# F. v. Secretary of Health and Human Services

> United States Court of Federal Claims · October 7, 2022

URL: https://www.frixlaw.com/law-library/cases/8212774

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** October 7, 2022
- **Precedential status:** Published
- **Opinion:** Opinion
- **Judges:** Daniel T. Horner
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/8212774

## How later opinions describe it (automated extraction)

- explaining that “[b]ecause causation is relative to the injury, a petitioner must provide a reputable medical or scientific explanation that pertains specifically to petitioner’s case.”

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 13-799V
Filed: September 9, 2022
Refiled in Redacted Form: October 7, 2022
PUBLISHED

Special Master Horner
J. F.,
Tetanus diphtheria acellular
Petitioner, pertussis (“Tdap”) vaccine;
v. Autoimmune/inflammatory
syndrome induced by adjuvants
SECRETARY OF HEALTH AND (“ASIA”)
HUMAN SERVICES,

Respondent.

Renee J. Gentry, Vaccine Injury Clinic, George Washington University Law School
Washington, DC, for petitioner.
Jennifer Leigh Reynaud, U.S. Department of Justice, Washington, DC, for respondent.

DECISION 1

On October 15, 2013, petitioner filed a petition under the National Childhood
Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), 2 alleging that she suffered
anaphylaxis caused by an adverse reaction to her June 18, 2011, Tetanus diphtheria
acellular pertussis (“Tdap”) vaccination. (ECF No. 1.) Petitioner amended her petition
on February 21, 2014, changing the alleged injury from anaphylaxis to
“autoimmune/inflammatory syndrome induced by adjuvants (‘ASIA’) with associated
symptoms.” (ECF No. 12.) For the reasons set forth below I conclude that petitioner is
not entitled to compensation.

1 When this decision was originally filed the undersigned advised his intent to post it on the United States

Court of Federal Claims’ website, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501
note (2012) (Federal Management and Promotion of Electronic Government Services). In accordance
with Vaccine Rule 18(b), petitioner filed a timely motion to redact certain information. This decision is
being reissued with redactions, namely reduction of petitioner and family names to initials and removal of
the name of petitioner’s gymnastics coach. Except for those changes and this footnote, no other
substantive changes have been made. This decision will be posted on the court’s website with no further
opportunity to move for redaction.
2 All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa-

10-34.

1
I. Applicable Statutory Scheme

Under the National Vaccine Injury Compensation Program, compensation
awards are made to individuals who have suffered injuries after receiving vaccines. In
general, to gain an award, a petitioner must make a number of factual demonstrations,
including showing that an individual received a vaccination covered by the statute;
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. Finally – and the key
question in most cases under the Program – the petitioner must also establish a causal
link between the vaccination and the injury. In some cases, the petitioner may simply
demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
shown that the vaccine recipient suffered an injury of the type enumerated in the
“Vaccine Injury Table,” corresponding to the vaccination in question, within an
applicable time period also specified in the Table. If so, causation is presumed and the
petitioner is automatically entitled to compensation, unless it is affirmatively shown that
the injury was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A); §
300 aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).

In many cases, however, the vaccine recipient may have suffered an injury not of
the type covered in the Vaccine Injury Table. In these cases, the presumptions
available under the Vaccine Injury Table are inoperative. Instead, the petitioner bears
the burden of showing by preponderant evidence that the vaccine recipient’s injury was
actually caused by the alleged vaccination, often referred to as “causation-in-fact”. §
300aa-13(a)(1)(B); § 300aa-11(c)(1)(C)(ii); see also Althen v. Sec’y of Health & Human
Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. Sec’y of Health & Human Servs.,
940 F.2d 1518, 1525 (Fed. Cir. 1991).

Under the preponderant evidence standard, the petitioner must show that it is
“more probable than not” that the alleged vaccination was the cause of the alleged
injury. Althen, 418 F.3d at 1279. The petitioner need not show that the vaccination was
the sole cause of the injury, but must establish that the vaccination was at least a
“substantial factor” and “but for” cause of the condition. Shyface v. Sec’y of Health &
Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). A petitioner may not receive a
Vaccine Program award based solely on his or her assertions; rather, the petition must
be supported by either medical records or by the opinion of a competent physician. §
300aa-13(a)(1). The petitioner must supply “proof of a logical sequence of cause and
effect showing that the vaccination was the reason for the injury;” and this proof must be
supported by “reputable medical or scientific explanation, i.e., evidence in the form of
scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278; Grant v. Sec’y
of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992).

In what has become the predominant framing of this burden of proof, the Althen
court described the causation-in-fact standard, as follows:

2
Concisely stated, Althen’s burden is to show by preponderant evidence that
the vaccination brought about her 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 proximate temporal relationship between
vaccination and injury. If Althen satisfies this burden, she is “entitled to
recover unless the [government] shows, also by a preponderance of the
evidence, that the injury was in fact caused by factors unrelated to the
vaccine.”

Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner
need not necessarily supply evidence from medical literature supporting petitioner’s
causation contention, so long as the petitioner supplies the medical opinion of an
expert. Id. at 1279-80. The court also indicated that, in finding causation, a Program
fact-finder may rely upon “circumstantial evidence,” which the court found to be
consistent with the “system created by Congress, in which close calls regarding
causation are resolved in favor of injured claimants.” Id. at 1280.

Generally, respondent bears the burden of demonstrating the presence of any
alternative cause by preponderant evidence only if petitioner satisfies her prima facie
burden. § 300aa-13(a)(1)(B); Walther v. Sec’y of Health & Human Servs., 485 F.3d
1146, 1150 (Fed. Cir. 2007). Respondent may also present evidence relating to an
alternative cause to demonstrate the inadequacy of petitioner’s evidence supporting her
case in chief, but petitioner does not bear the burden of eliminating alternative causes
where the other evidence on causation is sufficient to establish a prima facie case under
Althen. de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352-53 (Fed.
Cir. 2008); Walther, 485 F.3d at 1150.

In this case, petitioner has alleged that her Tdap vaccine caused her to suffer
ASIA, a condition that is not listed on the Vaccine Injury Table relative to the Tdap
vaccine. (ECF No. 12.) Thus, petitioner must satisfy the above-described Althen test in
order to show that she is entitled to a payment from the Vaccine Injury Compensation
Program.

II. Procedural History

Petitioner’s parents filed a petition for compensation on October 15, 2013
alleging that she suffered anaphylaxis as a result of her June 18, 2011 Tdap
vaccination. (ECF No. 1.) Thereafter, this case was assigned to Special Master
Millman. (ECF No. 2.) The parents filed various medical and school records marked as
Exhibits 1-25 along with an “affidavit” 3 by Mr. and Mrs. F. marked as Exhibit 26 and two
additional statements, one by petitioner and one by her brother, marked collectively as
Exhibit 27. (ECF No. 4.)

3 Actually an unsworn narrative signed and dated by both parents, but designated as an affidavit on filing.

3
On February 21, 2014, the petition was amended, changing the alleged injury
from anaphylaxis to ASIA. 4 (ECF No. 12.) Along with the amended petition, petitioner’s
parents filed a letter from her treating physician, pediatric rheumatologist Dr. Deborah
McCurdy, marked as Exhibit 28 and several medical articles filed collectively as Exhibit
29. (ECF Nos. 12-13.) An expert report from Dr. McCurdy was subsequently filed on
March 25, 2014, as Exhibit 30. (ECF No. 15.) (Dr. McCurdy’s expert submissions were
later struck as discussed below.) Additional medical records marked as Exhibits 31-33
were then filed on June 11 and June 27, 2014. (ECF Nos. 17, 20.)

Respondent filed two expert reports on September 10, 2014, one from
toxicologist Dr. Edward W. Cetaruk, and another from immunologist Dr. Lindsay
Whitton. (ECF No. 23; Exs. A-D.) On September 17, 2014, respondent filed an
additional expert report from pediatric rheumatologist, Dr. Carlos Rose, and a Rule 4(c)
report recommending against compensation. (ECF No. 26; Exs. E-F.) Petitioner’s
parents responded to respondent’s Rule 4(c) report on December 3, 2014, with a
supplemental expert report from Dr. McCurdy (Ex. 34-35 (later struck)), a letter from
immunologist Dr. Joshua Davidson (Exs. 36-37), a letter from petitioner’s pediatrician,
Dr. Demonteverde (Ex. 38), a letter from petitioner’s gymnastics coach (Ex. 39), and a
presentation from petitioner’s father responding to the government’s report (Ex. 40). 5
(ECF No. 31.) The medical literature accompanying Dr. McCurdy’s expert report and
Dr. Davison’s letter was filed later. 6 (ECF Nos. 33, 35.) Respondent then filed
supplemental expert reports on March 26, 2015. (ECF No. 37; Exs. G-I.)

On May 20, 2015, after petitioner had reached the age of majority, petitioner’s
parents filed a motion to amend the caption to make her the sole petitioner in her adult
capacity. The motion was granted on the same day. (ECF Nos. 39, 40.)

On April 1, 2015, Special Master Millman ordered the parties to propose mutually
agreeable dates for an entitlement hearing. (ECF No. 38.) However, in an email to
Special Master Millman’s law clerk on June 29, 2015, petitioner indicated that she was
attempting to secure a new expert and pursuing additional neurological exams to more
4 Anaphylaxis is a Table Injury for the Tdap vaccine if it occurs within four hours of vaccination.
42 C.F.R.
§ 100.3(a)(I). The amended petition does not invoke anaphylaxis but does allege that there was an
immediate vaccine reaction consisting of fatigue, headache, fever, and arm swelling, beginning one hour
after the vaccination. (ECF No. 12, p. 3.) In the interest of completeness I note that based on my review
of the record evidence petitioner did not suffer anaphylaxis as defined by the Qualifications and Aids to
Interpretation (“QAI”) that define the Table Injury of anaphylaxis. 42 C.F.R. § 100.3(c)(1). Nor did
petitioner establish that she suffered anaphylaxis caused-in-fact by her vaccination. Rather, petitioner’s
expert, Dr. Shoenfeld, later indicated that these symptoms constituted an arthus reaction. (Ex. 97, p. 31.)
5 This presentation is not a sworn witness statement. Rather, it is a rebuttal to the medical opinions
provided by respondent’s experts. Mr. F. confirms in his presentation that he is an engineering manager
rather than a medical doctor. Especially because petitioner subsequently provided expert medical
opinion to support her claim, I need not address the content of this report further. I do note, however, that
I have reviewed the presentation and considered any factual representations as unsworn fact witness
declarations.
6 These articles were identified as numbered “references” from Dr. Davidson’s and Dr. McCurdy’s

submissions. They were not given exhibit designations.

4
specifically diagnose her injury. (ECF No. 42.) Petitioner subsequently filed additional
medical records marked as Exhibits 41-42. (ECF No. 46.) However, petitioner’s first
attorney, Ms. Moss was then removed from the case by consented motion to substitute
counsel on October 12, 2015. (ECF No. 49.)

Petitioner then proceeded with her second attorney, Ms. Stadelnikas. (ECF No.
49.) From October 12, 2015, to September 22, 2016, petitioner continued to see
different specialists, collect updated medical records (Exs. 43-45, 47, 50-51), 7 and
attempted to secure additional expert support for her claim. (See ECF Nos. 53, 62-65,
70-74.) However, on January 5, 2017, a status conference was held where petitioner
notified the court that Ms. Stadelnikas intended to withdraw as petitioner’s attorney.
(ECF No. 75.) Petitioner filed additional medical records marked as Exhibits 52-54 on
January 13, 2017, but otherwise made no filings until her attorney filed a motion to
withdraw as counsel on February 6, 2017. (ECF Nos. 76, 78.) Ms. Stadelnikas was
removed as the attorney of record in this case on April 6, 2017. (ECF No. 82.)

Petitioner’s current counsel, Ms. Gentry, entered this case on May 9, 2017.
(ECF No. 88.) In March of 2018, petitioner filed further medical records (Exs. 55, 95)
and subsequently secured an expert report coauthored by Drs. Mikovits and Ruscetti
(Ex. 56) and supporting literature (Exs. 57-94) to further support her claim of Tdap-
induced ASIA. (ECF Nos. 90, 93, 95, 97, 98, 108, 109-111, 115-118.) (This report and
supporting literature would later be struck from the record by petitioner’s own motion as
discussed below.)8 Petitioner filed further medical records in February of 2019. (ECF
No. 116; Ex. 96.)

This case was then assigned to my docket on June 5, 2019. (ECF No. 119.)
Thereafter, petitioner filed an expert report from immunologist Dr. Yehuda Shoenfeld on
September 9, 2019, and the accompanying medical literature on November 12, 2019.
(ECF Nos. 122, 125-27; Exs. 97-124.) In response, respondent filed supplemental
reports from Drs. Whitton and Rose on February 28, 2020. (ECF No. 130; Exs. J-K.)

On September 10, 2019, I ordered petitioner to file a status report identifying
mutually agreeable dates in January or February of 2021 to hold an entitlement hearing.
However, the parties requested a status confernece to discuss which experts would
testify. (ECF No. 128.) During the conference, petitioner indicated that she no longer
intended to rely on the opinions of either Drs. Mikovits and Ruscetti or Dr. McCurdy.
However, to the extent their reports remained in the record, respondent maintained that
he had a right to cross examine these experts. (ECF No. 131.) Accordingly, petitioner
moved to strike the Mikovits and Ruscetti report and accompanying literature from the

7 Exhibit designations 46, and 48-49 were used for procedural filings related to issuance of subpoenas

and an invoice from Dr. McCurdy.

8 Exhibit designations 55-58 were initially used by prior counsel in connection with a motion for interim

attorneys’ fees and costs. These designations were then duplicated by subsequent counsel. Exhibits 56-
58 were subsequently struck. Accordingly, only Exhibit 55 remains duplicated. For purposes of this
decision Exhibit 55 refers to the medical records from Torrance Memorial Medical Center as filed at ECF
No. 97.

5
record and that motion was granted. (ECF No. 132; Order (Non-PDF) granting motion
at ECF No. 132, 3/31/2020.) The parties initially intended for Dr. McCurdy to testify
during the entitlement hearing due to her additional status as a treating physician, but
ultimately determined that her testimony was not necessary. (ECF No. 164.) Instead,
the parties agreed to also strike Dr. McCurdy’s expert opinion from the record. (ECF
No. 165.)

