VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-01123
Package ID: USCOURTS-cofc-1_17-vv-01123
Petitioner: Trey Cobb
Filed: 2017-08-21
Decided: 2023-10-04
Vaccine: HPV
Vaccination date: 2015-08-17
Condition: narcolepsy and cataplexy (type 1 narcolepsy)
Outcome: entitlement_granted_pending_damages
Award amount USD: 

AI-assisted case summary:
On August 21, 2017, Jeffrey and Kimberly Cobb filed a petition for compensation on behalf of their minor son, Trey Cobb, alleging that he developed narcolepsy and cataplexy (type 1 narcolepsy) that was caused or significantly aggravated by his human papillomavirus (HPV) vaccinations on August 25, 2014, and August 18, 2015. The petition stated that Trey was 13 and 14 years old at the time of these vaccinations. The case proceeded as an off-Table claim, requiring proof of causation under the Althen standard. Petitioner presented expert testimony from Dr. Lawrence Steinman, who theorized that molecular mimicry between components of the HPV vaccine and hypocretin (orexin), a neuropeptide involved in wakefulness, could trigger an autoimmune response leading to the destruction of orexin-producing neurons and thus narcolepsy. This theory was supported by BLAST search results showing sequence homology and the Latorre study, which identified orexin-specific T cells in narcolepsy patients. Respondent presented expert testimony from Dr. Lawrence Brown and Dr. Robert Fujinami, who argued that there was no established link between the HPV vaccine and narcolepsy, that the molecular mimicry theory was not supported by the evidence, and that the HPV vaccine might even offer protection against autoimmune disease. The Special Master found Dr. Steinman's theory persuasive, particularly with the addition of the Latorre paper, and determined that the onset of symptoms between one to three weeks after vaccination was a medically acceptable timeframe. The Special Master concluded that Petitioner had met his burden of proof for entitlement to compensation, and an order regarding damages would follow. Petitioner counsel was Mark Sadaka of the Law Offices of Sadaka and Associates, LLC. Respondent counsel was Debra Begley of the U.S. Department of Justice. Special Master Katherine E. Oler issued the ruling on October 4, 2023.

Theory of causation field:
Petitioner, Trey Cobb, received his third HPV vaccine on August 17, 2015. He developed symptoms of excessive daytime sleepiness and cataplexy, leading to a diagnosis of narcolepsy type 1. Petitioner alleged the HPV vaccine caused his condition. This was an off-Table claim. Petitioner's expert, Dr. Lawrence Steinman, theorized that the HPV vaccine contains molecular mimics of hypocretin (orexin) and its receptors. Using BLAST searches, Dr. Steinman identified homology between orexin and the HPV 11 L1 protein, suggesting a potential for molecular mimicry. He further supported this theory with the Latorre study, which found orexin-specific T cells in patients with narcolepsy, arguing this provided evidence of an autoimmune attack on orexin neurons. Dr. Steinman opined that this autoimmune response, triggered by the vaccine, led to the destruction of orexin-producing neurons and caused Petitioner's narcolepsy. Respondent's experts, Dr. Lawrence Brown and Dr. Robert Fujinami, argued against this theory, stating there was no established link between the HPV vaccine and narcolepsy, that the molecular mimicry theory was unsupported by evidence, and that alum adjuvants, like those in the HPV vaccine, might offer protection against autoimmune disease. The Special Master found Dr. Steinman's theory, particularly bolstered by the Latorre paper, to be persuasive. The Special Master also found the onset of symptoms between one to three weeks post-vaccination to be a medically acceptable timeframe. Petitioner met the Althen standard for entitlement. Petitioner counsel: Mark Sadaka. Respondent counsel: Debra Begley. Special Master: Katherine E. Oler. Decision Date: October 4, 2023.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_17-vv-01123-1
Date issued/filed: 2023-10-04
Pages: 29
Docket text: PUBLIC ORDER/RULING (Originally filed: 8/21/2023) regarding 83 Ruling on Entitlement. Signed by Special Master Katherine E. Oler. (sl) Service on parties made.
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Case 1:17-vv-01123-UNJ Document 85 Filed 10/04/23 Page 1 of 29
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1123V
Filed: August 21, 2023
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TREY COBB,
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Petitioner, *
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v.
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SECRETARY OF HEALTH AND *
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HUMAN SERVICES,
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Respondent. *
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Mark Sadaka, Law Offices of Sadaka and Associates, LLC, Englewood, NJ, for Petitioner
Debra Begley, U.S. Department of Justice, Washington, DC, for Respondent
RULING ON ENTITLEMENT1
Oler, Special Master:
On August 21, 2017, Jeffrey and Kimberly Cobb, filed a petition for compensation on
behalf of their then minor son, Trey Cobb (“Petitioner”) under the National Vaccine Injury
Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 (the “Vaccine Act” or “Program”). The
petition alleges that Trey Cobb developed narcolepsy and cataplexy (type 1 narcolepsy) that was
1 Because this Ruling contains a reasoned explanation for the action in this case, it must be made publicly
accessible and will be posted on the United States Court of Federal Claims' website, and/or
at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government
Services). This means the Ruling will be available to anyone with access to the internet. In accordance
with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information,
the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that
the identified material fits within this definition, I will redact such material from public access.
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa
(2012).
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Case 1:17-vv-01123-UNJ Document 85 Filed 10/04/23 Page 2 of 29
either caused by or significantly aggravated by his August 25, 2014 and August 18, 20153 human
papillomavirus (“HPV”) vaccinations. Pet. at 1; ECF No. 1.
Upon review of the evidence submitted, I find that Petitioner has preponderantly
established that the HPV vaccine can cause narcolepsy and cataplexy, and that it did so in this
case.
I. Procedural History
Mr. Jeffrey Cobb and Ms. Kimberly Cobb4 filed a petition on behalf of their son, Trey
Cobb, on August 21, 2017. ECF No. 1. They filed medical records in support of their petition on
August 22, 2017. Exs. 1-7. Petitioner filed additional medical records on December 12, 2017, and
an affidavit from Ms. Kimberly Cobb on December 15, 2017. Exs. 8-10.
Respondent filed his Rule 4(c) Report on March 5, 2018 recommending that entitlement
be denied. Resp’t’s Rep. at 1, ECF No. 21.
On August 15, 2018, Petitioner filed an expert report from Dr. Lawrence Steinman in
support of his claim. Ex. 11. Petitioner filed Dr. Steinman’s CV as Ex. 12 (hereinafter “Steinman
CV”) as well as supporting medical literature (Exs. 13-42).
On March 4, 2019, Respondent filed an expert report from Dr. Lawrence Brown (Ex. A)
and Dr. Brown’s CV (Ex. B; hereinafter “Brown CV”). On May 1, 2019, Respondent filed an
expert report from Dr. Robert Fujinami (Ex. C), Dr. Fujinami’s CV (Ex. D; hereinafter “Fujinami
CV”), and supporting medical literature (Ex. C, Tabs 1-9). On December 30, 2019, Respondent
filed additional medical literature. Ex. A, Tabs 1-20.
Petitioner filed a supplemental report from Dr. Steinman on December 30, 2019. Ex. 43.
Respondent filed a supplemental response from Dr. Fujinami on April 28, 2020 (Ex. E) and two
additional pieces of medical literature (Ex. E, Tabs 1-2).
I conducted an entitlement hearing via Zoom on September 21, 2021. See Minute Entry
dated 9/21/2021. Petitioner presented his own testimony and Dr. Steinman provided expert
testimony. Tr. at 3. Respondent presented testimony from Drs. Brown and Fujinami. Id.
3 The record from Petitioner’s well exam where he received his third HPV vaccine is unclear as to the date
of the appointment. The “charted date/time” is listed as 08/18/2015 14:17. Ex. 6 at 30. However when
Petitioner’s vital signs were measured at this appointment, the record documents they were taken on
08/17/2015 at 14:13. Id. Further, Dr. Strehle signed the record on 08/18/2015 at 1:15pm, which is before
the appointment was scheduled. Id. at 31. I additionally note that a separate record documents that Petitioner
received his third HPV vaccine on August 17, 2015. See Ex. 8 at 2. For these reasons, I find the evidence
supports that Petitioner received his third HPV vaccine on August 17, 2015. This finding does not impact
my analysis of Petitioner’s claim.
4 On September 28, 2021, a motion to amend the case caption was filed because Mr. Trey Cobb turned 18.
ECF No. 69. For the sake of clarity, Mr. Trey Cobb is the Petitioner in this case, and I have referred to him
as such throughout this ruling.
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Petitioner filed a post-hearing brief on January 5, 2022; Respondent filed his post-hearing
brief on April 6, 2022; and Petitioner filed a reply brief on May 6, 2022. ECF Nos. 76, 78, 79. The
parties filed a joint status report indicating the record was complete on May 23, 2022. This matter
is now ripe for adjudication.
II. Medical History
Petitioner was in good health prior to his allegedly causal HPV vaccinations. Petitioner
received his second HPV vaccination on August 25, 2014 during a routine visit with Dr. Fillman,
his primary care physician (“PCP”). Ex. 6 at 16. On August 17, 2015, Petitioner returned to his
PCP, where he received his third HPV vaccination. Id. at 30. Petitioner was 13- and 14-years old
respectively when he received his second and third HPV vaccines.
On October 20, 2015, Petitioner saw Brandon Schreiber, DC, a chiropractor, for mid to
lower back pain, headaches, and neck pain, attributed to football. Ex. 7 at 26. Petitioner stated he
had been experiencing these symptoms for two weeks and had experienced them “a few times”
prior. Id. Dr. Schreiber performed a chiropractic evaluation and manipulation. Id. at 24-25.
On October 21, 2015, Petitioner presented to Joshua Strehle, DO, at the Guthrie County
Hospital. Ex. 6 at 31. He reported that he had been experiencing a sore throat for the past twenty-
four hours. Id. Dr. Strehle noted that Petitioner’s rapid strep test was negative. Id. He was advised
to call if he developed new symptoms or was not improving within seven days. Id.
On November 17, 2015, Petitioner saw Martin Miller, DC, a chiropractor. Ex. 2 at 13.
Petitioner reported lower back pain and having “really low energy since school started, feels tired
all the time.” Id. Dr. Miller noted “mildly swollen, tender liver and spleen,” and also noted “mono”.
Id. at 14. Petitioner felt relief after chiropractic manipulation, and Dr. Miller advised him to rest
until his “liver swelling is decreased.” Id.
On November 23, 2015, Petitioner followed-up with Dr. Strehle reporting three months of
fatigue. Ex. 6 at 33. The medical record noted that over the past two weeks, Petitioner has been
unable to complete a full day of school and has begun napping two to three hours each day. Id.
