Court Opinion

ID: 4442752
Source: CourtListenerOpinion
Date Created: 2019-09-30 16:02:15.873718+00
Date Added: 2024-06-11T14:23:17.809028
License: Public Domain

In the United States Court of Federal Claims
                         OFFICE OF SPECIAL MASTERS

*********************
BRYAN QUINONES and                   *
DONNA QUINONES,                      *
as parents and legal representatives *       No. 11-154V
of their minor daughter, Y.Q.,       *       Special Master Christian J. Moran
                                     *
                   Petitioners,      *
                                     *
v.                                   *       Filed: September 4, 2019
                                     *
SECRETARY OF HEALTH                  *       Entitlement; measles, mumps, rubella
AND HUMAN SERVICES,                  *       (“MMR”) vaccine; febrile seizures;
                                     *       sequela
                   Respondent.       *
*********************
Ramon Rodriguez, III, Sands Anderson PC, Richmond, VA, for Petitioners;
Christine M. Becer, United States Dep’t of Justice, Washington, DC, for
Respondent.

                   PUBLISHED RULING ON ENTITLEMENT1

       Bryan and Donna Quinones filed a petition on behalf of their minor child,
Y.Q., under the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa–10
through 34 (2012). The Quinoneses allege that Y.Q. suffered from a seizure
disorder, sensory integration disorder, and behavioral changes after receiving a
measles, mumps, and rubella (“MMR”) vaccine on March 28, 2008. Pet., filed
Mar. 11, 2011, at 1, 7. Following an entitlement hearing split between January 26,
2017, and November 29, 2017, the undersigned finds that the Quinoneses are
entitled to compensation on their claim.

       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 ruling on its
website (https://www.uscfc.uscourts.gov/aggregator/sources/7). 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.
                   Procedural History, including Expert Qualifications

      This case’s progression in litigation followed a relatively routine path,
although the process took longer than usual. The Quinoneses filed their petition on
March 11, 2011. Within approximately six weeks, they filed medical records and a
statement of completion.
      The Secretary assessed those records in her report, filed pursuant to Vaccine
Rule 4, on June 24, 2011. The Secretary asserted that Y.Q. was not entitled to
compensation. The Secretary challenged the reliability of the opinions of two
people who treated Y.Q. and linked her problems to the MMR vaccination, Dr.
Palevsky and Mr. Sherr, a chiropractor.2 Instead, the Secretary urged that greater
weight be given to the opinions of other treating doctors, such as Dr. Bello-
Espinosa (a neurologist), who refrained from connecting the MMR vaccination to
Y.Q.’s problems. Resp’t’s Rep. at 17-19.

       After a status conference was held to discuss the Secretary’s report, the
petitioners were ordered to obtain a report from an expert by September 26, 2011.
This deadline was extended several times.
       The petitioners filed a report from Yuval Shafrir, a pediatric neurologist, on
September 12, 2012. Dr. Shafrir graduated from medical school in Israel. After
this graduation, he participated in various residencies and fellowships devoted to
either pediatrics or neurology. Exhibit 22 (curriculum vitae) at 1. He has received
board-certification in three disciplines: pediatrics, neurology and psychiatry with
special qualification in child neurology, and clinical neurophysiology. Id. at 2.

       He taught neurology and pediatrics at various institutions since 1988. He
currently teaches residents and medical students at Sinai Hospital Department of
Pediatrics and acts as an assistant professor of neurology and pediatrics at the
University of Maryland. Exhibit 22 at 3. His other employment is working in
private practice in Baltimore, Maryland. Id. at 3. Dr. Shafrir is a member of the
American Epilepsy Society.

     Dr. Shafrir’s curriculum vitae lists 10 articles that Dr. Shafrir has written.
The most recent of these articles was published in 1998. More recently, Dr. Shafrir
has made presentations at conferences and on invited grand rounds. Exhibit 22 at
6-7.

        2
            To distinguish chiropractors from medical doctors, this decision refers to Alan Sherr as
“Mr.”
                                                   2
       In his report, Dr. Shafrir reviewed Y.Q.’s extensive medical history. Exhibit
21 at 1-18. He recognized that by August 2012, when he was writing his report,
Y.Q.’s seizures were controlled but those seizures left her with “significant
residual problems,” notably neurobehavioral issues. Id. at 23.

       Dr. Shafrir opined that the MMR vaccination, which Y.Q. received four days
before her first seizure, caused the seizure.3 He stated that various pieces of
medical literature show that the MMR vaccine can cause adverse reactions within
five days. He further opined that Y.Q. suffered an immune-related disorder, like
acute disseminated encephalomyelitis (ADEM). Exhibit 21 at 21-24.

       Following the filing of Dr. Shafrir’s report, the parties attempted to resolve
the case based upon the costs and risks of continued litigation. These efforts,
however, did not succeed.
       The Secretary answered Dr. Shafrir’s report by filing a report from Gregory
Holmes, also a pediatric neurologist. Dr. Holmes graduated from medical school
in Virginia. He had an internship and residency in pediatrics at Yale University.
He also had a residency in neurology at the University of Virginia. Exhibit B
(curriculum vitae) at 1. He has received board certification in the same three
disciplines as Dr. Shafrir: pediatrics, neurology and psychiatry with special
qualification in child neurology, and clinical neurophysiology. Id. at 2.

       Like Dr. Shafrir, Dr. Holmes has held various teaching positions at various
institutions. Since 2002, he has been a professor of neurology and pediatrics at
Dartmouth Medical School. He has been serving, since 2009, as the inaugural
chair of the Department of Neurology at Dartmouth-Hitchcock Medical Center.
Exhibit B at 2.
       For more than 30 years, various institutions, including the National Institutes
of Health, has funded Dr. Holmes’s research. Much of Dr. Holmes’s research has
focused on seizures and epilepsy. Exhibit B at 4-5. He has served on editorial
boards of academic journals devoted to neurology, generally, and epilepsy,
specifically. Exhibit B at 6.

       3
         Dr. Shafrir acknowledged that because the onset of Y.Q.’s encephalopathy was four
days after the MMR vaccination, she did not satisfy the criteria for a Table case because the
Table associates the measles vaccine with an encephalopathy that develops 5-15 days after
vaccination. Exhibit 21 at 20; see also 42 C.F.R. § 100.3(a) ¶ (III)(B).
                                                3
      He belongs to several professional organizations, including the American
Epilepsy Society. Exhibit B at 11. In 2005, 2006, and 2007, he served as the
president elect, president, and past president of that group. Id. at 12.

      The list of “named lectureships,” and “invited lectures” runs more than a
dozen single-spaced pages. The titles relate to epilepsy and seizures. Exhibit B at
14-30. He has also made presentations at conferences of leading professional
organizations, including the American Academy of Clinical Neurophysiology,
American Academy of Neurology, American Academy of Pediatrics, American
EEG Society, American Epilepsy Society, Child Neurology Society, and the
Epilepsy Foundation of America. Id. at 30-36.

      His curriculum vitae lists more than 250 articles on which Dr. Holmes was
an author or co-author. He is author or co-author on another 100 review articles.
There are also more than 350 abstracts.

       For his work in this case, Dr. Holmes’s report also begins with a review of
Y.Q.’s medical history. Exhibit A at 1-5. Dr. Holmes, then, challenged various
aspects of Dr. Shafrir’s opinion. Dr. Holmes stated that “there is no clinical or
laboratory evidence to support the diagnosis of ADEM.” Id. at 6. He asserted that
“Dr. Shafrir does not specify the immune mechanisms that is the basis of [Y.Q.’s]
vaccine-related injury. While Dr. Shafrir ‘suspects that an immune mechanism is
at the basis of [Y.Q.’s] vaccine related injury’ a plausible mechanism of such
process is not provided.” Id. Finally, he asserted that the interval between
vaccination and onset of seizures was too quick for the vaccination to have caused
the seizures. Id.

        The petitioners obtained a supplemental report from Dr. Shafrir. Dr. Shafrir
agreed with Dr. Holmes that Y.Q. “did not have a typical presentation of acute
severe ADEM at any point in her course.” Exhibit 40 at 1. Dr. Shafrir also agreed
with Dr. Holmes that he (Dr. Shafrir) had “not provided the exact immune
mechanism which is the basis of [Y.Q.’s] vaccine related injury . . . . The reason
for this omission is simply because an exact immune mechanism is not known.
[H]owever there are plausible theories which are widely accepted by the court.”
Id. at 2. Dr. Shafrir’s February 2, 2014 report created gaps in his opinion that the
petitioners were directed to fill. Order, filed Apr. 2, 2014.

       Dr. Shafrir’s May 23, 2014 report disclosed opinions that advanced the
petitioners’ claim. With respect to diagnosis, Dr. Shafrir opined that Y.Q. “has
chronic autoimmune encephalopathy.” Exhibit 44 at 1. For the mechanism by
which the MMR vaccine can cause chronic autoimmune encephalopathy, Dr.

                                         4
Shafrir reviewed several medical articles. Dr. Shafrir’s summary included three
“non-mutually exclusive mechanisms:” “molecular mimicry,” “bystander
activation,” and “epitope spreading.” Id. at 2-3. Dr. Shafrir also presented his
opinion regarding timing. He proposed that reactions to MMR vaccination can
occur in less than five days. He also stated that any irritability that Y.Q. may have
developed in the one or two days immediately following vaccination was not
relevant to the question of causality. Id. at 5-6.
      Dr. Holmes’s next report responded to Dr. Shafrir’s previous two reports.
On the question of diagnosis, Dr. Holmes asserted “There is no supporting
evidence to indicate that [Y.Q.] had a chronic autoimmune encephalopathy.”
Exhibit O at 4. For the theory, Dr. Holmes maintained that “molecular mimicry,
bystander activation, and epitope . . . spread as a pathological phenomenon
following vaccination remain unproven.” Id. He also argued that even if these
processes could cause an adverse reaction, the amount of time required for them
would exceed four days. Id. at 4-5.

       The question of a four-day latency appeared again in Dr. Shafrir’s
September 2, 2014 report. Exhibit 64. He also reasserted that Y.Q. “had chronic
autoimmune encephalopathy” and much of this report was devoted to a discussion
of autoimmune encephalopathy / autoimmune encephalitis. Id. at 4-10.

       When the petitioners filed Dr. Shafrir’s September 2, 2014 report, the
existing schedule called for a series of submissions leading to a hearing on January
14, 2015. Order, filed June 24, 2014. One step was for the petitioners to submit
updated medical records. Order, filed Sept. 24, 2014, at 1-2. However, petitioners
inadvertently overlooked this obligation. Due to the lack of updated information,
the petitioners proposed to reschedule the hearing. See Pet’rs’ Mot. to Continue,
filed Nov. 14, 2014.

