Perekotiy v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 16-997V

(Not to be published)

*****************************

*

ANNA PEREKOTIY, on behalf of her minor * Chief Special Master Corcoran

child, S.K., *

* Filed: April 20, 2020

Petitioner, *

*

v. * Ruling on Entitlement; Atopic

* Dermatitis; Allergic Reaction;

SECRETARY OF HEALTH AND * Inactivated Polio Vaccine;

HUMAN SERVICES, * Hepatitis B Vaccine; Diphtheria,

* Tetanus, acellular Pertussis;

* Significant Aggravation; Loving test.

Respondent. *

*

*****************************

Andrew D. Downing, Van Cott & Talamante, Phoenix, AZ, for Petitioner.

Julia Collison, U.S. Dep’t of Justice, Washington, D.C., for Respondent.

DECISION ON ENTITLEMENT 1

On August 12, 2016, Anna Perekotiy filed a petition seeking compensation under the

National Vaccine Injury Compensation Program (“Vaccine Program”) 2 on behalf of her minor

child, S.K., alleging that S.K. experienced a severe adverse reaction (including some

developmental sequelae) to several vaccines that she received on September 18, 2013. Petition,

1

Although this Decision has been formally designated “not to be published,” it will nevertheless be posted on the

Court of Federal Claims’s website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012)). This

means that the Ruling will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-

12(d)(4)(B), however, the parties may object to the Decision’s inclusion of certain kinds of confidential information.

Specifically, under Vaccine Rule 18(b), each party has fourteen 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.

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) [hereinafter “Vaccine Act” or “the

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

filed Aug. 12, 2016 (ECF No. 1). She later amended her petition to allege solely that S.K.

developed a dermatological reaction—first after receiving the Hepatitis B vaccine on August 21,

2013, and then again after the Diphtheria, Tetanus, acellular Pertussis (“DTaP”) and inactivated

polio (“IPV”) vaccines administered on September 18, 2013. Amended Petition, filed March 6,

2017 (ECF No. 14) (“First Amended Pet.”).

Having completed my review of the evidentiary record and the parties’ filings, I hereby

deny Petitioner’s request for compensation. As discussed in more detail below, Petitioner has not

preponderantly established that the Hepatitis B vaccine caused the initial onset of S.K.’s atopic

dermatitis, or that the DTaP and IPV vaccines 3 S.K. received a month later significantly aggravated

her then-existing dermatologic condition. 4

I. Factual Background

A. S.K.’s Early History

S.K. was born on July 16, 2013, via spontaneous vaginal delivery. Ex. 14 at 9, 77. She

received the first dose of the Hepatitis B vaccine the same day with no reported adverse reaction.

Ex. 7 at 29, 31. On July 22, 2013, Petitioner brought S.K. to Dr. Jennifer Cropp, M.D., for her

newborn visit. Id. at 3. No abnormalities were noted during the visit. Id. Petitioner brought S.K.

back to Dr. Cropp at the end of July 2013 for a weight check. Ex. 7 at 7. During the visit, Petitioner

reported that S.K. was exhibiting drainage from her right eye throughout the day and redness under

her left armpit. Id. at 8–9. Dr. Cropp attributed the redness under S.K.’s armpit to moisture, and

she instructed Petitioner to keep the area clean and as dry as possible. Id. at 10. S.K.’s eye drainage

was diagnosed as Dacryostenosis 5, for which Dr. Cropp recommended warm compresses with eye

massages daily. Id. at 10.

B. Vaccinations at Issue and Development of Dermatologic Symptoms

S.K. received her second dose of the Hepatitis B vaccine on August 21, 2013, during her

one-month well-baby visit with Dr. Matthew Barcellona, M.D., of North Scottsdale Pediatric

Associates. Ex. 7 at 11–14. No abnormalities or dermatologic concerns were noted, and no adverse

reactions to the vaccine are documented in the immediate contemporaneous medical record. Id.

3

At the September 18, 2013 pediatric visit, S.K. also received the Haemophilus Influenza Type B (“Hib”) and

Pneumococcal vaccines. Ex. 7 at 23–24. Petitioner, however, does not allege that either of these vaccines caused or

significantly aggravated S.K.’s atopic dermatitis. First Amended Pet. at 1.

4

Atopic dermatitis is a common form of skin inflammation, often associated with allergic conditions, which leads to

itching and signs of eczema. Dorland’s Illustrated Medical Dictionary 466 (33d ed. 2020) (hereinafter Dorland’s).

5

Dacryostenosis is the narrowing of a tear duct. Dorland’s at 464, 983.

2

The following month, on September 16, 2013, S.K. returned to North Scottsdale Pediatric

Associates and was seen by Colin Petranu, M.D., for redness and rash that Petitioner reported had

developed three weeks prior (or approximately six days after receiving the second Hepatitis B

vaccination) with no subsequent improvement. Ex. 7 at 15. Following a physical examination, Dr.

Petranu noted that S.K. exhibited flaky skin on her head, and was positive for “erythematous, raw,

macerated neck folds without drainage or crusting.” Id. at 16. She was diagnosed with intertrigo 6

and seborrhea 7, for which she was prescribed a moisturizing cream, nystatin powder, continued

use of baby oil, and Ketaconazole cream. Id. at 17. Dr. Petranu indicated that if S.K.’s condition

did not improve, he would next consider using a steroid cream. Id.

Two days later, on September 18, 2013, Petitioner returned to North Scottsdale Pediatric

Associates for S.K.’s two-month well-baby visit with Dr. Barcellona. Ex. 7 at 19. During a physical

examination of S.K.’s skin, Dr. Barcellona noted “rough patches on body, scalp flakiness, red

macules in neck folds.” Id. at 21. Again, S.K. was diagnosed with intertrigo, but her seborrhea

diagnosis was changed to atopic eczema dermatitis. 8 Id. at 22. S.K. was prescribed hydrocortisone

and moisturizer. Id. At the conclusion of the visit, S.K. received four vaccines: DTaP, Hib, IPV,

and pneumococcal. Id. at 23–24. Petitioner refused the rotavirus vaccine and signed a waiver to

that effect. Id. at 22. No adverse reactions to these vaccines were documented during the visit.

At S.K.’s four-month well-baby visit with Dr. Barcellona on November 20, 2013,

Petitioner reported that S.K. had experienced a “[a] bad reaction to shots causing leg redness. [L]eg

is still red and rough, but parents feel it is much better.” Ex. 7 at 25. At the time, Petitioner also

indicated that she was not using the prescribed steroids to treat S.K.’s dermatologic condition

“because it is a steroid and steroids are ‘bad.’” Id. S.K.’s physical exam revealed rough patches of

red and scaly skin on her torso, scalp and legs. Id. at 27. Dr. Barcellona indicated that S.K.’s legs

“have terribly controlled eczema,” and it was unclear to him whether the “shot reaction was local

and eczema was bigger issue, or if shot caused more reaction,” but Petitioner nonetheless refused

further vaccination. Id.

On December 9, 2013, S.K. was seen by Reena Jain, PA-C, for evaluation of a persistent

rash following her vaccination on September 18, 2013. Ex. 10 at 1. A physical examination

revealed dry erythematous patches on S.K.’s scalp, face, abdomen, and both lower extremities Id.

6

Intertrigo is a superficial dermatitis caused by moisture, friction, warmth, and sweat retention that is characterized

by erythema, maceration, burning, itching, and sometimes erosions, fissures, exudations, and secondary infections.

Dorland’s at 939.

7

Seborrhea is characterized by a dry, scaly dermatitis in areas of the body with sebum-producing glands, including

the scalp, chest, back, axilla, and groin. Dorland’s at 1657.

8

An atopic eczema dermatitis is an allergic pruritic dermatitis that is characterized by erythema, edema, inflammatory

infiltrates in the dermis, crusting, and scaling. Dorland’s at 171, 586.

3

at 2. She was diagnosed with eczema and was prescribed Desonide lotion mixed with moisturizing

cream. Id. at 2. Petitioner was also advised to give infant Benadryl as directed on the box to help

with itching. Id.

Just over one month later, on January 15, 2014, Petitioner brought S.K. to Dr. Arturo

Gonzales, M.D. at Scottsdale Children’s Group for her six-month well-baby visit. Ex. 3 at 29–34.

During the visit, Petitioner relayed a past medical history for S.K. that included a rash on both legs

that had “lasted for quite some time” following administration of routine immunizations. Id. at 29.

Petitioner also informed Dr. Gonzales of S.K.’s atopic dermatitis diagnosis, and explained that she

was not applying the prescribed hydrocortisone cream because “it is a steroid.” Id. Dr. Gonzales

also noted that Petitioner was hesitant to give further immunizations until the cause of S.K.’s rash

was established. Id. During his physical examination of S.K., Dr. Gonzales noted an eczematous

rash on both legs. Id. at 33. At the conclusion of the visit, Dr. Gonzales requested a formal

evaluation with an allergist and pediatric dermatologist to reassure Petitioner of the diagnosis and

encouraged Petitioner to continue having S.K. vaccinated. Id. at 34. He also noted that “atopic

dermatitis is not a contraindication for vaccinations.” Id. Petitioner was to continue regularly

bathing, moisturizing, and using steroid creams to treat S.K.’s symptoms. Id.

C. Subsequent Allergy Testing and Treatment

S.K. had her first appointment with Ronald Jorgensen, M.D., of the Arizona Asthma &

Allergy Institute on January 22, 2014. Ex. 4 at 4. Regarding S.K.’s medical history, Dr. Jorgensen

noted that “[a]fter vaccination, she had redness down the right leg that lasted for a few days…She

had received several vaccinations on the same day including DTaP, IPV, Hib, pneumococcal, and

rotavirus vaccines.” 9 Id. at 13. Upon physical examination, Dr. Jorgensen noted a large dry patch

of skin on S.K.’s right leg and some dry skin on her arms and legs. Id. at 14. Based on these

findings, he instructed Petitioner to apply moisturizing products and corticosteroid cream, use

laundry detergent for sensitive skin, and to give S.K. Zyrtec syrup. Id. at 4. He also recommended

special testing to vaccines prior to their administration. Id. He suggested starting with the DTaP

vaccine using a skin prick and intradermal test, and if those were tolerated, he suggested following

up with one-tenth the dose, followed by the remainder of the dose. Id. at 14. Dr. Jorgensen also

speculated that S.K. was likely allergic to eggs, so he told Petitioner to avoid introducing S.K. to

egg products and egg-based vaccines for the time being. Id. He prescribed an epi-pen Jr. as a

precaution Id. at 5.

On January 29, 2014, S.K. returned to Dr. Jorgensen and was evaluated for a possible DTaP

vaccine allergy. Ex. 4 at 23. Her history of present illness notes that “[h]er eczema is currently

9

The vaccination record in this case clearly establishes that S.K. did not receive the rotavirus vaccine. Ex. 14 at 22.

