Exum v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 21-1513V

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PORTIA EXUM, * Chief Special Master Corcoran

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Petitioner, * Dated: August 29, 2024

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v. *

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SECRETARY OF HEALTH AND *

HUMAN SERVICES, *

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Respondent. *

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Amber Diane Wilson, Wilson Science Law, Washington, DC, for Petitioner.

Lauren Kells, U.S. Department of Justice, Washington, DC, for Respondent.

ENTITLEMENT DECISION 1

On June 25, 2021, Portia Exum filed a petition seeking compensation under the National

Vaccine Injury Compensation Program (the “Vaccine Program”). 2 Petitioner alleges that the

tetanus-diphtheria-acellular pertussis (“Tdap”) and measles-mumps-rubella (“MMR”) vaccines

she received on October 8, 2018, caused her to develop autoimmune hepatitis (“AIH”). Pet. at 1.

A one-day Entitlement Hearing was held on March 7, 2024. Now, having heard the witnesses at

hearing and reviewed the record, I find Petitioner is not entitled to compensation.

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 Ruling 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 Background

Pre-Vaccination History

Ms. Exum was born on January 29, 1988. Prior to the vaccinations at issue, she had a

history of gastrointestinal reflux issues, small intestinal bacterial overgrowth, and kidney stones at

different times. Ex. 2 at 9–12; Ex. 3 at 273–75, 265–71. Notably, during a May 2018 ER visit for

kidney stones, Petitioner’s AST and ALT levels (liver enzymes) were normal. Ex. 3 at 268.

Petitioner began preparing for overseas travel to Kenya and Tanzania in mid-August 2018.

She received anti-malarial medication on August 17, 2018. Ex. 3 at 74. She was instructed to begin

taking the medication two days before visiting areas with high risk for malaria, and to continue

taking it for seven more days after leaving. Id. On August 20, 2018, she received the MMR and

Tdap vaccines from her employer’s health clinic, but declined the typhoid vaccine. Id. at 72–73.

Post-Vaccination Period and Symptoms Onset

Petitioner traveled to Kenya and Tanzania from August 29 to September 8, 2018. Ex. 4 at

35. She reported receiving four or five bug bites during the trip. Id. Upon return, she felt fatigued,

and had GERD symptoms and indigestion in late September. Id. In October 2018, she reported

experiencing daily nausea. Id.

On October 26, 2018, Petitioner had a routine physical for life insurance purposes that

revealed elevated liver enzymes. Ex. 4 at 42 (ALT of 818 U/L with a 0-45 U/L range, AST of 546

U/L with a 0-33 U/L normal range). She followed up with a gastroenterologist on November 28,

2018, to address both the elevated liver enzymes and her ongoing nausea, as well as related GI

symptoms. Ex. 3 at 280. Her abdominal exam was unremarkable, with no signs of liver

enlargement or tenderness. Id. A physician’s assistant (“PA”) noted her recent abnormal liver

function tests, and that Petitioner reported right-sided distress. Id. at 282. The PA recommended

H. pylori testing, and that Petitioner use Pepcid and diet modifications to ease her GERD and

dyspepsia. Id. Petitioner was referred to a hepatologist to have an MRI of her liver. Id. at 283. Test

results two days after this visit showed even higher AST and ALT levels, but samples were

negative for H. pylori. Id. at 67–69.

Petitioner’s next treatment event occurred over five weeks later at a visit to her primary

care physician (“PCP”) on December 7, 2018. Ex. 3 at 61. She now reported upper right quadrant

abdominal pain, nausea, fatigue, and yellow eyes. Id. An abdominal exam was unremarkable, and

her PCP referred her to a hepatologist. Id. at 63. She also had her inter-uterine device (“IUD”)

removed on December 6, 2018, to eliminate it as a potential source of the liver issues. Id. at 242–

243. She then visited the same PCP on December 14, 2018, expressing concern for malaria or other

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insect diseases resulting from big bites during recent travel. Id. at 57. The PCP ordered additional

lab work, and referred her to an infectious disease specialist. Id. at 59. The lab work again showed

elevated AST and ALT, but autoantibody testing for markers associated with AIH (anti-nuclear

antibodies and anti-smooth muscle antibodies) were negative. Id. at 58.

On December 19, 2019, Petitioner saw a hepatologist for her elevated liver enzymes. Ex.

