Braun v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 17-1571V

(not to be published)

************************* Special Master Corcoran

MICHAEL BRAUN, on behalf of son H.B., *

a minor, * Filed: January 25, 2019

Petitioner, *

v. *

*

SECRETARY OF HEALTH *

AND HUMAN SERVICES, * Dismissal of Petition; Vaccine Act;

* Denial Without Hearing; FluMist

Respondent. * Vaccine; Encephalopathy;

* Developmental Delay.

*************************

Joseph P. Shannon, Shannon Law Group, P.C., Woodbridge, IL, for Petitioner.

Daniel A. Principato, U.S. Dep’t of Justice, Washington, DC, for Respondent.

DECISION DISMISSING PETITION1

On October 20, 2017, Michael Braun filed a petition seeking compensation under the

National Vaccine Injury Compensation Program (the “Vaccine Program”) on behalf of his minor

son, H.B.2 In it, Petitioner alleged that H.B. developed an encephalopathy and resulting

developmental delays following his receipt of the FluMist influenza (“flu”) vaccine on October

22, 2014. See generally Petition (ECF No. 1) (“Pet.”).

1

Although I am not formally designating this Decision for publication, it will nevertheless be posted on the Court of

Federal Claims’s website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means

the Decision will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B),

however, the parties may object to the Decision’s inclusion of certain kinds of confidential information. Specifically,

under Vaccine Rule 18(b), each party has fourteen days within which to request redaction “of any information

furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or

confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly

unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the Decision in its present form will be available.

Id.

2

The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,

100 Stat. 3758, codified as amended, 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the

Act”]. Individual section references hereafter will be to § 300aa of the Act.

Summation of Relevant Facts

H.B. was born on May 16, 2006. Ex. 1 at 5. It appears from the filed records that H.B.

was relatively healthy and developing normally during his first year of life. The records reveal

treatment for various illnesses (including ITP, a skin rash, and Lyme disease). See id. at 114,

126, 236-39, 254, 271.

During H.B.’s eighteen-month check-up on November 16, 2007, his treating pediatrician

assessed him with a speech delay and 2-3 word jargon. Ex. 1 at 131. His two-year well-visit

exam notes included a similar finding. Id. at 138 (H.B.’s speech was on a 15-18 month level).

Speech delays were noted again during both his three-year and four-year well-child

appointments. Id. at 139-41. His four-year visit also noted sensory issues. Id. at 141.

At a five-year well-child visit on May 20, 2011, H.B.’s pediatrician assessed him with a

“listening comprehension disability” in addition to speech concerns. Ex. 1 at 274. Records also

indicated that H.B. started occupational therapy in February 2011 for decreased visual motor

integration, visual perception, and motor coordination. Id. at 1522-23. Preschool assessment

records included in the pediatrician’s file indicated that H.B.’s language and writing skills were

in the low range. Id. at 1468-69. H.B.’s six, seven, and eight-year well-visits continued to note

that H.B. was attending occupational and speech therapy for the above-noted concerns. Id. at

280, 287-88, 291-92.

H.B. was eight-years-old when he received the FluMist vaccine on October 22, 2014. Ex.

1 at 2. No adverse symptoms were noted at the time of vaccine administration. H.B.’s next

medical visit following his receipt of the FluMist vaccine nearly two months later, occurred on

December 15, 2014. H.B. presented to a neurologist for “evaluation of his inattention” and

learning disabilities. Ex. 1 at 219. He was assessed with ADHD, inattentive type. Id. at 220. The

records from this December 2014 visit make no mention of any concerns or symptoms from the

time of the vaccine at issue. See id. at 219-20. Thereafter, on January 28, 2015, H.B. presented

to his pediatrician with complaints of speech, recall, and slight motor regression, though

treatment notes indicated “no obvious signs of increasing . . . regression.” Id. at 302-03. H.B.

was assessed with “[l]earning difficulties” and possible underlying developmental delay. Id. at

303.3

Neurodevelopmental evaluations conducted on February 18, 2015, and February 21,

2015, noted a history of “[r]egression in skills” with onset in November-December 2014, though

the exam also noted H.B.’s caretakers reported that he had experienced processing issues and

academic struggles from an early age. Ex. 1 at 170-71. His receipt of the FluMist vaccine was

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School assessment records from close-in-time to vaccination administration note that H.B.’s parents were concerned

that he was regressing further in both speech/language and the ability to follow directions. See Ex. 1 at 1599-1600

(evaluation from November 24, 2015), 1605 (February 5, 2015 letter from speech therapist noting an increase in

regression and focusing issues since the school year started).

