr. Kale tapered Petitioner’s prednisone to 15 mg a day and then recommended continuing the
taper with 10 mg per day for one week before stopping completely. Id. at 78. Dr. Kale’s
assessment at that visit was “severe labile immune thrombocytopenia (ITP).”27 Id. at 77. At this
visit, Dr. Kale did not reference a viral infection as the cause of Petitioner’s ITP.
Petitioner was seen for another follow up on March 15, 2017. Pet. Ex. 4 at 79. Petitioner
was down to 10 mg of prednisone and received Nplate 2 mcg/kg. Id. at 85. By her appointment
on March 30, 2017, Petitioner was off prednisone and her platelet count was at 101,000. Id. at
95. Petitioner continued to receive weekly Nplate treatments. Id. Again, Dr. Kale’s diagnosis
was “severe labile immune thrombocytopenia (ITP).” Id.
From April 2017 to July 2017, Petitioner’s platelet counts remained stable. Pet. Ex. 4 at
97-130. In August, her platelet count decreased to 50,000 “in the setting of an [upper respiratory
tract infection.” Id. at 134, 137. On October 17, 2017, Petitioner was seen by Dr. Alice De-Ling
25 IVIG is “used in the treatment of primary immunodeficiency disorders and [ITP].” Immune
Globulin Intravenous (Human), Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=78975 (last visited Dec. 27, 2022).
26 Nplate is a trademark for romiplostim, which is defined as “a thrombopoietin receptor agonist
used for treatment of [ITP].” Romiplostim, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=44074 (last visited Dec. 27, 2022); see
also Nplate, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/
definition?id=34407 (last visited Dec. 27, 2022).
27 Petitioner’s medical records continued to include references to idiopathic thrombocytopenia
purpura and/or ITP on the problem list and in other parts of the records. However, this visit
appears to mark the earliest date that Dr. Kale used the specific diagnosis of “immune
thrombocytopenia” without also referencing the alternative diagnosis of “thrombocytopenia due
to recent upper respiratory tract infection.”
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Ma, a hematologist at UNC Healthcare, “for a second opinion regarding therapy for chronic
ITP.” Pet. Ex. 6 at 8. Dr. Ma recommended either a splenectomy or Rituxan. Id. at 9. On
October 19, 2017, Petitioner returned to Dr. Kale and discussed similar treatment options. Pet.
Ex. 4 at 146. Petitioner decided she wanted to switch to Promacta28 with Nplate as a backup if
her platelet count dropped below 50,000. Id.
Petitioner’s diagnosis was confirmed as chronic ITP on November 16, 2017. Pet. Ex. 4 at
148. She began taking Promacta and was seen for various follow ups from November 2017
throughout 2018. Id. at 160-61, 169, 179, 183, 188, 191, 197, 200, 209, 215, 218, 224, 227. At
her December 7, 2018 follow up, her platelet count dropped to 39,000. Id. at 237. Dr. Kale
increased Petitioner’s Promacta dosage from 25 mg to 50 mg per day. Id.
Petitioner’s platelet count increased on December 19, 2018 to 248,000 on 50 mg
Promacta per day. Pet. Ex. 4 at 248. Dr. Kale switched her to alternating 25 mg and 50 mg
every other day, and her platelet count on January 11, 2019 was stable at 75,000. Id. at 248-49.
Petitioner mentioned she had gone to urgent care because she was having difficulty breathing,
and she had been prescribed 60 mg of Prednisone. Id. at 244; Pet. Ex. 7 at 6-8. However,
Petitioner claimed she had stopped taking the Prednisone prescribed during this appointment
three weeks ago. Pet. Ex. 4 at 244. In February 2019, Petitioner’s platelet count remained stable
on the alternating doses of Promacta. Id. at 257.
Dr. Kale ordered another CT, which was conducted on April 5, 2019, to check on
Petitioner’s meningioma. Pet. Ex. 4 at 264. The CT showed no change since 2017. Id. at 264,
267. Petitioner began to taper her Promacta by taking 50 mg three days a week and 25 mg the
other four days. Id. at 267. In June 2019, this was reduced to 50 mg twice a week and 25 mg
five days a week. Id. at 277. Petitioner tolerated this well in August. Id. at 285; Pet. Ex. 11 at 9,
16. On October 9, 2019, Petitioner’s platelets remained stable at 153,000, and Petitioner was
directed to taper her Promacta to 25 mg every day. Pet. Ex. 11 at 25, 31. On December 6, 2019,
Petitioner was clinically stable and her platelets were stable at 111,000. Id. at 39.
Dr. Ni Gorsuch, a hematologist, began seeing Petitioner on March 6, 2020, per the
Petitioner’s request. Pet. Ex. 14 at 19-37. Dr. Gorsuch and Petitioner discussed tapering off
Promacta; however, Petitioner decided to stay on Promacta for the time being. Id. at 27. On
June 4, 2020, Petitioner began the Promacta taper. Pet. Ex. 21 at 5. Petitioner discontinued
Promacta on June 19, 2020. Id. at 15. On July 16, 2020, Petitioner’s platelet count was 120,000
and Dr. Gorsuch noted Petitioner was stable without ITP relapse. Id. at 17-19. On October 19,
2020, Petitioner was seen by Dr. Gorsuch for a follow up. Id. at 23-31. Her ITP had not
relapsed. Id. at 24. This remained true throughout 2021. Pet. Ex. 21 at 32-37; Pet. Ex. 24 at 5-9.
28 Promacta, the trademark for eltrombopag olamine, “stimulates platelet production” and is
“used for the treatment of thrombocytopenia in patients with chronic [ITP] who have had an
insufficient response to other treatments.” Eltrombopag Olamine, Dorland’s Med. Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=15982 (last visited Nov. 7,
2022); see also Promacta, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=41191 (last visited Dec. 27, 2022).
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However, On January 11, 2022, Petitioner reported bruising and bleeding gums. Pet. Ex. 24 at
10. Her platelet count at this appointment was 110,000. Id. at 11.
No additional relevant medical records have been filed.
2. Petitioner’s Affidavits29
Prior to the vaccination at issue, Petitioner “was healthy, active[,] and had no
autoimmune diseases or hematological disorders, or any history of autoimmune disease or
hematological disorders.” Pet. Ex. 32 at ¶ 3. When Petitioner did get sick prior to the
vaccination in 2016, she sought care from an urgent care and CVS minute clinic instead of a
primary care physician. Id. at ¶¶ 6-7. In 2016, she began to establish care with permanent
primary care and medical providers. Id. at ¶ 7. Petitioner reviewed her 2013 medical records
that showed a slightly low platelet count. Id. at ¶ 12. She averred that at that time, she did not
have symptoms of decreased platelets. Id. Further, she was not notified of the 137,000 count,
nor was she instructed to return for follow up or seek treatment for this platelet count. Id.
Petitioner received her flu vaccine on October 9, 2016. Pet. Ex. 2 at ¶ 4. She started to
notice bruising on the front and back of her thighs in mid-November 2016, around two weeks
prior to her birthday on November 27, 2016. Id. at ¶¶ 10, 12. These bruises did not fade as
ordinary bruises she had in the past did. Id. at ¶ 10.
On November 30, 2016, Petitioner began menstruating. Pet. Ex. 2 at ¶ 15. Petitioner’s
cycle lasted for 10 days instead of her normal four to five days and she felt dizzy, lightheaded,
fatigued, and weak. Id. Petitioner continued to menstruate until December 9, 2016. Id.
On December 5, 2016, Petitioner developed a stuffy nose and other cold-like symptoms.
Pet. Ex. 2 at ¶ 16. She continued to experience “spontaneous bruising, dizziness,
lightheadedness, fatigue, weakness, and heavy menstruation[].” Id. The next day, Petitioner
made an appointment to see her OB/GYN. Id. at ¶ 17. On December 7, 2016, Petitioner visited
her OB/GYN where she underwent a full panel of blood work, and she was prescribed a Z-pak
for her stuffy nose. Id. at ¶ 18. On December 8, 2016, Petitioner’s physician notified her that
her “platelets were critically low at 12,000 and that [she] needed to see a hematologist as soon as
possible.” Id. at ¶ 19.
Dr. Kale saw Petitioner on December 12, 2016. Pet. Ex. 2 at ¶ 21. At this appointment,
she was diagnosed with ITP and was prescribed 60 mg of prednisone. Id. Petitioner’s platelet
count increased to 126,000 the following week and she began a prednisone taper. Id. at ¶ 22.
Petitioner returned for a follow up visit on December 27, 2016. Pet. Ex. 2 at ¶ 23. Her
platelet count had dropped to 32,000. Id. She restarted prednisone and her platelet count
increased. Id. Dr. Kale advised her she had ITP that was responsive to steroids and steroid
29 Petitioner submitted two affidavits executed on September 24, 2019 and March 3, 2022. Pet.
Exs. 2, 32. The second affidavit was not notarized.
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dependent. Id. In January 2017, Petitioner switched to Rituxan therapy and began to taper her
prednisone. Id. at ¶ 24. Petitioner’s platelets increased by early February 2017. Id.
Following a nosebleed, Petitioner returned to Dr. Kale’s office on February 12, 2017.
Pet. Ex. 2 at ¶ 25. Her platelet count had dropped to 9,000. Id. She immediately reported to the
hospital for possible IVIG treatment. Id. She was admitted to the hospital on February 14, 2017,
where she received two doses of IVIG and Nplate treatments. Id. at ¶ 26. She was discharged
the following day. Id. By March 2017, her platelets increased to 191,000 and she remained on
20 mg of prednisone. Id. Between March 2017 and October 2017, Petitioner was consistently
on prednisone and receiving weekly Nplate shots. Id. at ¶ 27. Her platelets fluctuated greatly
over this period. Id.
Petitioner saw Dr. Ma at UNC Healthcare on October 17, 2017 for a second opinion. Pet.
Ex. 2 at ¶ 28. Dr. Ma suggested Cellcept, Promacta, or a splenectomy as alternative courses of
treatment. Id. She recommended repeating Rituxan if the splenectomy failed. Id. However,
since Petitioner was on Nplate successfully, Dr. Ma recommended staying on Nplate or
switching to Promacta. Id.
From October 2017 to November 2017, Petitioner continued to take prednisone and
receive weekly Nplate shots. Pet. Ex. 2 at ¶ 29. On November 16, 2017, Petitioner began taking
Promacta at 25 mg per day. Id. She remained on Promacta, taking 25 mg every day except
Mondays and Fridays, when she took 50 mg. Id. at ¶ 30.
Petitioner weaned off Promacta in June 2020. Pet. Ex. 32 at ¶ 14. She follows up with
her hematologist once a year and has her platelets checked twice a year when she sees her
hematologist and when she gets her yearly physical. Id. Her platelets remain lower than normal;
however, they are stable enough for her to feel comfortable. Id.
Petitioner explained how her diagnosis has affected her emotionally, physically, and
psychologically. Pet. Ex. 2 at ¶ 31. She described that
[p]hysical activity is harder now. The long list of medications and treatments [she
has] been on have been very hard on [her] body. The steroids (prednisone and
dexamethasone) have made [her] shoulders, hips, and knees ache. They have also
caused significant weight gain and [she is] very sensitive to heat now and
overheat[s] easily. This limits [her] from being able to go outside or do things
with [her] daughter a lot during the hot summer months. [Her] moods are
affected, and [she has] a lot of mood swings. [She] also ha[s] extreme fatigue.
[She] ha[s] talked to [her] doctor about this, especially insomnia.
Id.
When Petitioner’s counts are lower, she must be extremely careful. Pet. Ex. 2 at ¶ 32.
She explained that her social life has been affected by her diagnosis. Id. at ¶ 33. She constantly
worries during her menstrual cycle every month. Id. She looks for bruises and blood blisters
and worries she will catch something during cold/flu season that would cause her platelets to
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decrease. Id. Petitioner also claims her diagnosis has also impacted her ability to work. Id. at ¶
34. She cannot work more than part time due to her extreme fatigue that results from her
medications. Id. Petitioner also suffered financially due to her diagnosis. Id. at ¶ 35.
D. Expert Reports
1. Petitioner’s Expert, Dr. Abhimanyu Ghose30
a. Background and Qualifications
Dr. Ghose is a medical doctor board certified in hematology, oncology, and internal
medicine. Pet. Ex. 15 at 3; Pet. Ex. 16 at 1. After receiving his M.B.B.S. in 2007 from Nilratan
Sircar Medical College in India, he worked in India as a physician before beginning a residency
in 2009 at the University of Toledo, Ohio and completed a fellowship in hematology oncology in
2015. Pet. Ex. 15 at 2; Pet. Ex. 16 at 2. He currently sees patients and conducts clinical research
at Arizona Oncology/US Oncology Network. Pet. Ex. 15 at 3; Pet. Ex. 16 at 1. In addition, he is
a clinical research professor of Internal Medicine, Hematology Oncology at A.T. Still University
School of Osteopathic Medicine in Arizona. Pet. Ex. 16 at 1. Prior to this appointment, he held
various hematology and oncology positions and has been an expert witness since 2019. Id. at 1-
2. He is a member of and has served on various societies and boards focused on hematology and
oncology. Id. at 8. Dr. Ghose has also authored or co-authored over 30 publications, abstracts,
and presentations. Id. at 3-6. Dr. Ghose sees patients with ITP on a regular basis. Pet. Ex. 15 at
3.
b. Opinion
i. Althen Prong One
Dr. Ghose opined that molecular mimicry is the causal mechanism that triggers
autoimmunity by the flu vaccination. Pet. Ex. 15 at 11. Specifically, antibodies against the
antigens in the vaccine cross-react with normal platelet antigens in the host. Id. at 8. In support
of his opinion, Dr. Ghose cited Perricone et al., in which the authors state that molecular mimicry
is the “most likely” theory by which vaccines induce ITP. Pet. Ex. 17(e) at 1. Molecular
mimicry describes the process in which “[a]ntibodies responsible for the clearance of virus
antigens may cross-react with antigens naturally present on platelets.” Id. at 2. While this is the
current prevailing theory, the pathogenic mechanisms of ITP have not been fully explained. Id.
In addition to Perricone et al., Dr. Ghose cited other supportive literature about molecular
mimicry. For example, in Cecinati et al.,31 the authors conducted a literature review of ITP
following vaccine administration. Pet. Ex. 17(p) at 1. They explained that ITP “following
vaccine administration depends on the development of autoantibodies that cross-react with the
30 Dr. Ghose provided one expert report. Pet. Ex. 15.
31 Valerio Cecinati et al., Vaccine Administration and the Development of Immune
Thrombocytopenic Purpura in Children, 9 Hum. Vaccines & Immunotherapeutics 1158 (2013).
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naturally present antigenic targets on platelets,” or molecular mimicry. Id. A “defective immune
regulation” caused by genetic abnormality also “may play a role in the pathogenesis of the
disease.” Id. at 2.
The authors in Cecinati et al. focused on the association between MMR and ITP. Pet. Ex.
17(p) at 1-2. They noted that “[v]accine-related thrombocytopenia is considered to be of
immune origin because antibodies can be detected on platelets in about 79% of cases.” Id. at 1.
Based on data from surveillance systems, they reported that cases of ITP following vaccination
are generally infrequent and less severe. Id. at 2. The authors also noted that the “[t]rivalent
inactivated [flu] vaccine (TIV) has been associated with ITP in a very small number of adult case
reports,” as well as a surveillance study by Garbe et al.32 Id. at 3; see Pet. Ex. 17(f).
Dr. Ghose relied on papers that show an association between ITP and MMR vaccinations,
as well as a variety of other vaccines, including diphtheria-tetanus-pertussis (“DTP”), hepatitis
A, varicella, and flu. Pet. Ex. 15 at 10. One of these was authored by Rinaldi et al., which
provided a review of bacteria, viruses, and vaccines associated with ITP. Pet. Ex. 17(d) at 1.
The authors postulated that the association between vaccinations and ITP is similar to that
between infections and ITP, and they identified molecular mimicry as the likely mechanism. Id.
at 8.
The first example of a study cited by Dr. Ghose reporting an association between the
MMR vaccine and ITP is a case-control study performed by Black et al. Pet. Ex. 17(q) at 1.
This study used the United Kingdom (“UK”) General Practice Research Database33 to identify
children who were diagnosed with ITP between January 1988 and December 1999. Id. at 1-2.
The authors identified all children who developed ITP within six weeks of receiving an MMR
vaccine, where another cause was not identified, as “‘possible vaccine-related’ cases.” Id. at 2.
Out of the 63 cases, 52 received an MMR vaccination before their date of ITP diagnosis. Id. Of
the 23 children between 13 and 24 months of age, eight developed ITP within six weeks of
receiving their first MMR vaccine. Id. at 3, 3 tbl.2. Based on their data, the authors concluded
there was a six-fold increase in the risk of ITP in children 13 to 24 months old during the six
weeks post-MMR vaccination. Id. at 4.
Another study reporting a causal association between the MMR vaccination and ITP was
by Miller et al. who studied UK immunization and hospital records between 1991 and 1994. Pet.
Ex. 17(c) at 1. The authors reviewed immunization records and hospital records for children
admitted to the hospital with ITP and found 28 admissions for ITP in 21 children with a prior
32 Edeltraut Garbe et al., Drug-Induced Immune Thrombocytopaenia: Results from the Berlin
Case-Control Surveillance Study, 68 Eur. J. Clinical Pharmacology 821 (2012). This article is
also cited by Petitioner’s other expert. Pet. Ex. 20(s).
33 The UK General Practice Research Database collects “[s]tandardized sets of information”
from “500 practices throughout the UK.” D. H. Lawson et al., The General Practice Research
Database: Scientific and Ethical Advisory Group, 91 Q. J. Med. 445, 445 (1998). The Office for
National Statistics (“ONS”) maintains and runs the “information resource on behalf of the
Department of Health.” Id.
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MMR vaccination. Id. The “study confirm[ed] a casual association between MMR vaccine and
ITP.” Id. at 2.
Next, Dr. Ghose offered studies about the association between the flu vaccine and ITP.
Pet. Ex. 15 at 10-11. He cited a large case-control surveillance study by Garbe et al., who used
data from Berlin hospitals on adults from 2000 to 2009. Pet. Ex. 17(f) at 1. Ninety of the 169
total cases of ITP were determined to be drug-related, and these included vaccines.34 Id. at 1-2,
9. Three of the vaccine cases were related to the flu vaccine. Id. Vaccine causality was
determined to be “probable” using the World Health Organization (“WHO”) standardized
causality assessment tool.35 Id. at 9. The “[flu] vaccination was associated with a statistically
significant [four]-fold risk.” Id.
Jadavji et al.36 reported on data obtained from 12 pediatric centers in Canada from 1992
to 2001. Pet. Ex. 17(l) at 1. The authors identified 61 patients who had decreased platelet counts
(< 50 109/l) within 30 days of vaccination. Id. Two of the patients developed
thrombocytopenia after the flu vaccine.37 Id. at 2.
×
Dr. Ghose also cited a number of case reports of ITP following flu vaccination. Pet. Ex.
15 at 10-11. Casoli and Tumiati38 reported a case of acute ITP that “presented with sudden onset
of petechiae and ecchymoses, as possible complication of antiinfluenza vaccination with
34 Since the Garbe et al. study was conducted on adults, there were no cases of ITP related to the
MMR vaccination. See Pet. Ex. 17(f) at 9.
35 The WHO assessment of causality includes the categories certain, probable, possible, unlikely,
unclassified, and unclassifiable. Pet. Ex. 17(f) at 3. “A drug reaction was evaluated as
‘probable’ when the ITP occurred with a reasonable time [after] administration[,] . . . was
unlikely to be attributed to other causes, and a positive dechallenge reaction was observed on
drug withdrawal.” Id. at 3-4.
36 Taj Jadavji, et al., Thrombocytopenia After Immunization of Canadian Children, 1992 to 2001,
22 Pediatric Infectious Disease J. 119 (2003).
37 Of note, the authors noted a limitation of the study, in that the majority of patients with post-
vaccination thrombocytopenia also had a viral infection or exposure to medication that could
suggest an alternate cause of the illness. Pet. Ex. 17(l) at 3.
38 P. Casoli & B. Tumiati, Acute Idiopathic Thrombocytopenic Purpura After Anti-Influenza
Vaccination, 9 Medicina (Firenze) 417 (1989). Only the abstract of this article was filed as the
article was in Italian.
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inactivated viruses” administered 15 days prior to onset. Pet. Ex. 17(i) at 1. Tsuji et al.39
reported the case of a 79-year-old who developed thrombocytopenia four days after receiving a
flu vaccine. Pet. Ex. 17(j) at 1. Nagasaki et al.40 reported ITP following flu vaccination in three
elderly patients, ages 75, 81, and 87. Pet. Ex. 17(g) at 1-2. The authors concluded that
“[v]accine-associated ITP [was] probably caused by molecular mimicry.” Id. at 2. They also
concluded that ITP was “strongly suspected” to be associated with the flu vaccine. Id. at 4.
Tishler et al.41 reported on a 68-year-old patient who developed severe thrombocytopenia
14 days following receipt of a flu vaccine. Pet. Ex. 17(h) at 1. Regarding causation, the authors
explained that “[t]he most popular hypothetical mechanism for the triggering of autoimmunity by
an infectious agent is that of molecular mimicry.” Id.
Shalmovitz and Johar42 described a 50-year-old man who developed Evans’ syndrome,
which is the combination of ITP and autoimmune hemolytic anemia with no known underlying
cause. Pet. Ex. 17(k) at 1. The patient had received a flu vaccine four days before his onset of
symptoms. Id. The authors postulated that the flu vaccine, through molecular mimicry, may
have been the cause of the patients Evans’ syndrome. Id. at 2. The authors performed a
PubMed43 search and came across eight case reports of patients who developed ITP after
receiving a flu vaccine. Id. The authors opined that these case reports “suggest that
immunizations may provide a trigger for the development of autoimmune disease in susceptible
individuals.” Id.
39 Takahiro Tsuji et al., Refractory Idiopathic Thrombocytopenic Purpura Following Influenza
Vaccination, 50 Rinsho Ketsueki 577 (2009). Again, only the abstract of this article was filed as
the article was originally in Japanese. This article is also cited by Petitioner’s other expert. Pet.
Ex. 20(x).
40 Joji Nagasaki et al., Postinfluenza Vaccination Idiopathic Thrombocytopenic Purpura in Three
Elderly Patients, 2016 Case Reps. Hematology 1. This article is also cited by Petitioner’s other
expert. Pet. Ex. 20(z).
41 Moshe Tishler et al., Immune Thrombocytopenic Purpura Following Influenza Vaccination, 8
Isr. Vaccine Rsch. Initiative 322 (2006).
42 Gil Z. Shlamovitz, & Sandeep Johar, A Case of Evans’ Syndrome Following Influenza
Vaccine, 44 J. Emergency Med. e149 (2013). This article is also cited by Petitioner’s other
expert. Pet. Ex. 20(p).
43 “PubMed is a free resource supporting the search and retrieval of biomedical and life sciences
literature . . . . The PubMed database contains more than 34 million citations and abstracts of
biomedical literature.” Nat’l Libr. Med., Nat’l Ctr. for Biotechnology Info., PubMed Overview,
https://pubmed.ncbi.nlm.nih.gov/about/ (last visited Nov. 9, 2022).
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And Mantadakis et al.44 described a case report of a 3-year-old boy who developed ITP
26 days after his second dose of the flu vaccine. Pet. Ex. 17(o) at 1. The researchers postulated
that the mechanism of thrombocytopenia following flu infection was most likely due to
molecular mimicry. Id. at 2. The authors concluded that while there was a risk of ITP six to
eight weeks following the MMR vaccine, more evidence was needed to explore the connection
between the flu vaccine and ITP. Id. at 2-3.
Lastly, Dr. Ghose cited two cases where immunosuppressed patients developed ITP
following flu vaccination. The first of these cases was reported in a letter authored by Ikegame
et al.45 about a bone marrow transplant recipient whose platelet count rapidly decreased two
weeks after receiving a flu vaccine. Pet. Ex. 17(m) at 1-2. At the time of vaccination, the patient
was receiving low doses of tracrolimus (1.7 mg/day) and prednisone (7 mg/day). Id. at 1. The
authors suggested that the causal theory was molecular mimicry, stating “[a]cute ITP may []
occur after vaccination” because “[a]ntibodies responsible for the clearance of virus antigens
may cross-react with antigens naturally present on platelets.” Id. at 2.
The second case report involving an immunosuppressed patient was authored by Mamori
et al.46 and described a 75-year-old patient with autoimmune liver disease (“AILD”) who
received a flu vaccine. Pet. Ex. 17(n) at 1. One week after vaccination, the patient began
experiencing symptoms and was diagnosed with ITP. Id. The authors concluded that “the [flu]
vaccine can exacerbate potential immune-mediated platelet destruction in AILD patients, thus
leading to severe autoimmune side effects.” Id. at 2.
ii. Althen Prongs Two and Three
Dr. Ghose opined ITP usually develops within four to 35 days following flu vaccination.
Pet. Ex. 15 at 12. Petitioner was vaccinated on October 9, 2016. Id.; see also Pet. Ex. 1 at 3;
Joint Submission at 1. Dr. Ghose opined Petitioner’s symptoms began in mid-November “when
she developed bruises on her thighs the size of a quarter.” Pet. Ex. 15 at 12. Dr. Ghose
explained this “[e]asy bruising is a classic sign of ITP.” Id. This would place Petitioner’s
symptom onset around 35 days after her vaccination, which is within Dr. Ghose’s proposed time
frame of 4-35 days. Id.
In support of his opinion as to the appropriate temporal association, Dr. Ghose cited
Cecinati et al. The authors performed a review of the available literature regarding ITP
following vaccine administration and concluded that “vaccine-related ITP usually occurs within
six weeks of vaccination.” Pet. Ex. 17(p) at 2.
44 Elpis Mantadakis et al., A Case of Immune Thrombocytopenic Purpura After Influenza
Vaccination: Consequence or Coincidence?, 32 J. Pediatric Hematology Oncology E227 (2010).
45 K. Ikegame et al., Idiopathic Thrombocytopenic Purpura After Influenza Vaccination in a
Bone Marrow Transplantation Recipient, 38 Bone Marrow Transplantation 323 (2006).
46 Satoshi Mamori et al., Thrombocytopenic Purpura After the Administration of an Influenza
Vaccine in a Patient with Autoimmune Liver Disease, 77 Digestion 159 (2008).
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Dr. Ghose also cited several case reports to support his timeline of temporal association.
In Nagasaki et al., three patients were diagnosed with thrombocytopenia following flu
vaccinations. Pet. Ex. 17(g) at 1-2. These patients began experiencing symptoms two weeks,
four weeks, and five weeks following flu vaccination. Id. In Tishler et al., the authors reported a
68-year-old patient who developed severe thrombocytopenia 14 days after a flu vaccine. Pet. Ex.
17(h) at 1. Casoli and Tumiati described a patient who developed ITP within 15 days of anti-flu
vaccination. Pet. Ex. 17(i) at 1. In the Mantadakis et al. case report, the three-year-old patient
developed ITP 26 days following “a second dose of immunization against seasonal [flu].” Pet.
Ex. 17(o) at 1.
Dr. Ghose found the time between vaccination and onset of symptoms to demonstrate an
appropriate temporal association in this case. Pet. Ex. 15 at 12. He determined the time between
Petitioner’s vaccination and onset of symptoms to be roughly 35 days in mid-November. Id. He
cited several case reports demonstrating an appropriate onset timeline to be within seven days to
six weeks. Id. Therefore, he opined that Petitioner’s ITP was temporally associated with her flu
vaccine. Id.
Lastly, Dr. Ghose concluded that “[t]he only event that led to [Petitioner’s] disease and
suffering was the [flu] vaccine.” Pet. Ex. 15 at 13.
2. Petitioner’s Expert, Dr. Marc Serota47
a. Background and Qualifications
Dr. Serota currently works as an attending physician at the Veteran’s Affairs Hospital in
Denver and as a supervising physician in dermatology at the University of Colorado. Pet. Ex. 19
at 1-2. He is board certified in pediatrics, allergy/immunology, and dermatology. Pet. Ex. 18 at
1; Pet. Ex. 19 at 1, 3. He received his B.A. and M.D. from the University of Missouri, Kansas
City in 2007. Pet. Ex. 19 at 1. Thereafter, he completed a pediatrics residency at Cohen’s
Children’s Hospital in New York, an allergy/immunology fellowship at Children’s Mercy
Hospital in Kansas City, Missouri, and a dermatology residency at the University of Colorado,
Denver. Id. Dr. Serota has authored or co-authored over 10 peer reviewed articles and abstracts
and has presented at over 25 lectures and professional conferences. Id. at 3-5.
b. Opinion
i. Althen Prong One
Dr. Serota defined ITP as “an acquired thrombocytopenia caused by autoantibodies
against platelet antigens.” Pet. Ex. 18 at 2 (quoting Pet. Ex. 20(aa) at 1). He explained that viral
infections, and less often bacterial infections, can trigger ITP. Id. at 3. In support of these
general propositions, Dr. Serota cited Cooper and Bussel, who stated that ITP probably occurs
due to a “combination of genetic susceptibility and environmental factors,” including viral
47 Dr. Serota provided one expert report. Pet. Ex. 18.
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infection. Id. at 5 (quoting Pet. Ex. 33 at 6). The authors suggested that viral infections can
initiate ITP through the mechanism of molecular mimicry. Id. (citing Pet. Ex. 33 at 6).
Dr. Serota opined that molecular mimicry is thought to be the mechanism that explains
how viral infections and drugs can cause ITP. Pet. Ex. 18 at 4. He cited an article by Perera and
Garrido48 that describes the complex mechanism of ITP triggered by molecular mimicry. Pet.
Ex. 20(m) at 1. Perera and Garrido wrote “immune thrombocytopenia (ITP) was thought to be
caused by the destruction and insufficient production of platelets, as mediated by
autoantibodies.” Id.
The trigger may be a loss of tolerance due to molecular mimicry with cross-
reaction of antibodies arising from infectious agents or drugs, genetic factors,
and/or platelet Toll receptors. This loss of tolerance activates autoreactive
effector B and T lymphocytes, which in turn initiates platelet destruction,
mediated by cytotoxic T lymphocytes and the release of pro-inflammatory
cytokines (IL-2/IL-17) by T helper (Th) cells (Th1/Th17). Th2
(antiinflammatory) and regulatory B (Breg) and Treg cells are also inhibited (with
decrease in IL-10/TGF-β), which leads to the disease becoming chronic. Some
isotypes of autoantibodies may increase the bleeding risk. Corticosteroids,
rituximab, and thrombopoietin receptor agonists (A-TPOs) all increase levels of
Tregs and TGF-β. The A-TPOs also increase Breg levels, which could explain
why complete remission has been seen in some cases.
Id.
Regarding infectious causes, Dr. Serota cited several case studies to demonstrate that an
influenza infection can cause ITP. Pet. Ex. 18 at 5. For example, Lee et al.49 reported a patient
with the 2009 H1N1 flu A virus who developed acute ITP and leukopenia on the third day of his
viral illness. Pet. Ex. 20(i) at 2-3. The authors noted that typical ITP develops two to three
weeks following vaccination; however, in the this reported case, ITP occurred during viral
infection. Id. at 3. The authors found this distinction and the mechanism of flu-associated ITP is
not fully understood. Id.
After discussing the relationship between flu infection and ITP, Dr. Serota moved to the
flu vaccine and its causal role in ITP. Pet. Ex. 18 at 6-9. He cited many of the same studies and
case reports cited by Dr. Ghose, described above, including those authored by Garbe et al.,
Nagasaki et al., Tsuji et al., and Shlamovitz and Johar. Pet. Exs. 17(f), 17(g), 17(j), 17(k). A
discussion of these articles will not be repeated here.
48 María Perera & Teresa Garrido, Advances in the Pathophysiology of Primary Immune
Thrombocytopenia, 22 Hematology 41 (2017).
49 Chun-Yi Lee et al., Acute Immune Thrombocytopenic Purpura in an Adolescent with 2009
novel H1N1 Influenza A Virus Infection, 74 J. Chinese Med. Ass’n 425 (2011).
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Dr. Serota also cited many papers that referenced molecular mimicry as the relevant
causal theory. For example, Isai et al.50 reviewed a database of reports of suspected adverse
reactions in the European Union from October 2009 to December 2010 for adjuvanted and non-
adjuvanted pandemic flu A/H1N1 vaccines. Pet. Ex. 20(n) at 1. The data included reports of
autoimmune adverse reactions where an adjuvanted or unadjuvanted A/H1N1 vaccine was
reported as suspect, interacting, or concomitant. Id. at 2. The authors reported that ITP was the
third most common autoimmune condition following flu vaccination. Id. at 3 tbl.2. David and
Shoenfeld51 found “vaccines could lead to ITP by molecular mimicry” when “[c]onsidering the
pathogenesis of autoimmune disorders following infections.” Pet. Ex. 20(o) at 1.
Perhaps the most compelling evidence of causation are the case reports referenced by Dr.
Serota, authored by Hamiel et al.52 and Almohammadi et al.,53 that discuss patients with
recurrent episodes of ITP following administration of the flu vaccination. Pet. Ex. 20(r) at 1; Pet.
Ex. 20(t) at 1.
Hamiel et al. described a four-and-one-half-year-old boy who presented in October 2013
with bleeding. Pet. Ex. 20(r) at 1. His platelet count was severely decreased at 17,000. Id. A
review of the child’s past medical records revealed that he had previously been hospitalized at
age one-and-one-half years and three-and-one-half years of age with similar symptoms of
bleeding. Id. at 2. All three of the child’s hospital admissions for ITP had taken place within
one week of his receipt of the flu vaccine. Id. And all three times the child received the Fluarix
trivalent flu vaccine. Id. After the last occurrence, the child did not receive any further annual
flu vaccines, and no recurrences of ITP were observed. Id. Using the WHO standardized case
causality assessment, the flu vaccine was determined to fall into the category of “certain”
causality. Id.
Almohammadi et al. described an adult who presented with epistaxis, gross hematuria,
and bleeding gums two days after receiving flu and pneumococcal conjugate vaccines. Pet. Ex.
20(t) at 1. The patient reported that he had experienced epistaxis after receipt of the flu
vaccination for the prior three years. Id. The authors concluded that it was “highly likely” that
the patient’s severe thrombocytopenia was “due to the [flu] vaccination” because of the temporal
association, lack of other causes, and history of only having epistaxis after prior flu vaccinations.
Id. at 2.
50 Alina Isai et al., Autoimmune Disorders After Immunisation with Influenza A/H1N1 Vaccines
with and Without Adjuvant: EudraVigilance Data and Literature Review, 30 Vaccine 7123
(2012).
51 Paula David & Yehuda Shoenfeld, ITP Following Vaccination, 99 Int’l J. Infectious Diseases
243 (2020).
52 Uri Hamiel et al., Recurrent Immune Thrombocytopenia After Influenza Vaccination: A Case
Report, 138 Pediatrics e1 (2016).
53 Abdullah Almohammadi et al., Epistaxis and Gross Haematuria with Severe
Thrombocytopaenia Associated with Influenza Vaccination, 12 BMJ Case Reps. 1 (2019).
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ii. Althen Prongs Two and Three
Dr. Serota agreed with Petitioner’s diagnosis of chronic ITP. Pet. Ex. 18 at 9. He opined
that Petitioner’s October 9, 2016 flu vaccine caused her ITP “to a reasonable degree of medical
certainty.” Id.
Dr. Serota disagreed with Respondent’s contention that Petitioner’s sinus infection or
upper respiratory infection could have caused her ITP. Pet. Ex. 18 at 9. Dr. Serota opined that
the onset of Petitioner’s ITP symptoms began on November 13, 2016, 35 days after her flu
vaccination. Id. at 1, 9. He based this date on the facts set forth in Petitioner’s affidavit, where
she began “to experience random and spontaneous bruising.” Id. at 1. Petitioner’s sinus
infection or upper respiratory infection began December 5, 2016 based on Petitioner’s affidavit.
Id. Therefore, Dr. Serota opined that Petitioner developed her sinus infection or upper
respiratory infection after the onset of her ITP. Id. at 9. Thus, Dr. Serota did not believe that
there was any other likely cause of Petitioner’s ITP, other than her flu vaccination. Id.
Dr. Serota cited studies that described the temporal association between ITP and
vaccinations generally in support of his opinion that the timeframe of 35 days is appropriate
given the mechanism of molecular mimicry. Pet. Ex. 18 at 7-9. Black et al. identified an
increased risk of developing ITP six weeks after vaccination. Pet. Ex. 17(q) at 1. Dr. Serota
explained that “[a]n autoimmune response to a stimulus does not occur immediately and
frequently takes between 10-60 days (depending on the particular nature and mechanisms of the
immunologic response) to develop.” Pet. Ex. 18 at 9. He continued, “[t]his timeframe is in
keeping with the published literature involving the development of ITP in similar vaccine related
cases.” Id.
In conclusion, Dr. Serota opined, “to a reasonable degree of medical certainty, that
[Petitioner] developed chronic ITP as a result of the antigenic exposure to the [flu] vaccine she
received on [October 9, 2016].” Pet. Ex. 18 at 9.
3. Respondent’s Expert, Dr. Lisa Baumann Kreuziger54
a. Background and Qualifications
Dr. Baumann Kreuziger is board certified in hematology and oncology. Resp. Ex. A at 1;
Resp. Ex. B at 2. She graduated from the University of Wisconsin-Madison, School of Medicine
and Public Health in 2006 and thereafter completed her internal medicine residency at the Mayo
Clinic and a fellowship at the University of Minnesota. Resp. Ex. B at 1. Dr. Baumann
Kreuziger currently holds various faculty, administrative, and hospital staff appointments. Id. at
2. She has been invited to lecture at over 40 functions and has worked on over 20 peer reviewed
workshops and presentations. Id. at 5-10. Dr. Baumann Kreuziger has authored or co-authored
over 50 publications. Id. at 15-19.
54 Dr. Baumann Kreuziger provided one expert report. Resp. Ex. A.
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b. Opinion
i. Althen Prong One
Dr. Baumann Kreuziger agreed that both genetic and environmental risk factors can
contribute to ITP. Resp. Ex. A at 4. Specific infections including H. pylori, hepatitis C, HIV,
cytomegalovirus, and EBV have been associated with ITP. Id. She also agreed that “[m]olecular
mimicry between viral infections, especially between the hepatitis C and HIV molecules has
been shown.” Id. (internal citations omitted). However, Dr. Baumann Kreuziger did not agree
that there is a causal association between the flu vaccine and ITP, or that molecular mimicry was
an appropriate mechanism to explain any purported relationship. Id. at 4-5.
Instead of molecular mimicry, Dr. Baumann Kreuziger suggested that “[m]echanistic
studies have shown that platelets treated with [flu] virus undergo lysis, or bursting, by the
classical complement pathway.” Resp. Ex. A at 4. Further, she opined that viral replication of
the viral protein, hemagglutinin (“HA”), is necessary to trigger the mechanism for a virus to
cause ITP. Id. Because the flu vaccine is a killed virus, she stated that it does not undergo viral
replication, and viral HA is not present, and therefore not able to trigger the molecular mimicry
necessary to cause ITP. Id.
In support of this opinion, she cited a study published in 1984 by Kazatchkine et al.55
Resp. Ex. A at 4 (citing Resp. Ex. E). This study showed that “incubation of human platelets
with suspensions of [flu] virus, but not with bacterial neuraminidase, results in complement and
antibody-mediated lysis of platelets in autologous serum. The crucial event was the interaction
of immunoglobulins with viral [HA] present on the platelet membrane.” Resp Ex. E at 1-2. This
“[b]inding of a viral protein to the platelet surface provides a model for immune
thrombocytopenias occurring during acute viral infections at the time of the specific immune
response.” Id. at 1. Platelets not treated with virus were also exposed to antibodies, but lysis did
not occur in these cells, suggesting the binding of viral HA was necessary. Id. at 4-5.
Although she rejected Petitioner’s proffered theory of molecular mimicry, Dr. Baumann
Kreuziger cited articles acknowledging the mechanism and its causal role in ITP. Swinkels et al.
stated that molecular mimicry is “[o]ne of the suggested mechanisms by which infections lead to
autoimmunity.” Resp. Ex. K at 3. “[C]ross reactivity may occur against platelet receptors,
which subsequently lead to autoantibodies specific for both the viral protein and platelet
receptors.”56 Id.
55 Michel D. Kazatchkine et al., Membrane-Bound Hemagglutinin Mediates Antibody and
Complement-Dependent Lysis of Influenza Virus-Treated Human Platelets in Autologous
Serum, 74 J. Clinical Investigation 976 (1984).
56 For a more detailed discussion of the mechanisms at play in the etiology ITP, see Resp. Ex. K
at 3-8.
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Swinkels et al. proposed a “simplified” model for immune thrombocytopenia, or ITP,
illustrated below.
Resp. Ex. K at 8 fig.3. This model contemplates a trigger in one who has a genetic
predisposition, and a causal theory of molecular mimicry between viral antigens and platelet
glycoproteins. See id. Additionally, there is a loss of immune tolerance, due to a genetic
predisposition or altered immune state. See id.
Dr. Baumann Kreuziger also dismissed the case reports cited by Petitioner’s experts,
stating, “[c]ase reports only provide information that an outcome such as an autoimmune disease
occurred after an event such as [flu] immunization. Case reports are highly prone to publication
bias.” Resp. Ex. A at 4-5. She cited a study authored by Albrecht et al.57 that evaluated case
reports and case series published in The Lancet from January 1996 to June 1997 and found “a
strong publication bias favoring positive results” as well as the need for the “opportunity . . . for
publication of follow-up reports.” Resp. Ex. C at 1. Albrecht et al., however, did not look at
adverse effects of vaccines but instead focused on “[i]nnovative or unusual treatment” and
outcomes. Id. at 2. Thus, their findings do not appear particularly relevant. Importantly, the
authors acknowledged the value of case reports, stating that “[f]requently, discovery of
therapeutic advances in medicine happens only serendipitously through unanticipated side
effects; therefore, case reports and series remain a cornerstone of medical progress.” Id. at 1.
57 Joerg Albrecht et al., Case Reports and Case Series from Lancet Had Significant Impact on
Medical Literature, 58 J. Clinical Epidemiology 1227 (2005).
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Instead of case reports, Dr. Baumann Kreuziger referenced case control and large cohort
studies, which she believes to be more reliable. Resp. Ex. A at 5. She acknowledged that Garbe
et al., cited by Petitioner’s experts, reported an increased risk of ITP following flu vaccination.
Id. (citing Pet. Ex. 17(f) at 7). She opined, however, that there was not a “preponderance of the
medical literature” reporting an association between the flu vaccination and ITP. Id.
Dr. Baumann Kreuziger cited a self-controlled case series from Hur et al.,58 in which the
authors analyzed 2.1 million adult Veterans who received flu vaccines between October 1, 2010,
and March 31, 2011. Resp. Ex. F at 1. The study found “[n]o significant risks” for ITP,
Guillain-Barré Syndrome (“GBS”), or Bell’s palsy following the 2010-2011 flu vaccine.59 Id.
Another study cited by Dr. Baumann Kreuziger was from Grimaldi-Bensouda et al.,60
which studied adults diagnosed with ITP from April 2008 to June 2011. Resp. Ex. D at 1. They
compared 198 patients with ITP from internal medicine and hematology centers in France with
878 controls and found no association between vaccinations, including the flu vaccine, and ITP,
using a 12-month window. Id. Using a two-month window, the authors found an increased risk
of ITP, “mainly attributable to vaccination against diphtheria-tetanus-pertussis-poliomyelitis;”
however, the increase was not statistically significant. Id. Notably, of the 198 patients with ITP,
the majority had not received the flu vaccine (no exposure within 12 months, 154 or 77.8%) and
187 (94.4%) had not been exposed to the flu vaccine within two months. Id. at 5 tbl.3. Because
the study population had limited exposure to the flu vaccine, it is not clear whether the results are
applicable to the facts of this case.
Two other studies cited by Dr. Baumann Kreuziger do not support her opinions because
the flu vaccine may not have been administered to the study participants. The first was a study
by Sauvé et al.61 Resp. Ex. I. Dr. Baumann Kreuziger stated that it was “a study of 107 cases of
post-vaccination ITP from Canada, [and] none of the cases had received a[] [flu] vaccine.” Resp.
Ex. A at 5 (citing Resp. Ex. I at 1-2, 2 tb.1). The study reviewed pediatric data from 1992 to
2002 and included patients who received the MMR, DTP/DTaP, meningococcus C, and varicella
vaccines. Resp. Ex. I at 2 tbl.1. It does not appear, however, that the children in the study
received the flu vaccine. See id.
58 Kwan Hur et al., Safety of the 2010-2011 Influenza Vaccinations in the Department of Veteran
Affairs, 28 Pharmacoepidemiology & Drug Safety 361 (2012).
59 Only the abstract of this study was filed, and therefore, it is difficult to provide a meaningful
analysis of it.
60 Lamiae Grimaldi-Bensouda et al., A Case-Control Study to Assess the Risk of Immune
Thrombocytopenia Associated with Vaccines, 120 Blood 4938 (2012).
61 Laura J. Sauvé et al., Postvaccination Thrombocytopenia in Canada, 29 Pediatric Infectious
Disease J. 559 (2010).
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The second study was from Rajantie et al.62 and reviewed data of children diagnosed with
ITP in Nordic countries during a three-year period. Resp. Ex. G at 1. Of 506 pediatric ITP
patients, the authors identified 35 patients that developed ITP within one month after
vaccination. Id. Regarding this study, Dr. Baumann Kreuziger said “35 had an immunization
within one month of the onset of ITP, but none of the cases were associated with the [flu]
vaccine.” Resp. Ex. A at 5. However, the flu vaccine was not identified as being administered
to the study population. Resp. Ex. G at 2.
ii. Althen Prongs Two and Three
Dr. Baumann Kreuziger agreed with Petitioner’s diagnosis of chronic ITP. Resp. Ex. A
at 3. However, she disagreed that Petitioner’s flu vaccine was the cause of her ITP. Id. Instead,
Dr. Baumann Kreuziger offered two alternate causes for Petitioner’s ITP: (1) an increased risk
for development of ITP because of a history of thrombocytopenia and (2) a proceeding viral
infection. Id. at 3-4.
The first alternate cause argument offered by Dr. Baumann Kreuziger is that “it is
possible that [Petitioner] had an increased risk for development of ITP given her history of
thrombocytopenia.” Resp. Ex. A at 3. She referenced Petitioner’s medical records from 2013
that showed Petitioner had a platelet count of 137,000. Id. (citing Pet. Ex. 12 at 8). Dr.
Baumann Kreuziger agreed that “[c]urrent consensus guidelines recommend a platelet count
<100,000 to diagnose ITP.” Id. (citing Resp. Ex. H at 2 (“A platelet count less than 100 x 109/L
was established as a threshold for diagnosis.”)).
Although she appeared to agree that Petitioner did not meet the criteria for ITP based on
her platelet count in 2013, Dr. Baumann Kreuziger explained that “having a platelet count
<150,000 has been shown to be associated with the development of ITP.” Resp. Ex. A at 3. She
cited a cohort study from Stasi et al.,63 in which 191 healthy individuals with platelet counts
between 100 x 109/ L and 150 x 109/L were monitored for six months. Resp. Ex. J at 1. During
the study, 12 of these individuals developed ITP, and the probability of developing ITP after 10
years was 6.9%. Id. at 4. Dr. Baumann Kreuziger asserted “[t]his is significantly higher than the
incidence of ITP in the general population.” Resp. Ex. A at 3 (citing Resp. Ex. K at 2).
Regarding an alternative cause, Dr. Baumann Kreuziger noted that Petitioner was treated
with azithromycin (Z-pak) for an infection when she was diagnosed with ITP. Resp. Ex. A at 4-
5. She observed that Petitioner’s treating physician, Dr. Kale, suggested an association between
Petitioner’s viral infection and ITP. Id. However, Dr. Baumann Kreuziger did not opine that,
more likely than not, Petitioner had an infection which triggered her ITP.
62 J. Rajantie et al., Vaccination Associated Thrombocytopenic Purpura in Children, 25 Vaccine
1838 (2007).
63 Roberto Stasi et al., Long-Term Outcome of Otherwise Healthy Individuals with Incidentally
Discovered Borderline Thrombocytopenia, 3 PLoS Med. e24 (2006).
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Dr. Baumann Kreuziger also stated that none of Petitioner’s treating physicians
documented that there was an association between her flu vaccine and ITP. Resp. Ex. A at 5.
Lastly, Dr. Baumann Kreuziger did not refute the opinions by Petitioner’s experts that
there was a temporal association between Petitioner’s vaccination and the onset of her ITP.
However, she opined that “to a reasonable degree of probability, the occurrence of ITP in
[Petitioner] was an incidental event and not caused by the [flu] vaccine that she received on
[October 9, 2016].” Resp. Ex. at A at 5.
4. Respondent’s Expert, Dr. Neil Romberg64
a. Background and Qualifications
Dr. Romberg currently works as an Assistant Professor of Pediatrics at the University of
Pennsylvania School of Medicine and as an attending physician at the Children’s Hospital of
Philadelphia. Resp. Ex. M at 1; Resp. Ex. N at 1. Dr. Romberg attended Pennsylvania State
University, College of Medicine and received his M.D. in 2004. Resp. Ex. N at 1. He then
completed his pediatric residency at New York University, School of Medicine and a fellowship
in allergy and clinical immunology at Yale University, School of Medicine. Id. He is board
certified in pediatrics and allergy and immunology. Id. at 2. “The focus of [his] career has been
the care for patients with inherited immunological disorders and to investigate the molecular
mechanisms that underlie their diseases.” Resp. Ex. M at 1-2. “Over the last 5 years [he] ha[s]
cared for approximately 75 patients with an autoimmune cytopenia, either ITP or autoimmune
hemolytic anemia (AIHA) or the overlap condition, Evans Syndrome.” Id. at 2. Dr. Romberg
has authored or co-authored over 30 publications. Resp. Ex. N at 7-12.
b. Opinion
Consistent with the other experts, Dr. Romberg agreed with Petitioner’s diagnosis. Resp.
Ex. M at 3-5. He explained that “ITP-associated platelet destruction is mediated by
autoantibodies which ‘flag’ cells for splenic destruction.” Id. at 5. Dr. Romberg opined that ITP
has genetic predispositions and external triggers, including several infectious diseases such as
HIV, hepatitis B virus, and hepatitis C virus. Id. at 6 (citing Pet. Ex. 20(a) at 4). ITP cases can
be described as acute or chronic. Id. Acute episodes resolve within 12 months and chronic cases
last greater than 12 months. Id. Dr. Romberg classified Petitioner’s ITP as chronic, primary
ITP. Id.
i. Althen Prong One
Unlike Dr. Baumann Kreuziger, Dr. Romberg agreed with the theory of molecular
mimicry. He agreed that it is “one popular theory” as to why some individuals develop certain
autoimmune diseases and others do not. Resp. Ex. M at 7. Dr. Romberg cited a systematic
64 Dr. Romberg provided one expert report. Resp. Ex. M.
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review by Bhattacharjee and Banerjee,65 which “analyze[d] the clinical profile and outcomes in a
total of 45 cases of new-onset ITP in COVID-19 patients.” Resp. Ex. O at 1. The study found
that ITP could occur secondary to a Covid-19 infection. Id. at 9. One suggested pathogenesis
was molecular mimicry. Id. at 6-7, 9.
In addition to Covid-19 infections, Dr. Romberg discussed the association between other
infections and ITP. He cited a study by Zeller et al. that examined data from Nordic countries on
over 500 children who were newly diagnosed with ITP from 1998 to 1999. Resp. Ex. Q at 2.
More than half of the patients (292, 57.7%) had an infection within the four weeks preceding
diagnosis. Id. at 3. These infections included viral upper respiratory infections, flu-like
infections, unspecified fever, bacterial infections, and chickenpox. Id.
In addition to infections, Dr. Romberg agreed that there is evidence linking the MMR
vaccine to ITP. Resp. Ex. M at 8. He cited a review by Di Pietrantonj et al.66 that provided a
thorough overview of both the MMR and varicella vaccines in children. Resp. Ex. T at 3. The
review found “evidence supporting an association between MMR vaccine and [ITP].” Id. at 4.
Dr. Romberg agreed that the “MMR vaccine likely conveys an increased ITP risk.” Resp. Ex. M
at 8. He cited a study from France et al.,67 in which the authors used data from 1991-2000 from
the Vaccine Safety Datalink (“VSD”) to examine the association between MMR and ITP. Resp.
Ex. R at 1-2. Data were reported on children under 18 with a platelet count of less than or equal
to 50,000/μL, clinical symptoms of spontaneous bleeding, and no fever. Id. at 2. The results of
the study confirmed an association between ITP and the MMR vaccine. Id. at 6.
While Dr. Romberg acknowledged the association between the MMR vaccine and ITP,
he opined that association does not extend to any other vaccine, including the seasonal flu
vaccine. Resp. Ex. M at 8-9. He cited several studies supporting his opinion.68 Id. at 8-11. One
was from O’Leary et al.,69 a retrospective cohort study of 1.8 million children who were
vaccinated at one of five health care Kaiser Permanente Health Care Systems from 2000 to 2009.
Resp. Ex. S at 2. They identified 197 cases of ITP, mostly attributable to the MMR vaccine. Id.
at 3-5. For hepatitis A vaccine, there was a significantly increased risk of ITP in children seven
65 Sukrita Bhattacharjee & Mainak Banerjee, Immune Thrombocytopenia Secondary to COVID-
19: A Systemic Review, 2 SN Comprehensive Clinical Med. 2048 (2020).
66 C. Di Pietrantonj et al., Vaccines for Measles, Mumps, Rubella, and Varicella in Children
(Review), Cochrane Database Systemic Revs. (2020).
67 Eric K. France et al., Risk of Immune Thrombocytopenic Purpura After Measles-Mumps-
Rubella Immunization in Children, 121 Pediatrics e687 (2008).
68 Some of the studies cited by Dr. Romberg were also referenced by Dr. Baumann Kreuziger,
and discussed above, and thus, will not be repeated here.
69 Sean T. O’Leary et al., The Risk of Immune Thrombocytopenic Purpura After Vaccination in
Children and Adolescents, 129 Pediatrics 248 (2012).
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to 17 years of age, and for Tdap and varicella vaccines, there was a significantly increased risk of
ITP in children 11 to 17 years of age. Id. at 1, 5, 5 tbl.2. O’Leary et al. noted that the study was
limited by methodologies used to study rare adverse events. Id. at 6. Of note, the authors “found
several elevated [incident rate ratios] that approached statistical significance in older children,”
including for the flu vaccine, but they concluded that “estimates in older children are less stable
because there are fewer cases of ITP on which to perform analyses.” Id. at 4. Additionally, of
the children with ITP, it appears that many were not exposed to the flu vaccine. See id. at 5
tbl.2.
In addition to citing studies, Dr. Romberg also referenced the vaccine package insert for
the Fluarix Quadrivalent Vaccine, 2019-2020 formula.70 Resp. Ex. V. Clinical trial data from
randomized, controlled studies establishing the safety of the Fluarix vaccine were provided. Id.
at 5-14. Dr. Romberg noted that the studies did not report ITP. Resp. Ex. M at 8-9.
Dr. Romberg also dismissed the case reports and case series cited by Petitioner’s experts.
Resp. Ex. M at 9. Regarding Petitioner’s reliance on this type of evidence, Dr. Romberg cited an
article by Murad et al.,71 where the authors proposed a tool “to evaluate the methodological
quality” of this type of evidence. Resp. Ex. W at 1, 3. They did not reject the use of case
reports, but instead “suggest[ed] using evidence derived from case reports and case series to
inform decision-making when no other higher level of evidence is available.” Id. at 1. Further,
they provided examples of how case reports provide a valuable role by describing new diseases,
unknown side effects of medication, novel treatments, providing education, and by the role they
play in quality improvement. Id. at 3 tbl.2.
Regarding the causal mechanism of molecular mimicry, Dr. Romberg rejected the
specific suggestion that flu vaccine proteins or platelet glycoproteins could act as molecular
mimics and cause ITP. Resp. Ex. M at 10-11. He cited an article by Ang et al.72 that used GBS
as an “paradigm for how post-infectious immune-mediated disease in humans can be triggered
by molecular mimicry.” Resp. Ex. P at 1. The authors also suggested criteria for determining
when molecular mimicry has triggered an immune-mediated disease: (1) “establishment of an
epidemiological association between an infectious agent and the immune-mediated disease;” (2)
“identification of T cells or antibodies directed against host target antigens in patients;” (3)
“identification of microbial mimic of target antigen;” and (4) “reproduction of the disease in an
animal model.” Id. at 2-5.
70 This is not the formula that Petitioner received. Petitioner received her Fluarix vaccine in
2016. The package insert filed states that the “safety experience with FLUARIX (trivalent [flu]
vaccine) is relevant to FLUARIX QUADRIVALENT because both vaccines are manufactured
using the same process and have overlapping compositions.” Resp. Ex. V at 5.
71 Mohammad Hassan Murad et al., Methodological Quality and Synthesis of Case Series and
Case Reports, 23 BMJ Evidence-Based Med. 60 (2018).
72 C. Wim Ang et al., The Guillain-Barré Syndrome: A True Case of Molecular Mimicry, 25
Trends in Immunology 61 (2004).
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Dr. Romberg opined “GBS and ITP are completely distinct autoimmune processes; the
former is driven by T-cell responses to peripheral nerve gangliosides while the latter is mediated
by autoantibodies to platelet glycoproteins.” Resp. Ex. M at 10. Dr. Romberg dismissed
Petitioner’s experts’ reliance on the article by Isai et al., which found molecular mimicry to be a
mechanistic theory for the development of ITP. Id. (citing Pet. Ex. 20(n)). Dr. Romberg rejected
this because the article “did not find ITP cases . . . to be more than expected.” Id. Therefore, he
concluded that the article failed to find an epidemiological association between the vaccine and
ITP. Id.
Dr. Romberg also dismissed the theory that HA was the molecular mimic that leads to
ITP. He explained that the theory assumes that ITP occurs when “HA protein entered the blood
stream, bound platelets without harming them but instead marked them for destruction by HA-
specific antibodies.” Resp. Ex. M at 10. He criticized Petitioner’s expert’s reliance on the article
written by Dr. Shoenfeld and dismissed this theory because (1) “this is not an example of
molecular mimicry, as the antibody is not to a self-antigen but to a microbial one,” and (2) this
theory “cannot explain the chronic nature of [Petitioner’s] ITP.”73 Id. (citing Pet. Ex. 20(o))
(emphasis omitted). Dr. Romberg cited an article by Sahler et al.74 to explain that the lifespan of
platelets is about 8-10 days, and therefore, they are continuously regenerated to maintain levels
of at least 150,000 per microliter of blood. Resp. Ex. Z at 1. Therefore, Dr. Romberg claimed,
“even if the small amount of HA protein administered by the intramuscular route did enter her
blood stream and bind to all of her platelets on October 9, 2016, these HA-bound cells would
have been destroyed and replaced several times over by December 7, 2016.” Resp. Ex. M at 10-
11.
Finally, Dr. Romberg opined that the vaccination lowered Petitioner’s risk of developing
ITP. He cited a literature review that recommended patients with ITP get vaccinated because the
therapies used to treat ITP are immunosuppressive. Resp. Ex. BB at 3.75 In addition, Dr.
Romberg cited a review by Elalfy and Nugent76 that provided a broad overview of the
association between viral infections, anti-viral therapy, and viral vaccines with ITP. Resp. Ex.
AA at 1. Elalfy and Nugent noted that “the incidence of post-immunization ITP is significantly
lower than that observed during the natural disease that” vaccines prevent. Id. at 2.
73 Respondent also criticized Petitioner’s reliance on articles written by Dr. Yehuda Shoenfeld
because some of Dr. Shoenfeld’s articles have been withdrawn from publication. Resp. Ex. M at
9. However, none of the withdrawn articles were relied on by Petitioner’s experts.
74 Julie Sahler et al., Platelet Storage and Transfusions: New Concerns Associated with an Old
Therapy, 8 Drug Discovery Today Disease Mechanisms e9 (2011).
75 Donald M. Arnold et al., Immune Thrombocytopenia (ITP) in Adults: Initial Treatment and
Prognosis, UpToDate, https://www.uptodate.com/contents/initial-treatment-of-immune-
thrombocytopenia-itp-in-adults (last updated Sept. 20, 2019).
76 Mohsen S. Elalfy & Diane Nugent, Viruses, Anti-Viral Therapy, and Viral Vaccines in
Children with Immune Thrombocytopenia, 53 Seminars Hematology S70 (2016).
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In conclusion, Dr. Romberg agreed that molecular mimicry is a causal theory. Resp. Ex.
M at 7. He agreed that ITP has been associated with viral infections and some vaccines,
including the MMR vaccine. Id. at 7-8. However, Dr. Romberg did not agree that there is
evidence the flu vaccine can cause ITP. Id. at 8. Specifically, Dr. Romberg dismissed the theory
that flu vaccine proteins and/or platelet glycoproteins could act as molecular mimics to cause
ITP. Id. at 10.
ii. Althen Prongs Two and Three
Dr. Romberg did not agree that Petitioner’s flu vaccine was the cause of her ITP. Resp.
Ex. M at 8-11. Dr. Romberg suggested Petitioner’s history of throat infections, upper respiratory
infections, or other viral infections she was “predisposed to” by working in day care was an
alternative cause of Petitioner’s ITP. Id. at 11. He reiterated evidence showing that viral
infections can cause ITP. Id.
He noted that Petitioner reported sinus symptoms on December 7, 2016, and she was
prescribed a Z-pak. Resp. Ex. M at 11. Petitioner’s hematologist, Dr. Kale, also reported she
had an upper respiratory infection on December 12, 2016. Id. Dr. Romberg opined that “a
proceeding viral infection [is], by far, the most likely trigger of [Petitioner’s] ITP.” Id.
Dr. Romberg did not offer an opinion about the temporal relationship between the
vaccine and onset of Petitioner’s ITP. He did not refute Petitioner’s expert opinions stating that
there was an appropriate time frame between vaccination and the onset of Petitioner’s ITP given
the mechanism of molecular mimicry.
IV. DISCUSSION
A. Standards for Adjudication
The Vaccine Act was established to compensate vaccine-related injuries and deaths. §
10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as
a simple, fair and expeditious means for compensating vaccine-related injured persons. The
Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty
and generosity.’” Rooks v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 1, 7 (1996) (quoting
H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).
Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The
preponderance standard requires a petitioner to demonstrate that it is more likely than not that the
vaccine at issue caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315,
1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health
& Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Petitioner need not make a specific type of
evidentiary showing, i.e., “epidemiologic studies, rechallenge, the presence of pathological
markers or genetic predisposition, or general acceptance in the scientific or medical communities
to establish a logical sequence of cause and effect.” Capizzano v. Sec’y of Health & Hum.
Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead, Petitioner may satisfy her burden by
presenting circumstantial evidence and reliable medical opinions. Id. at 1325-26.
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Petitioner must prove that the vaccine was “not only [the] but-for cause of the injury but
also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting
Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)); see also
Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). The received
vaccine, however, need not be the predominant cause of the injury. Shyface, 165 F.3d at 1351.
A petitioner who satisfies this burden is entitled to compensation unless Respondent can prove,
by a preponderance of the evidence, that the vaccinee’s injury is “due to factors unrelated to the
administration of the vaccine.” § 13(a)(1)(B). However, if a petitioner fails to establish a prima
facie case, the burden does not shift. Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).
“Regardless of whether the burden ever shifts to the [R]espondent, the special master
may consider the evidence presented by the [R]espondent in determining whether the [P]etitioner
has established a prima facie case.” Flores v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 157,
162-63 (2014); see also Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373, 1379 (Fed. Cir.
2012) (“[E]vidence of other possible sources of injury can be relevant not only to the ‘factors
unrelated’ defense, but also to whether a prima facie showing has been made that the vaccine
was a substantial factor in causing the injury in question.”); de Bazan v. Sec’y of Health & Hum.
Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008) (“The government, like any defendant, is permitted
to offer evidence to demonstrate the inadequacy of the [P]etitioner’s evidence on a requisite
element of the [P]etitioner’s case-in-chief.”); Pafford, 451 F.3d at 1358-59 (“[T]he presence of
multiple potential causative agents makes it difficult to attribute ‘but for’ causation to the
vaccination. . . . [T]he Special Master properly introduced the presence of the other unrelated
contemporaneous events as just as likely to have been the triggering event as the vaccinations.”).
B. Factual Issues
A petitioner must prove, by a preponderance of the evidence, the factual circumstances
surrounding her claim. § 13(a)(1)(A). To resolve factual issues, the special master must weigh
the evidence presented, which may include contemporaneous medical records and testimony.
See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a
special master must decide what weight to give evidence including oral testimony and
contemporaneous medical records). Contemporaneous medical records, “in general, warrant
consideration as trustworthy evidence.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d
1525, 1528 (Fed. Cir. 1993). But see Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378,
1382 (Fed. Cir. 2021) (rejecting the presumption that “medical records are accurate and complete
as to all the patient’s physical conditions”); Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed.
Cl. 532, 538 (2011) (“[T]he 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.”
(quoting Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,
968 F.2d 1226 (Fed. Cir. 1992))), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. App’x 952 (Fed. Cir. 2013).
There are situations in which compelling testimony may be more persuasive than written
records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of
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Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“[L]ike any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the
factual predicates for its application are weak or lacking.”); Lowrie v. Sec’y of Health & Hum.
Servs., No. 03-1585V, 2005 WL 6117475, at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005)
(“[W]ritten records which are, themselves, inconsistent, should be accorded less deference than
those which are internally consistent.” (quoting Murphy v. Sec’y of Health & Hum. Servs., 23
Cl. Ct. 726, 733 (1991), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992))). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379
(Fed. Cir. 2009); Bradley, 991 F.2d at 1575.
Despite the weight afforded medical records, special masters are not bound rigidly by
those records in determining onset of a petitioner’s symptoms. Valenzuela v. Sec’y of Health &
Hum. Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see
also Eng v. Sec’y of Health & Hum. Servs., No. 90-1754V, 1994 WL 67704, at *3 (Fed. Cl.
Spec. Mstr. Feb. 18, 1994) (Section 13(b)(2) “must be construed so as to give effect also to §
13(b)(1) which directs the special master or court to consider the medical records (reports,
diagnosis, conclusions, medical judgment, test reports, etc.), but does not require the special
master or court to be bound by them”).
C. Causation
To receive compensation through the Program, Petitioner must prove either (1) that she
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that she received, or (2) that she suffered an injury that was caused by a vaccination. See
§§ 11(c)(1), 13(a)(1)(A); Capizzano, 440 F.3d at 1319-20. Petitioner must show that the vaccine
was “not only a but-for cause of the injury but also a substantial factor in bringing about the
injury.” Moberly, 592 F.3d at 1321 (quoting Shyface, 165 F.3d at 1352-53).
Because Petitioner does not allege she suffered a Table Injury, she must prove a vaccine
she received caused her injury. To do so, Petitioner must establish, by preponderant evidence:
“(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 a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278.
The causation theory must relate to the injury alleged. Petitioner must provide a sound
and reliable medical or scientific explanation that pertains specifically to this case, although the
explanation need only be “legally probable, not medically or scientifically certain.” Knudsen v.
Sec’y of Health & Hum. Servs., 35 F.3d. 543, 548-49 (Fed. Cir. 1994). Petitioner cannot
establish entitlement to compensation based solely on her assertions; rather, a vaccine claim must
be supported either by medical records or by the opinion of a medical doctor. § 13(a)(1). In
determining whether Petitioner is entitled to compensation, the special master shall consider all
material in the record, including “any . . . conclusion, [or] medical judgment . . . which is
contained in the record regarding . . . causation.” § 13(b)(1)(A). The undersigned must weigh
the submitted evidence and the testimony of the parties’ proffered experts and rule in Petitioner’s
favor when the evidence weighs in her favor. See Moberly, 592 F.3d at 1325-26 (“Finders of
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fact are entitled—indeed, expected—to make determinations as to the reliability of the evidence
presented to them and, if appropriate, as to the credibility of the persons presenting that
evidence.”); Althen, 418 F.3d at 1280 (noting that “close calls” are resolved in Petitioner’s
favor).
Testimony that merely expresses the possibility—not the probability—is insufficient, by
itself, to substantiate a claim that such an injury occurred. See Waterman v. Sec’y of Health &
Hum. Servs., 123 Fed. Cl. 564, 573-74 (2015) (denying Petitioner’s motion for review and
noting that a possible causal link was not sufficient to meet the preponderance standard). The
Federal Circuit has made clear that the mere possibility of a link between a vaccination and a
petitioner’s injury is not sufficient to satisfy the preponderance standard. Moberly, 592 F.3d at
1322 (emphasizing that “proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and
the injury” does not equate to proof of causation by a preponderance of the evidence); Boatmon
v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. 2019); . While certainty is
by no means required, a possible mechanism does not rise to the level of preponderance.
Moberly, 592 F.3d at 1322; see also de Bazan, 539 F.3d at 1351.
V. CAUSATION ANALYSIS
A. Althen Prong One
Under Althen Prong One, Petitioner must set forth a medical theory explaining how the
received vaccine could have caused the sustained injury. Andreu, 569 F.3d at 1375; Pafford, 451
F.3d at 1355-56. Petitioner’s theory of causation need not be medically or scientifically certain,
but it must be informed by a “sound and reliable” medical or scientific explanation. Boatmon,
941 F.3d at 1359; see also Knudsen, 35 F.3d at 548; Veryzer v. Sec’y of Health & Hum. Servs.,
98 Fed. Cl. 214, 223 (2011) (noting that special masters are bound by both § 13(b)(1) and
Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”). If
Petitioner relies upon a medical opinion to support her theory, the basis for the opinion and the
reliability of that basis must be considered in the determination of how much weight to afford the
offered opinion. See Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed.
Cir. 2010) (“The special master’s decision often times is based on the credibility of the experts
and the relative persuasiveness of their competing theories.”); Perreira v. Sec’y of Health &
Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (stating that an “expert opinion is no better
than the soundness of the reasons supporting it” (citing Fehrs v. United States, 620 F.2d 255, 265
(Ct. Cl. 1980))).
For the following reasons, the undersigned finds Petitioner provided preponderant
evidence that the flu vaccination she received caused her ITP, and therefore, Petitioner satisfied
the first Althen prong.
All the experts agree, and many of the medical articles filed, establish that ITP is known
to be an autoimmune condition, and that at least as it relates to infectious triggers, molecular
mimicry is a likely causal mechanism. See, e.g., Pet. Ex. 15 at 9; Pet. Ex. 18 at 3; Resp. Ex. A at
4; Resp. M at 7. For example, Perera and Garrido found the trigger of ITP to be “loss of
tolerance due to molecular mimicry with cross-reaction of antibodies arising from infectious
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agents or drugs, genetic factors, and/or platelet Toll receptors.” Pet. Ex. 20(m) at 2. Swinkels et
al. noted that “[o]ne of the suggested mechanisms by which infections lead to autoimmunity is
the occurrence of molecular mimicry.” Resp. Ex. K at 3. Cooper and Bussel reported that
“[c]hildhood ITP often occurs following a viral illness,” with the infection initiating ITP
“probably” through molecular mimicry. Pet. Ex. 33 at 6. In Zeller et al., more than half the
patients had an infection four weeks before they were diagnosed with ITP. Resp. Ex. Q at 3.
The most common infections included viral upper respiratory infections, flu-like diseases, or
unspecified fever. Id. Finally, Bhattacharjee and Banerjee suggested “SARS-CoV-2-mediated
immune thrombocytopenia can be attributed to . . . mechanisms, including molecular mimicry.”
Resp. Ex. O at 1.
More specifically, flu infections have been associated with ITP via molecular mimicry.
Rinaldi et al. reported a case of ITP following “[a] case of 2009 H1N1 symptomatic [flu] A virus
infection.” Pet. Ex. 17(d) at 5. Kazatchkine et al. found platelets treated with flu A displayed
viral HA and were destroyed by immune cells. Resp. Ex. E at 1. Lee et al. reported the case of a
patient who developed “extensive cutaneous petechiae, ecchymosis[,] and painful bleeding of the
mouth” three days into an “[flu]-like illness.” Pet. Ex. 20(i) at 2. The patient’s infection was
confirmed to be the 2009 H1N1 flu A virus. Id. at 3. Kosugi et al.77 reported a patient who was
diagnosed with thrombotic thrombocytopenic purpura (“TTP”)78 two days after she was
diagnosed with flu A. Pet. Ex. 20(j) at 1. Finally, Ning et al.79 also reported a patient who
developed TTP following a flu A (H1N1) infection. Pet. Ex. 20(k) at 1-2.
Petitioner’s experts provided sound and reliable reasons for extending the application of
molecular mimicry from infections to vaccinations, and again cited supportive medical literature.
Perricone et al. described the “most likely” mechanism whereby vaccines cause ITP is
“molecular mimicry.” Pet. Ex. 17(e) at 1. Cecinati et al. stated that ITP after vaccination is
caused by the “development of autoantibodies that cross-react with the naturally present
antigenic targets on platelets.” Pet. Ex. 17(p) at 1.
Moreover, as compared with the paucity of medical literature regarding many alleged
post-vaccination adverse conditions, there is a wealth of medical literature that supports an
association between vaccinations and ITP. Further, there is a known causal association between
77 Nobuharu Kosugi et al., Influenza A Infection Triggers Thrombotic Thrombocytopenic
Purpura by Producing the Anti-ADAMTS13 IgG Inhibitor, 49 Internal Med. 689 (2010).
78 Thrombotic thrombocytopenic purpura is “a form of thrombotic microangiopathy usually seen
in adults, characterized by thrombocytopenia with thromboses in terminal arterioles and
capillaries; other symptoms include hemolytic anemia, azotemia, fever, and bizarre neurologic
manifestations.” Thrombotic Thrombocytopenic Purpura, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=101175 (last visited Dec. 27, 2022).
79 Junjie Ning et al., Case of Acquired Thrombotic Thrombocytopenic Purpura Associated with
Influenza A (H1N1) Virus and Literature Review, 57 J. Paediatrics & Child Health 282 (2020).
Only the first page of this article was filed.
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the MMR vaccine and ITP, and that association is reflected in the Vaccine Injury Table.80 While
the presumption of causation for ITP following the MMR vaccine has not been extended to other
vaccines, the evidence filed here supports vaccine causation as to the flu vaccine.
And more narrowly, and specific to the facts of this case, Petitioner provided
preponderant evidence, by expert opinion and medical literature, of an association between the
flu vaccine and ITP. Garbe et al. reported that “[flu] vaccination was associated with a
statistically significant [four]-fold risk” of developing ITP. Pet. Ex. 17(f) at 9. The study by
Jadavji et al. reported 61 admissions of ITP following vaccination; two of which occurred after
the flu vaccine. Pet. Ex. 17(l) at 2. Perricone et al. summarized the available studies and case
reports and concluded there was a link between ITP and the flu vaccine. Pet. Ex. 17(e) at 4.
Further, there is evidence that molecular mimicry is a sound and reliable mechanism by
which the flu vaccine can cause ITP. Perricone et al. stated that molecular mimicry is the likely
mechanism by which the flu vaccine triggers ITP. Pet. Ex. 17(e) at 4. Petitioner’s experts also
cited case studies in which patients developed ITP following flu vaccination and the authors
postulated the mechanistic cause was molecular mimicry. See, e.g., Pet. Ex. 17(g) at 2; Pet. Ex.
17(h) at 1; Pet. Ex. 17(k) at 2; Pet. Ex. 17(m) at 1-2; Pet. Ex. 17(n) at 2; Pet. Ex. 17(o) at 2; Pet.
Ex. 20(r) at 3; Pet. Ex. 20(t) at 2.
Petitioner’s experts also provided evidence as to the target of molecular mimicry.
Perricone et al. explained that “[i]n [flu], the target of molecular mimicry probably involves
[HA].” Pet. Ex. 17(e) at 4. David and Shoenfeld stated that “[t]he main antigen in the [flu]
vaccine, [HA], is believed to be one of the possible molecules involved” in “immunization
causing ITP by molecular mimicry.” Pet. Ex. 20(o) at 1. In addition, Wan Jamaludi et al.81
concluded relative to the flu vaccine and ITP, that “the target of molecular mimicry probably
involves [HA].” Id. at 2.
In addition, Petitioner’s experts cite numerous case studies reporting the development of
ITP following the flu vaccine.82 Respondent’s experts argued case reports should not be relied
on as evidence of an association between ITP and the flu vaccine and cited literature that
discusses the reliability of case reports and case series. See Resp. Ex. C at 1. Resp. Ex. W at 1.
While case reports alone do not establish causation, here there are studies by Garbe et al. and
Perricone et al. and numerous case reports.
Moreover, the undersigned finds the Hamiel et al. and Almohammadi et al. case reports
to be very persuasive evidence of causation. Hamiel et al. described the case of a child who
developed ITP three times, each time after a flu vaccination. The authors concluded that they
were “the first to show with a high degree of confidence an association between the trivalent
80 See 42 C.F.R. §§ 100.3(a)(V)(A), (c)(7).
81 WF Wan Jamaludin et al., Vaccine-Induced Immune Thrombocytopaenia Purpura in
Autologous Haematopoietic Stem Cell Transplantation, 73 Med. J. Malay. 430 (2018).
82 See Pet. Exs. 17(g)-17(k), 17(m)-17(o); Pet. Exs. 20(r), 20(v).
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[flu] vaccine and the development of ITP. The response to IVIG therapy strongly suggests an
immunologic mechanism . . . .” Pet. Ex. 20(r) at 3. Almohammadi et al. also described an adult
who had episodes of epistaxis after receipt of the flu vaccines on three consecutive occasions.
Pet. Ex. 20(t) at 1. These facts of these two case reports were interpreted by the authors as very
compelling evidence that the flu vaccine can cause ITP.
Additionally, the above case reports may represent evidence of rechallenge. “A
‘challenge/rechallenge’ circumstance exists when a person has a reaction to one administration
of a vaccine or drug and then suffers worsening symptoms after an additional administration of
the same vaccine or drug.”83 Hirmiz v. Sec’y of Health & Hum. Servs., 119 Fed. Cl. 209, 219
n.11 (2015); see also DePena v. Sec’y of Health & Hum. Servs., 133 Fed. Cl. 535, (2017)
(describing challenge/rechallenge as “when an individual . . . exhibits a more severe reaction to a
second administration of that vaccine”). Additionally, Congress stated that “[a]n adverse event
can be causally linked to a vaccine more readily if: . . . the event recurs on re-administration of
the vaccine (positive rechallenge).” H.R. Rep. No. 106-977, at 5 (2000).
In summary, Petitioner has offered a sound and reliable medical theory in support of her
claim. Thus, the undersigned finds Petitioner has provided preponderant evidence with respect
to the first Althen prong.
B. Althen Prong Three
A discussion of Althen Prong Two turns to some extent on the question of onset of
Petitioner’s ITP as well as the onset of her upper respiratory infection. Therefore, the
undersigned addresses Althen Prong Three before moving to Althen Prong Two.
Althen Prong Three requires Petitioner to establish a “proximate temporal relationship”
between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been
defined as a “medically acceptable temporal relationship.” Id. Petitioner must offer
“preponderant proof that the onset of symptoms occurred within a time frame for which, given
the medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” de Bazan, 539 F.3d at 1352. The explanation for what is a medically
acceptable time frame must also coincide with the theory of how the relevant vaccine can cause
the injury alleged (under Althen Prong One). Id.; Koehn v. Sec’y of Health & Hum. Servs., 773
F.3d 1239, 1243 (Fed. Cir. 2014); Shapiro, 101 Fed. Cl. at 542; see Pafford, 451 F.3d at 1358. A
temporal relationship between a vaccine and an injury, standing alone, does not constitute
preponderant evidence of vaccine causation. See, e.g., Veryzer, 100 Fed. Cl. at 356 (explaining
that “a temporal relationship alone will not demonstrate the requisite causal link and that
83 “An important attribute in the evaluation of the clinical evidence from case reports is
rechallenge, an adverse event that occurred after more than one administration of a particular
vaccine in the same individual. Each challenge in a patient, however, must meet the same
attributes of reasonable latency, documentation of vaccination receipt, and clinician diagnosis of
the health outcome.” Inst. of Med., Summary, in Adverse Effects of Vaccines: Evidence and
Causality 1, 13 (Kathleen Stratton et al. eds., 2012).
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[P]etitioner must posit a medical theory causally connecting the vaccine and injury”), aff’d, 475
F. App’x 765 (Fed. Cir. 2012).
The events leading up to Petitioner’s diagnosis of ITP are described in Petitioner’s
affidavits. She received the flu vaccination at issue on October 9, 2016, and observed bruising
on the front and back of her thighs in mid-November, two weeks before her birthday on
November 27, 2016. Dr. Serota opined, based on Petitioner’s affidavit and a review of her
medical records, that Petitioner began to experience symptoms of her ITP around November 13,
2016, approximately 35 days after she received her flu vaccine.
Dr. Ghose opined that onset of ITP occurs within four to 35 days following flu
vaccination. Cecinati et al. reported that “vaccine-related ITP usually occurs within six weeks of
vaccination.” Pet. Ex. 17(p) at 2. Dr. Ghose also cited seven case reports of nine patients who
developed ITP between 4 and 35 days after receiving a flu vaccination. See Pet. Ex. 17(g) at 1-
2; Pet. Ex. 17(h) at 1; Pet. Ex. 17(i) at 1; Pet. Ex. 17(j) at 1; Pet. Ex. 17(m) at 1-2; Pet. Ex. 17(n)
at 1-2; Pet. Ex. 17(o) at 1. One of these, authored by Nagasaki et al., contained three case reports
of patients whose onset of ITP occurred at two, four, and five weeks after flu vaccination. Pet.
Ex. 20(g) at 1-2. Neither Dr. Baumann Kreuziger nor Dr. Romberg provided evidence to
contradict Dr. Ghose and Dr. Serota’s timeline of onset or that onset was appropriate given the
theory of molecular mimicry.
Therefore, undersigned finds that onset occurred approximately 35 days after vaccination,
around November 13, 2016, and that this time frame is appropriate given the mechanism of
molecular mimicry. Therefore, Petitioner has met her burden of proof as to Althen Prong Three.
C. Althen Prong Two
Under Althen Prong Two, Petitioner must prove by a preponderance of the evidence that
there is a “logical sequence of cause and effect showing that the vaccination was the reason for
the injury.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1278). “Petitioner must
show that the vaccine was the ‘but for’ cause of the harm . . . or in other words, that the vaccine
was the ‘reason for the injury.’” Pafford, 451 F.3d at 1356 (internal citations omitted).
In evaluating whether this prong is satisfied, the opinions and views of the vaccinee’s
treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d
at 1326 (“[M]edical records and medical opinion testimony are favored in vaccine cases, as
treating physicians are likely to be in the best position to determine whether a ‘logical sequence
of cause-and-effect show[s] that the vaccination was the reason for the injury.’” (quoting Althen,
418 F.3d at 1280)). Medical records are generally viewed as trustworthy evidence, since they are
created contemporaneously with the treatment of the vaccinee. Cucuras, 993 F.2d at 1528.
Petitioner need not make a specific type of evidentiary showing, i.e., “epidemiologic studies,
rechallenge, the presence of pathological markers or genetic predisposition, or general
acceptance in the scientific or medical communities to establish a logical sequence of cause and
effect.” Capizzano, 440 F.3d at 1325. Instead, Petitioner may satisfy her burden by presenting
circumstantial evidence and reliable medical opinions. Id. at 1325-26.
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The undersigned finds Petitioner has proved Althen Prong Two by preponderant evidence
for the following reasons.
The evidence establishes that on December 5, 2016, Petitioner developed a stuffy nose
and other cold-like symptoms. By that time, she was already experiencing bruising, dizziness,
lightheadedness, fatigue, weakness, and heavy menstruation. On December 7, 2016, Petitioner
visited her OB/GYN where she underwent a full panel of blood work. Her physician prescribed
a Z-pak on that date for her cold symptoms. The next day, on December 8, Petitioner’s
physician notified her that her platelets were critically low at 12,000.
Dr. Serota opined that Petitioner developed ITP as a result of the antigenic exposure to
the flu vaccine she received. As described above, based on Petitioner’s affidavit and medical
records, Dr. Serota found the onset of Petitioner’s ITP was approximately November 13, 2016.
He also determined that Petitioner’s upper respiratory infection began on December 5, 2016,
when she began experiencing cold symptoms that required her doctor to prescribe the Z-pak.
Since Petitioner’s bleeding symptoms began several weeks before her viral infection, Dr. Serota
opined that her viral infection could not have caused her ITP. While both Dr. Baumann
Kreuziger and Dr. Romberg opine that Petitioner’s viral infection was the most likely trigger of
her ITP, neither offered evidence to refute the timeline described in Petitioner’s affidavit or
medical records, or the timeline described by Dr. Serota.
Thus, based on the chronology of events set forth in the Petitioner’s affidavit and medical
records, as well as the opinion of Dr. Serota consistent with the evidence, the undersigned finds
that the onset of Petitioner’s ITP occurred before the onset of her viral illness. Further, the
undersigned finds that there is no evidence that Petitioner had a viral infection before the onset of
her bleeding symptoms in mid-November.
This finding is not necessarily inconsistent with the opinions of Petitioner’s hematologist,
Dr. Kale. Dr. Kale initially diagnosed Petitioner with a differential diagnosis of “[s]evere
thrombocytopenia likely immune thrombocytopenia versus thrombocytopenia due to recent viral
upper respiratory tract infection.” Pet. Ex. 4 at 12. Dr. Kale suggested that Petitioner’s ITP
“[c]ould be from an acute viral upper respiratory infection which hopefully will improve over
time and not cause chronic ITP.” Id. By March 2017, however, Dr. Kale dropped the reference
to “thrombocytopenia due to viral illness.” Instead, the sole diagnosis was “severe labile
immune thrombocytopenia (ITP).” Id. at 77. Dr. Kale no longer documented that a viral
infection could have been the cause of her illness.
Further, while Dr. Kale did not note an association between her vaccination and ITP, it
does not appear that he was aware that Petitioner’s bruising began in November 2016, or that she
had received a vaccination prior to the onset of her ITP. Dr. Kale’s history does not include the
date that Petitioner’s bleeding symptoms began or the date on which Petitioner began having
cold symptoms. Dr. Kale’s history also does not include the fact that Petitioner had previously
received a flu vaccine. After considering all the evidence, the opinion made by Dr. Kale that
Petitioner may have had ITP due to a viral illness appears to be based on an incomplete
knowledge of the facts, and therefore, the undersigned gives it less weight.
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Given the undersigned’s findings on onset, the undersigned also finds that Petitioner’s
clinical course is consistent with post-vaccination ITP. She received her flu vaccine on October
9, 2016, and developed bruising approximately November 13, 2016. When she saw her
gynecologist on December 7, she described a heavy menstrual period that had lasted eight days.
Blood work showed very low platelet levels. This clinical course is consistent with ITP
following vaccination as described in the medical literature and case reports. See, e.g., Pet. Ex.
17(g) at 1-2 (describing a case of a woman who reported genital bleeding and purpura two weeks
after a flu vaccination and was diagnosed with ITP, and another case of a woman who
“experienced massive bleeding” that was diagnosed as ITP and began five weeks following a flu
vaccination); Pet. Ex. 17(h) (describing a man who developed severe thrombocytopenia with
gastrointestinal bleeding two weeks after administration of a flu vaccine).
Regarding Dr. Baumann Kreuziger’s opinion that Petitioner had a “possible” increased
risk for development of ITP because of her history of thrombocytopenia,84 the undersigned finds
this opinion is only noted to be a possibility and thus, insufficient to establish an alternative
cause for Petitioner’s ITP. Moberly, 592 F.3d at 1322 (emphasizing that “proof of a ‘plausible’
or ‘possible’ causal link between the vaccine and the injury” does not equate to proof of
causation by a preponderance of the evidence); Waterman, 123 Fed. Cl. at 573-74 (denying
Petitioner’s motion for review and noting that a possible causal link was not sufficient to meet
the preponderance standard); Boatmon, 941 F.3d at 1359-60; Paterek v. Sec’y of Health & Hum.
Servs., 527 F. App’x 875, 883 (Fed. Cir. 2013). While certainty is by no means required, a
possible mechanism does not rise to the level of preponderance. Moberly, 592 F.3d at 1322; see
also de Bazan, 539 F.3d at 1351.
Moreover, even if Dr. Baumann Kreuzier’s opinion that Petitioner was at risk for ITP
were true, this would simply make Petitioner more susceptible to developing ITP after
vaccination. It would not defeat her claim for vaccine-related ITP.
Further, the medical literature does not support a finding that Petitioner’s one time
platelet count of 137,000 increased her risk of developing ITP. The Stasi et al. study cited by Dr.
Baumann Kreuziger showed that the majority of those in the study did not develop ITP. “[A]t
the end of the study, . . . the probability of developing ITP at 10 y[ears] was 6.9% . . . .”85 Resp.
Ex. J at 4. In addition, none of Petitioner’s medical records support the conclusion she was
diagnosed with thrombocytopenia in 2013. She was not informed about the platelet count or told
that it was anything to be concerned about, and she was not referred to a hematologist for follow-
up.
For all the reasons described above, the undersigned finds that Petitioner has provided
preponderant evidence of a logical sequence of cause and effect required under Althen Prong
Two.
84 Specifically, Dr. Baumann Kreuziger opined that “it is possible that [Petitioner] has an
increased risk for development of ITP given her history of thrombocytopenia.” Resp. Ex. A at 3.
85 Stasi et al. also found “a 10 y[ear] probability of developing [an] autoimmune disorder[] [to
be] 12%.” Resp. Ex. J at 7.
38