3 at 232–38. She denied the presence of known risk factors for liver disease, such as alcohol

consumption or IV drug use. Id. at 232. She did acknowledge taking antimalarial medication

during travel, but denied taking any over-the-counter medications or supplements other than reishi

mushrooms. Id. The hepatologist noted that she had no signs of decompensated liver disease,

including icterus, jaundice, confusion, melena, hematochezia, hematemesis, bruising, weight loss,

or abdominal swelling, and an abdominal exam was again unremarkable. Id. at 232–33, 235. But

her liver MRI showed two hyper-intense lesions consistent with adenomas versus focal nodular

hyperplasia (“FNH”), and asymmetric dilation of the left renal vein. Id. at 235–36. The diagnostic

differential included elevated results from liver function tests (“LFTs”), and hepatic adenoma

versus FNH. Id. at 237. Lab results again showed elevated LFTs, but no signs of active hepatitis

infection. Ex. 8 at 73. The hepatologist ordered a liver biopsy and a repeat liver MRI with contrast

in six months. Ex. 3 at 237.

Petitioner underwent the liver biopsy on January 3, 2019, which expanded her differential

diagnoses to “infection, the effects of medications/drugs/herbal remedies, Wilson disease and

autoimmune hepatitis.” Ex. 3 at 229. The next day, she saw a hematology and oncology specialist,

who stated that her elevated LFTs were due to “obvious liver disease” that he diagnosed as

hepatitis. Id. at 222.

Subsequent Treatment for Hepatitis

On January 29, 2019, Petitioner visited an infectious disease specialist. Ex. 4 at 6. They

discussed her international travel from the early fall of 2018, and she reported that she had entered

bodies of water, received several insect bites, and felt extreme fatigue upon return. Id. at 8. The

specialist noted she was taking a four to six-week course of prednisone. Id. at 6. He affirmed

Petitioner’s hepatitis diagnosis, and ordered lab work. Id. at 8. The results revealed Petitioner had

experienced an Epstein-Barr viral infection at some prior point. Id. at 12; Ex. 3 at 207. Her LFTs

had improved, but were still elevated. Ex. 3 at 204.

Petitioner’s LFTs thereafter trended downwards during February and March 2019, but

remained elevated. Ex. 3 at 43–51. During a GI visit for reflux management in February, her treater

noted that she was taking kidney-oriented medication in addition to the prednisone to treat her

liver issues. Id. at 197. Her PCP later noted in April 2019 that her AIH was “improving.” Id. at

36–37. A visit to a hepatologist that same month revealed continued LFT improvement, although

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levels remained above normal. Id. at 192–96. She also continued to report some ongoing fatigue.

Id. at 34.

Petitioner visited her hepatologist again in August 2019. Ex. 3 at 162–65. Her LFTs

remained elevated, and the hepatologist ordered a metabolic screen to rule out hepatoxicity, and

instructed her to continue with her previously-prescribed medications. Id. at 165. Labs taken

shortly thereafter in September 2019 showed slightly elevated LFTs, but otherwise normal results.

Id. at 20–31.

By the first half of 2020, Petitioner’s liver concerns had mostly resolved, and testing began

from this time to 2022 to reveal normal LFTs. Ex. 10 at 56–61; Ex. 3 at 154. A repeat liver biopsy

performed in February 2021, however, showed “chronic hepatitis with minimal interface activity

and mild portal fibrosis (stage 1 of 4).” Ex. 14 at 41; Ex. 15 at 83. But a hepatology follow-up in

March 2022 revealed no signs of liver disease, and the latest records filed in this case show no

signs of liver disease through November 2023. Ex. 14 at 36–41; Ex. 46 at 6–7.

II. Hearing Witnesses

A. Petitioner’s Expert – Dr. Robert Gish, M.D.

Dr. Gish prepared two reports in this case. Gish First Report, dated July 11, 2022, filed as

Ex. 16 (ECF No. 18-1) (“Gish First Rep.”); Gish Supplemental Report, dated March 21, 2023,

filed as Ex. 38 (ECF No. 28-1). He also testified at the hearing.

Dr. Gish received his M.D. from the University of Kansas, and completed his internship

and residency at the University of California, San Diego. Gish CV at 3, filed on July 11, 2022, as

Ex. 37 (ECF No. 20-1). He then completed a fellowship in gastroenterology and hepatology, with

a special rotation in liver transplantation, at UCLA. Id. He is board-certified in internal medicine

and gastroenterology, and has a separate board certification for hepatology that is part of the

Certificate of Advanced Qualification in liver transplantation. Id. at 2. He is a member of multiple

professional societies including the National Viral Hepatitis Round Table, the American

Association for the Study of Liver Disease, and the American Liver Foundation. Id. at 4. He is a

licensed physician in California, Arizona (inactive), and Nevada. Id. at 2. He has been active as a

clinician and researcher for thirty-six years and has served on the editorial boards of many

prestigious journals in his field, including Hepatology and the Journal of Viral Hepatitis. Gish

First Report at 1.