Some nights he goes to bed as early as 8:00 p.m. and wakes up at 6:30 a.m. Id. Petitioner’s physical
exam was normal. Id. Dr. Strehle suggested his fatigue could be secondary to an acute viral illness
but noted it didn’t explain his ten weeks of fatigue. Id. Petitioner’s test for infectious mono was
negative. Id. at 1.
On December 29, 2015, Petitioner presented to Dr. Leona Holcomb, MD, a family
medicine doctor, for heat exposure. Ex. 3 at 5-8. Dr. Holcomb noted that Petitioner had been
diagnosed with infectious mono in early November and that his history of presentation started in
late August. Id. His blood test was negative so it was a clinical diagnosis. Id. at 5. Petitioner
informed Dr. Holcomb that he would fall asleep at 9:00pm and wake up by 7:00am, but would
sleep until 9:30am if he is able to. Id. He was unable to attend school the whole day, and would
have to go home to sleep in the afternoon. Id. Petitioner did not feel well rested when he woke up.
Id. Petitioner had gained 15 pounds in two weeks. Id. Dr. Holcomb diagnosed Petitioner with
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“chronic fatigue” and a noted family history of liver disease (father with hemochromatosis). Id. at
7. Dr. Holcomb believed it was most likely a viral illness, infectious mono as opposed to CMV
(cytomegalovirus). Id.
On February 11, 2016, Petitioner returned to Dr. Holcomb for his fatigue. Ex. 3 at 9-11.
Petitioner informed Dr. Holcomb he had not experienced any relief since being diagnosed. Id. at
9. Dr. Holcomb noted “?did have mono—the IGg was + but the IGa was negative.” Id. Petitioner’s
self-reported symptoms remained largely the same but Petitioner added that he has issues finding
words and has a fainting sensation when he laughs. Id. at 9. He is still able to complete his
homework. Id. Petitioner noted he was more irritable as well. Id. at 10. Petitioner also noted that
his eyes sometimes twitched, and he could not control the muscles in his face, his speech was
delayed and sometimes could not collect his thoughts. Id. Dr. Holcomb’s assessment was still
“chronic fatigue” with “soft neurologic symptoms”, and that this “could still be affect [sic] of
mono.” Id. at 11. Dr. Holcomb recommended a neurology consultation. Id.
On April 4, 2016, Petitioner visited Dr. Stephen Gutu, MD, a pediatric neurologist, at Blank
Children’s Hospital Neurology Clinic for fatigue and “facial twitching and muscle weakness since
October.” Ex. 1 at 1-3. Petitioner’s parents informed Dr. Gutu that Petitioner had a “mono-like
illness” in late August-September (2015) which resulted in three weeks of extreme fatigue, and
Petitioner missed 1.5 weeks of school as a result. Id. Petitioner gets 9-12 hours of sleep each night,
can fall asleep easily, but wakes frequently and never feels well rested. Id. Petitioner also sleeps
in the daytime and can fall asleep within one minute of sitting down. Id. Petitioner also experiences
daily incidents of muscle weakness and “falling” when he laughs or is very excited. Id. Petitioner
can feel when these incidents will occur and tries to preemptively sit or hold on to something. Id.
Petitioner denied losing consciousness during these falls. Id. Petitioner noted improvement since
the peak symptoms in the winter but indicated he still experiences significant effects. Petitioner
was referred for a sleep study. Id. at 3.
On April 18, 2016, Petitioner was seen for a consultation at the Iowa Clinic by Dr. Gregory
Hicklin. Ex. 5 at 19-20. Dr. Hicklin noted that given Petitioner’s age and symptoms, he suspected
Petitioner suffered from narcolepsy with cataplexy. Id. at 19. Dr. Hicklin recommended a
polysomnogram5 and HLA genotype testing. Id.
On April 26, 2016, Petitioner underwent a sleep study at West Lakes Sleep Center, which
was interpreted by Dr. Hicklin. Ex. 5 at 27-28. In a self-completed sleep questionnaire, Petitioner
had an Epworth sleepiness score6 of 15/24. Id. at 27. Petitioner’s mean sleep latency time was .50
minutes, indicating a pathological level of daytime sleepiness and his mean REM latency was 1.5
5 Polysomnogra(phy): the polygraphic recording during sleep of multiple physiologic variables, both
directly and indirectly related to the state and stages of sleep, to assess possible biological causes of sleep
disorders. https://www.dorlandsonline.com/dorland/definition?id=40298 (last accessed April 20, 2023).
6 Epworth Sleepiness Scale: a tool for measuring how sleepy a person is during daytime or working hours,
using a scale of 1 to 5 for whether the person is unlikely or likely to fall asleep in a series of situations such
as watching television, having a quiet conversation, or being stalled in traffic.
https://www.dorlandsonline.com/dorland/definition?id=104932 (last accessed March 20, 2023). The scale
has a maximum score of 25.
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minutes, suggesting narcolepsy. Id. at 28. The results of the polysomnogram (PSG)/multiple sleep
latency test (MSLT) led to Dr. Hicklin’s recommendation for CNS stimulants and avoiding
alcohol, sedatives, and using extreme caution when operating a vehicle or machinery. Id.
On April 28, 2016, Petitioner followed up with Dr. Hicklin regarding his sleep study
results. Ex. 5 at 11-12. Dr. Hicklin’s letter stated “He definitely has narcolepsy with cataplexy. His
multiple sleep latency test showed sleep onset in less than a minute, and REM sleep seen promptly
in all naps, and his nighttime sleep study showed early sleep onset REM. In addition, he gives a
great history of cataplexy.” Id. at 11. Dr. Hicklin noted that Petitioner has “multiple sleep
problems. Obviously he has narcolepsy with cataplexy but he also has the fragmented sleep that
may be seen with narcolepsy and obstructive sleep apnea” so he recommended tackling the
narcolepsy with cataplexy first. Id. at 12. Dr. Hicklin prescribed methylphenidate and fluoxetine
for Petitioner’s narcolepsy and talked to Petitioner’s school nurse about nap therapy during school
hours. Id.
On June 10, 2016, Petitioner returned to Dr. Gutu for a follow up. Ex. 1 at 5-7. Dr. Gutu
noted Petitioner’s history of present illness (HPI) was narcolepsy/cataplexy but other differential
diagnoses in April 2016 were possible complications from post mononucleosis fatigue syndrome.
Id. at 5. Dr. Gutu noted that Petitioner had a PSG and MSLT which were diagnostic of narcolepsy.
Id. Dr. Gutu recommended HLA DQB1 testing and that he continue with his medications.7 Id. at
7. Dr. Gutu referred Petitioner to Dr. Steven Zorn at the Iowa Sleep Disorders Center. Id.
Petitioner returned to Dr. Hicklin on June 20, 2016 for a follow up. Petitioner informed Dr.
Hicklin that the medications had helped him significantly; he sleeps well at night and has strategic
naps to feel more rested and alert. Ex. 5 at 6-7. Petitioner reported he still had episodes of
cataplexy. Id. at 6. Dr. Hicklin increased Petitioner’s fluoxetine dosage and recommended he get
an accommodation at school. Id. at 7. Dr. Hicklin recommended Petitioner follow up with his
neurologist, Dr. Gutu.
On June 27, 2016, Petitioner visited Dr. Steven Zorn at the Iowa Sleep Disorders Clinic.
Ex. 4 at 6-9. Dr. Zorn noted that his Epworth score was 16. Id. at 6.
On July 25, 2016, Dr. Zorn followed up with Petitioner after another PSG, which was
negative for obstructive sleep apnea (OSA). Ex. 4 at 10-12. Dr. Zorn did not believe Petitioner had
a secondary sleep problem. Id. at 10.
On August 5, 2016, Petitioner returned for another appointment with Dr. Zorn. Ex. 4 at 13-
15. Petitioner’s Epworth score was 12 and it was noted he was not experiencing side effects from
Concerta and that his dosage should be increased. Id. at 15.
On August 18, 2016, Petitioner returned to Iowa Sleep Disorders Center for another follow
up with Dr. Zorn. Ex. 4 at 16-18. Petitioner reported that his narcolepsy was under control and he
7 It is unclear from the medical records filed if Petitioner ever received genetic testing for the HLA DBQ1
gene.
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felt improved. Id. at 16. Petitioner also reported that he was not experiencing issues with his
stimulant medications. Id. Petitioner’s Epworth score was now 9. Id. at 18.
Petitioner’s last appointment with Dr. Zorn was on February 16, 2017. Ex. 4 at 19-21.
Petitioner had no medication side effects and Dr. Zorn recommended adding Xyrem for his
cataplexy. Id. at 19. Petitioner declined. Id.
No other relevant medical records were submitted.
III. Affidavit and Fact Testimony
A. Affidavit of Kimberly Cobb, Petitioner’s Mother
Petitioner filed an affidavit signed by Mrs. Kimberly Cobb on December 15, 2017. Ex. 10.
In it, she stated that her son was a normal teenager before his third HPV vaccine. Id. at 2. She
further averred that she believes the HPV vaccine caused her son to develop narcolepsy and
cataplexy. Id. Since the vaccination, Petitioner has been unable to engage in his normal activities
without taking medication. Id. He continues to suffer from narcolepsy and cataplexy, which has
caused him to experience “extreme fatigue, inconsistent sleeping patterns, irritability and fear of
collapse after excitement, restlessness, and muscle weakness.” Id. at 3.
B. Petitioner’s Testimony
Petitioner testified at the entitlement hearing on September 21, 2021. At the time of the
entitlement hearing, Petitioner was a 20-year old junior at the University of Iowa, majoring in
actuarial sciences. Tr. at 5. Petitioner’s symptoms began during the 2015-2016 school year, when
he was a high school freshman. Id. at 6. After receiving his third HPV vaccine, Petitioner began
feeling tired, and would fall asleep during almost every class, every day towards the beginning of
September 2015. Id. at 6-7. Petitioner also experienced cataplexy attacks, where he would laugh,
fall over, and have no control over his body. Id. at 7. Something that would elicit strong emotions
would trigger his cataplexy. Id. Petitioner’s words would slur, face would droop, eyes would close,
and head would bob. Id. Petitioner’s narcolepsy with cataplexy affected his social life; he would
fall asleep while standing up at football and basketball practice. Id. at 8. Whenever he attended
social events, he would fall asleep before others; eventually he stopped going to and being invited
to events with his friends, since he couldn’t participate. Id.
Petitioner testified that he first received his diagnosis around April 2016 and had completed
most of the school year without knowing his condition. Tr. at 8-9. Petitioner admitted he didn’t
know what to think at first but it was tough to learn it would never go away. Id. at 9. His family,
especially his mother, was devastated. Id. Petitioner’s friends were shocked because they thought
his cataplexy attacks were just him messing around. Id.
