Duncan v. Secretary of Health and Human Services

IN THE UNITED STATES COURT OF FEDERAL CLAIMS
___________________________________
)
JACQUELINE M. DUNCAN, )
)
Petitioner, )
)
v. ) No. 16-1367V
)
SECRETARY OF HEALTH AND ) Originally Filed: April 19, 2021
HUMAN SERVICES, ) Re-issued: May 4, 2021
)
Respondent. )
___________________________________ )
OPINION AND ORDER 1
Petitioner Jacqueline M. Duncan seeks review of a decision denying her request for vaccine
injury compensation. Ms. Duncan filed her petition in October 2016 pursuant to the National
Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10 et seq. (the “Vaccine Act”), alleging
that a human papillomavirus (“HPV”) vaccine she received on October 28, 2013 significantly
aggravated her Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal
Infections (“PANDAS”). In October 2020, the Special Master dismissed her petition for
insufficient proof. He determined that after four years of attempting to develop her case Ms.
Duncan had failed to present “minimally competent evidence to substantiate her claim.” Decision
Den. Comp. at 1, ECF No. 107. Ms. Duncan timely filed a Motion for Review before this Court,
raising primarily procedural objections to the Special Master’s decision.
For the reasons that follow, the Court DENIES her motion.
1 The Court originally issued this opinion under seal on April 19, 2021 and allowed the
parties 14 days from the date of filing to object to the public disclosure of any information
furnished by that party. Neither party proposed any redactions, and thus the opinion is publicly
released in full.
I. BACKGROUND
A. Factual History
1. Ms. Duncan’s Pre-Vaccination Condition
Ms. Duncan was born on February 5, 1997. Petr.’s Pet. ¶ 2, ECF No. 1. Prior to receiving
the HPV vaccine, she had a number of significant events in her medical history. Ms. Duncan
averred that in her early teens she began to struggle with “serious and repeated bouts [of] strep and
tonsil problems.” Id. ¶ 5. Due to this history, her doctor recommended a tonsillectomy, which she
underwent in November 2011. Petr.’s Ex. 25 (Rochester General Hospital Records) at 30–31,2
ECF No. 9-21. Ms. Duncan was then in the ninth grade. ECF No. 1 ¶ 5. Unfortunately, her post-
operative recovery was complicated. She missed at least a month of school and developed “severe
headaches, fatigue, [and] weakness” following her surgery. Id.; see Petr.’s Ex. 23 (Records of Dr.
Alice Tariot) at 11, ECF No. 9-19; see also Petr.’s Ex. 5 (Step By Step Academy Records) at 35,
ECF No. 9-1 (noting a “3 month healing process”).
Ms. Duncan’s medical records document that her complaints of aches and pains pre-dated
her tonsillectomy, beginning in the eighth grade. ECF No. 9-19 at 55. Around the same time, she
began to refuse to attend school due to anxiety and depression. ECF No. 9-1 at 35. Per a report
from her psychiatrist, these symptoms worsened following her November 2011 surgery. ECF No.
9-19 at 70. After episodes of self-injurious behavior, she was admitted in April 2012 to an
intensive, multiweek outpatient psychiatric program and discharged with diagnoses of generalized
anxiety disorder, bipolar disorder, and complaints of aches and pains. Id.; see ECF No. 9-1 at 35.
With additional outside counseling, Ms. Duncan eventually was able to return to school
and joined the cheerleading squad during her sophomore year. ECF No. 9-1 at 35; see ECF No. 1
2 Citations to Petitioner’s exhibits refer to the ECF page number of the relevant document.
2
¶ 7. In October 2012, however, she suffered a concussion during cheerleading practice. Petr.’s
Ex. 27 (Records of Dr. Sharada Menon) at 25, ECF No. 24-1; see ECF No. 1 ¶ 7. Ms. Duncan
claims that her head injury worsened her condition. ECF No. 1 ¶ 7; see ECF No. 24-1 at 22
(reporting headache, throbbing pain, nausea, and sensitivity to light two months after concussion).
In the months prior to receiving the HPV vaccine, Ms. Duncan’s records show that she was taken
to an urgent care for chest pain and reported feeling sick and tired. ECF No. 24-1 at 17.
2. Ms. Duncan’s Post-Vaccination Condition
On October 28, 2013, Ms. Duncan received the HPV vaccine.3 Both Ms. Duncan and her
mother claimed that Ms. Duncan experienced severe symptoms “within a few days” of the
injection. Aff. of Jacqueline M. Duncan ¶ 17, ECF No. 1-2; see Aff. of Khrystine Duncan ¶ 16,
ECF No. 1-3. These symptoms included “horrible fatigue, joint pain, headaches,” “electric
shocks” through her body, cold and grayish-blue skin, and the feeling of “bee stings.” ECF No.
1-2 ¶ 17. Ms. Duncan alleged that her fatigue and physical difficulties became “five times worse
than they were before the [HPV vaccine].” Id. ¶ 20.
Ms. Duncan did not identify any medical records created at or immediately after the time
of her vaccination that document these extreme symptoms. Based on the Court’s review, Ms.
Duncan was seen by her primary care physician on November 13, 2013 for complaints of stomach
pain, sore throat, and fatigue for three days. ECF No. 24-1 at 12. Her doctor diagnosed her with
an unspecified viral infection. Id. Ms. Duncan also was seen on January 2, 2014 for sore throat,
headache, body ache, and left ear pain for two weeks. Id. at 11. She was assessed as having acute
3 This was Ms. Duncan’s second dose of the HPV vaccine, the first having been
administered in 2011 with no negative side effects. ECF No. 1 ¶ 8. She does not allege that her
first dose contributed to a worsening of her condition. Unless otherwise specified, all references
to the HPV vaccine in this opinion refer to the vaccine she received in October 2013.
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sinusitis. Id. However, on January 14, 2014, Ms. Duncan presented at Rochester General
Hospital’s emergency room with complaints of “‘bee stings all over [her] body,’” fatigue,
weakness, nausea, dizziness, chest pain, and anxiety. Petr.’s Ex. 24 (Rochester General Hospital
Records) at 10, ECF No. 9-20; see ECF No. 24-1 at 10. She described a “sudden onset” of shooting
nerve pain that evening. ECF No. 9-20 at 10. She also reported having a virus, sinus infection,
and ear ache the week prior and sleep problems “‘for [the] past couple days.’” Id. Ms. Duncan
was discharged with diagnoses of nerve pain and dizziness. Id. at 14.
Following her emergency room visit, Ms. Duncan’s medical records document numerous
visits to a variety of practitioners. In January 2014, Ms. Duncan saw a rheumatologist at the
University of Rochester Medical Center. Petr.’s Ex. 8 (Records of Dr. Homaira Rahimi) at 2, ECF
No. 9-4. According to the medical history from the appointment, Ms. Duncan was “well until
about 2–3 years ago, when she began to develop fatigue and body pains.” Id. Ms. Duncan also
reported that “[a]bout 2 weeks ago” she “developed bee sting sensations on her body.” Id. at 3.
Dr. Rahimi diagnosed Ms. Duncan with reflex neurovascular dystrophy (“RND”), which was
described as analogous to fibromyalgia in adults. Id. at 2. Dr. Rahimi did not believe there was
evidence of an autoimmune condition. Id. at 6. In addition to counseling, Dr. Rahimi
recommended physical therapy for treatment of Ms. Duncan’s RND, id., which Ms. Duncan
participated in from February to April 2014, Petr.’s Ex. 26B (Strong Memorial Hospital Records)
at 6–7, ECF No. 9-23.
In February 2014, Ms. Duncan was evaluated by a specialist, Dr. Susan Schulman, and
diagnosed with PANDAS. ECF No. 24-1 at 125–128. Dr. Schulman believed that Ms. Duncan
has been suffering from undiagnosed PANDAS since 2010 (her eighth-grade year), which
worsened after her 2011 tonsillectomy. Id. at 125. Dr. Schulman began a protocol of antibiotics
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and vitamins and recommended intravenous immunoglobulin therapy. Id. at 129; see Petr.’s Ex.
7 (Records of Dr. Susan Schulman) at 2, ECF No. 9-3.
In 2014, Ms. Duncan moved with her family to Ohio before starting her senior year of high
school. ECF No. 1-3 ¶ 22. Ms. Duncan began seeing a new primary care physician, Dr. Lindsay
Wylie. ECF No. 1-2 ¶ 21. At her initial appointment with Dr. Wylie, Ms. Duncan discussed her
PANDAS diagnosis. Petr.’s Ex. 12 (Records of Dr. Lindsay Wylie) at 20, ECF No. 9-8. According
to Ms. Duncan, Dr. Wylie stated that Ms. Duncan’s prior strep and tonsillectomy problems could
have been aggravated by her HPV vaccine. ECF No. 1-2 ¶ 21. Dr. Wylie’s records document
several subsequent visits for Ms. Duncan’s complaints of, inter alia, sore throat, headache, ear
pain, abdominal pain, and night sweats. ECF No. 9-8 at 3, 5, 7, 10, 16.