Presently, Dr. Gish is a clinical adjunct professor of medicine at the University of Nevada

School of Medicine in both Reno and Las Vegas, and UCSD Skaggs School of Pharmacy and

Pharmaceutical Sciences. Gish CV at 1. He is also the Medical Director of the Hepatitis B

Foundation, which is the nation’s leading nonprofit research and advocacy organization for

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hepatitis B (HBV). Id. Dr. Gish has acknowledged, however, that he is not an expert in

immunology. Tr. at 90.

Dr. Gish began his testimony by discussing Petitioner’s medical history prior to

vaccination—which he deemed not to suggest any developing liver disease or alternative causes.

Tr. at 15. For example, she had no physical exam results indicating liver issues, and four normal

liver panel tests before receiving the vaccine. Id. When a patient has normal liver enzyme tests,

“the chance of that person having active liver disease that is hidden in some way is extremely

small.” Id. at 18. He also noted that liver disease patients typically present with symptoms like

fatigue, liver pain, jaundice, rashes, and mental confusion. Id. at 19. And when reviewing

Petitioner’s medical history, Dr. Gish looked for common causes of liver disease, such as

alcoholism, needle sharing, high-risk sexual behavior, and having medical procedures in

developing countries—but no such factors were evident. Id. at 19–20. Dr. Gish further pointed out

that Petitioner had tested negative for Epstein-Barr virus and Hepatitis B and C, which are

significant risk factors. Id. at 22.

At most, Petitioner’s receipt of anti-malarial medication before traveling to Africa was a

risk factor, “but that’s typically brief, transient, and doesn’t result in autoimmune disease long-

term.” Tr. at 22. He compared Petitioner’s course to that of the patient in a case report whose

hepatitis presented acutely after taking an anti-malarial medication. Id.; B. Beretta-Piccoli et al.,

Atovaquone/Proguanil-Induced Autoimmune-Like Hepatitis, 1 Hepatology Communications 293

(2017), filed on January 2, 2023, as Ex. A Tab 10 (ECF No. 25-10) (“Beretta-Piccoli”). In contrast

to Petitioner, the patient evaluated in Beretta-Piccoli displayed symptoms like jaundice and dark

urine early on, which are obvious clinical signs of liver disease. Id. at 83. Further, Petitioner had

stopped taking all of her medications and supplements after receiving the initial lab results in

October 2018 indicating the existence of elevated liver enzymes. Id. at 80. Thus, had the two herbal

supplements Petitioner had been taking caused her elevated liver enzymes, the levels should have

normalized once she stopped taking them—but she continued to have elevated liver enzymes. Id.

The above, plus Dr. Gish’s view that her disease onset had begun within a few weeks of

vaccination, permitted him to conclude that she fit the “ideal profile” for an adverse reaction to the

vaccine. Id. at 22.

To explain how the vaccines Petitioner received could have caused an autoimmune form

of hepatitis, Dr. Gish proposed that she had experienced an immune-mediated reaction to the

measles component of the MMR vaccine (and although his theories also touched on the Tdap

vaccine, he focused more on the MMR vaccine). Tr. at 38. He pointed to filed literature studying

both the measles vaccine mechanism in primates, and measles-induced immune suppression in

human tissue samples. Tr. at 38–42; R. Nanan et al., Measles Virus Infection Causes Transient

Depletion of Activated T. Cells from Peripheral Circulation, 12 J. of Clinical Virology 201 (1999),

filed on July 11, 2022, as Ex. 31 (ECF No. 19-7) (“Nanan”); T. Munyer et al., Depressed

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Lymphocyte Function after Measles-Mumps-Rubella Vaccination, 132 J. of Infectious Diseases 75

(1975), filed on July 11, 2022, as Ex. 32 (ECF No. 19-8) (“Munyer”).

Dr. Gish theorized that, in clearing the vaccine-induced measles infection from Petitioner’s

body, non-measles specific immune cells were activated, and stayed chronically activated

thereafter, resulting in a chronic autoimmune condition. Tr. at 46–49. In his opinion, Petitioner’s

immune self-tolerance was broken due to T-cell cross reaction, resulting from the suppression of

bystander immune cells by the measles virus, allowing the immune system to attack self antigens

(located on the surface or in the mitochondria of liver cells). Id. at 58. This autoimmune reaction

was later compounded by Petitioner’s simultaneous receipt of the Tdap vaccine. Id. at 62. Because

she had received the Tdap vaccine in the past, he explained, the antigen-specific response

generated by this booster vaccine may have amplified the existing response to the measles vaccine.

Id. Dr. Gish claimed independent medical/scientific literature supported this aspect of his theory,

but he did not specify which articles stood for the proposition. Id.