      Petitioners began to obtain updated medical records. Because some
providers failed to cooperate, the petitioners were forced to resort to a subpoena to
obtain the necessary information. This process of updating medical records
concluded in June 2015.

       With additional information about Y.Q. in hand, the parties returned to their
respective experts. Dr. Shafrir summarized the newly obtained records. Exhibits
90 at 1-11. To Dr. Shafrir, “The additional medical records do not relate to the
question of causality in this relationship between MMR vaccination and [Y.Q.’s]
encephalopathy. However, they establish the severity and extent of her chronic
encephalopathy.” Id. at 12. Dr. Holmes agreed. Exhibit P at 1.

                                          5
      Dr. Shafrir offered an opinion that an appearance of severe behavioral
changes after seizures is “highly suggestive of autoimmune encephalopathy” in
Y.Q. Exhibit 90 at 11. However, the nature of Y.Q.’s illness remained a point of
disagreement between the experts. Dr. Holmes commented: “there is no
radiological (MRI and CT scans), cerebral spinal fluid assessment, EEG or clinical
findings supporting the diagnosis of autoimmune encephalopathy.” Exhibit P at 1.

       In February 2016, the parties anticipated that a mutually convenient time for
a hearing would be in August 2016. The petitioners requested that the hearing be
held in Long Island, New York, near their residence. See Order, filed Feb. 26,
2016.

       On May 16, 2016, the petitioners filed the final pre-trial expert report. Dr.
Shafrir maintained his position that autoimmune encephalopathy, which he
described as a “new and exciting development in child neurology,” fit Y.Q.’s
clinical presentation. Exhibit 98 at 1. He also defended his assertion that MMR
can cause autoimmune encephalopathy and that it did so in this rare case.

      In anticipation of the scheduled August 4, 2016 hearing, the parties
submitted briefs. The petitioners filed theirs on June 6, 2016, and the Secretary
responded on June 27, 2016.

      The August 4, 2016 hearing did not proceed as scheduled due to an
unforeseen circumstance with the petitioners’ attorney. Order, filed July 15, 2016.
Thus, the hearing was rescheduled for January 26, 2017. Order, filed Aug. 9,
2016. Due to budgetary restrictions, the hearing could not be held on Long Island,
New York. Instead, it was conducted in Washington, DC.

       During the January 26, 2017 hearing, the Quinoneses’ testimony revealed
that other sources of information about Y.Q. had not been submitted into evidence.
Following the first session of the hearing, the Quinoneses were ordered to submit
the additional information, and the Secretary was ordered to file a response to the
questions in the January 24, 2017 order regarding the amount of time for which an
inference of causation was appropriate after a MMR vaccine and before the onset
of febrile seizures. Order, issued Feb. 2, 2017.
       The Secretary filed a response from Dr. Holmes (exhibit CCC) and a status
conference was held on February 28, 2017 to discuss the response. Whether Dr.
Holmes was setting forth his position or the Secretary’s position was unclear. The
Secretary was ordered to determine who would establish HHS’s position on timing
to discuss at a forthcoming status conference. Order, issued Feb. 28, 2017.

                                          6
      At a status conference on March 28, 2017, the Secretary confirmed that Dr.
Holmes represented the Secretary’s position on timing in this case. The
Quinoneses continued their efforts to gather and to submit additional information
about Y.Q. Order, issued Mar. 29, 2017.

       After a status conference on May 9, 2017, the undersigned provided detailed
instructions for the experts to address the sequencing of Y.Q.’s seizures and
epidemiology. A supplemental expert report schedule was set and planning for a
continuation of the entitlement hearing was begun. Order, issued May 10, 2017.
The Quinoneses filed a supplemental report from Dr. Shafrir (exhibit 123), and the
Secretary filed a supplemental report from Dr. Holmes (exhibit DDD).

       The entitlement hearing continued and concluded on November 29, 2017.
After the hearing, the parties were given the option of pursuing settlement or filing
post-hearing briefs. Order, issued Jan. 19, 2018. The parties considered settlement
but ultimately decided to proceed with filing post-hearing briefs. Pet’rs’ Stat.
Rep., filed Feb. 15, 2018.

       While the due dates for the post-hearing briefs were pending, the case was
referred to another special master for alternative dispute resolution. Order, issued,
May 16, 2018. During the ADR process, the Quinoneses filed their post-hearing
brief on July 23, 2018, and the Secretary filed his brief on September 10, 2018.
The case was eventually removed from the ADR process. Order, issued, Nov. 28,
2018. The Quinoneses filed their reply brief on January 11, 2019.
       On June 28, 2019, a status conference was held to discuss next steps. The
undersigned advised the parties that he was preliminarily ruling in favor of the
Quinoneses on entitlement. The parties were ordered to begin their preparations
for the damages phase of the case. Order, issued July 1, 2019. Further to that
order, the undersigned now issues this final ruling in favor of the Quinoneses on
entitlement.
                                        Facts

       Y.Q. was born in December 2006. Exhibit 2 at 1. Ms. Quinones described
her pregnancy and Y.Q.’s delivery as normal. Tr. 24-25. In her first year of life,
Y.Q. was brought to her pediatrician at Kids Care Pediatrics for relatively routine
illnesses. See Tr. 25-26. She periodically received vaccinations. See exhibit 8 at
55. According to Dr. Shafrir, she did not produce the expected levels of antibodies
in response to the polio and diphtheria-tetanus-pertussis vaccine. Tr. 128-29, 291.

                                          7
      On March 28, 2008, Y.Q. went to Kids Care Pediatrics for a well-baby visit.
She was healthy. Tr. 27, 96. During this appointment, she received the MMR
vaccine. Exhibit 6 at 10.

      According to affidavits from Y.Q.’s parents, in the first two days after
vaccination, Y.Q. started to run a fever. In addition, her parents noted that her eyes
were glassy. Exhibit 1 at 2; exhibit 2 at 1; Tr. 27-28, 108. Dr. Shafrir stated that
behavioral changes, such as irritability, the day after a vaccination are “very
common” and are not necessarily related to an immune reaction. Tr. 353, 362.

       A.     First Seizure and Follow-up: April 1, 2008 through May 3, 2008

       In the early evening of April 1, 2008, Y.Q. was brought to the Emergency
Department of Stony Brook University Medical Center. Her parents informed
medical personnel that Y.Q. “had vaccinations on Friday, started crankiness
Sunday, fever today Tmax 103.9, gave Tylenol and repeat Temp 102 at 3:40 PM.”
Exhibit 9 at 6. “At ~ 7 pm, baby fell over and shaking[,] turned blue in face[,]
lasted reportedly ~ 4-5 min, called 911.” Id.; accord at 30-31. The report also
indicates no vomiting, no diarrhea, and no symptoms of an upper respiratory
infection. Exhibit 9 at 6.

        The doctors ordered various laboratory tests. Exhibit 9 at 13-16. A note
written at 1:30 AM early in the morning of April 2, 2008 reads, Y.Q. “remains
alert, playful [with] parents.” Exhibit 9 at 7. At approximately 4:00 AM, Y.Q.
was discharged home with a diagnosis of “febrile seizures.” Id. at 7, 12; accord Tr.
31.4 In agreement with this diagnosis, Dr. Holmes testified that the evidence did
not show Y.Q. had any “encephalopathic process” at that point. Tr. 379.

       Consistent with the instructions given upon discharge from the emergency
room, Y.Q. was brought to Kids Care Pediatrics on April 2, 2008. There are two
records from this date. On one record, the chief complaint is “seen at VASB ER
for febrile [seizure].” The line for “neuro” on this form is blank. The doctor’s
assessment was “1st febrile sz.” The plan was to give Tylenol and Motrin. Exhibit
6 at 10; see also Tr. 32.

       For April 2, 2008, there is a second record in the files from Kids Care
Pediatrics. In this record, the chief complaint is “cranky, different behavior,
afebrile.” For “neuro,” the doctor stated “cranky, [normal] exam.” The
assessment was “s/p febrile sz.” The plan was “observation” with follow-up as
       4
         Mr. Quinones testified that the ER doctor associated the MMR vaccine with the fever.
Tr. 100, 109, 120. However, this association does not appear in the written records.
                                               8
needed. Exhibit 6 at 11. Dr. Holmes concurred that Y.Q. was neurologically
normal. Tr. 379-80.
       Although the pediatrician did not provide any details about how Y.Q.’s
behavior was different, Ms. Quinones attempted to present a more complete
picture. She testified:
               [Y.Q.] was 15 months at the time, so that’s when the
               aggression had started, and indecisiveness, she couldn’t
               make up her mind, she was tactile defensive, the sensory
               integration disorder, the look in her eyes, everything
               about her was different. She lost her vocabulary. She
               lost her eye contact, how to communicate with me. She
               would grunt and point and drool like she was severely
               disabled.

Tr. 53. Based on Ms. Quinones’s descriptions and the medical records, Dr. Shafrir
opined that Y.Q.’s behavioral changes after the vaccination and the changes after
the seizure are separate behavioral changes based on different biological
mechanisms. Tr. 354-55.

      The next appointment occurred the following day, April 3, 2008. The chief
complaint was “seen again, alert cooperative [no acute distress].” For “neuro,” the
doctor has written: “alert, gait standing tone & strength [normal].” He has noted a
“[deep tendon reflex] 1+ [illegible] [extraocular movements] [illegible] [pupils
equal and reactive to light and accommodation] for [illegible].”5 The diagnosis
was “status post simple febrile seizure. Neuro intact.” The plan for follow-up
remained “observation.” Exhibit 6 at 12. Dr. Shafrir recognized that because
Y.Q.’s gait was normal, she was not suffering from cerebral ataxia. Tr. 238.

      The final record on this page from Kids Care Pediatrics is the note of a
phone call that is undated.6 The note states “at Father’s request, spoke to Dr.
Carlos Cuello in St. Petersburg Florida & gave him the above written information.”
Exhibit 6 at 11; accord Tr. 101-02.

       5
         The experts provided some assistance with the poor handwriting in these records, but
they could not decipher everything that was written. Tr. 60, 65, 229-30, 495-99.
       6
         Given the context of other records, it appears that this phone call took place between
April 3, 2008, and May 3, 2008.
                                                9
       In addition to bringing Y.Q. to see her pediatrician, it appears that Ms.
Quinones also consulted a telephone service. The history of present illness portion
of the form states “febrile seizure last night, seen in SBUH ER, all [negative], now
T 103.5, gave [Tylenol]. Mom very concerned. S/P MMR.” Under “special
advice,” someone has written “fevers could be [secondary to] MMR, cont.
[Tylenol / Motrin] alt 3h.” Exhibit 8 at 87. Ms. Quinones remembered very little
about this telephone call. Tr. 55.
      On April 6, 2008, Ms. Quinones completed a VAERS form, reporting that
her daughter had an adverse event after the vaccination. The information on the
VAERS form is more or less consistent with the history given above. Exhibit 8 at
88-90.