Case 1:19-vv-01534-UNJ Document 94 Filed 07/11/23 Page 39 of 39
D. Alternative Causation
Because the undersigned concludes that Petitioner has established a prima facie case,
Petitioner is entitled to compensation unless Respondent can put forth preponderant evidence
“that Petitioner’s injury was in fact caused by factors unrelated to the vaccine.” Whitecotton v.
Sec’y of Health & Hum. Servs., 17 F.3d 374, 376 (Fed. Cir. 1994), rev’d on other grounds sub
nom., Shalala v. Whitecotton, 514 U.S. 268 (1995); see also Walther v. Sec’y of Health & Hum.
Servs., 485 F.3d 1146, 1151 (Fed. Cir. 2007). As discussed above in the analysis related to
Althen Prong Two, the undersigned found Respondent failed to establish evidence to show that
Petitioner’s ITP was caused by a source other than vaccination. Thus, Respondent did not prove
by a preponderance of evidence that Petitioner’s injury is “due to factors unrelated to the
administration of the vaccine.” § 13(a)(1)(B).
VI. CONCLUSION
For the reasons discussed above, the undersigned finds that Petitioner has established by
preponderant evidence that her flu vaccine caused her ITP. Therefore, Petitioner is entitled to
compensation. A separate damages order will issue.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Special Master
39