A three-day entitlement hearing was ultimately set to commence on March 12,
2021. (ECF No. 145.) Petitioner subsequently submitted several additional pieces of
medical literature to support her claim on January 29, 2021, and an updated curriculum
vitae for Dr. Shoenfeld. (ECF No. 151; Exs. 124-136.) A three-day entitlement hearing
was held beginning March 12th, 2021, and continuing to March 17th and 18th, 2021.
(See ECF Nos. 188, 190, 192, Transcript of Proceedings (“Tr”), filed 03/26/2021,
04/09/2021.) Petitioner presented testimony from herself and Dr. Shoenfeld.
Respondent presented testimony from two of his experts, Drs. Rose and Whitton. The
parties submitted their post-hearing briefs on May 18, 2021, September 29, 2021, and
October 25, 2021. (ECF Nos. 195, 200, 202.)

This case is now ripe for resolution.

III. Factual History

a. As Reflected in Petitioner’s Medical Records

Petitioner was born on May 19, 1997. (Ex. 1.) Prior to her June 18, 2011, Tdap
vaccination, she was a healthy child who received 20 vaccinations between May 22,
1997 and July 12, 2002. (See Ex. 2, p. 1.) Her medical history was largely
unremarkable beyond a eustachian tube disorder diagnosed during infancy and several
acute sinus issues arising during 2009 and 2010. (Ex. 25, p. 4, 7, 8, 29; See generally
Ex. 25.)

Petitioner received the Tdap vaccination in question on June 18, 2011. (Ex. 2, p.
1.) Four days later on June 22, she was seen by Dr. Peter J. Georgio for left arm pain.
(Ex. 4.) Petitioner reported progressively improving pain and swelling in her left arm
with no rash. (Ex. 4.) On exam, Dr. Georgio observed full range of motion and strength
with a painful sensation. (Ex. 4.) Petitioner was assessed of having a possible reaction
to the preservative in the Tdap vaccination and advised to continue using over the
counter pain medication to manager her symptoms. (Ex. 4.)

Petitioner reported to her pediatrician, Dr. Maria Lui on June 28, 2011 for a
routine well check. (Ex. 5, p. 1-3.) She had her blood pressure taken on her left arm.
(Ex. 5, p. 1.) Petitioner reported that after her Tdap injection she became feverish and
suffered a headache. (Id.) She further reported that her arm was red and swollen, and
that she had been experiencing episodes of vertigo and pixelated peripheral vision,
which occasionally occurs when she is ill. (Id.) Petitioner explained to Dr. Lui that she
had swine flu the previous year and that ever since it felt as if her immune system was

6
becoming weaker. 9 (Id.) During this visit, petitioner’s physical exam was normal. Dr.
Lui ordered tests for petitioner’s thyroid function and sedimentation rate, advised
petitioner to monitor her headaches, and made differential diagnoses of delayed allergic
reaction to the preservative in the Tdap vaccination and optical migraines. (Id. at 3.)
Petitioner’s test results were returned the following day with no abnormal findings other
than slightly elevated sedimentation rate. (Id. at 5-6.) This was interpreted as “a small
sign of inflammation which is probably due to her allergic [reaction]” and repeat test of
the sedimentation rate was recommended. (Id. at 4.) Subsequently on July 18, 2011,
petitioner’s sedimentation rate was within normal limits. (Id. at 7.)

Dr. Lui referred petitioner to pediatric neurologist Dr. Pantea Sharifi Hannauer on
July 19, 2011 for “post-vaccine reaction and headaches.” (Ex. 6, p. 2.) Petitioner
reported that her left arm became very swollen with a reduced range of motion and
painful to the touch following her Tdap vaccination. (Id.) Petitioner reported that this
condition lasted for about two weeks and that ice and ibuprofen “helped only a little.”
(Id.) Petitioner also reported that while her headaches waxed and waned, she was
consistently fatigued, and that in the five days preceding this visit, the pain had
increased again. (Id.) She no longer reported vertigo but was now suffering from light
sensitivity and intermittent nausea. (Id.) Petitioner’s physical and neurologic exams
were both normal. (Ex. 6, p. 3-4.) Dr. Hannauer believed that petitioner had “a
tendency for migraine headaches” and that “it is likely that the post-vaccine reaction
triggered her headaches and extreme fatigue.” (Id. at 4.) She recommended
Prednisone for petitioner’s headaches, Zofran for nausea, and over the counter antacid
to address any potential side effects. (Id.)

Petitioner returned to Dr. Hannauer for a follow up on July 28, 2011. (Ex. 6, p.
5.) During this visit, petitioner reported that while the Prednisone was effective in
reducing the severity of her headaches, they still occurred on a daily basis. (Id.)
Petitioner’s neurological exam was normal. (Id. at 6.) Dr. Hannauer prescribed
Topamax and Indomethacin and scheduled a 2-week follow up. (Id.)

Petitioner was next seen by immunologist Dr. Joshua Davidson on August 8,
2011 for further testing. 10 (Ex. 7, p. 1.) Petitioner’s bloodwork, reported on August 11,
2011, was normal apart from a somewhat elevated Helper/Suppressor Ratio of 2.96,
and slightly lowered CD3 and CD8 cells at 59% and 14%, respectively. 11 (Id. at 3.) Dr.

9 I asked petitioner about this notation during the hearing. She indicated that both she and her brother
had a flu-like illness at about the same time, but that she was never tested and has no confirmation it was
swine flu specifically. (Tr. 80.)

10 As explained in the procedural history above, Dr. Davidson also wrote a letter in support of petitioner’s

claim. (Ex. 36.) Dr. Davidson’s letter expressed support for the notion that petitioner’s claim can satisfy
the three-prong Althen test based on the ASIA theory. Because this was more fully addressed by Dr.
Shoenfeld, Dr. Davidson’s opinion will not be discussed further. Dr. Davidson’s records do not contain
any specific reference to ASIA. (Ex. 7.)
11
A notation dated August 23, 2011 explains that petitioner’s gender was incorrectly reported as male
when conducting these tests, but that the “reference range” remained unchanged and the results
remained the same once the error was corrected. (Ex. 7, p. 3.)

7
Davidson wrote a letter on August 24, 2011, explaining that petitioner was unable to
participate in her physical education courses at school. (Id. at 4.)

Petitioner initially submitted a VAERS report on July 11, 2011, with supplemental
updates made on August 1, 2011, and August 22, 2011. (Ex. 3.) In the report,
petitioner explains that within one hour of her June 18, 2011, Tdap vaccination, she
“developed a headache, [felt] tired and had a temperature of 101 Fahrenheit.” (Id. at 4.)
She further explained that the following day, “her left arm started to swell and for 3 days
she could not lift [her] left arm,” but that it “was better within 2 weeks.” (Id.) Petitioner
also included her June 28, 2011, visit to Dr. Lui, and her subsequent visit to Dr.
Hannauer. (Id.) Her August 22, 2011, supplemental update explained that she was
continuing to see an immunologist and neurologist and that occasionally her arms and
legs felt like they were falling asleep. (Id.) Petitioner’s diagnoses were listed as
“persistent headache, nausea, vertigo, fatigue,” with a history of vertigo, eustachian
tube disorder, and “no change” in her progress. (Id.)

Petitioner returned to Dr. Lui on September 2, 2011 for flu symptoms that began
the night before. (Ex. 5, p. 8.) She explained to Dr. Lui that she awoke at 2 AM with
nausea but could not vomit. She also reported myalgias, arthralgias, and ongoing
headaches since her June Tdap vaccination. Petitioner’s physical exam revealed mild
epigastric tenderness. She was ultimately diagnosed with acute gastroenteritis (“viral
unlikely flu”) and prescribed anti-nausea medication and over the counter painkillers for
joint pain. (Id.)

On September 26, 2011, petitioner saw neurologist Dr. Mary Kay Dyes on
referral by Dr. Lui. (Ex. 8.) Petitioner reported that her arm swelling and fever had
ultimately resolved, but that she was still experiencing daily headaches and fatigue. (Id.
at 1.) She described her headaches as “throbbing and occasionally ‘stingy’” with
varying intensity and occasional dizziness. (Id.) She was undergoing acupuncture and
felt that it provided relief, albeit temporarily. She denied any present numbness but
noted that her extremities would “fall asleep easily” and sometimes spontaneously. (Id.)
Petitioner reported that the steroids Dr. Lui prescribed did not help her headaches. Dr.
Dyes noted that petitioner had been seen by an immunologist who suggested a trial of
IVIG and that although petitioner was prescribed Topamax by her previous neurologist,
she had not taken it due to concerns regarding the side effects. Dr. Dyes exam did not
reveal any abnormal findings. (Id.) Dr. Dyes ultimately diagnosed petitioner with
Chronic Daily Headache (“CDH”) and recommended a brain MRI and lab work for
vitamin B12 and Monospot. (Id. at 2.) Dr. Dyes also recommended a trial of
nortriptyline and scheduled a one-month follow up appointment. (Id.)

The following day, September 27, 2011, petitioner was seen by
allergist/immunologist Dr. Helen Mawhinney. (Ex. 9, p. 1.) At this visit petitioner
continued to report the same history of present illness as she had to her previous
treating physicians but noted that her fatigue was slowly resolving. Petitioner also
reported that she was no longer experiencing light sensitivity, and that she was tested
for allergies to the inactive Tdap vaccine ingredients of aluminum phosphate,
formaldehyde, glutaraldehyde, and 2-phenoxethanol with no allergic reactions. (Id.)

8
Petitioner’s exam was unremarkable and revealed no additional symptoms beyond
those reported in her history of present illness. (Id at 2.) Dr. Mawhinney did not believe
that petitioner’s history was indicative of a serum sickness reaction, nor an IgE-
mediated reaction. She believed that the most likely inciting agent was the pertussis
component of the Tdap vaccine that caused a “severe hypersensitivity reaction”. (Id.)
She requested antibody titers for tetanus toxoid, diphtheria, and pertussis “to see if we
can identify any exaggerated responses to these components of the vaccine,” but felt
that beyond these tests, “further attempts to identify the nature of this reaction are
unlikely to be helpful.” (Id.) She recommended against future Tdap vaccinations. Dr.
Mawhinney stated that she did “not believe that [she could] shed any further light on the
nature of [petitioner’s] headaches” but that “[i]t would appear that in some way the
reaction to Tdap [was the trigger].” (Id.)

Petitioner underwent a brain MRI without contrast on October 8, 2011. (Ex. 8, p.
3.) The results were “degraded by dental/orthodontic hardware” but otherwise
appeared “unremarkable.” (Id.) On October 19, 2011, petitioner visited Dr. Lui for
headache, sinus pressure, and one week of ear discomfort. She was diagnosed with
Eustacian Tube Disorder and prescribed flonase, Claritin, and etodolac for her
headache. (Ex. 5, p. 9.)

Petitioner visited rheumatologist Dr. Deborah McCurdy on November 30, 2011,
for further exam regarding her Tdap reaction. 12 (Ex. 11A, p. 7.) In addition to the
history of present illness that she had reported to her previous treating physicians,
petitioner also noted that the most helpful treatment for her headache had been
acupuncture, and that she now feels “very cold at times.” (Id. at 8.) Petitioner also
explained to Dr. McCurdy that she had abandoned competitive gymnastics ever since
she “blacked out mid vault and landed on her head” shortly after receiving her Tdap
vaccination. (Id. at 7.) Dr. McCurdy’s exam showed no abnormalities beyond possible
problems with weight gain. (Id. at 8-9.) According to Dr. McCurdy, petitioner’s lab
results showed a mildly elevated sedimentation rate in June that returned to normal by
July. (Id. at 12.) Dr. McCurdy did note that petitioner’s tetanus antibodies were “very
high suggesting an exaggerated response to the vaccine,” and “moderately positive
anti-histone antibodies suggesting an immune reaction to the vaccine.” (Ex. 11A, p.
12.) Petitioner’s immune workup was “basically within normal limits” with minor
deviations of peripheral blood B and T lymphocytes from normal limits that were “likely
not of clinical significance.” (Id.)

Dr. McCurdy believed that, based on the immediate reaction, petitioner had
suffered an arthus reaction, stating that:

The reaction to the injection was immediate suggesting an arthus reactions
(type III hypersensitivity reactions) perhaps to previous vaccines. Although

12 As discussed in the procedural history above, petitioner also submitted an expert opinion by Dr.

McCurdy to support her claim. However, she ultimately determined that she would not rely on Dr.
McCurdy’s opinion and filings associated with Dr. McCurdy’s opinion have been struck. Accordingly, only
Dr. McCurdy’s opinion as a treating physician as reflected in her medical records has been considered.

9
arthus reactions are rare after vaccinatio[n], they may occur after tetanus
toxoidcontaining [sic] or diphtheria toxoidcontaining [sic] vaccines. An
arthus reaction is a local vasculitis associated with deposition of immune
complexes and activation of complement. Immune complexes form in the
setting of high local concentration of vaccine antigens and high circulating
antibody concentration. Arthus reactions are characterized by severe pain,
swelling, induration, edema, hemorrhage, and occasionally by necrosis.
These symptoms and signs usually occur 412 [sic] hours after vaccination.
They usually abate over time, however, care should be used with
vaccinations, especially Tdap in the future.

(Ex. 11A, p. 12.) However, Dr. McCurdy noted that because petitioner’s immune
complexes were negative, her headaches were likely unrelated to an immune disorder.
(Id. at 13.) She explained to petitioner’s parents that IVIG therapy would likely be
ineffective due to the fact that petitioner’s condition was unrelated to earlier immune
complexes that may have resulted from her Tdap vaccine but had now cleared. She
recommended medications for chronic migraine headaches, including those in the anti-
depressant and anti-convulsant groups. She also recommended aqua or physical
therapy, continued acupuncture, sleep hygiene, and a diet adjustment. (Id.)

Petitioner saw Dr. McCurdy six times between February 1, 2012, and February
15, 2013, without any significant improvement in her symptoms or developments in her
diagnosis. (Ex. 11A, pp. 24-28, 29-31, 32-36, 37-39, 40-42, 43-46.) Dr. McCurdy
ordered Antinuclear ab labs, which demonstrated normal ANAs. (Ex. 11B, pp. 6-7, 27,
41, 47.) Additionally, petitioner began physical and occupational therapy at Body
Dynamics on December 6, 2011. (Ex. 18, p. 1.) She attended at least 82 sessions
between December 6, 2011 and March 26, 2013, however, there is no record of a
specific discharge date. (See Ex. 18, pp. 1-87.)

