Moses v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
*************************
MICHAEL MOSES, parent on behalf of * No. 19-739V
P.M., a minor, *
* Special Master Christian J.
Petitioner, * Moran
*
* Filed: May 18, 2022
v. *
* Entitlement; measles, mumps,
* and rubella (“MMR”) vaccine;
SECRETARY OF HEALTH * pneumococcal conjugate
AND HUMAN SERVICES, * vaccine; varicella vaccine;
* systemic juvenile idiopathic
Respondent. * arthritis (“sJIA”)
*************************
Phyllis Widman, Widman Law Firm, LLC, Northfield, NJ, for petitioner;
Catherine Stolar, United States Dep’t of Justice, Washington, DC, for respondent.
PUBLISHED DECISION DENYING COMPENSATION 1
Michael Moses claims that the measles, mumps, and rubella (“MMR”),
pneumococcal conjugate, and varicella vaccines his son, P.M., received caused him
to develop systemic juvenile idiopathic arthritis (“sJIA”). The parties have
submitted reports from experts and argued their positions through legal briefs. Mr.
Moses has not shown that the MMR, pneumococcal conjugate, or varicella
vaccines can cause sJIA. Additionally, Mr. Moses has not demonstrated a logical
sequence of cause and effect connecting the vaccines to P.M.’s condition. Further,
Mr. Moses has not put forth a medically acceptable timeframe from which to infer
1
The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal
Management and Promotion of Electronic Government Services), requires that the
Court post this decision on its website. This posting will make the decision
available to anyone with the internet. Pursuant to Vaccine Rule 18(b), the parties
have 14 days to file a motion proposing redaction of medical information or other
information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by
the special master will appear in the document posted on the website.
vaccine-causation. Accordingly, Mr. Moses has not met his burden of establishing
that the MMR, pneumococcal conjugate, and varicella vaccines caused P.M.’s
sJIA. Thus, his case is dismissed.
I. Facts
P.M. was born via cesarean section on June 4, 2015 and had a normal
newborn screening. Exhibit 13 at 15-18. Prior to vaccination, P.M. was relatively
healthy with no significant health concerns.
On June 6, 2016, P.M. visited his pediatrician, Katherine Kormanik, M.D.,
for his twelve-month well visit. Id. at 210. P.M. was growing and developing
normally and noted to be a healthy infant. Id. at 220-22. At this visit, P.M.
received his MMR, pneumococcal conjugate, and varicella vaccines. Id. at 223;
exhibit 1 at 2-4 (vaccination record).
On June 24, 2016, P.M. presented to Dr. Kormanik with complaints of low-
grade fevers, waking at night, and fussiness for the last five days. Exhibit 2 at 25.
P.M.’s parents reported that P.M. had not been “acting like himself,” had been
crying while laying down, and had developed a rash with small red spots on his
back and abdomen. Id. Dr. Kormanik noted that P.M. had received his MMR
vaccine more than two weeks prior. Id. at 28. Upon physical exam, Dr. Kormanik
observed a runny nose and fever, swollen gums, a rash on the abdomen and back,
and a pustule or papule on the hand. Id. at 29. Dr. Kormanik suspected possible
early hand, foot, and mouth syndrome, “viral rash vs MMR side effect,” and
teething. Id.
P.M. visited Dr. Kormanik’s colleague, pediatrician John Goetz, M.D., on
June 28, 2016. Id. at 38. Dr. Goetz observed rashes on P.M.’s chest and hand and
swollen tonsils. Id. Dr. Goetz diagnosed P.M. with pharyngitis (sore throat) and
viral exanthem (rash). Id. at 39. He noted that P.M. had received his MMR and
varicella vaccine three weeks earlier. Id.
On July 1, 2016, P.M.’s mother left a voicemail message for Dr. Kormanik,
stating that P.M. “seems to ‘hurt’ when he is moved or his position is changed,”
and that he still had a rash with fevers. Exhibit 2 at 50.
P.M. returned to Dr. Kormanik on July 2, 2016. Id. at 54. P.M.’s parents
reported that P.M. would “cry in pain with movements” and did “not want to move
as much as he did prior to becoming ill.” Id. at 55. Mr. Moses asked if “[P.M.’s]
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‘bones hurt’ given how small movements . . . can cause him to cry significantly.”
Id. Dr. Kormanik observed a blanching, maculopapular rash scattered across
P.M.’s abdomen, back, and legs, a blister-like lesion on P.M.’s left hand, enlarged
tonsils, and swollen hands and feet. Id. at 56. Dr. Kormanik diagnosed P.M. with
post-strep glomerulonephritis, atypical Kawasaki disease, and nephrotic syndrome.
Id. Dr. Kormanik recommended that P.M.’s parents take him to the emergency
room.
Following the appointment with Dr. Kormanik, P.M. went to the emergency
room on July 2, 2016. Exhibit 5 at 3. His parents reported that P.M. had a rash for
the past twelve days and a fever for the past nine days. Id. Rheumatologist James
Nocton, M.D., examined P.M. Dr. Nocton noted that P.M.’s lesion on his left hand
and his fever indicated “potential coxsackie virus infection,” but the prolonged
duration of his fevers, extremity swelling, and rash were “not typical for
coxsackievirus.” Id. at 19. Additionally, Dr. Nocton stated that P.M.’s erythrocyte
sedimentation rate was “somewhat disproportionate for a viral illness.” Id.
While at the hospital, P.M.’s rash and fever improved with IVIg,
methylprednisolone, and solumedrol therapy. Id. at 24, 28; see also id. at 189 (Dr.