Petitioner now has to structure his days and weeks around his narcolepsy. Tr. at 10. If he
doesn’t, he can’t get any work done. Id. Petitioner has a strict sleep schedule and limited social
life. Id. Petitioner testified that he does not have the energy to do things a typical college student
does. Id. His major is quite demanding and as a result, does not allow him to do much else in terms
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of intramurals or clubs, because they generally happen at night and he has to sleep at that time. Id.
Petitioner testified that he begins to wind down around 7:00pm every night because he is tired. Id.
Petitioner also does not drive more than 15 minutes without caffeine or medications or both
because he does not trust himself. Id. at 10-11.
Petitioner regulates his cataplexy attacks with Xyrem. Tr. at 11. He once went on a trip
where he did not take his medication for three to four days and had attacks ten times per day on
the trip. Id.
Petitioner testified that his routine involves going to bed around 10:00pm. Tr. at 12. He
goes to bed as late as he can because Xyrem lasts for 2.5-3 hours, so he wakes up during the night
to take two doses of Xyrem and tries to go back asleep. Id. He wakes up around 4:00am and tries
to go back to sleep until 5:45am. Id. Petitioner then takes “a decent amount of caffeine” prior to
going to the gym and then returns home to sleep another 30 minutes. Id. Petitioner takes
methylphenidate (Ritalin) and drinks coffee before going to class. Id. at 12-13. Petitioner will stay
awake during his 8:30am class but will usually fall asleep during his 10:30am class. Id. at 13. He
will nap around lunch, go to his afternoon class and fall asleep a few times in that class. Id.
Petitioner used to take more medications in high school but did not enjoy the side effects,
including increased heart rate. Tr. at 13-14. He now regulates his symptoms through diet and sleep.
Id. at 14. Petitioner can get about two hours of work done before his “brain kind of turns off.” Id.
Petitioner also testified that his cataplexy can occur at any time, including when he’s driving. Id.
at 16.
Lastly, Petitioner attributed some weight gain to his condition. Tr. at 16. Petitioner was
always skinny, but gained 20 pounds in about two weeks his freshman year (during football
season). Id. at 17. Xyrem has helped him lose the weight he had gained. Id. Petitioner’s mood is
also affected by his condition; he is often short tempered when tired. Id. When Petitioner meets
new people, others think he is unfriendly or unenergetic or that he is using drugs because his eyes
are droopy and he looks tired. Id. It is a lot of effort and energy for Petitioner to smile all the time.
Id. Petitioner would not be able to function normally without his medication, and would not be
able to sleep at night. Id. at 18.
IV. Expert Opinions and Qualifications
A. Dr. Lawrence Steinman
1. Qualifications
Dr. Steinman received his medical degree from Harvard University in 1973 and completed
his residency at Stanford University in pediatrics and pediatric and adult neurology. Steinman CV
at 1. Dr. Steinman is board certified in neurology. Id. at 2. He has taught neurology, pediatrics,
and genetics since 1980 and is currently a professor at Stanford University in the departments of
Neurology, Pediatrics, and Genetics; he is also the George A. Zimmermann Professor of
Neurological Sciences at Stanford University. Id. at 1. Dr. Steinman has approximately 50 patents
and has published approximately 600 peer-reviewed papers. Id. at 2-46; Tr. at 20, 26. Dr. Steinman
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has published 10 papers specific to the topic of narcolepsy. Tr. at 19-20, 23. He also treats patients
with neuroimmunological diseases and approximates he has treated thousands of such patients
over the course of his career. Id. at 27. I recognized him as an expert in neurology,
neuroimmunology, and immunology. Id.
2. Expert Reports
Dr. Steinman authored two expert reports. Exs. 11 (“First Steinman Rep.”); 43 (“Second
Steinman Rep.”).
a. First Expert Report
In his first expert report, Dr. Steinman opined that Petitioner’s narcolepsy with cataplexy
was caused by the August 2015, or third dose of the HPV vaccine. First Steinman Rep. at 1, 27.
Dr. Steinman theorized that the components of the “HPV vaccine contain molecular mimics of
hypocretin, also called orexin,” and that “[t]he HPV vaccine also contains mimics of the
hypocretin-2 receptor, also known as the orexin-2 receptor.” Id. at 7. Dr. Steinman opined that the
mechanism of molecular mimicry caused Petitioner’s immune system to attack the cells in his
brain that produce hypocretin and that the resulting hypocretin deficiency caused him to develop
narcolepsy. Id. at 9.
Prior to delving into the crux of his molecular mimicry theory, Dr. Steinman discussed the
potency of the HPV vaccine. First Steinman Rep. at 9. He cited to the Souayah paper to support
his position that the HPV vaccine elicits an abnormally strong immune response. Dr. Steinman
stated that, “Gardasil elicits a stronger immune response than the natural viral infection. There is
a 40-fold increase in HPV antibodies as compared to what is seen in natural HPV infection.” Id.
(citing Souayah et al., Guillain-Barre Syndrome After Gardasil Vaccination: Date from Vaccine
Adverse Event Reporting System, 2006-2009, 29 VACCINE 886-889 (2011) (filed as Ex. 21)
(hereinafter “Souayah”)).
To support his theory of causation, Dr. Steinman noted that molecular mimicry “can trigger
clinical neuroinflammatory disease in a susceptible individual if the mimicry is directed to a
‘disease causing’ epitope.” First Steinman Rep. at 9. Based on his own research, Dr. Steinman
opined that his “criterion for a ‘meaningful molecular mimic’” is that the self-antigen and foreign
antigen share a sequence of at least five amino acids out of 12, or at least four out of 11. Id. at 10.
Moreover, the matching amino acids need not be consecutive. Id. (citing to Gautam et al., A
polyalanine peptide containing only five native myeline basic protein residues induces
autoimmune encephalomyelitis, 127 JOURNAL OF EXPERIMENTAL MEDICINE 605-609 (1992) (filed
as Ex. 32; (hereinafter “Gautam 1”); Gautam et al., Minimum structural requirements for peptide
presentation by major histocompability complex class II molecules: Implications in induction of
autoimmunity, 161 PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES USA, 767-771 (1994)
(filed as Ex. 33; hereinafter “Gautam 2”); Gautam et al., A viral peptide with limited homology to
a self-peptide can induce clinical sign of experimental autoimmune encephalomyelitis, 161
JOURNAL OF IMMUNOLOGY, 60-64 (1998) (filed as Ex. 34; hereinafter “Gautam 3”)).
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Using the web-based Basic Local Alignment Search Tool (“BLAST”), Dr. Steinman
compared the amino acid sequence structure of hypocretin and the brain’s hypocretin receptors
with the HPV 6, 11, 16, 18 L1 proteins in the HPV vaccine. First Steinman Rep. at 13-21. Based
on the BLAST search results, Dr. Steinman opined that there is homology between hypocretin and
hypocretin receptors (HRCT-R2) and components of the vaccine that is sufficient to cause
clinically relevant neuroinflammation. Id. at 13, 14, 17, 19, 21.
Dr. Steinman stated that he developed his theory of causation based in part on the results
of a study in which laboratory mice were implanted with “cells that were primed with the papilloma
virus peptide,” all of whom developed severe relapsing-remitting experimental autoimmune
encephalomyelitis (“EAE”). First Steinman Rep. at 21 (citing Ufret-Vincenty, et al., In Vivo
Survival of Viral Antigen-specific T Cells that Induce Experimental Autoimmune
Encephalomyelitis, 188 JOURNAL OF EXPERIMENTAL MEDICINE, 1725-1738 (1998) (filed as Ex.
36). Dr. Steinman acknowledged that the use of adjuvants in this study drastically increased the
incidence of EAE in the test group, but he nevertheless found the results compelling. Id.
Dr. Steinman acknowledged that, for several reasons, it is not possible to test Petitioner for
immunity for the HPV molecular mimics. First Steinman Rep. at 22. He noted that such a test
would constitute medical research requiring ethical review and substantial funding. Id.
Dr. Steinman opined that “immunity to nervous system antigens like myelin is rather
widespread in normal individuals.” First Steinman Rep. at 24. He continued, saying that “immunity
to myelin is necessary but not sufficient” for development of an autoimmune disease. Id. Dr.
Steinman added that most people with immunity to nervous system antigens do not develop
autoimmune diseases because “[o]ther genetic and environmental factors are necessary before
these self-reactive immune responses to myelin for example, or to orexin and HCRT-R2 might
trigger inflammation in the brain.” Id. Dr. Steinman argued that the medical literature suggesting
that the HPV vaccine elicits a stronger immune response than a natural infection supports his
theory that the HPV vaccine caused Petitioner’s narcolepsy. Id.
Dr. Steinman cited to a cohort study of adolescent girls in which the authors found that the
incidence of narcolepsy among those who had received the HPV vaccine was 2.61 per 100,000, as
opposed to an incidence of 1.81 per 100,000 among unvaccinated subjects. First Steinman Rep. at
26 (citing Arnheim-Dahlstrom, et al., Autoimmune, neurological, and venous thromboembolic
adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus
vaccine in Denmark and Sweden: cohort study, 347 BRITISH MEDICAL JOURNAL f9506 (2013)
(filed as Ex. 40) (hereinafter “Arnheim-Dahlstrom”). Dr. Steinman conceded that the difference
between the two groups did not rise to the level of statistical significance, but nevertheless found
the result persuasive due to the large sample size (230,018 subjects). Id.
Dr. Steinman opined that the timing of the diagnosis of Petitioner’s narcolepsy (April 2016,
approximately nine months after receiving the third dose) is consistent with the medical literature
on vaccines and narcolepsy. First Steinman Rep. at 27. For example, a Finnish study linked the
Pandemrix vaccine to a 12.7-fold increase in the risk of developing narcolepsy within eight months
of vaccination. Id. (citing Partinen, et al., Increased Incidence of Clinical Picture of Childhood
Narcolepsy following the 2009 H1N1 pandemic vaccination campaign in Finland, 7 PLoS ONE 3
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(2012) (filed as Ex. 41). A British study found a similar elevated risk, with onset occurring from
three to 14 months after vaccination. Id. (citing Winstone et al., Clinical features of narcolepsy in
children vaccinated with AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine in England,
56 DEV. MED. CHILD NEUROL. 1117-23 (2014) (filed as Ex. 42)).
b. Second Expert Report
In his second expert report, Dr. Steinman first responded to comments from Dr. Brown.
Second Steinman Rep. at 1. Dr. Steinman indicated that he agrees with Dr. Brown’s diagnosis of
“narcolepsy with cataplexy which presented at a typical age.” Id. Dr. Steinman likewise agreed
with Dr. Brown’s statement that he strongly recommends that his patients, including those with
narcolepsy, receive all vaccines, including HPV. Id. Dr. Steinman noted that the recommendation
to administer or withhold a vaccine is based on weighing the risks and benefits for that individual
person, and that rare adverse events sometimes occur. Id. at 2.
