VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-00498 Package ID: USCOURTS-cofc-1_16-vv-00498 Petitioner: B.W. Filed: 2016-04-21 Decided: 2020-10-27 Vaccine: MMR Vaccination date: 2014-03-28 Condition: immune thrombocytopenic purpura (ITP) Outcome: compensated Award amount USD: 29345 AI-assisted case summary: Heather Wright, as mother and natural guardian of minor child B.W., filed a petition on April 21, 2016, seeking compensation under the National Vaccine Injury Compensation Program. Petitioner alleged that the measles-mumps-rubella (MMR) vaccine B.W. received on March 28, 2014, caused him to develop immune thrombocytopenic purpura (ITP). Respondent initially moved to dismiss the claim, arguing that B.W. did not satisfy the statutory prerequisite that the vaccine-related injury or its residual effects lasted for more than six months. The Special Master initially agreed and dismissed the claim. However, on review, the Court of Federal Claims reversed this decision, finding that the ongoing platelet testing, triggered by symptoms of ITP, constituted residual effects that satisfied the six-month requirement. The case was remanded for further proceedings. Subsequently, Respondent conceded entitlement. The Special Master then awarded B.W. $25,000.00 for pain and suffering and $4,345.55 to satisfy a Medicaid lien, for a total award of $29,345.55. The decision does not detail the specific onset of symptoms, diagnostic tests beyond platelet counts, or the specific mechanism of causation beyond the general association of ITP with the MMR vaccine. Petitioner's counsel was Leah V. Durant, and Respondent's counsel was Traci R. Patton. Special Master Brian H. Corcoran issued the initial dismissal and the final award decision, while Senior Judge Eric G. Bruggink issued the opinion reversing the dismissal. Theory of causation field: Petitioner Heather Wright, on behalf of minor B.W., alleged that the MMR vaccine administered on March 28, 2014, caused Immune Thrombocytopenic Purpura (ITP). This was pursued as a Table claim, meaning causation-in-fact was presumed if the injury occurred within the Table's timeframe. The primary dispute centered on the six-month severity requirement. Petitioner argued that ongoing platelet count monitoring, triggered by bruising and other symptoms, constituted residual effects lasting more than six months. Respondent initially argued this monitoring was insufficient. The Court of Federal Claims reversed the Special Master's dismissal, finding that the medically indicated platelet tests, performed due to B.W.'s history of ITP and presentation of symptoms like bruising, satisfied the severity requirement. Respondent later conceded entitlement. The Special Master awarded $25,000.00 for pain and suffering and $4,345.55 for a Medicaid lien. Experts included Dr. Catherine Shaer for Petitioner and Dr. Joan Gill for Respondent regarding the initial claim. Post-hearing, Dr. Guy Jordan (psychologist) testified for Petitioner regarding psychological sequelae, and Dr. Judith Miller (psychologist) testified for Respondent. The Special Master ultimately found the physical injury's sequelae, specifically the ongoing monitoring, met the severity requirement, leading to entitlement. The final award was $29,345.55. Attorneys included Leah V. Durant for Petitioner and Traci R. Patton for Respondent. Special Master Brian H. Corcoran issued the initial dismissal and final award. Senior Judge Eric G. Bruggink issued the opinion reversing the dismissal. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_16-vv-00498-0 Date issued/filed: 2019-03-06 Pages: 18 Docket text: PUBLIC DECISION (Originally filed: 1/18/2019) regarding 53 DECISION of Special Master Signed by Special Master Brian H. Corcoran. (mml) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 1 of 18 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-498V (Not to be published) * * * * * * * * * * * * * * * * * * * * * * * * * HEATHER WRIGHT, * as Mother and Natural Guardian of minor * child, B.W., * * Special Master Corcoran Petitioner, * * Filed: January 18, 2019 v. * * Six-Month Residual Effects SECRETARY OF HEALTH AND * Requirement; Immune HUMAN SERVICES, * Thrombocytopenic Purpura (“ITP”); * Measles-Mumps-Rubella (“MMR”) Respondent. * Vaccine. * * * * * * * * * * * * * * * * * * * * * * * * * * Leah V. Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for Petitioner. Traci R. Patton, U.S. Dep’t of Justice, Washington, DC, for Respondent. ENTITLEMENT DECISION1 Heather Wright, as legal representative of her child, B.W., filed a petition on April 21, 2016, seeking compensation under the National Vaccine Injury Compensation Program (“Vaccine Program”).2 ECF No. 1. Petitioner alleged that the measles-mumps-rubella (“MMR”) vaccine B.W. received on March 28, 2014, caused him to develop immune thrombocytopenic purpura (“ITP”). Pet. at 1. 1 Although this Decision has been formally designated “not to be published,” it will nevertheless be posted on the Court of Federal Claims’ website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means that 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 whole decision will be available to the public in its current form. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa- 10–37 (2012) (hereinafter “Vaccine Act” or “the Act”). Individual section references hereafter shall refer to § 300aa of the Act. Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 2 of 18 Although Respondent takes no position on whether B.W. developed ITP within an appropriate time frame after vaccination sufficient to support a “Table claim,”3 he asserts that B.W. does not satisfy the statutory prerequisite that petitioners establish that their vaccine-related injury or the residual effects thereof lasted for more than six months.4 Resp’t’s Mot. to Dismiss & Rule 4(c) Report at 1–2, filed Sept. 21, 2016 (ECF No. 12) (“Rule 4(c) Rep.”) (citing Section 11(c)(1)(D)).5 On these grounds, Respondent moves to dismiss Petitioner’s claim. Id. at 2. For the reasons set forth below, I find that Petitioner has failed to satisfy the severity requirement. Accordingly, her claim is DISMISSED. I. Factual Background B.W. was born on March 21, 2012. Ex. 2 at 57, filed July 6, 2016 (ECF No. 6). Before receiving the MMR vaccine, he was in generally good health, though somewhat behind schedule on his vaccinations. Id. at 57–61. At his two-year-old well-child visit on March 28, 2014, B.W. received several vaccinations, including MMR. Id. at 53–54, 58–60. Approximately two weeks later, on April 15, 2014, B.W. presented at the emergency room at Ty Cobb Regional Medical Center in Lavonia, Georgia, accompanied by his father and paternal grandmother, with bruises on his forehead, abdomen, and all four extremities. Ex. 3 at 3–4, filed Apr. 22, 2016 (ECF No. 6).6 Within a matter of hours, lab results revealed that B.W.’s platelet count was only 43,000—far below the normal range of 150,000 to 400,000.7 Id. at 13. He was 3 The Vaccine Injury Table (“Table”) lists certain vaccines associated with specific injuries and illnesses. Section 14(a); 42 C.F.R. § 100.3(a) (2017). When a Petitioner demonstrates that she received a covered vaccine and subsequently suffered an associated injury or illness within the time period provided by the Table, she need not show causation-in-fact in order to be entitled to compensation under the Vaccine Act. Shalala v. Whitecotton, 514 U.S. 268, 269–70 (1995). ITP following the MMR vaccine (with onset between seven and thirty days post-vaccination) is one such Table claim. 42 C.F.R. § 100.3(a). 4 Alternatively, a Vaccine Program petitioner may satisfy the statutory prerequisite if she dies as a result of her vaccine injury, or if her injury requires surgical intervention and inpatient care. Section 11(c)(1)(D). Petitioner does not purport to satisfy either alternative, however, and relies solely on the six-month requirement. Pet’r’s Br. Supporting Entitlement to Compensation at 7, filed Nov. 30, 2018 (ECF No. 52) (“Pet’r Br.”) 5 Respondent takes no position on whether Petitioner has satisfied the requirements for a Table claim. Rule 4(c) Rep. at 2 n.2. However, he reserves the right to file a supplemental Rule 4(c) Report should I find that the six-month residual effects requirement has been satisfied. Id. 6 B.W.’s bruises were sufficiently severe to raise concerns that they might have been the result of nonaccidental trauma, so treaters contacted law enforcement, who investigated Ms. Wright for possible child abuse. Ex. 4 at 74, filed Apr. 22, 2016 (ECF No. 6). The duration and depth of this investigation are unclear from the record as filed. 7 Platelet counts reveal “the number of platelets (thrombocytes) per cubic milliliter of blood.” Crabbe v. Sec’y of Health & Human Servs., No. 10-762V, 2011 WL 4436724, at *2 n.9 (citing Pagana et al., Mosby’s Manual of Diagnostic and Laboratory Tests 416 (4th ed. 2010)). 2 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 3 of 18 diagnosed with thrombocytopenia8 and discharged to his father and grandmother’s care that same evening. Id. at 8. The following day, B.W. arrived at Children’s Hospital of Atlanta (“CHOA”) by ambulance. Ex. 4 at 45–46. Notes from this visit reflect some initial treater uncertainty about whether his bruising was the result of nonaccidental trauma or ITP (see id. at 74; Ex. 2 at 66), but treaters again ultimately concluded that his low platelet count (68,000 that day) was diagnostic of ITP. Ex. 4 at 91. B.W. was discharged to his mother’s care later that evening with a diagnosis of “thrombocytopenia likely secondary to acute ITP.” Id. Over the following weeks, B.W. saw various pediatricians at the Longstreet Clinic in Gainesville, Georgia, for frequent blood checks. See Ex. 2 at 88, 94, 102, 107, 115, 117. His platelet counts fluctuated significantly over these visits: 180,000 on April 21; 68,000 on May 2; and 111,000 on May 7. Id. at 88, 94, 115. However, his bruising, though still visible, did not appear to worsen. See, e.g., id. at 90, 107, 113. Following an April 29th visit with pediatrician Garrick Bailey, M.D., B.W. was referred to hematology for more detailed analysis of his blood condition. Id. at 101. B.W. saw two hematologists at CHOA, Benjamin Watkins, M.D., and Michael Briones, D.O. Id. at 123–28. They concluded that he had ITP resulting from his MMR vaccination, but noted that his thrombocytopenia was “not severe at this time” and recommended follow-up visits “every 1–2 months until resolution.” Id. at 127. On July 8, 2014—less than three months after onset of his ITP—B.W. presented to Dr. Bailey for a platelet count at Petitioner’s request. Ex. 2 at 142. At that visit, Dr. Bailey noted that B.W.’s ITP had “resolved.” Id. at 144. B.W. thereafter never returned to a hematologist for official clearance otherwise.9 Sporadic platelet count checks over the following months never showed platelet counts outside the normal range. See, e.g., id. at 136 (platelet count of 312,000 on September 10). These checks were conducted at visits for other complaints in response to concerns about B.W.’s history of ITP. See, e.g., id. at 136 (September 10th visit for headache), 155 (January 26, 2015 visit for bruising on shins and abdomen). Since resolution of his ITP, B.W. has largely remained in good physical health. Petitioner reports that, at age three and a half years, B.W. was diagnosed with attention deficit hyperactive disorder (“ADHD”). Ex. 14 at 4, filed Feb. 21, 2018 (ECF No. 45-1) (“Jordan Rep.”).10 Notes from 8 Decreased platelet count. Dorland’s Illustrated Medical Dictionary 1922 (32nd ed. 2012). 9 A follow-up with Drs. Watkins and Briones was scheduled for June 10, 2014. Ex. 2 at 128. However, Ms. Wright stated that she canceled this follow-up visit due to a stomach bug. Ex. 9 at 15, filed July 6, 2016 (ECF No. 9-2). She did not reschedule. Id. 10 While Petitioner informed Dr. Guy Jordan that B.W. had been diagnosed with ADHD and prescribed Adderall at age three and a half (Jordan Rep. at 4), the medical records filed in this case provide no clear support for such a 3 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 4 of 18 treaters, both before and after his ADHD diagnosis, consistently characterize B.W. as very active, playful, and happy. See, e.g., Ex. 2 at 92, 121 (notes from April 18, 2014: “[n]o obvious distress, active, happy, appropriate for age;” May 2, 2014: “[n]o obvious distress, interactive, very playful/active”); Ex. 9 at 27 (January 21, 2016: “smiles, playful, and active and alert”). Medical records do not reflect any stated concerns from Ms. Wright about her son’s psychological well- being or behavioral development, except for concerns about excessive activity levels. See, e.g., Ex. 2 at 140; Ex. 9 at 11. II. Procedural History As noted above, Petitioner filed her claim on April 21, 2016. Medical records were filed over the coming months. Then, on September 21, 2016, Respondent filed a combined Rule 4(c) Report and Motion to Dismiss, arguing that Petitioner could not meet the severity requirement under the Vaccine Act, given that B.W.’s ITP had resolved in less than six months from onset. Petitioner responded to the Motion to Dismiss on October 5, 2016, and Respondent filed his Reply on October 28, 2016. The parties filed expert reports from Drs. Shaer and Gill in early 2017. The case was originally assigned to the Special Processing Unit (as it initially appeared to meet the requirements of a Table claim and was therefore anticipated as likely to settle), but was reassigned to me after Respondent raised the severity issue as a roadblock to the claim. I thereafter inquired of the parties as to whether a hearing would help resolve the issue, and they agreed. To that end, both filed prehearing briefs on September 8, 2017. A one-day hearing took place on September 21, 2017. At the close of the hearing, I noted to both sides that it was my preliminary conclusion that (based on existing Program case law directly relevant to ITP) Ms. Wright was not going to be able to satisfy the severity requirement simply on the basis of ongoing monitoring of B.W.’s platelet levels after those levels had become normal. Tr. at 99–100; Order at 1, dated Sept. 21, 2017 (ECF No. 38) (“Post-Hr’g Order”) (“I reject Petitioner's argument that subsequent monitoring of a resolved condition that has never recurred can satisfy the Act’s severity requirement”). However, it was conceivable, based on testimony at the hearing, that an alleged psychological response to B.W.’s treatment could itself satisfy the six-month requirement if the response and accompanying treatment extended beyond that time period. See Tr. at 101; Post-Hr’g Order at 1. I therefore asked the parties to submit post-hearing briefs and supporting evidence on the newly-raised issue of whether B.W. may have suffered a psychological or trauma-type sequalae of his injury that would satisfy the six-month requirement. Post-Hr’g Order at 1–2. Petitioner filed a post-hearing brief on December 29, 2017, and Respondent did the same on February 12, 2018. The parties thereafter diagnosis during the stated time period. See, e.g., Ex. 9 at 7, 46, (no current medications listed at May 6, 2016 visit; ADD and ADHD listed as negative in past medical history at April 21, 2016 visit). 4 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 5 of 18 filed expert reports from Drs. Jordan and Miller. Respondent submitted his final brief in support of dismissal on September 28, 2018, and Petitioner responded on November 30, 2018. III. Expert Reports and Testimony Each party offered testimony from one medical expert at the September 21, 2017 hearing: Catherine Shaer, M.D., on behalf of Petitioner, and Joan Gill, M.D., on behalf of Respondent. Each party subsequently solicited a report from an additional expert—Guy Jordan, Ph.D., for Petitioner, and Judith Miller, Ph.D., for Respondent—to address the separate question of whether psychological trauma existed sufficient to satisfy the severity requirement. Neither Ms. Wright nor any other lay witness offered testimony or an affidavit on the severity issue. A. Dr. Catherine Shaer Dr. Catherine Shaer prepared one report for Petitioner and testified at the September 2017 hearing. Her curriculum vitae (“CV”) reflects that she received her B.A. from Quinnipiac College in Hamden, Connecticut, and her M.D. from University of Texas Health Science Center in San Antonio. Ex. 12 at 1, filed Feb. 3, 2017 (ECF No. 22-2). She completed a three-year residency in pediatrics at Children’s National Medical Center in Washington, D.C. in 1981 and is board- certified in pediatrics. Id. She served for many years as the medical director of the spina bifida program at Children’s National Medical Center. Id. at 3. From 2008 to 2014, Dr. Shaer worked as a medical officer at the Health and Human Services Division of Vaccine Injury Compensation, where she reviewed Vaccine Program claims on behalf of Respondent. Id. at 2. For the past four years, she has done similar work for petitioners’ attorneys, reviewing potential vaccine claims and offering testimony and reports on behalf of Vaccine Program claimants. Id. at 1. She published articles, most often on spina bifida, in several medical journals throughout the late 1980s and 1990s. Id. at 7–8. Dr. Shaer’s two-page expert report briefly summarizes the course of B.W.’s ITP and her conclusion that later-in-time blood draws could be directly attributed to his April 2014 ITP diagnosis. See generally Ex. 11, filed Feb. 3, 2017 (ECF No. 22-1). Noting that blood draws are not routine pediatric care practice for children older than twenty-four months, she concluded that “but for the fact that [B.W.] developed ITP he would not have had blood drawn to check his platelet count in June and September of 2014 and January and July of 2015.” Id. at 2. At hearing, Dr. Shaer testified about B.W.’s clinical course and the duration of his ITP. Drawing both on her experience as a pediatrician and her familiarity with Vaccine Program requirements, she opined that the residual effects of B.W.’s ITP lasted longer than six months. Tr. at 21. She also testified about a phone conversation she had with the Ms. Wright, and offered some 5 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 6 of 18 opinions about how Ms. Wright’s response to B.W.’s ITP diagnosis might play into his behavioral development. Id. at 29–38. Dr. Shaer discussed the appropriate monitoring of a child who has previously been diagnosed with ITP, such as B.W. She emphasized that visible bruising—as seen on B.W. more than six months after his ITP was initially identified—constitutes a visual manifestation of a low platelet count (and is indicated as such in the Vaccine Injury Table). Tr. at 19. On cross- examination, however, she clarified that bruising alone would not be diagnostic of ITP, and that ITP is exclusively defined by a low platelet count. Id. at 44–45. She also conceded that B.W.’s platelet count did not fall to levels constituting thrombocytopenia at any time more than six months after his initial diagnosis, and agreed that notes from treating physicians reflected that his ITP had in fact resolved by July 8, 2014.11 Id. at 54–56, 64. In addition, Dr. Shaer testified that, pursuant to guidelines from the American Academy of Pediatrics, routine check-ups for children need not include regular platelet counts unless treaters suspect a problem. Tr. at 20. Platelet counts conducted for B.W. after September 28, 2014 (six months after vaccination and claimed onset of his ITP), she testified, constituted “management of his condition.” Id. at 22. She also noted that, given that B.W.’s ITP did not resolve (as some cases do) within a matter of days, the “appropriate thing” for treating doctors to do was to continue monitoring his platelet counts “until they knew it was normalized.” Id. at 17–18. Dr. Shaer also testified, as a sort of hybrid fact-expert witness, about Petitioner’s account of B.W.’s ITP diagnosis and treatment. Dr. Shaer summarized a telephone conversation she had with Ms. Wright on September 9, 2015. Tr. at 29–38. According to Ms. Wright, B.W. initially presented with an alarmingly large bruise on his side, which medical professionals feared was due to nonaccidental trauma. Id. at 30. An investigation involving police departments from multiple jurisdictions ensued, during which B.W. was separated from his mother. Id. at 30–31. Dr. Shaer was unsure how long this period of separation lasted. Id. at 30. Ms. Wright mentioned to Dr. Shaer (in a hearsay statement that Petitioner herself has never corroborated) that B.W.’s behavior changed “after all this happened,” and he became “hard to control.” Tr. at 32. But Dr. Shaer did not provide further details about B.W.’s changed demeanor. At best, she speculated that any changes in B.W.’s demeanor as a result of his ITP diagnosis might be attributable in part to a form of vulnerable child syndrome. Id. at 32–35. Vulnerable child syndrome, Dr. Shaer explained, occurs when a parent responds to her child’s health problems with excessive and irrational levels of concern, which can influence the nature of her interactions with the child. Id. at 32–33. This in turn can affect the sick child’s behavior. Id. at 34. Dr. Shaer noted 11 On cross-examination, Dr. Shaer also conceded that she erred in typing some dates in her report. Tr. at 46. While her report states that B.W.’s platelet count was regularly monitored through July 8, 2015, she agreed with Respondent’s counsel that the correct date was July 8, 2014. Id. at 47. 