VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-00642 Package ID: USCOURTS-cofc-1_17-vv-00642 Petitioner: Elizabeth Doles Filed: 2017-05-16 Decided: 2025-07-11 Vaccine: polio; Tdap Vaccination date: 2016-04-04; 2016-04-22 Condition: significant aggravation of multiple sclerosis / CNS demyelination Outcome: compensated Award amount USD: 137400 AI-assisted case summary: On May 16, 2017, Elizabeth Doles filed a petition alleging that a polio vaccine administered on April 4, 2016, and a Tdap vaccine administered on April 22, 2016, caused her to suffer from Acute Disseminated Encephalomyelitis (ADEM). She later amended her petition to allege central nervous system (CNS) demyelination, best characterized as multiple sclerosis (MS), and that the vaccines either caused or significantly aggravated her condition. The case proceeded as an off-Table claim, as ADEM and MS are not listed on the Vaccine Injury Table for these vaccines. Initially, Special Master Millman noted a conflict in diagnosis, suggesting MS was more likely than ADEM, and that symptoms appeared to begin around June 4, 2016. Respondent's Rule 4(c) report recommended against compensation, citing an unclear diagnosis and failure to prove causation. Petitioner's treating physician, Dr. Slavenka Kam-Hansen, opined that Petitioner suffered from ADEM caused by the vaccinations. However, another expert retained by Petitioner, Dr. John G. Steel, opined that Petitioner had MS, not ADEM, and that the vaccines "unmasked" her underlying, asymptomatic MS or radiographically isolated syndrome (RIS), leading to an attack of focal myelitis or transverse myelitis (TM). Dr. Steel argued that while vaccines do not typically cause MS in healthy individuals, they can trigger attacks in susceptible individuals with subclinical MS. Respondent's expert, Dr. Subramaniam Sriram, agreed that Petitioner had MS but concluded the vaccines did not cause or exacerbate it, and that MS diagnosis precluded a separate diagnosis of TM. Special Master Daniel T. Horner issued a ruling on entitlement on February 1, 2021, finding that Petitioner was entitled to compensation for a significant aggravation of her pre-existing MS, rather than a separate attack of TM. He concluded that the medical evidence, including expert opinions from Dr. Steel and Dr. Sriram, indicated Petitioner had pre-existing, clinically silent MS prior to vaccination. Special Master Horner relied on the Langer-Gould study, interpreting it as evidence that vaccines could aggravate subclinical autoimmunity into overt MS. On review, Judge Stephen S. Schwartz vacated this decision, finding that the Special Master had misinterpreted the Langer-Gould study and that the parties had not been given a fair opportunity to address the Special Master's theory of significant aggravation of MS. The case was remanded. On remand, the original Special Master again found entitlement for significant aggravation of MS, this time explicitly grounding the decision in Dr. Steel's opinions. Judge Schwartz again vacated the decision, finding the Special Master's interpretation of Dr. Steel's opinions inconsistent with his prior ruling and arbitrary and capricious, and reassigned the case to a new Special Master. The new Special Master, on September 20, 2023, found that Petitioner had not met her burden of proof for causation, specifically under Loving prong four/Althen prong one, and denied the petition. She concluded that Petitioner had not provided a sound and reliable medical or scientific explanation for how the vaccines could have significantly aggravated her MS. While she noted that she would have found the Langer-Gould study supportive of Petitioner's theory if she had considered it, she ultimately found that the study's findings did not support causation in Petitioner's specific circumstances and that Petitioner's other evidence was insufficient. Petitioner's motion for review of this decision was denied by Judge Schwartz, who sustained the Special Master's decision to deny the petition, finding that the Special Master's error in disregarding the Langer-Gould study was harmless because, even if considered, it would not have changed the outcome, and Petitioner's other evidence was insufficient. On October 5, 2021, Special Master Horner issued a decision awarding damages based on a stipulation. Petitioner Elizabeth Doles was awarded a lump sum of $137,400.00, consisting of $135,000.00 for pain and suffering and $2,400.00 for past unreimbursable expenses. This award was based on the prior entitlement ruling that Petitioner's MS was significantly aggravated by the Tdap and polio vaccines. The later supplemental record reflects the case's extended remand path. After multiple judge-review opinions and reassignment, a 2025 remand proffer again awarded Ms. Doles $137,400.00, consisting of $135,000.00 for pain and suffering and $2,400.00 for past unreimbursable expenses. Theory of causation field: Polio vaccine on April 4, 2016, and Tdap vaccine on April 22, 2016, age 67, alleged to cause or significantly aggravate CNS demyelination later characterized as multiple sclerosis, with symptom onset around June 4, 2016. COMPENSATED after an unusually complex review/remand history. Initial entitlement was granted, damages of $137,400 were awarded, then respondent obtained review and remands over the Langer-Gould study and MS aggravation analysis; after reassignment and further proceedings, a 2025 remand proffer again awarded $137,400 ($135,000 pain and suffering + $2,400 past unreimbursable expenses). Latest damages/remand proffer decision filed July 11, 2025. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_17-vv-00642-0 Date issued/filed: 2021-02-26 Pages: 30 Docket text: PUBLIC DECISION (Originally filed: 2/1/21) regarding 73 Ruling on Entitlement. Signed by Special Master Daniel T. Horner. (et) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 1 of 30 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 17-642V Filed: February 1, 2021 PUBLISHED Special Master Horner ELIZABETH DOLES, Ruling on Entitlement; Ruling on Petitioner, the Written Record; Multiple v. Sclerosis; Significant Aggravation; Diphtheria SECRETARY OF HEALTH AND acellular Pertussis (Tdap) HUMAN SERVICES, Vaccine; Polio Vaccine Respondent. Joseph Alexander Vuckovich, Maglio Christopher & Toale, PA, Washington, DC, for petitioner. Catherine Elizabeth Stolar, U.S. Department of Justice, Washington, DC, for respondent. RULING ON ENTITLEMENT1 On May 16, 2017, petitioner filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), alleging that she suffered acute disseminated encephalomyelitis (“ADEM”) as a result of her receipt of the polio vaccination on April 4, 2016 and/or the tetanus, diphtheria, and pertussis (“Tdap”) vaccination on April 22, 2016. (ECF No. 1.) On July 5, 2019, petitioner amended her petition, now alleging that the vaccinations she received in April of 2016 caused her central nervous system (“CNS”) demyelination best categorized as multiple sclerosis (“MS”). (ECF No. 44.) Petitioner alleged that her condition was caused, or alternatively significantly aggravated, by her vaccinations. (Id. at 2-3.) For the reasons set forth below I conclude that petitioner is entitled to compensation for a significant aggravation of her MS. 1 Because this decision contains a reasoned explanation for the special master’s action in this case, it will be posted on the United States Court of Federal Claims’ website in accordance with the E-Government Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the decision will be available to anyone with access to the Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information the disclosure of which would constitute an unwarranted invasion of privacy. If the special master, upon review, agrees that the identified material fits within this definition, it will be redacted from public access. 1 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 2 of 30 I. Applicable Statutory Scheme Under the National Vaccine Injury Compensation Program, compensation awards are made to individuals who have suffered injuries after receiving vaccines. In general, to gain an award, a petitioner must make a number of factual demonstrations, including showing that an individual received a vaccination covered by the statute; received it in the United States; suffered a serious, long-standing injury; and has received no previous award or settlement on account of the injury. Finally – and the key question in most cases under the Program – the petitioner must also establish a causal link between the vaccination and the injury. In some cases, the petitioner may simply demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be shown that the vaccine recipient suffered an injury of the type enumerated in the “Vaccine Injury Table,” corresponding to the vaccination in question, within an applicable time period following the vaccination also specified in the Table. If so, the Table Injury is presumed to have been caused by the vaccination, and the petitioner is automatically entitled to compensation, unless it is affirmatively shown that the injury was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A); § 300 aa- 11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B). In many cases, however, the vaccine recipient may have suffered an injury not of the type covered in the Vaccine Injury Table. In such instances, an alternative means exists to demonstrate entitlement to a Program award. That is, the petitioner may gain an award by showing that the recipient’s injury was “caused-in-fact” by the vaccination in question. § 300aa-13(a)(1)(B); § 300aa-11(c)(1)(C)(ii). In such a situation, of course, the presumptions available under the Vaccine Injury Table are inoperative. The burden is on the petitioner to introduce evidence demonstrating that the vaccination actually caused the injury in question. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1525 (Fed. Cir. 1991). The showing of “causation-in-fact” must satisfy the “preponderance of the evidence” standard, the same standard ordinarily used in tort litigation. § 300aa- 13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that standard, the petitioner must show that it is “more probable than not” that the vaccination was the cause of the injury. Althen, 418 F.3d at 1279. The petitioner need not show that the vaccination was the sole cause of the injury or condition, but must demonstrate that the vaccination was at least a “substantial factor” in causing the condition, and was a “but for” cause. Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). Thus, the petitioner must supply “proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury;” the logical sequence must be supported by “reputable medical or scientific explanation, i.e., evidence in the form of scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278; Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). A petitioner may not receive a Vaccine Program award based solely on his or her assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. § 300aa-13(a)(1). 2 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 3 of 30 In what has become the predominant framing of this burden of proof, the Althen court described the “causation-in-fact” standard, as follows: Concisely stated, Althen’s burden is to show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal relationship between vaccination and injury. If Althen satisfies this burden, she is “entitled to recover unless the [government] shows, also by a preponderance of the evidence, that the injury was in fact caused by factors unrelated to the vaccine.” Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner need not necessarily supply evidence from medical literature supporting petitioner’s causation contention, so long as the petitioner supplies the medical opinion of an expert. Id. at 1279-80. The court also indicated that, in finding causation, a Program fact-finder may rely upon “circumstantial evidence,” which the court found to be consistent with the “system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants.” Id. at 1280. Generally, respondent bears the burden of demonstrating the presence of any alternative cause by preponderant evidence only if petitioner satisfies her prima facie burden. § 300aa-13(a)(1)(B); Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146, 1150 (Fed. Cir. 2007). Respondent may also present evidence relating to an alternative cause to demonstrate the inadequacy of petitioner’s evidence supporting her case in chief, but petitioner does not bear the burden of eliminating alternative causes where the other evidence on causation is sufficient to establish a prima facie case under Althen. de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352-53 (Fed. Cir. 2008); Walther, 485 F.3d at 1150. In this case, petitioner has alleged first and foremost that her Tdap and/or polio vaccines caused her to suffer ADEM, MS, or, more generally, central nervous system demyelination. Because these conditions are not listed on the Vaccine Injury Table relative to either the Tdap or polio vaccines, petitioner would need to satisfy the above- described Althen test for establishing causation-in-fact to prevail on the basis that her vaccinations initially caused her condition. Significantly, however, respondent argues that petitioner suffered underlying, pre-existing MS that prevents her from demonstrating that her vaccinations initially caused her central nervous system demyelination. (ECF No. 70, p. 23.) This raises an additional question of whether petitioner may have nonetheless experienced any significant aggravation of that condition consistent with her alternative pleading of the claim. (ECF No. 44, pp. 2-3.) The Vaccine Act defines a significant aggravation as any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness 3 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 4 of 30 accompanied by substantial deterioration of health. § 300aa-33(4). Where a petitioner in an off-Table case is seeking to prove that a vaccination aggravated a pre-existing injury, petitioners must establish the three Althen prongs along with three additional factors described in the prior Loving case. See Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144 (Fed. Cl. 2009) (combining the first three Whitecotton factors for claims regarding aggravation of a Table injury with the three Althen factors for off table injury claims to create a six-part test for off-Table aggravation claims); see also W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013)(applying the six-part Loving test.). The additional Loving factors require petitioners to demonstrate aggravation by showing: (1) the vaccinee’s condition prior to the administration of the vaccine, (2) the vaccinee’s current condition, and (3) whether the vaccinee’s current condition constitutes a “significant aggravation” of the condition prior to the vaccination. Id. For the reasons discussed below, I conclude that this claim is best addressed under the significant aggravation test articulated in Loving. II. Procedural History This case was originally assigned to Special Master Millman. (ECF No. 4.) Upon review of the records filed initially (Exs. 1-12), Special Master Millman raised the issue of a conflict in diagnosis. (ECF No. 9.) Special Master Millman suggested that the medical records favored the diagnosis of multiple sclerosis (“MS”) rather than ADEM. (Id. at 1.) Additionally, Special Master Millman noted that upon her review of the records, it appears that petitioner’s onset of symptoms was June 4, 2016. (Id.) Subsequently, petitioner filed additional records and a Statement of Completion. (ECF Nos. 14-16.) On April 24, 2018, respondent filed his Rule 4(c) report, recommending against compensation. (ECF No. 21.) Respondent indicated that the medical records presented an unclear diagnosis, and even assuming petitioner can establish that she suffered ADEM, petitioner failed to meet her burden in proving causation. (Id. at 16-17.) On May 30, 2018, petitioner filed a letter from her treating physician, Dr. Slavenka Kam-Hansen to support her claim. (ECF No. 23; Ex. 17.) Dr. Kam-Hansen opined that petitioner suffered ADEM. (Id.) Respondent indicated that he intended to continue defending the claim. (ECF Nos. 24, 25.) However, petitioner advised an additional report from a different expert would be filed and, on May 24, 2019, petitioner filed a report from Dr. John G. Steel. (ECF No. 34; Ex. 20.) Dr. Steel did not support Dr. Kam-Hansen’s ADEM opinion. This case was reassigned to my docket on June 6, 2019 upon Special Master Millman’s retirement. (ECF No. 41.) Respondent requested that petitioner file an amended petition and updated medical records clarifying the nature of the injury in light of Dr. Steel’s report opining that petitioner has MS rather than ADEM. (ECF No. 42.) On July 5, 2019, petitioner filed an amended petition alleging that her vaccinations caused her to suffer from “residual effects and complications of CNS demyelination, 4 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 5 of 30 including but not limited to: fatigue, significantly heightened temperature sensitivity, pain and neuropathy in her right upper extremity, and the severe emotional and psychological effects of these and other chronic symptoms,” noting that Dr. Steel felt the condition was best categorized as MS. (ECF No. 44, p. 2.) In response, respondent filed a report from neurologist, Dr. Subramaniam Sriram. (ECF No. 52.) On January 31, 2020, petitioner filed a supplemental expert report responding to respondent’s expert report. (ECF No. 57.) Thereafter, respondent filed his supplemental expert report from Dr. Sriram on May 14, 2020. (ECF No. 62.) Petitioner then requested that this case be resolved based on the written record. (ECF No. 63.) On July 29, 2020, petitioner filed a motion for findings of facts and conclusions of law accompanied by a supporting memorandum. (ECF Nos. 67, 68.) Petitioner, in her motion, alleges that the polio and Tdap vaccinations administered on April 4 and 22, 2016 triggered an attack of acute partial transverse myelitis (“APTM”), revealing petitioner’s clinically silent MS. (ECF No. 68.) On October 27, 2020, respondent filed a response contending that petitioner had not met her burden of proof and that the case should be dismissed. (ECF No. 70.) Petitioner filed a reply on December 4, 2020. (ECF No. 72.) Special masters “must determine that the record is comprehensive and fully developed before ruling on the record.” Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (citing Simanski v. Sec’y of Health & Human Servs., 671 F.3d 1368, 1385 (Fed. Cir. 2012); Jay v. Sec’y of Health & Human Servs., 998 F.2d 979, 983 (Fed. Cir. 1993.)); see also Vaccine Rule 8(d); Vaccine Rule 3(b)(2). The parties must have a full and fair opportunity to present their case and develop a record sufficient for review. Id. In light of all of the above, and upon review of the entire record, I conclude that the parties had a full and fair opportunity to develop the record of this case and that the case is ripe for resolution on the existing record. III. Medical History a. Pre-Vaccination Petitioner, 67 at the time of the vaccinations at issue, has a history of Graves’ disease. (Ex. 2, p. 51-54.) Petitioner sought treatment at Cambridge Health Alliance for her hypothyroid condition. (Ex. 3.) Her primary care records from 2010 to 2012 indicated she also had a bladder hernia, degenerative joint disease, and underwent a hysterectomy. (Id.) She is allergic to penicillin. (Id. at 7.) Petitioner has received several vaccinations in the past. (Id.) In 2011, petitioner received a physical exam in order to travel to Sri Lanka for work. (Id. at 28.) Her exam was normal and she requested several immunizations, denying any allergies to flu vaccine and history of Guillan-Barre syndrome. (Id. at 29-30, 33.) In 2015, petitioner had a physical therapy evaluation for ongoing knee and hip pain that worsened over 10 years. (Ex. 4, p. 141- 43; Ex. 14, p. 44.) 5 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 6 of 30 b. Vaccination and Initial Treatment Petitioner received a polio vaccination on April 4, 2016 and a Tdap vaccination more than two weeks after on April 22, 2016. (Ex. 1.) Petitioner had a mammogram and pap smear on April 4, 2016 (Ex. 5) and an evaluation for colonoscopy on April 8, 2016 (Ex. 7.) Petitioner had a colonoscopy on April 13, 2016. (Ex. 4, p. 116; Ex. 7, p. 6; Ex. 14, p. 28.) On April 21, 2016, petitioner visited Capital Cardiology Associate PA for an evaluation of an abnormal EKG. (Ex. 14, p. 24.) Dr. Bipinpreet Nagra recommended an echocardiogram and stress test due to petitioner’s family history. (Id.) On April 22, 2016, petitioner visited Lotus Medical Care for “PPD reading,2 Tetanus shot, forms to be signed.” (Ex. 19, p. 3.) Dr. Arkadiy Shraytman noted the visit was for screening of tuberculosis, follow up exam, and immunization. (Id. at 5.) Petitioner returned to Lotus Medical Center on May 27, 2016 for “Polio titer” and low back pain and primary generalized osteoarthritis were also noted as problems. (Id. at 7.) On June 1, 2016, petitioner visited Lotus Medical again to review her results and occipital neuralgia and iodine-deficiency were noted. (Id. at 10-12.) On June 5, 2016, petitioner sought treatment at Capital Health Regional Medical Center emergency room for right side weakness and numbness, which began two nights prior. (Ex. 2, p. 50-51.) Two hours prior to arriving at the emergency room, petitioner reported experiencing itchiness and redness from scratching along AC joint and right shoulder. (Ex. 8, p. 39.) Petitioner had a consultation for a transient ischemic attack (TIA). (Ex. 8, p. 2.) Petitioner presented with achy pain in her right upper extremity, including her shoulder, neck stiffness, and mild weakness in her right grip. (Id.) Petitioner’s head CT did not show any acute changes, only chronic lacunar infarctions. (Id.) Dr. Rajat Kumar examined petitioner and assessed that she presented with transient right upper extremity achiness and grip weakness. Dr. Kumar indicated that petitioner’s CAT scan found lacunar infarcts and therefore, recommended additional imaging. (Ex. 2, pp. 60-61.) Petitioner underwent several imaging studies on June 5, 2016. Her angiography of the neck and head without contrast found no evidence of aneurysmal dilation or significant stenosis. (Id. at 36-37, 42-43.) Petitioner’s brain MRI without contrast found no acute infarction, intracranial mass or hemorrhage, but did find multiple nonspecific foci of white matter hyperintensity that suggest a clinical diagnosis of a demyelinating disease. (Id. at 40.) Petitioner’s head CT without contrast also found no signs for acute intracranial hemorrhage, but revealed patchy regions of white matter hypoattenuation that may reflect microvascular ischemic changes, age indeterminate infarcts, and/or demyelinating disease. (Id. at 47-48.) Additionally, right maxillary sinus disease was noted. (Id. at 48.) Petitioner received steroids and her symptoms improved. (Ex. 8, p. 54.) Petitioner was discharged to 2 PPD refers to a tuberculin skin test. 6 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 7 of 30 rehab and was found to have an acute demyelinating disease with transverse myelitis.3 (Ex. 8, p. 33. 