Dr. Steinman went on to reprise his analysis of the BLAST results from his first expert
report. Second Steinman Rep. at 2. Dr. Steinman opined that the comparison of the amino acid
chains in hypocretin with the HPV 11 L1 protein found in the HPV vaccine have yielded new
insight. Id. at 2-3. Having found in his first report that this comparison revealed a “degree of
homology sufficient to induce clinical[ly] relevant neuroinflammation,” Dr. Steinman cited to
medical literature where the hypocretin epitope in question “was identified as being a target or
cytotoxic T cells found in the cerebrospinal fluid in patients with Type 1 narcolepsy.” Id. at 3, 5.
(citing Latorre et al., T cells in patients with narcolepsy target self-antigens of hypocretin neurons,
562 NATURE 62-68 (2018) (filed as Ex. 44) (hereinafter “Latorre”). Dr. Steinman opined that the
data “dramatically bolster” Petitioner’s theory of causation, and that “this is about as close to
discovering a ‘smoking gun’ in a vaccine as modern science can currently provide.” Id. at 6.
The Latorre study used two different methods “to interrogate the T cell repertoire of
patients with narcolepsy.” Latorre at 1. The authors stated that “[t]he findings of [their] study
demonstrate the existence, in patients with narcolepsy, of autoreactive CD4+ and—in some
cases—CD8+ T cells that target self-antigens expressed by neurons that produce [hypocretin].” Id.
at 5. They stated that “[t]he findings of autoreactive CD4+ and CD8+ T cells in narcolepsy raises
questions as to their possible pathogenic role.” Id. at 5.
Dr. Steinman next described an enhanced search process that he used to identify molecular
mimics between the HPV vaccine and the self-antigens that are targeted in narcolepsy. Second
Steinman Rep. at 6-11. He reiterated and emphasized his opinion that there is sufficient homology
between the two to say that the HPV vaccine could have caused Petitioner’s narcolepsy by way of
molecular mimicry. Id.
Finally, Dr. Steinman disagreed with Dr. Fujinami’s opinion that the use of altered peptide
ligands in the HPV vaccine makes it more likely than not that the HPV vaccine “would favor
protection against autoimmune disease/narcolepsy rather than inducing narcolepsy.” Second
Steinman Rep. at 10 (citing Fujinami Rep. at 3). He argued that, instead, “the known experience
in humans is that altered peptides can exacerbate disease when injected into a human.” Id. (citing
Bielekova et al., Encephalitogenic potential of myelin basic protein peptide (amino acids 83-99)
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in multiple sclerosis: Results of a phase II clinical trial with an altered peptide ligand, 6 NATURE
MED. 10, 1167-75 (2000) (filed as Ex. 45) (hereinafter “Bielekova”); Genain and Zamvil, Specific
immunotherapy: One size does not fit all, 6 NATURE MED. 10, 1098-1100 (2000) (filed as Ex. 46);
Kappos et al., Induction on a non-encephalitogenic type 2 T helper-cell autoimmune response in
multiple sclerosis after administration of an altered peptide ligand in a placebo-controlled,
randomized phase II trial, 6 NATURE MED. 10, 1176-82 (2000) (filed as Ex. 47) (hereinafter
“Kappos”).
3. Testimony
During the entitlement hearing on September 21, 2021, Dr. Steinman described his process
for conducting BLAST searches and the results that he received. Tr. at 29-30. He indicated that he
conducts BLAST searches when asked to provide an expert opinion in a case and that if the results
do not show sufficient homology between the vaccine and a self-antigen, he declines the case. Id.
at 29. Dr. Steinman identified a paper published in Nature a few months after his first expert report,
in which one of the parts of orexin was attacked by the immune system of people with narcolepsy.
Id. at 31. Dr. Steinman testified that his BLAST results revealing the homologies between orexin
and the HPV vaccine components was “inescapably associated with autoimmunity and
narcolepsy.” Id. He further testified that BLAST is commonly accepted in the medical community
as a way of identifying potential immune system targets. Id. at 44-45.
Dr. Steinman responded to Dr. Fujinami’s reliance on medical literature suggesting that
altered peptide ligands may actually reduce the chance of an autoimmune reaction. Tr. at 60-66.
Dr. Steinman opined that, while initially promising in laboratory animals, three studies involving
altered peptide ligands did not yield good results in humans. Id. (citing Ruiz et al., Microbial
Epitopes Act as Altered Peptide Ligands to Prevent Experimental Autoimmune Encephalomyelitis,
189 J. EXP. MED. 8 1275-83 (1999) (filed as Ex. C, Tab 4); Bielekova, et al.; Kappos, et al.). In
fact, Dr. Steinman noted that two of the trials were discontinued because of allergic reactions to
the altered peptide in human subjects. Id. at 63-64.
Dr. Steinman opined that, based on the medical record, the onset of Petitioner’s narcolepsy
occurred two to three weeks after he received the third dose of the HPV vaccine. Tr. at 68-69. Dr.
Steinman went on to opine that, while detailed data on the timing of narcolepsy onset after
vaccination is not available, two to three weeks is “typical of an autoimmune reaction causing a
neuroinflammatory condition.” Id. at 69-70.
The Respondent elected not to ask Dr. Steinman any questions on cross examination during
the Petitioner’s case-in-chief or during rebuttal. Tr. at 75, 163.
B. Dr. Lawrence Brown
1. Qualifications
Dr. Brown received his medical degree from New York University in 1971. Ex. B (“Brown
CV”) at 1. Until his retirement in July 2021, he held the position of Associate Professor of
Neurology and Pediatrics at the University of Pennsylvania School of Medicine and was co-
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director of the Pediatric Neuropsychiatry Center at the Children’s Hospital of Philadelphia. Id. at
2; Tr. at 146. He is board certified in pediatrics and neurology with special competence in pediatric
neurology and sleep medicine. Brown CV at 2. Dr. Brown’s research focuses on sleep disorders
and other neurological conditions in children and infants. Id. at 10-11. He has co-authored nearly
40 peer-reviewed journal articles, 36 book chapters and reviews, and has been an associate editor
of all four editions of the Clinical Handbook of Pediatrics. Id. at 10-14. I recognized Dr. Brown
as an expert in neurology. Tr. at 147-48.
2. Expert Report
Dr. Brown authored one expert report. Ex. A (hereinafter “Brown Rep.”). Dr. Brown
provided a detailed clinical description of narcolepsy, including the typical presentation, causes,
diagnostic criteria, and treatment modalities. Brown Rep. at 2-5.
Dr. Brown agreed with the diagnosis of narcolepsy with cataplexy. Brown Rep. at 6. Dr.
Brown acknowledged that narcolepsy has been associated with the Pandemrix flu vaccine, “but
this was only true in a single situation.” Id. at 5. He stated that “[i]t remains unclear whether the
increase in incidence of narcolepsy in 2009 to 2010 was related to an antigen contained in the
vaccine, the influenza vaccination itself, or to both.” Id. (citations omitted). Dr. Brown emphasized
his opinion that the Pandemrix situation was unique and noted that other flu vaccines formulated
over the past few years had not caused an increase in narcolepsy. Id. at 5-6. Dr. Brown opined that
“[t]here is no reported association of HPV vaccines and narcolepsy” and there is no question that
Trey Cobb has a diagnosis of narcolepsy with cataplexy which presented at a typical age. Id.
Specifically, Dr. Brown states,
While it is true that he had a third Gardasil vaccination about the time that he first
developed symptoms, there is no scientific support that would suggest that this was
anything but an unrelated coincidence. I understand that narcolepsy type 1 is most
likely an autoimmune disorder targeting orexin containing neurons in the
hypothalamus. Molecular mimicry has been hypothesized to be the cause of the
regional epidemic of narcolepsy caused by the Pandemrix flu vaccine in 2009-2010,
this has never been demonstrated in other flu vaccines or, more to the point, in HPV
vaccines.
Brown Rep. at 6. Finally, Dr. Brown concluded, “I feel strongly that Trey Cobb suffers from
idiopathic narcolepsy type 1 which has no direct or indirect association with administration of the
HPV vaccine.” Id.
3. Testimony
During the entitlement hearing on September 21, 2021, Dr. Brown reiterated his opinion
that Petitioner’s medical record meets the clinical criteria for narcolepsy with cataplexy. Tr. at 152.
Dr. Brown expressed a lack of certainty as to the timing of onset of Petitioner’s narcolepsy but
agreed that the medical record shows no evidence of cataplexy prior to Petitioner’s third dose of
the HPV vaccine. Id. at 152-53. Dr. Brown opined that nearly all narcolepsy cases are idiopathic,
meaning that there is “no clear etiology for what causes the loss of orexin receptors in that part of
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the hypothalamus.” Id. at 155. Dr. Brown also stated that there were reasons to believe
autoimmunity is involved but the HLA genotype was also commonly associated with type 1
narcolepsy. Id. at 148. Daytime sleepiness is common, particularly amongst teenagers, and one of
those reasons is narcolepsy. Id. at 148-49. Among common type 1 narcolepsy symptoms is weight
gain and irritability. Id. at 149. Dr. Brown also reiterated his opinion that “there is little evidence
that [the] HPV vaccine causes narcolepsy,” based on the Torstensen article. Id. at 150; Torstensen
et al., Type 1 narcolepsy is not present in 29 HPV-vaccinated individuals with subjective sleep
complaints, 68 DANISH MEDICAL JOURNAL 1-4 (2018) (filed as Exs. A, Tab 19 and C, Tab 6)
(hereinafter “Torstensen”). The study included half a million women and within the 700 women
with significant complaints, 27 had sleep complaints but none fulfilled the clinical criteria for
narcolepsy. Id. Between the Torstensen study and the Red Book of Immunizations from the
Academy of Pediatrics, Dr. Brown asserted he did not believe there was any increased serious risk
that the HPV vaccine causes narcolepsy. Id.
C. Robert S. Fujinami, Ph.D.
1. Qualifications
Dr. Fujinami received his Ph.D. in immunology and microbiology from Northwestern
University in 1977. Ex. D (“Fujinami CV”) at 1. Since 2007, he has held two positions within the
University of Utah School of Medicine, Professor in the Department of Pathology and Adjunct
Professor in the Department of Neurology. Id. Dr. Fujinami is the author of more than 150 peer-
reviewed journal articles. Id. at 20-50. His research focuses on neuroinflammation in the context
of central nervous system autoimmune diseases and the role of infections in initiating seizures
leading to epilepsy. First Fujinami Rep. at 1. Dr. Fujinami has published extensively on the topic
of molecular mimicry and autoimmunity. See generally Fujinami CV at 20-50. He is a professor
in the department of pathology at the University of Utah; he serves as vice dean for faculty, and
assistant vice president of academic affairs for University of Utah Health. Tr. at 78-79. I recognized
Dr. Fujinami as an expert in immunology. Tr. at 81.
