VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-01571 Package ID: USCOURTS-cofc-1_17-vv-01571 Petitioner: H.B. Filed: 2019-01-25 Decided: 2019-07-15 Vaccine: FluMist Vaccination date: 2014-10-22 Condition: encephalopathy and resulting developmental delays Outcome: denied Award amount USD: AI-assisted case summary: Michael Braun filed a petition on January 25, 2019, on behalf of his minor son, H.B., alleging that H.B. developed encephalopathy and resulting developmental delays after receiving the FluMist influenza vaccine on October 22, 2014. H.B., born May 16, 2006, had a history of speech delays and sensory issues noted from his eighteen-month well-visit. By age five, he was diagnosed with a listening comprehension disability and began occupational and speech therapy. His six, seven, and eight-year well-visits continued to note his attendance in therapy. At age eight, shortly after receiving the FluMist vaccine, H.B. was evaluated for inattention and learning disabilities, diagnosed with ADHD, and noted to have speech, recall, and slight motor regression. Subsequent evaluations noted regression in skills, processing issues, and severe fine motor/visual motor deficits. Concerns for progressive neurodegenerative disorder, neuro-metabolic disorder, and mitochondrial disorder were raised. A hospitalization in June 2015 for psychosis included a concern for autism. Dr. Rosario Trifiletti later diagnosed H.B. with autoimmune encephalopathy, believing it was related to the vaccine, though his notes were inconsistent and the onset was over a year post-vaccination. The Special Master, Brian H. Corcoran, dismissed the petition, finding no evidence of an acute encephalopathic reaction close in time to the vaccination and noting substantial evidence of developmental problems predating the vaccine. The Special Master noted that Petitioner had several chances to offer evidence but the record did not contain sufficient persuasive evidence establishing that H.B.'s developmental problems were initiated by the FluMist vaccine. He concluded that Petitioner would not be able to establish preponderant evidence in favor of his claim. The court, Judge Patricia E. Campbell-Smith, affirmed the Special Master's decision on July 15, 2019, finding that the Special Master did not err in applying the correct legal standards, in dismissing the case without an expert report, or in considering the pre-vaccination medical records. The court concluded that the Special Master's decision was not arbitrary, capricious, or otherwise not in accordance with law. The petition was denied. Theory of causation field: Petitioner alleged that H.B., born May 16, 2006, developed encephalopathy and developmental delays following receipt of the FluMist vaccine on October 22, 2014. The theory of causation was that the FluMist vaccine caused an acute encephalopathic reaction leading to developmental regression. The Special Master, Brian H. Corcoran, dismissed the petition, finding a lack of evidence of an acute encephalopathic reaction close in time to the vaccination and substantial evidence of developmental problems predating the vaccine. The Special Master noted that Petitioner had not established preponderant evidence for his claim, particularly the lack of persuasive medical record evidence supporting an acute encephalopathic reaction close in time to vaccination. Dr. Rosario Trifiletti's opinion of autoimmune encephalopathy over a year post-vaccination was deemed not persuasive due to inconsistencies and the significant time lapse. The court affirmed, finding no error in the Special Master's application of legal standards, dismissal without an expert report, or consideration of pre-vaccination records. The court concluded the decision was not arbitrary, capricious, or otherwise not in accordance with law. The case was denied. Petitioner's counsel was Joseph P. Shannon. Respondent's counsel was Daniel A. Principato. Special Master was Brian H. Corcoran. Judge was Patricia E. Campbell-Smith. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_17-vv-01571-0 Date issued/filed: 2019-03-01 Pages: 9 Docket text: PUBLIC DECISION (Originally filed: 1/25/2019) Regarding 30 DECISION of Special Master (Signed by Special Master Brian H. Corcoran). (cr) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-01571-PEC Document 33 Filed 03/01/19 Page 1 of 9 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. Case 1:17-vv-01571-PEC Document 33 Filed 03/01/19 Page 2 of 9 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 3 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). 