6 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 7 of 18 that presentation of vulnerable child syndrome varies widely—some children may begin to have temper tantrums, while others may become quiet and withdrawn. Id. In Dr. Shaer’s view, the degree of concern Ms. Wright expressed about B.W.’s ITP was excessive, which she posited could affect B.W.’s behavior. Tr. at 32, 38. She noted that Ms. Wright demonstrated ongoing anxiety and fear about B.W.’s condition, and that she appeared to believe her child continued to suffer from ITP, even though he had long been stable at the time of their conversation. Id. at 31, 69. When asked whether the tests and examinations B.W. underwent in the days after his bruising was first noted could have been traumatizing for the child, Dr. Shaer again focused on Ms. Wright’s likely reaction to such procedures, reiterating that excessive concern on her part could in turn affect B.W. Id. at 36–38. Ultimately, Dr. Shaer did not consider a specific diagnosis of vulnerable child syndrome to be particularly important in this case. She stated that “we can even forget that term,” emphasizing instead that Ms. Wright’s response to B.W.’s diagnosis was of such a nature that she felt B.W. should receive some kind of psychological examination in order to ascertain the full extent of how his mother’s reaction to his ITP might be affecting his behavior. Id. at 39. On cross- examination, however, she conceded that nothing in B.W.’s medical record showed any signs of behavioral or psychological problems. Id. at 58, 66. B. Dr. Joan Gill Dr. Joan Gill prepared one report on Respondent’s behalf and testified at hearing. As noted on her CV, she received her B.S. at St. Norbert College in West De Pere, Wisconsin, and her M.D. from the Medical College of Wisconsin in Milwaukee. Ex. C12 at 1, filed May 23, 2017 (ECF No. 28-4). She completed both a pediatric internship and residency at Milwaukee Children’s Hospital, followed by a fellowship in pediatric hematology-oncology at the Medical College of Wisconsin and the Blood Center of Southeastern Wisconsin. Id. at 1–2. Dr. Gill is board certified in pediatric hematology/oncology, and she has served as a professor, first of pediatrics and more recently of population health and epidemiology, at the Medical College of Wisconsin since 1981. Id. at 2, 4. Her numerous publications on blood disorders have appeared in many medical journals. Id. at 11– 25. Dr. Gill’s three-page report provides a detailed overview of B.W.’s ITP, which she states “resolved within three months.” Ex. B at 1–2, filed May 23, 2017 (ECF No. 28-1). Platelet counts measured after resolution of B.W.’s ITP were often requested by Ms. Wright, according to her review of the medical records, but consistently reflected platelet levels “well within the normal range.” Id. at 2–3. 12 Before hearing, Respondent filed three documents as Exhibits A, B, and C. After hearing, Respondent submitted three additional pieces of evidence, also filed as Exhibits A, B, and C. 7 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 8 of 18 At hearing, Dr. Gill distinguished between acute and chronic ITP, explaining that chronic ITP is characterized by thrombocytopenia lasting longer than one year (formerly six months). Tr. at 78. Dr. Gill noted that almost all vaccine-related ITP cases are acute. Id. Discussing B.W.’s medical records, Dr. Gill agreed with notes from a treating physician indicating that his ITP had resolved by July 8, 2014. Tr. at 82. After that date, in her view, his medical records revealed visits only in response to other illnesses and injuries. Id. On cross- examination, she explained further that platelet counts ordered after that date were likely related to B.W.’s history of ITP, but that he did not actually have ITP any time after July 8 (as his platelet counts were always normal on that date and thereafter). Id. at 93. She concurred with Dr. Shaer’s statement that bruising alone (absent a low platelet count)—as seen in B.W.’s case more than six months after his ITP diagnosis—would not be diagnostic of ITP. Id. at 83. Based on her review of B.W.’s records, Dr. Gill concluded that his ITP had resolved fully within less than six months after diagnosis (and after vaccination). Id. at 78 Though outside her specialty, Dr. Gill was also briefly questioned by counsel for both parties about the possibility of B.W. experiencing vulnerable child syndrome or a related psychological or behavioral issue. Tr. at 85, 91. In her view, there was “absolutely no evidence” of any psychological trauma. Id. at 85. When asked by Petitioner’s counsel to speculate about whether B.W.’s ITP diagnosis and the ensuing nonaccidental trauma investigation would have been traumatic, she guessed that any separation between B.W. and his mother likely concluded quickly, as Ms. Wright brought B.W. to his appointment the day after the investigation began. Id. at 97. s C. Dr. Guy Jordan After the hearing, Petitioner referred B.W. to a licensed psychologist, Dr. Guy Jordan, for evaluation. Dr. Jordan received his B.A. from Valdosta State College in Georgia, followed by his M. Ed. and Ph.D. from the University of Georgia. Ex. 15 at 1, filed Feb. 21, 2018 (ECF No. 45- 2). He is board-certified psychologist. Id. Throughout his career, he has served as a clinical psychologist at Northeast Georgia Medical Center, operated an independent psychological consulting practice, and served as an adjunct professor at Brenau College. Id. at 2–3. He has given numerous professional presentations on topics related to families and psychological development. Id. at 4–5. Dr. Jordan’s ten-page report summarizes his findings from his evaluation of B.W., which took place on January 24, 2018 (nearly four years after B.W.’s March 2014 vaccinations and subsequent ITP onset). See generally Jordan Rep. B.W. was accompanied by Ms. Wright at this visit, and Dr. Jordan’s assessments appear to be based largely on Ms. Wright’s reported recollections rather than his contemporaneous observations of B.W. See id. at 2–3. On the basis of 8 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 9 of 18 these statements, he retroactively diagnosed B.W. with separation anxiety disorder lasting for approximately six months following his ITP diagnosis. Id. at 2. Dr. Jordan defined separation anxiety disorder as “developmentally inappropriate and excessive fear or anxiety concerning separation from those to whom the individual is attached.” Jordan Rep. at 2. He summarized Ms. Wright’s description of B.W.’s changed behavior, noting: The mother reported that it was impossible to have sitters for the child after this incident of her child being identified as having ITP. The child’s behavior changed to fighting, biting, kicking, and screaming with daycare workers. The mom was attending college and working and had to quit both college and employment to care for the child. The child would scream and would not want to stay with the aunt or with the grandmother. After the child was taken to the hospital and received testing, the child never wanted to be left at day care at the grandmother or the aunt’s home. The child would kick, bite and slap to not be separated from the mother and separation anxiety symptoms were described as prevalent daily in the 2-year-old child. Id. Relying on these assertions, Dr. Jordan concluded that B.W. developed separation anxiety disorder approximately four years prior, shortly after his second birthday. Id. Noting that Ms. Wright described B.W.’s symptoms as lasting roughly six months, Dr. Jordan concluded that B.W.’s separation anxiety disorder lasted “approximately six months.” Jordan Rep. at 2. At the time of his evaluation, B.W. continued to exhibit one trait characteristic of separation anxiety disorder: “apprehension and worry about continued care-taking by his mother being stable and uninterrupted.” Id. at 6. Dr. Jordan stated that this trait alone is insufficient for a formal diagnosis of separation anxiety disorder, however. Id. at 7. Dr. Jordan opined further that B.W.’s separation anxiety disorder arose from the experience of being diagnosed with and treated for ITP. Jordan Rep. at 2. He seems, however, to have based this conclusion almost entirely on the temporal association between the ITP diagnosis and Ms. Wright’s account of when his behavior changed. See id. at 9. Dr. Jordan administered both an intellectual and educational assessment to B.W. Jordan Rep. at 5. B.W. performed generally well on these tests, scoring above average in almost all categories. Id. at 5–6. Dr. Jordan also noted that B.W.’s ADHD is somewhat severe, despite the fact that he is medicated, and that he frequently engages in disruptive behavior. Id. at 6. D. Dr. Judith Miller In response to Dr. Jordan’s assessment of B.W., Respondent consulted with an expert psychologist, Dr. Judith Miller. As reflected in her CV, Dr. Miller received her B.S., M.S., and 9 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 10 of 18 Ph.D. from the University of Utah. Ex. C at 1, filed May 29, 2018 (ECF No. 50-3). She currently serves as a professor of psychology in psychiatry at the University of Pennsylvania, as well as in several leadership roles in the autism program at the Children’s Hospital of Philadelphia. Id. at 1– 2. She is board-certified in psychology. Id. at 2. Her written publications, largely focusing on autism, have appeared in numerous medical and scientific journals. Id. at 16–23. Dr. Miller prepared one eight-page report regarding this case. See Ex. B, filed May 29, 2018 (ECF No. 50-1) (“Miller Rep.”). She criticized Dr. Jordan’s conclusions, both on the basis of B.W.’s medical record and the general plausibility of a two-year-old experiencing separation anxiety disorder. See generally id. Although Dr. Miller did not meet with B.W. or his mother in person, she performed a detailed review of his medical records. Miller Rep. at 2–3. Based on this review, she concluded that B.W. never experienced separation anxiety disorder. Id. at 8. She based this conclusion first and foremost on the fact that B.W.’s medical records reveal no concern about behavioral issues or separation anxiety following his ITP diagnosis, even though his mother brought him for frequent medical visits, which included regular behavioral screenings. Id. at 4–6. She highlighted numerous points in the medical record after the ITP diagnosis where Ms. Wright indicated that she had no concern about B.W.’s psychological condition or development. Id. at 3 (e.g., citing Ex. 2 at 140 “9/10/14 ‘does not really stop playing; acts fine (despite headache); no obvious distress, jumping climbing, running, talkative,’” 177 “12/23/14 Well Child visit at 30 months. Recent medical problems? ‘ITP[.]’ Concerns about behavior? ‘No.’ Other concerns? ‘No.’”). Furthermore, Dr. Miller highlighted treaters’ consistent characterization of B.W. as happy, active, and playful throughout his medical record, including after vaccination. Id. Dr. Miller disputed the premise of Dr. Jordan’s conclusion that a change in B.W.’s behavior was evidenced by the fact that he could no longer attend daycare after vaccination. Miller Rep. at 2. She pointed out that pre-vaccination medical records also reflect that B.W. did not regularly attend daycare. Id.13 Regardless of whether B.W.’s records accurately reflect his behavior after his ITP diagnosis, Dr. Miller indicated that any diagnosis of separation anxiety disorder in a two-year old would be highly unusual. Miller Rep. at 6. In order for such a diagnosis to be appropriate, “the patient has to be capable of having the cognition that harm/illness/death could lead to a prolonged or permanent separation, and typically the patient is able to articulate this worry.” Id. With regard to the crying and other behaviors recounted to Dr. Jordan by Ms. Wright, Dr. Miller explained that 13 Additionally, Dr. Miller took issue with Petitioner’s assertion (made primarily in written briefings, and alluded to in Dr. Shaer’s testimony) that the April 2014 nonaccidental trauma investigation resulted in a lengthy separation between B.W. and his mother. Miller Rep. at 2. In her view, medical records showed that the whole investigation actually lasted only three and a half hours. Id. (citing Ex. 6 at 10 (“[Patient] seen at CAC for multiple bruises and low platelets, concern on physical abuse [. . .] case started at 2:30pm and case finished at 6pm”)). 10 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 11 of 18 behaviors characteristic of separation anxiety are, in fact, developmentally appropriate for children until about age four, and thus typically would not be indicative of separation anxiety disorder. Id. In addition, because two-year-old children “are not capable of long-range thinking,” they are therefore “incapable of worrying about or understanding the implications of a long-term separation.” Id. (emphasis in original). For this reason, a two-year-old would not be diagnosed with separation anxiety disorder unless he exhibited “severe, prolonged, and inconsolable crying for hours when separated.” Id. (emphasis in original). Relatedly, Dr. Miller criticized Dr. Jordan’s conclusion that B.W.’s worries about receiving continuous, stable care indicated the continuing presence of one trait of separation anxiety disorder at the time of his evaluation. Miller Rep. at 7–8. Reiterating that separation anxiety disorder is marked by excessive or inappropriate fear and concern, she noted that B.W. was living in foster care at the time of his evaluation, making such fears entirely reasonable for a child of his age and living situation. Id. IV. Applicable Legal Standards A. Burden of Proof for Table Claims Petitioner pleaded her case as a Table claim. Pet. at 5. Table claim petitioners need not independently demonstrate that the vaccine at issue can cause the claimed injury, nor that the vaccine did cause the injury in that case. Shalala v. Whitecotton, 514 U.S. 268, 270 (1995). Instead, so long as the claimed injury occurred within a medically reasonable time frame following vaccination, causation is presumed. Id. This presumption of causation does not excuse Table claim petitioners from other statutory requirements for compensation, however. Song v. Sec’y of Health & Human Servs., 31 Fed. Cl. 61, 65 (1994), aff’d, 41 F.3d 1520 (Fed. Cir. 1994) (unpublished table decision); Crabbe v. Sec’y of Health & Human Servs., No. 10-762V, 2011 WL 4436724, at *1 (Fed. Cl. Spec. Mstr. Aug. 26, 2011). Thus, Table or not, Vaccine Program claimants not asserting a vaccine-related death or other injury requiring a surgical intervention and inpatient care must demonstrate that they suffered the residual effects or complications from their vaccine-related injury for more than six months. Section 11(c)(1)(D). B. Analysis of Fact Evidence The process for making determinations in Vaccine Program cases regarding factual issues begins with consideration of the medical records. Section 11(c)(2). The special master is required to consider “all [] relevant medical and scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the 11 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 12 of 18 record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then required to weigh the evidence presented, including contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to afford greater weight to contemporaneous medical records than to other evidence, provided that such determination is evidenced by a rational determination). Medical records that are created contemporaneously with the events they describe are presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s health problems). Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). This presumption is based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people honestly report their health problems to those professionals; and (iii) medical professionals record what they are told or observe when examining their patients in as accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d at 1525 (Fed. Cir. 1993). Accordingly, if the medical records are clear, consistent, and complete, then they should be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). In determining the accuracy and completeness of medical records, the Court of Federal Claims has listed four possible explanations for inconsistencies between contemporaneously created medical records and later statements: (1) a person’s failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional’s failure to document everything reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203– 04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to afford greater weight to contemporaneous medical records or other evidence, there must be evidence that this decision was the result of a rational determination. Burns, 3 F.3d at 417. C. Analysis of Expert Evidence Petitioners regularly present statements from medical experts in support of their claims. Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s case. Where both sides offer expert reports, a special master’s decision may be “based on the credibility of the experts and the relative persuasiveness of their competing theories.” Broekelschen v. Sec’y of 12 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 13 of 18 Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion “connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too great an analytical gap between the data and the opinion proffered.” Snyder ex rel. Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706 at 743 (2009) (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec’y of Health & Human Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for review denied, 108 Fed. Cl. 743 (2013), aff’d, 540 F. App’x 999 (Fed. Cir. 2013) (citing Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010)). Expert opinions based on unsupported facts may be given relatively little weight. See Dobrydnev v. Sec’y of Health & Human Servs., 556 F. App’x 976, 992–93 (Fed. Cir. 2014) (“[a] doctor’s conclusion is only as good as the facts upon which it is based”) (citing Brooke Group Ltd. v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993) (“[w]hen an expert assumes facts that are not supported by a preponderance of the evidence, a finder of fact may properly reject the expert’s opinion”). Expert opinions that fail to address or are at odds with contemporaneous medical records may therefore be less persuasive than those which correspond to such records. See Gerami v. Sec’y of Health & Human Servs., No. 12-442V, 2013 WL 5998109, at *4 (Fed. Cl. Spec. Mstr. Oct. 11, 2013), aff’d, 127 Fed. Cl. 299 (2014). Weighing the relative persuasiveness of competing expert testimony, based on a particular expert’s credibility, is part of the overall reliability analysis to which special masters must subject expert testimony in Vaccine Program cases. Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1325–26 (Fed. Cir. 2010) (“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special masters are expected to consider the credibility of expert witnesses in evaluating petitions for compensation under the Vaccine Act”). D. Consideration of Medical Literature Respondent filed medical and scientific literature in this case, but not every filed item factors into the outcome of this decision. While I have reviewed all of the medical literature submitted in this case, I discuss only those articles that are most relevant to my determination or are central to Petitioner’s case. Moriarty v. Sec’y of Health & Human Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“[w]e generally presume that a special master considered the relevant record evidence even though he does not explicitly reference such evidence in his decision”) (citing Hazlehurst v. Sec’y of Health & Human Servs., 604 F.3d 1343, 1352 (Fed. Cir. 2010)); see also Paterek v. Sec’y of Health & Human Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (“[f]inding 13 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 14 of 18 certain information not relevant does not lead to—and likely undermines—the conclusion that it was not considered”). ANALYSIS As previously noted, this case turns not on whether B.W. developed ITP within a medically-appropriate time frame after receiving the MMR vaccine, or whether he had ITP (a recognized Table injury related to the MMR vaccine), but rather on whether Petitioner has made a sufficient showing to satisfy the six-month residual effects requirement. Petitioner puts forth two arguments in this regard: first, that the ongoing monitoring of B.W.’s platelet count satisfies the requirement, and second, that B.W. suffered a diagnosable psychological disorder as a result of his ITP that lasted longer than six months. Pet’r Br. At 8–17. Respondent contends that medical monitoring such as platelet counts does not satisfy the six-month requirement, and that B.W. did not suffer a psychological disorder or other mental illness as a result of his ITP. Resp’t’s Br. in Support of Dismissal at 2–4, filed Sept. 28, 2018 (ECF No. 51) (“Resp’t Br.”). I. Ongoing Monitoring Does Not Satisfy the Six-Month Residual Effects Requirement Petitioner first argues that B.W. satisfies the six-month residual effects requirement through the “ongoing medical management” of his ITP in the form of platelet count checks that occurred intermittently over the months following his diagnosis. Pet’r Br. at 8. However, the present case is facially indistinguishable from Crabbe, in which a special master found that recurrent blood testing did not satisfy the six-month residual effects requirement for a petitioner who suffered ITP after vaccination. 2011 WL 4436724, at *5. There, the special master found that “[a]lthough it is possible that the history of ITP prompted [the petitioner’s] physicians to order blood tests that they might not have ordered otherwise, testing for a possible recurrence is not a ‘residual effect’ within the meaning of the statute.” Id. Petitioner unsuccessfully attempts to distinguish her case from Crabbe by characterizing subsequent platelet counts as “management” of B.W.’s ITP. See, e.g., Pet’r Br. at 10. Using this term does not change the fact that such blood tests were done only to test for potential recurrence of B.W.’s ITP, not to manage existing symptoms or sequelae thereof. In my post-hearing Order, I explicitly rejected Petitioner’s argument that “subsequent monitoring of a resolved condition that has never recurred can satisfy the Act’s severity requirement.” Post-Hr’g Order at 1. My view on this issue has not changed, and I conclude that ongoing monitoring for possible ITP recurrence fails to satisfy the six-month residual effects requirement. 14 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 15 of 18 II. Petitioner Has Failed to Show that B.W. Suffered a Vaccine Injury-Related Psychological Disorder or Mental Illness Petitioner asserts that B.W. suffered a psychological disorder or mental illness as a result of his ITP for more than six months, thereby satisfying the six-month residual effects requirement. Pet’r Br. at 13. It is true that psychological sequelae of a vaccine-related injury may be sufficient to satisfy the six-month residual effects requirement. See, e.g., Tauer v. Sec’y of Health & Human Servs., No. 08-703V, 2009 WL 2045676, at *1 (Fed. Cl. Spec. Mstr. June 22, 2009) (decision on stipulation). Here, however, I do not find that Petitioner has sufficiently demonstrated that B.W. suffered such an injury, nor that any psychological trauma he may arguably have experienced could be explicitly linked to his ITP. First, the record does not support the conclusion that B.W. suffered from separation anxiety disorder beginning in the spring or summer of 2014, and after B.W.’s ITP diagnosis. There is no such contemporaneous diagnosis in the medical record filed in this case, and so Petitioner relies solely on Dr. Jordan’s professional opinion. However, although I do not question Dr. Jordan’s qualifications as a psychologist, the specifics of his diagnosis are undercut by the lapse in time between the alleged disorder and Dr. Jordan’s evaluation nearly four years later. It is also readily apparent from Dr. Jordan’s report that he bases his diagnosis almost entirely on Ms. Wright’s recounted statements, which cannot be confirmed through any source of evidence (as she did not testify, provide a written affidavit, or provide any other form of record support for her assertions). Petitioner attempts to cure the hearsay nature of her statements to Dr. Jordan recalling B.W.’s status in 2014 by asking for the opportunity to present her own live testimony on these matters at yet another fact hearing. Pet’r Br. at 16. But hearing live testimony on this topic from Ms. Wright would not aid her claim. The fundamental fact remains that the record does not suggest that B.W. experienced notable anxiety or psychologic distress beginning around the time his ITP manifested, so Petitioner’s testimony would be seeking to vary contemporaneous records that are presumed accurate, as numerous Program decisions have observed. See, e.g., Burns, 3 F.3d at 417. Also, Petitioner has already had ample opportunities to offer substantiation for these allegations, but has submitted nothing along the lines of witness statements or other corroborative evidence in support. And in any event, I would still require persuasive expert support for the diagnosis— bringing me back to Dr. Jordan, whose opinion is too thinly bulwarked by corroborative proof beyond the Petitioner’s unsupported statements to be reliable. See Dobrydnev, 556 F. App’x at 992–93 (citing Brooke Group Ltd., 509 U.S. at 242 (finding expert opinions based on unsupported factual allegations to be worthy of little to no weight). Similarly, Dr. Jordan’s finding that B.W.’s separation anxiety disorder lasted for approximately six months—a critical component to satisfaction of the severity requirement— appears conclusory. He seems to accept Ms. Wright’s assertion that B.W.’s behavioral changes 15 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 16 of 18 lasted for six months despite the fact that medical records indicate no significant change in B.W.’s demeanor around that time. And many of the statements upon which Dr. Jordan bases his diagnosis are unsupported by or at odds with other evidence. For example, while Dr. Jordan notes that B.W. had to cease attending daycare due to behavioral issues (Jordan Rep. at 2), medical records consistently reflect that B.W. did not attend daycare either before or after vaccination. See, e.g., Ex. 2 at 15, 30, 57, 85. Furthermore, Dr. Jordan appears to unquestioningly accept Ms. Wright’s characterization of B.W. as anxious, confrontational, and unhappy after his ITP diagnosis, contrary to medical records that consistently describe him as happy and playful. See, e.g., id. at 92, 121. In addition, regardless of the factual discrepancies between Dr. Jordan’s report and B.W.’s medical records, Respondent’s expert has persuasively established that it is highly unlikely that a two-year-old such as B.W. could have developed separation anxiety disorder. As explained by Dr. Miller, children of such a young age are cognitively incapable of worrying about the future in a manner necessary for a diagnosis of separation anxiety disorder, and it is developmentally appropriate for two-year-old children to display some separation anxiety behaviors. Miller Rep. at 6. Dr. Jordan’s report does not distinguish between the ordinary separation anxiety behaviors exhibited by healthy two-year-old children and the excessive, inappropriate responses that would characterize a true separation anxiety disorder. Accordingly, I find that any separation anxiety behavior that B.W. may have displayed as a two-year-old was more likely developmentally- appropriate behavior for a child of his age than a disproportionate reaction to his ITP diagnosis. Furthermore, I find that even if Petitioner could substantiate her claim that B.W. suffered from some other psychological distress, she has not persuasively related such a condition to the ITP diagnosis. Dr. Jordan’s attribution of such symptoms to B.W.’s ITP diagnosis and treatment seems to be based largely on a temporal association alone. He notes that “[n]o separation anxiety had been experienced prior to the identification and treatment of his ITP. It therefore appears that the development of ITP and subsequent medical treatment created the separation anxiety symptoms.” Jordan Rep. at 9. But it is well-established in the Vaccine Program that temporal associations alone do not suffice to show causation. See McCarren v. Sec’y of Health & Human Servs., 40 Fed. Cl. 142, 147 (1997). Furthermore, although Dr. Jordan acknowledges other elements of B.W.’s life that could be linked to behavioral issues and psychological trauma,14 he does not address whether these could have played a greater role in bringing about the alleged changes in B.W.’s behavior.15 14 See Jordan Rep. at 1 (noting nonaccidental trauma investigation following ITP diagnosis), 4 (noting that B.W. was diagnosed with ADHD at age 3; that B.W. lived with his mother and siblings in a trailer without ready access to running water in 2016; and that B.W. was placed in foster care in the fall of 2016). 15 In addition to arguing that B.W. experienced psychological trauma as the direct result of his ITP, Petitioner also seems to suggest that the April 2014 nonaccidental trauma investigation that was prompted by initial treater discovery of B.W.’s bruises (which were not initially understood to be evidence ITP but rather of potential abuse) also had a psychological impact on him, given that it led to his removal from her home for a period of time. Pet’r Br. at 5. 16 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 17 of 18 Testimony from Dr. Shaer about a possible diagnosis of vulnerable child syndrome (which would occur as a result of the ITP diagnosis) is similarly unpersuasive. Her statements were too speculative (based entirely on Ms. Wright’s demeanor, not on B.W.’s) and well outside her area of medical expertise, as she acknowledged. See Tr. at 32–33. Dr. Jordan otherwise concluded that B.W. did not experience vulnerable child syndrome. Jordan Rep. at 4. Ultimately, I find Dr. Miller’s assessment of B.W.’s psychological course following his ITP diagnosis to be more persuasive than Dr. Jordan’s. Accordingly, I conclude that Petitioner has failed to show by preponderant evidence that B.W. experienced separation anxiety disorder or another psychological injury for more than six months after vaccination.16 CONCLUSION Having reviewed the medical records, expert reports, medical literature, and the parties’ respective arguments, I do not find that Petitioner has shown with sufficient preponderant evidence Accordingly, this more indirect effect of the ITP could also be a cause of a sequela sufficient to satisfy the severity requirement. Petitioner’s argument is not without merit. An investigation for nonaccidental trauma certainly has the potential to be stressful and anxiety-inducing (although B.W.’s life had already been marked by significant instability not connected to his ITP). However, Petitioner has not corroborated with evidence any facts about the extent, nature, or scope of this investigation, making it difficult to conclude in the first place that it could have caused trauma at all. In particular, it is not clear how long the investigation lasted, or how long B.W. was in fact separated from his mother. See, e.g., Pet’r Br. at 5 (separation lasted “some time”); Ex. 9 at 15 (note from April 21, 2016 doctor’s visit: “has a court case involving his ITP? abuse”); Tr. at 97 (Dr. Gill noting that Ms. Wright brought B.W. in for doctor’s visit the day after nonaccidental trauma investigation began, concluding from that fact that separation lasted less than one day); Miller Rep. at 2 (citing Ex. 6 at 10, reading “case started at 2:30pm and case finished at 6pm” to mean that investigation lasted three and a half hours). And even if the investigation due to misapprehension about the causes of B.W.’s bruises was sufficient to have caused him psychological harm, Petitioner has not demonstrated that such harm persisted for more than six months, for the reasons stated above (i.e., record evidence does not suggest B.W. was psychologically abnormal, Dr. Miller was more persuasive than Dr. Jordan in establishing a lack of such trauma based on the record, etc.). 16 In ruling as I do, I am opting to resolve the secondary question of a possible sequela of B.W.’s ITP on the record, rather than via hearing. I am empowered to do so under the Act, which gives special masters broad discretion in determining how best to resolve claims. See generally Section 12(d); see also Vaccine Rule 8(d). Previous decisions have affirmed the propriety of resolving a vaccine claim without hearing when live testimony would not be dispositive in the matter. See, e.g., D’Tiole v. Sec’y of Health & Human Servs., 726 F. App’x 809, 812 (Fed. Cir. 2018); Hooker v. Sec’y of Health & Human Servs., No. 02-472V, 2016 WL 3456435, at *21 (Fed. Cl. Spec. Mstr. May 19, 2016) (discussing a special master’s discretion in holding a hearing and the factors that weighed against holding a hearing in the matter); Murphy, v. Sec’y of Health & Human Servs., No. 90-882V, 1991 WL 71500, at *2 (Cl. Ct. Spec. Mstr. Apr. 19, 1991) (finding no justification for a hearing where the claim is fully developed in the written records and the special master does not need to observe the fact witnesses for the purpose of assessing credibility). Here, the lack of evidence supporting Petitioner’s severity allegations can be determined based solely on the record plus the expert reports of Drs. Jordan and Miller. To the extent that record does not include witness statements from Petitioner or others that might have corroborated her allegations, that insufficiency is solely the product of Petitioner’s failure to offer such evidence at the proper time (such as at the fall 2017 hearing, or prior to the present decision). 17 Case 1:16-vv-00498-EGB Document 57 Filed 03/06/19 Page 18 of 18 that B.W.’s ITP or its residual effects lasted for more than six months. Accordingly, Petitioner has not established entitlement to an award of damages and I must DISMISS her claim.17 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Special Master 17 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their right to seek review. 18 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_16-vv-00498-1 Date issued/filed: 2020-02-19 Pages: 11 Docket text: **REVERSED PURSUANT TO 83 C.A.F.C. MANDATE, DATED APRIL 1, 2022. ** JUDGE VACCINE REPORTED OPINION re: 60 Order on Motion for Review, Judge Vaccine Reported Opinion. Signed by Senior Judge Eric G. Bruggink. (jpk1) Service on parties made. Modified on 4/6/2022 to indicate opinion has been reversed. (dls). -------------------------------------------------------------------------------- Case 1:16-vv-00498-EGB Document 68 Filed 02/19/20 Page 1 of 11 In the United States Court of Federal Claims No. 16-498V (Filed: July 16, 2019) (Re-issued for Publication: February 19, 2020) 1 * * * * * * * * * * * * * * * * * * * * * * * HEATHER WRIGHT, as the legal representative of her minor son, B.W., National Childhood Vaccine Injury Act; Petitioner, Motion for review; Severity requirement; v. Residual effect; MMR vaccine; Immune SECRETARY OF HEALTH AND thrombocytopenic HUMAN SERVICES, purpura (“ITP”). Respondent. * * * * * * * * * * * * * * * * * * * * * * * Leah V. Durant, Washington, DC for petitioner. Traci R. Patton, Senior Trial Attorney in the Torts Branch of the Civil Division, Department of Justice, Washington, DC, with whom are, Joseph H. Hunt, Assistant Attorney General, C. Salvatore D’Alessio, Acting Director, Catharine Reeves, Deputy Director, and Heather L. Pearlman, Assistant Director, for respondent. OPINION BRUGGINK, Judge. This case was brought by petitioner, Heather Wright, on behalf of her minor son, B.W., under the National Childhood Vaccine Injury Act 1 Pursuant to Vaccine Rule 18(b), this opinion was initially filed under seal to afford the parties14 days to propose redactions. The parties did not propose any redactions. Accordingly, this opinion is reissued in its original form for publication. Case 1:16-vv-00498-EGB Document 68 Filed 02/19/20 Page 2 of 11 (“Vaccine Act”). The petition alleges that B.W. suffered from immune thrombocytopenic purpura (“ITP”) after receiving his measles-mumps- rubella (“MMR”) vaccine on March 28, 2014, and is entitled to compensation because the management of the condition through repeated platelet tests satisfies the statute’s six-month residual effect requirement. Respondent moved to dismiss for failure to meet the severity requirement. The Special Master agreed with respondent after further briefing and a hearing. The case is now before this court on a motion for review of that decision. The motion is fully briefed, and oral argument was held on July 11, 2019. Because we find the Vaccine Act’s severity requirement met in these circumstances, we grant the motion for review and reverse the Special Master’s decision. The petitioner bears the burden of proving by a preponderance of the evidence that it is entitled to compensation under the Vaccine Act. In a Table claim, as is presented here, causation is presumed if the resulting injury, disability, illness, or condition corresponds with the vaccine listed and occurs within the designated time period. See 42 U.S.C.S § 300a-14 (2012); 42 C.F.R. § 100.3(a) (2017); W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013). Still, petitioner must prove that the individual experiencing the vaccine-related injury: (1) “suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the administration of the vaccine,” (2) died, or (3) was hospitalized or underwent surgery in response to the vaccine-related illness, disability, injury, or condition. 42 U.S.C.S. § 300aa-11(c)(1)(D). BACKGROUND I. Factual History B.W. was born on March 21, 2012. At his two-year well-child visit on March 28, 2014, he was relatively healthy, although he was behind on vaccinations. He was thus administered MMR, DTap, ActHib, pneumococcal, Hepatitis A, and Varicella vaccines at that visit. On April 15, 2014, B.W.’s father and paternal grandmother brought him to the Emergency Room at Ty Cobb Regional Medical Center in Lavonia, Georgia after finding bruises on his forehead, abdomen, arms, and legs. X-rays and blood tests were performed. The x-rays were normal but the blood tests showed a low platelet count. His platelet count was 43,000, far below the normal range of 150,000 to 400,000. He was diagnosed with 2 Case 1:16-vv-00498-EGB Document 68 Filed 02/19/20 Page 3 of 11 ITP and discharged that day with a recommendation to see his primary care provider within a week in order to be referred to a hematologist.2 Because Ms. Wright did not have many details regarding B.W.’s visit to Ty Cobb the previous day, she was concerned about his ITP diagnosis and brought BW to Children’s Healthcare of Atlanta (“CHOA”) the following day, April 16, 2014. Another Complete Blood Count (“CBC”) was performed, and B.W.’s platelet count was again found to be low at 68,000. The treating physician at CHOA discharged B.W. that day with a diagnosis of “‘thrombocytopenia likely secondary to acute ITP.’” Wright v. Sec’y of Health & Human Servs., No. 16-498V, 2019 WL 1061472 at 3 (Fed. Cl. Spec. Mstr. Jan. 18, 2019) (hereinafter “Decision”) (quoting Pet’r’s Ex. 4 at 91). She also recommended following up with a hematology clinic and suggested finding one closer to home because petitioner lived three hours from CHOA. Over the next few weeks, B.W.’s platelet count was checked every three to four days by pediatricians at The Longstreet Clinic in Gainesville, Georgia. The counts were as follows: 180,000 on April 21, 181,000 on April 25, 80,000 on April 29, 68,000 on May 2, and 111,000 on May 7. On April 29, 2014, Dr. Garrick Bailey, M.D. referred B.W. to the Hematology/Oncology Department of CHOA. On May 13, 2014, B.W. saw hematologists Benjamin Watkins, M.D. and Michael Briones, D.O., at which point his platelet count was 80,000.3 Drs. Watkins and Briones reviewed the previous platelet counts and concluded that B.W. had ITP as a result of his MMR vaccine. They recommended follow-up visits “‘every 1-2 months until resolution’” since his ITP was not viewed as severe. Id. (quoting Pet’r’s Ex. 2 at 127). A follow-up visit was scheduled for June 10, 2014, but was canceled by petitioner due to a stomach bug and never rescheduled. However, on July 2 Thrombocytopenia purpura is defined in the Vaccine Act’s regulations “by the presence of clinical manifestations, such as petechiae, significant bruising, or spontaneous bleeding, and by a serum platelet count less than 50,000/mm3 with normal red and white blood cell indices.” 