Ms. Duncan also began seeing Dr. Allen Lewis in 2014. Based on lab work conducted in
February 2015, Dr. Lewis recommended treating Ms. Duncan for elevated levels of, inter alia,
Lyme and strep A. Petr.’s Ex. 9 (Records of Dr. Allen Lewis) at 14, ECF No. 9-5; see Petr.’s Ex.
10 (Integrative Pediatrics of Ohio Lab Results), ECF No. 9-6. Dr. Lewis noted that Ms. Duncan’s
symptoms worsened after she underwent an explorative laparoscopy in September 2015, ECF No.
9-5 at 5, including “a lot of neuropathy” and “bee sting type of sensations,” id. at 3. In addition to
other treatments, Dr. Lewis recommended a consult with Dr. Michael Joseph for Ms. Duncan’s
pain. Id. at 5. Ms. Duncan’s mother claimed that Dr. Lewis “felt that . . . both [Ms. Duncan’s]
PANDAS and Lyme were exacerbated or caused” by the HPV vaccine. ECF No. 1-3 ¶ 23.
Ms. Duncan had her initial visit with Dr. Joseph in March 2016. Petr.’s Ex. 28 (Records
of Dr. Michael Joseph) at 11, ECF No. 26. He noted Ms. Duncan’s history of tonsillectomy
followed by symptoms of anxiety, fatigue, physical sensitivity, and night terrors. Id. These
symptoms returned following Ms. Duncan’s concussion, and she reported “increased muscle
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spasms, fatigue, needle[] like pain, [and] drenching sweat.” Id. Dr. Joseph’s records document
her prior diagnoses of RND, PANDAS, and Lyme, as well as symptoms of “[r]ock hard muscles,
freezing feeling,” “[s]hock pain,” and “[f]atigue every day.” Id. Per a September 2016 medical
record, Ms. Duncan and her mother reported that they “had a revelation that her symptoms became
significantly worse after her [HPV] vaccine.” Id. at 55.
Aside from her physical condition, Ms. Duncan claimed her academic performance and
social activities declined after receiving the HPV vaccine in October 2013. ECF No. 1-2 ¶¶ 4, 9,
14; see ECF No. 1-3 ¶¶ 4, 9, 21, 22. Ms. Duncan’s mother alleged that following her 2011
tonsillectomy Ms. Duncan was unable to return to school for three months and required tutoring.
ECF No. 1-3 ¶ 9. Ms. Duncan’s school records show that in her freshman year (2011), before she
received the HPV vaccine, Ms. Duncan received only two credits because she did not pass most
of her courses. Petr.’s Ex. 29 (Wayne Central School District Records) at 1, ECF No. 28-1. Ms.
Duncan also was unable to return to dancing, an activity she previously participated in
competitively. ECF No. 1-3 ¶¶ 4, 9. Although Ms. Duncan alleged that she was able to return to
school during her sophomore year and participate in cheerleading, following her HPV vaccination,
she spent her junior year either at home with a tutor or in an alternative classroom for students
with special needs. ECF No. 1-2 ¶¶ 12, 14; see ECF No. 1-3 ¶¶ 12, 21. Ms. Duncan’s school
records show she received 4.5 credits during her junior year and had an unweighted GPA of 76.
ECF No. 28-1 at 1. Ms. Duncan took classes online during her senior year, receiving the highest
academic scores of her high school years and graduating in May 2015. ECF No. 1-3 ¶ 22; see
Petr.’s Ex. 30 (Olentangy Local School District Records) at 71, ECF No. 28 -2.
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B. Proceedings Before the Special Master
On October 19, 2016, Ms. Duncan filed a petition seeking vaccine injury compensation.
The petition alleged that the HPV vaccine Ms. Duncan received in October 2013 significantly
aggravated her underlying PANDAS. ECF No. 1 ¶ 10. Ms. Duncan subsequently filed medical
records and later a statement of completion on December 27, 2016. 4 Petr.’s Am. Statement of
Completion, ECF No. 17.
Based on the evidence submitted by Ms. Duncan, Respondent filed a Rule 4(c) report in
March 2017, concluding that she was not entitled to compensation. Respt.’s Rule 4(c) Report at
1–2, ECF No. 20. Respondent asserted, inter alia, that Ms. Duncan failed to provide a reliable
medical theory connecting the HPV vaccine to any medical conditions she allegedly suffered after
the vaccination. Id. at 8. Moreover, Respondent noted that, despite Ms. Duncan’s allegation that
she suffered severe symptoms within days, none of the contemporaneous medical records indicated
that Ms. Duncan became much worse in the weeks and months after her vaccination. Id. at 8–9.
In April 2017, Ms. Duncan filed a one-page letter from Dr. Joseph, stating his opinion that
the HPV vaccine “greatly exacerbated” Ms. Duncan’s symptoms. Petr.’s Ex. 31 (Letter of Dr.
Joseph) at 1, ECF No. 30-1. The Special Master determined, however, that Dr. Joseph’s letter did
not, by itself, establish that the HPV vaccine aggravated Ms. Duncan’s PANDAS. See ECF No.
107 at 2. To assist Ms. Duncan and her attorney, the Special Master proposed a set of instructions
to guide experts in the presentation of vaccine-related opinions, including specific topics that
should be discussed in each party’s expert reports. See Order (July 21, 2017), ECF No. 48; see
also Order Regarding Expert Reports (Aug. 8, 2017), ECF No. 49. In a series of status reports
4
Since filing her initial Statement of Completion, Ms. Duncan has on numerous occasions
supplemented her Exhibit List with a variety of additional materials and filed an additional
Amended Statement of Completion on May 12, 2017 (ECF No. 35).
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filed between September 2017 and August 2018, Ms. Duncan’s counsel reported difficulties
obtaining additional expert reports.5
Having not filed any additional or supplemental expert reports for over a year, the Special
Master held a status conference in September 2018. Order (Sept. 28, 2018) at 1, ECF No. 77. Ms.
Duncan’s counsel stated during the conference that he was attempting to obtain an opinion from a
biomedical engineer, as well as a treating physician. Id. The Special Master explained that
opinions from individuals without medical degrees are uncommon in the Vaccine Program and
generally less persuasive. Id. The Special Master set a deadline for Ms. Duncan to submit any
expert reports, and he warned that further delay could result in a show cause order. Id.
In November 2018, Ms. Duncan submitted a report from Dr. James Lyons-Weiler. Petr.’s
Ex. 39 (Expert Report of Dr. Lyons-Weiler), ECF No. 78. Dr. Lyons-Weiler opined that the “HPV
vaccination can significantly aggravate PANDAS through molecular mimicry .” Id. at 4. He
explained that the adjuvant in the vaccine can “caus[e] the immune system to mount an attack
against foreign proteins that are co-present at the time of immunization, e.g., chronic or repeated
Strep-A infection.” Id. at 4–5. Dr. Lyons-Weiler opined to a “reasonable degree of scientific
probability” that the HPV vaccine caused a significant aggravation of Ms. Duncan’s PANDAS.
Id. at 1. At a subsequent status conference, the Special Master noted several substantive
deficiencies with Dr. Lyons-Weiler’s report and ordered supplemental information. Order (Feb.
5 For example, Ms. Duncan filed status reports on September 22, 2017 (ECF No. 53)
(advising that Dr. Joseph and Dr. Wiley were not responsive to counsel’s request for expert
reports); November 7, 2017 (ECF No. 55) (advising that counsel was attempting to retain an expert
in immunology); December 5, 2017 (ECF No. 61) (reporting that the immunologist retained by
counsel would not be able to provide a report in compliance with the instructions); April 9, 2018
(ECF No. 68) (documenting unsuccessful efforts to retain other experts); May 11, 2018 (ECF No.
70) (same); June 11, 2018 (ECF No. 72) (same); July 11, 2018 (ECF No. 7 4) (same); and August
27, 2018 (ECF No. 76) (same).
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22, 2019) at 1, ECF No. 79. The Special Master also set a deadline for an expert report of a treating
physician or other medical doctor. Id.
After requesting several enlargements of time, all of which were granted, Ms. Duncan filed
a supplemental report by Dr. Joseph in November 2019. Petr.’s Ex. 58 (Expert Report of Dr.
Michael Joseph), ECF No. 96-1. Like Dr. Lyons-Weiler, Dr. Joseph also articulated a molecular
mimicry theory, explaining that the adjuvant in the HPV vaccine caused Ms. Duncan’s immune
system to overreact and fight against her own cells. Id. at 3. In his opinion, this caused a significant
aggravation of her PANDAS symptoms. Id. In December 2019, the Special Master held a status
conference to discuss several deficiencies with Dr. Joseph’s report. See Order to Show Cause at
3, ECF No. 97. Given these deficiencies and the “extended amount of time it took petitioner to
submit [Dr. Joseph’s] expert report,” id. at 3, on February 24, 2020, the Special Master issued an
Order to Show Cause why Ms. Duncan’s petition should not be dismissed for failure to present “a
credible, competent, and complete opinion in support of her claim that the HPV vaccination
significantly aggravated her PANDAS,” id. at 4.