      On May 3, 2008, Y.Q. was seen at Kids Care Pediatrics again. The chief
complaint was “fever x 1d, vomiting x 1.” The diagnosis was “viral illness.”
There is also a notation saying “h/o febrile seizure.” Exhibit 6 at 12. With
reference to this appointment, Ms. Quinones testified that Y.Q. was inconsolable
and was having severe diarrhea “all day long.” Tr. 58. More succinctly, Ms.
Quinones described the situation was “horrible.” Tr. 57. It appears that Y.Q. did
not go to a subsequently scheduled appointment on June 17, 2008, and a note
indicates that Y.Q. switched to “holistic healer.” Exhibit 6 at 12.

      B.     Initial Appointments at Northport Wellness Center:
             May-July 2008
       Ms. Quinones brought Y.Q. to the Northport Wellness Center for the first
time on May 5, 2008. Exhibit 7 at 19. Ms. Quinones wrote that the purpose of the
appointment was “MMR shot reaction.” Id. at 19; Tr. 60. For the “present
history,” Ms. Quinones stated: “[On] April 1st Y.Q. had a seizure (four days after
receiving her MMR). Since she has had good days & bad. Bad days consist of
inconsolable crying, tantrums, fevers, aggression less interaction, restlessness,
[and] does not cuddle.” Id. at 20.

        Cuddling (or Y.Q.’s lack of cuddling) carries a significant importance to Dr.
Shafrir’s opinion that the MMR vaccine harmed Y.Q. permanently. Dr. Shafrir
testified that the “most important record” is the questionnaire that Ms. Quinones
submitted five weeks after the seizure. Tr. 311. On this form, as just recited, Ms.
Quinones has checked boxes for “constipation,” “diarrhea,” “anemia,” and
“behavioral changes.” Exhibit 7 at 20. In handwritten notes, Ms. Quinones has
elaborated that Y.Q. has, among other problems, “inconsolable crying, tantrums,

                                         10
less interaction, and not cuddling.” Id. In Dr. Shafrir’s opinion, not cuddling is an
extreme behavioral change for Y.Q. at this age. Tr. 350, 504.
       At this initial appointment, Alan Sherr saw Y.Q. Mr. Sherr is a chiropractor.
Mr. Sherr determined that Y.Q. suffered from “encephalitis.” Exhibit 7 at 17;
accord Tr. 230-31. Dr. Holmes said that it is unclear what criteria Mr. Sherr was
using to diagnose Y.Q. with encephalitis and that chiropractors, such as Mr. Sherr,
are not qualified to diagnose encephalitis. Tr. 381. Regardless of Mr. Sherr’s
(lack of) qualifications to diagnose encephalitis, to treat Y.Q.’s pain and
inflammation, Mr. Sherr also performed craniosacral treatments. Exhibit 7 at 28;
Tr. 61-62. Mr. Sherr recommended various supplements, including glutathione.
Exhibit 7 at 11; Tr. 44. Dr. Shafrir stated that he does not use glutathione for an
autoimmune problem. Tr. 233-36. Dr. Holmes agreed that supplements would not
help an MMR-related encephalopathy. Tr. 381. For any patient suspected of
suffering post-MMR encephalitis, Dr. Holmes would recommend admitting that
patient for continuous EEG monitoring, MRI imaging, a spinal tap, and other
testing. Tr. 382
       Y.Q.’s next significant appointment at Northport Wellness Center occurred
eight days later.7 On May 13, 2008, she was seen by Lawrence Palevsky. Dr.
Palevsky is a pediatrician. Exhibit 118 (curriculum vitae). Ms. Quinones stated
that she found this group of doctors from the “ARI website.” Exhibit 7 at 27.8 In
addition to recording a history from around the time of Y.Q.’s vaccination, Dr.
Palevsky updated her current status. He recorded that “since [Y.Q.] started these
supplements last week,” Y.Q. has had “more regular bowel movements not [with]
constipation or diarrhea so much, more playful, more consolable, less destructive,
more willing to cuddle, less restless.” However, her “vocabulary [was] still not
back.” Id.; accord Tr. 65. Y.Q. also “still has tantrums.” Exhibit 7 at 11; see also
Tr. 63-64 (describing tantrums). Dr. Palevsky examined her. For her neurologic
system, Dr. Palevsky stated that Y.Q. was “alert [moves all extremities], [normal]

       7
         Mr. Sherr’s handwritten notes from visits from May 5, 2008 to April 10, 2010 appear as
pages 17-18 in exhibit 7. They are very difficult to read, and the experts have not based their
opinions on any of these notations. See Tr. 19-20.
       8
         ARI probably refers to "Autism Research Institute." Ms. Quinones stated Mr. Sherr is a
DAN! (Defeat Autism Now!) doctor. Tr. 43. His partner, Dr. Palevsky, is also a DAN! doctor.
Tr. 62-63. Ms. Quinones testified that she found Mr. Sherr and Dr. Palevsky after researching
Y.Q.’s symptoms for a long time on the internet and after reading the book Evidence of Harm.
Tr. 43.
                                              11
tone, tantrums, irritable but consolable, fussy, no words, some pointing.” Id. at 11-
12.
      Dr. Palevsky’s impression was that Y.Q. suffered from “post MMR
encephalitis” and “post MMR enteritis.” Exhibit 7 at 12; accord Tr. 104. Dr.
Palevsky ordered various tests. See exhibit 7 at 25; exhibit 8 at 45.
       A return appointment with Dr. Palevsky occurred on June 10, 2008. For the
recent history, Dr. Palevsky stated:
             Cont’d ther-biotic probiotics, omega-cure, glutathione,
             homeopathic spray. Added vit A + vit C after one week,
             developed fever, diarrhea inconsolable crying, decreased
             eating. Seen by Dr. Sherr, who stopped vit A. Stayed off
             vit A for another week, once fever resolved, put back on
             vit A a few days ago, no fever yet. Received one B12
             injection 4 days ago + will continue [every] 3 days.
Exhibit 7 at 12. For Y.Q.’s current status, Dr. Palevsky noted some improvements.
He wrote:
             no further seizures. Inconsolable crying resolving since
             fevers resolved last week. Diarrhea + constipation
             resolving – [normal] stools. More interested in cuddling.
             Pointing consistently, words coming back slowly. Rare
             throwing self back [with] head banging -- some biting,
             hair pulling.

Id.; accord Tr. 65-66. Dr. Palevsky also recorded his observations:

             babbling in office, imitations of words and word sounds
             as if speaking in a sentence. Good eye contact,
             interactive, playing, climbing, pointing, laughing, still
             [with] slight temper. Color improving.

Exhibit 7 at 12. Dr. Shafrir interpreted Dr. Palevsky’s notation as documenting
“continued neurologic improvements.” Tr. 240. Dr. Palevsky also stated he
reviewed the results of the laboratory’s testing with Ms. Quinones. Dr. Palevsky
noticed the high titer for hepatitis B. Exhibit 7 at 12.
      At the conclusion of this appointment, Dr. Palevsky recommended that the
parents continue a dairy-free diet, probiotics, omega-care, glutathione,

                                         12
homeopathic spray, vitamin A + C, and vitamin B12 injections. Dr. Palevsky also
encouraged an early intervention evaluation and proposed returning in one month.
Exhibit 7 at 29. Ms. Quinones did not have a clear recollection of requesting
services. Tr. 62-69; see also Tr. 115 (Mr. Quinones’s testimony).

      The next appointment occurred on July 7, 2008. In the intervening month,
Y.Q. had had no further seizures. Three weeks before the appointment, Y.Q. had a
“short-lived” fever that apparently resolved with one Motrin. Ms. Quinones also
reported “pointing continues, vocabulary increasing, picking up new words, some
pretend play, some repetitive behavior. Head banging, throwing self back
continues, cont[inued] to pull hair, hit, some spaciness, still aloof.” Exhibit 7 at
13.

      As to vocabulary, an aspect that Dr. Palevsky described as “increasing,” Ms.
Quinones did not recall whether her daughter could say “mommy.” Tr. 70. With
the notation of expanded vocabulary, Dr. Shafrir stated that this record showed
improvement. Tr. 240.9

       With respect to Y.Q.’s health while Dr. Palevsky was treating her from June
to July 2008, Dr. Holmes opined that she was sick, but not with psychiatric
problems. Tr. 463-64, 500. Dr. Holmes attributed Y.Q.’s crankiness and not
wanting to be cuddled to her illness that was causing her to have diarrhea for
months. Tr. 398-99. Similarly, Dr. Holmes stated that any problems with
language, which appear to have resolved by July 7, 2008, could be due to a
sickness. Tr. 427.

       C.      Second Seizure and Follow-up: July 28, 2008 through
               October 18, 2008
      On July 28, 2008, Y.Q. suffered another seizure. See exhibit 10 at 185
(ambulance record). The emergency medical services initiated CPR because they
could not obtain a heart rate or pulse. Id.; see also exhibit 9 at 78; Tr. 38.
      In the Emergency Department, Ms. Quinones said that Y.Q. had a seizure “a
few weeks ago S/P MMR vaccination. [Patient] had MMR vaccination today. Pt
has had temps of 105 @ at home [with] Tylenol given.” Exhibit 10 at 173.10 The

       9
         Dr. Shafrir also stated in his experience of treating autistic children, physicians who
practice alternative medicine “always say the patient improves.” Tr. 241.
       10
          The report that Y.Q. received an MMR vaccination “today” appears to be mistaken.
See Tr. 71.
                                                 13
physical exam in the Emergency Department revealed that Y.Q. was “lethargic”
with “eyes deviated to [the] left.” She was also on Ativan. At this time, she was
not responding to pain. Id.

       Late in the evening on July 28, 2008, a neurologist consulted on Y.Q.’s case.
In brief, the history is consistent with the facts as presented above. In detail, the
history of present illness from the resident stated:

             19m old F girl [with] [history of] post-measles
             encephalitis developed after MMR vaccination in March
             2008 [presents with] tonic-clonic seizure that started
             about 10:00 PM today (with urinary incontinence,
             foaming at mouth) lasting about 30-40 min until EMS
             came in. In ambulance found to be pulseless (~ 2 min)
             and was resuscitated. In ED given 1 mg Ativan + 200
             mg phosphenytoin X1 [illegible] on EEG. As per Mom,
             today had temp of 101 running temp since Sat, but [no]
             cough, running nose, abdominal pain, ear pain. Has been
             having diarrhea/intermittent fevers up to 105 + more ever
             since MMR vaccination. No sick contacts. No family
             [history of] seizures. No vomiting. At the time of onset
             of seizure, pt was laying on bed with mom falling asleep.