2. Expert Reports
Dr. Fujinami authored two expert reports in this matter. Exs. C (hereinafter “First Fujinami
Rep.”); E (hereinafter “Second Fujinami Rep.”).
a. First Expert Report
In his first expert report, Dr. Fujinami disagreed with Dr. Steinman’s theory that the HPV
vaccine caused Petitioner’s narcolepsy by means of molecular mimicry. First Fujinami Rep. at 2.
Dr. Fujinami criticized Dr. Steinman’s citation of medical literature in which researchers induced
development of experimental autoimmune encephalomyelitis (“EAE”) in laboratory animals. Id.
Dr. Fujinami pointed out that this study involved an injection of peptides in a powerful adjuvant
such as Freund’s adjuvant as opposed to the aluminum adjuvant in the HPV vaccine. Id. Dr.
Fujinami opined that other studies have found that laboratory animals injected with whole myelin
with an aluminum adjuvant did not develop EAE. Id. (citing Sicotte et al., Immunization with
myelin or recombinant Nogo-66/MAG in alum promotes axon regeneration and sprouting after
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corticospinal tract lesions in spinal cord, 23 MOLECULAR AND CELLULAR NEUROSCIENCE 251-63
(2003) (hereinafter Sicotte); Wallberg et al., Vaccination with myelin oligodendrocyte
glycoprotein adsorbed to alum effectively protects DBA/1 mice from experimental autoimmune
encephalomyelitis, 33 EUROPEAN JOURNAL OF IMMUNOLOGY 1539-47 (2003) (hereinafter
“Wallberg”). He stated further research has suggested that laboratory animals injected with a
protein often used to induce EAE with an aluminum adjuvant “were actually protected from
autoimmune neuroinflammatory disease.” Id. at 3. Dr. Fujinami opined that these data support his
contention that “if there were molecular mimicry with ‘disease-relevant’ immunologic epitope(s)
contained in the HPV vaccine cross-reacting…with orexin/hypocretin or HCRT-R2 epitopes, then
it would not induce neural autoimmune disease.” Id. (emphasis in original).
In response to Dr. Steinman’s analysis of the BLAST results showing similarity between
the HPV L1 protein from the vaccine and hypocretin and HCRT-R2, Dr. Fujinami opined that “we
do not know if these autoantibodies are pathogenic for narcolepsy.” First Fujinami Rep. at 3.
Dr. Fujinami further opined that Dr. Steinman’s own research on altered peptide ligands
supported Dr. Fujinami’s criticism of Dr. Steinman’s theory of causation. First Fujinami Rep. at
3. Dr. Fujinami noted that “suppression of autoimmune disease is more likely than not to occur if
there were actual ‘disease-relevant’ mimicking peptides in the alum-based HPV vaccine with
cross-reactivity to orexin/hypocretin or HCRT-R2.” Id.
Dr. Fujinami stated that there is no association between HPV vaccination and development
of narcolepsy. First Fujinami Rep. at 3. Dr. Fujinami acknowledged that one batch of the influenza
vaccine Pandemrix that was administered in Sweden was associated with increased cases of
narcolepsy. Id. He cited to studies conducted after the Swedish narcolepsy cases by various
entities, including the CDC and WHO, which found no link between the HPV vaccine and
narcolepsy. Id. (citing Torstensen, et al.). Dr. Fujinami also noted that the authors of a large cohort
study found “‘no evidence supporting associations between exposure to qHPV vaccine and
autoimmune, neurological, and venous thromboembolic adverse events.’” Id. at 4 (quoting
Arnheim-Dahlstrom, et al.).
Dr. Fujinami concluded by reiterating his opinion that “the HPV vaccination(s) the
Petitioner received did not cause his narcolepsy.” First Fujinami Rep. at 4.
b. Second Expert Report
In his second expert report, Dr. Fujinami disagreed with Dr. Steinman’s contention that the
article by Latorre bolsters Dr. Steinman’s theory of causation. Second Fujinami Rep. at 1 (citing
Second Steinman Rep. at 3). Dr. Fujinami pointed out the authors state that their ‘results do not
support a molecular mimicry between HCRT (hypocretin) and TRIB2 antigens and influenza virus,
and raise questions as to the role of HLA-DQB1*06:02 in antigen presentation.” Id. (quoting
Latorre, et al.). Dr. Fujinami opined that the conclusion in the La Torre article actually “runs
counter to Dr. Steinman’s proposed molecular mimicry theory where the ‘mimicking’ hypocretin
epitope found in the HPV and influenza vaccines causes narcolepsy through the mimicry
mechanism.” Id.
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Dr. Fujinami also reiterated his position that “altered peptide ligands in weak adjuvants
such as alum could be used to protect animals against disease.” Second Fujinami Rep. at 1. He
disagreed with Dr. Steinman’s reliance on two articles in which patients with multiple sclerosis
were injected with whole myelin. Id. at 1-2 (citing Bielekov, et al.; Kappos, et al.). Dr. Fujinami
pointed out that these authors were analyzing a new treatment protocol in patients who had an
ongoing disease, which he noted is “very different than treating individuals before the occurrence
of the disease and demonstrating protection.” Id. at 2. He also asserted that his original point was
“that immunizing individuals who do not have narcolepsy or MS with mimicking peptides in alum
would not induce disease.” Id. Dr. Fujinami further opined that “treating relapsing-remitting MS
patients with peptide mimics did not make the disease worse,” which, he asserted, does not support
Dr. Steinman’s theory of causation. Id.
Dr. Fujinami concluded by reiterating his opinion that “molecular mimicry is not a likely
mechanism for vaccination causing narcolepsy in the Petitioner.” Second Fujinami Rep. at 2.
3. Testimony
During the entitlement hearing on September 21, 2021, Dr. Fujinami opined that the type
of adjuvant used in a vaccine determines the strength of the immune response. Tr. at 89. He went
on to cite his own work on molecular mimicry, testifying that, in order for the immune response
to be robust enough for molecular mimicry to cause disease, a vaccine must contain a powerful
adjuvant such as complete Freund’s adjuvant. Id. at 90. Dr. Fujinami opined that, by contrast, there
is evidence that weak adjuvants such as alum and incomplete Freund’s adjuvant offer some
protection from autoimmune disease. Id. at 92, 94.
Dr. Fujinami also disagreed with Dr. Steinman’s criticism of his altered peptide ligand
literature. Tr. at 100. Dr. Fujinami noted that the trials in which human subjects did not tolerate
the altered peptides well are not comparable to Petitioner’s situation. Id. at 100-01. Dr. Fujinami
noted that the patients in those studies already had full-blown multiple sclerosis, and thus were not
comparable to a patient like Petitioner who did not have an autoimmune disorder. Id. at 101.
Dr. Fujinami restated his opinion that, based on the medical literature, there is no
association between the HPV vaccine and narcolepsy. Tr. at 107-09 (citing Arnheim-Dahlstrom at
5). He referenced Arnheim-Dahlstrom, who observed no significant association between the HPV
vaccine and narcolepsy, and noted his agreement with that study. Id. at 108.
V. Applicable Law
A. Petitioner’s Burden in Vaccine Program Cases
Under the Vaccine Act, when a petitioner suffers an alleged injury that is not listed in the
Vaccine Injury Table, a petitioner may demonstrate that he suffered an “off-Table” injury.
§ 11(c)(1)(C)(ii).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
off-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit
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in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005). Althen requires that
petitioner establish by preponderant evidence that the vaccination he received caused his injury
“by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical
sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a
showing of a proximate temporal relationship between vaccination and injury.” Id. at 1278.
Under the first prong of Althen, a petitioner must provide a “reputable medical theory,”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at
1355-56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound
and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d
543, 548 (Fed. Cir. 1994). Proof that the proffered medical theory is reasonable, plausible, or
possible does not satisfy a petitioner’s burden. Boatmon v. Sec’y of Health & Hum. Servs., 941
F.3d 1351, 1359-60 (Fed. Cir. 2019).
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325-26). However, special masters are “entitled to require some indicia
of reliability to support the assertion of the expert witness.” Boatmon, 941 F.3d at 1360, quoting
Moberly, 592 F.3d at 1324. Special Masters, despite their expertise, are not empowered by statute
to conclusively resolve what are complex scientific and medical questions, and thus scientific
evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian,
but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.” Id. at
1380. Accordingly, special masters must take care not to increase the burden placed on petitioners
in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of Health & Hum.
Servs., 121 Fed. Cl. 230, 245 (2015), vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017);
see also Hock v. Sec’y of Health & Hum. Servs., No. 17-168V, 2020 U.S. Claims LEXIS 2202 at
*52 (Fed. Cl. Spec. Mstr. Sept. 30, 2020).
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion
testimony are favored in vaccine cases, as treating physicians are likely to be in the best position
to determine whether a ‘logical sequence of cause-and-effect show[s] that the vaccination was the
reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed
as particularly trustworthy evidence, since they are created contemporaneously with the treatment
of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”). As with expert testimony offered to establish a theory of causation, the opinions or
diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions
or bases. The views of treating physicians should also be weighed against other, contrary evidence
also present in the record. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011),
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aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health & Hum. Servs., No. 06-522V, 2011
WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed. Cl. 344,
356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed. Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to
the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health &
Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012),
aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-
355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den’d (Fed. Cl.
Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Law Governing Analysis of Fact Evidence
The process for making factual determinations in Vaccine Program cases begins with
analyzing the medical records, which are required to be filed with the petition. Section 11(c)(2).
The special master is required to consider “all [] relevant medical and scientific evidence contained
in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s
report which is contained in the record regarding the nature, causation, and aggravation of the
petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic
or evaluative test which are contained in the record and the summaries and conclusions.” Section
13(b)(1)(A). The special master is then required to weigh the evidence presented, including
contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3
F.3d 413, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to
afford greater weight to contemporaneous medical records than to other evidence, such as oral
testimony surrounding the events in question that was given at a later date, provided that such
determination is evidenced by a rational determination).
Medical records created contemporaneously with the events they describe are generally
trustworthy because they “contain information supplied to or by health professionals to facilitate
diagnosis and treatment of medical conditions,” where “accuracy has an extra premium.” Kirby v.
Sec’y of Health & Hum. Servs., 997 F.3d 1378 (Fed. Cir. 2021) citing Cucuras, 993 F.2d at 1528.
This presumption is based on the linked proposition that (i) sick people visit medical professionals;
(ii) sick people honestly report their health problems to those professionals; and (iii) medical
professionals record what they are told or observe when examining their patients in as accurate a
manner as possible, so that they are aware of enough relevant facts to make appropriate treatment
decisions. Sanchez v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825 at *2 (Fed.