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included in the health history, but it was noted that H.B. exhibited no signs of a reaction. Id. at

173. The examination revealed below average processing/memory skills and “severe” fine

motor/visual motor deficits, along with below average gross motor and language skills. Id. at

177-79. The impression included progressive neurodegenerative disorder, neuro-metabolic

disorder, mitochondrial disorder/abnormalities, and storage disorder. Id. at 179. An MRI

conducted on March 3, 2015, revealed normal imaging. Id. at 22.

H.B. was seen by a neurologist at Goryeb Children’s Hospital (“Goryeb Children’s”) on

March 17, 2015. Ex. 1 at 305. His past health history was significant for “developmental delays

most motor” with onset in the “first year of life” (well before the vaccination at issue). Id. at

307. His neurological exam revealed an abnormal mental status, along with motor dysfunction.

Id. The assessment included a movement disorder and developmental delay. Id. at 305. Shortly

thereafter, H.B. presented for a rheumatology consult at Goryeb Children’s. Id. at 185-89. The

health history taken during this visit (similar to those taken earlier) noted an onset of

language/speech regression and behavioral changes over the course of the year. Id. at 189. H.B.’s

receipt of the FluMist vaccine was mentioned during the visit, but notes asserted (contrary to the

medical history) the vaccination “preceded many of his symptoms according to his mother.” Id.

at 186.

An April 1, 2015, pediatric visit note indicated that H.B. was “being evaluated for

worsening ADHD symptoms.” Ex. 1 at 262. H.B.’s father reported during this visit that H.B.’s

symptoms “began soon after” receipt of the FluMist vaccine in October 2014. Id. H.B. was seen

by an infectious disease specialist at Goryeb Children’s the following day, on April 2, 2015. Id.

at 476. H.B.’s health history included an onset of deterioration in handwriting and concentration

at the beginning of the 2014 school year. Id. Notes indicate that the specialist considered

diagnoses of Sydenham’s chorea and PANDAS, but did not arrive at a firm conclusion. Id.

Subsequent evaluations during June 2015 show further discussion of a movement disorder

diagnosis, as well as post-acute immune syndrome, and active Lyme disease. Id. at 168. The

record also reveals that H.B. was hospitalized for psychosis (including episodes of crying,

uncontrolled screaming, and hallucinating) during the first week of June 2015. Id. at 565-70.

Notably, this hospital record also referenced a concern for autism. Id. at 566. An MRI conducted

during the hospitalization revealed normal imaging. Id. at 1000-01.

H.B. was seen by another neurologist, Dr. Rosario Triffiletti, in April 2015 for further

evaluation of his overall health course. Ex. 1 at 1151, 1153, 1159-60. Exam notes from an April

22, 2015 visit included a reference to an undated “flu vaccine[,]” but offered no opinion

regarding its relationship to H.B.’s symptoms. See id. at 1160. The April 22nd note also included

a concern for separation anxiety and speech delay. Id. Notes from a November 20th visit

mentioned a “dx autoimmune encephalopathy[,]” but similarly included no description or

opinion regarding onset or trigger. Id. at 1153. Follow-up visits with Dr. Triffiletti also indicated

concerns for additional diagnoses including anxiety, OCD behaviors, and autism. Id. at 1152

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(December 20, 2016 note indicating concern for anxiety and OCD behaviors), 1150 (May 30,

2017 note indicating “ASD progressing”). The records from visits with Dr. Triffiletti indicate

H.B. was treated with IVIG for a number of months. See, e.g., Ex. 1127, 1150, 1152, 1174.