2 Case 1:17-vv-01571-PEC Document 33 Filed 03/01/19 Page 3 of 9 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 3 Case 1:17-vv-01571-PEC Document 33 Filed 03/01/19 Page 4 of 9 (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 4 Case 1:17-vv-01571-PEC Document 33 Filed 03/01/19 Page 5 of 9 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. 5 Case 1:17-vv-01571-PEC Document 33 Filed 03/01/19 Page 6 of 9 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 Case 1:17-vv-01571-PEC Document 33 Filed 03/01/19 Page 7 of 9 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 Case 1:17-vv-01571-PEC Document 33 Filed 03/01/19 Page 8 of 9 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 Case 1:17-vv-01571-PEC Document 33 Filed 03/01/19 Page 9 of 9 (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 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_17-vv-01571-1 Date issued/filed: 2019-07-18 Pages: 11 Docket text: JUDGE VACCINE REPORTED OPINION originally issued under seal on 6/19/2019, see 35 Opinion/Order denying 31 Motion for Review; and sustaining the Special Master's decision. Signed by Judge Patricia E. Campbell-Smith. (TQ) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-01571-PEC Document 38 Filed 07/18/19 Page 1 of 11 In the United States Court of Federal Claims No. 17-1571V (E-Filed: July 15, 2019)1 ____________________________________ ) MICHAEL BRAUN, on behalf of son ) H.B., a minor, ) Vaccine (FluMist); National ) Childhood Vaccine Injury Act of Petitioner, ) 1986, 42 U.S.C. §§ 300aa-1 to -34 ) v. ) (2012). ) SECRETARY OF HEALTH AND ) HUMAN SERVICES, ) ) Respondent. ) ____________________________________) Joseph P. Shannon, Woodridge, IL, for petitioner. Daniel A. Principato, Trial Attorney, with whom were Joseph H. Hunt, Assistant Attorney General, C. Salvatore D’Alessio, Acting Director, Catharine E. Reeves, Deputy Director, Torts Branch, Civil Division, United States Department of Justice, Washington, DC, for respondent. OPINION AND ORDER CAMPBELL-SMITH, Judge. On January 25, 2019, the special master issued his decision denying compensation in this vaccine case. See ECF No. 30. On February 22, 2019, petitioner, on behalf of his minor son H.B., filed: (1) a motion for review of the special master’s decision, ECF No. 31; and (2) the memorandum in support of the motion for review, ECF No. 31-1. 1 Pursuant to Rule 18(b) of the Vaccine Rules of the United States Court of Federal Claims (Appendix B to the Rules of the United States Court of Federal Claims), this opinion was initially filed under seal on June 19, 2019. Pursuant to ¶ 4 of the ordering language, the parties were to propose redactions of the information contained therein on or before July 3, 2019. No proposed redactions were submitted to the court. Case 1:17-vv-01571-PEC Document 38 Filed 07/18/19 Page 2 of 11 Respondent filed its response brief on March 22, 2019. See ECF No. 34. Petitioner’s motion is fully briefed and ripe for decision. The special master denied petitioner compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2012) (the Vaccine Act). As explained below, the special master’s entitlement decision survives this court’s review. Accordingly, petitioner’s motion for review is DENIED. I. Background Petitioner filed this case seeking compensation for an injury suffered by H.B., allegedly as the result of receiving the influenza vaccine, FluMist, at the age of eight. See ECF No. 1. In reaching his decision, the special master identified the following relevant facts.2 H.B. was born on May 16, 2006. See ECF No. 30 at 2. During his first year of life, his development appeared normal, though he was treated for several illnesses, including Lyme disease. See id. H.B. was first diagnosed with a delay in speech development by his pediatrician at his eighteen-month well-visit. See id. Similar notes were made at his two-, three-, and four-year well-visits. See id. In addition to the speech delays, his doctor noted sensory issues at H.B.’s four-year well-visit. See id. At his five- year well-visit, H.B.’s doctor assessed him with a “listening comprehension disability,” in addition to the previously noted concerns. Id. At preschool, H.B. exhibited language skills in the “low range.” Id. And his six-, seven-, and eight-year well-visits noted that H.B. was participating in occupational and speech therapy to address these concerns. See id. On October 22, 2014, H.B. received the FluMist vaccine, and experienced no immediate adverse reaction. See id. On December 14, 2014, H.B. was seen by a neurologist