After missing the deadline to respond to the show cause order, and then receiving a 60-day
enlargement of time, Ms. Duncan submitted her response on July 20, 2020, arguing that her case
should not be dismissed. Petr.’s Resp. to Ct.’s Feb. 24, 2020 Order to Show Cause, ECF No. 101.
She also provided additional exhibits in support of her petition, including a supplemental report
by Dr. Lyons-Weiler. Petr.’s Ex. 66 (Supplemental Report of Dr. Lyons-Weiler), ECF No. 102-
8. She did not file a motion for a ruling on the record, as she indicated she would in her
enlargement motion. Respondent filed a reply to Petitioner’s response on August 24, 2020. Reply
to Petr.’s Resp. to Order to Show Cause, ECF No. 105. The Special Master ordered Ms. Duncan
to file any reply, as well as to “submit any material from Dr. Joseph as discussed in petitioner’s
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July 31, 2020 status report,” by no later than September 8, 2020. Order (Aug. 31, 2020) at 1, ECF
No. 106. Ms. Duncan filed nothing in response to the order.
C. Special Master’s Decision
On October 19, 2020, the Special Master issued a decision denying Ms. Duncan
compensation. The Special Master found that after four years Ms. Duncan had “not presented
minimally competent evidence to substantiate her claim.” ECF No. 107 at 1.
The Special Master rejected each of Ms. Duncan’s procedural objections to the method of
adjudication. First, he expressly disagreed with Ms. Duncan’s claim that the dismissal was
imposed as a sanction. Id. at 5. Rather, the Special Master explained that Ms. Duncan’s claim
was being dismissed because of the deficiencies in her experts’ reports. Id. Second, he disagreed
with Ms. Duncan’s argument that the case should be resolved on summary judgment. Id. at 4–5.
Citing binding precedent, he noted that a special master may “decide cases on written submissions
other than motions for summary judgment.” Id. at 4 (quoting Kreizenbeck v. Sec’y of HHS, 945
F.3d 1362, 1365 (Fed. Cir. 2018) (emphasis in original)). The Special Master found that resolving
Ms. Duncan’s case based on written submissions was appropriate because she was afforded a full
and fair opportunity to present her case. Id. (quoting Kreizenbeck, 945 F.3d at 1366).
The Special Master then summarized the backgrounds and opinions of Ms. Duncan’s
experts. Id. at 6–10. After evaluating each expert’s qualifications and the bases underlying their
opinions, the Special Master found Dr. Lyons-Weiler unqualified to opine about causation
because, among other things, he does not possess a medical license and does not appear to have
performed research or published peer-reviewed work relevant to the issues in this matter. Id. at
10–11. The Special Master also took issue with Dr. Lyons-Weiler’s selective reliance upon the
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affidavits of Ms. Duncan and her mother, rather than contemporaneous medical records, and his
failure to review all the available information about Ms. Duncan. Id. at 11–12.
The Special Master expressed similar concerns regarding Dr. Joseph’s November 2019
report, which was based on a review of only certain parts of Ms. Duncan’s medical records and
did not identify the bases for his assertions about Ms. Duncan’s medical history. Id. In addition,
the Special Master found that, although qualified to opine on issues of chronic pediatric pain, Dr.
Joseph either lacked or failed to disclose any specialized experience relevant to the issues in this
matter, including in areas of immunology, molecular mimicry, and treating patients with
PANDAS. Id. at 13.
Aside from the lack of qualifications, the Special Master also found the opinions expressed
by Dr. Lyons-Weiler and Dr. Joseph unpersuasive. Id. More specifically, the Special Master
found that the expert opinions were not sufficient to meet Ms. Duncan’s burden on two elements
of proof: (1) the medical theory causally connecting the vaccine and alleged injury and (2) the
timing of Ms. Duncan’s worsening symptoms. Id. at 14–16.
With respect to the former, the Special Master determined that the experts’ molecular
mimicry theory was not sufficiently specific to Ms. Duncan’s case because it did not explain
persuasively a connection between the HPV vaccine and PANDAS. Id. at 14. The Special Master
acknowledged that medical literature submitted by Ms. Duncan indicated that strep infections can
lead to PANDAS through the process of molecular mimicry, but Ms. Duncan’s experts did not
identify any link between the molecular structures of strep bacteria and the HPV vaccine. Id.
(citing Petr.’s Ex. 60 (PANDAS—Questions and Answers) at 2, ECF No. 102-2). Accordingly,
he determined that the experts’ “bare assertion of molecular mimicry” did not establish Ms.
Duncan’s burden of proof. Id. at 14.
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With respect to timing, the Special Master found that Ms. Duncan did not establish that her
PANDAS worsened in a “timeframe for which it is medically acceptable to infer causation.” Id.
at 14–15 (citation omitted). The Special Master acknowledged Ms. Duncan’s experts’ opinion
that adverse symptoms from an HPV vaccine would be expected to appear within zero to 365 days
after the vaccination; however, he accepted “for sake of argument” a narrower timeframe of one
to 20 days that “Ms. Duncan propose[d].” Id. at 15. The Special Master found that Ms. Duncan’s
medical records did not document any worsening symptoms in the 20 days following her
vaccination. Id. He explained that the only evidence of Ms. Duncan experiencing severe
symptoms “‘within a few days’ of receiving the vaccination” came from the affidavits of Ms.
Duncan and her mother, which were created three years after the events. Id. (citation omitted). In
addition, the Special Master found that Dr. Lyons-Weiler and Dr. Joseph did not explain in their
respective reports which symptoms Ms. Duncan allegedly suffered within a few days of the
vaccination that they believe constituted a worsening of her PANDAS. Id. at 16. He concluded
that Ms. Duncan, therefore, also did not produce reliable evidence on this element. Id.
Because she failed to submit persuasive evidence to meet her burden on at least two
elements of proof, the Special Master dismissed Ms. Duncan’s case. Id. Ms. Duncan timely filed
a motion for review. Petr.’s Mot. for Review, ECF No. 109
II. LEGAL STANDARDS
A. Standard of Review
This Court has jurisdiction to review a special master’s decision upon the timely request
of either party. 42 U.S.C. § 300aa-12(e)(2). Under the Vaccine Act, a court deciding a motion for
review may:
(A) uphold the findings of fact and conclusions of law of the special master’s decision, (B)
set aside any findings of fact and conclusions of law of the special master found to be
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arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and
issue its own findings of fact and conclusions of law, or (C) remand the petition to the
special master for further action in accordance with the court’s direction.
Id. § 300aa-12(e)(2)(A)–(C).
In conducting its review, the Court employs “a highly deferential standard.” Hines v. Sec’y
of HHS, 940 F.2d 1518, 1528 (Fed. Cir. 1991). “If the special master has considered the relevant
evidence of record, drawn plausible inferences and articulated a rational basis for the decision,
reversible error will be extremely difficult to demonstrate.” Id.; see Hayman v. United States, No.
02-725V, 2005 WL 6124101, at *2 (Fed. Cl. May 9, 2005) (decision should stand so long as the
special master “consider[ed] all the relevant factors, ma[de] no clear error in judgment, and
articulate[d] a rational connection between the facts found and the choice made”).
This “great deference” extends in particular to a special master’s findings of fact, which
are reviewed under the arbitrary and capricious standard. Munn v. Sec’y of HHS, 970 F.2d 863,
870 & n.10 (Fed. Cir. 1992). On a motion for review, it is not the Court’s role “to reweigh the
factual evidence;” rather, “the probative value of the evidence [and] the credibility of the witnesses
. . . are all matters within the purview” of the special master as fact-finder. Id. at 871. Accordingly,
the Court should not substitute its judgment for that of the special master even though it may have
reached a different conclusion. Johnson v. Sec’y of HHS, 33 Fed. Cl. 712, 720 (1995).
B. Petitioner’s Burden of Proof for an Off-Table Significant Aggravation Claim
In an off-Table injury case, it is the petitioner’s burden to show, by a preponderance of the
evidence, “that the vaccine was ‘not only a but-for cause of the [claimed] injury but also a
substantial factor in bringing about the injury.’” Moberly v. Sec’y of HHS, 592 F.3d 1315, 1321–
22 (Fed. Cir. 2010) (quoting Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352–53 (Fed. Cir. 1999));
see 42 U.S.C. § 300aa-13(a)(1)(A). Where the injury alleged is a significant aggravation of a pre-
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existing condition, the petitioner must prove causation by showing the six elements of proof set
forth in Loving v. Secretary of Health and Human Services, 86 Fed. Cl. 135, 144 (2009), and
adopted in W.C. v. Secretary of Health and Human Services, 704 F.3d 1352, 1357 (Fed. Cir. 2013).
These elements are:
(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.
Loving, 86 Fed. Cl. at 144.6
As relevant here, the petitioner’s medical theory must show that the vaccine at issue can
cause the injury alleged. This requirement is satisfied by providing “a reputable medical or
scientific explanation that pertains specifically to the petitioner’s case.” Moberly, 592 F.3d at
1322. “[T]he explanation need only be ‘legally probable, not medically or scientifically certain.’”
