VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-01728 Package ID: USCOURTS-cofc-1_21-vv-01728 Petitioner: E.A.F. Filed: 2021-08-19 Decided: 2024-08-14 Vaccine: MMR Vaccination date: 2018-08-06 Condition: immune thrombocytopenic purpura (ITP) Outcome: dismissed Award amount USD: AI-assisted case summary: Stephanie and Ashton Felix, parents of E.A.F., a minor child, filed a petition under the National Vaccine Injury Compensation Program on August 19, 2021. E.A.F. received a measles-mumps-rubella (MMR) vaccine on August 6, 2018, at approximately 2.8 years of age. Approximately two weeks later, E.A.F. developed symptoms of immune thrombocytopenic purpura (ITP), characterized by bruising and a significantly low platelet count of 7,000/mm³. E.A.F. was hospitalized and received intravenous immune globulin (IVIg) treatment, which increased his platelet count to 20,000/mm³ after one dose. The discharge summary noted a diagnosis of ITP and mild anemia, and recommended holding vaccines for at least six months after IVIg and avoiding rough play. Subsequent platelet counts on August 24, 2018, were 140,000/mm³ (with a note of potential clumping), followed by counts between 72,000/mm³ and 117,000/mm³ through October 18, 2018. On October 22, 2018, a pediatric hematology-oncology fellow assessed E.A.F. as having a stable platelet count and improving iron deficiency anemia, with a plan to avoid live vaccines for 6-12 months and no rough play while thrombocytopenic. Platelet counts thereafter rose to 166,000/mm³ on November 5, 2018, 225,000/mm³ on December 12, 2018, and 301,000/mm³ on April 1, 2019. The petition alleged that E.A.F. suffered residual effects and complications from the ITP lasting more than six months. The petitioners presented medical records and sworn statements from family members and their pediatrician, Dr. Sarah Giguere, arguing that restrictions on physical activity and delayed vaccinations constituted ongoing medical care and residual effects. The respondent, the Secretary of Health and Human Services, moved to dismiss the claim, arguing that the ITP had resolved within six months and that the alleged restrictions were not medically directed or necessary. Chief Special Master Brian H. Corcoran granted the motion to dismiss on April 29, 2024, finding that the petitioners failed to establish the statutory severity requirement, as E.A.F.'s condition resolved well within six months and there was insufficient evidence of medically directed ongoing restrictions. Special Master Corcoran noted that the medical records did not document any ongoing restrictions after E.A.F.'s platelet count normalized, and that Dr. Giguere's later statement appeared to endorse a course of conduct after the fact rather than describe real-time medical instructions. The Special Master also found that alleged psychological distress and vaccine restrictions did not satisfy the severity requirement, citing Wright v. Secretary of Health & Human Services. This decision was reviewed by Judge Armando O. Bonilla of the Court of Federal Claims, who sustained the Special Master's dismissal on August 14, 2024, agreeing that the evidence did not demonstrate residual effects lasting more than six months, particularly in light of the Federal Circuit's decision in Wright v. Secretary of Health & Human Services, which clarified that ongoing monitoring and precautionary measures do not necessarily constitute residual effects. The case was ultimately dismissed for failure to meet the severity requirement. Petitioners were represented by John Leonard Shipley, and Respondent was represented by Mallori Browne Openchowski. The Special Master was Brian H. Corcoran, and the reviewing judge was Armando O. Bonilla. Theory of causation field: Petitioners alleged that E.A.F., a 2.8-year-old child, developed immune thrombocytopenic purpura (ITP) after receiving an MMR vaccine on August 6, 2018. The ITP was characterized by a low platelet count and bruising, requiring hospitalization and IVIg treatment. The petition alleged residual effects and complications lasting more than six months. The Special Master, Brian H. Corcoran, dismissed the claim, finding that the ITP resolved within six months, as evidenced by normalized platelet counts by November 5, 2018, and that there was insufficient evidence of medically directed ongoing physical activity restrictions or other residual effects. The Court of Federal Claims, Judge Armando O. Bonilla, sustained the dismissal, agreeing that the evidence did not meet the six-month severity requirement under the Vaccine Act, citing Wright v. Secretary of Health & Human Services, which held that ongoing monitoring and precautionary measures like avoiding rough play while thrombocytopenic or delaying vaccinations due to IVIg treatment do not constitute residual effects. Petitioners were represented by John L. Shipley, and Respondent by Mallori B. Openchowski. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_21-vv-01728-0 Date issued/filed: 2024-06-04 Pages: 10 Docket text: PUBLIC DECISION (Originally filed: 04/29/2024) regarding 42 DECISION of Special Master, Signed by Chief Special Master Brian H. Corcoran. (nh) Service on parties made. -------------------------------------------------------------------------------- Case 1:21-vv-01728-AOB Document 45 Filed 06/04/24 Page 1 of 10 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 21-1728V STEPHANIE FELIX and ASHTON Chief Special Master Corcoran FELIX, on behalf of E.A.F., Petitioners, Filed: April 29, 2024 v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. John Leonard Shipley, Davis, CA, for Petitioners. Mallori Browne Openchowski, U.S. Department of Justice, Washington, DC, for Respondent. DECISION1 Stephanie and Ashton Felix, acting on behalf of their minor child E.A.F., have filed a Petition under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa- 10, et seq.2 (the “Vaccine Program”), regarding E.A.F.’s development of immune thrombocytopenic purpura (“ITP”) after receipt of a measles-mumps-rubella (“MMR”) vaccine on August 6, 2018. The case was assigned to the Special Processing Unit of the Office of Special Masters (the “SPU”). 1 Because this unpublished decision contains a reasoned explanation for the action in this case, I am required to post it on the United States Court of Federal Claims' website in accordance with the E- Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2018). Case 1:21-vv-01728-AOB Document 45 Filed 06/04/24 Page 2 of 10 Based on a review of all submitted evidence and arguments, and for the foregoing reasons, I hereby GRANT Respondent’s Motion to Dismiss the claim for failure to establish the statutory severity requirement. Resp. Motion to Dismiss (ECF No. 27), citing Section 11(c)(1)(D)(i). Accordingly, the claim is DISMISSED. I. Procedural History On August 19, 2021, Petitioners initiated their claim “out of an abundance of caution with respect to the applicable statute of limitations.” Petition (ECF No. 1) at ¶ 16. Petitioners subsequently obtained and filed supporting medical records, and an initial statement from Stephanie Felix, as Exhibits (“Exs.”) 1 – 12. On May 13, 2022, Petitioners amended their petition in relevant part, clarifying that they alleged that E.A.F.’s ITP caused residual effects and complications lasting for more than six months. Amended Petition (ECF No. 18) at ¶ 15. The case was assigned to the SPU. Order (ECF No. 20). On August 7, 2022, Respondent filed his Rule 4(c) Report (ECF No. 26) and a Motion to Dismiss the Claim for Failure to Satisfy the Severity Requirement (ECF No. 27). See also Section 11(c)(1)(D)(i). On December 5, 2022, Petitioners filed a supplemental statement from Stephanie Felix as Ex. 13 (ECF No. 29) and their Opposition to Respondent’s Motion to Dismiss (ECF No. 30) (“Pet. Opp.”). I warned Petitioners that the existing record did not appear to establish six months’ severity – but allowed them to file any additional fact evidence. Scheduling Order filed June 23, 2023 (ECF No. 33).3 Petitioners filed three additional witnesses’ statements. Exs. 14, 16 – 17,4 followed by Petitioners’ Brief on August 21, 2023 (ECF No. 37). Respondent filed a Response on October 18, 2023 (ECF No. 40). Petitioners filed a Reply on October 27, 2023 (ECF No. 41). The matter is ripe for adjudication. II. Medical Records E.A.F. was born without complications in fall 2015, was generally healthy, and had an established pediatric care practice (“PCP”). See generally Exs. 6, 9, 10. E.A.F. was 3 In opposing Respondent’s motion to dismiss, Petitioners requested a further opportunity to file both fact evidence and/or an expert child psychiatrist/ psychologist’s opinion. See Pet. Opp. At n. 3. But experts are not routine in SPU cases, see Scheduling Order filed May 20, 2022 (ECF No. 20) at 1. Petitioners were ordered to first seek statements from E.A.F.’s treaters and any other fact witnesses, and any other evidence that may be available, to establish the requisite factual foundation for their claim. Scheduling Order filed June 23, 2023 (ECF No. 33) at 2 – 3. 