for an “evaluation of his inattention and learning disabilities.” Id. The neurologist appointment was H.B’s first medical appointment following administration of the vaccine. Id. The neurologist diagnosed H.B. with Attention-Deficit/Hyperactivity Disorder (ADHD), and made no mention of the vaccine in his notes. See id. On January 28, 2015, H.B. visited his pediatrician “with complaints of speech, recall, and slight motor regression,” but the doctor noted “no obvious signs of increasing . . . regression.” Id. The doctor “assessed [H.B.] with ‘[l]earning difficulties’ and possible underlying development delay.” Id. Neurological examinations on February 18 and February 21, 2015, noted a history of “[r]egression in skills” beginning in November to December 2014, and noted reports 2 For clarity of the narrative, the court has omitted the extensive citations to the record included in the special master’s decision. 2 Case 1:17-vv-01571-PEC Document 38 Filed 07/18/19 Page 3 of 11 of “processing issues and academic struggles from an early age.” Id. The fact that H.B. received the FluMist vaccine was recorded, but the notes from his neurological evaluation specifically stated that he did not show signs of any adverse reaction to the vaccine. See id. at 2-3. “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 3. The doctor recommended further consideration of “progressive neurodegenerative disorder, neuro-metabolic disorder, mitochondrial disorder/abnormalities, and storage disorder.” Id. H.B. had a magnetic resonance imaging (MRI) test on March 3, 2015, the results of which were “normal.” Id. H.B. was evaluated by both a neurologist and a rheumatologist at Goryeb Children’s Hospital in March 2015. The examinations noted H.B.’s past developmental delays and regression in the preceding year. Id. The rheumatologist cited “H.B.’s receipt of the FluMist vaccine . . . , but [the doctor’s] notes asserted (contrary to the medical history) the vaccination ‘preceded many of his symptoms according to his mother.’” Id. On April 1, 2015, H.B. was evaluated by his pediatrician for “worsening ADHD symptoms.” Id. During that visit, his father stated that H.B.’s symptoms “began soon after” he received the FluMist vaccine. Id. The next day, an infectious disease specialist evaluated H.B., and considered a diagnosis of Sydenham’s chorea or PANDAS, but did not make a final decision as to either. See id. In June, H.B.’s doctors discussed diagnoses for a movement disorder, post-acute immune syndrome, and active Lyme disease. See id. Also in June 2015, H.B. was hospitalized for psychosis, and the hospital notes suggested a concern that he is autistic. The hospital administered a second MRI, which again was “normal.” Id. In April 2015, H.B. was evaluated by another neurologist, Dr. Rosario Trifiletti.3 In an exam note dated April 22, 2015, Dr. Trifiletti referenced H.B.’s FluMist vaccine, but did not discuss the vaccine’s relationship to H.B.’s symptoms. See id. During following visits in November 2015, December 2015, and May 2017, Dr. Trifiletti recorded concerns about autoimmune encephalopathy, anxiety, obsessive-compulsive disorder behaviors, and autism, but did not connect those conditions with the FluMist vaccine. See id. at 3-4. Finally, on October 17, 2016, H.B. attended an additional neurology consult at the Children’s Hospital of Pennsylvania. See id. at 4. The health history from that appointment listed the following: “regression (with onset in 2014), PANDAS, ADHD, Lyme disease, and Sydenham’s chorea.” Id. “The differential diagnosis included autoimmune encephalitis and genetic/metabolic disorder,” but testing was negative for 3 Petitioner, respondent, and the special master refer to Dr. Triffiletti, but the doctor’s letterhead and signature spell his name Trifiletti. See, e.g., ECF No. 27-3 at 1. 3 Case 1:17-vv-01571-PEC Document 38 Filed 07/18/19 Page 4 of 11 autoimmune encephalitis. Id. In November 2016, H.B. had a third MRI, which was “unremarkable.” Id. In his motion for review of the special master’s decision, petitioner does not object to the special master’s recitation of the facts and supporting medical records. Petitioner’s short statement of the case includes only the following facts related to H.B.’s medical condition: H.B. is a twelve year-old boy born in Morristown, New Jersey as one of a set of identical twins. For the first eight years of his life, H.B. was a healthy child. Just like his brother, H.B. had a slight speech delay, but no other significant health issues. On October 22, 2014, H.B.’s life changed. After