On March 8, 2012, petitioner was seen by ear, nose, and throat specialist Dr.
Quinton Gopen upon referral by Dr. McCurdy for “pressure problems in her ear” and
accompanying dizziness. (Ex. 12, p.1.) Petitioner’s mother reported that petitioner had
been diagnosed with drug-induced lupus, but this diagnosis is not recorded in any of
petitioner’s medical records. 13 (Id.) Petitioner otherwise reported the same symptoms
that she had previously reported, and Dr. Gopen diagnosed her with eustachian tube
disorder and recommended using flonase more regularly. (Id. at 2.)

Petitioner next saw Dr. Lonnie Kaye Zeltzer at the UCLA Pediatric Pain Clinic on
referral by Drs. Lui and McCurdy on July 16, 2012. (Ex. 13.) Petitioner continued to
report symptoms consistent with her prior visits but also included to a year and a half of
joint pain. (Id. at 1.) Petitioner’s physical and mental exams were both within normal
limits. (Id. at 3.) Dr. Zeltzer assessed petitioner with “post-vaccination syndrome . . .
with persistent headache, dizziness, and fatigue. Likely central headaches now, with

13
Many of petitioner’s records indicate a history of lupus based on this report of drug induced lupus, but
she has not submitted any records indicating that she ever formally or definitively carried such a
diagnosis. This summary does not include all such repeated references to lupus.

10
heightened SNS stress responsivity,” and “secondary amenorrhea, likely related to the
vigorous exercise of gymnastics.” (Id.) Dr. Zeltzer recommended education about
petitioner’s pain and stress, continued acupuncture and Pilates, additional physical
therapy and yoga, and Elavil or Neurontin. (Id.)

Petitioner’s records next describe a visit to Dr. Colin Robinson at UCLA’s
Pediatric Rheumatology Clinic roughly a year later on July 31, 2013. (Ex. 31, p. 2.)
During this visit, petitioner reported that she had been better since school had let out,
that her fatigue had improved throughout the school year, and that her more severe
headaches occurred less often. (Id.) Petitioner noted that her headaches were more
severe when she had to “focus mentally.” (Id.) She reported arthralgias in her left knee,
wrist, and elbow, as well as continued numbness in her arms and legs approximately
twice a week. (Id.) Petitioner’s physical exam was normal and Dr. Robinson assessed
chronic headaches, chronic fatigue, and “[p]ositive antihistone antibody, possibly as a
response to TDaP vaccination, most recent titer 1.4 (weak positive), improving
symptoms, stable Ab level over past two visits.” (Id. at 4.)

On October 23, 2013, petitioner was referred to Dr. Gopen once more for throat
pain and bilateral ear pain. (Ex. 31, p. 5.) Dr. Gopen erroneously noted that petitioner
had a history of drug-induced rheumatoid arthritis. (Id.) He believed that petitioner
“may have reflux or other diagnosis causing irritation at the back of her throat that she is
having as referred otalgia.” (Id.)

Petitioner was next seen by Dr. Jennifer Long at UCLA’s Head and Neck clinic
on October 30, 2013 with a chief complaint of throat pain. (Ex. 31, p. 6.) Petitioner
explained that this pain was different from a typical sore throat as it involved the bilateral
sides of the larynx. (Id.) Dr. Long’s impression was that petitioner showed “signs and
symptoms of laryngopharyngeal reflux” but that her diet was “actually quite good from a
reflux standpoint given the degree of laryngeal swelling present.” (Id. at 7.) She also
believed that petitioner had likely suffered from “a component of muscle tension
dysphonia that is worsening her pain especially after voice use.” (Id.) Dr. Long
prescribed omeprazole and referred petitioner to voice therapy. (Id.)

Petitioner also had a follow-up appointment with Dr. McCurdy on October 30,
2013. (Ex. 31, p. 7.) During this visit, petitioner reported that her fatigue had been
worse since she started home schooling in September, and that she felt “too tired to do
anything” in spite of sleeping regularly throughout the night. (Id. at 7-8.) Her
headaches continued to improve, as did her arthralgias and numbness. (Id. at 8.) Dr.
McCurdy assessed petitioner as suffering from sore throat and ear pain, feeling of being
in a fog, and positive antihistone antibodies as a possible response to her Tdap
vaccination. (Id. at 16.)

Dr. Long referred petitioner to Speech and Language Pathologist (“SLP”) Lisa
Joy Bolden on November 14, 2013, with a diagnosis of mild dysphonia. (Ex. 31, p. 16.)
SLP Bolden noted that petitioner’s throat pain began approximately one week after she
began taking Omega-3 supplements with Gamma Linolenic Acid (GLA) which could be

11
contributing to her pain. (Id. at 17.) SLP Bolden felt petitioner’s rehabilitation potential
was excellent based on successful trial therapy and recommended an additional three
months of voice therapy. (Id. at 18.)

Petitioner next saw Dr. McCurdy on February 5, 2014. (Ex. 31, p. 19.) Dr.
McCurdy noted that in addition to petitioner’s earlier symptoms of headache, fatigue,
brain fog, and abdominal pain, her symptoms now included an almost 20-pound weight
loss (98 lb, 5.2 oz), muscle loss, vision changes, and myopathy. (Id. at 20.) Petitioner
had discontinued GLA, which helped with her throat pain, but made her joint aches
worse. (Id.) Petitioner was also suffering from significant constipation at that time, had
changed her diet, and used calcium citrate to no effect. (Id.) Dr. McCurdy noted that
petitioner’s positive anti-histone antibodies persisted “despite treatment with Plaquenil,
which she discontinued in 2013.” (Id. at 23.) Dr. McCurdy recommended continued
physical therapy, aqua therapy if physical therapy did not work, a follow up with Dr.
Zeltzer for pain management, laxative until her constipation subsided, possible Provigil,
physical exercise, and a neuro-ophthalmology evaluation. (Id.)

Petitioner saw Dr. Long again on February 19, 2014 for a video laryngoscopy
with stroboscopy and medical speech evaluation. (Ex. 31, p. 25.) Petitioner’s
videolaryngostroboscopy was normal apart from mild edema and erythema. (Id.) Dr.
Long’s impression was that petitioner’s dysphonia had resolved. (Id.)

Petitioner was next seen by Ophthalmologist Dr. Stacy Pineles on April 14, 2014,
for problems related to blurry vision, occasional black spots, and difficulty in dark
lighting. (Ex. 31, p. 26.) Dr. Pineles explained that she believed petitioner’s symptoms
were caused by migraine based on her normal eye exam. (Id.) Dr. Pineles referred
petitioner to Dr. Lekha Rao to discuss migraine treatment and suggested an
electroretinogram could be done to rule out retinal disease. (Id.)

Petitioner was seen by Dr. Joyce Matsumoto at UCLA’s neurology department on
April 24, 2014, with a chief complaint of headache. (Ex. 31, p. 27.) Petitioner had lost
an additional 12 pounds, weighing in at 85 lbs, 8.6 oz. (Id. at 28-29.) Dr. Matsumoto
believed that petitioner’s chronic headache/migraine was “likely triggered by her
reaction to the vaccine” and that they were “likely [a] large component” of her other
symptoms. (Id. at 29.) Petitioner reported that she was also suffering from disrupted
sleep, was eating smaller meals, not drinking enough fluids, and occasionally
experiencing “presyncopal/lightheaded feeling.” (Id.) Dr. Matsumoto emphasized the
importance of adequate nutrition and augmented petitioner’s migraine medication
regimen with B2 and magnesium supplements. (Id.)

On April 28, 2014, petitioner was seen by pediatric allergist Dr. Maria Garcia-
Lloret for a consultation on her weight loss. (Ex. 31, p. 30.) Petitioner explained that
she was experiencing adverse reactions to an increasing number of foods which was
causing difficulties maintaining a nutritious diet. (Id.) Petitioner had lost 30 pounds
since 2012, explained that she was hungry and wanted to eat, but that she would feel
full very quickly regardless of what she was eating. (Id. at 30-31.) Petitioner denied any

12
ongoing fevers, joint pain, weakness, or malaise. (Id. at 31.) Dr. Garcia-Lloret
assessed petitioner with a history of multiple pollen and food allergies, oral allergy
syndrome, food restriction with weight loss with an “unclear etiology but allergic process
unlikely to be a main cause.” (Id.) Dr. Garcia-Lloret wanted to rule out inflammatory
bowel disease or other systemic inflammatory processes and referred petitioner to a
pediatric gastrointestinal specialist for a delayed gastric emptying study. (Id. at 32.)
She recommended CBC and ESR labs, a chemical panel, and an Immunocap for
various foods. (Ex. 31, p. 32.) She also prescribed a trial of Loratadine, and potentially
montelukast. (Id.)

Petitioner next saw Dr. Zeltzer on May 7, 2014, for further evaluation of her
headache and fatigue. (Ex. 31, p. 32.) Petitioner’s mother reported that petitioner
passed out for the first time the week before, and petitioner reported that her head
would pulse for a long time and her vision and hearing would go out when she would
stand up. (Id. at 33.) Petitioner’s primary complaint during this visit was disruptions
with her sleep schedule, stating that she could take up to two hours to fall asleep and
that she would wake up once or twice a night. (Id.) Dr. Zeltzer noted “no evidence of
SLE but rather post-vaccination reaction with multiple symptoms, normal ANA, normal
ESR, and weakly positive histone.” (Id. at 32.) Dr. Zeltzer prescribed melatonin to help
petitioner sleep and referred her to Dr. Bruce Levine for biofeedback. 14 (Id. at 35.)

Petitioner was next seen at the UCLA Pediatric Rheumatology department on
May 13, 2014. (Ex. 31, p. 35.) At this point petitioner’s weight had decreased to 79 lbs,
2.3 oz and she was in the 0-percentile BMI for her age. (Id. at 36.) Beyond these
updates, the medical record is an almost verbatim copy of Dr. McCurdy’s February 5,
2014 report of petitioner’s condition and treatment recommendations. (Compare Ex. 31,
p. 9 with Ex. 31, p. 39.) Petitioner’s April 28, 2014 lab work indicated slightly elevated
MCH concentration, reduced neutrophil and lymphocyte percent, reduced glucose,
slightly elevated albumin, slightly elevated ALT (SGPT), and normal ESR. (Ex. 31, pp.
36-39.)

Following her visit to pediatric rheumatology, petitioner was seen by pediatric
gastroenterologist Dr. Elaheh Vahabnezhad on May 21, 2014. (Ex. 31, p. 40.)
Petitioner reported that since November, she was feeling full for longer periods of time
and described herself as having an appetite but feeling like she could not eat. (Id.) She
was recorded as losing roughly 33 pounds over the past year weighing in at about
78lbs. (Id. at 40, 42.) Petitioner’s constipation had resolved. (Id.) She developed a
“cyst like” raised bump along her left buttock that “comes and goes on its own” but lasts
for several weeks at a time. (Id.) She felt that her throat would feel tight at times and
explained that she was experiencing irregular menstruation. (Id. at 41.) Dr.
Vahbnezhad made differential diagnoses of potential gastroparesis, inflammatory bowel
disease, celiac disease, potential fatty acid deficiency, and potential malignancy based
on enlarged lymph nodes. (Ex. 31, p. 44.) Dr. Vahbnezhad recommended nutritional
therapy and a 3 to 4 week follow up after analyzing the results of petitioner’s gastric
emptying study. (Id.)

14 Petitioner has not submitted any records from Dr. Levine.

13
On May 23, 2014, petitioner was seen by Dr. Reena Gupta at Osborne Head and
Neck Institute with a chief complaint of throat pain. (Ex. 53, p. 16.) Dr. Gupta observed
symptoms of decreased vocal range and difficulty projecting. (Id.) Dr. Gupta diagnosed
petitioner with dysphonia, throat pain, and an unclassified autoimmune disease. (Id. at
19.) Based on petitioner’s complicated medical history, Dr. Gupta thought that
petitioner’s throat symptoms were related to her general health and it was therefore best
to defer to petitioner’s rheumatologist and GI specialists. (Id. at 18.)

Petitioner was seen by Drs. Benjamin Kretzmann and McCurdy at UCLA
pediatric rheumatology on June 10, 2014. (Ex. 44, p. 51.) Dr. Kretzmann
recommended that petitioner stick to Dr. McCurdy’s earlier recommendations of
physical therapy and exercise. Dr. McCurdy reviewed petitioner’s medical history and
confirmed that there “had been no change.” (Id.) Petitioner did believe that she was
eating more, however. (Id.)

On August 16, 2014, petitioner reported to the UCLA Emergency Department
with hypothermia and severe weight loss. (Ex. 44, p. 55.) Upon admission petitioner
weighed approximately 60 pounds. (Id. at 52.) The attending physician concluded that
petitioner was severely malnourished and recommended inpatient treatment in order to
explore the source of her condition as either psychological or biological. (Id. at 56.)
Petitioner had “exponentially elevated” LFTs which the attending physician believed
could be a sign of liver failure even though she was showing that her liver still had
capacity to have synthetic function. (Id.) Petitioner was observed to have dry-scaly
skin, lanugo-like hair on her abdomen, gross hyperpigmentation patches over her arms
and legs, and petechiae. (Id. at 61.) She was put on IV nutrition and monitored over
the course of about three weeks. (See generally Id. at 52-242.)

During her treatment, petitioner was seen by a variety of specialists including
general pediatricians, gastroenterologists, nutritionists, rheumatologists, and
psychiatrists. (Ex. 44, p. 243.) Petitioner’s discharge summary explained that she was
diagnosed with hepatitis during her stay and received work-ups for autoimmune,
infectious, and toxic etiologies of the disease, all off which were negative. (Id.) The
most likely etiology for petitioner’s hepatitis was thought the be malnutrition caused by
anorexia nervosa, however the treating physicians found it difficult to make this specific
diagnosis due to petitioner and her family becoming defensive when the topic was
approached. 15 (Id.) During her stay, petitioner received IV nutrition, her LFTs were
reduced considerably, and although she remained hypothermic upon discharge, she did

15 It was noted in the discharge summary that petitioner:

[h]as a dietary history strongly concerning for restrictive eating behavior and there is a
strong concern for anorexia nervosa (BMI 10.5, wt loss of 27kg over 1 yr, restrictive eating
behavior, lack of medical cause found). Pt does not have insight into her condition. Parents
have poor insight into their daughter's condition. Rather than accepting fully that she has
an eating disorder, they choose to believe that she has an eating disorder, but that it is 2/2
TDap Vaccine induced gastroparesis and feelings of fullness.