4 All witness statements filed in the case were sworn under penalty of perjury. See 28 U.S.C.A. § 1746 (providing that such a declaration may be afforded “like force and effect” as an affidavit). 2 Case 1:21-vv-01728-AOB Document 45 Filed 06/04/24 Page 3 of 10 receiving vaccines on an alternative schedule. Ex. 6 at 76 (vaccination summary); see also, e.g., id. at 12, 24, 30, 32 (PCP records noting parents’ instructions regarding vaccinations). At a July 23, 2018, well-child visit, pediatrician Sarah Giguere, D.O., assessed E.A.F. with constipation and anemia due to high milk intake. Ex. 6 at 29. E.A.F. also received hepatitis A and varicella vaccines at this encounter. Id. At an August 6, 2018, follow-up with Dr. Giguere, E.A.F. received the at-issue MMR vaccine. Ex. 6 at 32. Fifteen (15) days later, on August 21, 2018, Dr. Giguere saw E.A.F. on an urgent basis. Ex. 6 at 33. His mother recounted that E.A.F. had developed symptoms including “several bruises on his body over the past 24 – 48 hours after leaving school.” Id. “CPS [child protective services] has been called and questioned him.” Id.5 Dr. Giguere’s assessment was thrombocytopenia6 potentially representing ITP, which should be further evaluated in a hospital emergency room. Id. at 34. Accordingly, later that same day, the mother brought E.A.F. to the Rady Children’s Hospital (“RCH”) emergency room. Ex. 2 at 17. A complete blood count (“CBC”) revealed a low platelet count of 7,000. Id. at 21. E.A.F. was assessed with “severe thrombocytopenia, likely acute ITP” and admitted to the hematology-oncology floor to receive IVIg. Id. at 23. After receiving one dose of IVIg, E.A.F.’s platelet count had risen to 20,000. Id. at 30, 49. On August 22, 2018, at 12:00 a.m., Jenny Kim, M.D., a pediatric hematology- oncology fellow, assessed that E.A.F. was likely “Ok to [discharge] today with repeat [bloodwork] in 2 days. If [platelets] dropping or new bleeding [symptoms,] would repeat IVIg dose.” Ex. 2 at 29. The August 22, 2018, RCH discharge summary notes E.A.F.’s diagnosis of ITP, as well as mild anemia (attributed to his previously-noted high milk intake) for which he had been started on daily iron. Ex. 2 at 14. E.A.F. would “return to clinic on 8/24 for CBC check and iron studies. Would hold vaccines (except influenza vaccine) for at least 6 months after IVIg. He may not have full response to vaccines after recent IVIg administration.” Id. Finally, the family was instructed to “avoid rough play.” Id. at 15. 5 Later that day, the mother recounted that Dr. Giguere “discussed CPS but thought mom should bring E.A.F. to the ED for further work-up.” Ex. 2 at 17. 6 Thrombocytopenia is defined as a decrease in the number of platelets. Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=49875&searchterm=thrombocytopenia (last accessed Apr. 24, 2024). 3 Case 1:21-vv-01728-AOB Document 45 Filed 06/04/24 Page 4 of 10 Repeat CBCs (all performed at RCH) revealed a platelet count of 140,000 on August 24, 2018;7 117,000 on September 17, 2018; 72,000 on October 11, 2018; and 90,000 on October 18, 2018. Those CBCs also tested E.A.F.’s iron levels. Ex. 2 at 47 – 52; Ex. 4 at 1 – 7. Two months after the ITP onset and hospitalization, on October 22, 2018, Jennifer Han, M.D., a pediatric hematology-oncology fellow at RAH, saw E.A.F. for a single “routine follow-up.” Ex. 2 at 49. Dr. Han reviewed the interim platelet counts (listed above), and the family’s history of “No new petechiae. No severe bruising. Mild bruising to bilateral shins. Doing well overall in the interim.” Id. Dr. Han assessed that E.A.F. was a “3 y.o. previously healthy male with ITP with overall stable platelet count and iron deficiency anemia that is improving on iron supplementation.” Id. at 48. She offered the following plan: “Avoid aspirin and NSAIDs. Call clinic with bleeding symptoms. Call clinic prior to invasive procedures. Discharge from clinic. We also reviewed that he should not have any live vaccines for 6 – 12 months after IVIg, and no rough play while thrombocytopenic. Family expressed understanding and agreement with the plan. Labs with CBCd in 2 weeks. RTC [return to clinic] in 4 weeks for labs (CBC, diff, iron studies) and exam.” Id. Further CBCs (performed at RCH) revealed E.A.F.’s platelet count to be 166,000 on November 5, 2018; 225,000 on December 12, 2018; and 301,000 on April 1, 2019. Ex. 8 at 8, 10; Ex. 2 at 57. However, there were no further evaluations at RCH, or with any other medical provider, during this time period. On April 4, 2019, the mother brought E.A.F. to an urgent care center for evaluation of a generalized rash, noting his prior history of ITP. Ex. 3 at 8. They were sent to pediatrician Stephanie Cone, M.D., who found a rapid strep test to be positive, assessed scarlet fever, and prescribed amoxicillin. Ex. 2 at 35 – 36. On July 8, 2019, the pediatrician Dr. Giguere offered conservative management for E.A.F.’s symptoms of abdominal pain, decreased appetite, constipation, and an oral ulcer. Ex. 6 at 38 – 39. Dr. Giguere also assessed that E.A.F.’s spontaneous nose bleeds represented vasomotor rhinitis. Id. at 38 At an October 14, 2019, well-child visit, Dr. Giguere exempted E.A.F. from receiving future MMR vaccines, and recorded that someone had reported E.A.F.’s case to VAERS. Ex. 6 at 45. Dr. Giguere also assessed E.A.F. to be a “4 y.o. healthy male with 7 A comment on the August 24, 2018, CBC reads: “The reported platelet count may be inaccurate due to platelet clumping. Platelets appear adequate on peripheral blood smear.” Ex. 2 at 47. 4 Case 1:21-vv-01728-AOB Document 45 Filed 06/04/24 Page 5 of 10 normal growth and developmental milestones.” Id. at 48. The only treatment provided was a prescription steroid for eczema. Id. On March 23, 2020, pediatrician Karen S. Loper, M.D., evaluated E.A.F. for a recent history of cough, throat pain, and swollen lymph nodes. Ex. 6 at 51. He was assessed with strep A pharyngitis, to be treated with amoxicillin. Id. at 53. On May 27, 2020, a pediatric nurse practitioner (“NP”) administered E.A.F.’s second Hep B vaccine. Ex. 6 at 55 – 56. The NP noted both E.A.F.’s history of ITP, and a current “assessment and plan” of iron deficiency anemia secondary to inadequate iron intake, upon ordering a CBC. Id. Afterwards, a June 19, 2020, CBC found a platelet count of 297,000. Ex. 2 at 59. On June 26, 2020, Dr. Giguere recorded that the mother wanted E.A.F. to receive “either polio or varicella” vaccine on that date. Ex. 6 at 58. After further discussion, E.A.F. received an inactivated polio vaccine (“IPV”). Id. Dr. Giguere also recorded that the last CBC was “completely normal” but “mom prefers to get CBC after every visit.” Id. Afterwards, a July 7, 2020, CBC found a platelet count of 274,000. Ex. 2 at 60. On July 24, 2020, Dr. Giguere administered a varicella vaccine to E.A.F., and recorded that his “vaccines [were] now UTD [up to date] for MMR exception for one year, school note provided.” Ex. 6 at 64. E.A.F. received urgent care for pharyngitis on July 31, 2020, and for an upper respiratory infection on October 9, 2020. Ex. 3 at 5 – 6, 10 – 12. On April 8, 2021, E.A.F. received a DTaP vaccine at the pediatrics practice. Id. at 67. On May 17, 2021, Dr. Giguere saw E.A.F. for abdominal pain, constipation, and wheezing. Id. at 69 – 71. No further medical records have been filed. III. Sworn Statements I have fully reviewed the sworn statements from E.A.F.’s mother (one of the co- Petitioners), grandmother, caregiver, and the aforementioned pediatrician Dr. Giguere. To briefly summarize, the mother attests that RCH hematology team wanted to continue monitoring E.A.F.’s platelet counts, restrict physical activity, and restrict further vaccinations for at least six months after his August 2018 MMR vaccine and ITP acute course. Ex. 5 at ¶¶ 13, 15; Ex. 13 at ¶¶ 3 - 4. She recalls that an (unnamed) RCH hematologist repeated this advice in a November 2018 telephone call (although E.A.F.’s platelet count had normalized by that time). Ex. 5 at ¶ 17; Ex. 13 at ¶ 5. The family could 5 Case 1:21-vv-01728-AOB Document 45 Filed 06/04/24 Page 6 of 10 not obtain insurance coverage or otherwise afford further hematology appointments. Ex. 5 at ¶¶ 18, 21; Ex. 13 at ¶¶ 5, 8. However, the mother “kn[e]w that [E.A.F.’s] primary care doctor was speaking with the hematologist regarding his ongoing condition and monitoring of his condition.” Ex. 5 at ¶ 21. She maintains that E.A.F.’s physical activity, receipt of further vaccines, and psychological health were negatively impacted for over six months, based