The final record of note is dated October 17, 2016, and references an additional neurology

consult from Children’s Hospital of Pennsylvania (“CHOP”). Ex. 1 at 379-84. H.B.’s health

history included regression (with onset in 2014), PANDAS, ADHD, Lyme disease, and

Sydenham’s chorea. Id. at 379-80. It was also noted that he was receiving IVIG treatment from

Dr. Triffiletti for possible PANDAS. Id. at 380. The differential diagnoses included autoimmune

encephalitis and genetic/metabolic disorder. Id. at 384. Lab testing conducted during a follow-

up visit at CHOP, however, revealed negative serum NMDA and Mayo autoimmune

encephalitis panels. Id. at 830-31. An additional brain MRI conducted in November 2016 was

unremarkable. Id. at 830.

Procedural History

Petitioner originally filed this petition pro se, but upon motion to substitute counsel,

Joseph Shannon became the attorney of record on January 23, 2018 (ECF No. 11). Counsel filed

the majority of H.B.’s medical records in May 2018. See ECF Nos. 16-21. Thereafter,

Respondent filed the Rule 4(c) Report on July 31, 2018, contesting Petitioner’s right to an

entitlement award. See Respondent’s Report, filed July 31, 2018 (ECF No. 25). Specifically,

Respondent asserted that the filed medical records did not support Petitioner’s contention that

H.B. suffered from an acute encephalopathy close-in-time to receipt of the FluMist vaccination.

The report similarly revealed that H.B. had experienced developmental problems in the years

prior to vaccination (as early as 2008).

Following the filing of records and the Rule 4(c) Report, I held a status conference with

the parties on August 23, 2018, at which time I outlined my concerns to Petitioner about his

claim’s viability. See Order, dated Aug. 23, 2018 (ECF No. 26) (“August 23rd Order”). Given

the existence of numerous other decisions pursuing theories similar to the one proposed herein

(involving a claimed injury of a developmental problems after an encephalopathic event), I

impressed upon Petitioner my strongly-held view that his claim likely faced reasonable basis

problems given its overall nature. Id. at 1-2. In particular, the record did not support his assertion

that H.B. had experienced any type of encephalopathic reaction to the FluMist vaccine he

received, or that his developmental regression was more than temporally related to any symptom

alleged to be vaccine-induced. Moreover, I noted that H.B.’s treaters expressed concern for

developmental regression in the years prior to his receipt of the FluMist vaccine. Thus, based

on record evidence, it did not appear likely that Petitioner could demonstrate that the FluMist

vaccine initiated (or worsened) any of the adverse symptoms H.B. experienced thereafter.

In light of the above, I set a deadline for Petitioner to show cause why his claim should

not be dismissed. See August 23rd Order at 2. I urged counsel to cite to H.B.’s filed medical

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records (including any evidence of acute encephalopathic reaction close-in-time to vaccination),

and to differentiate this claim from others that have been unsuccessfully litigated the in Program.

Id.

Parties’ Respective Arguments

Petitioner filed a brief responding to my Show Cause Order on October 10, 2018. See

Brief in Support of Reasonable Basis, filed Oct. 10, 2018 (ECF No. 27-1) (“Brief”). In it,

Petitioner argues that H.B.’s school record evidences a “severe regression in H.B.’s speech and

gross motor skills, and neurologic function” within approximately two weeks of his receipt of

the FluMist vaccine. Id. at 1 (citing Ex. 1 at 1568; Affidavit of Michael Braun, dated May 1,

2018, filed as Ex. 1 at 1443-45 (ECF No. 21)). For additional support, Petitioner cites to medical

record evidence (importantly, dated over one year post-vaccination) indicating H.B.’s treating

neurologist, Dr. Triffiletti, diagnosed him with an encephalopathic reaction “with sudden onset

following an influenza vaccine,” and resulting in various developmental problems. Id. (citing

Ex. 1 at 916; Ex. 3 at 1).