Nocton’s record). P.M. was discharged from the hospital on July 6, 2016, after
being fever free for 36 hours. Id. at 26-27. His diagnosis at discharge was
“incomplete Kawasaki disease.” Id. at 7.
On July 7, 2016, P.M. saw Dr. Kormanik for a fever. Exhibit 2 at 75.
P.M.’s parents noted that he was “just as fussy as when he was admitted” to the
hospital on July 2, 2016. Id. Dr. Kormanik observed that P.M. was
uncomfortable, cried with movement, and had a rash on his left lower leg and
upper chest. Id. at 76. Dr. Kormanik’s assessment was “[i]ncomplete Kawasaki
disease with continued fevers.” Id. She prescribed prednisolone. Id. at 74.
P.M. visited Dr. Nocton for a follow-up appointment on July 11, 2016.
Exhibit 5 at 188. Dr. Nocton noted that P.M.’s recurrence of his fever and rash,
irritability in the morning, worsening anemia, and elevated white blood cell and
platelet counts were more consistent with sJIA than Kawasaki’s disease. Id. at
191. Dr. Nocton wrote, “This form of arthritis often starts with fever and rash in a
characteristic pattern of 1-2 temp spikes each day with an evanescent, salmon-
colored macular rash that comes and goes with the fever.” Id.
When P.M.’s fever and rash did not resolve, he was readmitted to the
hospital on July 14, 2016. Exhibit 5 at 231-32. At the hospital, P.M. was
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examined by rheumatologist Judyann Olson, M.D. Dr. Olson wrote that P.M.’s
differential diagnosis included “systemic JIA vs incomplete [K]awasaki disease vs
macrophage activation syndrome [(MAS)].” Id. at 252. Dr. Olson started P.M. on
anakinra. Id. Anakinra is a medication to respond to inflammation in rheumatoid
arthritis. Dorland’s Illus. Med. Dictionary 70 (33d ed. 2020).
Infectious disease specialist Michael Chusid, M.D., examined P.M. on July
17, 2016. Id. at 237. Dr. Chusid noted that P.M.’s fevers “started . . .
approximately 10 days after receipt of an MMR vaccination.” Id. Dr. Chusid
“[s]trongly suspect[ed] MMR was [the] trigger” for P.M.’s illness due to the
“temporal association.” Id. at 239. Dr. Chusid advised P.M. to avoid future live
vaccines, including a second MMR vaccine and a live influenza vaccine, “unless
the mechanism of his disease becomes better elucidated.” Id. at 240.
P.M. was discharged from the hospital on July 19, 2016. Exhibit 5 at 229-
31. P.M. had not developed any rashes during his hospitalization. Id. at 230.
Additionally, since beginning anakinra, P.M.’s fever had gone down. Id. At
discharge, his diagnoses were MAS and systemic onset JIA. Id. at 229.
On July 25, 2016, P.M. saw Dr. Nocton for a follow-up appointment. Id. at
473-75. Since his discharge from the hospital, he had not had a fever, rash, joint
pain, or swelling, and his energy level was almost back to baseline. Id. at 474. Dr.
Nocton stated that P.M.’s fever pattern of high spikes once to twice a day, fine
macular rash, leukocytosis, anemia, and thrombocytosis were consistent with
systemic onset JIA. Id. Dr. Nocton noted that P.M. “never developed the classic
systemic JIA rash” or “objective” arthritis. Id. However, Dr. Nocton opined that
his “fever pattern,” possible arthralgias, and laboratory test results indicated that he
would have developed “a more characteristic and recognizable systemic JIA
pattern,” had his physicians not “treat[ed] him early, initially with IVIG and
steroids, and then subsequently with anakinra.” Id. Dr. Nocton concluded that
P.M.’s “marked elevation of transaminases, subsequent fall in his [white blood
cells], hemoglobin, and platelets, and extreme elevation of the ferritin” were
consistent with MAS. Id.
P.M. saw Dr. Nocton again on August 10, 2016. Exhibit 6 at 6-7. P.M.’s
parents reported that he was doing well, was not experiencing symptoms, and
remained on anakinra. Id.
P.M. periodically followed up with Dr. Nocton over the next two-and-a-half
years. See exhibits 6-12, 15-16. P.M. seemed to be growing and developing
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normally, so his parents and Dr. Nocton tried to wean him off anakinra on several
occasions. However, Dr. Nocton increased P.M.’s dose or restarted anakinra a few
times due to concern about possible recurrence of symptoms. See, e.g., exhibit 8 at
79 (anakinra restarted after P.M. experienced a recurrence of irritability, rash,
lethargy, and intermittent abnormal gait).
On February 15, 2019, P.M. visited Dr. Nocton for a follow-up appointment.
Dr. Nocton noted that P.M. “continued to do very well” and recommended that he
stop anakinra. Exhibit 15 at 131-33. Dr. Nocton suggested discontinuation of
anakinra because P.M. seemed to be doing well even as his parents weaned him
off. Dr. Nocton noted that P.M. “ha[d] been asymptomatic with a normal physical
examination and normal laboratory tests despite decreasing the frequency of
anakinra to every seventh day.” Id. at 133. Additionally, Dr. Nocton told P.M.’s
parents that he showed “no sign of active systemic onset JIA.” Id. Dr. Nocton
recommended that P.M. receive the MMR vaccine, which he was unable to do
while on anakinra. Id.
The last medical record with Dr. Nocton is from April 1, 2019. At this visit,
P.M.’s parents reported that P.M. had been receiving anakinra once every seven
days and not received anakinra in the last week. Dr. Nocton again recommended
that his parents discontinue anakinra so that P.M. could receive the MMR
vaccination. Exhibit 16 at 161-63.
