Court Opinion

ID: 4573033
Source: CourtListenerOpinion
Date Created: 2020-10-05 17:02:39.156962+00
Date Added: 2024-06-11T13:31:38.202401
License: Public Domain

In the United States Court of Federal Claims
                                           No. 16-997V
                             (Filed Under Seal: September 17, 2020)
                                   (Reissued: October 5, 2020) 1

************************************
                                    *
ANNA PEREKOTIY, on behalf of her    * Vaccine case; Motion for Review
minor child, S.K.,                  * Diphtheria, Tetanus, Cellular Pertussis (DTaP)
                                    * Hepatitis B Inactivated Polio (IPV) Vaccines;
                  Petitioner,       * atopic eczema dermatitis; Althen prongs;
                                    * Loving prongs, Motion for Review denied
            v.                      *
                                    *
SECRETARY OF HEALTH AND             *
HUMAN SERVICES,                     *
                                    *
                  Respondent.       *
*************************************

Andrew Donald Downing, Phoenix Arizona, for Petitioner.

Zoe Wade, Julia Marter Collison, and Lynn Elizabeth Ricciardella, United States Department of
Justice, Washington, DC, for Respondent.

                                    OPINION AND ORDER

DAMICH, Senior Judge

        On May 20, 2020, Petitioner filed, on behalf of her daughter, S.K., a petition for review
of the Chief Special Master’s Decision denying compensation under the National Childhood
Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2018)(“Vaccine Act”). Petitioner had
alleged that the S.K.’s exposure to the Hepatitis B vaccine on August 21, 2013, caused her to
develop atopic dermatitis, and that the subsequent vaccinations for Diphtheria, Tetanus, acellular
Pertussis (“DTaP”) and inactivated polio (“IPV”) administered on September 18, 2013,
significantly aggravated her skin condition. On April 20, 2020, Chief Special Master Brian H.
Corcoran denied compensation on grounds that Petitioner had not preponderantly established
that the Hepatitis B vaccine caused the initial onset of S.K.’s atopic dermatitis, or that the DTaP

       1
         Vaccine Rule 18(b), included in Appendix B of the Rules of the United States Court of
Federal Claims, affords each party fourteen days in which to object to the disclosure of (1) trade
secrets or commercial or financial information that is privileged or confidential or (2) medical
information that would constitute “a clearly unwarranted invasion of privacy.” Neither party
objected to the public disclosure of any information contained in this opinion.

                                                 1
and IPV vaccines S.K. received a month later significantly aggravated her then-existing
dermatologic condition.

       In her motion for review, Petitioner requests this Court to enter judgment in her favor
arguing that the Chief Special Master improperly weighed the evidence and misapplied the
relevant legal standards. For the reasons set forth below, the Court finds that the Chief Special
Master’s factual findings are supported by substantial evidence and that he correctly applied the
relevant legal standards. Petitioner’s motion for review is, therefore, denied.

   I.       Background

            A. Factual Background

        S.K. was born healthy on July 16, 2013. 2 At the time of her birth, she received her first
dose of the Hepatitis B vaccine. There was no reported adverse reaction. On July 22, 2013, S.K.
was seen by Dr. Jennifer Cropp, M.D., for a newborn baby visit. At that visit, the doctor did not
note any abnormalities. At her two-week exam, S.K. exhibited drainage from her right eye. S.K.
also presented redness in her left armpit, which Dr. Cropp attributed to moisture. Dr. Cropp
instructed Petitioner to keep the area clean and dry.

       S.K received her second dose of Hepatitis B vaccine on August 21, 2013, by Dr. Matthew
Barcellona, M.D., of North Scottsdale Pediatric Associates, during a one-month well-baby
check. At that time no abnormalities or dermatological concerns and no adverse reactions to the
vaccine were noted in the doctor’s notes.

        Approximately one month later, on September 16, 2013, S.K. was seen by Dr. Colin
Petranu, M.D., of North Scottsdale Pediatric Associates, complaining of redness and rash that
petitioner reported had developed three weeks prior (or approximately six days after receiving
her second Hepatitis B vaccination) and had failed to improve. The doctor noted that S.K.
exhibited flaky skin on her head, diagnosed as seborrhea, 3 as well as red, raw, macerated neck
folds without drainage or crusting, diagnosed as intertrigo. 4 S.K. was prescribed a moisturizing
cream and the doctor indicated that if it did not improve he would consider prescribing a steroid
cream.