             [History of] one seizure episode on April 1st. Was seen
             in ED, told that it was [secondary to] dehydration/fever
             . . . . That seizure lasted 5 min and was similar to the one
             today.
Exhibit 9 at 27-32.

       The attending neurologist’s comment was succinct: “19 mo old with 2nd
febrile seizure --- this one prolonged [with] partial onset.” Exhibit 9 at 27.
       On July 29, 2008, Y.Q. was admitted to the pediatric intensive care unit of
Stony Brook University Hospital and Medical Center. This admission report
indicated that a CT scan of Y.Q.’s head showed bilateral “white matter paucity in
parietal lobe.” Exhibit 9 at 78; but see exhibit 11 at pdf 35 / 220 (7/28/08 CT scan
that, while having limited ability to evaluate the slices due to motion artifact, did
not note any abnormalities or disease). The admitting doctor’s problem list was:
      Active: R/O Encephalitis (day: 1)
      Active: S/P questionable cardiac arrest (day: 1)
                                          14
       Active: S/P status epilepticus (day: 1)
       Chronic: H/o questionable MMR Encephalitis (day: 1)

Exhibit 9 at 79. His review of the neurologic system was “Pt with developmental
delay / PDD with [history of] seizure in past. Now presenting in status epilepticus;
was loaded with phosphenytoin and had no new clinical seizures overnight. Peds
Neuro following and to evaluate continuous EEG.” Id. Dr. Holmes offered that
Y.Q. suffering a cardiac arrest was “unlikely.” Tr. 384.

        Ms. Quinones discussed this report of developmental delay and her
comments were not consistent. Initially, when asked about whether Y.Q. had a
history of developmental delay, Ms. Quinones said “No,” and “All her milestones
were met.” Tr. 74. But, after Ms. Quinones was informed that the July 28, 2008
report was shortly after the vaccination, Ms. Quinones said Y.Q. “was regressing.
She was going backwards.” Id. Ms. Quinones identified language as a primary
skill in which Y.Q. was not developing normally. Id. On the topic of
developmental delay at Y.Q.’s second seizure, Dr. Holmes said Y.Q. was talking
less than she had been. Tr. 446-47 (referencing exhibit 9 at 79).

       The 24-hour video EEG was abnormal. It showed “diffuse background
slowing” and “right hemispheric slowing which is higher in voltage with absence
of sleep architecture.” Exhibit 11 at pdf 36 / 221. The EEG did not show
subclinical seizures. Tr. 290. The EEG also did not show that the status
epilepticus caused lasting brain damage. Tr. 289. In Dr. Shafrir’s view, the
slowing on the EEG was consistent with an encephalopathy. Tr. 303. An MRI
was also abnormal. Id. at pdf 34 / 219; see also Tr. 531.
      The records from Kids Care Pediatrics include a note indicating that on July
28, 2008, Y.Q. suffered a febrile seizure lasting approximately 40 minutes for
which she was given Ativan. Y.Q. is “now seeing holistic healer Dr. Palevsky,
Sherr. Parents think that [after] MMR shot, seizure caused loss of milestones.”
Exhibit 6 at 12.11

      The records from Northport Wellness Center similarly contain a record of a
telephone call, informing Dr. Palevsky that Y.Q. had a fever for the past few days
and developed a seizure that lasted 30 minutes. Dr. Palevsky “asked to have CSF
[cerebrospinal fluid] sent for measles / mumps / rubella virus cultures.” Exhibit 7

       11
            The identity of the person who communicated with Kids Care Pediatrics is not readily
apparent.

                                                15
at 13; accord Tr. 80-81. Subsequently, a doctor added measles IgG onto the tests
for previously drawn CSF. Exhibit 9 at 52. Although it appears this test was
performed, the result is not readily apparent. Exhibit 11 at pdf 17 / 202; Tr. 18-19
(representation from the attorneys that they could not find results from this test).

      Results from more routine studies on Y.Q.’s CSF were generally within
normal limits. For example, her protein was 30.7 mg/dL when the range of
expected value is 15.0-45.0 mg/dL. Exhibit 11 at pdf 14 / 199.
       During this admission to Stony Brook, a consulting doctor created a report
on August 1, 2008. The report indicates some questions about the consistency of
the history the parents provided and sheds light on the role of Mr. Sherr, the
chiropractor treating Y.Q.
             On arrival to [the hospital unit on July 29, 2008, a] more
             extensive history [was] taken from previously agitated
             parents which revealed first seizure on 4/1/08 was
             believed by parents to be secondary to MMR vaccine and
             her holistic physician. Dr. Sherr had labelled the patient
             as having post-MMR encephalitis. Parents believe
             [patient] had lost milestones over months since MMR.
             Speech had declined, [patient’s] activity was ‘erratic’ and
             [patient] was ‘constantly variable.’ Parents also report
             [patient] has had cyclic episodes of fever for one week,
             [increasing] [illegible] and non-bloody, non-muscoid
             diarrhea described as usual color but more watery.
             Mother notes occasional constipation also, but
             progression of episodes and overall course since vaccine
             are often described poorly with no documentation and
             explanations and details change with retelling.
             Originally parents report patient had been getting worse,
             later explain she has been regaining milestones on
             holistic therapy – including gluten-free, lactose-free,
             casein-free diet (not followed strictly as per parents),
             vitamin supplements and unspecified chelation therapy.

             Parents have been told by Dr. Sherr that measles is alive
             in her gut and reactivating monthly causing fever and
             diarrhea and encephalitic symptoms. Apparently no tests
             were done to support or confirm this belief because ‘I’ve

                                         16
               seen this so often I can diagnose this with clinical exam’
               (Dr. Sherr on phone on 7/29/08 with Resident).
Exhibit 10 at pdf 36-37 / 131-32. On cross-examination, the Secretary asked Dr.
Shafrir whether he agreed with the statement, attributed to Mr. Sherr, that the
measles virus was “alive in her gut.” Dr. Shafrir disagreed. Tr. 242.
       Y.Q.’s discharge from Stony Brook came on August 1, 2008, five days after
she was admitted. The discharge report presents an excellent summary of her stay
in the hospital. The discharge report indicates that the consulting neurologists
opined that Y.Q. was “neurologically” “intact.” Exhibit 9 at pdf 24-26; see also
Tr. 241. Other specialists consulted included doctors from infectious diseases,
gastroenterology, and genetics. Follow-up appointments were scheduled. Exhibit
9 at pdf 24-26.
       The final diagnoses were “status epilepticus due to febrile seizure.” Pending
the results of outstanding studies, the doctors had not reached any conclusion about
the cause of the underlying febrile seizure. Exhibit 9 at pdf 24-26. From his
review of this hospital stay, Dr. Holmes stated that there was no indication that
Y.Q.’s treating physicians were concerned about autoimmune encephalopathy, and
that the only connection between the first two seizures was that they both occurred
in the context of a febrile illness. Tr. 386.

      Three days after this discharge, Dr. Palevsky saw Y.Q., and reviewed the
records that her parents brought to him. Dr. Palevsky noted that “multiple requests
[were] made for measles testing to be done, [but] chart doesn’t indicate test is
pending.”12 Exhibit 7 at 14. With respect to the care the family received during
the hospitalization, Dr. Palevsky stated: “Parents bullied, talked down to on
pediatric unit for dietary changes, use of vitamin A, vitamin B12, use of alternative
approaches, parenting styles. Parents felt treated poorly.” Id.; accord Tr. 77. Dr.
Palevsky’s notes also indicated: “Since being in [hospital], broke out in rash under
neck which spread down her back, trunk, thighs – spotted -- mid way last week, --
patches blotches on [right] + [left] arm. [Ms. Quinones] suggested it could be a
measles rash, denied by medical staff.” Exhibit 7 at 14.

      For Y.Q.’s current status, her “parents feel she’s interacting more, talking
more, ‘smarter,’ alert more, sleeping well since [discharge] from hospital, showing
more babbling, words, more affectionate, [illegible] [with] some eye deviation.”

       12
          Actually, the discharge report stated that after the lumbar puncture was performed,
“specific tests ordered [included] . . . CSF for measles IgG.” Exhibit 9 at pdf 26 / 25.
                                               17
Exhibit 7 at 14. Dr. Palevsky’s record is consistent with Ms. Quinones’s memory.
She testified “I definitely saw changes and she regained what she had lost, so by
August, probably she was a little better. I don’t remember when she regained full
speech.” Tr. 78. With a caveat about expectations of holistic doctors, Dr. Shafrir
acknowledged that this report showed improvements. Tr. 243.
       Dr. Palevsky added that the parents “restarted supplements this week.”
Exhibit 7 at 14. Dr. Palevsky’s note concludes: “tried DMSA challenge, couldn’t
catch urine pre-provocation, pills not given. Met [with] EI [probably early
intervention] for evaluation – felt motor skills were [within normal limits],
recommended speech and psychology.” Exhibit 7 at 14.

      Dr. Palevsky recommended 13 actions. Some of these were suggestions for
supplements. The 11th item reads:
            For fever, make sure she’s well hydrated.
            Lavender essential oil to tops of ear lobe, back of neck and down
      spine 2-3x/ day. German chamomile essential oil to tops of ear lobes, back
      of neck + down spine 1-2 times a day.
            Warm bath, bundle to bed.
            Yarrow flower in bath tub when having fever.
            Catnip tea with chamomile tea + honey for fever.
            Motrin as needed.

       Dr. Palevsky also requested that Y.Q. “return in one month” (item 12) and
maintain her follow-up appointments with infectious disease, neurology, genetics,
and gastrointestinal (item 13). He also suggested that the MRI should be repeated
(also item 13). Exhibit 7 at 31. Ms. Quinones did not obtain the repeat MRI that
Dr. Palevsky suggested. Tr. 80. A later record indicates that Y.Q. “was not
followed by neurology as choice of parents.” Exhibit 11 at pdf 95 / 280 (record
dated April 3, 2009).
       On October 18, 2008, Y.Q. was “picked up by arms [and] may have pulled
out shoulder.” Thus, her parents brought her to the Emergency Department at St.
Catherine of Siena Medical Center. The past medical history on the triage form
states: “post measles encephalitis from vaccine.” Exhibit 60 at 3; see also Tr. 82.
It appears that after a doctor examined her, Y.Q. was discharged to follow up with
her primary medical doctor. Id. at 6. Ms. Quinones recalled that Y.Q. was not
meeting her developmental milestones as she was in the midst of “years of diarrhea
and screaming and fever.” Tr. 82.

