VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-01494 Package ID: USCOURTS-cofc-1_16-vv-01494 Petitioner: Ebonie Weaver Filed: 2016-11-14 Decided: 2025-05-27 Vaccine: DTaP; Hib; IPV; RotaTeq; hepatitis B Vaccination date: 2013-12-10 Condition: seizure disorder and significant worsening of preexisting developmental delays Outcome: compensated Award amount USD: 1626851 AI-assisted case summary: On November 14, 2016, Ebonie Weaver, on behalf of her minor daughter T.M., filed a petition alleging that vaccines administered on December 10, 2013, caused T.M. to develop a seizure disorder and significantly worsen her preexisting developmental delays. T.M. was nine months old at the time of vaccination and had shown developmental concerns prior to the shots. Within 24 hours of vaccination, T.M. experienced a complex febrile seizure. The initial decision by Chief Special Master Brian H. Corcoran denied entitlement, finding insufficient evidence that the initial seizure caused T.M.'s subsequent chronic seizure disorder or significantly aggravated her developmental delays. This decision was appealed, and the U.S. Court of Federal Claims reversed, finding that the Chief Special Master had improperly elevated the burden of proof by requiring contemporaneous medical screening evidence of brain injury. The court determined that T.M.'s regression and the opinions of her treating physicians provided sufficient evidence of a vaccine-induced brain injury. The case was remanded, and entitlement was ultimately granted for both the seizure disorder and the significant aggravation of developmental delays. Following the grant of entitlement, a damages award was issued on May 27, 2025. The final decision awarded T.M. a total of $1,626,851.05, comprising a lump sum of $1,537,438.76 for life care expenses in the first year after judgment, lost future earnings, and pain and suffering, a lump sum of $89,412.29 for a Medicaid lien, and an amount sufficient to purchase an annuity for ongoing care. Petitioner was represented by Edward Kraus of Kraus Law Group, LLC, and Respondent was represented by Meghan R. Murphy of the U.S. Department of Justice. Attorney's fees and costs were awarded separately. Theory of causation field: DTaP, Hib, IPV, RotaTeq, and hepatitis B vaccines on December 10, 2013, age nine months, followed within 24 hours by fever/complex febrile seizure and alleged seizure disorder with significant worsening of preexisting developmental delays. COMPENSATED. Petitioner Ebonie Weaver alleged the vaccines triggered fever and seizures that worsened T.M.'s developmental course. Entitlement and damages were resolved after litigation; award recorded as $1,626,851. Later fee decision did not change the injury outcome. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_16-vv-01494-1 Date issued/filed: 2022-10-21 Pages: 37 Docket text: PUBLIC DECISION (Originally filed: 09/23/2022) regarding 81 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 1 of 37 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-1494V (to be published) * * * * * * * * * * * * * * * * * * * * * * * * * EBONIE WEAVER * parent of T. M. a minor, * Filed: September 23, 2022 * Petitioner, * * v. * * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Edward Kraus, Kraus Law Group, LLC, Chicago, IL, for Petitioner. Megan R Murphy, U.S. Department of Justice, Washington, DC, for Respondent. DECISION DENYING ENTITLEMENT1 On November 14, 2016, Ebonie Weaver, on behalf of her minor daughter, T.M., filed a Petition under the National Vaccine Injury Compensation Program (the “Vaccine Program”),2 alleging that as a result of receiving several vaccines on December 10, 2013, T.M. experienced a seizure disorder and a significant worsening of her preexisting developmental delays. Petition 1 This Decision will be posted on the United States Court of Federal Claims’ website in accordance with the E- Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published Ruling’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen (14) 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 entire 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, Pub. L. No. 99-660, 100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”). All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa. Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 2 of 37 (ECF No. 1) (“Pet.”) at 1–2, 40. An entitlement hearing in the matter was held on February 9–10, 2022. Having reviewed the record, all expert reports, and testimony provided at trial, I hereby deny an entitlement award. Petitioner has offered sufficient reliable evidence for me to conclude that simply by producing a fever attributable to the oft-experience vaccination “malaise,” the vaccines T.M. received could be, and were, likely responsible for her initial febrile seizure in December 2013. Febrile seizures can lead to a more all-encompassing seizure disorder—but the record in this case does not support the conclusion that T.M.’s subsequent seizures were likely caused by the first, given an absence of evidence that her brain was likely damaged by the first febrile seizure. Petitioner otherwise has not established that T.M.’s preexisting developmental problems were aggravated by the vaccine-caused febrile seizure. I. Factual Background Pre-Vaccination History T.M. was born on March 29, 2013, with Apgar scores of 9/9. Ex. 6 at 32–34. She received a vaccine at this time and was released home two days later. Ex. 3 at 3; Ex. 6 at 4. T.M. had her five-day well-child visit on April 3, 2013, at the Aunt Martha’s Health Center (“AMHC”), and was deemed normal. Ex. 4 at 11. On July 15, 2013, T.M. received her four-month vaccinations at AMHC—the DTaP, Hib, a second dose of hepatitis B, inactivated poliovirus vaccine, and pneumococcal vaccines. Ex. 3 at 3; Ex. 4 at 8. The physician performing the associated exam observed at this time (as memorialized under the record subheading “Concerns”) that T.M.’s eyes were different sizes. Ex. 4 at 8. T.M. was also at this exam assessed for developmental delays. Based on an “Ages and Stages Questionnaire” (ASQ), Petitioner reported to the examining treater that T.M. could not push up on her elbows, her movements were not symmetrical, and she did not roll and reach for objects. Id. It was also noted, however, that it might be premature to conclude anything about T.M.’s developmental status, since T.M. was not quite four months old. Id. T.M. had another well-child visit on December 6, 2013, at which time Ms. Weaver requested administration of six-month vaccinations. Ex. 8 at 5. However, the previously-received round of vaccines could not be verified, so Petitioner was told to return another time. Id. At this appointment Petitioner put down on the intake form that there was a smoker in the home. Id. at 1. It was also noted that T.M. was not meeting certain developmental milestones; thus, she did not sit alone, roll from front to back, pass a toy from hand to hand, imitate vowel sounds, make constant sounds, or say “mama” or “dada.” Id. 2 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 3 of 37 Upon returning to AMHC a few days later (December 10, 2013), T.M. received additional vaccines—her second DTaP dose, second Hib, third hepatitis B, second IPV, first rotavirus, and second pneumococcal dose. Ex. 3 at 3. Ms. Weaver now reported that T.M. was “babbling— little[;] smiles at mom[;] mom said she was rolling up but now she doesn’t do much[;] doesn’t sit up.” Ex. 8 at 4. She further stated that T.M. “was doing everything normal until 4 months now she is not doing much.” Id. Based upon this reported history, T.M. was referred to a developmental clinic. Id. The record thus establishes the existence of developmental concerns before, or at least at the time of, the vaccinations at issue in this case. First Post-Vaccination Febrile Seizure The next day—December 11, 2013—T.M. was taken by ambulance to the emergency room (“ER”) at Franciscan Health in Chicago Heights, Illinois, for treatment of a 25-minute seizure that had occurred prior to arrival, and which thereafter manifested intermittently for 10 additional minutes. Ex. 25 at 5–11. Ms. Weaver reported that she had heard T.M. grunt in her crib that morning, and had observed her shaking with clenched hands and pulsating limbs. Ex. 16 at 2. Upon admittance, the ER physician took specific note of the fact that T.M. had received several vaccines the day before, and was febrile upon arrival, although Petitioner was uncertain if she had experienced a fever earlier in the day. Ex. 25 at 8. T.M.’s father reported that her tongue was swollen, and she was drooling more than usual. Id. On exam, T.M. was minimally responsive, and displayed myoclonus-like twitching in all extremities. Ex. 25 at 9. She had to be intubated due to periods of apnea, and initial treater impressions were that T.M. was experiencing seizure, unspecified fever, and respiratory distress. Id. at 11. Testing was conducted, including a flu panel, brain CT and chest x ray, but all yielded negative results, although T.M.’s bloodwork did show some abnormalities, such as a high white blood cell count (“WBC”) of 18.7 × 109/L.3 Id. at 10, 26, 30. T.M. was given antibiotics and transferred to Advocate Children’s Hospital in Oak Lawn, Illinois, for treatment in its pediatric intensive care unit (“PICU”). Id. at 68. Upon admittance, T.M.’s parents informed treaters that they had found her shaking and grunting around 2:00 a.m., leading them to take her to the ER, where she was given Tylenol for her fever (101.1 degrees), which in turn had helped to end the shaking. Ex. 7 at 59–60; 84. They also reported her receipt of six-month vaccines the day prior, as well as her referral to early intervention (“EI”) due to suspected developmental delay. Id. at 84; Ex. 8 at 4. An EEG4 was 3 While this medical record does not specify what a normal range would be, a typical white blood cell count for children will generally range between 5 to 10 per 109/L. Leukemia & Lymphoma Society, Understanding Blood Counts, https://www.lls.org/treatment/lab-and-imaging-tests/understanding-blood-counts (last visited Sept. 23, 2022). 4 An electroencephalogram, or EEG, is a “diagnostic test that measures the currents emanating from nerve cells in the brain. The fluctuations in current are shown in waves, which correlate with different neurologic conditions.” See 3 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 4 of 37 performed with negative/normal results, and T.M. was extubated with no further seizure activity while at the PICU, and remained afebrile. Ex. 7 at 68, 83, 88. T.M. tested negative for a staph infection but was nevertheless treated with an antibiotic. Id. at 83, 93. One treater opined that T.M. had experienced a complex febrile seizure. Id. at 83. A flu vaccine was ordered, although it is unclear from the records whether it was received. Id. at 85. T.M. was discharged on December 12, 2013, with a diagnosis of febrile seizure. Id. at 88. Four days later, T.M. returned to AMHC for a follow-up. Ex. 4 at 1. By this time, Ms. Weaver had prepared and submitted a VAERS report5 implicating the vaccines received earlier that month in T.M.’s febrile seizure. Id. at 7. T.M. was now doing well, but was referred to a neurologist for an outpatient EEG study. Id. Two days later, on December 18, 2013, T.M. returned to the ER with a history of three episodes of vomiting, a small wet stool, and no fever the previous day. Ex. 7 at 5–16, 37. T.M.’s diagnosis was for vomiting, and she was discharged with a prescription for Zofran. Id. at 7. No seizures were reported at this time. Treatment in 2014 and Monitoring of Developmental Problems T.M. had a follow-up at AMHC on January 14, 2014. Ex. 4 at 5. The treating physician noted that T.M. had been intubated after a febrile seizure, specifically identifying as causal “DTaP induced versus febrile seizure.” Id. Several months passed, however, before T.M.’s second seizure manifested. On March 18, 2014, T.M. was taken back to the ER for evaluation of a second febrile seizure and upper respiratory infection symptoms. Ex. 7 at 221–22. The consulting physician was informed that T.M. “was not acting herself,” and at daycare she had been “[t]ired and w[]oozy,” having a temperature of 99.1 degrees. Id. at 241. T.M. was also reported to have displayed full body, tonic-clonic movements lasting less than ten minutes, with a post-ictal state lasting one to two hours. Id. Prior to this event T.M. had displayed a runny nose, congestion and cough for a week, with one episode of diarrhea. Id. at 242. One physician deemed these symptoms to constitute the likely etiology of T.M.’s subsequent fever. Id. at 244. She was also noted to have low truncal tone, but with good head control, and no focal neurological deficits were observed during physical exam. Id. at 241. Bloodwork resulted in normal findings. Id. at 240. Caredio v. Sec'y of Health & Hum. Servs., No. 17-0079V, 2021 WL 4100294, at *2 (Fed. Cl. Spec. Mstr. July 30, 2021), mot. for review den’d, __ Fed. Cl. __, 2021 WL 6058835 (2021). 5 The Vaccine Adverse Event Reporting System (“VAERS”) is a national warning system designed to detect safety problems in U.S.-licensed vaccines. See About VAERS, VAERS, https://vaershhs.gov/abouthtml (last visited Sept. 23, 2022). It is managed by both the CDC and the FDA. VAERS monitors and analyzes reports of vaccine related injuries and side effects from both healthcare professionals and individuals. See generally Carda v. Sec'y of Health & Hum. Servs., No. 14-191V, 2017 WL 6887368, at *6 (Fed. Cl. Spec. Mstr. Nov. 16, 2017). 4 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 5 of 37 T.M. remained hospitalized overnight in order to monitor her condition after the observed seizure activity, although treaters noted that at the time of her admission that she was “back to baseline” already. Ex. 7 at 239, 240–45. That night, T.M. had a fever that resolved with Tylenol, and displayed no further seizures. Id. at 240. The attending physician also discussed T.M.’s developmental delays with Petitioner and her grandmother, referring her to EI. Id. at 239–40. T.M. was discharged with febrile seizure and told to alternate between Motrin and Tylenol. Id. at 241. The following month, T.M. had a well-child visit at AMHC on April 1, 2014. Ex. 4 at 4. Her diagnoses at that time included developmental delay and febrile seizure, she was again referred to EI plus neurology. Id. Her developmental problems continued to be of concern going forward— although the record does not at this time reveal an increased tempo in reported issues or a heightening of concern beyond what had previously been reported or discussed with prior treaters. See, e.g., Ex. 3 at 85–88 (April 8, 2014, pediatric well-check visit). On May 1, 2014, T.M. was brought to the ER by ambulance after a purported third seizure (reported by a daycare educator). Ex. 1 at 1. T.M. had begun to “shake, foam at the mouth, and her eyes rolled back in her head while she was holding her.” Id. at 2. T.M. now had a fever of 102.2 degrees, but was awake, alert, and crying but consolable. Id. at 4. She was discharged home the same day with impression of febrile seizure. Id. at 5–6. The next day, T.M. was evaluated by the Illinois Bureau of Early Intervention. Ex. 3 at 34– 47; Ex. 26 at 1. Petitioner reported that T.M. “had a seizure at 8 months due to shots and at 10 months due to a cold,” with subsequent additional seizures “every two months.” Ex. 3 at 34. She also stated a family history of some developmental problems, having a brother with autism and a nephew with ADHD. Id. T.M.’s results showed a 54% cognitive delay, 54% receptive language delay, 76% expressive language delay, 58% gross motor delay, 54% fine motor delay, 31% social/emotional delay, and 31% self-help delay. Id. at 47. She was recommended for therapies in cognitive development, physical development, and language/speech. Id. at 43. T.M. was subsequently taken to a pediatric neurologist, Dr. Lubov Romantseva, on May 8, 2014, for evaluation of her seizures and developmental delays. Ex. 2 at 10. The history provided at this examination reported that T.M.’s seizures began at “9 months of age, (4 months prior to presentation) with seminology of eyes locking, body stiffening, cyanotic lips, and tonic clonic activity in all extremities lasting 15 to 20 min[utes] in duration with no focal Todd’s Phenomenon6 afterwards, but a several hour period where she was not back to her normal self.” Id. at 15. It was also reported that about a few times a day T.M. would turn her head to one side with her eyes shifting in the other direction, and that she would then become unresponsive. Id. Other 6 “Todd’s Phenomenon” (also referred to as Todd paralysis) is defined as a “hemiparesis or monoparesis lasting for a few minutes or hours, or occasionally for several days, after an epileptic seizure.” Todd paralysis, Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=96185&searchterm=Todd+paralysis (last visited Sept. 23, 2022). 5 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 6 of 37 developmental plateaus and regressions in specific behaviors were also discussed. Id. Dr. Romantseva noted that T.M. had displayed normal eye and hearing exams in the past. Id. A repeat EEG was ordered, lab work for inborn errors of metabolism, and continued EI therapies, plus a prescription of low dose Keppra (an anti-epileptic drug). Id. at 17. T.M.’s diagnoses were epileptic seizures, febrile seizures, staring spell, and developmental delay. Id. at 10. A week later, T.M. had a well-child check on May 13, 2014. Ex. 3 at 76–80. In review of developmental milestones, it was reported that T.M. was able to do a precise pincer grasp, bang blocks together, look for dropped or hidden items, feed herself, and wave goodbye. Id. at 77–78. She was still showing gross motor delays, however, and some hesitancy in obtaining the full range of six-month vaccines was stated. Id. at 79. Nevertheless, T.M. at this time did receive her first doses of several vaccines, including varicella and MMR. Id. at 3, 80. Two months later, in July 2014 another EEG was performed, revealing normal results except for some evidence of slow wave activity. Ex. 2 at 42–43. By the fall of 2014, T.M. began showing some improvement developmentally, although overall deficits remained. At an early September well-child pediatric visit, for example, T.M. was reported to be rolling more frequently, and getting up on her knees but not crawling. Ex. 3 at 71, 74. It was also reported, however, that she was not saying any words, communicating through crying, and not reaching, and she was receiving many different kinds of developmental-oriented therapies. Id. The treating pediatrician, Dr. Lester Hockenberry, specifically stated at this time that “I do not believe her delay is in any way related to vaccination,” but noted that Petitioner was “waiting to hear back from her lawyer before additional vaccines are given.” Id. That same month T.M. returned to see Dr. Romantseva for evaluation of both her prior febrile seizures and developmental delay (with regression noted to have begun around one year, or March 2014). Ex. 2 at 53. At this time, T.M. had been tolerating her anti-seizure medication, and had experienced no additional seizures since March (although the aforementioned records suggest a febrile seizure occurred in May). Id. at 75. Dr. Romantseva reported global developmental delays but also acknowledged some improvement. Id. at 76. And Dr. Romantseva reiterated the need for diagnostic lab work to determine the source of T.M.’s delays and seizures, since the summer EEG had yielded normal results (although labs performed at this time were mostly inconclusive). Ex. 2 at 61, 63–64, 76. During the second half of December 2014, T.M. was again taken to the ER after the occurrence of a seizure. Ex. 9 at 4–6. Her father reported at this time, however, that he had forgotten to administer T.M.’s Keppra that morning. Id. at 5. The seizure lasted ten minutes until it resolved on its own—T.M. was crying loudly, had muscle stiffness, and was not focusing on her parents post seizure. Id. The ER physician noted that T.M. had a history of cerebral palsy (although 6 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 7 of 37 the record reviewed in this case does not support this diagnosis) and epilepsy. Id. T.M. returned to baseline by the time she was examined, and subsequently discharged the same day. Id. at 6.7 Treatment in 2015 to Present and Efforts at Diagnosing Seizure Activity T.M.’s concurrent developmental delay and seizure activity has continued on from early 2015 to the present. See, e.g., Ex. 28 at 7–8 (T.M. provided bilateral ankle braces for motor activity in May 2015, revealed little spasticity); Ex. 13 at 22 (follow-up with rehab specialist in September 2015 to evaluate secondary effects of braces) and 24–25 (assessed at that time with “mild [cerebral palsy] vs autism”); Ex. 15 at 10–11 (October 2015 visit, prescribed bilateral knee immobilizers and a gait training device). She did not learn to walk until she was almost four years old, with a stiff and wide gate. Ex. 27 at 45 (February 2017 visit to Dr. Romantseva). She continues to be nonverbal, and still needs diapers. Id.; Ex. 58 at 15, 21 (August 2019 pediatric well-check visit). Treatment of developmental issues reveals no heightening or specific worsening, although the overall trajectory is not improving. Nor have any treaters directly linked T.M.’s developmental issues with her prior seizures or vaccinations. At the same time, some did start to consider whether an autism diagnosis might be appropriate. See, e.g., Ex. 15 at 45–46 (Dr. Romantseva referring T.M. for an autism evaluation in November 2015); Ex. 59 at 20–23 (August 2019 visit with Dr. Romantseva, again referring to autism as potentially explanatory for developmental issues). 2016 saw a more forceful recurrence of seizure activity that was less apparent in the prior year. Thus, T.M. was again taken to the ER in May 2016 while experiencing an ongoing, active afebrile seizure. Ex. 14 at 5, 13. In the course of T.M.’s subsequent hospitalization, however, Petitioner reported that T.M. had been congested for several days, had experienced multiple contacts with others suffering from colds, and had also missed her morning Keppra dose. Ex. 24 at 51. Dr. Romantseva saw T.M. in connection with this event, and the records set forth her impression—a “3 year old girl with focal epilepsy, language and developmental delays, idiopathic diplegia who presented with status epilepticus last night, likely triggered by a combination of viral illness and missed medication dose.” Id. at 60. And in October, T.M. had another seizure resulting in overnight hospitalization. Ex. 29 at 47, 53. Such seizure activity has been afebrile, and has continued on an intermittent basis—although in many instances the seizure seemed to have an explanation. See, e.g., Ex. 27 at 45 (January 2017 seizure—afebrile but proposed by Dr. Romantseva to be attributable to recurrent ear infections); Ex. 59 at 21 (August 2019 visit to Dr. Romantseva referencing seizure that occurred in December 2018, but attributing it in part to fact 7 At a January 2016 pediatric visit focused on following up from this occurrence, it was noted in the record that the seizure had been milder than prior events. Ex. 13 at 6. But it was also recorded that Petitioner had been “advised by previous physician not to continue DTaP at this time,” (although the December 2015 seizure was proximately attributed to the missed Keppra dose and not a vaccine). Id. at 7. 