P.M. saw pediatrician Sarah Gaethke, M.D., for a five-year well visit on
November 25, 2020. Exhibit 47 at 17. Dr. Gaethke noted that P.M.’s mother
declined to allow P.M. to receive varicella and MMR vaccines. Dr. Gaethke wrote
that there was “no reason not to give live vaccines” because P.M. was “no longer
on immune suppression and [Dr. Nocton] did not feel that the vaccines were the
cause of the original symptoms.” Id. at 20.
On October 1, 2020, Kristin Moeller, R.N., wrote that Dr. Kormanik and
P.M.’s rheumatologist “recommended” that P.M. receive the MMR vaccine, but
P.M.’s father declined to consent. Id. at 40. On October 5, 2020, P.M.’s mother
asked Dr. Kormanik to sign a school waiver excusing P.M. from getting the MMR
vaccine. Id. at 34. A member of the nursing staff informed P.M.’s mother via
email that Dr. Kormanik could not sign the waiver because “[s]he cannot say that
MMR is medically contraindicated as we do not know for certain that this was a
cause of [P.M.’s] JIA.” Id. at 35. Dr. Kormanik followed up with P.M.’s mother
via email, stating that there was “no medical evidence to link MMR to the cause of
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[P.M.’s] JIA for [her] to sign the waiver.” Id. Dr. Kormanik suggested that P.M.’s
mother reach out to P.M.’s rheumatologist for additional advice. Id.
No additional medical records relating to P.M.’s condition have been filed.
II. Procedural History
Mr. Moses filed a petition for compensation on behalf of P.M. on May 17,
2019. Pet., filed May 17, 2019. He filed medical records on May 20, 2019. The
Secretary reviewed this material and recommended that compensation be denied.
Resp’t’s Rep., filed Sept. 23, 2019. The Secretary argued that Mr. Moses failed to
offer a theory connecting the vaccines to P.M.’s condition, and that temporal
association alone was not enough to meet his burden. Id. at 13-15.
The parties then proceeded to the expert report stage. To advance his case,
Mr. Moses presented an initial report from Arthur E. Brawer, M.D., on March 20,
2020. Exhibit 19. Due to deficiencies in Dr. Brawer’s first report, he was ordered
to submit a supplemental report. Order, issued Mar. 24, 2020. Dr. Brawer
submitted a supplemental report on August 7, 2020. Exhibit 32. The Secretary
then submitted a report from Craig D. Platt, M.D., Ph.D., on December 4, 2020,
and a report from Carlos D. Rose, M.D., on December 11, 2020. Exhibits C and E.
Mr. Moses submitted a rebuttal report from Dr. Brawer on March 19, 2021.
Exhibit 38. The Secretary then provided responsive reports from Dr. Rose and Dr.
Platt on May 3, 2021. Exhibits F and G. The parties also filed several medical
articles their experts cited.
Following the completion of the expert report stage, the parties were
instructed to file briefs advocating for their positions. Order, issued June 22, 2021.
Mr. Moses filed a brief in support of entitlement on September 20, 2021, and the
Secretary submitted his brief on December 3, 2021. Mr. Moses submitted a reply
brief on January 3, 2022. The case is now ready for adjudication.
III. Standards for Adjudication
A petitioner is required to establish his case by a preponderance of the
evidence. 42 U.S.C. § 300aa-13(1)(a). The preponderance of the evidence standard
requires a “trier of fact to believe that the existence of a fact is more probable than
its nonexistence before [he] may find in favor of the party who has the burden to
persuade the judge of the fact’s existence.” Moberly v. Sec’y of Health & Hum.
Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted). Proof of
6
medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931
F.2d 867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.
Cir. 2009) (reversing a special master’s decision that petitioners were not entitled
to compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d
1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961
(Fed. Cir. 1993) (disagreeing with the dissenting judge’s contention that the special
master confused preponderance of the evidence with medical certainty).
When pursuing an off-Table injury, a petitioner bears a burden “to show by
preponderant evidence that the vaccination brought about [the vaccinee’s] injury
by providing: (1) a medical theory causally connecting the vaccination and the
injury; (2) a logical sequence of cause and effect showing that the vaccination was
the reason for the injury; and (3) a showing of a proximate temporal relationship
between vaccination and injury.” Althen v. Sec’y of Health & Hum. Servs., 418
F.3d 1274, 1278 (Fed. Cir. 2005).
IV. Analysis
A. Althen Prong 1: A Causal Theory Connecting the Vaccine to
P.M.’s Injury
The first Althen prong requires the petitioner to provide a “sound and
reliable” medical theory demonstrating that the vaccine can cause the alleged
injury. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed.
Cir. 2019) (quoting Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548
(Fed. Cir. 1994)). The petitioner must also offer “a reputable or scientific
explanation that pertains specifically to [his] case.” Moberly, 592 F.3d at 1322.
Through Dr. Brawer, Mr. Moses has attempted to present three theories by
which the MMR, pneumococcal conjugate, and varicella vaccines can cause sJIA.2
Dr. Brawer opined that molecular mimicry, channelopathies, and mitochondrial
2
The Secretary noted that Dr. Brawer did not distinguish between the three
vaccines when providing his causation theories. See Resp’t’s Br., filed Dec. 3,
2021, at 27.
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dysfunctions are all potential mechanisms for causation. However, these theories
lack persuasiveness. Each theory is discussed individually below.
1. Molecular Mimicry
Dr. Brawer presented molecular mimicry as a potential theory, explaining
that “vaccine antigens of infectious agents can cross-react with self antigens
present on a variety of body cells, including immunocompetent cells, thereby
triggering systemic inflammatory reactions.” Exhibit 19 at 3.