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_19-vv-01534-1
Date issued/filed: 2025-03-24
Pages: 24
Docket text: PUBLIC RULING (Originally filed: 2/26/2025) regarding 133 Findings of Fact & Conclusions of Law. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made.
--------------------------------------------------------------------------------
Case 1:19-vv-01534-UNJ Document 134 Filed 03/24/25 Page 1 of 24
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: February 26, 2025
* * * * * * * * * * * * * * * * * * * * * * * * *
CHRISTINA MITCHELL, * PUBLISHED
*
Petitioner, * No. 19-1534V
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Decision Awarding Damages; Influenza
AND HUMAN SERVICES, * (“Flu”) Vaccine; Immune
* Thrombocytopenia Purpura (“ITP”); Pain
Respondent. * and Suffering; Lost Wages; Unreimbursable
* Expenses.
* * * * * * * * * * * * * * * * * * * * * * * * *
David John Carney, Green & Schafle LLC, Philadelphia, PA, for Petitioner.
Adam Nemeth Muffett, U.S. Department of Justice, Washington, DC, for Respondent.
RULING ON DAMAGES1
On October 2, 2019, Christina Mitchell (“Petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42
U.S.C. § 300aa-10 et seq. (2018).2 Petitioner alleges that she suffered chronic immune
thrombocytopenia purpura (“ITP”) as the result of an influenza (“flu”) vaccination administered
on October 9, 2016. Petition at Preamble (ECF No. 1). On January 11, 2023, the undersigned
1 Because this Ruling contains a reasoned explanation for the action in this case, the undersigned
is required to post it 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 Ruling 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, the undersigned agrees that the
identified material fits within this definition, the undersigned will redact such material from
public access.
2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§ 300aa-10 to -34 (2018). All citations in this Ruling to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.