(Ex. 44, pp. 243-44.)

14
show an improved overall temperature curve. (Id.) The discharge summary noted that
petitioner’s malnutrition was due to “inadequate intake from restrictive eating habits vs
organic due to symptomatic gastroparesis,” but the ultimate discharge diagnosis was
“eating disorder NOS.” (Id. at 242, 244.)

After she was discharged from the hospital, petitioner saw Dr. Chiaki Jutabha for
regular follow-ups regarding her eating disorder. (See generally Ex. 42, pp. 2-21.)
Petitioner’s first visit to Dr. Jutabha was on September 8, 2014. (Id. at 2.) Petitioner
reported that she was feeling much better and that she was able to eat “better foods
and more variety.” (Id.) She had gained 7 pounds since being discharged and was
taking in about 2100 kcal/day. (Id.) Petitioner noted that she had severe lower back
pain on her left side the day before, but that it had resolved, she was also experiencing
dysuria. (Id.) Petitioner’s AST was within normal limits and ALT was “returning back to
normal.” Dr. Jutabha ultimately assessed petitioner with an “eating disorder of unknown
etiology.” (Id. at 4.) Petitioner was asked to follow up in 3-4 days for a weigh check
with a plan to do biweekly weight checks until petitioner’s weigh stabilized, in which
case she the weight checks would be reduced to once per week. (Ex. 42, p. 4.) On
October 22, 2014, petitioner received an abdominal ultrasound on a referral from Dr.
Jutabha. (Ex. 45, p. 12.) Comparing this ultrasound to one conducted on August 18,
2014, during petitioner’s inpatient treatment at UCLA, the impression was that petitioner
had improved hepatic echotexture compared to the prior study, suspected gallbladder
sludge or cholesterol polyps, and bilateral heterogeneous renal echotexture and
indistinct corticomedullary differentiation suggesting either medical renal disease, right
renal sinus cyst, or hydroureter. (Id.) Petitioner continued to see Dr. Jutubha through
May of 2015 and continued to regain weight. (Ex. 42, p. 35.)

Petitioner was seen by Dr. Dana Kennedy at Torrance Memorial Medical
Center’s emergency department on November 8, 2014, with a chief complaint of chest
pain and tightness. (Ex. 55, p. 19.) She denied any other symptoms, including any
headaches or gastrointestinal symptoms. (Id.) Petitioner underwent a chest X-ray
which appeared normal, with “[n]o definite evidence of acute infiltrate, effusion, or
pneumothorax.” (Id. at 37.) Petitioner was ultimately discharged with orders to take
Tylenol or ibuprofen for pain while monitoring for future chest pains and breathing
difficulties. (Id. at 43.) Petitioner underwent a kidney and bladder ultrasound study by
Dr. Theodore Hall study on December 3, 2014. (Ex. 45, p. 11.) Dr. Hall did not find any
remarkable results. (Id.)

On December 17, 2014, petitioner was seen again by Dr. McCurdy. (Ex. 42, p.
21.) Petitioner was found to have consistently improved since her hospitalization in
August and reported eating around 2,400 calories per day. (Id.) Her physical exam
was normal, she weighed almost 90 pounds, but reported that she was still experiencing
regular headaches. (Id. at 21-22.) Petitioner noted minor arthralgias in her toes but
explained that physical therapy was helping. (Id. at 21.) Petitioner was on a regiment
of ascorbic acid, cholecalciferol, magnesium oxide, and omega-3 fatty acids which
seemed to be helping her symptoms. (Id. at 21-22.) Dr. McCurdy recommended that

15
petitioner continue physical therapy, continue taking her medication, and an ANA and
anti-histone antibody study with her next round of lab work. (Id. at 22-23.)

On February 27, 2015, petitioner was seen by Dr. Ana Lopez-O’Sullivan at the
Torrance Memorial Medical Center Emergency Department with a chief complaint of
headache. (Ex. 55, p. 78.) Petitioner explained that she was not taking pain medication
because she did not believe in it, denied fever, cough, congestion, rash, neck pain,
changes in her hearing or vision, nausea, vomiting, photophobia, and any weakness or
numbness of her extremities. (Id.) Dr. Lopez-O’Sullivan noted that she did not suspect
any serious causes for petitioner’s symptoms and convinced petitioner and her parents
that there was no need for a CT scan, but that if petitioner’s symptoms became severe
she could order an outpatient MRI to explore any causes that she had not yet
considered. (Id. at 79.) Petitioner was discharged with a diagnosis of “headache” and
advised to take over-the-counter pain medication as needed and to return to the
emergency department if the symptoms became severe. (Id. at 109.)

On March 4, 2015, petitioner underwent a Pulse Wave Profiler study to measure
her Heart Rate Variability, a Surface EMG study to measure her muscle tone and
balance, and a thermal scan to measure her organ and glad control. (Ex. 51, p. 25.)
The results of these studies were compiled to generate a “personal neural efficiency
index” measured by a “COREScore” rating. (Id. at 36.) Petitioner showed a score of 73
for her heart rate variability, 68 for her muscle tone and balance, and 52 for her organ
and gland control resulting in an aggregate COREScore of 66, indicating an overall
“challenged” neural efficiency index. (Id. at 37.)

Petitioner saw Dr. McCurdy for another follow up visit on March 18, 2015. (Ex.
42, p. 26.) During this visit petitioner reported that she was having trouble focusing,
suffering from continued headaches, fatigue, and nausea, throat pain on her left side,
constant urination, sensitivity to smell and light, and easy indentation of her skin. (Id. at
26-27.) Petitioner had not followed up with psychology. (Id. at 26.) She weighed just
under 102 pounds but was having trouble gaining more weight. (Id. at 26, 28.) Dr.
McCurdy recommended consults with ophthalmology, neurology, and psychology,
continued physical therapy and vitamins, additional B vitamins for headache and focus
issues, and cortisol, ANA, and anti-histone antibody labs. (Id. at 30-31.) Petitioner next
saw Dr. Sande Okelo for pulmonary function testing on April 15, 2015. (Ex. 42, p. 31.)
Petitioner’s spirometry, lung volume, and diffusion capacity tests did not reveal any
abnormalities. (Id. at 32.)

Petitioner began seeing psychologist Dr. Kelly Mothner, PhD on May 19, 2015.
(Ex. 52, p. 30.) Petitioner saw Dr. Mothner once to twice a week until at least December
20, 2016. (See Ex. 52, pp. 2-30; Ex. 54.) Notably, Dr. Mothner and petitioner explored
somatic responses to petitioner’s anxiety on July 13, 2015, suggesting that she
physically feels “tight” when she is anxious versus feeling “loose” when she is not. (Id.
at 26-27.) However, beyond this notation, Dr. Mothner’s records are largely
unremarkable and focus on petitioner’s progress with dealing with her anxiety disorder.
(See generally Ex. 52.)

16
On June 17, 2015, petitioner was seen by gastroenterologist Danice Hertz on
referral from Dr. Simone Gold. 16 (Ex. 45, p. 2.) Dr. Hertz’s preliminary impression was
a reported history of severe reaction to a Tdap vaccination with possible Systemic
Lupus Erythematosus leading to severe malnutrition. (Id.) Dr. Hertz noted that
petitioner was slowly improving but dealing with constipation lasting for two months.
(Id.) Dr. Hertz recommended continuing a high fiber diet, increased fluids, and
increased magnesium, citracel caplets, and miralax. (Id.)

Petitioner saw Dr. Bette Geller Jackson, Ph.D. throughout June and July of 2015
for a series of Neuropsychological-Educational Assessments. (Ex. 50, p. 181.)
Petitioner’s parents requested these evaluations in order to determine whether
petitioner suffered from any learning, processing, or psychological disorders. (Id. at
197.) Dr. Geller Jackson’s diagnostic impression included generalized anxiety disorder,
somatic symptom disorder, and attention deficit hyperactivity disorder. (Id. at 197.) She
recommended that petitioner be given additional time and extended breaks on
standardized tests, that she be evaluated for an anxiety disorder, attend individual
psychotherapy to “help alleviate her feelings of anxiety and to deal with her somatic
issues,” engage in extracurricular enrichment activities, and participate in mindfulness
training, yoga, meditation, and exercise. (Id. at 197-98.)

On July 21, 2015, petitioner was seen by gastroenterologist Dr. William Stuppy
for an expanded GI panel. (Ex. 51, p. 1.) Petitioner’s results were normal, with a
borderline low result for her total intestinal SIgA (Stool). (Id.) Petitioner was also seen
by Dr. Johannes Czernin for a gastric emptying study at the UCLA Nuclear Medicine
Clinic. (Ex. 51, pp. 7-8.) Dr. Czernin concluded that petitioner had “[b]orderline
abnormal gastric emptying at 49%” but that this was a marked improvement to a prior
study that noted only 22% after 90 minutes. (Id. at 7.) On July 31, 2015, petitioner
underwent an exhaled air analysis conducted by Dr. Jorge Vargas. (Ex. 42, pp. 36-37.)
Dr. Vargas interpreted petitioner’s results as normal with a slightly lower than predicted
BMR. (Id. at 37.) Petitioner tested negative for Lyme Disease on August 18, 2015.
(Ex. 51, pp. 5-6.)

Petitioner was seen by Dr. Ryan F. Osborne at Osborne Head and Neck Institute
on September 18, 2015, with a chief complaint of ear clogging. (Ex. 53, p. 9.) She
described her symptoms as moderate to severe, beginning three weeks earlier, with a
sudden onset following a hyperbaric oxygen treatment. (Id.) Dr. Osborne diagnosed
petitioner with impacted cerumen, dysfunction of eustachian tube, candidal otitis
externa, and conductive hearing loss, external ear. (Id. at 10.) He conducted a left ear
debridement and cleansing and prescribed ciprodex otic suspension drops and a
clotrimazole 1% solution. (Id. at 10, 13.) Petitioner was again seen by Dr. Osborne on
a follow-up for her ear complaint the following week on September 24, 2015. (Id. at 4.)
She explained that her symptoms persisted were slightly improved but that she did not
believe the medicated ear drops were working. (Id.) Dr. Osborne treated patient with
boric acid powder which she requested be removed and conducted an “extensive

16 Although this record suggests that petitioner was previously being treated by Dr. Gold, she has not

submitted any records of this treatment beyond a letter written on October 15, 2015. (Ex. 43.)

17
debridement” and disimpaction of petitioner’s left ear. (Ex. 53, pp. 7-8.) Dr. Osborne
suggested that petitioner may need to return for weekly debridement, but no further
records of treatment for petitioner’s ear problem exist. (Id. at 7.)

On October 15, 2015, Dr. Simone Gold wrote a letter detailing petitioner’s
symptoms and her suspected diagnosis. (Ex. 43.) Dr. Gold notes that petitioner’s most
severe symptom was her gastrointestinal slowing which led to her malnourishment and
weight loss. (Id. at 1.) Dr. Gold explained that she believed that petitioner suffered from
an uncommon condition called “dysautonomia,” triggered by her Tdap vaccination. (Id.
at 1-2.)

Petitioner saw Dr. Michael Arata on October 23, 2015, with chief complaints of
“severe mental fog, chronic fatigue, weakness, chronic headaches, urinary urgency,
digestive discomfort, malnutrition, sleep disturbances, and visual disturbances.” (Ex.
47, p. 1.) Petitioner’s physical exam was normal; however, based on her subjective
reports, Dr. Arata diagnosed petitioner with an unspecified disorder of the autonomic
nervous system, mild cognitive impairment, fatigue, chronic headache disorder,
constipation, bloating, urinary urgency, unspecified sleep disturbance, paresthesia of
skin, blurred vision, unspecified protein-calorie malnutrition, and gastroparesis. (Id. at
5.) Dr. Arata recommended an organic acids test and a PLA-2 “to see what’s going on
in the body,” noting that:

Abnormally high levels of these microorganisms can cause or worsen
behavior disorders, hyperactivity, movement disorders, fatigue and
immune function. Many people with chronic illnesses and neurological
disorders often excrete several abnormal organic acids. The cause of
these high levels could include: oral antibiotic use, high sugar diets,
immune deficiencies, and genetic factors.

(Id.) Dr. Arata also recommended a qEEG assessment with neurofeedback, adjusting
petitioner’s diet to include more protein and less carbohydrates, and for petitioner to
continue her organic diet. (Id.)

Petitioner next saw Dr. Robert Roberts and Suzanne Cambou on November 4,
2015 for an allergy and immunology consultation. (Ex. 95, p. 313.) Dr. Cambou
described petitioner’s earlier diagnoses of drug induced lupus and dysautonomia as
“questionable” on this visit. (Id. at 314.) Petitioner’s physical exam was normal, and Dr.
Roberts recommended a variety of labs including Tetanus toxoid antibodies, ESR, CRP,
Rubella antibodies, Measles antibodies, B and T Cell subsets, IgM, IgG, IgE, IgA,
Gelatin IgE, Diphtheria toxoid antibodies, CBC with differential, B pertussis antibodies,
and Almond IgE testing. (Id. at 318.)

Petitioner saw Dr. Arata on December 16, 2015, for a follow up on blood work
and an evoke assessment. (Ex. 47, p. 7.) Petitioner was reported that her metabolism
was changing and that she was losing weight again. (Id.) Dr. Arata noted that
petitioner’s blood work revealed low progesterone and estrogen. (Id. at 8.) Her

18
quantitative EEG revealed elevated levels suggestive of ADD. (Id.) Dr. Arata
recommended progesterone, screen toxicity testing, hair toxin screening, adding
broccoli or other cruciferous vegetables to petitioner’s diet, eliminating bananas,
neurofeedback training, and a 7-day food diary. (Id.)

Petitioner returned to Dr. Arata the following week on December 23, 2015, to
follow up on her evoke results, discuss her 7-day food diary, and discuss her GPL
results. (Ex. 47, p. 10.) Dr. Arata explained that petitioner reverse T3 hormone was “on
the higher side,” and listed diagnoses of an unspecified disorder of the autonomic
nervous system, mild cognitive impairment, fatigue, chronic headache disorder,
bloating, unspecified protein-calorie malnutrition, and headache. (Id. at 13.)