7 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 8 of 37 that T.M. had been off her Keppra medication for two weeks prior, while alternative treater diagnoses were explored). T.M. has thus continued to receive medication and other treatments aimed at control of further seizures. See e.g., Ex. 12 at 30–31 (increase in Keppra dose in May 2015). But testing to evaluate their possible etiology continued to yield normal results, and has failed to result in an explanation associated with any underlying brain injury that may have occurred close-in-time to the December 2013 vaccinations at issue. Ex. 15 at 26–27 (November 2015 EEG); Ex. 24 at 18– 19 (March 2016 brain MRI results deemed unremarkable pre and post-contrast); Ex. 14 at 32–33 (normal CT scan in May 2016, performed in wake of ER visit due to afebrile seizure). Lab studies also continue to yield negative results. Ex. 58 at 39, Ex. 59 at 105. At most, an August 2016 ambulatory EEG (performed at Dr. Romantseva’s direction) yielded (for the first time) abnormal results due to “regional epileptiform discharges.” Ex. 24 at 294. However, no seizures or focal slowing occurred during the test, and ultimately the results were termed consistent with “an active epileptogenic source in the midline parieto-occipital region” of the brain. Id. Notably, this test result was obtained more than two and one-half years after vaccination—and after T.M. had experienced several prior seizures, with at least two directly attributed to a missed Keppra dose, as discussed above. II. Hearing Testimony A. Melodie Weaver Ms. Weaver, T.M.’s mother and the Petitioner, was the first testifying witness. See generally Tr. at 5–29. She lives with T.M. and her two siblings, aged “twelve, eight, and five.” Tr. at 5. She recalled that her pregnancy with T.M. “started off fairly normal, full term, didn’t need any medication, vaginal birth.” Id. at 6. She was not in labor long, and there were no complications. Id. Ms. Weaver recalled T.M. to have been “[a] typical happy baby, chunky, because I breastfed, and was meeting her milestones a little bit slower. . .it was like a little bit of delay, but everything other than that was pretty normal.” Tr. at 6. These delays, she specified, were more physical in manifestation, such as “wanting to pull up or, like, use her body.” Id. at 7. Ms. Weaver testified that they continued to allow T.M. to have more tummy time to support continual meetings of her milestones. Id. All of these events occurred at T.M.’s four-month checkup. Id. Ms. Weaver then addressed the December 2013 appointment when the relevant vaccines were administered. T.M. was now “gaining a little bit more skills, like just doing a little bit more— a little bit more active, interacting with [them], things like that.” Tr. at 7. Nevertheless, Ms. Weaver 8 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 9 of 37 recalled discussing with medical treaters that T.M. was displaying some concerning problems like weakness. Id. at 9. At this appointment T.M. was referred to developmental assessment. Id. That same evening, T.M. had “a high fever, and so [they] administered, like, Tylenol, the cold rags, just like normal procedures, how you try to bring down a fever, and it subsided enough for us to think that, you know, we would go ahead and lay her down and everything would be okay the next day.” Tr. at 10. Later, however, T.M.’s fever spiked again, and Ms. Weaver was awoken when she saw “the whole bassinet just shaking,” and she heard “gagging.” Id. at 11. T.M. now appeared to be experiencing a seizure, with her “arms extended out, shaking, seemed to be unconscious, and, like, struggling to breathe, eyes rolling up to the top of her head, drooling.” Id. Petitioner recalled calling 911, with T.M. subsequently being transported to the hospital. Id. at 12– 13. After an overnight stay at the hospital, T.M. was brought home, and Petitioner recalled that T.M. was at that time “lethargic and, like, lazy, and didn’t want to participate in her daily activities.” Tr. at 13. This lethargy continued until T.M.’s follow-up appointment. Id. By this time, T.M. seemed developmentally stagnant. Id. Ms. Weaver also noted that the treaters “kept referencing the vaccine can cause febrile seizures, and in a baby that young, it is common.” Id. Ms. Weaver then recounted T.M.’s second seizure from March 2014, stating that T.M. was in her back seat in her car seat, and then displayed a “stiff body, eyes rolling up, drooling out the mouth, like the whole car seat just like shaking because of the throbbing motion, like—it looks like she’s in pain.” Tr. at 15. Ms. Weaver then took her back to the hospital, where treaters attributed a “low-grade fever” as causal of the seizure. Id. at 17. Petitioner did not herself witness T.M.’s third seizure (from early May 2014). Tr. at 17. By this time, Petitioner recalled, T.M.’s developmental issues were more pronounced, and thereafter T.M. began to have to relearn things like “[r]olling, getting up to crawl stance, engaging to our voices and things like that, all of that had eventually stopped, and she stopped interacting with us.” Id. at 19. Later, Dr. Romantseva proposed a seizure treatment plan for T.M., with a focus on medication to control seizure activity and help Petitioner care more effectively for T.M. when seizures did manifest. Tr. at 21. T.M. still had seizures while on the medication, but had not experienced any (as of the trial date) for two years. Id. All of the testing resulted in normal determinations, and thus had not provided any insight to Petitioner’s knowledge about potential explanations for T.M.’s condition. Id. at 22. One rehab specialist, however, had proposed that cerebral palsy might explain it. Id. T.M. had also been taken to an autism specialist, although she was never diagnosed with autism and her tentative cerebral palsy diagnosis was also withdrawn, 9 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 10 of 37 leaving only a diagnosis of developmental delay. Id. at 22–23. T.M. has otherwise received ‘[p]hysical therapy, occupational therapy, and speech.” Id. at 23. Currently, T.M. is “still very dependent.” Tr. at 24. She requires “hand-over-hand assistance to just be able to eat, and [they] clothe her, and [they] have to dress her. She’s not potty- trained yet. She’s nonverbal.” Id. T.M. can feed herself somewhat using a utensil, but will return to “fist feeding.” Id. T.M. can also walk at “a slower speed and as long as the ground is, like, at one level, like it’s very restricted.” Id. at 25. Her mental capacities and attention span also seem to Petitioner to have improved over time, in comparison to where she was. Id. at 26. B. Petitioner’s Experts 1. Dr. Mahbubul Huq, M.B.B.S., Ph.D. Dr. Huq, a pediatric neurologist and clinical geneticist, submitted one report and testified for the Petitioner. See generally Tr. at 30–204, 363–65; Report, dated Aug. 25, 2021, filed as Ex. 60 (ECF No. 42-1) (“Huq Rep.”). He proposed that T.M.’s overall seizure disorder was attributable to the vaccines she received in December 2013, and that her preexisting developmental delay was in turn worsened by her seizure activity. Dr. Huq received his medical degree from Dhaka Medical College in Bangladesh and his Ph.D. in medical science at Tokushima University in Japan. Tr. at 31–32; Curriculum Vitae, filed Jan. 24, 2022, filed as Ex. 122 (ECF No. 65-2) (“Huq CV”) at 1. He completed his residency in pediatrics and his fellowship in pediatric neurology at Wayne State University and the Children’s Hospital of Michigan. Tr. at 32. He did a clinical and post-doctoral fellowship in genetics at Baylor College and a medical fellowship in genetics at the University of British Columbia in Vancouver. Id.; Huq CV at 1. Dr. Huq previously worked as a professor of pediatrics and neurology at Wayne State University and as a clinical geneticist at the University of British Columbia. Tr. at 32–33; Huq CV at 2. He is currently a professor of pediatrics at Central Michigan University and a professor of neurology at Wayne State University. Tr. at 32. He is a member of the American Academy of Neurology and is licensed to practice in the state of Michigan. Id. at 33. Dr. Huq’s research focuses on “genetics of metabolic disorder, autism, Tourette’s syndrome” and he has also published papers focusing on the genetics of epilepsy. Tr. at 34; Huq CV at 21–30. In addition to research, Dr. Huq teaches clinical courses to graduate students, medical residents, and fellows, and he has lectured on advanced genetics at Wayne State University. Tr. at 35; Huq CV at 7–8. He currently has seven half-day clinics, is on in-patient service for six to eight weeks a year and spends weekends as an attending physician in a community hospital as a consultant. Tr. at 35. Dr. Huq estimates he sees 250–300 patients a year, 30% of which have epilepsy. Id. at 35–36. He estimates another 30% of his patients have developmental delays. Id. at 10 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 11 of 37 36. He is involved with all aspects of treatment, including genetic testing (close to 100% of his epileptic patients undergo genetic testing). Id. at 36. Dr. Huq’s testimony began with consideration of the overall medical record. He described Ms. Weaver’s pregnancy with T.M. as uncomplicated, but noted the evidence of pre-vaccination concerns about T.M.’s development. Tr. at 38–40, 126; Huq Rep. at 2–3, 11; Ex. 4 at 8. In fact, T.M. was understood to be displaying developmental lag at the December 2013 pediatric visit when she received the vaccines at issue, although Dr. Huq did not find the record was detailed enough to gain insight into the extent of this lag. Tr. at 38–40, 363–64; Huq. Rep. at 2–3; Ex. 8 at 4–5. In his experience, developmental lag occurs when a child fails to meet expected milestones, although because of the wide variation in the population for childhood development, catch-up is possible (although ultimately progress can only be discerned in retrospect). Tr. at 40, 126. As a result, when a child is suspected of being delayed, further assessment, therapy, and genetic testing is important, as most developmentally delayed children he treats improve with such intervention (unless there is an underlying neurodegenerative condition). Id. at 40–41, 137, 364–65; Huq Rep. at 3. Dr. Huq next addressed T.M.’s first seizure the day after the administration of her six- month vaccines in December 2013. Tr. at 42; Ex. 8 at 4, 6. He deemed it best classified as a febrile seizure—common to children (since they occur in approximately 2–4% of the pediatric population), although their ultimate cause is not well understood. Tr. at 58. Dr. Huq proposed, however, that underlying genetic factors (evidenced by tentative findings linking defined areas of the chromosome to the development of febrile seizure) as well as certain polymorphisms in inflammation-related genes might likely explain why some children tended to experience febrile seizures when others do not. Id. at 65–66. Infections by certain viruses (herpesvirus 6, influenza, pneumococcus infection, etc.) may also lead to febrile seizures. Id. at 66, 188. Dr. Huq defined T.M.’s first seizure as “complex,” since it lasted more than 30 minutes. Tr. at 42–44, 64–65; Ex. 7 at 59. As he explained, the term complex refers to “[a]nything atypical, such as if it is a focal seizure, if it is longer than 15 minutes, or if there are multiple occurrences within the same illness or 24 hours.” Id. at 65. A simple seizure, by contrast, reflects “whole-body convulsion, less than 15 minutes.” Id. Dr. Huq maintained there was no persuasive scientific authority establishing which children were more at risk for complex versus simple seizures. Id. at 95. He pointed to one study finding that some children who develop febrile, complex seizures may have underlying hippocampal malnutrition, but agreed the medical record did not in this case suggest that was true of T.M. Id. at 95–96; D. Lewis et al., Do Prolonged Febrile Seizures Produce Medial Temporal Sclerosis? Hypotheses, MRI Evidence and Unanswered Questions, 135 Progress in Brain Research 263 (2002) filed as Ex. 87 (ECF No. 47-9). 11 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 12 of 37 T.M.’s second febrile seizure, in March 2014, was not an uncommon occurrence either (although Dr. Huq felt it was rare for a child to experience more than four such febrile seizures). Tr. at 49; Ex. 2 at 21. But in the following two years, her tempo of seizures increased. Although T.M. was taking antiepileptic medication, she experienced “close to ten seizures” through 2015 and 2016, some without fevers, and Dr. Huq felt they were for the most part epileptic in origin. Tr. at 56, 117–18; 157–58; Huq Rep. at 2–3. He admitted, however, that some could have been merely “breakthrough” seizures attributable to a missed anti-seizure medicine dose or some other factor (although he contended that going off a medicinal course did not guarantee a seizure reaction). Tr. at 117, 118–22, 123. Dr. Huq did not categorize T.M.’s seizures overall as intractable, but he would not say they were easy to control either. Id. at 57, 118, 123–24. Because T.M. did not appear to have any brain malformation or genetic cause that could explain her subsequent epilepsy, Dr. Huq proposed that the initial seizure was the most likely cause of her subsequent seizures, and he attempted to explain how this could be so. Tr. at 203–04. A child’s immature brain is more susceptible to alterations, as neural networks are still forming. Id. at 97; Y. Ben-Ari & G. Holmes, Effects of Seizures on Developmental Processes in the Immature Brain, 5 Lancet Neurology 1055 (2006), filed as Ex. 20 (ECF No. 8-10) (“Ben-Ari & Holmes”). As a result, children who experience febrile seizures are two to three times more likely to develop epilepsy—with an even higher risk for those who experience prolonged complex seizures, which are more likely to harm the brain. Tr. at 66–67, 90–91, 116; Huq Rep. at 8. The concept of “lowering the seizure threshold” as a result of successive injury to the brain explains the causal association of initial seizures to subsequent events. Tr. at 94, 96, 201–02; Huq Rep. at 8. After an initial “extrinsic insult,” less may be required for a susceptible individual8 to experience more seizure activity. Tr. at 95; Ben-Ari & Holmes at 1056. Thus, the initial seizure itself could set the stage for future aberrant responses to similar stimuli, leading to more seizures. Tr. at 91. S. Shinnar et al., MRI Abnormalities Following Febrile Status Epilepticus in Children: The FEBSTAT Study, 79 Neurology 871 (2012), filed as Ex. 100 (ECF No. 49-4) (children with a first febrile seizure that lasted longer than ten minutes were more likely to have abnormal development compared to those with a brief simple febrile seizure). Animal studies, Dr. Huq noted, also corroborated the fact that “seizures can induce changes that will make the network even more susceptible to have a seizure.” Tr. 101–03; Huq Rep. at 11; G. Smith et al., Early-Life Status Epilepticus Induces Long-Term Deficits in Anxiety and Spatial Learning in Mice, 4 Int. J. Epilepsy 36 (2017), filed as Ex. 101 (ECF No. 49-5) (demonstrating the effect a single occurrence of a status epilepticus can have on long-term impairments such as anxiety disorders and spatial learning behaviors); K. Chen et al., Febrile Seizures in the Developing Brain Result in Persistent Modification of Neuronal Excitability in Limbic Circuits, 5 Nat. 8 Susceptibility, Dr. Huq maintained, referred to “a pre-existing lowered threshold for [handling] any kind of insult.” Tr. at 192–93. 12 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 13 of 37 Medicine 888 (1999), filed as Ex. 23 (ECF No. 9-3) (“Chen”) (when an immature or developing brain is exposed to hyperthermia-induced seizures, persistent modifications in neuronal excitability are present in the limbic system). Evidence from the medical record, however, suggested that the foregoing theory might not apply to T.M.—since there was no proof, from around the time of the first and second seizures, that her brain had been harmed. As Dr. Huq admitted, several tests run on T.M. in the timeframe after the first seizure produced normal results. Tr. at 47–48 (“[a] viral respiratory panel that was normal. The CT head was normal, chest x-ray was normal. They have her broad-spectrum antibiotic, like ciprofloxacin and vancomycin, routine blood count, too”), 173. Dr. Huq also noted that the need for intubation was not per se evidence of anything abnormal about the first seizure. Id. at 46. More significantly, the results of an EEG performed at that time were deemed normal. Ex. 7 at 68, 83, 88. And T.M. underwent several EEGs throughout her treatment process, without consistent determinations or early evidence of brain malformation or erratic activity. Tr. at 141– 49; Huq Rep. at 2–3. An EEG, Dr. Huq acknowledged, can not only confirm the presence of seizure activity, but can also establish the diagnosis of epilepsy in 30-40% of cases. Tr. at 138–39. T.M.’s EEGs were normal up until May 7, 2016 (over two years post-vaccination), when she underwent a continuous monitoring9 EEG which showed diffuse slowing (with another EEG in August producing slightly different results but still confirming the presence of epilepsy). Tr. at 141–43, 145–47; Ex. 24 at 293. Nor did any MRIs ever confirm any kind of brain harm after the first seizure. Ex. 24 at 18–19. Dr. Huq nevertheless attempted to diminish the significance of the relevant EEG findings. He noted that routine EEGs identify abnormalities in only 30% of cases, and thus a “normal” EEG reading did not rule out the possibility of harm to the brain due to seizure activity. Tr. at 45, 139. Indeed, even some of the later “normal” EEG results in the years after T.M.’s first seizure confirmed her epilepsy. Id. at 148–49. Nor did normal MRI imaging results disprove his theory. Although MRIs can reveal brain injury caused by epilepsy, or the presence of some underlying brain malformation that could encourage seizure activity, Dr. Huq would not expect to see these neuronal changes until many years later (if ever). Id. at 93, 150; Huq Rep. at 6. Thus, a “clean” MRI did not mean no brain issues were present. Tr. at 151–52, 169, 173; Huq Rep. at 3. And even though T.M.’s treating physicians did not perform additional MRIs on T.M. after March 16, 2016, this was because her seizures were not intractable, and in any event MRIs require sedation which is harmful for the developing brain, further diminishing their use under the circumstances. Tr. at 174. 9 Continuous monitoring EEGs take longer than routine EEGs and are typically video recorded. Tr. at 143. 13 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 14 of 37 With the foregoing as backdrop, Dr. Huq went on to propose how T.M.’s December 2013 vaccinations could have triggered an overall seizure disorder.10 First, he explained generally how vaccinations interact with the human immune system. When vaccines are administered, they are recognized by pattern recognition receptors. Tr. at 76. The activated immune cells spread throughout the body, which creates (by design) inflammation reflective of the innate immune response. Id. at 76–77, 160, 196; Huq Rep. at 6. In particular, vaccine antigens attract locally- present immune cells which secrete pro-inflammatory cytokines intended to further the overall immune response (including “teaching” the immune system to recognize the relevant antigen presented by a vaccine in the future). Tr. at 76; Huq Rep. at 6, 8. Vaccination (especially in the relevant context, where several vaccines were administered on a single occasion) thus encourages an inflammatory reaction. Tr. at 63, 79–80, 82, 109, 159, 197; Huq Rep. at 4. The presence of such pro-inflammatory cytokines has been linked to the development of febrile seizures. Tr. at 68, 70–71; Huq Rep. at 4, 6, 8–10; C. Dubé et al., Interleukin-1β Contributes to the Generation of Experimental Febrile Seizures, 57 Ann. Neurology 152 (2004), filed as Ex. 40 (ECF No. 26-10); A. Vezzani et al., The Role of Inflammation in Epileptogenesis, 69 Neuropharmacology 16 (2013), filed as Ex. 112 (ECF No. 70-2) (“Vezzani”). This likely occurs, Dr. Huq maintained, because the cytokines cause excitation and inhibition in the overall neural environment. Tr. at 69. Indeed, the very context of inflammation itself could be contributory to seizures. Id. at 73–74, 81–82; Huq Rep. at 6, 8–9.11 Thus, the upregulation of pro-inflammatory cytokines occurring in the context of T.M.’s vaccination likely caused her to have a fever after getting vaccinated, which in turn induced her initial seizure. Tr. at 63, 68, 71–72, 189–190, 197–99; Huq Rep. at 5, 10; And this initial seizure, coupled with localized inflammation caused by the vaccine, may have induced systemic changes that could “produce an epileptic state in the brain and cause subsequent recurrent seizure.” Tr. at 64, 69, 73, 109. Dr. Huq emphasized that a consensus has formed that febrile status can cause epilepsy, despite prior uncertainty. Id. at 194. Besides the more general association with vaccination-caused febrile seizures, Dr. Huq noted that certain vaccines (including those received in December 2013 by T.M.) have been more directly associated with febrile seizures (and possibly epilepsy more generally after an initial febrile seizure). Certain inactivated vaccines (like DTaP) are known to increase the risk of febrile seizure within 24 hours, while live vaccines (such as the MMR) can increase the risk within five to fourteen days. Tr. at 78; Huq Rep. at 4. And Dr. Huq noted the existence of case reports and small studies linking vaccines to febrile seizures. Tr. at 82–83; Huq Rep. at 5; Y. Sun et al., Risk 10 Dr. Huq did generally admit that only in about 40% of cases is the cause of early-onset epilepsy identified. Id. at 58. 11 Dr. Huq also noted that anti-inflammatory treatments often proved effective for ameliorating epilepsy—although it was not evident in this case that T.M. received them. Tr. at 75, 171. 