54.) The next day, petitioner returned to Capital Health and was admitted. (Ex. 4, p. 43.) Petitioner also saw Dr. Kumar again for a neurology consult for weakness. Dr. Kumar noted white matter lesions in the periventricular region and subcortically that do not demonstrate enhancement, but observed active demyelinating disease in the right lateral cervical area at C3-C4 that did enhance. (Ex. 8, p. 74.) Dr. Kumar assessed petitioner with acute demyelinating CNS disease, noting her presentation was “suggestive of multiple sclerosis.” (Ex. 8, pp. 71-76.) Petitioner received a consultation from Dr. Michael S. Beede on June 11, 2016, for “positive ANA, in the context of previous Graves disease, and with new multiple sclerosis.” (Ex. 8, p. 64.) Petitioner’s brain and cervical MRI were compatible with the diagnosis of MS. (Id. at 64, 152.) Dr. Beede indicated that the positive ANA may be either from petitioner’s thyroid disease or MS. (Id. at 65.) Petitioner underwent various MR imaging on June 6, 2016. (Ex. 2, pp. 16-28.) An MRI of the thoracic spine with and without contrast revealed overall no abnormal signal or enhancement within the thoracic spinal cord. (Id. at 16.) However, certain regions demonstrated enhancement that were indeterminate and there were mild degenerative changes in the thoracic spine. (Id. at 16-17.) Additionally, there was a small disc protrusion that caused mild right subarticular zone stenosis. Follow up was recommended. (Id. at 17.) The MRI of the lumbar spine with and without contrast showed degenerative changes in the lumbar spine and a possible impingement upon certain nerve roots. Additionally, the MRI findings also suggested an atypical hemangioma and follow up was recommended. (Id. at 20-21.) The MRI of the cervical spine with and without contrast found an abnormal signal within the spinal cord involving the right lateral column. (Id. at 23-24.) The brain MRI with and without contrast taken on June 6, 2016 was compared with the MRI without contrast taken on the day before. The more recent MRI still showed multiple regions of white matter hyperintensity mostly in the periventricular and subcortical area running perpendicular to the ependymal surface regions; however, the white matter lesions did not demonstrate enhancement. (Ex. 2, pp. 27-28.) She had a chest x-ray that showed bibasilar subsegmental atelectasis and cardiomegaly. (Id. at 31.) And petitioner’s head CT did not reveal any acute intracranial findings. However, “scattered areas of white matter hypoattenuation are unchanged with corresponding signal abnormality on the preceding brain MRI, most compatible with a demyelinating process. There is no mass effect.” (Id. at 34.) Petitioner was discharged to rehab from Capital Health on June 14, 2016 with multiple diagnoses including acute demyelinating CNS disease/multiple sclerosis, acute weakness of the right side. (Id. at 50.) During her stay, petitioner was found to have an acute demyelinating disease with TM and was treated with high dosage of steroids. 3 In fact, the discharge diagnosis was “acute demyelinating CNS disease/multiple sclerosis.” (Ex. 8, p. 54.) Only the “hospital course” notation references “acute demyelinating disease with transverse myelitis.” (Id.) 7 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 8 of 30 Petitioner showed drastic improvements but was still weak and therefore needs rehab and a neurological follow up. (Id. at 51.) Petitioner was admitted into St. Lawrence Rehabilitation Center for general debility upon discharge from Capital Health. (Ex. 4, p. 10.) Dr. Madhu Jain, upon review of systems, noted that petitioner reported double vision in the right eye (premorbid). (Id.) Upon examination, petitioner was noted with decreased grip strength and overall strength, decreased fine motor control, and decreased balance. Dr. Jain’s impression was mild right-side weakness with new onset diagnosis of MS post steroid therapy with continued weakness in right upper and lower extremity. Petitioner was recommended both physical and occupational therapy to address transfers, ambulation, and self-care. (Id. at 11.) On June 23, 2016, petitioner visited Dr. Shukia for a follow up evaluation of her right-sided weakness. (Ex. 2, p. 2.) Petitioner reported that while she was at Capital Health System, she had a brain MRI that showed some white matter changes, but a couple of days after being discharged, she experienced right leg weakness and returned for a C-spine MRI, which showed an enhancing area of abnormal signal. (Id. at 3.) Petitioner sought treatment at St. Lawrence Rehab and reported that her strength significantly improved. Dr. Shukia reported that other than a mild limping feeling in the right leg, petitioner seemed to have returned to baseline. Dr. Shukia suggested a full work up including a spinal tap. However, he noted that petitioner did not have any episode of blindness and that “this lesion in the C-spine is also not more than 2 segments of the cervical column.” Petitioner also visited Dr. Shukia on July 14, 2016 for a follow up evaluation for history of possibility of demyelinating disease. (Ex. 2, p. 1.) Dr. Shukia noted that petitioner had a “somewhat bloody” spinal tap that tested positive for oligoclonal bands. (Id.) Upon physical examination, petitioner presented normal upper and lower extremity strength. Dr. Shukia’s impression was that petitioner presented with a demyelinating disease, most likely MS and discussed petitioner’s options regarding treatment and medicine during this visit. (Id.) Petitioner had an occupational therapy evaluation and treatment on June 27, 2016 for MS exacerbation. (Ex. 4, p. 43.) Petitioner showed improvements after one month in rehabilitation in upper extremity strength, coordination, and endurance, but had mild deficits in right shoulder strength and fine motor coordination. (Ex. 4, p. 46.) c. Subsequent Post-Vaccination History On July 6, 2016, petitioner received an initial consultation from Dr. Chitharanjan Rao at the Lawrenceville Neurology Center. (Ex. 4, p. 8.) Dr. Rao’s assessment was that petitioner has a history of acute/subacute onset right sided weakness since June 5, 2016 “in the setting of TDP vaccination in early April 2016.” (Id.) However, the symptoms have nearly resolved and no further episodes, and therefore petitioner is normal from a neurological standpoint notwithstanding the mild sensory loss in her left hand and diffuse hyperreflexia. Dr. Rao diagnosed petitioner with likely ADEM, probably related to her vaccination, but MS is a possibility. (Id.) Dr. Rao recommended 8 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 9 of 30 continuing physical and occupational therapy and avoiding receiving vaccinations for the season. (Id. at 9.) Petitioner returned to Lotus Medical on July 12, 2016 for a follow up appointment post hospitalization for possible MS. (Ex. 19, p. 12.) Dr. Shraytman ruled out ADEM, but noted MS and low back pain among petitioner’s list of problems. (Id. at 13-14.) Aside from seeking treatment from Dr. Rao, petitioner continued visiting Dr. Shukia for her demyelinating disease. (Ex. 4, p. 104; Ex. 14, p. 18.) Dr. Shukia continued to believe that petitioner most likely has MS. (Id.) Petitioner had a broken pinky toe and was treated at Champion Orthopedics on August 1, 2016. (Ex. 4, pp. 95- 97.) Petitioner underwent physical therapy at St. Lawrence Rehabilitation Center from June 27, 2016 and was discharged on August 10, 2016. (Ex. 6.) Petitioner “progressed very well with therapy [and met] all goals therefore has been discharged with [home exercise program].” (Id. at 5.) A cervical spine MRI performed on August 17, 2016 again showed lesions and enhancement compatible with a demyelinating process related to petitioner’s history of MS. (Ex. 4, p. 49-51.) Petitioner received a follow up evaluation for her MS from Dr. Rao on August 19, 2016.4 (Ex. 4, p. 1; Ex. 14, p. 1.) According to Dr. Rao, petitioner’s VEP tests indicated a mild conduction delay involving the right optic nerve but her spinal tap was traumatic and negative for oligoclonal bands.5 (Ex. 4, p. 1, 33-35, 52.) Petitioner reported paresthesia in her right and left upper extremity, numbness in her left hand, hyperpathia to touch, but believed she was much better with nearly normal gait. (Id. at 1.) Upon review of petitioner’s MRI imaging, Dr. Rao indicated that the results were consistent with a history of MS and that no new abnormal findings were detected. (Id. at 2.) Petitioner began receiving primary care at Beth Israel Deaconess Medical Center after moving back to Boston from New Jersey in September 2016. (Ex. 11, p. 2.) Petitioner reported that three neurologists had diagnosed her with MS; however, she “saw a neurologist in whom she now has a lot of confidence who diagnosed her as having [ADEM].” (Id.) Petitioner reported experiencing continuing weakness and dysesthesias and acute cramping in right upper extremity. (Id.) Dr. Harvey Bidwell noted ADEM after polio vaccine and Tdap injection as part of petitioner’s history of present illness. (Id. at 12.) Dr. Bidwell accepted petitioner’s diagnosis of ADEM and referred petitioner for physical and occupational therapy. (Id. at 25.) In addition, petitioner saw Simone D. Martell, LCSW for emotional support in coping with a neurological disease diagnosis. (Id. at 10-12, 17-21.) 4 Petitioner additionally had follow-up visits with Dr. Rao on July 28, 2016 August 18, 2016. The exams were similar and Dr. Rao had the same observations/conclusions. 5 As Special Master Millman previously observed, Dr. Rao incorrectly stated that petitioner did not have oligoclonal bands and seemed unaware that petitioner had abnormal VEP on the right. (ECF No. 9, p. 1.) Dr. Rao concluded that the lesions of her spinal cord were consistent with petitioner’s history of MS, yet Dr. Rao concluded that petitioner did not have MS but ADEM. (Id.) 9 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 10 of 30 On September 20, 2016, petitioner was admitted to the emergency department at Beth Israel Deaconess Medical Central for seizures. (Ex. 10, p. 3.) Petitioner reported a recent diagnosis of ADEM6 and symptoms of aura and weakness to extremities (right7 leg arm and leg numbness). (Id. at 6, 8.) Petitioner had a neurology consult for right hand and leg spasms. (Id. at 27.) Upon examination Dr. Fay Gao found that petitioner had subjective positive sensory symptoms but no objective deficits to all sensory modalities tested. (Id. at 30.) Dr. Gao noted that “[w]hile tonic spasm can occur in the setting of recent demyelination, [petitioner] does not have any other significant signs of myelopathy such as weakness, loss of sensation, though her reflexes are somewhat brisk. A superimposed peripheral sensory neuropathy is possible as well.” (Id. at 30- 31.) In addition, since the symptoms were brief and resolved, Dr. Gao noted that petitioner should follow up with her neurologist and thus, no additional head imaging was ordered; however, Dr. Gao recommended blood work up and routine EEG. (Id. at 13, 31.) Petitioner was discharged on the same day. (Id. at 20, 26.) On September 27, 2016, petitioner had a neurological consultation with Dr. Slavenka Kam-Hansen for complaints of development of left lower leg burning following vaccinations. (Ex. 15, p. 5.) Toward the end of October in 2016, petitioner returned to the Japanese Acupuncture Center of Independent Practitioners for acupuncture treatment. (Ex. 9, p. 2.) Petitioner experienced “hot spots” in legs, fatigue, and symptoms in her right and left arm. (Id. at 3-6.) Petitioner continued seeking weekly treatment throughout 2016 and into January 2017 but remained symptomatic. (Id. at 6- 7.) Petitioner returned to Dr. Kam-Hansen seven weeks after her initial consultation on November 14, 2016. (Ex. 15, p. 15.) Dr. Kam-Hansen listed petitioner’s neurological problems as presumed ADEM following two vaccinations in April, where the onset of lower leg burning sensation and pressure in right shoulder began in May. (Id.) Dr. Kam-Hansen noted that petitioner was initially diagnosed with MS until Dr. Rao diagnosed ADEM instead. Petitioner reported continued burning sensation in her left shin, foot, and hip as well as throbbing, achy, and pins and needles sensation in her right shoulder running down to her fingertips. (Id.) Additionally, petitioner reported experiencing focal seizures again. (Id.) Dr. Kam-Hansen concluded that petitioner has ADEM rather than MS, but time will give a clearer diagnosis since recovery after ADEM can take months. (Id. at 16.) Subsequent imaging was ordered and petitioner returned to see Dr. Kam-Hansen to discuss the results. (Id. at 18.) Petitioner’s imaging did not show any new lesions and the cervical cord lesion decreased. (Id. at 18, 51-54) On March 23, 2017, petitioner received another physical therapy evaluation for her diffuse body aches, balance issues, and weakness. (Ex. 15, p. 21.) Petitioner reported sensitivity to cold in her right arm and hot spots and weakness in her legs. 6 Petitioner reported a possible diagnosis of ADEM or MS. (Ex. 10, p. 22.) 7 In another part of the emergency room records, it was noted that petitioner had left lower extremity numbness. (Ex. 10, p. 11.) 10 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 11 of 30 (Id.) The evaluation resulted in physical therapy diagnoses including impaired muscle performance and “impaired motor function and sensory integrity associated with non- progressive disorders of the CNS acquired in adolescent or adulthood.” (Id.) It was noted that petitioner’s presentation seems to be a combination of ADEM related impairments combined with deconditioning; however, petitioner had a good prognosis in light of high functionality and general improvement since onset of symptoms. (Id. at 25- 26.) She continued with therapy. On August 3, 2017, petitioner visited Dr. Bidwell for a follow up visit. Petitioner reported fatigue, incontinence, and remaining symptoms of burning sensation in her left shin and foot, throbbing, achy, and pins and needle sensation in her right shoulder to her fingertips. (Ex. 50, p. 4.) Dr. Bidwell assessed that petitioner has a history of ADEM following vaccination in April 2016 and still has fatigue, sensory and pain symptoms, and incontinence. (Id. at 6.) He added that petitioner’s November 2016 imaging did not show any new lesions and the lesions in her spinal cord decreased. (Id.) Additionally, petitioner saw Dr. Bidwell for urinary and fecal incontinence worsened by petitioner’s ADEM in August 17, 2017. (Ex. 15, p. 48; Ex. 50, p. 8-9.) Thereafter, petitioner had a urogynecology evaluation at Beth Israel Deaconess Medical Center in October 2017. (Ex. 16, p. 9; Ex. 50, p. 12.) Petitioner was diagnosed with Stage II cystocele and urogenital atrophy. (Ex. 50, p. 16.) Dr. Roger Lefevre indicated that “[a]lthough her documented ADEM lesions occur in the C3-C4 distribution, her urinary and fecal incontinence may be due in part to autonomic/neurogenic dysfunction in the setting of ADEM.” (Ex. 16, p. 13.) Petitioner visited the emergency department in late October 2017 due to swelling, pain, and tenderness in her right toes, which was caused by stubbing them against a chair. (Ex. 51, p. 37.) Petitioner had a closed displaced fracture, but otherwise stable and released home. (Id. at 39.) Additionally, on November 15, 2017, petitioner presented to Dr. Adam Landsman as a new patient with complaint of pain in her right foot. (Id. at 41.) Dr. Landsman did not recommend surgery, but instead for follow up evaluations and repeat radiographs. (Id. at 42.) Thereafter, also in November 2017, petitioner returned to Dr. Bidwell reporting that she had a fracture in her toe. (Ex. 50, p. 25.) Otherwise, this visit was similar to petitioner’s visit in August with no particular changes to petitioner’s neurological symptoms. (Id. at 25-28.) In early 2018, petitioner sought treatment again from Dr. David Baron, whom she last saw in 2012. (Ex. 51, p. 43.) Petitioner reported developing ADEM following polio and Tdap vaccinations and experiencing mild spasms in her left arm. (Id.) On March 22, 2018, petitioner went to the emergency department following a mechanical fall and complained of left wrist pain. (Id. at 46.) She was diagnosed with a closed nondisplaced fracture in her left hand. (Id. at 49.) During an encounter on August 13, 2018 with Dr. Baron, petitioner reported that her right arm numbness/encephalopathy “has not been as bad recently.” (Ex. 51, p. 57.) Dr. Baron accepted ADEM as the primary encounter diagnosis and noted that it was “thought due to vaccine.” (Id. at 58.) Two months later, during another encounter, 11 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 12 of 30 petitioner was minimally symptomatic and stopped taking gabapentin. (Id. at 61.) At this visit in October 2018, Dr. Baron assessed petitioner with neuropathic pain generally as the primary encounter diagnosis. (Id.) In March 2019, petitioner returned to Dr. Bidwell for a referral for physical therapy to improve balance and leg strength. (Ex. 50, p. 30.) Additionally, petitioner requested a form to that would allow her to avoid vaccinations. (Id.) Aside from Dr. Bidwell, petitioner also sought care at Cambridge Health Alliance. During a visit on March 27, 2019, petitioner indicated that she hasn’t had symptoms for the past two years, but started having right arm paresthesia and right shoulder pain over the past few days. (Ex. 51, p. 2; Ex. 53, p. 2.) After consulting with the on-call neurologist and Dr. Kam- Hansen, Dr. Jaeyoung Yang reported that petitioner’s neurological exam was normal. (Ex. 51, p. 67.) In April 2019, petitioner continued seeking urology treatment from Dr. Heidi Rayala. (Ex. 51, p. 7.) Dr. Rayala described petitioner as having a history of ADEM following vaccination in 2016, “which is when her urination problems started.” (Id.) In October 2019, petitioner visited Cambridge Health Alliance to visit Dr. Baron, her PCP. (Ex. 53, p. 2.) Dr. Baron noted that petitioner was doing well and the plan was to follow up with Dr. Kam-Hansen regarding her neurological symptoms. (Id. at 9.) IV. Expert Opinions a. Petitioner’s Experts i. Slavenka Kam-Hansen, M.D. On May 29, 2018, Dr. Slavenka Kam-Hansen, a treating neurologist, authored a letter indicating that petitioner first sought treatment at the Neurological Clinic of Beth Israel Deaconess Medical Center on September 27, 2016. (Ex. 17.) Dr. Kam-Hansen noted that petitioner’s multiple symptoms started a few weeks after being vaccinated for a Peace Corps mission. Dr. Kam-Hansen examined petitioner again on November 14, 2016 and found petitioner suffering from symptoms of pain, sensory changes and fatigue and sensory changes in her left leg. (Id. at 1.) Dr. Kam-Hansen characterized petitioner’s condition as ADEM, indicating that: [T]he fact that there was a temporal relationship between her symptom start and the preceding vaccination, as well as the lack of any prior neurological symptoms which would suggest the presence of MS before June of 2016, means that ADEM was more likely to cause her symptoms. MS affected individuals start having symptoms usually in the 3rd to 4th decennium of their life and [petitioner] did not have any of these-as a matter of fact, she wanted to join the Peace Corps which supports more her being in good physical shape and thus not affected by a chronic disease such as MS prior to her enlisting. 