On September 18, 2013, Dr. Barcellona specifically notes that Petitioner refused the rotavirus vaccination and signed

a waiver to that effect. Id.

4

flared” and her symptoms were not controlled with the medication she had previously been

prescribed. Id. A physical exam revealed skin lesions and eczema patches on both legs, and

dermatitis on her torso, arms, and face. Id. at 24. Dr. Jorgensen then conducted a skin prick test 10

with the DTaP vaccine, which raised a wheal 3mm by 4mm in size with 15mm by 10mm erythema

flare. Id. at 20, 25. The result was interpreted by Dr. Jorgensen as a positive allergic reaction. Id.

at 25. Petitioner was therefore advised to avoid Diphtheria Tetanus-containing vaccines in the

future. Id.

On February 19, 2014, S.K. returned to Dr. Jorgensen to be evaluated for possible allergy

to IPV. Ex. 4 at 27. A physical exam performed by Dr. Jorgensen was positive for skin lesions and

dermatitis on both her lower extremities and face. Id. at 28. Unlike the DTaP test, the skin prick

test with IPV showed no reaction. Id. at 29. When S.K. was injected with one-tenth of the dose of

IPV, however, she experienced a reaction with a wheal size of 3mm by 3mm in size and an

erythema flare 15mm x 9mm in size. Id. The challenge to polio was discontinued. Id. Based upon

S.K.’s reaction to both the DTaP and IPV vaccines, Dr. Jorgensen concluded that she was likely

allergic to both, and he advised against S.K. receiving childhood vaccinations for at least another

six months, at which point he recommended individually testing each vaccine for an allergic

reaction. Id.

On April 24, 2014, S.K. returned to Dr. Gonzales for her nine-month well-child visit. Ex.

3 at 20. The medical record from this visit reported that S.K.’s past medical conditions included

atopic dermatitis and severe allergy to eggs, oats, and vaccines. Id. Both the review of systems and

physical examination findings, however, were negative for pruritus, rash, and skin lesions. Id. at

21–24. Identical findings were documented during S.K.’s twelve-month well-child visit on July

29, 2014. Id. at 15–17. S.K. continued to be seen by a number of physicians throughout 2014 and

2015, and while some documented her history of rash post-vaccination during their review of

systems or when documenting S.K.’s past medical history, no physician documented the presence

of a rash or lesions during physical examination after February 19, 2014. See Ex. 6 at 2, 8. The

subsequent medical records filed in this matter do not discuss the presence of a rash, but rather

focus on S.K.’s orthopedic and cognitive impairments. See Ex. 8 (discussing neurological

evaluations for developmental delays); Ex. 9 (discussing a consultation for S.K.’s gait

abnormality).

10

During a skin prick test, a drop of the suspected allergen is placed on the patient’s skin. A needle is then used to

puncture the skin through the droplet of allergen and the fluid is allowed to flow under the skin via the puncture site.

After one minute, the excess fluid is wiped away and the skin is observed for fifteen minutes to see if a reaction

develops. Introduction to the allergen may result in a raised bump, called a wheal, and a red inflamed area, called a

flare. A reaction is positive if the wheal is three millimeters in diameter or larger and the flare diameter is ten

millimeters or greater. Mosby’s Manual of Diagnostic and Laboratory Tests 1024–27 (6th ed. 2018).

5

II. Expert Reports

A. Dr. David Axelrod

David Axelrod, M.D., provided one 11 expert report on behalf of Petitioner. Report, filed as

Ex. 37 on July 11, 2017 (ECF No. 20-1) (“Axelrod Rep.”). In it, Dr. Axelrod opined that S.K.’s

exposure to the Hepatitis B vaccine on August 21, 2013, initiated a TH2 immune response 12 that

caused S.K.’s atopic dermatitis. Id. at 5. He also proposes that the vaccinations S.K. received on

September 18, 2013, further encouraged the TH2 immune response, thereby exacerbating S.K.’s

atopic dermatitis. Id.

Dr. Axelrod is a clinical immunologist and is currently employed by a consulting firm in

York, Pennsylvania. Dr. Axelrod Curriculum Vitae, filed as Ex. 16 on May 8, 2017 (ECF No. 16-

2) (“Axelrod CV”) at 2. He received his bachelor’s degree from the University of Michigan where

he also attended medical school and received both a medical and Masters degree. Id. at 1. Dr.

Axelrod then completed his internship and his residency training at the University of Toronto and

the William Beaumont Hospital-Royal Oak. Id. He then completed a fellowship at McGill

University-Royal Victoria Hospital. Id. He subsequently served as a medical staff fellow at the

National Institute of Health Laboratory of Clinical Immunology. Id. Dr. Axelrod is board certified

in Internal Medicine, Rheumatology, and Allergy and Immunology, and he has authored numerous

publications on those subjects. Id. at 3–5; Axelrod Rep. at 1. He is not board certified in

dermatology.

In his report, Dr. Axelrod explained how atopic dermatitis may result from a TH2 T cell-

driven allergic reaction to certain products such as egg, latex, gelatin, and yeast—common

components of vaccines. Axelrod Rep. at 2. The IgE antibody that is produced by the TH2 reaction

is implicated in immediate allergic reactions such as anaphylaxis, urticaria, angioedema, and

gastrointestinal disorders. See E.H. Chung, Vaccine Allergies, 3 Clinical and Experimental

Vaccine Research 50, 51 (2014), filed as Ex. 23 on May 9, 2017 (ECF No. 17-7) (“Chung”); R.

Wood, Allergic Reactions to Vaccines, 24 Pediatric Allergy and Immunology 521, 521 (2013),

filed as Ex. 26 on May 9, 2017 (ECF No. 17-10) (“Wood”). Immediate IgE-mediated reactions

typically occur within minutes of exposure to an allergen, and almost always present within four

hours of exposure. Chung at 51. While rare, immediate reactions have been reported at an average

11

Petitioner filed an initial report by Dr. Axelrod on March 8, 2017 (see ECF No. 16), but later submitted an amended

version of the report, which is the one discussed herein.

12

TH2 is a subset of helper T cells that produces interleukin-4 (“IL-4”) and interleukin-13 (“IL-13”), which in turn is

responsible for stimulating IgE and IgG antibody production and the inhibition of macrophage functions. E. Maggi,

The TH1/TH2 Paradigm in Allergy, 3 Immunotechnology 233, 234–35 (1998), filed as Ex. 22 on May 9, 2017 (ECF

No. 17-6) (“Maggi”). Individuals suffering from atopic dermatitis exhibit high proportions of TH2-like helper T cells

after contact challenge. Maggi at 236.

6

rate of 0.22 per 100,000 doses of vaccinations among children and adolescence, with thirty-one

percent of those cases reporting an immediate reaction after receipt of the first dose. Id. In the

absence of prior exposure to the vaccine, an immediate reaction is suggestive of either pre-

sensitization to a component of the vaccine or a non-immunologically mediated response to the

dose. Id.

Unlike immediate reactions, delayed reactions are generally not IgE-mediated, begin about

forty-eight hours after exposure, and peak in severity between seventy-two and ninety-six hours

after exposure. Chung at 51. Such delayed reactions are typically characterized by rashes,

including urticaria and erythema multiforme. Id. at 51–52; Wood at 521–22. While delayed

reactions may be immunologically or non-immunologically mediated, evidence suggests that they

are less likely to be the result of an immunological mechanism and should therefore not be

diagnosed as a vaccine allergy. See L. Echeverría-Zudaire et al., Consensus Document on the

Approach to Children with Allergic Reactions After Vaccination or Allergy to Vaccine

Components, 43 Allergologia et immunopathologia 304, 311 (2015), filed as Ex. 25 on May 9,

2017 (ECF No. 17-9) (“Zudaire”).

While the general proposition that vaccines can cause an allergic reaction in the recipient

is supported by the literature supplied in this case in connection with Dr. Axelrod’s report, those

same articles emphasize the importance of distinguishing between true allergic reactions to

specific components of a vaccine versus a reaction that is merely temporally related or mediated

by a non-immunological mechanism. See Zudaire at 308, 311–312 (noting that delayed reactions

should not be diagnosed as vaccine allergies and providing examples of reactions that can simulate

allergic reactions). One possible reaction that may be mischaracterized as a vaccine allergy is the

appearance of a rash, which may actually correspond to the exacerbation of a preexisting condition

such as atopic dermatitis. Id. at 312. Notably, however, neither Zudaire or Dr. Axelrod explain

how the first exposure to a particular vaccine can exacerbate preexisting atopic dermatitis.

B. Dr. Schield Wikas

Schield Wikas, D.O., provided one expert report on behalf of Petitioner. Report, filed as

Ex. 38 on Dec. 19, 2017 (ECF No. 26-1) (“Wikas Rep.”). In his report, Dr. Wikas opines that

S.K.’s exposure to latex and yeast components in the Hepatitis B vaccines she received elicited a

primary adaptive immune response to those components. Id. at 6. Her subsequent exposure to the

DTaP and IPV vaccines then incited “an adaptive, secondary, memory immune response” to the

latex and yeast components of those vaccines, resulting in exacerbation of atopic dermatitis. Id.

Dr. Wikas is a board-certified dermatologist with specialties in medical dermatology,

dermatologic surgery, sclerotherapy, and hair transplantation and restoration. Dr. Wikas

Curriculum Vitae, filed as Ex. 39 on Dec. 19, 2017 (ECF No. 26-2). He does not hold any

7

certifications in immunology. Dr. Wikas received his bachelors and Masters degrees from the

University of Cincinnati College of Pharmacy before obtaining his Doctor of Osteopathic

Medicine degree from the Kansas City University of Medicine and Biosciences. Id. Dr. Wikas then

completed his internship at Cuyahoga Falls General Hospital and his Residency in dermatology at

Cleveland Clinic Foundation. Id. Since 1984, Dr. Wikas has worked for Tri-County Dermatology

where he serves as the director of the dermatology residency program. Id. at 7. Additionally, he

has published several articles on topics within the field of dermatology and serves as a clinical

instructor for medical students and residents. Id.

As Dr. Wikas noted in his report, atopic dermatitis is a common skin disease that typically

affects children under the age of five. Wikas Rep. at 4. In its early acute stage, TH2 cells are present

in abundance, and they promote the production of cytokines like IL-4 and IL-13, which in turn

result in the production of IgE antibody. Id. In the subsequent chronic stage of the disease process,

both TH1 (which is responsible for initiating phagocytosis through the production of interleukin-

2, interferon gamma, and tumor necrosis factor) and TH2 cells are present. Id. (citing Maggi at

234). During this phase, production of the cytokine interleukin-5 (“IL-5”) leads to an increase in

eosinophils—white blood cells that are involved in the pathogenesis of allergic reactions and

inflammation. Id. (citing Maggi at 234).