        2
         The Court derives much of the background from the previous ruling in this case, see
generally Perekotiy v. Sec’y of HHS, No. 16-997V, slip op. (Fed. Cl. Spec. Mstr. April 20, 2020).
        3
        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 Illustrated
Medical Dictionary 1657 (33d ed. 2020) (hereinafter “Dorland’s”).
        4
         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.

                                                 2
        Two days later, on September 18, 2013, S.K. was seen for her two-month well-baby visit.
The examination showed that S.K. had rough patches on her body, scalp flakiness, and red
macules in her neck folds. S.K. was again diagnosed with intertrigo, but her seborrhea diagnosis
was changed to atopic eczema dermatitis. 5 During this visit, S.K. received four vaccines: DTaP,
Hib, IPV, and pneumococcal. Petitioner refused the rotavirus vaccine and signed a waiver to that
effect.

        On November 20, 2013, petitioner returned to Dr. Barcellona with S.K. Petitioner
reported S.K. had a bad reaction to her shots causing leg redness. The skin exam revealed red
and rough patches as well as scaly skin on her torso, scalp, and legs. Petitioner was not
administering steroids which had previously been prescribed to treat S.K.’s skin condition,
because petitioner felt steroids are “bad.” Dr. Barcellona noted it was unclear whether the shot
reaction was local, and her eczema was the bigger issue, or if the shot caused more reaction.

        On December 9, 2013, S.K. was seen by a certified physician assistant, for evaluation of
a persistent rash following her September 18, 2013, vaccinations. The record indicated that S.K.
exhibited dry red patches on her scalp, face, abdomen, and both lower extremities. She was
diagnosed with eczema.

        At her six-month well-baby visit, on January 15, 2014, the records noted that S.K. had
eczematous rash on both legs. The doctor then recommended that S.K. undergo formal
evaluation with an allergist and pediatric dermatologist, and Petitioner was encouraged to
continue to have S.K. vaccinated.

        On January 22, 2014, S.K. saw Dr. Ronald Jorgensen, of the Arizona Asthma and
Allergy Institute. A physical examination revealed a large dry patch on S.K.’s right leg and
some dry skin on her arms and legs. Dr. Jorgensen recommended testing of vaccines prior to the
administration of the vaccines. He suggested that S.K. take a skin prick and intradermal test of
the DTaP vaccine. After the skin prick test, if it was found that those were tolerated, he
suggested following up with a one-tenth dose, followed by the remainder of the dose. Dr.
Jorgensen also suspected S.K. might be allergic to eggs, so he instructed petitioner to avoid eggs
and egg-based vaccines and prescribed an Epi Pen Jr. as a precaution.

        On January 29, 2014, Dr. Jorgensen gave S.K. a skin prick test of the DTaP vaccine.
Following the test, S.K exhibited a raised wheal of 3 x 4 mm, and an erythema flare 10 x 15 mm
in size. Dr. Jorgensen interpreted these results as a positive allergic reaction to the DTaP vaccine
and advised petitioner to avoid Diphtheria-Tetanus-containing vaccines in the future.

        Then, on February 19, 2014, S.K. received a skin prick test of the IPV vaccine, again by
Dr. Jorgensen. The skin prick test of the IPV vaccine showed no reaction. S.K. was then given
an intramuscular injection with a one-tenth dose of IPV, which generated a wheal 3 x 3 mm in
size, and an erythema flar5 x 9 mm in size. Dr. Jorgensen concluded S.K. was likely allergic to

       5
        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
both the DTaP and IPV vaccines and advised against receiving further vaccinations for at least
six months.

        S.K.’s nine-month well-baby visit was on April 24, 2014. The medical records showed
that S.K.’s physical examination was negative for pruritis, rash, and skin lesions, and positive for
atopic dermatitis and severe allergies to eggs, oats, and vaccines. At her twelve-month well-
baby visit on July 29, 2014, the same findings were noted.

           B. Procedural Background

        Petitioner filed a petition for compensation under the Vaccine Act on August 12, 2016,
alleging that S.K. experienced a server adverse reaction (including some developmental
seqeulae) to several vaccines that she received on September 18, 2013. On July 17, 2017,
Petitioner filed a second amended petition claiming that the S.K.’s exposure to the Hepatitis B
vaccine on August 21, 2013, caused her to develop atopic dermatitis, and that the subsequent
vaccinations for Diphtheria, Tetanus, acellular Pertussis (“DTaP) and inactivated polio (“IPV”)
administered on September 18, 2013, significantly aggravated her skin condition.