Id. (quoting Knudsen v. Sec’y of HHS, 35 F.3d 543, 548–49 (Fed. Cir. 1994)). In addition, the
petitioner must show “that the onset of symptoms occurred within a timeframe for which . . . it is
medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y of HHS, 539 F.3d 1347, 1352
(Fed. Cir. 2008).
Once the petitioner successfully establishes causation by a preponderance of the evidence,
the burden shifts to the respondent to prove that factors unrelated to the vaccine were principally
6 The Loving factors combine the first three prongs of the four-prong test articulated in
Whitecotton v. Secretary of Health and Human Services, 81 F.3d 1099, 1107 (Fed. Cir. 1996), to
evaluate an on-Table significant aggravation claim and the three-prong test announced in Althen
v. Secretary of Health and Human Services, 418 F.3d 1274, 1278 (Fed. Cir. 2005), to demonstrate
causation in an off-Table injury case. W.C., 704 F.3d at 1356, 1357.
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responsible for the significant aggravation. Knudsen, 35 F.3d at 547; see 42 U.S.C. § 300a-
13(a)(1)(B).
III. DISCUSSION
Petitioner’s Motion raises four objections to the Special Master’s decision, most of which
address the procedural manner in which her petition was dismissed. Specifically, she alleges that
the Special Master abused his discretion by: (1) dismissing her petition as a sanction, (2) not
requiring Respondent to move for summary judgment and to submit rebuttal evidence, (3) failing
to evaluate Ms. Duncan’s evidence using a summary judgment standard of review, and (4) not
giving appropriate weight to the opinion of her treating physician and for creating burdensome
requirements for the physician’s report. Having considered the parties’ arguments, as well as the
record in this case, the Court rejects Ms. Duncan’s objections and declines to set aside the Special
Master’s decision.
A. The Special Master’s Decision to Deny Compensation Was Not a Sanction.
In her first objection, Ms. Duncan contends that the Special Master abused his discretion
by dismissing Ms. Duncan’s case for “failure to prosecute and/or failure to comply with the court’s
orders.” ECF No. 109 at 6 (quoting ECF No. 97 at 1). Relying on the language of the Order to
Show Cause, Ms. Duncan characterizes the subsequent decision denying compensation as
imposing a “sanction of dismissal,” which she argues is reserved only for extreme cases involving
circumstances not present here. Id. Respondent argues that the Special Master did not dismiss
Petitioner’s case as a sanction, but rather issued a comprehensive decision resolving her claim on
the merits. Respt.’s Mem. in Resp. to Petr.’s Mot. for Review at 11–12, ECF No. 111.
The decision denying compensation explicitly belies Ms. Duncan’s claim. Directly
addressing this argument, the Special Master explained that “the dismissal is not a consequence of
15
[Ms. Duncan] missing a deadline” or “punish[ment] for misconduct.” ECF No. 107 at 5
(“Although Ms. Duncan suggests that a dismissal with prejudice is a ‘sanction’ reserved for
extreme cases, . . . the term ‘sanction’ fits this situation poorly, if at all.”). Rather, “[Ms. Duncan’s]
case is being dismissed because her evidence is not adequate.” Id. The Special Master’s decision
went on to evaluate the evidence Ms. Duncan presented and to determine that such evidence did
not meet her burden on at least two elements of an off-Table significant aggravation claim. Id. at
6–16. Ms. Duncan has provided no reason for this Court not to take the decision at face value as
an “evaluat[ion] based upon the evidence that [Ms. Duncan] has presented,” id. at 5, and to instead
interpret the decision as a de facto sanction.7
Because the Special Master did not dismiss Ms. Duncan’s case as a sanction, this case is
distinguishable from the cases on which Ms. Duncan relies. In Simanski v. Secretary of Health
and Human Services, the United States Court of Appeals for the Federal Circuit held that a special
master abused his discretion by dismissing a case as a sanction for the petitioner’s refusal to
produce supplemental expert reports in response to court orders. 671 F.3d 1368, 1381 (Fed. Cir.
2012). The Court held that the orders at issue were couched in terms of providing the petitioners
“the option” of supplementing the record. Id. at 1382. In such circumstance, the Court held that
7 At oral argument, Petitioner’s counsel seemed to concede that the Special Master
dismissed Ms. Duncan’s claim on the merits, arguing that the Order to Show Cause and the denial
decision applied different standards—the former involving a failure to prosecute and the latter
involving a determination that Ms. Duncan’s evidence did not satisfy her burden. Hr’g Tr. at 8:10–
13, ECF No. 117. He further argued that the “switch” in standard was procedurally unfair. Id. at
8:18–9:15. Petitioner’s counsel is correct that the Order at its outset directed Ms. Duncan to show
cause why her case should not be dismissed for lack or prosecution or non -compliance with the
Special Master’s orders. ECF No. 97 at 1. Although the show cause order could have been more
clearly framed, the analysis section of the order gave Ms. Duncan sufficient notice that it was
premised on the Special Master’s assessment that she had not submitted preponderant evidence,
including “credible, competent, and complete opinion[s],” to carry her burden. Id. at 4.
16
“the special master should not have dismissed the petition for noncompliance with prior orders”
when the petitioners had elected the option of resting on their submissions. Id.
In Mocsek v. Secretary of Health and Human Services, the Federal Circuit likewise held
that dismissal of the petitioner’s claim for failure to comply with a court-ordered deadline was not
warranted. 776 F. App’x 671, 674–75 (Fed. Cir. 2019). As in this case, the special master in
Mocsek identified deficiencies in the petitioner’s expert reports and ordered her to file an additional
expert report by a date certain. Id. at 673. After missing the deadline and failing to respond to an
order to show cause, the case was dismissed for failure to prosecute and insufficient evidence. Id.
The Court found that dismissal of the petition, “as opposed to some lesser sanction, . . . was an
abuse of discretion” under the circumstances of the case. Id. at 674.
Here, Petitioner did not refuse or fail to file an expert report in response to an order, and
the Special Master expressly stated that the dismissal was not a sanction. The Special Master
considered Ms. Duncan’s evidence, including her expert reports, and determined on the merits that
the evidence failed to carry her burden. Accordingly, the Court need not decide whether or not
the particular events that transpired in the years leading up to the Special Master’s decision make
this an “extreme case[],” ECF No. 109 at 2, in which the sanction of dismissal was appropriate.
B. The Special Master Did Not Abuse His Discretion by Not Requiring Respondent
to File a Motion for Summary Judgment or Rebuttal Evidence.
Ms. Duncan next argues that the Special Master abused his discretion by dismissing her
petition without requiring Respondent to move for summary judgment or file rebuttal evidence.
Id. at 7. Respondent argues that the Special Master was permitted to rule on the parties’ written
submissions, and that it was under no obligation to submit rebuttal evidence where Ms. Duncan,
as the burdened party, had not established a prima facie case. ECF No. 111 at 13.
17
As Ms. Duncan correctly acknowledges, “the Vaccine Rules [do] not absolutely require . .
. a motion for summary judgment.” ECF No. 109 at 7. Likewise, neither the rules nor the relevant
precedent requires that Respondent produce rebuttal evidence in every case. See Simanski, 671
F.3d at 1379. Rather, in reviewing the method of adjudicating Ms. Duncan’s claim, the material
inquiry is whether the Special Master “afford[ed] each party a full and fair opportunity to present
its case and create a record sufficient to allow review of [his] decision.” Kreizenbeck, 945 F.3d at
1366 (quoting R. 3(b)(2), Rules of the U.S. Court of Federal Claims, app. B (“Vaccine Rules”)).
Here, the Special Master provided such opportunity.
1. The Vaccine Rules Allow, But Do Not Require, Summary Judgment.
Consistent with Congress’s directives, the rules governing proceedings in Vaccine Act
cases “provide for less-adversarial, expeditious, and informal . . . resolution of petitions,” including
“the opportunity for summary judgment” and the “opportunity for parties to submit arguments and
evidence on the record” without routine use of hearings. 42 U.S.C. § 300aa -12(d)(2)(A), (C), (D);
see Vaccine R. 3(b)(2), 8(d). As relevant here, the Vaccine Rules provide that special masters may
“decide a case on the basis of written submissions,” which “may include a motion for summary
judgment,” “without conducting an evidentiary hearing.” Vaccine R. 8(d). Determining whether
a hearing is necessary, or whether a case is suitable for a ruling on the record, lies within the “wide
discretion” of the special masters. Kreizenbeck, 945 F.3d at 1365.
The text of the Vaccine Act and Vaccine Rules thus make clear that the parties have the
option of filing a motion for summary judgment in a vaccine case, but neither authority can be
construed to require Respondents to seek summary judgment. Kreizenbeck recently affirmed this
interpretation, holding that “Rule 8(d) contemplates that special masters can decide cases on
written submissions other than motions for summary judgment.” Id. at 1366 (emphasis in
18
original). In Kreizenbeck, the Federal Circuit rejected the petitioners’ argument that, in light of
their objection to a ruling on the record, the special master was obliged to either hold a hearing or
resolve their case on summary judgment. Id. at 1365. As the Court explained, the language of the
Vaccine Act does not “suggest[] a consent-based limitation on a special master’s authority to rule
on the record.” Id. Rather, the Act requires only that the parties have the opportunity to “submit
arguments and evidence on the record,” id. (quoting 42 U.S.C. § 300aa-12(d)(2)(D)), and to seek
summary judgment if appropriate, id. (citing 42 U.S.C. § 300aa-12(d)(2)(C)).