on instructions from his treating providers. Ex. 5 at ¶¶ 22 – 24; Ex. 13 at ¶¶ 9 – 12. The grandmother lives several hundred miles away but visited regularly. Ex. 16 at ¶ 2. As a longtime registered nurse with training in pediatrics, she “knew that it was critical [for E.A.F.] to avoid physical activity that could result in internal bleeding and all precautions should be taken.” Id. at ¶ 3. The grandmother avers that for months, E.A.F.’s physical activity was restricted, and he wore a protective helmet which she believed was recommended by an unspecified doctor. Id. at ¶ 4 – 7. The caregiver recalls taking “extraordinary steps to restrict E.A.F.’s activities to keep him safe,” including “wear[ing] the helmet provided by his mother,” for more than six months. See Ex. 14 at ¶¶ 6 - 9. E.A.F.’s ITP acute course and the subsequent restrictions impacted his physical, emotional, and mental development. Id. at ¶¶ 9 – 13. Finally, Dr. Giguere recalls being E.A.F.’s “primary pediatrician at all times relevant to his treatment for ITP.” Ex. 17 at ¶ 3. Dr. Giguere confirms that after seeing E.A.F. for administration of his MMR vaccine and tentatively assessing him with ITP in August 2018, she did not personally evaluate him for nearly a year. Id. at ¶¶ 4 – 9. Dr. Giguere does not attest that she or the pediatrics practice had any coordination of E.A.H.’s care with the RCH hematology team. See generally Ex. 17. But she avers: I understand that E.A.F.’s platelet levels returned to normal by November 5, 2018, and remained within the normal range for all subsequent testing. However, I viewed certain treatment and restrictions as medically prudent despite these test results. For example, I believe it was prudent to restrict E.A.F.’s physical interactions for the six (6) months following his ITP diagnosis. I do not think it would have been advisable to allow him to unnecessarily risk being injured by participating in potentially rough play with other kids during this timeframe. I also think it was necessary to restrict the vaccinations E.A.F. received for the six (6) months following his ITP diagnosis. Finally, I believe that it was prudent to delay E.A.F. receiving another MMR vaccine until June 26, 2020, as a result of his ITP diagnosis. I view all of these restrictions as part of his ongoing medical care, and sequela, from his ITP injury/ illness. 6 Case 1:21-vv-01728-AOB Document 45 Filed 06/04/24 Page 7 of 10 Ex. 17 at ¶ 12. IV. Parties’ Arguments Petitioners maintain that they can establish severity despite a relevant, recent Federal Circuit decision, Wright v. Sec’y of Health & Hum. Servs., 22 F.4th 999, 1005 (Fed. Cir. 2022), that suggests mere ongoing monitoring of ITP is not evidence of severity. Wright, they argue, turned on a treater’s affirmative, specific assessment that the vaccinee’s ITP had “resolved,” even though treaters thereafter continued to monitor platelet levels. Pet. Opp. at 10; Pet. Brief at 4. Here, in contrast, despite E.A.F.’s platelet levels returning to normal, E.A.F.’s pediatrician Dr. Giguere avers that it was “medically prudent” to restrict his physical activity and vaccinations for more than six months, as part of his ongoing medical treatment for ITP. Pet. Opp. at 4 – 5. Petitioners further aver that the additional fact witnesses’ statements demonstrate how these restrictions impacted E.A.F.’s physical and emotional development. Id. at 5. Petitioners therefore argue that they have established ITP residual effects and complications lasting for over six months. In maintaining that severity is not met, Respondent emphasizes that all objective, contemporaneous evidence indicates that E.A.F.’s ITP resolved less than six months post-vaccination and onset. Resp. Response at 9. Even considering the additional sworn statements, there is not preponderant evidence that any physician ordered ongoing physical activity restrictions after E.A.F.’s platelet count had normalized. Resp. Response at 10. Hematologist Dr. Han’s October 2018 note cautioned against rough play only “while thrombocytopenic,” and that Dr. Giguere’s 2023 statement “reads as a comment on the reasonableness of the course that was taken, and not a recitation of her real-time recommendation.” Id. (internal citations omitted). The other witnesses’ assessments are rebutted by the medical records, which indicate normal growth and development. Resp. Response at 10 – 11. “The record therefore demonstrates that to the extent Petitioners restricted E.A.F.’s activities after November of 2018, it was not medically directed or necessary. While these activities may have been motivated by well-meaning parental concern,” they do not constitute “residual effects or complications” under Section 11(c)(1)(D)(i). Id. at 11, citing Wright, 22 F.4th at 1004. V. Applicable Legal Standards In another recent decision, I discussed at length the legal standards governing the burden of proof for Table claims, the analysis of fact evidence, ruling on the record, and the six-month severity requirement at Section 11(c)(1)(D)(i) (both generally, and applying to ITP in particular). I hereby fully adopt and incorporate herein that discussion, in Sections IV and V of Michie v. Sec’y of Health & Hum. Servs., No. 19-0453V, 2023 WL 10410004, at *4-10 (Fed. Cl. Spec. Mstr. Dec. 4, 2023). There, I noted that ITP’s objective 7 Case 1:21-vv-01728-AOB Document 45 Filed 06/04/24 Page 8 of 10 hallmark is an abnormally low platelet count. Michie, 2023 WL 10410004, at *6; see also 42 C.F.R. § 100.3(c)(7) (providing that ITP “is defined 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”) (emphasis added). As previously emphasized, the Federal Circuit has established that under Section 11(c)(1)(D)(i), the phrase “residual effects” means “something remaining or left behind from a vaccine injury,” that “never goes away or recurs after the original illness.” Wright, 22 F.4th at 1005. The phrase “is focused on effects within the patient, particularly lingering signs and symptoms of the original vaccine injury.” Id. at 1006. Put another way “[a] residual effect must be a change within the patient that is caused by the vaccine injury.” Id. at 1001 (emphasis added). VI. Analysis E.A.F. fortunately recovered from ITP well within six months after the August 2018 vaccination and onset and did not suffer any recurrence of that condition. Thus, E.A.F.’s parents face the not-uncommon challenge of establishing that this acute condition nevertheless caused “residual effects” rendering them eligible for compensation under the Act. I find no reason to doubt Petitioners’ explanation that they were unable to obtain insurance coverage or otherwise afford hematology evaluations after October 22, 2018. But shortly after that date, E.A.F.’s platelet level normalized – and never again objectively fell to levels consistent with ITP. And there is insufficient evidence of any medical provider’s decision to maintain physical activity restrictions beyond that point. Most persuasive is the hematologist’s previous, specific explanation that E.A.F. should be restricted from rough play “while thrombocytopenic.” Ex. 2 at 48.8 Of course, E.A.F. was never again thrombocytopenic. It is also reasonable to presume that any ongoing restrictions would have been noted in contemporaneous medical records – but no such documentation exists. See Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993) (holding 8 The hospital’s website explains further, in plain language: Thrombocytopenia is when there aren’t as many normal platelets in the blood as there should be. Platelets… help the blood clot… Children with a low platelet count should take care to avoid injuries, especially to the head, because of the risk of bleeding. Rady Children’s Hospital, Thrombocytopenia, https://www.rchsd.org/health-article/thrombocytopenia/ (last accessed Apr. 26, 2024). 