12 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 13 of 30 (Id.) Additionally, Dr. Kam-Hansen opined that it is highly likely the polio and Tdap vaccinations administered in April of 2016 caused petitioner to develop ADEM. She indicated that petitioner has a history of Graves disease, which increases the risk of other autoimmune conditions and stated that it has been established that vaccination can trigger an autoimmune process that leads to central nervous system demyelination. (Id. at 2.) Dr. Kam-Hansen concluded that “further immunization carries a high and unacceptable risk for [petitioner]” based on her view that petitioner’s ADEM was caused by the vaccinations petitioner received in April of 2016. (Id.) ii. John G. Steel, M.D., FAAN Additionally, petitioner retained board-certified neurologist, John G. Steel to support her claim. Dr. Steel received his medical degree from University of North Carolina School of Medicine in 1977 and completed his neurology residency from the University of California, San Francisco in 1981. (Ex. 20, p. 1.) Dr. Steel worked as clinical faculty for neurology with East Carolina School of Medicine for about 15 years and then practiced in a multispecialty group in New Bern, North Carolina until his retirement in 2017. (Id.) However, he retained an active license and continued doing medical legal consulting, including providing prior testimony in the Vaccine Program. (Id.) Dr. Steel opined that petitioner “experienced an attack of focal myelitis (inflammation of the spinal cord), caused by neuroimmune activation from receiving two vaccinations in close proximity.” (Ex. 20, p. 3.) Specifically, Dr. Steel indicated that the vaccinations “unmasked” the underlying, asymptomatic MS or radiographically isolated syndrome (“RIS”), referring to a common phenomenon where people with no symptoms or abnormalities on neurological examination who have lesions typical for MS on MRI scans. (Id.) It is Dr. Steel’s opinion that petitioner meets the current diagnostic criteria for MS. He explained that the former diagnostic criteria required documentation of multiple neurological attacks in time and space throughout a patient’s life, whereas currently, the presence of biomarkers can substitute for clinical evidence events as diagnostic criteria. (Id.) Dr. Steel explained that MS is the most common inflammatory immune-mediated CNS demyelinating disease amongst others including ADEM, transverse myelitis (“TM”), neuromyelitis optica (“NMO”), and focal myelitis. (Id. at 3.) These disorders share common histopathological findings on microscopic study of damaged tissues and brain magnetic imaging. (Id. at 4.) He further explained that “the ability of MRI to distinguish these disorders by their characteristic appearance is high when the disease is classic, but poor when the attacks are mild or very early in the course of the disease.” (Id.) However, these disorders differ in epidemiology and clinical factors including speed of onset, diversity of symptoms, severity of attacks, outcome, and prognosis. (Id.) Relevant to this case, MS is an autoimmune disorder of the CNS where the immune system is overly active and erroneously targets normal body tissue, causing suppression of regulatory cells and an abnormality of the homeostasis of immune regulation in the CNS. (Id.) 13 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 14 of 30 Relying on epidemiological evidence and clinical experience, Dr. Steel stated that vaccinations combined with other non-specific immunogenic stresses may trigger an immune-mediated attack of demyelination in persons who are susceptible for genetic or other reasons. (Id. at 4.) Moreover, “[t]he dissemination of MS clinical events in time means that relating onset of symptoms to specific immune challenges is difficult, and it is likely that triggering of clinically significant MS by vaccine is underreported for this reason.” (Id.) Because vaccines stimulate a heightened immune reaction response, they may have unintended effects of activating the immune system in the CNS in susceptible persons who are already undergoing an autoimmune process. (Id. at 5.) Dr. Steel indicated that mechanisms may include molecular mimicry, epitope spreading, bystander activation, T-helper cell activation, and cytokine induction. A case may involve multiple mechanisms; however, he further described the theory of molecular mimicry relative to vaccinations, explaining “that antibodies formed in response to the vaccine may attack myelin related epitopes if these epitopes are like the antigens in their chemical and physical structure.” (Id.) Additionally, there is convincing evidence linking reported TM following various vaccinations including measles and rubella, combined diphtheria, tetanus, and polio, and hepatitis B. (Id. at 4.) Based on evidence that vaccinations can trigger single attacks of TM, ADEM, optic neuritis, and spinal myelitis, Dr. Steel opined that a vaccine can trigger attacks in patients with subclinical MS. (Id. at 5.) Specifically, Dr. Steel opined that petitioner is “a person with an undiagnosed susceptibility (i.e., clinically silent MS) who developed an attack of focal spinal myelitis after immunization.” (Id. at 5.) Dr. Steel found that petitioner’s MRI scans showed silent lesions that are typical of MS patients, that her cerebrospinal fluid (“CSF”) showed presence of oligoclonal bands that indicates on-going production of immunoproteins within the CNS compartment, and that she had abnormal visual evoked responses in the right optic nerve, all consistent with a diagnosis of MS. (Id. at 3.) Of note, Dr. Steel stated that oligoclonal bands are present in patients with ADEM, but not seen in isolated attacks of transverse myelitis (“TM”) or neuromyelitis optica (“NMO”) and that optic neuropathy may be seen in MS, NMO, ADEM, but not TM. (Id.) Therefore, Dr. Steel opined that petitioner experienced an attack of spinal myelitis due to immune stimulation from receiving two vaccinations in close temporal proximity and that her underlying, subclinical MS was unmasked by the vaccines. (Id. at 5.) In his supplemental report responding to respondent’s expert, Dr. Steel agreed that petitioner has MS, not ADEM, and that petitioner’s polio and Tdap vaccinations did not cause her MS. (Ex. 54, p. 1.) Rather, Dr. Steel reiterated that he opined a causal relationship between vaccines and myelitis only and that the vaccines at issue did in fact contribute to petitioner’s attack of TM, which revealed petitioner’s clinically silent MS. (Id.) He further explained that “[t]he family of immune-mediated inflammatory demyelinating disorders exists along a spectrum of severity ranging from limited, highly focal involvement of the central nervous system (optic neuritis, segmental myelitis, Transverse Myelitis) to multifocal involvement with potentially devastating outcomes (Multiple Sclerosis, Acute Demyelinating Encephalomyelitis, Neuromyelitis Optica).” (Id. 14 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 15 of 30 at 2.) Along this spectrum, the disorders share in common many features including the activation of the immune system to attack normal constituents and differ in spatial and temporal aspects and prognosis. Thus, “[c]ausation is likely multifactorial, with contributing factors including genetic predisposition, environment, nutritional status, comorbidities, and exposure to various triggers.” (Id.) He further explained TM in detail and, relying on the Transverse Myelitis Consortium Working Group’s published diagnostic criteria, indicated that petitioner met “all the inclusion criteria and exclusion criteria except that her symptoms and signs were unilateral.” Dr. Steel concluded that petitioner had an attack of Acute Partial Transverse Myelitis (APTM), which is defined as an idiopathic inflammation of the spinal cord causing asymmetric or mild loss of function due to a lesion that is less than the full transverse anatomy of the spinal cord. (Id. at 3 citing Thomas F. Scott, Nosology of Idiopathic Transverse Myelitis Syndromes, 115 ACTA NEUROL SCAND 371 (2007) (Ex. 65).) Additionally, Dr. Steel noted that acute partial myelitis is strongly associated with MS. (Id.) Dr. Steel then explained that vaccines can trigger TM, pointing to various studies and reports. In particular, Dr. Steel discussed a Kaiser-Permanente study that identified 780 incident cases of CNS acute demyelinating syndromes following vaccinations. The study analyzed the risks of suffering an acute demyelinating syndrome following vaccination and found that among the identified cases, the most common detected disorder was MS. (Id. at 5 citing Annette Langer-Gould et al., Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases, 71 JAMA NEUROL 1506 (2014) (Ex. 63).) The study concluded that the observations of short-term increase in risk after vaccination in younger patients suggest that vaccines may accelerate the transition from subclinical to overt autoimmunity in patients with existing disease. (Id.) Thus, Dr. Steel opined that “it is reasonable to consider that at-risk individuals, such as [petitioner], are more likely to develop complications, [such as a CNS acute demyelinating syndrome,] following vaccination.” (Id. at 6.) In this case, considering petitioner’s pre-existing autoimmune disorder and clinically silent MS, Dr. Steel opined that petitioner experienced an attack of APTM, a neurological impairment due to the spinal cord lesion, that was most likely triggered by the vaccinations she received in April of 2016. (Id. at 7.) Petitioner’s onset of pain in the right arm and shoulder, associated with neck stiffness and weakness of her right grip, her progression of right-leg weakness, and her imaging studies including her MRI and CSF, are all consistent with a diagnosis of MS. (Id. at 2.) b. Respondent’s Expert, Subramaniam Sriram, M.B.B.S In response, respondent retained Dr. Subramaniam Sriram to defend this case. Dr. Sriram currently holds a teaching position as a professor in neurology and microbiology immunology. (Ex. A.) Additionally, Dr. Sriram is the director of the MS Clinic at Vanderbilt Medical Center, where he cares for over 1000 MS patients. He is board-certified in internal medicine and neurology and authored many publications on MS. (Id. at 1.) 15 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 16 of 30 Dr. Sriram agreed with Dr. Steel that petitioner has MS and that she met the necessary McDonald criteria for dissemination in space and time to warrant such diagnosis. (Ex. A, p. 7.) Dr. Sriram explained that in some MS patients, there are silent lesions, described as extensive lesions seen radiologically in other parts of the central nervous system predominantly in the white matter of the periventricular regions but do not cause clinical symptoms. He concluded that “[although petitioner] did not have a clinical event before her admission on 6/5/16, other than a prior history of burning sensation in the left leg, the MRI brain lesions in the left frontal, left occipital and right deep white matter suggest otherwise and indicate prior subclinical involvement.” (Id. at 8.) Generally, MS is caused by an autoimmune response, but there is a lack of supporting evidence in identifying the specific autoantigen. However, the current evidence indicates that MS is mediated by T lymphocytes, which target the white matter of the CNS, and ongoing inflammatory response in the CNS results in demyelinating lesions in the myelin of the CNS. Patients with MS can have neurological deficits pertaining to the optic nerves, brainstem, or spinal cord and demyelination in the spinal cord may lead to weakness of the arm and legs. (Id. at 7, 8-9.) Dr. Sriram stated however that “[t]he prevailing opinion among scientists and the medical community is that there is no causal connection between vaccines and the development of acute clinical worsening, often referred to as a relapses.” (Id. at 9.) Specifically, studies have failed to show that vaccines initiated and/or propagated clinical worsening and even further that some studies show a decreased risk of developing MS in individuals who received vaccinations. (Id. 9-10.) Dr. Sriram responded to Dr. Kam-Hansen’s letter, opining that petitioner had ADEM. Because ADEM is considered to be a monophasic inflammatory disorder that manifests usually in encephalopathy, the absence of encephalopathy excludes a diagnosis of ADEM. (Id. at 11.) Upon review of the record and considering petitioner’s onset, symptoms, and MRI findings, Dr. Sriram concluded that petitioner did not meet the criteria for ADEM. (Id. at 11-12.) Additionally, ADEM is more common in children and despite Dr. Kam-Hansen’s reference to petitioner’s age as exclusive of MS, Dr. Sriram, instead weighed petitioner’s age as against a diagnosis of ADEM. (Id. at 13.) In response to Dr. Steel’s first report, Dr. Sriram emphasized that there is no evidence that vaccinations are likely to trigger relapses and that the clinical evidence Dr. Steel presented does not pertain to MS and/or involves vaccinations that are not relevant to this case. (Id. at 14-15.) Additionally, Dr. Sriram opined that “[t]he prevailing opinion does not support the view that vaccines, even when given in ‘close temporal proximity,’ in any way ‘trigger’ onset or relapses in patients with MS, including individuals with previously clinically silent MS.” (Id. at 15.) In fact, he opined that, in light of how well-studied MS is, the relationship between the vaccinations at issue and the occurrence of a relapse is coincidental and not causal. (Id.) Therefore, Dr. Sriram concluded that the receipt of the polio and Tdap vaccines did not play a role in petitioner’s development of a clinical relapse of MS. He stated that “[o]ther than offering 16 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 17 of 30 a temporal relationship between [petitioner’s] receipt of the Tdap and polio vaccines and the development of clinical and new MRI lesions, Dr. Steel does not provide a biological basis on which vaccines can cause worsening of MS.” (Id. at 16.) Dr. Sriram also provided a supplemental report addressing Dr. Steel’s second report. (Ex. O.) He explained that MS is a chronic demyelinating disorder that requires evidence of lesions which are disseminated in space and time and clinically; and may present symptoms of neurological deficits pertaining to the optic nerves, brainstem, or spinal cord. He further indicated that “[t]he clinical picture of incomplete transverse myelitis is the most common feature of the myelitic syndrome of MS and fits the clinical finding seen in [petitioner].” (Id. at 1.) However, Dr. Sriram stated that Dr. Steel’s theory, that petitioner has clinically silent MS that was unmasked after a TM attack, was an attempt to “re-define the myelitic syndrome that is a characteristic of MS as a separate disease entity with a different etiology.” (Id.) Although the diagnosis of MS is not in dispute, Dr. Sriram explained that Dr. Steel was trying to fault petitioner’s myelitis as caused by the vaccine rather than recognizing the myelitis as part petitioner’s MS syndrome. (Id. at 2.) Dr. Sriram addressed the medical literature cited by Dr. Steel to support his theory and highlighted several points in rebuttal including examining the paper filed as Exhibit 68 which stated that patients with MRI abnormalities consistent with MS cannot be diagnosed with idiopathic or primary TM. (Id. at 2 (citing Transverse Myelitis Consortium Working Group, Proposed Diagnostic Criteria and Nosology of Acute Transverse Myelitis, 59 NEUROLOGY 499 (2002) (Ex. 68).) He also opined that “the initial presentation of an inflammatory demyelinating condition like TM becomes a feature of MS once the MS diagnosis is made; it does not remain a separate disease for which there is no clear etiology,” citing to his prior reference, the Krupp et al. paper. (Id. at 3 (citing Ex. L, pp. 1-3.) Additionally, Dr. Sriram rebutted the possibility of vaccines triggering TM, noting that the case reports cited by Dr. Steel did not include any cases of TM in a patient with MS. (Id. at 4.) And specifically, Dr. Sriram criticized the Frohman and Wingerchuk paper, stating that they “cannot simultaneously claim that vaccines cause transverse myelitis in patients with underlying MS and at the same time draw a line between postvaccination transverse myelitis and MS-associated transverse myelitis.” (Id. at 4-5 (citing Elliot M. Frohman & Dean M. Wingerchuk, Transverse Myelitis, 363 N. ENGL J. MED 546 (2010) (Ex. 39).) Overall, Dr. Sriram insisted that the references Dr. Steel cited in his reports failed to provide a credible medical connection between TM as seen in the context of MS and vaccination. (Id. at 3-6.) In summary, Dr. Sriram opined that “[t]here is nothing in the clinical history, MRI findings or the course of disease to suggest that the transverse myelitis is anything other tha[n] what is seen in relapsing remitting MS.” (Id. at 6.) Therefore, he opined that the vaccinations played no role in the development of petitioner’s myelitic symptoms, which were a manifestation of petitioner’s underlying MS. (Id. at 7.) 17 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 18 of 30 V. Analysis a. Diagnosis “The function of a special master is not to ‘diagnose’ vaccine-related injuries, but instead to determine ‘based on the record as a whole and the totality of the case, whether it has been shown by a preponderance of the evidence that a vaccine caused the [petitioner]’s injury.’” Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1382 (Fed. Cir. 2009) (quoting Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994)). “Although the Vaccine Act does not require absolute precision, it does require the petitioner to establish an injury – the Act specifically creates a claim for compensation for ‘vaccine-related injury or death.’” Stillwell v. Sec'y of Health & Human Servs., 118 Fed. Cl. 47, 56 (2014) (quoting 42.U.S.C. § 300aa- 11(c)). Accordingly, the Federal Circuit has concluded that it is “appropriate for the special master to first determine what injury, if any, [is] supported by the evidence presented in the record before applying the Althen test to determine causation.” Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1343, 1351-53 (Fed. Cir. 2011). As a threshold matter, there has been some indication in this case, both in the medical records and in Dr. Kam-Hansen’s written opinion, that petitioner’s correct diagnosis is ADEM. (Ex. 4, p. 9; Ex. 11, p. 25; Ex. 15, p. 16; Ex. 17, p. 1.) However, Drs. Steel and Sriram, who have each offered multiple reports and discussed their conclusions at greater length, have both concluded that petitioner’s ultimate diagnosis is MS. (Ex. 20, p. 3; Ex. 54, p. 1; Ex. A.) This is based not only on their expertise, but also on their review of the complete medical records. Dr. Kam-Hansen, though a treating physician, was less persuasive. In particular, she stressed petitioner’s pre- vaccination state of health without addressing the radiological evidence of lesions, discussed further below, that seem to evidence dissemination in time and space (i.e. non-enhancing lesions present in the brain MRI and an enhancing lesion in the cervical spine MRI). (Alan J. Thompson et al., Diagnosis of Multiple Sclerosis: 2017 Revisions of the McDonald Criteria, 17 LANCER NERUOL 162, 168 (2018) (Ex. C, p. 7 (Panel 5)).) In any event, Dr. Kam-Hansen’s opinion is not shared among all of petitioner’s treating physicians, who were split as to whether MS or ADEM was petitioner’s correct diagnosis. Moreover, on this record, the relevant literature suggests that while MS may initially be mistaken for ADEM in the short-term, there is not preponderant evidence that ADEM itself evolves into MS. (Nathan P. Young, Brian G. Weinshenker & Claudia F. Lucchinetti, Acute Disseminated Encephalomyelitis: Current Understanding and Controversies, 28 SEMIN NEUROL 84 (2008) (Ex. 33.) Accordingly, I will address the causation-in-fact analysis in this case in the context of MS rather than ADEM. Accord Samuels v. Sec'y of Health & Human Servs., No. 17-071V, 2020 WL 2954953 (Fed. Cl. Spec. Mstr. May 1, 2020) (explaining that “Dr. Gelfand persuasively established that there are meaningful clinical and diagnostic differences between ADEM and CIS. Even if ADEM is a type of CNS demyelinating injury, and even if it can constitute an initial MS ‘flare,’ from a medical/scientific standpoint it is better understood as a narrower condition in most cases than Dr. Steinman allowed, with symptoms specific to it that are distinguishable from a first MS presentation.”). 18 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 19 of 30 b. Factors Relevant to a Significant Aggravation Analysis Having concluded that petitioner more likely experienced MS rather than ADEM, the next question to be resolved is the clinical course of petitioner’s MS. An examination of petitioner’s clinical history under the first three prongs of the above- discussed Loving test show this case to be one of significant aggravation of petitioner’s pre-existing MS rather than including any separate attack of TM as argued by petitioner. i. Condition before and after vaccination (Loving prongs one and two) Petitioner’s pre-vaccination medical records contain no significant evidence of any outward clinical signs or symptoms of MS or any other central nervous system demyelinating condition prior to her vaccination. However, both Dr. Steel and Dr. Sririam agree that petitioner’s post-vaccination MRI study of June 5, 2016 revealed non- enhancing lesions that suggest she had pre-existing, subclinical MS prior to her vaccination. (Ex. 20, pp. 3-4; Ex. A, pp. 7-8.) Specifically, Dr. Steel characterized petitioner’s MRI as revealing “lesions in the brain consistent with MS, likely preexistent, likely old, and clinically silent” and opined that this pre-existing MS represented an underlying susceptibility. (Ex. 54, p. 6.) Accordingly, in light of these expert opinions, the weight of evidence favors a finding that petitioner had pre-existing clinically silent MS.8 Additionally, regardless of ultimate diagnosis, it is undisputed that petitioner experienced an attack of CNS demyelination less than two months following the vaccinations at issue in this case. (Ex. 2, p. 51.) This is evidenced both by petitioner’s first outward clinical manifestation of symptoms and also by objective imaging. (Id.) It is also undisputed by the retained experts that petitioner was ultimately correctly diagnosed with MS by at least some of her physicians. (Ex. 2, pp. 2, 50; Ex. 14, p. 18; Ex. 20, p. 3; Ex. 54, p. 3; Ex. A, p. 8; Ex. O, p. 6; ECF No. 70, p. 12.) The question of whether that initial attack of CNS demyelination constitutes a manifestation of 8 Prior cases in this program have discussed an article by Cotton, et al, which has not been filed into the record of this case. That article suggests that lesions enhance for a median duration of two weeks. See, e.g. W.C. v. Sec'y of Health & Human Servs., No. 07-456V, 2011 WL 4537877 (Fed. Cl. Feb. 22, 2011), aff'd, 100 Fed. Cl. 440 (2011), aff'd, 704 F.3d 1352 (Fed. Cir. 2013). Based on the timeline of petitioner’s treatment, this would suggest that the presence of non-enhancing lesions may not in itself be dispositive of whether petitioner’s MS pre-dated her vaccinations. However, Dr. Sriram opined that petitioner’s non- enhancing lesions also included so called “black holes,” non-enhancing lesions that remain hypointense on T1 imaging. (Ex. A, p. 8.) Dr. Sriram appears to offer a professional judgment that this type of lesion would necessarily be “old” and Dr. Steel has not challenged that judgment on petitioner’s behalf. In fact, he agreed that petitioner likely had preexisting MS that he opined left her susceptible to a vaccine injury. (Ex. 20, p. 5; Ex. 54, p. 6.) An additional factor is that the experts find significance in the fact that petitioner had both enhancing and non-enhancing lesions at the time of her initial MRI, which contributed to their assessment that the lesions represented dissemination in time. In sum, both parties have presented expert opinion that petitioner’s MS predated her vaccinations and, especially given the lack of dispute, I accept their shared professional judgment based on the record of this specific case. However, it does not necessarily appear that this result would follow in all cases based merely on the presence of non-enhancing lesions. 