Petitioner returned to Dr. McCurdy on July 12, 2016. (Ex. 95, p. 319.) She
continued to complain of mental fog and headaches. (Id.) Dr. McCurdy noted that
petitioner was “doing neuro feedback in Playa del Rey,” which seemed to be helping.
(Id.) Petitioner’s lab work was normal besides an elevated vitamin D level, and she was
advised to stop taking Vitamin D supplements. (Id. at 323.) Dr. McCurdy
recommended that petitioner continue her therapies to decrease pain, to check ANA
and anti-histone antibodies, and to look for a dysautonomia specialist or treatment. (Id.
at 322.)

Petitioner was seen by Drs. McCurdy and Terwa Yong on January 24, 2017, for
a follow up to her July 12 visit. (Ex. 95, p. 323.) Petitioner reported that she was
enjoying college and doing well, but that she was recently having issues sleeping on
account of her headaches becoming more severe. (Id. at 323-24.) She was still taking
vitamin D despite having been advised to stop. (Id. at 324.) Her antihistone antibodies
remained slightly elevated. (Id. at 326.) Dr. Yong recommended a renewed physical
therapy prescription, discontinuing vitamin D supplements, continued neurofeedback,
massage, and acupuncture as needed, and lab work including fungal culture urine,
antinuclear antibodies, sedimentation rates, CBC analysis, a comprehensive metabolic
panel, c-reactive protein, and histone antibody IgG testing (Id. at 328.)

On October 11, 2017, petitioner was seen by nephrologist Dr. Patricia Weng for a
consultation on her polyuria. (Ex. 95, p. 329.) Petitioner reported that six months prior
to this visit she had experienced gross hematuria, right flank pain, and felt that she had
possibly passed a kidney stone. (Id. at 330.) She also reported that she was
experiencing gross hematuria as recently as a week and a half earlier. (Id.) Dr. Weng
believed that petitioner may have had a kidney stone and recommended urinalysis,
complete metabolic profile, complete blood count, osmolality and iron studies, a renal
ultrasound, and a litholink 24 hour urine collection. (Id. at 334-35.) Dr. Weng added an
addendum to this record noting that petitioner showed normal renal function, elevated
vitamin D levels, microscopic hematuria, and a slightly elevated calcium-creatinine ratio
which would not explain the polyuria or gross hematuria. (Id. at 335.) Dr. Weng noted
that petitioner’s polyuria had an unclear etiology and further recommended a follow up
renal ultrasound if petitioner tested negative for kidney stones because in that case, her
gross hematuria may indicate lower GI tract bleeding. (Id.)

19
Petitioner was seen by Dr. Ellen Baker at the Torrance Memorial Medical Center
Emergency Department on November 30, 2017, with chief complaints of right flank pain
and lower abdominal pain. (Ex. 55, p. 141.) Petitioner’s urine was positive for trace
leukocytes and sent for urinalysis and culture; her chemistry panel was normal. (Id. at
142.) Dr. Baker ordered Rocephin, IV fluids, and an ultrasound for completeness. (Id.)
Petitioner’s testing did not reveal that she was passing a kidney stone. (Id.) Petitioner
was prescribed ciprofloxacin and told to follow-up with her primary care physician. (Id.)

Petitioner followed up on her polyuria issues with Dr. Steven Lerman on
December 3, 2017. (Ex. 95, p. 335.) Dr. Lerman believed that petitioner’s kidneys
looked “relatively stable and structurally fine.” (Id.) His assessment was that the best
plan of action was to monitor petitioner’s symptoms over the next six to twelve months,
with a repeat ultrasound after that time. (Id.) Dr. Lerman made two addendums to this
record. The first was on December 22, 2017, where he noted that petitioner’s ED
ultrasound raised the question of nonobstructing kidney stones and that her urinalysis
revealed red and white blood cells but with a negative culture. (Id. at 336.) He
recommended hydration, possibly pyridium and/or ditropan if petitioner’s symptoms
persisted, and a non-contrast CT scan to assess for stones. (Id.) Dr. Lerman’s second
addendum was made on January 5, 2018. (Id.) He noted that petitioner was clinically
better with random episodes of polyuria. (Ex. 95, p. 336.) Petitioner’s CT scan
revealed a “4mm non obstructing left lower pole stone.” (Id.) Dr. Lerman recommended
observation and a similar CT scan in 2 years. (Id.)

Petitioner saw Dr. McCurdy again on March 7, 2018. (Ex. 96, p. 47.) Dr.
McCurdy reported that petitioner had developed Raynaud’s Syndrome “over the last few
months,” that only involved one finger or toe. (Id.) Petitioner reported that she was in
pain, but Dr. McCurdy did not observe any necrotic lesions. (Id.) Dr. McCurdy did
however, observe small skin lesions that take a long time to heal, very dry skin on
petitioner’s face that she reported does not clear up, and a lesion that would not heal.
(Id.) Petitioner also reported that for two to three days it had felt like she had a hair in
her throat. (Id.) Dr. McCurdy recommended Derma-Smooth for petitioner’s face, a
renewed physical therapy prescription, continued alternative treatments, and a variety of
labs. (Id. at 52.) Petitioner received a bilateral kidney ultrasound on January 9, 2019,
which did not reveal any abnormalities or detectable kidney stones. (Ex. 96, p. 94.) No
further medical records have been filed.

b. As reflected in witness statements

i. Petitioner’s parents’ letter to the court

Petitioner filed a letter from her parents on October 15, 2013, providing an
assessment of her condition up to that point. (Ex. 26.) This letter indicates that, prior to
her vaccination, petitioner was a high performing competitive gymnast, training four to
five hours each day, six days per week. (Id. at 2.) She would spend much of her time
outside and with her family, she was physically fit, and had reached puberty. (Id.) Her
parents explain that since her vaccination, petitioner is unable to engage in much

20
physical activity, has been provided handicap parking access, and suffers from
debilitating headaches that limit her daily productivity. (Id. at 3.) According to this letter,
petitioner was, at the time, only able to engage in normal walking or riding her bike for a
few blocks, as more rigorous physical activities would exacerbate her symptoms. (Id.)

Petitioner’s parents list out the symptoms that she experienced following her
vaccination including: headaches that spikes under stress, inability to focus for long
periods of time, chronic fatigue, mental fogginess, anxiety, inability to sleep, leg pain,
numbness of the legs, bone pain, random bruising and tenderness, arthralgias, nausea,
and allergies to fruits and vegetables. (Ex. 26, p. 3.) They explain that petitioner was
enrolled in driver’s ed, but that she was worried about her physical ability to drive due to
her symptoms, specifically, her anxiety which they report worsened all of her other
symptoms. (Id.) They also explain that she ceased taking prednisone and plaquenil
after becoming “puffy looking,” and that her complexion had become “more erratic”
since the vaccination. (Id.)

Petitioner’s parents indicate that prior to her vaccination, petitioner had a “pretty
normal diet” and ate reasonably for a person her age, with no dietary restrictions and
regular meals. (Ex. 26, pp. 3-4.) However, after her vaccination, petitioner parents
report that she developed allergic reactions to a variety of fruits and vegetables that
cause lesions in her mouth lasting a week or more depending on the amount of food
she had eaten. (Id. at 4.) Notably, petitioner developed an “aversion to cold foods” and
would become emotional when asked to heat up her leftovers, explaining to her parents
that she could not “look at or be around cold leftovers, she can be around and eat them
once they have been heated, but not cold.” (Id.) Additionally, petitioner’s parents report
that sweets tended to make petitioner more anxious and irritable. (Id.)

Petitioner’s parents also describe a change in petitioner’s emotional state
following her Tdap vaccination. Prior to petitioner’s vaccination, they describe her as a
“well-connected and respected friend, daughter, sister, niece, granddaughter etc.,” who
made “a positive impression on anyone she met.” (Ex. 26, p. 4.) After her vaccination,
however, they report that she has developed significant anxiety after being forced to quit
gymnastics and leave the “stable environment and base of friends” that she had formed
at her gymnastics gym. (Id. at 4-5.) Petitioner’s parents also write that petitioner had
become “disconnected from her friendships.” (Id. at 5.) They indicate that her social life
changed dramatically. (Ex. 26, p. 5.) Petitioner’s parents explain that petitioner had
developed significant anxiety issues following her vaccination and she had become
significantly needy and demanding of her parents’ time. (Ex. 26, pp. 6-7.) Petitioner’s
parents describe a level of dependency that they believe is not normal and believe that
this adversely impacted their family dynamic. (Id.)

Prior to her vaccination, petitioner’s parents describe her as a high achieving
student who was able to focus intently on her studies and thus earn top grades. (Ex.
26, p. 8.) She would spend the early morning finalizing homework assignments, go to
school at 8:30 am, and go to gymnastics from 2:30 to 8:00 pm. (Id.) She would then
eat her dinner on the drive home from gymnastics, and then complete her homework

21
from 9:00 pm to 11:00 pm. (Id.) Petitioner’s parents write that this was a schedule that
petitioner was happy with and she would “adamantly” deny any desire to cut back on
her gym hours. (Id.) After her vaccination, petitioner’s parents describe her as bright,
but challenged by her condition, needing to “take a step back from regular coursework .
. . as her symptoms . . . [did] not allow her to keep mentally focused to endure a heavier
coursework . . . .” (Id. at 8-9.) They explain that “she now has to study in short bursts
as her headache escalates when she has to intently focus on the task at hand.” (Id. at
9.) Petitioner ultimately needed to be placed on a special curriculum at school and
would often leave early due to exhaustion and mental fatigue. (Id.)

ii. Petitioner and her brother’s letters to the court

Petitioner also submitted her own letter to the court and a letter from her younger
brother on October 15, 2013. (Ex. 27.) She breaks her letter down into two sections, a
“before” section and an “after” section. (Id. at 1.) Before her vaccination, petitioner
reports that she was “doing gymnastics every day from 2:30-8 during the school year
and 12:30-7 during the summer.” (Id.) She spent every day with her closest friends at
the gym and viewed that group as a family. (Id.) She enjoyed school, received good
grades, and rarely missed class. (Id.) She would always finish her homework even
though she would work late into the night. (Ex. 27, p. 1.) She reports that she was
“athletic and strong.” (Id.) She also reports that she “had never had a headache in her
life and besides from a small cold here and there was rarely sick.” (Id.)

After her vaccination, petitioner reports that she rarely sees her friends, has quit
gymnastics, doesn’t “usually feel good enough to do any activities with [her] friends,”
has difficulties in school, has a hard time retaining information and focusing, and is
unable to handle the long school day so only attended class for half of the day. (Ex. 27,
p. 1.) Further, petitioner reports that she lost a lot of strength, had constant headache
and nausea, suffered from anxiety to the point that she needed her mother to sleep in
her room with her for a year, and would wake up frequently throughout the night. (Id.)
She also notes symptoms including numbness of her extremities, dizziness, extreme
fatigue, muscle and joint pain, and that she “never felt good.” (Id.) She indicates that
she was unable to focus enough to drive and unable to get her license. (Id.)

Petitioner’s brother states in his letter that prior to vaccination she was in
gymnastics, had great attendance at school and gymnastics, was very healthy, and had
very few doctor appointments. (Ex. 27, p. 2.) He further writes that after petitioner’s
vaccination, her illness made petitioner’s gymnastics training “hazardous” to her and her
teammates. (Id.) He also notes that petitioner was only attending school for half of the
day because she would be overcome by her headache and nausea and that she could
no longer maintain good health. (Id.) He also explains that petitioner’s doctor
appointments were “through the roof” and that their parents now focus much more on
petitioner “especially because of her anxiety.” (Id.)

22
iii. Gymnastics coach’s letter to the court

Petitioner submitted a short letter from her former gymnastics coach on
December 3, 2014. (Ex. 39.) She writes that:

[Petitioner] was a competitive gymnast training at All Olympia Gymnastics
Center from the period of September 2006, through July 2011. [She] was a
level 4 State Champion and competitive gymnast with the best scores in her
age category through 2011. When [petitioner] unexpectedly had to leave
gymnastics for an illness, she was training level 8 and well on her way to
compete at the college level. All her coaches and fellow gymnasts have
missed her. J. was bright, consistent, focused and motivated, her
attendance was consistent and she was a role model for young gymnasts
and a joy to coach.

(Id. at p. 2.)

iv. Petitioner’s Testimony

Petitioner explained that prior to the vaccination in question, she was generally
healthy with no major illnesses and received the typical childhood vaccines. (Tr. 11-12.)
She noted that she excelled academically and participated in a demanding gymnastics
program, training around six to seven hours each day. (Id. at 13.) Petitioner further
testified that after receiving the Tdap vaccine in question, she experienced a headache,
swollen arm, nausea, fatigue, tingling in her fingers and arms, leg numbness, joint pain,
anxiety, photophobia, and brain fog. (Id. at 23-28.) She testified that her symptoms did
not occur simultaneously, but spiked at different times, with some remitting entirely as
she learned to treat and manage her condition. (Id. at 30-32.) Due to her symptoms,
petitioner was unable to learn how to drive, forced to continue living with her parents,
limit her social engagement due to fatigue, and seek special accommodations at school,
including standing up for the majority of classes and extra time on exams. (Id. at 32-
36.) Petitioner further testified that she currently experienced headaches, brain fog,
fatigue, limb numbness, photophobia, difficulty sitting for long periods, myofascial
tightening, kidney stones, and rarely, gastrointestinal symptoms. (Id. at 36-39)

Petitioner also recounted her 2014 hospitalization, stating that she was
hospitalized for three weeks and confined to a wheelchair for a period after. (Tr. 39-40.)
Petitioner also testified that as her physical symptoms progressed, she developed
symptoms of anxiety which she felt were primarily due to the uncertainty surrounding
her condition and loss of social outlets like gymnastics. (Id. at 40-44.)

On cross examination, petitioner clarified that she began to experience episodes
of numbness around October of 2011. (Tr. 68-69.) The remainder of petitioner’s
testimony recounts her symptoms and the progression of her condition consistent with
the medical records recorded above.

23
IV. Expert Opinions

a. Petitioner’s Expert, Yehuda Shoenfeld, M.D., FRCP 17

Dr. Shoenfeld identifies “autoimmune/inflammatory syndrome induced by
adjuvants” or “ASIA” as a pertinent medical condition that can explain petitioner’s
medical history. 18 (Ex. 97, pp. 21, 30-31.) According to Dr. Shoenfeld, this is a
syndrome developed in 2011 that posits that exposure to an adjuvant, which is an agent
that enhances an antigen-specific immune response, can lead to an aberrant
autoimmune response. (Id. at 21.) During the hearing, Dr. Shoenfeld explained ASIA as
a collection of symptoms and signs in a genetically susceptible person 19 that join
together prior to development of a full-blown, well-defined autoimmune disease. (Tr. at
110-113.) In other words, ASIA is a syndrome that follows an insulting agent but
precedes manifestation of the final autoimmune disease. (Id.)