The resulting inflammation causes dry skin prone to cracking and which subsequently

cannot serve as an effective barrier against pathogens and other irritants. Wikas Rep. at 4; see S.

Weidinger et al., Atopic Dermatitis, 387 Lancet 1109, 1115–16 (2016), filed as Ex. C, Tab 8 on

Feb. 25, 2019 (ECF No. 41-10) (“Weidinger”). Infiltration of the compromised barrier allows

further stimulation of the TH2/TH1 cycle, encouraging a chronic, relapsing pattern. Wikas Rep. at

4; see also L. Schneider et al., Atopic Dermatitis: A Practice Parameter Update 2012, 131 J.

Allergy Clinical Immunology 295, 296 (2012), filed as Ex. C, Tab 3 on Feb. 25, 2019 (ECF No.

41-5) (“Schneider”). This reaction, according to Dr. Wikas, can not only be initiated by exposure

to components of vaccines, but the same exposure can exacerbate an existing case. Wikas Rep. at

4–5 (citing Zudaire at 312; N. Saulnier et al., Gene Expression Profiling of Patients with Latex

and/or Vegetable Food Allergy, 16 Eur. Rev. for Med. and Pharmacological Sci. 1197, 1207

(2012), filed as Ex. 27 on May 9, 2017 (ECF No. 18-1) (“Saulnier”)). 13

Relying on Dr. Axelrod’s report and the accompanying literature, Dr. Wikas attributed

S.K.’s atopic dermatitis exacerbation to an allergic reaction to the latex and yeast components of

the vaccines she received in September 2013. Wikas Rep. at 6. He did not address the absence of

record evidence that S.K. had ever previously experienced latex and yeast allergies, however. He

otherwise noted the temporal relationship between S.K.’s atopic dermatitis flare and the receipt of

13

Despite Dr. Wikas being board certified in dermatology, most of Dr. Wikas’ report mimics that of Dr. Axelrod—

an immunologist—and it is also evident that Dr. Wikas relied heavily if not exclusively on the literature previously

submitted by Dr. Axelrod. See generally Axelrod Rep.; Wikas Rep.

8

her September 18, 2013 14 vaccinations, which he considered direct evidence of a causal

association. Id.

C. Dr. Francis Lobo

Francis Lobo, M.D., a clinical immunologist, provided one expert report on behalf of

Respondent in this matter. Dr. Lobo Report, filed as Ex. A on Sept. 7, 2017 (ECF No. 22-1) (“Lobo

Rep.”). Dr. Lobo opined that S.K. did not experience an allergic reaction leading to the

development and subsequent exacerbation of atopic dermatitis, but rather a mild, transient infantile

atopic dermatitis most likely unrelated to vaccine administration. Id. at 8.

Dr. Lobo is currently employed as a clinician at Yale University School of Medicine

Department of Internal Medicine in the Allergy and Clinical Immunology section. Dr. Lobo

Curriculum Vitae, filed as Ex. B on Sept. 7, 2017 (ECF No. 22-6) (“Lobo CV”). He received his

bachelor’s degree in biology from the University of Pennsylvania before receiving a Masters

degree in the history of medicine from the University of Cambridge. Id. at 1. He then obtained his

medical degree from Yale University School of Medicine. Id. Dr. Lobo then completed his

residency in internal medicine as well as a post-doctoral fellowship in allergy and immunology at

Yale-New Haven Hospital. Id. He is board certified in allergy and immunology. Id. at 2.

Dr. Lobo’s clinical duties include seeing approximately seventy-five patients a week,

including both pediatric and adult patients. Lobo Rep. at 2. He also serves as a faculty member

and instructor at Yale University, where he teaches basic and clinical immunology to medical

students, residents, and fellows. Id. Additionally, Dr. Lobo has written and published several

articles on topics within the field of allergy and immunology. Lobo CV at 3–4.

In his report, Dr. Lobo first noted that the temporal relationship between S.K.’s August

2013 vaccination and development of atopic dermatitis thereafter was too attenuated to establish a

causal connection. Lobo Rep.at 4–5. He emphasized that acute allergic reactions such as urticaria,

swelling, wheezing, hypotension, and anaphylaxis are generally short-lived, presenting and

resolving within twenty-four hours of exposure. Id. Therefore, onset of atopic dermatitis six or

seven days after vaccination was inconsistent with an allergic reaction. Id.

Dr. Lobo also challenged Petitioner’s contention that S.K. likely had an allergy to latex,

yeast, DTaP, or IPV. He first emphasized the fact that S.K. could not exhibit an allergic reaction

to microbial components of the vaccines she had never encountered before September 18, 2013.

Lobo Rep. at 5. Without prior exposure, it would be impossible for her to have developed the

14

Dr. Wikas incorrectly noted that S.K. received the DTaP, Hib, IPV, and pneumococcal vaccines on September 16,

2013, and his opinion reflects this mistake when he opines on the timing of secondary adaptive immune responses.

Wikas Rep. at 6. Like Dr. Axelrod, Dr. Wikas also mistakenly reports that S.K. received the Rotavirus vaccine. Id.

9

antibodies required to mount an adaptive immune response and mediate an allergic reaction. Id.

Additionally, Dr. Lobo opined that the skin testing S.K. subsequently underwent had not been

interpreted in a manner consistent with diagnostic protocol. Id. at 6. In his understanding, a positive

response to a skin prick test requires a wheal three millimeters greater than the control. Id. S.K.’s

treating allergist, however, interpreted the results of her DTaP skin prick test as positive, despite

exhibiting a wheal size only two millimeters larger than the saline control. 15 Though Dr. Lobo

conceded that S.K. did through testing demonstrate an erythematous reaction to IPV, that reaction

occurred only after S.K. was injected intramuscularly, and was limited to a localized erythema

rather than the systemic reaction he would expect to see when a true allergen is rapidly

disseminated throughout the body. Id. This distinction, according to Dr. Lobo, implied that the

erythema S.K. exhibited following the IPV injection by Dr. Jorgensen was not evidence of an

allergic reaction, but rather a “miniscule effect of the trauma of the injection.” Id.

Even if S.K. did have a true allergy to latex—a non-microbial component of certain

vaccines—Dr. Lobo emphasized that it is unlikely S.K. received a vaccine containing latex on

September 18, 2013. Lobo Rep. at 5 (“[l]atex is not present in [the pneumococcal vaccine] or IPV,

is present in only one of three available DTaP preparations, and is present in one of the two Hib

vaccines from Sanofi Pasteur.”); see also Centers for Disease Control, Latex in Vaccine

Packaging, filed as Ex. A, Tab 1 (ECF No. 22-2).

D. Dr. Jonathan Spergel

Jonathan Spergel, M.D., PhD, a board-certified allergist and immunologist, provided one

expert report on behalf of Respondent. Spergel Report, filed as Ex. C on Feb. 25, 2019 (ECF No.

41-1) (“Spergel Rep.”). In it, Dr. Spergel opined that there was no evidence of a causal relationship

between vaccines and the initiation or exacerbation of atopic dermatitis. Id. at 4. Additionally, he

proposed that the reactions S.K. experienced are better classified as irritant reactions rather than

allergic reactions. Id. at 3.

Dr. Spergel is currently employed as a physician and chief of the allergy and immunology

division at the Children’s Hospital of Philadelphia. Spergel Curriculum Vitae, filed as Ex. D on

Feb. 25, 2019 (ECF No. 41-2) (“Spergel CV”). He received his bachelor’s degree in chemistry

from Princeton University, and then he obtained his medical degree and PhD from the Mt. Sinai

School of Medicine. Id. at 1. Dr. Spergel thereafter completed an internship and residency in

pediatrics at Yale-New Haven Hospital, followed by a fellowship in allergy and immunology at

Children’s Hospital in Boston, Massachusetts. Id. Besides his clinical duties, Dr. Spergel serves

as an instructor in pediatric allergy and immunology at the Perelman School of Medicine at the

University of Pennsylvania, where he is also a faculty member of the Skin Disease Research Core

15

Dr. Lobo noted also that S.K.’s saline control exhibited erythema, which is indicative of dermatographism—a type

of urticaria that results from firm stroking or scratching the skin. Lobo Rep. at 6; see also Dorland’s at 490, 492.

10

Center. Id. Though he is not board certified in dermatology, Dr. Spergel has significant experience

studying atopic dermatitis and other immunologically-mediated dermatological disorders, and he

has served on several committees dedicated to atopic dermatitis and eczema. Id. at 3–4. Dr. Spergel

has also published numerous articles and presented on the topics of allergy, immunology, and

atopic dermatitis. Id. at 5–32.

Dr. Spergel’s report began by examining some of the common causes of atopic dermatitis

that might better explain S.K.’s development of the disease and/or its subsequent exacerbation.

Atopic dermatitis is the most common pediatric skin disorder, affecting approximately ten to

twenty percent of all children. Spergel Rep. at 2; C. Flohr et al., Atopic Dermatitis and the Hygiene

Hypothesis Revisited, 41 Current Problems in Dermatology 1, 1 (2011), filed as Ex. C, Tab 9 on

Feb. 25, 2019 (ECF No. 41-11) (“Flohr”). Dr. Spergel agreed with Petitioner’s experts that the

mechanism through which atopic dermatitis is initiated and perpetuated involves a TH2 T cell-

driven inflammation during the acute phase, and a subsequent TH2/TH1 T cell-mediated chronic

phase. Spergel Rep. at 2–3.

Common triggers for atopic dermatitis include “viral infections, bacterial infections,

aeroallergens (including animal dander), food allergies and poor skin care.” Spergel Rep. at 3

(citing P. Arkwright et al., Management of Difficult-to-Treat Atopic Dermatitis, 1 J. Allergy

Clinical Immunology: In Practice 142, 143–44 (2013), filed as Ex. C, Tab 1 on Feb. 25, 2019 (ECF

No. 41-3)). Dr. Spergel did not, however, accept vaccines as a potentially causal or aggravating

agent of atopic dermatitis, citing literature that he maintained cast doubt on that proposal. Spergel

Rep. at 4 (citing Chung at 51); see also Flohr at 21–26, 28; C. Grüber, Early Atopic Disease and

Early Childhood Immunization – Is There a Link?, 63 Allergy 1464, 1464 (2008), filed as Ex. C,

Tab 10 on Feb. 25, 2019 (ECF No. 41-12) (“Grüber”).

Dr. Spergel emphasized two important points about the development of any allergy. First,

he noted that TH2 responses are antigen-specific—they require a prior exposure to the allergen and

sensitization to it thereafter. Second, he stressed that IgE antibodies normally increase during the

first few years of life, thereby making pediatric allergies inevitably more common during this stage

of development regardless of antigen exposure. Spergel Rep. at 5–6; see also R. Nickel et al.,

Variability of Total Serum Immunoglobulin E levels from birth to the Age of 10 Years. A

Prospective Evaluation in a Large Birth Cohort (German Multicenter Allergy Study), 35 Clinical

and Experimental Allergy 619, 619 (2005), filed as Ex. C, Tab 12 on Feb. 25, 2019 (ECF No. 41-

14) (“Nickel”).