                                        18
       D.      Third Seizure: April 3, 2009

       In the morning of April 3, 2009, Y.Q., who was then two years old, had
decreased activity and had a fever of 101.5. At approximately 2:45 PM, her fever
was increasing, and she looked flushed. Then, her eyes fluttered, her face, arms,
and legs shook. The episode lasted approximately 3-4 minutes and she was given
Diastat, which resolved the seizure. EMS was called and the ambulance brought
her to Stony Brook. Exhibit 11 at pdf 95 / 220. The triage form from the
Emergency Department states as part of the past medical history “febrile seizures
post measles encephalitis.” Id. at pdf 94 / 219.

        She was seen by a neurologist who also obtained a history. This report
stated that Y.Q. had had “rhinorrhea x several days [and] rash.” Id. at pdf 98 / 283.
The neurologist’s past medical history noted the first seizure four days after MMR
vaccination and the second seizure was a prolonged febrile episode of status
epilepticus. It also stated “post measles encephalopathy (as per parents).” Under
developmental history, the neurologist has written: “norm” and “dev. delay(?).”
Id. at pdf 99 / 284. Both Dr. Shafrir and Dr. Holmes recognized that the treating
neurologist characterized her neurologic exam as normal. Tr. 245 (Dr. Shafrir);
447 (Dr. Holmes noting that Y.Q. had regained any losses in speech).

       The neurologist ordered an EEG. The impression was “normal waking
EEG.” Exhibit 11 at pdf 109 / 294; accord Tr. 245. A comment was “This EEG
does not exclude the clinical diagnosis of seizures or epilepsy.” Exhibit 11 at pdf
109 / 294.

       It appears that Y.Q. was discharged later on April 3, 2009. Her parents were
given instructions about “Childhood Seizures” and directed to follow up with a
neurologist in 5-7 days. Id. at pdf 104 / 289-91; see also Tr. 387 (Dr. Holmes’s
brief testimony about the third seizure). Ms. Quinones testified that she followed
up with Dr. Horn, who was “very biased,” and then Dr. Bello. Tr. 83.13
       E.      Fourth Seizure and Follow-up: September 3, 2009 through
               November 3, 2009

     On September 3, 2009, Y.Q. was in her usual state of health, not sick. Tr.
84. Then she started “‘twitching’ to upper torso and extremities, ‘spitting up’

       13
           The first outpatient record from Dr. Bello appears to be from October 19, 2009, which
is after the next seizure. The petitioners have not located any record from Dr. Bello from earlier
than October 19, 2009. See Pet’rs’ Status Rep., filed Feb. 23, 2017, at 2.

                                                19
mucous,” and her “‘lips turned blue.’” Although Ms. Quinones gave her Diastat,
the behavior continued for approximately 25 minutes. Exhibit 12 at pdf 32 / 347.
It appears that an ambulance was called, although the record of transport is largely
illegible. See id. at pdf 34 / 349.

       When she was initially examined in the Emergency Department, Y.Q. was
“awake, crying [and] inconsolable.” She was not having any “seizure-like
activity.” She also felt warm to the touch. Id. at pdf 32 / 347.
       A resident in neurology was consulted. The history of present illness begins:
“Patient is known to our service for several previous seizures.” The remainder
repeats Y.Q.’s history of seizures. With respect to the seizure earlier that day, the
resident stated that by the examination, Y.Q. was “now back to normal mental
status.” Exhibit 11 at pdf 122 / 307. The attending neurologist added: “treated by
holistic doctors. Offered medication in the past, parents refused.” Id.

      The doctors kept Y.Q. overnight. During this time, she had a 24-hour video
EEG. The impression was “abnormal . . . due to frequent left para – central sharp
waves with phase reversals at CZ. This finding is indicative of focal cerebral
dysfunction in the left para – central region.” The doctor recommended correlation
with neuro-imaging. Exhibit 14 at pdf 2 / 1. Dr. Shafrir interpreted this EEG as
showing a worsening. Tr. 291.

      After the video EEG, a neurologist again examined Y.Q. The doctor
prescribed Keppra and recommended another MRI. The doctor approved a
discharge home. Exhibit 12 at pdf 12 / 327.14 In addition to including the
prescription for Keppra, the discharge plan ordered an MRI on an outpatient basis
and scheduled a follow-up appointment at a neurology clinic on October 19, 2009.
Exhibit 11 at pdf 120 / 305.

       The day following the discharge from Stony Brook, Y.Q.’s parents brought
her to a different hospital for a second opinion. Exhibit 15 at 38. The chief
complaint was “Mom wants to know why [Y.Q.] has seizures and behavioral
problems.” Id. at 13. The doctor at the Schneider Children’s Hospital of the North
Shore-Long Island Jewish Health System recorded a brief history of the seizures,
including the fact that the MMR vaccination preceded the first seizure by four
days. For medications, the note states probiotic and cellular defense. Another

       14
          Although this note is dated September 3, 2009, the overall context suggests that the
correct date was September 4, 2009.

                                               20
medication listed is Keppra.15 For development, the record states “Patient has been
evaluated and has had [speech therapy].” In separate handwriting, the next line
reads: “Mom feels child has had [developmental] regression after MMR, with
return of speech.” Id.

       The assessment / plan reads:
              2½ [year old] female with known seizure disorder, cyclic
              fevers, reports of developmental regression and chronic
              diarrhea. Mom has not followed with pediatrician since
              15mo and has been assessed solely at DAN Center,
              which has supported her belief that MMR vaccine is the
              root of all her problems. She presents at the
              recommendation of pediatrician who would like all blood
              work done.

Id. at 15.
       Again, Y.Q. stayed overnight in a hospital. Discharge from the hospital
occurred the following afternoon. The plan was for Y.Q. to be seen, as an
outpatient, by doctors with specialization in neurology, gastroenterology, asthma
and allergy, and behavior and development. Exhibit 15 at 37; see also id. at 27.

       On September 10, 2009, Y.Q.’s parents brought her to the Queen’s Long
Island Medical Group. She was a “well-child” but needed a referral to obtain an
MRI. Exhibit 16 at 1-2. An MRI was performed at Stony Brook on September 14,
2009. It revealed a “T2 hyperintensity in the terminal zones of myelination in the
parietal lobes which is less pronounced than on the previous study indicating
normal progression of myelination. Again noted are prominent perivascular spaces
in the bilateral frontal lobes especially.” Exhibit 14 at 13.

      Another visit with Queen’s Long Island Medical Group took place on
October 5, 2009. The reason for the visit was that Y.Q. was having a fever for four
days. Ms. Quinones reported that she gets a fever up to 104 “every month.”

       15
          In the Schneider Children’s record, the word “refused” is close to the word “Keppra.”
However, the word “refused” could refer to recent vaccinations. Tr. 86. In any event, another
record indicates that on September 5, 2008, while at Stony Brook, Y.Q. was started on Keppra.
Exhibit 15 at 39. Ms. Quinones testified that Y.Q. tried Keppra but “she started getting worse,
way worse, overturning furniture, throwing tantrums. And I researched, the side effect was
Keppra rage, so we had to discontinue.” Tr. 85.
                                               21
Exhibit 16 at 3. The doctor wanted Ms. Quinones to treat the symptoms of fever
with “Tylenol / Motrin.” Id. at 4.
       On October 19, 2009, a pediatric neurologist, Lourdes Bello, saw Y.Q. in
her office at the request of Dr. Palevsky. Dr. Bello’s history of present illness
mentions that Y.Q. has been taking a dose of Keppra without significant side
effects. The past history includes the recitation of “post MMR vaccination
encephalitis.” Exhibit 14 at 4.16 It also states that Y.Q. “has been followed by a
holistic physician who relates her symptoms to her initial episode of encephalitis.
Her parents had been reluctant, until this last episode, to the administration of anti-
seizure medication. She also has returned episode of high fever every month with
unexplained diarrhea with a temperature that goes up to 105.” Exhibit 14 at 3-4.
Under developmental history, Dr. Bello recorded “her milestones have been
achieved on time. Her mother states that she [had] loss of speech after she had the
episode of vaccination. She recovered after intervention.” Id. at 4. Dr. Shafrir
acknowledged that Dr. Bello’s history did not note any behavioral problems. Tr.
247.
       After obtaining this information, Dr. Bello conducted a neurologic exam.
Based upon her examination, Dr. Bello reported: “She was awake, alert and
interactive with appropriate orientation. She followed commands with good
attention and concentration. She displayed an age appropriate language and
articulate speech.” Exhibit 14 at 5.

       Dr. Bello’s impression was that Y.Q.

               has a very high risk for recurrent episode of status
               epilepticus and in the past she had [an] episode of cardiac
               arrest that has been necessary to admit her in the hospital.
               Explained to the parents upon admission and now during
               the visit that it is very important that Y.Q. gets
               medication in order to prevent these episodes that are
               becoming more frequent.

Exhibit 14 at 5-6. Dr. Bello also stated that after reviewing the results of the MRI,
the “findings [that] were present during her admission for possible measles
encephalitis are not present any more.” Id.; accord Tr. 88. Dr. Bello closed her
       16
           Dr. Bello added that she did “not have details from [the] admission” when Y.Q.
presented with changes in her mental status after the MMR vaccination. Exhibit 14 at 5. Dr.
Shafrir stated that this notation meant that Dr. Bello did not review the medical records from that
hospitalization. Tr. 249.
                                                22
letter by stating “I expect her to be under control.” Exhibit 14 at 5-6. Dr. Holmes
agreed with Dr. Bello’s finding and added a diagnosis of epilepsy. Tr. 387-88.
      On November 3, 2009, Y.Q. returned to see Dr. Palevsky for the first time in
15 months. His note begins by saying in those 15 months Y.Q. “has been seeing
Dr. Sherr.” See exhibit 7 at 34 (May 21, 2009 note from Alan Sherr stating that
Y.Q. is “under [his] care”).

      Dr. Palevsky has a lengthy description of Y.Q.’s current behavior:
             [She] did summer camp – did well, no hitting, no biting.
             At home-bites, hits throws herself on the floor, hitting,
             spitting throws up, go after dog, makes herself throw up.
             [She] has order, compulsion about things, very repetitive,
             gets angry very easily. Parents have tried time-outs,
             discipline, nothing seems to work.

Exhibit 7 at 15. Additionally, Dr. Palevsky recorded that Y.Q. was restless,
especially at bed time.

      Dr. Palevsky made eight recommendations, mostly about supplements which
Y.Q. had not been taking. He also asked that Y.Q. return in one month. Id. at 35.