Case 1:19-vv-01534-UNJ Document 134 Filed 03/24/25 Page 2 of 24
issued a Ruling on Entitlement, finding that Petitioner was entitled to compensation. Ruling on
Entitlement dated January 11, 2023 (ECF No. 78).
The parties were unable to resolve damages and requested that the Court enter a schedule
for damages briefs. Since then, the parties’ briefs have been filed.
I. PROCEDURAL HISTORY
Petitioner filed her petition on October 2, 2019. Petition. The early procedural history
from October 2019 through 2022 was set forth in the undersigned’s Ruling on Entitlement and
will not be repeated here. See Ruling on Entitlement at 5.
Thereafter, the parties engaged in settlement discussions but were not able to resolve this
matter informally and requested to submit the damages items that remained in dispute to the
Court’s resolution by briefing. See Petitioner’s (“Pet.”) Status Report (“Rept.”), filed Feb. 16,
2024 (ECF No. 115); Joint Status Rept., filed Mar. 18, 2024 (ECF No. 117). During settlement
discussions, Petitioner filed various records, including updated medical records, expert reports,
and an affidavit, and Respondent filed expert reports. Pet. Exhibits (“Exs.”) 36-53; Resp. Exs.
CC-DD.
On June 3, 2024, Petitioner filed a brief in support of her claim for damages. Pet. Brief in
Support of Damages (“Pet. Br.”), filed June 3, 2024 (ECF No. 122). Respondent filed his
responsive brief on July 18, 2024. Respondent’s Response to Pet. Br. (“Resp. Br.”), filed July
18, 2024 (ECF No. 126). Petitioner filed a reply on August 1, 2024. Pet. Reply Br. in Support
of Damages (“Pet. Reply Br.”), filed Aug. 1, 2024 (ECF No. 128).
This matter is now ripe for adjudication.
II. FACTUAL HISTORY
A. Medical Record History
The Ruling on Entitlement issued on January 11, 2023, and it set forth a summary of
Petitioner’s medical records and affidavits. See Ruling on Entitlement at 6-12. Further, the
parties have set forth summaries of relevant facts which support their respective positions in their
briefs, which the undersigned has reviewed as well as all of the medical records and evidence
filed in this matter.
A brief summary of some facts relevant to this Decision follows. While all the records
are important, these entries provide specific information about Petitioner’s condition important to
the undersigned’s Ruling.
Prior to the vaccination at issue, Petitioner had a medical history that included annual
examinations, acute pharyngitis, acute bronchitis, strep throat, and upper respiratory infections.
Pet. Ex. 8 at 2-13; Pet. Ex. 9 at 1-7. On September 12, 2013, Petitioner went in for an annual
2