14 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 15 of 37 of Febrile Seizures and Epilepsy after Vaccination with Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliovirus, and Haemophilus Influenzae Type B, 307 JAMA 823 (2012), filed as Ex. 55 at 6 (ECF No. 32-3) (“Sun”) (finding that the relative risks of febrile seizures were increased on the day of the first and second vaccinations, but the absolute risks were low). Although no studies have explicitly associated the DTaP vaccine with subsequent epilepsy, Dr. Huq maintained a connection had not been ruled out either. Tr. at 181; Huq Rep. at 7. Indeed, the DTaP vaccine is contraindicated when seizure activity occurs after receipt of certain doses. Tr. at 89; General Recommendations on Immunization, 60 Centers for Disease Control and Prevention 1 (2011), filed as Ex. 119 (ECF No. 70-9). Next, Dr. Huq attempted to set forth how T.M.’s epilepsy could have exacerbated her preexisting developmental issues, leading to a “more profound delay.” Tr. at 62, 64. Developmental impairment generally is more likely in a child under two years old experiencing recurrent seizures than if the onset occurs in an older child. Tr. at 99; Huq Rep. at 11; S. Haut et al., Susceptibility of Immature and Adult Brains to Seizure Effects, 3 Lancet Neurology 608 (2004), filed as Ex. 81 (ECF No. 47-3) (“Haut”) (explaining that age is a significant factor when analyzing the susceptibility of the brain to injuries induced by a seizure(s)); B. Hermann et al., The Neurodevelopmental Impact of Childhood-Onset Temporal Lobe Epilepsy on Brain Structure and Function, 43 Epilepsia 1062 (2002), filed as Ex. 82 at 8 (ECF No. 47-4) (finding that the presence of recurrent seizures in the developing brain appears to be associated with an adverse effect on both brain structure and function). Haut thus observed “a consensus that seizures affect brain function.” Tr. at 108; Haut at 614. Dr. Huq conceded that T.M. already was displaying develop mental delay before her seizure activity began, although its cause could not be identified.12 Tr. at 124–26; 127–32. But she was not experiencing a progressively worsening condition pre-vaccination, as might be seen in connection with other kinds of disease processes associated with developmental loss. Tr. at 105– 06, 110. He thus disagreed with Respondent’s expert, Dr. John Zempel, that T.M.’s developmental delays at eight months of age (or right before the December 2013 vaccinations) were moderate to severe. Id. at 363. By the time of her third seizure in May 2014, however, T.M.’s developmental problems were more pronounced and global in nature, as evidenced by treater statements in the medical record. Tr. at 52–54; Ex. 7 at 241. T.M.’s subsequent visit to the neurologist noted continued loss of milestones. Ex 2 at 75. 12 Dr. Huq noted that there were no identified genetic or brain-structural causes of T.M.’s developmental delays, nor could they be attributed to anything during pregnancy or her early childhood. Tr. at 59; Huq Rep. at 4. T.M.’s initial developmental issues also could have been “evidence of . . . a neurometabolic disorder, where the disease is progressive and neuronal loss is happening,” or some other infectious process. Tr. at 51–52. Though extensive testing performed on T.M. showed no signs of neurodegenerative or progressive disease, Dr. Huq noted that a whole genome test had never been performed. Tr. at 111, 133–36, 191. It thus could not on this record be definitively concluded T.M. did not have an underlying neurodegenerative condition (although Dr. Huq proposed that this was unlikely). Id. at 111, 133–36, 191–92. A metabolic condition was also proposed at one time as explanatory. Id. at 56. 15 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 16 of 37 Dr. Huq therefore proposed that T.M. had experienced some pre-vaccination developmental lag, but after the “insult” of vaccination she settled at “a lower state of development.” Tr. 105–06, 110. The ongoing seizures were contributing to this environment of developmental limitation. Id. at 55. Seizures are known to have “detrimental” effects on brain function. Id. at 107–08; Haut at 614–15. Seizures may also lead to further “development of epilepsy, cognitive impairments, and psychiatric impairments.” Tr. at 108; Huq Rep. at 11. It was likely, Dr. Huq argued, that T.M.’s seizures “significantly aggravated whatever . . . propensity she might have for delayed development.” Tr. at 110, Huq Rep. at 11. On cross-examination, however, Dr. Huq conceded that it was possible that the causal relationship ran “the other way,” with T.M.’s seizure disorders being a product of her preexisting developmental issues, rather than the former only exacerbating the latter. Thus, he admitted that “preexisting neurological dysfunction will increase the risk of febrile [seizure] status” Tr. at 194, 196; see also Haut at 613 (“[t]here are few data on the effects of a single brief seizure. Most studies are in patients with epilepsy, which introduces the possibility that abnormalities are present before the seizure happens”) (emphasis added). Finally, Dr. Huq addressed the timeframe between T.M.’s vaccinations and her first seizure, deeming it consistent with the short interval for initial inflammatory changes (which could occur within 24 hours to a few days after vaccination). Tr. at 112, 199. He noted that filed medical literature supported the acceptability of onset of a febrile seizure following the DTaP vaccine in such a timeframe. Tr. at 112–13. A broader state of epilepsy would occur within weeks, months, or even years after the first seizure, though Dr. Huq admitted that the longer the timeframe, the less probable an association existed. Tr. at 113–14, 199–200. But T.M.’s overall course herein was reasonably consistent with the first seizure being causal of what followed. Tr. at 113–14, 199–200. 2. Dr. Marcel Kinsbourne Dr. Kinsbourne, a pediatric neurologist, submitted two reports for the Petitioner in support of the opinion that T.M.’s vaccinations were causal of her epilepsy injury. See generally Report, dated Sept. 22, 2017, filed as Ex. 30 (ECF No. 25-1) (“Kinsbourne Rep.”); Report, dated Apr. 9, 2018, filed as Ex. 47 (ECF No. 30-1) (“Supp. Kinsbourne Rep.”). Although Dr. Kinsbourne did not testify at trial, Petitioner has not formally disclaimed his opinions, and I therefore will summarize them below. Dr. Kinsbourne received his medical degree from Oxford University in England, along with his Bachelor of Arts, and his Master of Arts. Curriculum Vitae, dated Jan. 24, 2022, filed as Ex. 123 (ECF No. 65-3) (“Kinsbourne CV”) at 1. He then received his M.D. from the State of North Carolina. Id. After his schooling, Dr. Kinsbourne did several years of different post-doctoral 16 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 17 of 37 training in neurology, pediatrics, and chest diseases. Id. at 1–2. He is a member of the American Board of Pediatrics and Royal College of Physicians. Id. at 2. Dr. Kinsbourne was previously a professor of psychology, professor of pediatrics, lecturer in neurology, adjunct professor of linguistics and cognitive science, adjunct professor of occupational therapy director of the behavioral neurology department at the Eunice Kennedy Shriver Center, and other positions related to neurologic and cognitive studies. Id. at 2–3. Dr. Kinsbourne has been on several editorial boards, professional societies, and administrative assignments. Id. at 4–6. His research has considered pediatric disorders, developmental delays and factors, cerebral deficiencies, learning disabilities, therapies, and epilepsy. Id. at 6–39.13 Dr. Kinsbourne’s first report began with a short recitation of the factual background history of T.M.’s illness. Kinsbourne Rep. at 1–3. He then highlighted the fact that the DTaP vaccine (which T.M. received in December 2013) has been determined to trigger seizure activity in infants. Id. at 3; Le Saux et al., Decrease in Hospital Admissions for Febrile Seizures and Reports of Hypotonic-Hyporesponsive Episodes Presenting to Hospital Emergency Departments Since Switching to Acellular Pertussis Vaccine in Canada: A Report From IMPACT, 112 Pediatrics e348, e349–50 (2003) filed as Ex. 53 (ECF No. 32-1) (“LeSaux”). In fact, Dr. Kinsbourne purported that “some 80 percent of DTaP provoked seizures occur within a day of the administration of the vaccine,” as medical scientific authorities have recognized (like the Centers for Disease Control), although the report itself does not substantiate this specific figure. Kinsbourne Rep. at 3. In explaining how a vaccine could produce a seizure, Dr. Kinsbourne highlighted the interplay between vaccination and the human immune system. Vaccines trigger an immediate, innate immune response, with the goal of secondarily stimulating an adaptive, memory response that will allow effective reactions in the future to the relevant presenting viral or bacterial antigens. Kinsbourne Rep. at 4; D. van Duin et al., Triggering TLR Signaling in Vaccination, 27 Trends in Immunology 49 (2006), filed as Ex. 44 (ECF No. 27-4). This activation causes pattern recognition and the (initial) release of proinflammatory cytokines (specifically IL-1β). Kinsbourne Rep. at 4– 5. But the proinflammatory cytokines can, in turn, establish a neuroinflammatory environment in which seizures are more likely, due to a “lowering” of the threshold for them. Id. at 5; J. Choi et al., Cellular Injury and Neuroinflammation in Children with Chronic Intractable Epilepsy, 6 J. Neuroinflammation 1 (2009), filed as Ex. 37 (ECF No. 26-7) (findings suggest that active neuroinflammation and cellular injury could play a pathogenic role or be a consequence of epilepsy in children).14 13 See Holmes v. Sec’y of Health & Hum. Servs., 08-185V, 2011 WL 2600612, at *2 (Fed. Cl. Spec. Mstr. April 26, 2011). 14 Dr. Kinsbourne also argued (despite the fact that T.M.’s initial seizure was unquestionably febrile in origin) that the pertussis toxoid has been shown to have its own pathologic path to triggering seizure activity through neuronal excitation. Kinsbourne Rep. at 5; J. Choi & S. Koh, Role of Brain Inflammation in Epileptogenesis, 49 Yonsei Med J. 17 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 18 of 37 Further support for the argument that febrile seizures could increase neuronal excitability was identified from articles involving epilepsy patients. See, e.g., Chen at 6 (suggesting that early- life febrile seizures can lead to continuous effects on neuronal excitability due to the long-lasting nature of presynaptic hippocampal interneuronal terminals); R. Badawy et al., On The Midway to Epilepsy: Is Cortical Excitability Normal in Patients with Isolated Seizures?, 24 Int’l J. Neural Systems 1430002-1 (2014), filed as Ex. 32 (ECF No. 26-2) (“Badawy”) (patients with isolated seizures compared to controls had increased cortical excitability which suggested the presence of a mild degree of cortical hyperexcitability). Dr. Kinsbourne acknowledged, however, that excitability did not definitively mean that a patient would develop epilepsy, as noted in some of these articles. See Badawy at 6 (cortical excitability is disrupted in patients with a single seizure, and that such disruption can persist even with a lack of recurring seizures). In addition, Dr. Kinsbourne sought to explain how T.M.’s seizure activity might have negatively impacted her developmental problems. He opined (based on a reading of the medical record) that T.M.’s seizures were localized to the midline parieto-occipital region of the brain, and he proposed it was likely that “a hyperexcitable network in that region” had some association with her established, pre-vaccination development issues. Kinsbourne Rep. at 4. Medical literature had observed generally a connection between childhood seizure disorders/epilepsy and progressive development issues. Id. at 6; Ben-Ari & Holmes at 1056, 1060. And the kinds of seizure disorders associated with developmental delay were often triggered by an initial event. T. Baram & C. Hatalski, Neuropeptide-Mediated Excitability: A Key Triggering Mechanism for Seizure Generation in the Developing Brain, 21 Trends Neuroscience 471 (1998), filed as Ex. 33 (ECF No. 26-3) (“Baram & Hatalski”) (“[s]urprisingly, the majority of developmental seizures are not spontaneous but are provoked by injurious or stressful stimuli”). Thus, Dr. Kinsbourne opined that T.M.’s developmental delay was likely aggravated by her vaccine-induced epilepsy/seizure disorder. Kinsbourne Rep. at 6. 1 (2008), filed as Ex. 36 (ECF No. 26-6). While the whole-cell pertussis vaccine (which has been supplanted by vaccines containing the acellular pertussis toxoid) has more demonstrated adverse capacity, there is still “an adequate amount of pertussis-specific antigens to provoke a protective antibody response in the recipient”—sufficient in turn to cause seizures. Supp. Kinsbourne Rep. at 2; Le Saux at e351–52; L. Jackson et al., Retrospective Population-Based Assessment of Medically Attended Injection Site Reactions, Seizures, Allergic Responses and Febrile Episodes after Acellular Pertussis Vaccine Combined with Diphtheria and Tetanus Toxoids, 21 Pediatric Infectious Disease J. 781 (2002), filed as Ex. 52 (ECF No. 31-5). My determination that vaccines “can cause” febrile seizures, purely through the innate reaction they provoke, and that this occurred in T.M.’s case, obviates the need to consider closely the reliability or persuasiveness of this aspect of Petitioner’s case. I also note that although Dr. Huq indicated in his testimony that he embraced Dr. Kinsbourne’s opinion, he did not primarily rely upon the pertussis component issue in theorizing that the vaccines T.M. received could have caused her seizures. Tr. at 184 (“that is not my main hypothesis”). I give Dr. Huq’s opinion somewhat more weight than Dr. Kinsbourne’s overall. 18 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 19 of 37 Dr. Kinsbourne’s supplemental report addressed some of Respondent’s arguments, but also added detail to his prior expert opinion. He agreed that he largely relied on circumstantial evidence that vaccines can trigger seizures, although he deemed this sufficient for present circumstances. Supp. Kinsbourne Rep. at 1. He reiterated his argument that even if the acellular pertussis- containing vaccines presented less risk of associated seizure, the risk had not been eliminated. Id. at 2–3. He maintained that the possession of an antecedent development delay, as was true here, was actually associated with longer-lasting (and hence damaging) seizures. Id. at 4. And he questioned the supposition (unsupported by evidence) that T.M.’s epilepsy either predated vaccination, or had some to-date unidentified relationship with those problems independent of vaccination. Id. at 5–6. C. Respondent’s Expert—Dr. John Zempel Dr. Zempel, a pediatric epileptologist, submitted three reports and testified for the Respondent in support of the argument that T.M.’s vaccinations were not causal of her larger seizure disorder or epilepsy. See generally Tr. at 205–362; Report, dated Feb. 1, 2018, filed as Ex. A (ECF No. 29-1) (“Zempel Rep.”); Report, dated June 12, 2018, filed as Ex. C (ECF No. 34) (“Second Zempel Rep.”); Report, dated Oct. 16, 2021, filed as Ex. D (ECF No. 53-1) (“Third Zempel Rep.”). Dr. Zempel attended the University of Wisconsin-Madison, obtaining a B.S. in Molecular Biology. Tr. at 205; Curriculum Vitae, filed Feb. 2, 2018, filed as Ex. B (ECF No. 29-8) (“Zempel CV”) at 1. He then become part of the Medical Scientist Training Program at Washington University, attaining his M.D. and PhD in Neurobiology. Tr. at 205; Zempel CV at 1. Dr. Zempel remained at Washington University for his internship and residency in pediatrics. Zempel CV at 2. Following this he did a residency in adult neurology, a residency in child neurology, a pediatric epilepsy fellowship, and finally a clinical neurophysiology fellowship. Id. at 2. He was later hired by Washington University as a faculty member, progressing from assistant, associate, to full-time professor in neurology and pediatrics. Tr. at 206. Dr. Zempel is board certified in psychiatry and neurology, child neurology, clinical neurophysiology, and pediatrics. Zempel CV at 2–3. Dr. Zempel presently works in a weekly outpatient clinic “specializ[ing] in the care of children with intractable epilepsy.” Tr. at 206. Half of his time is devoted to inpatient services, between the neurology floor, ICU consultation service, emergency room, and neonatal neurology service. Id. He is also the medical director of the EEG Laboratory in the Clinical Neurophysiology Laboratory, where pediatric seizures are evaluated for treatment. Id. at 206–07. Dr. Zempel also performs many second opinions and gets referrals from neurologists, with a focus on cases of intractable epilepsy. Id. at 207–08. He is a member of the American Epilepsy Society and the Child Neurology Society. Id. at 209. Dr. Zempel has published numerous articles on neuroscience and epilepsy, but none on febrile seizures. Id. at 209; Zempel CV at 5–8. 19 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 20 of 37 Dr. Zempel’s analysis began with an overview of the different types of seizures—and he noted at the outset that not all seizures “fit” into a diagnosis of epilepsy. Provoked seizures “can be associated with stroke, head injury, hypoglycemia, infection, and variety of triggers,” such as independent environmental stimuli (a fever, stress, sleep deprivation, etc.). Tr. at 210–211. An unprovoked seizure, by contrast, does not need a stimulus to occur. Id. at 210. Epilepsy can be characterized by a high probability of recurrent unprovoked seizures. Id. at 210–11. A febrile seizure, Dr. Zempel explained, is a classic kind of provoked seizure. Tr. at 211. “Simple” febrile seizures usually last less than 15 minutes, have no focal features, are generalized tonic clonic,15 and will occur on one side of the body. Id. at 212. A complex febrile seizure, however, will usually last longer than 15 minutes—although some that are focal can also be deemed complex despite their length, and having more than one seizure in a 24-hour period may suggest the presence of complex seizures. Id. Regardless, children who experience a febrile seizure of any kind are not necessarily displaying a presenting symptom of something larger, and “only a fraction of cases go on to develop epilepsy.” Id. at 211, 217. Dr. Zempel next discussed epilepsy broadly, defining it to be a condition involving unprovoked seizures occurring randomly and without a clear explanation. Tr. at 214. The diagnosis of epilepsy is usually based on clinical evidence—in particular, proof of two or more unprovoked seizures—and the goal of treatment is to determine a treatment approach to limit the likelihood of future seizures. Id. Epilepsy will be deemed “intractable” when antiseizure medications prove ineffective (although this does not mean seizures can never be controlled in such a patient). Id. at 215. Its causes are various, but they can include “injury, an injury prenatally, an injury at birth, an injury any time in the rest of your life, including strokes and other—and accidents and trauma can very clearly cause your brain to transition to a state where unprovoked seizures are more likely.” Id. at 216. Some cases have strong genetic bases, with epilepsy running in families, and it can also be related to a developmental problem. Id. It cannot be assumed, Dr. Zempel opined, that the occurrence of a febrile seizure is evidence of the presence of epilepsy in a larger sense. Relevant medical literature reflects ample debate “over whether you have febrile seizures and epilepsy as separate pieces, [or] whether your febrile seizures are really a presentation of epilepsy with fever,” with general agreement that a single febrile seizure is not, by itself, evidence of likely epilepsy. Tr. at 236. Nevertheless, Dr. Zempel admitted that children who experience a complex febrile seizure more commonly develop epilepsy than those whose febrile seizures are shorter. Id. at 333 Dr. Zempel went on to define “febrile status epilepticus,” or a febrile seizure evidencing epilepsy, as “continu[ed] seizure 15 “Tonic-clonic” is defined as “a spasm or seizure consisting of a convulsive twitching of the muscles.” Tonic-Clonic, Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=50263 (last visited Sept. 23, 2022). 