Johnson v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 21-1937V

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*

MICHAEL JOHNSON, * Chief Special Master Corcoran

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Petitioner, * Filed: March 25, 2026

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v. *

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SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

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Respondent. *

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Mark T. Sadaka, Law Offices of Sadaka Associates, LLC, Englewood, NJ, for Petitioner.

James V. Lopez, U.S. Department of Justice, Washington, DC, for Respondent.

ENTITLEMENT DECISION 1

On September 30, 2021, Michael Johnson filed a petition for compensation under the

National Vaccine Injury Compensation Program (the “Vaccine Program”). 2 Petition (ECF No. 1).

Petitioner alleges his receipt of an influenza (“flu”) vaccine on October 28, 2020, caused him to

develop “hemolytic anemia resulting in permanent tooth loss.” Id. at Preamble.

Although the matter had been set for hearing, the parties later opted to resolve the claim on

the basis of the written record, and have filed briefs in support of their respective positions.

Petitioner’s Brief, dated May 19, 2025 (ECF No. 68) (“Br.”); Respondent’s Response, dated Aug.

21, 2025 (ECF No. 70) (“Opp.”); Petitioner’s Reply, dated Sept. 25, 2025 (ECF No. 71) (“Reply”).

Now, for the reasons set forth in greater detail below, I deny entitlement.

1

Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information

furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or

confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly

unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public

in its present form. Id.

2

The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,

100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”).

Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).

I. Factual History

Vaccination and Early Reaction

Mr. Johnson was 50 years old when he received the flu vaccine on October 28, 2020, at

Bon Secours Mercy Health Employee Health Services in Chesapeake, Virginia. Ex. 9 at 22; Ex. 5

at 1. At the time of vaccination, his medical history included stage 1 sarcoidosis, 3 hypertension,

hyperlipidemia, unstable angina, left bundle branch block, chronic fatigue syndrome, recurrent

kidney stone, type II diabetes mellitus, idiopathic peripheral autonomic neuropathy, “dizziness and

giddiness,” cervical disc disorder with radiculopathy, panic disorder, unspecified peripheral

vascular disease, obstructive sleep apnea, anxiety, and smokeless tobacco abuse. See Ex. 1 at 456;

Ex. 8 at 18, 23, 30, 35, 41, 50; Ex. 9 at 2. In addition, Petitioner is a veteran, and has a ten percent

disability rating for traumatic arthritis attributable to his military service. Ex. 4 at 77.

Five days later, on November 2, 2020, Petitioner went to an urgent care center complaining

of “[c]hest tightness, Chills, Body Aches, Hand tingling and Fatigue,” and reporting “Onset: 5

Day(s)” (meaning the same day as vaccination). Ex. 1 at 2–6. Petitioner stated that he “got a flu

shot last week and for the last 5 days he has been extremely fatigued, with chest tightness with

body aches, intermittent hand tingling, intermittent nausea, and chills.” Id. (Petitioner’s affidavit

offered in support of his claim also maintains that he felt like he had caught the flu “[r]ight after

receiving the vaccine,” and was experiencing chills, tingling in his hands, and was having difficulty

walking. Ex. 6 at 1).

The physical exam performed at this time yielded normal results. Ex. 1 at 2–6. However, a

complete blood count (“CBC”) was abnormal, including a low red blood cell (“RBC”) count of

2.16 (range: 4.14–5.8), low hemoglobin of 8 (range: 13–17.7), and low hematocrit of 22.3%

(range: 37.5–51%). Id. at 10. Petitioner was assessed with weakness, myalgias, abnormality of

RBCs, and anemia, and sent to the emergency department (“ED”) for further evaluation. Id. at 6–

7. There, Petitioner appeared “pale and ill appearing.” Ex. 2 at 458. A second CBC test produced

abnormal results, and direct antiglobulin testing (“DAT” or “Coombs test”) 4 was positive for

3

“Sarcoidosis” is defined as “a chronic, progressive, systemic granulomatous reticulosis of unknown etiology,

characterized by hard tubercles (q.v.). It can affect almost any organ or tissue, including the skin, lungs, lymph nodes,

liver, spleen, eyes, and small bones of the hands and feet. Laboratory findings may include hypercalcemia and

hypergammaglobulinemia. There is usually low or absent reactivity to tuberculin, and in active cases, the Kveim test

is positive.” Sarcoidosis, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=44637&searchterm=sarcoidosis (last visited Mar. 25, 2026).

It is not evident from the filed record in this case how long Petitioner’s prior sarcoidosis diagnosis existed, or when it

was first proposed by past treaters.

4

“Antiglobulin test” is “a test for the presence of nonagglutinating antibodies against red blood cells, using antihuman

globulin antibody to agglutinate cells coated with the nonagglutinating antibody. The direct antiglobulin test detects

antibodies bound to circulating red cells in vivo. It is used in the evaluation of autoimmune and drug-induced immune

2

immunoglobulin G (“IgG”) and C3b/C3d. Id.

Later that same day, Petitioner was admitted to Maryview Medical Center for treatment of

anemia, and he remained hospitalized for five days. Ex. 2 at 455–64. On admission, hospitalist

Nabeel Mohamed, M.D., noted Petitioner’s receipt of a “flu shot a week ago,” but proposed that

the “[e]tiology of the anemia is uncertain at this point,” ordering additional work-up and a

hematology consultation. Id. at 470. Later, internist Jacob Peterson, M.D., described Petitioner as

suffering from a “warm autoimmune hemolytic anemia of unknown trigger.” Id. at 477. Dr.

Peterson added that Petitioner was “not on any medications that are classically associated with

hemolytic anemia, but recent nonspecific illness may represent a viral trigger.” Id. at 542.

Petitioner was also at this time evaluated by a hematologist, Dr. Moussa Sissoko, who

assessed him with Coombs-positive hemolytic anemia, based on the “DAT . . . with positive IgG

as well as positive C3 B/C3d.” Ex. 2 at 518, 542–48. It was proposed that Petitioner receive a

tapering steroid treatment plus Rituxan (a monoclonal antibody treatment used for some

autoimmune conditions). Id. at 548. Dr. Sissoko also opined that “[p]atient might need not to have

flu shot anymore since he said that every time he has a flu shot []he gets sick. I would recommend

in the future to have nasal flu instillation instead of IM.” Id. Mr. Johnson was discharged on

November 7, 2020, in stable condition, with a diagnosis of hemolytic anemia. Id. at 464. Because

of a slow response, his steroid treatment was extended, and another physician instructed Petitioner

not to receive the flu vaccine in the future. Id. at 465, 469, 482.

That November, Petitioner had several follow-up visits as an outpatient with hematologist

Tien Do, M.D. See, e.g., Ex. 3 at 2–4. Petitioner reported having difficulty sleeping and feeling

angry (likely a side effect of his steroid dosage), plus a rash. Id. A record from one of these visits

indicated that he had experienced some kind of allergy to the flu vaccine causing an “[u]nknown”

reaction, and Dr. Do noted that Petitioner had reported post-vaccination cough and aches. Id. at 2–

4, 11. But Petitioner’s CBC labs were “slow[ly] improving from previous numbers,” and he was

assessed with autoimmune hemolytic anemia requiring further treatment with steroids and

Rituxan. Id. at 11.