Case 1:19-vv-01534-UNJ Document 134 Filed 03/24/25 Page 3 of 24
appointment with her OB/GYN. Pet. Ex. 12 at 6. At this appointment, her platelet count was
below normal at 137,000 (range 155,000-379,000). Id. at 7.
On October 9, 2016, Petitioner received a flu vaccination. Pet. Ex. 1 at 3. On October
21, 2016, Petitioner saw her OB/GYN for her annual visit. Pet. Ex. 3 at 11-12. Petitioner
reported she felt dizzy during her menstrual period and headaches the week prior. Id. She
reported no other abnormalities during this appointment. Id.
Petitioner had an appointment on December 7, 2016 with her OB/GYN due to a
prolonged, heavy period. Pet. Ex. 3 at 8. She reported heavy bleeding for eight days, passing
clots, and feeling dizzy. Id. Nurse Practitioner, Elizabeth Newsome, performed a general
examination and noted no abnormalities. Id. Blood work was ordered. Id. The following day,
on December 8, 2016, Petitioner’s lab results came back showing a platelet count of 12,000
(range 150,000-400,000). Id. at 13-14. Petitioner was advised her platelet count was critically
low and she needed to see a hematologist immediately. Id. at 13.
Dr. Gautam Kishore Kale, a hematologist-oncologist, evaluated Petitioner on December
12, 2016. Pet. Ex. 4 at 5. Dr. Kale diagnosed Petitioner with “[s]evere thrombocytopenia likely
immune thrombocytopenia versus thrombocytopenia due to recent upper respiratory tract
infection.” Id. at 12. He noted that her ITP “[c]ould be from an acute viral upper respiratory
infection which hopefully will improve over time and not cause chronic ITP.” Id. During this
appointment, Petitioner also complained of increased clumsiness and cognitive slowing. Id. Dr.
Kale sent Petitioner for a computerized tomography (“CT”) that showed no evidence of bleeding,
however there was a 12 mm area of high density that Dr. Kale postulated was calcium or a
meningioma.3 Id. at 12, 24. He did not find it to be of concern and determined her symptoms
could be from her upper respiratory infection. Id. An ultrasound of her abdomen showed
increased spleen size. Id. at 12. Petitioner was prescribed prednisone4 to increase her platelet
count. Id.
On December 19, 2016, Petitioner was seen for a follow up appointment. Pet. Ex. 4 at
18. Her platelet count had increased to 126,000. Id. at 24. Dr. Kale’s assessment was again
“severe thrombocytopenia likely immune thrombocytopenia versus thrombocytopenia due to
recent viral upper respiratory tract infection.” Id. He decided to taper her prednisone and
monitor her platelet count weekly with the hope that her ITP was not chronic and would improve
over time. Id. at 25.
3 Meningioma is “a benign, slow-growing tumor of the meninges.” Meningioma, Dorland’s
Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=30336 (last
visited Feb. 11, 2025).
4 Prednisone is “a synthetic glucocorticoid derived from cortisone, administered orally as an
antiinflammatory and immunosuppressant in a wide variety of disorders.” Prednisone, Dorland’s
Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=40742 (last
visited Feb. 11, 2025).
3

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After beginning the taper, Petitioner was seen for a follow up visit on December 27,
2016. Pet. Ex. 4 at 27, 30. Her platelet count had dropped to 32,000. Id. at 30, 33. Dr. Kale
increased her prednisone to 40 mg per day. Id. at 34.
On January 3, 2017, Petitioner was seen for another follow up appointment. Pet. Ex. 4 at
35. Her platelet count was stable at 42,000 on 40 mg of prednisone. Id. at 38, 42. Based on this,
Dr. Kale opined that Petitioner’s thrombocytopenia appeared to be steroid dependent. Id. at 42.
Dr. Kale and Petitioner discussed other treatment options including high dose dexamethasone5
and a slow prednisone taper, Rituxan,6 or a splenectomy.7 Id. Petitioner wanted to stop taking
steroids because of her “sense of anxiety” and they made her feel “a little edgy” and gain weight.
Id. at 38, 42. She also indicated she did not want a splenectomy at this time. Id. at 38.
Petitioner decided to consider these options and continue taking prednisone. Id. at 42. On
January 10, 2017, Petitioner was seen for another follow up appointment. Id. at 45. Petitioner
had decided to start Rituxan and continue taking prednisone until Rituxan became effective. Id.
at 51.
Petitioner was seen again on February 6, 2017. Pet. Ex. 4 at 53. Her diagnosis was
“isolated thrombocytopenia likely ITP.” Id. at 56. Petitioner was tapering off prednisone and
was taking 30 mg and reducing by five mg every five to seven days. Id. She had received three
of her four doses of Rituxan and was receiving her final dose that day. Id. She indicated that
“she did not fill her prescription for lorazepam[,] which was ordered for anxiety/insomnia.” Id.
at 57. Her platelet count had dropped to 11,000 the previous week, on January 30, 2017. Id. at
57-59. She had then received high dose dexamethasone and her platelet count had increased to
183,000 on February 6. Id. She had another follow up appointment on February 13, 2017. Id. at
62. After tapering her prednisone to 20 mg per day, Petitioner’s platelet count dropped to 9,000
and she experienced epistaxis (nosebleed). Id. at 67-68. Her prednisone was increased to 60 mg
5 Dexamethasone is administered as “an antiinflammatory and immunosuppressant in a wide
variety of disorders.” Dexamethasone, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=13599 (last visited Feb. 11, 2025).
6 Rituxan is used “in the treatment of CD20-positive, B-cell non-Hodgkin lymphoma;
administered intravenously.” Rituximab, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=43977 (last visited Feb. 11, 2025).
7 Splenectomy is the “excision . . . of the spleen.” Splenectomy, Dorland’s Med. Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=46675 (last visited on Feb. 11,
2025).
4

Case 1:19-vv-01534-UNJ Document 134 Filed 03/24/25 Page 5 of 24
per day. Id. at 69. She agreed to be admitted to the hospital for intravenous immune globulin
(“IVIG”)8 and to start Nplate.9 Id.
The next follow up appointment was March 1, 2017. Pet. Ex. 4 at 71. Petitioner had
responded well to IVIG and Nplate. Id. at 77. Her platelet count was up to 191,000. Id. Dr.
Kale explained to Petitioner that IVIG may remain effective for two-to-four weeks and since she
was two weeks post-treatment, he would continue to monitor her platelets closely. Id. at 77-78.
Dr. Kale tapered Petitioner’s prednisone to 15 mg a day and then recommended continuing the
taper with 10 mg per day for one week before stopping completely. Id. at 78. Dr. Kale’s
assessment at that visit was “severe labile immune thrombocytopenia (ITP).” Id. at 77.
Petitioner was seen for another follow up on March 15, 2017. Pet. Ex. 4 at 79. Petitioner
was down to 10 mg of prednisone and received Nplate 2 mcg/kg. Id. at 85. By her appointment
on March 30, 2017, Petitioner was off prednisone and her platelet count was at 101,000. Id. at
95. Petitioner continued to receive weekly Nplate treatments. Id. Again, Dr. Kale’s diagnosis
was “severe labile immune thrombocytopenia (ITP).” Id.
From April 2017 to July 2017, Petitioner’s platelet counts remained stable. Pet. Ex. 4 at
97-130. On August 10, 2017, her platelet count decreased to 50,000 “in the setting of an [upper
respiratory tract infection.” Id. at 134, 136-37. On October 17, 2017, Petitioner was seen by Dr.
Alice De-Ling Ma, a hematologist at UNC Healthcare, “for a second opinion regarding therapy
for chronic ITP.” Pet. Ex. 6 at 8. Dr. Ma recommended either a splenectomy or Rituxan. Id. at
9. On October 19, 2017, Petitioner returned to Dr. Kale and discussed similar treatment options.
Pet. Ex. 4 at 146. Petitioner decided she wanted to switch to Promacta10 with Nplate as a backup
if her platelet count dropped below 50,000. Id. She decided against splenectomy. Pet. Ex. 37 at
6.
Petitioner’s diagnosis was confirmed as chronic ITP on November 16, 2017. Pet. Ex. 4 at
148. She began taking Promacta and was seen for various follow ups from November 2017
throughout 2018. Id. at 160-61, 169, 179, 183, 188, 191, 197, 200, 209, 215, 218, 224, 227. At
her December 7, 2018 follow up, her platelet count dropped to 39,000. Id. at 237. Dr. Kale
increased Petitioner’s Promacta dosage from 25 mg to 50 mg per day. Id.
8 IVIG is “used in the treatment of primary immunodeficiency disorders and [ITP].” Immune
Globulin Intravenous (Human), Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=78975 (last visited Feb. 11, 2025).
9 Nplate (romiplostim) is “a thrombopoietin receptor agonist used for treatment of [ITP].”
Romiplostim, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/
definition?id=44074 (last visited Feb. 11, 2025).
10 Promacta (eltrombopag olamine) “stimulates platelet production” and is “used for the
treatment of thrombocytopenia in patients with chronic [ITP] who have had an insufficient
response to other treatments.” Eltrombopag Olamine, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=15982 (last visited Feb. 11, 2025).
5

Case 1:19-vv-01534-UNJ Document 134 Filed 03/24/25 Page 6 of 24
Petitioner’s platelet count increased on December 19, 2018 to 248,000 on 50 mg
Promacta per day. Pet. Ex. 4 at 248. Dr. Kale switched her to alternating 25 mg and 50 mg
every other day, and her platelet count on January 11, 2019 was stable at 75,000. Id. at 248-49.
Petitioner mentioned she had gone to urgent care because she was having difficulty breathing,
and she had been prescribed prednisone 60 mg. Id. at 244; Pet. Ex. 7 at 6-8. However,
Petitioner claimed she had stopped taking the Prednisone prescribed during this appointment
three weeks ago. Pet. Ex. 4 at 244. In February 2019, Petitioner’s platelet count remained stable
on the alternating doses of Promacta. Id. at 257.
Dr. Kale ordered another CT, which was conducted on April 5, 2019, to check on
Petitioner’s meningioma. Pet. Ex. 4 at 264. The CT showed no change since 2017. Id. at 264,
267. Petitioner began to taper her Promacta by taking 50 mg three days a week and 25 mg the
other four days. Id. at 267. In June 2019, this was reduced to 50 mg twice a week and 25 mg
five days a week. Id. at 277. Petitioner tolerated this well in August. Id. at 285; Pet. Ex. 11 at 9,
16. On October 9, 2019, Petitioner’s platelets remained stable at 153,000, and Petitioner was
directed to taper her Promacta to 25 mg every day. Pet. Ex. 11 at 25, 31.
On December 6, 2019, Petitioner was clinically stable and her platelets were stable at
111,000. Pet. Ex. 11 at 39. Her diagnosis remained chronic ITP. Id. at 36. She reported “doing
well overall.” Id. Review of systems noted that Petitioner had “good energy levels.” Id.
Fatigue was not reported. See id. at 36-37. ECOG Performance Status was “0.” Id. at 38.
Dr. Ni Gorsuch, a hematologist, began seeing Petitioner on March 6, 2020, per
Petitioner’s request. Pet. Ex. 14 at 19-37. Dr. Gorsuch and Petitioner discussed tapering off
Promacta; however, Petitioner decided to stay on Promacta for the time being. Id. at 27. On
June 4, 2020, Petitioner began the Promacta taper. Pet. Ex. 21 at 5. Petitioner discontinued
Promacta on June 19, 2020. Id. at 15. On July 16, 2020, Petitioner’s platelet count was 120,000
and Dr. Gorsuch noted Petitioner was stable without ITP relapse. Id. at 17-19. Petitioner saw
her gynecologist for an annual examination on August 7, 2020 and reported regular monthly
menses that were not heavy or painful and that she was “doing well” off Promacta. Pet. Ex. 39 at
15-16.
On October 19, 2020, Petitioner was seen by Dr. Gorsuch for a follow up. Pet. Ex. 14 at
23-31. Her ITP had not relapsed. Id. at 24. This remained true throughout 2021. Pet. Ex. 21 at
32-37; Pet. Ex. 24 at 5-9.
Petitioner returned to gynecologist, Dr. Megan Mansell Morris on November 19, 2021
for an annual gynecological examination. Pet. Ex. 39 at 11-12. Petitioner reported regular
monthly menses that were not heavy or painful. Id. at 12.
On January 11, 2022, Petitioner reported bruising and bleeding gums and requested blood
work. Pet. Ex. 24 at 10. Petitioner “[was] considered to be in remission with a baseline platelet
level around 110-120.” Id. Her last platelet count in August 2021 was 112,000. Id. If her
platelet level went below 100,000, she was directed to see her hematologist. Id. at 11. However,
her platelet count at this appointment was 110,000. Id. at 11. Her platelets were tested next on
April 12, 2022 and were 106,000. Pet. Ex. 36 at 10.
6

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Petitioner returned to Dr. Gorsuch on September 12, 2022. Pet. Ex. 37 at 5. Dr. Gorsuch
documented that Petitioner discontinued Promacta over one year prior and “ha[d] no signs of
relapse requiring treatment.” Id. He noted her condition was chronic “but not symptomatic.” Id.
Petitioner denied heavy monthly menstruation and spontaneous bleeding but reported occasional
bruises. Id. Petitioner’s platelets were 100,00. Id. at 9. Petitioner had “mild anemia”
(hemoglobin 11.9) “likely due to recent menstruation,” which was to be monitored. Id. at 6, 9.
She was instructed to monitor and report any “excessive bruising or spontaneous bleeding.” Id.
at 10.
On November 1, 2022, Petitioner returned to see her gynecologist, Dr. Morris, for follow
up. Pet. Ex. 39 at 3. Her problem list included ITP. Id. She also reported heavy bleeding with
menstruation. Id. at 4-5. Petitioner presented “for consultation to help stop periods [due to] ITP.
[Petitioner] state[d] menses are regular but are becoming increasingly heavy over time.” Id. at 5.
Petitioner experienced large clots with her last period and presented to the emergency room. Id.
She also reported a platelet drop of 30,000 to 40,000. Id. Dr. Morris recommended an
ultrasound to determine best treatment plan, which could include tranexamic acid (“TXA”),
Mirena, ablation, and hysterectomy. Id. Petitioner requested a prescription for TXA until she
determined a plan. Id. Assessment was “[a]bnormal uterine bleeding,” and Petitioner’s
fingerstick hemoglobin was low at 10.4. Id.
On November 30, 2022, Petitioner underwent an ultrasound which showed findings of
“[s]lightly thickened inhomogeneous myometrium” consistent with adenomyosis.11 Pet. Ex. 39
at 6, 8. Petitioner had not taken TXA yet because her last period in November 2022 “was not
very bad and she did not need to take it.” Id. at 8. Dr. Morris recommended an intrauterine
device (“IUD”), endometrial ablation, or hysterectomy. Id. Dr. Morris opined that given
Petitioner’s age and suspected adenomyosis, “ablation would be a temporary fix and [] she
would likely require[] hysterectomy later.” Id. Assessment was “[m]enorrhagia,” or
“[e]xcessive bleeding in the premenopausal period.” Id. at 8.
Petitioner had a telehealth visit with Dr. Gorsuch on December 12, 2022. Pet. Ex. 41 at
6. Her platelet count was 72,000 at this visit. Id. at 8. Dr. Gorsuch’s assessment was “minimum
change in her platelet count despite having menstruation a day ago. Overall, she does not need
treatment for chronic thrombocytopenia.” Id. at 6. Dr. Gorsuch also noted Petitioner had mild
anemia (hemoglobin 11.2) likely due to her blood loss for her menstrual cycle and continued to
heavy bleeding during menstruation at times. Id. at 6, 8. Petitioner denied excessive fatigue,
shortness of breath or dizziness. Id. at 6. Dr. Gorsuch added that Petitioner’s anemia was “not
symptomatic.” Id.
11 Adenomyosis is “a benign condition characterized by endometrial glands and stroma within
the myometrium, accompanied by hypertrophy of the myometrium.” Adenomyosis, Dorland’s
Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=965 (last visited
Feb. 11, 2025).
7