20 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 21 of 37 activity or lack of return to normal in between [febrile] seizures for more than 30 minutes.” Id. at 213. Dr. Zempel agreed that T.M.’s initial seizure was likely a complex febrile seizure (despite some doubts about its length). Tr. at 225–26. And he agreed it was likely vaccine-associated. Id. at 358–59. But he disputed the fact that it reflected the first step in a vaccine-triggered epilepsy, observing that the record did not establish that the initial febrile seizure had caused injury to T.M.’s brain. For example, the CT scan conducted at that time detected no injury. Id. at 228. More importantly, the EEG (which can reveal brain wave activity) also resulted in normal findings— even though after a “prolonged or intense seizure” EEG readings more commonly reveal abnormal results. Id. at 229–31. Although EEGs alone cannot be relied upon to diagnose epilepsy, they can be used to “clinch” the diagnosis. Id. at 250. Subsequent record evidence from the months after the first seizure also revealed no likely brain injury associated with that initial seizure. T.M.’s second and third EEGs (performed July 3, 2014, and November 12, 2015) produced normal results. Tr. at 246–47. Her fourth EEG was comparable in terms of no revealing ongoing seizure activity, although Dr. Zempel observed that (in contrast to the first three) there were some distinctions that could in part be attributed to medications T.M. was by this time receiving. Id. at 249–50. Only by the time of the EEG performed about two years after the relevant vaccinations did epileptiform abnormalities appear (and for the first time), thus now establishing that “in the future that there could be recurrent unprovoked seizures.” Id. at 254–55. Overall, this aspect of the medical record (reflected in particular by EEG results) did not, in Dr. Zempel’s estimation, establish any instance in which T.M. experienced a “catastrophic” seizure capable thereafter of snowballing into a series of ever-more damaging seizures. Tr. at 274– 75. And literature offered by Dr. Huq confirmed that some kind of brain-injuring event associated with a specific seizure would need to be demonstrated to attribute subsequent seizure activity to the prior event. See T. Salmenperä et al., MRI Volumetry of the Hippocampus, Amygdala, Entorhinal, Cortex, and Perirhinal Cortex after Status Epilepticus, 40 Epilepsy Research 155 (2000), filed as Ex. 95 (ECF No. 48-8) (status epilepticus does not regularly lead to damage in the medial temporal lobe structures; instead, the hippocampus is the most severely affected brain region in patients with a history of status epilepticus). T.M.’s treatment record was also inconsistent with a “seizures begetting seizures” scenario in other ways, Dr. Zempel argued, or at least did not confirm the supposition that this encapsulated T.M.’s experience. For example, no lumbar puncture was performed which could have identified an underlying infectious cause for the initial seizure—an omission that suggested to Dr. Zempel that initial treaters did not suspect the seizure to be more than febrile in nature (although he qualified the strength of this inference). Tr. at 232–33. In fact, T.M.’s neurologist did not conclude 21 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 22 of 37 that vaccination could have been causal for T.M.’s epilepsy course. Id. at 243. There was otherwise no indication of neuronal injury or cerebral inflammation after the December 2013 seizure, and T.M. quickly returned to a baseline level of health once she was discharged from the hospital. Id. at 233–35. And her next seizure (experienced almost three months later) was deemed a simple febrile seizure occurring in the context of evidence of some kind of upper respiratory infection— which by itself could lower a seizure threshold (independent of whether the initial seizure had established circumstances for future seizure events). Id. at 236. More evidence diminishing the centrality of the initial febrile seizure in T.M.’s subsequent history were the results of the MRI performed in March 2016. Its findings were deemed by treaters as unremarkable, which Dr. Zempel interpreted to mean that brain abnormalities associated with epilepsy, like cortical malformation, were not present. Tr. at 261–65.16 And T.M.’s epilepsy was effectively managed by a single antiseizure medication (and a low dose of it as well), further underscoring that her epilepsy was not particularly acute in nature. Id. at 243–44. The instances in which T.M. appeared to suffer seizures after missed medication were also considered by Dr. Zempel as corroborating the likelihood that seizures after the December 2013 febrile seizure event were not the product of it, although Dr. Zempel conceded that seizures were not inevitable simply because a medicine dose was skipped or missed. Ex. 9 at 4–6 (on Dec. 30, 2014, T.M. had a seizure that lasted roughly ten minutes, after her father forgot to administer her Keppra that morning); Tr. at 246. Also significant to Dr. Zempel’s opinion was the record proof of T.M.’s pre-vaccination developmental delay, which he felt overall was more extensive than Petitioner and her experts allowed—and which in turn rebutted the conclusion that her developmental issues had been worsened by T.M.’s concurrent epilepsy. As early as T.M.’s well-child visit on July 15, 2013, treaters observed that her eyes were not the same size, suggesting to Dr. Zempel that her developmental problems already were manifesting. Tr. at 219; Ex. 4 at 8. There were also the missed milestones noted at her December 2013 pediatric visit (when she received the vaccines in question). Id. at 220–21. Indeed, he found especially important the Petitioner’s contemporaneously-recorded statement from this visit that T.M. was “not doing much,” and was also at this time referred to a developmental clinic for evaluation. Id. at 221–22; Ex. 8 at 4. All of these factors suggested the presence of a significant problem for the future. Id. at 223. Developmental delays can, Dr. Zempel admitted, relate to epilepsy, since both are signs of underlying brain dysfunction—but more importantly, “[p]reexisting developmental delay prior to the onset of seizures is clearly a strong risk factor for the [later] development of epilepsy.” Tr. at 16 At worst, an incidental cavum septum pellucidum (“the median cleft between the two laminae of the spetum pellucidum”) was observed, but Dr. Zempel opined that this was “probably a normal variant.” Tr. At 263. Cavum Septi Pellucidi, Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=63907 (last visited Sept. 23, 2022). 22 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 23 of 37 224. And the record overall established the existence of “very significant delays,” before, and then at, the time of the December 2013 vaccinations. Id. at 241–42. Besides analyzing the record, Dr. Zempel commented on other aspects of the Petitioner’s causation theory. He agreed that vaccination activates the immune system with the intent of protecting an individual from illness. Tr. at 270 (“it is not surprising or unexpected that vaccination would activate immune mechanisms since that’s precisely what we’re trying to do with vaccination”). Id. But he denied that there was any direct evidence offered in this case (particularly in the form of epidemiologic proof) that supports the conclusion that “standard childhood vaccination is a risk—a strong risk factor for developing epilepsy.” Id. at 271. While he accepted that the wild Bordetella pertussis virus is known to precipitate seizures, he denied that this conclusion applied equally to the vaccine pertussis component. Id. at 278. And literature offered to substantiate this point more commonly discussed infection as the inciting factor in inflammation (and thus was distinguishable from the circumstances implicated in vaccination). Id. at 271–72. Dr. Zempel also made some specific points about individual items of literature offered by Petitioner’s experts. Baram & Hatalski, for example, was cited by Dr. Kinsbourne for the proposition that developmental-related seizures are usually provoked at the outset—a contention which Dr. Zempel deemed to overly simplify a complex question. Tr. at 265. Rather, “the translation between seizures and epilepsy is often a fraught one because many children who have seizures in the neonatal period don’t go on to develop epilepsy.” Id. Ultimately, the association between developmental problems and seizure disorders/epilepsy presented, in Dr. Zempel’s opinion, a “chicken or the egg question,” in which it was hard to know whether seizures occurred because the patient had an overall susceptibility, or whether the seizure itself caused an injury that then made the individual further, or more, susceptible. Id. at 265–66. Dr. Zempel generally agreed that the rat model applied in Chen showed febrile seizures could result in “permanent and persistent modification of excitability.” Tr. at 267; Chen at 889. But, he maintained, excitability does not automatically correlate with an increase of epilepsy. Id. at 267–68. And while some retrospective studies have noted ties between those who experience intractable temporal lobe epilepsy later in life and a history of prolonged febrile seizures, the inverse (studies finding an association of childhood febrile seizures with the subsequent development of epilepsy) was more difficult to ascertain. Id. at 268–69. Another article, cited by Dr. Kinsbourne as evidence that prolonged seizures can cause epilepsy and development delay, was directly challenged by Dr. Zempel. Tr. at 287; D. Hesdorffer et al., Distribution of Febrile Seizure Duration and Associations with Development, 70 Annals Neurology 1, 7 (2011), filed as Ex. 50 (ECF No. 31-3) (“Hesdorffer”).17 Hesdorffer noted that “prolonged febrile seizures are associated with an increased risk of developing epilepsy. Indeed, 17 The filed copy of Hesdorffer does not have page numbers, so I shall refer to the pages in ECF-filed order. 23 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 24 of 37 animal data indicate the duration of febrile seizures is correlated with the severity and duration of subsequent unprovoked seizures, as well as increased risk of cognitive dysfunction.” Hesdorffer at 7; Tr. at 287. But Dr. Zempel maintained that this was more an associated than causal relationship, especially with the multitude of factors that he considers cause epilepsy. Tr. at 287– 89. In fact, Hesdorffer explicitly observed that developmental delay could itself be a risk factor for epilepsy. Hesdorffer at 8; Tr. at 289. Dr. Zempel also took issue with some of the items of literature filed by Dr. Huq. One such item, for example, only noted that vaccination could be a risk factor increasing the possibility of seizure—as opposed to a statistically-significant causal factor. Tr. at 292–93, 295; N. Andrews et al., Post-licensure Comparison of the Safety Profile of diphtheria/tetanus/whole cell pertussis/haemophilus influenza type b vaccine and a 5-in-1 diphtheria/tetanus/whole cell pertussis/haemophilus influenza type b/polio vaccine in the United Kingdom, 28 Vaccine 7215 (2010), filed as Ex. 65 (ECF No. 45-4) at 7220. Vezzani did not in fact stand for the proposition that vaccination can cause epileptogenesis. Tr. at 303–04; Vezzani at 11 (concluding that a “disease modifying drug that regulates inflammation” would assist in treatment of epilepsy, but without mention of the capacity of vaccines to promote such inflammation in the first place). And Dr. Zempel questioned the weight to be given the Sun article. Even though Sun explicitly sought to determine the risk of febrile seizure and epilepsy after DTaP-IPV-Hib vaccination, it found only a small increased risk of febrile seizures on the day of vaccination for infants at three and five months of age, with no associated risk of epilepsy overall. Sun at 823; Tr. at 304. And he deemed Sun to be particularly robust and involving a large sample. Tr. at 305–06. III. Procedural History This claim was initiated in November 2016, and Petitioner filed medical records thereafter with the statement of completion filed in January 2017. (ECF No. 12). Respondent’s Rule 4(c) Report was filed on March 6, 2017. (ECF No. 16). Expert reports were filed over the course of the ensuing four years. The case was eventually reassigned to me in March 2021, and after reviewing the pre-hearing briefs filed by both parties, I held a two-day hearing on the matter on February 9-10, 2022. The claim is now ripe for resolution. IV. Applicable Legal Standards A. Petitioner’s Overall Burden in Vaccine Program Cases 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 24 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 25 of 37 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).18 In this case, Petitioner does not assert 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). In attempting to establish entitlement to a Vaccine Program award of compensation for a Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen v. Sec'y of Health and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal relationship between vaccination and injury.” Each Althen prong requires a different showing and is discussed in turn along with the parties’ arguments and my findings. Under Althen prong one, petitioners must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or scientifically certain.” Id. at 549. 18 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). 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). 25 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 26 of 37 However, the Federal Circuit has repeatedly stated that the first prong requires a preponderant evidentiary showing. See Boatmon v. Sec'y of Health & Hum. Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019) (“[w]e have consistently rejected theories that the vaccine only “likely caused” the injury and reiterated that a “plausible” or “possible” causal theory does not satisfy the standard”); see also Moberly v. Sec'y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010). This is consistent with the petitioner's ultimate burden to establish his overall entitlement to damages by preponderant evidence. W.C. v. Sec'y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted). If a claimant must overall meet the preponderance standard, it is logical that they are also required to meet each individual prong with the same degree of evidentiary showing (even if the type of evidence offered for each is different). Petitioners may offer a variety of individual items of evidence in support of the first Althen prong, and are not obligated to resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec'y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325–26). No one “type” of evidence is required. Special masters, despite their expertise, are not empowered by statute to conclusively resolve what are essentially thorny scientific and medical questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act's preponderant evidence standard.” Andreu, 569 F.3d at 1380. Nevertheless, even though “scientific certainty” is not required to prevail, the individual items of proof offered for the “can cause” prong must each reflect or arise from “reputable” or “sound and reliable” medical science. Boatmon, 941 F.3d at 1359–60. The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec'y of Health & Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions and views of the injured party's treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly trustworthy evidence, since they are created contemporaneously with the treatment of the patient. Cucuras v. Sec'y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). However, medical records and/or statements of a treating physician's views do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, 26 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 27 of 37 conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec'y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases. The views of treating physicians should also be weighed against other, contrary evidence also present in the record—including conflicting opinions among such individuals. Hibbard v. Sec'y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians' conclusions against each other), aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec'y of Health & Hum. Servs., No. 06–522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den'd, 100 Fed. Cl. 344, 356–57 (2011), aff'd without opinion, 475 F. App’x. 765 (Fed. Cir. 2012). The third Althen prong requires establishing a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disorder's etiology, it is medically acceptable to infer causation.” de Bazan v. Sec'y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine can cause an injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec'y of Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl. 353 (2012), aff'd mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Hum. Servs., No. 11– 355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den'd (Fed. Cl. Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir. 2014). B. Significant Aggravation Claim Where, as here, a petitioner alleges significant aggravation of a preexisting condition, the Althen test is expanded, and the petitioner has additional evidentiary burdens to satisfy. Loving v. Sec’y of Health & Hum. Servs., 86 Fed. Cl. 135, 144 (2009). In Loving, the Court of Federal Claims combined the Althen test with the test from Whitecotton v. Sec’y of Health & Hum. Servs., 81 F.3d 1099, 1107 (Fed. Cir. 1996), which related to on-Table significant aggravation cases. The resultant “significant aggravation” test has six components, which require establishing: (1) the person’s condition prior to administration of the vaccine, (2) the person’s current condition (or the condition following the vaccination if that is also pertinent), (3) whether the person’s current condition constitutes a “significant aggravation” of the person’s condition prior to vaccination, (4) a medical theory 27 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 28 of 37 causally connecting such a significantly worsened condition to the vaccination, (5) a logical sequence of cause and effect showing that the vaccination was the reason for the significant aggravation, and (6) a showing of a proximate temporal relationship between the vaccination and the significant aggravation. Loving, 86 Fed. Cl. at 144; see also W.C., 704 F.3d at 1357 (holding that “the Loving case provides the correct framework for evaluating off-table significant aggravation claims”). In effect, the last three prongs of the Loving test correspond to the three Althen prongs. In Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072 (Fed. Cir. 2020), the Federal Circuit further elaborated on the Loving framework. Under Prong (3) of the Loving test, the Petitioner need not demonstrate an expected outcome, but merely that the injured individual’s relevant post-vaccination condition was worse than pre-vaccination. Sharpe, 964 F.3d at 1081. And a claimant may make out a prima facie case of significant aggravation overall without eliminating a preexisting condition as the potential cause of her significantly aggravated injury (although the Circuit’s recasting of the significant aggravation standard still permits Respondent to attempt to establish alternative cause, where a petitioner’s showing is enough to make out a prima facie case, and thereby shift the burden of proof to Respondent). Id. at 1083. C. Law Governing 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 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) (determining that 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). As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as trustworthy evidence.” Cucuras, 993 F.2d at 1528; 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, Rickett v. Sec'y of Health & Hum. 28 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 29 of 37 Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked propositions explains why such records deserve some weight: (i) sick people visit medical professionals; (ii) sick people attempt to 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 (Fed. Cir. 1993) (“[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 often found to be deserving of greater evidentiary weight than oral testimony—especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (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.”)). However, the Federal Circuit has also noted that there is no formal “presumption” that records are accurate or superior on their face when compared to other forms of evidence. Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly 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 may be required when determining the weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; 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 29 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 30 of 37 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. La Londe 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. D. Analysis of Expert Testimony Establishing a sound and reliable medical theory 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 Pharm., 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). Under Daubert, the factors for analyzing the reliability of testimony are: (1) whether a theory or 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). However, in the Vaccine Program the Daubert factors play a slightly different role than they do when applied in other federal judicial settings—e.g., the district courts. Typically, Daubert factors are employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases 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, 88 Fed. Cl. at 742–45. 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. 30 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 31 of 37 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 and the relative persuasiveness of their competing theories.” 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. 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 review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 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, 592 F.3d at 1325–26 (“[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”). E. Consideration of Medical Literature Both parties filed numerous items of 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”). ANALYSIS I. Febrile Seizures and Their Relationship to Seizure Disorders Both side’s experts agreed that vaccines can trigger febrile seizures, as a result of the vaccine’s stimulation of the innate immune system (which includes upregulation of pro- inflammatory cytokines specifically associated with fever). Huq Rep. at 4; Tr. at 358–59. This issue is thus uncontested—and I find it is wholly consistent with medical science pertaining to 31 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 32 of 37 febrile seizures. But this highlights the larger, and hotly-disputed, question in this case: whether a single febrile seizure, vaccine-caused or not, will inevitably lead to some form of epilepsy—and thus whether a vaccine-caused febrile seizure is more likely than not causal of a child’s subsequently-manifesting epilepsy. The Vaccine Program has confronted this question before. Although the results have varied (depending on the specific facts at issue, as well as the relative strength of showing made in each case) it is clear that vaccine-instigated febrile seizures cannot be properly considered causal of all forms of epilepsy, simply because more seizures follow the first event. See, e.g., Caredio v. Sec'y of Health & Hum. Servs., No. 17-0079V, 2021 WL 4100294 (Fed. Cl. Spec. Mstr. July 30, 2021), mot. for review den’d, __. Fed. Cl. __, 2021 WL 6058835 (2021). In Caredio, an infant’s autoimmune epilepsy was argued to have been caused by a flu vaccine. The child experienced an initial febrile seizure close-in-time to the vaccination event—and although there was no dispute that the febrile seizure was vaccine-caused, the onset of the child’s form of epilepsy was deemed to have occurred slightly later (within two weeks of vaccination). Caredio, 2021 WL 4100294, at *2–3, 15. Indeed, the petitioners’ causation expert disclaimed any relationship between the febrile seizure and the child’s epilepsy, the course of which progressively unfolded in the months thereafter. Id. at *12. Although denial of entitlement in Caredio turned on a failure to establish that the relevant vaccine “could cause” autoimmune epilepsy, the decision helpfully demonstrates how an initial febrile seizure could have no relationship to a child’s subsequently-diagnosed epilepsy. A different well-reasoned decision, by contrast, connected an earlier febrile seizure to epilepsy. Ginn v. Sec'y of Health & Hum. Servs., No. 16-1466V, 2021 WL 1558342 (Fed. Cl. Spec. Mstr. Mar. 26, 2021) (five vaccines, including the flu vaccine, triggered a febrile seizure in four- year-old that contributed/led to development of epilepsy). In Ginn, an infant experienced a febrile seizure within 24 hours of receiving several vaccines. Two months later, the child had a second seizure (not identified as febrile), and an EEG performed at this time now revealed the presence of abnormality consistent with epilepsy. Ginn, 2021 WL 1558342, at *1–2. The child was thereafter diagnosed with epilepsy. In finding for the petitioners (and in a case where, as here, Dr. Huq served as the claimant’s expert), the special