      F.     Fifth Seizure: November 10, 2009

       On the evening of November 9, 2009, Y.Q. had a fever and did not eat as
much. The next day, at approximately 6:45 PM, she had a seizure. After
approximately 15 minutes, her parents gave her Diastat, but it had no effect.
Exhibit 13 at pdf 18 / 440. When an ambulance arrived, her pupils were dilated,
and she was unconscious. Id. at 21 / 443. The ambulance brought her to Stony
Brook. In the Emergency Department, she was given another dose of Diastat,
which improved her condition slightly. The doctors then gave her 1 mg of Ativan
intravenously and the Ativan broke her seizure. Id. at 440.

      A neurologist came to evaluate Y.Q. at approximately 8:00 PM on
November 10, 2009. The neurologist added that before she had her seizure, Y.Q.
missed her morning dose of Keppra. During the seizure in the Emergency
Department, she had desaturated and was placed on a face mask. When the
neurologist was examining her, Y.Q. was “post ictal” and “responsive to verbal
commands.” Exhibit 12 at pdf 81 / 396. The neurologic resident’s notes of past
medical history include: “febrile seizures since 15 mo.” “post measles
encephalitis” “monthly fevers + diarrhea” “evaluated for autism due to [history of]
                                         23
loss of speech and eye contact post immunization [with] MMR.” The attending
neurologist revised this note, stating “Disagree re ‘measles encephalitis.’ This is
mother’s report as febrile seizures occurred post MMR.” Id. at pdf 82 / 397;
accord Tr. 252.

     After an examination, the neurology team admitted Y.Q. to the Pediatric
Department. They ordered various tests, including a head CT, a lumbar puncture,
an EEG, labs in the morning, and Keppra now. Id. at pdf 84 / 399.
      The CT scan did not show any “acute intracranial pathology.” Exhibit 13 at
pdf 60/ 482. However, the 24-hour video EEG was abnormal. “Intermittent high
voltage slowing [was] seen over the left hemisphere.” Id. at pdf 62 / 484.

       While in the hospital, a pediatrician created a comprehensive assessment.
Dr. Stern also obtained a history that Y.Q. “missed Keppra doses x2.” Exhibit 12
at pdf 93 / 408. He stated, “Mom attributes loss of milestones @ 15 months to
MMR vaccine and has sought out ‘vaccine reversal’ therapy from her current
[primary medical doctor].” For developmental and behavioral history, he recorded
“no concerns until 15 mo, has had speech delay since. No current [occupational
therapy] / speech therapy.” Id. at pdf 95 / 410. The items in his plan included
“Mom requests measles [immunoglobulin] of LP performed.” Id. at pdf 100 / 415.

        While still in the hospital, Dr. Bello consulted on Y.Q.’s case. Her
impression was “epilepsy symptomatic with seizures associated with fever. Status
[epilepticus] triggered by withdrawal / missed one dose [of Keppra].” Exhibit 13
at pdf 6 / 428. Under plan, Dr. Bello wrote “I believe seizures are multifactorial,
not only febrile. [Y.Q.] has abnormal MRI in the past with focal spike over the
[left] hemisphere. Keppra should be optimized.” Id. at pdf 7 / 429. Dr. Shafrir
interpreted Dr. Bello’s use of the term “symptomatic” as indicating that Dr. Bello
believed that the epilepsy was secondary to some problem in Y.Q.’s brain, even if
the doctors could not identify the cause of the epilepsy. Tr. 189, 293. Dr. Holmes
concluded that Y.Q. was predisposed to seizures but there was not a firm etiology
for the seizures. Tr. 390.

      Other events were summarized in the discharge report. The expected
follow-up care was to see a neurologist in three weeks. Exhibit 12 at pdf 78-80 /
393-95.

      G.     Remainder of 2009, 2010, and 2011
      Before this appointment with the neurologist occurred, Y.Q. saw Dr.
Palevsky on December 8, 2009. Dr. Palevsky records many behavioral concerns.
                                         24
Exhibit 7 at 15-16. For example, Y.Q. “can’t make a decision — wants, doesn’t
want” and she “screams [with] radio in kitchen when turned on.” Id. at 15. On
physical exam, she was “alert, active, [moves all extremities].” She had “NL
tone.” She was “happy, playful [and] calm.” Id. at 16. For assessment, Dr.
Palevsky indicated “seizures, fever, [and] food allergies.” Id. Dr. Palevsky
continued his recommendations for supplements, a restricted diet, and to continue
Keppra with Diastat for emergencies. Id. at 36.
      Although Y.Q. saw Dr. Bello less frequently in 2010, one appointment
occurred on In January 11, 2010. Her parents reported that Y.Q. has had “some
episodes of monthly fever without seizures.” Exhibit 14 at 14. Dr. Bello
emphasized the need to prevent fevers. Dr. Bello’s conclusion stated, in part:

              recommendations were given about the management of
              these recurrent episodes of fever that it [sic, presumably
              Y.Q.] has been experiencing in monthly basis for more
              than one year. Extensive workup had been done in the
              past and no apparent reason has been found for these
              episodes of fever. I explained the importance of
              controlling the fever despite the fact that she has been
              recommended not to give the medication for it by her
              primary pediatrician according to her mother. I chose . . .
              to keep the current dose of Keppra 3.5 mL twice a day
              that seems to be working for her.

Exhibit 14 at 15.17

       Other portions of the history that Dr. Bello obtained indicated that Y.Q.
“appears to be cranky and irritable and she is worried about the presence of new
seizures. Other than that[,] no new symptoms from the neurological point of view
at present.” Exhibit 14 at 15. Dr. Shafrir interpreted crankiness and irritability as
example of behavioral problems. Tr. 250.

      Dr. Bello conducted a neurologic examination, recording the following
information: “She was awake. She displayed an appropriate affect, and age-
appropriate fund of knowledge and skill development was demonstrated. Speech

       17
         Although Dr. Bello’s report states that mom said that Y.Q.’s primary pediatrician
(meaning Dr. Palevsky) had recommended not giving medication, Dr. Palevsky’s December 8,
2009 recommendations included maintaining Keppra.
                                             25
and language and participation in tests of neurologic examination were age
appropriate.” Exhibit 14 at 15.
      Dr. Bello’s strongest recommendation was to prevent fevers as mentioned
above. Dr. Bello also ordered lab tests. “Other than that[,] no other intervention is
needed at this point.” Id. Dr. Bellow recommended a follow-up in four months.
       On May 3, 2010, Dr. Bello recorded that since the last admission in
November 2009, Y.Q. “has not had any other episodes of seizures and she is doing
very well.” However, Ms. Quinones expressed “significant behavioral issues.”
Ms. Quinones also believed that Y.Q. “has sensory integration disorder.” Exhibit
14 at 19. Dr. Bello referred them to a behavioral pediatrician and to occupational
therapy. Id. at 20. Ms. Quinones reported that children protection services has
been involved with Y.Q. due to allegations of paternal drug abuse. Id. at 19. Ms.
Quinones stated that she was currently separated from her husband and feared for
her safety. Id.
        In a follow-up appointment nearly five months later, Dr. Bello reported that
Y.Q. “was evaluated by a specialist in sensory integration disorder and they agreed
that she meets the criteria.” Id. at 22. Y.Q. had not had any seizures in the interim.

       The specialist who concluded that Y.Q. suffered from sensory integration
disorder is not readily apparent.18 However, on December 1, 2010, a
developmental psychologist, Janet E. Fischel, PhD, spent approximately 75
minutes with Y.Q. Dr. Fischel noted behavioral concerns and recommended that
Ms. Quinones explore whether the local school system could provide some
intervention. Exhibit 20 at 2-4.

        Earlier in 2010, on September 16, 2010, Mr. Sherr, the chiropractor
affiliated with Dr. Palevsky, completed a form to aid in determining whether Y.Q.
was entitled to disability benefits pursuant to the Social Security Act. Mr. Sherr’s
treating diagnosis was “Post Encephalitis as a result of MMR inoculation.” Y.Q.’s
current symptoms included: “irate behavior, mood changes, toxicity changes,
muscle spasms, intermittent fevers + seizures.” Exhibit 8 at 117. In response to a
question about the “etiology of impairment,” Mr. Sherr wrote “MMR Inoculation

       18
          During the hearing, the petitioners’ attorney identified Dr. Fischel as a consultant
relevant to the sensory integration disorder. Tr. 22. However, the record that the attorney
identified, exhibit 20 at 1, indicates that the family cancelled an appointment with Dr. Fischel
scheduled for July 21, 2010.
                                                26
— May 2008.” Id. at 118. Mr. Sherr also indicated that he could not provide a
medical opinion about Y.Q.’s ability to work. Id. at 120.
       In 2011, Dr. Bello saw Y.Q. three times. Dr. Bello continued to report that
although Y.Q. was not having more seizures, she was having behavioral problems.
See exhibit 61 at 3 (Mar. 22, 2011), exhibit 36 at 3 (Aug. 13, 2011), exhibit 39 at 2
(Dec. 7, 2011); accord Tr. 88-89. In 2011, Y.Q. began receiving some early
intervention services through the local school system. See exhibit 120, passim.
      H.     2012 through 2016

      By June 2012, Dr. Bello was recommending a psychological evaluation for
Y.Q. However, Ms. Quinones was resisting. Exhibit 39 at 5. However, on August
17, 2012, Y.Q. was involved in a violent episode resulting in a visit to the
Emergency Department of Stony Brook. Exhibit 62 at 20. In Stony Brook, Y.Q.
received a psychiatric consult. Id. at 46.

       The behavioral issues for which Y.Q. received psychiatric and psychological
treatment need not be detailed here. Dr. Holmes testified that the behavioral
problems are linked to her epilepsy in that the seizures and the behavioral issues
both flow from some disorganization or problem in Y.Q.’s brain. Tr. 409, 426,
430; c.f. Tr. 520 (Dr. Shafrir’s assessment of Dr. Holmes’s opinion that the same
process causes seizures and psychiatric problems). Thus, if Ms. Quinones
establishes that the March 28, 2008 MMR vaccine caused epilepsy, then she will
receive compensation for Y.Q.’s psychological problems as a sequela to those
seizures. For purposes of this decision, it is sufficient to note that Y.Q.’s
psychological problems remain severe. See exhibit 39 at 6 (Dr. Bello’s note from
Sept. 26, 2012), exhibit 83 at 3-6 (service plan from Amanda Romano, dated May
7, 2013), exhibit 62 at 218 (admission to Stony Brook on May 24, 2013), exhibit
61 at 18-20 (Dr. Bello’s note from Sept. 18, 2013), exhibit 62 at 400 (discharge
from Stony Brook on Oct. 21, 2013), exhibit 62 at 762 (Emergency Department
triage on Jan. 14, 2014), exhibit 85 at 171 (discharge from South Oaks Hospital on
Jan. 25, 2014), exhibit 80 at pdf 478-82 (psychiatry evaluation at Stony Brook on
Oct. 23, 2014), exhibit 83 at 107 (Peterson Krag service plan, dated Nov. 26,
2014), exhibit 113 at 3-9 (psychological evaluation performed by school system
when Y.Q. was in second grade on June 1, 2015), exhibit 115 at 7 (abnormal video
EEG, dated Aug. 24, 2015).
      Records from Longwood School district indicate that Y.Q. scores within the
average range on standardized tests. However, she continues to have significant
psychological problems. See exhibits 113, 121.