receiving the Flumist vaccination, H.B. began to regress in his speech and recall ability in a matter of weeks. After many failed attempts to treat H.B.’s condition by many different specialists, Dr. Rosario [Trifiletti] diagnosed him with autoimmune encephalopathy and began IVIg treatment. Dr. [Trifiletti] believed H.B’s condition was related to the administration of the Flumist vaccine. ECF No. 31-1 at 2 (citations omitted). Petitioner’s assertion that Dr. Trifiletti believed H.B’s condition was related to the vaccine he received is apparently based on the following statement in a referral letter from Dr. Trifiletti to the Psychology Program at Children’s Specialized Hospital: “[H.B.] has been treated for autoimmune encephalopathy (G93.40), which seemed to occur with sudden onset following an influenza vaccine in early 2015.” ECF No. 27-3 at 1; see also ECF No. 31-1 at 9. On July 31, 2018, respondent filed its report pursuant to Rule 4(c) of the Rules of the United States Court of Federal Claims, Appendix B (Vaccine Rules). See ECF No. 25. Therein, respondent argued that petitioner was not entitled to recover for H.B.’s injury because “on the existing record . . . petitioner has failed to establish by preponderant evidence that H.B.’s conditions were caused or significantly aggravated by the FluMist vaccination.” Id. at 12. On August 23, 2018, the special master convened a status conference to discuss deficiencies in petitioner’s medical evidence. See ECF No. 26 (status conference order). Following the conference, the special master directed petitioner to “file a brief showing cause why his claim should not be dismissed due to a lack of reasonable basis.” Id. at 2. After reviewing both petitioner’s brief, ECF No. 27, and respondent’s response, ECF No. 29, the special master dismissed the petition, see ECF No. 30. II. Legal Standards This court has jurisdiction to review the decision of a special master in a Vaccine Act case. 42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court of Federal 4 Case 1:17-vv-01571-PEC Document 38 Filed 07/18/19 Page 5 of 11 Claims reviews the decision of the special master to determine if it is ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law[.]’” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1350 (Fed. Cir. 2008) (quoting 42 U.S.C. § 300aa-12(e)(2)(B) and citing Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1277 (Fed. Cir. 2005)). This court uses three distinct standards of review in Vaccine Act cases, depending upon which aspect of a special master’s judgment is under scrutiny. These standards vary in application as well as degree of deference. Each standard applies to a different aspect of the judgment. Fact findings are reviewed . . . under the arbitrary and capricious standard; legal questions under the “not in accordance with law” standard; and discretionary rulings under the abuse of discretion standard. Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). Petitioner bears the burden of proving, by a preponderance of the evidence, that “the vaccination brought about her injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing 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. “Because causation is relative to the injury, a petitioner must provide a reputable medical or scientific explanation that pertains specifically to the petitioner’s case, although the explanation need only be ‘legally probable, not medically or scientifically certain.’” Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010) (quoting Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994)). III. Analysis Petitioner objects to the special master’s decision for three reasons. First, petitioner alleges that the special master erred by applying the “reasonable basis standard” in considering whether petitioner’s medical evidence was sufficient to support his claim. See ECF No. 31-1 at 3-5. Second, petitioner claims that the special master erred in dismissing the case before allowing petitioner to submit an expert report. See id. at 6-7. And finally, petitioner argues that the special master placed too much emphasis on the medical records that pre-dated the vaccination. See id. at 7-9. The court will address each argument in turn. 5 Case 1:17-vv-01571-PEC Document 38 Filed 07/18/19 Page 6 of 11 A. The Special Master Did Not Err in Evaluating the Basis for Petitioner’s Claim Petitioner articulates his first objection as follows: “The special master’s decision erroneously conflates the standards of ‘reasonable basis,’ which, per statute, only has application in the