8 Case 1:21-vv-01728-AOB Document 45 Filed 06/04/24 Page 9 of 10 that medical records are generally given weight than later recollections); see also Leming v. Sec’y of Health & Hum. Servs., 161 Fed. Cl. 744, 760 (2022) (explaining that a reliance on the contemporaneous medical records did not reflect “any lack of sincerity or bad faith on Ms. Leming’s part in reporting what she understood Dr. Forbes’ advice to be”), not disturbed on appeal, -- F.4th ----, 2024 WL 1608658 (Fed. Cir. 2024). Dr. Giguere’s later statement does not cure this deficiency in the claim. First, she does not attest to any particular expertise in treating ITP, or that she was coordinating with the hematology team on E.A.F.’s ongoing care. She also does not explain why it would be medically “prudent” or necessary to restrict the activity of a child whose repeat CBCs and clinical presentation were otherwise consistently recorded to be normal. And as Respondent observes, Dr. Giguere seems to endorse a course of conduct after the fact, rather than describe real-time medical instructions – which again, are not documented in the medical records. Again – well before expiration of the severity period, E.A.F. appears to have recovered from ITP, and it has not recurred. Ex. 6 at 48 (Dr. Giguere’s medical record assessment that E.A.F. was “healthy… with normal growth and developmental milestones” over one year after the vaccination and onset); accord Ex. 17 at ¶ 10 (Dr. Giguere’s affidavit). My conclusion encompasses Petitioners’ allegations of psychological distress. Although psychological distress due to a vaccine injury can be a reasonable and related sequela of some injuries, this kind of injury (which is insidious and often not characterized by painful symptoms), coupled with the fact that it occurred to a very young child, is not one that is likely to involve such sequela in the first place. It is simply unlikely that ITP in a minor would be associated with subsequent psychological effects sufficient to satisfy the severity requirement. Wright v. Sec’y of Health & Hum. Servs., 2019 WL 1061472, at *11 - 13 (Fed. Cl. Spec. Mstr. Jan. 18, 2019) (finding no contemporaneous medical record documentation of the alleged psychological effects, and that a later-retained expert’s opinion was “conclusory” and based on parents’ assertions), reversed on other grounds, 146 Fed. Cl. 608 (2019), remanded, 2020 WL 6281782 (Fed. Cl. Spec. Mstr. Sept. 25, 2020), reversed, 22 F.4th 999 (Fed. Cir. 2022). Similarly, here, the medical records do not document any concerns, and to the contrary, indicate that E.A.F. was developing normally.9 9 I also recognize Petitioners’ assertion that E.A.F.’s repeated blood draws were “traumatic.” Pet. Opp. at n. 4. But they have not distinguished their case from Wright, in which the Federal Circuit held that such blood draws in a similarly-aged child did not fulfill the severity requirement. Wright, 22 F.4th 999, 1007 (characterizing such blood draws as “routine”). 9 Case 1:21-vv-01728-AOB Document 45 Filed 06/04/24 Page 10 of 10 The only other evidence of severity pointed to by Petitioners is the fact that vaccination was not recommended by later treaters. In particular, a hematologist determined that E.A.F. should not receive further vaccines (except flu) for over six months – based on the reasoning that his IVIg infusion may prevent a “full response.” Ex. 2 at 14, 48; accord Ex. 6 at 76 (pediatrician’s immunization records).10 E.A.F.’s pediatrician also granted a longer exemption from MMR vaccines. Ex. 6 at 45, 64; see also Ex. 17 at ¶ 12 (attesting that this was “medically prudent”). However, these kind of treatment recommendations do not establish severity either. Petitioners have only asserted “concern about the impact [these vaccine restrictions] might have on [E.A.F.’s] health,” Ex. 13 at ¶ 11 (emphasis added). This falls short of any actual demonstrated impact, as Wright would require. See, e.g., Michie, 2023 WL 10410004, at *7-8 (“lingering risk of a future injury after a second vaccination… is not evidence of ‘effects within the patient’”); Leming, 2022 WL 3371016, at *8 (Fed. Cl. Spec. Mstr. Jan. 26, 2022) (concluding that a restriction against further vaccines did not constitute evidence that ITP “or any related immunodeficiency persisted for more than six months”). Conclusion For the reasons explained above, Petitioners have failed to establish that E.A.F. suffered from ITP or its residual effects or complications for over six months, under the meaning of Vaccine Act Section 11(c)(1)(D). Accordingly, this claim must be dismissed. The Clerk of the Court is directed to enter judgment in accordance with this Decision.11 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 10 But see Resp. Response at 2, and above summary of the medical records, noting that Petitioners had previously instituted an alternative schedule which spaced out E.A.F.’s vaccinations. 11 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing the right to seek review. 10 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_21-vv-01728-1 Date issued/filed: 2024-08-14 Pages: 9 Docket text: VACCINE REPORTED OPINION AND ORDER re: 47 VACCINE OPINION AND ORDER: Petitioners' motion for review (ECF 43) is DENIED and the OSM decision (ECF 42) is SUSTAINED. The Clerk of Court is directed to ENTER Judgment accordingly. Signed by Judge Armando O. Bonilla. (ead) Service on parties made. -------------------------------------------------------------------------------- Case 1:21-vv-01728-AOB Document 49 Filed 08/14/24 Page 1 of 9 In the United States Court of Federal Claims FOR PUBLICATION No. 21-1728V (Filed: August 14, 2024∗) ) STEPHANIE FELIX and ASHTON FELIX, ) parents of E.A.F., a minor, ) ) Petitioners, ) ) v. ) ) SECRETARY OF HEALTH AND ) HUMAN SERVICES, ) ) Respondent. ) ) John L. Shipley, Davis, CA, for petitioners. Mallori B. Openchowski, Trial Attorney, Torts Branch, Civil Division, U.S. Department of Justice, Washington, DC, for respondent. With her on the briefs were Brian M. Boynton, Principal Deputy Assistant Attorney General, and C. Salvatore D’Alessio, Director, and Heather L. Pearlman, Deputy Director, Torts Branch, Civil Division, U.S. Department of Justice, Washington, DC. OPINION AND ORDER BONILLA, Judge. Parents of a minor seek review of a decision of the United States Court of Federal Claims Office of Special Masters (OSM) denying entitlement under the National Childhood Vaccine Injury Act (Vaccine Act), 42 U.S.C. § 300aa-10 et seq. Petitioners specifically challenge OSM’s dismissal of their Table Injury claim, attributed to their child’s adverse effects to a Centers for Disease Control and ∗ This decision was initially filed under seal on July 30, 2024, in accordance with Rule 18(b) of the Vaccine Rules of the United States Court of Federal Claims, to allow the parties to propose redactions based upon privacy concerns. No proposed redactions were filed. Case 1:21-vv-01728-AOB Document 49 Filed 08/14/24 Page 2 of 9 Prevention (CDC) recommended vaccination. OSM dismissed the petition relatively early in the proceedings “for failure to establish the statutory severity requirement.” Felix v. Sec’y of Health & Hum. Servs., No. 21-1728, 2024 WL 2831368 (Fed. Cl. Spec. Mstr. Apr. 29, 2024). For the reasons discussed herein, the Court finds OSM’s decision was not arbitrary, capricious, an abuse of discretion, or otherwise contrary to law. Accordingly, the motion for review is DENIED and the OSM decision is SUSTAINED. BACKGROUND Petitioners Stephanie and Ashton Felix are the parents of an eight-year-old child identified herein as E.A.F. During a pediatric wellness visit on August 6, 2018, E.A.F. received the first dose of the measles, mumps, and rubella (MMR) vaccination. While the Felixes previously delayed certain CDC-recommended vaccines citing over-immunization concerns, the MMR vaccination was required for E.A.F. to attend preschool. Up until this point, E.A.F. was generally in good health and had no significant medical conditions. Two weeks later, E.A.F. returned to the pediatrician after developing “bumps behind [his] head” and experiencing severe bruising. ECF 11-2 at 33–34. The pediatrician suspected immune thrombocytopenic purpura (ITP)1 and instructed Ms. Felix to bring E.A.F. to the hospital for additional testing.2 Upon admission, a complete blood count (CBC) revealed a low platelet count of 7,000/mm .3 Confirming 3 the ITP diagnosis, E.A.F. “responded well” to intravenous immune globulin (IVIG) treatment, increasing his platelet count to 20,000/mm after only one dose.4 ECF 8-2 3 at 14. The discharging physician directed that E.A.F. return in two days for another CBC. The doctor further recommended to “hold vaccines (except influenza vaccine) for at least 6 months after IVIG . . . [as E.A.F.] may not have full response to vaccines after recent IVIG administration.” Id. The family was also advised to “avoid rough play.” Id. at 15. 1 ITP is a blood disorder, characterized by low platelet levels, which can prevent blood from clotting and lead to severe bleeding and bruising. A typical platelet count is between 150,000 and 400,000 per cubic millimeter (mm3), with a platelet count under 50,000/mm3 indicating the patient is thrombocytopenic. 42 C.F.R. § 100.3(c)(7). ITP can also be distinguished between acute (short-term) ITP and chronic (long-term) ITP. Acute ITP is the most common type and often lasts less than six months. Chronic ITP lasts six months or longer and mostly affects adults with underlying health conditions. See Nat’l Heart, Lung, and Blood Inst., Immune Thrombocytopenia, https://perma.cc/B559- XG58 (“Acute ITP in children often goes away on its own within a few weeks or months and does not return.”) (last visited July 30, 2024). 