At a subsequent visit with Dr. Do later in November 2020, Petitioner reported that “he had

two blisters in his mouth that eventually popped and made him lose two teeth,” adding that when

in the ED he had been informed that a mouth infection due to the medications he was receiving

had likely occurred. Id. at 27–28. Petitioner “also complain[ed] of a tickle in this throat, heart

pounding very ha[r]d then slowing way down, stiff fingers that he has to pull back into place,

swelling in both feet, still not sleeping and terrible mood swings” that had “gotten worse.” Id. Dr.

hemolytic anemia and erythroblastosis fetalis. The indirect antiglobulin test detects serum antibodies that bind to red

cells in an in vitro incubation step. It is used in typing of erythrocyte antigens and in compatibility testing (cross-

match).” Antiglobulin test, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=112414 (last visited Mar. 25, 2026).

3

Do prescribed some additional medications, and on that same day his Rituxan treatments were

concluded. Ex. 2 at 203–07.

2021-22 Treatment and Cessation of Anemia Signs

In early January 2021, Petitioner was hospitalized at the Hampton Veterans Affairs

Medical Center for “fever, malaise, chest tightness of one day duration.” Ex. 4 at 64. At this time,

he tested positive for COVID-19. Id. at 66. Petitioner was discharged in stable condition with the

diagnoses “[a]utoimmune hemolytic anemia on chronic steroid; Steatosis of liver; Sarcoidosis,

pulmonary; Chronic fatigue syndrome; Obesity; Chronic post-traumatic stress disorder; Diabetes

II likely [secondary to] chronic steroid use; Kidney stone, [status post] removal; sleep apnea, not

on CPAP at this time.” Id. at 281. Later that month he returned to an emergency department

reporting chest pain and ongoing COVID-19 symptoms, but was quickly discharged in stable

condition, with the assessment that his symptoms were likely due to COVID. Id. at 220–26, 265–

72.

Petitioner also continued to treat for his previously-diagnosed hemolytic anemia. He had a

telephonic consultation in late-January 2021 with Dr. Do. Ex. 3 at 47–48. He now reported

lingering symptoms he deemed related to his COVID infection, 5 and Dr. Do addressed further

steroid tapering, advising a follow-up with a dermatology specialist for any steroid-related rash.

Id. Later that spring, serologic monitoring revealed improved CBC results (a slightly low RBC

count of 4.4 (range: 4.7–6.1), normal hemoglobin of 14.7 (range:14–18), normal hematocrit of

44.2% (range:42–52%), and normal platelet count of 181 (range: 140–440)). Ex. 4 at 30.

Mr. Johnson saw Dr. Do again on March 29, 2021 (now five months post-vaccination), and

complained of “swelling in the left leg, redness in both legs, rash on left arm that is itchy and

SOB.” Ex. 3 at 60–61. A repeat CBC again yielded good results—a normal RBC count of 4.47

(range: 4.1–5.1), a normal hemoglobin of 14.6 (range: 12–16), normal hematocrit of 42.9% (range:

36–48%), and a normal platelet count 156 (range: 40–440). Id. at 65–66. By this time, Petitioner

had completed his prednisone taper, and the plan was to continue to periodically monitor his CBC,

to refer petitioner to a pulmonologist for his shortness of breath from COVID-19, and for Petitioner

to follow-up with his dermatologist regarding his rash. Id. at 68.

Two months later, on May 19, 2021, Petitioner took himself again to a hospital emergency

department, complaining of “left sided upper back/flank pain” for one week, plus evaluation of

abrasions from a fall the prior day. Ex. 4 at 152, 159, 165. A repeat CBC performed at this time

again yielded normal results (RBC count of 4.86 (range: 4.7–6.1), hemoglobin of 15.4 (range:14–

18), hematocrit of 46.4% (range:42–52%)), but a slightly low platelet count of 137 (range: 140–

5

Throughout this timeframe, Petitioner received other kinds of treatments associated with his ongoing COVID

infection recovery, but they do not bear on this claim’s outcome.

4

440). Id. at 30. Petitioner was prescribed pain medication and discharged in stable condition. Id.

at 165. Another CBC performed in early June was also normal. Id. at 30.

On August 30, 2021, Mr. Johnson’s primary care physician consulted an infectious disease

physician related to the “risk/benefit of COVID vaccines.” Ex. 10 at 372. At this time, Petitioner’s

documented history included “severe autoimmune hemolytic anemia after flu vaccine.” Id.

However, the specialist’s opinion was that “[a]utoimmune hemolytic anemia has not been reported

as a common adverse reaction,” with at most a possible association with the COVID vaccine. Id.

Over three months later, in mid-December 2021, Petitioner again underwent a CBC that

produced normal results. Ex. 10 at 194–95. Petitioner at this time also continued to receive

treatment for other concerns (and the possibility that they related to his prior COVID infection).

Id. at 192–93. It was proposed at this time that he should not receive a COVID vaccine, given his

prior “severe autoimmune hemolytic anemia after flu vaccine.” Id. at 196.

In January 2022, Petitioner had a hematology consultation with a nurse practitioner. Ex. 10

at 101–06. It was noted at this time that his prior CBC labs had not been concerning for anemia.

Id. A work-up for his history of autoimmune hemolytic anemia was ordered, and the treater advised

Petitioner to follow-up in two months. Id. No other medical records relevant to the claim have

been filed.

II. Expert Reports

A. Petitioner’s Expert – Dr. Clinton F. Merrill, Jr.

Dr. Merrill prepared two written reports for Petitioner. Report, dated Oct. 5, 2023, filed as

Ex. 16 (ECF No. 37-1) (“First Merrill Rep.”); Report, dated Aug. 6, 2024, filed as Ex. 25 (ECF

No. 45-1) (“Second Merrill Rep.”).

Dr. Merrill graduated from the University of Wyoming with a Bachelor of Science in

Chemistry, and received his medical degree from Creighton University School of Medicine. See

Curriculum Vitae, filed as Ex. 17 (ECF No. 37-2) (“Merrill CV”) at 1. Thereafter, he completed

his internship and residency in Internal Medicine at St. Joseph Hospital, followed by a fellowship

in Hematology and Medical Oncology at Michigan State University College of Human Medicine.

Id. He currently holds an active hospital staff position at the Wyoming Medical Center and

maintains an active practice in both Internal Medicine and Medical Oncology and Hematology.

First Merrill Rep. at 7. Dr. Merrill is board certified by the American Board of Internal Medicine

in Internal Medicine, Medical Oncology and Hematology. Merrill CV at 2. In addition, he is an

active member of several professional societies, including the American Society of Clinical

Oncology, the American Society of Hematology, the American Medical Association, and the

5

International Society on Thrombosis and Hemostasis. Id. at 3.

First Report

Dr. Merrill began with a brief summary of Petitioner’s relevant medical history (although

he provided a fairly truncated evaluation of the substantial comorbidities Petitioner was suffering

from at the time of vaccination). First Merrill Rep. at 1–3. He then provided an explanation of

Petitioner’s diagnosis of warm autoimmune hemolytic anemia (“AIHA”). Id. at 3–4. He deemed

AIHA a rare disease, in which autoantibodies attack red blood cells/erythrocytes. Id. at 3. AIHA

is associated with a number of other conditions, including likely autoimmune diseases such as

lupus. Id. at 3–4. It can also be triggered by infection or certain drugs, but in such cases is more

likely short-lived. Id. at 4. AIHA is diagnosed with serologic testing, and is treated with steroids

and Rituxan (the same medications used for Petitioner’s AIHA). Id. at 4.