context of a petition for fees and costs, and that of causation, which requires a showing of preponderant evidence.” Id. at 3 (citing 42 U.S.C. § 300aa- 15(e)(1)). According to petitioner, by discussing causation in terms of establishing a reasonable basis, rather than a preponderance of the evidence, “the special master incorrectly held Petitioner to a higher standard of proof than is required.” Id. at 4. Because the applicable standard of proof is a legal question, this court reviews this aspect of the special master’s decision de novo. See Hammitt v. Sec’y of Health & Human Servs., 98 Fed. Cl. 719, 725 (2011) (citing Broekelschen, 618 F.3d at 1345). The problem with petitioner’s argument is two-fold. First, the court disagrees with petitioner’s assertion that the special master applied the reasonable basis standard in reaching his ultimate conclusion that petitioner’s case should not proceed. At the outset of his analysis, the special master stated that because petitioner did not claim an injury reflected by the Vaccine Injury Table, petitioner must “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. Secretary of Health and Human Services, 418 F.3d 1274 (Fed. Cir. 2005).” ECF No. 30 at 6. As noted above, the Althen standard specifically requires that a petitioner prove his case by a preponderance of the evidence. See Althen, 418 F.3d at 1278. As such, the court reads the special master’s citation to Althen as an invocation of the preponderance standard. The special master did use the phrase “reasonable basis” twice in his analysis of the foundation for petitioner’s claim. See ECF No. 30 at 8 (“Furthermore, the case law cited by Petitioner in [an] attempt[ ] to bolster the claim is not supportive of a finding of reasonable basis to proceed.”); and (“Given the above, the claim as alleged lacks reasonable basis, and is appropriately dismissed.”). But the special master framed his central conclusion, as follows: 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. Thus, after careful review of the medical records and Petitioner’s filings, I concluded that Petitioner will not be able to establish preponderant evidence in favor of his claim, therefore the matter should not proceed any further. 6 Case 1:17-vv-01571-PEC Document 38 Filed 07/18/19 Page 7 of 11 ECF No. 30 at 6 (citations omitted). This formulation of the special master’s ultimate finding makes clear that he was looking to the preponderance standard as the measure for whether petitioner met his burden in this case. Nonetheless, even if the special master conflated the reasonable basis and preponderance standards in the course of his analysis, the court finds such an error to be a harmless one. The reasonable basis standard, which petitioner correctly identifies as the standard required when considering an award of attorneys’ fees, is—contrary to petitioner’s assertions—less exacting than the preponderance of the evidence standard and thus, is easier to satisfy. The analysis in Austin v. Secretary of the Department of Health and Human Services, No. 10-362V, 2013 WL 659574 (Fed. Cl. Jan. 31, 2013), is instructive on this point. Therein, the special master explains: For purposes of awarding fees and costs, the Vaccine Act creates three classes of litigants, two explicitly, and one by implication. The first class is comprised of those petitioners who establish vaccine causation of an injury. They are entitled to the award of reasonable attorneys’ fees and costs as part of the compensation for their claim. § 15(e)(1)(A) and (B). Those who do not prevail on the merits of their petition fall into one of the other two classes. The second class is comprised of those litigants who can demonstrate that their unsuccessful claim was brought in good faith and upon a reasonable basis. They may, in the discretion of the special master, be awarded reasonable fees and costs. § 15(e)(1)(A) and (B) . . . . The third class is the one created by implication, for if only the losing litigants who establish reasonable basis and good faith are eligible to receive fees and costs, it follows that those who fail those tests may not be awarded fees and costs. Id. at *7. This delineation of the paths on which a vaccine case may travel makes clear that a petitioner can establish a reasonable basis for his claim without proving causation by a preponderance of the evidence, but a petitioner can not prove causation without also establishing a reasonable basis for the claim. Put another way, under the structure of the Vaccine Act, there is no category of petitioner who fails to show a reasonable basis for his claim, but successfully proves causation by a preponderance of the evidence. Assuming, for the sake of evaluating petitioner’s argument, that the special master dismissed petitioner’s case for failing to meet the reasonable basis standard, the logical implication of such a finding is that petitioner also would be unable to carry the heavier preponderance burden. As such, petitioner’s claim was properly dismissed, and any error was harmless in the analysis of petitioner’s claim. 