2 Given E.A.F.’s age and unexplained bumps and bruises, child protective services was notified. 3 For clarity, the Court stylistically adopts the subscript cubic measurement (i.e., mm3) to distinguish platelet counts from footnote numbers. 4 Mild anemia (attributed to high milk intake) was also diagnosed, for which E.A.F. was prescribed iron supplements. 2 Case 1:21-vv-01728-AOB Document 49 Filed 08/14/24 Page 3 of 9 When E.A.F. returned to the hematology clinic on August 24, 2018, the CBC revealed a platelet count of 140,000/mm , noting however: “The reported platelet 3 count may be inaccurate due to platelet clumping.” Id. at 47. Three subsequent CBCs through October 18, 2018, measured platelet counts of between 72,000/mm and 3 117,000/mm . See ECF 8-4 at 1–3. During a routine October 22, 2018 follow-up 3 examination, a pediatric hematology-oncology fellow assessed E.A.F. as an otherwise healthy three-year-old “with ITP with overall stable platelet count and iron deficiency anemia that is improving on iron supplementation.” ECF 8-2 at 52. The treatment plan included avoiding “live vaccines for 6–12 months after IVIG, and no rough play while thrombocytopenic.” Id. at 56–57. CBCs administered on November 5, 2018, December 13, 2018, and April 1, 2019, measured E.A.F.’s platelet counts at 166,000/mm , 225,000/mm , and 301,000/mm respectively. ECF 17-1 at 8–11. 3 3 3, E.A.F. went to his primary care physician for a regular checkup on October 14, 2019. During this wellness visit, E.A.F. was assessed as a “healthy” four-year-old “with normal growth and developmental milestones.” ECF 11-2 at 48. E.A.F. was nonetheless medically exempted from receiving the second (and final) dose of the MMR vaccine due to his previous adverse reaction. Since then, E.A.F.’s medical records reflect he was otherwise up to date on vaccinations and that his platelet counts never fell below 270,000/mm –characterized as “completely normal.” Id. at 3 58, 64; ECF 8-2 at 59–60. The Felixes filed a petition for compensation under the National Vaccine Injury Compensation Program’s Vaccine Injury Table on August 19, 2021. Finding that the claim failed to demonstrate the Vaccine Act’s six-month residual effect severity requirement, OSM granted respondent’s motion to dismiss on April 29, 2024. In support, OSM explained that E.A.F.’s ITP likely resolved within three months, evidenced by his platelet count returning to normal levels. OSM further explained that, under the recent decision of the United States Court of Appeals for the Federal Circuit in Wright v. Secretary of Health & Human Services, 22 F.4th 999 (Fed. Cir. 2022), petitioners’ reliance on continued testing, restrictions on physical activity, and delayed vaccines was misplaced. Petitioners timely filed this motion for review. DISCUSSION I. Standard of Review In reviewing a Vaccine Act decision, this Court may: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or 3 Case 1:21-vv-01728-AOB Document 49 Filed 08/14/24 Page 4 of 9 otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or (C) remand the petition to the special master for further action in accordance with the court’s direction. 42 U.S.C. § 300aa-12(e)(2). The Federal Circuit clarified the applicable standards of review as follows: findings of fact are reviewed for arbitrariness or capriciousness; discretionary rulings are reviewed for abuse of discretion; and legal conclusions are reviewed de novo. Turner v. Sec’y of Health & Hum. Servs., 268 F.3d 1334, 1337 (Fed. Cir. 2001) (citations omitted). II. OSM Dismissal The motion for review asserts four bases to set aside OSM’s decision and remand this matter for continued proceedings. First, petitioners claim OSM applied the wrong legal standard in granting respondent’s motion to dismiss. Second, petitioners allege OSM erred in precluding their retention and presentation of an expert witness. Third and fourth, petitioners assert OSM erroneously concluded that delayed vaccines and restrictions of physical activity, respectively, did not qualify as residual effects of E.A.F.’s ITP diagnosis. These intertwined issues are resolved below. Addressing the proper standard of review, petitioners aver respondent’s motion to dismiss was more akin to a motion for summary judgment and, thus, OSM should have converted the dispositive motion and drawn all inferences in their favor as the non-movant. In support, petitioners cite Vaccine Rule 8(d), which states: “The special master may decide a case on the basis of written submissions without conducting an evidentiary hearing. Submissions may include a motion for summary judgment, in which event the procedures set forth in RCFC 56 will apply.” The Vaccine Rules, sanctioned by the Federal Circuit, belie this argument. Nevertheless, whether decided as a motion to dismiss or a motion for summary judgment, the Felixes were entitled to receive–and did receive–all reasonable inferences drawn in their favor as the non-movant. Vaccine Rule 8(a) allows special masters to “determine the format for taking evidence and hearing argument based on the specific circumstances of each case and after consultation with the parties.” This rule was meant to “provide for a less- adversarial, expeditious, and informal proceeding for the resolution of petitions.” Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1364 (Fed. Cir. 2020) (quoting 42 U.S.C. § 300aa-12(d)(2)(A)). Contrary to petitioners’ contention, subsection (d) twice employs the permissive term “may” to describe the discretionary decision whether to conduct an evidentiary hearing and, critical here, identify the non-exhaustive types of alternative proceedings OSM may conduct. A plain reading 4 Case 1:21-vv-01728-AOB Document 49 Filed 08/14/24 Page 5 of 9 of the text allows for–but does not expressly limit non-evidentiary hearing proceedings to–motions for summary judgment. Id. at 1366 (“Rule 8(d) contemplates that special masters can decide cases on written submissions other than motions for summary judgment.”) (citing Simanski v. Sec’y of Health & Human Servs., 671 F.3d 1368, 1385 (Fed. Cir. 2012)).5 Indeed, the Federal Circuit recently concluded that special masters are authorized to entertain motions to dismiss for failure to state a claim upon which relief can be granted under the guise of Rule 12(b)(6). W.J. v. Sec’y of Health & Hum. Servs., 93 F.4th 1228, 1242–43 (Fed. Cir. 2024). Even so, special masters do not enjoy unlimited discretion to resolve disputes at any point in the litigation: The Vaccine Act requires special masters to determine whether hearings or witness testimony are reasonable and necessary. 42 U.S.C. § 300aa- 12(d)(3)(B). Special masters must “afford[] each party a full and fair opportunity to present its case and creat[e] a record sufficient to allow review of the special master’s decision.” Vaccine Rule 3(b)(2). As a result, special masters must determine that the record is comprehensive and fully developed before ruling on the record. Simanski, 671 F.3d at 1385 (finding due process violation where special master ruled on the record at “an early procedural stage” before respondent had “present[ed] its position with respect to the petition and the supporting evidence”); Jay v. Sec’y of Dep’t of Health & Human Servs., 998 F.2d 979, 983 (Fed. Cir. 1993). Kreizenbeck, 945 F.3d at 1366. To this end, as made plain in Jay, the procedural posture of the dispositive motion considered by OSM carries with it the standard of review generally commensurate with that motion: Thus, as our previous discussion makes clear, in vaccine cases, as in other cases, summary judgment is summary judgment. If to dispose of the case the special master must resolve conflicts of fact or weigh conflicting evidence, or is statutorily constrained to do so, he or she may not render summary judgment. We will therefore treat this appeal as any other involving a grant of summary judgment, determining de novo whether there exist genuine issues of material fact and whether one of the parties is entitled to judgment as a matter of law. 5 Compare, e.g., Swint-Moore v. Sec’y of Health & Hum. Servs., No. 18-1112, 2022 WL 1124478, at *6 (Fed. Cl. Spec. Mstr. Mar. 29, 2022) (“Although [r]espondent styled his motion as a motion to dismiss, I am construing it as a motion for summary judgment.”), with Michie v. Sec’y of Health & Hum. Servs., No. 19-453, 2023 WL 10410004 (Fed. Cl. Spec. Mstr. Dec. 4, 2023) (OSM granted motion to dismiss MMR-based ITP claim for failure to satisfy Vaccine Act’s six-month residual effect severity requirement). 