Cl. Spec. Mstr. Apr. 10, 2013).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005 WL
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6117475 at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are generally found to be deserving of greater evidentiary weight than oral testimony -- especially
where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony
which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)).
However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475 at *19 (“[w]ritten
records which are, themselves, inconsistent, should be accorded less deference than those which
are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination
regarding a witness’s credibility is needed when determining the weight that such testimony should
be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent and
compelling.” Sanchez, 2013 WL 1880825 at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs.,
No. 90-2808V, 1998 WL 408611 at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional’s failure to document everything
reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;
or (4) a person’s purposeful recounting of symptoms that did not exist. LaLonde v. Sec’y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory connecting the vaccine to the injury often
requires a petitioner to present expert testimony in support of her claim. Lampe v. Sec’y of Health
& Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually
evaluated according to the factors for analyzing scientific reliability set forth in Daubert v. Merrell
Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs.,
617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d
1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability of testimony are:
(1) whether a theory or technique can be (and has been) tested; (2) whether the theory or technique
has been subjected to peer review and publication; (3) whether there is a known or potential rate
of error and whether there are standards for controlling the error; and (4) whether the theory or
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technique enjoys general acceptance within a relevant scientific community.” Terran, 195 F.3d at
1316 n.2 (citing Daubert, 509 U.S. at 592-95).
The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora. Daubert factors are employed by judges to exclude
evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these
factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health
& Hum. Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”).
Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to
require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592
F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a
particular expert’s credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the
reliability of expert testimony often turn on credibility determinations”).
D. Consideration of Medical Literature
Although this decision discusses some but not all of the medical literature in detail, I
reviewed and considered all of the medical records and literature submitted in this matter. See
Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally
presume that a special master considered the relevant record evidence even though [s]he does not
explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health & Hum. Servs.,
115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every piece of
evidence or testimony in her decision.’” (citation omitted)), aff’d, 601 F. App’x 982 (Fed. Cir.
2015).
VI. Analysis
Because Petitioner does not allege an injury listed on the Vaccine Injury Table, his claim
is classified as “off-Table.” As noted above, to prevail on an “off-Table” claim, Petitioner must
prove by preponderant evidence that he suffered an injury and that this injury was caused by the
vaccination at issue. See Capizzano, 440 F.3d at 1320.
Although the petition pleads a significant aggravation claim, both parties have agreed that
Petitioner’s narcolepsy symptoms began after third HPV vaccination. See Pet’r’s Post-Hearing
Brief at 1 (“This lack of orexin caused daytime sleepiness, significant weight gain, and a sudden
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loss of muscle tone (cataplexy) shortly after Trey receive at the third Gardasil vaccine on August
17, 2015”); see also First Steinman Rep. at 27 (“To a reasonable degree of medical certainty, by a
preponderance of the evidence, the Petitioner developed narcolepsy with cataplexy from the
Gardasil immunization in August 2015). Accordingly, I have analyzed this case pursuant to Althen
v. Secretary of Health and Human Services.
A. Narcolepsy and Cataplexy Generally
Narcolepsy is a chronic neurological disorder, characterized by excessive and irresistible
sleepiness, cataplexy, hypnagogic hallucinations, and sleep paralysis. Brown Rep. at 2. Excessive
daytime sleepiness (“EDS”) is a core clinical feature of narcolepsy that presents in both children
and adults. Id. Narcolepsy is a lifelong condition, which typically begins in childhood or early
adulthood “with a peak in mid-adolescence.” Id. Narcolepsy is not a common disorder, appearing
in 1:2000 to 1:5000 of the population. Id.
Narcolepsy has two classifications: type 1 (narcolepsy with cataplexy) and type 2
(narcolepsy without cataplexy). Brown Rep. at 2. According to Dr. Brown, “clinicopathologic
studies involving patients with narcolepsy type 1 demonstrate selective loss of orexin-secreting
neurons in the hypothalamus and little or no detectable orexin8 in cerebrospinal fluid.” Id. at 3.
Genetic factors also play an “important role” in the predisposition for narcolepsy. Id. The HLA
DQB1-0602 gene has been found to be strongly supportive of a narcolepsy diagnosis but not
routinely tested. Id. at 4. Narcolepsy is diagnosed with polysomnography but can also be confirmed
with a lumbar puncture measuring orexin levels. Id.
“Cataplexy is characterized by sudden, transient loss of muscle tone”, which typically
occurs as a response to “strong emotions such as laughter, surprise, anger, fright, or anticipation
of reward.” Brown Rep. at 3. The severity of cataplexic attacks ranges from “a slight head or
shoulder drop to a sudden collapse to the floor.” Id.
B. Petitioner Has Carried His Burden of Proof
I have discussed the Althen prongs in the order of their significance to the case.
1. Althen Prong One
In the context of the Program, “to establish causation, the standard of proof is
preponderance of evidence, not scientific certainty.” Langland v. Sec’y of Health & Hum. Serv.,
109 Fed. Cl. 421, 441 (2013). Petitioner’s burden under Althen’s first prong is to provide a medical
theory causally connecting the vaccination and the injury. Id. This theory must be sound and
reliable. Boatmon, 941 F.3d at 1359.
8 Various medical articles refer to orexin and hypocretin interchangeably. For ease of reference, I have
consistently referred to the neuropeptide as orexin.
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a. Dr. Steinman’s Theory9
Humans have a limited number of neurons that produce orexin. Orexin is a neuropeptide
that regulates appetite and wakefulness. Tr. at 35. A substantial enough decrease in orexin-
producing neurons leads to the development of narcolepsy. Id. at 84; Latorre at 63; NIH, National
Institute of Neurological Disorders and Stroke, Narcolepsy Fact Sheet, 1-10, 3 (filed as Ex. 48)
(hereinafter “Narcolepsy Fact Sheet”). Type 1 narcolepsy is generally considered to be an
autoimmune condition whose pathogenesis likely involves an immune response to orexin. Tr. at
36; Narcolepsy Fact Sheet at 3-4; Brown Rep. at 6 (stating that “narcolepsy type 1 is most likely
an autoimmune disorder targeting orexin containing neurons in the hypothalamus.”). Dr. Steinman
contends there is homology between components of orexin and the L protein portion of the
Gardasil vaccine. According to Dr. Steinman, this homology can result in a cross-reactive immune
response which causes the destruction of neurons that produce orexin and eventually leads to
narcolepsy.
i. Step 1: BLAST Search
BLAST, or Basic Local Alignment Search Tool, is a program that “finds regions of
similarity between biological sequences.” NIH, National Library of Medicine, BLAST;
blast.ncbi.nlm.nih.gov/Blast.cgi; Tr. at 28-29. Dr. Steinman, through a BLAST search, identified
homologies, or what Dr. Steinman believes are “meaningful molecular mimics,” between the
Gardasil vaccine and orexin, thus linking the vaccine to narcolepsy. First Steinman Rep. at 10-21.
Dr. Steinman defined a “meaningful molecular mimic” as “a run of 5 or more of 12 amino acids
that are identical.” Id. at 10.
Dr. Steinman bases his position that five or more identical amino acids will produce disease
on three papers. These papers, each authored by Gautam and Dr. Steinman, address the question
of how much homology between a self-antigen and a foreign antigen is enough to induce
autoimmunity. The researchers in Gautam found that five identical amino acids out of 12 could
trigger neuroinflammation, in the form of experimental autoimmune encephalomyelitis (EAE; the
animal model of MS). The amino acids only need to be in identical locations and do not have to
be in consecutive order. Gautam 3 at 60. According to Dr. Steinman, the three papers collectively
demonstrate that a sequence of five out of 12 amino acids is sufficient to lead to neurologic disease.
Tr. at 30; Gautam 1; Gautam 2; Gautam 3.
With respect to the BLAST search in this case, Dr. Steinman noted that the sequence
“RAGAEPAPRP” from orexin is structurally similar to “RAGTVGEPVP” from the HPV 11 L1
protein in the Gardasil vaccine. First Steinman Rep. at 13-14. Through his BLAST search, Dr.
Steinman identified a five amino acid overlap in this region (RAG_ _ _ _P_P). Dr. Steinman opined
that the Gautam papers demonstrate that this is sufficient to induce autoimmunity via the
mechanism of molecular mimicry.
9 Dr. Steinman has advanced two different theories in this case. One theory proposes mimicry between the
orexin receptor and the Gardasil vaccine. Because I find his theory concerning orexin itself to be more
persuasive, I have focused my analysis in that area.
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Dr. Fujinami disagreed that the Gautam papers support causation in this case. He opined
that the use of complete Freund’s adjuvant (CFA) was necessary to induce disease in those studies.
Tr. at 90. Unlike CFA, Dr. Fujinami remarked that alum (used in the Gardasil vaccine) is a weak
adjuvant. See Second Fujinami Rep. at 1. Dr Fujinami opined that alum was not potent enough to
cause disease, and further, that it has been shown to have protective effects.
Dr. Fujinami referenced the Sicotte and Wallberg papers. These authors individually
studied the effects of immunization on genetically susceptible animals with myelin adsorbed in
alum and found that those animals did not develop any autoimmune neuroinflammatory CNS
disease, or EAE. First Fujinami Rep. at 2-3; see also Sicotte; Wallberg. The papers actually found
that mice vaccinated with myelin adsorbed with alum protected the mice from EAE. Wallberg at
1539; Sicotte at 259. Based on these studies, Dr. Fujinami opined that “[t]he Sicotte et al and
Wallberg et al articles support my argument (presented in my previous report) that the mimicking
epitope in hypocretin/HPV given to an individual in alum would protect from disease
(neuroinflammation) rather than induce destruction of the neurons involved in narcolepsy.”
Second Fujinami Rep. at 1. At the entitlement hearing, Dr. Fujinami testified that “depending on
the type of adjuvant you use, you can either protect against autoimmune disease or you can induce
autoimmune disease.” Tr. at 90.
In response to Dr. Fujinami’s position, Dr. Steinman identified the Souayah paper as
significant to his theory that the Gardasil vaccine induces an abnormal immune response, and in
concert with the amino acid sequences he identified via BLAST search, as to how the HPV vaccine
causes narcolepsy. The Souayah paper notes that the Gardasil vaccine results in a 40 fold increase
in HPV antibodies when compared with HPV infection. Tr. at 67; Souayah at 888. According to
Dr. Steinman, this stronger immune response can lead to autoimmunity. Tr. at 67.
Ultimately, I find Petitioner’s position to be more persuasive on this issue. While Dr.