        In support of her claims, Petitioner submitted expert reports from Dr. David Axelrod, a
clinical immunologist, and Dr. Schield Wikas, a board-certified dermatologist. Petitioner also
relied on the medical reports by S.K.’s treating dermatologist, Dr. Jorgensen. In response,
Respondent submitted expert reports from Dr. Francis Lobo, a clinical immunologist, and Dr.
Jonathan Spergel, a board-certified allergist and immunologist. Both parties also submitted
various amounts of scientific and medical literature in support of their positions.

        On March 18, 2019, Petitioner advised the Chief Special Master that she elected to move
for a ruling on the record, rather than proceeding with a hearing. On May 16, 2019, Petitioner
filed a motion for decision on the record. Respondent filed his responsive brief on July 11, 2019;
Petitioner filed her reply on August 14, 2019. On April 20, 2020, the Chief Special Master
issued his ruling on entitlement (“Dec.”).

         After summarizing the cases’ factual and procedural history, the Chief Special Master
provided an extensive description of the credentials, reports and the medical and scientific
literature relied upon by the experts. He also set forth the legal standards for his review of the
experts’ opinions, for his review of the medical and scientific literature, and for Petitioner to
establish causation and significant aggravation.

        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 turned on whether the
Hepatitis B vaccine could cause atopic dermatitis in the manner proposed, whether it did, and
whether S.K.’s onset was within a medically acceptable timeframe. To answer these questions,
the Chief Special Master first focused on the issue of causation analyzing the claim under the
three prongs as set forth in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.
2005). He then focused on Petitioner’s second claim–significant aggravation–analyzing that

                                                  4
claim to see if it met the required six prong test as set forth in Loving v. Sec’y of Health &
Human Servs., 86 Fed. Cl. 135 (2009).

         In accordance with his analysis, the Chief Special Master concluded that petitioner had
not preponderantly satisfied any of the Althen prongs for her first claim. In his analysis, the
Chief Special Master held that the vaccine might be associated with atopic dermatitis. Dec. at
26. He further found that some of the literature filed in the case by Petitioner supported the
conclusion that the vaccine could trigger the allergic reaction. Id. However, Respondent filed
literature as well, to which the Chief Special Master weighed against Petitioner’s literature. This
analysis led to the finding that Respondent’s literature failed to overcome Petitioner’s showing.
Id. at 27.

        Not relying solely on the literature, the Chief Special Master then focused on a 2008
epidemiological study, Grüber, and its conclusion that the vaccination did not pose an increased
risk for either the development or exacerbation of atopic dermatitis. Id. This study was not
rebutted by Petitioner. Id. In the end, the Chief Special Master then concluded that taken
together–both the Respondent’s literature and the Grüber study–that evidence sufficiently
rebutted Petitioner’s evidence and therefore Petitioner did not satisfy Althen prong I. Id.

        Similarly, the Chief Special Master found that Petitioner did not offer preponderant
evidence to satisfy the second prong of Althen—requiring a logical sequence between cause and
effect between the alleged injury and the vaccine received. Id. In particular he noted the
following: that S.K. had received the Hepatitis B shot at birth and did not have any adverse
reaction, that the second dose was administered and not until six days later did S.K begin
exhibiting dermatological symptoms which was not diagnosed until a month later as atopic
dermatitis, and that no allergy testing was done for the Hepatitis B vaccine. Id. He therefore
concluded that “there was insufficient evidence that S.K. was allergic to the Hepatitis B
vaccine.” Id. For those reasons, the Chief Special Master found that the Petitioner had not
satisfied her burden under Althen prong 2.

        And finally, with regard to the third prong, the Chief Special Master found that even if
Petitioner had satisfied Althen prongs 1 and 2, Petitioner’s claims would fail under the third
prong stating:

         Respondent’s experts, along with 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 was inconsistent with the most scientifically reliable/medically acceptable
         timeframe
Id. at 27-28. (emphasis in the original). The Special Master did not credit Petitioner’s
argument for a longer timeframe as presented by her expert Dr. Axelrod. Id. at 28.