Regarding antigen specificity, Dr. Spergel explained that it is only after an individual is

initially exposed to the allergen and then undergoes the sensitization process will they experience

a TH2-mediated allergic response upon subsequent exposures to that allergen. Spergel Rep. at 5–

6. He opined that such allergen sensitization is not associated with general sensitization, and thus

11

an individual would not automatically develop additional allergies to other substances. Id. at 6.

Rather, the development of additional allergies may instead be attributable to the naturally-

increasing levels of IgE occurring during early childhood development. Id. (citing Nickel at 619).

This contention was undercut, however, by another piece of literature offered on behalf of

Respondent, in which the authors observed that “[i]ncreases in [total] IgE levels were temporally

related to the onset of respiratory allergies and of specific sensitization.” P. Matricardi et al.,

Longitudinal Trends of Total and Allergen-Specific IgE Throughout Childhood, 64 Allergy 1093,

1097 (2009), filed as Ex. C, Tab 13 on Feb. 25, 2019 (ECF No. 41-15) (“Matricardi”) (emphasis

added). Matricardi concluded that both specific IgE and total IgE levels increased whenever a child

experienced an allergen-specific response. Id. at 1097.

Despite the findings of Matricardi, Dr. Spergel’s report and other pieces of accompanying

literature emphasized the importance of identifying specific allergens that may lead to an adverse

reaction such as atopic dermatitis. Spergel Rep. at 3–5; S. Dreskin et al., International Concensus

(ICON):Allergic Reactions to Vaccines, 9:32 World Allergy J. 1, 9–16 (2016), filed as Ex. C, Tab

5 on Feb. 25, 2019 (ECF No. 41-7) (“Dreskin”). Consistent with the opinions of Drs. Axelrod and

Wikas, Dreskin notes that people rarely experience allergic reactions to vaccine antigens, but there

is some evidence suggesting that certain vaccine components (i.e., gelatin, egg, yeast, and latex)

may cause allergic reactions in a small proportion of the population. Dreskin at 9. Even people

with allergies to these components are typically able to receive vaccinations as usual because the

components are present in such small amounts that they are unable to produce adverse reactions.

Id. In individuals with unusually high levels of IgE antibody, however, these components may

induce severe reactions. Id. Therefore, practitioners employ skin testing against both the vaccine

itself, as well as those specific components most likely to induce an allergic reaction. Id. at 12.

Dreskin cautions that these tests, however, must be interpreted carefully because false positives

may result due to irrelevant IgE responses or irritant effects of the vaccine. Id.

While he agreed with S.K.’s egg allergy diagnosis, Dr. Spergel contended that the positive

skin prick test results for IPV and DTaP were likely false positives. Spergel Rep. at 3. He noted

that individuals with atopic dermatitis experience very high rates of false positives during skin

prick tests, and there is evidence that individuals with atopic dermatitis experience higher rates of

sensitizations (including food allergies) and other immune-mediated inflammatory diseases. Id.

(citing D. Fleischer et al., Oral Food Challenges in Children with a Diagnosis of Food Allergy,

158 J. Pediatrics 578, 581 (2011), filed as Ex. C, Tab 2 on Feb. 25, 2019 (ECF No. 41-4)

(“Fleischer”)); see also Weidinger at 1109–11; Dreskin at 12.

Given this predisposition, along with S.K.’s erythematous reaction to the saline control,

Dr. Spergel reasoned that S.K.’s skin prick test result could not be reliably interpreted as a truly

positive allergic reaction, and it was more likely than not evidence of an irritant reaction. Spergel

Rep. at 3. Dr. Spergel found further support for this conclusion from the fact that S.K. experienced

12

mainly an erythematous reaction, rather than anaphylaxis—the type of IgE-mediated reaction one

would expect to see when an allergic individual is exposed to the target allergen. Id. At the same

time, however, literature establishes that other forms of allergic reaction less severe than

anaphylaxis (e.g., erythema, pruritus, urticaria, and angioedema) are also mediated by IgE

production. Dreskin at 2; Zudaire at 310.

The record in this case shows that S.K. did receive skin prick testing against IPV and

DTaP—though Dr. Spergel questioned the reliability of the test given S.K.’s erythematous reaction

to the saline control—but did not undergo the same testing for other specific vaccine components

such as yeast and latex. Ex. 4 at 20, 25, 29. Thus, according to Dr. Spergel, there was no evidence

that S.K. ever suffered from allergies to either latex or yeast, and her development and subsequent

exacerbation of atopic dermatitis cannot be attributed to an allergic reaction to those kinds of

components. Spergel Rep. at 5–6. In furtherance of that opinion, Dr. Spergel pointed out that even

if S.K. did have an allergy to the vaccines she received on September 18, 2013, she could not have

experienced any reaction within minutes of vaccine administration because she had not been

previously exposed to the vaccines, and she could not have developed sensitization to them. Id. at

4.

Dr. Spergel did provide some alternative explanations for S.K.’s atopic dermatitis and its

exacerbation. Such factors include exposure to cat dander from the family’s pet, exposure to egg—

a food allergy S.K. was known to have—via breastmilk, poor skin care and refusal to use topical

medications, use of irritating soaps and detergents, bacterial, viral, and fungal infections, and

rubbing already aggravated skin. Spergel Rep. at 4.

III. Procedural Background

As noted above, this case was initiated on August 12, 2016. Medical records were filed

between August 16-17, 2016, and Respondent filed his Rule 4(c) Report responding to those filings

on February 7, 2017. Respondent’s Report, filed Feb. 7, 2017 (ECF No. 10). On March 6, 2017,

Petitioner filed her first amended petition, in which she limited her claim solely to atopic dermatitis

as the alleged injury. Both parties then submitted the aforementioned expert reports. On July 19,

2017, Petitioner filed her second amended petition. Amended Petition, filed July 19, 2017 (ECF

No. 21) (Second Amended Pet.”).

On February 2, 2018, I issued a pre-hearing order setting the entitlement hearing in this

case for April 2, 2019. Prehearing Order, filed Feb. 2, 2018 (ECF No. 31). On September 20, 2018,

however, Respondent filed a motion to dismiss, to which Petitioner filed her opposition on

September 28, 2018. Motion to Dismiss, filed Sept. 20, 2018 (ECF No. 35) (“Mot. to Dismiss”);

Response to Mot. to Dismiss, filed Sept. 28, 2018 (ECF No. 36) (“Resp. to Mot. to Dismiss”).

Respondent’s Reply was filed October 2, 2018. Respondent’s Reply to Resp. to Mot. to Dismiss,

13

filed Oct. 2, 2018 (ECF No. 37).

In reaction to these filings, on March 14, 2019, I issued a scheduling order offering

Petitioner the opportunity to request a ruling on the record rather than proceed to hearing. Petitioner

opted to do so by filing dated May 16, 2019. Motion for Decision on the Record, filed May 16,

2019 (ECF No. 45) (“Mot. for Ruling”). Respondent filed his opposition on July 11, 2019, and

Petitioner filed her Reply on August 14, 2019. Response to Mot. for Ruling, filed July 11, 2019

(ECF No. 47) (“Resp. to Mot. for Ruling”); Reply, filed Aug. 14, 2019 (ECF No. 48) (“Reply for

Ruling”).

IV. Parties’ Respective Arguments

A. Petitioner’s Motion

Petitioner argues that S.K. experienced a severe dermatological reaction after receiving the

Hepatitis B vaccine on August 21, 2013, and that this reaction was then exacerbated by the IPV

and DTaP vaccines administered on September 18, 2013. Mot. for Ruling at 10. Relying on the

reports of Drs. Axelrod and Wikas, as well as the medical literature filed in the matter, Petitioner

posits that components contained within the Hepatitis B vaccine S.K. received—namely latex and

yeast—initiated a delayed IgE-mediated response, leading to an increased production of

inflammatory eosinophils, thereby resulting in an acute onset of atopic dermatitis. Id. at 10–12.

The subsequent receipt of the IPV and DTaP vaccines then significantly aggravated her condition

by initiating an immediate IgE-mediated response. Id. Her condition then entered the chronic phase

where both TH1 and TH2 are present, causing persistent dry, cracked skin that fails to barricade

against other allergens and irritants that can perpetuate inflammation. Id. at 13.

Petitioner contends that this perpetuating “inflammatory milieu” began around August 27,

2013—six days after S.K. received the second dose of the Hepatitis B vaccine. Mot. for Ruling at

14; Ex. 7 at 15 (noting “redness and rash on neck x3 weeks”). A few weeks later, on September

18, 2013, Dr. Barcellona again noted rough dry patches of skin on S.K.’s body, and he diagnosed

her with atopic dermatitis. Ex. 7 at 21–22. During the same visit, he administered IPV and

pneumococcal vaccines into S.K.’s left leg and the DTaP vaccine into her right leg. Id. at 23–24.

According to Ms. Perekotiy, S.K. immediately exhibited symptoms of a reaction to the vaccines—

her daughter’s legs turned purple. Statement of Anna Perekotiy, filed as Ex. 1 on Aug. 16, 2016

(ECF No. 4-1) at ¶ 5. In the months following, S.K.’s legs remained red, and she continued to

scratch and cry in pain. Id. at ¶ 7; Ex. 58 (photograph dated Nov. 1, 2013 displaying rash on legs

and torso). Petitioner contends that this condition persisted for over a year—citing to medical

records where Ms. Perekotiy reported her daughter’s rash had been present for over a year, as well

as a photograph that depicts S.K.’s rash on March 29, 2014 (just over six months from the time of

her September 18, 2013 vaccinations). Ex. 1 at 24; Ex. 12 at 3; Ex. 59.

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Between September 18, 2013 and February 19, 2014, S.K. was evaluated by pediatricians,

dermatologists, and an allergist for her atopic dermatitis. During these visits, the physical

examinations revealed a persistent rash on her legs, torso, face, and arms. Ex. 3 at 33; Ex. 4 at 14,

24, 28; Ex. 7 at 27; Ex. 10 at 2. Her clinical presentation led some treaters to question whether the

vaccines she received contributed to her condition. Ex. 7 at 27 (noting that it is “unclear if shot

reaction was local and eczema was bigger issue, or if [the] shot caused more reaction”). Another

treater, Dr. Jorgensen, concluded that S.K. had experienced an allergic drug reaction to IPV and

DTaP. Ex. 4 at 28. This opinion was supported by skin prick tests and low dose introductions of

IPV and DTaP that Dr. Jorgensen interpreted as positive for TH2-mediated erythematous reactions.