master emphasized not only that febrile seizures could propagate further seizure activity, but also that evidence (particularly in the form of the EEG findings from the second seizure event) corroborated that brain changes/damage had occurred after the first seizure—providing sufficient evidence to link the two under the petitioners’ causation theory. Id. at *8–9. Thus, the evidence connecting the initial febrile seizure to the child’s epilepsy that was missing in Caredio was supplied in Ginn—underscoring the importance of such connective proof for causation purposes. Even though the seizure disorder in Caredio was ultimately autoimmune 32 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 33 of 37 in nature, the distinction between febrile seizures and later epilepsy remains—as recognized in Ginn. II. Petitioner Has Not Preponderantly Established that T.M.’s Single, Vaccine-Caused Febrile Seizure Lead to or Caused Her Subsequent Seizure Disorder This claim largely turns on the second Althen prong. As discussed above, I can easily determine herein that almost any vaccine, alone or grouped with others, could cause sufficient inflammation to trigger a single febrile seizure. In addition, although both experts also agreed that an initial febrile seizure does not inevitably mean a child will experience epilepsy (see, e.g., Tr. at 116, 236), Dr. Huq did offer persuasive preponderant evidence in support of the conclusion that as a general matter, children who experience febrile seizures are more likely to develop epilepsy later (although it is not a certainty—and the initial seizure could simply unmask a propensity to seize, rather than be considered the instigating factor). But the medical record in this case does not support the conclusion that T.M.’s December 2013 post-vaccination febrile seizure caused her epilepsy. Specifically, the record does not establish that the initial febrile seizure harmed T.M.’s brain sufficiently to conclude that it likely “explains” what transpired thereafter. On the contrary, persistent testing performed over the next two-plus years, whether in the form of EEGs or MRIs, did not confirm the presence of a seizure-induced brain malformation or injury that could then (under a “seizures beget seizures” theory) be deemed causal of all subsequent seizures. See, e.g., Ex. 7 at 68 (normal EEG readings based on EEG performed on December 11, 2013); Ex. 2 at 42– 43 (July 2014 EEG produced normal results with no evidence of epileptiform activity); Ex. 15 at 26–27 (November 2015 EEG produced normal results); Ex. 24 at 18–19 (March 2016 brain MRI deemed to have yielded normal results); Ex. 14 at 32–33 (normal CT scan in May 2016, performed in wake of ER visit due to afebrile seizure). Dr. Huq acknowledged this absence of proof of brain injury. Tr. at 47-48, 141-49, 173. Only by August 2016 did an EEG yield results that T.M.’s neurologist deemed to corroborate the presence of epileptiform activity. Ex 24 at 294. Dr. Huq reasonably pointed out in reaction that a normal EEG reading did not rule out epilepsy—but the totality of the screening evidence in this case does not establish brain injury close-in-time to the vaccine-caused febrile seizure. T.M.’s post-vaccination seizure activity after the first, admittedly vaccine-caused febrile seizure, is also not of a character or tempo that would render it likely related to the first event. Thus, T.M.’s second febrile seizure (and second seizure event otherwise) occurred in March 2014—three months after her first febrile seizure, with nothing in the record suggesting an association between the two. Moreover, the second seizure was attributed to a then-existing likely 33 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 34 of 37 upper respiratory infection. Ex. 7 at 221–22. T.M. recovered quickly thereafter, suffering no additional seizures for two months. But the May 2014 seizure event was also attributed to a febrile seizure. Ex. 1 at 1–6. Thereafter, for the remainder of that year T.M. received anti-seizure medications, which controlled her seizure activity enough so that her next seizure event—in December 2014 (and thus now a year after the vaccine-related initial first seizure)—was deemed to have been likely caused by a missed Keppra dose. Ex. 9 at 4–6. This history is not supportive of an association with the initial febrile seizure.19 Rather, it suggests a non-intractable and treatable epilepsy. And to the extent the continued epileptic activity may have eventually damaged T.M.’s brain, such that subsequent EEG and other testing evidence began to confirm more activity, that course cannot be attributed to the first febrile seizure event— and thus not to the December 2013 vaccines either. Admittedly, the first seizure met the definition of a complex seizure given its length. And Dr. Huq credibly established that complex seizures are often associated with brain damage. But that fact must be balanced against T.M.’s quick recovery in December 2013–January 2014, as well as the lack of overall evidence of brain harm discussed above. The possibility that a complex seizure could harm the brain or increase neuronal dysfunction, as Dr. Huq maintained, is not in this case borne out by the actual medical record. The fact that T.M.’s seizures occurred in the context of established developmental concerns also weighs against a conclusion that her first seizure caused what followed. The record incontrovertibly establishes that developmental issues were raised with respect to T.M. before the December 2013 vaccination event. And Dr. Zempel credibly and persuasively established that medical science supports the conclusion that seizure activity can not only accompany developmental issues (or in some cases cause them), but that it might occur because of underlying developmental problems. This is not a case where the injured infant’s developmental symptoms all post-date vaccination. Although I do not purport to find that T.M.’s developmental issues explain her subsequent seizure activity and epilepsy, Petitioner did not persuasively rebut this kind of evidence, and it therefore further diminishes the possibility that the initial febrile seizure alone explained why T.M. continued to experience seizures afterward. This is not a case where expert input on either side appreciably “moved the needle” in the direction of one determination over the other. Both experts were sufficiently qualified to offer the opinions they provided, and they largely agreed on the core science in question. Although Dr. Huq did not establish that all post-febrile seizure events are necessarily related to the first, his overall interpretation of the record was clear, even if I did not ultimately accept it. And he persuasively 19 I also note that no contemporaneous treaters opined that T.M.’s epilepsy stemmed from the first febrile seizure. Although treater opinions do not compel a fact finding either way, there is an absence of such evidence in this case in support of Petitioner’s claim. 34 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 35 of 37 demonstrated that an initial febrile seizure could create the conditions for epilepsy. But the record in this case paints a picture of a child likely susceptible to seizure activity generally, but whose course could not be deemed inevitable once the first febrile seizure occurred. T.M.’s initial febrile seizure was likely vaccine-caused—but that seizure in turn was not the cause of what followed.20 I emphasize again—the contention that a vaccine-caused febrile seizure could constitute the first “domino” in a chronic seizure disorder is scientifically reliable. Bulwarked with evidence that a child’s brain had likely been harmed by the initial seizure, such a claim could well produce a favorable entitlement decision, as occurred in Ginn. But a first, vaccine-caused seizure cannot be deemed responsible for epilepsy that is diagnosed later simply due to its temporal priority, in the absence of record evidence corroborating the presence of brain injury that could credibly be attributed to the vaccine-induced initial seizure. The initial seizure does not “prove” injury to the brain by itself. And the subsequent epileptic events cannot be relied upon either, since arguing that a single initial vaccine-caused seizure had to have caused what comes next amounts to the kind of “post hoc ergo propter hoc” reasoning rejected by the Program when considering causation-in-fact claims. Pafford v. Sec'y of Health & Hum. Servs., No. 01-0165V, 2004 WL 1717359, at *9 (Fed. Cl. Spec. Mstr. July 16, 2004), mot. for rev. denied, 64 Fed. Cl. 19 (2005), aff'd, 451 F. 3d 1352 (Fed. Cir. 2006). III. Petitioner Did Not Establish that T.M.’s Pre-Vaccination Developmental Problems Were Exacerbated by Vaccination My finding with respect to a lack of sufficient “did cause” proof that the first, vaccine- caused febrile seizure T.M. experienced was causal of her overall epilepsy also bears on Petitioner’s claim that her pre-existing developmental delays were exacerbated by the December 2013 vaccinations. For even if the progression of her symptoms literally worsened after January 2014 (essentially all the Circuit now requires Petitioners need prove under Loving),21 and even if I assume that a vaccine-induced febrile seizure could cause sufficient brain injury to worsen preexisting developmental issues, I do not also find that in this case the first, vaccine-caused febrile seizure was the source of worsening for T.M.—as must be established under Loving prong five (the counterpart to Althen prong two). 20 The December 2013 seizure alone is not a basis for compensation even if Petitioner had limited her claim to it, since its sequelae did not last the six months necessary to meet the Act’s severity requirement. Watts v. Sec’y of Health & Hum. Servs., No. 17-1494V, 2019 WL 4741748, at *7 (Fed. Cl. Spec. Mstr. Aug. 13, 2019). 21 In the wake of Sharpe, the first three Loving prongs can easily be satisfied—and are here. Hence, the record establishes in this case that (a) T.M.’s developmental issues existed pre-vaccination, and (b) those same issues became more pronounced in the following months, as she aged and it became more evident the degree and extent of her developmental delay (Loving prongs one and two). The intervening vaccinations in December 2013 predated the time when her developmental issues were more easily observed, making the determination that her delay was aggravated post-vaccination (the third Loving prong). 35 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 36 of 37 As noted above, the record does not support the conclusion that T.M.’s first seizure in December 2013 harmed her brain, or was otherwise causal of the febrile or breakthrough seizures (after missed anti-seizure medication doses) she experienced later in 2014 and then afterward. In addition, even though I cannot conclude that the same record preponderantly establishes that her preexisting developmental issues were more likely causal of her seizure disorder (rather than the other way around), Dr. Zempel’s testimony, coupled with some of the filed medical literature, raised reasonable questions about that possibility that Petitioner did not effectively address (other than simply to maintain that febrile seizures in many cases do constitute a precursor event to a larger seizure disorder, or may hasten that occurrence due to brain injury—evidence of which is lacking here). Tr. at 219, 265–66; Baram & Hatalski at 1; Ben Ari & Holmes at 1056, 1060. Thus, this record does not establish that the progression of T.M.’s developmental issues after the first febrile seizure was likely attributable to that seizure. Rather, awareness and understanding of the scope and nature of T.M.’s delay, as its clinical manifestations became more obvious, was occurring concurrently, and contemporaneously, with her slowly-unfolding epilepsy—not that the latter was worsening the former. Indeed, it could be concluded from this record (as already mentioned) that T.M.’s epilepsy was a secondary aspect of her developmental problems, or even “caused” by them initially. But this record does not preponderantly establish that a single, vaccine-caused initial febrile seizure aggravated her developmental problems.22 CONCLUSION It is never a happy occasion when a special master denies entitlement to a person who has suffered greatly in the care of a child stricken with a debilitating disease or condition. This is unquestionably the case with respect to Ms. Weaver, who has struggled to help her daughter (and demonstrates great love for her in so doing). But my personal sympathies are not a basis for awarding damages. Rather, I must find that the legal standards for entitlement are met. And unfortunately, they have not been met in this case, since the initial, undoubtedly vaccine-related febrile seizure has not been shown to be the “linchpin” to what followed. Accordingly, I am compelled to DENY entitlement in this case. 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.23 22 I also note that Petitioner does not argue herein that the December 2013 vaccinations worsened her developmental problems in some other form independent from the seizure activity, e.g., by initiating some kind of autoimmune- mediated process that led to brain damage of some other form of encephalopathic injury. And there is no evidence in this case of any autoimmune injury—certainly T.M.’s epilepsy is not of the autoimmune form. 23 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. 36 Case 1:16-vv-01494-AOB Document 82 Filed 10/21/22 Page 37 of 37 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 37 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_16-vv-01494-2 Date issued/filed: 2023-03-13 Pages: 15 Docket text: JUDGE VACCINE REPORTED OPINION AND ORDER reissued 89 OPINION AND ORDER GRANTING petitioner's 83 Motion for Review, the Decision 77 & 81 Denying Entitlement issued by the Office of Special Masters is REVERSED-IN-PART and VACATED-IN-PART, and this case is REMANDED for further proceedings consistent with this opinion. Signed by Judge Armando O. Bonilla. (ead) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 1 of 15 In the United States Court of Federal Claims FOR PUBLICATION No. 16-1494V (Filed: March 13, 2023) ) EBONIE WEAVER, ) parent of T.M., a minor, ) ) Vaccine Act, 42 U.S.C. § 300aa-10 et seq.; Petitioner, ) Off-Table Causation-in-Fact & ) Significant Aggravation Claims; v. ) Complex Febrile Seizure; ) Abnormal Screenings; Epilepsy SECRETARY OF HEALTH ) AND HUMAN SERVICES, ) ) Respondent. ) ) Edward Kraus, Kraus Law Group, LLC, Chicago, IL, for plaintiff. Meghan R. Murphy, Torts Branch, Civil Division, U.S. Department of Justice, Washington, DC, for defendant, with whom on the briefs were Brian M. Boynton, Principal Deputy Assistant Attorney General, C. Salvatore D’Alessio, Director, Heather L. Pearlman, Deputy Director, and Lara A. Englund, Assistant Director, Torts Branch, Civil Division, U.S. Department of Justice, Washington, DC. OPINION AND ORDER BONILLA, Judge. Petitioner Ebonie Weaver, parent of a minor child identified herein as T.M., seeks 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, 42 U.S.C. § 300aa-10 et seq. Ms. Weaver claims a vaccine-induced complex febrile seizure caused T.M. to develop a chronic seizure disorder and, concomitantly, significantly aggravated T.M.’s preexisting developmental delay.  This decision was initially filed under seal on February 24, 2023, 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 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 2 of 15 For the reasons set forth below, the Court finds the Chief Special Master improperly elevated petitioner’s burden of proof by requiring contemporaneous medical screening evidence documenting brain injury under a “seizures beget seizures” theory of causation. The legal error further extended to petitioner’s significant aggravation claim. Accordingly, Ms. Weaver’s motion is GRANTED, the decision of the OSM is REVERSED-IN-PART and VACATED-IN-PART, and this matter is REMANDED for further proceedings consistent with this opinion. BACKGROUND I. Medical History T.M. was born on March 29, 2013. No complications were reported during delivery (at 39½ weeks) and her Apgar scores for appearance (skin color), pulse (heart rate), grimace (reflexes), activity (muscle tone), and respiration (breathing rate and effort) totaled 9 out of 10 after one minute and, again, after five minutes.1 T.M. was discharged from the hospital on March 31, 2013. During her April 3, 2013 follow-up wellness visit, healthcare providers found five-day-old T.M. to be in good health. On July 15, 2013, during her four-month wellness visit, T.M. received the following vaccines: diphtheria, tetanus, and acellular pertussis (DTaP) (1st dose); haemophilus influenzae type b (Hib) (1st dose); hepatitis B (HepB) (2nd dose); inactivated poliovirus (IPV) (1st dose); rotavirus (RV) (1st dose); and pneumococcal conjugate (PVC) (1st dose). During T.M.’s physical examination, the healthcare provider checked the “well child” box under “Assessment” on the medical form but noted “Developmental Delay.” See ECF 7-4 at 8. When asked about T.M.’s developmental progress using the Ages and Stages Questionnaires® (ASQ),2 Ms. Weaver reported T.M. was not meeting the following milestones: pushing up to elbows, symmetrical movement, and rolling and reaching for objects. The healthcare provider documented their impression as “ASQ – Delay but is not 4 mo[nth]s yet.” See ECF 7-4 at 8. 1 See JOHNS HOPKINS ALL CHILDREN’S HOSPITAL, https://www.hopkinsallchildrens.org/Patients- Families/Health-Library/HealthDocNew/What-Is-the-Apgar-Score (last visited Feb. 22, 2023) (“A baby who scores a 7 or above on the test is considered in good health. . . . Ten is the highest score possible, but few babies get it. That’s because most babies’ hands and feet remain blue until they have warmed up.”). 2 The Ages and Stages Questionnaires® are a screening tool used to measure developmental progress in children between the ages of one month and five years. See AGES AND STAGES QUESTIONNAIRES, https://agesandstages.com/products-pricing/asq3/ (last visited Feb. 22, 2023). 2 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 3 of 15 On December 6 and 10, 2013, nine-month-old T.M. returned for her six-month wellness visit.3 During the December 10, 2013 visit, Ms. Weaver reported T.M. “was doing everything normal until 4 months and now she is not doing much.” See ECF 7-8 at 4; see also ECF 11-1 at 70. Documenting developmental milestones, the healthcare provider noted T.M. occasionally meets 9 of the 16 milestones, is “babbling – little” and “smiles at mom,” but she does not sit alone, roll from front to back or vice versa, pass a toy from hand to hand, imitate beginning consonant sounds, or say “mama” or “dada.” ECF 7-8 at 4. The healthcare provider referred T.M. to a developmental clinic for further evaluation and early intervention treatment. During the December 10, 2013 wellness visit, T.M. received the following vaccines: HepB (3rd dose); DTaP (2nd dose); Hib (2nd dose); IPV (2nd dose); PVC (2nd dose); and RV (2nd dose). ECF 7-8 at 6. That evening, T.M. developed a fever which Ms. Weaver treated with Tylenol. On December 11, 2013 at approximately 2:00 a.m.–less than 24 hours after receiving the vaccines–T.M. was taken by ambulance to the emergency room and treated for a complex febrile seizure lasting 35 minutes. Ms. Weaver reported the following symptoms to the paramedics and hospital staff: grunting, body shakes, clenched hands, curled toes, pulsating limbs, heavy drooling, and eyes rolled upward.4 When examined at 4:00 a.m., T.M. presented with fever and shaking and “seizure-like activity.” See ECF 11-1 at 8. Showing signs of respiratory distress, T.M. was intubated and placed on a ventilator. T.M.’s bloodwork showed an abnormally high white blood cell count; a flu panel, Computed Tomography (CT or CAT) brain scan, and chest x-ray yielded negative results. T.M. was given antibiotics and transferred to another hospital for treatment in the facility’s pediatric intensive care unit. Following her hospital transfer, T.M.’s fever broke and she was extubated with no further seizure activity. An electroencephalogram (EEG) of T.M.’s brain activity performed that afternoon was interpreted to be normal. During evening rounds, a treating physician documented the likely diagnosis as complex febrile seizure. T.M. was discharged the following day. Six days later, on December 18, 2013, T.M. returned to the emergency room after experiencing three episodes of vomiting and diarrhea, but no reported fever or additional seizures. By this time, Ms. Weaver had filed a Vaccine Adverse Event Reporting System (VAERS) report suggesting a link between T.M.’s febrile seizure 3 The December 10, 2013 follow-up visit was necessary after healthcare providers were unable to verify T.M.’s vaccine history on December 6, 2013; consequently, no vaccines could be administered during the initial check-up. 4 T.M.’s father also reported that T.M.’s tongue was swollen and confirmed the excess drooling. 3 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 4 of 15 and her recent vaccinations.5 T.M. was prescribed a nausea medication, instructed to stay hydrated, and discharged. During a January 14, 2014 wellness visit, the treating physician documented their assessment of T.M.’s December 11, 2013 episode as a “DTaP induced versus febrile seizure.” See ECF 7-4 at 5. On March 18, 2014, T.M. returned to the emergency room after suffering a second febrile seizure and remained hospitalized overnight for observation. Medical staff flagged T.M.’s “significant developmental delay” and urged Ms. Weaver to seek early intervention for T.M. through prescribed physical and occupational therapy. See ECF 7-7 at 241; accord id. at 239–40. In early April 2014, healthcare providers continued to raise concerns that T.M. was not meeting developmental milestones. On May 1, 2014, T.M. suffered a third febrile seizure while at daycare and again transported by ambulance to the emergency room. According to her daycare provider, T.M. “began to shake, foam at the mouth, and her eyes rolled into the back of her head while [the teacher] was holding her.” See ECF 7-1 at 2. Prior to her discharge later that day, T.M.’s body temperature measured 102.2 degrees. Over the following week, T.M. was evaluated by the Illinois Bureau of Early Intervention and a pediatric neurologist. She was diagnosed as suffering from “[e]pileptic seizures, [f]ebrile seizures, [s]taring spell, and [d]evelopmental delay.” See ECF 7-2 at 10. T.M. was prescribed a low dose of the anti-epileptic drug Keppra. During a May 13, 2014 wellness visit, Ms. Weaver reluctantly authorized the administration of three more vaccines: measles, mumps, and rubella (MMR) (1st dose); varicella/chickenpox (1st dose); and hepatitis A (HepA) (1st dose). Two months later, on July 3, 2014, T.M. underwent a two-hour EEG. The results were found “within normal limits and appropriate for [the] patient[’s] age”; however, the entry under “[a]bnormalities” reads: “slow wave activity was present throughout the recording and was unresponsive to stimulation.” ECF 7-2 at 43. Through the fall of 2014, T.M.’s overall development showed few signs of improvement. During a September 4, 2014 wellness visit, 17-month-old T.M. did not meet any of the 11 evaluated developmental milestones.6 Concerned the vaccinations were causing or contributing to T.M.’s continuing health issues, Ms. Weaver declined to authorize additional scheduled vaccinations for T.M. 5 Co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), VAERS “is a national early warning system to detect possible safety problems in U.S.