Citing to his own 2011 publication, Dr. Shoenfeld provides a set of relevant
diagnostic criteria and indicates that diagnosis of ASIA requires fulfillment of either two
major or one major and two minor criteria. (Ex. 97, p. 22 (citing Yehuda Shoenfeld &
Nancy Agmon-Levin, ‘ASIA’ – Autoimmune/inflammatory syndrome induced by
adjuvants, 36 J. OF AUTOIMMUNITY 4 (2011) (EX. 98).) Specifically:

17 After striking previously filed expert reports, petitioner relies on the expert opinion of immunologist Dr.

Yehuda Shoenfeld. (Ex. 97.) Dr. Shoenfeld filed one report and also testified at the entitlement hearing.
He was proffered at the hearing without objection as an expert in immunology and autoimmunity. (Tr.
104-05.) Dr. Shoenfeld received his medical degree from Tel Aviv University in 1978. (Ex. 124, p. 1.) He
served as senior resident in the internal medicine department and outpatient clinic of hematology and
immunology at Beilinson Medical Center in Petach Tikva, Israel from 1976 to 1978. (Id.) He has held
several fellowships in hematology and oncology and has served as a senior physician or department
head at five separate hospitals throughout Israel and Russia. (Id.) Dr. Shoenfeld has over 40 years of
experience researching immunology, has held multiple academic positions, and currently serves as an
Appointed Professor of Medicine with Tel-Aviv University’s Sackler Faculty of Medicine. (Id. at pp. 3-4.)
18 Further to this, Dr. Shoenfeld indicates that “[a]ccording to her clinical presentation and the assessment

by pediatric rheumatologist – the diagnosis of myofasciitis was raised which is related to ASIA syndrome.
It is worth noting that the treating physicians highlight the possibility of the relationship of the vaccine
administration and disease development.” (Ex. 97, p. 28.) In discussing his own opinion of petitioner’s
case, Dr. Shoenfeld at turns discusses her presentation as “ASIA/MMF,” but never discusses MMF as a
standalone explanation for petitioner’s condition nor ever explicitly confirms that petitioner can be properly
diagnosed as having MMF. Accordingly, MMF will be discussed to the extent it purportedly contributes to
the evidence supporting ASIA, but will not be discussed further vis-à-vis petitioner’s own medical history.

19 According to Dr. Shoenfeld, HLA-DRB1 is the haplotype gene most commonly associated with

autoimmune disease, while TPTN22 has been found to be associated to a lesser extent. (Tr. 113-116.)
However, regarding petitioner’s own condition, Dr. Shoenfeld conceded that genetic testing was never
completed and thus there is no evidence that petitioner was indeed a genetically prone individual carrying
the HLA-DRB1 haplotype. (Id. at 116-18.)

24
(EX. 97, p. 24.) Dr. Shoenfeld asserts that petitioner meets two major and one minor
criteria, because she experienced typical clinical manifestations of neurological
manifestations (tingling), fogginess/forgetfulness, fever, dizziness, blurred vision,
lethargy (which he equates to chronic fatigue), weakness, sleeping disturbances,
arthralgia, and cognitive impairment, as well as relevant autoantibody findings. (Tr.
125.) According to Dr. Shoenfeld, the validity of these diagnostic criteria for ASIA have
been validated through the registry that he had his research group created and the
resulting publications. (Tr. 120-27, 196-97 (citing Abdulla Watad et al., The
autoimmune/inflammatory syndrome induced by adjuvants (ASIA/Shoenfeld’s
syndrome: descriptive analysis of 300 patients from the international ASIA syndrome
registry, 37 CLIN. RHEUMATOL. 483 (2018) (Ex. 121); Abdulla Watad et al.,
Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) demonstrates distinct
autoimmune and autoinflammatory disease associations according to the adjuvant
subtype: Insights from an analysis of 500 cases, 203 CLIN. IMMUNOL. 1 (2019) (Ex.
122)).) Later papers have refined these criteria, however. 20 (Compare Shoenfeld &
Agmon-Levin, supra, at Ex. 98 (Table 2) and Watad et al, supra, at Ex. 121 (Table 1).)
In fact, Dr. Shoenfeld testified that he is still developing different diagnostic parameters
for ASIA. (Tr. 140.)

Overall, Dr. Shoenfeld believes petitioner developed ASIA based on her pre-
vaccination health, post-vaccination condition, antihistone antibody levels, and the fact
that at least two of petitioner’s treating physicians mentioned ASIA and that her
condition was a possible vaccine reaction. (Tr. 144-46.) Dr. Shoenfeld concluded that
petitioner’s condition fell within the typical two-to-42-day window for onset of an

20 In fact, the 2011 paper lists the major and minor criteria, but does not explicitly explain what the

thresholds for diagnosis are (i.e., how many major and minor criteria are required to label a case as
ASIA). (Shoenfeld & Agmon-Levin, supra, at Ex. 98.) The threshold identified by Dr. Shoenfeld was
developed later. (Tr. 126.)

25
autoimmune reaction. (Tr. 172.) However, he also testified that ASIA symptoms could
manifest anywhere from immediately after insult to years later. (Id. at 225-26.)

Dr. Shoenfeld explained that petitioner exhibited a mildly elevated sedimentation
rate ten days after her vaccination which would indicate an acute inflammatory
condition. Petitioner’s sedimentation rate returned to normal levels roughly a month
after her vaccination, but Dr. Shoenfeld indicated that this typically occurs when
inflammation becomes chronic. (Id. at 150-51.) Dr. Shoenfeld testified that he believed
petitioner’s appropriate diagnosis was ASIA, encompassing aspects of dysautonomia, 21
undifferentiated connective tissue disease (“UCTD”), 22 and “unspecified vaccine
reaction.” (Tr. 151.) Dr. Shoenfeld testified that petitioner also suffered from joint pain
which satisfies a second diagnostic criteria of ASIA. (Id. at 164-65.) Dr. Shoenfeld also
noted that petitioner’s brain fog, chronic fatigue, sleep abnormalities, vision changes,
allergies, and extremity tingling were all consistent with ASIA. (Id. at 167-68.) He
testified that his conclusions were further supported by the fact that some of petitioner’s
treating physicians also diagnosed her with ASIA, that her VAERS report documented
symptoms of ASIA (headache, fatigue, and fever), and that other physicians believed
that her condition, while not necessarily ASIA, was nonetheless vaccine related. (Id. at
169.)

Dr. Shoenfeld states that the efficacy of most vaccines currently in use for
humans or animals depends on “the presence of an adjuvant in conjunction with the
infection antigen.” (Ex. 97, p. 22.) Adjuvants increase efficacy and length of the
immune response to the infectious antigen and enable increased vaccine production by
allowing manufacturers to use less antigen per dose. (Id.) However, Dr. Shoenfeld
writes, the use of adjuvants can “also provoke an enhanced immune response.” (Id.
citing Sunita Awate et al., Mechanisms of action of adjuvants, 4 FRONT IMMUNOLOGY 114
(2013) (Ex. 101).) Because of this, “newer more effective and perhaps safer adjuvants”
such as virosome, new oil based adjuvants, and “adjuvants that utilize [t]oll-like receptor
signaling pathways” have been developed. (Ex. 97, pp. 22-23 (citing Shoenfeld &
Agmon-Levin, supra, at Ex. 98).) He writes that on rare occasions vaccines may induce
the appearance of “autoantibodies, enigmatic inflammatory conditions and overt
autoimmune disease,” that can cause non-specific manifestations like arthritis, neuronal
damage, fatigue, encephalitis, and vasculitis. (Ex. 97, p. 22.) Dr. Shoenfeld suggests
that these events have been documented in case-reports, case series, studies, and
21
He opined that petitioner’s gastroparesis confirmed her dysautonomia due to the fact that the GI tract is
fully autonomic and therefore, the dysfunction of the GI tract suggests dysfunction of the autonomic
nervous system, also known as dysautonomia. (Tr. 159-60.) Dr. Shoenfeld conceded however, that he
was unable to determine what exactly led to petitioner’s dramatic weight loss during her treatment, and
only suggests that she suffered from gastroparesis because her records did not point to malabsorption.
(Id. at 160-63.) Dr. Shoenfeld further explained that dysautonomia has a variety of etiologies, including
autoimmunity, and that in this case, petitioner suffered from autoimmune dysautonomia, manifesting as
gastroparesis.

22 However, upon cross examination he was unable to cite to a record supporting this assertion. (Tr. 200-

02.) Additionally, he explained that a diagnosis of UCTD requires a positive ANA test, but conceded that
petitioner had two negative ANA tests, and still suggested that she suffered from UCTD based only on
her symptoms. (Id. at 202-03.)

26
VAERS reports weeks, months, and even years following vaccination. (Id.) He further
cites the causal link found between the 1976 swine flu vaccine and an increase in
occurrences of Guillain-Barre syndrome (“GBS”). (Id.)

Dr. Shoenfeld asserts that a number of animal studies have been conducted
showing a causal link between vaccines and autoimmune conditions. (Ex. 97, p. 22.)
He refers to one study of immunizations in puppies that “resulted in production of 9
different autoantibodies including lupus-associated ones.” 23 (Id.) A second study Dr.
Shoenfeld relies on is focused on specific vaccination protocols of diabetic prone
newborn mice and rats which resulted in an increased incidence of diabetes. (Id. (citing
J. Bart Classen, The Timing of Immunization Affects the Development of Diabetes in
Rodents, 24 AUTOIMMUNITY 137 (1996) (Ex. 99)).) Dr. Shoenfeld cites a more recent
study of intra-peritoneal immunization of salmon with oil-adjuvanted vaccines that
resulted in the production of several autoantibodies and autoimmune diseases
evidenced by “granulomatous diseases of the liver and peritoneum, thrombo-embolic
disease and immune mediate glomerulonephritis.” 24 (Ex. 97, p. 22 (citing Minoru Satoh
et al., Polyclonal hypergammaglobulinemia and autoantibody production induced by
vaccination in farmed Atlantic salmon, 30 FISH & SHELLFISH IMMUNOLOGY 1080 (2011)
(Ex. 100)).)

Dr. Shoenfeld explains several mechanisms by which the human immune system
can turn on itself to trigger autoimmune responses to vaccines. The first and most
common mechanism is “molecular mimicry between infectious antigens and self-
antigens . . . .” (Ex. 97, p. 26.) The second is “epitope spreading, whereby invading
antigens accelerate an ongoing autoimmune process by local activation of antigen
presenting cells and over processing of antigens . . . .” (Id.) The third and final
mechanism is bystander activation of B lymphocytes “which enhances cytokine
production and further induce the expansion of auto reactive T-cells.” (Id.) Dr.
Shoenfeld then argues that because vaccine adjuvants such as alum generate an
increased immune response, vaccines “may provoke more exaggerated, anarchic
immune responses than infections.” (Ex. 97, p. 27 (citing Eitan Israeli et al., Adjuvants
and Autoimmunity, 18 LUPUS 1217 (2009) (Ex. 111)).)

Dr. Shoenfeld testified that the reason ASIA progresses to different defined
autoimmune diseases is because different autoantibodies are generated in response to
different insults, and those autoantibodies attack the host in different ways via molecular
mimicry, causing the variety of autoimmune diseases seen following ASIA. (Tr. 135-38.)

23 Dr. Shoenfeld does not provide a citation to this study.

24 It should be noted that this study, appearing in the Journal of Fish & Shellfish Immunology, relates to

vaccine efficacy for vaccines used to support aquaculture by preventing infection in farmed salmon stock.
Nothing in this paper purports to have any implications outside of that context. (Classen, supra, at Ex.
99.) During the hearing I asked Dr. Shoenfeld directly if it was appropriate to use a fish model (i.e., non-
mammalian) to evidence what happens in the human immune system. He did not directly address my
concern, instead contending that ASIA is supported by animal models broadly. (Tr. 233-34.) However,
the other animal modes he cited were mammals. (Id. at 233-38.) I am not prepared to credit Dr.
Shoenfeld’s reliance on this article on this record.

27
Dr. Shoenfeld opines that petitioner received the Tdap vaccine, and that the alum
adjuvant in that vaccine hyperstimulated her immune system, leading to her symptoms.
He further testified that he believed petitioner will ultimately develop molecular mimicry
in response to the vaccine ingredients which will determine whether her condition
ultimately becomes a specific autoimmune disease. (Tr. at 143.) Dr. Shoenfeld testified
that he was unable to say with any certainty whether petitioner’s condition was induced
via molecular mimicry, and that it would require petitioner to develop a distinct
autoimmune disease in order to say for sure, but he opines based on petitioner’s
symptoms that there is a possibility that molecular mimicry was occurring. (Id. at 223.)

Dr. Shoenfeld suggests that post-vaccination adverse immune responses can
occur over a wide period of time, ranging from months to years after the vaccination.
(Ex. 97, p. 24 (citing Charles M. Poser & Peter O. Behan, Late Onset of Guillain-Barre
Syndrome, 3 J. OF NEUROIMMUNOLOGY 27 (1982) (Ex. 106)).) He acknowledges that in
some cases, a period of 4 to 6 weeks has been considered plausible in the onset of
autoimmune diseases following vaccination but cites a study by Ozawa et al to contend
that post-vaccine adverse effects can manifest as late as several years following
vaccination. (Ex. 97, p. 25 (citing Kazuki Ozawa et al., Suspected Adverse Effects After
Human Papillomavirus Vaccination: A Temporal Relationship Between Vaccine
Administration and the Appearance of Symptoms in Japan, 40 DRUG SAFETY 1219
(2017) (Ex. 108)).) Dr. Shoenfeld explains that the Ozawa study observed 120 female
patients who received the HPV vaccine over two and a half years. The authors
observed definite or probable vaccine-related symptoms in 72 of those patients. The
researchers observed onset of symptoms occurring between 1 and 1532 days with an
average of 319.7 ± 349.3 days. (Ex. 97, p. 25 (citing Ozawa et al., supra, at Ex. 108).)
Dr. Shoenfeld relies on these findings to suggest that “post vaccination symptoms could
start with [a] quite long latency period post vaccination.” (Ex. 97, p. 26.)