Although Ms. Duncan acknowledges Kreizenbeck, she suggests that Simanski is more
instructive. ECF No. 109 at 7. As discussed above, Simanski reversed a special master’s decision
dismissing a petition for failure to comply with orders seeking supplemental expert reports where
such orders were not expressly framed as directives. 671 F.3d at 1382. The Court’s decision was
further grounded on the fact that the respondent in Simanski had not yet filed a report under
Vaccine Rule 4(c) setting forth its position on the petitioners’ entitlement to compensation and had
“indicated at several points that it intended to file a motion for summary judgme nt” arguing that
the petitioners had not met their burden of proof. Id. at 1379. The Court noted that, “[i]n such a
case, if the respondent believes the petitioner’s evidence is insufficient to set forth facts that could
justify a compensation award, the proper course is for the respondent to move for summary
judgment.” Id. at 1382.
Ms. Duncan appears to interpret Simanski as broadly requiring summary judgment in any
case where the respondent disputes that a petitioner has met her burden. Such reading cannot be
reconciled with the plain language of the rules and Kreizenbeck. Nor should the Court read the
Simanski decision divorced from the context of that particular case, which—unlike the instant
matter—was in an early procedural stage where the respondent had not responded at all to the
19
petitioner’s claims. The Court in Kreizenbeck similarly described Simanski by reference to its
procedural posture. Kreizenbeck, 945 F.3d at 1366 (“A party may seek summary judgment when,
for example, they believe at an early stage of the proceedings that no material facts are in dispute
and they will prevail as a matter of law,” id. (quoting Simanski, 671 F.3d at 1385) (emphasis
added)). Because Respondent filed a Rule 4(c) report in this case and did not indicate an intention
to move for summary judgment, the Court does not agree that Simanski is applicable here.
2. Respondent Is Not Required to Submit Rebuttal Evidence in All Cases.
The Vaccine Act employs a burden-shifting framework. 42 U.S.C. § 300aa-13(a)(1).
Initially, Ms. Duncan, as the petitioner, has the affirmative duty to establish her entitlement to
compensation by a preponderance of the evidence. Id. § 300aa-13(a)(1)(A). Only if she
successfully establishes a prima facie case does the burden then shift to Respondent “to prove by
a preponderance of the evidence that [Ms. Duncan’s] significant aggravation was caused by some
factor other than the vaccine.” Loving, 86 Fed. Cl. at 144 (citing 42 U.S.C. § 300aa–13(a)(1)).
As is no less true in the context of other civil actions, the petitioner—as the party with the
initial burden—can fail to establish a prima facie case for various reasons. The respondent may
offer in rebuttal documents or testimony that undermine the petitioner’s evidence. de Bazan, 539
F.3d at 1353 (“The 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.”). Or, as is the case here, the respondent may simply argue that the petitioner’s evidence on
its face is insufficient to carry her burden. See Simanski, 671 F.3d at 1379 (holding that special
master could rule on the merits without the respondent filing evidence to contest the petition); see
also Prima Facie Case, Black’s Law Dictionary 1441 (11th ed. 2019) (“[a] party’s production of
enough evidence to allow the fact-trier to infer the fact at issue and rule in the party’s favor”).
20
Here, Respondent’s position consistently has been that Ms. Duncan provided “insufficient
evidence . . . regarding [her] claim of significant aggravation,” and therefore the Special Master
should deny compensation and dismiss the case. ECF No. 20 at 9; see ECF No. 105 at 3; ECF No.
111 at 2 n.2, 18. The Special Master ultimately agreed and, as discussed below, his decision should
be upheld under this Court’s deferential review. Because the Special Master determined that Ms.
Duncan’s evidence did not “carr[y] persuasiveness on elements [of her claim] for which she bears
the burden of proof,” ECF No. 107 at 16, the burden never shifted to Respondents. Thus, the
Special Master did not abuse his discretion by denying compensation without requiring rebuttal
evidence from Respondent.
3. Whether the Special Master Abused His Discretion by Ruling Sua Sponte on the
Record.
Although special masters maintain broad authority in conducting proceedings, “[their]
discretion to rule on the record is not without limitation.” Kreizenbeck, 945 F.3d at 1366; see
Simanski, 671 F.3d at 1385 (“authority may not be used in a way that deprives a party of procedural
rights provided by the Vaccine Act and the Vaccine Rules”); Jay v. Sec’y of HHS, 998 F.3d 979,
983 (Fed. Cir. 1993) (resolving aspects of a vaccine case at an arbitrary point in the litigation raises
due process concerns). The Special Master was required to provide Ms. Duncan with an adequate
opportunity to present her case and develop the evidentiary record. Kreizenbeck, 945 F.3d at 1366
(quoting Vaccine R. 3(b)(2)). The record of the proceedings before the Special Master
demonstrates that he did.
At its essence, Ms. Duncan’s objection focuses on the fact that the Special Master, without
alleged notice or awaiting a motion by either party, issued sua sponte a ruling on the record. ECF
No. 109 at 7; Hr’g Tr. at 8:9–17, ECF No. 117. Neither party cited in the briefs a case in which a
21
special master disposed of a petition in circumstances analogous to this case.8 The Court located
a recent case, Porcello v. Secretary of Health and Human Services, No. 17-1255V, 2020 WL
8672052 (Fed. Cl. Nov. 25, 2020), that provides a rough equivalent. In Porcello, the petitioner
filed a motion for summary judgment, claiming that she had met her burden to demonstrate
entitlement to compensation. Id. at *3. The respondent filed a response, arguing that her motion
should be denied and the petition dismissed for insufficient evidence. Id. The special master
issued an order not only denying summary judgment, but also denying compensation on the merits.
Id. Like Ms. Duncan, the Porcello petitioner claimed that “dismissal of her claim in the face of
no procedurally correct motion from Respondent seeking such relief is arbitrary and capricious
and not in accordance with the law” and that, without notice of “the issues that the Special Master
found probative in his ruling,” she “did not have a full and fair opportunity to develop and present
her evidence and arguments.” Id. at *4 (citations omitted).
Acknowledging the “unusual” procedural path of the case, Porcello held that the special
master did not abuse his discretion by ruling on the record in the manner he did. Id. at *5. The
8 The Court noted this fact at the hearing on Petitioner’s Motion and allowed both parties
the opportunity to supplement the record with any additional citations to procedurally analogous
cases. ECF No. 117 at 73:9–24. Respondent filed a response citing f ive cases. Respt.’s Resp. to
Ct.’s Inquiry Regarding Applicable Cases, ECF No. 115. These cases are not exactly on point.
See, e.g., Padmanabhan v. Sec’y of HHS, 638 F. App’x 1013, 1014 (Fed. Cir. 2016) (dismissal
under Vaccine Rule 21 for failure to prosecute); Seid v. Sec’y of HHS, No. 17-604V, 2019 WL
1504371, at *1 (Fed. Cl. Spec. Mstr. Mar. 4, 2019) (dismissal after the petitioner moved for a
ruling on the record); Wanless v. Sec’y of HHS, No. 05-286V, 2005 WL 6120650, at *1 (Fed. Cl.
Spec. Mstr. Sept. 29, 2005) (dismissal after counsel represented that the petitioner would be
dismissing for inability to obtain expert report). Petitioner filed a notice citing one case. Petr.’s
Notice of Filing Ex. #68, ECF No. 118. Although the sua sponte ruling in that case gets closer to
the circumstances here, the reasons it was set aside are inapplicable. Campbell v. Sec’y of HHS,
69 Fed. Cl. 775, 780–83 (2006) (holding that special master denied petitioners a full and fair
opportunity to present case where the record contained factual disagreements and ambiguities that
should have been explored at evidentiary hearing and where special master relied on medical
articles she introduced into the record shortly before ruling).
22
petitioner “had multiple opportunities to provide evidentiary and affidavit support for her claim,
all of which she took advantage,” and remanding for another “opportunity to present her case in a
different way” with “already-admitted evidence” would not likely alter the decision. Id.This Court reaches a similar conclusion. Over the course of years, the Special Master
afforded Ms. Duncan numerous opportunities to submit preponderant evidence establishing that
the HPV vaccine caused a significant aggravation of her PANDAS symptoms, including multiple
extensions of time to file outstanding medical records and expert reports. See, e.g., Order (Dec. 5,
2016), ECF No. 13; Order (Sept. 25, 2017), ECF No. 54; Order (Aug. 1, 2019), ECF No. 89; Order
(Aug. 19, 2019), ECF No. 91; Order (Oct. 3, 2019), ECF No. 95. To be certain, the record reflects
Ms. Duncan’s difficulties in obtaining expert reports. See, e.g., Status Report of Petr. (Nov. 7,
2017), ECF No. 55. Eventually, however, she submitted such reports and developed a broad record
including, inter alia, four affidavits in total from her and her mother; 24 exhibits containing
medical, school, and other records; four reports in total submitted by two experts; and 25 medical
articles or other literature. See Petr.’s Notice of Filing Ex. & Am. Ex. List, ECF No. 96; see also
Petr.’s Notice of Filing Ex. #59-67, ECF No. 102.