-licensed vaccines.” See VAERS, https://vaers.hhs.gov/about.html (last visited Feb. 22, 2023). 6 Although T.M. was reportedly “rolling more frequently” and “up on her knees,” she was not yet crawling. See ECF 7-3 at 71. Moreover, the healthcare provider checked “no” for the following developmental milestones: vocabulary 3 to 6+ words; listens to story; points to one or more body parts; gestures what they want; understands simple commands; walks, stoops, climbs stairs; stacks blocks; feeds self with fingers; drinks from a cup; looks for fallen objects; and social play. Id. 4 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 5 of 15 On December 30, 2014, T.M. suffered a breakthrough seizure and returned to the emergency room. The seizure reportedly “last[ed] for about ten minutes [and] then resolved on its own.” See ECF 7-9 at 5. Hospital staff attributed the episode to T.M. missing her morning dose of Keppra. By the time T.M. was examined by a doctor two hours after her arrival at the hospital, she had returned to her baseline and discharged. T.M.’s development showed no documented signs of improvement throughout 2015 and into 2016. On May 8, 2016, T.M. experienced an active afebrile seizure and was taken to the emergency room. Medical staff attributed the episode to T.M.’s reported congestion, exposure to viral illness, and a missed Keppra dose. A continuous-video EEG identified the following abnormalities: absent posterior dominant rhythm (PDR); excessive beta activity; and diffuse slowing. The EEG report further noted: “EEG is consistent with a global encephalopathy and drug-induced fast activity.”7 See ECF 9-4 at 62. An August 16-17, 2016 follow-up ambulatory (24-hour) EEG revealed the following abnormalities: “regional epileptiform discharges involving the posterior quadrant maximal over midline parieto-occipital region.” Id. at 293- 94. The results were deemed “consistent with an active epileptogenic source in the midline parieto-occipital region [of the brain].” Id. Since then, T.M. has experienced several afebrile seizures resulting in additional trips to the emergency room and, in at least one instance, being admitted to the hospital. In diagnosing T.M., healthcare providers generally offer non-vaccine related explanations (e.g., recurrent ear infections, missed Keppra doses, exploring alternative treatments). Her current diagnoses include epilepsy and global encephalopathy (i.e., global developmental delay). Nearing her 10th birthday, T.M.’s global and profound developmental delays continue. She remains nonverbal, wears diapers, and continues to experience seizures. II. Petition and OSM Decision Ms. Weaver’s petition presents a causation claim and significant aggravation claim, asserting the December 10, 2013 vaccines administered to T.M. caused her seizure disorder and significantly worsened her developmental delays. In support of her causation claim, Ms. Weaver relies upon the “seizures beget seizures” theory, asserting that T.M.s’ initial vaccine-induced febrile seizure lowered her seizure threshold, paving the way for her chronic seizure disorder. The resulting brain damage from the attributable seizures, Ms. Weaver continues, significantly aggravated T.M.’s preexisting developmental delays. 7 “Encephalopathy is a term for any disease of the brain that alters brain function or structure.” See NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE, https://www.ninds.nih.gov/health- information/disorders/encephalopathy#:~:text=Encephalopathy%20is%20a%20term%20for,increased %20pressure%20in%20the%20skull (last visited Feb. 22, 2023). Although the parties dispute the import of this diagnosis, the OSM decision under review makes no mention of the May 8, 2016 EEG. 5 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 6 of 15 On September 23, 2022, the OSM issued a decision denying entitlement. The Chief Special Master found the December 10, 2013 vaccinations were responsible for T.M.’s ensuing fever and at least contributed to her initial febrile seizure. Citing the “absence of evidence that [T.M.’s] brain was likely damaged by the first febrile seizure,” however, the Chief Special Master concluded T.M.’s subsequent seizures were not likely attributable to the first. Weaver v. Sec’y of Health & Hum. Servs., No. 16-1494V, 2022 WL 12542485, at *1 (Fed. Cl. Spec. Mstr. Sept. 23, 2022). The Chief Special Master also held Ms. Weaver failed to establish that T.M.’s preexisting developmental delays were significantly aggravated by her initial vaccine-induced febrile seizure. 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 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 under the arbitrary and capricious standard; discretionary rulings are reviewed under an abuse of discretion standard; and legal conclusions are reviewed de novo under the “not in accordance with law” standard. Turner v. Sec’y of Health & Hum. Servs., 268 F.3d 1334, 1337 (Fed. Cir. 2001) (citing Munn v. Sec’y of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992)). II. Causation-In-Fact To prove causation-in-fact for an injury not listed in the Vaccine Injury Table, 42 U.S.C. § 300aa–14(a) (“off-Table injury”), a petitioner must demonstrate by preponderant evidence: 6 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 7 of 15 (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury. Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). To satisfy this burden, a petitioner need not prove their claim to a medical or scientific certainty; rather, they must simply show that it is “more likely than not” that the vaccine caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010). The three Althen prongs comprise an overlapping analysis determining whether a vaccine more likely than not caused injury. Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (“[T]he statute requires only that the claimant show that it is more likely than not that this claimant’s [injury] was caused by the vaccine.”) (emphasis in original). Under the first prong, petitioner must provide a reputable medical or scientific explanation for their theory of causal connection. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2009) (quoting Moberly, 592 F.3d at 1322). To satisfy the second prong, petitioner must show how the facts of their case align with the medical theory presented and demonstrate a logical connection between the vaccine and the injury (i.e., a logical sequence of cause and effect). See Capizzano, 440 F.3d at 1326 (“[M]edical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether ‘a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.’”) (quoting Althen, 418 F.3d at 1280) (citing 42 U.S.C. § 300aa–13(a)(1)). Finally, the third prong requires petitioner to show the injury occurred within the expected time frame of the proposed medical theory. See de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). In this case, the Chief Special Master found Ms. Weaver satisfied Althen prongs one and three. In addressing prong one, the Chief Special Master found that Ms. Weaver provided a credible medical theory demonstrating how vaccines can cause a febrile seizure and, in turn, how a febrile seizure can cause a chronic seizure disorder. See Weaver, 2022 WL 12542485, at *25 (“I can easily determine herein that almost any vaccine, alone or grouped with others, could cause sufficient inflammation to trigger a single febrile seizure.”) (emphasis in original); id. at *27 (“I emphasize again—the contention that a vaccine-caused febrile seizure could constitute the first ‘domino’ in a chronic seizure disorder is scientifically reliable.”) (emphasis in original). Regarding prong three, the Chief Special Master credited testimony demonstrating the requisite timing between T.M.’s vaccination and her complex febrile seizure. See id. at *12 (“Finally, Dr. Huq addressed the timeframe between T.M.’s vaccinations and her first seizure, deeming it consistent with the short interval for initial inflammatory changes (which could occur within 24 hours to a few days after vaccination).”). Neither of these conclusions are contested here. 7 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 8 of 15 Accordingly, the Court focuses on the determination that Ms. Weaver did not satisfy the second Althen prong. A. Contemporaneous Evidence of Brain Injury The Chief Special Master improperly elevated Ms. Weaver’s burden of proof under Althen prong two. In denying compensation, the Chief Special Master focused on the absence of abnormal screening results evidencing brain injury contemporaneous with T.M.’s first febrile seizure, finding: [T]he medical record in this case does not support the conclusion that T.M.’s December 2013 post-vaccination febrile seizure caused her epilepsy. Specifically, the record does not establish that the initial febrile seizure harmed T.M.’s brain sufficiently to conclude that it likely “explains” what transpired thereafter. On the contrary, persistent testing performed over the next two-plus years, whether in the form of EEGs or [magnetic resonance imaging (MRIs)], did not confirm the presence of a seizure-induced brain malformation or injury that could then (under a “seizures beget seizures” theory) be deemed causal of all subsequent seizures. See Weaver, 2022 WL 12542485, at *25 (emphasis in original) (citing three EEGs, an MRI, and a CT scan yielding normal results between December 2013 and May 2016). The Chief Special Master noted that it was not until August 2016 that epileptiform activity in T.M.’s brain was corroborated by an EEG yielding abnormal results. Id. Upon these findings, the Chief Special Master concluded T.M.’s first vaccine-induced seizure could not be deemed responsible for her epilepsy “in the absence of record evidence corroborating the presence of brain injury that could credibly be attributed to the vaccine-induced febrile seizure.” Id. at *27. Requiring abnormal screening results to substantiate T.M.’s initial brain injury contradicts the spirit of the Vaccine Act and the standard to which petitioners are held. The preponderance of the evidence standard applicable under the Act does not require medical certainty. Rather, causation is determined on a case-by-case basis with “no hard and fast per se scientific or medical rules.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Moreover, under the National Vaccine Injury Program, close calls regarding causation are resolved in favor of injured claimants. Althen, 418 F.3d at 1280. The question whether T.M.’s brain was harmed by her initial vaccine-induced complex febrile seizure, leading to her chronic seizure disorder, is a close call and, as such, must be resolved in Ms. Weaver’s favor. 8 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 9 of 15 Under the scientifically sound theory that a vaccine-caused complex febrile seizure could serve as the proverbial “first domino” to topple culminating in T.M.’s development of a chronic seizure disorder, the second Althen prong required Ms. Weaver to produce only a measure of reliable evidence that her brain was more likely than not harmed by the initial seizure. While a concurrent abnormal EEG or other medical screening may provide such evidence, the absence of an abnormal screening alone is not determinative. The Federal Circuit has rejected the requirement that a petitioner satisfy the second Althen prong by presenting specific medical evidence or scientific proof to establish a logical sequence of cause and effect, concluding that such a requirement “impermissibly raises a claimant’s burden under the Vaccine Act.” See Capizzano, 440 F.3d at 1325–26. The court highlighted the inherent value of opinions from treating physicians and medical experts. See id. at 1325. Relevant circumstantial evidence may satisfy the preponderance standard. Id. In this case, T.M.’s treating physicians and medical expert opined that T.M.’s regression evidences the impact of her initial vaccine-induced seizure (and subsequent seizures) on her development. In contrast, expert witness testimony regarding the probative value of the initial EEGs and other screening tests were, at best, inconclusive. 1. Treating Physicians “[Medical opinion] testimony is ‘quite probative’ since ‘treating physicians are likely to be in the best position to determine whether a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.’” Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1375 (Fed. Cir. 2009) (quoting Capizzano, 440 F.3d at 1326) (additional citations omitted). Indeed, “in certain cases, a petitioner can prove a logical sequence of cause and effect between a vaccination and the injury (Althen prong two) with a physician’s opinion to that effect where the petitioner has proved that the vaccination can cause the injury (Althen prong one) and that the vaccination and injury have a close temporal proximity (Althen prong three).” Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1333 (Fed. Cir. 2016) (citing Capizzano, 440 F.3d at 1326). Under Ms. Weaver’s scientifically reliable seizures beget seizures theory of causation, children who experience febrile seizures–particularly complex febrile seizures–are more likely to develop seizure disorders, including epilepsy. The proffered theory is sufficiently borne out by the circumstantial evidence presented. The causal link between T.M.’s December 10, 2013 vaccinations and her initial complex febrile seizure within 24 hours is well documented in T.M.’s contemporaneous emergency room records. Further, the medical opinions of T.M.’s pediatric neurologist connected T.M.’s initial febrile seizure and her currently diagnosed seizure disorder. Contemporaneous medical records prepared by other healthcare professionals further document T.M.’s developmental regression and 9 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 10 of 15 substantiate a causal connection between T.M.’s initial febrile seizure and her current diagnosis. In the days and months following T.M.’s third febrile seizure over the course of five months, pediatric neurology specialist Lubov Romantseva, MD, noted T.M.’s developmental plateaus and regressions occurred contemporaneously with T.M.’s vaccinations and the onset of her febrile seizures. See, e.g., ECF 7-2 at 15, 16, 76. To this point, the frequency of T.M.’s febrile seizures and the possible impact of the antiseizure medication prescribed immediately following T.M.’s third febrile seizure proves corroborative. Prior to taking a daily dose of Keppra, T.M. suffered febrile seizures on December 11, 2013, March 18, 2014, and May 1, 2014. Her subsequent December 30, 2014, and May 8, 2016 febrile seizures occurred on days when T.M. did not take her medication. Dr. Romantseva continues to treat T.M. and, based on the record presented, her opinions supply substantiated evidence of causation. See Mondello v. Sec’y of Health & Hum. Servs., 132 Fed. Cl. 316, 323 (2017) (“Medical records ‘warrant consideration as trustworthy evidence’ because these records are ‘generally contemporaneous to medical events,’ and ‘accuracy has an extra premium.’”) (citing Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993)). T.M.’s developmental evaluations timeline further supports the conclusion that T.M. experienced developmental regression as a result of her vaccine-induced December 11, 2013 complex febrile seizure and subsequent febrile seizures. At her December 10, 2013 wellness visit–during which T.M. received the vaccine regimen at issue–she was reported to meet some (but not all) developmental milestones. See ECF 7-8 at 4. During a 12-month wellness visit conducted on April 8, 2014– one month after T.M. suffered a second febrile seizure in three months–Lester Hockenberry, MD, documented that T.M. met only 1 of 13 developmental milestones. See ECF 7-3 at 85–86. By September 4, 2014, Dr. Hockenberry reported that T.M. did not meet a single developmental milestone. See ECF 7-3 at 71. The Court finds the contemporaneous medical opinions regarding T.M.’s developmental regression probative in determining T.M. suffered a brain injury after her first vaccine-induced febrile seizure. Relevant here, the Chief Special Master seemingly conflated T.M.’s pre-seizure developmental concerns with her post-seizure developmental regression. See Weaver, 2022 WL 12542485, at *26 (“The fact that T.M.’s seizures occurred in the context of established developmental concerns also weighs against a conclusion that her first seizure caused what followed.”). As expert witnesses for both parties explained, there is a significant difference between developmental delay and regression. Pediatric Neurologist John Zempel, MD, for example, distinguished between the “many kids who have development delay,” and the “uncommon” phenomenon of regression, which requires immediate evaluation and treatment by a neurologist. See ECF 72 at 251. In turn, Pediatric Neurologist Ahm M. Huq, MD, 10 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 11 of 15 explained that a loss of once-mastered skills is “unusual” and, in the absence of evidence of illness or degenerative condition, is compelling evidence of harm to the brain. Id. at 105–06. Dr. Huq further noted the adverse impact brain seizures can have on child development, particularly during their early years of critical development. See id. at 107. Notwithstanding the negative screenings cited by the Chief Special Master, discussed infra, the Court finds sufficient evidence in the record to support Ms. Weaver’s contentions that T.M.’s December 11, 2013 vaccine-induced complex febrile seizure made her more susceptible to future seizures and that indications of a lowered seizure threshold were partially masked by the prescribed antiseizure medication. The Court notes the plausibility of this explanation for why T.M.’s allegedly lower seizure threshold did not result in significantly more seizures: it would strain credulity to suggest it is merely coincidental that on the two reported days T.M. missed a Keppra dosage, she suffered additional seizures. T.M.’s ensuing developmental regression further evidences the brain damage she suffered. In reaching these conclusions, the Court finds several similar OSM decisions instructive. See, e.g., Silverio v. Sec’y of Health & Hum. Servs., No. 15-235V, 2019 WL 6694020 (Fed. Cl. Spec. Mstr. Nov. 14. 2019) (complex febrile seizure triggered propensity for additional seizures; Althen prong two satisfied by treating physician’s testimony despite normal EEG, MRI, and CT scans; first abnormal reading occurred two years after initial complex febrile seizure using a continuous EEG); Fuller v. Sec’y of Health & Hum. Servs., No. 15-1470V, 2019 WL 7576382 (Fed. Cl. Spec. Mstr. Dec. 17, 2019) (complex febrile seizure increased risk of developing epilepsy under seizures beget seizures theory; Althen prong two satisfied in part by expert testimony; first conclusively abnormal EEG was conducted three years after the initial seizure); Ginn v. Sec’y of Health & Hum. Servs., No. 16-1466V, 2021 WL 1558342 (Fed. Cl. Spec. Mstr. Mar. 26, 2021) (considering normal MRI results as evidence ruling out alternative causes under Althen prong two, but not ruling out vaccinations as the potential cause). Put simply, requiring contemporaneous abnormal screening evidence to prove brain injury under a “seizures beget seizures” theory of causation improperly elevates a petitioner’s burden under the second Althen prong. 2. EEGs and Other Screenings As noted in the Chief Special Master’s decision, medical experts for both parties testified to the limitations of EEGs and other screening tests in detecting brain injury or abnormality. See, e.g., ECF 72 at 250 (Dr. Zempel: “If you have epileptiform abnormalities, that makes it more likely that you have a diagnosis of epilepsy. A normal EEG does not rule out that you have epilepsy.”); id. at 44–45, 148–49 (Dr. Huq: “a short-term EEG has a 30 percent chance of capturing the abnormal. A long-term EEG usually have [sic] 60 percent, 60 or 70 percent. So a 11 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 12 of 15 positive EEG is helpful, and negative EEG cannot rule out the diagnosis. It’s always a clinical diagnosis.”). Moreover, in reviewing T.M.’s abnormal August 2016 EEG results, Dr. Zempel reiterated: I think that this is the first time we’ve seen evidence of epileptiform activity on an EEG. Again, I think that means it’s more likely in the future that there could be recurrent unprovoked seizures, but there are children out there who have these abnormalities and don’t have epilepsy, and there are children who have epilepsy and don’t have any abnormalities. Id. at 255 (emphasis added). Regarding T.M.’s normal screening results during the first two years following her initial complex febrile seizure, Dr. Huq opined on their limited import because “[t]here are patients who have seizures every day and can have normal EEG[s].” Id. at 148–49. As noted above, Dr. Huq explained that the short-term EEGs performed in the two years following T.M.’s initial complex febrile seizure have only a 30 percent chance “of capturing the abnormal[,]” whereas long-term EEGs–like the one performed in May 2016 (and August 2016)–capture abnormalities in 60 to 70 percent of individuals. Id. at 143, 148–49. Overall, both experts agreed that T.M.’s abnormal August 2016 EEG was consistent with epilepsy, and Dr. Huq, in particular, opined that her multiple EEGs (including those that were normal) were consistent with this diagnosis. With respect to MRIs, Dr. Huq explained they would not likely detect molecular changes in the brain that occur after status epilepticus or a complex febrile seizure, and that the molecular changes might not be detectable for years. See id. at 93. In turn, although highlighting an MRI’s ability to detect prolonged seizures and significant brain injuries, Dr. Zempel declined to opine that an MRI would detect all injuries in 100% of cases. See ECF 73 at 7–8. As for CT scans, Dr. Zempel testified he was “much less confident that a significant injury would appear on CT scan.” Id. at 6. Consistent with the Federal Circuit’s decision in Capizzano, the nature and extent of the Chief Special Master’s reliance upon EEG and other screening evidence was in error. See 440 F.3d at 1325–28. While abnormal screening results may be probative, the law does not require abnormal screening results to prove a particular injury under the Vaccine Act. B. Burden to Eliminate Alternative Causes To the extent the Chief Special Master assigned Ms. Weaver the burden of eliminating alternative independent potential causes for T.M.’s injury as part of her prima facie causation claim, the burden shift constitutes legal error. Under the Vaccine Act, once a petitioner has met their burden on causation, the burden shifts 12 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 13 of 15 to the Secretary to establish by a preponderance of the evidence that the injury or harm was unrelated to the vaccine. See Walther v. Sec’y of Health & Hum. Servs., 485 F.3d 1146, 1151 (Fed. Cir. 2007) (citations omitted). As stated by this Court: The Act only requires a showing of “but for” causation and that the vaccine was a “substantial factor,” not that the vaccine was the only cause. Thus the coincidence of another potential causal agent is not fatal to a claim under the Act. If petitioner meets its burden on causation, then it is the government’s burden to prove that some other cause is to blame, not petitioner’s to disprove it. Mondello, 132 Fed. Cl. at 325. Importantly, while evidence of other possible sources of injury can be relevant in the causation analysis, the Federal Circuit has clarified: first, that a special master may not require the petitioner to shoulder the burden of eliminating all possible alternative causes in order establish a prima facie case[;] and second, that a special master may find that a factor other than a vaccine caused the injury in question only if that finding is supported by a preponderance of the evidence. Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373, 1380 (Fed. Cir. 2012) (internal citations omitted).8 8 The Secretary seeks to apply the holding in Stone to this case. Readily distinguishable from this case, in Stone, the special master concluded that the children’s SCN1A gene mutation was the sole cause of their severe myoclonic epilepsy of infancy (SMEI) (also known as Dravet syndrome), and that the petitioners failed to establish the existence of any brain damage. See 676 F.3d at 1375, 1377–78, 1385. In affirming the OSM’s decision, the Federal Circuit held: “[t]he special master did not reject the petitioners’ evidence of brain damage on the ground that it was circumstantial; rather, he found that [the expert’s] inference of brain damage, in the face of clinical records showing no brain damage, was unpersuasive and that it was therefore insufficient to carry the petitioners’ burden on causation.” Id. at 1385. It is also worth noting that in Stone, unlike here, the burden of proof shifted to the respondent to demonstrate by a preponderance of the evidence that the gene mutation “was ‘more likely than not the “but for” and “substantial factor” that caused’ the SMEI in both children.” Id. at 1377 (citations omitted). Here, it is undisputed–and confirmed by both parties’ experts–that T.M.’s August 2016 EEG was abnormal, demonstrated global encephalopathy, and is consistent with T.M.’s epilepsy diagnosis. Compare ECF 9-4 at 293–94 and ECF 72 at 145–46, 254–55 with Stone, 676 F.3d at 1382 n.2, 1385 (finding EEG evidence “questionable”; petitioner’s expert witness unpersuasive). Additionally, the Court finds T.M.’s medical records—particularly the medical opinions of her pediatric neurologist and contemporaneous developmental assessments—amply support the conclusion that T.M. experienced developmental regression, which is probative circumstantial evidence of brain injury in this case. 13 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 14 of 15 In this case, rather than hold the Secretary to their shifted burden of proof, the Chief Special Master faulted Ms. Weaver for not refuting or otherwise addressing the notion that T.M.’s developmental delay could have caused or increased her risk or propensity for seizures. See Weaver, 2022 WL 12542485, at *26 (“Although I do not purport to find that T.M.’s developmental issues explain her subsequent seizure activity and epilepsy, Petitioner did not persuasively rebut this kind of evidence, and it therefore further diminishes the possibility that the initial febrile seizure alone explained why T.M. continued to experience seizures afterward.”) (emphasis added); id. (“[T]he record in this case paints a picture of a child likely susceptible to seizure activity generally, but whose course could not be deemed inevitable once the first febrile seizure occurred. T.M.’s initial febrile seizure was likely vaccine-caused—but that seizure in turn was not the cause of what followed.”) (emphasis in original). The law is clear: Ms. Weaver is not required to prove that T.M.’s initial vaccine-induced complex febrile seizure was the sole or predominant cause of her epilepsy. See Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999) (petitioners must demonstrate vaccine was a but-for cause of and a substantial factor in the resulting injury; petitioners are not required to establish the vaccine was the only or predominate cause of the injury). III. Significant Aggravation Under the Vaccine Act, claimants may seek compensation for preexisting injuries that were “significantly aggravated” by vaccination. 42 U.S.C. § 300aa- 11(c)(1)(C)(i-ii). To prove an off-Table significant aggravation claim, petitioners must satisfy the six-prong test adopted in Loving v. Sec’y of Health & Hum. Servs., 86 Fed. Cl. 135, 143–44 (2009). Under the Loving framework, a petitioner must establish by a preponderance of the evidence: (1) the person’s condition prior to administration of the vaccine, (2) the person’s current condition (or the condition following the vaccination if that is also pertinent), (3) whether the person’s current condition constitutes a “significant aggravation” of the person’s condition prior to vaccination, (4) a medical theory causally connecting such a significantly worsened condition to the vaccination, (5) a logical sequence of cause and effect showing that the vaccination was the reason for the significant aggravation, and (6) a showing of a proximate temporal relationship between the vaccination and the significant aggravation. Id. at 144. Here, Ms. Weaver argues T.M.’s vaccine-induced complex febrile seizure and resulting seizure disorder exacerbated her preexisting developmental delay. 14 Case 1:16-vv-01494-AOB Document 94 Filed 03/13/23 Page 15 of 15 In addressing the significant aggravation claim, the Chief Special Master found that T.M.’s contemporaneously documented pre-vaccine developmental issues “literally worsened” and became “more pronounced” in the months and years after she was vaccinated, thereby satisfying the first three Loving factors. See Weaver, 2022 WL 12542485, at *27 & n.21 (emphasis in original). Turning to the fourth factor, the Chief Special Master “assum[ed] that a vaccine-induced febrile seizure could cause sufficient brain injury to worsen preexisting developmental issues.”9 See id. at *27. In assessing the fifth Loving factor, the Chief Special Master relied upon his findings under the second Althen prong, concluding that T.M.’s initial vaccine- induced complex febrile seizure was similarly not “the source of worsening” for her developmental delay. See Weaver, 2022 WL 12542485, at *27. The Chief Special Master explained: “My finding with respect to a lack of sufficient ‘did cause’ proof that the first, vaccine-caused febrile seizure T.M. experienced was causal of her overall epilepsy also bears on Petitioner’s claim that her pre-existing developmental delays were exacerbated by the December 2013 vaccinations.” See id.; accord id. at *28 (“[T]he initial, undoubtedly vaccine-related febrile seizure has not been shown to be the ‘linchpin’ to what followed.”). Given the Court’s conclusion reversing the causation determination under Althen prong two, the extension of the erroneous finding in analyzing the Loving factors necessitates a reevaluation on remand.10 CONCLUSION For the foregoing reasons, Petitioner’s Motion for Review (ECF 83) is GRANTED, the Decision Denying Entitlement issued by the Office of Special Masters (ECF 77 & 81) is REVERSED-IN-PART and VACATED-IN-PART, and this case is REMANDED for further proceedings consistent with this opinion. It is so ORDERED. ___________________ Armando O. Bonilla Judge 9 The assumption is presumably based on the Chief Special Master’s findings regarding Althen prong one (i.e., the counterpart to the third Loving factor). 10 On remand, the Chief Special Master must also address the sixth Loving factor (i.e., proximate temporal relationship between the vaccination and the significant aggravation)–the counterpart to the third Althen prong–as his initial decision is silent on that issue. The Court declines to make these factual findings in the first instance on petitioner’s motion for review. See, e.g., Mondello, 132 Fed. Cl. at 325. 15 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_16-vv-01494-3 Date issued/filed: 2023-06-06 Pages: 3 Docket text: PUBLIC ORDER/RULING (Originally filed: 05/08/2023) regarding 98 Ruling on Entitlement. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-01494-AOB Document 100 Filed 06/06/23 Page 1 of 3 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-1494V * * * * * * * * * * * * * * * * * * * * * * * * * EBONIE WEAVER * parent of T.M. a minor, * Filed: May 8, 2023 * Petitioner, * * v. * * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Edward Kraus, Kraus Law Group, LLC, Chicago, IL, for Petitioner. Megan R. Murphy, U.S. Department of Justice, Washington, DC, for Respondent. REMAND RULING ON ENTITLEMENT1 On November 14, 2016, Ebonie Weaver, on behalf of her minor daughter, T.M., filed a Petition under the National Vaccine Injury Compensation Program (the “Vaccine Program”),2 alleging that as a result of receiving several vaccines on December 10, 2013, T.M. experienced a seizure disorder and a significant worsening of her preexisting developmental delays, due to a single, initial, vaccine-induced febrile seizure. Petition (ECF No. 1) at 1–2, 40. An entitlement hearing in the matter was held on February 9–10, 2022, at which time I heard fact testimony as well as the opinions of two testifying experts (with the second of 1 The parties may object to the published Ruling’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen (14) 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 entire Ruling 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, Pub. L. No. 99-660, 100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”). All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa. Case 1:16-vv-01494-AOB Document 100 Filed 06/06/23 Page 2 of 3 Petitioner’s experts only offering written expert reports). I found Petitioner not entitled to compensation. Decision, dated September 23, 2022 (ECF No. 81) (the “Decision”). In particular,3 I determined that Petitioner had established that the vaccines T.M. received could cause febrile seizures (as well as seizure disorders caused by an initial, vaccine-related febrile seizure), and that she experienced such a seizure as well (which occurred in a medically acceptable timeframe)— but that Petitioner had not also preponderantly demonstrated that the vaccine-caused febrile seizure T.M. had experienced was also responsible for T.M.’s subsequent seizure disorder. Decision at 33–35. Thus, Petitioner had only satisfied two of the three of the causation prongs set forth in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). I also found that Petitioner’s significant aggravation claim (that her pre-vaccination developmental issues were worsened by the febrile seizure) was unsuccessful for similar reasons. Id. at 35–36. Otherwise, I found that the first three prongs of the test for significant aggravation (under Loving v. Sec’y of Health & Hum. Servs., 86 Fed. Cl. 135, 144 (2009)) had been met. Id. at 35 n.21. Petitioner sought review of my Decision and was successful. See Order, dated February 24, 2023 (ECF No. 89) (the “Remand Order”). The Remand Order reversed my Althen prong two finding, determining that Petitioner had established entitlement on her causation claim as a result. But the Court left unresolved whether Petitioner had met Loving prongs five and six, based on the Court’s Althen prong two determination plus the fact that I did not in my decision explicitly address whether the sixth Loving factor had been satisfied (Remand Order at 1 n.10). On remand, I ordered Respondent to show cause why I should not rule favorably on entitlement on the significant aggravation claim as well. Order to Show Cause, dated February 27, 2023 (ECF No. 90). I noted in particular that because I already had determined (implicitly) in my original Decision that the third Althen prong had been met, it was likely I could also find based on that same record that the timing of Petitioner’s developmental worsening after her first febrile seizure (admittedly induced by vaccination) was also medically acceptable. Respondent reacted to my Order to Show Cause on March 31, 2023. ECF No. 97. He represents therein that the reversal of my Althen prong two finding “would also necessitate a finding for petitioner under Loving prong five.” ECF No. 97 at 2. He did not, however, address the sixth Loving prong. Petitioner has not filed a responsive brief of her own. In light of Respondent’s reaction to the Order to Show Cause, and based upon my own review of the record in the wake of the Remand Order, I hereby find entitlement for Petitioner on all claims asserted in this matter, to the extent not addressed or resolved in the Remand Order. Regarding significant aggravation, I note that since the Court has construed the record to support the theory that T.M.’s initial (and unquestionably-established) vaccine-caused febrile seizure was a substantial factor for all that came after, and therefore a basis for vaccine compensation, that 3 Although the Decision has been vacated, I incorporate by reference my summary of the medical records and trial testimony from that document—especially since the Court took less issue with the specifics of those determinations than how I ultimately weighed those facts, and accepted some of my Althen determinations as well. 2 Case 1:16-vv-01494-AOB Document 100 Filed 06/06/23 Page 3 of 3 same view of the record also supports the determination that T.M.’s preexisting developmental problems were similarly caused to worsen post-vaccination due to the same single vaccine-caused seizure. I also find that (with respect to Loving prong six) the timeframe for worsening of Petitioner’s preexisting developmental issues was medically acceptable when measured from the date of vaccination, consistent with my Althen prong three determination. The record reveals T.M.’s developmental issues were observed throughout the spring of 2014, concurrent with her experiencing more regular febrile seizures. See Decision at 5–8. And Petitioner’s experts offered reasonable, sufficiently-persuasive testimony to conclude that this timeframe of worsening was medically acceptable. Id. at 15–16. Petitioner has prevailed in this case. An order setting forth a process for resolving damages shall issue hereafter. Any questions regarding this Ruling may be directed to my law clerk, Madison Atkinson, at madison_atkinson@cfc.uscourts.gov. IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 3 ================================================================================ DOCUMENT 4: USCOURTS-cofc-1_16-vv-01494-4 Date issued/filed: 2025-05-27 Pages: 12 Docket text: PUBLIC DECISION (Originally filed: 05/01/2025) regarding 112 DECISION Stipulation/Proffer. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 1 of 12 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-1494V * * * * * * * * * * * * * * * * * * * * * * * * * * EBONIE WEAVER, * parent of T.M., a minor, * Chief Special Master Corcoran * Petitioner, * Filed: May 1, 2025 * v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Edward Kraus, Kraus Law Group, LLC, Chicago, IL, for Petitioner. Meghan Murphy, U.S. Dep’t of Justice, Washington, DC, for Respondent. DECISION AWARDING DAMAGES1 On November 14, 2016, Ebonie Weaver, on behalf of her minor daughter, T.M., filed a petition seeking compensation under the National Vaccine Injury Compensation Program.2 Petition (ECF No. 1) at 1. Petitioner alleged that T.M. suffered a “seizure disorder and its sequelae that were more likely than not caused by an adverse reaction to DTaP, Hib, IPV, Rotateq, and hepatitis B vaccines administered to her on December 10, 2013.” Id. Petitioner further alleged that “T.M. also experienced a significant worsening of her developmental delays and was assessed to be more than 50 percent delayed in all areas.” Id. at 9. On May 8, 2023, I issued a Remand Ruling on Entitlement in favor of Petitioner. See Ruling, dated May 8, 2023 (ECF No. 93). The parties have since then endeavored to agree on the proper amount of damages. On April 30, 2025, Respondent filed a proffer proposing an award of compensation. 1 Under Vaccine Rule 18(b), each party has fourteen (14) 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 present form. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”). Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix). Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 2 of 12 Proffer, dated Apr. 30, 2025 (ECF No. 111). I have reviewed the filing, and based upon that review I conclude that the Respondent’s proffer (as attached hereto) is reasonable. I therefore adopt it as my Decision in awarding damages on the terms set forth therein. The proffer awards: • A lump sum payment of $1,537,438.76, representing compensation for life care expenses in the first year after judgment ($69,676.14), lost future earnings ($1,217,762.62), and pain and suffering ($250,000.00), to be paid through an ACH deposit to Petitioner’s counsel’s IOLTA account for prompt disbursement to Petitioner as guardian(s)/conservator(s) of the estate of T.M., for the benefit of T.M. (with the proffer specifying confirmation of Petitioner’s guardianship capacity before payment is made); • A lump sum payment of $89,412.29, representing compensation for satisfaction of the Illinois Department of Healthcare and Family Services Medicaid lien, payable jointly to Petitioner and: Illinois Department of Healthcare Family Services P.O. Box 19146 Springfield, Illinois 62794-9146 Case Number: 93-226-0106397791 ATTN: HFS Representative Petitioner agrees to endorse this payment to the Illinois Department of Healthcare and Family Services; and • An amount sufficient to purchase the annuity contract, subject to the conditions described in Section II. C. in the Proffer. Proffer at II. These amounts represent compensation for all elements of compensation under 42 U.S.C. § 300aa-15(a) to which Petitioner is entitled. I approve a Vaccine Program award in the requested amount set forth above to be made to Petitioner. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the Court is directed to enter judgment herewith.3 IT IS SO ORDERED. 3 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly or separately) a notice renouncing their right to seek review. 2 Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 3 of 12 /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 3 Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 4 of 12 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS __________________________________________ ) EBONIE WEAVER, ) Parent of T.M., a minor, ) ) Petitioner, ) No. 16-1494V ) Chief Special Master Corcoran v. ) ECF ) SECRETARY OF THE DEPARTMENT OF ) HEALTH AND HUMAN SERVICES, ) ) Respondent. ) __________________________________________) RESPONDENT’S PROFFER ON AWARD OF COMPENSATION On November 14, 2016, Ebonie Weaver, on behalf of her minor daughter, T.M., filed a petition for compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa- 10 et seq., alleging that T.M. suffered a “seizure disorder and its sequelae that were more likely than not caused by an adverse reaction to DTaP, Hib, IPV, Rotateq, and hepatitis B vaccines administered to her on December 10, 2013.” Petition at 1. Petitioner further alleges that “T.M. also experienced a significant worsening of her developmental delays and was assessed to be more than 50 percent delayed in all areas.” Petition at 9. On May 8, 2023, Chief Special Master Corcoran issued a Remand Ruling on Entitlement in favor of petitioner. ECF Nos. 98, 100. Respondent now proffers the following regarding the amount of compensation to be awarded.1 1 The parties have no objection to the amount of the proffered award of damages. However, respondent reserves his right, pursuant to 42 U.S.C. § 300aa-12(f), to seek review of the Chief Special Master’s May 8, 2023, Remand Ruling on Entitlement, finding petitioner entitled to an award under the Vaccine Act. This right accrues following the issuance of the damages decision. -1- Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 5 of 12 I. Items of Compensation A. Life Care Items Respondent engaged life care planner Linda Curtis RN MS CCM CNLCP, and petitioner engaged Susan Guth, LCSW, CCM, CLCP, to provide an estimation of T.M.’s future vaccine- injury related needs. For the purposes of this proffer, the term “vaccine related” is as described in the Chief Special Master’s May 8, 2023, Remand Ruling on Entitlement. All items of compensation identified in the life care plan are supported by the evidence and are illustrated by the chart entitled Appendix A: Items of Compensation for T.M., attached hereto as Tab A.2 Petitioner agrees. B. Lost Future Earnings The parties agree that based upon the evidence of record, T.M. will not be gainfully employed in the future. Therefore, respondent proffers that T.M. should be awarded lost future earnings as provided under the Vaccine Act, 42 U.S.C. § 300aa-15(a)(3)(B). Respondent proffers that the appropriate award for T.M.’s lost future earnings is $1,217,762.62. Petitioner agrees. C. Pain and Suffering Respondent proffers that T.M. should be awarded $250,000.00 in actual pain and suffering. See 42 U.S.C. § 300aa-15(a)(4). Petitioner agrees. 