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Petitioner returned for an annual examination with Dr. Morris on January 16, 2023. Pet.
Ex. 42 at 5. Petitioner reported no gynecological complaints and regular menses that were not
heavy or painful. Id. at 7. Her menses lasted five days, and two of those days she had a heavy
flow. Id. She also noted she “[h]a[d] not needed to take TXA.” Id. Petitioner’s platelets were
tested on April 19, 2023 and were 116,000. Pet. Ex. 40 at 6, 12. Fingerstick hemoglobin was
normal at 12.8. Pet. Ex. 42 at 8, 25.
Her next visit to a health care provider was April 19, 2023, when she saw Physician
Assistant (“PA”) Anna Becker for an annual health review. Pet. Ex. 40 at 4. At that visit,
Petitioner reported having “situational anxiety, mostly triggered by specific situations” including
“going to the doctor’s offices, checkout lines in grocery stores, [and] driving on the highway.”
Id. She had developed “anxiety attacks” which led to hyperventilation and dizziness. Id. These
occurred “a few times a week,” resolving when she would leave the situation. Id. She reported
seeing a counselor, which she “found helpful.”12 Id. She also tried using “deep breaths.” Id.
Assessments included “[a]nxiety.” Id. at 5. Treatment was initiated with Alprazolam 0.25 mg,
twice daily as needed for acute anxiety. Id. at 6. A prescription for Xanax was also given to be
taken as needed. Id. Her platelet count at this visit was 116,000. Id.
Ms. Becker held a video visit with Petitioner on May 24, 2023 for follow up of her
anxiety. Pet. Ex. 51 at 4. Petitioner reported that she had taken Xanax two to three times since
the prior visit, and while the medication improved her anxiety, it did not completely resolve it.
Id. Driving had been more difficult. Id. Petitioner also described being very anxious when she
cannot leave a situation. Id. She was especially concerned about upcoming jury duty. Id.
Assessment was anxiety. Id. at 5. Treatment with Alprazolam as needed was continued. Id. at
5.
On September 12, 2023, Petitioner saw Dr. Gorsuch. Pet. Ex. 49 at 5. Petitioner’s
platelets were 147,000. Id. at 8. Assessment noted Petitioner continued to have minimal
changes in her platelets “despite having no treatment for a long time.” Id. at 5. Dr. Gorsuch
noted Petitioner “[did] not need treatment for chronic thrombocytopenia” and Petitioner agreed
to continue following up with only primary care. Id. She was also instructed to monitor for
signs and symptoms of recurrent ITP. Id. At this visit, Dr. Gorsuch also noted that Petitioner
had intermittent menorrhagia, “[o]therwise, [she had] no signs of other bleeding.” Id. at 6. She
had an appointment scheduled to see her gynecologist to discuss treatment of her menorrhagia.
Id. at 5. Hemoglobin was low at 11.9. Id. at 8. Final diagnoses were ITP and “[e]xcessive and
frequent menstruation.” Id. at 24.
In January 2024, Petitioner saw Ms. Becker and requested her platelets be checked due to
spotting when not on her period, which she reported was unusual for her. Pet. Ex. 51 at 7.
Petitioner “denie[d] recent easy bruising[] [and] easy bleeding.” Id. Petitioner’s platelet count
was 149,000, which was “stable and in the higher range for [Petitioner].” Id. at 9-10. Petitioner
12 On February 7, 2025, Petitioner filed a status report, stating “she never saw a mental health
counselor for her anxiety related to her ITP.” Pet. Status Rept., filed Feb. 7, 2025, at 1 (ECF No.
132). Petitioner believed this notation was an error. Id.
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also reported that her anxiety had slightly worsened and she had experienced several episodes at
the grocery store, associated with palpitations, increased heart rate, shortness of breath, and
anxiety. Id. at 7. The episodes were short and resolved after five to 10 minutes. Id. Petitioner
noted that she had a high level of stress in her life at the time. Id. Assessment included history
of ITP and anxiety. Id. at 8.
Petitioner also saw her gynecologist for an annual examination in January 2024. Pet. Ex.
53 at 8. Petitioner reported her “recent episode of intermenstrual spotting” as well as two “very
heavy days of clotting” before her period was over. Id. at 10. Petitioner reported she “[h]a[d]
not needed to take TXA.” Id. Petitioner expressed interest in a hysterectomy. Id. at 12.
Repeat blood work one month later, on February 16, 2024, revealed a platelet count of
82,000. Pet. Ex. 51 at 13.
Petitioner returned to Dr. Morris on July 1, 2024 for a consult regarding a hysterectomy.
Pet. Ex. 53 at 3, 5. At this visit, Petitioner reported “worsening periods since 10/2022. . . .
[Petitioner] strongly desire[d] to avoid hormonal [treatment]. She state[d] her last period in June
was the heaviest she has had to date and she passed large clots. . . . Menses do occur regularly
but are extremely heavy and painful.” Id. at 5. Dr. Morris noted that Petitioner had ITP and her
platelets were last tested in May 2024 and were 100,000.13 Id. Petitioner had previously been
prescribed TXA, although she never took it when last prescribed. Id. at 6. Petitioner requested a
hysterectomy. Id. Labs drawn that day showed normal hemoglobin of 12.4 and platelets of
96,000 (range 150,000 to 450,000).14 Id. at 23. Dr. Morris recommended a robotic
hysterectomy due to Petitioner’s obesity and ITP and referred Petitioner to a surgeon. Id. at 6.
On July 29, 2024, Petitioner saw Dr. Amr Sherif Mohamed Rifaa El Haraki in
consultation. Pet. Ex. 54 at 311. Petitioner reported “intense vaginal bleeding with her periods
since 2016.” Id. Due to her ITP diagnosis, Petitioner was “worried about heavy bleeding due to
her heavy periods.” Id. An endometrial biopsy and ultrasound were performed. Id. at 313. The
ultrasound showed “[b]lurring of the endometrial myometrial junction with possible myometrial
cystic spaces, which can be seen in the setting of adenomyosis.” Id. It also showed “[r]estricted
movement between the uterine and bowel surfaces” and “[p]ossible cystic structures along the
posterior uterine serosa and in the left adnexa” that were not well visualized. Id. The
endometrial biopsy showed “[p]roliferative endometrium” and “[b]enign squamous epithelial
cells,” but did not show any other abnormalities. Id. at 316. Assessment was abnormal uterine
bleeding (“AUB”) and history of ITP. Id. at 314. Petitioner was offered medical treatment but
she preferred surgical intervention. Id. The plan was for a vaginal hysterectomy with bilateral
salpingectomy. Id.
13 Lab records confirming this blood work were not filed.
14 This record documented “[a]ctual platelet count may be somewhat higher than reported due to
aggregation of platelets in this sample.” Pet. Ex. 53 at 23.
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Petitioner underwent a total laparoscopic hysterectomy on August 23, 2024 as an
outpatient procedure. Pet. Ex. 54 at 28. Pre-operative diagnoses were AUB and ITP. Id.
Operative findings included Stage IV endometriosis.15 Id. at 28-29. There were no
complications and she was discharged the same day. Id. at 27-30.
No additional medical records have been filed.
B. Petitioner’s Affidavit and Declarations
1. Pre-Ruling on Entitlement Affidavit and Declaration16
Prior to the vaccination at issue, Petitioner “was healthy, active[,] and had no
autoimmune diseases or hematological disorders, or any history of autoimmune disease or
hematological disorders.” Pet. Ex. 32 at ¶ 3. Petitioner received her flu vaccine on October 9,
2016. Pet. Ex. 2 at ¶ 4. She started to notice bruising on the front and back of her thighs in mid-
November 2016, around two weeks prior to her birthday on November 27, 2016. Id. at ¶¶ 10,
12. These bruises did not fade as ordinary bruises she had in the past did. Id. at ¶ 10.
On November 30, 2016, Petitioner had her menstrual period. Pet. Ex. 2 at ¶ 15.
Petitioner’s cycle lasted for 10 days instead of her normal four to five days and she felt dizzy,
lightheaded, fatigued, and weak. Id. She continued to experience “spontaneous bruising,
dizziness, lightheadedness, fatigue, weakness, and heavy menstruation[].” Id. at ¶ 16. On
December 7, 2016, Petitioner visited her OB/GYN where she underwent a full panel of blood
work. Id. at ¶ 18. On December 8, 2016, Petitioner’s physician notified her that her “platelets
were critically low at 12,000 and that [she] needed to see a hematologist as soon as possible.”
Id. at ¶ 19.
Dr. Kale saw Petitioner on December 12, 2016. Pet. Ex. 2 at ¶ 21. At this appointment,
she was diagnosed with ITP and was prescribed 60 mg of prednisone. Id. Petitioner’s platelet
count increased to 126,000 the following week and she began a prednisone taper. Id. at ¶ 22.
Petitioner returned for a follow up visit on December 27, 2016. Pet. Ex. 2 at ¶ 23. Her
platelet count had dropped to 32,000. Id. She restarted prednisone and her platelet count
increased. Id. Dr. Kale advised her she had ITP that was responsive to steroids and steroid
dependent. Id. In January 2017, Petitioner switched to Rituxan therapy and began to taper her
prednisone. Id. at ¶ 24. Petitioner’s platelets increased by early February 2017. Id.
15 Endometriosis is “a condition in which tissue containing typical endometrial granular and
stromal elements occurs in locations outside the uterine cavity, chiefly on the ovaries and pelvic
peritoneum.” Endometriosis, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=16340 (last visited Feb. 11, 2025).
16 Petitioner submitted an affidavit executed on September 24, 2019 and a declaration executed
on March 3, 2022. Pet. Exs. 2, 32.
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Following a nosebleed, Petitioner returned to Dr. Kale’s office on February 12, 2017.
Pet. Ex. 2 at ¶ 25. Her platelet count had dropped to 9,000. Id. She immediately reported to the
hospital for possible IVIG treatment. Id. She was admitted to the hospital on February 14, 2017,
where she received two doses of IVIG and Nplate treatments. Id. at ¶ 26. She was discharged
the following day. Id. By March 2017, her platelets increased to 191,000 and she remained on
20 mg of prednisone. Id. Between March 2017 and October 2017, Petitioner was consistently
on prednisone and receiving weekly Nplate shots. Id. at ¶ 27. Her platelets fluctuated greatly
over this period. Id.
Petitioner saw Dr. Ma at UNC Healthcare on October 17, 2017 for a second opinion. Pet.
Ex. 2 at ¶ 28. Dr. Ma suggested Cellcept, Promacta, or a splenectomy as alternative courses of
treatment. Id. She recommended repeating Rituxan if the splenectomy failed. Id. However,
since Petitioner was on Nplate successfully, Dr. Ma recommended staying on Nplate or
switching to Promacta. Id.
From October 2017 to November 2017, Petitioner continued to take prednisone and
receive weekly Nplate shots. Pet. Ex. 2 at ¶ 29. On November 16, 2017, Petitioner began taking
Promacta at 25 mg per day. Id. She remained on Promacta, taking 25 mg every day except
Mondays and Fridays, when she took 50 mg. Id. at ¶ 30.
Petitioner weaned off Promacta in June 2020. Pet. Ex. 32 at ¶ 14. She followed up with
her hematologist annually and had her platelets checked twice a year with her hematologist and
at her yearly physical. Id. Her platelets remain lower than normal; however, they are stable
enough for her to feel comfortable. Id.
Petitioner explained how her diagnosis has affected her emotionally, physically, and
psychologically. Pet. Ex. 2 at ¶ 31. She described that
[p]hysical activity is harder now. The long list of medications and treatments [she
has] been on have been very hard on [her] body. The steroids (prednisone and
dexamethasone) have made [her] shoulders, hips, and knees ache. They have also
caused significant weight gain and [she is] very sensitive to heat now and
overheat[s] easily. This limits [her] from being able to go outside or do things
with [her] daughter a lot during the hot summer months. [Her] moods are
affected, and [she has] a lot of mood swings. [She] also ha[s] extreme fatigue.
[She] ha[s] talked to [her] doctor about this, especially insomnia.
Id.
When Petitioner’s counts are lower, she must be extremely careful. Pet. Ex. 2 at ¶ 32.
She explained that her social life has been affected by her diagnosis. Id. at ¶ 33. She constantly
worries during her menstrual cycle every month. Id. She looks for bruises and blood blisters
and worries she will catch something during cold/flu season that would cause her platelets to
decrease. Id. Petitioner also claims her diagnosis has also impacted her ability to work. Id. at ¶
34. She cannot work more than part time due to her extreme fatigue that results from her
medications. Id. Petitioner also suffered financially due to her diagnosis. Id. at ¶ 35.
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2. Supplemental Declaration17
Petitioner’s supplemental declaration, executed October 2, 2023, includes information
covered in her previous affidavits and provides additional information about her clinical course,
consistent with her affidavits and medical records. See Pet. Ex. 50. Specifically, as it relates to
anxiety, Petitioner described the mental toll of ITP; she constantly checks for bruises, worries
about her menstrual cycle every month, and worries during flu seasons that she could catch an
illness that could decrease her platelet counts. Id. at 4-6. She stated, “[t]he anxiety is very real.”
Id. at 6.
3. Affidavit and Declarations Regarding Lost Wages
Specific to her claim for past and future last wages, in her first affidavit, executed
September 24, 2019, Petitioner averred that she worked part-time at a preschool. Pet. Ex. 2 at ¶
34. She did not believe she would work more than part time due to the extreme fatigue she
experienced from her ITP and medications. Id.
On March 3, 2022, Petitioner signed a declaration describing her condition at that time,
but she did not discuss her employment. See Pet. Ex. 32 at 1-5. She was not taking any
medications for her ITP at that time, but she stated that she continued to experience fatigue, joint
pain, and weight issues. Id. at ¶ 14.
In her last declaration, executed October 2, 2023, Petitioner explained that her husband
was the primary earner in her family, and that for the past 10 years, she held part-time
employment so that she could be home with her daughter. Pet. Ex. 50 at ¶ 22. She explained
that during the COVID pandemic, there was a period of time that she did not work because she
was too anxious about becoming sick due to her ITP. Id. at ¶ 21. Additionally, she explained
that she currently works part time and has not applied for full-time positions because she does
not believe that she could handle full-time employment. Id.
Petitioner’s daughter was born in 2010, and Petitioner stayed home with her for five
years. Pet. Ex. 50 at ¶ 22. In 2015, Petitioner’s daughter started preschool, and Petitioner began
substitute work at the same school. Id. In 2016, when her daughter started kindergarten,
Petitioner began working a permanent part-time position, five days per week, from 9:00 a.m.
until 1:00 p.m. Id. She continued to work after she developed ITP, although “it became
increasingly more difficult.” Id. However, after the COVID pandemic began, Petitioner asserted
that “[i]t was nearly impossible for [her] to work at the preschool due to [her] ITP, frequent
illnesses[,] and severe anxiety [she] had about COVID” and her illness. Id. She returned to
work in October 2022, at early morning drop-off for 1.5 hours per day, five days per week. Id. at
¶ 23.
17 Although labeled an affidavit, it is not notarized, and is therefore referred to as a declaration.
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Petitioner stated that when she began working at the preschool in 2016, her plan was to
work at the school until her daughter started middle school and “then find employment working
formal full-time hours.” Pet. Ex. 50 at ¶ 23. However, she stated that due to her illness, “it is
exceedingly difficult” to work full time due to fatigue and the risk of illness. Id. Currently,
Petitioner works a school year calendar, late August through late May. Id. at ¶ 24. Before her
ITP, Petitioner had planned to work full-time in a preschool during the school years, and to work
at camps or programs in the summer to earn money during summer months. Id.
III. EXPERT REPORTS
A. Petitioner’s Expert, Dr. Abhimanyu Ghose
Dr. Ghose is board certified in hematology oncology and internal medicine. Pet. Ex. 43
at 1. He is an expert in hematological disorders, including ITP. Id.
He explained that patients with ITP can be asymptomatic. Pet. Ex. 43 at 2. However,
“many [] suffer from the consequences of low platelets, which are typically bleeding
manifestations” that “can vary from bruising on the skin, bleeding from the nose, heavy periods,”
and hemorrhage. Id. ITP can also lead to fatigue and “worsened quality of life.” Id. Dr. Ghose
cited McMillan et al.,18 which reported on the quality of life in adults with chronic ITP and
“concluded that patients with chronic ITP had a lower quality of life than people without ITP and
there was a reasonable likelihood that someone with chronic ITP would have negative impacts
on their work or school such as absences, missing promotions or failing to advance.” Id. at 2-3
(citing Pet. Ex. 17(a)).
Dr. Ghose opined Petitioner was in good health prior to developing ITP. Pet. Ex. 43 at 3.
“[Her] disease was refractory to steroids and challenging to treat warranting frequent lab work
through blood draws, doctor visits[,] and even traveling for second opinion.” Id. “She continues
to have fluctuations in her platelet counts even though she is not dependent on medication or
Promacta for her chronic ITP. Her platelets continue to be below normal, indicating that she has
an ongoing chronic ITP that is not overly symptomatic,” although she has “ongoing spontaneous
bruising and heavy menstrual cycles.” Id. Petitioner is also “prone to ongoing bouts of
increased fatigue, immune system complications, and frequent sickness.” Id. Although she is no
longer on medication, Petitioner requires ongoing monitoring. Id. Dr. Ghose opined “there is a
reasonable likelihood of relapse in her condition since it is chronic.” Id. He added,
“[Petitioner’s] discontinuance of Promacta is not a sign that her chronic ITP is in remission or
cured. Quite the opposite, she is at a 15-53% risk of relapse given her diagnosis.” Id. at 4.
With regard to her chronic autoimmune illness and the nature of Petitioner’s work in
childcare at a preschool, Dr. Ghose opined that he “would reasonably expect her to be prone to
ongoing infections and illnesses that are abundant in that setting.” Pet. Ex. 43 at 4. Although
“she is able to become employed,” Petitioner “is at risk for frequent illnesses, absences, and
18 Robert McMillan et al., Self-Reported Health-Related Quality of Life in Adults with Chronic
Immune Thrombocytopenic Purpura, 83 Am. J. Hematology 150 (2008).
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inability to earn promotions due to her erratic attendance and participation in the workforce.” Id.
“She may also have issues maintaining employment with frequent illnesses, increased fatigue,
body aches, and immune complications which will prevent her from advancing in her career and
increasing her annual earnings.” Id.
Dr. Ghose concluded Petitioner “should be able to continue working in her field at the
current part-time allotment but with limitations.” Pet. Ex. 43 at 4. “[He] expect[s] that
[Petitioner] will be unable to maintain full-time employment or common part-time hours (20-25
hours per week) due to her chronic ITP and the symptoms associated with it.” Id.
B. Respondent’s Expert, Dr. Lisa Baumann Kreuziger
Dr. Kreuziger agreed that Petitioner, due to her use of Promacta, she “can have long-term
remission after discontinuation of therapy, but monitoring is needed as relapse is possible.”
Resp. Ex. CC at 2.
She also agreed ITP patients “can experience fatigue and fatigue can affect their quality
of life.” Resp. Ex. CC at 2. But she contended that “[f]atigue [was] not consistently
documented” in Petitioner’s records. Id. at 3. “Therefore, there is not corroborating evidence
within the medical record of severe fatigue that would affect her ability to work.” Id.
In response to Dr. Ghose’s assertion that Petitioner will have frequent illnesses due to her
work in childcare, Dr. Kreuziger opined Petitioner had experienced illnesses prior to her ITP,
“and if frequent illnesses occurred, they would not be attributable to her ITP.” Resp. Ex. CC at
3.
Dr. Kreuziger also addressed Petitioner’s complaint of heavy menstrual bleeding. Resp.
Ex. CC at 4. “When platelet counts are low, heavy menstrual bleeding can occur,” explained Dr.
Kreuziger. Id. Thus, “[c]ontrolling her menstrual cycles would not influence her platelet
counts.”
Overall, she opined Petitioner requires monitoring with appointments and bloodwork.
Resp. Ex. CC at 4. She is not symptomatic, and she does not require subspecialty (hematology)
care. Id. Despite Dr. Ghose’s assertions, Petitioner’s treating physicians and Petitioner’s
medical records do not consistently document fatigue or other symptoms “that would impact her
ability to work or to work at the level she alleges.” Id. Thus, Dr. Kreuziger opined
“[Petitioner’s] ITP does not require treatment outside of the need for monitoring through her
primary care physician.” Id.
C. Staci L. Schonbrun, Labor Market Consultant
Ms. Schonbrun summarized Petitioner’s employment history. Pet. Ex. 47 at 5. Petitioner
was a preschool teacher at the time of her vaccination and subsequent development of ITP. Id.
Petitioner was out of work for periods of time in 2016, but largely maintained her employment
until the COVID pandemic began in March 2020. Id. Petitioner did not return to work
following the preschool’s reopening. Id. Petitioner reported that in 2016 “she continued
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working but with difficulties,” including fatigue and sickness, which “made it difficult to
maintain her ITP and blood counts.” Id. “When the COVID shutdown occurred and she was no
longer working, she found that her blood counts stabilized and by June 2020 she came off her
medication.” Id. Petitioner “was afraid to return to work because she was fearful of coming out
of remission and going back on the medication which was problematic.” Id. She returned to
work in October 2022, working 1.5 hours per day as opposed to four hours per day. Id. Based
on information obtained, Ms. Schonbrun believed the most significant issue is Petitioner’s
fatigue, followed by joint pain and anxiety. Id.
With regard to earning capacity, Ms. Schonbrun conceded “[f]rom 2017 to 2019[,]
[Petitioner] did return to work in a similar capacity and when averaged this results in annual
earnings of $6,632.97,” which is “a reasonable measure of [Petitioner’s] pre-injury earning
capacity during the years that her daughter is in school as she is the primary caregiver.” Pet. Ex.
47 at 8. Once Petitioner’s daughter graduated from high school “it is reasonable that [Petitioner]
pre-injury would have worked in the same or similar capacity, but on a full-time rather than part-
time basis.” Id. Ms. Schonbrun noted that in 2022, “82.2% of employed mothers whose
youngest children were between 6-17 worked in full time.” Id.
Petitioner has worked 1.5 hours per day for five days per week since returning to work in
October 2022. Pet. Ex. 47 at 9. Ms. Schonbrun opined that “[i]t is probable that her present
wages are representative of her post-injury earning capacity.” Id. Ms. Schonbrun calculated
Petitioner’s past and future lost wages using the median wage of childcare workers in North
Carolina and Petitioner’s earning capacity pre- and post-injury. Id. Because “Dr. Ghose opined
that [Petitioner] would exit the labor force earlier than an average person due to her medical
condition,” and due to her current hours, Ms. Schonbrun “did not further reduce her participation
rate but [] utilized her present employment as a permanent basis over the remainder of her work
life expectancy instead.” Id. at 10.
IV. PARTIES’ CONTENTIONS
A. Pain and Suffering
1. Petitioner’s Contentions
In her first submission, Petitioner requested a pain and suffering award of $200,000, but
then increased her request to $250,000.00 in her reply brief. Pet. Brief at 1; Pet. Reply Br. at 1-2,
1 n.1. Petitioner contends her case has been severe, lasting over seven years with continued
treatment and procedures due to the residual effects of her ITP. Pet. Reply Br. at 2.
2. Respondent’s Contentions
Respondent argues that based on the facts of this case, Petitioner should be awarded
$70,000.00 for pain and suffering. Resp. Br. at 6. Respondent contends Petitioner was actively
treated for her ITP for three-and-one-half years, from December 2016 until June 2020. Id. at 6.
In the first 11 months, Petitioner’s platelet counts waxed and waned. Id. She was given a
diagnosis of chronic ITP in November 2017 and prescribed Promacta. Id. Thereafter, her
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platelets stabilized. Id. Petitioner began to wean off Promacta and by June 2020, she had
discontinued taking Promacta. Id. Respondent asserts that while she was on Promacta,
Petitioner did not have any relapse in symptoms, and that she has not had any relapses since
stopping Promacta in June 2020. Id. at 6-7. Additionally, Respondent notes Petitioner’s expert
hematologist, Dr. Ghose, agreed Petitioner has not had a relapse of her ITP since stopping
Promacta. Id. at 8 (citing Pet. Ex. 43 at 2-3).
As to duration, Respondent contends Petitioner’s injury lasted three-and-one-half years,
until June 2020 and that there is no evidence in the medical records to support Petitioner’s
contention of ongoing ITP symptoms. Resp. Br. at 8.
B. Lost Wages
1. Petitioner’s Contentions
Petitioner seeks an award of total lost earnings in the amount of $281,268.00, from 2016
to 2047. Pet. Br. at 26; Pet. Reply Br. at 1. This amount includes lost earnings of $14,994.00
from 2016 to 2023 and Petitioner’s lost earnings capacity of $266,275.00 from 2023 to 2047.
Pet. Br. at 26.
2. Respondent’s Contentions
Respondent contends “[P]etitioner experienced a loss of earnings from September 2020
through the 2023-2024 school year.” Resp. Br. at 11. Respondent’s expert, Patrick F. Kennedy,
Ph.D., calculated these lost earnings to be $14,694.00. Id. at 11-12 (citing Resp. Ex. DD at 4,
22). However, Respondent disagrees that Petitioner is entitled to future lost earnings. Id. at 12.
C. Unreimbursable Expenses
The parties agree on an amount of past unreimbursable expenses. Resp. Br. at 4; Pet.
Reply Br. at 1. They agree that Petitioner should be awarded $7,676.42 for past unreimbursed
expenses. Resp. Br. at 4; Pet. Br. at 30; Pet. Reply Br. at 1.
V. LEGAL FRAMEWORK AND ANALYSIS
Petitioner bears the burden of proof with respect to each element of compensation
requested. Brewer v. Sec’y of Health & Hum. Servs., No. 93-0092V, 1996 WL 147722, at *22-
23 (Fed. Cl. Spec. Mstr. Mar. 18, 1996).
A. Pain and Suffering
Compensation awarded pursuant to the Vaccine Act shall include “[f]or actual and
projected pain and suffering and emotional distress from the vaccine-related injury, an award not
to exceed $250,000.” § 15(a)(4).
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There is no formula for assigning a monetary value to a person’s pain and suffering and
emotional distress. I.D. v. Sec’y of Health & Hum. Servs., No. 04-1593V, 2013 WL 2448125, at
*9 (Fed. Cl. Spec. Mstr. May 14, 2013) (“Awards for emotional distress are inherently subjective
and cannot be determined by using a mathematical formula.”); Stansfield v. Sec’y of Health &
Hum. Servs., No. 93-0172V, 1996 WL 300594, at *3 (Fed. Cl. Spec. Mstr. May 22, 1996)
(“[T]he assessment of pain and suffering is inherently a subjective evaluation.”). Factors to be
considered when determining an award for pain and suffering include: (i) awareness of the
injury; (ii) severity of the injury; and (iii) duration of the suffering. I.D., 2013 WL 2448125, at
*9 (quoting McAllister v. Sec’y of Health & Hum. Servs., No. 91-1037V, 1993 WL 777030, at
*3 (Fed. Cl. Spec. Mstr. Mar. 26, 1993), vacated & remanded on other grounds, 70 F.3d 1240
(Fed. Cir. 1995)).
The undersigned may look to prior pain and suffering awards to aid in the resolution of
the appropriate amount of compensation for pain and suffering in this case. See, e.g., Doe 34 v.
Sec’y of Health & Hum. Servs., 87 Fed. Cl. 758, 768 (2009) (finding that “there is nothing
improper in the chief special master’s decision to refer to damages for pain and suffering
awarded in other cases as an aid in determining the proper amount of damages in this case”).
The undersigned may also rely on her experience adjudicating similar claims. Hodges v. Sec’y
of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (noting that Congress contemplated
the special masters would use their accumulated expertise in the field of vaccine injuries to judge
the merits of individual claims). Importantly, however, it must also be stressed that pain and
suffering is not determined based on a continuum. See Graves v. Sec’y of Health & Hum.
Servs., 109 Fed. Cl. 579 (2013).
In Graves, Judge Merow rejected the special master’s approach of awarding
compensation for pain and suffering based on a spectrum from $0.00 to the statutory
$250,000.00 cap. Judge Merow noted that this constituted “the forcing of all suffering awards
into a global comparative scale in which the individual petitioner’s suffering is compared to the
most extreme cases and reduced accordingly.” Graves, 109 Fed. Cl. at 589-90. Instead, Judge
Merow assessed pain and suffering by looking to the record evidence, prior pain and suffering
awards within the Vaccine Program, and a survey of similar injury claims outside of the Vaccine
Program. Id. at 595.
Application of the three factors in this matter begins with awareness. Here, there is no
dispute regarding this element pain and suffering. Petitioner was fully aware of her ITP and its
relevant sequalae.
Regarding severity, the undersigned largely agrees with the arguments set forth in
Petitioner’s briefs, outlining the evidence establishing that Petitioner’s ITP was severe. See Pet.
Br. at 18-23; Pet. Reply Br. at 3-9. Based on the undersigned’s review of the records, affidavit,
and declarations, the evidence supports a finding that Petitioner’s ITP caused bruising,
nosebleeds, heavy bleeding during menses, dizziness from anemia, low platelet counts, mild
anemia, frequent visits to physicians, frequent diagnostic and laboratory testing, monitoring, and
treatment. She experienced anxiety over going to medical appointments and due to her worry of
relapse.
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Before she went into remission, her platelet counts would acutely decrease and then
improve with therapy. Over the course of two years, from December 2016 to December 2018,
Petitioner’s platelet counts were 50,000 or below on at least seven occasions.
Date Platelet Count
December 8, 2016 12,000
December 27, 2016 32,000
January 3, 2017 42,000
January 30, 2017 11,000
February 13, 2017 9,000
August 10, 2017 50,000
December 7, 2018 39,000
Treatment included significant doses of prednisone, as well as multiple different
medications, including Rituxan, dexamethasone, IVIG, Nplate, and Promacta. Steroids made her
feel edgy and gain weight. Petitioner sought treatment many times when her platelets were low,
including visits to Urgent Care and one admission to the hospital.
Petitioner was diagnosed with severe labile immune thrombocytopenia due to the
refractory nature of her illness and lack of remission in spite of treatment with several different
medications given during the early years of therapy, and before treatment with Promacta. In
2017, Petitioner was diagnosed with chronic ITP. She began Promacta in November 2017 and
continued to take it until June 2020, until she was diagnosed as stable with no relapses. In 2022,
Dr. Gorsuch, her hematologist, noted her condition remained chronic, although he determined
she was asymptomatic.
In 2017, Petitioner reported a “sense of anxiety” and feeling “a little edgy” on steroids.
Pet. Ex. 4 at 38, 42. She was prescribed lorazepam, but did not fill the prescription. In 2023,
Petitioner sought treatment for situational anxiety and anxiety attacks triggered by events that
included going to doctors’ offices. While visits to doctors’ offices were not the only situations
that created anxiety, the evidence shows that they were stress inducing. Treatment included
medication as needed. Further, Petitioner’s affidavit and declarations describe the worry she
experienced over her concerns about relapsing. She explained how she worries monthly during
her menstrual cycle and during cold/flu season. She also constantly checks for bruises and blood
blisters.
Petitioner also suffered from heavy menses from 2016 until 2024, when she elected to
undergo a hysterectomy. Her records establish there were two diagnoses, AUB and ITP, relevant
to her decision to undergo a hysterectomy. During her early clinical course of ITP, prior to her
remission, her excessive bleeding during menstruation was attributed in part to her low platelet
counts. Her platelets were first tested in December 2016 by her OB/GYN following Petitioner’s
complaints of a prolonged, heavy period. Her platelets were 12,000, which prompted her to see a
hematologist, leading to her ITP diagnosis. In part, she was diagnosed with ITP after she
reported heavy periods.
18