Id. at 25, 29; Mot. for Ruling at 15 (citing Letter from Treating Immunologist, Ronald Jorgensen,

M.D., filed as Ex. 55 on Feb. 2, 2018 (ECF No. 33-1)).

B. Respondent’s Opposition

Respondent first argues that Petitioner has not established that the Hepatitis B vaccine S.K.

received on August 21, 2013, caused her initial onset of atopic dermatitis. Resp. to Mot. for Ruling

at 12. In support of his position, Respondent points out that Petitioner’s experts discussed examples

of an immediate IgE-mediated anaphylactic responses to allergens, such as latex, but the record

does not support a finding that S.K. ever experienced such a reaction. Id. Additionally,

epidemiological studies have found no link between immunization and the initiation or

exacerbation of atopic dermatitis. Id.; see Flohr at 1; Grüber at 1464. And even if Petitioner’s

theory of causation was medically reliable, there is no evidence to support a logical sequence of

cause and effect—namely because the record (as reflected in subsequent testing) does not support

a finding that S.K. suffered from latex and/or yeast allergies. Resp. to Mot. for Ruling at 13. Nor

did Petitioner adequately explain how an IgE-mediated reaction based upon such an allergy—a

response that generally appears and resolves within twenty-four hours—could thereafter lead into

a chronic disease process six days after exposure. Resp. to Mot. for Ruling at 14.

Respondent also disputes Petitioner’s success in establishing that the IPV and DTaP

vaccines S.K. received on September 18, 2013, could have significantly aggravated her atopic

dermatitis (which Respondent allows existed as of that date, even if it had not been initially caused

by the Hepatitis B vaccine). Resp. to Mot. for Ruling at 14. Focusing on the record at the outset,

Respondent observes that although Ms. Perekotiy claims that S.K. experienced an immediate

reaction to the IPV and DTaP vaccines, the medical record does not reflect any phone calls or

doctor visits for two months following the vaccination. Id. Additionally, the record itself is vague

in its description of S.K.’s dermatologic condition, and it is not immediately clear that her clinical

course was affected by the vaccinations that she received. Id. at 14–15.

Regarding Petitioner’s proposed mechanism of causation, Respondent argues once again

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that there is no evidence that S.K. experienced any kind of immediate, IgE-mediated reaction of

the sort typically associated with latex and yeast allergies. Resp. to Mot. for Ruling at 15. This, in

combination with literature finding no link between vaccination and atopic dermatitis generally,

rebuts Petitioner’s proposed theory of causation. Id.; see Flohr at 1; Grüber at 1464. Additionally,

Respondent highlights the fact that TH2 responses are antigen-specific, and therefore require

sensitization to a specific allergen before a response will occur. Resp. to Mot. for Ruling at 15. But

this sensitization would not have occurred, since S.K. had never been exposed to the IPV and

DTaP vaccines prior to the first doses she received on September 18, 2013. Id. As a result, the

initial receipt of a vaccine could not inherently make an individual more allergic. Id. at 16. Instead,

Respondent proposes that S.K.’s atopic dermatitis was more likely the result of a known food

allergy to egg. Id. at 16–17. While none of the vaccines S.K. received contain egg-product, S.K.

was likely exposed to egg via breastmilk. Id. at 17.

C. Petitioner’s Reply

In her Reply, Petitioner emphasizes that S.K. did undergo allergy testing, and that the

results of those tests were interpreted by a treating physician as positive reactions. Reply for Ruling

at 2. That same treating physician recommended that S.K. not receive any more vaccinations unless

subsequent allergy testing was negative. Id. (citing Ex. 55 at 1). This evidence, according to

Petitioner, offers significant support for her claim, and such evidence is not easily minimized by

Respondent. Much of the Reply then focuses on bolstering the credentials of Drs. Axelrod and

Wikas. Reply for Ruling at 3–6. Lastly, Petitioner argues that S.K. did meet the six-month severity

requirement based upon medical records documenting a past medical history of rash lasting for

more than a year, as well as photographs provided by S.K.’s mother—the latest of which is dated

approximately six months after S.K. received her September 2013 vaccinations. Id. at 6–7.

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

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 & Human Servs., 592 F.3d 1315, 1321 (Fed.

Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006). 16

In this case, Petitioner does not assert a Table claim.

16

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

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

16

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 & Human 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 & Human Servs., 165 F.3d 1344,

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

Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his 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: “(1) a medical theory causally connecting the vaccination and the injury; (2) a

logical sequence of cause and effect showing that the vaccination was the reason for the injury;

and (3) a showing of proximate temporal relationship between vaccination and injury.” Althen v.

Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).

Each of the Althen prongs 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 & Human 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 & Human 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

concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121,

124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-

159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

17

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 & Human Servs., 121 Fed. Cl. 230, 245 (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, many decisions

of the Court of Federal Claims and Federal Circuit have emphasized that petitioners need only

establish a causation theory’s biological plausibility (and thus need not do so with preponderant

proof). Tarsell v. United States, 133 Fed. Cl. 782, 792–93 (2017) (special master committed legal

error by requiring petitioner to establish first Althen prong by preponderance; that standard applied

only to second prong and petitioner’s overall burden); see also Contreras, 121 Fed. Cl. at 245;

Andreu, 569 F.3d at 1375. At the same time, there is contrary authority from the Federal Circuit

suggesting that the same preponderance standard used overall in evaluating a claimant’s success

in a Vaccine Act claim is also applied specifically to the first Althen prong. See, e.g., Broekelschen

v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010) (affirming special

master’s determination that expert “had not provided a ‘reliable medical or scientific explanation’

sufficient to prove by a preponderance of the evidence a medical theory linking the [relevant

vaccine to relevant injury].”) (emphasis added). Regardless, one thing remains: petitioners always

have the ultimate burden of establishing their Vaccine Act claim overall with preponderant

evidence. W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations

omitted); Tarsell, 133 Fed. Cl. at 793 (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 & Human 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 & Human 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 & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates

18

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 & Human 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 & Human Servs.,

No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review

denied, 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 & Human 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 &

Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012),

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

355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. denied (Fed. Cl. Dec.

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

B. Standards Applicable to Significant Aggravation Claim

Where a petitioner so alleges significant aggravation of a preexisting condition, the Althen

test is expanded, and the petitioner has additional evidentiary burdens to satisfy. Loving v. Sec’y

of Health & Human Servs., 86 Fed. Cl. 135, 144 (2009). In Loving, the Court of Federal Claims

combined the Althen test with the test from Whitecotton v. Sec’y of Health & Human Servs., 81

F.3d 1099, 1107 (Fed. Cir. 1996), which related to on-Table significant aggravation cases. The

resultant “significant aggravation” test has six components, which require establishing:

(1) the person’s condition prior to administration of the vaccine, (2) the person’s

current condition (or the condition following the vaccination if that is also

pertinent), (3) whether the person’s current condition constitutes a “significant

aggravation” of the person’s condition prior to vaccination, (4) a medical theory

causally connecting such a significantly worsened condition to the vaccination, (5)

a logical sequence of cause and effect showing that the vaccination was the reason

for the significant aggravation, and (6) a showing of a proximate temporal

relationship between the vaccination and the significant aggravation.

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Loving, 86 Fed. Cl. at 144; see also W.C., 704 F.3d at 1357 (holding that “the Loving case provides

the correct framework for evaluating off-table significant aggravation claims”). In effect, the last

three prongs of the Loving test correspond to the three Althen prongs.

Subsumed within the Loving analysis is the requirement to evaluate the likely natural

course of an injured party’s preexisting disease, in order to determine whether the vaccine made

the petitioner worse than he would have been but for the vaccination. Locane v. Sec’y of Health &

Human Servs., 685 F.3d 1375, 1381–82 (Fed. Cir. 2012) (upholding special master’s determination

that petitioner had failed to carry her burden of proof in establishing that her preexisting injury

was worsened by the relevant vaccine); Hennessey v. Sec’y of Health & Human Servs., No. 01-

190V, 2009 WL 1709053, at *41–42 (Fed. Cl. Spec. Mstr. May 29, 2009), mot. for review denied,

91 Fed. Cl. 126 (2010). The critical point of examination is thus “whether the change for the worse

in [petitioner’s] clinical presentation was aggravation or a natural progression” of the underlying

condition. Hennessey, 2009 WL 1709053, at *42. 17 The Federal Circuit has upheld the

determinations of special masters that worsening was not demonstrated in connection with

establishing a petitioner’s overall preponderant burden of proof for a non-Table causation-in-fact

claim. See, e.g., Snyder/Harris v. Sec’y of Health & Human Servs., 553 F. Appx. 994, 999–1000

(Fed. Cir. 2014); Locane, 685 F.3d at 1381–82. 18

C. 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

17

The legislative history of the Vaccine Act strongly supports interpreting “significant aggravation” as requiring a

claimant to establish that a vaccine rendered a preexisting condition qualitatively worse than it would have been

otherwise—not simply that the affected individual experienced a post-vaccination symptom that contrasts with the

individual’s comparatively better pre-vaccination health. See H.R. Rep. No. 99-908, at 15 (1986) (“This [significant

aggravation] provision does not include compensation for conditions which might legitimately be described as pre-

existing (e.g., a child with monthly seizures who, after vaccination, has seizures every three and a half weeks), but is

meant to encompass serious deterioration (e.g., a child with monthly seizures who, after vaccination, has seizures on

a daily basis” (emphasis added)).

18

This is consistent with the fact (well recognized by controlling precedent) that evidence of “worsening” relevant to

Respondent’s alternative cause burden may reasonably by evaluated by a special master in determining the success of

a petitioner’s prima facie showing. Snyder/Harris, 553 F. Appx. at 1000 (“‘[N]o evidence should be embargoed from

the special master’s consideration simply because it is also relevant to another inquiry under the statute.’” (quoting

Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373, 1380 (Fed. Cir. 2012))); see also de Bazan at 1353 (“[t]he

government, like any defendant, is permitted to offer evidence to demonstrate the inadequacy of the petitioner’s

evidence on a requisite element of the petitioner’s case-in-chief.”).

20

required to weigh the evidence presented, including contemporaneous medical records and

testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (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).

Medical records that are created contemporaneously with the events they describe are

presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s

health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human 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 sub nom. Rickett v. Sec’y of Health

& Human Servs., 468 F. Appx. 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption

is based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people

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 & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.

Apr. 10, 2013); Cucuras v. Sec’y of Health & Human 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 & Human Servs., No. 03-1585V, 2005

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

records are generally 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 Dep’t of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991) (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.”)).

There are, however, situations in which compelling oral testimony may be more persuasive

than written records, such as where records are deemed to be incomplete or inaccurate. Campbell

v. Sec’y of Health & Human 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

21

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 & Human

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 & Human

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. Lalonde v. Sec’y

of Health & Human 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.