Dr. Gish then briefly discussed an item of literature that he proposed was supportive of his

theory. S. Subramanian et al., Postinfectious Autoimmune Hepatitis-Induced Liver Failure: A

Consequence of Hepatitis A Virus Infection, 7 ACG Case Reports J. 1 (2020), filed on July 11,

2022, as Ex. 25 (ECF No. 19-1) (“Subramanian”). But he did not reference Subramanian for its

primary findings (which focused on how a hepatitis A infection could secondarily result in

autoimmune hepatitis), but instead on a separate item of literature it discussed, “Vento” (which

Petitioner never filed in this case). In Vento, researchers followed family groups that developed

autoimmune hepatitis after Hepatitis A infections. Tr. at 66–68. The results of the Vento study

supported the idea that a genetic disposition made patients susceptible to AIH, and Dr. Gish felt

that this in turn suggested that Petitioner was likely genetically susceptible as well. Id. at 69. But

he admitted that no genetic testing had been performed that would corroborate the contention about

Petitioner’s susceptibility. Id. at 96.

Dr. Gish also reviewed Petitioner’s clinical course, deeming it consistent with his causal

theory. Tr. at 70. In particular, he opined that Petitioner’s AIH symptoms onset began within an

acceptable 10-week timeframe for an environmental trigger (in this case the vaccine). Id. He

pointed to evidence of her fluctuating but elevated liver enzymes between October 2018 and

January 2019 as establishing the existence of ongoing AIH, confirmed by the biopsy taken in

January 2019. Id. at 70–74, 75. Thus, he concluded that “the timing of symptoms, the timing of

laboratory tests, the liver biopsy, all fits a classic triggering event and onset of autoimmune

disease.” Id. at 82.

On cross-examination, Dr. Gish acknowledged that he has seen patients who developed

AIH after traveling, and after taking herbal supplements as well. Tr. at 91–92. He denied that

Petitioner’s previous small bowel overgrowth (“SIBO”) could have caused her AIH, explaining

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that SIBO is linked to a specific type of AIH which Petitioner did not have. Id. at 94. He

acknowledged that Petitioner’s AIH could have been idiopathic, and stated that an environmental

trigger can typically only be identified in half of cases. Id. at 95.

When asked about the molecular mimicry component of his causal theory, Dr. Gish agreed

that he had not identified a specific homology between the MMR and Tdap vaccines and liver

proteins. Tr. at 108. He also attempted to explain further the immune suppression mentioned in his

earlier testimony and report, and how the MMR vaccine “both suppresses and activates the

immune system” at the same time. Id. at 112–16. He specified that the innate immune response is

suppressed, leading the adaptive immune response to compensate. Id. at 113. Concurrently, a

variety of antigen-presenting cells are activated, producing “off-target effects.” Id. Then, in a

genetically susceptible individual, “[y]ou end up stimulating an arm of the immune system that

isn’t getting turned off. These are the T-regs that are suppressed in some ways or can’t be activated

and the immune system goes down this long pathway.” Id.

B. Respondent’s Experts

1. Jeffrey Crippin, M.D. - Dr. Crippin authored one report in this case, and

testified at the hearing. Crippin Report, filed on October 31, 2022, as Ex. A (ECF No. 23-1).

Dr. Crippin received his medical degree from the University of Kansas, and completed an

internal medicine residency at Kansas University Medical Center, where he served as chief

resident. Crippin CV at 1–2, filed on March 4, 2024, as Ex. E (ECF No. 56-1). He then completed

a three-year fellowship in Gastroenterology and Hepatology at the Mayo Clinic, Rochester,

Minnesota. Id. at 2. He currently works at the Barnes-Jewish Hospital in St. Louis, and is a

Professor of Medicine at the Washington University School of Medicine. Id. at 1. He is board

certified in Internal Medicine and Gastroenterology, and has received the Certificate of Added

Qualification in transplant hepatology. Id. at 6–7. He has extensive experience in patients with

autoimmune hepatitis, and has treated 300-400 patients with the disease over the course of his

career. Crippin Report at 1.

Dr. Crippin agreed with Petitioner’s AIH diagnosis, but denied that the vaccines she

received were more likely than not the cause of her illness. Tr. at 123. Rather, he pointed out

numerous other potential causal factors in her record, although he was unable to specify a most

likely cause. Id. at 125–27. These factors included Petitioner’s international travel in the months

prior to her illness, her use of anti-malarial medication and herbal supplements, and a prior history

of kidney stones, an IUD, and her SIBO. Id. at 125–27, 128–29. Further, she had tested positive

for Epstein-Barr virus antibodies in December 2018. Id. at 127; Ex. 3 at 207. He admitted,

however, that it was impossible to determine when she had Epstein-Barr from that test—“It could

have been earlier that year, it could have been five years ago.” Id. Although she experienced fatigue

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(a symptom of the virus) upon returning from travel, she was not tested for the virus at the time.