5 Case 1:21-vv-01728-AOB Document 49 Filed 08/14/24 Page 6 of 9 998 F.2d at 983. The same holds true in resolving motions to dismiss. See, e.g., W.J., 93 F.4th at 1235. Thus, in ruling upon a motion to dismiss, the special master must accept as true the facts asserted by the petitioner in determining whether the claim for relief under the Vaccine Act is both “sufficient” and “plausible on its face.” Id. (citing cases). The record presented demonstrates OSM satisfied the foregoing procedural and substantive requirements in this case. Procedurally, OSM afforded the Felixes ample opportunity to present their claim and address the noticed challenge (i.e., Vaccine Act’s six-month residual effect severity requirement), including filing extensive medical records, an amended petition, and a series of briefs and affidavits in response to the motion to dismiss.6 As for the Felixes’ asserted request to retain and present expert testimony, the undersigned concludes OSM did not abuse its discretion in this regard. Not all vaccine cases merit expert witness testimony particularly where, as here, petitioners have been given “a full and fair opportunity to present [their] case and creat[e] a record sufficient to allow review of the special master’s decision” through medical evidence and proffered affidavits in accordance with Vaccine Rule 3(b)(2). See, e.g., K.A. v. Sec’y of Health & Hum. Servs., 164 Fed. Cl. 98, 115–19 (2022) (OSM’s decision to deny requests to retain and present particular expert witness did not deprive the parties of “a full and fair opportunity to present his case” or otherwise amount to an abuse of discretion), aff’d, No. 23-1315, 2024 WL 2012526 (Fed. Cir. May 7, 2024) (per curiam) (table); Guilliams v. Sec’y of Dep’t of Health & Hum. Servs., No. 11-716, 2012 WL 1145003, at *10 n.20 (Fed. Cl. Mar. 14, 2012) (“An expert opinion may not be required for claims that present a well- established history of recovery under the [Vaccine] Program or that are listed on the Vaccine Injury Table.”) (citations omitted). Here, more specifically, there is a notable disconnect between the expert witness request made during the OSM proceedings and the resulting harm asserted now. In opposing the motion to dismiss–and buried in a footnote–petitioners proffer: “If necessary, [p]etitioners are confident that they will be able to present an expert opinion from a child psychiatrist/psychologist who can speak to the psychological effect that E.A.F.’s ITP injury had on him, and the duration of such [an] effect.” ECF 30 at 11 n.3. Petitioners thereafter include two generic references to allowing them “the opportunity to establish through evidence and expert opinion that E.A.F.’s residual effects and complications from the ITP injury he suffered following his MMR vaccination lasted more than six months.” Id. at 10; accord id. at 8. In their motion for review, petitioners shift their focus away from the alleged psychological impact and instead assert that an expert witness could have substantiated their claims of: 6 See, e.g., ECF 8, 11, 17 (medical records), 18 (amended petition), 24 (scheduling order noticing challenge), 26–27 (respondent’s report, motion to dismiss), 29-1 (petitioners’ affidavit), 30 (response to motion to dismiss), 33 (scheduling order noting concerns with establishing severity requirement and allowing submission of additional support), 36–38 (petitioners’ affidavits, supplemental brief), 40 (respondent’s supplemental brief), 41 (petitioners’ supplemental brief). 6 Case 1:21-vv-01728-AOB Document 49 Filed 08/14/24 Page 7 of 9 (1) “ongoing complications associated with ITP and the treatment necessary to address these complications,” (2) “the reasonableness, and medical necessity, for E.A.F. adhering to restrictions on physical activity,” and (3) “the reasonableness, and medical necessity, for E.A.F. to avoid receiving certain vaccinations.”7 ECF 43-1 at 16. Even putting aside the substantive shift from psychological to physiological manifestations, the Federal Circuit’s recent decision in Wright underscores the implausibility that an expert witness could overcome the statutory deficiency in petitioners’ vaccine claim. Accordingly, there is no reason for this Court to set aside OSM’s discretionary decision to preclude the retention and presentation of expert witness testimony on these issues. In Wright, the Federal Circuit considered a factual scenario strikingly similar to the one presented today: a two-year-old child otherwise in good health experienced ITP roughly two weeks after receiving the MMR vaccine. 22 F.4th at 1003. When admitted to the hospital, the child exhibited severe bruising and a low platelet count (i.e., below 50,000/mm ). Id. Within three months, the child’s platelet count returned 3 to (and thereafter maintained) normal levels. Id. Seeking to satisfy the six-month residual effect severity requirement under 42 U.S.C. § 300aa-11(c)(1)(D) notwithstanding the acute nature of the diagnosed blood disorder, the petitioner in Wright cited the child’s incidents of bruising and consequent blood tests to rule out ITP over the next two years. 22 F.4th at 1003–04. Rejecting both bases, the Federal Circuit succinctly explained: “A residual effect must be a change within the patient that is caused by the vaccine injury.” Id. at 1001; accord id. at 1004–05. The Federal Circuit noted that in a typical ITP case the blood disorder “is rarely chronic, i.e., lasting more than 6 months, and chronic cases are thought to be the result of an autoimmune disorder rather than viral vaccination or viral infection.” Id. at 1003 (citing National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table–II, 60 Fed. Reg. 56,289, 56,295 (Nov. 8, 1995)). Like E.A.F, the child in Wright experienced a significant platelet level drop after an MMR vaccine and recovered within three months. To ensure their continued good health and promptly diagnose any recurrence, both children underwent periodic CBCs to monitor platelet levels. The Federal Circuit squarely held that such ongoing monitoring does not satisfy the Vaccine Act’s six-month residual effect severity requirement.8 Id. at 1005–07. In E.A.F.’s case, the proactive protective measures also included restricting physical activity and delaying scheduled vaccinations for specified periods of time. Contrary to petitioners’ argument, the recommended precautions are not an extended 7 Petitioners’ motion for review includes only one mention of “E.A.F.’s psychological well-being” in the statement of facts section of the brief. See ECF 43-1 at 7. 8 The episodic bruising, in turn, was similarly not attributable to ITP once the acute blood disorder resolved. Id. at 1005. 7 Case 1:21-vv-01728-AOB Document 49 Filed 08/14/24 Page 8 of 9 course of treatment (or ongoing medical care) contemplated by–and potentially exempted from–the holding in Wright. As explained by the Federal Circuit: “During a long course of treatment, the patient generally has some lingering condition such that symptoms will likely recur if the treatment were stopped. Otherwise, the long course of treatment would not be necessary.” Id. at 1007. The recommended restriction on E.A.F.’s physical activity was “no rough play while thrombocytopenic.” ECF 8-2 at 56–57 (emphasis added). E.A.F.’s platelet count returned to normal levels as of November 5, 2018 (i.e., within three months of the vaccine) and, thereafter, continuously measured above 150,000/mm . Put simply, the acute blood disorder 3 did not linger beyond the critical six-month mark, and there were no recurring attributable symptoms.9 Similarly, the recommendation that E.A.F. “should not have any live vaccines for 6–12 months after IVIG,” id. (emphasis added), was not attributed to the possible recurrence or exacerbation of ITP. Rather, it was to ensure the efficacy of future vaccines which might be compromised by the infusion of pooled antibodies and biological agents administered through the August 2018 IVIG treatment. The facts presented in this case simply do not lend themselves to a finding that the doctor’s orders qualify as: (1) long-lasting residual effects of acute ITP, (2) a likelihood of recurrence absent proactive (and invasive) medical treatment, or (3) some somatic change underlying an undiagnosed chronic blood disorder or related condition.10 The undersigned finally circles back to OSM’s substantive consideration of the respondent’s motion to dismiss, and specifically, the lens through which OSM viewed the Felixes’ claim and record evidence. As detailed herein, there is no basis to conclude OSM “has failed to consider the relevant evidence of record, drawn implausible inferences, or failed to provide a rational basis for the decision.” See W.J., 93 F.4th at 1235. Adhering to the precedent and teachings of the Federal Circuit’s recent decision in Wright, OSM properly concluded that the Felixes’ claim of MMR- induced acute ITP–as pled and substantiated–failed to satisfy the Vaccine Act’s six-month residual effect severity requirement. To conclude otherwise would require 9 The temporary limitation placed on E.A.F.’s physical activity, while understandably difficult for him and his family given his age and relative cognitive ability, also did not rise to qualifying painful suffering contemplated under Wright. See 22 F.4th at 1006–07. 