D. 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 & Human 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 Pharmaceuticals,

Inc., 509 U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328,

1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316

(Fed. Cir. 1999)). “The Daubert 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).

The Daubert factors play a slightly different role in Vaccine Program cases than they do

when applied in other federal judicial fora (such as the district courts). Daubert factors are usually

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

that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors

are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health

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

22

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 of his own 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, 618 F.3d at 1347 (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. 136, 146 (1997));

see also Isaac v. Sec’y of Health & Human Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed.

Cl. Spec. Mstr. July 30, 2012), mot. for rev. denied, 108 Fed. Cl. 743 (2013), aff’d, 540 F. Appx.

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 & Human 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”).

Expert opinions based on unsupported facts may be given relatively little weight. See

Dobrydnev v. Sec’y of Health & Human Servs., 556 F. Appx. 976, 992–93 (Fed. Cir. 2014) (“[a]

doctor’s conclusion is only as good as the facts upon which it is based”) (citing Brooke Group Ltd.

v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993) (“[w]hen an expert assumes

facts that are not supported by a preponderance of the evidence, a finder of fact may properly reject

the expert’s opinion”)). Expert opinions that fail to address or are at odds with contemporaneous

medical records may therefore be less persuasive than those which correspond to such records. See

Gerami v. Sec’y of Health & Human Servs., No. 12-442V, 2013 WL 5998109, at *4 (Fed. Cl. Spec.

Mstr. Oct. 11, 2013), aff’d, 127 Fed. Cl. 299 (2014).

E. Consideration of Medical Literature

Both parties filed medical and scientific literature in this case, but not every filed item

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

in this case, I discuss only those articles that are most relevant to my determination and/or are

23

central to Petitioner’s case—just as I have not exhaustively discussed every individual medical

record filed. Moriarty v. Sec’y of Health & Human Servs., 844 F.3d 1322, 1328 (Fed. Cir. 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 & Human Servs., 527 F. Appx. 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”).

F. Resolution of Case Via Ruling on Record

The parties have requested that I resolve this matter on the papers, rather than by holding

a hearing. The Vaccine Act and Rules not only contemplate but encourage special masters to

decide petitions on the papers where (in the exercise of their discretion) they conclude that doing

so will properly and fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d). The decision

to rule on the record in lieu of hearing has been affirmed on appeal. See Kreizenbeck v. Sec’y of

Health & Human Servs., No. 08-209V, slip op. at 8 (Fed. Cir. Jan. 6, 2020); 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. 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; Murphy 23 Cl. Ct. at 730–31.

ANALYSIS

Petitioner has two associated, non-Table claims: one alleging that the Hepatitis B vaccine

directly caused S.K.’s atopic dermatitis, and a significant aggravation claim based on two vaccines

she received approximately one month later. Both claims must be established by a preponderance

of the evidence, though the specific factors that must be proven differ between the claims. As set

forth below, I find that although Petitioner offers several items of reliable evidence, she has not

preponderantly established either claim.

I. Overview of Atopic Dermatitis

The experts largely agreed on the characteristics of atopic dermatitis, but a few additional

points are in order. Atopic dermatitis is a complex skin allergy disease that most often manifests

in young children, and is generally characterized by skin irritation, dryness, sweating, and itching.

A. Cantani, Pediatric Allergy, Asthma and Immunology 473 (U. Heilmann ed., 2008)

24

(“Cantani”). 19 As discussed by both parties’ experts, the pathogenesis of atopic dermatitis involves

the production of a specific antibody, IgE, and the corresponding/subsequent stimulation of the

skin’s inflammatory response. See Axelrod Rep. at 2; Spergel Rep. at 2–3. Foreign antigens that

are introduced to the body are captured by Langerhans cells 20, which reside in the epidermis layer

of the skin and carry IgE antibodies on their cell membranes. Cantani at 478. The Langerhans cells

then migrate and interact with T-cells, such as memory TH2 cells, and mast cells. Id. at 478, 484;

Maggi at 236.

Activated TH2 cells subsequently support the proliferation and release of interleukins while

mast cells initiate the release of histamines—key mediators of an inflammatory response. Cantani

at 478, 484. Significantly, skin mast cells can also be activated by nonimmunological stimuli,

including viral proteins and components of bacterial membranes. Id. at 484. Following the initial

release of histamine, an individual may experience signs of a Type I hypersensitivity, such as

pruritic, erythematous, or macular rashes as well as vasodilation. 21 Id. In a second phase, TH1

cells—characteristic of delayed-type hypersensitivity reactions—predominate and play a key role

in producing skin lesions. Id. at 489–90. As TH2 gives way to TH1 proliferation, the individual may

experience worsening inflammation. Id. at 490; see also Spergel Rep. at 2–3.

Clinical presentation of atopic dermatitis in infants generally presents as an erythematous

rash on the face. Cantani at 501. Scratching and itching may worsen the disease, as well as

exposure to additional allergens and irritants after the condition’s symptomatic manifestation. Id.

at 497–500. Because individuals with atopic dermatitis are more likely to also experience

sensitizations, identification and removal of food allergens from an individual’s diet plays a

significant role in the management and treatment of the condition. Id. at 497, 512; see also

Fleischer at 581; Weidinger at 1110.

II. Petitioner Has Not Preponderantly Established that the Hepatitis B Vaccine

Did Cause S.K.’s Initial Presentation of Atopic Dermatitis

There is no dispute in this case about the administration of the vaccines in question, S.K.’s

diagnoses, or the date S.K. most likely experienced onset (around August 27, 2013). Thus,

Petitioner’s claim regarding initiation of S.K.’s atopic dermatitis turns on whether the Hepatitis B

19

Cantani is a medical treatise on the topic of pediatric allergy and immunology. It is not being filed in this matter

because it is not controversial, nor contrary to the testimony provided by the parties’ experts, and my determination

of entitlement does not turn on my general reference to it. I cite to it merely because it provides supplemental

information and context absent from the parties’ existing literature filings.

20

Langerhans cells are predominantly located in the skin but can also be found in the lungs, lymph nodes, spleen, and

thymus. They are antigen-presenting cells, and they are most commonly implicated in the mediation of allergic

reactions. Dorland’s at 315.

21

Vasodilation describes the dilation of blood vessels leading to increased blood flow. Dorland’s at 1996.

25

vaccine could cause atopic dermatitis in the manner proposed, whether it did so here, and whether

S.K.’s onset was within a medically acceptable timeframe. I find that Petitioner has not

preponderantly satisfied any of the Althen prongs for this claim.

The first Althen prong requires petitioners to establish a “reputable medical theory”

demonstrating that the vaccine received can cause the type of injury alleged. Here, both parties

agree that atopic dermatitis, like other types of allergic reactions, is immunologically mediated by

IgE generated in response to increased T cell and cytokine activity. See Axelrod Rep. at 2; Wikas

Rep. at 4; Spergel Rep. at 2–3. Individuals suffering from atopic dermatitis also tend to exhibit

higher rates of sensitization, such as food allergies and other immune-mediated inflammatory

diseases. Fleischer at 581. Thus, the immune character of the condition has been established—

opening the door to a conclusion that a vaccine might be associated with that condition.

In addition, I find that preponderant evidence (particularly some of the literature filed in

this case) supports the conclusion that exposure to potentially allergenic vaccine components could

trigger the kind of immunologic reaction necessary to produce an IgE-mediated allergic reaction.

See, e.g., Chung at 50; Dreskin at 9–16 (emphasizing that although vaccine antigens themselves

rarely cause allergic reactions, other vaccine components may induce an allergic response and

should be identified so as to modify vaccine administration if necessary); Spergel Rep. at 5–6. But

this alone is insufficient to support finding that vaccines can also cause atopic dermatitis—a

condition that much of the literature distinguishes from a true allergic reaction. See, e.g., Zudaire

at 311–12.

On that specific subject, Respondent offered certain items of literature aimed at rebutting

Petitioner’s points regarding the capacity of a vaccine to cause atopic dermatitis—although not all

were equally persuasive. For example, Flohr, a review article, considered numerous studies on

different aspects of atopic dermatitis, including studies evaluating the effects of vaccination on the

development and exacerbation of the condition. Flohr at 21. Some of the studies Flohr considered

found that there was an increased risk for atopic dermatitis following vaccination, but Flohr

identified sources of error in those studies and therefore rejected their conclusions. Id. (discussing

a Danish cross-sectional study that found a twofold increase in atopic dermatitis risk in children

following receipt of the measles, mumps, and rubella vaccine, and two UK studies that found

increased risk of atopic dermatitis in children following receipt of diphtheria/tetanus and polio

containing vaccines).

Though not insignificant, the weight I give to literature reviews is less than what I would

give to other forms of more direct evidence, such as epidemiological studies and research studies

centering on some aspect of the relevant condition. Flohr’s conclusions are further diminished by

the lack of follow-up studies addressing the sources of error alleged by Flohr. Without subsequent

studies, there exists merely a handful of studies—some of which do find a causal relationship

26

between vaccines and atopic dermatitis—along with a single review of those studies that alleges

unverified sources of error and therefore arrives at the opposite conclusion. Thus, Flohr alone is

not sufficient to overcome Petitioner’s showing.

But Respondent also offered a 2008 epidemiological study, Grüber, involving over 2,000

children. Grüber focused on children who were at a high risk of developing atopic dermatitis,

versus children already suffering from it, to see if childhood vaccinations had any effect on the

initiation or exacerbation of atopic dermatitis. Grüber at 1464. Ultimately, Grüber concluded that

vaccination did not pose an increased risk for either the development or exacerbation of atopic

dermatitis. Grüber at 1469. This is a very persuasive study worthy of substantial weight, and it was

not rebutted by Petitioner. This study, along with the findings of Flohr, sufficiently rebut

Petitioner’s arguments, thereby making Petitioner’s overall showing insufficient to establish an

entitlement award.

Petitioner also failed to offer preponderant evidence to support the second Althen prong,

which requires establishing a logical sequence of cause and effect between the alleged injury and

the vaccine received. The medical record reveals that prior to receiving the Hepatitis B vaccine on

August 21, 2013, S.K. (who had previously received the same vaccine at birth, one month before,

but with no reaction) had not exhibited any dermatologic symptoms consistent with atopic

dermatitis. Ex. 7 at 11–14 (discussing physical examination findings on August 21, 2013, which

were negative for any dermatologic concerns). Only six days later (as reported to treaters by Ms.

Perekotiy) did S.K. begin exhibiting dermatologic symptoms, which were thereafter diagnosed as

atopic dermatitis the following month. Id. at 15, 21–22 (noting that S.K.’s symptoms began

approximately three weeks prior).