Next, Dr. Merrill considered some of the possible pathologic mechanisms for how AIHA

might occur (partially depending on the instigating agent). First Merrill Rep. at 4–5. All would

involve an autoimmune process—reflecting some combination of “a cross-reaction between

antigens of infectious agents and self-molecules (named ‘molecular mimicry’), reduction of

immune tolerance (thus allowing immune aberrant responses), production of autoantibodies

specifically capable of cross-reaction with self, and/or foreign antigen “modification of erythrocyte

membrane.” Id. at 4. The immune system can mistakenly “recognize” self-antigens as foreign

(through production of autoantibodies) in different ways—whether due to existing cell

apoptosis/necrosis (in which intracellular contents are released in the body), a neoplastic process,

or due to mimicking similarity between the foreign and self-antigens. Id. at 4–5. Individual

susceptibility may also play a role. Id. at 5. Regardless, once produced the autoantibodies “activate

the complement cascade, and mainly destroy erythrocytes via antibody dependent cellular

cytotoxicity and phagocytosis.” Id.

Vaccines could also trigger such a process, and Dr. Merrill evaluated that possibility within

the context of “drug-induced AIHA.” This kind of AIHA cause, he maintained, was very rare, and

arises as a result of either “antibodies that activate an immune response only while the drug is

present,” or where the drug itself more generally impacts the disease process (but with less

certainty as to how). First Merrill Rep. at 5. Many pharmaceutical treatments have (usually via

case reports) been associated with AIHA—including vaccines. Id. As evidence, he noted the

existence of VAERS 6 reports establishing what he deemed to be 90 instances of vaccine-associated

6

The Vaccine Adverse Event Reporting System (“VAERS”) is a national warning system designed to detect safety

problems in U.S.-licensed vaccines. See About VAERS, VAERS, https://vaers.hhs.gov/about.html (last visited Mar.

13, 2026). It is managed by both the CDC and the FDA. VAERS monitors and analyzes reports of vaccine related

injuries and side effects from both healthcare professionals and individuals. But it has been observed in the Program

that VAERS data is not particularly probative of causation, unless supplemented with other reliable evidence—since

6

AIHA, including six cases involving the flu vaccine. W. Barcellini, Drug-Induced Hemolytic

Anemia, in UpToDate (R. Brodsky & J. Timauer, eds., 2022), filed as Ex. 22 (ECF No. 38-5)

(“Barcellini”) (identifying various drugs (approximately 150) to be associated with AIHA). (At

the same time, however, Dr. Merrill also proposed that “[t]he actual incidence of AIHA following

vaccination is also most likely extremely under reported,” since only when symptoms were

significant would any consideration of possible explanations be undertaken. First Merrill Report

at 6).

More generally, Dr. Merrill noted that vaccines have been recognized as likely antecedents

to certain autoimmune disease processes, via several reliable pathogenic mechanisms, including

molecular mimicry. First Merrill Rep. at 6 (citing Y. Pacheco et al., Bystander Activation and

Autoimmunity, 103 J. of Autoimmunity 1, 1 (2019), filed as Ex. 23 (ECF No. 38-6)). All things

being equal, vaccines were likely to initiate autoimmune processes in a manner comparable to a

wild infectious process (even though ironically the vaccine’s intent is to prevent a wild infection).

M. Vadala et al., Vaccination and Autoimmune Diseases: Is Prevention of Adverse Health Effects

on the Horizon?, 8 EPMA J. 295, 305 (2017), filed as Ex. 24 (ECF No. 38-7) (“Vadala”).

Thus, Dr. Merrill opined that the elements of causation could be met in this case. He

admitted that “the pathogenesis of autoimmune cytopenias as well as autoimmunity in general

remain poorly defined,” and that vaccine-induced AIHA was likely quite rare. First Merrill Rep.

at 6. Nevertheless, because AIHA was autoimmune in nature, because “exogenous factors” could

trigger it, and because vaccines were known occasionally to be such factors, it was likely the flu

vaccine could cause AIHA. Id. at 7. In addition, there were no other possible explanations for

Petitioner’s AIHA, “consistent with the opinions of his treating providers,” some of whom had

opined he should not in the future receive the flu vaccine. Id. And the onset timeframe (measured

from date of vaccination) was reasonable, although Dr. Merrill in this report did not expand on

why that was so. Id.

Second Report

Dr. Merrill’s supplemental report largely responded to the opinions contained in the report

of Respondent’s expert, Dr. You-Wen He. First, Dr. Merrill attempted to rebut Dr. He’s arguments

that AIHA has not generally been considered even a possibly vaccine-associated adverse event.

Second Merrill Rep. at 2–3. Dr. Merrill maintained that the 2012 IOM Report did not specifically

look for AIHA or anemia. Id. at 2. In addition, he noted the existence of several more recent case

reports 7 in which AIHA was observed to occur post-vaccination (although he primarily referenced

a VAERS report only establishes a temporal, post-vaccination occurrence, and does not independently confirm the

reported adverse event either.

7

See, e.g., S. Montagnani et al., Autoimmune Hemolytic Anemia Following MF59-Adjuvanted Influenza Vaccine

Administration: A Report of Two Cases, 45 The Annals of Pharmacotherapy e8 (2011), filed as Ex. 11 (ECF No. 58-

7

for this point a study specific to the COVID vaccine, rather than the flu vaccine at issue in this

matter). Id. at 2–3; J. Jacobs et al., Autoimmune Haemolytic Anaemia and Immune

Thrombocytopenia following SARS-CoV-2 and non-SARS-cOv-2 Vaccination: 32 Years of Passive

Surveillance Data, 201 Br J Haematol. 227 (2023), filed as Ex. 33 (ECF No. 60-1) (“Jacobs”)

(finding a total of 863 AIHA and immune thrombocytopenic purpura (“ITP”) reports following

vaccination). Later, Dr. Merrill repeated his “underreporting” contention, maintaining that only

individuals suffering from the most severe form of AIHA would ever be evaluated in studies

relevant to causation, and that passive surveillance systems like VAERS inherently missed likely

vaccine-associated adverse events. Second Merrill Rep. at 4–5).

Second, Dr. Merrill endeavored to defend the relevance of his proposed autoimmune

mechanisms against Dr. He’s argument that no specific evidence had been offered showing that

the flu vaccine itself could likely cause AIHA via those mechanisms. Second Merrill Rep. at 3–4.

Dr. Merrill stressed that Dr. He had not disputed the general scientific reliability/acceptance of the

proposed mechanisms, and added that there was to his knowledge no requirement in the Vaccine

Program that covered vaccines be shown to likely cause a given injury via any particular

mechanism (and that to look for this was to seek virtual certainty of causation). Id. at 3. At bottom,

“the pathogenesis of AIHA is complex and still not fully understood,” and therefore it was enough

to posit possible mechanisms for how vaccine-induced AIHA might occur. Id. at 4.

Dr. Merrill then discussed Dr. He’s contention that Petitioner’s pre-vaccination sarcoidosis

could be the cause of his subsequent anemia. Second Merrill Rep. at 5–8. As a threshold matter,

Dr. Merrill contested the strength of this sarcoidosis diagnosis, observing that it stemmed from

records pertaining to treatment more than 15 years before vaccination, the diagnosis itself could

not be corroborated from the existing record, and Petitioner had not been experiencing symptoms

“consistent with active sarcoidosis” in that entire timeframe. Id. at 8; see also Id. at 5–6. In

addition, Dr. Merrill pointed out that support for the alleged sarcoidosis-AIHA association came

from mostly case reports, some of which were thirty to forty-years old. Id. at 6–8.

B. Respondent’s Expert – Dr. You-Wen He, Ph.D.

Dr. He, an academic physician and immunologist, authored one expert report for Respondent.

Report, dated Feb. 7, 2024, filed as Ex. A (ECF No. 40-1) (“He Rep.”).