                                                  5
        Thereafter, the Chief Special Master analyzed the remaining three factors under Loving.
Again, the Chief Special Maser found that Petitioner had not satisfied any of those elements,
either. First, he found that the Petitioner had not provided a reliable theory of causation. He
analyzed the literature provided by Petitioner in his decision but found that the Grüber study was
“especially difficult to overcome.” Id. at 29. Petitioner did not rebut this study, “an
epidemiologic study that goes directly to [Petitioner’s] central contentions.” Id. He further
noted that “a petitioner need not offer epidemiologic evidence to prevail,” id. (emphasis in the
original), but that he could consider relevant studies that relate to a claim. Id. Epidemiologic
studies, he noted, are “entitled to evidentiary weight.” Id. Therefore, relying on the study, the
Chief Special Master concluded that:

             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.
Id. at 30.

       Next, the Chief Special Master held that Petitioner was able to show that S.K.’s atopic
dermatitis worsened after vaccination but that she did not prove that it worsened due to the
vaccination. Id. at 30. First, relying again on the Grüber study, the Chief Special Master held:

             . . . 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.
Id. The Chief Special Master also reviewed the medical records finding that the record did not
otherwise persuasively link the DTaP or IPV vaccines to S.K.’s worsening. The Chief Special
Master reviewed the evidence presented by Petitioner. He then reviewed Drs. Lobo and Spergel
expert reports finding that their reports raised reasonable points about the reliability of Dr.
Jorgensen’s testing results. Id.

       And finally, with regard to the final and sixth Loving factor, the Chief Special Master
found that Petitioner had met her burden. Id. at 32. However, the Chief Special Master wrote:

             But despite these findings, Petitioner has not provided sufficient evidence to
             carry her burden; especially when rebutted with the epidemiological evidence

                                                      6
         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 expert, Dr. Spergel.
         Thus, I find that Petitioner has failed to meet her overall burden under Loving.

       In finding that Petitioner had not satisfied Althen or Loving, the Chief Special Master
denied Petitioner’s request for compensation.

         Thereafter, Petitioner timely filed a motion for review on May 20, 2020 and Respondent
filed a response on June 19, 2020. Petitioner then filed a motion to file a reply brief on June 26,
2020. Respondent did not object. Therefore, the Court GRANTS Petitioner’s motion to file a
reply brief. The case is now ripe for decision.

   II.     Discussion

           A. Standard of Review

         Under the Vaccine Act, a court may set aside a Special Master’s findings of fact or
conclusions of law only if they are found to be “arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B). With respect to findings
of fact, the special master has broad discretion to weigh expert evidence and make factual
determinations. See Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir.
1993). “If the special master has considered the relevant evidence of the record, drawn plausible
inferences and articulated a rational basis for the decision, reversible error will be extremely
difficult to demonstrate.” Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1528 (Fed.
Cir. 1991). This Court ought not to second-guess the Special Master’s fact-intensive
conclusions, particularly in cases “in which the medical evidence of causation is in dispute.”
Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). In such cases,
which often involve expert testimony, the Federal Circuit has “unambiguously explained that
special masters are expected to consider the credibility of expert witnesses in evaluating petitions
for compensation under the Vaccine Act.” Porter v. Sec’y of Health & Human Servs., 663 F.3d
1242, 1250 (Fed. Cir. 2011). “Such credibility determinations are ‘virtually unreviewable’” on
appeal. Id. at 1251. With respect to questions of law, legal rulings are reviewed de novo under
the “not in accordance with law” standard. See, e.g., Moberly v. Sec’y of Health & Human
Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Munn v. Sec’y of Health & Human Servs., 970
F.2d 863, 870 n.10 (Fed. Cir. 1992).

           B. Legal Standards

        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—

                                                 7
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, 592 F.3d at 1321; Capizzano v. Sec’y of Health & Human
Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006). In this case, Petitioner does not assert a Table
claim; therefore, the claims are analyzed under the standard as set forth for a non-table injury.

        “In off-Table cases . . . it is the petitioners’ burden to prove actual causation by a
preponderance of the evidence.” Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351,
1359 (Fed. Cir. 2019) (citing Moberly, 592 F.3d at 1322). To establish entitlement to an award
of compensation for a non-Table injury, a petitioner must show that the vaccine brought about
the injury, by providing:

          (1) a medical theory causally connecting the vaccination and the injury; (2) a
          logical sequence of cause and effect showing that the vaccination was the
          reason for the injury; and (3) a showing of a proximate temporal relationship
          between vaccination and injury.