Notwithstanding the quantity of materials submitted in support of her petition, the Special
Master on numerous occasions explained to Ms. Duncan the inadequacies in her evidence. See,
e.g., Order (Sept. 24, 2018), ECF No. 77 (noting that reports from experts without medical degrees
are uncommon); Order (Feb. 22, 2019), ECF No. 79 (noting several deficiencies in Dr. Lyons-
Weiler’s report and identifying an unflattering article about the expert); ECF No. 9 7 at 3 (noting
deficiencies in Dr. Joseph’s report). He also warned Ms. Duncan at least once before issuing the
Order to Show Cause that her failure to timely cure the inadequacies could result in dismissal.
ECF No. 77 at 1.
23
After over three years of litigation, the Special Master issued an Order to Show Cause in
February 2020. He allowed Ms. Duncan almost five months to respond, including granting Ms.
Duncan’s request for an extension of time to file a response, any remaining evidence, and a motion
for a ruling on the record. Order (May 20, 2020), ECF No. 100. The Special Master also provided
Ms. Duncan the opportunity to file a reply to Respondent’s response to the show cause order, as
well as to submit additional materials from Dr. Joseph. Order (Aug. 31, 2020) at 1, ECF No. 106.
Ms. Duncan did not take advantage of this opportunity, and the Special Master issued his decision
in October 2020.
Given these facts, the Special Master did not abuse his discretion in determining that Ms.
Duncan had full and fair occasion to offer evidence and arguments in support of her case. See
Kreizenbeck, 945 F.3d at 1366; see also Porcello, 2020 WL 8672052 at *5. Additionally, the
record Ms. Duncan developed is comprehensive and allows the Court to sufficiently review the
Special Master’s decision. See Kreizenbeck, 945 F.3d at 1366. As in Porcello, the Court does not
see how remanding the case to the Special Master to allow for a more typical procedure —like
motions for a ruling on the record—would likely result in a different outcome. 9 See Porcello, 2020
WL 8672052 at *5. The Special Master evaluated the credibility and persuasiveness of Ms.
Duncan’s already-submitted evidence, most importantly her experts’ opinions, and his weighing
of that evidence was within his discretion.
9 The parties agreed at oral argument that remand would be the appropriate remedy in the
event the Court does not uphold the Special Master’s decision. ECF No. 117 at 53:13–19, 70:11–
16. Petitioner’s counsel indicated that, if remanded, he would file any remaining evidence Ms.
Duncan had to offer and a motion for a ruling on the record. Id. at 61:8–18, 70:11–16.
24
C. The Special Master Did Not Apply an Erroneous Standard of Review.
Because the Special Master was not required to resolve Ms. Duncan’s case on summary
judgment, he did not commit any error by not applying the summary judgment standard. Rather,
the Special Master appropriately weighed Ms. Duncan’s evidence against the governing legal
standard. Applying the deferential review afforded to his decision, the Court finds, with one
exception that does not warrant remand, that the Special Master’s findings were not arbitrary and
capricious.
1. The Special Master Applied the Appropriate Standard of Review.
Ms. Duncan contends that “[w]hen a petition is decided on the merits, the special [m]aster
must view the evidence in [the] light most favorable to the petitioner, draw all reasonable
inferences in petitioner’s favor, and resolve all doubt over factual issues in favor of petitioner.”
ECF No. 109 at 8 (citation omitted). She claims that the Special Master’s decision should be
reversed because he did not utilize the proper standard. Id. As Respondent correctly observes,
ECF No. 111 at 14, each of the cases Ms. Duncan relies on to support the familiar summary
judgment standard involved appeals from orders on motions for summary judgment. See ECF No.
109 at 6. Ms. Duncan does not provide a rationale for applying this more favorable standard where
a special master decides a case, as he is permitted to do, “on written su bmissions other than
motions for summary judgment.” Kreizenbeck, 945 F.3d at 1366 (emphasis in original).
To the contrary, when a special master decides a case on the merits his statutorily defined
role requires that he make findings of fact based on his assessment of the evidence and conclusions
of whether such evidence satisfies the preponderance standard with respect to the parties’ claims.
See 42 U.S.C. §§ 300aa-12(d), -13; see also Vaccine R. 3(b)(1). Indeed, “Congress envisioned
that the special masters would become specialists in vaccine-related injuries and would use ‘their
25
accumulated expertise in the field [to] judg[e] the merits of the individual claims.’” Simanski, 671
F.3d at 1371 (citation omitted). For that reason, this Court employs a “uniquely deferential” review
of special master decisions and is directed not to “second guess the Special Masters fact-intensive
conclusions.” Hodges v. Sec’y of HHS, 9 F.3d 958, 961 (Fed. Cir. 1993) (the special master’s
resolution of a vaccine case “is essentially a judicial process”); see 42 U.S.C. § 300aa-12(e)(2).
Thus, the Court finds no error in the standard applied by the Special Master in reviewing
Ms. Duncan’s evidence, which appropriately assessed the weight of her evidence rather than
presuming the facts in Ms. Duncan’s favor.
2. The Special Master’s Findings Were Not Arbitrary and Capricious.
Utilizing the deferential arbitrary-and-capricious standard of review, the Court finds that
Ms. Duncan has not demonstrated that the Special Master’s decision should be set aside. Ms.
Duncan argues that the Special Master based his decision on a perceived lack of qualifications of
her experts and a selective view of her evidence. ECF No. 109 at 10, 11. Respondent argues that
the Special Master’s findings were “rational, based on the record, [and] in accordance with the
law.” ECF No. 111 at 11. With one exception, the Court agrees with Respondent.
First, the Special Master determined that “based strictly on qualifications,” Ms. Duncan’s
experts did not “present a minimally credible case” that the HPV vaccine significantly aggravated
Ms. Duncan’s PANDAS. ECF No. 107 at 13. The decision described several reasons underlying
this finding. For example, the Special Master noted that, despite opining on the expected course
of Ms. Duncan’s PANDAS, Dr. Lyons-Weiler is not a medical doctor. Id. at 10. He has a Ph.D.
in Ecology, Evolution and Conservation Biology, a master’s degree in Zoology, and a bachelor’s
degree in Biology. Id. at 7, 11; see ECF No. 78 at 1. Dr. Lyons-Weiler did not indicate in his
report or curriculum vitae any experience studying or researching PANDAS or working with
26
PANDAS patients. ECF No. 107 at 10. He also has been found by special masters in other vaccine
cases as unqualified to opine on vaccine causation issues. Id. at 11 (citing A.S. v. Sec’y of HHS,
No. 16-551V, 2019 WL 5098964, at *11 (Fed. Cl. Spec. Mstr. Aug. 27, 2019); Kamppi v. Sec’y of
HHS, No. 15-1013V, 2019 WL 5483161, at *11 (Fed. Cl. Spec. Mstr. July 24, 2019)). The Special
Master explained that Dr. Joseph, although well qualified to opine on issues in his area of practice,
has no specialized experience in immunology and no background in studying or researching
molecular mimicry, nor did he indicate any degree of experience treating PANDAS. Id. at 13.
Moreover, the Special Master found that the reliability of both experts’ opinions was reduced by
the fact that they reviewed a very limited number of the relevant records. Id. at 12.
These findings bear on the Special Master’s assessment of the credibility of Ms. Duncan’s
experts and the reliability of their testimony—matters that he was permitted and, in fact, expected
to consider as factfinder. See Porter v. Sec’y of HHS, 663 F.3d 1242, 1250–51 (Fed. Cir. 2011);
see also Moberly, 592 F.3d at 1325–26. The Court sees no reason to disturb his determination,
which was both rationally explained and supported by record evidence.
Second, the Special Master found that Ms. Duncan failed to establish Loving prong 4
because her medical theory was merely a “bare assertion[] of molecular mimicry” unconnected to
the specific facts of her case. ECF No. 107 at 14. Ms. Duncan argues that this “is not an accurate
reflection of the evidence,” claiming that the reports of Dr. Lyons-Weiler and Dr. Joseph explained
how the vaccine through the process of molecular mimicry caused Ms. Duncan’s immune system
to attack itself and thus aggravate her PANDAS symptoms. ECF No. 109 at 10. That explanation,
if it exists, is not directly apparent to this Court.
To be sure, both experts broadly explained the theory of molecular mimicry and generally
opined that it provides the causal link between the HPV vaccine and Ms. Duncan’s aggravated
27
PANDAS symptoms. See ECF No. 78 at 5; see also ECF No. 96-1 at 3. But neither expert’s
molecular-mimicry explanation provided a specific link between the HPV vaccine and PANDAS.
