Quinones v. Secretary of Health and Human Services

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