Id. at 128. He also noted that a large number of AIH cases are idiopathic, meaning that no specific

trigger can be identified. Id. at 130.

Dr. Crippin then discussed one of the case reports Petitioner filed, pointing out differences

from Petitioner’s clinical course. Id. at 131; W. Saliba & M. Elias, Acute Hepatitis Following MMR

Vaccination, 16 European J. of Internal Medicine 379 (2005), filed on July 11, 2022, as Ex. 21

(ECF No. 18-6) (“Saliba”). Saliba featured a patient who experienced acute hepatitis rather than

AIH, and no liver biopsy was performed to help determine the cause. Id. at 131; The patient had

also recently given birth, putting her at greater risk of viruses due to pregnancy-related immune

suppression. Tr. at 131–32. Further, the Saliba patient developed symptoms of her liver illness

within two weeks of vaccination, whereas Petitioner first exhibited potential symptoms no sooner

than six to eight weeks after vaccination. Id. at 132.

Dr. Crippin also noted that he had not been able to locate any controlled studies showing a

link between AIH and either the MMR or Tdap vaccines. Tr. at 130. And he similarly was unaware

of studies showing the combined administration of both vaccines at once was a risk factor for AIH.

Id. at 133. On cross, he reiterated his prior testimony that he could not determine the time when

Petitioner was infected with Epstein-Barr virus, and that there were no other infections noted in

her records. Id. at 135. Ultimately, he declined to identify which of the various factors he deemed

the most likely cause, and stated again that this could be an idiopathic case. Id. at 137–38, 140–

41.

2. Andrew MacGinnitie, M.D., Ph.D. - Dr. MacGinnitie wrote one report in

this case, and testified at the hearing. MacGinnitie Report, filed October 31, 2022, as Ex. C (ECF

No. 23-3) (“MacGinnitie Rep.”).

Dr. MacGinnitie is the Chief of the Division of Allergy, Asthma, and Immunology at

Children’s Hospital of Wisconsin, and a Professor of Pediatrics at Medical College of Wisconsin.

Tr. at 142–43. He graduated from the University of Chicago Pritzker School of Medicine with both

an M.D. and a Ph.D. from the Department of Pathology. MacGinnitie CV, filed on October 31,

2022, as Ex. D (ECF No. 23-4) He then completed a residency in Pediatrics in the Boston

Combined Residency Program, training at Boston Children’s Hospital and Boston Medical Center,

followed by an Allergy/Immunology fellowship at Boston Children’s Hospital. Id. He is board

certified in both Allergy/Immunology and Pediatrics. Id. at 11. He maintains an active clinical

practice seeing more than 1600 patients annually and has extensive experience in caring for

children and adults with a variety of immunologic diseases, including reactions to vaccines.

MacGinnitie Report at 2. Dr. MacGinnitie also performs research, and has published articles in a

number of areas related to Allergy/Immunology including food allergy, vaccine reactions, and

primary immunodeficiency. Id.

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Dr. MacGinnitie opined that the vaccines Petitioner received had no relationship to her

AIH. Tr. at 148. First, he criticized Dr. Gish’s reliance on case reports in the absence of

epidemiological studies connecting AIH and the Tdap and MMR vaccines. Tr. at 150. In his view,

case reports cannot reliably connect a vaccine to an illness because they do not provide an accurate

comparison with the baseline rate of an illness in the general population. Id. Further, none of the

case studies filed involved the effects of simultaneous administration of the Tdap and MMR

vaccine in causing AIH. Id. at 151; see, e.g., M. van Gemeren et al., Vaccine-Related Autoimmune

Hepatitis: The Same Disease as Idiopathic Autoimmune Hepatitis? Two Clinical Reports and

Review, 52 Scandinavian J. of Gastroenterology 18 (2017) (combination of Tdap and hepatitis A

vaccine), filed on July 11, 2022, as Ex. 26 (ECF No. 19-2); see also P. Perumalswami et al.,

Vaccination as a Triggering Event for Autoimmune Hepatitis, 29 Seminars in Liver Disease 331

(2009) (hepatitis A and yellow fever vaccines), filed on March 6, 2024, as Ex. 27 (ECF No. 61).