Dr. He is a Professor of Integrative Immunobiology in the Department of Integrative

Immunobiology at Duke University School of Medicine. See Curriculum Vitae, dated Feb. 14, 2024,

filed as Ex. B (ECF No. 41-22) (“He CV”) at 1. He received his medical degree from the Fourth

Military Medical University in China and received his Ph.D. from the Miami School of Medicine.

5); F. Shlamovitz & S. Johar, A Case of Evan’s Syndrome following Influenza Vaccine, 44 J. Emergency Med. E149

(2013), filed as Ex. 31 (ECF No. 58-6).

8

Id. Dr. He went on to complete a senior fellowship in the Department of Immunology at the

University of Washington and completed his residency at Qindu Hospital in China. Id. Dr. He has

been conducting research in immunology since he graduated from medical school in 1986. He Rep.

at 1. Over the past 27 years, he has been invited to lecture nationally and internationally on the topic

of host immune responses to microbial infections and tumors. Id. Dr. He has also served as a co-

Principal Investigator for four clinical trials focusing on cancer immunotherapy using personalized

cancer vaccines. Id. In addition, he has been published extensively and has served as an ad hoc

reviewer for more than 30 scientific journals. Id.; He CV at 7–16.

Like Dr. Merrill, Dr. He included in his report an overview of Petitioner’s relevant medical

history. He Report at 2–3. He accepted the AIHA diagnosis (although he did not purport to have

the specific expertise in hematology necessary to comment on it). Id. at 4. Dr. He noted AIHA is

believed to be antibody-mediated, and although it is more often than not deemed idiopathic in

origin, he accepted its association with “viral infections, autoimmune disorders,

lymphoproliferative disorders, immunodeficiency states, and pregnancy”—but denied vaccination

could also be so linked. Id. at 4, 6.

In support, Dr. He noted that the Institute of Medicine (the “IOM”) had made no mention

of AIHA as a possible vaccine-associated adverse event, despite listing many others. He Report at

4; Institute of Medicine, Adverse Effects of Vaccines: Evidence and Causality (K. Stratton, et al.,

eds., 2012), filed as Ex. A, Tab 2 (ECF No. 40-3) (“2012 IOM Rep.”). A more recent review article

linked vaccination to 12 of 46 possible adverse events—but again made no mention of AIHA. See

M. Dudley, et al., The State of Vaccine Safety Science: Systematic Reviews of the Evidence, 20

Lancet Infect Dis e80 (2020), filed as Ex. A, Tab 3 (ECF No. 40-4) (“Dudley”). Given how

commonly the flu vaccine was administered, this absence of even passive surveillance supporting

evidence was a telling factor weighing against an association. He Report at 4. And the existence

of VAERS reports of AIHA after vaccination was weak and unreliable proof of causation, since

VAERS reports did not involve confirmed instances of the putative vaccine-caused event, and also

provided no comparison to background rates of the event’s occurrence (which would be required

to determine if the risk was heightened in the context of vaccination). Id. at 8.

Dr. Merrill had attempted to justify the lack of evidence corroborating an AIHA-flu vaccine

association by proposing that there was “underreporting” of AIHA as a possible vaccine injury,

but Dr. He maintained that this was erroneous. He Report at 12. The general incidence of AIHA

was already quite low, while millions of individuals received the flu vaccine every year—meaning

“any increased risk of AIHA upon influenza vaccination will be highly likely presented with

sufficient epidemiologic evidence”—if such a relationship existed. Id. But articles relying merely

on surveillance data, like Dudley, observed no such connection.

Dr. He then reviewed in a point-by-point manner some of Dr. Merrill’s contentions. See

generally He Report at 6–13. Dr. He accepted as a general matter Dr. Merrill’s explanations for

9

how autoimmune mechanisms might propagate disease, but denied that they had been shown

specifically to bear on the context of alleged flu vaccine-caused AIHA. Id. at 6–7. The same was

true for evidence relating to drug-induced AIHA; while some drugs had been credibly linked to

AIHA, no comparable evidence existed for the flu vaccine. Id. at 8.

In addition, Dr. He differentiated between the general scientific reliability of the

mechanisms by which autoimmune diseases might work and their applicability in the context of

this case. He Report at 9–12. For example, Dr. He allowed that molecular mimicry (the concept

that “shared antigenic epitope similarity between infectious pathogens or vaccines and human

proteins renders cross-reactivities by host adaptive immunity”) had a certain degree of validity

(although he characterized it as an “old theory”). Id. at 9. But he noted that more recent scientific

and medical thinking called it into question as an all-purpose explanation for autoimmunity, noting

that amino acid sequential similarity is very common in nature, but occurs without a high incidence

of autoimmune disease. Id. at 9. 8 Rather, autoimmune reactions were more likely the product of

“the strength/extent of the immune activation induced by the overall immunological encounters,”

and not the mere possibility of peptide mimicry. Id. at 10. The same was true for other putative

mechanisms—and in any event, AIHA has not been shown to develop via any of them. Id.

Vaccination also could not be deemed completely congruent in impact, immunologically-

speaking, with a wild infection, even if vaccines are intended to stimulate the immune system (for

the purpose of building immune memory to a particular foreign pathogen). He Report at 10–12.

Instead, Dr. He emphasized that “[i]mmune activation in response to infections and vaccinations

are fundamentally different,” with the former far stronger. Id. at 10. The “depth of an immune

response induced by the virus infection” would inherently exceed a vaccination response. Id. at

11. And the pathways by which vaccines are “seen” by the immune system (intramuscular

injection) was also relevant, since wild viral infections would invade the body via the “respiratory

mucosa,” replicating and causing harm by that function alone. Id. This made it far less likely that

the kind of aberrant immune response seen in autoimmune processes would occur after

vaccination.

Dr. Merrill had proposed that there was in this case no alternative explanation for

Petitioner’s AIHA, but Dr. He identified one from Mr. Johnson’s medical history: sarcoidosis. He

Report at 13. Dr. He purported that there was “extensive evidence” to support a sarcoidosis/AIHA

association, and that evidence included both case reports and more analytic articles. See, e.g., R.

Mayock et al., Manifestations of Sarcoidosis, 35 Am. J. Med. 67, 80 (1963), filed as Ex. A, Tab

20 (ECF No. 41-10) (studying 145 patients with sarcoidosis and finding that 31 patients had

hemoglobin values below 11 gm. per cent, 3 patients with hemolytic anemia); P. Brito-Zerón et

al., Coexistence of Immune-Mediated Diseases in Sarcoidosis. Frequency and Clinical

8

Dr. He offered several items of literature for this contention—but they are articles with which I am very familiar in

adjudicating Vaccine Act claims, and therefore I do not include a summary or reference of them.

10

Significance in 1737 Patients, 88 Joint Bone Spine 1 (2021), filed as Ex. A, Tab 30 (ECF No. 41-

20) (reporting that the frequency of IMDs in patients with sarcoidosis was approximately 2-fold

higher than the frequency observed in the general population). This preexisting comorbidity was

also more consistent with his sudden onset than vaccination. A one-day onset was “too soon to

activate host innate and adaptive immune responses” due to the vaccine, whereas a preexisting

condition could more logically fit the facts. He Report at 13.

III. Procedural History

The matter was initiated in September 2021, but not activated out of “pre-assignment

review” until the summer of 2022, while records pertinent to the claim were obtained and filed.