                                         27
       Y.Q.’s parents testified during the January 26, 2017 hearing that her most
recent seizure was September 4, 2015. Tr. 36-37, 46, 104. They also stated that
she likes to express herself through art. Tr. 91.

                           Standards for Adjudication

       Compensation under the Vaccine Act is available in two major forms. Table
injuries, which presume causation, can be established if a prescribed injury occurs
during a set period of time following a specific vaccination. 42 U.S.C. § 300aa-
11(c)(1)(C)(i). Alternatively, petitioners can receive compensation for injuries not
provided for in the Vaccine Injury Table by bringing a successful petition for
compensation under 42 U.S.C. § 300aa-11(c)(1)(C)(ii) of the Vaccine Act.
       Petitioner’s burden of proof as an off-Table injury is explicitly defined by
Congress. The Act provides that a petitioner must show, by a preponderance of the
evidence, that the vaccination caused or significantly aggravated his illness or
injury. See 42 U.S.C. § 300aa–13(a)(1) and 42 U.S.C. § 300aa-11(c); see also
Moberly, 592 F.3d at 1322 (noting that petitioners must prove causation by the
traditional tort standard of preponderance). As for what is specifically required to
meet this burden, the statute requires that the conclusion of the court or special
master may not be “based on the claims of a petitioner alone, unsubstantiated by
medical records or by medical opinion.” 42 U.S.C. § 300aa-13(a)(1). The statute
does not speak to the strength or reputability of the medical opinion, just that a
medical opinion or medical records are necessary for a claim to be meritorious.
See id.
       In drawing conclusions on causation, the Federal Circuit has noted that
special masters must be careful not to raise petitioners’ burden by establishing tests
that create requirements not in the statute itself. Capizzano v. Sec'y of Health &
Human Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006) (rejecting a test that required
“epidemiologic studies, rechallenge, the presence of pathological markers or
genetic disposition, or general acceptance in the scientific or medical
communities”); Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1279
(Fed. Cir. 2005) (rejecting a test requiring “confirmation of medical plausibility
from the medical community and literature” to prove causation in fact); Knudsen v.
Sec'y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994) (“to require
identification and proof of specific biological mechanisms would be inconsistent
with the purpose and nature of the vaccine compensation program”).
      Instead, special masters must consider all the evidence and decide whether
the causal link between the vaccination and the injury was logical and legally

                                         28
probable. See Knudsen, 35 F.3d at 549 (“The sole issues for the special master are,
based on the record evidence as a whole and the totality of the case, whether it has
been shown by a preponderance of the evidence that a vaccine caused the []
injury”); Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir.
1992) (“Causation in fact requires proof of a logical sequence of cause and effect
showing that the vaccination was the reason for the injury”); Hines v. Sec'y of
Health & Human Servs., 940 F.2d 1518, 1525 (Fed. Cir. 1991) (“causation in fact
requires proof of a logical sequence of cause and effect showing that the
vaccination was the reason for the injury”).
       In determining whether preponderant evidence exists, the Federal Circuit has
set forth a three-part framework for evaluating claims of vaccine injury causation.
As explained in Althen, and subsequent opinions, petitioners must put forth: “(1) a
medical theory causally connecting the vaccination and the injury; (2) a logical
sequence of cause and effect showing that the vaccination was the reason for the
injury; and (3) a showing of a proximate temporal relationship between vaccination
and injury.” Althen, 418 F.3d at 1278.
                                      Analysis

I.    Prong one - Theory
       Although the theory connecting a vaccine to an injury is frequently a
difficult point of evaluation, see Hibbard v. Sec’y of Health & Human Servs., 698
F.3d 1355, 1365 (Fed Cir. 2012), this case is exceptional. Here, at the start of the
hearing, the Secretary admitted that the MMR vaccine can cause febrile seizures.
Tr. 10, 12.
        This admission, in turn, is well rooted. In 2012, the Institute of Medicine
evaluated 19 epidemiological studies and 15 publications regarding mechanistic
evidence for a causal relationship between the MMR vaccine and febrile seizures.
The IOM found “The evidence convincingly supports a causal relationship
between MMR vaccine and febrile seizures.” Court Exhibit 1001 (Institute of
Medicine, Adverse Effects of Vaccines Evidence and Causality, Stratton, Kathleen
et al. (eds) (2012)) at 132.

       The Secretary acknowledged the conclusions of the IOM when the Secretary
proposed changes to the Vaccine Injury Table. National Vaccine Injury
Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg.
45132, 45139 (proposed July 29, 2015). However, the Secretary independently
concluded that he did not need to revise the Table because the “injury is transient
in nature.” Id. at 45135. Based upon two epidemiologic studies, the Secretary
                                         29
determined that “the overwhelming majority of children who have febrile seizures
recover quickly and have no lasting effects. Only very rarely can febrile seizures
lead to serious injury or disability . . . . [T]he Program will consider causation-in-
fact claims for febrile seizures leading to serious injury or death on a case-by-case
basis.” Id. at 45139-40.
      Thus, on the most basic level, the evidence supports a finding that the MMR
vaccine can cause febrile seizures. But, the more complicated questions are the
appropriate temporal interval and what are the consequences, if any, to an MMR-
induced febrile seizure? These questions are taken up in the following sections.

II.   Prong three - Timing

       In addition to presenting a reliable medical theory explaining how the MMR
vaccine can cause febrile seizures, the Quinoneses must also show that Y.Q.’s first
febrile seizure occurred in a medically appropriate timeframe to infer causation.
Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).
To satisfy the third Althen prong, the petitioners’ burden is to present
“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.” Id. ; accord Shapiro v. Sec'y of Health & Human
Servs., 101 Fed. Cl. 532, 542-43 (2011), reconsideration denied after remand, 105
Fed. Cl. 353 (2012), aff’d without opinion, 503 Fed. App’x 952 (Fed. Cir. 2013).

      A.     Onset of Neurologic Problem
      Of the two parts to the temporal prong, the easier-to-resolve part addresses
when Y.Q. began to have neurologic problems. Dr. Shafrir opined that the onset of
Y.Q.’s neurologic problem was her febrile seizure. Tr. 176. This opinion is
persuasive.

       In contrast, Dr. Holmes asserted that Y.Q. started having neurologic
problems the day after vaccination. Tr. 398, 404. Dr. Holmes grounded his
opinion on an affidavit that Y.Q.’s mother submitted for this litigation. See exhibit
A at pdf 6-7 (Dr. Holmes’s first report citing Donna Quinones’s affidavit, exhibit
1). Dr. Holmes’s acceptance of this affidavit seems opportunistic in that, in the
undersigned’s experience, the Secretary’s experts typically do not rely upon
assertions found in affidavits, uncorroborated by medical records created
contemporaneously. Regardless, Dr. Shafrir persuasively pointed out that the
normal process by which a vaccine can make a child feel discomfort a day later

                                          30
differs from the unexpectedly adverse process by which a vaccine causes a
neurologic problem. Tr. 353-55.
      B.    Appropriate Temporal Interval

      While the IOM determined that the MMR vaccine can cause febrile seizures,
the IOM did not define the amount of time for which an inference of causation is
appropriate. See Court Exhibit 1001. Similarly, the Secretary’s Notice of
Proposed Rulemaking did not set out any temporal limits on this question.
       The IOM’s analysis warrants a more detailed examination. The IOM made
slightly different statements about the timing found in studies, depending on
whether the studies were epidemiologic or mechanistic. In the mechanistic studies,
the “latency between vaccination and the development of symptomology … ranged
from hours to 28 days after administration of a vaccine containing measles,
mumps, and rubella alone or in combination; however, most of the cases discussed
above presented between 7 and 14 days after vaccination.” Court Exhibit 1001 at
132. The epidemiologic studies “found an increase in seizures within 7 to 14 days
following MMR vaccination.” Id. at 124.
       While the epidemiologic studies reached a consensus that seizures were
increased in the second week after the MMR vaccination, two studies found some
evidence of an increased incidence within the first week. In the first study,
researchers from the Centers for Disease Control and Prevention Vaccine Safety
Datalink Working Group consulted information contained in the Vaccine Safety
Datalink project, which collects information from health maintenance
organizations. These researchers determined that the relative risk for experiencing
a febrile seizure within 1-7 days of an MMR vaccination was 1.73 with a 95%
confidence interval of 0.72-4.15. Exhibit 24 (William E. Barlow et al., The Risk of
Seizures after Receipt of Whole-Cell Pertussis or Measles, Mumps, and Rubella
Vaccine, 345 No. 9 N. Engl. J. Med. 656 (2001)) at 659 (table 1).
      In the second study, Danish researchers analyzed more than a half million
computerized medical records of children born in Denmark from 1991 through
1998. This group found that the relative risk for febrile seizures in the week after
MMR vaccination was 2.46 with a 95% confidence interval of 2.22-2.73. Exhibit
NN (Mogens Vestergaard et al., MMR vaccination and febrile seizures: evaluation
of susceptible subgroups and long-term prognosis, 292 No. 3 JAMA 351 (2004)) at
353.

                                         31
       In response to the studies, the Secretary offered some criticisms through the
report and testimony of Dr. Holmes. Exhibit CCC; Tr. 406-08, 489-90. This
critique shows that the studies are not perfect, but perfection is not the standard.
Epidemiologic studies can undermine a petitioner’s claim that a vaccine caused an
injury. See, e.g., Heddens v. Sec'y of Health & Human Servs., No. 15-734V, 2018
WL 5726991, at *3 (Fed. Cl. Spec. Mstr. Oct. 5, 2018), mot. for rev. denied, 143
Fed. Cl. 193 (2019). Here, these two studies support a finding that the MMR
vaccine can cause febrile seizures toward the end of the first week following
vaccination.