Althen, 418 F.3d at 1278. Petitioner’s burden to show a proximate temporal relationship means
“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. 008). That is, the
time between vaccination and onset of symptoms must be consistent with petitioner’s proposed
theory of causation under Althen prong I. Id. at 1352.

        When a petitioner alleges a significant aggravation of a pre-existing condition, she must
satisfy each of the three Althen prongs, but must also adduce evidence 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), and (3) whether the person’s current condition [or condition
         following the vaccination] constitutes a ‘significant aggravation’ of the person’s
         condition prior to vaccination.

Loving, 86 Fed. Cl. at 144.

           C. Petitioner’s Objections

        When evaluating a motion for review, as stated above, it is the Court’s task to determine
whether the Special Master, or in this case, the Chief Special Master, properly considered the
relevant evidence in the record before him, came to factual conclusion based on plausible
inferences, and provided a reasoned explanation for his conclusion and decision. Hines, 940
F.2d at 1528. It is not the Court’s task to second-guess the Special Master, especially in cases
“in which the medical evidence of causation is in dispute.” Hodges, 9 F.3d at 961. Thus, on
review, the Court accords deference to the Chief Special Master’s factual findings and fact-based
conclusions.

                                                  8
        Nevertheless, the majority of Petitioner’s memorandum expresses general disagreement
with the Chief Special Master’s evaluation and weighing of the evidence. Specifically,
Petitioner argues four points of error by the Chief Special Master. First, Petitioner alleges that
the Chief Special Master should have afforded greater weight to S.K.’s treating dermatologist.
Second Petitioner contents that the Chief Special Master should have found Petitioner’s evidence
on Althen prong I ultimately persuasive. Third, Petitioner argues that her expert witness’s
testimony, that six days from exposure to onset of symptoms, is a medically reasonable
timeframe. Fourth, and final, Petitioner argues that Petitioner’s evidence in support of her
significant aggravation claim was persuasive under Loving.

       In light of the Chief Special Master’s detailed and reasoned decision, this Court
concludes that none of these arguments provides a basis for this Court to set aside the Chief
Special Master’s Decision.

               1. The Challenged Findings of Fact were Not Legal Error

        In her first objection, Petitioner contends that the Chief Special Master committed legal
error by giving insufficient deference to S.K.’s treating dermatologist. Specifically, Petitioner
asserts that:

           •   The Chief Special Master minimized the multiple important pieces of evidence
               submitted by Dr. Jorgenson, the treating physician;

           •   The Chief Special Master erred by not giving Dr. Jorgensen credible
               deference for his opinions as he was S.K.’s treating physician and in the
               best position to determine the factual and medical issues surrounding
               vaccination and treatment, including onset of relevant symptoms and
               causation assignment citing Andreu v. Sec’y of Health & Human Servs.,
               569 F.3d 1367 (Fed. Cir. 2009); Zatuchni v. Sec’y of Health & Human
               Servs., 69 Fed. Cl. 612, 623 (2006);

           •   The Chief Special Master should have found that the testimony by Dr. Jorgensen
               that S.K. should not undergo further immunizations supported vaccine causation
               citing to Kelley v. Sec’y of Health & Human Servs., 68 Fed. Cl. 84, 98, 100
               (2005); Andreu v. Sec’y of Health & Human Servs., No. 98-817V, 2008 WL
2009746 (Fed. Cl. Mar. 3, 2008).

        A good portion of Petitioner’s motion for review is her disagreement with the Chief
Special Master’s determination that Respondent’s expert witness was more persuasive than
S.K.’s treating dermatologist, Dr. Jorgensen.

        Turning to the decision, the Chief Special Master discussed the medical records provided
by Dr. Jorgensen by setting forth a summary of Dr. Jorgensen’s allergy testing and treatment of
S.K. and noted his conclusion that S.K. was likely allergic to both DTaP and IPV vaccines. Dec.

                                                 9
at 4-5. According to Petitioner, this should have resulted in the Chief Special Master finding her
witness more persuasive.