Respondent’s Rule 4(c) Report opposing compensation was filed in January 2023 (ECF No. 29),

and the matter was reassigned to me from a different special master later that winter. After some

delay, Petitioner filed Dr. Merrill’s first expert report in the fall of 2023, and expert opinions were

obtained by both sides, with completion of the process in August 2024. I initially proposed to the

parties that the matter be resolved via hearing (ECF No. 47), but after issuance of a prehearing

order and some compliance with it, the parties expressed the desire to adjudicate the claim on the

basis of the written record. See Scheduling Order, dated Mar. 12, 2025 (setting Ruling on Record

schedule). The parties filed briefs in support of their respective positions, and the matter is now

ripe for resolution.

IV. Parties’ Arguments

Petitioner

Petitioner contends that his AIHA was likely caused by his receipt of the flu vaccine on

October 28, 2020. Br. at 1. In his briefing, Petitioner addresses all three prongs of the test set by

the Federal Circuit in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir.

2005) for causation claims.

Petitioner first maintains that his expert, Dr. Merrill, has offered a biologically plausible

explanation for how the flu vaccine can trigger AIHA. Br. at 10. According to Dr. Merrill, warm

AIHA “results from the production of IgG autoantibodies that bind to red blood cell surface

antigens and mediate extravascular hemolysis via macrophage Fc receptor recognition, typically

in the spleen.” Id. (referencing First Merrill Rep. at 3–4). It occurs at body temperature, which not

only aligns with Petitioner’s case, as confirmed by his laboratory profile, but further distinguishes

the condition from cold agglutinin diseases. Id. Moreover, Dr. Merrill’s proposed explanation—

“dysregulated immune activation through mechanisms such as molecular mimicry, bystander

activation, and epitope spreading—is not only recognized in the medical and scientific literature,

but “real-world epidemiologic data” as well. Id. at 10, 11; see also B. Fattizzo & W. Barcellini,

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Autoimmune Hemolytic Anemia: Causes and Consequences, 18 Ex. Rev. Clinical Immunology

731, 731–32 (2022), filed as Ex. 19 (ECF No. 38-2) (describing pathogenesis of AIHA as

multifactorial, and thus, implicating both endogenous immune dysregulation and exogenous

triggers such as vaccines, infections, and drugs); Vadala at 296–97 (linking various autoimmune

disease, including hematologic ones, to vaccination, with a focus on immune priming in

genetically susceptible individuals); Jacobs at 2–3 (documenting over 100 reports of post-influenza

vaccine AIHA in the VAERS database).

In addition, Petitioner argues that Respondent’s expert, Dr. He, “is a laboratory-based

immunologist with no clinical training or board certification in hematology, autoimmune

cytopenias, or vaccine-related injury.” Br. at 12. Thus, his opinion “lacks both methodological

reliability and clinical foundation, and would not survive scrutiny under Daubert v. Merrell Dow

Pharmaceuticals, 509 U.S. 579 (1993), were this a federal evidentiary proceeding. Id.

As for the second, “did cause” Althen prong, Petitioner notes that he has preponderantly

established a logical sequence of cause and effect showing that the flu vaccine did cause his AIHA.

Br. at 13. Dr. Merrill concluded that the flu vaccine was the proximate cause of Petitioner’s AIHA

due to Petitioner’s rapid onset of symptoms, classic serologic and hematologic markers, and the

absence of any plausible alternative explanation. Id. Specifically, Petitioner emphasizes the

documented treater support concluding that the flu vaccine was the most probable precipitating

factor, as well as his positive direct antiglobulin test, elevated LDH, undetectable haptoglobin, and

compensatory reticulocytosis. Id. at 14. Moreover, Petitioner underwent a comprehensive

infectious and autoimmune workup that ruled out several potential infectious triggers. Id.; see also

Ex. 2 at 466, 467. Accordingly, Petitioner argues that he has provided a “clear, medically

grounded, and case-specific explanation for how the flu vaccine led to [his] injury.” Br. at 15.

Finally, Petitioner contends that he has satisfied his burden under Althen prong three, as

the temporal relationship between his receipt of the flu vaccine and his subsequent development

of AIHA is “direct, biologically supported, and unbroken by competing causes.” Br. at 16.

Petitioner notes that he developed symptoms (i.e., fatigue, chills, tingling in hands, and shortness

of breath) within 48 hours of receiving the flu vaccine on October 28, 2020, and by day five, he

was hospitalized with a laboratory-confirmed diagnosis of warm AIHA. Id. at 15; Ex. 2 at 541. Dr.

Merrill further argues that such a timeframe is medically appropriate based on immunologic

principles and aligns with the established literature on vaccine-triggered autoimmune disorders.

Br. at 15. Additionally, the record evidence does not indicate any plausible alternative explanation

for Petitioner’s injury. Id. at 16.

In his reply, Petitioner reiterates the arguments set forth in his initial brief and maintains

that Respondent’s opposition relies on an “unduly narrow reading of the Vaccine Act, improperly

elevating Petitioner’s burden of proof.” Reply at 2–4.

12

Respondent

Respondent accepts Petitioner’s diagnosis of warm AIHA, adding that it “can arise

spontaneously (primary idiopathic warm AIHA) or is associated with conditions or medications

that predispose to the production of autoantibodies (secondary warm AIHA).” Opp. at 13. But the

flu vaccine is not also so associated with AIHA.

Respondent first maintains that Dr. Merrill’s opinions pertaining to Althen prong one are

not reliable. Opp. at 14. Dr. Merrill failed to provide “any one preponderant causal mechanism to

establish AIHA caused by [the] flu vaccine”, but instead discussed only general concepts of

autoimmunity and mechanisms for autoantibody production in systemic autoimmune diseases. Id.;

see also Vadala; J. Suurmond & B. Diamond, Autoantibodies in Systemic Autoimmune Diseases:

Specificity and Pathogenicity, 125 J. Clinical Investigation 2194 (2015), filed as Ex. 20 (ECF No.

38-3); Y. Pacheco et al., Bystander Activation and Autoimmunity, 103 J. Autoimmunity 1 (2019),

filed as Ex. 23 (ECF No. 38-6). Moreover, Dr. He had noted that “there is a complete lack of

clinical evidence to support any causal link between [the flu] vaccination and AIHA,” as evidenced

by the 2012 IOM report which did not even identify AIHA as a possibly-recognized adverse event.

Opp. at 15; He Rep. at 4.

In addition, Dr. He emphasizes that a vast number of flu vaccines are administered each

year, and “the lack of clinical reports to suggest a relation between [the flu] vaccine and AIHA

indicates that [flu] vaccine is highly unlikely to cause AIHA.” Opp. at 15. Of note, Dr. Merrill

references several studies that identify various drug associations with AIHA, yet no such

confirmation has been shown regarding the flu vaccine specifically. Id. at 16; see also G. Garratty,

Drug-Induced Immune Hemolytic Anemia, Hematology 73, 74 (2009), filed as Ex. 21 (ECF No.

38-4); Barcellini at 1. To justify this lack of causal evidence, Dr. Merrill argues that the

“pathogenesis of autoimmune cytopenia as well as autoimmunity in general remain poorly

defined,” yet several articles (such as the Dudley vaccine safety review) indeed find associations

between other autoimmune cytopenias and vaccines. Opp. at 16; Dudley at e83; see also C.

Gidengil et al., Safety of Vaccines Used for Routine Immunization in the United States: An Update,

244 Comparative Effectiveness Rev. 19 (2021), filed as Ex. A, Tab 18 (ECF No. 41-8) (noting

moderate evidence to support an increased risk of ITP following MMR vaccine). Here, by contrast,

no similar evidence exists.

Application of Dr. Merrill’s proposed causal mechanisms of molecular mimicry, bystander

activation, and epitope spreading in the context of flu vaccine and AIHA were incompletely

established and have little direct support, as acknowledged by both experts herein. Opp. at 16–18.