Dr. Shoenfeld further stresses a causative role for aluminum oxyhydroxide
(“alum”) adjuvants in the emergence of macrophagic myofasciitis. (Ex. 97, p. 27.) Alum
is specifically used as an adjuvant in the Gardasil HPV vaccine and has been
“implicated . . . in several autoimmune phenomena.” (Id.) Dr. Shoenfeld explains that
concerns regarding alum adjuvants originally arose “following recognition of their
causative role in the so-called macrophagic myofasciitis (MMF) lesion detected in
patients with myalgic encephalomyelitis/chronic [fatigue syndrome].” (Id. (citing Naval
Daver & Hagop Kantarjian, Malignancy-Associated Haemophagocytic
Lymphoistiocytosis in Adults, 18 THE LANCET 169 (2009) (Ex. 112)).) He notes that “[i]t
was previously shown that poorly biodegradable aluminum-coated particles injected into
muscle are promptly phagocytosed in muscle and the draining lymph nodes,” which
“can disseminated within phagocytic cells throughout the body and slowly accumulate in
[the] brain.” (Ex. 97, p. 27.) According to Dr. Shoenfeld, “[t]his strongly suggests that
long-term adjuvant biopersistence within phagocytic cells is a prerequisite for slow brain
translocation and delayed neurotoxicity.” (Id.) Dr. Shoenfeld cites “macrophagic
myofasciitis syndrome” or “MMF” as a “the most evaluated post-vaccination condition . .
. in which a causal link was clearly delineated.” (Ex. 97, p. 23 (citing Romain Gherardi et
al., Macrophagic myofasciitis: an emerging entity, 352 THE LANCET 347 (1998) (EX. 102);

28
Romain Gherardi et al., Macrophagic myofasciitis lesions assess long-term persistence
of vaccine-derived aluminum hydroxide in muscle, 124 BRAIN: A J. OF NEUROLOGY 1821
(2001) (EX. 103); Christopher Exley et al., A role for the body burden of aluminum in
vaccine-associated macrophagic myofasciitis and chronic fatigue syndrome, 72 MED.
HYPOTHESES 135 (2009) (Ex. 104).)

Based on all of the above, Dr. Shoenfeld opines in his report that petitioner’s own
medical history can be explained as “ASIA/MMF, Dysautonomia, and/or simply [a]
vaccine reaction and subsequent autoimmune symptoms” caused by her June 18, 2011
Tdap vaccine. (Ex. 97, p. 31.) He opines that she suffered an initial arthus reaction
within one hour of vaccination that included headache, fever, and arm pain, and then
developed new progressive symptoms of brain fog, gastroparesis, limb
tingling/numbness, face blisters, and Raynaud’s syndrome. (Id.)

b. Respondent’s Experts 25

i. Edward W. Cetaruk, M.D., FACMT 26

Dr. Ceteruk’s opinion is most notable for challenging the role of aluminum in the
ASIA theory. Dr. Cetaruk charges that the ASIA theory does not differentiate between
the “chemical composition of the different adjuvants or their mechanism of interaction
with the immune system to exert their adjuvant effect . . . [and the] theory that all
adjuvants are immunologically, pharmacologically and toxicologically equivalent and

25 As explained above, petitioner did not file Dr. Shoenfeld’s report until September of 2019. (ECF No.
122.) Before that she had relied on expert opinions that she ultimately moved to strike from the record.
Accordingly, most of the expert reports submitted by respondent are responsive to expert opinions that
are no longer a part of the record. This includes both of the reports respondent filed by Dr. Cetaruk as
well as the first two reports filed by both Drs. Rose and Whitton. Nonetheless, these reports remain a part
of the record. Moreover, despite the change in experts, petitioner has consistently pursued her claim
under the ASIA theory. Accordingly, these earlier reports from respondent’s experts remain at least
partially relevant. However, there is substantial overlap among respondent’s expert opinions. Each
expert opines from a different perspective (toxicology, immunology, and rheumatology respectively), but
all three address their criticisms of Dr. Shoenfeld’s ASIA concept broadly. The resulting reports will be
addressed selectively so as to avoid what is cumulative.
26 Respondent filed two reports by toxicologist Dr. Edward W. Cetaruk to discuss ASIA and why he

believed the ASIA theory fails to support petitioner’s claim. (Exs. A, G.) Both reports were filed before Dr.
Shoenfeld became involved in the case and Dr. Cetaruk was not subsequently called to testify at the
entitlement hearing. Dr. Cetaruk’s first report is discussed herein; however, Dr. Cetaruk’s supplemental
report responds directly to Dr. McCurdy’s report, which has now been struck. (Ex. G.) That report
focuses largely on contesting Dr. McCurdy’s own underlying understanding of the ASIA theory, a point
that is now moot, as well as on contesting the general acceptance of ASIA, which is further addressed by
Drs. Whitton and Rose. (Id.) Accordingly, that report will not be discussed further. Dr. Cetaruk received
his medical degree from New York University School of Medicine. (Ex. B, p. 2.) He is board certified by
the American Board of Emergency Medicine with Special Qualifications in Medical Toxicology and the
National Board of Medical Examiners. (Ex. B, p. 1.) He currently holds a position with Toxicology
Associates in Denver, Colorado and as an Assistant Clinical Professor of Medicine in the Department of
Medicine, Section of Clinical Pharmacology and Toxicology at the University of Colorado Health Sciences
Center. (Id.)

29
can all cause autoimmune disease is not supported by the medical and scientific
literature.” (Ex. A, p. 2.) Dr. Cetaruk explains that adjuvants can be derived from a
number of very different classes of chemical compounds. Only aluminum salts are used
in the United States; however, “Dr. Shoenfeld generalizes that all vaccine adjuvants,
regardless of their chemical composition, mechanism of action or administered dose are
potential causes of autoimmune disease.” (Id. at 4.)

For example, Dr. Cetaruk explains that Dr. Shoenfeld relies in part on animal
research by Reeves, et al., relating to antibody production in mice following the use of
pristane, a hydrocarbon adjuvant, leading to lupus. 27 (Ex. A, p. 6.) However, he notes
that there are no reports in the medical literature of lupus caused by exposure to
pristane in humans and conversely no experimental studies replicating the Reeves
results using aluminum-based adjuvants. (Id.) Dr. Cetaruk cites a study by Potter, et
al., examining the dose-response relationship between adjuvants and development of
plasmacytomas (malignant plasma cell tumors). Potter found that higher doses of
pristane produced plasmacytomas, but neither aluminum hydroxide nor lower doses of
pristane produced plasmacytomas. (Ex. A, Tab 16, p. 1.) According to Dr. Cetaruk, this
study shows that contrary to Dr. Shoenfeld’s generalization, aluminum salts and
pristane do not necessarily have the same mechanism and do not have the same
effects. (Ex. A, p. 7.)

Dr. Cetaruk stresses that aluminum salts are used as adjuvants in the United
States precisely because they are considered to have fewer potential side effects. (Ex.
A, p. 7.) Further, Dr. Cetaruk explains that human populations are routinely exposed to
aluminum, absorbing it primarily through ingestion, with no corresponding reports of
increased incidences of autoimmune disease. (Id.) For example, he notes that
aluminum accumulation and toxicity is a significant complication for dialysis patients;
however, despite being a well-studied population, there are no studies reporting
increased rates of autoimmune disease among dialysis patients. (Id. at 8.)

Dr. Cetaruk indicates that histologic finding of aluminum at the injection site has
long been recognized; however, he cites three prior studies that show that aluminum
found in macrophage lysosomes is consistent with how the body handles aluminum
generally (not just from vaccines) and is not indicative of any pathologic condition, let
alone showing any of the subjects to suffer autoimmunity specifically. (Ex. A, pp. 8-9

27 As noted above, Dr. Ceraruk’s reports were filed in this case before Dr. Shoefeld became personally

involved in this case. His references to what Dr. Shoenfeld relies upon refer to Dr. Shoenfeld’s
publications regarding ASIA rather than his expert report filed in this specific case. In this case, Dr.
Shoenfeld does not specifically cite any study by Reeves in his report. (Ex. 97.) However, he does cite a
2013 paper by Cruz-Tapias, et al., on which he was an author. (Paola Cruz-Tapias et al., Autoimmune
(autoinflammatory) syndrome induced by adjuvants (ASIA) – animal models as a proof of concept, 20
CURR. MEDICINAL CHEM. 4030 (2013) (Ex. 117).) The Cruz-Tapias paper is a review of prior animal model
studies that purport to provide proof of concept for ASIA. (Id.) The Reeves study discussed by Dr.
Cetaruk is in turn cited in the Cruz-Tapias et al, paper for the proposition that adjuvants broadly have
been documented as inductors of autoimmunity. (Cruz-Tapias et al., supra, at Ex. 117, pp. 1, 6 (ref. 2);
see also Westley Reeves et al., Induction of autoimmunity by pristane and other naturally-occurring
hydrocarbons, 30(9) TRENDS. IMMUNOL. 455 (2009) (Ex. A, Tab 18).)

30
(citing Maria Fiejka, et al., Effect of aluminium hydroxide administration on normal mice:
tissue distribution and ultrastructural localization of aluminium in liver, 78 PHARMACOL. &
TOXICOL. 123 (1996) (Ex. A, Tab 6), Kiyokazu Kametani, Detection of aluminium by
energy dispersive x-ray microanalysis at high accelerating voltages with semi-thin
sections of biological sample, 51(4) J. ELECTRON MICROSCOPY 265 (2002) (Ex. A, Tab
11); Armand Verbueken, et al., Ultrastructural localization of aluminum in patients with
dialysis-associated osteomalacia, 30(5) CLIN. CHEM. 763 (1984) (Ex. A, Tab 24)).) A
further study by Verdier, et al., tested diphtheria-tetanus vaccines adjuvanted with either
aluminum hydroxide or aluminum phosphate and found that histologic findings of
macrophagic myofasciitis represented normal tissue changes that were not associated
with abnormal clinical signs. (Ex. A, p. 9 (citing Francois Verdier et al., Aluminium
assay and evaluation of the local reaction at several time points after intramuscular
administration of aluminium containing vaccines in the Cynomolgus monkey, 23
VACCINE 1359 (2005) (Ex. A, Tab 25)).)

i. J. Lindsay Whitton, M.D., Ph.D. 28

During the hearing, Dr. Whitton analogized ASIA to a table with four legs – the
four legs being the four conditions originally leading to the ASIA concept (siliconosis,
MMF, Gulf war syndrome, and post-vaccinal injuries). (Tr. 405-09.) According to Dr.
Whitton each “leg” has significant short-comings and is unable to stand on its own.
However, Dr. Whitton also contends that these four “legs” cannot act together to support
the same table, because they implicate different adjuvants in different quantities that are
not fungible. (Id.) Even if one “leg” were strong enough to stand on its own, that would
not add any support to the remaining legs. (Id.)

Dr. Whitton “utterly rejects the validity of ASIA,” describing it as “an invented
syndrome that has been largely discredited.” (Ex. J, pp. 5, 9.) He contends that ASIA is
“speculative” and has “numerous flaws” that have not been rebutted by Dr. Shoenfeld
as originator of the idea. He suggests that ASIA “barely deserves the title of scientific
hypothesis.” (Id. at 5.) Dr. Whitton observes that ASIA has no ICD9 or ICD10 code and
is not recognized by the vast majority of the medical profession. (Id.; Tr. 397-99.)
Moreover, he stresses writing by Dr. Shoenfeld himself that suggests ASIA constitutes
unproven speculation. Specifically, he quotes Dr. Shoenfeld as noting in a 2015 paper
regarding vaccines and autoimmunity that “every attempt for an epidemiological study

28 Respondent filed three expert reports by Dr. Whitton. (Exs. C, H, J.) Dr. Whitton’s third report includes

a direct response to Dr. Shoenfeld’s report. Additionally, Dr. Whitton testified at the entitlement hearing.
At the hearing Dr. Whitton was proffered without objection as an expert in immunology and virology. (Tr.
387.) Because Dr. Whitton’s third report and hearing testimony are comprehensive of his opinion, his first
two reports will not be separately addressed. Dr. Whitton received his medical degree from the University
of Glasgow in 1979. He is a member of the American Association of Pathologists, the American
Association of Immunologists, the American Society of Virology, the American Society of Microbiology,
the American Academy of Microbiology, and the American Association for the Advancement of Science.
(Ex. D, p. 1.) He has held multiple teaching positions since 1986 and currently serves as a Professor in
the Department of Immunology and Microbial Science at Scripps Research Institute in La Jolla, California.
(Id.) Dr. Whitton has also published 185 pieces of medical literature covering topics on biochemistry,
immunology, and virology. (Ex. D, pp. 2-13.)

31
has so far failed to deliver a connection.”29 (Ex. J, p. at 5 (quoting Luisa Eca Guimaraes
et al., Vaccines, adjuvants and autoimmunity, 100 PHARMACOL. RES. 190 (2015) (Ex. J,
Tab 6)).) Examining the 2011 and 2013 papers in which Dr. Shoenfeld and colleagues
purport to validate the ASIA concept with a registry of patients, Dr. Whitton observes the
diagnostic criteria to be “breathtakingly broad” 30 and also notes that the criteria have
changed from the 2011 to the 2013 paper, charging this as evidence that “ASIA is built
on shifting sands.” (Id. at 6.)

Dr. Whitton cites a 2015 review of ASIA that concluded that:

[i]t is also apparent that the broadness of the current ASIA criteria lack
stringency and, as a result, very few cases of autoimmune disease could
be excluded from a diagnosis of ASIA. The current studies involving human
cases are so diverse, in both external stimuli and in resulting conditions,
that there is currently a lack of reproducible evidence for any consistent
relationship between adjuvant and autoimmune condition.

(Ex. J, p. 9 (quoting David Hawkes et al., Revisiting adverse reactions to vaccines: a
critical appraisal of autoimmune syndrome induced by adjuvants (ASIA), 59 J.
AUTOIMMUNITY 77 (2015) (Ex. J, Tab 13)).)