7 Case 1:17-vv-01571-PEC Document 38 Filed 07/18/19 Page 8 of 11 The court notes that despite its decision to sustain the special master’s decision as to the petitioner’s first objection, petitioner’s confusion regarding the standard applied was not altogether unreasonable. The court encourages continued efforts at achieving precision as the special masters work to fairly and efficiently administer justice through the Vaccine Program. Such precision allows not only for effective review, but also for effective communication of the special master’s decision to the petitioner. B. The Special Master Did Not Err by Dismissing the Case before Allowing Petitioner to File an Expert Report According to petitioner, the special master erred in dismissing the petition before affording petitioner the opportunity to submit an expert report. Specifically, petitioner alleges the special master acted improperly because: (1) once counsel was retained, he consulted with an expert, Dr. Lawrence Steinman, who provided “assurances . . . of the feasibility of the claim,” ECF No. 31-1 at 6; (2) special masters have previously found that “a reasonable basis can still exist where an expert interprets ambiguous evidence to reach a result that differs from the court’s interpretation,” id.; (3) the special master knew of Dr. Steinman’s involvement with the case, see id.; and (4) the cases cited by the special master were cases in which expert reports were considered, see id. at 7. The special master explained his decision to dismiss the case without allowing petitioner to file an expert report, as follows: 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. ECF No. 30 at 8. When the special master excludes evidence or otherwise limits the record upon which he relies, such decisions are reviewed for an abuse of discretion. See Munn, 970 F.2d at 870. A special master abuses his discretion when: “‘(1) the [special master’s] decision is clearly unreasonable, arbitrary, or fanciful; (2) the decision is based on an erroneous conclusion of the law; (3) the [special master’s] findings are clearly erroneous; or (4) the record contains no evidence upon which the court rationally could have based its decision.’” Stillwell v. Sec’y of Health & Human Servs., 118 Fed. Cl. 47, 55 (2014) (quoting Hendler v. United States, 952 F.2d 1364, 1380 (Fed. Cir. 1991)). 8 Case 1:17-vv-01571-PEC Document 38 Filed 07/18/19 Page 9 of 11 Determinations subject to review for abuse of discretion must be sustained unless “manifestly erroneous.” Piscopo v. Sec’y of Health & Human Servs., 66 Fed. Cl. 49, 53 (2005) (citations omitted); see also Milmark Servs., Inc. v. United States, 731 F.2d 855, 860 (Fed. Cir. 1984) (holding that decisions within the trial court’s discretion are to be sustained unless “manifestly erroneous”) (citation omitted). Contrary to petitioner’s suggestion, the special master’s decision to dismiss the petition before hearing expert testimony was not an abuse of his discretion. It was the special master’s considered opinion that the deficiencies in the medical record could not be overcome by any findings an expert report might offer. The special master found not—as petitioner suggests—that the record contained ambiguous evidence, but rather that it contained “no evidence of an encephalopathic injury close-in-time to H.B.’s receipt of the FluMist vaccine.” ECF No. 30 at 8. Because the special master based his decision on an extensive review of the medical records at issue here, his decision was not arbitrary. Nor was the decision clearly erroneous—as the record evidence recited by the special master, and reproduced at length above, supports his conclusion. The fact that the special master knew that Dr. Steinman was involved with the case is simply immaterial to the determination of whether his testimony would be of value in the proceedings. C. The Special Master Did Not Err in Considering H.B.’s Pre-Vaccination Medical Records In his final objection, petitioner argues that the special master “incorrectly gives greater weight to the scant evidence