19 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 20 of 30 petitioner’s overall course of MS, as respondent contends, or a separate attack of TM, as petitioner contends, is addressed under Loving prong three, below. ii. Significant aggravation (Loving prong three) Contrary to petitioner’s assertion, it appears that petitioner’s clinical history is more consistent with a significant aggravation of her underlying MS rather than an isolated attack of TM distinct from her overall clinical course of MS. Dr. Steel’s assertion of a separate attack of TM does not appear on this record to be consistent with the way in which the medical community understands these conditions. For example, petitioner has filed literature broadly cautioning that idiopathic or primary TM should be distinguished from disease-associated TM, suggesting that “[i]dentification of etiologies may suggest medical treatment, whereas no clearly established medical treatment currently exists for idiopathic ATM.” (Transverse Myelitis Consortium Working Group, Proposed Diagnostic Criteria and Nosology of Acute Transverse Myelitis, 59 NEUROLOGY 499 (2002) (Ex. 68, p. 1).) Moreover, Dr. Sriram stressed that MS is an exclusionary factor in the diagnosis of TM under the prevailing diagnostic criteria. (Ex. O, pp. 2-3.) Dr. Steel suggested that it is not sufficient to rely on the Working Group diagnostic criteria for acute TM generally. (Ex. 54, p. 3.) Instead, Dr. Steel suggested that subsequent literature distinguishes between idiopathic TM, acute complete TM (“ACTM”), and acute partial (“APTM”). Under this revised framework, only idiopathic TM requires exclusion of MS. (Thomas F. Scott, Nosology of Idiopathic Transverse Myelitis Syndromes, 115 ACTA NEUROL SCAND 371 (2007) (Ex. 65, p. 3 (Table 1)).) Dr. Steel contends that petitioner’s case is consistent with the latter APTM. (Id.) Critically, however, Dr. Steel acknowledges that APTM, in contrast to ACTM, “is strongly associated with multiple sclerosis, either as an initial presenting disease or as part of the ongoing relapsing-remitting course of MS.” (Id.) Moreover, the authors explain that: Once the specific causes (secondary transverse myelitis) have been ruled out by an initial workup, including probable or definite MS in patients presenting with classic cerebral lesions identified on MRI, the majority of cases with either ACTM or APTM will remain idiopathic. However, a minority of patients initially designated as idiopathic will eventually achieve a diagnosis of a more specific disease state (secondary transverse myelitis). We consider a patient with a syndrome of acute myelitis to be ‘as of yet idiopathic cause.’ This patient needs to be monitored over time to determine whether this syndrome will eventually be incorporated within a diagnosis of more specific disease (e.g. Devic’s syndrome, systemic lupus erythematosus, sarcoidosis). When patients present with APTM and cerebral MRI showing lesions typical of MS, the transition rate to [clinically definite] MS is known to be quite high, in the range of 80-90% within a few years. 20 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 21 of 30 (Scott, supra, at Ex. 65, p. 5.) Thus, contrary to Dr. Steel’s opinion, even this more nuanced understanding of acute TM still does not suggest that an APTM attack is generally accepted as having a distinct etiology when presenting in the context of MS. In fact, the literature that Dr. Steel cited for the specific proposition that immunization may trigger attacks of myelitis in the context of underlying disease (Frohman and Wingerchuk), specifically limits postvaccination TM to longitudinally extensive TM rather than partial TM, the latter of which, consistent with the above, is associated instead with a high risk of MS. (Elliot M. Frohman & Dean M. Wingerchuk, Transverse Myelitis, 363 N. ENGL. J. MED 564 (2010) (Ex. 39, p. 3 (chart)).) Significantly, Dr. Steel also acknowledged that petitioner’s overall presentation around the time her symptoms first manifested is more consistent with ongoing MS than with an isolated attack of transverse myelitis. (Ex. 20, p. 3.) Dr. Steel opined that petitioner’s spinal lesion is distinct from complete transverse myelitis, because it did not cross the midline of the spinal cord. (Id.) He also opined that the presence of oligoclonal bands and optic neuropathy distinguish petitioner’s condition from transverse myelitis generally. (Id.) Further, there is agreement that petitioner’s presentation at the time of her clinical attack evidenced dissemination in time and space, a key diagnostic consideration for MS that is not consistent with an isolated attack. (Ex. 20, p. 3; Ex. A, pp. 7-8; see also Thompson et al., supra, at Ex. C.) Dr. Steel explained that petitioner’s spinal lesion, though typical of MS, is not itself diagnostic. (Ex. 20, p. 3.) However, he agreed that the presence of oligoclonal bands in petitioner’s cerebral spinal fluid suggested dissemination in time. (Id.) Dr. Steel further indicated that petitioner’s abnormal visual evoked responses in the right optic nerve evidenced dissemination in space. (Id.) Additionally, although he stressed that petitioner’s outward clinical symptoms began post-vaccination, her MRI “revealed lesions in the brain consistent with MS, likely preexistent, likely old, and clinically silent.” (Ex. 54, p. 6.) This assessment of petitioner’s own clinical presentation leaves Dr. Steel’s opinion even further at odds with this reliance on Frohman and Wingerchuk. That literature includes a diagnostic flow chart that specifically indicates that findings of demyelination on brain MRI, oligoclonal bands, and abnormal visual evoked response should lead to the conclusion of a high risk of MS rather than TM. (Frohman & Wingerchuck, supra, at Ex. 39, p. 3.) Under this framework, only the absence of all of these findings would allow for a reconsideration of the clinical history that could potentially lead to a diagnosis of idiopathic, postinfectious, or postvaccination TM. (Id.) In fact, respondent argued that “if Dr. Steel had employed the methodology outlined by Frohman and Wingerchuk, he would have concluded that petitioner’s ‘focal myelitis’ or APTM was caused by her underlying MS, not her preceding vaccinations.” (ECF No. 70, p. 23.) This is also consistent with the way in which these conditions have been understood in prior program cases. For example, in Pek v. Secretary of Health & Human Services, the special master noted a distinction between acute demyelinating injuries such as transverse myelitis and chronic, relapsing demyelinating injuries such as multiple sclerosis. 2020 WL1062959 (Fed. Cl. Spec. Mstr. Jan. 31, 2020). He described a theory of acute injury evolving into a chronic injury as conceivable though yet to be seen. 21 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 22 of 30 For all the reasons discussed above, I conclude that it is more likely than not that petitioner’s post-vaccination symptoms were a part of the overall clinical course of her pre-existing MS rather than a separate attack of TM. Moreover, consistent with the Vaccine Act’s definition of significant aggravation, this constitutes a change for the worse in petitioner’s MS, resulting in markedly greater disability, pain, or illness accompanied by substantial deterioration of health. § 300aa-33(4). This leaves only the question of whether that significant aggravation was vaccine related. c. Causation-in-Fact Analysis i. Medical theory causally connecting the vaccination and injury (Althen prong one/Loving prong four) Petitioner’s burden under the first Althen prong/fourth Loving prong is to provide, by preponderant evidence, “a medical theory causally connecting the vaccination and the injury.” Althen, 418 F.3d at 1278. Such a theory must only be “legally probable, not medically or scientifically certain.” Knudsen v. Sec’y of Human & Health Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Moreover, 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 v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1380 (Fed. Cir. 2009). However, to satisfy this prong, petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen, 35 F.3d at 548; Boatmon, 941 F.3d at 1359. Although Dr. Steel focused in significant part on TM, there is also little dispute on this record as to the autoimmune or immune-mediated nature of MS and the fact that clinical attacks in MS can be associated with immune insults.9 Dr. Sriram indicated that the “cause of MS is thought to be autoimmune in nature although supportive evidence such as the identification of an auto-antigen is lacking.” (Ex. A, p. 8.) However, he explained that the prevailing opinion is that MS is mediated by T lymphocytes that create an “ongoing inflammatory response in the central nervous system, [which] results in the development of lesions in the white matter and in particular the myelin membranes of the central nervous system,” and this demyelination causes clinical disability such as weakness of the arms and legs, as is the case with petitioner. (Id.) Additionally, Dr. Steel explained that MS can be conceived as a disorder of immune regulation involving the balance between regulatory T-cells and dendritic cells. (Ex. 20, p. 4.) Dr. Steel opined that vaccines can create a heightened immune response and in 9 To be clear, Dr. Sriram does not agree that vaccines trigger clinical attacks of MS. However, he did indicate that “[t]he current opinion on the development of MS is based on the assumption that the inflammatory response and the attendant demyelination is due to an autoimmune process.” (Ex. A, p. 9.) That an autoimmune process would have an external trigger is not necessarily controversial. In that regard, in specific response to Dr. Steel’s assertion that immunogenic stressors may trigger an immune- mediated attack of CNS demyelination, Dr. Sriram focused exclusively on whether vaccines could be such a trigger and did not dispute the broader assertion that CNS demyelination can be related to immunogenic stressors. (Ex. A, pp. 13-15.) 22 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 23 of 30 turn the “antibodies formed in response to the vaccine may attack myelin related epitopes if these epitopes are likely the antigens in their chemical and physical structure.” (Id. at 5.) In light of the background provided by both experts, Dr. Steel is persuasive in opining that for the entire family of immune-related demyelinating disorders, including MS, “[c]ausation is likely multifactorial, with contributing factors including genetic predisposition, environment, nutritional status, comorbidities, and exposure to various triggers.” (Ex. 54, p. 2.) In that context, the record of this case contains one especially relevant and persuasive study related to significant aggravation of MS. (Annette Langer-Gould et al., Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases, 71 JAMA NEUROLOGY 1506 (2014) (Ex. 62)10.) In 2014 a nested case-controlled study was conducted among Kaiser Permanente patients in southern California. A study population of 780 incident cases of central nervous system acquired demyelinating syndromes (“CNS ADS”), including MS, were identified along with a control population of 3,885. Although the study found no long-term association between vaccination and MS, it did uncover a statistically significant increased risk of onset of CNS ADS within 30 days of any vaccination among individuals under 50 years of age. Although the study focused on HPV and Hepatitis B vaccinations, the study examined a wide range of vaccinations, including both polio and tetanus vaccinations, and concluded that the increased risk followed all vaccinations. The study authors explained in light of their overall findings that “this association disappeared after 30 days, suggesting that, at most, vaccines are redundant enhancers of preexisting autoimmunity.” (Id. at 5.) More specifically, the authors observed that [t]his argues against causality because the risk in the vaccinated group should remain elevated regardless of whether the time window between exposure and clinical disease expression is defined as 15 days or 3 years. However, our findings are consistent with vaccines acting as a proinflammatory cofactor in individuals with subclinical autoimmunity because this mechanism would be expected to hasten symptom onset but not change the long-term risk of developing MS or [clinically isolated syndrome]. (Id. at 7 (emphasis added).) In conclusion, the Langer-Gould authors explained that “[i]n younger patients, we observed a short-term increase in risk after vaccination of any type, which suggests that vaccines (like infections) may accelerate the transition from subclinical to overt autoimmunity in patients with existing disease.” (Id.) Consistent with that Langer-Gould observation, Dr. Steel opined that in petitioner’s case “[t]he vaccinations likely did not cause the MS but rather unmasked it, i.e. caused it to become clinically significant during her medical evaluation. Clinically 10 This exhibit was designated as Ex. 63 when filed. (ECF No. 57.) However, this is incorrect, and the exhibit should be Ex. 62 in accord with the updated exhibit list. (ECF No. 57-1.) 23 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 24 of 30 asymptomatic MS is termed radiographically isolated syndrome (RIS). The term RIS refers to people with no symptoms or abnormalities on neurological examination who have lesions typical for MS on MRI scans. This phenomenon is relatively common. Following the attack of myelitis, [petitioner] meets current diagnostic criteria for Multiple Sclerosis. She experienced a clinically symptomatic event in a limited time window following vaccinations. This event, called a Clinically Isolated Event, was her first episode of neurological symptoms typical of an MS relapse in a person not known to have MS.” (Ex. 20, p. 3 (emphasis original).) In addressing the Langer-Gould article, Dr. Sriram offered no critique of the value or methodology of the study but contended that the study’s overall finding against causality is contrary to petitioner’s claim. (Ex. O, p. 5.) Dr. Sriram suggests that Dr. Steel “misquotes” the Langer-Gould study (Id.), but I do not see where this is the case.11 Dr. Steel’s discussion of the paper appears accurate and Dr. Steel has offered no opinion that vaccinations initially cause MS in healthy patients. Rather, Dr. Steel agreed in his first report that “there is little evidence that vaccinations cause multiple sclerosis in healthy patients” and in his second report confirmed that he has “made no assertion of a causal relationship between the vaccines and MS.” (Ex. 20, p. 5; Ex. 54, p. 1.) As noted above, he opined that the etiology of demyelinating conditions is multifactorial. Although Dr. Sriram considers the cause of autoimmunity in MS to be enigmatic and does not endorse the mechanism proposed by the Langer-Gould authors, that mechanism of vaccine involvement as an inflammatory cofactor is potentially consistent with Dr. Sriram’s own description of MS as developing due to T-lymphocyte inflammation of the central nervous system. Critically, this also remains consistent with petitioner’s burden of proof for a significant aggravation claim. Petitioner need only demonstrate that her vaccination 11 By “misquote” it appears Dr. Sriram may refer to the fact that petitioner was not under 50 years of age and did not experience symptom onset within 30 days of vaccination. (Ex. O, p. 5.) While these points are both correct, they do not call the validity of the study into question. Nor am I persuaded that they are meaningful barriers to petitioner’s reliance on this study in this case, especially with regard to Althen prong one/Loving prong four, which speaks to general medicine only. That a statistically significant risk was found remains evidence that vaccines are a relevant antecedent event. That is, it is evidence tending to show that vaccines did contribute to significantly aggravate subclinical autoimmunity into overt MS among the examined population. Importantly, however, this is only a statistical observation. Nothing in the Langer-Gould paper purports to set an outside limit of 30 days for the expected reaction to occur. Rather, the study only suggests that the rate of onset occurring within 30 days post-vaccination resulted in an identifiable, statistically significant cluster. With regard to petitioner’s age, the Langer-Gould authors strongly suggest their finding was age limited primarily due to the limits of their study population. They explained that they separately examined the association among those over and under age 50 precisely because new onset of MS after age 50 is rare overall and further indicated that the study was limited by a small number of older individuals. (Ex. 62, pp. 3, 7.) Nothing in the substance of the article, nor Dr. Sriram’s reports, indicates any reason why the mechanism hypothesized would be age dependent. Dr. Sriram has likewise cited literature in this case showing that despite an unexplained increase in incidence of MS among women over 50 years or age over several decades, mean age of initial onset remains 36.2 years of age (up from 32.6 during the 1950’s). (Nils Koch-Henriksen et al., Incidence of MS has Increased Markedly Over Six Decades in Denmark Particularly with Late Onset and in Women, 90 NEUROLOGY e1954 (2018) (Ex. N, p. 5 (Table 1)).) 24 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 25 of 30 affected her condition; she does not have a burden to demonstrate that her ultimate condition is worse than her expected outcome. Sharpe v. Sec’y of Health & Human Servs., 964 F.3d 1072, 1081 (Fed. Cir. 2020). Moreover, it is well established that petitioner need only demonstrate that her vaccine was a substantial contributing factor to her injury rather than the sole cause of injury. Shyface, 165 F.3d at 1353 (explaining that although the Shyfaces did not prove that the DPT vaccine was the only or predominant cause of his death, the requirements of the Vaccine Act are met prima facie upon proof of the substantial factor criterion.). That is, petitioner’s vaccination need not explain her entire clinical history of MS in order to have affected her condition in the context of her immediate post-vaccination clinical attack.12 Nor must the vaccination be the sole cause of her clinical attack. Accord Quackenbush v. Sec’y of Health & Human Servs., No. 14-1000V, 2018 WL 1704523 (Fed Cl. Spec. Mstr. Mar. 14, 2018) (finding that petitioner satisfied the Loving test to demonstrate that the flu vaccine significantly aggravated petitioner’s pre-existing MS). Although Dr. Sriram has cited literature that includes discussion of epidemiologic evidence generally weighing against the idea of vaccine-related MS, including evidence speaking both to initial onset and to clinical worsening or relapsing of MS,13 such evidence does have limitations.14 I am not prepared on this record to conclude that this 12 I also note that, although she experienced a period of some improvement, the medical records reflect that the sequela of petitioner’s first clinical attack of MS likely persisted for more than six months. (See e.g., Ex. 9, pp. 6-7; Ex. 15, p. 21; Ex. 50, p. 4; Ex. 51, p. 57.) 13 Specifically: Ex. A, pp. 9-10 (citing Mia Topsoe Mailand & Jette Lautrup Frederiksen, Vaccines and Multiple Sclerosis: A Systemic Review, 264 J Neurol 1035 (2017) (Ex. E); Giovanni Ristori et al., Effects of Bacille Calmette-Guerin After the First Demyelinating Event in the CNS, 82 Neurology 41 (2013) (Ex. F); Ellen Bible, Multiple Sclerosis: Disease Activity is Reduced in CIS After BCG Vaccination, 10 NATURE REVIEWS Neurology 62 (2014) (Ex. G); Frank De Stefano et al., Vaccinations and Risk of Central Nervous System Demyelinating Diseases in Adults, 60 ARCH NEUROL 504 (2003) (Ex. H); Mauricio F. Farez & Jorge Correale, Immunizations and Risk of Multiple Sclerosis: Systemic Review and Meta-Analysis, 258 J Neurol 1197 (2011) (Ex. I); Alexander Hapfelmeier et al., A Large Case-Control Study on Vaccination as Risk Factor for Multiple Sclerosis, 93 NEUROLOGY e916 (2019) (Ex. J); Miguel A. Hernan, Alvaro Alonso & Sonia Hernandez-Diaz, Tetanus Vaccination and Risk of Multiple Sclerosis, 67 NEUROLOGY 212 (2006) (Ex. K); Christian Confavreux et al., Vaccinations and the Risk of Relapse in Multiple Sclerosis, 344 N. ENGL. J. MED 319 (2001) (Ex. P).) 