Petitioner maintains that S.K.’s atopic dermatitis was the result of a delayed IgE-mediated

allergic response to the latex and yeast components of the Hepatitis B vaccine. Mot. for Ruling at

12. But Respondent points out that such delayed reactions (occurring within forty-eight hours of

allergen expose, and then peaking within seventy-two to ninety-six hours post-exposure (three to

four days later) are not usually IgE-mediated. Chung at 51; Wood at 521–22. In fact, as Zudaire

emphasizes, such reactions merely simulate an allergic response, and should therefore not be

diagnosed as a true vaccine allergy. Zudaire at 311–12. Additionally, no allergy testing was

conducted against the Hepatitis B vaccine or any of its alleged components (latex and yeast). See

Ex. 4 at 25, 29 (discussing allergy test results for Diphtheria/Tetanus and IPV vaccines). Without

positive allergy test results, there is insufficient evidence that S.K. was allergic to any component

of the Hepatitis B vaccine. For these reasons, I find that Petitioner has not satisfied her burden

under Althen prong two.

Petitioner’s showing under the third Althen prong is similarly flawed—and would compel

dismissal of this claim even if she had met the first two prongs. Respondent’s experts, along with

27

much of the literature submitted in this matter, proposed that the onset of delayed allergic reactions

will occur at least within forty-eight hours of allergen exposure, peaking three to four days post-

exposure. Chung at 51; Wood at 521–22. But the medical records in this case suggest that S.K. did

not display symptoms of atopic dermatitis until August 27, 2013—six days post-vaccination. Ex.

7 at 15. Thus, the medical record establishing S.K.’s onset is inconsistent with the most

scientifically reliable/medically acceptable timeframe.

Petitioner argues for a longer timeframe, with Dr. Axelrod opining that adaptive immune

responses to an allergen can occur up to twenty-five days after exposure. Axelrod Rep. at 4. In

support of this contention, Petitioner cited two articles, only one of which was filed in this matter. 22

See A. Abbas et al., Cellular and Molecular Immunology 10 (8th ed. 2015) (“Abbas”). Her reliance

on Abbas, however, is misplaced. Abbas demonstrates only that the secondary immune response

(primarily mediated by memory B cells) is as a general rule more robust than the primary response

to a specific antigen. Id. But even though it is true that S.K. had been administered the Hepatitis B

vaccine once prior (thus suggesting the second dose would prompt a more robust reaction), it is

not apparent how the findings of Abbas translate into response times for initial, IgE-mediated

allergic reactions. Abbas also notes that memory T cells react “much more rapidly and vigorously”

during a secondary immune response than during the primary response—consistent with the other

literature suggesting that an allergic response would be far more immediate. Id. This further

undercuts Petitioner’s argument that longer, delayed response times are typical of secondary

immune responses. I therefore find that Petitioner has failed to meet her burden in establishing the

third Althen prong with respect to her Hepatitis B-oriented claim.

III. Petitioner Has Not Preponderantly Established that the DTaP and IPV Vaccines

Significantly Aggravated S.K.’s Preexisting Atopic Dermatitis

The parties agree that S.K. was already experiencing atopic dermatitis when she received

the DTaP and IPV vaccines in mid-September 2018, and thereafter experienced symptoms for

some period of time (although Respondent contests that this period was sufficiently severe to meet

a core claim requirement). This leaves three primary issues to be resolved: (a) could these vaccines

aggravate atopic dermatitis, (b) did they do so in this case, and (c) was the aggravation worse than

what otherwise would be expected for a child already suffering from this condition. I find that

Petitioner has not satisfied these elements.

22

The second article Petitioner cited to in support of this proposition in Dr. Axelrod’s report was not filed in this case.

Axelrod Rep. at 4, 6. Instead, Petitioner filed an article from 1949 discussing the speed of secondary immune responses

to various forms of tetanus toxoid (none of which are the same as the vaccines administered to S.K.). J. Miller et al.,

The Speed of the Secondary Immune Response to Tetanus Toxoid with a Review of War Reports and Observations on

Simultaneous Injection of Toxoid and Antitoxin, 3 Pediatrics 64 (1949), filed as Ex. 31 on May 9, 2017 (ECF No. 18-

5). I give this second article very little weight due to its age, as well as the fact that the study did not consider any of

the vaccines at issue in this matter.

28

A. Petitioner has not Provided a Reliable Theory of Causation (Loving Factor Four)

The Fourth Loving factor largely tracks the first Althen prong, asking whether a petitioner

has established a scientifically/medically reliable theory that the vaccine in question “could cause”

aggravation of the alleged preexisting condition. Loving, 86 Fed. Cl. at 144. Here, Petitioner was

unable to preponderantly establish that the vaccines S.K. received in September 2013 could trigger

further adverse events in a person already suffering from atopic dermatitis.

The literature filed in this matter establishes that individuals already suffering from atopic

dermatitis will likely display future additional sensitivity to any stimuli, vaccine or not, rendering

them more disposed to experience other IgE-mediated inflammatory reactions. Fleischer at 581;

see Weidinger at 1110 (noting that two-thirds of infants with moderate atopic dermatitis exhibit

sensitization to food allergens). In large part, this may be due to the propensity of atopic individuals

to overproduce IgE, and may also be attributed to the defective skin barrier caused by the ongoing

inflammatory TH2/TH1 cycle and the damage it causes. See Wikas Rep. at 4; Schneider at 296.

As a result, allergens different from the initial dermatitis-causing exposure could

exacerbate existing symptoms. Weidinger, for example, found that among children with moderate

existing atopic dermatitis, exposure to food allergens sometimes resulted in IgE-mediated

immediate reactions, such as pruritis, urticaria, and flushing. Weidinger at 1110. In some instances,

that immediate reaction was later followed by worsening eczema and atopic dermatitis. Id. This

sensitivity explains why skin prick tests in individuals with atopic dermatitis have higher rates of

false positives, and why such an individual may experience an erythematous reaction even to saline

controls. Weidinger at 1110. And as discussed by Respondent’s expert, Dr. Spergel, the literature

recognizes that irritant reactions resulting in erythema and exacerbated atopic dermatitis may also

occur in atopic individuals following vaccination. Id. at 1109–11; Dreskin at 12; Zudaire at 312;

Spergel Rep. at 3. Thus, Petitioner has offered some reliable evidence in favor of the conclusion

that the IPV or DTaP vaccines could similarly aggravate existing atopic dermatitis (at least

transiently).

In opposition to these arguments, Respondent again relies on the findings of Flohr and

Grüber, which dealt specifically with the propensity of vaccines to cause or exacerbate atopic

dermatitis—and they are equally persuasive in rebutting the significant aggravation claim. Grüber

is especially difficult for Petitioner to overcome. Although she has cited some reliable subsequent

review articles that support her contention that vaccines might exacerbate an existing case of atopic

dermatitis (see, e.g., Zudaire at 312), Petitioner has not rebutted Grüber, an epidemiologic study

that goes directly to her central contentions in this case. As I have often noted, while petitioners

need not offer epidemiologic evidence to prevail, I may consider those relevant studies that bear

on a claim, and reliable studies are entitled to evidentiary weight. McCollum v. Sec’y of Health &

Human Servs., No. 14-790V, 2017 WL 5386613, at *17–18 (Fed. Cl. Spec. Mstr. Sept. 15, 2017),

29

mot. for review den’d, 135 Fed. Cl. 735 (2017), aff’d, 760 Fed. Appx. 1003 (Fed. Cir. 2019).

Overall, Petitioner’s showing on this Loving element was not ultimately persuasive and

was not aided by her expert showing. Respondent, on the other hand, offered credible and

persuasive expert testimony that (coupled with the filed literature) substantially detracted from

Petitioner’s proffered theory. Because of the foregoing, my weighing process did not produce a

finding in Petitioner’s favor on the fourth Loving factor, despite the fact that Petitioner offered

some reliable evidence. As science advances, and/or this issue is subject to further (or updated)

study, more evidence may be developed that supports the kind of claim asserted herein. But it does

not exist today. Under the legal standards I must apply, the evidence in this case does not support

a finding that the DTaP and IPV vaccines can likely produce atopic dermatitis exacerbations.

B. Petitioner has Established a Worsening of S.K.’s Condition, but not a Causal Relationship

Between Vaccination and the Exacerbation (Loving Factors Three and Five)

Petitioner has successfully demonstrated that S.K.’s atopic dermatitis worsened following

vaccination, but she has failed to establish that the worsening was due to vaccination. See

Hennessey, 2009 WL 1709053, at *42. Here, S.K.’s medical record, when amplified by Ms.

Perekotiy’s testimony and photographs, maps S.K.’s clinical course from onset to resolution of her

atopic dermatitis. This evidence persuasively establishes that S.K.’s post-vaccination condition

differed from her pre-vaccination condition in general severity. But for the reasons mentioned

above, the relationship between S.K.’s worsening condition and the vaccines she received was

most likely merely temporal—not causal.

On September 16, 2013—two days prior to receiving the two vaccines relevant to the

significant aggravation claim—S.K. was evaluated by Dr. Petranu for redness and a rash. Ex. 7 at

15. His physical evaluation revealed that S.K. had flaky skin on her head and was positive for

“erythematous, raw, macerated neck folds without drainage or crusting.” Id. at 16. Even on the

day of vaccination, S.K. displayed rough patches on her body, scalp flakiness, and red macules in

her neck folds. Id. at 21. Thus, there was no evident change in S.K.’s condition, and no lower

extremity involvement was noted during either of these visits.

The subsequent record is silent on an immediate reaction but is supplemented by Ms.

Perekotiy’s unrebutted contention that within minutes of the DTaP and IPV vaccines being

administered, S.K.’s legs (the situs of administration) became purple. Statement of Anna Perekotiy

at ¶ 5. Then, on October 27, 2013, Petitioner took a picture of S.K. where her legs appear to be

covered in red splotches—a condition that was not previously noted in the medical record. Ex. 57.

A second picture taken on November 1, 2013 again demonstrates extensive redness on S.K.’s legs,

lower torso, and head. Ex. 58. These closer-in-time alleged reactions are corroborated by

subsequent statements made to treaters about S.K.’s worsening condition. See Ex. 4 at 13; Ex. 10

30

at 1. 23

As the overall record demonstrates, S.K.’s condition prior to her receipt of the September

2013 vaccinations did not involve her lower extremities and appeared limited to her scalp and

neck. Ex. 7 at 16, 21. Thus, S.K.’s development of atopic dermatitis symptoms in her legs, where

she had previously had no signs of the disease, establish the worsening of her pre-vaccination

condition. But the record only supports a temporal association between the vaccination and

subsequent leg rash—not that the vaccines themselves “more likely than not” caused a reaction

thereby inducing the rash and subsequent exacerbation of atopic dermatitis.