2 The chart at Tab A illustrates the annual benefits provided by the life care plan. The annual benefit years run from the date of judgment up to the first anniversary of the date of judgment, and every year thereafter up to the anniversary of the date of judgment. -2- Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 6 of 12 E. Medicaid Lien Respondent proffers that T.M. should be awarded funds to satisfy an Illinois Department of Healthcare Family Services Medicaid lien in the amount of $89,412.29, which represents full satisfaction of any right of subrogation, assignment, claim, lien, or cause of action the State of Illinois may have against any individual as a result of any Medicaid payments the State of Illinois has made to or on behalf of T.M. from the date of her eligibility for benefits through the date of judgment in this case as a result of her vaccine-related injury suffered on or about December 10, 2013, under Title XIX of the Social Security Act. II. Form of the Award The parties recommend that the compensation provided to T.M. should be made through a combination of lump sum payments and future annuity payments as described below, and request that the Chief Special Master’s decision and the Court’s judgment award the following:3 A. A lump sum payment of $1,537,438.76, representing compensation for life care expenses in the first year after judgment ($69,676.14), lost future earnings ($1,217,762.62), and pain and suffering ($250,000.00), to be paid through an ACH deposit to petitioner’s counsel’s IOLTA account for prompt disbursement to petitioner as guardian(s)/ conservator(s) of the estate of T.M., for the benefit of T.M. No payments shall be made until petitioner provides respondent with documentation establishing that she has been appointed as the guardian(s)/conservator(s) of T.M.’s estate. If petitioner is not authorized by a court of competent jurisdiction to serve as guardian(s)/conservator(s) of the estate of T.M., any such payment shall be made to the party or 3 Should T.M. die prior to entry of judgment, the parties reserve the right to move the Court for appropriate relief. In particular, respondent would oppose any award for future medical expenses, lost future earnings, and future pain and suffering. -3- Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 7 of 12 parties appointed by a court of competent jurisdiction to serve as guardian(s)/conservator(s) of the estate of T.M. upon submission of written documentation of such appointment to the Secretary. Further, if guardianship/conservatorship is no longer required under the laws of the state of Illinois after T.M. has attained the age of majority, any such payment shall be paid to T.M. upon submission of written documentation of the termination of guardianship/conservatorship to the Secretary. B. A lump sum payment of $89,412.29, representing compensation for satisfaction of the Illinois Department of Healthcare and Family Services Medicaid lien, payable jointly to petitioner and: Illinois Department of Healthcare Family Services P.O. Box 19146 Springfield, Illinois 62794-9146 Case Number: 93-226-0106397791 ATTN: HFS Representative Petitioner agrees to endorse this payment to the Illinois Department of Healthcare and Family Services. C. An amount sufficient to purchase the annuity contract,4 subject to the conditions described below, that will provide payments for the life care items contained in the life care plan, 4 In respondent’s discretion, respondent may purchase one or more annuity contracts from one or more life insurance companies. The parties further agree that the annuity payments cannot be assigned, accelerated, deferred, increased, or decreased by the parties and that no part of any annuity payments called for herein, nor any assets of the United States or the annuity company, are subject to execution or any legal process for any obligation in any manner. Petitioner and petitioner’s heirs, executors, administrators, successors, and assigns do hereby agree that they have no power or right to sell, assign, mortgage, encumber, or anticipate said annuity payments, or any part thereof, by -4- Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 8 of 12 as illustrated by the chart at Tab A attached hereto, paid to the life insurance company5 from which the annuity will be purchased.6 Compensation for Year Two (beginning on the first anniversary of the date of judgment) and all subsequent years shall be provided through respondent’s purchase of an annuity, which annuity shall make payments directly to petitioner only so long as T.M. is alive at the time a particular payment is due. At the Secretary’s sole discretion, the periodic payments may be provided to petitioner in monthly, quarterly, annual or other installments. The “annual amounts” set forth in the chart at Tab A describe only the total yearly sum to be paid to petitioner and do not require that the payment be made in one annual installment. 1. Growth Rate Respondent proffers that a four percent (4%) growth rate should be applied to all non- medical life care items, and a five percent (5%) growth rate should be applied to all medical life care items. Thus, the benefits illustrated in the chart at Tab A that are to be paid through annuity assignment or otherwise, and further agree that they will not sell, assign, mortgage, encumber, or anticipate said annuity payments, or any part thereof, by assignment or otherwise. 5 The Life Insurance Company must have a minimum of $250,000,000 capital and surplus, exclusive of any mandatory security valuation reserve. The Life Insurance Company must have one of the following ratings from two of the following rating organizations: a. A. M. Best Company: A++, A+, A+g, A+p, A+r, or A+s; b. Moody’s Investor Service Claims Paying Rating: Aa3, Aa2, Aa1, or Aaa; c. Standard and Poor’s Corporation Insurer Claims-Paying Ability Rating: AA-, AA, AA+, or AAA; d. Fitch Credit Rating Company, Insurance Company Claims Paying Ability Rating: AA-, AA, AA+, or AAA. -5- Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 9 of 12 payments should grow as follows: four percent (4%) compounded annually from the date of judgment for non-medical items, and five percent (5%) compounded annually from the date of judgment for medical items. Petitioner agrees. 2. Life-Contingent Annuity The petitioner will continue to receive the annuity payments from the Life Insurance Company only so long as T.M. is alive at the time that a particular payment is due. Written notice shall be provided to the Secretary of Health and Human Services and the Life Insurance Company within twenty (20) days of T.M.’s death. 3. Guardianship/Conservatorship No payments shall be made until petitioner provides respondent with documentation establishing that she has been appointed as the guardian(s)/conservator(s) of T.M.’s estate. If petitioner is not authorized by a court of competent jurisdiction to serve as guardian(s)/ conservator(s) of the estate of T.M., any such payment shall be made to the party or parties appointed by a court of competent jurisdiction to serve as guardian(s)/conservator(s) of the estate of T.M. upon submission of written documentation of such appointment to the Secretary. Further, if guardianship/conservatorship is no longer required under the laws of the state of Illinois after T.M. has attained the age of majority, any such payment shall be paid to T.M. upon submission of written documentation of the termination of guardianship/conservatorship to the Secretary. 6 Petitioner authorizes the disclosure of certain documents filed by the petitioner in this case consistent with the Privacy Act and the routine uses described in the National Vaccine Injury Compensation Program System of Records, No. 09-15-0056. -6- Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 10 of 12 III. Summary of Recommended Payments Following Judgment A. Lump Sum paid to the court-appointed guardian(s)/ conservator(s) of the estate of T.M. for the benefit of T.M.: $1,537,438.76 B. Medicaid lien: $ 89,412.29 C. An amount sufficient to purchase the annuity contract described above in section II. C. Respectfully submitted, YAAKOV M. ROTH Acting Assistant Attorney General C. SALVATORE D’ALESSIO Director Torts Branch, Civil Division HEATHER L. PEARLMAN Deputy Director Torts Branch, Civil Division ALEXIS B. BABCOCK Assistant Director Torts Branch, Civil Division /s/ Meghan R. Murphy MEGHAN R. MURPHY Trial Attorney Torts Branch, Civil Division U. S. Department of Justice P.O. Box l46, Benjamin Franklin Station Washington, D.C. 20044-0146 Tel: (202) 616-4264 Email: Meghan.R.Murphy@usdoj.gov Dated: April 30, 2025 -7- Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 11 of 12 Appendix A: Items of Compensation for Weaver (Malone) Page 1 of 2 Lump Sum Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Compensation Year 1 Years 2-5 Years 6-11 Years 12-32 Years 33-Life 2025 2026-2029 2030-2035 2036-2056 2057-Life Ins Premium 5% M 4,151.64 4,151.64 4,151.64 4,151.64 Ins Maximum out of Pocket 5% 7,800.00 7,800.00 7,800.00 7,800.00 Medicare Part B Premium 5% M 2,220.00 Medicare Part B Deductible 5% 257.00 Medigap G 5% M 1,420.44 Medicare Part D 5% M 801.81 Neurology 5% * Mileage: Neurology 4% M 103.60 103.60 103.60 103.60 103.60 EEG 5% * Emergency Room 5% * Sedation for Dental Care 5% * Care Management 4% M 2,370.00 2,370.00 2,370.00 2,370.00 2,370.00 Levetiracetam 5% * Diastat 5% * Diapers 4% M 851.06 851.06 851.06 851.06 851.06 Disposable Underwear 4% M 184.47 184.47 184.47 184.47 184.47 Wipes 4% M 160.54 160.54 160.54 160.54 160.54 Reusable Underpads 4% M 42.90 42.90 42.90 42.90 42.90 Gloves 4% M 184.73 184.73 184.73 184.73 184.73 Communication Device 4% * Physical Therapy 4% * Physical Therapy Mileage 4% 302.40 151.20 Occupational Therapy 4% * Occupational Therapy Mileage 4% 302.40 151.20 Speech Therapy 4% * Speech Therapy Mileage 4% 302.40 151.20 Assistive Tech Evaluation 4% * ABA Assessment 4% * ABA Treatment 4% * Personal Care Attendant 4% M 52,920.00 52,920.00 52,920.00 Community Integrated Living 4% M 119,681.00 119,681.00 Weaver v. HHS, 16-1494 Tab A (Appendix A to Proffer) Page 1 of 2 Case 1:16-vv-01494-AOB Document 116 Filed 05/27/25 Page 12 of 12 Appendix A: Items of Compensation for Weaver (Malone) Page 2 of 2 Lump Sum Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Compensation Year 1 Years 2-5 Years 6-11 Years 12-32 Years 33-Life 2025 2026-2029 2030-2035 2036-2056 2057-Life Community Day Services 4% M 44,040.00 44,040.00 Transportation Allowance 4% M 3,353.00 3,353.00 Lost Future Earnings 1,217,762.62 Pain and Suffering 250,000.00 Medicaid Lien 89,412.29 Annual Totals 1,626,851.05 69,222.54 68,768.94 182,922.94 175,670.55 Note: Compensation Year 1 consists of the 12 month period following the date of judgment. Compensation Year 2 consists of the 12 month period commencing on the first anniversary of the date of judgment. As soon as practicable after entry of judgment, respondent shall make the following payment to the court-appointed guardian(s)/ conservators(s) of the estate of T.M. for the benefit of T.M., for lost future earnings ($1,217,762.62), pain and suffering ($250,000.00), and Yr 1 life care expenses ($69,676.14): $1,537,438.76. As soon as practicable after entry of judgment, respondent shall make the following payment jointly to petitioner and the State of Illinois, as reimbursement of the state's Medicaid lien: $89,412.29. Annual amounts payable through an annuity for future Compensation Years follow the anniversary of the date of judgment. Annual amounts shall increase at the rates indicated in column "G.R." above, compounded annually from the date of judgment. Items denoted with an asterisk (*) covered by health insurance and/or Medicare. Items denoted with an "M" payable in 12 monthly installments at the discretion of respondent. Weaver v. HHS, 16-1494 Tab A (Appendix A to Proffer) Page 2 of 2 ================================================================================ DOCUMENT 5: USCOURTS-cofc-1_16-vv-01494-5 Date issued/filed: 2025-12-19 Pages: 6 Docket text: PUBLIC DECISION (Originally filed: 11/24/2025) regarding 119 DECISION Fees Stipulation/Proffer. Signed by Chief Special Master Brian H. Corcoran. (ers) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-01494-AOB Document 120 Filed 12/19/25 Page 1 of 6 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-1494V * * * * * * * * * * * * * * * * * * * * * * * * * * EBONIE WEAVER, * parent of T.M., a minor, * Chief Special Master Corcoran * Petitioner, * Filed: November 24, 2025 * v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Edward Kraus, Kraus Law Group, LLC, Chicago, IL, for Petitioner. Meghan Murphy, U.S. Dep’t of Justice, Washington, DC, for Respondent. DECISION GRANTING IN PART MOTION FOR FINAL AWARD OF ATTORNEY’S FEES AND COSTS 1 On November 14, 2016, Ebonie Weaver, on behalf of her minor daughter, T.M., filed a petition seeking compensation under the National Vaccine Injury Compensation Program.2 Petition (ECF No. 1) at 1. Petitioner alleged that T.M. suffered a “seizure disorder and its sequelae that were more likely than not caused by an adverse reaction to DTaP, Hib, IPV, Rotateq, and hepatitis B vaccines administered to her on December 10, 2013.” Id. Petitioner succeeded in establishing entitlement, and damages were issued in this case this past spring. 1 Under Vaccine Rule 18(b), each party has fourteen (14) 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 present form. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”). Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix). Case 1:16-vv-01494-AOB Document 120 Filed 12/19/25 Page 2 of 6 Petitioner has now filed a motion for a final award of attorney’s fees and costs. Motion for Final Award of Attorney’s Fees and Costs, dated Oct. 31, 2025 (ECF No. 117) (“Mot.”). This is Petitioner’s second, final fees and costs request (Petitioner originally filed for, and was granted, Interim Fees in 2022 (Decision, dated Aug. 25, 2022 (ECF No. 77) (“Interim Fee Dec.”)). The expenses requested in Petitioner’s Final Motion for Attorney’s Fees and Costs were incurred after filing their Motion for Interim Fees. Mot. at 1. Petitioner requests $121,257.38 in fees and costs (reflecting $75,555.20 in attorney’s fees and $15,639.95 in costs for the work performed by attorneys at Kraus Law Group, plus $45,702.18 in Petitioner’s outstanding costs to establish and maintain a guardianship over T.M.’s estate). Mot. at 1. Respondent reacted to the present fees request on November 3, 2025. See Response, dated Nov. 3, 2025 (ECF No. 118) (“Resp.”). Respondent agrees that Petitioner has satisfied the statutory requirement for a fees award, and otherwise defers the calculation of the amount to be awarded to my discretion. Resp. at 2–3. Petitioner did not file a Reply. For the reasons set forth below, I hereby GRANT IN PART Petitioner’s motion, awarding fees and costs in the total amount of $121,041.38. ANALYSIS I. Calculation of Attorney’s Fees Because Petitioner’s claim was successful, she is entitled to a fees and costs award— although only “reasonable” fees or costs may be awarded in the Program. Determining the appropriate amount of the fees award is a two-part process. The first part involves application of the lodestar method—“multiplying the number of hours reasonably expended on the litigation times a reasonable hourly rate.” Avera v. Sec’y of Health & Hum. Servs., 515 F.3d 1343, 1347–48 (Fed. Cir. 2008) (quoting Blum v. Stenson, 465 U.S. 886, 888 (1984)). The second part involves adjusting the lodestar calculation up or down to take relevant factors into consideration. Id. at 1348. This standard for calculating a fee award is considered applicable in most cases where a fee award is authorized by federal statute. Hensely v. Eckerhart, 461 U.S. 424, 429–37 (1983). An attorney’s reasonable hourly rate is determined by the “forum rule,” which bass the proper hourly rate to be awarded on the forum in which the relevant court sits (Washington, D.C., for Vaccine Act cases), except where an attorney’s work was not performed in the forum and there is a substantial difference in rates (the so-called “Davis” exception”). Avera, 515 F.3d at 1348 (citing Davis Cty. Solid Waste Mgmt. & Energy Recovery Special Serv. Dist. v. U.S. Envtl. Prot. Agency, 169 F.3d 755, 758 (D.C. Cir. 1999)). A 2015 decision established the hourly rate ranges for attorneys with different levels of experience who are entitled to the forum rate in the Vaccine 2 Case 1:16-vv-01494-AOB Document 120 Filed 12/19/25 Page 3 of 6 Program. See McCulloch v. Sec’y of Health & Hum. Servs., No. 09-293V, 2015 WL 5634323, at *19 (Fed. Cl. Spec. Mstr. Sept. 1, 2015). Petitioner requests the following rates for her attorney and support staff, based on the years work was performed: 2022 2023 2024 2025 Amy Kraus $494.00 $436.00 N/A $494.00 (Attorney) Edward Kraus $472.00 $497.00 $525.00 $564.00 (Attorney) Brynna Gang $350.00 N/A $412.00 $443.00 (Attorney) Amanda Ramos $170.00 $177.00 $186.00 N/A (Paralegal) Megan N/A N/A N/A $180.00 Vignocchi (Paralegal) Mr. Kraus, Mrs. Kraus, and Ms. Gang practice in Chicago, IL—a jurisdiction that has been deemed “in forum.” Accordingly, counsel should be paid forum rates as established in McCulloch. See Piatek v. Sec'y of Health & Hum. Servs., No. 16-524V, 2021 WL 5755318 (Fed. Cl. Spec. Mstr. Sept. 20, 2021). Upon review, most of the requested hourly rates are consistent with the OSM Attorneys’ Forum Hourly Rate Fee Schedules and what has been awarded to these practitioners in the past. I will, however, adjust Ms. Kraus’s 2022 rate to $414.00, consistent with the rate I awarded her in my Decision granting Petitioner’s Interim Fee request. Interim Fee Dec. at 3. This reduces the amount of fees to be awarded by $216.00.3 Otherwise, I find the time devoted to the matter since the first interim award to have been reasonable, and will make no adjustments to the award in that respect. II. Calculation of Attorney’s Costs Petitioners seeks $45,702.18 in outstanding costs, comprised of $15,639.95 in outstanding litigation costs, $10,193.77 in costs to establish a minor guardianship of T.M.’s estate, and $19,868.46 in costs to maintain guardianship of T.M.’s estate for six years. Mot. at 1. 3 Calculated by: $494.00 – $414.00 = $80 x (0.4 hours + 2.30 hours) = $216.00. See Mot. at 5 (fee entries dated Aug. 11, 2022). 3 Case 1:16-vv-01494-AOB Document 120 Filed 12/19/25 Page 4 of 6 a. Litigation Costs Just as they are required to establish the reasonableness of requested fees, petitioners must also demonstrate that requested litigation costs are reasonable. Presault v. United States, 52 Fed. Cl. 667, 670 (2002): Perreira v. Sec’y of Dep’t of Health & Hum. Servs., 27 Fed. Cl. 29, 34 (1992). Reasonable costs include the costs of obtaining medical records and expert time incurred while working on a case. Fester v. Sec’y of Health & Hum. Servs., No. 10-243V, 2013 WL 5367670, at *16 (Fed. Cl. Spec. Mstr. Aug. 27, 2013). When petitioners fail to substantiate a cost item, such as by not providing appropriate documentation to explain the basis for a particular cost, special masters have refrained from paying the cost at issue. See, e.g., Gardner-Cook v. Sec’y of Health & Hum. Servs., No. 99-480V, 2005 WL 6122520, at *4 (Fed. Cl. Spec. Mstr. June 30, 2005). Petitioner seeks $15,639.95 in outstanding costs, including the filing fee, medical record retrieval costs, mailing costs, and costs associated with the work of Medical Legal Services for the coordination of future care, report, and plan for the Petitioner. Mot. at 31–93. I find those costs requested to be reasonable overall, they shall be reimbursed in full. All other requested costs in this matter are commonly incurred in the Vaccine Program and are reasonable herein. b. Costs to Establish a Minor Guardianship over T.M.’s Estate Petitioner also seeks reimbursement of attorneys’ fees and costs related to the guardianship proceedings undertaken by Anthony M. Abou Ezzi of Ezzi Law and for the projected maintenance of the guardianship for T.M., until T.M. reaches the age of majority. See Mot. at 1, 95–105. Special Masters have awarded fees-related costs incurred in the establishment of a guardianship estate, and also where guardianship is incorporated into the terms of stipulation or proffer. See e.g., Strickland v. Sec'y of Health & Hum. Servs., No. 18-269V, 2023 WL 2364907, at *8 (Fed. Cl. Mar. 6, 2023); Martin v. Sec'y of Health & Hum. Servs., No. 16-318V, 2019 WL 625442 (Fed. Cl. Spec. Mstr. Jan 22, 2019); Derenzo v. Sec'y of Health & Hum. Servs., No. 16- 35V, 2018, WL 1125231 (Fed. Cl. Spec. Mstr. Jan 9, 2018); Cansler v. Sec'y of Health & Hum. Servs., No. 09-596V, 2011 WL 597791, at *3 (Fed. Cl. Spec. Mstr. Feb. 2, 2011). Here, Petitioner’s guardianship attorney, Mr. Ezzi, incurred fees and costs relative to the establishment of a guardianship of the estate of T.M. in the amount of $13,193.77 - $12,802.50 in fees for the establishment of the guardianship, and $391.27 for costs associated with establishing the guardianship. Mot. at 101–102. Mr. Ezzi charged at an hourly rate of $300.00 per hour for work performed in 2023, and $325 for work performed in 2024 and 2025. Id. at 95–102. Mr. Kraus issued a $3,000.00 retainer to Mr. Ezzi, and I have already reimbursed that expense in the section above. So I need to weigh and decide the reasonableness of the remaining $10,193.77. As the 4 Case 1:16-vv-01494-AOB Document 120 Filed 12/19/25 Page 5 of 6 establishment of the guardianship was necessary for compensation to be awarded, these fees and costs shall be awarded in full. c. Petitioner’s Costs to Maintain a Minor Guardianship over T.M.’s Estate Petitioner additionally requests that the fees and costs associated with the maintenance of the guardianship of T.M.’s estate be reimbursed - in the amount of $19,868.46. Mot. at 1–2. This amount consists of an expected $3,954.00 per year for six years (when T.M. reaches the age of majority), reduced to present day value using a 3% return rate. Id. at 1–2, 103–105 In support of this request, petitioner submitted an invoice from Mr. Ezzi which outlined the number of hours per year and costs associated with maintaining and discharging T.M.s’ estate for one year. Mot. at 103–05. Expenses used to maintain a minor guardianship were only considered an allowable expense recently, when the Federal Circuit ruled that the expenses of the creation and maintenance of a guardianship come within Section 15(e)(1) of the Vaccine Act, and are therefore an allowable expense. McCulloch v. Sec'y of Health & Hum. Servs., 923 F.3d 998 (Fed. Cir. 2019). Thus, this class of expense is compensable. And I have reviewed the projected expenses to comply with the requirements of the state court, and deem them reasonable. Petitioner will be awarded a total of $19,868.46 for the maintenance of the guardianship of T.M.’s estate. CONCLUSION Based on the foregoing, and in the exercise of the discretion afforded to me in determining the propriety of a final fees award, I GRANT IN PART Petitioner’s Motion for Attorney’s Fees and Costs awarding total amount of $121,041.38, reflecting (a) $75,339.20 in attorney’s fees and $15,639.95 in costs; and (b) $45,702.18 in Petitioner’s unreimbursed costs and future costs to establish and maintain a guardianship over T.M.’s estate, 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 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. 5 Case 1:16-vv-01494-AOB Document 120 Filed 12/19/25 Page 6 of 6 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 6