14 For example, Farez and Correale, explain that meta-analyses of pooled data have significant limitations and must be interpreted with caution. (Farez & Correale, supra, at Ex. I, p. 7.) Moreover, a chart in their paper characterizes the quality of data available from many underlying studies as either unclear, unavailable, or of only low to moderate quality. (Id. at 8.) Additionally, a review article filed by petitioner notes that although the Institute of Medicine has rejected a causal relationship between MS and common vaccinations including tetanus, there is separate evidence of vaccines being associated with MS relapses, most notably vaccines against HPV and yellow fever. (Dimitrios Karussis & Panayiota Petrou, The Spectrum of Post-Vaccination Inflammatory CNS Demyelinating Syndromes, 13 Autoimmunity Reviews 215 (2014) (Ex. 60, p. 6.) Accordingly, the record of this case demonstrates that the epidemiologic evidence is not in complete agreement, leaving generalizations difficult. A further issue highlighted by this article is the fact that, although there is a “nonnegligible” risk of CNS demyelination following vaccination, that risk is far lower than the risk of CNS demyelination resulting from the infections vaccinations are intended to prevent. (Id. at 7.) One cited study observed a 30% risk of developing CNS demyelination after influenza infection versus a 5% risk following influenza vaccination. (Id. at 6.) This complicates the statistical observations of studies that purport to find no increased risk of CNS 25 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 26 of 30 type of evidence defeats petitioner’s presentation of a reasonable expert discussion of the mechanism of vaccine-affected inflammation leading to autoimmune CNS demyelination coupled with a significantly sized case controlled study of unchallenged quality purporting to detect a statistically significant risk of clinical manifestation of MS following vaccination. Dr. Steel likewise agrees that the epidemiological evidence indicates that “MS, a chronic, recurrent and progressive disorder, is not likely caused by any single immune insult event.” (Ex. 20, p. 4.) However, Dr. Steel also cautioned that “since all vaccine injuries are quite rare relative to the total number of vaccinations administered . . . [i]t is possible for a given adverse event to occur, but not to occur with sufficient frequency to produce an epidemiological signal.”15 (Ex. 54, p. 7.) He also suggested that “[t]he dissemination of MS clinical events in time means that relating onset of symptoms to specific immune challenges is difficult, and it is likely that triggering of clinically significant MS by vaccine is underreported for this reason.” (Ex. 20, p. 4.) Mailand and Fredericksen, a literature review on vaccines and MS that is often cited as authoritative and was relied upon by Dr. Sriram in this case, agrees, noting that: Another problem of studying MS risk factors is the lag between onsets of the initial symptoms and final diagnosis. Time between symptoms and diagnosis varies considerably depending on several factors, including individual health-seeking behaviour, health care systems, diagnostic techniques, etc. As a result, studies with short follow-up have a risk of disregarding potential association. However, studies with a too long follow- up risk diluting a potential association or to find false positive association due to subsequent triggers. Finally, manifestations of MS vary significantly between patients, making it difficult to compare the course of the disease. demyelination among vaccinated groups compared to controls without accounting for infectious illnesses. For example, DeStefano et al, a study cited by Dr. Sriram, purported not to find any association between several vaccinations and onset of MS. (De Stefano et al., supra, at Ex. H, p. 1.) That study controlled for age, sex, HMO status, race, ethnicity, ancestry, family medical history, education, material status, occupation, residence history, cigarette smoking, pet ownership, etc. (Id. at 2.) Yet, there is no indication that they screened subjects for their health status relating to illness or infection despite identifying infection as potentially relevant to the pathogenesis of MS. For all these reasons, it is significant that only a fraction of the broader body of epidemiological studies discussed by the review literature has been filed in this case. 15 Interestingly, Dr. Sriram goes still further, stressing that certain of the prior epidemiologic studies suggest not the lack of any association but instead that tetanus vaccine has a protective effect against MS. (Ex. A, pp. 9-10.) He similarly stresses that “[a]s clinicians we don’t withhold immunizations on the belief that [vaccinations] may ‘trigger’ relapses in MS patients.” (Ex. A, p. 15.) This is confounded by the possibility of infection being the more significant risk as compared to vaccination as noted in n. 14, supra. That vaccines protect against the still greater risk does not mean that they are themselves entirely risk free. Dr. Sriram has presented this logic in prior cases and it has been rejected. Jane Doe/74, 2010 WL 2788239, infra. Mailand and Fredericksen, a literature review relied upon by Dr. Sriram, likewise identifies the potential protective effect of tetanus vaccination, but explains that many of the relevant studies lack statistical power or contain confounding factors. (Ex. E, p. 12.) They explain that the protective effect “might exist” but that further study is necessary. (Id.) 26 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 27 of 30 (Ex. E, p. 14.) In any event, the Federal Circuit has previously stressed that a petitioner is not obligated to present an epidemiological case supporting her claim. Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). As noted above, petitioner’s burden is to provide a legally probable rather than medically certain theory of causation. The Langer-Gould findings add to the body of epidemiology even as that body of epidemiology tempers the findings of any one study. In fact, the Langer-Gould authors assert that “[o]ur findings reconcile the anecdotal clinical reports of a CNS ADS onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increase of MS or other forms of CNS ADS following vaccination.” (Ex. 62, p. 7.) Notable in that regard, Mailand and Frederiksen does include the Langer-Gould study among its review of the relevant body of literature. However, Mailand and Frederiksen, like Dr. Sriram, only address the long-term findings of Langer-Gould as weighing against a causal relationship and do not address at all the specific short-term finding highlighted by Dr. Steel and discussed in this decision. Again, this underscores the difficulty posed by seeking to rely on review literature given the record of this case. It also raises the question of what additional findings may be contained in the studies reviewed by Mailand and Frederisksen (and other literature reviews) that were not explicitly discussed. With regard to specific studies that were filed in this case, respondent also suggests that the study by Destefano et al, should be preferred to Langer-Gould in terms of the specific findings regarding a short-term association between vaccinations and clinical manifestation of MS. (ECF No. 70, n. 12.) However, respondent has not articulated any basis for preferring one study over the other in terms of the quality or validity of the studies themselves. Notably, the Langer-Gould study was conducted more recently than the Destefano study. The Langer-Gould authors reviewed and discussed the prior Destafano study and explained that it was limited by the small number of vaccinated cases, incomplete case-finding methods, imprecise estimates or unclear timing of onset, confounding factors such as healthcare utilization, and undefined delay between vaccination and symptom onset. (Ex. 62, p. 2.) Although the Langer-Gould study likewise has limitations, the study authors suggest that “[o]ur study overcomes many of the methodological limitations of previous MS vaccine safety studies with a larger sample size, rigorous case-finding methods, inclusion of MS precursors, prospectively recorded symptom onset dates, and complete vaccination records.” (Id. at 7.) Respondent also cited Confavreux et al., as being consistent with Destefano, et al. (ECF No. 70, n. 12.) The Langer-Gould authors did not address the earlier Confavreux study. The Confavreux study is closer in size to Langer-Gould; however, the case-crossover model of the Confravreux study, in which different periods are examined such that the subjects act as their own controls, would seem to make direct comparisons to Langer-Gould difficult. Notably, the Federal Circuit’s Althen decision itself affirmed the decision in Althen which involved a tetanus toxoid vaccine causing CNS demyelinating disease in the form 27 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 28 of 30 of ADEM and optic neuritis.16 See generally Althen, 418 F.3d 1274. Since then, there have been several cases where special masters ruled in favor of petitioners who developed demyelinating disease after vaccination, including cases linking both TM and MS to tetanus vaccines. See Smith v. Sec'y of Health & Human Servs., No. 08–864V, 2016 WL 2772194 (Fed. Cl. Spec. Mstr. Apr. 18, 2016) (awarding compensation for MS linked to a hepatitis B vaccine); Jane Doe/74 v. Sec'y of Health & Human Servs., No. [Redacted], 2010 WL 2788239 (Fed. Cl. Spec. Mstr. June 28, 2010) (awarding compensation for TM and MS linked to tetanus-diphtheria and measles-mumps-rubella (“MMR”), hepatitis B, and meningococcal vaccines); Johnson v. Sec'y of Health & Human Servs., No. 99–219V, 2000 WL 1141582 (Fed. Cl. Spec. Mstr. Jul. 27, 2000) (awarding compensation for ADEM linked to a tetanus-diphtheria (“Td”) vaccine); Hargrove v. Sec'y of Health & Human Servs., No. 05–694V, 2009 WL 1220986 (Fed. Cl. Spec. Mstr. Apr. 14, 2009 (awarding compensation for TM linked to a diphtheria- tetanus-acellular pertussis (“DTaP”) vaccine and/or other vaccinations); Werderitsh v. Sec'y of Health & Human Servs., No. 99–310V, 2006 WL 1672884 (Fed. Cl. Spec. Mstr. May 26, 2006) (awarding compensation for MS linked to a hepatitis B vaccine). ii. Logical sequence of cause and effect showing the vaccination was the reason for the injury (Althen prong two/Loving prong five) The second Althen prong/fifth Loving 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 & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). However, medical records and/or statements of a treating physician 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. See 42 U.S.C. §300aa-13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec'y of Health & Human 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”). In light of all of the above analysis, this aspect of petitioner’s claim does not need be addressed at length. Consistent with all of the above, both petitioner’s and respondent’s respective experts agree that prior to vaccination petitioner’s MS was clinically silent and that after vaccination she suffered a clinical attack of her MS 16 Although CNS demyelinating conditions are not entirely interchangeable, in some instances the precise diagnosis has not been dispositive of the causation analysis. E.g., Samuels, 2020 WL 2954953 at *19 (noting that “this is not a case where defining the injury is key to its resolution.”); Harmon v. Sec'y of Health & Human Servs., No. 12-298V, 2017 WL 2872293, at *22 (Fed. Cl. Spec. Mstr. June 6, 2017) (finding that petitioner suffered “a CNS demyelinating condition, most likely an atypical form of multiple sclerosis.”); Hitt v. Sec’y of Health & Human Servs., No. 15-1283V, 2020 WL 831822, at n.8 (Fed. Cl. Spec. Mstr. Jan. 24, 2020) (finding preponderant evidence of an initial diagnosis of transverse myelitis followed by a subsequent diagnosis of multiple sclerosis, but noting that “the importance of the diagnosis is diminished” by respondent’s expert’s agreement that either condition can be caused by the flu vaccine.). 28 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 29 of 30 consistent with an acute presentation following an antecedent event. (Ex. 20, pp. 3, 5; Ex. 54, pp. 1, 6-7; Ex. A, pp. 7-8, 13.) Specifically, Dr. Steel opined that prior to vaccination petitioner’s condition was best characterized as radiographically isolated syndrome, but that she “experienced a clinically symptomatic event in a limited time window following vaccinations.” He indicated that following this post-vaccination myelitis, petitioner met the diagnostic criteria for MS based on this clinically isolated event. (Ex. 20, p. 3.) Although Dr. Sriram did not agree petitioner’s vaccinations were a relevant event, he similarly opined more generally that petitioner’s “enhancing lesions suggested a recent acute event.” (Ex. O, p. 7.) Treating physician opinions in this case are less helpful due to the uncertainty surrounding their diagnoses. Those who discussed causal factors tended to view petitioner’s condition as ADEM. iii. Proximate temporal relationship between vaccination and injury (Althen prong three/Loving prong six) 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 & Human 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.; Shapiro v. Sec'y of Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl. 353 (2012), aff'd mem., 503 Fed. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Human Servs., No. 11–355V, 2013 WL 3214877, at *26 (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). As explained above, petitioner experienced an attack of CNS demyelination less than two months following the vaccinations at issue in this case. (Ex. 2, p. 51, 59; Ex. 8, p. 2.) More specifically, on June 5, 2016, petitioner sought treatment at Capital Health Regional Medical Center emergency room for right side weakness and numbness, which began two nights prior, i.e. June 3, 2016.17 (Ex. 2, p. 51, 59.) June 3, 2016 was approximately 60 days following her April 4, 2016 polio vaccination and 42 days following her April 22, 2016 Tdap vaccination. (Ex. 1.) Petitioner has filed literature which indicates that, while CNS demyelination often occurs within three to four weeks of vaccination, it has previously been shown to occur up to six months following vaccination. (Karussis & Petrou, supra, at Ex. 60, p. 7.) This provides some evidence supporting a temporal relationship. E.g., Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1383-84 (Fed. Cir. 2015) ) (stating that “[t]he special master further erred in setting a hard and fast deadline” for onset and noting that 17 The previously assigned special master characterized onset as occurring June 4, 2016, but did not specify the basis for that conclusion. (ECF No. 9, p. 2.) 29 Case 1:17-vv-00642-SSS Document 76 Filed 02/26/21 Page 30 of 30 the medical literature filed in the case “do not purport to establish any definitive timeframe for onset of clinical symptoms.”). But perhaps more significantly, onset in this case is also consistent with prior cases that have identified the relevant temporal period for vaccine-related CNS demyelination, including MS and ADEM, as being up to about 42 days, comparing that period to the timing of adaptive immune response otherwise commonly accepted for peripheral demyelinating conditions such as Guillain-Barre Syndrome (“GBS”). See e.g., Smith, 2016 WL 2772194, at *18; Quackenbush, 2018 WL 1704523, at *20. Other cases involving GBS have in turn found a period of up to about two months to be medically reasonable for autoimmune demyelination. Barone v. Sec’y of Health & Human Servs., No. 11-707V, 2014 WL 6834557, at *13 (Fed. Cl. Spec. Mstr. Nov. 12, 2014). Importantly, although the above-discussed Langer-Gould study found that the association between vaccination and clinical onset of MS that they observed disappeared after 30 days, this is only a statistical observation relating to risk. (Langer- Gould et al., supra, at Ex. 62, pp. 5, 7.) The ability to identify a 30-day window in which a disproportionate number of cases see onset of clinical symptoms provides evidence that the vaccination is a relevant and identifiable antecedent event. It does not, however, purport to identify any outside limit for the pathologic process at work. Rather, the period routinely recognized in his program as medically reasonable for the manifestation of autoimmune demyelination, and especially CNS demyelination, remains the controlling consideration with regard to Althen prong three. The experts agree that it is the fact that inflammation results in demyelination that leads to outward disability. VI. Conclusion For all the reasons discussed above, after weighing the evidence of record within the context of this program, there is preponderant evidence that petitioner’s multiple sclerosis was significantly aggravated as a result of her receipt of the tetanus, diphtheria, and pertussis (“Tdap”) vaccination administered on April 22, 2016 and/or the polio vaccination administered on April 4, 2016. A separate damages order will be issued. IT IS SO ORDERED. s/Daniel T. Horner Daniel T. Horner Special Master 30 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_17-vv-00642-1 Date issued/filed: 2021-11-01 Pages: 5 Docket text: PUBLIC DECISION (Originally filed: 10/5/2021) regarding 84 DECISION Stipulation/Proffer, Signed by Special Master Daniel T. Horner. (mly) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-00642-SSS Document 85 Filed 11/01/21 Page 1 of 5 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 17-642V Filed: October 5, 2021 UNPUBLISHED ELIZABETH DOLES, Special Master Horner Petitioner, v. Damages Decision Based on Proffer; Tetanus, diphtheria, acellular SECRETARY OF HEALTH AND pertussis (“Tdap”) Vaccine; Multiple HUMAN SERVICES, Sclerosis; Significant Aggravation Respondent. Joseph Vuckovich, Maglio Christopher & Toale, P.A., for petitioner. Catherine Stolar, U.S. Department of Justice, Washington, DC, for respondent. DECISION AWARDING DAMAGES1 On May 16, 2017, Elizabeth Doles (“Petitioner”) filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). Petitioner initially alleged that she suffered from Acute Disseminated Encephalomyelitis. (ECF No.1, p. 1-2.) On July 5, 2019, petitioner filed an amended petition, alleging that she “has suffered from central nervous system (CNS) demyelination” and further alleging that her expert opined that “Petitioner’s neurological injuries are best characterized as multiple sclerosis (MS).” (ECF No. 44, p. 2.) On February 1, 2021, a ruling on entitlement was issued, finding Petitioner entitled to compensation for a significant aggravation of MS. (ECF No. 73.) On October 4, 2021, Respondent filed a proffer on award of compensation (“Proffer”) indicating Petitioner should be awarded $135,000.00 in compensation for pain and suffering and $2,400.00 in compensation for past unreimbursable expenses. (ECF No. 82.) In the Proffer, Respondent represented that Petitioner agrees with the proffered award. Id. 1 Because this unpublished decision contains a reasoned explanation for the action in this case, I am required to post it on the United States Court of Federal Claims' website in accordance with the E- Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Case 1:17-vv-00642-SSS Document 85 Filed 11/01/21 Page 2 of 5 Based on the record as a whole, I find that Petitioner is entitled to an award as stated in the Proffer. Pursuant to the terms stated in the attached Proffer, I award Petitioner a lump sum payment of $137,400.00, representing $135,000.00 in compensation for pain and suffering and $2,400.00 in compensation for past unreimbursable expenses, in the form of a check payable to Petitioner. This amount represents compensation for all damages that would be available under § 15(a). The clerk of the court is directed to enter judgment in accordance with this decision.3 IT IS SO ORDERED. s/Daniel T. Horner Daniel T. Horner Special Master 3 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing the right to seek review. 2 Case 1:17-vv-00642-SSS Document 85 Filed 11/01/21 Page 3 of 5 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS ) ELIZABETH DOLES, ) ) Petitioner, ) ) No. 17-642V v. ) Special Master Horner ) ECF SECRETARY OF HEALTH AND ) HUMAN SERVICES, ) ) Respondent. ) ) RESPONDENT’S PROFFER ON AWARD OF COMPENSATION On May 16, 2017, Elizabeth Doles (“petitioner”) filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (“Vaccine Act” or “Act”), alleging that her receipt of a polio vaccine and a tetanus, diphtheria, and acellular pertussis (“Tdap”) vaccine on April 4, 2016 and April 22, 2016, respectively, caused or significantly aggravated Acute Disseminated Encephalomyelitis. ECF No. 1, at 1-2. On April 24, 2018, the Secretary of Health and Human Services (“respondent”) filed a Rule 4(c) Report setting forth the reasons why petitioner was not entitled to compensation. ECF No. 21. On July 5, 2019, petitioner filed an amended petition, alleging that as a result of her April 4, 2016 and April 22, 2016 vaccinations, she “has suffered from central nervous system (CNS) demyelination.”1 ECF No. 44 at 2. On February 1, 2021, following briefing by both parties, the 1 In the amended petition, petitioner further alleged that “Dr. John Steel, a neurology expert retained by Petitioner, has opined that Petitioner’s neurological injuries are best characterized as multiple sclerosis (MS).” ECF No. 44 at 2. Case 1:17-vv-00642-SSS Document 85 Filed 11/01/21 Page 4 of 5 Special Master issued a Ruling on Entitlement finding petitioner entitled to compensation for a significant aggravation of MS.2 ECF No. 73. I. Items of Compensation A. Pain and Suffering Respondent proffers that petitioner should be awarded $135,000.00 in pain and suffering. See 42 U.S.C. § 300aa-15(a)(4). Petitioner agrees. B. Past Unreimbursable Expenses Evidence supplied by petitioner documents that she incurred past unreimbursable expenses related to her vaccine-related injury. Respondent proffers that petitioner should be awarded past unreimbursable expenses in the amount of $2,400.00. See 42 U.S.C. § 300aa- 15(a)(1)(B). Petitioner agrees. These amounts represent all elements of compensation to which petitioner is entitled under 42 U.S.C. § 300aa-15(a). Petitioner agrees. II. Form of the Award Petitioner is a competent adult. Evidence of guardianship is not required in this case. Respondent recommends that the compensation provided to petitioner should be made through a lump sum payment as described below and requests that the Special Master’s decision and the 2 The parties have no objection to the amount of the proffered award of damages set forth herein. However, respondent reserves his right, pursuant to 42 U.S.C. § 300aa-12(e), to seek review of the Special Master’s February 1, 2021 Ruling on Entitlement. This right accrues following issuance of the damages decision. 