At best, the experts appear to deduce that PANDAS, as an autoimmune disorder, can be caused by
the HPV vaccine because the HPV vaccine contains an adjuva nt and adjuvants can cause
autoimmunity. See ECF No. 78 at 4–5; see also ECF No. 96-1 at 3. Such explanation could apply
equally to any case involving an adjuvanted vaccine and an alleged injury relating to an
autoimmune disorder or disease. See Caves v. Sec’y of HHS, 100 Fed. Cl. 119, 135 (2011) (“there
is an important difference between the general theory of molecular mimicry . . . and the more
specific theory that the . . . vaccine [at issue] is capable of triggering an autoimmune response that
culminates in the [petitioner’s injury]”).
Both experts highlighted Ms. Duncan’s history of strep-A infections as making her
predisposed to molecular mimicry. See ECF No. 78 at 5; see also ECF No. 96-1 at 3. Ms. Duncan
further relied on medical literature explaining that PANDAS is caused when a child’s immune
system attacks healthy molecular structures that are being mimicked by the molecular structure of
the strep bacteria. ECF No. 101 at 6 (citing Petr.’s Ex. 60 (ECF No. 102 -2)). As the Special
Master noted, however, the cited PANDAS article does not discuss the HPV vaccine, and neither
expert attempted to draw similarities between the molecular structures of strep and the HPV
vaccine. ECF No. 107 at 14. Thus, the Special Master did not act arbitrarily and capriciously in
finding that Ms. Duncan’s experts did not provide a medical theory sufficient to establish Loving
prong 4.
Third, the Special Master concluded that Ms. Duncan’s experts neglected to “identif[y] the
specific ways in which her PANDAS became worse.” Id. at 16. Ms. Duncan disagrees, arguing
that the Special Master did not consider evidence that Ms. Duncan experienced severe symptoms
28
within a few days of receiving the vaccine. ECF No. 109 at 10 (citing Ms. Duncan’s affidavit
(ECF No. 1-2)). The decision shows that the Special Master considered such evidence and,
considering the evidence as a whole, determined that it carried less weight. He explained that the
affidavits drafted by Ms. Duncan and her mother for purposes of this litigation were the only
evidence she submitted to establish symptoms occurring near the date of her vaccination. ECF
No. 107 at 15. The affidavits’ recounting of Ms. Duncan’s symptoms, however, was not
corroborated by the medical records created around the time of her vaccination. Id. The Special
Master also noted other inconsistencies with record evidence that put into question the accuracy
of the assertions in the affidavits. Id. at 11 (comparing statements that Ms. Duncan was a “straight
A” student with school records showing poor academic performance in the year before Ms. Duncan
received the vaccine). The Special Master’s assessments were well within his discretion. Because
her experts appear to have simply accepted Ms. Duncan’s account of her symptoms as the basis
for their conclusions, they are reasonably subject to the same criticism. See Burns v. Sec’y of HHS,
3 F.3d 415, 417 (Fed. Cir. 1993) (finding “special master did not err in accepting the
contemporaneous medical records over the testimony of fact witnesses” and rejecting expert
opinion based on facts not substantiated by the record).
Moreover, as the Special Master observed, the experts did little more than list the
symptoms Ms. Duncan has experienced since she received the vaccine and provide a conclusory
opinion that such symptoms constitute a significant aggravation of her pre -existing PANDAS
condition. See ECF No. 96-1 at 2, 4; see also ECF No. 78 at 4. Neither expert explained based
on medical expertise whether these symptoms were associated with Ms. Duncan’s PANDAS and,
if so, whether they represented new or worsened symptoms.
29
Finally, the Special Master found that Ms. Duncan failed under Loving prong 6 to show
that aggravated PANDAS symptoms occurred within one to 20 days of her receiving the vaccine.
ECF No. 107 at 15. Ms. Duncan claims that, in making this determination, the Special Master
disregarded her experts’ opinion that adverse symptoms could occur within zero to 365 days after
an HPV vaccination. ECF No. 109 at 10. On this point, Ms. Duncan is correct.
The Special Master acknowledged the 365-day timeframe asserted by Ms. Duncan’s
experts but stated that Ms. Duncan “propose[d] a narrower span” of 20 days or less. ECF No. 107
at 15 (citing Petr.’s Ex. 67 (“Severe somatoform and dysautonomic syndromes after HPV
vaccination: case series and review of literature”), ECF No. 102-9). The study to which the Special
Master referred involved 18 girls aged 12 to 24 who complained of symptoms appearing one to 20
days after receiving the HPV vaccination. ECF No. 102-9 at 1. As a threshold matter, Ms. Duncan
cited this study in her response to the Special Master’s show cause order to demo nstrate the
“logical sequence” element (Loving prong 5) of her claim. ECF No. 101 at 7. She did not propose
the study as an alternative to her experts’ opinion. Indeed, after discussing the study, Ms. Duncan
specifically referenced her experts’ opinion that 365-days is the proper timeframe. Id.“[F]or the sake of argument,” however, the Special Master accepted the shorter range. 10
ECF No. 107 at 15. By doing so, he never assessed or determined whether the experts’
significantly longer suggestion of zero to 365 days was appropriate. See Koehn v. Sec’y of HHS,
773 F.3d 1239, 1244 (Fed. Cir. 2014). This omission is potentially material to the Loving prong 6
analysis because, although the Special Master reasonably found that Ms. Duncan did not
demonstrate by a preponderance of evidence that her PANDAS symptoms worsened within 20
10 In this Court’s experience, when one assumes facts or arguments arguendo, one typically
accepts the facts or arguments most favorable to the proponent, which in this case would b e the
longer timeframe.
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days of her vaccination, the record contains evidence of later-appearing symptoms within 365
days. See ECF No. 107 at 15 (discussing January 14, 2014 medical record that documents Ms.
Duncan’s complaint of “bee stings all over [her] body, fatigue, chest pain, and anxiety” and expert
testimony opining that Ms. Duncan’s symptoms “escalated severely in early 2014”) (citations
omitted). Because he disregarded without any rational explanation Ms. Duncan’s expert testimony
identifying a more generous timeframe, the Special Master’s finding that Ms. Duncan did not
establish the “timing” prong was arbitrary and capricious. See Johnson, 33 Fed. Cl. at 727 (finding
special master erred by totally disregarding and ignoring expert testimony in the record).
Ultimately, however, this error does not warrant setting aside the decision because the
“timing” prong was not the only ground for dismissal in this case. See ECF No. 107 at 16. As
discussed above, the Special Master’s finding that Ms. Duncan failed under Loving prong 4 to
establish a persuasive medical theory connecting the HPV vaccine to an aggravation of PANDAS
was not arbitrary or capricious. Thus, he had sufficient basis to deny her claim. See Koehn, 773
F.3d at 1244 (failure to meet burden under any one of the Althen prongs is dispositive).
D. The Special Master Did Not Abuse His Discretion in Assessing the Weight of Dr.
Joseph’s Opinion or by Imposing Burdensome Expert Report Requirements.
Finally, Ms. Duncan asserts that the Special Master impermissibly “disregarded and/or
downplayed the opinion” of her treating physician, Dr. Joseph, and “created requirements [for
expert reports] which were unduly burdensome to a treating physician.” ECF No. 109 at 11.
Considering the record as a whole, the Court rejects this objection.
1. The Special Master’s Evaluation of Dr. Joseph’s Opinion
The Federal Circuit has explained that, in addition to medical records, “medical opinion
testimony [is] 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
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reason for the injury.’” Capizzano v. Sec’y of HHS, 440 F.3d 1317, 1326 (Fed. Cir. 2006) (citation
omitted). The Act, however, also expressly specifies that any “diagnosis, conclusion, [medical]
judgment, test result, report, or summary” relevant to “the nature, causation, and aggravation” of
a petitioner’s injury “shall not be binding on the special master or court.” 42 U.S.C. § 300aa-
13(b)(1). Rather, it is the duty of the special master to consider the record as a whole and evaluate
the “weight to be afforded to any such [evidence].” Id. In “[w]eighing the persuasiveness of
particular evidence,” including expert opinions, the special master is expected “to assess the
reliability of [the] testimony.” Moberly, 592 F.3d at 1325. This assessment “often turn[s] on
credibility determinations, particularly in cases . . . where there is little supporting evidence for the
expert’s opinion.” Id. at 1325–26. A special master’s findings as to credibility of an expert witness
and the persuasiveness of his medical theories are “virtually unchallengeable on appeal.” Lampe
v. Sec’y of HHS, 219 F.3d 1357, 1362 (Fed. Cir. 2000) (“‘That level of deference is especially apt
in a case in which the medical evidence of causation is in dispute,’” id. (quoting Hodges, 9 F.3d at
961)).