in the record of H.B.’s pre-vaccination condition than the wealth of evidence demonstrating H.B.’s severe regression post-vaccination.” ECF No. 31-1 at 7. Petitioner compliments the special master’s recitation of H.B.’s medical history, but takes issue with his treatment of those records. “The special master’s decision does well to review the extensive record submitted by Petitioner, however, the weight given to H.B.’s pre-vaccination development and possible ASD diagnosis is arbitrary in light of the substantial post-vaccination evidence of an autoimmune encephalopathy with severe regression.” Id. at 9. Such findings of fact are properly reviewed by the court under the arbitrary and capricious standard, which is “well understood to be the most deferential possible” review. Munn, 970 F.2d at 870. “Accordingly, it is not the role of this court to ‘reweigh the factual evidence,’ ‘assess whether the special master correctly evaluated the evidence,’ or ‘examine the probative value of the evidence or the credibility of the witnesses.’” Stillwell, 118 Fed. Cl. at 55 (quoting Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000)). “If the special master has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely difficult to demonstrate.” Hines v. Sec’y of Dep’t of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991). 9 Case 1:17-vv-01571-PEC Document 38 Filed 07/18/19 Page 10 of 11 Here, the special master appropriately considered all of H.B.’s medical records. This is, in fact, his charge. See 42 U.S.C. § 300aa-13(a)(1) (stating, in part, that the special master may not find that a petitioner is entitled to compensation “based on the claims of the petitioner alone, unsubstantiated by medical records or medical opinion”); see also 42 U.S.C. § 300aa-13(b)(1)(A) (“In determining whether to award compensation to a petitioner under the Program, the special master or court shall consider . . . any diagnosis, conclusion, [or] medical judgment . . . which is contained in the record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury, condition, or death.”). Moreover, in order to prove his case, petitioner must demonstrate that the vaccine brought about H.B.’s injury by providing: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing 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. In order to effectively evaluate any part of this test, the special master would necessarily need to consider H.B.’s physical and mental condition prior to receiving the FluMist vaccine. Without such a foundational understanding of H.B.’s health, the special master would not be able to evaluate whether any changes occurred after H.B. received the vaccine. The special master’s analysis of H.B.’s medical records was detailed and thoughtful. He recited the facts, explained the parties’ arguments, discussed applicable case law, and engaged in a thorough discussion of H.B.’s medical condition. While the special master did note that the post-vaccination records “must be weighed against the substantial medical evidence strongly suggesting that H.B. had experienced developmental problems long before the vaccination,” ECF No. 30 at 7, he devoted a greater portion of his analysis to discussing deficiencies in the post-vaccination records, id. at 7-8. The court understands that petitioner disagrees with the special master’s analysis, but in such circumstances, it is not the purview of the court to “reweigh the factual evidence,” or to substitute its judgment for that of the special master. Stillwell, 118 Fed. Cl. at 55 (citation omitted). Because the special master considered the relevant evidence, drew plausible inferences, and articulated a rational basis for his decision, the court concludes that the weight the special master assigned to H.B.’s pre-vaccination records was not in error. IV. Conclusion For the above-stated reasons, the court sustains the special master’s decision to dismiss petitioner’s case. Accordingly, it is hereby ORDERED that: (1) Petitioner’s motion for review, ECF No. 31, is DENIED; 10 Case 1:17-vv-01571-PEC Document 38 Filed 07/18/19 Page 11 of 11 (2) The decision of the special master, filed January 25, 2019, ECF No. 30, is SUSTAINED; (3) The clerk’s office is directed to ENTER final judgment in accordance with the special master’s January 25, 2019 decision, ECF No. 30; and (4) The parties shall separately FILE any proposed redactions to this opinion, with the text to be redacted clearly blacked out, on or before July 3, 2019. IT IS SO ORDERED. s/Patricia E. Campbell-Smith PATRICIA E. CAMPBELL-SMITH Judge 11