2 Case 1:17-vv-00642-SSS Document 85 Filed 11/01/21 Page 5 of 5 Court’s judgment award the following3: a lump sum payment of $137,400.00, in the form of a check payable to petitioner. Summary of Recommended Payments Following Judgment Lump sum payable to petitioner, Elizabeth Doles: $137,400.00 Respectfully submitted, BRIAN M. BOYNTON Acting Assistant Attorney General C. SALVATORE D’ALESSIO Acting Director Torts Branch, Civil Division HEATHER L. PEARLMAN Deputy Director Torts Branch, Civil Division DARRYL R. WISHARD Assistant Director Torts Branch, Civil Division /s/ Catherine E. Stolar CATHERINE E. STOLAR Trial Attorney Torts Branch, Civil Division U.S. Department of Justice P.O. Box 146 Benjamin Franklin Station Washington, D.C. 20044-0146 Tel.: (202) 353-3299 Fax: (202) 616-4310 Email: catherine.stolar@usdoj.gov DATED: October 4, 2021 3 Should petitioner 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 lost earnings and future pain and suffering. 3 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_17-vv-00642-2 Date issued/filed: 2022-04-26 Pages: 10 Docket text: JUDGE VACCINE REPORTED OPINION reissuing 90 Opinion and Order on Motion for Review initially filed April 1, 2022. Signed by Judge Stephen S. Schwartz. (cmc) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-00642-SSS Document 95 Filed 04/26/22 Page 1 of 10 In the United States Court of Federal Claims No. 17-642V (Filed Under Seal: April 1, 2022) (Reissued: April 26, 2022) FOR PUBLICATION *************************************** ELIZABETH DOLES, * * Petitioner, * * v. * * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * *************************************** Jennifer G. Maglio, Maglio Christopher & Toale Law Firm, Sarasota, FL, for Plaintiff. Catherine E. Stolar, Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, Washington, D.C. for Defendant, United States. With her on briefs were Brian M. Boynton, Acting Assistant Attorney General, C. Salvatore D’Alessio, Acting Director, Heather L. Pearlman, Deputy Director, Darryl R. Wishard, Assistant Director, Torts Branch, Civil Division, United States Department of Justice, Washington, D.C. OPINION AND ORDER Petitioner Elizabeth Doles experienced various neurological symptoms after receiving two vaccinations — first for polio, then for tetanus, diphtheria, and pertussis (“Tdap”). She sought relief under the National Childhood Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 to 34 (“Vaccine Act”), and the Special Master awarded damages. See Special Master’s Ruling on Entitlement (“Ruling”) at 1 (ECF 73); Special Master’s Decision Awarding Damages (“Decision”) at 2 (ECF 83). The government moved for review, raising arguments about the nature of Petitioner’s medical condition and about whether and how the vaccines relate to her condition.  This Opinion was issued under seal on April 1, 2022. The parties were directed to propose redactions by April 15, 2022. No proposed redactions were submitted. The Court hereby releases publicly the Opinion and Order of April 1 in full. Case 1:17-vv-00642-SSS Document 95 Filed 04/26/22 Page 2 of 10 Finding errors in the Special Master’s Ruling, I REMAND for additional proceedings.1 BACKGROUND To obtain compensation under the Vaccine Act, a petitioner must prove that a vaccine caused an injury. Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). There are two ways to show causation: (1) through “a statutorily-prescribed presumption of causation upon a showing that the injury falls under the Vaccine Injury Table (‘Table injury’),” id. (citing 42 U.S.C. § 300aa-14(a)), or (2) by proof of causation in fact “where the complained-of injury is not listed in the Vaccine Injury Table (‘off-Table injury’),” id. (citing 42 U.S.C. §§ 300aa-13(a)(1), 300aa-11(c)(1)(C)(ii)(I)). For off-Table injuries, causation in fact has three elements: “(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.” Id. While some Vaccine Act petitioners claim novel injuries resulting from vaccines, others claim that an existing medical condition was “significantly aggravated” by a vaccine. 42 U.S.C. § 300aa-11(c)(1)(C)(i)–(ii); see Loving ex rel. Loving v. Sec’y of Dept. of Health & Hum. Servs., 86 Fed. Cl. 135, 143 (2009) (“[T]he Vaccine Act specifies that significant-aggravation and new-injury circumstances constitute separate avenues to potential recovery.”). Petitioners in the latter category must prove three additional elements: “(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), [and] (3) whether the person’s current condition constitutes a ‘significant aggravation’ of the person’s condition prior to vaccination[.]” Loving, 86 Fed. Cl. at 144; W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013). A petitioner always must prove causation of off-Table injuries by preponderance of the evidence. See, e.g., Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d 1355, 1366 (Fed. Cir. 2012); Althen, 418 F.3d at 1278.2 Although the petitioner’s burden does not “require identification and proof of specific biological mechanisms,” Knudsen, 35 F.3d at 549, “a ‘plausible’ or ‘possible’ causal theory” is 1 This Court has jurisdiction. See 42 U.S.C. §§ 300aa-11(c), 300aa-16(a). The government timely moved for review. See 42 U.S.C. § 300aa-12(e)(1). 2 The government can rebut proof of causation by showing, “also by a preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine.” Althen, 418 F.3d at 1278 (quoting Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 547 (Fed. Cir. 1994)); see 42 U.S.C § 300aa- 13(a)(1)(B). - 2 - Case 1:17-vv-00642-SSS Document 95 Filed 04/26/22 Page 3 of 10 not enough, see Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019) (quoting Moberly ex rel. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)). Proof of causation requires “a reputable medical or scientific explanation that pertains specifically to the petitioner’s case.” See Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010); Moberly, 592 F.3d at 1322; see also Knudsen, 35 F.3d at 549 (“[C]ausation can be found in vaccine cases based on epidemiological evidence and the clinical picture regarding the particular [patient] without detailed medical and scientific exposition on the biological mechanisms.”). This Court may set aside a special master’s conclusions as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B). “Fact findings are reviewed … under the arbitrary and capricious standard; legal questions under the ‘not in accordance with law’ standard; and discretionary rulings under the abuse of discretion standard.” Munn v. Sec’y of Dep’t of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). When this Court finds error, it may either substitute its own findings and conclusions or remand for additional proceedings. 42 U.S.C. § 300aa-12(e)(2)(B)–(C). The relevant facts and history of the case are as follows. Petitioner — a 67- year-old woman at the time of her vaccinations — alleged in her Amended Petition that she suffers from central nervous system demyelination “best characterized” as multiple sclerosis (“MS”). Am. Pet. ¶¶ 5–6 (ECF 44). She does not plead exactly when her symptoms began, but she went to the emergency room 44 days after her second vaccination for symptoms that began two nights before. Id. at ¶¶ 1–3; Ruling at 6. She claims that her vaccines “actually caused, or, alternatively, significantly aggravated” her injury. Am. Pet. at ¶ 10. Because Petitioner’s alleged injury does not appear on the Table for the relevant vaccines, 42 U.S.C. § 300aa-14(a); 42 C.F.R. § 100.3(a)(I), (II), (VI), (VII), she must prove causation rather than benefit from the statutory presumption. Althen, 418 F.3d at 1278. Central nervous system demyelination is a general term describing a number of medically distinct conditions — including MS, acute disseminated encephalomyelitis (“ADEM”), and focal myelitis or transverse myelitis (“TM”), among others, see Steel Rebuttal Report at 2 (ECF 57-2) — so Petitioner presented two experts to explain her theory of injury in more detail. The first was Dr. Slavenka Kam-Hansen, one of Petitioner’s treating physicians, who opined in a letter that Petitioner suffered from ADEM because of the vaccines. Kam-Hansen Letter at 2 (ECF 23-2). Dr. Kam-Hansen opined “that ADEM was more likely to cause [Petitioner’s] symptoms” than MS. Id. at 1. But then - 3 - Case 1:17-vv-00642-SSS Document 95 Filed 04/26/22 Page 4 of 10 Petitioner changed course. Her second expert, Dr. John G. Steel, submitted reports arguing that Petitioner did not have ADEM, but instead experienced focal myelitis or TM because of the vaccines. Steel Rebuttal Report at 1, 7; see Steel Report at 3, 5 (ECF 34-2). Dr. Steel opined that Petitioner has MS, but — although the record of his opinions is not entirely clear — he did not appear to argue that the vaccines caused or aggravated that condition. Rather, he seems to have argued that her MS put her at heightened risk for TM when she received vaccinations. Steel Rebuttal Report at 1–2, 6–7.3 “Although there is little evidence that vaccinations cause multiple sclerosis in healthy patients,” he wrote, “there is convincing evidence that vaccinations occasionally trigger single attacks of TM[] [and other conditions], and there is good reason to think that such an event is more likely in patients with subclinical MS.” Steel Report at 5. Defendant submitted an expert report from Dr. Subramaniam Sriram, who agreed with Dr. Steele that Petitioner has MS, not ADEM, Sriram Report at 7, 13 (ECF 52-1), but concluded that Petitioner’s MS was not caused or exacerbated by the vaccines. Id. at 16; Sriram Rebuttal Report at 7 (ECF 62-1). He opined that the diagnosis of MS made it inappropriate to diagnose TM as a separate condition. Sriram Rebuttal Report at 1–2. In response, Dr. Steel emphatically objected not only to Dr. Sriram’s characterization of Petitioner’s condition, but to Dr. Sriram discussing MS in the first place. Dr. Steel referred to MS as a “red herring” that “has served to confuse the issue,” insisting that he “made no assertion of a causal relationship between the vaccines and MS” and that his opinion was “regarding the myelitis only.” Steel Rebuttal Report at 1. He criticized Dr. Sriram for addressing MS at all: “Dr. Sriram’s rebuttal … focused on MS but did not address the actual causal relationship that I have asserted, between Ms. Doles’ April 2016 vaccinations and her subsequent attack of spinal myelitis. By discussing MS only, he failed to address our central point.” Id. at 1–2. Petitioner’s own argument before the Special Master was in the same vein as Dr. Steel’s. Petitioner maintained that “Dr. Steel’s theory of general causation” was that her vaccines “can provoke an autoimmune process leading to central nervous system demyelination which manifests as [a form of TM] and this is more likely to occur in patients who are already undergoing another autoimmune process, such as clinically silent MS.” Reply Mem. in Supp. of Pet.’s Mot. for Findings of Fact and 3 Dr. Steel also opined that “[t]he vaccinations likely did not cause the MS but rather unmasked it, i.e. caused it to become clinically significant during her medical evaluation.” Steel Report at 3. That language could be read as opining that Petitioner’s vaccinations aggravated her MS, but it is difficult to understand in the context of Dr. Steel’s other opinions. - 4 - Case 1:17-vv-00642-SSS Document 95 Filed 04/26/22 Page 5 of 10 Conclusions of Law (“Reply Mem.”) at 2 (ECF 72). Petitioner identifies no place in her expert reports or briefing where she plainly argued that her MS itself had been aggravated by the vaccines. Rather, she argued consistently that her MS was an underlying risk factor that put her at risk for other conditions. Pet.’s Mem. in Supp. of Her Mot. for Findings of Fact and Conclusions of Law at 18–20 (ECF 68); Reply Mem. at 2. The Special Master — who resolved the parties’ arguments on the papers, without a hearing — took a tack different from either of the parties. He specifically rejected both Dr. Kam-Hansen’s view that Petitioner experienced ADEM and Dr. Steel’s view that Petitioner experienced TM, instead agreeing with Dr. Sriram that Petitioner has MS alone. Ruling at 18, 20–22. But unlike Dr. Sriram (or Petitioner and her experts, for that matter), the Special Master determined that Petitioner’s MS had been significantly aggravated by her vaccines. Id. at 19. The Special Master’s main support for that conclusion was a study by Langer-Gould et al., which he interpreted as providing “evidence tending to show that vaccines did contribute to significantly aggravate subclinical autoimmunity into overt MS among the examined population.” See id. at 24 n.11 (citing Annette Langer-Gould et al., Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases, 71 JAMA Neurol. 1506 (2014) (“Langer-Gould”) (ECF 57-10)). The Special Master thus issued a Ruling on Entitlement and a Decision based on a theory of injury (MS) and a theory of causation (significant aggravation) that Petitioner never advanced in her expert reports or briefing.4 The Special Master placed the date of Petitioner’s condition “approximately 60 days following her … polio vaccination and 42 days following her … Tdap vaccination.” Id. at 29. DISCUSSION The Special Master’s resolution was erroneous for at least two reasons. First, it was unfair to the parties and frustrates this Court’s review. Although the formal requirements of this Court’s Rules and the Federal Rules of Civil Procedure and Evidence do not apply to proceedings before the special masters, see 42 U.S.C. § 300aa-12(d)(2); RCFC App. B, Rule 8(b)(1), the special masters are bound by an obligation to be fair to both parties, and to provide both parties the opportunity to present a case. See RCFC App. B, Rule 8(b)(1) (“In receiving evidence, the special master … must consider all relevant and reliable evidence governed by principles of fundamental fairness to both parties.”); id. Rule 3(b)(2) (“The special master is responsible for … affording each party a full and fair opportunity to present its 4 Petitioner even conceded before the Special Master that “the studies cited by Dr. Steel do not involve vaccines triggering MS[.]” Reply Mem. at 4. - 5 - Case 1:17-vv-00642-SSS Document 95 Filed 04/26/22 Page 6 of 10 case[.]”); see also Dickerson v. Sec’y of Dep’t of Health & Hum. Servs., 35 Fed. Cl. 593, 598 (1996) (“[T]he Court of Federal Claims has promulgated rules of procedure for use by special masters governed by the principles of fundamental fairness to both parties.”). The special masters must also conduct their proceedings in a way that “create[es] a record sufficient to allow review of” their decisions. See RCFC App. B, Rule 3(b)(2). Given those principles, this Court has required special masters to give parties notice and an opportunity to comment on the evidence and issues the special master considers. See, e.g., Davis v. Sec’y of Health & Hum. Servs., 94 Fed. Cl. 53, 65– 66 (2010). The Special Master failed to do so. As explained, the Special Master adopted a theory of injury and causation that Petitioner never advanced and that does not appear to have been obvious from the evidence submitted. Compare Sword v. United States, 44 Fed. Cl. 183, 190 (1999) (finding no surprise where “the Special Master’s explanation was hardly out of left field”). As a result, the government never had its opportunity to explain why those theories were mistaken. Compare Hines ex rel. Sevier v. Sec’y of Dep’t of Health & Hum. Servs., 940 F.2d 1518, 1525–26 (Fed. Cir. 1991) (finding that the special master taking judicial notice of a “[w]ell-known medical fact[]” without “inform[ing] the parties in advance that he intended to do so” did not “violate[] the principles of fundamental fairness” because the objecting party could have raised her concerns on review before the Court of Federal Claims and did not do so) (quotes omitted), with Campbell ex rel. Campbell v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 781–82 (2006) (finding it “patently unfair” for the special master to rely on extra-record articles of dubious reliability without giving the parties an adequate opportunity to respond to them). To the extent the Special Master relied on evidence in the record, the government addressed that evidence as it related to Petitioner’s characterization of her injury, not the Special Master’s different characterization. Both parties agree that they were “surprise[d]” — Petitioner’s word — by the Special Master’s decision to treat this case as one of significant aggravation of an existing condition. Pet.’s Mem. in Resp. to Resp’s. Mot. for Rev. (“Pet.’s Resp.”) at 1 (ECF 89). And because of the lack of adversarial development of the Special Master’s theory, I cannot be sure that the record is adequate for review. Second — possibly because of the departure from ordinary adversarial processes — the Special Master’s Ruling misinterpreted its primary medical authority, the Langer-Gould study. A summary of that study will show why. The Langer-Gould investigators used the records of a large health system to investigate the association between vaccinations of any type and central nervous system demyelinating conditions, including MS. Langer-Gould at 2. The investigators - 6 - Case 1:17-vv-00642-SSS Document 95 Filed 04/26/22 Page 7 of 10 bifurcated their findings between patients younger than 50 and those 50 or older. Id. at 3. The investigators expressed the association between vaccination and conditions such as MS in terms of an odds ratio, plus a 95% confidence interval, for developing demyelinating conditions during different time periods (up to three years) after vaccination. Id. at 3, 6 (Figure 2). An odds ratio is a way of expressing the relative risk of a condition in a “case” group exposed to a given factor versus a “control” group that was not exposed. Fed. Jud. Ctr., Reference Manual on Scientific Evidence 568 (3d ed. 2011). “An odds ratio of 1 indicates no association” between the disease and the factors investigated: The risk of the disease is the same whether the group was exposed or not. Id. at 291. “A confidence interval is a range of values within which the true value is likely to fall.” Germaine v. Sec’y of Health & Hum. Servs., 155 Fed. Cl. 226, 229 (2021) (quotes and alterations omitted) (quoting Reference Manual on Scientific Evidence 621). “By definition, when a statistician uses a 95% confidence interval, that statistician estimates that a sample to be drawn from the population will fail to capture the mean population 1 out of 20 times.” Lax v. APP of N.M. ED, PLLC, CIV No. 20-264 SCY/JFR, 2022 WL 715735, at *8 n. 9 (D.N.M. Mar. 10, 2022). A confidence interval that straddles an odds ratio of 1.0 is “statistically insignificant,” meaning that it is statistically indistinguishable from no change in risk. Germaine, 155 Fed. Cl. at 228–29 (citation omitted) (quoting Reference Manual on Scientific Evidence 621) (discussing the related concept of relative risk). Looking at all types of vaccines combined, the investigators found no association between vaccinations and MS. For every time period after vaccination, the confidence interval for developing MS straddled an odds ratio of 1.0. Langer- Gould at 6 (Figure 2). There was one statistically significant association between vaccines and the broader universe of demyelinating conditions — an odds ratio of 2.32, with a confidence interval of 1.18 to 4.57 — but only for patients under age 50, and only within 14 days of the vaccine. Id. There was no association between vaccines and demyelinating conditions for patients 50 or older for any time period post- vaccination. Id. For patients younger than 50, the association between vaccinations and demyelinating conditions disappeared after 14 days. Id. In short, Langer-Gould found no association between MS — the condition the Special Master identified as Petitioner’s injury — and vaccinations. The only association found involved demyelinating conditions generally, i.e., conditions other than the demyelinating condition Petitioner has. Even if there were an association between Petitioner’s personal condition and vaccinations, it did not exist for patients in Petitioner’s age group, only younger patients. And even if there were an association for her age group, the effect disappears soon after vaccination, such that there is no - 7 - Case 1:17-vv-00642-SSS Document 95 Filed 04/26/22 Page 8 of 10 association between vaccinations and demyelinating conditions for either age group at the time the Special Master found Petitioner’s symptoms in fact developed. In short, there is no way to look at the study’s data and find an association between vaccinations and Petitioner’s own condition.5 Although there can be association without causation, there cannot be causation without association. See, e.g., Olaf M. Dekkers, The Long and Winding Road to Causality, 34 European J. of Epidemiology 533 (2019) (“[T]he fundamental prerequisite before judging causality is the presence of an association. …. In short: no causation without association.”); Handbook of Causal Analysis for Social Research 285 (Stephen L. Morgan ed., 2013) (“Typically, all we can observe in data is whether or not two or more variables are associated, either unconditionally or after conditioning on some other set of other variables. Causality is not observed but must be inferred from these associations. … [I]f two variables are causally related, they must be associated. As the old adage goes, ‘no causation without association.’”).6 The fact that the Langer-Gould study shows no association relevant to Plaintiff means that it does not evidence causation: A finding of causation would have to be despite the Langer-Gould study, not because of it. It was therefore error for the Special Master to treat the Langer-Gould study as supporting Petitioner’s proof of causation. The Special Master’s Ruling acknowledged that Langer-Gould “found no long- term association between vaccination and MS,” Ruling at 23, but dismissed the point as “only a statistical observation” because a possible mechanism for causation — specifically, “vaccine involvement as an inflammatory cofactor” — might hypothetically take effect later than 30 days after vaccination or in patients older than 50. Id. at 24 & n.11, 30. That hypothesis, however, is not evidence; it was a theory the Langer-Gould study was supposed to test by looking for an association. The Special Master was not permitted to adopt a hypothesis as a theory of causation without evidence to support it. See Germaine, 155 Fed. Cl. at 227–28 (citing Knudsen, 35 F.3d at 549, and Boatmon, 941 F.3d at 1360). And the Langer-Gould study, again, provided no such evidence: It found an association in some circumstances, but not circumstances like Petitioner’s. One might argue that the study supports an inference of causation in the limited circumstance where there was a statistical association. But because association is a prerequisite for conclusions about causation, the Langer-Gould study 5 Dr. Sriram raised some of these points in a supplemental report. See Sriram Rebuttal Report at 5. 