Petitioner next offered case law in support of his argument that his claim has reasonable

basis to proceed. Brief at 9-12 (citing Spahn v. Sec’y of Health & Human Servs., No. 09-386V,

2014 WL 12721080 (Fed. Cl. Spec. Mstr. Sept. 11, 2014), mot. for review den’d, 133 Fed. Cl.

588 (2017)). In Spahn, the presiding special master allowed a facial tics/Td vaccine claim to

proceed to the expert stage (due primarily to opposing counsel’s argument that petitioner could

not satisfy the Althen one prong). Nevertheless, Petitioner argues the record evidence in the

present matter is factually similar to the evidence offered in Spahn, and he thus asks that I allow

him to file an expert report in support of his claim.4

Petitioner also submitted additional medical records in support of his claim. See ECF No.

27-2 (undated letter from school speech pathologist indicating that H.B. appeared to regress in

language skill around December 2014); ECF No. 27-3 (August 3, 2018 letter from Dr. Triffiletti

noting that H.B. has been treated for autoimmune encephalopathy following receipt of the

FluMist vaccine). Two medical articles discussing encephalopathy following influenza A/B

infection (but not vaccination) also accompanied Petitioner’s show cause brief. See generally

Ex. 4 & 5. In addition, Petitioner cites to various cases in the Program awarding entitlement for

a FluMist-induced vaccine injury. Id. at 12-13 (citing L.A. v. Sec’y of Health & Human Servs.,

No. 12-629V, 2016 WL 7664473 (Fed. Cl. Spec. Mstr. Dec. 15, 2016) (awarding entitlement

for FluMist/encephalitis injury with two-day onset); Agnew v. Sec’y of Health & Human Servs.,

No. 12-551V, 2016 WL 1612853 (Fed. Cl. Spec. Mstr. Mar. 30, 2016) (awarding entitlement

for FluMist/acute hepatitis injury with ten-day onset); Day v. Sec’y of Health & Human Servs.,

4

Petitioner’s brief further indicates that counsel spoke with Dr. Lawrence Steinman (prior to filing the claim).

According to counsel, Dr. Steinman reviewed the case file and informed counsel that the facts of the present matter

could plausibly support a Program claim. Brief at 12-13.

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No. 12-551, 2015 WL 8028393 (Fed. Cl. Spec. Mstr. Nov. 13, 2015) (awarding entitlement for

HPV/FluMist/neuromyelitis optica injury with three-day onset)).5

Respondent filed a response on November 9, 2018. See Response, dated Nov. 9, 2018

(ECF No. 29). Respondent maintains that Petitioner has offered no contemporaneous medical

record evidence credibly establishing that H.B. suffered an encephalopathy following his

October 2014 vaccination. Id. at 3-4. In particular, Respondent argues that the treater statements

offered by Dr. Trifilletti to be unpersuasive given the year-long gap between his medical

evaluation and Petitioner’s alleged injury. Id. Accordingly, Respondent asserts that the

documented medical record evidences nothing more than a weak temporal relationship between

receipt of the FluMist vaccine and onset of developmental regression thereafter, assuming that

onset of H.B.’s developmental problems did not in fact actually begin well before he received

the vaccine at issue. Id. at 4.

ANALYSIS

To receive compensation under the Vaccine Program, a petitioner must prove either (1)

that he suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table –

corresponding to one of his vaccinations, or (2) that he suffered an injury that was actually

caused by a vaccine. See §§ 13(a)(1)(A) and 11(c)(1). An examination of the record, however,

does not uncover any evidence that H.B. suffered a “Table Injury.” Accordingly, Petitioner seeks

to establish entitlement via a causation-in-fact, non-Table claim – meaning he must meet the test

for such a claim set forth by the Federal Circuit in Althen v. Sec’y of Health & Human Servs.,

418 F.3d 1274 (Fed. Cir. 2005).

Petitioner has had several chances to offer evidence into the record that would support his

claim. The record, however, does not contain sufficient persuasive evidence establishing that

H.B.’s developmental problems were initiated by the FluMist vaccine via the theory proffered

herein. (see § 11(c)(1)(C)(i)-(ii)). Thus, after careful review of the medical records and

Petitioner’s filings, I conclude that Petitioner will not be able to establish preponderant evidence

in favor of his claim, and therefore the matter should not proceed any further.