42 C.F.R. § 100.3(c)(7). 3 The International Working Group on ITP uses a platelet count of less than or equal to 100,000/mm3 to diagnose ITP. Resp’t’s Ex. B at 2. This is higher than the 50,000/ mm3 used in the statute. See 42 C.F.R. § 100.3(c)(7). 3 Case 1:16-vv-00498-EGB Document 68 Filed 02/19/20 Page 4 of 11 8, 2014, Dr. Bailey performed another platelet count at petitioner’s request and concluded that B.W.’s ITP had “resolved.” Id. (quoting Pet’r’s Ex. 2 at 144). Given B.W.’s history of ITP, the pediatricians who saw him over the next two years continued to order platelet testing in response to his continued presentation with bruising. On September 14, 2014, B.W. was seen for bruising and headaches. His platelet count was 312,000. On January 26, 2015, B.W.’s platelets were counted when he was seen for bruising on his shins and abdomen; the count at that visit was 381,000. On April 13, 2016, platelet testing was ordered after B.W. was brought in for bruising on his back and extremities, as well as petechiae on his mid and lower back.4 Pet’r’s Ex. 9 at 41. B.W.’s platelet count was 289,000. Lastly, on September 14, 2016, B.W. was seen again for bruising and the platelet test showed a platelet count of 318,000. Between these visits, B.W. was seen several times for bruising, or bruising was indicated on his medical record if he was seen for something else. Those dates include: October 9, 2014 (experienced bruising after falling from a cart), December 5, 2014 (bruising), April 16, 2015 (bruises noted at three-year well-child visit), June 28, 2015 (finger contusion due to car door), and March 2016 (bruises on face after dog bite).5 II. Procedural History On April 21, 2016 Heather Wright filed a petition for compensation on behalf of her minor son under the National Childhood Vaccine Injury Act, 42 U.S.C.S. §§ 300aa-1 to-34 (2012). Petitioner alleged that her son had developed ITP as a result of receiving the MMR vaccine on March 28, 2014. Originally, this case was assigned to the Special Processing Unit because it looked to be a Table claim that was likely to settle. See 42 C.F.R. § 100.3(a). 4 Petechiae are “‘small hemorrhages in the skin.’” Crabbe v. Sec’y of Health & Human Servs., No. 10-762V, 2011 WL 4436742, at *7-8, n.9 (Fed. Cl. Spec. Mstr. Aug. 26, 2011) (quoting Kathleen D. Pagana & Timothy J. Pagana, Mosby’s Manual of Diagnostic and Laboratory Tests (4th ed. 2010) at 416). 5 B.W. was also seen on May 6, 2016, for a nosebleed. Nosebleeds are also a common symptom of ITP. See Guido v. Sec’y of Health & Human Servs., No. 16-435V, WL 4277579, at *7 (Fed. Cl. Spec. Mstr. Aug. 25, 2017). 4 Case 1:16-vv-00498-EGB Document 68 Filed 02/19/20 Page 5 of 11 Respondent, however, filed a combined Vaccine Rule 4(c) Report and a Motion to Dismiss on September 21, 2016, at which point the case was reassigned to Special Master Corcoran. In it, respondent argued that petitioner could not meet the severity requirement for compensation under the Vaccine Act because B.W.’s ITP resolved in less than six months after he received the vaccine. The motion was fully briefed and an evidentiary hearing was held on September 21, 2017. At the hearing, both parties provided expert testimony. Dr. Catherine Shaer testified for petitioner, and Dr. Joan Gill testified for respondent. Dr. Shaer testified that the continued platelet testing that B.W. underwent when he was seen for bruising, even after Dr. Bailey concluded that B.W.’s condition had resolved, constituted “management of his condition.” Hr’g Tr. 22. She explained that, when a child with a recent history of ITP is presented to a medical professional because he exhibits bruising, it is appropriate for platelet counts to be tested. Even though bruises are not in and of themselves diagnostic of ITP, they are “one of the manifestations of a low platelet count that you can actually visually see.” Hr’g Tr. 19 (Dr. Shaer). Dr. Gill, on the other hand, focused on Dr. Bailey’s July 8, 2014 declaration that B.W.’s ITP had resolved. She explained the differences between acute and chronic ITP and opined that, though the subsequent testing that B.W. underwent was related to his history of ITP, the platelet counts show that his ITP in fact never returned. Dr. Gill noted, like Dr. Shaer, that, although bruising is symptomatic of ITP, it is not diagnostic unless it is accompanied by a low platelet count. After a thorough analysis of the facts, Special Master Corcoran found Dr. Gill persuasive and concluded that petitioner had not met the Vaccine Act’s severity requirement. He held that subsequent monitoring of an earlier- resolved condition was insufficient without recurrence of the condition more than six months after the vaccine administration. Based on the testimony at the hearing, however, the Special Master found it conceivable that B.W. may have suffered a psychological response lasting more than six months (and thus satisfying the severity requirement) and requested post-hearing briefs and supporting evidence from each party to that respect. Post-hearing briefs were filed on December 29, 2017, by petitioner and on February 12, 2018, by respondent. Both parties filed expert reports on the psychological issue after that. 5 Case 1:16-vv-00498-EGB Document 68 Filed 02/19/20 Page 6 of 11 Special Master Corcoran issued his opinion dismissing the complaint on January 18, 2019. He concluded that this case was indistinguishable from Crabbe v. Secretary of Health & Human Services, No. 10-762V, 2011 WL 4436742 (Fed. Cl. Spec. Mstr. Aug. 26, 2011), in which the Special Master held that neither monitoring ITP through platelet counts nor the possibility of recurrence were residual effects. He further held that, even if continued testing constituted “management,” that would not mean that the management was necessary to manage symptoms or sequelae of ITP. Decision at 14. The Special Master also rejected petitioner’s separate argument that B.W. showed evidence of separation anxiety that could be traced to the ITP episode. It is not necessary to discuss that issue in any detail, however, because we grant the petitioner’s motion on other grounds. On February 19, 2019, petitioner filed the present motion for review. Respondent filed a response on March 21, 2019. Oral argument was held on July 11, 2019. DISCUSSION I. Standard of Review On a motion for review, the court can: (1) uphold the special master’s finding of fact and conclusions of law and sustain his decision, (2) set aside any of the special master’s finding of fact or conclusions of law that are found to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law” and issue our own findings of fact and conclusions of law, or (3) remand to the special master for further action according to this court’s discretion. 42 U.S.C.S. § 300aa-12(e)(2)(A)-(C) (2012). Findings of fact are reviewed under the arbitrary and capricious standard; legal conclusions are reviewed de novo, and discretionary decisions are reviewed 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). Weighing and evaluating factual evidence and determining its probative value are within the Special Master’s purview as fact finder. Broekelschen v. Sec’y of Health & Human Servs., 89 Fed. Cl. 336, 343-44 (2009). On review, we do not reweigh, reevaluate or redetermine the value of factual evidence unless the Special Master is found to have been arbitrary and capricious, in which case we may “substitute [our] own findings of fact” if 6 Case 1:16-vv-00498-EGB Document 68 Filed 02/19/20 Page 7 of 11 we determine that the Special Master was arbitrary and capricious in his review. Id.; Munn, 970 F.2d at 870. In this case, we have no reason to question the Special Master’s thorough analysis of the facts; rather, we reach a different conclusion on an admittedly close question of law. II. Petitioner’s Record Demonstrates That Petitioner Suffered Residual Effects Of The Vaccine-Related Illness More Than Six Months After Receiving The Vaccine Petitioner argues that the Special Master erred in holding that B.W.’s repeated platelet testing six months after receiving the vaccination and beyond was not a residual effect or complication as required by the statute. Because the platelet tests were necessary given the subsequent manifestation of symptoms, petitioner asserts that this was treatment or management of B.W.’s condition and thus met the statutory requirement. In doing so, Ms. Wright also challenges the Special Master’s reliance on Crabbe because, unlike in Crabbe, her son’s treating physicians ordered subsequent platelet counts in response to his history of ITP and “their desire to ensure that his platelets permanently stabilized so he would not suffer any relapses.” Pet’r’s Mot. for Review 16. Petitioner cites two other cases as helpful, H.S. v. Secretary of Health & Human Services, No. 14-1057V, 2005 WL 1588366 (Fed. Cl. Spec. Mstr. Mar. 13, 2015) and Faup v. Secretary of Health & Human Services, No. 12-87V, 2015 WL 443802 (Fed. Cl. Spec. Mstr. Jan. 13, 2015). In those cases, the doctors’ concern about the presence of a vaccine-injury, as evidenced by continuing physical restrictions and on- going medication, were found to be residual effects of the injuries, even if the patient was asymptomatic at the time of these continuing effects. Petitioner analogizes this to her case, arguing that, just as relapse-preventing restrictions and medication are residual effects because they manage the “underlying vaccine injury,” B.W.’s platelet tests are residual effects because they too manage his underlying vaccine-injury. Pet’r’s Mot. for Review 17. At oral argument, petitioner argued that the court need not narrowly construe the statute using medical definitions because the plain meaning of “residual effects” is clear. Counsel urged the court to define the term broadly to encompass any subsequent monitoring for an earlier vaccine-related injury even if the injury has been resolved. 7 Case 1:16-vv-00498-EGB Document 68 Filed 02/19/20 Page 8 of 11 For its part, respondent agrees with the Special Master that petitioner did not show by a preponderance of evidence that B.W. suffered residual effects of his vaccine-related injury for more than six months. It emphasizes Dr. Bailey’s July 8, 2014 notation that B.W.’s ITP was resolved and cites Crabbe as persuasive.6 Respondent argues that only “symptoms that manifest because of the vaccine-related injury” are residual effects necessitating compensation under the Vaccine Act. Resp’t’s Resp. 8 (emphasis omitted) (citing Parsley v. Sec’y of Health & Human Servs., No. 08-781V, 2011 WL 2463539, at *16 (Fed. Cl. Spec. Mstr. May 27, 2011)). Further, respondent disputes that the tests B.W. received more than six months after his vaccination were monitoring or treatment of ITP because CBCs are merely diagnostic tests and did not show a recurrence of the injury. The tests were not a residual effect because B.W. was never re-diagnosed with ITP, urges Respondent. To be compensable, the government argues, the residual effects or complications “must manifest as a symptom.” Resp’t’s Resp. 12. The government also flags in the record the notation that the subsequent tests were ordered at Ms. Wright’s request, and suggests that they are thus not reflective of any concern of the treating physicians. The question posed by the respondent is whether what occurs after the six-month period must be a recurrence within the patient of the prior medical condition or of some physical sequela resulting from that condition, as opposed to merely treatment or management done to the patient, even if physical symptoms trigger a concern that there has been a relapse. There is no question that the testing was triggered by the prior ITP. In that sense, the testing is causally linked to the condition. We understand respondent’s concern that, if a condition has fully resolved, prescribing monitoring to occur beyond the six-month period is a very attenuated link to the severity concerns of the Act. For that reason, respondent argues that the “residual effects” requirement should involve something more than mere cause and effect in a general sense. Instead, it prefers the medical definition of “residual effect” relied on in Parsley: “refer[s] to something left behind or 6 Respondent also relies on testimony from Drs. Shaer and Gill for this point. 8 Case 1:16-vv-00498-EGB Document 68 Filed 02/19/20 Page 9 of 11 resulting from an illness, disability, or condition.” 2011 WL 2463539 at *61.7 I.e., a return of the condition or physical sequela. This definition often precludes claimants who suffer a vaccine related injury from compensation if the injury resolves before the six-month time frame and not does return, even if the patient is tested for possible recurrence later. See, e.g., Id. at *16; Crabbe, 2011 WL 4436742 at *20. Petitioner did not offer a competing dictionary definition but, at oral argument, suggested that the Act’s severity requirement be interpreted based the plain meaning of its terms because it is not ambiguous. Under either approach, we find that petitioner has met the test. See United States v. Ron Pair Enters., 489 U.S. 235, 240-41 (1989) (explaining that a court need not inquire beyond a statute’s plain language when the statutory scheme is coherent and consistent). The Special Master relied on Crabbe, calling it “indistinguishable” from the case before us. In Crabbe, a child was diagnosed with ITP after receiving the MMR vaccine and underwent platelet counts more than six months after the vaccination, once when he was presented with “redness around his eyes and neck” and the other when he was presented with a runny nose and high fever. Both blood tests showed normal platelet levels; thus, the Special Master concluded that platelet tests were not “residual effects” because they were merely testing for a possible recurrence of ITP. In Crabbe, the petitioner did not offer expert witness testimony to the effect that the child’s “problems [were] related to the vaccine injury.” Crabbe, No. 10- 762V, 2011 WL 4436742 at *17 (citing Song v. Sec’y, Health & Human Servs., 31 Fed. Cl. 61, 63 (1994)). Unlike in Crabbe, however, the platelet tests B.W. underwent after September 28, 2014 (January 26, 2015, April 13, 2016, and September 14, 2016), were ordered because B.W. presented with bruising and, in one instance, petechiae, both of which are symptoms of ITP. See 42 C.F.R. § 100.3 (c)(7). The record is clear that the treating physicians ordered platelet 7 Both parties refer to this definition of residual effects, and it is the definition relied upon in Crabbe. See Resp’t’s Resp. 8; Pet’r’s Mot. for Review 15 n.4; Crabbe, 2011 WL 4436742 at *20. The Special Master in Parsley relied on Abbott v. Sec’y of Health & Human Servs., 27 Fed. Cl. 792 (1993), rev’d on other grounds, 19 F.3d 39 (Fed. Cir. 1994) to define residual effect based on how a medical professional would understand the term. 9 Case 1:16-vv-00498-EGB Document 68 Filed 02/19/20 Page 10 of 11 counts because of B.W.’s history of ITP. Both sides’ expert witnesses agreed that this response—ordering platelet counts when a patient with a history of ITP is presented with bruising—was within the doctor’s reasonable standard of care. The present case, therefore, poses circumstances in between physical sequela of the condition and mere monitoring. We thus conclude that it is, in fact, distinguishable from Crabbe because the subsequent testing in this case was directly related to B.W.’s presentation of symptoms of ITP. The response of B.W.’s doctors to his bruising is analogous to that in H.S. v. Secretary of Health & Human Services. In H.S., a patient who fractured his skull after an episode of syncope following a vaccination was compensated under the Vaccine Act because his physician’s instruction to restrict physical activity continued more than six-months after he received the vaccine, even though the patient did not exhibit on-going symptoms. 2005 WL 1588366 at *8-9. The Special Master concluded that the activity restriction was a sufficient residual effect to allow for compensation. She found that the patient’s doctors “believed that the restriction from activity was medically necessary as part of H.S.’s treatment precisely to ensure that further consequences of the injury would not manifest in the future.” Id. at *8 (emphasis in original). Similarly, because B.W.’s doctors were exercising a reasonable standard of care by testing his platelets in response to the bruising he continued to exhibit more than six months after vaccination, those tests were also causally connected to the vaccine injury, and, we conclude, a residual effect.8 Using either the definition supplied by Parsley or a more general understanding of the terms, testing for a condition that could return ought to be compensated under the Vaccine Act when that testing is causally connected to the underlying vaccine-injury and triggered by subsequent symptoms of the conditions. The fact that those tests did not reveal the presence of ITP is not controlling. The tests became necessary when later symptoms triggered concern because of the earlier injury; they were not mere monitoring. 8 Respondent conceded at oral argument that B.W.’s platelet tests were connected to his history of ITP. Dr. Gill, testifying on behalf of respondent before the Special Master, likewise testified that it is unlikely B.W. would have undergone continued platelet testing if it were not for his history with ITP. 10 Case 1:16-vv-00498-EGB Document 68 Filed 02/19/20 Page 11 of 11 Our conclusion is consistent with the purpose of the Vaccine Act, which is to award “vaccine-injured persons quickly, easily, and with certainty and generosity.” Weddel v. Sec’y of Health & Human Servs., 100 F.3d 929, 932 (Fed. Cir. 1996) (quoting H.R. Rep. No. 99-908, at 3 (1986)). The act was meant to remedy the problem that “the opportunities for redress and restitution are limited, time consuming, expensive, and often unanswered” “for the relatively few who are injured by vaccines—through no fault of their own.” Cloer v. Sec’y of Health & Human Servs., 654 F.3d 1322, 1325 (Fed. Cir. 2011) (quoting H.R. Rep. No. 99-908, at 4 (1986)). By establishing a rule of prima facie proof for Table claims, the Act further “establishes a scheme of recovery designed to work faster and with greater ease than the civil tort system.” Shalala v. Whitecotton, 514 U.S. 268, 269- 70 (1995) (citing H.R. Rep. No. 99-908, at 3-17 (1986)). Given this purpose, we hold that the Act’s severity requirement is met when a petitioner has suffered an injury recognized by the Act and, for more than six months after the vaccine was administered, repeatedly undergoes unscheduled medical tests triggered by symptoms directly linked to the asserted vaccine-related injury. CONCLUSION Because the record indicates that B.W.’s on-going platelet counts were a result of the ITP he suffered following his MMR vaccine, we conclude that the Special Master erred as a matter of law in holding that there was no residual effect of the vaccine-related injury within the meaning of the Act. We therefore grant petitioner’s motion for review and remand the case back to the Special Master for further proceedings consistent with this opinion. s/Eric G. Bruggink ERIC G. BRUGGINK Senior Judge 11 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_16-vv-00498-2 Date issued/filed: 2020-10-27 Pages: 29 Docket text: PUBLIC DECISION (Originally filed: 9/25/2020) regarding 76 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (omg) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 1 of 29 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-498V (To be published) * * * * * * * * * * * * * * * * * * * * * * * * * HEATHER WRIGHT, * as Mother and Natural Guardian of minor * child, B.W., * * Chief Special Master Corcoran Petitioner, * * Filed: September 25, 2020 v. * * Immune Thrombocytopenic SECRETARY OF HEALTH AND * Purpura (“ITP”); HUMAN SERVICES, * Measles-Mumps-Rubella (“MMR”) * Vaccine; Damages; Emotional Respondent. * Distress; Vulnerable Child * Syndrome. * * * * * * * * * * * * * * * * * * * * * * * * * Leah V. Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for Petitioner. Traci R. Patton, U.S. Dep’t of Justice, Washington, DC, for Respondent. DECISION FINDING ENTITLEMENT AND AWARDING DAMAGES1 Heather Wright, as legal representative of her child, B.W., 2 filed a petition on April 21, 2016, seeking compensation under the National Vaccine Injury Compensation Program (“Vaccine 1 This Decision will be posted on the Court of Federal Claims’ website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means that 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 whole Decision will be available to the public in its current form. Id. 2 Petitioner’s counsel previously indicated that she had not been able to contact Ms. Wright for several months, raising the question of whether she should remain as Petitioner. Counsel has since filed a Status Report indicating that she has been able to resume communication with Ms. Wright, who intends to remain B.W.’s representative in the matter. Status Report, filed Aug. 14, 2020 (ECF No. 75). Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 2 of 29 Program”).3 ECF No. 1. Petitioner alleged that the measles-mumps-rubella (“MMR”) vaccine B.W. received on March 28, 2014, caused him to develop immune thrombocytopenic purpura (“ITP”). Pet. at 1. After a fact hearing the matter was dismissed, but Petitioner’s appeal was successful, returning the case to a litigation track. Respondent filed an Amended Rule 4(c) Report on November 8, 2019, representing that he would no longer defend the case, and after the parties were unable to resolve damages on their own, I ordered them to commence briefing the matter for my resolution. In total, Petitioner requests $100,000.00 in past pain and suffering, and $4,345.55 in satisfaction of a Medicaid lien sought by the State of Georgia. Petitioner’s Damages Brief at 4, filed Feb. 21, 2020 (ECF No. 70) (“Pet. Damages Brief”). Based on my review of the record and the parties’ submissions, I find that Petitioner is entitled to damages in this case, because she has established a Table claim based on B.W.’s ITP after receipt of the MMR vaccine. However, the amount of that award shall be $25,000.00 in actual pain and suffering, plus $4,345.55 in satisfaction of the Medicaid lien. The basis for my determination is set forth below. I. Brief Factual History B.W. was born on March 21, 2012. Ex. 2 at 57, filed July 6, 2016 (ECF No. 6). Before receiving the MMR vaccine, he was in generally good health, though somewhat behind schedule on his vaccinations. Id. at 57–61. At his two-year-old well-child visit on March 28, 2014, B.W. underwent his twenty-four-month development screening. Id. at 58–59. He was found to be developing normally and no behavioral concerns were noted. Id. At this visit, B.W. also received several vaccinations, including MMR. Id. at 53–54, 58–60. Approximately two weeks later, on April 15, 2014, B.W. presented at the emergency room at Ty Cobb Regional Medical Center in Lavonia, Georgia, accompanied by his father and paternal grandmother, with bruises on his forehead, abdomen, and all four extremities. Ex. 3 at 3–4, filed Apr. 22, 2016 (ECF No. 6).4 Within a matter of hours, lab results revealed that B.W.’s platelet count was only 43,000—far below the normal range of 150,000 to 400,000.5 Id. at 13. He was 3 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa- 10–37 (2012) (hereinafter “Vaccine Act” or “the Act”). Individual section references hereafter shall refer to § 300aa of the Act. 4 B.W.’s bruises were sufficiently severe to raise concerns that they might have been the result of nonaccidental trauma, so treaters contacted law enforcement, who investigated Ms. Wright for possible child abuse. Ex. 4 at 74, filed Apr. 22, 2016 (ECF No. 6). The duration and depth of this investigation are unclear from the record as filed. 5 Platelet counts reveal “the number of platelets (thrombocytes) per cubic milliliter of blood.” Crabbe v. Sec’y of Health & Hum. Servs., No. 10-762V, 2011 WL 4436724, at *2 n.9 (citing Pagana et al., Mosby’s Manual of Diagnostic and Laboratory Tests 416 (4th ed. 2010)). 2 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 3 of 29 diagnosed with thrombocytopenia (a condition characterized by abnormally low platelet levels)6 and discharged to his father and grandmother’s care that same evening. Id. at 8. The following day, B.W. arrived at Children’s Hospital of Atlanta (“CHOA”) by ambulance. Ex. 4 at 45–46. Notes from this visit reflect some initial treater uncertainty about whether his bruising reflected nonaccidental trauma or ITP (see id. at 74; Ex. 2 at 66), but treaters again ultimately concluded that his low platelet count (68,000 that day) established the presence of ITP. Ex. 4 at 91. B.W. was discharged to his mother’s care later that evening with a diagnosis of “thrombocytopenia likely secondary to acute ITP.” Id. Over the following weeks, B.W. saw various pediatricians at the Longstreet Clinic in Gainesville, Georgia, for frequent blood checks. See Ex. 2 at 88, 94, 102, 107, 115, 117. His platelet counts fluctuated significantly over these visits: 180,000 on April 21; 68,000 on May 2; and 111,000 on May 7. Id. at 88, 94, 115. However, his bruising, though still visible, did not appear to worsen. See id. at 90, 107, 113. Following an April 29th visit with pediatrician Garrick Bailey, M.D., B.W. was referred to hematology for more detailed analysis of his blood condition. Id. at 101. B.W. saw two hematologists at CHOA, Benjamin Watkins, M.D., and Michael Briones, D.O. Id. at 123–28. They concluded that he had ITP resulting from his MMR vaccination, but noted that his thrombocytopenia was “not severe at this time” and recommended follow-up visits “every 1– 2 months until resolution.” Id. at 127. On July 8, 2014—less than three months after onset of his ITP (in the form of the visible bruising)—B.W. presented to Dr. Bailey for a platelet count at Petitioner’s request. Ex. 2 at 142. At that visit, Dr. Bailey noted that B.W.’s ITP had “resolved.” Id. at 144. B.W. thereafter never returned to a hematologist for official clearance.7 Sporadic platelet count checks over the following months never showed platelet counts outside the normal range. See, e.g., id. at 136 (platelet count of 312,000 on September 10). These checks were conducted at visits for other complaints in response to concerns about B.W.’s history of ITP. See, e.g., id. at 136 (September 10th visit for headache), 155 (January 26, 2015 visit for bruising on shins and abdomen). Since resolution of his ITP, B.W. has largely remained in good physical health. Petitioner has, however, offered evidence that at age three and a half years B.W. was diagnosed with attention deficit hyperactive disorder (“ADHD”). Ex. 14 at 4, filed Feb. 21, 2018 (ECF No. 45-1) (“Jordan Rep.”).8 Notes from treaters, both before and after his ADHD diagnosis, consistently characterize 6 Dorland’s Illustrated Medical Dictionary 1892 (33d ed. 2020). 7 A follow-up with Drs. Watkins and Briones was scheduled for June 10, 2014. Ex. 2 at 128. However, Ms. Wright stated that she canceled this follow-up visit due to a stomach bug. Ex. 9 at 15, filed July 6, 2016 (ECF No. 9-2). She did not reschedule. Id. 8 While Petitioner informed Dr. Guy Jordan that B.W. had been diagnosed with ADHD and prescribed Adderall at age three and a half (Jordan Rep. at 4), the medical records filed in this case provide no clear support for such a 3 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 4 of 29 B.W. as very active, playful, and happy. See Ex. 2 at 92, 121 (notes from April 18, 2014: “[n]o obvious distress, active, happy, appropriate for age;” May 2, 2014: “[n]o obvious distress, interactive, very playful/active”); Ex. 9 at 27 (January 21, 2016: “smiles, playful, and active and alert”). Medical records do not reflect any stated concerns from Ms. Wright about her son’s psychological well-being or behavioral development, except for concerns about excessive activity levels. See Ex. 2 at 140, 177–78; Ex. 6 at 21; Ex. 9 at 11–12. II. Procedural History As noted above, Petitioner filed her claim on April 21, 2016. Medical records were filed over the coming months. Then, on September 21, 2016, Respondent filed a combined Rule 4(c) Report and Motion to Dismiss, arguing that Petitioner could not meet the severity requirement under the Vaccine Act, given that the record seemed to support the conclusion that B.W.’s ITP had resolved in less than six months from onset. Petitioner responded to the Motion to Dismiss on October 5, 2016, and Respondent filed his Reply on October 28, 2016. The parties filed expert reports from Drs. Shaer and Gill in early 2017. The case was originally assigned to the Office of Special Masters’ Special Processing Unit (as it was deemed likely to settle), but it was reassigned to me after Respondent raised the severity issue as a roadblock to the claim. I thereafter inquired of the parties as to whether a hearing would help resolve the issue, and they agreed. To that end, both filed prehearing briefs on September 8, 2017, and a one-day hearing took place on September 21, 2017. During the hearing, the testimony of one expert per side (Dr. Shaer for Petitioner, Dr. Gill for Respondent) was heard. After the hearing, I informed Petitioner that my preliminary determination was that she could not establish severity based solely on the need for ongoing platelet count testing (which the record conclusively establishes did not reveal recurrence of the problem), but that she might be able to do so if she better substantiated her contention that B.W. had experienced subsequent psychological sequelae that lasted more than six months post-onset. To that end, Petitioner filed a post-hearing brief on December 29, 2017, and Respondent did the same on February 12, 2018. The parties also filed expert reports from Drs. Jordan and Miller regarding B.W.’s psychological condition post-vaccination. Respondent submitted his final brief in support of dismissal on September 28, 2018, and Petitioner responded on November 30, 2018. On January 18, 2019, I issued a Decision denying entitlement, based on my interpretation of case law pertaining to ITP platelet testing post-onset. Decision, filed Jan. 18, 2019 (ECF No. 53). Thereafter, Petitioner filed a Motion for Review on February 19, 2019, and the parties further briefed the issue of the six-month severity requirement before oral argument, which was held on diagnosis during the stated time period. See, e.g., Ex. 9 at 7, 46, (no current medications listed at May 6, 2016 visit; ADD and ADHD listed as negative in past medical history at April 21, 2016 visit). 4 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 5 of 29 July 11, 2019. Motion for Review, filed Feb. 19, 2019 (ECF No. 54). On July 16, 2019, Petitioner’s Motion for Review was granted, with the Court of Federal Claims determining that post-onset platelet count testing for more than six months after vaccine administration was sufficient to establish severity. Reported Opinion, filed July 16, 2019 (ECF No. 60). The case was remanded to me for further consideration. I thereafter conferred with the parties, informing them of my view that Petitioner could now likely meet the requirements of a Table claim and urging them to consider settlement. Minute entry, dated Aug. 16, 2019. Respondent filed an Amended Rule 4(c) Report on November 8, 2019 indicating that he would no longer defend the case, and on December 16, 2019, I ordered the parties to brief damages, since they were unable to settle the matter themselves. The parties completed this process on May 28, 2020. III. Damages Evidence - Experts I include herein a brief overview of the expert testimony and opinions offered throughout the case and bearing on the damages issue to be decided. A. 2017 Hearing Testimony 1. Petitioner’s Expert – Dr. Catherine Shaer, M.D. Dr. Shaer received her bachelor’s degree from Quinnipiac College in Hamden, Connecticut, and her medical degree from University of Texas Health Science Center in San Antonio. Ex. 12 at 1, filed Feb. 3, 2017 (ECF No. 22-2). She completed a three-year residency in pediatrics at Children’s National Medical Center in Washington, D.C. in 1981 and is board- certified in pediatrics. Id. She served for many years as the medical director of the spina bifida program at Children’s National Medical Center. Id. at 3. From 2008 to 2014, Dr. Shaer worked as a medical officer at the Health and Human Services Division of Vaccine Injury Compensation, where she reviewed Vaccine Program claims on behalf of Respondent. Id. at 2. For the past four years, she has done similar work for petitioners’ attorneys, reviewing potential vaccine claims and offering testimony and reports on behalf of Vaccine Program claimants. Id. at 1. She published articles, most often on spina bifida, in several medical journals throughout the late 1980s and 1990s. Id. at 7–8. Dr. Shaer’s two-page expert report mostly focused on her conclusion that later-in-time blood draws B.W. received could be directly attributed to his April 2014 ITP diagnosis, and her testimony at hearing was consistent with the report. See generally Ex. 11, filed Feb. 3, 2017 (ECF No. 22-1); Tr. at 19, 44-45. She thus opined that the residual effects of B.W.’s ITP lasted longer than six months. Tr. at 21. She conceded, however, that B.W.’s platelet count did not fall to levels 5 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 6 of 29 constituting thrombocytopenia at any time more than six months after his initial diagnosis, and agreed that notes from treating physicians reflected that his ITP had in fact resolved by July 8, 2014, despite ongoing testing thereafter. Id. at 54–56, 64. Dr. Shaer’s report did not discuss B.W.’s psychological condition prior to or following his ITP diagnosis. However, she testified about a September 2015 phone conversation she had with Ms. Wright and offered some opinions about how Ms. Wright’s response to B.W.’s ITP diagnosis might play into his behavioral development. Tr. at 29–38. In this call, Ms. Wright purportedly informed Dr. Shaer that B.W. presented in April 2014 with an alarmingly large bruise on his side, which medical professionals feared could be due to nonaccidental trauma. Id. at 30. An investigation involving police departments from multiple jurisdictions ensued, during which B.W. was separated from his mother. Id. at 30–31. Dr. Shaer was unsure how long this period of separation lasted. Id. at 30. More specifically, Dr. Shaer testified that Petitioner had mentioned to her9 that B.W.’s behavior changed “after all this happened,” and he became “hard to control.” Tr. at 32. Dr. Shaer accordingly speculated that any changes in B.W.’s demeanor as a result of his ITP diagnosis might be attributable in part to a form of vulnerable child syndrome. Id. at 32–35. Vulnerable child syndrome, Dr. Shaer explained, occurs when a parent responds to her child’s health problems with excessive and irrational levels of concern, which can influence the nature of her interactions with the child. Id. at 32–33. This in turn can affect the sick child’s behavior. Id. at 34. Dr. Shaer noted that presentation of vulnerable child syndrome varies widely—some children may begin to have temper tantrums, while others may become quiet and withdrawn. Id. In Dr. Shaer’s view, the degree of concern Ms. Wright expressed about B.W.’s ITP was excessive, exaggerated, and irrational, which she posited could affect B.W.’s behavior. Tr. at 32, 38 (noting that “the mother took the trauma well beyond what I would consider rational, and I think it’s certainly reasonable to…consider that that could have affected the child because I don’t see how it couldn’t.”), 57 (emphasizing that she “was concerned about [Ms. Wright’s] reaction to this whole thing and its effect on the child…” and she “thought that [Ms. Wright] was…that long after this episode that she…it was almost like she was in the throes of it again. It was a very exaggerated response and the way she spoke about it with so much emotion and fear in her voice concerned me.”). She noted that Ms. Wright demonstrated ongoing anxiety and fear about B.W.’s condition, and that she appeared to believe her child continued to suffer from ITP, even though he had long been stable at the time of their conversation. Id. at 31, 69. Dr. Shaer admitted, however, that the tests B.W. underwent were not likely to be painful or traumatizing, and again focused on Ms. Wright’s likely reaction to such procedures, reiterating that excessive concern on her part 9 Dr. Shaer noted at least one instance in which Ms. Wright was inaccurate in her recollection of events. Tr. at 30. She also acknowledged that Ms. Wright “couldn’t explain to me things in a logical fashion. She’s not the most clear, sort of focused person.” Tr. at 38. 6 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 7 of 29 could in turn affect B.W. Id. at 36–38. She also noted that B.W. had “a very chaotic family situation” and acknowledged that “[t]here’s a lot of reasons children could have developmental or behavioral problems.” Tr. at 35, 38. Ultimately, Dr. Shaer did not consider a specific diagnosis of vulnerable child syndrome to be particularly important in this case. She stated that “we can even forget that term,” emphasizing instead that Ms. Wright’s response to B.W.’s diagnosis was of such a nature that she felt B.W. should receive some kind of psychological examination in order to ascertain the full extent of how his mother’s reaction to his ITP might be affecting his behavior. Tr. at 39. On cross- examination, however, she conceded that nothing in B.W.’s medical record showed any signs of behavioral or psychological problems. Id. at 58, 66. 2. Respondent’s Expert – Dr. Joan Gill, M.D. Dr. Gill’s testimony at the fact hearing10 was consistent with her written report, and largely focused on the timeframe in which B.W.’s ITP resolved. Ex. B at 1–2, filed May 23, 2017 (ECF No. 28-1); Tr. at 78, 82. She was, however, briefly questioned by counsel for both parties about the possibility that B.W. experienced vulnerable child syndrome or a related psychological or behavioral issue, as Dr. Shaer had suggested, and she denied seeing record evidence of either. Tr. at 85, 91. When asked by Petitioner’s counsel to speculate about whether B.W.’s ITP diagnosis and the ensuing nonaccidental trauma investigation would have been traumatic, she speculated that any separation between B.W. and his mother likely concluded quickly, as Ms. Wright brought B.W. to his appointment the day after the investigation began, and that such an experience was unlikely to be psychologically traumatic in so young a child. Id. at 97. B. Post-Hearing Expert Opinions Specific to Damages and Severity 1. Petitioner’s Expert – Dr. Guy Jordan, Ph.D. Petitioner offered a single expert report from a psychologist, Dr. Guy Jordan. See generally Jordan Rep. According to Dr. Jordan’s evaluation, which was conducted after the September 2017 10 As noted on her CV, Dr. Gill received her bachelor’s degree from St. Norbert College in West De Pere, Wisconsin, and her medical degree from the Medical College of Wisconsin in Milwaukee. Ex. C at 1, filed May 23, 2017 (ECF No. 28-4). She completed both a pediatric internship and residency at Milwaukee Children’s Hospital, followed by a fellowship in pediatric hematology-oncology at the Medical College of Wisconsin and the Blood Center of Southeastern Wisconsin. Id. at 1–2. Dr. Gill was board certified in pediatric hematology/oncology, and she served as a professor, first of pediatrics and more recently of population health and epidemiology, at the Medical College of Wisconsin since 1981. Id. at 2, 4. Her numerous publications on blood disorders have appeared in many medical journals. Id. at 11–25. Dr. Gill is now deceased. 