10 In Leming v. Secretary of Health & Human Services, OSM categorically held that a delayed vaccine due to an increased related health risk does not satisfy the Vaccine Act’s six-month residual effect severity requirement. See No. 18-232, 2022 WL 3371016, at *8 (Fed. Cl. Spec. Mstr. Jan. 26, 2022) (“[T]he mere risk of a future associated problem that could be triggered a second time by vaccination cannot satisfy severity.”) (citing cases), reconsideration denied, 2022 WL 3444742 (Fed. Cl. Spec. Mstr. Feb. 18, 2022), motion for review denied, 161 Fed. Cl. 744 (2022), rev’d on other grounds, 98 F.4th 1107 (Fed. Cir. 2024). In deciding the motion for review and appeal in Leming, respectively, neither this Court nor the Federal Circuit found it necessary to address the issue. See 161 Fed. Cl. at 760 n.6; 98 F.4th at 1113 n.3. Likewise, the undersigned limits today’s decision to the conclusion that delayed vaccinations attributed to an IVIG treatment administered to resolve acute ITP cannot singularly satisfy the statutory residual effect severity requirement. 8 Case 1:21-vv-01728-AOB Document 49 Filed 08/14/24 Page 9 of 9 assuming facts belied by the record presented–i.e., recurring or chronic ITP despite temporal lab results documenting E.A.F.’s platelet count returned to (and thereafter maintained) normal levels within three months of the MMR vaccine. OSM thoughtfully examined this evidence in reaching its decision, considering the record in the light most favorable to the Felixes. As such, there is no basis to find the OSM decision “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B). CONCLUSION For the foregoing reasons, petitioners’ motion for review (ECF 43) is DENIED and the OSM decision (ECF 42) is SUSTAINED. The Clerk of Court is directed to ENTER judgment accordingly. It is so ORDERED. ___________________ Armando O. Bonilla Judge 9 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_21-vv-01728-cl-extra-10804029 Date issued/filed: 2025-02-21 Pages: 1 Docket text: Supplementary opinion from CourtListener cluster 10337441 -------------------------------------------------------------------------------- In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 21-1728V STEPHANIE FELIX and ASHTON Chief Special Master Corcoran FELIX, on behalf of E.A.F., Petitioners, Filed: January 17, 2025 v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. John Leonard Shipley, Davis, CA, for Petitioners. Mallori Browne Openchowski, U.S. Department of Justice, Washington, DC, for Respondent. DECISION ON ATTORNEYS’ FEES AND COSTS1 On August 19, 2021, Stephanie and Ashton Felix, acting on behalf of their minor child E.A.F., filed a Petition under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 (the “Vaccine Program”). Petitioners alleged that following his receipt of an August 6, 2018, measles-mumps-rubella (“MMR”) vaccine, E.A.F. suffered from immune thrombocytopenic purpura (“ITP”), with residual effects and complications lasting for more than six months. Petition (ECF No. 1); see also Amended Petition filed May 13, 2022 (ECF No. 18); 42 C.F.R. §§ 100.3(a)(V)(A) and (c)(7) (listing of MMR/ITP on the Vaccine Injury Table). 1 Because this unpublished decision contains a reasoned explanation for the action in this case, I am required to post it on the United States Court of Federal Claims' website in accordance with the E- Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2018). In May 2022, the case was assigned to the Special Processing Unit of the Office of Special Masters, since it alleged a Table injury. But there was a threshold issue of whether the injury was sufficiently severe, under the meaning of Section 11(c)(1)(D)(i), to be eligible for the Program. After receiving Petitioners’ additional fact evidence and both parties’ briefing (completed in October 2023), I concluded that Petitioners had not made that showing, requiring dismissal of their claim. Decision granting Respondent’s Motion to Dismiss dated Apr. 29, 2024 (ECF No. 42) (hereinafter “Dismissal Decision”). The Court of Federal Claims sustained that finding. Opinion and Order dated July 30, 2024 (ECF No. 47) (hereinafter “CFC Opinion”). On August 14, 2024, Petitioners submitted their (first and final) request for attorneys’ fees and costs. ECF No. 50. Petitioners represented that they did not incur any out-of-pocket expenses. ECF No. 50-3. On August 19, 2024, Respondent deferred to the Court’s determination as to whether the case meets the statutory requirements for an award of attorneys’ fees and costs, and if so, the appropriate amount to be awarded. Response (ECF No. 51) at 2, 4. Petitioners have not filed a reply. For the reasons set forth below, Petitioners’ motion is granted. Petitioners’ Claim Had Reasonable Basis Motivated by a desire to ensure that petitioners have adequate assistance from counsel when pursuing their claims, Congress determined that attorney’s fees and costs may be awarded even in some unsuccessful claims. H.R. REP. NO. 99-908, at 22 reprinted in 1986 U.S.C.C.A.N. 6344, 6363; see also Sebelius v. Cloer, 133 S. Ct. 1886, 1895 (2013) (discussing this goal when determining that attorneys’ fees and costs may be awarded even when the petition was untimely filed). This is consistent with the fact that “the Vaccine Program employs a liberal fee-shifting scheme.” Davis v. Sec’y of Health & Human Servs., 105 Fed. Cl. 627, 634 (2012). Indeed, it may be the only federal fee- shifting statute that permits unsuccessful litigants to recover fees and costs. However, Congress did not intend that every losing petition be automatically entitled to attorney’s fees. Perreira v. Sec’y of Health & Human Servs., 33 F.3d 1375, 1377 (Fed. Cir. 1994). The special master or court may award attorney’s fees and costs to an unsuccessful claimant only if “the petition was brought in good faith and there was a reasonable basis for the claim for which the petition was brought.” Section 15(e)(1). Reasonable basis is a prerequisite to a fee award for unsuccessful cases – but establishing it does not automatically require an award, as special masters are still empowered by the Act to deny or limit fees. James-Cornelius on behalf of E. J. v. Sec'y of Health & Human Servs., 984 F.3d 1374, 1379 (Fed. Cir. 2021) (“even when these two 2 requirements are satisfied, a special master retains discretion to grant or deny attorneys’ fees”). As the Federal Circuit has explained, whether a discretionary fees award is appropriate involves two distinct inquiries, but only reasonable basis is at issue herein.3 Reasonable basis is deemed “an objective test, satisfied through objective evidence.” Cottingham v. Sec’y of Health & Human Servs., 971 F.3d 1337, 1344 (Fed. Cir. 2020) (“Cottingham I”). The reasonable basis requirement looks “not at the likelihood of success [of a claim] but more to the feasibility of the claim.” Turner, 2007 WL 4410030, at *6 (quoting Di Roma v. Sec’y of Health & Human Servs., No. 90-3277V, 1993 WL 496981, at *1 (Fed. Cl. Spec. Mstr. Nov. 18, 1993)). The Federal Circuit recently explained “that a reasonable basis analysis is limited to objective evidence, and that subjective considerations, such as counsel’s subjective views on the adequacy of a complaint, do not factor into a reasonable basis determination.” James-Cornelius, 984 F.3d at 1379. Although easier to meet than the preponderant standard required for compensation, “courts have struggled with the nature and quantum of evidence necessary to establish a reasonable basis.” Wirtshafter v. Sec’y of Health & Human Servs., 155 Fed. Cl. 665, 671 (Fed. Cl. 2021). “[I]t is generally accepted that ‘a petitioner must furnish some evidence in support of the claim.’” Id. Citing the prima facie elements of a successful claim described in Section 11(c)(1), the Federal Circuit recently instructed that the level of objective evidence sufficient for a special master to find reasonable basis should be “more than a mere scintilla but less than a preponderance of proof.” Cottingham I, 971 F.3d at 1345-46. “This formulation does not appear to define reasonable basis so much as set its outer bounds.” Cottingham v. Sec’y of Health & Human Servs., 159 Fed. Cl. 328, 333, (Fed. Cl. 2022), aff’d without op., 2023 WL 754047 (Fed. Cir. Nov. 14, 2023) (“Cottingham II”). “[T]he Federal Circuit’s statement that a special master ‘could’ find reasonable basis based upon more than a mere scintilla does not mandate such a finding.” Cottingham II, 159 Fed. Cl. at 333 (citing Cottingham I, 971 F.3d at 1346). Furthermore, reasonable basis is not a static inquiry. Reasonable basis may exist when a claim is filed but cease to exist as further evidence is presented. Perreira, 33 F.3d at 1377. In Perreira, the Federal Circuit affirmed a special master’s determination that reasonable basis was lost after Petitioner’s “expert opinion, which formed the basis of the claim, was found to be unsupported by either medical literature or studies.” Id. at 1376. 