        Further support for the finding that the MMR vaccination can cause an
adverse event in as few as five days after the vaccination is found within the
Vaccine Injury Table. There, the Secretary has indicated that the MMR
vaccination is the presumptive cause of an encephalopathy — as defined in the
regulation — that develops 5-15 days after vaccination. 42 C.F.R. § 100.3(a)
¶ (III)(B) (2011). The regulatory definition of encephalopathy does not encompass
Y.Q.’s presentation on April 1, 2008. For instance, Y.Q. did not suffer an
extended loss of consciousness. However, it seems likely that the process by
which MMR vaccine can cause an injury as severe as an encephalopathy in five
days could also cause a less severe injury (a febrile seizure) in 4.5 days. As Dr.
Shafrir explained, there is not much biological difference between an injury
appearing four days after vaccination and five days after vaccination. Tr. 137-38,
176. The analogy between febrile seizures and encephalopathy is strengthened by
decisions of special masters that found febrile seizures were a manifestation of an
encephalopathy under the earlier and broader definition of the term
“encephalopathy.” Fuller v. Sec’y of Health & Human Servs., No. 90-3709V,
1996 WL 65734, at *8 (Fed. Cl. Spec. Mstr. Jan. 31, 1996) (respondent’s expert
conceded that the child-vaccinee “suffered seizures following her DPT vaccination
and that these seizures constituted an encephalopathy”); Cepeda v. Sec’y of Health
& Human Servs., No. 90-2664V, 1994 WL 390352, at *5 (Fed. Cl. Spec. Mstr.
July 12, 1994) (citing cases).

      Finally, non-binding precedent supports a finding that four days is an
appropriate interval to infer that MMR vaccine caused a febrile seizure. One
example is Cusati v. Sec’y of Health & Human Servs., No. 99-492V, 2005 WL
4983872, at *2-3 (setting out chronology of events), *10 (finding entitlement)
(Fed. Cl. Spec. Mstr. Sept. 22, 2005).

                                         32
      For all these reasons, the petitioners have established that the MMR vaccine
can cause febrile seizures appearing as early as four days after the vaccination.19
And, because Y.Q.’s febrile seizure occurred approximately 4.5 days after
vaccination, the petitioners have established the third prong of Althen.

III.   Prong two - Logical Sequence of Cause and Effect
        The remaining prong from Althen is to demonstrate that the MMR vaccine
did cause Y.Q.’s febrile seizure. The undersigned has already found that the MMR
vaccine can cause febrile seizures on the fourth day after vaccination. Therefore, it
is a relatively short step to finding that the MMR vaccine was causal in Y.Q.’s
case. Dr. Shafrir’s testimony on this point carries the burden of proof. Tr. 178-90.

IV.    Sequela
       Although the Quinoneses, by establishing the Althen prongs, have
demonstrated that the MMR vaccine was the cause-in-fact of Y.Q.’s febrile
seizure, the Quinoneses also must demonstrate that Y.Q.’s injury lasted for more
than six months. In other words, the Quinoneses bear the burden of proving that
the febrile seizure caused a lasting consequence. Hellebrand v. Sec'y of Health &
Human Servs., 999 F.2d 1565, 1570 (Fed. Cir. 1993) (once the initial injury has
been established, petitioner must establish by a preponderance of the evidence that
the initial injury caused the sequela). This question is the most beguiling issue in
the case.
      Citing the same two epidemiologic studies that analyzed the rate of febrile
seizures in the first week after MMR vaccination, the Secretary stated that: “The
long-term rate of epilepsy was not increased in children who had febrile seizures

       19
           Drawing lines between an appropriate temporal interval and an inappropriate temporal
interval is difficult. See Paluck v. Sec'y of Health & Human Servs., 104 Fed. Cl. 457, 482
(2012) (ruling that the special master should not have set a “hard and fast” deadline of two
weeks), aff’d, 786 F.3d 1373, 1384 (Fed. Cir. 2015) (holding that the special master erred in
setting a “hard and fast” deadline of three weeks).
        However, the evidence, while nearly balanced, tips in favor of a finding that four days is
appropriate. Having made this finding, the undersigned is not sure that three days would be
appropriate. See Austin v. Sec’y of Health & Human Servs., No. 10-362V, 2012 WL 592891, at
*6 n.15 (Fed. Cl. Spec. Mstr. Jan. 24, 2012) (deferred ruling on motion for interim fees and
noting that a claim that MMR vaccine caused a seizure 24-48 hours later may not be supported
by reasonable basis); but see Austin v. Sec'y of Health & Human Servs., No. 10-362V, 2013 WL
659574, at *11 (Fed. Cl. Spec. Mstr. Jan. 31, 2013) (granting motion for final fees and
concluding that there was an “extremely weak” reasonable basis until petitioner could not obtain
a favorable expert report).
                                                33
following MMR vaccination compared with children who had febrile seizures of a
different etiology.” 80 Fed. Reg. at 45139 (citing Vestergaard and Barlow). The
Secretary declined to list febrile seizures on the proposed Vaccine Injury Table
because they “only very rarely have long term consequences.” Id. at 45140. Of
course, petitioners can be awarded compensation on off-Table claims before the
Secretary determines than a vaccine-injury combination has reached the threshold
to be included on the Vaccine Injury Table.
       The Secretary’s acknowledgment that febrile seizures produce long-term
consequences “very rarely” implies that febrile seizures can lead to lasting
problems. In his Notice of Proposed Rulemaking, the Secretary did not define the
situation or situations in which febrile seizures could cause long-term
consequences. Instead, the Secretary left this determination to be made on a “case-
by-case basis,” again with the implication that some cases can establish long-term
consequences from febrile seizures. Id.20
       Here, the Secretary retained an expert, Dr. Holmes, who opined that the
April 1, 2008 febrile seizure did not carry a lasting consequence for Y.Q. In
contrast, the Quinoneses’s expert, Dr. Shafrir, saw the April 1, 2008 febrile seizure
as a turning point in her life. Overall, both parties could have advanced their
positions more effectively by developing evidence in more detail.21

       Sources of information about Y.Q.’s functioning after the April 1, 2008
febrile seizure include records from Kids Care Pediatric, Dr. Palevsky, Stony
Brook University Hospital, and Y.Q.’s mother’s testimony. The earliest material
comes from Y.Q.’s traditional pediatrician. The day after the febrile seizure, the
doctor recorded a chief complaint that Y.Q. was “cranky [with] different
behavior.” Exhibit 6 at 11. Yet, at the same time, her neurologic exam was
normal.

      More details are found in the records Dr. Palevsky created. The
Quinoneses’s decision to have Y.Q. treated by a holistic doctor, Dr. Palevsky,
increases the difficulty in determining whether the April 1, 2008 febrile seizure
caused lasting consequences. Nevertheless, Dr. Palevsky’s records show that by

       20
           Because this case does not present a legal question about the meaning of a regulation,
this case does not implicate deference to an agency’s interpretation. See Kisor v. Wilkie, 139 S.
Ct. 2400 (2019).
       21
          The relative thinness of the parties’ evidentiary development is consistent with the
parties’ post-hearing memoranda in which each party devoted less than one page to this issue.
See Pet’rs’ Br. at 11; Resp’t’s Resp. at 7.
                                               34
May 5, 2008 (or slightly more than one month after the febrile seizure), Y.Q. had
“tantrums, fevers, aggression less interaction, restlessness [and] does not cuddle.”
Exhibit 7 at 20. Y.Q. continues to be plagued by tantrums and aggressiveness
years later.

       To be sure, Dr. Palevsky’s records note some improvements with Y.Q. See,
e.g., exhibit 7 at 12 (June 10, 2008: “good eye contact, interactive”). However,
this improvement is tempered by the presence of “head banging,” “biting,” and
“hair pulling.” Id.; see also id. at 13 (July 7, 2008: “head banging … continues”).

       In addition, when Y.Q. was discharged following her second seizure, the
discharge report indicates that the neurologists considered her to be neurologically
“intact.” Exhibit 9 at pdf 24-26. Similarly, after the third seizure on April 3, 2009,
the treating neurologist found her neurologically normal. Exhibit 11 at pdf 99 /
284; see also Tr. 245, 447.

       Y.Q.’s improvements do not preclude a finding that the April 1, 2008 febrile
seizure carried long-term consequences. Dr. Shafrir explained that the symptoms
in a person with autoimmune epilepsy or autoimmune encephalitis wax and wane.
Tr. 283, 514-15. This testimony is persuasive. See Moriarty v. Sec'y of Health &
Human Servs., 130 Fed. Cl. 573, 575 (2017) (“After [the vaccinee’s] seizures
ended, she continued to receive treatment for deficits in language, attention,
memory, and other skills”); Fuller, 1996 WL 65734, at *10 (“While “[the
vaccinee’s] developmental delay was not immediately apparent [following her
encephalopathy],[] by the time she was called upon to express herself verbally, all
care providers noted [her] language delay. Later, her attention deficit disorder and
hyperactivity, as well as behavior problems, and some fine and gross motor deficits
were noted”); Lurtz v. Sec’y of Health & Human Servs., No. 90-1703V, 1998 WL
321926 (Fed. Cl. Spec. Mstr. June 4, 1998); Clark v. Sec'y of Health & Human
Servs., No. 90-537V, 1991 WL 33243, at *6 (Cl. Ct. Spec. Mstr. Feb. 25, 1991);
but see Finley v. Sec'y of Health & Human Servs., No. 00-405V, 2002 WL
1488758, at *11 (Fed. Cl. Spec. Mstr. May 29, 2002), mot. for rev. denied, 55 Fed.
Cl. 355 (2003), app. dismissed, 60 F. App'x 801 (Fed. Cir. 2003).

       In short, the evidence about any sequela to Y.Q.’s April 1, 2008 febrile
seizure is relatively thin. While the evidence is not especially conclusive, “clear
and convincing” is not the evidentiary threshold. Instead, the evidentiary threshold
is merely a preponderance of the evidence and the Quinoneses have passed that
measure. Cf. Althen, 418 F.3d at 1280 (“close calls regarding causation are
resolved in favor of injured claimants”). The sequela have satisfied the six-month
severity requirement. Accordingly, the Quinoneses are entitled to compensation.
                                          35
                                   Conclusion

       The Federal Circuit has stated that compensation is appropriate when a
petitioner can provide evidence of a reputable medical theory attributing the
vaccinee’s injury to the vaccination, evidence of an appropriately proximate
temporal relationship between the two, and evidence that the causal association is
logical. The Quinoneses have met this standard and, therefore, are entitled to
compensation on behalf of Y.Q. under the Vaccine Act.

      An order regarding damages will be issued shortly.

      IT IS SO ORDERED.
                                             s/Christian J. Moran
                                             Christian J. Moran
                                             Special Master

                                        36