6 But see Stephen L. Morgan & Christopher Winship, Counterfactuals and Causal Inference: Methods and Principles for Social Research 447 n.9 (2d ed. 2015) (noting “cases for which this may not be true, such as when individual-varying causal effects perfectly cancel out each other or when suppression effects exist”). - 8 - Case 1:17-vv-00642-SSS Document 95 Filed 04/26/22 Page 9 of 10 provides no support for a hypothesis of causation in circumstances where an association was lacking. See Broekelschen, 618 F.3d at 1345 (“[A] petitioner must provide a reputable medical or scientific explanation that pertains specifically to the petitioner’s case[.]”). To dismiss that finding as a “statistical observation” thus misunderstands what the Langer-Gould study was investigating and the conclusions it reached. That is not to say that the Langer-Gould study disproves causation in Petitioner’s case. Scientific studies sometimes yield different results, so perhaps some other study shows an association that Langer-Gould did not. When scientific studies differ, the proper course is to weigh them, in which case a special master’s conclusions about inconsistent medical evidence would be upheld unless arbitrary or capricious. See Broekelschen, 618 F.3d at 1349; Greene v. Sec’y of Health & Hum. Servs., 146 Fed. Cl. 655, 665, aff’d, 841 F. App’x 195 (Fed. Cir. 2020); Moreno v. Sec’y of Dept. of Health & Hum. Servs., No. 95–706V, 2005 WL 6120645, at *6–7, 9–10 (Fed. Cl. 2005). Likewise, the Federal Circuit has made clear that published research is not strictly necessary to show causation in the first place. See Andreu ex rel. Andreu v. Sec’y of Dep’t of Health & Hum. Servs., 569 F.3d 1367, 1378 (Fed. Cir. 2009); Althen 418 F.3d at 1280. But when the Court or a special master does resort to medical literature, a study’s findings must be interpreted using correct statistical methods — just as its words must be assigned their correct common or technical meanings.7 Because of the importance the Special Master attached to the Langer-Gould study and the government’s lack of opportunity to respond to the Special Master’s treatment of the rest of the record, I cannot conclude that the Special Master’s errors are harmless. See Davis, 94 Fed. Cl. at 65–66. But for the same reason, the record is insufficient for me to issue new findings. 42 U.S.C. § 300aa-12(e)(2)(B); RCFC App. B, Rule 3(b)(2). The best course is therefore to remand for further proceedings. 42 U.S.C. § 300aa-12(e)(2)(C). On remand, the Special Master should give the parties the opportunity for briefing — and, if appropriate, new written or live evidence — on 7 Another possible error in the Special Master’s Ruling deserves brief attention. The Special Master wrote that his conclusion about the Langer-Gould study was “consistent with petitioner’s burden of proof for a significant aggravation claim” because “Petitioner need only demonstrate that her vaccination affected her condition; she does not have a burden to demonstrate that her ultimate condition is worse than her expected outcome.” Ruling at 24–25 (citing Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072, 1081 (Fed. Cir. 2020)). As the parties agree, that is not the law for causation. Resp’s. Mem. in Supp. of Mot. for Rev. at 9 (ECF 86-1); Pet.’s Resp. at 5–6. Petitioner argues that in context, the Special Master meant to refer to the standard for aggravation of injuries. Pet.’s Resp. at 6–7. I find the Ruling’s language too cryptic to be sure. Be that as it may, the Special Master should use the correct standard on remand. - 9 - Case 1:17-vv-00642-SSS Document 95 Filed 04/26/22 Page 10 of 10 whether Petitioner’s vaccinations aggravated her MS. The Special Master should interpret the medical evidence under the correct legal and scientific standards. CONCLUSION For the foregoing reasons, the government’s motion for review is GRANTED and the Special Master’s Decision (ECF 83) is VACATED. The case is REMANDED for the Special Master to consider the parties’ arguments on aggravation of MS and to re-evaluate the medical evidence under the correct legal and scientific standards. The Special Master shall issue a new entitlement decision within ninety days of this decision. See 42 U.S.C. § 300aa-12(e)(2); RCFC App. B, Rule 28(b). IT IS SO ORDERED. s/ Stephen S. Schwartz STEPHEN S. SCHWARTZ Judge - 10 - ================================================================================ DOCUMENT 4: USCOURTS-cofc-1_17-vv-00642-3 Date issued/filed: 2023-01-06 Pages: 9 Docket text: JUDGE VACCINE REPORTED OPINION reissuing 113 Opinion and Order on Motion for Review initially filed December 16, 2022. Signed by Judge Stephen S. Schwartz. (cmc) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-00642-SSS Document 119 Filed 01/06/23 Page 1 of 9 In the United States Court of Federal Claims No. 17-642V (Filed: December 16, 2022) (Reissued: January 6, 2023) FOR PUBLICATION *************************************** ELIZABETH DOLES, * * Petitioner, * * v. * * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * *************************************** Benjamin Alexander Christian, Maglio Christopher & Toale Law Firm, Sarasota, FL, for Petitioner. With him on briefs was Jennifer Anne Gore Maglio, Maglio Christopher & Toale Law Firm, Sarasota, FL. Catherine Elizabeth Stolar, Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, Washington, D.C., for Respondent. With her on briefs were Brian M. Boynton, Principal Deputy Assistant Attorney General, C. Salvatore D’Alessio, Acting Director, Heather L. Pearlman, Deputy Director, and Darryl R. Wishard, Assistant Director. OPINION AND ORDER Petitioner Elizabeth Doles experienced various neurological symptoms after receiving two vaccinations. She sought relief under the National Childhood Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 to 34 (“Vaccine Act”), and the Special Master awarded damages. See Special Master’s Ruling on Entitlement (“Ruling”) at 1 (ECF 73); Special Master’s First Decision Awarding Damages (“First  This Opinion was issued under seal on December 16, 2022. The parties were directed to propose redactions by December 30, 2022. No proposed redactions were submitted. The Court hereby releases publicly the Opinion and Order of December 16 in full. Case 1:17-vv-00642-SSS Document 119 Filed 01/06/23 Page 2 of 9 Decision”) at 2 (ECF 83). The government moved for review, and I remanded to the Special Master for additional proceedings. See Doles v. Sec’y of Health & Hum. Servs., 159 Fed. Cl. 241 (2022). On remand, the Special Master again awarded damages. See Special Master’s Decision on Remand (“Second Decision”) at 2 (ECF 102). The government moved for review once more, arguing that the Special Master misconstrued the record, committed legal error, and reached a decision that was arbitrary and capricious. The case has been fully briefed and I have heard oral argument.1 I REMAND for additional proceedings and ORDER that the case be reassigned to another Special Master.2 BACKGROUND I. The Vaccine Act To obtain compensation under the Vaccine Act, a petitioner must prove that a vaccine caused an injury. Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). There are two ways to show causation: (1) through “a statutorily-prescribed presumption of causation upon a showing that the injury falls under the Vaccine Injury Table (‘Table injury’),” id. (citing 42 U.S.C. § 300aa-14(a)), or (2) by proof of causation in fact “where the complained-of injury is not listed in the Vaccine Injury Table (‘off-Table injury’),” id. (citing 42 U.S.C. §§ 300aa-13(a)(1), 300aa-11(c)(1)(C)(ii)(I)). For off-Table injuries, causation in fact has three elements: “(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.” Id. While some Vaccine Act petitioners claim novel injuries resulting from vaccines, others claim that an existing medical condition was “significantly aggravated” by a vaccine. 42 U.S.C. § 300aa-11(c)(1)(C)(i)–(ii); see Loving ex rel. Loving v. Sec’y of Dept. of Health & Hum. Servs., 86 Fed. Cl. 135, 143 (2009) (“[T]he Vaccine Act specifies that significant-aggravation and new-injury circumstances constitute separate avenues to potential recovery.”). Petitioners in the latter category must prove three additional elements: “(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), [and] (3) whether the person’s current condition constitutes a ‘significant aggravation’ of the person’s condition prior 1 U.S. Mot. for Review of Decision on Remand (“Second Mot. for Review”) (ECF 105); Pet.’s Resp. to Mot. for Review of Decision on Remand (“Second Resp.”) (ECF 109); Tr. (ECF 112). 2 This Court has jurisdiction. See 42 U.S.C. §§ 300aa-11(c), 300aa-16(a). The government timely moved for review. See 42 U.S.C. § 300aa-12(e)(1). - 2 - Case 1:17-vv-00642-SSS Document 119 Filed 01/06/23 Page 3 of 9 to vaccination[.]” Loving, 86 Fed. Cl. at 144; W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013). A petitioner always must prove causation of off-Table injuries by preponderance of the evidence. See, e.g., Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d 1355, 1366 (Fed. Cir. 2012); Althen, 418 F.3d at 1278.3 Although the petitioner’s burden does not “require identification and proof of specific biological mechanisms,” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 549 (Fed. Cir. 1994), “a ‘plausible’ or ‘possible’ causal theory” is not enough, see Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019) (quoting Moberly ex rel. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)). Proof of causation requires “a reputable medical or scientific explanation that pertains specifically to the petitioner’s case.” See Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010); Moberly, 592 F.3d at 1322; see also Knudsen, 35 F.3d at 549 (“[C]ausation can be found in vaccine cases based on epidemiological evidence and the clinical picture regarding the particular [patient] without detailed medical and scientific exposition on the biological mechanisms.”). A theory of causation must be supported by medical records or an expert’s opinion. Althen, 418 F.3d at 1279 (citing 42 U.S.C. § 300aa-13(a)(1)). II. Procedural and Factual History The relevant facts and history of the case are fully presented in my previous opinion. Doles, 159 Fed. Cl. 241. Briefly, Petitioner alleged in her Amended Petition that she suffers from central nervous system demyelination “best characterized” as multiple sclerosis (“MS”). Am. Pet. ¶¶ 5–6 (ECF 44). She claimed that her vaccines “actually caused, or, alternatively, significantly aggravated” her injury. Id. at ¶ 10. Because Petitioner’s alleged injury does not appear on the Table for the relevant vaccines, 42 U.S.C. § 300aa-14(a); 42 C.F.R. § 100.3(a)(I), (II), (VI), (VII), she must prove causation rather than benefit from the statutory presumption. Althen, 418 F.3d at 1278. Central nervous system demyelination is a general term describing a number of medically distinct conditions — including MS, acute disseminated encephalomyelitis, and focal myelitis or transverse myelitis (“TM”), among others, see Steel Rebuttal Report at 2 (ECF 57-2) — so Petitioner presented experts to explain her theory of injury in more detail. 3 The government can rebut proof of causation by showing, “also by a preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine.” Althen, 418 F.3d at 1278 (quoting Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 547 (Fed. Cir. 1994)); see 42 U.S.C § 300aa- 13(a)(1)(B). - 3 - Case 1:17-vv-00642-SSS Document 119 Filed 01/06/23 Page 4 of 9 Her main expert, Dr. John G. Steel, submitted reports arguing that Petitioner experienced focal myelitis or TM because of the vaccines. Steel Rebuttal Report at 1, 7; see Steel Report at 3, 5 (ECF 34-2). Dr. Steel opined that Petitioner’s vaccines “unmasked” her MS, “i.e. caused it to become clinically significant during her medical evaluation.” Steel Report at 3. But while his opinions are at least somewhat ambiguous, he seems to have meant (at least in part) that Petitioner’s MS put her at heightened risk for TM when she received vaccinations: “Although there is little evidence that vaccinations cause multiple sclerosis in healthy patients,” he wrote, “there is convincing evidence that vaccinations occasionally trigger single attacks of TM[] [and other conditions], and there is good reason to think that such an event is more likely in patients with subclinical MS.” Steel Report at 5; see also id. at 1–2, 6– 7. Defendant submitted an expert report from Dr. Subramaniam Sriram, who agreed with Dr. Steel that Petitioner has MS, Sriram Report at 7, 13 (ECF 52-1), but concluded that Petitioner’s MS was not caused or exacerbated by the vaccines. Id. at 16; Sriram Rebuttal Report at 7 (ECF 62-1). He opined that the diagnosis of MS made it inappropriate to diagnose TM as a separate condition. Sriram Rebuttal Report at 1–2. In response, Dr. Steel emphatically objected not only to Dr. Sriram’s characterization of Petitioner’s condition, but to Dr. Sriram discussing MS in the first place. Dr. Steel referred to MS as a “red herring” that “has served to confuse the issue,” insisting that he “made no assertion of a causal relationship between the vaccines and MS” and that his opinion was “regarding the myelitis only.” Steel Rebuttal Report at 1. He criticized Dr. Sriram for addressing MS at all: “Dr. Sriram’s rebuttal … focused on MS but did not address the actual causal relationship that I have asserted, between Ms. Doles’ April 2016 vaccinations and her subsequent attack of spinal myelitis. By discussing MS only, he failed to address our central point.” Id. at 1–2. Petitioner’s original argument before the Special Master was in the same vein as Dr. Steel’s. Petitioner maintained that “Dr. Steel’s theory of general causation” was that her vaccines “can provoke an autoimmune process leading to central nervous system demyelination which manifests as [a form of TM] and this is more likely to occur in patients who are already undergoing another autoimmune process, such as clinically silent MS.” Reply Mem. in Supp. of Pet.’s Mot. for Findings of Fact and Conclusions of Law (“First Reply Mem.”) at 2 (ECF 72). Petitioner argued consistently that her MS was an underlying risk factor that put her at risk for other conditions. Pet.’s Mem. in Supp. of Her Mot. for Findings of Fact and Conclusions of Law at 18– 20 (ECF 68); First Reply Mem. at 2. - 4 - Case 1:17-vv-00642-SSS Document 119 Filed 01/06/23 Page 5 of 9 In his entitlement ruling, the Special Master — who resolved the parties’ arguments on the papers, without a hearing — considered whether Petitioner’s condition “constitutes a manifestation of petitioner’s overall course of MS, as respondent contends, or a separate attack of TM, as petitioner contends[.]” Ruling at 19–20. The Special Master adopted what he considered to be the government’s view and rejected what he considered to be Petitioner’s view: “An examination of petitioner’s clinical history … show[s] this case to be one of significant aggravation of petitioner’s pre-existing MS rather than including any separate attack of TM as argued by petitioner.” Id. at 19. In so doing, the Special Master rejected “Dr. Steel’s assertion of a separate attack of TM,” which the Special Master thought “does not appear on this record to be consistent with the way in which the medical community understands these conditions.” Id. at 20. The Special Master stated that Dr. Steel had “opined a causal relationship between vaccines and myelitis only.” Id. at 14. But the Special Master found that Dr. Steel’s understanding of the relevant conditions was “at odds with” one of Dr. Steel’s main authorities. Id. at 21 (discussing Elliot M. Frohman & Dean M. Wingerchuk, Transverse Myelitis, 363 N. Engl. J. Med. 564 (2010) (“Frohman & Wingerchuk”)). The Special Master referred to Dr. Steel when spelling out his conclusions about aggravation of MS, but did not explicitly ground those conclusions in Dr. Steel’s causation opinions. He found it most significant, rather, that Dr. Steel opined that “MS can be conceived as a disorder of immune regulation” with a “multifactorial” etiology. Id. at 22–23, 24. The Special Master went on to conclude that Petitioner was entitled to damages for aggravation of her MS. Because the Special Master surprised the parties in characterizing Petitioner’s injury as aggravation of MS, it violated fundamental fairness and frustrated this Court’s review. See Doles, 159 Fed. Cl. at 247. I therefore ordered the Special Master “to consider the parties’ arguments on aggravation of MS and to re-evaluate the medical evidence under the correct legal and scientific standards.” Id. at 249. Neither party presented new evidence on remand, and the Special Master did not hear testimony. See Second Decision at 6. The Special Master again concluded that Petitioner was entitled to damages for aggravation of MS. But this time, the Special Master expressly rooted his findings in Dr. Steel’s opinions: “Dr. Steel’s medical opinion has been consistent in identifying a significant aggravation of petitioner’s MS, notwithstanding his further references to [TM].” Id. at 7. He found that Dr. Sriram had correctly characterized Dr. Steel’s opinions, id. at 9 (“Dr. Sriram, fully understood Dr. Steel’s opinion.”); id. at 10 (“Dr. Sriram correctly paraphrased Dr. Steel .… Dr. Sriram understood that Dr. Steel had offered an opinion that petitioner’s vaccines had acted upon her MS disease process.”). He also found that - 5 - Case 1:17-vv-00642-SSS Document 119 Filed 01/06/23 Page 6 of 9 “Dr. Steel cites to researchers who have included statements in their papers expressing views consistent with the theory offered by Dr. Steel in this case,” including Frohman & Wingerchuk. Id. at 33. The government moved for review once more. DISCUSSION The Special Master’s new decision roots his causation finding primarily in Dr. Steel’s opinion. The government argues that the Special Master erred because Dr. Steel, contrary to the Special Master’s finding, did not opine in support of the Special Master’s conclusions about aggravation of MS. Second Mot. for Review at 14–16. The question at this phase of the case is what to do with the Special Master’s interpretation of Dr. Steel’s reports. The general contours of the standard of review are settled. To obtain relief under the Vaccine Act, a petitioner must support a theory of injury with medical records or expert opinion. Althen, 418 F.3d at 1279 (citing 42 U.S.C. § 300aa-13 (a)(1)). This Court may set aside a special master’s factual conclusions as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B). When the special master’s findings of fact are “supported by substantial evidence,” they must be upheld. Doe v. Sec’y of Health & Hum. Servs., 601 F.3d 1349, 1355 (Fed. Cir. 2010). That standard — which applies to special masters’ interpretations of expert opinion — is “well understood to be the most deferential possible.” Munn v. Sec’y of Dep’t of Health & Hum. Servs., 970 F.2d 863, 870 (Fed. Cir. 1992). Yet it obligates special masters to articulate the reasons for their decisions. Here, whatever interpretations of Dr. Steel’s reports might be conceivably defensible, the Special Master’s interpretation departs from that in his original ruling. But the Special Master did not acknowledge the difference or explain why he adopted a different reading on remand. Because he did not do so, there is no way to review his findings, and they must be set aside. The Special Master’s duty to explain his changed interpretation flows from several different sources. The Vaccine Act’s “arbitrary and capricious” standard of review is borrowed from the Administrative Procedure Act (“APA”) and is similar in substance. See Hines on Behalf of Sevier v. Sec’y of Dep’t of Health & Hum. Servs., 940 F.2d 1518, 1527 (Fed. Cir. 1991); see also, e.g., McCarren v. Sec’y of Dep’t of Health & Hum. Servs., 40 Fed. Cl. 142, 145 (1997); Skinner v. Sec’y of Dep’t of Health & Hum. Servs., 30 Fed. Cl. 402, 408 (1994). Among other aspects of the APA standard, it is arbitrary and capricious to change positions without explanation: “[A]n ‘unexplained - 6 - Case 1:17-vv-00642-SSS Document 119 Filed 01/06/23 Page 7 of 9 inconsistency’ … is ‘a reason for holding an interpretation to be an arbitrary and capricious change[.]’” Encino Motorcars, LLC v. Navarro, 579 U.S. 211, 222 (2016) (quoting Nat. Cable & Telecomms. Assn. v. Brand X Internet Servs., 545 U.S. 967, 981–982 (2005)) (alteration omitted); see also F.C.C. v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009) (“[T]he requirement that an agency provide reasoned explanation for its action would ordinarily demand that it display awareness that it is changing position.”); Towne v. United States, 106 Fed. Cl. 704, 710 (2012) (collecting cases). The same is true when agencies change position on remand. See Dep’t of Homeland Sec. v. Regents of the Univ. of California, 140 S. Ct. 1891, 1908 (2020) (explaining that new agency action on remand has to comply with applicable procedures). If it is arbitrary and capricious for an agency to change its position without explanation, the same should be true when the standard applies to a special master. Making a similar point from a different direction, the Federal Circuit has explained that decisions of special masters are not arbitrary and capricious if they articulate a rational basis for their conclusions and are supported by substantial evidence. See, e.g., Hines, 940 F.2d at 1528. If a special master does not explain why his interpretation of the record contradicts his earlier interpretation, he has not fully articulated a rational basis supported by substantial evidence. Moreover, a special master is not ordinarily free on remand to contradict prior factual conclusions that have not been disturbed on review in this Court. In Kottenstette v. Secretary of Health & Human Services — much like in this case — the Court of Federal Claims remanded a case to a special master “for the limited purpose of reconsideration under the correct legal standard[.]” 