7 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 8 of 29 fact hearing, B.W. suffered from Separation Anxiety Disorder and behavioral disturbances as a result of his ITP and the efforts to treat it. Dr. Jordan received his bachelor’s degree in Psychology from Valdosta State College. Dr. Jordan Curriculum Vitae, filed as Ex. 15 on Feb. 21, 2018 (ECF No. 45-2) at 1. He then obtained his Master of Education in Educational Psychology followed by his Ph.D. in Educational Psychology from the University of Georgia. Id. Dr. Jordan has been licensed to practice in the state of Georgia since 1983. Id. Throughout his career, Dr. Jordan has served as a consultant and educator in the areas of clinical and school psychology. Id. at 2–4. He has also published some articles discussing topics such as child development and school psychology. Id. at 4–5. Dr. Jordan’s evaluation begins with a detailed history of B.W.’s condition and psychological state, based upon a history provided by Petitioner. Jordan Rep. at 1–2. B.W. was reported to have been a well-behaved baby and was developing normally prior to the receipt of several vaccines in March 2014. Id. at 2. But his behavior purportedly changed drastically following the onset of his ITP, and B.W. began fighting, kicking, biting, and screaming at daycare workers and babysitters. Id. As a result, B.W. was unable to attend daycare and Ms. Wright was unable to obtain childcare for him. Id. Petitioner also told Dr. Jordan that B.W. would exhibit violent behaviors, such as screaming, slapping, biting, and kicking, and would refuse to stay with family members in the absence of his mother. Id. This constellation of behaviors persisted for approximately six months. Id. In Dr. Jordan’s view, these behaviors were consistent with a diagnosis of Separation Anxiety Disorder, which he opined could have been triggered by the forced separation of B.W. from his mother during his initial hospitalization, diagnosis, and treatment for ITP in April 2014. Jordan Rep. at 3. Dr. Jordan described Separation Anxiety Disorder as “fear and apprehension in a child when separated from the primary caregiver and fear reaction is exaggerated and more intense than the circumstances should trigger.” Id. He emphasized that a single event—such as B.W.’s initial hospitalization—could be sufficient to induce separation anxiety symptoms. Id. Dr. Jordan also noted that B.W. experienced improvement in his symptoms after being reunited with his mother and reestablished with his daily routine. Id. This improvement, however, was limited, and according to Ms. Wright, B.W. was subsequently diagnosed with Attention Deficit Hyperactivity Disorder (“ADHD”) and prescribed Adderall.11 Jordan Rep. at 4. This intervention again resulted in some improvement, but Ms. Wright continued to express concerns regarding B.W.’s behavior at pre-school. Specifically, she noted that B.W. is more immature and selfish than other children his age. Id. These behavioral 11 While Petitioner informed Dr. Jordan that B.W. had been diagnosed with ADHD and prescribed Adderall at age three and a half (Jordan Rep. at 4), the medical records filed in this case provide no clear support for such a diagnosis during the stated time period. See, e.g., Ex. 9 at 7, 46, (no current medications listed at May 6, 2016 visit; ADD and ADHD listed as negative in past medical history at April 21, 2016 visit). 8 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 9 of 29 issues persisted following B.W.’s placement in foster care, which coincided with his starting kindergarten. Id. B.W.’s foster parents reported that he was easily distracted, talkative, and unable to sit still and pay attention. Id. B.W. was prescribed additional medication to alleviate these symptoms, and his foster parents reported improvement in his social behaviors as a result. Id. at 5. B.W.’s teacher, however, continues to express concerns regarding B.W.’s ADHD symptoms, including fidgeting, talkativeness, interrupting other children, playing rough, and delayed development in the areas of language, comprehension, articulation, and motor coordination. Id. As part of Dr. Jordan’s evaluation, B.W. participated in intellectual and educational assessments and scored above average in most categories. Id. at 5–6. Given these results, Dr. Jordan indicated that B.W. will likely be successful in school as long as his ADHD symptoms are adequately managed. Id. Dr. Jordan did not attribute B.W.’s ADHD to his ITP diagnosis or treatment. Id. at 9 (“The etiology of the ADHD is unknown…”). In January 2018—nearly four years after B.W.’s ITP diagnosis—Dr. Jordan conducted an interview with B.W., during which B.W. reported an incident where he bruised himself around the eye after running into another child. Jordan Rep. at 6. He indicated that the bruise took a while to resolve, but he was unable to provide a specific timeline. Id. He also expressed sadness at being taken away from his mother as a general matter and questioned what would happen to him if everyone in his family died. Id. Dr. Jordan explained that these feelings and questions are consistent with Separation Anxiety Disorder, though they are not sufficient to support a formal diagnosis of mental illness. Id. Dr. Jordan also explained, however, his view (contrary to Dr. Shaer’s) that it was unlikely that B.W. suffered from vulnerable child syndrome. Jordan Rep. at 4. He opined that the steps Ms. Wright took in obtaining care for her son’s condition were appropriate and responsible. Id. He felt that Ms. Wright approached B.W.’s care in a manner that promoted “a return of the child’s behavioral and emotional levels to a standard of normalcy as experienced prior to the vaccine injury.” Id. Thus, he did not agree that Ms. Wright’s emotional perceptions surrounding her child’s injury likely affected B.W.’s psychological state. Id. 2. Respondent’s Expert – Dr. Judith Miller, Ph.D. Dr. Judith Miller, a clinical psychologist, provided a single expert report on behalf of Respondent. Respondent Psychological Evaluation, filed as Ex. A on May 29, 2018 (ECF No. 50- 1) (“Miller Rep.”). Her report was based on her review of the medical records filed in this matter, as well as Dr. Jordan’s evaluation report, but she did not interview B.W. Id. at 1. Dr. Miller concluded that B.W. never suffered from Separation Anxiety Disorder or severe emotional distress as a result of his ITP diagnosis, monitoring, and treatment. Id. at 5, 8. 9 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 10 of 29 Dr. Miller received her bachelor’s, master’s, and Ph.D. in clinical psychology from the University of Utah. Dr. Judith Miller Curriculum Vitae, filed as Ex. C on May 29, 2018 (ECF No. 50-3) (“Miller CV”) at 1. She also completed a fellowship at the University of Utah Medical School’s Neurobehavior Clinic in addition to a postdoctoral fellowship at the Emory School of Medicine’s Autism Resource Center. Id. She has served as a professor in the field of psychology since 2002, and she is currently and associate professor of psychology in psychiatry at the University of Pennsylvania Perelman School of Medicine. Id. She also holds several positions at the Children’s Hospital of Philadelphia Center for Autism Research. Id. Dr. Miller has published numerous journal articles, the majority of which focus on autism. Id. at 16–28. Though her primary area of expertise is autism, Dr. Miller explained that she is familiar with differential diagnoses such as Separation Anxiety Disorder and ADHD because they are often considered when evaluating children for autism spectrum disorder. Miller Rep. at 1. Dr. Miller first described B.W.’s pre-vaccination condition, noting that B.W. spent much of this time period living with his mother and two siblings in a homeless shelter. Miller Rep. at 2. The records also indicated that B.W. was regularly seen by a pediatrician for routine health screenings and sick visits. Ex. 2–6, 9. During these visits, he was regularly screened for developmental problems. Ex. 2 at 177–78; Ex. 6 at 8. B.W. was consistently found to be developing normally and no behavioral concerns were documented. Miller Rep. at 2; see also Ex. 2 at 41–42, 58–59. Next, Dr. Miller described the events immediately preceding B.W.’s ITP diagnosis. Miller Rep. at 2. Around the time of the April 2014 hospital visits, when B.W.’s bruising first manifested, a child abuse investigation was conducted but was closed within three and a half hours, and B.W. was discharged into his mother’s care the next day without further investigation or separation. Id. at 2, 4; see also Ex. 2 at 72–75; Ex. 4 at 76. Ms. Wright was thereafter attentive towards her son and his medical condition, continuing to monitor B.W.’s symptoms, request testing, and accompanying him to follow-up and sick visits with his pediatrician and specialists following his ITP diagnosis. Miller Rep, at 3–5. The records from these visits established that Petitioner consistently described B.W.’s behavior as active and playful, and she did not express any concerns regarding his behavioral or social development. Id. Developmental screenings performed after B.W.’s ITP diagnosis also showed that B.W. was developing normally. Miller Rep. at 4–5; see also Ex. 2 at 177 (describing results for B.W.’s thirty-month developmental screening results as passing). Dr. Miller notes that these findings are consistent with the observations of B.W.’s treating physicians, who noted B.W. appeared to be happy, active, and cheerful. Miller Rep. at 4–5; see also Ex. 2 at 90, 111, 142, 153; Ex. 5 at 22– 23, 26; Ex. 6 at 2, 5, 8. 10 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 11 of 29 Dr. Miller next addressed the applicability of Dr. Jordan’s Separation Anxiety Disorder diagnosis. Miller Rep. at 5–8. She explained that Separation Anxiety Disorder is characterized by “excessive worries and thoughts about harm coming to a caregiver (or to oneself) that would lead to prolonged or permanent separation.” Id. at 6. Such a diagnosis is proper only if the individual in question is mentally capable of understanding that injury or death can lead to prolonged separation. Id. At two years old, however, children are incapable of understanding the implications of prolonged separation. Id. They do, however, exhibit behaviors consistent with separation anxiety, and such behaviors are considered developmentally normal in young children. Id. Dr. Miller did not find any evidence in the record to support a diagnosis of Separation Anxiety Disorder for B.W. While Ms. Wright reported to Dr. Jordan a change in B.W.’s behavior following his initial hospitalization for ITP, none of the contemporaneous medical records corroborate these recollections, and they were in fact contrary to the positive image of B.W.’s mental health that the record did establish. Miller Rep. at 6–7.; see also Ex. 2 at 90, 111, 142, 153; Ex. 5 at 22–23, 26; Ex. 6 at 2, 5, 8. Moreover, Dr. Miller observed several instances where Ms. Wright told B.W.’s physicians that she did not have any behavioral concerns and B.W. was socializing well with other children and attending school. Miller Rep. at 5; see also Ex. 2 at 177– 78; Ex. 6 at 21; Ex. 9 at 12).12 Dr. Miller also challenged Dr. Jordan’s opinion that B.W. continues to exhibit some symptoms of Separation Anxiety Disorder. Miller Rep. at 7. Rather, Dr. Miller considered B.W.’s sadness and concern as natural reactions to B.W.’s unstable home life. Id. B.W. spent the majority of his early childhood living in a homeless shelter. Id. at 7–8. While living in a trailer with his mother and siblings, he did not have access to running water and was ultimately removed from the home and placed in the foster care system as a result of these conditions. Id. Such circumstances are not conducive to a wholly-positive mental disposition, and Dr. Miller did not find B.W.’s emotional reaction to those conditions excessive. Id. Rather, his sadness and concerns for the future demonstrate nothing more than situational awareness appropriate for his age. Id. IV. Briefing on Damages As discussed earlier, Petitioner requests $100,000.00 in past pain and suffering and $4,345.55 in satisfaction of a Medicaid lien. Pet. Damages Brief at 4. Respondent posits that Petitioner is entitled to an award between $5,000.00 and $10,000.00 for actual pain and suffering, 12 In addition, blood draws that were performed to diagnose and monitor B.W.’s ITP were easily completed and the only comfort measure required was distraction. Miller Rep. at 5; see also Ex. 3 at 6 (documenting blood draw absent any notes of distress); Ex. 4 at 21 (documenting a finger-stick blood draw that was completed in a single attempt), 69, 80, 82; Ex. 9 at 52. 11 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 12 of 29 but concedes her entitlement to a lump sum payment of $4,245.55 in satisfaction of the Medicaid lien. Respondent’s Brief, filed Apr. 7, 2020 (ECF No. 71) (“Resp. Damages Brief”) at 14.13 A. Petitioner’s Post-Hearing Brief Though initially filed in opposition to Respondent’s Motion to Dismiss, Petitioner’s second Post-Hearing Brief offers several arguments that are also relevant to the issue of damages. Petitioner’s Post-Hearing Brief, filed Nov. 30, 2018 (ECF No. 52) (“Pet. Post-Hr’g Brief”). Specifically, Petitioner therein discussed Dr. Jordan’s credentials and psychological evaluation of B.W.—both of which are critical in determining an appropriate award of damages—at length. Id. at 13–17. Petitioner first notes that Dr. Jordan has over forty years of experience and has evaluated over 8,000 children and adolescents throughout his career as a licensed psychologist. Pet. Post- Hr’g Brief at 13. She also emphasizes that Dr. Jordan’s evaluation was comprehensive, including extensive review of B.W.’s medical records and case filings; interviews with Ms. Wright, B.W.’s foster parent, and B.W.’s teacher; and his own personal observations of B.W. Id. at 13–14. Ultimately, this evaluation led Dr. Jordan to conclude that B.W. suffered from Separation Anxiety Disorder, and his separation from Ms. Wright during the child abuse investigation likely contributed to his psychological condition. Id. at 14. By contrast, Dr. Miller relied solely on the medical records and Dr. Jordan’s opinion. Id. And Dr. Miller’s primary focus is in the area of autism—a disorder B.W. does not have. Id. at 15. Thus, Petitioner argues, Dr. Jordan’s broader approach and experience as a school psychologist renders his opinion more reliable overall. Id. Petitioner next argues that although the medical records are inconsistent on the subject, Dr. Jordan’s diagnosis of Separation Anxiety Disorder still had preponderant support. Pet. Post-Hr’g Brief at 15–16. Thus, the records document brief encounters that do not fully capture the range of behaviors B.W. was exhibiting following his ITP diagnosis. Id. at 16. But by incorporating medical record documentation, Dr. Jordan’s evaluation, and Ms. Wright’s own observations, an overall accurate and comprehensive understanding of B.W.’s psychological condition following his ITP diagnosis can be ascertained. Id. at 15–17. 13 The Act does not allow petitioners to recover compensation “for any item or service to the extent that payment has been made . . . under any Federal or state health benefits program . . . .” Section 15(g). This means that where claimants have received prior treatment for their vaccine injury under a Federal program like Medicaid, a lien arises against any Vaccine Program award for the value of that medical service. See, e.g., Simmons v. Sec’y of Health & Hum. Servs., No. 11-216V, 2019 WL 2572256 (Fed. Cl. Spec. Mstr. May 28, 2019). Petitioner calculates a Medicaid lien exists against her award in the sum of $4,345.55. Pet. Damages Brief at 12; Medicaid Lien, filed as Ex. 16 on Feb. 21, 2020 (ECF No. 69-1). Petitioner has offered substantiating documentation in support of the lien, and no objection has been made regarding this portion of Petitioner’s request. 12 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 13 of 29 B. Petitioner’s Brief on Damages Petitioner’s claim is premised on her allegation that between April 2014 and September 2016, B.W. suffered physical and emotional trauma, including Separation Anxiety Disorder, as a result of undergoing fifteen blood draws from April 15, 2014 to April 13, 2016. Pet. Damages Brief, at 9–10; see also Ex. 3 at 5–6 (documenting the first of B.W.’s blood draws); Ex. 9 at 14– 16 (documenting the last of B.W.’s blood draws). She emphasizes that these blood draws would not have been necessary but for B.W.’s ITP diagnosis, and she supports this contention with the testimony of Dr. Catherine Shaer—an expert in pediatrics. Pet. Damages Brief at 10; Tr. at 19–21. She also alleges that B.W. was acutely aware of his condition. Pet. Damages Brief at 9. She claims that B.W. developed a fear of needles and would shake and cry so much during blood draws that he had to be restrained before a successful draw could be completed. Id. And she maintains that B.W. experienced behavioral changes consistent with Separation Anxiety Disorder as a result of his diagnosis and follow-up care. Id. at 10. Thus, Petitioner argues that B.W. not only understood the nature of his condition, but also experienced severe physical and emotional anguish over a two- year-and-five-month period as a result. Id. at 9–10. Petitioner was not able to reference comparable reasoned decisions relating to the best calculation of pain and suffering in ITP cases, but notes that many Program cases alleging ITP are resolved through settlement. Pet. Damages Brief at 6. In her Brief, Petitioner provides a list of such cases, for which the average settlement award totals more than the requested amount of $100,000.00 (although these amounts are not broken down by damages sub-categories). Id. at 6– 7. She also argues that Table-injuries, such as that suffered by B.W., tend to settle for larger amounts than Non-Table claims, and the amounts for which these cases have settled has been steadily increasing year after year. Id. at 7. C. Respondent’s Post-Hearing Brief Regarding Petitioner’s claim of psychological distress and Separation Anxiety Disorder, Respondent noted in his second Post-Hearing Brief (which was filed as his “Brief in Support of Dismissal”) that Dr. Jordan’s opinions are overly reliant on the history reported by Ms. Wright— years after the events in question and after this case was filed. Respondent’s Brief in Support of Dismissal at 3, 6–7, filed Sept. 28, 2018 (ECF No. 51) (“Resp. Post-Hr’g Brief”). Respondent further argues that the contemporaneous medical records—which are devoid of any behavioral, psychological, or developmental concerns and often describe B.W. as “happy” and developmentally normal—should be given more weight, with the opinions formed based on those records (like those of Dr. Miller) deemed more reliable. Id. at 6–11. That record does not support the conclusion that B.W. experienced any form of psychological trauma as a result of his ITP diagnosis. 