Dr. Brawer relied on an experimental study in mice to support molecular
mimicry as a mechanism for causation. Exhibit 29 (Marijana Stojanović et al.,
Role of Molecular Mimicry and Polyclonal Cell Activation in the Induction of
Pathogenic ß2-Glycoprotein I-Directed Immune Response, 56 J. Immunology
Rsch. 20 (2012)). The study found that “molecular mimicry has played a role in
the rise of” autoantibodies against glycoproteins following immunization with the
tetanus toxoid. Exhibit 29 at 26. Dr. Brawer cited another animal study that tested
the induction of bystander activation in mice. Exhibit 30 (Susan van Aalst et al.,
Bystander Activation of Irrelevant CD4+ T Cells Following Antigen-Specific
Vaccination Occurs in the Presence and Absence of Adjuvant, PLoS ONE (May
10, 2017)). The study found that an antigen-specific response led to bystander
activation in mice. Id. at 9. However, the study’s authors stated that “clear
evidence of vaccine-induced [autoimmune diseases] is not yet established.” Id.
Dr. Platt challenged Dr. Brawer’s molecular mimicry theory, claiming that
molecular mimicry is not part of the etiology of sJIA. Dr. Platt stated, “Dr. Brawer
does not provide any references that support a ‘molecular mimicry’ mechanism for
sJIA” involving “cross reactivity between a vaccine antigen and a channel
protein.” Exhibit C at 7. Dr. Platt relied on an article that concluded sJIA has no
connection to autoantibodies or activation of the immune system. See exhibit C,
tab 1 (Berent Prakken et al., Juvenile Idiopathic Arthritis, 377 Lancet 2138
(2011)). Another article stated that “systemic JIA is an autoinflammatory disease
rather than a classical antigen driven lymphocyte-mediated autoimmune disease.”
Exhibit C, tab 3 (Yu-Tsan Lin et al., The Pathogenesis of
Oligoarticular/Polyarticular vs Systemic Juvenile Idiopathic Arthritis, 10
Autoimmunity Revs. 482 (2011)). Similarly, Dr. Rose stated, “Autoantibodies and
antigen specific T cells are not found in patients with sJIA.” Exhibit E at 25. The
Secretary also noted that one of Dr. Brawer’s references acknowledges that sJIA is
an autoinflammatory disease, not an autoimmune disease. Resp’t’s Br., filed Dec.
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3, 2021, at 22-23 (citing exhibit 36 (F. Ciccarelli et al., An Update on
Autoinflammatory Diseases, 21 Current Medicinal Chemistry 261 (2014)) at 266).
Dr. Platt and Dr. Rose persuasively explained why Dr. Brawer’s theory
regarding the role molecular mimicry in sJIA is untenable. Given that sJIA is
autoinflammatory in nature and has no relationship to autoantibodies, Dr. Brawer’s
molecular mimicry theory lacks persuasiveness.
2. Channelopathies
Dr. Brawer offered the theory that vaccines contain toxic chemicals that can
trigger channelopathies, thus causing sJIA. Specifically, Dr. Brawer asserted that
the vaccines P.M. received can trigger ion channel autoantibodies. Exhibit 19 at 2.
Dr. Brawer opined that “physiological disruption of regulatory T cell channel
functions can occur upon exposure to chemicals present in vaccines,” including
organosiloxanes and silica. Exhibit 32 at 2. He explained that organosiloxanes are
“capable of adhering to any protein, including channel proteins, via hydrophobic
bonding, therefore inducing conformational changes that translate into altered
channel functions.” Id.
To support this theory, Dr. Brawer cited an article that describes calcium
signaling and ion channels in neutrophil function. Exhibit 32 (citing exhibit 23
(Roland Immler et al., Calcium Signalling and Related Ion Channels in Neutrophil
Recruitment and Function, 48 European J. Clinical Investigation 12964 (2018)).
Dr. Brawer did not elaborate on how this article supports his theory in his expert
report. See id. Additionally, he referenced articles discussing cardiac
channelopathies (exhibit 20), autoimmune neuromyotonia (exhibit 21), and genetic
neurological channelopathies (exhibit 22).3 To establish the applicability of this
theory to the vaccines P.M. received, Dr. Brawer relied on a list of vaccines,
including the pneumococcal and MMR vaccines, that purportedly contain toxic
chemicals that can trigger channelopathies. See exhibit 40; exhibit 35 at 2.
3
Exhibit 20 (Pietro Enea Lazzerini et al., Autoimmune Channelopathies as a
Novel Mechanism in Cardiac Arrhythmias, 14 Nature Revs. Cardiology 521
(2017)); exhibit 21 (Chiara Cerami et al., Autoimmune Neuromyotonia Following
Human Papilloma Virus Vaccination, 43 Muscle & Nerve 466 (2013)); exhibit 22
(J. Spillane et al., Genetic Neurological Channelopathies: Molecular Genetics and
Clinical Phenotypes, 87 J. Neurology, Neurosurgery & Psychiatry 37 (2016)).
9
Both Dr. Platt and Dr. Rose disputed Dr. Brawer’s theory that the vaccines
P.M. received can trigger channelopathies and cause sJIA. The experts challenged
the relevancy of the articles Dr. Brawer relied on to support this theory. Dr. Platt
claimed that the Immler article (exhibit 23) “does not show that there are
antibodies generated against neutrophil ion channels that cause an
autoinflammatory disorder such as sJIA, nor any other human disease.” Exhibit C
at 8. Dr. Platt noted that with the channelopathies discussed in exhibits 20 and 21,
such as cardiac arrhythmias and autoimmune neuromyotonia, scientists have
observed a “direct relationship between disruption of channel function and disease
pathophysiology.” Exhibit C at 8 (citing exhibit 20 at 12, exhibit 21 at 2).