3 Claimants must also establish that the petition was brought in good faith. Simmons v. Sec’y of Health & Human Servs., 875 F.3d 632, 635 (Fed. Cir. 2017) (quoting Chuisano v. Sec’y of Health & Human Servs., 116 Fed. Cl. 276, 289 (2014)). “[T]he ‘good faith’ requirement . . . focuses upon whether petitioner honestly believed he had a legitimate claim for compensation.” Turner v. Sec’y of Health & Human Servs., No. 99- 0544V, 2007 WL 4410030, at *5 (Fed. Cl. Spec. Mstr. Nov. 30, 2007). But good faith is not disputed herein, and I do not ascertain evidence in the record calling it into question. 3 At issue here, Vaccine Act Section 11(c)(1)(D)(i) requires the establishment of an injury and residual effects lasting for over six months after the date of vaccination. This is a threshold requirement for entitlement. Black v. Sec’y of Health & Human Servs., 33 Fed. Cl. 546, 550 (1995) (reasoning that the “potential petitioner” must not only make a prima facie case, but clear a jurisdictional threshold, by “submitting supporting documentation which reasonably demonstrates that a special master has jurisdiction to hear the merits of the case”), aff’d, 93 F.3d 781 (Fed. Cir. 1996) (internal citations omitted). As previously discussed, E.A.F. received a covered MMR vaccine in August 2018, and shortly developed ITP, which condition’s objective hallmark is a platelet count below 50,000. But E.A.F.’s platelets normalized within two months – and never again objectively fell to levels consistent with ITP. See generally Dismissal Decision at 3 – 5, 7 – 8. While this claim was pending, the Federal Circuit confirmed that the meaning of “residual effects” under Section 11(c)(1)(D)(i) includes only actual, somatic “conditions within the patient.” Accordingly, mere monitoring after a past history of ITP are not sufficient “residual effects.” Wright v. Sec’y of Health & Hum. Servs., 22 F.4th 999, 1006 (Fed. Cir. 2022). Petitioners received an additional opportunity to develop the record, in an attempt to distinguish their case from that in Wright. But ultimately this case did not contain preponderant evidence of any medically necessary restrictions on E.A.F.’s physical activity or ongoing vaccinations, or sufficient psychological distress, that constituted a sufficient somatic condition that could satisfy the severity requirement. Dismissal Decision at 8 – 9; see also CFC Opinion at 7 – 8, n. 10. Overall, I find that the claim was feasible initially, weakened by the subsequent Federal Circuit holding in Wiright, but still warranted some additional development and evaluation of the evidence even after Wright’s clarifications. Although the claim did not succeed, it meets the exceedingly low bar for reasonable basis, and fees should therefore awarded. Accord Wright v. Sec’y of Health & Human Servs., No. 16-498V, 2022 WL 17850714 (Fed. Cl. Spec. Mstr. Nov. 9, 2022) (granting interim attorneys’ fees and costs for that MMR-ITP claim despite the similar severity dispute); Michie v. Sec’y of Health & Human Servs., No. 19-453V, 2024 WL 1522347 at *2 – 3 (Fed. Cl. Spec. Mstr. Mar. 13, 2024) (explaining that fees were warranted despite the intervening precedent in Wright). My reasonable basis determination extends to the petitioners’ (unsuccessful) motion for review, which challenged the above determinations as well as my discretion to refuse expert involvement in the case, and the applicable legal standard (concerning a motion to dismiss versus a motion for summary judgment). “[W]hile Program counsel 4 should not utilize the appellate process as a means of earning unjustified fees from the Vaccine Program, claimants do possess the right of appeal, and therefore should not be denied fees on reasonable basis grounds that is facially unlikely to undo an earlier unfavorable outcome.” Loyd v. Sec’y of Health & Hum. Servs. No. 16-811V, 2023 WL 4170791 at *3 (Fed. Cl. Spec. Mstr. May 30, 2023). Attorneys’ Fees and Costs Calculation The Vaccine Act permits an award of reasonable attorney's fees and costs. Section 15(e). Counsel must submit fee requests that include contemporaneous and specific billing records indicating the service performed, the number of hours expended on the service, and the name of the person performing the service. See Savin v. Sec’y of Health & Hum. Servs., 85 Fed. Cl. 313, 316 – 18 (2008). Counsel should not include in their fee requests hours that are “excessive, redundant, or otherwise unnecessary.” Saxton v. Sec’y of Health & Hum. Servs., 3. F.3d 1517, 1521 (Fed. Cir. 1993) (quoting Hensley v. Eckerhart, 461 U.S. 424, 434 (1983)). It is “well within the special master's discretion to reduce the hours to a number that, in his experience and judgment, [is] reasonable for the work done.” Id. at 1522. Furthermore, the special master may reduce a fee request sua sponte, apart from objections raised by respondent and without providing a petitioner notice and opportunity to respond. See Sabella v. Sec’y of Health & Hum. Servs., 86 Fed. Cl. 201, 209 (2009). A special master need not engage in a line-by-line analysis of petitioner's fee application when reducing fees. Broekelschen v. Sec’y of Health & Hum. Servs., 102 Fed. Cl. 719, 729 (2011). The petitioner “bears the burden of establishing the hours expended, the rates charged, and the expenses incurred.” Wasson v. Sec’y of Health & Hum. Servs., 24 Cl. Ct. 482, 484 (1991). The Petitioner “should present adequate proof [of the attorney's fees and costs sought] at the time of the submission.” Id. at n. 1. Petitioner's counsel “should make a good faith effort to exclude from a fee request hours that are excessive, redundant, or otherwise unnecessary, just as a lawyer in private practice ethically is obligated to exclude such hours from his fee submission.” Hensley, 461 U.S. 434. Petitioners argue that John L. Shipley’s attorney work warrants hourly rates of $375.00 in 2021; $400.00 in 2022; and $425.00 in 2023 (as well as lower rates for his time spent on paralegal tasks). ECF No. 50-4 at 3. These rates have been awarded to Mr. Shipley in previous Vaccine Program cases, and they are also reasonable herein. See, e.g., Ferguson v. Sec’y of Health & Human Servs., No. 19-1867V, 2022 WL 1421850, at *2 (Fed. Cl. Spec. Mstr. Mar. 25, 2022); Marcum v. Sec’y of Health & Human Servs., No., 20-65V, 2023 WL 2756218, at *5 – 6 (Fed. Cl. Spec. Mstr. Apr. 3, 2023); Cross v. Sec’y of Health & Human Servs., No. 1958V, 2023 WL 4401124, at *2 (Fed. Cl. Spec. Mstr. June 2, 2023). 5 Petitioners further request that Mr. Shipley receive an increased hourly rate of $475.00 performed in 2024 – noting that in that year, he surpassed twenty (20) years of general legal experience (having been admitted to the California state bar in 2003). ECF No. 50-4 at 3. They accurately note that $475.00 is the “base rate” for attorneys with at least 20 years of experience in practice, pursuant to OSM’s Attorneys Forum Hourly Rate Fee Schedule for 2024. That is appropriate context for the somewhat significant year-to- year increase in his fees, which is hereby approved. Mr. Shipley billed a total of 103.4 attorney hours and 18.7 paralegal hours on this case. ECF No. 50-1 at 1. As reflected in his billing entries, that work included analysis and briefing of the case-specific evidence, in the context of evolving Federal Circuit precedent, regarding the statutory severity requirement. I find that this time is adequately documented and reasonably incurred. Finally, Mr. Shipley requests reimbursement for $508.09 in costs associated with the petition filing fee, mileage associated with one in-person case meeting, and obtaining medical records. ECF No. 50-2 at 1 – 3. These costs are also adequately documented and reasonably incurred. Based on my review and the absence of any specific objections raised by Respondent, the fees and costs will be awarded in full. Conclusion Based on the foregoing, and in the exercise of the discretion afforded to me in determining the propriety of a fees award, I hereby GRANT Petitioner’s Motion for attorney’s fees and costs. Petitioners are awarded attorneys’ fees and costs in the total amount of $46,989.59 (representing $46,851.50 in fees and $508.09 in costs), to be paid through an ACH deposit to Petitioner’s counsel’s IOLTA account for prompt disbursement. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.4 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 4 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices renouncing their right to seek review. 6