At best, Saliba involved the MMR vaccine, but the injury therein was acute hepatitis rather than

AIH (a chronic condition). Id. at 152; Saliba. In another, the patient received six vaccines at the

same time, and although the MMR was one of them, it was impossible, in Dr. MacGinnitie’s

opinion, to isolate the effects of only one or two. Id. at 152–53; G. Veerappan et al., Vaccination-

Induced Autoimmune Hepatitis, 50 Digestive Diseases and Sciences 212 (2005), filed on March 5,

2024, as Ex. 24 (ECF No. 58-1).

Dr. MacGinnitie next criticized Petitioner’s molecular mimicry theory. Tr. at 156. After

explaining the concept briefly, he noted that Dr. Gish had not identified any specific homology

(meaning molecular similarity) between the vaccines and the liver cell antigens where an

autoimmune cross-reaction would begin or occur—a crucial starting point if molecular mimicry

was a reasonable explanation for Petitioner’s injury. Id. at 158. Even if he had, however, it would

not be sufficient to prove the theory in Dr. MacGinnitie’s view, as there is a “massive overlap

between microbial and human proteins” in nature, but which does not commonly result in

autoimmunity. Id. at 158. He also criticized Petitioner’s reliance on bystander activation as a

disease mechanism, noting that articles filed in the case regarding AIH did not consider this to be

a pathologic explanation. Id. at 160; C. Mack et al., Diagnosis and Management of Autoimmune

Hepatitis in Adults and Children: 2019 Practice Guidance and Guidelines from the American

Association for the Study of Liver Diseases, 72 Hepatology 671 (2020), filed on January 26, 2023,

as Ex. A, Tab 1 (ECF No. 25-1). Beyond this, Petitioner had not displayed clinical signs of

significant inflammation, which would have occurred shortly after vaccination had such an

autoimmune response occurred. Id. at 159.

Dr. MacGinnitie also addressed Petitioner’s argument that her immune system was likely

suppressed by the measles vaccine, allowing an autoimmune response to occur. He noted the

absence of strong evidence showing that the measles vaccine (as opposed to the wild virus)

suppresses the immune system to any pathologic degree. Tr. at 162; MacGinnitie Rep. at 8–9. And

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he deemed articles filed to support this contention as lacking in clinical value or were outdated. Id.

at 162–64; Nanan (published in 1999); Munyer. Up-to-date clinical manuals relied upon by

treaters, however, acknowledge the immune-suppressive nature of the wild measles virus, but not

the vaccine (the receipt of which functions to prevent this immune suppression in the first place).

Tr. at 165–66; AMERICAN ACADEMY OF PEDIATRICS, RED BOOK (2021): REPORT OF THE

COMMITTEE ON INFECTIOUS DISEASES 503 (32d ed. 2021), filed on January 26, 2023, as Ex. C, Tab

4 (ECF No. 26-4); see also M. Mina, Measles, Immune Suppression, and Vaccination: Direct and

Indirect Nonspecific Vaccine Benefits, 74 J. Infection S10, S15 (2017), filed as Ex. C., Tab 3 (ECF

No. 26-3) (noting the benefit of measles vaccine in blunting the immunosuppressive character of

a wild measles virus infection). He also noted that the theory did not fit how AIH occurs. Since

AIH is autoimmune in character, it reflects an aberrant overstimulated/ overactive immune

process—not one that has been suppressed (and thus a measles infection-like reaction might

actually reduce the possibility of an autoimmune process developing). Id. at 162.

Dr. MacGinnitie challenged Dr. Gish’s argument that whole cell pertussis 3 could itself

stimulate a class of T-helper cells (which encourage the production of certain proinflammatory

cytokines)—and thus, because Petitioner had likely received the whole cell pertussis vaccine as a

child, the Tdap booster she had received in 2018 might have increased the possibility of a

comparable memory response. Tr. at 169. He acknowledged the importance of the relevant T-

helper cells in fighting bacterial and fungal infections, but deemed the re-stimulation of them

unlikely to cause autoimmune disease. Id. at 170. Thus, although Petitioner had offered a study

showing that patients vaccinated with whole cell pertussis produced more inflammatory cytokines

than those vaccinated with acellular pertussis, the study did not establish that the levels of produced

cytokines were anywhere near levels sufficient to propagate an autoimmune inflammatory

environment. Id. at 171–72; R. Antunes et al., Th1/Th17 Polarization Persists Following Whole-

Cell Pertussis Vaccination Despite Repeated Acellular Boosters, 128 J. Clinical Investigation

3853 (2018), filed on July 11, 2022, as Ex. 34 (20-1). And since Petitioner had not been tested for

these cytokines, it was pure speculation to propose she had possessed them in pathologic levels

after vaccination. Id. at 173.