However, Dr. Platt asserted, unlike with the other channelopathies, there is no
evidence in the medical literature of a direct relationship between ion channel
dysfunction and sJIA. Id. at 6.
Additionally, Dr. Rose pointed out that “nowhere in the literature has there
been . . . a claim or suggestion that sJIA has anything to do with an abnormality of
the conductivity of cells nor with the function of gated ion channels.” Exhibit E at
32. Given that Dr. Brawer only referenced medical literature discussing
channelopathies in unrelated diseases, the Secretary argued that Dr. Brawer’s
theory lacks support. Resp’t’s Br. at 25-26.
Further, the Secretary asserted that there is no credible evidence that the
pneumococcal conjugate and MMR vaccines contain the chemicals that Dr. Brawer
claims are toxic and trigger channelopathies. He argued that the list of vaccines
containing toxic chemicals that Dr. Brawer relied on “has no supporting citations”
and “cannot be verified.” Resp’t’s Br. at 25. He added, “The lack of reputable
research to support Dr. Brawer’s opinion regarding vaccine toxicity renders it of
limited value in this case, and should be afforded little evidentiary weight by this
court. Id. (citing McCabe v. Sec’y of Health & Hum. Servs., No. 13-570V, 2018
WL 3029175, at *53 (Fed. Cl. Spec. Mstr. May 17, 2018)).
Dr. Platt and Dr. Rose identified several gaps in Dr. Brawer’s
channelopathies theory. Furthermore, the references Dr. Brawer provided to show
that the MMR and pneumococcal conjugate vaccines contain toxic chemicals, such
as organosiloxanes and silica, lack credibility. Thus, Mr. Moses has failed to
establish, by preponderant evidence, that the vaccines P.M. received contain toxic
chemicals that trigger channelopathies. Therefore, Mr. Moses’s channelopathies
theory does not satisfy his burden under Althen prong one.
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3. Mitochondrial Dysfunction
Dr. Brawer also offered mitochondrial dysfunction as a potential mechanism
for causation. He opined that “vaccination induced dysfunction of [mitochondrial
membrane] ion channels can result in dysfunction and/or spillage of mitochondrial
organelles.” Exhibit 32 at 2. He explained that this process can result in chronic
autoinflammatory or autoimmune diseases. Id.To support this theory, Dr. Brawer relied on literature discussing
mitochondrial dysfunction in diseases other than sJIA. One article discusses the
role of mitochondrial dysfunction in cardiovascular, pulmonary, hepatic,
neoplastic, and neurological disorders. Exhibit 24 (Charles S. Dela Cruz & Min-
Jong Kang, Mitochondrial Dysfunction and Damage Associated Molecular
Patterns (DAMPs) in Chronic Inflammatory Diseases, 41 Mitochondrion 37
(2018)). Another article describes how channelopathies can cause mitochondrial
dysfunction and lead to inflammation in Alzheimer’s disease and osteopenia.
Exhibit 26 (Marie Strickland et al., Relationships Between Ion Channels,
Mitochondrial Functions and Inflammation in Human Aging, 10 Frontiers in
Physiology 158 (2019)) at 10. These articles lack relevance to P.M.’s case because
they involve diseases other than sJIA. Dr. Brawer also relied on an article that
concludes that environmental pollutants can cause mitochondrial dysfunction in
children. Exhibit 25 (Robert K. Naviaux, Cell Danger Response Biology—The
New Science that Connects Environmental Health with Mitochondria and the
Rising Tide of Chronic Illness, 51 Mitochondrion 40 (2020). However, the
Naviaux article does not posit that vaccines are a trigger for mitochondrial
dysfunction.
Additionally, Dr. Brawer offered one of his own case reports involving
patients who developed rheumatoid arthritis or systemic lupus erythematosus after
receiving the flu vaccine. Exhibit 27 (Arthur E. Brawer & Sai Koyoda, The Onset
of Rheumatoid Arthritis and Systemic Lupus Erythematosus Following Influenza
Vaccination: Report of Three Cases, 4 Clinical Microbiology & Infectious
Diseases 1 (2019)). This case report does not involve the MMR, pneumococcal
conjugate, or varicella vaccines; instead, it only reports cases involving the
influenza vaccine. See id. Additionally, it focuses on rheumatoid arthritis and
systemic lupus erythematosus, both autoimmune diseases. Id. As discussed above,
sJIA is an autoinflammatory disease. Therefore, this case report has little value in
supporting Dr. Brawer’s theory regarding mitochondrial dysfunction. Overall, Dr.
Brawer was unable to offer any medical literature to support his theory regarding
mitochondrial dysfunction. Although literature is not required, Althen, 418 F.3d at
11
1274, “a scientific theory that lacks any empirical support will have limited
persuasive force.” Caves v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 119, 134
(2011), aff’d without opinion, 463 F. App’x 932 (Fed. Cir. 2012).
In sum, Dr. Brawer’s opinions regarding the means by which the MMR,
pneumococcal conjugate, and varicella vaccines can cause sJIA are not persuasive.
Dr. Platt and Dr. Rose identified several flaws and gaps in Dr. Brawer’s theories.
Therefore, Mr. Moses has not met his burden of proof on Althen prong one.
B. Althen Prong 3: A Showing of a Proximate Temporal
Relationship Between Vaccination and P.M.’s Injury
The resolution of the timing prong affects Althen prong two. See Capizzano
v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). Thus,
this prong is addressed before an evaluation of the logical sequence of cause and
effect.