         However, the Chief Special Master then considered the contradictory expert reports of
Dr. Lobo and Dr. Spergel. Specifically, the Chief Special Master noted that both Dr. Lobo and
Dr. Spergel’s reports indicated that S.K. could not exhibit an allergic reaction to the antigenic
components of a vaccine she had not previously encountered, because a prior exposure is
required to generate the antibodies that cause an allergic reaction upon a subsequent exposure.
Id. at 9-10, 11. The Chief Special Master further discussed that both Dr. Lobo and Dr. Spergel
raised issues concerning the reliability of Dr. Jorgensen’s allergy testing results. Dr. Lobo
opined S.K.’s skin testing results were not interpreted in a manner consistent with diagnostic
protocol. Id. at 10. Dr. Spergel explained individuals with atopic dermatitis experience higher
rates of sensitizations and other immune-mediated inflammatory diseases. Id. at 12. Given this
predisposition, as well as S.K.’s erythematous reaction to the saline control, and the fact S.K.
experienced an erythematous as opposed to the anaphylactic response to the vaccine itself, Dr.
Spergel opined S.K.’s skin prick test results most likely evidenced an irritant reaction as opposed
to a true positive allergic reaction. Id. at 12-13.

       Weighing all the evidence, ultimately, the Chief Special Master found Dr. Jorgensen’s
conclusion unpersuasive, explaining:

             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 [ ], 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 [2013], 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).
Id. at 31.

        Thus, the Court holds that the opinions of Dr. Lobo and Dr. Spergel provide evidentiary
support for the Chief Special Master’s findings in this case, including his determination not to
credit Dr. Jorgensen’s medical conclusions. 6 It is clear that the Chief Special Master thoroughly

        6
         In a footnote, Petitioner argues that the treating physician records should negate the
experts’ testimony relying on Capizzano, 440 F.3d at 1324. However, “there is nothing . . . that
mandates that the testimony of a treating physician is sacrosanct – that it must be accepted in its
                                                     10
evaluated and weighed the evidence of record submitted, but was not persuaded by Petitioner’s
evidence in light of the greater weight of contrary evidence. Therefore, the Court holds that the
Chief Special Master did not commit legal error, nor was his decision arbitrary or capricious. 7

               2. The Special Master Did Not Err In His Determination That Petitioner
                  Did Not Meet Her Burden of Proof Under Althen Prong I

        In her second objection, Petitioner challenges the factual determination by the Chief
Special Master that the epidemiological study involving 2184 children aged 1-2—the Grüber
study—provided by the Respondent was persuasive. Instead, Petitioner argues that: “Despite []
S.K.’s compelling evidence presented in the form[] of testing, letters, experts’ opinions, and
photographs of the damage done to her, the Special Master, for unknown reasons, gave that piece
of ‘paper’ [the Grüber study] substantial weight. . . ” ECF No. 57 at 13. Moreover, Petitioner
argues that her experts provided a plausible theory. By not accepting her theory, Petitioner
asserts that the “Chief Special Master expects her to prove the specific biological mechanism of
injury well beyond legal probability.” Id. at 17.

         In her reply brief, Petitioner directs this Court’s attention to Andreu and its holding that
“[w]hile considerable deference must be accorded to the credibility determinations of special
masters, this does not mean that a special master can cloak the application of an erroneous legal
stand in the guise of a credibility determination, and thereby shield it from appellate review.”
ECF No. 62 at 4 citing Andreu, 569 F.3d at 1379. According to Petitioner, “the Chief Special
Master cloaked his inappropriately high burden of proof and refusal to accept the mechanism of
injury in a credibility determination.” ECF No. 62 at 5-6. “This warrants reversal.” Id. at 6. In
support, Petitioner argues that she has produced a well-qualified expert immunologist (Dr.
Axelrod), a well-qualified expert dermatologist (Dr. Wikas), and a well-qualified treating
physician (Dr Jorgensen). Id at 4. Petitioner further points out that Respondent did not produce
an expert in dermatology and argues that Respondent did not counter Dr. Wikas’s testimony. Id.
at 4-5. Nor, argues the Petitioner, does the Chief Special Master discuss “why Dr. Axelrod or
Dr.Wikas were less ‘credible.’” Id. at 5. And finally, Petitioner complains that because the case
did not go to a live hearing, the credibility determination seemed to have “boiled down to the
CV’s and expert reports.” Id. at 4.