Dr. MacGinnitie concluded with a brief consideration of the onset interval of one to five

months Dr. Gish proposed for vaccine-induced AIH. Tr. at 174. Although he opined that case

reports should carry little evidentiary weight, he noted that the case reports Dr. Gish cited showed

documented hepatitis (not simply the first symptoms) had begun within a far shorter timeframe:

within ten to thirty days of vaccination. Id. at 174; see, for example, T. Sasaki et al., Autoimmune

Hepatitis Following Influenza Virus Vaccination: Two Case Reports, 97 Medicine 1 (2018), filed

on July 11, 2022, as Ex. 28 (ECF No. 19-4) (one week onset and one month onset). Other items of

3

The now largely-discontinued DPT vaccine included whole cell pertussis, but the version administered today (Tdap)

employs an acellular form of pertussis thought to be less likely to cause certain side effects. See Andreu v. Sec'y of

Health & Hum. Servs., 569 F.3d 1367 n1 (Fed. Cir. 2009) for discussion of case law on the safety concerns prompting

the switch to an acellular formulation.

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literature Petitioner referenced for a shorter onset timeframe involved distinguishable diseases or

other vaccines. Tr. at 175–76; L. Schonberger et al., Guillain-Barré Syndrome Following

Vaccination in the National Influenza Immunization Program, United States, 1976-1977, 110 Am.

J. of Epidemiology 105, filed on March 21, 2023, as Ex. 39 (ECF No. 28-2) (flu vaccine and

Guillain-Barré syndrome).

III. Procedural History

As noted above, the case was initiated in 2021. Respondent filed his Rule 4(c) Report

disputing Petitioner’s right to compensation on August 19, 2022. Expert reports were filed through

the end of 2022, the trial was held in March 2024, and the matter is now ripe for resolution.

IV. 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

he 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 his 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; §

11(c)(1)(C)(ii)(I); see also 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). 4

There is no Table injury for AIH, so Petitioner can only assert a causation-in-fact claim.

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 his assertions;

4

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).

11

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

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, 121 Fed.

Cl. at 245 (“[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 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

12

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).

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

13

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.

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

14

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

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 his 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

15

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

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”);

16

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.

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

conclusion that it was not considered”).

ANALYSIS

The failure to establish even one of the three Althen prongs in the context of a causation-

in-fact claim is sufficient basis for a claim’s dismissal. Dobrydnev v. Sec’y of Health & Hum.

Servs., 566 Fed. Appx. 976, 980 (Fed. Cir. 2014). Petitioner could not preponderantly establish

prongs one and two. 5

First, Petitioner has not preponderantly established that it is likely that the MMR and Tdap

vaccines—alone or in combination—can cause AIH. Dr. Gish’s opinion (which goes a bit beyond

his expertise in hepatologic matters and into immunology) has some reliable points in its favor,

but ultimately fails to persuasively “connect the dots” into a causal explanation. His points about

the immune-suppressive character of the MMR vaccine, for example, relied on a false equivalence

between the impact of the measles wild virus and vaccine, attempting to treat the impact of the two

as the same. 6 In fact, as Dr. MacGinnitie noted, the measles vaccine’s impact is to make immune

suppression less likely—and there is a contradictory quality to arguing that immune suppression

5

I thus need not also evaluate the sufficiency of Petitioner’s third prong showing under the circumstances.

6

See, e.g., Tr. at 37 (Dr. Gish responding affirmatively to the question, “[w]ould it be expected that Mrs. Exum

suffered a mild vaccine strain measles infection from the administration of her vaccine?”). But this kind of argument

has been rejected in the Program before. See, e.g., Snyder v. Sec'y of Health & Hum. Servs., No. 01-162V, 2009 WL

332044, at *104 (Fed. Cl. Spec. Mstr. Feb. 12, 2009) (“petitioners have failed to demonstrate that the MMR vaccine

causes immunosuppression. There is no evidence that children receiving the vaccine have higher rates of infection in

the months after vaccination than children who do not receive the vaccine”), mot. for review den’d, 88 Fed. Cl. 706

(2009).

17

would cause a disease reaction that occurs due to an uncontrolled immune response. He similarly

made assumptions about the impact of the Tdap vaccine (and its promotion of inflammation

through stimulation of T-helper cells) that rely more on supposition than independent evidence—

and he could not imbue these contentions with reliability by drawing on immunologic expertise he

lacks. And the idea that both vaccines administered at the same time raise the risk of an aberrant

response is a barely-plausible contention that lacked corroboration from materials filed in this case.

More generally, it was not shown that the vaccines at issue could likely promote an

autoimmune response resulting in AIH—and consideration of the typical “building blocks” relied

upon by petitioners in comparable Program cases illuminates why. Autoimmune diseases involve

mistaken self-attacks propagated by antibodies generated in response to a foreign antigen that (due

to molecular and/or structural similarities with a self-antigen protein) then cross-react with the self

tissue, often in a chronic/persistent manner. See, e.g., Bielak v. Sec'y of Health & Hum. Servs., No.