First, as noted above, there is thin evidence suggesting that vaccines can cause or

exacerbate atopic dermatitis generally. See Grüber at 1469. Petitioner’s overreliance on the

temporal association between S.K.’s exacerbation and vaccination is insufficient to sustain her

claim in the face of scientific and epidemiological evidence to the contrary. See Moberly, 592 F.3d

at 1323–24. Not all adverse post-vaccination events are caused by vaccination (since, were that

the case, all a claimant would need to do to prevail in any Vaccine Act case would be to show

onset of injury after vaccination). 24

Second, the record does not otherwise persuasively link the DTaP or IPV vaccines to S.K.’s

worsening. At best, Petitioner can point to the skin-prick testing performed by Dr. Jorgensen in

the winter of 2014 as supporting the conclusion that S.K. was allergic to either the antigenic

components of these two vaccines or their ingredients. Ex. 4 at 20, 25, 29. However (and as

discussed above), S.K. could not have been predisposed to a response to these vaccines (whether

antigenically-specific or to other components) before first receiving them in September 2018, and

because she unquestionably was displaying symptoms of atopic dermatitis by this time, any post-

vaccination reaction is equally if not more likely attributable to the general sensitivity a person

with atopic dermatitis would display to any stimuli. Fleischer at 581; see Weidinger at 1110. In

addition, Drs. Lobo and Spergel raised reasonable points about the reliability of Dr. Jorgensen’s

testing results, and they persuasively noted that there is no evidence in this case that S.K. did

possess an allergy to latex or yeast. Dr. Lobo Rep. at 6; Spergel Rep. at 3; see Ex. 4 at 20, 25, 29

(discussing skin prick tests against IPV and DTaP generally, but also showing a failure to test

against yeast and latex).

23

Although contemporaneous medical records are presumptively correct and are usually the best evidence of a

particular contention like the date of occurrence of a symptom, subsequent records that consistently corroborate the

symptom’s occurrence at a particular time can preponderantly establish that as a fact, even if earlier records do not

exist. See, e.g., Cooper v. Sec’y of Health & Human Servs., No. 16-1387V, 2018 WL 1835179, at *6–7 (Fed. Cl. Spec.

Mstr. Jan. 18, 2018).

24

The record also hints in places that Petitioner’s reluctance to treat S.K. with prescribed steroidal topical creams or

other medications may well also have been a factor in any worsening of the atopic dermatitis (or at least its failure to

improve). See, e.g., Ex. 7 at 25 (Dr. Barcellona noting that Petitioner was not using the prescribed steroids to treat

S.K.’s dermatologic condition “because it is a steroid and steroids are ‘bad.’”). This Decision, however, does not turn

on the finding of such an alternative explanation.

31

Accordingly, even though Petitioner has preponderantly established that S.K.’s course

worsened post-vaccination, she has not also shown that such worsening can be reliably vaccine-

attributed. Petitioner relies too much on the obvious temporal relationship between vaccination

and her subsequent symptoms. This is an insufficient basis for the conclusion that the DTaP and

IPV vaccines caused S.K.’s atopic dermatitis exacerbation.

C. Other Loving Factors

The sixth and final Loving factor requires petitioners to establish a proximate temporal

relationship between the significant aggravation of their condition and the received vaccine.

Loving, 86 Fed. Cl. at 144. Petitioner maintains that S.K. experienced significant aggravation of

her atopic dermatitis within minutes of receiving the IPV and DTaP vaccinations in both legs. Mot.

for Ruling at 2 (citing Statement of Anna Perekotiy at ¶ 5).

Respondent correctly notes that the medical record from that September 2013 visit do not

document any adverse reactions. Response to Mot. for Ruling at 3–4; Ex. 7 at 23–24. However,

subsequent contemporaneous medical records pre-dating the initiation of this litigation are

consistent with Petitioner’s allegations. For example, a letter written by Dr. Jorgensen dated

January 28, 2014 provides a medical history in which Petitioner reported S.K. developed redness

in her legs the day she received the DTaP and IPV vaccinations. Ex. 4 at 13. In addition, and

although not as persuasive as contemporaneous records, Petitioner’s testimony and the consistency

of her reporting in subsequent medical records preponderates in her favor. Thus, Petitioner has met

her burden under the sixth Loving factor.

I will not provide a lengthy analysis of Loving factors one (establishing a petitioner’s pre-

vaccination condition) and two (establishing a petitioner’s post-vaccination condition), because

both parties appear to agree that S.K. experienced atopic dermatitis prior to and following her

September 18, 2013 vaccinations. Mot. for Ruling at 2 (citing Ex. 7 at 22); Response to Mot. for

Ruling at 14–15 (discussing the overall course of S.K.’s atopic dermatitis both before and after

vaccination).

But despite these findings, Petitioner has not provided sufficient evidence to carry her

burden; especially when rebutted with the epidemiological evidence offered by Respondent in this

matter. Specifically, Petitioner’s literature offered in support of her proposed theory, while

appearing to be viable at first glance, was substantially outweighed by the Grüber epidemiological

study, which found no causal connection between childhood vaccination and the development or

exacerbation of atopic dermatitis. Similarly, Petitioner’s experts failed to provide adequate support

for the proposed theory. Though qualified to offer an opinion in the matter, Drs. Axelrod and

Wikas were less credible overall in the opinions they offered when compared to Respondent’s

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expert, Dr. Spergel. Thus, I find that Petitioner has failed to meet her overall burden under Loving.

IV. Petitioner Has Met the Six-Month Severity Requirement

Besides contending that Ms. Perekotiy has not met her primary Althen or Loving

evidentiary burdens, Respondent argues that S.K.’s atopic dermatitis course post-vaccination did

not meet the six-month severity requirement set forth in Section 11 of the Vaccine Act. Response

to Mot. for Ruling at 5–6. This argument was also the subject of Respondent’s Motion to Dismiss.

See generally Mot. to Dismiss.

According to Respondent, S.K. exhibited symptoms of atopic dermatitis between

approximately August 27, 2013 and February 19, 2014, as noted by her treating physicians during

physical examination. Response to Mot. for Ruling at 5–6; Ex. 7 at 15–19; Ex. 4 at 28. Physical

examinations after February 19, 2014, however, were negative for dermatologic symptoms.

Response to Mot. for Ruling at 5. Thus, Respondent contends, Petitioner cannot establish sufficient

severity, since S.K.’s course of aggravated dermatitis was over within five months of vaccination.

Petitioner argues in response that subsequent records do in fact reference S.K.’s atopic

dermatitis, describing a disease course of at least six months. See, e.g., Ex. 6 at 8 (review of systems

documenting a “present rash” as of June 16, 2015); Ex. 9 at 12 (Petitioner reported on September

16, 2015 a rash that lasted for one year); Ex. 12 at 3 (history of present illness prepared on

September 15, 2015 describing Petitioner report of a rash that lasted for over a year). Petitioner

also submitted a photograph of S.K. that was taken on March 29, 2014 (six months post-

vaccination), in which S.K. still appears to have red, cracked skin on her lower extremities. Ex.

59.

I find that Petitioner has provided just enough evidence to preponderantly establish the six-

month severity requirement. This determination does not arise solely from the medical record.

While some of the medical records dated after February 2014 contain references to a rash lasting

longer than six months, all of those references are contained in either the review of systems or past

medical history sections—portions of the medical record that rely on patient reporting and are

therefore subject to biases and mistaken memory. In addition, none of S.K.’s treating physicians

documented present dermatologic symptoms during physical examination after February 2014.

There is overall thin evidence to be found in the record that S.K.’s atopic dermatitis persisted for

long as a concern.

Nonetheless, other corroborative evidence helps satisfy this core vaccine injury claim

requirement. The March 29, 2014 photograph of S.K. (in which she displays a red, splotchy rash

and cracked skin on her lower extremities) is particular trustworthy, probative evidence that S.K.

did in fact continue to experience residual symptoms of her atopic dermatitis. I also give some

33

weight to the statements of Petitioner that S.K.’s dermatitis did not immediately subside despite

the contrary suggestions of the medical record. These items of evidence, when weighed in light of

the leniency and disposition toward generosity that the Program mandates petitioners are to

receive, are enough to satisfy severity in this case, even if the evidence on this issue is close. See,

e.g., Wright v. Sec’y of Health & Human Servs., 146 Fed. Cl. 608, 614 (2019) (emphasizing the

need to keep in mind Program policy goals when evaluating severity); see also Purtill v. Sec’y of

Health & Human Servs., No. 18-832V, 2019 WL 7212162, at *6 (Fed. Cl. Spec. Mstr. Nov. 12,

2019) (close calls on elements of entitlement claims should be decided in a petitioner’s favor),

citing Roberts v. Sec’y of Health & Human Servs., No. 09-427V, 2013 WL 5314698, at *10 (Fed.

Cl. Spec. Mstr. Aug. 29, 2013).

V. Respondent Has Established an Alternative Cause for S.K.’s Atopic Dermatitis

I also find that even if the Petitioner had met her primary burden of proof, Respondent

would have met his shifted burden, because he has offered preponderantly-supported alternative

causes for the exacerbation of S.K.’s atopic dermatitis. See Althen, 418 F.3d at 1278 (citing

Knudsen, 35 F.3d at 547).

Specifically, Dr. Spergel proposed that S.K.’s exposure to egg via the breastmilk she was

consuming could explain the exacerbation of her condition. Spergel Rep. at 5. Much of the

literature in this matter supports the proposition that exposure to food allergens frequently

exacerbates atopic dermatitis. See, e.g., Weidinger at 1116 (emphasizing the importance of

avoiding food allergens in children with atopic dermatitis). There is no dispute that S.K. was being

breast-fed throughout this period. See, e.g., Ex. 7 at 11, 19.

Petitioner’s claim was undercut further by the fact that atopic dermatitis is understood to be

self-perpetuating, independent of intervening factors. Once the skin barrier is compromised, more

irritants may easily enter the body, refueling the TH2/TH1 cycle. Wikas Rep. at 4. Additionally, the

itchy sensation produced by atopic dermatitis often leads to scratching and rubbing, which

similarly perpetuates inflammation. K. Malik et al., An Update on the Pathophysiology of Atopic

Dermatitis, 35 Dermatologic Clinics 317, 322–23 (2017), filed as Ex. C, Tab 4 on Feb. 25, 2019

(ECF No. 41-6). I find that these baseline aspects of the conditions all better explain any

exacerbation experienced herein than the September 2018 vaccines.

CONCLUSION

This was a difficult case. I take S.K.’s condition seriously and the negative impact that it

had on her life and those of her parents. Petitioner’s good faith arguments were backed by many

solid items of proof. But on the fundamental point of causation, it was not a close case. The

Vaccine Act permits me to award compensation to a petitioner alleging a “non-Table Injury” only

34

if she can show by medical records or competent medical opinion that the injury was more likely

than not vaccine-caused. The evidence in the record did not ultimately preponderate in a favorable

ruling.

Accordingly, and for the aforementioned reasons, I DENY entitlement in this case. 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. 25

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

25

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

renouncing their right to seek review.

35