13 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 14 of 29 In support of his position, Respondent references the opinions of Dr. Miller. Resp. Post- Hr’g Brief at 7–11. Respondent emphasizes Dr. Miller’s credentials as a licensed clinical psychologist with over twenty-five years of experience diagnosing children with autism spectrum, anxiety, and attention disorder. Id. at 7. Respondent also takes note of the circumstances under which Dr. Jordan performed his evaluation of B.W., observing that B.W. (who was almost six years old when he met with Dr. Jordan) was living with a foster parent during that time period. Id. at 11. Though Petitioner’s experts facially acknowledge the tumultuous circumstances in which B.W. has been raised, Respondent argues that it is these external sources of uncertainty and instability that are most likely responsible for B.W.’s current state of mind, rather than psychological trauma associated in any way with the impact of the MMR vaccine on his life. Id. D. Respondent’s Specific Brief on Damages Though Respondent does not dispute B.W.’s ITP diagnosis, he notes several inconsistencies between Petitioner’s allegations regarding the severity of the injury and B.W.’s awareness of the situation and the medical record. First, Respondent observes that the contemporaneous medical records regarding B.W.’s blood draws do not corroborate the fear and violent reactions B.W. is alleged to have displayed. Resp. Damages Brief at 10. The only support for these allegations arises from discussions between Petitioner and Petitioner’s counsel. Id. (citing Pet. Damages Brief at 9 n.2). Respondent also notes that Petitioner herself has never provided an affidavit in this matter, and thus the record is devoid of any substantiating direct witness evidence about B.W.’s purported condition. Resp. Damages Brief at 10–11. Second, Respondent maintains that B.W.’s overall injury was mild, making a pain and suffering award of the magnitude sought by Petitioner inappropriate. Resp. Damages Brief at 13– 14. To this end, Respondent emphasizes that B.W.’s physicians described B.W.’s condition as “not severe.” Id. at 13 (citing Ex. 2 at 124). In addition, B.W. was hospitalized only once between April 2014 and September 2016, and it was for a period of less than twenty-four hours. Resp. Damages Brief at 13–14. Additionally, B.W. never required oral, intravenous, or injectable medication to treat his condition. Id. at 13. The only medical intervention performed as a result of B.W.’s ITP was regular platelet checks, which occurred approximately fifteen times over the course of two years and five months. Id. at 14. E. Petitioner’s Reply Brief on Damages In her Reply, Petitioner argues that Respondent’s proposed award of $10,000.00 does not adequately account for the duration and severity of B.W.’s condition. Petitioner’s Reply Brief, filed May 28, 2020 (ECF No. 73) (“Reply”) at 3, 5–6, 9. She emphasizes that B.W required almost two and one-half years of monitoring for his condition. Reply at 5. Petitioner also argues that the 14 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 15 of 29 testimony of Drs. Shaer and Jordan provides ample evidence of the physical and emotional trauma B.W. sustained in connection with his ITP diagnosis. Id. at 8–9. Thus, Petitioner maintains that $100,000.000 is a proper pain and suffering award. Id. at 9. V. Applicable Law A. Standard of Law for Table Claims To receive compensation in 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 the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006). In this case, Petitioner asserts a Table claim. For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. Section 13(a)(1). Table claim petitioners need not independently demonstrate that the vaccine at issue can cause the claimed injury, nor that the vaccine did cause the injury in that case. Shalala v. Whitecotton, 514 U.S. 268, 270 (1995). Instead, so long as the claimed injury occurred in accordance with the Table’s injury definitions and onset timeframe, causation is presumed. Id. This presumption of causation does not excuse Table claim petitioners from other statutory requirements for compensation, however. Song v. Sec’y of Health & Hum. Servs., 31 Fed. Cl. 61, 65 (1994), aff’d, 41 F.3d 1520 (Fed. Cir. 1994) (unpublished table decision); Crabbe v. Sec’y of Health & Hum. Servs., No. 10-762V, 2011 WL 4436724, at *1 (Fed. Cl. Spec. Mstr. Aug. 26, 2011). Thus, Table or not, Vaccine Program claimants not asserting a vaccine-related death or 15 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 16 of 29 other injury requiring a surgical intervention and inpatient care must demonstrate that they suffered the residual effects or complications from their vaccine-related injury for more than six months. Section 11(c)(1)(D). B. Legal Standards Governing Factual Determinations The process for making determinations in Vaccine Program cases regarding factual issues begins with consideration of the medical records. Section 11(c)(2). The special master is required to consider “all [] relevant medical and scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then required to weigh the evidence presented, including contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to afford greater weight to contemporaneous medical records than to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such determination is evidenced by a rational determination). Medical records that are created contemporaneously with the events they describe are presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s health problems). Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993); Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his contemporaneous medical records, the special master’s decision to rely on petitioner’s medical records was rational and consistent with applicable law”), aff’d sub nom. Rickett v. Sec’y of Health & Hum. Servs., 468 F. Appx. 952 (Fed. Cir. 2011) (non- precedential opinion). This presumption is based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people honestly report their health problems to those professionals; and (iii) medical professionals record what they are told or observe when examining their patients in as accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec’y of Health & Hum. Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d at 1525 (“[i]t strains reason to conclude that petitioners would fail to accurately report the onset of their daughter’s symptoms”). Accordingly, if the medical records are clear, consistent, and complete, then they should be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records are generally found to be deserving of greater evidentiary weight than oral testimony—especially 16 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 17 of 29 where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec’y of Dep’t of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991) (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)). There are, however, situations in which compelling oral testimony may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“’[w]ritten records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent’”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination regarding a witness’s credibility is needed when determining the weight that such testimony should be afforded. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). When witness testimony is offered to overcome the presumption of accuracy afforded to contemporaneous medical records, such testimony must be “consistent, clear, cogent, and compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and completeness of medical records, the Court of Federal Claims has listed four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person’s failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional’s failure to document everything reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. Lalonde v. Sec’y of Health & Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to afford greater weight to contemporaneous medical records or other evidence, such as testimony at hearing, there must be evidence that this decision was the result of a rational determination. Burns, 3 F.3d at 417. C. Analysis of Expert Testimony Establishing an appropriate damages award often requires a petitioner to present expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999)). “The Daubert factors for analyzing the reliability of testimony are: (1) whether a theory or 17 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 18 of 29 technique can be (and has been) tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether there is a known or potential rate of error and whether there are standards for controlling the error; and (4) whether the theory or technique enjoys general acceptance within a relevant scientific community.” Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95). The Daubert factors play a slightly different role in Vaccine Program cases than they do when applied in other federal judicial fora (such as the district courts). Daubert factors are usually employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health & Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 742–45 (2009). In this matter (as in numerous other Vaccine Program cases), Daubert has not been employed at the threshold, to determine what evidence should be admitted, but instead to determine whether expert testimony offered is reliable and/or persuasive. Respondent frequently offers one or more experts in order to rebut a petitioner’s case. Where both sides offer expert testimony, a special master’s decision may be “based on the credibility of the experts….” Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion “connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)); see also Isaac v. Sec’y of Health & Hum. Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for rev. denied, 108 Fed. Cl. 743 (2013), aff’d, 540 F. Appx. 999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on a particular expert’s credibility, is part of the overall reliability analysis to which special masters must subject expert testimony in Vaccine Program cases. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1325–26 (Fed. Cir. 2010) (“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special masters are expected to consider the credibility of expert witnesses in evaluating petitions for compensation under the Vaccine Act”). Expert opinions based on unsupported facts may be given relatively little weight. See Dobrydnev v. Sec’y of Health & Hum. Servs., 556 F. Appx. 976, 992–93 (Fed. Cir. 2014) (“[a] 18 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 19 of 29 doctor’s conclusion is only as good as the facts upon which it is based”) (citing Brooke Group Ltd. v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993) (“[w]hen an expert assumes facts that are not supported by a preponderance of the evidence, a finder of fact may properly reject the expert’s opinion”)). Expert opinions that fail to address or are at odds with contemporaneous medical records may therefore be less persuasive than those which correspond to such records. See Gerami v. Sec’y of Health & Hum. Servs., No. 12-442V, 2013 WL 5998109, at *4 (Fed. Cl. Spec. Mstr. Oct. 11, 2013), aff’d, 127 Fed. Cl. 299 (2014). D. Consideration of Medical Literature Both parties filed medical and scientific literature in this case, but not every filed item factors into the outcome of this decision. While I have reviewed all the medical literature submitted in this case, I discuss only those articles that are most relevant to my determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“[w]e generally presume that a special master considered the relevant record evidence even though he does not explicitly reference such evidence in his decision”) (citation omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. Appx. 875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the conclusion that it was not considered”). E. Consideration of Comparable Special Master Decisions In reaching a decision in this case, I have considered other decisions issued by special masters (including my own) involving similar injuries, vaccines, or circumstances. I also reference some of those cases in this Decision, in an effort to establish common themes, as well as demonstrate how prior determinations impact my thinking on the present case. There is no error in doing so. It is certainly correct that prior decision in different cases do not control the outcome herein.14 Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1358– 59 (Fed. Cir. 2019); Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). Thus, the fact that another special master reasonably determined elsewhere, on the basis of facts not in evidence in this case, that preponderant evidence supported the conclusion that petitioner’s injury X was entitled to an award of Y does not compel me to reach the same conclusion in this case. Different actions present different background medical histories, different experts, and different items of medical literature, and therefore can reasonably result in contrary determinations. 14 By contrast, Federal Circuit rulings concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014). Special masters are also bound within a specific case by determinations made by judges of the Court of Federal Claims after a motion for review is resolved, as is the case here. 19 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 20 of 29 However, it is equally the case that special masters reasonably draw upon their experience in resolving Vaccine Act claims. Doe v. Sec’y of Health & Hum. Servs., 76 Fed. Cl. 328, 338–39 (2007) (“[o]ne reason that proceedings are more expeditious in the hands of special masters is that the special masters have the expertise and experience to know the type of information that is most probative of a claim”) (emphasis added). They would therefore be remiss in ignoring prior cases presenting similar theories or factual circumstances, along with the reasoning employed in reaching such decisions. This is especially so given that special masters not only routinely hear from the same experts in comparable cases but are also repeatedly offered the same items of medical literature. It defies reason and logic to obligate special masters to “reinvent the wheel”, so to speak, in each new case before them, paying no heed at all to how their colleagues past and present have addressed similar causation injuries or fact patterns. It is for this reason that prior decisions can have high persuasive value—and why special masters often explain how a new determination relates to such past decisions. Even if the Federal Circuit does not require special masters to distinguish other relevant cases (Boatmon, 941 F.3d at 1358), it is still wise to do so. F. Pain and Suffering Determinations The sole damages issue before me is the amount of pain and suffering to be awarded in this case, since both sides agree some amount is appropriate. There is no mathematic formula for assigning a monetary value to a person’s pain and suffering and emotional distress. I.D. v. Sec'y of Health & Hum. Servs., No. 04-1593V, 2013 WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May 14, 2013) (“[a]wards for emotional distress are inherently subjective and cannot be determined by using a mathematical formula”); Stansfield v. Sec'y of Health & Hum. Servs., No. 93-0172V, 1996 WL 300594, at *3 (Fed. Cl. Spec. Mstr. May 22, 1996) (“the assessment of pain and suffering is inherently a subjective evaluation”). Many Vaccine Program cases discuss calculation of two subcategories of pain and suffering awards—past (or “actual”) and projected—and then add them together, to come up with the total sum (with the future component discounted to net present value). See, e.g., Collado v. Sec’y of Health & Hum. Services, No. 17-0225V, 2018 WL 3433352, at *6–8 (Fed. Cl. Spec. Mstr. June 6, 2018). Here, I do not find the total sum to be awarded needs to be so separately calculated. Petitioner has not requested a bifurcated award, based on prior suffering plus anticipated future experience—and more importantly, Petitioner has not established entitlement to a future award, given that his single, vaccine-caused ITP occurrence has not been shown to have resulted in life- long sequelae or likely future emotional harm. Thus, an award for actual/past pain and suffering is all that is warranted in this case. The Vaccine Act caps the awardable amount of total pain and suffering damages at $250,000.00. Section 15(a)(4). A persuasive Court of Federal Claims decision issued within the last seven years suggests that special masters should calculate the total pain and suffering award 20 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 21 of 29 appropriate (whatever it is) before applying the cap, rather than treating the $250,000.00 amount as the top of a “range” of potential awards, with cases falling within a spectrum based on comparable severity. Graves v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 579, 589–90 (2013). Special masters have accepted Graves’s methodology since the case’s issuance. See, e.g., Bruegging v. Sec’y of Health & Hum. Servs., No. 17-0261V, 2019 WL 2620957 (Fed. Cl. Spec. Mstr. May 13, 2019); Reed v. Sec’y of Health & Hum. Servs., No. 16-1670V, 2019 WL 1222925 (Fed. Cl. Spec. Mstr. Feb. 1, 2019). Although a persuasive argument can be made that the passage of time has rendered the cap an artificial limitation on total recoverable pain and suffering, it still reflects Congress’s judgment that there should be an outer bound for pain and suffering awards—and implicit to that is the reasonable likelihood that many cases will warrant some lower figure. Nevertheless, I have in prior cases followed Graves, and I will apply it herein as well—although I do so mindful of the need to consider the overall strength of Petitioner’s showing herein. In calculating pain and suffering awards, Court of Federal Claims judges and special masters have frequently considered three primary factors: (a) severity of the injury, (b) awareness of the injury, and (c) duration of the suffering. Collado, 2018 WL 343352, at *6. Awareness is often deemed a function of whether the injured party was mentally competent (see, e.g., Meyers v. Sec’y of Health & Hum. Servs., No. 18-0909V, 2020 WL 3755335, at *3 (Fed. Cl. Spec. Mstr. June 5, 2020)). When considering this aspect of a petitioner’s experience, the question is whether there were any impediments that may have prevented petitioner from perceiving their injury. See Cates v. Sec’y of Health & Hum. Servs., No. 18-277V, 2020 WL 3751072, at *2 (Fed. Cl. Spec. Mstr. June 5, 2020) (noting that the petitioner was a competent adult and did not suffer from any impairments that would have diminished her awareness of her injuries). Thus, when an infant or young child is injured, it is reasonable to consider whether the child’s age and limited cognitive abilities would have impaired their awareness of the injury. Duration and severity, by contrast, relate to the amount of pain or loss of normal function imposed by the injury, and the length and invasiveness of treatments required for it. As a number of decisions on the subject reached in cases involving shoulder injuries related to vaccine administration reveal, the amount to be awarded should take into account not only how painful (both in terms of immediacy and duration) the injury has proven, but the degree of treatment it required—measured in terms of things like whether surgical intervention was needed (and if so, how invasive it was), and how many treater visits were necessary. See, e.g., Smallwood v. Sec’y of Health & Hum. Servs., No. 18-029V, 2020 WL 2954958 (Fed. Cl. Spec. Mstr. Apr. 29, 2020). Emotional distress can be considered within the foregoing framework, but also as a distinct pain and suffering component. Emotional distress need not arise from the physical pain associated with the alleged injury to justify a pain and suffering award. Youngblood v. Sec’y of Dep’t of Health & Hum. Servs., No. 91-1442V, 1993 WL 22177, at *2–3 (Fed. Cl. Spec. Mstr. Jan. 13, 1993), 21 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 22 of 29 (finding that emotional distress is an appropriate factor to be considered when calculating an award for pain and suffering) rev’d on other grounds, 32 F.3d 552 (Fed. Cir. 1994). In some cases, evaluation of emotional distress may require a separate inquiry, distinct from that related to the experience of physical pain. Youngblood, 1993 WL 22177, at *2 (concluding that “[i]t is reasonable to assume that §15(a)(4) of the statute contemplates emotional distress as being related to something other than physical pain and suffering because it allows compensation for both.” (emphasis added)). Nevertheless, reasoned special master analyses accounting for emotional distress are rare, and considerations of emotional injury are usually subsumed under the broader category of “pain and suffering.” See, e.g., Carlson v. Sec’y of Health & Hum. Servs., No. 14-82V, 2015 WL 6684866, at *1 (Fed. Cl. Spec. Mstr. Oct. 7, 2015) (adopting a stipulation awarding a lump sum of $20,000.00 to a petitioner who alleged (among other things) psychologic injury as a result of the flu vaccine, but failing to outline what portion of the award was related to the psychological component of the claim). Special masters have found that loss of enjoyment of life, anguish, disappointment, and frustration as an injured child realizes he is different from his peers, and/or is unable to engage in the same activities as other children his age, exemplify compensable emotional distress under Section 15(a)(4). See Youngblood, 1993 WL 22177, at *2–3; Brewer v. Sec’y of Health & Hum. Servs., No. 93-092V, 1996 WL 147722, at *22 (Fed. Cl. Spec. Mstr. Mar. 18, 1996) (citing McGhee v. Sec’y of Dep’t of Health & Hum. Servs., No. 92-332V, 1993 WL 371000, at *7 (Fed. Cl. Spec. Mstr. Sept. 8, 1993)). As with any damages issue, however, it remains a petitioner’s burden to provide preponderant evidence of emotional distress. See Brewer, 1996 WL 147722, at *22. ANALYSIS I. Petitioner Has Established a Viable Table Claim In this matter, Petitioner alleges that her son developed ITP eighteen days after he received the MMR vaccine. Pet. at 1–2. ITP following receipt of the MMR vaccine is a recognized Table injury, and causation may be presumed if onset occurred between 7-30 days post-vaccination. 