18-761V, 2023 WL 35509, at *33 (Fed. Cl. Spec. Mstr. Jan. 3, 2023) (“[m]olecular mimicry is

predominantly driven by B cell activity, occurring when antibodies are produced in response to

antigenic components of the vaccine—but which (due to mimicry between the presenting vaccine

antigens and self-tissues) cause harmful cross-reactions, by mistakenly attacking the self

antigens”).

Thus, litigants commonly attempt to show at a minimum (a) what homology might exist

between a vaccine’s antigens and a self structure relevant to the situs of harm (here the liver), and

(b) what evidence exists that the vaccine would cause the production of the likely pathogenic

antibodies. See K.A. v. Sec'y of Health & Hum. Servs., No. 16-989V, 2022 WL 20213037, at *9

(Fed. Cl. Spec. Mstr. Apr. 18, 2022), mot. for review den’d, 164 Fed. Cl. 98 (2022), aff'd, 2024

WL 2012526 (Fed. Cir. May 7, 2024) (“[b]ecause homology is common in nature (given the total

limited number of amino acids that constitute proteins), it is important to focus on homology

specific to the “disease-related” situs for the cross-reactive attack”). Here, however, Dr. Gish has

not made this showing—which, as Dr. MacGinnitie noted, is by itself not necessarily sufficient

evidence to conclude an autoimmune process linked to vaccination has been established. And case

reports (only a few of which, like Saliba, even involved a relevant vaccine) are known to be weak

evidence of causation. Campbell v. Sec'y of Health & Hum. Servs., 97 Fed. Cl. 650, 668 (2011)

(“‘[c]ase reports do not purport to establish causation definitively, and this deficiency does indeed

reduce their evidentiary value,’ even if they should receive some weight”).

Second, the record does not support the conclusion that Petitioner’s vaccinations caused

her AIH. Nothing in the medical record (beyond the symptoms Petitioner began to experience

post-vaccination) tends to support the conclusion that the vaccines caused her AIH—and to

determine otherwise would be to elevate the temporal relationship between vaccination and injury

into evidence of causation. Grant v. Sec'y of Health & Hum. Servs., 956 F.2d 1144, 1148 (Fed.

Cir. 1992) (“[a] proximate temporal association alone does not suffice to show a causal link

18

between the vaccination and the injury”). 7 More important are the circumstances in which

Petitioner received these vaccines. While Dr. Gish did observe the absence of many risk factors

for AIH relevant to Petitioner, he did not persuasively limit or exclude all of them. Petitioner’s

recent post-vaccination foreign travel, plus her acknowledged receipt of anti-malarial medications

and supplements, her IUD, and her Epstein-Barr infection were all reasonably-likely causal

factors. 8 In this context, there are too many other possible explanations to find the vaccines were

a substantial factor as well (especially given the thin showing overall on the “can cause” prong)—

and collectively they further undermine Petitioner’s showing.

I so conclude even though I do not purport to identify what was the most likely cause of

Petitioner’s AIH, based on the record before me. But even though claimants are never obligated to

rule out alternative causes as part of their initial burden, special masters may of course consider

evidence in the record undermining vaccine causation when evaluating whether the second Althen

prong has been established. Stone v. Sec'y of Health & Hum. Servs., 676 F.3d 1373, 1380 (Fed.

Cir. 2012) (“[t]he special master is entitled to consider the record as a whole...and no evidence

should be embargoed from the special master's consideration simply because it is also relevant to

another inquiry under the statute.”). I can thus legitimately determine vaccination was not likely

causal of Petitioner’s AIH, even if I cannot conclude what was most likely causal.

CONCLUSION

A Program entitlement award is only appropriate for claims supported by preponderant

evidence. Here, Petitioner has not made such a showing. Petitioner is therefore not entitled to

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. 9

7

For this same reason, I do not give weight to the pre-vaccination absence of evidence of liver disease or hepatitis as

proof of the vaccine’s role in causing what manifested after. The fact a claimant was not sick before the vaccination,

but sick after, is simply another form of post hoc ergo propter hoc reasoning that the Program rejects.

8

At most, Dr. Gish distinguished the malarial medication as likely causal, with his arguments about the more abrupt

form of AIH that seemed to be evident in Beretta-Piccoli. But his contentions about her mere cessation of these

medications as undermining a causal role were unpersuasive—especially since Petitioner herein maintains a one-time

receipt of two vaccines resulted in a chronic/persistent disease process.

9

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.

19

IT IS SO ORDERED.

s/ Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

20