Fujinami’s cited literature does show that alum was associated with protection from disease in two
studies, this finding should not be extrapolated to every covered alum-containing vaccine (DTaP,
Tdap, Hep A, Hep B, Hib, pneumococcal, and HPV).10 This would suggest that every covered
vaccine containing alum would protect from autoimmune disease, a conclusion that would
seemingly run counter to at least one injury on the Vaccine Injury Table (tetanus toxoid containing
vaccines-brachial neuritis).
ii. Step 2: The Latorre Paper
While molecular mimicry is a theory that is generally accepted in the Vaccine Program, a
“simple invocation of the term generally does not carry a petitioner’s burden of proof.” Deshler v.
Sec’y of Health & Hum. Servs., No. 16-1070V, 2020 WL 4593162, at *20 (Fed. Cl. Spec. Mstr.
July 1, 2020) (citing Forrest v. Sec’y of Health & Hum. Servs., No. 14-1046V, 2019 WL 925495,
at *3 (Fed. Cl. Spec. Mstr. Jan. 18, 2019)). This is in part because “the finding of sequence
homology does not necessarily mean the similarity has significance to the immune system.” Tullio
v. Sec’y of Health & Hum. Servs., No. 15-51V, 2019 WL 7580149, at *15 (Fed. Cl. Spec. Mstr.
10 CDC, Vaccine Safety, www.cdc.gov/vaccinesafety/concerns/adjuvants.html (last accessed August 10,
2023).
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Dec. 19, 2019), mot. for rev. denied, 149 Fed. Cl. 448 (2020); see also Caredio v. Sec’y of Health
& Hum. Servs., No. 17-0079V, 2021 WL 4100294, at *31 (Fed. Cl. Spec. Mstr. July 30, 2021),
mot. for rev. denied, 2021 WL 6058835 (2021) (“demonstration of homology alone is not enough
to establish a preponderant causation theory”) (citing Schultz v. Sec’y of Health & Hum. Servs.,
No. 16-539V, 2020 WL 1039161, at *22 n. 24 (Fed. Cl. Spec. Mstr. Jan. 24, 2020) (“[m]ere
demonstration of theoretical homology alone, based on computer-driven searches involving
databases of amino acid sequences, does not carry the day”)).
Dr. Steinman opined that the Latorre paper fills this gap. In Latorre, the authors collected
blood samples from sixteen patients with type 1 narcolepsy, from three patients with type 2
narcolepsy, and from 13 controls who had the HLA-DQB1*0602 allele but did not have
narcolepsy. Id. They tested the samples and found orexin-specific CD4+ cells in all 19 patients
with type 1 and type 2 narcolepsy. Id. Specifically, “the epitope RAGAEPAPRP was identified as
being a target of cytotoxic T cells found in the cerebrospinal fluid in patients with Type 1
narcolepsy.” Second Steinman Rep. at 5. RAGAEPAPRP is the same amino acid sequence found
in orexin that is homologous to the L1 protein in the Gardasil vaccine. Latorre’s findings that are
pertinent to this case are depicted below:
Latorre at 67.11
This second step in Dr. Steinman’s theory is an important one. When Dr. Steinman only
presents BLAST search sequence homology in a given case, the Respondent’s expert typically
remarks that this is insufficient to show that the particular homology would cause disease. Indeed
in this case, before Petitioner filed the Latorre study, Dr. Fujinami stated: “it has not been proven
that there are any pathogenic “disease-relevant” mimicking peptides in the HPV vaccine as opined
by Dr. Steinman.” First Fujinami Rep. at 3. By citing Latorre, Dr. Steinman has demonstrated that
11 Although the highlighted region is difficult to read, it is the amino acid sequence “RAGAEPAPRP”.
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the orexin peptide targeted in type 1 narcolepsy has sequence homology with a component of the
Gardasil vaccine.
Dr. Fujinami disagreed with Dr. Steinman on the import of the Latorre paper. He testified
it is not clear that the T cells discussed by the authors are pathogenic. Tr. at 103-04. However, the
Latorre authors discuss the pathogenic potential of both CD8+ and CD4+ T cells.
CD8+ T cells have the potential to directly kill HCRT neurons… By contrast, auto
reactive CD4+ T cells may have an indirect effect that promotes the generation of
pathogenic CD4+ T cells or autoantibodies… By producing high levels of IFNγ
and GM-CSF, autoreactive CD4+ T cells may also promote local inflammation and
loss of integrity of the blood-brain barrier, triggering the influx of effector
inflammatory cells and pathogenic antibodies.
Latorre at 67. Further, in describing one patient with type 2 narcolepsy who had recently developed
cataplexy (thus qualifying him for a type 1 narcolepsy diagnosis), the authors noted, “The previous
finding of relatively high levels of CD4+ and CD8+ T cells against [orexin] in this patient would
be consistent with an autoimmune attack that has not (yet) led to a complete loss of neurons that
produce [orexin].” Latorre at 67. Although the authors indicate there is a question about the
pathogenic role of CD4+ and CD8+ T cells in narcolepsy, they do find this above-noted evidence
to be “consistent” with an autoimmune attack. Id. I find the Latorre paper to be persuasive evidence
in support of Althen prong one.
b. Epidemiology
Respondent cited to the Torstensen study, a sample of 29 girls and women in Denmark
who were evaluated for their sleep complaints after receiving the HPV vaccine. Torstensen.
Torstensen stated “[w]e here aimed to evaluate whether sleep-related symptoms following HPV
vaccination could be associated with development of narcolepsy type 1.” Id. at 1. Testing was
conducted to confirm whether these sleep complaints were diagnostic of type 1 narcolepsy; testing
included polysomnographs, MLST, genetic testing for HLA-DQB1*06:02, and CSF for
hypocretin-1. Id. at 2. The authors noted that “[t]he study was not designed to assess with
epidemiological tools the prevalence of type 1 narcolepsy in the vaccine group compared with the
background population.” Id. at 3. The authors concluded that none of the subjects met the
requirements for a type 1 narcolepsy diagnosis. Id. The authors further concluded that there was
no association between the HPV vaccine and the development of type 1 narcolepsy; a conclusion
that appears to be based on the fact that none of the 29 subjects had narcolepsy. Id. (“If there was
any association with narcolepsy type 1, one would expect to identify this association in this
particular group of individuals.”). Because of this unique set of circumstances, I do not find the
Torstensen paper to be especially persuasive in this case as it pertains to the question of vaccine
causation. The stated aim of the study was to evaluate whether the symptoms reported by the study
participants were associated with narcolepsy, not to assess “the prevalence of type 1 narcolepsy in
the vaccine group compared with the background population.” Id. at 3.
Respondent also cited to Arnheim-Dahlstrom for epidemiological support. Arnheim-
Dahlstrom was a wide cohort study of adverse events after HPV vaccination in adolescent girls in
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Denmark and Sweden between 2006-2010. Arnheim-Dahlstrom at 1. The authors conclude that
there is “no evidence supporting associations between exposure to [HPV] vaccine and
autoimmune, neurological, and venous thromboembolic adverse events.” Id. The Arnheim-
Dahlstrom study supports Respondent’s position that the HPV vaccine did not cause Petitioner’s
narcolepsy.12
Dr. Fujinami filed two WHO reports regarding narcolepsy and the H1N1 Pandemrix
vaccine. Ex. C, Tabs 8, 9. In the 2013 WHO Report, it was noted that there was a possible increased
risk for adults to develop narcolepsy after the H1N1 vaccination but risk was lower in children.
Ex. C, Tab 8 at 12. The same report did not mention any connection between the HPV vaccine and
narcolepsy. The 2015 WHO Report stated that increased risk had been consistently produced in
H1N1 vaccine/narcolepsy study results. Ex. C, Tab 9 at 8. The report also discussed the general
safety of the HPV vaccine but not in conjunction with narcolepsy. Id. at 6-8.
The experts agree that the Pandemrix vaccine has been linked to an increased risk of
developing narcolepsy. The experts also agree that “molecular mimicry has been hypothesized to be
the cause of the regional epidemic of narcolepsy caused by the Pandemrix flu vaccine in 2009 and
2010.” Brown Rep. at 6; Tr. at 37 (Dr. Steinman); Tr. at 154 (Dr. Fujinami).
When presented, epidemiological may be relevant evidence that bears on the causation
analysis. D’Toile, 2016 WL 7664475 at *22; see also W.C., 704 F.3d at 1361 (special master was
not arbitrary in denying compensation, and noting that the special master properly relied on several
epidemiological studies in reaching his decision); Lampe, 219 F.3d at 1365 (stating “[a]n
epidemiological study may be probative medical evidence relevant to a causation determination”);
C.K. v. Sec’y of Health & Hum. Servs., 113 Fed. Cl. 757, 770 (2013) (a special master may evaluate
contradictory evidence offered by Respondent). At the same time, petitioners need not offer
epidemiologic evidence to meet their burden under Althen. See Andreu, 569 F.3d at 1378-79 (citing
Capizzano, 440 F.3d at 1325-26). Indeed, because vaccine injuries are rare events, the fact that a
particular epidemiologic study suggests a vaccine is generally safe should not prevent a claimant
from prevailing. See Harris v. Sec’y of Health & Hum. Servs., No. 10–322V, 2014 WL 3159377,
at *11 (Fed. Cl. Spec. Mstr. June 10, 2014) (epidemiologic studies cannot absolutely refute causal
connections, because it is possible that a larger study could always detect an increased risk).
Although I have considered the epidemiologic evidence filed in this case, I do not find that it
prevents Petitioner from meeting his burden.
c. Other Vaccine Program Cases
12 According to Dr. Steinman, the Arnheim-Dahlstrom paper demonstrated an increased rate of narcolepsy
after HPV vaccination, even though it “did not reach ‘statistical significance’.” First Steinman Rep. at 26.
He argued that the paper shows the incidence rate for the vaccinated (2.61) is higher than the unvaccinated
(1.81). However, this position is not consistent with the authors’ conclusion, that there is no increase of
autoimmune, neurological, or venous thromboembolic adverse events after the HPV vaccine. Arnheim-
Dahlstrom at 8. Ultimately, I am not persuaded by Dr. Steinman’s position on this issue.
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A number of cases alleging narcolepsy have been filed in the Vaccine Program. Although
prior decisions from different cases do not control the outcome herein (Boatmon, 941 F.3d at 1358-
59), I will discuss several cases with similar theories of causation.
One special master found that Dr. Steinman presented a persuasive theory as to how the
FluMist vaccine could cause type 1 narcolepsy, though she denied entitlement based on Althen
prongs two and three. Henkel v. Sec’y of Health & Hum. Servs., No. 15-1048V, 2022 WL
16557979 (Fed. Cl. Spec. Mstr. Aug. 31, 2022); mot. for rev. denied, 165 Fed. Cl. 153; appeal
docketed, No. 23-1894 (Fed. Cir. May 17, 2023). The Althen prong one theory presented by Dr.