Ms. Duncan’s final objection does not specifically challenge any particular findings with
respect to Dr. Joseph’s opinion. Instead, she alleges generally that the Special Master did not give
Dr. Joseph’s report “the proper weight to be afforded to a treating physician under th e Vaccine
Act.” ECF No. 109 at 12. The Special Master, however, was not bound under the Act to accept
Dr. Joseph’s opinion without inquiring into its credibility and reliability. See 42 U.S.C. § 300aa-
13(b)(1); see also Moberly, 592 F.3d at 1325. Ms. Duncan’s mere disagreement with the
evidentiary weight assigned by the Special Master to Dr. Joseph’s testimony is not sufficient to
overturn his finding. See Lampe, 219 F.3d at 1362.
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As the decision demonstrates, the Special Master evaluated Dr. Joseph’s opinion that the
HPV vaccine significantly aggravated Ms. Duncan’s PANDAS. He summarized the substance of
Dr. Joseph’s reports, reviewed Dr. Joseph’s professional qualifications, and articulated several
reasons why he found Dr. Joseph to be unqualified to opine on the relevant medical theory at issue
in this case and, in any event, why his opinion was unpersuasive. ECF No. 107 at 6 –7, 9–10, 12–
13, 14–16. These reasons included, inter alia, that: (1) Dr. Joseph did not begin treating Ms.
Duncan until almost two-and-one-half years after she received the HPV vaccine, id. at 12; (2) it
was not until six months after Dr. Joseph began seeing Ms. Duncan that his records first mention
the HPV vaccine, documenting only Ms. Duncan’s belief that her symptoms significantly
worsened after the vaccination, id. (citation omitted); (3) Dr. Joseph’s records (which are current
through December 2016) do not reflect his conclusion that the HPV vaccine affected Ms. Duncan’s
condition, id.; (4) he did not specifically identify when Ms. Duncan experienced significantly
aggravated PANDAS symptoms, what those symptoms were, or the basis for his assertions, id. at
9–10; and (5) he appeared simply to have adopted Dr. Lyons-Weiler’s explanation of the medical
theory purportedly connecting the HPV vaccine to an aggravation of PANDAS, id. at 9, 13.
Because the Special Master “clearly articulated why he declined to afford significant
weight” to Dr. Joseph’s medical opinion, and such explanation is both reasoned and supported by
the record, the Court finds that the Special Master acted within his discretion in assessing this
evidence. See Cedillo v. Sec’y of HHS, 617 F.3d 1328, 1348 (Fed. Cir. 2010) (no error in treatment
of evidence from treating physicians); see also Moberly, 592 F.3d at 1325–26 (same); Holmes v.
Sec’y of HHS, 115 Fed. Cl. 469, 489 (2014) (special master did not abuse discretion in evaluating
opinions of treating physicians).
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2. The Special Master’s Instructions to Witnesses Offering Opinion Testimony
Ms. Duncan also argues that the Special Master’s eight-page order setting forth instructions
for expert reports were unduly burdensome for treating physicians. ECF No. 109 at 11. Ms.
Duncan claims that Dr. Joseph, as a treating physician, should not have been expected to review
voluminous medical records, cite medical articles, or take other steps to support his opinion in
ways one would expect of a retained expert. Id. She contends that the Special Master’s order
made it difficult to obtain a written opinion meeting the criteria of the instructions. Id.In his decision, the Special Master framed the instructions as guidelines. He explained that
the purpose of the instructions was to “assist Ms. Duncan and her attorney” by “guid[ing] any
expert in the presentation of reports.” 11 ECF No. 107 at 2; see ECF No. 97 at 2 (explaining that
the Special Master “proposed instructions to guide the parties’ expert reports”); see also Order
Regarding Petr.’s Comments on Expert Instructions at 1, ECF No. 51 (“The instructions are drafted
to help the parties, particularly the petitioner, to present evidence on all relevant topics.”).
Although the Special Master expected treating physicians to follow with the instructions, he
clarified that he would still consider any expert submission even if it was not in strict compliance.
ECF No. 51 at 1. He warned, however, that “a relatively conclusory statement from a treating
doctor may not be given much evidentiary weight.” 12 Id.11Despite being provided with the proposed instructions and the opportunity to comment,
Ms. Duncan did not object prior to the instructions becoming final. See Order (July 21, 2017),
ECF No. 48. Instead, after the final instructions issued, Ms. Duncan sought clarification about
whether they applied to treating physicians. Petr.’s Resp. Ct.’s Orders of 7/21/17 & 8/8/17
Regarding Expert Report Instructions at 1-2, ECF No. 50.
12 The instructions take a relatively stronger tone on the effect of non-compliance, noting
that “the topics listed below constitute the minimum content for an expert’s report” and that failure
of the expert to address all the topics may result in the expert being “directed to write a
supplemental report.” ECF No. 49 at 3 n.1.
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Regardless of whether the instructions set forth requirements or only suggestions, Ms.
Duncan’s point is not without some merit. The level of specificity detailed in the Special Master’s
instructions, which cover eight topics containing around 30 sub-topics, could likely be “very
intimidating to [a] treating physician,” ECF No. 50 at 2, who as Ms. Duncan points out may not
charge an hourly fee to draft an opinion letter on behalf of a patient, ECF No. 109 at 11. As the
Federal Circuit has explained, “[t]he Vaccine Act does not contemplate full blown tort litigation.”
Knudsen, 35 F.3d at 549. Rather, it “established a federal ‘compensation program’ under which
awards are to be ‘made to vaccine-injured persons quickly, easily, and with certainty and
generosity.’ The program is supposed to be ‘fair, simple, and easy to administer.’” Id. (internal
citations omitted). The Court has therefore cautioned against imposing requirements on expert
testimony that hinder “the purpose and nature of the . . . program,” id., or “impermissibly raise[] a
claimant’s burden under the Vaccine Act,” Capizzano, 440 F.3d at 1325.
Nevertheless, Ms. Duncan recognizes that expert testimony, as with any evidence, “must
be reliable and probative.” ECF No. 109 at 11. The Vaccine Act and the Vaccine Rules grant
special masters “broad authority in conducting proceedings under the Act, including full control
over discovery and the power to require the production of evidence and information. ” Simanski,
671 F.3d at 1371 (citing 42 U.S.C. § 300aa–12(d)(3); Vaccine R. 3(a), 7(a), 8(c)). This is no less
true with respect to expert opinions. See Moberly, 592 F.3d at 1324 (“[T]he special master is
entitled to require some indicia of reliability to support the assertion of the expert witness.”); see
also Ryman v. Sec’y of HHS, 65 Fed. Cl. 35, 40–41 (2005) (special master acts as both a “gate-
keeper” to determine whether expert testimony should be admitted, credited, and relied on and “a
trier-of-fact [who] therefore may properly consider the credibility and applicability of medical
theories”).
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Here, the Court need not determine whether the expert instructions in general improperly
crossed the boundary between a proper exercise of the Special Master’s gate-keeper/trier-of-fact
function and an improper heightening of Ms. Duncan’s burden. Ms. Duncan does not argue that
the instructions altered her burden or were inconsistent with the Federal Circuit’s precedent
regarding the elements of a prima facie significant aggravation claim. See ECF No. 51 at 1.
Moreover, the Special Master’s decision to deny compensation was not based on mere non-
compliance with some technical aspect of the expert instructions. Setting aside the instructions
altogether, the reasons why the Special Master decided not to credit Dr. Joseph’s opinion were
rational, clearly articulated, and supported by the record.
Ms. Duncan’s chief complaint appears to be that the Special Master should not have
required Dr. Joseph to review the “thousands [of] medical records in this case.” ECF No. 109 at
11. The instructions, however, did not contain such requirement. See ECF No. 49 at 3 (requiring
under the “Review of Materials” topic only that an expert identify all the materials he considered,
but not specifying what materials must be reviewed). That the Special Master found Dr. Joseph’s
opinion unpersuasive because Dr. Joseph reviewed only a limited number of medical records is
not unreasonable under the particular circumstances of this case. Dr. Joseph did not begin treating
Ms. Duncan until years after she received the vaccination. ECF No. 107 at 12; see ECF No. 26-1
at 11. His own records submitted by Ms. Duncan do not reflect his opinion that the HPV vaccine
significantly worsened Ms. Duncan’s PANDAS. See generally ECF No. 26-1. The Court sees no
error in the Special Master’s decision not to afford significant weight to Dr. Joseph’s medical
opinion about the cause of Ms. Duncan’s allegedly worsened condition when he did not review
medical records documenting Ms. Duncan’s condition before her vaccination (except one record
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regarding her October 2012 concussion) or within the weeks immediately following her
vaccination. ECF No. 96-1 at 1–2 (listing “Material Reviewed by Expert”).
IV. CONCLUSION
Ms. Duncan has not shown that the Special Master, considering the record as a whole,
abused his discretion in the manner in which he resolved her petition or that his decision to deny
compensation was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with
the law. Thus, for the reasons discussed above, the Court DENIES Ms. Duncan’s Motion for
Review. Pursuant to Vaccine Rule 30(a), the Clerk is directed to enter judgment in accordance
with this decision.
SO ORDERED.
Dated: April 19, 2021 /s/ Kathryn C. Davis
KATHRYN C. DAVIS
Judge
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