        The Court turns to the last argument first and notes that it was Petitioner who requested
the matter be decided on the papers. Thus, the Court is confused when she complains that the
credibility determination turned on the CV’s and expert reports. Of course, that was what was
before the Chief Special Master and that is what he reviewed. When a case is submitted on the
papers, that is exactly what a court turns to in order to decide a case. However, the Chief Special
Master did not only look at the CV’s and expert reports. In his decision, the Chief Special
Master acknowledged Petitioner’s literature as well. Indeed, in his decision he writes:

entirety and cannot be rebutted.” Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706,
745-746 n.67. The Chief Special Master was under no legal obligation to credit Dr. Jorgensen’s
findings, and his decision not to credit those findings is supported by evidence in the record.
       7
         The Chief Special Master also articulated alternative causation findings, i.e.
breastfeeding, but the Court need not address this issue in light of its analysis.
                                                 11
         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 . . . 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. … [and that]
         there exists merely a handful of studies—some of which do find a causal
         relationship between vaccines and atopic dermatitis . . .”

Dec. at 26-27. Thus, it is clear that the Chief Special Master also reviewed the literature and
medical studies that were filed by the parties.

        Here, the Chief Special Master’s finding that Petitioner failed to meet her burden on
causation turned in large part on his assessment of the witnesses’ respective credibility. Contrary
to Petitioner’s argument that the Chief Special Master did not explain why her witnesses were
less credible, his decision explained this determination. For instance, with regard to Dr. Wikas
he wrote:

          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 her September 18, 2013 which he considered direct evidence
         of a causal association.
Id. at 8-9. Then, in a footnote, the Chief Special Master noted that:

         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.
Id. at 8 fn. 13. With regard to Dr. Axelrod, the Chief Special Master wrote:

         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

                                                 12
            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.
Id. at 7.

       Noting that Dr. Spergel was not board-certified in dermatology, the Chief Special Master
noted however that Dr. Spergel had “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 12. He also noted that Dr. Spergel had also
published numerous articles and presented on the topics of allergy, immunology, and atopic
dermatitis. Id. He further noted Dr. Spergel’s conclusion:

            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. 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. (internal citations omitted).

        Thus, after weighing this evidence, the Chief Special Master was able to conclude:

            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 expert, Dr. Spergel.
Id. at 32-33. The Chief Special Master fully weighed each of the experts’ testimony and his
finding that Petitioner’s experts were less credible in their opinions concerning causation is
supported by the record.

        Furthermore, merely positing a possible or plausible theory is insufficient to satisfy a
petitioner’s burden under Althen prong I. Boatmon, 941 F.3d at 1360 (holding special master
erred in allowing a theory that was at best “plausible” to satisfy petitioner’s burden of proof).
Although a Vaccine Act claimant is not required to present proof of causation to the level of
scientific certainty, the special master is entitled to require some indicia of reliability to support
the assertion of the expert witness. Daubert is not required, but reliability and reputability are.
Id. at 1360 (internal citations omitted).

       In this case, Respondent offered an epidemiological study as well. Although, as noted by
the Chief Special Master, a Petitioner is not required to offer epidemiological studies; a Special

                                                   13
Master may, however, consider studies presented that bear on a claim and afford them
evidentiary weight. Dec. at 29; see also, Andreu, 569 F.3d at 1379. Here, the Chief Special
Master weighed the Grüber study against evidence presented by Petitioner and determined that
the Grüber study was “very persuasive” and “worthy of substantial weight.” Dec. at 27. In
coming to this conclusion, the Chief Special Master noted that: (1) the Grüber study involved
over two thousand children, (2) the study focused on children who were at high risk of
developing atopic dermatitis, or who already suffered from it, and (3) the study “dealt
specifically with the propensity of vaccines to cause or exacerbate atopic dermatitis” – issues the
chief special master observed “go[] directly to [petitioner’s] central contentions in this case.” Id.
at 27, 29. Thus, in support of these findings, the Chief Special Master explicitly gave the
reasons for his reliance on the Grüber study, rather than the literature and medical studies
provided the Petitioner.

       And finally, the Chief Special Master did not apply a heightened burden to her claim.
The Chief Special Master thoroughly evaluated the evidence of record, including Drs. Axelrod
and Wikas opinions regarding vaccine causation, and found that Petitioner failed to show that the
vaccines S.K. received more likely than not caused her injury.