Steinman in Henkel was virtually identical to the one advanced in the case at bar.
The other special masters who have recently evaluated this question have determined that
petitioners did not advance persuasive causal theories. Although A.T. involved a claim similar to
that of Mr. Cobb, the Respondent in A.T. presented studies that were not discussed in this case and
generally defended the case differently.13 A.T. v. Sec’y of Health & Hum. Servs., No. 16-393V,
2021 WL 6495241 (Fed. Cl. Spec. Mstr. Dec. 17, 2021). Respondent also refuted Dr. Steinman’s
molecular mimicry theory through discussion of the Silvanovich paper, an analysis that was not
conducted here. In E.S., Petitioner was diagnosed with narcolepsy type II, which is arguably not
an auto-immune condition; and further, was not diagnosed until years after vaccination. E.S. v.
Sec’y of Health & Hum. Servs., No. 17-480V, 2020 WL 9076620 (Fed. Cl. Spec. Mstr. Nov. 13,
2020).
The remainder of the narcolepsy cases were decided before the Latorre paper was
published. Dougherty v. Sec’y of Health & Hum. Servs., No. 15-1333V, 2018 WL 3989519 (Fed.
Cl. July 5, 2018), mot. for review den’d, 141 Fed. Cl. 223 (2018) (flu vaccine and narcolepsy);
McCollum v. Sec’y of Health & Hum. Servs., No. 14-790V, 2017 WL 5386613 (Fed. Cl. Sept. 15,
2017); mot. for review den’d, 135 Fed. Cl. 735 (2017), aff’d, 760 F. App’x 1003 (Fed. Cir. 2019)
(flu vaccine and narcolepsy); D’Toile v. Sec’y of Health & Human Servs., No. 15-085V, 2016 WL
7664475 (Fed. Cl. Spec. Mstr. Nov. 28, 2016), mot. for review den’d, 2017 WL 2729570 (Fed. Cl.
Mar. 2, 2017), aff’d, 726 F. App’x 809 (Fed. Cir. 2018) (FluMist vaccine and narcolepsy);
Garrison v. Sec’y of Health & Hum. Servs., No. 14-762V, 2015 WL 7424016 (Fed. Cl. Spec. Mstr.
Oct. 29, 2015) (finding Petitioner met her burden in a flu vaccine narcolepsy case where
Respondent did not present his own expert opinion).
13 For example, Respondent’s expert cited Hvid et al., Human papillomavirus vaccination of adult women
and risk of autoimmune and neurological diseases, 283 JOURNAL OF INTERNAL MEDICINE 154-65 (2018)
as additional epidemiological evidence in support of their position. Hvid was a population based study of
all women aged 18-44 in Denmark and Sweden who received the quadrivalent HPV vaccine between 2006-
2010. Although a number of narcolepsy cases post-vaccination were reported, the authors of the Hvid paper
found there was no association between narcolepsy and the HPV vaccine. Respondent also cited Phillips et
al., Safety of Human Papillomavirus Vaccines: an Updated Review, 41 DRUG SAF. 329 (2018). This
review “identified 109 studies, including 15 population-based studies in over 2.5 million vaccinated
individuals across six counties. All vaccines demonstrated an acceptable safety profile.” I further note that
in this case, Respondent elected not to conduct a cross examination of Dr. Steinman, although Respondent’s
current counsel of record was not present at the entitlement hearing.
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“[T]he purpose of the Vaccine Act’s preponderance standard is to allow the finding of
causation in a field bereft of complete and direct proof of how vaccines affect the human body.”
Althen, 418 F.3d at 1280. “[C]lose calls regarding causation are resolved in favor of injured
claimants.” Id. This case is indeed a close call. Ultimately, I find that Petitioner has presented
preponderant evidence in support of his causal theory that molecular mimicry between components
of orexin and a portion of the Gardasil vaccine “can cause” type 1 narcolepsy.
2. Althen Prong Three
The timing prong contains two parts. First, Petitioner must establish the “timeframe for
which it is medically acceptable to infer causation” and second, they must demonstrate that the
onset of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed.
Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012),
aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013).
Although a temporal association alone is insufficient to establish causation, under the third
prong of Althen, a petitioner must show that the timing of the injury fits with the causal theory.
See Althen, 418 F.3d at 1278. The special master cannot infer causation from temporal proximity
alone. See Thibaudeau v. Sec’y of Health & Hum. Servs., 24 Cl. Ct. 400, 403–04 (1991); see also
Grant, 956 F.2d at 1148 (“[T]he inoculation is not the cause of every event that occurs within the
ten[-]day period ... [w]ithout more, this proximate temporal relationship will not support a finding
of causation.” (quoting Hasler v. United States, 718 F.2d 202, 205 (6th Cir. 1983))).
Petitioner developed the onset of narcolepsy between one and three weeks after his third
HPV vaccination. Petitioner’s medical records consistently reflect this window of onset. See Ex.
2 at 13 (medical record from November 17, 2015 where Petitioner told Dr. Miller he had really
low energy since school started and feels tired all the time); Tr. at 6-7 (Petitioner’s testimony that
school started at the end of August); Ex. 6 at 33 (medical record from November 23, 2015 where
Petitioner reported three months of fatigue to Dr. Strehle); Ex. 3 at 5 (medical record from
December 29, 2015 where Petitioner’s history of presentation was noted to have begun in late
August); Ex. 1 at 1-3 (April 4, 2016 visit with Dr. Gutu where the medical record documents that
Petitioner had a mono-like illness in late August-September which resulted in excessive fatigue).
Dr. Steinman conceded that there are no studies regarding the appropriate onset interval
for narcolepsy after HPV vaccine that are directly applicable to this case. Tr. at 69. He opined that
the Schonberger and Langmuir studies are analogous to this case and support the onset of
narcolepsy approximately two weeks after vaccination. Tr. at 70-71. Schonberger et al., Guillain
Barre Syndrome following vaccination in the National Influenza Immunization Program, United
States, 1976-1977, 110 AMERICAN JOURNAL OF EPIDEMIOLOGY 2, 105-23, (1979) (filed as Ex. 50)
(hereinafter “Schonberger”). Schonberger demonstrates that the swine flu vaccine can cause
Guillain Barré syndrome (GBS), a demyelinating disease of the peripheral nervous system. The
increased risk for developing GBS after swine flu vaccination was concentrated within the five
weeks after vaccination but extended up to eight weeks after vaccination. Schonberger at 105.
Langmuir found an increased risk of developing GBS within six weeks of receipt of the H1N1
vaccination. Langmuir et al., An Epidemiologic and Clinical Evaluation of Guillain-Barré
Syndrome Reported in Association with the Administration of Swine Influenza Vaccines, 119 AM
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J EPIDEMIOL 841-79 (1984) (filed as Ex. 49).
Dr. Steinman also cited to Souayah et al., who reviewed VAERS data from 2006-2009
identifying cases of GBS after the Gardasil vaccine. Souayah at 886. At the entitlement hearing,
Dr. Steinman testified that the “onset of symptoms was within six weeks after [Gardasil]
vaccination in 70 percent of the patients in whom the date of vaccination was known.” Tr. at 71.
Dr. Steinman also testified that this article provided additional support for the temporal interval
between Petitioner’s third Gardasil vaccination and the onset of his type 1 narcolepsy. Id. at 70
(Dr. Steinman testifying that this window is “typical of an autoimmune reaction causing a
neuroinflammatory condition”).
I find that between one and three weeks is a medically acceptable timeframe to infer
causation. Although Schonberger and Langmuir involve the onset of GBS after swine flu vaccine,
I find Dr. Steinman provided persuasive testimony on the applicability of those studies to the
present case. Additionally, the Souayah article, which pertains to the HPV vaccine and GBS also
provides support for the temporal interval in the case at bar. Although none of the three studies
involves Petitioner’s same vaccine and condition, they all support the point that an adaptive
immune reaction would likely cause the onset of a neuroinflammatory condition within several
weeks of vaccination. Petitioner has satisfied the third Althen prong.
3. Althen Prong Two
Under Althen’s second prong, Petitioner must “prove a logical sequence of cause and effect
showing that the vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. The sequence
of cause and effect must be “'logical' and legally probable, not medically or scientifically certain.”
Id. Petitioner is not required to show “epidemiologic studies, rechallenge, the presence of
pathological markers or genetic disposition, or general acceptance in the scientific or medical
communities to establish a logical sequence of cause and effect.” Id. (omitting internal citations).
Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead,
circumstantial evidence and reliable medical opinions may be sufficient to satisfy the second
Althen prong. Isaac v. Sec’y of Health & Hum. Servs., No. 08-601V, 2012 WL 3609993, at *25
(Fed. Cl. Spec. Mstr. July 30, 2012), mot. for rev. denied, 108 Fed. Cl. 743 (Fed. Cl. 2013), aff’d,
540 Fed.Appx. 999 (Fed. Cir. 2013).
In this case, the evidence of Petitioner’s medical history is undisputed. Petitioner was
healthy prior to vaccination. Between one to three weeks after receipt of the third dose of the HPV
vaccine, he developed excessive fatigue, which constituted the onset of his type 1 narcolepsy.
Although the cause of type 1 narcolepsy is unknown, researchers believe that the loss of orexin-
producing neurons may be initiated by “immunological responses that manifest in genetically
predisposed individuals upon triggering by environmental factors.” Latorre at 63. Petitioner’s
medical course is consistent with his theory of molecular mimicry.
When a petitioner has established that vaccination can cause a given condition and has
demonstrated that the timing prong has also been met, it allows the petitioner to establish that
vaccination was a but-for cause of his condition. The Federal Circuit has provided guidance with
respect to this issue. “Evidence demonstrating petitioner’s injury occurred within a medically
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acceptable time frame bolsters a link between the injury alleged and the vaccination at issue under
the “but-for” prong of the causation analysis.” Capizzano, 440 F.3d at 1326 (finding medical
opinions that explain how a vaccine can cause the injury alleged coupled with evidence
demonstrating a close temporal relationship “are quite probative” in proving actual causation).
Pafford, 451 F.3d at 1358; see also Contreras, 107 Fed. Cl. at 295, (finding that there is a “logical
overlap between the three Althen prongs, and that evidence that goes to one prong may also be
probative for another prong”). Petitioner has met the second Althen prong.
VII. Conclusion
Upon careful evaluation of all the evidence submitted in this matter, including the medical
records, the affidavits and testimony, as well as the experts’ opinions and medical literature, I
conclude that Petitioner has preponderantly demonstrated that he is entitled to compensation under
the Vaccine Act. An order regarding damages will issue shortly.
IT IS SO ORDERED.
s/ Katherine E. Oler
Katherine E. Oler
Special Master
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