The third Althen prong requires the petitioner to show a “proximate
temporal relationship” between the vaccination and the alleged injury. Althen, 418
F.3d at 1281. The timing prong of Althen actually contains two parts. A petitioner
must show the “timeframe for which it is medically acceptable to infer causation”
and 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). An appropriate temporal interval must align with what is known about
the disease’s etiology. Veryzer v. Sec’y of Health & Hum. Servs., 100 Fed. Cl.
344, 356 (2011); Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352
(2008); see also Shapiro v. Sec’y of Health & Hum. Servs., No. 99-552V, 2012
WL 273686, at *11 (Fed. Cl. Spec. Mstr. Jan. 10 2012) (finding that a petitioner’s
onset of autoimmune thyroid disease occurred too rapidly because the etiology of
the disorder “is such that a relatively long interval between vaccination and the
onset of symptoms would be expected”), mot. for rev. denied, 105 Fed. Cl. 353(2012), aff’d, 503 Fed. App’x 952 (2013).
Mr. Moses argued that 1-28 days is a medically acceptable timeframe for
onset of sJIA following vaccination. Pet’r’s Br., filed Sept. 20, 2021, at 11. In his
supplemental report, Dr. Brawer used the appropriate timeframe for onset of
rheumatoid arthritis to support this assertion. See exhibit 32 at 2-4. Dr. Brawer
claimed that the onset of vaccine-induced rheumatoid arthritis is “highly variable,”
but offered a range of 1-28 days. Id. at 2. Dr. Brawer discussed examples of
12
rheumatoid arthritis developing within 24 hours after a triggering event. Id. at 3.
He also asserted that P.M.’s onset of sJIA occurred within two weeks of
vaccination. Id. at 4 (citing exhibit 2 at 25).
The parties do not dispute that the onset of P.M.’s symptoms began within
two weeks after receiving the vaccinations. Instead, the Secretary’s experts argued
that two weeks is not a medically acceptable timeframe to infer vaccine-causation.
Both Dr. Platt and Dr. Rose cautioned against analogizing rheumatoid arthritis,
which is an autoimmune disease, to sJIA, which is an autoinflammatory disease.
See exhibit C at 9; exhibit E at 35. Further, Dr. Platt claimed that the anecdotes
Dr. Brawer referenced describing patients experiencing an onset of rheumatoid
arthritis within 24 hours following an adverse event are irrelevant to this case
because P.M.’s onset occurred two weeks following vaccination. See exhibit C at
9.
Dr. Platt and Dr. Rose agreed that sJIA is an autoinflammatory condition
caused by activation of the innate immune system. Id.; exhibit E at 40. Therefore,
Dr. Platt opined, “An overactive innate immune response to the vaccine[s] would
require a much shorter timeframe to trigger an autoinflammatory disease.” Exhibit
C at 9. Similarly, Dr. Rose asserted that onset of sJIA two weeks after vaccination
is “way too long” for activation of the innate immune system. See exhibit E at 29-
30, 40. Dr. Rose noted that if the vaccines were the cause, “P.M. would have
shown fever, rash, or some degree of irritability, even if not the full-blown
syndrome, within 24-48 hours” following vaccination. Id. at 30. Dr. Rose also
discussed pathogen associated molecular patterns (“PAMPS”) and damage
associated molecular patterns (“DAMPs”), alarm signals that trigger an innate
immune response. Id. at 25.
In response, Dr. Brawer argued that P.M.’s onset of sJIA did not occur until
two weeks after vaccination because “the abnormal reactivity of [P.M.’s] innate
immune system was not caused by PAMPs (pathogen associated molecular
patterns), but was . . . triggered by DAMPS (damage associated molecular
patterns).” Exhibit 38 at 1. He further explained that “several weeks can elapse
before vaccination induced mitochondrial dysfunction can precipitate the onset of
an autoinflammatory disease process.” Id. at 2. He asserted that it is possible for
weeks to pass “until the innate immune system encounters an ‘alarm molecule.’”
Id.Dr. Rose responded that Dr. Brawer “provides no justification for why a
two-week interval between vaccination and onset of sJIA is expected when
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DAMPs are activated, as opposed to PAMPs.” Exhibit F at 3. Dr. Rose stated that
he has “never come across a distinction between DAMPs and PAMPs with respect
to their relationship with sJIA onset.” Id. Dr. Platt also noted that in Dr. Rose’s
initial report, he “specifically noted that both PAMPs and DAMPs are involved in
rapid initiation of the innate [immune] response,” which Dr. Brawer did not
address. Exhibit G at 2 (citing exhibit E at 25-26). Given Dr. Rose’s expertise in
children’s rheumatic diseases and experience treating patients with sJIA, his
opinion on this point is persuasive. See exhibit B (Dr. Rose’s CV); exhibit E at 1-4
(describing Dr. Rose’s qualifications); see also McCabe, 2018 WL 3029175, at *55
(finding that a theory lacked credibility when it was “not even on the radar of those
who specialize in the field”). 4
Dr. Brawer’s attempt to analogize rheumatoid arthritis to sJIA with respect
to an appropriate timeframe is not persuasive. As discussed above, sJIA is an
autoinflammatory disease with a different pathogenesis from rheumatoid arthritis.
Dr. Platt and Dr. Rose convincingly explained that given that sJIA is caused by an
innate immune response, the onset of vaccine-induced sJIA would occur much
more rapidly than two weeks following vaccination. Furthermore, Dr. Brawer
failed to provide credible support for his contention that P.M.’s onset two weeks
after vaccination was due to the involvement of DAMPs. Therefore, Mr. Moses
has not met his burden of proof regarding the third Althen prong.