My decision is rooted in both the facts of this case as well as applicable decisions in

previously-litigated matters involving causation theories highly similar to the present. See, e.g.,

Austin v. Sec’y of Health & Human Servs., No. 5-579V, 2018 WL 32386608 (Fed. Cl. Spec.

Mstr. May 15, 2018), aff’d, slip op (Fed. Cl. Oct. 23, 2018); R.V. v. Sec’y of Health & Human

Servs., No. 08-504V, 2016 WL 3882519 (Fed. Cl. Spec. Mstr. Feb. 19, 2016), mot. for review

den’d, 127 Fed. Cl. 136 (2016). The theory that vaccines can cause developmental injuries (in

the absence of strong proof of encephalopathy) have rarely been successful in the Program, and

I find no compelling reason here to diverge from those holdings. Petitioner has not offered

5

Counsel also filed five videos taken of H.B. by his father. See ECF No. 28.

6

evidence showing how H.B.’s case is factually different from those already decided.

In particular, there is a lack of medical record evidence close-in-time to H.B.’s receipt of

the FluMist vaccine supporting Petitioner’s contention that H.B. experienced an acute

encephalopathic reaction. Counsel maintains that H.B.’s regression was first seen by school

officials, as evidenced by an educational assessment dated November 25, 2014 (over one month

following H.B.’s receipt of the FluMist vaccine), and a speech evaluation (dated over two

months post-vaccination). Brief at 3; Ex. 1 at 1586 (IEP note indicating H.B. was struggling to

process information); Ex. 2 at 1 (speech note indicating regression in oral motor function).

Notably, however, medical visits close-in-time to H.B.’s receipt of the FluMist vaccine make no

mention of any encephalopathic reaction. See, e.g., Ex. 1 at 219-20 (December 15, 2014

assessment of ADHD, inattentive type), 302-03 (January 28, 2015 assessment for speech and

fine motor regression following diagnosis of ADHD).

Admittedly, the record does evidence some treater concern for regression following

receipt of the FluMist vaccine, but such records evidence nothing more than a temporal

relationship between vaccination and injury (given the lack of record support for an acute

encephalopathic reaction). See, e.g., Ex. 1 at 168, 170-73, 177-79, 271, 262, 305, 565-66; see

also Austin, 2018 WL 3238608, at *23-24 (discussing the medical record evidence necessary to

establish a non-Table encephalopathy claim). Moreover, such records must be weighed against

the substantial medical evidence strongly suggesting that H.B. had experienced developmental

problems long before the vaccination. See, e.g., Ex. 1 at 139-41, 141, 274, 281, 288, 307.

The record next reveals that H.B. was hospitalized in late May 2015 for various adverse

symptoms (including screaming episodes, visual/auditory hallucinations, and generalized

distress). See Ex. 1 at 966 (May 20, 2015 hospitalization record). Notably, H.B.’s hospital record

revealed a concern for psychosis and autism. Id. at 565-66. A closer examination of the record,

however, reveals that no hospital treater opined that H.B. had experienced an encephalopathic

reaction induced by a vaccine. In addition, evidence that could corroborate that an

encephalopathy did in fact occur at this time, such as an MRI, revealed no abnormalities that

might corroborate this assertion. See Ex. 1 at 1000-01.

As noted above, H.B. was first diagnosed with an encephalopathy by Dr. Triffiletti in

November 2015 (over one year after his receipt of the Flumist vaccine). Ex. 1 at 1150-53.