        Again, as this Court ought not to second-guess the Special Master’s fact-intensive
conclusions, particularly in cases “in which the medical evidence of causation is in dispute,”
Hodges, 9 F.3d at 961, the Court will not do so here. The Federal Circuit has “unambiguously
explained that special masters are expected to consider the credibility of expert witnesses in
evaluating petitions for compensation under the Vaccine Act.” Porter, 663 F.3d at 1250. The
relevant inquiry for this Court is whether the special master weighed the evidence in the record
and explained why he assigned more weight to some evidence rather than to other evidence.
And that is exactly what the Chief Special Master did; and he concluded that Dr. Spergel was
more persuasive than Drs. Axelrod and Wikas. This conclusion was supported by evidence and
therefore not improper.

               3. The Decision That Six Days Was Not An Appropriate Framework Was
                  Not Error

        In her third argument, petitioner again challenges the Chief Special Master’s weighing of
the evidence. Petitioner asserts: “Chief Special Master Corcoran’s analysis directly contradicts
the expert testimony of Petitioner’s immunologist, Dr. Axelrod,” who “clearly explained the
appropriateness of timing in S.K.’s case. . . . Therefore, the Special Master erred in holding that
this timeframe was too long . . . .” ECF No. 57 at 18.

        However, the Chief Special Master explained in detail the evidence he relied on in
rejecting Dr. Axelrod’s conclusion that six days was a medically reasonable timeframe for S.K.’s
onset of symptoms following her Hepatitis B vaccination. In his Decision, the Chief Special
Master first noted, “Respondent’s experts, along with 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.” Dec. at 27-28 (citing
Chung at 51; Wood at 521-22). He then reasoned that S.K.’s onset approximately six days
following exposure “is inconsistent with the most scientifically reliable/medically acceptable

                                                 14
timeframe.” Id. at 28. The Chief Special Master further explained that one of the articles Dr.
Axelrod submitted to support his opinion that adaptive immune responses to an allergen can
occur for up to twenty-five days, did not appear to actually support that position. Id. Thus, it is
clear, that the Chief Special Master’s finding is supported by evidence in the record; therefore, it
will not be disturbed.

       4. The Chief Special Master’s Determination That Petitioner Did Not Satisfy Her
       Burden Under Loving Is Supported By Evidence In The Record, Therefore, The
       Determination Was Neither Arbitrary Nor Capricious.

        It is true, as Petitioner asserts, that she produced literature that supports the conclusion
that the IPV and DTaP vaccines could, at least transiently, aggravate existing atopic dermatitis.
Id. at 29. However, the Chief Special Master found the Grüber study persuasive evidence in
opposition to this contention. Id. He further found that Respondent “offered credible and
persuasive testimony that (coupled with the filed literature) substantially detracted from
Petitioner’s proffered theory.” Id. at 30. The Chief Special Master also found that Respondent’s
experts “raised reasonable points about the reliability of Dr. Jorgensen’s testing results” finding
that he did not find Dr. Jorgensen’s conclusions persuasive. Id. at 31. And he explained that he
found respondent’s expert, Dr. Spergel, more credible than petitioner’s experts. Id. at 32-33.
Therefore, the Court holds that the Chief Special Master’s findings are grounded in the record,
and thus not arbitrary or capricious.

       IV. Conclusion

        Petitioner has failed to point to any other evidence in the record to show that the findings
were not substantiated by the record. As long as the special master’s findings of fact are “based
on evidence in the record that [is] not wholly implausible, [this Court is] compelled to uphold
that finding as not being arbitrary or capricious.” Cedillo, 617 F.3d at 1338. By her own
arguments, Petitioner essentially concedes that the Chief Special Master weighed the evidence in
the record. Petitioner does not contend his findings are wholly without evidentiary support.
Rather, she maintains respondent’s evidence was afforded too much weight, and Petitioner’s
evidence too little. The relevant inquiry, however, is whether the Chief Special Master’s factual
determinations are based on evidence in the record. The Court holds that the Decision itself
reflects that they are.

       For the reasons stated above, the court DENIES Petitioner’s motion for review and
SUSTAINS the decision of the Chief Special Master. The Clerk is directed to enter judgment
accordingly.

        In addition, pursuant to Vaccine Rule 18(b), the parties shall review this decision and
submit any proposed redactions, by providing the Court with redlined pages showing the
redactions, within 14 days from the date of this Opinion and Order.

                                                 15
IT IS SO ORDERED.
                         s/Edward J. Damich
                         EDWARD J. DAMICH
                         Senior Judge

                    16