Case 1:19-vv-01534-UNJ Document 134 Filed 03/24/25 Page 19 of 24
However, after Petitioner began taking Promacta, and her platelet counts improved, it is
not clear what role her ITP played in her heavy bleeding during menses. At Petitioner’s annual
examination with her gynecologist in August 2020, following her discontinuation of Promacta,
Petitioner reported her menses were not heavy or painful. At her next annual examination in
November 2021, Petitioner reported regular monthly menses that were not heavy or painful.
Petitioner denied heavy monthly menstruation at a visit with Dr. Gorsuch in September 2022.
But, in November 2022, Petitioner reported heavy bleeding with menstruation to her
gynecologist, Dr. Morris, who suspected adenomyosis. By her visit with Dr. Morris in January
2023, Petitioner reported no gynecological complaints and regular menses that were not heavy or
painful. One year later, in January 2024, Petitioner reported to her gynecologist that she had
intermenstrual spotting and two days of clotting during her period, and she expressed interest in a
hysterectomy. Petitioner returned to Dr. Morris on July 1, 2024 for a consult regarding a
hysterectomy, reporting worsening periods since October 2022. The pathology report from her
endometrial biopsy in July 2024 showed “[p]roliferative endometrium.” Pet. Ex. 54 at 316. The
surgeon who performed her hysterectomy in August 2024 reported that operative findings
included Stage IV endometriosis.
Neither Dr. Morris nor the surgeon opined that Petitioner’s ITP caused or contributed to
her AUB in 2024, or was otherwise an indication for hysterectomy. The records do not show
that Petitioner experienced untoward bleeding or any other complications of her hysterectomy
due to her ITP. The undersigned notes that Petitioner did suffer heavy bleeding prior to her
treatment with Promacta, and that during at least some of that time, her ITP may have played a
role in her bleeding as evidenced by her abnormally low platelet counts. Since that time,
however, while there have been an occasional references to ITP in the context of Petitioner’s
heavy menses, these are generally reports by Petitioner of her history of ITP. There is no
opinion by Petitioner’s treating physicians or the medical experts that her hysterectomy in 2024
was medically indicated due to ITP.
Petitioner cited medical literature for the proposition that ITP has been associated with
heavy menstrual bleeding. Pet. Reply Br. at 12-13 (citing Pet. Ex. 20(a);19 Pet. Ex. 20(aa)).20
The article from Arnold and Cuker, however, does not support a finding that Petitioner’s
hysterectomy was indicated due to her ITP at the time that it was performed in 2024. The second
article, by Provan et al., discusses criteria for diagnosis and recommendations for treatment of
ITP; it does not state that patients with stable ITP who have heavy menstrual bleeding should be
treated with hysterectomy. And the third article cited, authored by van Dijk et al.,21 concluded
19 Drew Provan et al., Updated International Consensus Report on the Investigation and
Management of Primary Immune Thrombocytopenia, 3 Blood Advances 3780 (2019).
20 Donald M. Arnold & Adam Cuker, Immune Thrombocytopenia (ITP) in Adults: Clinical
Manifestations and Diagnosis, UpToDate, https://www.uptodate.com/contents/immune-
thrombocytopenia-itp-in-adults-clinical-manifestations-and-diagnosis (last updated July 2, 2020).
21 Petitioner did not file this article. Wobke E.M. van Dijk et al., Menstrual Problems in Chronic
Immune Thrombocytopenia: A Monthly Challenge-A Cohort Study and Review, 198 Brit. J.
Haematology 753 (2022).
19

Case 1:19-vv-01534-UNJ Document 134 Filed 03/24/25 Page 20 of 24
women may be prone to menstrual problems. However, their conclusion does not support a
finding that heavy menstrual bleeding due to ITP necessitates a hysterectomy.
The medical literature cited by Petitioner establishes that women with ITP may
experience heavy bleeding, but it does not support a finding that hysterectomy is indicated here,
where in 2024, when Petitioner underwent her hysterectomy, her platelet count and ITP were
stable, and where there is no medical opinion suggesting that surgery was warranted based on her
ITP. Moreover, her physicians documented other causes of her AUB, including adenomyosis
and endometriosis.
Further, there is no opinion by either parties’ experts that Petitioner’s hysterectomy was
performed due to heavy bleeding or other sequelae of her ITP.
Finally, the undersigned agrees that Petitioner’s platelet counts, while stable and within
levels that do not cause active bleeding, are not within normal limits, and this fact increases the
value of her pain and suffering award. The most recent platelet counts in the medical records
show that in May 2024, Petitioner’s platelet count was 100,000 and in July 2024, it was 96,000
(normal values 150,000-450,000). However, while this is an important fact relevant to an
assessment of Petitioner’s award for pain and suffering, there is no evidence that these platelet
levels were the reason for her hysterectomy, as discussed above.
As for duration, the undersigned finds that Petitioner’s experienced the most severe phase
of her ITP from 2016 to 2018, when her platelet counts were erratic and her illness was
refractory to medical treatment. After December 2018, treatment with Promacta was effective,
and Petitioner’s severely labile course became stable. However, she continued to receive
medical treatment until June 2020. From 2018 until 2020, Petitioner’s course was less severe,
but it continued to require medical treatment. In 2020, Petitioner was able to discontinue her
medication and her condition became generally asymptomatic thereafter. The undersigned
acknowledges that Petitioner has and continues to experience emotional distress due to worry
and stress related to the potential of relapse. The undersigned finds that the duration of
Petitioner’s severely labile condition was two years and the duration of her moderate condition
lasted another two years. Since June 2020, she has been largely asymptomatic. During these
past four to five years, however, she has experienced some ongoing distress due to the threat of
and worry about relapse.
There are no reasoned decisions to inform the undersigned as to the value of Petitioner’s
pain and suffering. Petitioner cites to Ebenstein for the proposition that it represents another case
of severe ITP which warrants a higher award for pain and suffering. See Ebenstein v. Sec’y of
Health & Hum. Servs., No. 06-0573V, 2010 WL 5113185 (Fed. Cl. Spec. Mstr. Sept. 1, 2010)
(finding Petitioner entitled to compensation). However, damages in that case were resolved
through a proffer, with all items of damages combined into one total, so that the amount
proffered for pain and suffering is not known. See Ebenstein v. Sec’y of Health & Hum. Servs.,
No. 06-0573V, 2012 WL 1611850 (Fed. Cl. Spec. Mstr. Apr. 3, 2012).
Relying on Wright, Respondent argues that mere testing for a vaccine condition is not
considered a residual effect of the vaccine-related injury. Wright v. Sec’y of Health & Hum.
20

Case 1:19-vv-01534-UNJ Document 134 Filed 03/24/25 Page 21 of 24
Servs., 22 F.4th 999, 1006 (Fed Cir. 2022). The context of the Federal Circuit’s holding in
Wright, however, was case specific and related to whether Petitioner had met the severity
requirement of the Act to justify an award for compensation. Here, the question is the value of
Petitioner’s pain and suffering. There is no question that Petitioner here experienced her
vaccine-related injury far longer than six months. Further, in Wright, there was no assertion
based on the residual effect of anxiety, whereas here there is such a claim supported by a
diagnosis of anxiety necessitating medical treatment.
The undersigned awards $180,000.00 for Petitioner’s pain and suffering. This award
acknowledges the severity and refractory nature of her illness for two years, the following two
year period that required continuing treatment which led to remission, and the emotional distress
and anxiety she has experienced since the onset of her illness in 2016. In determining an award
in this case, the undersigned does not rely on a single decision or case. Rather, the undersigned
has reviewed the particular facts and circumstances in this case, giving due consideration to the
circumstances and damages in other cases cited by the parties and other relevant cases, as well as
her knowledge and experience adjudicating similar cases.
B. Lost Wages
Pursuant to the Vaccine Act, a petitioner may also recover “compensation for actual and
anticipated loss of earnings determined in accordance with generally recognized actuarial
principles and projections” when their “earning capacity is or has been impaired by reason of
[their] vaccine-related injury for which compensation is to be awarded.” § 15(a)(3)(A).
1. Past Lost Wages
Petitioner was a part-time preschool teacher when she received the vaccination at issue
and developed ITP. As explained in her declarations, she continued to work after she was
diagnosed with ITP, and until the COVID pandemic began in March 2020, when she stopped
working due to anxiety and stress about becoming ill. She returned to the preschool in October
2022, but took reduced hours, only working 1.5 hours instead of 4 hours per day for five days per
week.
There is no foundational evidence to show that Petitioner experienced a reduction or loss
of wages from the date of her diagnosis in 2016, until Petitioner quit working due to the COVID
pandemic in 2020.
Petitioner contends that from the date of her vaccine injury in 2016 to the date of her
economist’s report in 2023, the present value of her lost earnings was $14,994.00. Pet. Br. at 25
(citing Pet. Ex. 52 at 4-6, 10-14). Respondent’s calculation for past lost earnings is $14,694.00,
which covers September 2020 through the 2023-2024 school year. Resp. Br. at 11-12 (citing
Resp. Ex. DD at 4, 13).
The undersigned finds that from October 2016 until March 2020, Petitioner continued to
work and did not experience a loss of wages. The undersigned awards compensation for a loss
of wages from March 2020 (or September 2020 if Petitioner was compensated by her employer
21

Case 1:19-vv-01534-UNJ Document 134 Filed 03/24/25 Page 22 of 24
for the remainder of the 2019-2020 school year), until the period reflected by the date of the
filing of this Ruling, based on the calculations performed by Respondent’s expert, Dr. Kennedy,
using the same foundational information and appropriate adjustments for taxes, discount rate,
etc. as cited in his expert report, updated to reflect the current date. See Resp. Ex. DD at 4.
2. Future Lost Wages
Petitioner seeks lost earnings of $266,275.00 from 2023 to 2047. Pet. Br. at 26.
Respondent contends that Petitioner has not proven she is entitled to future lost wages. The
undersigned finds that Petitioner is entitled to future lost wages based on the opinions of Dr.
Ghose.
Dr. Ghose has opined that Petitioner has an autoimmune illness which contributes to
fatigue, insomnia, and joint discomfort, which are caused by her chronic ITP. He opined that
Petitioner is expected to miss time from work, and that she has physical limitations (“standing,
sitting, lifting, carrying, bending, kneeling[,] and frequently changing positions”). Pet. Ex. 43 at
4. He further opined that she can work, but that she should continue her current part-time
position. Additionally, Petitioner will leave the work force earlier than average due to her
illness, according to Dr. Ghose.
Dr. Ghose cited two studies about patients, like Petitioner, who had sustained remissions
after treatment with thrombopoietin receptor agonists such as Promacta. See Pet. Ex. 44 at 2, 4
(noting 28 out of 54 patients had complete remission after treatment, and eight patients had a
sustained response after treatment was withdrawn);22 Pet. Ex. 45 at 1 (“Of the 49 evaluable
patients, 26 patients showed sustained response after discontinuing eltrombopag without
additional ITP therapy . . . . Platelet response following eltrombopag cessation may be sustained
in an important percentage of adult primary ITP patients who achieved [complete response] with
eltrombopag.”).23 No predictive factors for relapse were identified in either study. Follow up in
the first study was 5-27 months and 6-25 months in the second study. Pet. Ex. 44 at 2; Pet. Ex.
45 at 1.
Respondent’s expert, Dr. Kreuziger, noted Petitioner’s medical records do not
consistently document fatigue or other symptoms that warrant a finding that she is unable to
work full-time. Specifically, she cited Dr. Gorsuch’s records in 2022 and 2023, documenting
Petitioner’s performance status as 0, defined as “fully active, able to carry on all pre-disease
performance without restriction.” Resp. Ex. CC at 3 (citing Pet. Ex. 37 at 7, 9; Pet. Ex. 41 at 7-
8). Dr. Gorsuch also documented that Petitioner was asymptomatic. Pet. Ex. 37 at 5; Pet. Ex. 41
22 Matthieu Mahévas et al., The Temporary Use of Thrombopoietin-Receptor Agonists May
Induce a Prolonged Remission in Adult Chronic Immune Thrombocytopenia. Results of French
Observational Study, 158 Brit. J. Haematology 865 (2014).
23 Tomás José González-López et al., Successful Discontinuation of Eltrombopag After
Complete Remission in Patients with Primary Immune Thrombocytopenia, 90 Am. J.
Hematology E40 (2015).
22

Case 1:19-vv-01534-UNJ Document 134 Filed 03/24/25 Page 23 of 24
at 6. Additionally, Ms. Becker, in 2024, documented a review of systems in which Petitioner
denied fatigue. Resp. Ex. CC at 3 (citing Pet. Ex. 40 at 5-6).
Generally, the references in Petitioner’s medical records to fatigue relate back to the
diagnosis of her ITP in December 2016 and during the period of early treatment in February
2017. See Pet. Ex. 4 at 56-57. Otherwise, references to fatigue are contained in Petitioner’s
affidavit/declarations.
Therefore, Dr. Kreuziger is correct to say that the medical records do not consistently
report fatigue. However, Petitioner asserts that she does have fatigue. And Dr. Ghose explained
fatigue and other physical limitations can occur in chronic ITP, which would prevent Petitioner
from working full-time. He also opined that she should continue to work at her current level of
7.5 hours per week. Thus, while this is a close call, the undersigned finds that Petitioner has
presented evidence to support a finding that her fatigue limits her from working full-time.
Next, the evidence establishes that Petitioner has not previously worked full-time but has
always held part-time employment so that she could care for her daughter. Once her daughter
went to high school, she planned to seek more full-time work. That plan, however, relates to
future events. Moreover, Petitioner has not worked full time in a number of years, and has not
presented any evidence of full time employment in the past. Therefore, the undersigned finds it
is speculative to assume that Petitioner would return to full time employment in the future if she
had not developed ITP.
Compensation awarded for a petitioner’s anticipated loss of earnings may not be based on
speculation. See, e.g., J.T. v. Sec’y of Health & Hum. Servs., No. 12-618V, 2015 WL 5954352,
at *7 (Fed. Cl. Spec. Mstr. Sept. 17, 2015) (indicating §15(a)(3)(A) “does not envision that
‘anticipated loss of earnings’ includes speculation” and thus refusing to allow lost wages on a
planned business venture that was too indefinite), mot. for rev. den’d, 125 Fed. Cl. 164 (2016).
Basing claims of future wages on a petitioner’s own expectancies that differ from the generally
accepted work life expectancy of an individual would likely be speculative, and not calculated in
a “cautious manner.” Brown v. Sec’y of Health & Hum. Servs., No. 00-0182V, 2005 WL
2659073, at *6 (Fed. Cl. Spec. Mstr. Sept. 21, 2005).
The undersigned finds that based on the Petitioner’s prior work record, her medical
records, the expert reports, and the medical literature, there is preponderant evidence to establish
that Petitioner would have continued to work part-time, 20 hours per week during the school year
from August until the following May, each year until the age of retirement, if she had not
developed ITP. The evidence also establishes that the Petitioner can and does work 7.5 hours per
week during the school year. Petitioner has not shown by preponderant evidence that she would
have become employed full-time in the future.
In summary, the undersigned finds that Petitioner is entitled to future lost earnings, for
part-time employment of 20 hours per week less 7.5 hours (reflecting her current work schedule),
for a nine month school year, based on her current employment. The appropriate adjustments for
taxes, net discount rate, and work life expectancy shall be considered, and further the
23

Case 1:19-vv-01534-UNJ Document 134 Filed 03/24/25 Page 24 of 24
calculations shall be “in accordance with generally recognized actuarial principles and
projections.” § 15(a)(3)(A).
C. Unreimbursable Expenses
The Vaccine Act further permits a Petitioner to recover “actual unreimbursable expenses
incurred before the date of judgment,” including those that “(i) resulted from the vaccine-related
injury for which [P]etitioner seeks compensation, (ii) were incurred by or on behalf of the person
who suffered such injury, and (iii) were for diagnosis, medical or other remedial care,
rehabilitation . . . determined to be reasonably necessary.” § 15(a)(1)(B).
Here, the parties do not dispute Petitioner’s request for unreimbursable expenses.
Therefore, Petitioner shall be awarded $7,676.42 for past unreimbursed expenses.
VI. CONCLUSION
In determining an award in this case, the undersigned does not rely on a single decision
or case. Rather, the undersigned has reviewed the particular facts and circumstances in this case,
giving due consideration to the circumstances and damages in other cases cited by the parties and
other relevant cases, as well as her knowledge and experience adjudicating similar cases.
The undersigned finds that Petitioner shall be awarded (1) $180,000.00 for pain and
suffering and (2) $7,676.42 for past unreimbursed expenses.
Regarding lost earnings, the parties’ expert economists shall calculate the lost wages in
accordance with the undersigned findings herein. The parties shall endeavor to come to an
agreement as to the proper calculation including the appropriate discount rate. If the parties are
unable to do so, the undersigned will resolve the dispute.
A joint status report shall be filed in 30 days, not later than Friday, March 28, 2025,
reporting the lost earnings calculation reached by the parties. If an agreement is not reached, the
status report shall be accompanied by brief letters from the parties’ respective experts stating
their calculations as well as any disagreement that they have with the opposing expert’s
calculation.
Once all items of damages have been resolved, a Damages Decision will issue with the
final award for compensation.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Special Master
24

================================================================================
DOCUMENT 3: USCOURTS-cofc-1_19-vv-01534-2
Date issued/filed: 2025-04-22
Pages: 2
Docket text: PUBLIC DECISION (Originally filed: 3/28/2025) regarding 136 DECISION of Special Master. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made.
--------------------------------------------------------------------------------
Case 1:19-vv-01534-UNJ Document 142 Filed 04/22/25 Page 1 of 2
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: March 28, 2025
* * * * * * * * * * * * * * * * * * * * * * * * *
CHRISTINA MITCHELL, * PUBLISHED
*
Petitioner, * No. 19-1534V
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Decision Awarding Damages; Influenza
AND HUMAN SERVICES, * (“Flu”) Vaccine; Immune
* Thrombocytopenia Purpura (“ITP”); Pain
Respondent. * and Suffering; Lost Wages; Unreimbursable
* Expenses.
* * * * * * * * * * * * * * * * * * * * * * * * *
David John Carney, Green & Schafle LLC, Philadelphia, PA, for Petitioner.
Adam Nemeth Muffett, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION AWARDING DAMAGES1
On October 2, 2019, Christina Mitchell (“Petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42
U.S.C. § 300aa-10 et seq. (2018).2 Petitioner alleges that she suffered chronic immune
thrombocytopenia purpura (“ITP”) as the result of an influenza (“flu”) vaccination administered
on October 9, 2016. Petition at Preamble (ECF No. 1). On January 11, 2023, the undersigned
1 Because this Decision contains a reasoned explanation for the action in this case, the
undersigned is required to post it 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, the undersigned agrees that the
identified material fits within this definition, the undersigned will redact such material from
public access.
2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§ 300aa-10 to -34 (2018). All citations in this Decision to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.