Admittedly, records from a November 4, 2015 visit indicate that H.B. was assessed with an

encephalopathic reaction. Id. at 1153. The November 4th record, however, makes no mention of

H.B.’s receipt of FluMist, but seems to be based on the symptoms reported from H.B.’s May

2015 hospitalization—over six months from the date of vaccination. See id. A later-in-time

letter, dated August 3, 2018, and authored by Dr. Triffiletti, clarified that he assessed H.B. with

an autoimmune encephalopathy following receipt of the FluMist vaccine in 2014 (Ex. 3 at 1).

Based on my overall assessment, however, Dr. Triffilett’s opinion regarding causation seems to

7

be based primarily on the health history provided by H.B.’s caretakers (as it is clear from the

record that the he did not examine H.B. until over one-year post-vaccination). In addition, the

disparity between Dr. Triffiletti’s notes from 2015 and his more recent 2018 letter further call

into question the reliability of any association of H.B.’s symptoms to the Flumist vaccine. Such

evidence cannot establish a causal link between an injury and a vaccination.

The remaining records make no mention of any purported vaccine-induced injury (nor do

they attempt to link H.B.’s alleged encephalopathic reaction to any symptoms he experienced).

Notably, as emphasized above, multiple filed records also reflect that H.B.’s treaters expressed

concern for developmental problems prior to his receipt of the FluMist vaccine in 2014. See,

e.g., Ex. 1 at 131, 138-39; see also Ex. 1 at 271-74, 1522-23, 1467-69. Although Petitioner

directly disputes any assertion that these earlier-in-time records are related to the onset of H.B.’s

injuries alleged herein, Petitioner did not offer persuasive medical or scientific support analyzing

these records and distinguishing H.B.’s symptoms from those alleged to be vaccine-caused.

Furthermore, the case law cited by Petitioner in attempts to bolster the claim is not

supportive of a finding of reasonable basis to proceed. Petitioner cites to Spahn (involving a

claimed injury of tics induced by the Td vaccine), but in that case the special master ordered

expert reports based on a dispute regarding the ability of the Td vaccine to cause tics (as it relates

to the Althen one prong). See Spahn, 2014 WL 12721080, at *4. And as I have discussed

extensively above, this case’s deficiencies center on the lack of persuasive medical record

evidence supporting Petitioner’s contention that H.B. experienced a vaccine-induced

encephalopathic reaction. Spahn is thus unhelpful to Petitioner as it does not explain why I

should allow him to proceed with this case in light of such a deficiency. The remaining cases

(L.A., Agnew, and Day) involve injuries that are distinguishable from those alleged herein (or

involve an onset significantly closer-in-time to the alleged injury). More importantly, these cases

involved at least some persuasive medical record evidence supporting the various theories

alleged therein (unlike the present matter).

Ultimately, the medical record itself is fatal to Petitioner’s claim. The record contains

unexplained and unrebutted facts that suggest either H.B.’s injuries predated vaccination, or that

they are attributable to an entirely different illness (given the multiple differential explanations

noted in his overall health course). But most importantly, the record contains no evidence of an

encephalopathic injury close-in-time to H.B.’s receipt of the FluMist vaccine, and the treater

statements offered over one year post-vaccination are not persuasive given the extensive

contemporaneous record. An expert opinion would not aid Petitioner in light of this absence.

The plain record itself, without such further supplementation or substantiation, does not support

Petitioner’s claim, and therefore I cannot rule in his favor based upon the record as it stands.

Given the above, the claim as alleged lacks reasonable basis, and is appropriately

dismissed. In so doing, I am aware of Petitioner’s disappointment, and his fervent desire

8

(motivated by a reasonable wish to provide good care for H.B.) to proceed with the claim. But I

must balance such concerns against the waste of judicial resources that will be occasioned by

allowing this matter to go forward. My experience with similar claims tells me (based on review

of the record) that this claim will not succeed where countless others failed. Because Petitioner

has not – despite due opportunity – shown otherwise, I must DISMISS his claim.

In the absence of a timely-filed motion for review (see Appendix B to the Rules of the

Court), the Clerk SHALL ENTER JUDGMENT in accordance with this decision.6

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Special Master

6

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their

right to seek review.

9