Moreover, and as argued by Dr. He, “it is not appropriate for [P]etitioner to transplant the

mechanism by which some infections can cause AIHA onto [the] flu vaccine.” Id. at 20 (citing He

Rep. at 10). Not only does the wild flu virus have the capacity to activate more immune pathways

13

than the flu vaccine, but none of the referenced literature herein establishes an association between

wild-type influenza virus and AIHA in the first place. Id. Yet AIHA has been associated with other

wild infections—the human immune deficiency virus, Epstein-Barr virus, cytomegalovirus,

haptotropic virus, and COVID-19. Id.; see also C. Brugnara & R. Brodsky, Warm Autoimmune

Hemolytic Anemia (AIHA) in Adults, in UpToDate (R. Means, Jr. & J. Tirnauer, eds., 2023), filed

as Ex. A, Tab 1 at 5 (ECF No. 40-2) (“Brugnara & Brodsky”). Thus, Respondent argues that

Petitioner has failed to present a reliable and persuasive medical theory demonstrating that the flu

vaccine can cause AIHA, and therefore, his claim fails under Althen prong one. Opp. at 22.

Respondent further argues that the second, “did cause” Althen prong has not been met. He

notes that Petitioner relies on his rapid, post-vaccination onset of symptoms and that the diagnosis

was confirmed by hemolysis markers and the absence of a plausible alternative explanation. Id. at

22. But there is no record evidence that specifically connects Petitioner’s symptoms (i.e., fatigue,

hand tingling, nausea, and chills) to an autoimmune response likely triggered by his receipt of the

flu vaccine. Id. Moreover, there are multiple instances in the record where Petitioner’s treaters

opined that the etiology of Petitioner’s anemia is uncertain. Id. at 23; see also Ex. 2 at 470, 477

(documenting internist Dr. Peterson’s observations that Petitioner had “warm autoimmune

hemolytic anemia of unknown trigger”). Dr. He also emphasizes Petitioner’s “long disease

history” of sarcoidosis prior to his receipt of the vaccine at issue, as well as the extensive evidence

supporting a causal association between sarcoidosis and AIHA. Opp. at 23 (referencing He Rep.

at 13). Accordingly, Respondent argues that Petitioner has failed to satisfy his burden under Althen

prong two.

Lastly, Respondent briefly argues that Petitioner has failed to produce reliable evidence of

a temporal relationship between the flu vaccine and his AIHA. He notes Petitioner’s reported onset

of symptoms as occurring on the same day as his vaccination, and therefore “too soon to activate

host innate and adaptive immune responses to cause autoimmune disease.” Opp. at 24 (citing He

Rep. at 13). In addition, not only does literature filed by Petitioner not support such a rapid onset

of AIHA, but Dr. Merrill’s embrace of an onset within two days of vaccination is outside what he

describes as the typical range of “3 to 10 days post-exposure for cytopenic conditions.” Id. (citing

Br. at 15).

V. Applicable Legal Standards

A. Petitioner’s Overall Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that

she suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—

corresponding to one of the vaccinations in question within a statutorily prescribed period of time

or, in the alternative, (2) that her illnesses were actually caused by a vaccine (a “Non-Table

Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §

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11(c)(1)(C)(ii)(I); see also Moberly ex rel. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d

1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320

(Fed. Cir. 2006). 9 There is no Table claim for the injury of hemolytic anemia/AIHA after receipt

of any covered vaccine.

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance

of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that

leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence

before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s

existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.

476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).

Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d

867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not

only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”

Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344,

1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed.

Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on her assertions;

rather, the petition must be supported by either medical records or by the opinion of a competent

physician. Section 13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a

Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal

Circuit in Althen v. Sec'y of Health and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1) a

medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause

and effect showing that the vaccination was the reason for the injury; and (3) a showing of

proximate temporal relationship between vaccination and injury.”

Each Althen prong requires a different showing. Under Althen prong one, petitioners must

provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type

of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a

petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”

Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must

only be “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioners may satisfy the first Althen prong without resort to medical literature,

epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical

9

Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority.

Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning

legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003),

aff’d 104 F. App’x. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V, 2014 WL

504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

15

theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing

Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by

statute to conclusively resolve what are essentially thorny scientific and medical questions, and

thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of

the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence

standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden

placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of

Health & Hum. Servs., 121 Fed. Cl. 230, 245 (May 6, 2015) (“[p]lausibility . . . in many cases may

be enough to satisfy Althen prong one” (emphasis in original)).

In discussing the evidentiary standard applicable to the first Althen prong, the Federal

Circuit has consistently rejected the contention that it can be satisfied merely by establishing the

proposed causal theory’s scientific or medical plausibility. See Cerrone v. Sec’y of Health & Hum.

Servs., 146 F.4th 1113, 1121 (Fed. Cir. 2025) (claimant’s contention that Althen prong one requires

only a showing of plausibility “understates the burden [a petitioner] bears under the first factor in

the Althen formulation”); Kalajdzic v. Sec’y of Health & Hum. Servs., No. 2023-1321, 2024 WL

3064398, at *2 (Fed. Cir. June 20, 2024) (arguments “for a less than preponderance standard”

deemed “plainly inconsistent with our precedent” (citing Moberly, 592 F.3d at 1322)); Boatmon v.

Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also Howard v. Sec'y of

Health & Hum. Servs., 2023 WL 4117370, at *4 (Fed. Cl. May 18, 2023) (“[t]he standard has been

preponderance for nearly four decades”), aff’d, 2024 WL 2873301 (Fed. Cir. June 7, 2024)

(unpublished). And petitioners always have the ultimate burden of establishing their overall

Vaccine Act claim with preponderant evidence. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d

1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell v. United States, 133 Fed. Cl. 782, 793

(2017) (noting that Moberly “addresses the petitioner’s overall burden of proving causation-in-fact

under the Vaccine Act” by a preponderance standard).

The second Althen prong requires proof of a logical sequence of cause and effect, usually

supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,

569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956

F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions

and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d

at 1367; Capizzano, 440 F.3d at 1326 (“medical 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 particularly

trustworthy evidence, since they are created contemporaneously with the treatment of the patient.

Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

16

Medical records and statements of a treating physician, however, do not per se bind the

special master to adopt the conclusions of such an individual, even if they must be considered and

carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,

test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y

of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates

that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and

cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the

opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their

suppositions or bases. The views of treating physicians should be weighed against other, contrary

evidence also present in the record—including conflicting opinions among such individuals.

Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious

for special master to weigh competing treating physicians’ conclusions against each other), aff’d,

698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,

2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed.

Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between

the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the

phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant

proof that the onset of symptoms occurred within a timeframe which, given the medical

understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan

v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what

is a medically acceptable timeframe must align with the theory of how the relevant vaccine can

cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum.

Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d

mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V,

2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. den’d (Fed. Cl. Dec. 3,

2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Legal Standards Governing Factual Determinations

The process for making determinations in Vaccine Program cases regarding factual issues

begins with consideration of the medical records. Section 11(c)(2). The special master is required

to consider “all [ ] relevant medical and scientific evidence contained in the record,” including

“any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained

in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability,

injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are

contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special

master is then required to weigh the evidence presented, including contemporaneous medical

records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.

17

1993) (determining that it is within the special master's discretion to determine whether to afford

greater weight to contemporaneous medical records than to other evidence, such as oral testimony

surrounding the events in question that was given at a later date, provided that such determination

is evidenced by a rational determination).

As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as

trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95

Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his

contemporaneous medical records, the special master's decision to rely on petitioner's medical

records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum.

Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked

propositions explains why such records deserve some weight: (i) sick people visit medical

professionals; (ii) sick people attempt to honestly report their health problems to those

professionals; and (iii) medical professionals record what they are told or observe when examining

their patients in as accurate a manner as possible, so that they are aware of enough relevant facts

to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V,

2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.

Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to

conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”).

Accordingly, if the medical records are clear, consistent, and complete, then they should

be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL

6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records

are often found to be deserving of greater evidentiary weight than oral testimony—especially

where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also

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), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States

v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral

testimony which is in conflict with contemporaneous documents is entitled to little evidentiary

weight.”)).

However, the Federal Circuit has also noted that there is no formal “presumption” that

records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health

& Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which

compelling oral or written testimony (provided in the form of an affidavit or declaration) may be

more persuasive than written records, such as where records are deemed to be incomplete or

inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like 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, 2005 WL

6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less

18

deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)).

Ultimately, a determination regarding a witness's credibility is needed when determining the

weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of

Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to

contemporaneous medical records, such testimony must be “consistent, clear, cogent, and

compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,

No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the

accuracy and completeness of medical records, the Court of Federal Claims has listed four possible

explanations for inconsistencies between contemporaneously created medical records and later

testimony: (1) a person's failure to recount to the medical professional everything that happened

during the relevant time period; (2) the medical professional's failure to document everything

reported to her or him; (3) a person's faulty recollection of the events when presenting testimony;

or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health

& Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making

a determination regarding whether to afford greater weight to contemporaneous medical records

or other evidence, such as testimony at hearing, there must be evidence that this decision was the

result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory often requires a petitioner to present

expert testimony in support of her claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,

1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the

factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509

U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.

Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).

Under Daubert, the factors for analyzing the reliability of testimony are:

(1) whether a theory or technique can be (and has been) tested; (2) whether the

theory or technique has been subjected to peer review and publication; (3) whether

there is a known or potential rate of error and whether there are standards for

controlling the error; and (4) whether the theory or technique enjoys general

acceptance within a relevant scientific community.

Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95).

In the Vaccine Program the Daubert factors play a slightly different role than they do when

applied in other federal judicial settings, like the district courts. Typically, Daubert factors are

19

employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence

that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are

used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &

Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have

been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of

expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the

persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88

Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not

been employed at the threshold, to determine what evidence should be admitted, but instead to

determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts in order to rebut a petitioner’s case.

Where both sides offer expert testimony, a special master's decision may be “based on the

credibility of the experts and the relative persuasiveness of their competing theories.”

Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing

Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert's conclusion

“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too

great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743

(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum.

Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for

review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo,

617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on

a particular expert's credibility, is part of the overall reliability analysis to which special masters

must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26

(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);

see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court

has unambiguously explained that special masters are expected to consider the credibility of expert

witnesses in evaluating petitions for compensation under the Vaccine Act”).

D. Consideration of Medical Literature

Both parties filed medical and scientific literature in this case, but not all such items factor

into the outcome of this decision. While I have reviewed all the medical literature submitted, I

discuss only those articles that are most relevant to my determination and/or are central to

Petitioner’s case—just as I have not exhaustively discussed every individual medical record filed.

Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072, 2016 WL 1358616, at *5 (Fed. Cir.

Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record

evidence even though he does not explicitly reference such evidence in his decision”) (citation

omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir.

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2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the

conclusion that it was not considered”).

E. Determination of Claim on Basis of Record

The parties have agreed to my resolving this case based on written submissions and

evidentiary filings, including the expert reports filed by each side. The Vaccine Act and Rules not

only contemplate but encourage special masters to decide petitions on the papers rather than via

evidentiary hearing, where (in the exercise of their discretion) they conclude that the former means

of adjudication will properly and fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d).

The choice to do so has been affirmed on appeal. See D'Toile v. Sec'y of Health & Human Servs.,

No. 15-85V, 2018 WL 1750619, at *2 (Fed. Cir. Apr. 12, 2018); see also Hooker v. Sec'y of Health

& Human Servs., No. 02-472V, 2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19,

2016) (citing numerous cases where special masters decided on the papers in lieu of hearing and

that decision was upheld). I am simply not required to hold a hearing in every matter, no matter

the preferences of the parties. See Hovey v. Sec'y of Health & Human Servs., 38 Fed. Cl. 397, 402–

03 (1997) (special master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d

at 417.

ANALYSIS

I. Hemolytic Anemia and Program’s Treatment of it as a Possible Vaccine Injury

It is not disputed that Mr. Johnson was properly diagnosed with warm AIHA. See Opp. at

13. But some discussion of its nature, and how prior Program cases have addressed it as an alleged

vaccine-associated adverse event, would still be beneficial in explaining my determination. AIHA

is understood to be a rare autoimmune disease oftentimes characterized by autoantibody-mediated

destruction of self-red blood cells. Brugnara and Brodsky at 2, 3 (“almost always IgG, although

IgA and warm-acting IgM have [also] been reported” as driving AIHA). Warm AIHA, the

diagnosis herein, occurs where the destructive autoantibodies are active at body temperature. Id.

It is also understood to either arise spontaneously or in the setting of a condition or medication that

predisposes an individual to the production of an autoantibody. Id. at 3.

As noted above, there is no Table claim for AIHA. At most, a different hematologic

injury—ITP—is a Table injury, but only after receipt of the MMR vaccine. 42 U.S.C.A. 300aa-

14(a)(V)(A). But reasoned decisions exist finding that ITP can be caused by other vaccines as well.

Johnson v. Sec’y of Health & Hum. Servs., No. 14-113V, 20017 WL 772534 (Fed. Cl. Spec. Mstr.

Jan. 6, 2017) (petitioner presented sufficient evidence to conclude the HPV can cause ITP); Walls

v. Sec’y of Health & Hum. Servs., No. 16-557V, 2020 WL 13801342, at *16 (Fed. Cl. Spec. Mstr.

June 23, 2020) (petitioner preponderantly established that vaccines such as DTaP, Hib, Hep B, and

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PCV can cause ITP). Nevertheless, although ITP is also likely autoimmune-mediated, it involves

destruction of platelets rather than erythrocytes, and thus is distinguishable as an injury despite

some of the overlap.

I am aware of some prior cases in which hemolytic anemia has been claimed as a vaccine

injury, and some have been successfully settled. But there are few relevant reasoned decisions in

which claims of purported vaccine-caused anemia have resulted in a favorable entitlement

decision. See, e.g., Berenji v. Sec’y of Health & Hum. Servs., No. 14-699V, 2019 WL 4640228

(Fed. Cl. Spec. Mstr. Aug. 30, 2019).

In Berenji, a petitioner alleged that receipt of several covered vaccines aggravated an

asymptomatic case of Evan’s syndrome (a chronic autoimmune disorder characterized by

concurrent AIHA and ITP), with several secondary conditions occurring as a result. Berenji, 2019

WL 4640228, at *1. The special master allowed for the possibility that a vaccine could plausibly10

worsen preexisting Evans syndrome (perhaps by causing the failure of regulatory immune factors

to function), but ultimately found it had not been demonstrated the vaccines at issue did cause this

to occur (since the illness at issue was known to be difficult to treat (and hence likely to persist

independently of vaccination), and the petitioner’s course was not shown to differ materially from

what a non-vaccinated patient with Evans syndrome would experience. Id. at *15, 21. Accordingly

(although in part because the case involved a claim of significant aggravation), 11 Berenji provides

little guidance herein, and is not particularly supportive of causation. But the claim that AIHA

could be vaccine-caused is not one that the Program has clearly embraced or rejected, making it

more than reasonable for evaluation herein (and in future cases as well).