Further to this critique, Dr. Whitton cites a 2017 publication of a 5-year study of
people receiving allergy shots. (Ex. J, p. 9 (citing Rohan Ameratunga et al., Evidence
refuting the existence of autoimmune/ autoinflammatory syndrome induced by adjuvants
(ASIA), J. ALLERGY CLIN. IMMUNOL. PRACT. (2017) (Ex. J, Tab 14).) Allergy shot
recipients receive a higher dose of alum than do routine vacinees, yet the study
subjects experienced lower rates of autoimmune disorders. The authors concluded that
their data do not support ASIA by vaccine adjuvants. (Ameratunga et al., supra, at Ex.
J, Tab 14.) Dr. Whitton also cites a review article discussing at length the
methodological flaws of many animal model studies purportedly supporting ASIA. (Ex.
J, p. (citing Rohan Ameratunga et al., Perspective: scientific and ethical concerns
pertaining to animal models of autoimmune/ autoinflammatory syndrome induced by
adjuvants (ASIA), AUTOIMMUNITY REV. (2018) (Ex. J, Tab 15)).) He explains that a
number of studies published in support of ASIA have subsequently been withdrawn.
(Ex. J, pp. 10-12.)

29 Not quoted by Dr. Whitton, the paper continues: “Despite this, efforts to unveil the connection between

the trigger of the immune system by adjuvants and the development of autoimmune conditions should be
undertaken.” (Ex J, Tab 6, p. 1.)
30
With respect to the breadth of the diagnostic criteria, Dr. Whitton explains that the first major diagnostic
criteria for ASIA is exposure to an external stimuli, including either infection or vaccination, prior to clinical
manifestation. This, he suggests, will capture virtually the entire global population. (Ex. J, p. 6.) He also
notes that the minor criteria include both development of an autoimmune disorder and presence of
autoantibodies (a common feature of autoimmune disease). Dr. Whitton suggests, therefore, that the
ASIA diagnostic criteria will per se identify anyone with any autoimmune condition as suffering vaccine-
related ASIA. (Id.) Dr. Whitton’s implication is that this falls short of any kind of meaningful screening
process. For example, he rhetorically posits that he, a healthy individual exposed to vaccines and having
only occasional muscle aches and minor complaints, could be diagnosed with ASIA. (Id.)

32
According to Dr. Whitton, the lack of meaningful screening from the diagnostic
criteria is compounded by an expansive understanding of the appropriate time interval
between vaccination and disease. (Ex. J, p. 6.) Dr. Whitton cites Dr. Shoenfeld’s report
as accepting up to a ten-year latency for post-vaccination ASIA. (Ex. J, p. 6 (citing Ex.
97, p. 29).) Dr. Whitton charges this as effectively “unlimited.” (Id.) Dr. Whitton offers
specific criticisms of the papers Dr. Shoenfeld cites with respect to this prolonged
latency. (Ex. J, pp. 7-9 (discussing Poser & Behan, supra, at Ex. 106; Ozawa et al.,
supra, at Ex. 108).) Dr. Whitton also explains more broadly that these papers seek to
identify correlations, based on what he characterizes as extremely long timeframes and
then outrageously purport to identify the remote vaccinations as initiating causes with no
support. 31

Turning to the specific contention that an adjuvant can drive the innate immune
response to cause autoinflammatory disease, Dr. Whitton stresses that the safety of
alum has been well established over a 90-year period of use and that the innate
immune response to an adjuvant is very short lived, terminating within hours to days.
(Ex. J, p. 10.) He asserts that “[t]here is no known way for a strong innate response to a
vaccine adjuvant to be perpetuated, which would happen if an adjuvant were to drive a
serious autoinflammatory disease.” (Id.; Tr. 390-96.) Interestingly, Dr. Whitton cites a
study by Dr. Shoenfeld (not filed by petitioner in this case) which he posits as evidence
tending to disprove Dr. Shoenfeld’s own theory that alum leads to autoimmunity. (Ex. J,
pp. 12-13.) In a 2013 paper, Dr. Shoenfeld and colleagues tested the safety of four
different adjuvants in mice that were genetically modified to be susceptible to the
autoimmune condition of lupus. (Favoino et al., Effects of adjuvants for human use in
systemic lupus erythematosus (SLE)-prone (New Zealand black/New Zealand white) F1
mice, 175 CLIN. EXPER. IMMUNOL. 34 (2013) (Ex. J, Tab 18).) By Dr. Whitton’s
explanation, the study injected the mice with quantities of alum that were between
70,000-170,000 times the weight adjusted dose a human would receive from
vaccination. (Ex. J, p. 13.) Even with these higher doses and a genetic susceptibility,
there was no statistically significant difference in proteinuria (which was used as a
gauge of disease activity). Dr. Whitton further testified, without citing any specific study,
that animal models have shown that the immunostimulatory effect of alum adjuvants “is
very restricted in two key ways.” (Tr. 393.) First, the effect is local and not systemic, so
it only impacts the area near the injection site and therefore would not be linked to any
systemic disorders. Second, the immunostimulatory effect has been shown to decrease
significantly in as little as 24 hours after exposure, suggesting that the adjuvants do not
continuously stimulate the immune system. (Id. at 393-96.)

Dr. Whitton also addresses in depth the condition of MMF. (Ex. J, pp. 14-19.)
MMF was cited in Dr. Shoenfeld’s report as “[p]erhaps the most evaluated post-

31 For example, Dr. Whitton explains that Dr. Shoenfeld relies on a paper purporting to show that GBS

may occur from weeks to months after an initial event, citing incidences occurring up to 10 months post-
vaccination. (Ex. J, p. 7 (citing Ex. Poser & Behan, supra, at Ex. 106).) A well-known study by Langmuir
et al., however, shows that incidences of GBS post swine flu vaccination returned to background rates
much earlier than that (8 weeks). (Id.) Dr. Whitton equates this scholarship with proposing red clothing
as a cause of neurologic disease based on the fact that some people with GBS wore red clothing in the
year prior to suffering their condition. (Id.)

33
vaccination condition, in which a causal link was clearly delineated.” (Ex. 97, p. 23.)
Quoting this same statement from literature coauthored by Dr. Shoenfeld, Dr. Whitton
suggests that MMF constitutes a “cornerstone” of ASIA. (Ex. J, p. 15 (quoting Yehuda
Shoenfeld & Nancy Agmon-Levin, ‘ASIA’ – Autoimmune/inflammatory syndrome
induced by adjuvants, 36 J. AUTOIMMUNITY 4 (2011) (Ex. J, Tab 27)).) Dr. Whitton
explains that MMF is “a histological lesion that contains, and results from, the injection
of alum.” (Ex. J, p. 14.) The name derives from the fact that muscle biopsy of the
lesions shows inflammatory infiltrate rich in macrophages (the “itis”) and located in the
connective tissue (fascia) and muscle (myo). (Id.) According to Dr. Whitton, MMF is a
“small, highly-localized” lesion that results from injection of adjuvants. (Id. at 15.) The
critical issue, per Dr. Whitton, is that this histological lesion has not been shown to
cause systemic disease, as Dr. Shoenfeld suggests. (This is also consistent with Dr.
Cetaruk’s discussion, supra, of studies regarding aluminum at injection sites – Dr.
Whitton also similarly cites Verdier, et al., supra, at Ex. A, Tab 25.)

Dr. Whitton explains that publications asserting that MMF constitutes a systemic
disease come from a specific French research group and the idea has not gained any
widespread acceptance. (Ex. J, p. 16.) In particular, this group produced a 1998 study
that is cited by Dr. Shoenfeld in this case. (Id. (citing Gherardi et al., supra, at Ex. 102).)
According to Dr. Whitton the study has a critical sampling bias. The study examined 18
individuals that were referred for diagnosis of muscle diseases. If no diagnosis was
available, these individuals were then biopsied at the site of injection, found to have
MMF lesions, and therefore categorized as suffering a systemic MMF condition. Dr.
Whitton explains that the selection bias is two-fold. First, the subjects are preselected
on the basis that they have signs and symptoms of a muscle disease. Second, only
those who ultimately have idiopathic conditions are biopsied. (Id. at 17.) Especially
given that MMF lesions are harmless and potentially common, without a control group,
the authors have generated only the illusion of a correlation. Dr. Whitton notes that this
same issue was replicated in a follow up study that was also cited by Dr. Shoenfeld.
(Id.) Despite this issue, the researchers purport to diagnose MMF as a systemic
disorder based on the histopathologic results. (Id.) Dr. Whitton stresses that this has
been examined multiple times by the World Health Organization (“WHO”) and has been
rejected. The WHO indicates there is not association between histological MMF lesions
and systemic disease. (Id. at 18.)

Finally, Dr. Whitton notes that even if petitioner did experience a short-lived
arthus reaction, Dr. Shoenfeld has not established how that could be related to his
theory of causation. An arthus reaction is mediated by antibodies of the adaptive
immune response whereas Dr. Shoenfeld which contends that the persistence of alum
in macrophages leads to chronic stimulation of the innate immune response. (Ex. J, p.
21.)

34
i. Carlos D. Rose, M.D. 32

Dr. Rose received his medical degree from the University of Buenos Aires School
of Medicine in 1977. (Ex. F, p. 1.) He completed his residency in internal medicine at
the University of Buenos Aires Hospital in 1982, serving as chief resident. (Id. at 4.) He
has held several fellowships in rheumatology and pediatric rheumatology. (Id. at 5.) He
has held certifications in internal medicine by the Argentina Ministry of Public Health, in
general pediatrics by the American Board of Pediatrics, by the State of Delaware, in
adult rheumatology by the Argentine Society of Rheumatology and Ministry of Public
Health, and in pediatric rheumatology by the American Board of Pediatrics. (Id. at 5-6.)
Dr. Rose has served as staff physician in rheumatology at the Central Military Hospital
in Buenos Aires, Argentina, the Spanish Hospital in Buenos Aires, and at The Alfred I
DuPont Institute of the Nemours Foundation in Wilmington, Delaware. (Id. at 6.) He
has taught biochemistry and internal medicine at the University of Buenos Aires School
of Medicine, and Pediatrics at the University of Pennsylvania School of Medicine and
Jefferson Medical College. (Ex. F, pp. 6-7.) Dr. Rose has published over 84 peer-
reviewed articles on pediatric rheumatology, biochemistry, and internal medicine. (Id. at
13-18.)

Based on his review of the medical records, Dr. Rose opines that petitioner “does
not have a definable rheumatic or autoimmune disease.” (Ex. E, p. 11.) He further
notes that “[h]er diagnoses are primary chronic headache and chronic fatigue. These
are symptom-based constructs of practical value for treating physicians but do not
constitute biologic entities with a specific immunologic mechanism.” (Id.) Dr. Rose
stresses that headaches are the most common somatic complaint in children and
adolescents. (Id. at 16.) Most often, the headaches are primary (i.e., the headache is
the disease). (Id.) Even with new symptoms arising post-vaccination, Dr. Rose
disagrees that there is any basis for causally attributing petitioner’s symptoms to either
autoimmunity or her Tdap vaccine. 33 (Id. at 16-17.)

Dr. Rose opines that petitioner’s positive Anti-histone antibody (AHA), the one
biomarker present that could theoretically point to an autoimmune condition, is likely a

32 Like Dr. Whitton, Dr. Rose has presented three reports in this case, the third and final being a direct

response to Dr. Shoenfeld’s report. (Exs. E, I, K.) Dr. Rose also testified during the entitlement hearing
and was proffered without objection as an expert in pediatric rheumatology. (Tr. 268.) Focus will be on
Dr. Rose’s initial report (Ex. E), which set forth his initial diagnostic opinion. The second report (Ex. I) was
a rebuttal to Dr. McCurdy’s report which has now been struck. The third report includes a summary of
updated medical records and a response to Dr. Shoenfeld’s report; however, the diagnostic assessment
did not change and Dr. Rose’s response to Dr. Shoenfeld reflected substantially the same criticisms of
ASIA as advanced by Drs. Cetaruk and Whitton.

33 Dr. Rose explains that petitioner’s condition “has been labeled in different ways” by her treating

physicians but notes that Dr. McCurdy in particular referenced a vaccine-reaction without providing a
unifying diagnosis. (Ex. E, pp. 7-8.) Petitioner has variously been characterized as suffering pain
amplification syndrome, migraine, sinusitis, Eustachian tube disorder, chronic headache, allergy
syndrome, gastroparesis. (Id.) Given the number of diagnostic categories offered, the vagueness of
symptoms, and the paucity of physical findings, Dr. Rose suggests that there should be concern for a
functional mechanism. (Id. at 8.)

35
false positive. (Ex. E, pp. 12-13; see also Tr. 281-87.) Petitioner had “moderately”
elevated AHA on November 30, 2011 – 1.7 U/ml (against a reference range of 0.0-0.9).
(Ex. E, pp. 7-9 (citing Ex. 11A).) Later, on July 31, 2013, she had “weak positive” AHA
of 1.4 U/ml. (Ex. E, p. 8.) AHA are a part of the family of antinuclear antibodies (ANA).
(Id. at 12-13.) They have long been known to be found in patients with either systemic
lupus (SLE) or drug induced lupus (DIL) and are used to help differentiate DIL from
SLE. Dr. Rose explains that AHAs are “intricately linked” to ANAs. (Id.) In this case,
however, petitioner was negative for ANA. According to Dr. Rose, “most
rheumatologists will question the meaning of an AHA positive in the absence of ANA
positivity.” (Id.) Dr. Rose further cautions that antibody levels are variable rather than
binary (positive or negative). There is some degree of antibody present in “normal”
people and variable amounts in those with autoimmunity. In petitioner’s case, further
caution is warranted both because petitioner was positive for only a single autoantibody
when tested against a large number of antibodies and had a moderate autoantibody
level followed by a weak positive with no correlating change in the severity of her
symptoms. Accordingly, Dr. Rose opines a false positive is likely. (Id.)

With respect to her initial post-vaccination presentation, Dr. Rose explained
during the hearing that petitioner’s first symptoms appeared four days after her
vaccination and included swelling of the left arm, tenderness to palpation, and painful
sensation with no rash or reduced range of motion. Dr. Rose disagrees that petitioner
experienced a fever at the time of her presentation to urgent care because it was below
the threshold of 37 degrees Celsius. (Tr. 270-72.) Dr. Rose noted that her white blood
cell count, lymphocytes, platelets, hemoglobin, and PSH were all normal. Further,
petitioner’s “elevated” sedimentation rate was only moderate, at 22 and reverted to
normal rates of 19 shortly after her initial test which would happen in the event of
common cold or virus. (Id. at 274-76.) Dr. Rose also testified that arthus reactions are
very rare and that the only way to affirmatively diagnose such a reaction is via biopsy of
the injection site, and because petitioner did not receive a biopsy, there is nothing in the
medical record to support any

[Text truncated at 120,000 characters. The full text is on the page linked above.]

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/8212774. Public record. Not legal advice.