C. Althen Prong 2: A Logical Sequence of Cause and Effect
The second Althen prong requires a petitioner to show a logical sequence of
cause and effect usually supported by the medical records. Althen, 418 F.3d at
1278; Capizzano, 440 F.3d at 1326.
Here, the logical sequence of cause and effect put forth by Mr. Moses lacks
persuasiveness. Dr. Brawer asserted that P.M.’s sJIA was a “direct consequence”
of the MMR, pneumococcal conjugate, and varicella vaccines because “P.M. did
not suffer from any systemic inflammatory arthritis condition” before receiving the
vaccinations, and other diagnoses were ultimately “discarded.” Exhibit 19 at 2. In
his second report, he elaborated that P.M.’s vaccines were a “direct cause” of his
condition because “[a]ll other potential causes, including infections” were ruled
out. Exhibit 32 at 4.
4
Dr. Brawer has treated over 150 patients with juvenile arthritis over the
course of his 44-year career. Exhibit 32 at 1. He did not state how many of those
patients had sJIA.
14
In response, Dr. Platt asserted that Dr. Brawer’s opinion assumes that sJIA
has an “identifiable trigger.” Exhibit C at 6. However, Dr. Platt explained that
“there is no single precipitating cause that has been identified in research regarding
sJIA.” Id. He relied on the Lin article, which states, “Not one single triggering
factor is responsible for the onset or exacerbation of JIA.” Id. (citing exhibit C, tab
3 (Lin)). Dr. Platt also noted that “it is impossible to know that P.M. indeed did
not have a viral or bacterial infection in the weeks prior to his disease onset.” Id.Therefore, Dr. Platt concluded that the lack of another identified cause or
triggering event does not establish a logical sequence of cause and effect
connecting the vaccines to P.M.’s condition. See id.Additionally, Dr. Platt asserted that P.M.’s robust response to anakinra is
inconsistent with Dr. Brawer’s causal theory that P.M.’s vaccines created cross-
reacting autoantibodies. See exhibit C at 7-8. He explained that unlike
medications used to treat autoantibody-driven diseases, “anakinra blocks IL-1, a
cytokine that drives an innate immune response.” Id. at 8. Dr. Platt noted that
P.M. was not prescribed therapies used to treat autoantibody-driven diseases, such
as rituximab or plasma exchange. Id. Dr. Rose agreed with Dr. Platt that because
P.M. responded “fully” to anakinra, this is more consistent with the
autoinflammatory etiology of sJIA, rather than an autoantibody-driven disorder.
See exhibit E at 25.
Dr. Rose also pointed out that the timing of P.M.’s onset is inconsistent with
Dr. Brawer’s assertion that P.M.’s condition was a direct consequence of the
vaccines. Exhibit E at 30-31. Dr. Rose noted that the medical records do not show
that P.M. developed a fever, joint pain, irritability, or rash until two weeks post-
vaccination. Id. at 31. Dr. Rose opined that if the vaccines were the cause of
P.M.’s condition, he would have developed symptoms within 24-48 hours after
vaccination. As discussed in section III.B, the timeframe in which P.M. developed
symptoms of sJIA does not align with the etiology of the disease. Dr. Platt and Dr.
Rose persuasively identified gaps in Dr. Brawer’s theory that cast doubt on the
logical sequence of cause and effect.
With respect to the second prong, the Federal Circuit has instructed special
masters to carefully consider the views of treating doctors. Capizzano, 440 F.3d at
1326. Mr. Moses finds some support from P.M.’s treating physician, Dr. Chusid.
Mr. Moses asserted that Dr. Chusid “strongly suspected that the vaccines caused
P.M.’s condition.” Id. He cited Dr. Chusid’s record from July 17, 2016, in which
Dr. Chusid wrote that P.M.’s fevers “started on 6/18/16 approximately 10 days
15
after receipt of [the] MMR vaccination . . . . Prior to that he had always been
well . . . .” Id. (citing exhibit 5 at 237). Dr Chusid stated that he “[s]trongly
suspect[ed] MMR was [the] trigger for onset of [P.M.’s] current inflammatory
reaction given [the] temporal association.” Exhibit 5 at 239. Dr. Chusid also
recommended that P.M.’s primary care provider submit a VAERS report “for
consideration of compensation for potential vaccine-mediated damage.” Id. at 240.
Dr. Chusid’s statement associating the MMR vaccine with P.M.’s sJIA is
entitled to consideration; however, it is outweighed by contrary opinions from
P.M.’s other treating doctors. See Myers v. Sec’y of Health & Hum. Servs., 13-
885V, 2016 WL 7665435, at *7 (Fed. Cl. Spec. Mstr. Nov. 17, 2016) (“The views
of treating physicians should also be weighed against other, contrary evidence also
present in the record—including conflicting opinions among such individuals.”).
Dr. Kormanik, P.M.’s pediatrician, and Dr. Nocton, P.M.’s rheumatologist,
indicated that the vaccines were not the cause of P.M.’s condition. See exhibit 47
at 35 (Dr. Kormanik refusing to sign a school waiver excusing P.M. from receiving
the MMR vaccine because there was “no medical evidence to link” the MMR
vaccine and P.M.’s sJIA); id. at 40 (nurse’s note indicating that both Dr. Kormanik
and Dr. Nocton recommended P.M. receive the MMR booster vaccine); id. at 20(Dr. Gaethke’s note indicating that Dr. Nocton did not believe the vaccines were
the cause of P.M.’s sJIA); exhibit 15 at 131 and exhibit 16 at 163 (Dr. Nocton’s
recommendations that P.M. discontinue anakinra so that he could receive the
MMR vaccine). Dr. Rose also noted that if Dr. Nocton believed that the vaccines
were the cause of P.M.’s condition, he would not have advised P.M. to receive the
MMR vaccination in 2019. Exhibit E at 31.