II. Petitioner Has Not Carried His Althen Burden of Proof

I address the Althen prongs in order of their importance to my decision rather than in the

order in which they are delineated in that decision.

Prong Three

The most glaring deficiency to Petitioner’s causation showing is the fact that his purported

onset—the same day as vaccination—has not been shown to be a medically acceptable causal

timeframe. Not only did Petitioner report to treaters on November 2, 2020, that his onset had begun

five days before (October 28th), but blood testing performed at this later time yielded abnormal

results, corroborating the conclusion that Petitioner’s AIHA likely was already occurring. Ex. 1 at

2–6, 10. Even if it had been preponderantly demonstrated that the flu vaccine can cause AIHA, it

10

As noted above, plausibility is not the relevant evidentiary standard for resolution of any of the causation prongs.

11

Petitioner has not in this case alleged his AIHA began pre-vaccination but was worsened by it, and the record would

not support either finding.

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is not likely that any autoimmune disease process could begin so quickly—and this is so even in

the context of a person with considerable comorbidities like Petitioner. This is simply too fast for

an autoimmune process to be triggered by vaccination – resulting in the production of the

autoantibodies responsible for attacking blood cells, and then later resulting in outward clinical

symptoms.12 Rather, an autoimmune process is usually thought to involve the adaptive immune

response (in which the immune system generates antibodies in reaction to a foreign antigen), but

such a process is never thought to occur in so short a timeframe, and can often take a week or

more. See Curry v. Sec’y of Health & Hum. Servs., No. 22-279V, 2025 WL 1693655, at *21 (Fed.

Cl. Spec. Mstr. Apr. 28, 2025) (“[a] s is well understood in the Program, [], the adaptive immune

response lags the innate, initial response, and takes time to unfold and cause the production of

purportedly cross-reactive antibodies.” It is not instantaneous—and certainly requires more than a

few days.”).

Dr. Merrill’s opinion did not render such a rapid onset timeframe more persuasive or

medically/scientifically likely. He also did not establish, even through case report instances

involving other vaccines, sufficient evidence in which AIHA occurred post-vaccination in a

comparably-fast timeframe. See, e.g., H. Tsuchiya et al., A Case of Coombs-Negative Autoimmune

Hemolytic Anemia, Possibly Caused by Influenza Vaccination, 28 Acta Paediatr. Jpn. 78 (1986),

filed as Ex. 26 (ECF No. 58-1) at 2 (discussing case report of a 9-year-old boy who was

administered flu vaccines (25 days and 5 days) prior to AIHA onset); A. Seltsam et al.,

Vaccination-Associated Immune Hemolytic Anemia in Two Children, 40 Transfusion 907, 907–08

(2000), filed as Ex. 27 (ECF No. 58-2) (case reports of two children who developed AIHA

approximately four days and 2 weeks post vaccination). And he did not sufficiently flesh out any

other pathogenic mechanism in which onset of symptoms (triggered first by RBC destruction)

could happen so fast after instigation by some foreign factor.

Prong One

It also has not been preponderantly demonstrated that the flu vaccine can likely cause

AIHA at all—regardless of the timeframe in which it might reasonably occur under the proposed

causation theory. Even if AIHA can be associated with some pharmaceutical interventions, it has

not been established by the evidence filed in this case that vaccines are also thought to possess

such an association. At most, Dr. Merrill referenced passive surveillance reports of anemia

occurring temporally after receipt of a vaccine - a kind of evidence that is not generally given much

weight in Program cases when evaluating causation. Hiatt v. Sec’y of Health & Hum. Servs., No.

19-1363V, 2025 WL 3230494, at *19 (Fed. Cl. Spec. Mstr. Oct. 24, 2025), mot. for review den’d,

No. 19-1363, 2026 WL 730718 (Fed. Cl. Feb. 5, 2026). The possibility (as Dr. Merrill speculated)

that AIHA is underreported as a vaccine-associated adverse event (or even as a disease at all) is

12

Even the Table claim for ITP (an analogous blood cell-impacting autoimmune condition) attributable to the MMR

vaccine requires an onset of no sooner than seven days post-vaccination. 42 C.F.R. § 100.3(a)(V)(A).

23

not an excuse for an absence of preponderant evidence supporting causation. Similarly, Dr. Merrill

invoked the fact that much about AIHA’s pathogenesis remains unknown to explain his inability

to offer more evidence specific to the flu vaccine and how it might cause this injury (Second

Merrill Rep. at 4)—an unpersuasive contention that amounts to requesting that the preponderant

standard be lowered, simply because vaccine causation specific to this injury has not been a

widely-embraced research topic. Caves v. Sec’y of Dep’t of Health & Hum. Servs., 100 Fed. Cl.

119 (2011), aff’d sub nom. Caves v. Sec’y of Health & Hum. Servs., 463 F. App’x 932 (Fed. Cir.

2012) (“[t]he standard of proof does not operate as a sliding scale that varies depending upon the

quantity and quality of the scientific evidence that is available”). That standard demands a

preponderant showing – not merely evidence supporting the plausibility of causation.

In response, Dr. He noted a number of bases for concluding (at least given the record filed

in this case) that it is not likely the flu vaccine can cause AIHA. Although he acknowledged its

autoimmune nature, Dr. He persuasively observed that as a general matter there was little evidence

that AIHA could be vaccine-associated (adding that VAERS data is not particularly helpful in

assessing causation). He also noted that contentions about underreporting of AIHA as a vaccine

injury flew in the face of the fact that the flu vaccine is highly-administered (thus calling into

question why there are not more reports of a putative association, if one existed). And he recounted

the limits to theories that all autoimmune processes likely occur via molecular mimicry, or that

antigenic similarity between a foreign antigen and self-protein or tissue structure is alone enough

to render cross-reactivity due to mimicry likely. He Rep. at 9–12.

Overall, Dr. Merrill’s causation theory was thin, constructed of the kinds of arguments seen

all too often in Program cases and yet rejected. It is certainly not beyond the realm of possibility

that the autoimmune attack at the heart of AIHA could be vaccine-associated, but the evidence

necessary to find that contention preponderantly established has not been offered in this case.

Prong Two

Resolution of this Althen prong presents the closest case. The instances of treater

acceptance of a vaccine association both direct and indirect (to the extent treaters agreed Petitioner

should not receive certain vaccines in the future after his alleged reaction) do support the

contention the flu vaccine caused Petitioner’s injury (even if those treater suppositions provide

little explanation for the perceived association, beyond the temporal relationship—and even where

some treaters disclaim an opinion as to causation). On the other hand, Dr. He compellingly

demonstrated a basis for a possible sarcoidosis-AIHA relationship (although in doing so he

ironically relied on the kind of case report evidence frequently deemed of low probative value),

but Dr. Merrill accurately noted that this possible alternative cause was not fully corroborated by

the record—let alone shown to be an active concern within even a few years of the vaccination at

issue.

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Regardless, I have not found (on the basis of the evidence before me) that the flu vaccine

likely “can cause” AIHA, or that Petitioner’s injury began in a medically-acceptable timeframe.

These findings—which did not present close calls at all—are a sufficient basis for denying

entitlement, since all three Althen prongs must be met by a petitioner. Dobrydnev v. Sec’y of Health

& Hum. Servs., 566 Fed. Apps. 976, 980 (Fed. Cir. 2014).

CONCLUSION

Because Petitioner did not carry his preponderant burden of showing causation, I am

compelled to deny compensation.

In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the

Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision. 13

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

13

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices

renouncing their right to seek review.

25