42 C.F.R. §100.3(a)(V)(A), (c)(7). In his supplemental Rule 4(c) Report, Respondent indicated that he “does not dispute that B.W. meets the requirements of a Table ITP injury following MMR vaccine.” Supplemental Rule 4(c) Report, filed Nov. 8, 2019 (ECF No. 63). And although Respondent initially challenged Petitioner’s claim based on the severity of the injury, arguing that B.W.’s condition or sequelae related to the injury persisted for the statutorily required period of six months (Respondent’s Pre-Hearing Brief, filed Sept. 8, 2017 (ECF No. 33) at 6–7), the Court of Federal Claims has determined that severity is established based upon the record of post-onset platelet count testing. Reported Opinion, filed July 16, 2019 (ECF No. 60). 22 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 23 of 29 In light of the above and based upon my own careful consideration of the record as well as the Court’s finding on the severity issue, I determine that Petitioner has preponderantly satisfied all Table and statutory requirements and has therefore established entitlement to compensation. II. Calculation of Pain and Suffering Award in this case A. Prior Decisions and Awards As both Petitioner and Respondent acknowledged in their respective briefs, virtually all damages decisions involving ITP as a vaccine injury have been the result of stipulation or proffers, leaving few reasoned decisions addressing what amount of pain and suffering is appropriate for this kind of injury, which presents insidiously and does not often produce lasting or harmful sequelae. Thus, although previously-settled ITP injury cases provide some insight into the proper magnitude of award herein, they are less valuable guidance than a reasoned decision would be. What is evident from the existing body of relevant case law is that damages awards for ITP vary dramatically. See Fantell v. Sec’y of Health & Hum. Servs., No. 17-892V, 2019 WL 2713139 (Fed. Cl. Spec. Mstr. June 3, 2019) (stipulation awarding a minor child $75,000 for ITP following receipt of several vaccinations); DeWeese v. Sec’y of Dep’t of Health & Hum. Servs., No. 09- 469V, 2011 WL 5056993 (Fed. Cl. Spec. Mstr. Sept. 22, 2011) (stipulation awarding $100,000 for ITP following receipt of several vaccinations); Braveman v. Sec’y of Health & Hum. Servs., No. 08-137V, 2008 WL 4684336 (Fed. Cl. Spec. Mstr. Oct. 6, 2008) (stipulation awarding minor child a lump sum of $15,000 for damages related to ITP following receipt of the MMR vaccine); Ball v. Sec’y of Dep’t of Health & Hum. Servs., No. 99-424V, 2008 WL 2337854 (Fed. Cl. Spec. Mstr. May 16, 2008) (stipulation awarding $230,000 for ITP following MMR and Hepatitis B vaccination); Cost v. Sec’y of Health & Hum. Servs., No. 07-234V, 2008 WL 1989095 (Fed. Cl. Spec. Mstr. Apr. 16, 2008) (stipulation awarding a minor child a lump sum of $15,000 for damages related to ITP following receipt of the MMR vaccine). Such a wide range of awards suggest that ultimately the individual facts of a given case are paramount. B. A Modest Pain and Suffering Award is Appropriate in This Case Here, considering the record and applying the “severity-duration-awareness” factors that go into calculation of a pain and suffering award, I determine that an award more modest than what Petitioner requests is most appropriate. 23 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 24 of 29 1. Severity of Injury (Physical or Emotional) B.W.’s ITP was overall quite mild, featuring little in the way of medical intervention other than initial treatment and several subsequent blood draws required to ascertain platelet levels. Though there are numerous instances throughout the record in which B.W. was initially observed to have bruising, there is no indication that these bruises caused him any pain or distress, or that they recurred on a regular basis thereafter. See Ex. 3 at 3 (noting that “pt does not appear to be in pain” and that nothing exacerbated his pain); id. at 6 (noting that B.W. “denie[d] meds/discomfort [at] this time”); Ex. 2 at 92 (documenting minor bruising, but no mention of pain); id. at 107 (documenting “few scattered bruises…not concerning” and no notes regarding pain); id. at 140 (complaints of a headache but no trauma to head or face is noted—the only documented bruising is on B.W.’s shins); Ex. 4 at 76 (noting that B.W.’s bruise was not tender during palpitation). Additionally, his bruising was often characterized as “minor” and non-concerning. Ex. 2 at 92, 107, 127 (noting that B.W.’s ITP was “not severe” and “tends to be more mild and associated with self resolution”). And there are several visits in which no bruising is noted. Ex. 2 at 144, 159, 163, 168, 178; Ex. 8 at 3; Ex. 9 at 2–3. At worst, B.W. underwent repeated blood draws to test for platelet amounts. While there is no question that blood draws can be unpleasant, they are generally not considered to be an overly invasive or physically traumatic procedure, and Petitioner has pointed to no Program decisions in which testing procedures required for post-onset condition monitoring were found to support a high pain and suffering award (even though this same evidence was determined to be sufficient to establish the claim’s six-months severity—a different consideration, as discussed below). Petitioner also has not established how the majority of B.W.’s blood draws were performed (i.e., via finger stick or venous puncture) such that it could be determined that such post-onset monitoring was exceptionally painful or physically traumatic.15 And there is no evidence that B.W. experienced severe pain during these instances, or that he required more than a parent’s presence to comfort him. See Ex. 4 at 65–69, 71, 73 (documenting B.W.’s pain level as “0” at all times during his admission and noting that the only comfort measures provided were from the parent); Ex. 2 at 90 (describing B.W. as active and playful during his appointment on May 2, 2014); Ex. 6 at 2 (noting that B.W. “smiles, [is] playful, and active and alert” without distress). There is similarly no evidence to suggest that B.W. suffered from any physical complications as a result of having his blood drawn. 15 Dr. Shaer was unaware of how these blood draws were performed—either by venipuncture or a much less invasive finger stick. Tr. at 37. From the medical record, it is known that the second blood draw performed on B.W. on April 16, 2014, was a venous puncture and required several tubes of blood to be drawn. Ex. 4 at 80–81. Then, the blood draw performed on May 13, 2014 was completed with a simple finger stick. Ex. 4 at 21. Records documenting the other thirteen blood draws B.W. underwent do not indicate which method was used. 24 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 25 of 29 In addition to physical severity, Petitioner also alleges that he experienced severe psychological trauma as a direct result of his ITP diagnosis and treatment. Pet. Damages Brief at 9–10. The blood draws allegedly provoked a violent, fearful reaction in B.W., later contributing to his development of Separation Anxiety Disorder. Jordan Rep. at 2. But the record and expert evidence does not support this contention whatsoever. Petitioner largely relies on the psychological evaluation performed by Dr. Jordan, and to a lesser degree, the hearing testimony of Dr. Shaer. But both experts themselves relied heavily on hearsay information provided by Ms. Wright (who never offered a written witness statement in this case). Jordan Rep. at 2–3 (noting that “Separation anxiety lasted according to the mother’s description of symptoms approximately 6 months.” (emphasis added)); Tr. at 31–32, 66 (noting Dr. Shaer’s opinion that there was no evidence of psychological trauma outside of the conversation she had with Ms. Wright). Indeed, Dr. Jordan relied exclusively on the information provided by Ms. Wright in making his diagnosis of Separation Anxiety Disorder (which he admitted was no longer a supportable diagnosis as of 2018, given additional information obtained from B.W.’s foster parents and treaters). Jordan Rep. at 2–3, 6–7. In addition, nearly all of Dr. Jordan’s conclusions about B.W.’s mental state after manifestation of his ITP are directly contradicted by the contemporaneous medical records. For example, while Dr. Jordan opines that B.W. began to exhibit violent behaviors such as kicking, biting, slapping, and screaming shortly after his ITP diagnosis, medical records documenting B.W.’s behavior during the relevant time period describe B.W. as active and playful, and those records do not establish that Petitioner ever expressed any concerns regarding B.W.’s behavioral or social development. Ex. 2 at 90, 111, 142, 153; Ex. 5 at 22–23, 26; Ex. 6 at 2, 5, 8. Developmental screenings that were performed after B.W.’s ITP diagnosis showed that B.W. was developing normally. Ex. 2 at 177 (describing results for B.W.’s thirty-month developmental screening results as passing). During these treatment visits, Petitioner herself indicated that she did not have any concerns regarding B.W.’s behavior, and he was reported to be socializing well with others. See Ex. 2 at 177–78; Ex. 6 at 21; Ex. 9 at 12.16 Where the medical records note a happy, pleasant, well-socialized child, Dr. Jordan describes a fearful, violent, ill-adjusted boy. Compare Ex. 2 at 90, 111, 142, 153; Ex. 5 at 22–23, 26; Ex. 6 at 2, 5, 8 with Jordan Rep. at 2–4. The medical records filed in this matter appear to be complete and accurate, and neither party has persuasively discredited their reliability. They are therefore entitled to substantial weight. Lowrie, 2005 WL 6117475, at *20. Conversely, expert opinions (such as Dr. Jordan’s) that fail to 16 Dr. Jordan also indicated that B.W.’s violent behavior and separation anxiety symptoms required his mother to remove him from daycare and made arranging for childcare especially difficult. Jordan Rep. at 2. The medical records indicate, however, that B.W. was not in daycare prior to his March 2014 vaccination, and he did not start attending daycare until after his ITP diagnosis. See Ex. 2 at 15, 26, 30, 40, 46, 57 (noting that B.W. was not in daycare between June 16, 2013 and March 16, 2013), 58 (indicating B.W. has childcare), 124, 177 (noting that B.W. is attending daycare on May 13, 2014 and December 23, 2014). 25 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 26 of 29 address or are at odds with contemporaneous medical records are generally deemed less persuasive. See Gerami, 2013 WL 5998109, at *4; Cucuras, 993 F.2d at 1528; see also Murphy, 23 Cl. Ct. at 733 (citing United States Gypsum Co., 333 U.S. at 396 (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)). And I am not required to accept the conclusions of an expert based only on the ipse dixit of that expert, especially if “there is simply too great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co, 522 U.S. at 146); see also Isaac, 2012 WL 3609993, at *17 (citing Cedillo, 617 F.3d at 1339). Indeed, expert opinions rooted in incorrect facts may be rejected for that reason alone. Dobrydnev, 556 F. Appx. at 992–93. Petitioner has provided no persuasive explanation for the stark contrast between the contemporaneously-documented medical records and the hearsay reports subsequently provided by Petitioner following commencement of litigation. I also find that Dr. Miller’s points about the weaknesses of Dr. Jordan’s opinion compelling—even in the face of the fact that Dr. Miller herself never interviewed B.W. Although Dr. Jordan did conduct an extensive psychological evaluation of B.W., including an interview with B.W., and his mother, several interviews with B.W.’s foster parent and teachers, and the administration of intellectual and educational assessments, none but his interview with Ms. Wright were cited as influential in forming his diagnosis of Separation Anxiety Disorder. Jordan Rep. at 1–3. The relevancy of the other interviews and assessments appear limited to ADHD, which Dr. Jordan does not ascribe to B.W.’s vaccination. Id. at 4–9. Dr. Miller’s assessment was more record- based, and she persuasively demonstrated the absence of proof that B.W. had been scarred psychologically by his ITP. There is otherwise no persuasive evidentiary grounds in this case to find that B.W.’s ITP resulted in lasting psychological harm. Dr. Shaer’s speculation that B.W. may have experienced vulnerable child syndrome was not only disputed by Petitioner’s other expert, Dr. Jordan, but undercut by her own admissions at hearing. Jordan Rep. at 4; Tr. at 39. The record does not suggest B.W. did in fact incur psychologic damage due to his ITP, while it also contains ample evidence of other harmful or mentally-painful occurrences relating to the circumstances of his upbringing that Petitioner has not distinguished (let alone addressed).17 And, as noted above, too much of Petitioner’s arguments on this point rely on statements of the Petitioner reported by others, rather 17 For example, Dr. Shaer expressed substantial concern about the effect Ms. Wright’s behavior and anxiety would have had on B.W.’s mental state. Tr. at 32–35. She also noted that Ms. Wright demonstrated ongoing anxiety and fear about B.W.’s condition, and that she appeared to believe her child continued to suffer from ITP, even though he had long been stable at the time of their conversation. Id. at 31, 69. The unstable and precarious nature of B.W.’s home life could also have contributed to any alleged emotional distress. Throughout the medical record, it is noted that B.W. was living in a women’s shelter with his mother and siblings. Ex. 2 at 15, 26, 30, 40, 46, 57, 85, 91, 99. Eventually, Ms. Wright, along with her children, moved into a trailer without running water. Jordan Rep. at 4. In October 2016, B.W. was removed from his mother’s care and placed into a foster home due to the poor living conditions in which he had been found. Id. Dr. Miller opined that the sadness and concern Dr. Jordan reported observing in B.W. were more likely related to his recent foster care placement than any injury he suffered four years previously, when he was only a toddler. Miller Rep. at 7–8. 26 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 27 of 29 than direct evidence from her—and while I have considered those statements (since the rules of evidence do not prohibit admission of bald hearsay in the Vaccine Program), I reasonably take into account their hearsay character in giving them less weight—especially where, as here, they are outright rebutted by the actual record. See, e.g., Chinea v. Sec’y of Health & Hum. Servs., No. 15-095V, 2019 WL 1873322, at 30 n.40 (Fed. Cl. Spec. Mstr. Mar. 15, 2019) (noting that statements possessing a “hearsay quality” should be afforded less weight). Accordingly, given the absence of corroborating evidence, I find that Petitioner has not preponderantly established that B.W. suffered from severe emotional distress and psychological injury in the form of Separation Anxiety Disorder as a direct result of his vaccine-induced ITP. 2. Limited Duration of ITP Sequelae Second, the duration of any suffering experienced by B.W. due to his vaccine-induced ITP was not notably long. Indeed, the medical record indicates that by July 2014—approximately three months after the onset of his ITP—B.W. had normal platelet counts. See Ex. 2 at 142–46. Unquestionably B.W. was thereafter monitored for another twenty-one months, during which time he underwent more blood draws. Ex. 2 at 136–41, 151–56; Ex. 9 at 23–25, Ex. 9 at 14–16, 35. But it does not appear that the subsequent monitoring was more than an inconvenience. Indeed, B.W.’s condition does not appear to have been inherently painful even during the three months he actually exhibited low platelet counts. Ex. 3 at 3 (noting that “pt does not appear to be in pain” and that nothing exacerbated his pain); id. at 6 (noting that B.W. “denie[d] meds/discomfort [at] this time”); Ex. 2 at 92 (documenting minor bruising, but no mention of pain). In so finding, I note the distinction between a showing of durational severity sufficient to meet the general requirements for a Program claim, and severity in calculating a pain and suffering award. Six-month severity is largely a durational consideration that obligates petitioners to show that they “suffered the residual effects or complications” for their vaccine-caused injury for a sufficient time after vaccine administration to render the claim actionable. Section 11(c)(1)(D)(i); see also Wyatt v. Sec’y of Health & Hum. Servs., No. 14-706V, 2018 WL 7017751, at *22–23 (Fed. Cl. Spec. Mstr. Dec. 17, 2018). This ensures that the Program focuses on significant injuries, rather than transient, vaccine-caused harm that has quickly resolved without lasting deleterious impact. See, e.g., Watts v. Sec’y of Health & Hum. Servs., No. 17-1494V, 2019 WL 4741748, at *7–8 (Fed. Cl. Spec. Mstr. Aug. 13, 2019). Here, by contrast, severity for pain and suffering purposes is a multi-dimensional consideration that involves more than the durational impact of an injury-causing vaccination. Rather, severity in this context gives weight to degrees of suffering, invasiveness, and the need to bear with pain and the treatment attention that the injury demands. See, e.g., DeLozier v. Sec’y of Health & Hum. Servs., No. 15-124V, slip op. at 5–6 (Fed. Cl. Spec. Mstr. Aug. 11, 2020) (citing Smallwood, 2020 WL 2954958), Mot. for Rev. docketed, Sept. 10, 2020. That kind of severity is 27 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 28 of 29 simply absent from the facts of this case. The length of time it took for medical providers to ensure to their satisfaction that ITP was in fact no longer a concern for B.W. is not alone enough to support a large pain and suffering award. 3. Awareness Finally, the “awareness” component does not militate in favor of a high pain and suffering figure. Respondent’s psychology expert, Dr. Miller, did raise some concerns regarding B.W.’s cognitive abilities at the onset of his injury. See Miller Rep. at 6. But while Dr. Miller explained why a two-year-old child would not necessarily be aware of the prolonged effects of separation from a parent, she did not raise similar concerns regarding that child’s ability to understand physical pain and suffering. Id. Though B.W. was still quite young when he experienced the onset of his injury, nothing in the record indicates that he was unable to feel and understand the pain associated with the blood draws that were performed as a result of his condition. Thus, while B.W. may not have fully appreciated the nature of his injury, it is more likely than not that he was able to understand and appreciate the pain he felt whenever he was required to undergo a blood draw. Given all of the above, I find a total award of $25,000.00 in pain and suffering is reasonable and fair. ITP is on the mild end of vaccine injuries generally, and the evidence in this case supports the conclusion that B.W.’s ITP resolved fairly quickly, even if monitoring for its recurrence continued for some time. Petitioner has not otherwise established any lasting, credible physical or emotional harm from the ITP. While some award is fair—to compensate for the fear from the injury itself, and in recognition of the limited trauma of the condition’s discovery and need for a period of time to watch for its recurrence—nothing comparable to what Petitioner requests is justified, under the facts of this case or in light of relevant precedent. The number I arrive at is also more than twice what Respondent proposes, thus underscoring my determination that more than a nominal amount is justified. CONCLUSION In light of the above, I calculate damages as follows: Damages category Requested Awarded Difference Pain and Suffering $100,000.00 $25,000.00 $75,000.00 Medicaid Lien $4,345.55 $4,345.55 $0.00 Total $104,345.55 $29,345.55 $75,000.00 28 Case 1:16-vv-00498-EGB Document 77 Filed 10/27/20 Page 29 of 29 As a result, I approve a Vaccine award of $29,345.55, which represents compensation for pain and suffering ($25,000.00) and in satisfaction of a Medicaid lien ($4,345.55) in the form of a check payable to Petitioner.18 This amount represents compensation for all items of damages that would be available under Section 15(a). 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.19 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 18 I am aware that the Petitioner has proposed that the payment be made in trust for the benefit of B.W. Reply at 2–3. Petitioner has not, however, provided a mechanism for accomplishing this. Once judgment enters in the case, and after the parties signal their willingness to accede to it, Petitioner may request relief from judgment under Vaccine Rule 36 and propose how any such trust would be structured. 19 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their right to seek review. 29