Although Dr. Chusid suspected that the MMR vaccine was the cause of
P.M.’s condition, statements of a treating physician do not bind a special master to
adopt his conclusions. Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706,
746 n.67 (2009). Furthermore, the value of Dr. Chusid’s statement is undermined
by conflicting statements from P.M.’s other treating physicians concluding that the
MMR vaccine was not the cause of his sJIA. See K.T. v. Sec’y of Health & Hum.
Servs., 132 Fed. Cl. 175, 187 (2017) (one treating doctor’s recommendation to
avoid future vaccinations was counterbalanced by the opinion of another treating
doctor); Hopkins v. Sec’y of Health & Hum. Servs., 62 Fed. Cl. 333, 335 (2004)
(special master may reject the opinions from treating doctors favoring vaccine-
causation when other treating doctors did not favor vaccine-causation). Therefore,
Mr. Moses has not presented a logical sequence of cause and effect connecting
P.M.’s vaccines to his sJIA.
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Special masters have reached different conclusions in cases involving sJIA
and JIA. Compare Jimenez v. Sec’y of Health & Hum. Servs., No. 17-1190V,
2021 WL 3179643, at *22-23, 26 (Fed. Cl. Spec. Mstr. June 23, 2021) (finding that
cytokines from the hepatitis A and human papillomavirus vaccines can cause sJIA
and accepting a one-week post-vaccination onset), and Cabrera v. Sec’y of Health
& Hum. Servs., No. 13-598V, 2017 WL 510466, at *16 (Fed. Cl. Spec. Mstr.
(crediting molecular mimicry as a theory by which the DTaP vaccine can cause
JIA, an autoimmune disease, and recognizing a three-week post-vaccination onset
as medically acceptable), with Koehn v. Sec’y of Health & Hum. Servs., No. 11-
355V, 2013 WL 3214877, at *28 (Fed. Cl. Spec. Mstr. May 30, 2013) (rejecting
the proposed temporal interval for a cytokine-mediated theory when the onset of
sJIA occurred seven months following the human papillomavirus vaccine), mot.
for rev. denied, 113 Fed. Cl. 757 (2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014), and
Putman v. Sec’y of Health & Hum. Servs., No. 19-1921V, 2022 WL 600417, at
*21-23 (Fed. Cl. Spec. Mstr. Jan. 31, 2022) (finding that the petitioner failed to
establish that the MMR vaccine can cause JIA).
These cases do not weigh heavily in the analysis for three reasons. First,
despite an instruction for the parties to cite any similar cases, Order, issued June
22, 2021, at 7, the parties did not discuss any similar cases in their briefs.
Therefore, any arguments based on analogous cases appears to have been waived.
Vaccine Rule 8(f)(1). Second, decisions of other special masters are nonbinding.
Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1358 (Fed. Cir.
2019). Third, the differences in outcome in these cases may primarily derive from
disparities in evidence. See Lampe v. Sec'y of Health & Human Servs., 219 F.3d
1357, 1368 (Fed. Cir. 2000) (recognizing that special masters may weigh evidence
differently). As explained above, the evidence in this case is insufficient to
establish, more likely than not, that P.M.’s vaccinations caused his sJIA.
V. A Hearing Is Not Required
Special masters possess discretion to decide whether an evidentiary hearing
will be held. 42 U.S.C. § 300aa-12(d)(3)(B)(v) (promulgated as Vaccine Rule 8(c)
& (d)), which was cited by the Federal Circuit in Kreizenbeck v. Sec’y of Health &
Hum. Servs., 945 F.3d 1362, 1365 (Fed. Cir. 2018).
Mr. Moses has enjoyed a fair and full opportunity to present his case. After
Dr. Brawer presented his initial opinions, Dr. Platt and Dr. Rose critiqued them,
persuasively pointing out gaps and flaws in Dr. Brawer’s reports. Mr. Moses then
presented a rebuttal opinion from Dr. Brawer, which Dr. Platt and Dr. Rose again
17
critiqued. Mr. Moses had the opportunity to address the gaps in Dr. Brawer’s
opinion during the briefing process, but he devoted only three pages to the Althen
analysis. See Pet’r’s Br. at 9-11. In contrast, the Secretary spent approximately 17
pages pointing out faults in Mr. Moses’s arguments on all three Althen prongs.
See Resp’t’s Br. at 20-36. Mr. Moses’s two-page reply requested a hearing but did
not sufficiently address any of the Secretary’s criticisms. See Pet’r’s Reply, filed
Jan. 3, 2022, at 1-2. Therefore, Mr. Moses’s efforts to repair any deficiencies
during the briefing process were not persuasive.
Mr. Moses was unable to offer a reliable theory by which the MMR,
pneumococcal conjugate, or varicella vaccines can cause sJIA. Additionally, Mr.
Moses’s logical sequence of cause and effect lacked persuasiveness. Finally, the
two-week time interval for P.M.’s onset of sJIA did not fit with innate immune-
mediated nature of the condition. Therefore, a hearing would not resolve the
problems in Mr. Moses’s case.
VI. Conclusion
Mr. Moses has not met his burden of demonstrating that the MMR,
pneumococcal conjugate, or varicella vaccines were the cause-in-fact of P.M.’s
sJIA. Accordingly, the Clerk’s Office is instructed to enter judgment in accord
with this decision unless a motion for review is filed. Information about filing a
motion for review, including the deadline, can be found in the Vaccine Rules,
available through the Court’s website.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
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