Case 1:19-vv-01534-UNJ Document 142 Filed 04/22/25 Page 2 of 2
issued a Ruling on Entitlement, finding that Petitioner was entitled to compensation. Ruling on
Entitlement dated January 11, 2023 (ECF No. 78).
Because the parties were unable to resolve damages, they requested that the Court enter a
schedule for damages briefs, and on February 26, 2025, the undersigned issued a Ruling on
Damages. Ruling on Damages dated Feb. 26, 2025 (ECF No. 133). That Ruling awarded
Petitioner (1) $180,000.00 for pain and suffering and (2) $7,676.42 for past unreimbursed
expenses. See id. The parties were directed to have their expert economists calculate the
appropriate amount for lost wages in accordance with the undersigned’s findings. Id. at 24.
On March 28, 2024, Petitioner filed a joint status report in response to the undersigned’s
Ruling on Damages. Joint Status Report (“Rept.”), filed Mar. 28, 2025 (ECF No. 135). In the
joint status report, Petitioner stated “[t]he parties have agreed to . . . $15,150.00 in past lost
earnings and $107,355.00 in future lost earnings. These figures already account for the
appropriate adjustments for taxes, discount rates, and present value.” Id. at 1. Based on the
record as a whole, the undersigned finds that Petitioner is entitled to an award as stated in the
Joint Status Report and Ruling on Damages.
Pursuant to the terms stated in the attached Joint Status Report,
Petitioner is awarded a lump sum of $310,181.42 (representing $180,000.00 for
pain and suffering, $7,676.42 for past unreimbursed expenses, $15,150.00 in past
lost earnings, and $107,355.00 in future lost earnings), to be paid through an
ACH deposit to Petitioner’s counsel’s IOLTA account for prompt disbursement.
This amount represents compensation for all damages that would be available under 42
U.S.C. § 300aa-15(a).
In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of
the Court SHALL ENTER JUDGMENT herewith.3
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Special Master
3 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of
notice renouncing the right to seek review.
2

================================================================================
DOCUMENT 4: USCOURTS-cofc-1_19-vv-01534-cl-extra-10849103
Date issued/filed: 2025-04-22
Pages: 1
Docket text: Supplementary opinion from CourtListener cluster 10382515
--------------------------------------------------------------------------------
       In the United States Court of Federal Claims
                              OFFICE OF SPECIAL MASTERS
                                   Filed: March 28, 2025

*************************
CHRISTINA MITCHELL,        *                        PUBLISHED
                           *
               Petitioner, *                        No. 19-1534V
                           *
v.                         *                        Special Master Nora Beth Dorsey
                           *
SECRETARY OF HEALTH        *                        Decision Awarding Damages; Influenza
AND HUMAN SERVICES,        *                        (“Flu”) Vaccine; Immune
                           *                        Thrombocytopenia Purpura (“ITP”); Pain
               Respondent. *                        and Suffering; Lost Wages; Unreimbursable
                           *                        Expenses.
*************************

David John Carney, Green & Schafle LLC, Philadelphia, PA, for Petitioner.
Adam Nemeth Muffett, U.S. Department of Justice, Washington, DC, for Respondent.

                            DECISION AWARDING DAMAGES 1

       On October 2, 2019, Christina Mitchell (“Petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42
U.S.C. § 300aa-10 et seq. (2018). 2 Petitioner alleges that she suffered chronic immune
thrombocytopenia purpura (“ITP”) as the result of an influenza (“flu”) vaccination administered
on October 9, 2016. Petition at Preamble (ECF No. 1). On January 11, 2023, the undersigned



1
  Because this Decision contains a reasoned explanation for the action in this case, the
undersigned is required to post it 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, the undersigned agrees that the
identified material fits within this definition, the undersigned will redact such material from
public access.
2
 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§ 300aa-10 to -34 (2018). All citations in this Decision to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.
issued a Ruling on Entitlement, finding that Petitioner was entitled to compensation. Ruling on
Entitlement dated January 11, 2023 (ECF No. 78).

        Because the parties were unable to resolve damages, they requested that the Court enter a
schedule for damages briefs, and on February 26, 2025, the undersigned issued a Ruling on
Damages. Ruling on Damages dated Feb. 26, 2025 (ECF No. 133). That Ruling awarded
Petitioner (1) $180,000.00 for pain and suffering and (2) $7,676.42 for past unreimbursed
expenses. See id. The parties were directed to have their expert economists calculate the
appropriate amount for lost wages in accordance with the undersigned’s findings. Id. at 24.

         On March 28, 2024, Petitioner filed a joint status report in response to the undersigned’s
Ruling on Damages. Joint Status Report (“Rept.”), filed Mar. 28, 2025 (ECF No. 135). In the
joint status report, Petitioner stated “[t]he parties have agreed to . . . $15,150.00 in past lost
earnings and $107,355.00 in future lost earnings. These figures already account for the
appropriate adjustments for taxes, discount rates, and present value.” Id. at 1. Based on the
record as a whole, the undersigned finds that Petitioner is entitled to an award as stated in the
Joint Status Report and Ruling on Damages.

       Pursuant to the terms stated in the attached Joint Status Report,

           Petitioner is awarded a lump sum of $310,181.42 (representing $180,000.00 for
           pain and suffering, $7,676.42 for past unreimbursed expenses, $15,150.00 in past
           lost earnings, and $107,355.00 in future lost earnings), to be paid through an
           ACH deposit to Petitioner’s counsel’s IOLTA account for prompt disbursement.

       This amount represents compensation for all damages that would be available under 42
U.S.C. § 300aa-15(a).

       In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of
the Court SHALL ENTER JUDGMENT herewith. 3

       IT IS SO ORDERED.

                                                      s/Nora Beth Dorsey
                                                      Nora Beth Dorsey
                                                      Special Master




3
 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of
notice renouncing the right to seek review.


                                                 2


================================================================================
DOCUMENT 5: USCOURTS-cofc-1_19-vv-01534-cl-extra-11228476
Date issued/filed: 2025-12-19
Pages: 1
Docket text: Supplementary opinion from CourtListener cluster 10761891
--------------------------------------------------------------------------------
                                             CORRECTED

    In the United States Court of Federal Claims
                                 OFFICE OF SPECIAL MASTERS
                                    (Filed: September 26, 2025)


* * * * * * * * * * * * * *
CHRISTINA MITCHELL,        *
                           *                                  No. 19-1534V
          Petitioner,      *
                           *                                  Special Master Dorsey
v.                         *
                           *                                  Attorneys’ Fees and Costs
                           *
SECRETARY OF HEALTH        *
AND HUMAN SERVICES,        *
                           *
          Respondent.      *
* * * * * * * * * * * * * *

David John Carney, Green & Schafle LLC, Philadelphia, PA, for petitioner.
Adam Nemeth Muffett, U.S. Department of Justice, Washington, D.C., for respondent.

                        DECISION ON ATTORNEYS’ FEES AND COSTS1

        On October 2, 2019, Christina Mitchell (“Petitioner”), filed a petition for compensation
under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42
U.S.C. § 300aa-10 et seq. (2018).2 Petitioner alleged that she suffered chronic immune
thrombocytopenia purpura (“ITP”) as the result of an influenza (“flu”) vaccination administered
on October 9, 2016. Petition at Preamble (ECF No. 1). On January 11, 2023, the undersigned
issued a ruling on entitlement, finding that Petitioner was entitled to compensation. Ruling on
Entitlement dated Jan. 11, 2023 (ECF No. 78). On March 20, 2024, the undersigned issued a
damages decision. Damages Decision dated Mar. 28, 2025 (ECF No. 136).


1
 Because 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, the undersigned agrees that the identified
material fits within this definition, the undersigned will redact such material from public access.
2
 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine
Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to -34 (2018).
All citations in this Decision to individual sections of the Vaccine Act are to 42 U.S.C. § 300aa.
       On April 9, 2025, petitioner filed a motion for attorneys’ fees and costs. Motion for
Attorney Fees and Costs (“Fees App.”) (ECF No. 140). Petitioner requests compensation in the
amount of $207,308.88, representing $174,534.25 in attorneys’ fees and $32,774.63 in costs.
Fees App. at 3. Pursuant to General Order No. 9, petitioner warrants that she has not incurred
any costs in pursuit of this claim. Fees App. Ex. C. Respondent filed his response on January 8,
2025, indicating that he “is satisfied the statutory requirements for an award of attorneys’ fees
and costs are met in this case.” Response at 2. (ECF No. 98). Petitioner did not file a reply.

       The matter is now ripe for disposition.

      For the reasons discussed below, the undersigned GRANTS IN PART petitioner’s
motion and awards a total of $189,655.45.

           I.      Discussion

        Under the Vaccine Act, the special master shall award reasonable attorneys’ fees and
costs for any petition that results in an award of compensation. 42 U.S.C. § 300aa-15(e)(1).
When compensation is not awarded, the special master “may” award reasonable attorneys’ fees
and costs “if the special master or court determines that the petition was brought in good faith
and there was a reasonable basis for the claim for which the petition was brought.” Id. at
§15(e)(1). In this case, because petitioner was awarded compensation pursuant to a damages
decision, she is entitled to a final award of reasonable attorneys’ fees and costs.

                      a. Reasonable Attorneys’ Fees

         The Federal Circuit has approved use of the lodestar approach to determine reasonable
attorney’s fees and costs under the Vaccine Act. Avera v. Sec’y of Health & Human Servs., 515
F.3d 1343, 1349 (Fed. Cir. 2008). Using the lodestar approach, a court first determines “an
initial estimate of a reasonable attorney’s fee by ‘multiplying the number of hours reasonably
expended on the litigation times a reasonable hourly rate.’” Id. at 1347-58 (quoting Blum v.
Stenson, 465 U.S. 886, 888 (1984)). Then, the court may make an upward or downward
departure from the initial calculation of the fee award based on other specific findings. Id. at
1348.

        Counsel must submit fee requests that include contemporaneous and specific billing
records indicating the service performed, the number of hours expended on the service, and the
name of the person performing the service. See Savin v. Sec’y of Health and Human Servs., 85
Fed. Cl. 313, 316-18 (2008). Counsel should not include in their fee requests hours that are
“excessive, redundant, or otherwise unnecessary.” Saxton v. Sec’y of Health and Human Servs.,
3 F.3d 1517, 1521 (Fed. Cir. 1993) (quoting Hensley v. Eckerhart, 461 U.S. 424, 434 (1983)). It
is “well within the special master’s discretion to reduce the hours to a number that, in [her]
experience and judgment, [is] reasonable for the work done.” Id. at 1522. Furthermore, the
special master may reduce a fee request sua sponte, apart from objections raised by respondent
and without providing a petitioner notice and opportunity to respond. See Sabella v. Sec’y of
Health & Human Servs., 86 Fed. Cl. 201, 209 (2009).
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                                   i. Reasonable Hourly Rates

        Petitioner requests a total of $174,534.25 in attorneys’ fees. Petitioner requests the
following hourly rates for the work of her counsel: for Mr. David Carney: $325.00 per hour for
work performed in 2019, $350.00 per hour for work performed in 2020, $375.00 per hour for
work performed in 2021, $400.00 per hour for work performed in 2022, $425.00 per hour for
work performed in 2023, $450.00 per hour for work performed in 2024, and $475.00 per hour for
work performed in 2025; for Mr. Adam M. Green $450.00 per hour for work performed in 2024;
and for Mr. Evan R. Baker, $200.00 per hour for work performed in 2023, and $450.00 per hour
for work performed in 2024. Fees App. Ex. A. Additionally, for law clerks, Petitioner requests
$157.50 per hour for work performed in 2024; and for paralegals: $145.00 per hour for work
performed from 2019-2022, $175.00 per hour for work performed from 2023-2024, and $185.00
per hour for work performed from 2023-2024. Id. These rates are consistent with what counsel
has previously been awarded for their Vaccine Program work and I find them to be reasonable
herein. I shall also award the requested law clerk and paralegal time at the provided rates.

                                 ii.     Reasonable Hours Expended

        In reducing an award of fees, the goal is to achieve rough justice, and therefore a special
master may take into account their overall sense of a case and may use estimates when reducing
an award. See Florence v. Sec’y of Health & Human Servs., No. 15-255V, 2016 WL 6459592, at
*5 (Fed. Cl. Spec. Mstr. Oct. 6, 2016) (citing Fox v. Vice, 563 U.S. 826, 838 (2011). It is well
established that an application for fees and costs must sufficiently detail and explain the time
billed so that a special master may determine, from the application and the case file, whether the
amount requested is reasonable. Bell v. Sec’y of Health & Human Servs., 18 Cl. Ct. 751, 760
(1989); Rodriguez, 2009 WL 2568468. Petitioner bears the burden of documenting the fees and
costs claimed. Id. at *8.

        The undersigned has reviewed the submitted billing entries and finds that reduction is
required. The undersigned recognizes that this case was relatively complex and involved a lost
wages component, multiple experts, and briefing; however, the number of hours spent on certain
aspects of this case was excessive. Of note, Mr. Carney spent approximately 100 hours
($38,550.00) reviewing medical literature supplied by the experts and reviewing the experts’
respective reports and approximately 95.7 hours ($38,112.25) on briefing, including drafting the
motion for a ruling on the record and reply brief (73.9 hours totaling $29,560.00) and the damages
brief (21.8 hours totaling $8,552.25). See Fees App. Ex. A.

        In evaluating the reasonableness of billing, the amount of time spent on working on a
case must be consistent with counsel’s experience and corresponding billing rate. An attorney
may not combine relatively high hourly rates with a relatively large number of hours unless
circumstances warrant it. A relatively high hourly rate is warranted when an attorney possesses
knowledge and experience to work relatively quickly. See Larsen v. Sec’y of Health & Human
Servs., No. 19-56V, 2024 WL 5377991, at *2 (Fed. Cl. Spec. Mstr. Nov. 15, 2024) (finding that
spending 66.2 hours attorney and paralegal hours drafting the pre-hearing brief, 19.2 hour
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drafting a GBS brief, and 69.8 hours on hearing preparation was excessive); see also Barclay v.
Sec’y of Health & Human Servs., No. 07-605V, 2014 WL 2925245, at *6 (Fed. Cl. Spec. Mstr.
Feb. 7, 2014) (finding that spending approximately 80 hours in continued work on expert reports,
approximately 44 hours in writing a pretrial brief, approximately 44 hours in preparing for and
participating in the hearing, and approximately 55 hours for writing one post-hearing brief was
not reasonable). Mr. Carney possesses more than 15 years of experience practicing law, with
about 14 of those years representing petitioners in the Vaccine Program. In the undersigned’s
experience, the amount of time counsel billed for reviewing the experts’ medical literature and
reports brief writing was excessive.

        Additionally, there are various entries for time completing administrative tasks. “Clerical
and secretarial tasks should not be billed at all, regardless of who performs them.” Paul v. Sec’y
of Health & Human Servs., No. 19-1221V, 2023 WL 1956423, at *3 (Fed. Cl. Spec. Mstr. Feb.
13, 2023); see also Rochester v. United States, 18 Cl. Ct. 379, 387 (1989) (stating that services
that are “primarily of a secretarial or clerical nature ... should be considered as normal overhead
office costs included within the attorneys’ fee rates”). For example, attorney and paralegal time
was billed for the following entries: “drafted exhibit list, and cover sheet” “Filed Petition,
Exhibit list and Cover Sheet with the Court electronically” “prepared and bates stamped exhibits
1-8; drafted NOF and filed exhibits” and “received records, downloaded, audited for accuracy,
and saved to file the records from . . . . ” See Fees. App., Ex. A at 18-19, 26-27, 33 37-42, 50.
There are nearly 60 billing entries for clerical and administrative tasks, resulting in $5,485.80 in
charged fees.

        A special master need not engage in a line-by-line analysis of a petitioner’s fee
application when reducing fees. Broekelschen v. Sec’y of Health & Human Servs., 102 Fed. Cl.
719, 729 (2011). Special masters may rely on their experience with the Vaccine Program and its
attorneys to determine the reasonable number of hours expended. Wasson v. Sec’y of Health
and Human Servs., 24 Cl. Ct. 482, 484 (Fed. Cl. Nov. 19, 1991) rev’d on other grounds and aff’d
in relevant part, 988 F. 2d 131 (Fed. Cir. 1993). Just as “[t]rial courts routinely use their prior
experience to reduce hourly rates and the number of hours clamed in attorney fee requests …
[v]accine program special masters are also entitled to use their prior experience in reviewing fee
application.” Saxton, 3 F. 3d at 1521. In this case, considering counsel’s excessive billing and
billing for clerical and administrative work, I find a 10% reduction in overall fees reasonable.
This results in a reduction of $17,453.43. Accordingly, Petitioner is entitled to final attorneys’
fees in the amount of $157,080.82.

                       b. Attorneys’ Costs

        Petitioner requests a total of $32,774.63 in attorneys’ costs. This amount is comprised of
acquiring medical records, postage, legal research, the Court’s filing fee, and the following
expert services: economist, Dr. Robert Cook for 17.5 hours, at $300.00 per hour, totaling $5,250;
vocational expert, Ms. Staci Schonbrun at Labor Market Consulting Services for 9.3 hours, at
$200.00 per hour, totaling $1,860; immunologist, Marc Serota, M.D. for 24 hours, at $400.00 per
hour, totaling $10,026.00, and hematologist, Dr. Abhimanyu Ghose for 22 hours, at $600.00 per
hour, totaling $13,200.00, See Fees App. Ex. B.
                                                  4
        The undersigned has reviewed the costs and finds them to be largely reasonable;
however, a small reduction is required. Ms. Schonbrun billed $200.00 to “Open File.” See Fees
App. Ex. B at 56. This charge appears to be administrative in nature and has not been
substantiated by the record. Without further information, the undersigned cannot ascertain the
purpose of this cost, nor its reasonableness, and it will therefore not be compensated. See
Matnzer v. Sec’y of Health & Human Servs., No. 22-323V, 2025 WL 1453581, at *3 (Fed. Cl.
Spec. Mstr. Mar. 27, 2025) (finding that the vocational expert’s charge for “Open File” had not
been substantiated); Nosches v. Sec’y of Health & Human Servs., No. 16-1657V, 2019 WL
1149944, at *3 (Fed. Cl. Spec. Mstr. Feb. 26, 2019) (finding that there was insufficient
information to establish the purpose and reasonableness of a $400.00 “File set up fee”). This
results in an additional reduction of $200.00. Petitioner is therefore awarded final attorneys’
costs of $32,574.63.

             II.      Conclusion

        Based on all of the above, the undersigned finds that it is reasonable compensate
petitioner and her counsel as follows:

    Attorneys’ Fees Requested                                                   $174,534.25
    (Total Reduction from Billing Hours)                                        ($17,453.43)
    Total Attorneys’ Fees Awarded                                               $157,080.82

    Attorneys’ Costs Requested                                                   $32,774.63
    (Reduction of Costs)                                                          ($200.00)
    Total Attorneys’ Costs Awarded                                               $32,574.63

    Total Attorneys’ Fees and Costs Awarded                                      $189,655.45

       Accordingly, the undersigned awards $189,655.45 representing reimbursement for
Petitioner’s attorneys’ fees and costs, to be paid through an ACH deposit to Petitioner’s
counsel’s IOLTA account for prompt disbursement.

       In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of
Court SHALL ENTER JUDGMENT in accordance with this decision.3

          IT IS SO ORDERED.

                                                               s/Nora Beth Dorsey
                                                               Nora Beth Dorsey
                                                               Special Master


3
  Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing
the right to seek review.
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