861 F. App’x 433, 442 (Fed. Cir. 2021) (internal quotations omitted). On remand, the special master “reweighed the facts to come to contrary findings ... despite declining to reopen the evidentiary record.” Id. The Federal Circuit (in an unpublished decision) concluded that was error. Id. The Special Master seems to have changed his interpretation of Dr. Steel’s opinions. In the original ruling that vaccines had aggravated Petitioner’s MS, the Special Master appeared to fault Dr. Steel for opining that Petitioner had experienced an attack of TM distinct from MS. Ruling at 20. The Special Master characterized Dr. Steel’s opinion as extending to “myelitis only,” id. at 14, consistent with what the Special Master took to be Petitioner’s overall argument that her condition “constitutes … a separate attack of TM” rather than “a manifestation of petitioner’s overall course of MS[.]” Id. at 19–20. - 7 - Case 1:17-vv-00642-SSS Document 119 Filed 01/06/23 Page 8 of 9 In the remand decision, the Special Master now interprets Dr. Steel as having opined that Petitioner experienced TM as an aggravation of her MS. Second Decision at 7. That is different from the Special Master’s earlier view that Dr. Steel treated the two conditions as separate and opined only on the former. The Special Master even seems to have changed his view of whether Dr. Steel’s opinion is supported or contradicted by the same published authority. Compare, e.g., Ruling at 21 (stating Dr. Steel’s opinion was “contrary to” study by Frohman & Wingerchuk), with Second Decision at 21 (stating Dr. Steel’s opinion was supported by Frohman & Wingerchuk). Before, the Special Master seems to have found that vaccines aggravated Petitioner’s MS in spite of Petitioner’s different medical characterization. Now, the Special Master enlists Petitioner’s expert to support the same causation finding. Those readings of Dr. Steel’s opinions are difficult to square. Petitioner argues that the two opinions are consistent and that the remand opinion simply “offers more detail as to [the Special Master’s] thought process in getting from A to B.” Tr. at 55. But “[s]quint as [I] may,” see Microsoft Corp. v. I4I Ltd. P’ship, 564 U.S. 91, 104 (2011), the more natural reading is that the Special Master’s findings in fact changed. Petitioner also argues that the Special Master was entitled to adopt a theory of causation supported by medical literature and consistent with her medical records even if no expert opined in support. Tr. at 45–46. Even if that is true, the Special Master chose to rely on his characterization of Dr. Steel’s opinions, so his opinion should be reviewed on that ground too. The Special Master has not explained the shift. Such unexplained changes on remand, as mentioned above, are arbitrary and capricious, frustrate this Court’s review, and exceed the scope of the Special Master’s authority on remand. When the Special Master’s findings are contradicted by his own prior findings on the same record, there is no way to determine whether his substantive conclusions are arbitrary and capricious, or whether they are supported by substantial evidence. The Special Master’s opinion should therefore be vacated. Although I find that the Special Master’s change of position is arbitrary and capricious, I “make no determination on the weight of the objective evidence in the record or whether that evidence establishes” preponderant evidence of causation, “for these are factual findings for the Special Master and not this court.” Cottingham on Behalf of K.C. v. Sec’y of Health & Hum. Servs., 971 F.3d 1337, 1347 (Fed. Cir. 2020). The question of what Dr. Steel’s opinion actually was, and whether Petitioner has established a theory of causation by preponderance of the evidence, remain questions for a special master. - 8 - Case 1:17-vv-00642-SSS Document 119 Filed 01/06/23 Page 9 of 9 At the same time, it appears to me that the record could benefit from review by fresh eyes. “Albeit with the best of intentions,” see Regents of Univ. of California v. Credit Suisse First Bos. (USA), Inc., 482 F.3d 372, 380 (5th Cir. 2007), the Special Master’s review of the record has yielded apparently contradictory interpretations of essential evidence. On remand, a different special master should consider the record anew. See RCFC App. B, Rule 3(d) (authorizing reassignment “[w]hen necessary for the efficient administration of justice”); cf. Contreras v. Sec’y of Health & Hum. Servs., 844 F.3d 1363, 1369 (Fed. Cir. 2017) (suggesting reassignment, under circumstances different from this case, where “fundamental fairness [was] best served by assigning the case to a different special master on remand”). CONCLUSION For the foregoing reasons, the government’s motion for review is GRANTED and the Special Master’s Decision (ECF 102) is VACATED. The case is REMANDED to the Office of Special Masters for further proceedings consistent with this opinion. The Office of Special Masters is DIRECTED to reassign the case to another special master. See RCFC App. B, Rule 3(d). The new special master shall review the record, order any necessary supplemental briefing from the parties, and issue a new entitlement decision within ninety days of this decision. See 42 U.S.C. § 300aa- 12(e)(2); RCFC App. B, Rule 28(b). The evidentiary record shall not be supplemented on remand. IT IS SO ORDERED. s/ Stephen S. Schwartz STEPHEN S. SCHWARTZ Judge - 9 - ================================================================================ DOCUMENT 5: USCOURTS-cofc-1_17-vv-00642-6 Date issued/filed: 2023-09-20 Pages: 12 Docket text: JUDGE VACCINE REPORTED OPINION reissuing 137 Opinion and Order on Motion for Review initially filed August 30, 2023. Signed by Judge Stephen S. Schwartz. (cmc) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 1 of 12 In the United States Court of Federal Claims No. 17-642V (Filed: August 30, 2023) (Reissued: September 20, 2023) FOR PUBLICATION *************************************** ELIZABETH DOLES, * * Petitioner, * * v. * * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * *************************************** Benjamin Alexander Christian, mctlaw, Sarasota, FL, for Petitioner. Catherine Elizabeth Stolar, Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, Washington, D.C., for Respondent, United States. With her on briefs were Brian M. Boynton, Principal Deputy Assistant Attorney General, C. Salvatore D’Alessio, Director, Heather L. Pearlman, Deputy Director, and Darryl R. Wishard, Assistant Director. OPINION AND ORDER Petitioner Elizabeth Doles, after experiencing neurological symptoms following two vaccinations, sought relief under the National Childhood Vaccine Injury Compensation Program. 42 U.S.C. §§ 300aa-10 to 34 (“Vaccine Act”). After the Special Master originally assigned to the case awarded damages, see Special Master’s Ruling on Entitlement (“Ruling”) at 1 (ECF 73); Special Master’s First Decision Awarding Damages (“First Decision”) at 2 (ECF 83), I granted the government’s motion for review and remanded for additional proceedings, see Doles v. Sec’y of Health & Hum. Servs., 159 Fed. Cl. 241 (2022) (Doles I). The original Special Master awarded damages a second time. See Special Master’s Decision on Remand (“Second  This Opinion was issued under seal on August 30, 2023. The parties were directed to propose redactions by September 13, 2023. No proposed redactions were submitted. The Court hereby releases publicly the Opinion and Order of August 30 in full. Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 2 of 12 Decision”) at 2 (ECF 102). I granted the government’s motion for review once more and reassigned to a different special master. Doles v. Sec’y of Health & Hum. Servs., 163 Fed. Cl. 726 (Doles II), reconsideration denied, 163 Fed. Cl. 616 (2023). The new Special Master has found against Petitioner, see Special Master’s Decision on Remand (“Third Decision”) (ECF 129), who has filed a third motion for review.1 I called for supplemental briefs, which the parties duly filed.2 I deemed oral argument unnecessary. See Young v. United States, 94 Fed. Cl. 671, 675–76 (2010). The motion for review is DENIED. The Special Master erred in several ways, but her decision to deny the petition is SUSTAINED.3 BACKGROUND I. The Vaccine Act To obtain compensation under the Vaccine Act, a petitioner must prove that a vaccine caused an injury. Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). There are two ways to show causation: (1) through “a statutorily-prescribed presumption of causation upon a showing that the injury falls under the Vaccine Injury Table (‘Table injury’),” id. (citing 42 U.S.C. § 300aa-14(a)), or (2) by proof of causation in fact “where the complained-of injury is not listed in the Vaccine Injury Table (‘off-Table injury’),” id. (citing 42 U.S.C. §§ 300aa-13(a)(1), 300aa-11(c)(1)(C)(ii)(I)). For off-Table injuries, causation in fact has three elements: “(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.” Id. While some Vaccine Act petitioners claim novel injuries resulting from vaccines, others claim that an existing medical condition was “significantly aggravated” by a vaccine. 42 U.S.C. § 300aa-11(c)(1)(C)(i)–(ii); see Loving ex rel. Loving v. Sec’y of Dept. of Health & Hum. Servs., 86 Fed. Cl. 135, 143 (2009) (“[T]he Vaccine Act specifies that significant-aggravation and new-injury circumstances constitute separate avenues to potential recovery.”). Petitioners in the latter category must prove three additional elements: “(1) the person’s condition prior to administration of the vaccine, (2) the person’s current condition (or the condition 1 See Mot. for Review of Decision on Remand (“Pet.’s Mot.”) (ECF 132); Pet.’s Mem. in Supp. of Mot. for Review (“Pet.’s Brief”) (ECF 132-1); see also Resp’t’s Resp. to Mot. for Review (“Resp’t’s Brief”) (ECF 133). 2 See May 18 Order (ECF 134); Pet.’s Supplemental Brief (ECF 135); Resp’t’s Supplemental Brief (ECF 136). 3 This Court has jurisdiction. See 42 U.S.C. §§ 300aa-11(c), 300aa-16(a). Petitioner timely moved for review. See 42 U.S.C. § 300aa-12(e)(1). - 2 - Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 3 of 12 following the vaccination if that is also pertinent), [and] (3) whether the person’s current condition constitutes a ‘significant aggravation’ of the person’s condition prior to vaccination[.]” Loving, 86 Fed. Cl. at 144; W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013). When a petitioner claims an aggravation, the Loving and Althen factors combine into a new composite test, with the Althen elements renumbered as parts four through six. Loving, 86 Fed. Cl. at 144. A petitioner always must prove causation of off-Table injuries by preponderance of the evidence. See, e.g., Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d 1355, 1366 (Fed. Cir. 2012); Althen, 418 F.3d at 1278.4 Although the petitioner’s burden does not “require identification and proof of specific biological mechanisms,” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 549 (Fed. Cir. 1994), “a ‘plausible’ or ‘possible’ causal theory” is not enough, see Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019) (quoting Moberly ex rel. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)). Proof of causation requires “a reputable medical or scientific explanation that pertains specifically to the petitioner’s case.” Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010); Moberly, 592 F.3d at 1322; see also Knudsen, 35 F.3d at 549 (“[C]ausation can be found in vaccine cases based on epidemiological evidence and the clinical picture regarding the particular [patient] without detailed medical and scientific exposition on the biological mechanisms.”). A theory of causation must be supported by medical records or an expert’s opinion. Althen, 418 F.3d at 1279 (citing 42 U.S.C. § 300aa-13(a)(1)). II. Procedural and Factual History The relevant facts and history of the case through the current remand are fully presented in my previous opinions. Doles I, 159 Fed. Cl. at 244–46; Doles II, 163 Fed. Cl. at 729–31. Briefly, Petitioner — a 67-year-old woman at the time of her vaccinations — alleged in her Amended Petition that she suffers from central nervous system (“CNS”) demyelination “best characterized” as multiple sclerosis (“MS”). Am. Pet. ¶¶ 5–6 (ECF 44). She claimed that her vaccines “actually caused, or, alternatively, significantly aggravated” her condition. Id. at ¶ 10. She does not plead exactly when her symptoms began, but she went to the emergency room 44 days after her second vaccination for symptoms that began two nights before. Id. at ¶¶ 1–3; Ruling at 6; Third Decision at 29 n.14. 4 The government can rebut proof of causation by showing, “also by a preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine.” Althen, 418 F.3d at 1278 (quoting Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 547 (Fed. Cir. 1994)); see 42 U.S.C § 300aa- 13(a)(1)(B). - 3 - Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 4 of 12 Because Petitioner’s alleged injury does not appear on the Table for the relevant vaccines, 42 U.S.C. § 300aa-14(a); 42 C.F.R. § 100.3(a)(I), (II), (VI), (VII), she must prove causation rather than benefit from the statutory presumption. Althen, 418 F.3d at 1278. Central nervous system demyelination is a general term describing a number of medically distinct conditions — including MS, acute disseminated encephalomyelitis, and focal myelitis or transverse myelitis, among others, see Steel Rebuttal Report at 2 (ECF 57-2) — so Petitioner presented experts to explain her theory of injury in more detail. The original Special Master’s first ruling determined that Petitioner’s MS had been significantly aggravated by her vaccines. Ruling at 19. The original Special Master’s main support for that conclusion was a study by Langer-Gould et al., which he interpreted as providing “evidence tending to show that vaccines did contribute to significantly aggravate subclinical autoimmunity into overt MS among the examined population.” See id. at 24 n.11 (citing Annette Langer-Gould et al., Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases, 71 JAMA Neurol. 1506 (2014) (“Langer-Gould”) (ECF 57-10)). On review, I concluded that the original Special Master had misinterpreted Langer-Gould. Doles I, 159 Fed. Cl. at 247–49. Langer-Gould in fact found no association — in any patient population — between vaccinations and MS. Id. at 247. There was an association between vaccines and the broader universe of demyelinating conditions, but only for patients under age 50, and only within 14 days of the vaccine. Id. There was no association between vaccines and demyelinating conditions for patients 50 or older for any time period post-vaccination. Id. For patients younger than 50, the association between vaccinations and demyelinating conditions disappeared after 14 days. Id. As I put it originally: In short, Langer-Gould found no association between MS — the condition the Special Master identified as Petitioner’s injury — and vaccinations. The only association found involved demyelinating conditions generally, i.e., conditions other than the demyelinating condition Petitioner has. Even if there were an association between Petitioner’s personal condition and vaccinations, it did not exist for patients in Petitioner’s age group, only younger patients. And even if there were an association for her age group, the effect disappears soon after vaccination, such that there is no association between vaccinations and demyelinating conditions for either age group at the time the Special Master found Petitioner’s symptoms in fact developed. [T]here is no way to look at the study’s data and find an association between vaccinations and Petitioner’s own condition. - 4 - Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 5 of 12 Id. at 248. “Although there can be association without causation, there cannot be causation without association,” so “a finding of causation would have to be despite the Langer-Gould study, not because of it.” Id. Because the original Special Master had arbitrarily and capriciously misinterpreted Langer-Gould,5 I remanded with instructions “to re-evaluate the medical evidence under the correct legal and scientific standards.” Id. at 249. On remand, the original Special Master contradicted aspects of his reasoning in the first ruling, and without explaining why — or even acknowledging — he had done so. See Doles II, 163 Fed. Cl. at 732 (comparing Ruling at 19–21 and Second Decision at 7, 21). Because that was arbitrary and capricious too, I vacated the Second Decision, remanded a second time, and ordered reassignment for a new special master to “review the record, order any necessary supplemental briefing from the parties, and issue a new entitlement decision[.]” Id. at 733. The matter was reassigned to the new Special Master, who accordingly issued the Third Decision. The new Special Master concluded that “any consideration of Langer-Gould would be improper, based on the plain language in Doles I,” and therefore did not include Langer-Gould in her consideration of “Loving prong four,” i.e., Petitioner’s evidence of a medical theory of causation. Third Decision at 16, 16 n.11. The new Special Master then evaluated the remaining record evidence, including Petitioner’s medical records and the parties’ expert reports and published literature. Id. at 24–29. She found that “Petitioner has not provided a sound and reliable medical or scientific explanation for how the vaccines she received could have significantly aggravated her MS.” Id. at 28–29. The new Special Master therefore concluded that “Petitioner has not met her burden under Loving prong four/Althen prong one.” Id. at 29; see also id. at 32 (“Based on the evidence presented in this case, and for the reasons discussed in this decision, I conclude that Petitioner has not demonstrated that the … vaccines can cause a significant aggravation of MS.”). The new Special Master did, however, explain how she would have interpreted Langer-Gould if she had believed she was permitted to do so on remand. Her reasoning was as follows, in full: The Langer-Gould authors found a statistically significant increased risk of CNS acute demyelinating syndrome onset in patients under the age of 50 within 30 days of vaccination. Langer-Gould at 1509-10. These findings indicate that susceptible individuals can have a CNS 5 And had fallen short of the procedural standard of “fundamental fairness” by adopting his own theory of causation without notice to the parties. Doles I, 159 Fed. Cl. at 246–47; see RCFC App. B, Rule 8(b)(1). - 5 - Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 6 of 12 autoimmune disorder triggered by vaccination. Even though Petitioner was older than 50, and developed [her first episode of MS] 42 days after vaccination, I would have found this study still provides support for her causation theory. I note that Petitioner’s presentation was somewhat unusual in that she did not have her first clinical manifestation of MS until she was 67 years old. As the McDonald Criteria note, MS typically presents between the ages of 20 and 50. Between 0 and 5% have onset at age 60 or older. Accordingly, finding a study sufficiently powered to detect a statistically significant increase in MS onset in patients older than 60 would likely prove difficult. Indeed, Langer-Gould noted as a limitation that “the number of older individuals was relatively small.” [Langer-Gould] at 1512. Petitioner’s burden under Loving prong four/Althen prong one is to provide a sound and reliable medical or scientific explanation for how the vaccines at issue caused the significant aggravation of her injury. The standard is not one of scientific certainty, “nor must the findings of the Court meet the standards of the laboratorian.” Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991) (internal citation omitted). The study’s broadly stated conclusion that “vaccines (like infections) may accelerate the transition from subclinical to overt autoimmunity in patients with existing disease” provides strong support for Petitioner’s theory that the vaccines she received did just that. Langer-Gould at 1512. For those reasons, had I considered this study, I would have found that it, coupled with Fujinami, Frohman & Wingerchuk, and Petitioner’s other evidence constitutes preponderant evidence in support of the fourth Loving prong. Id. at 29 n.14 (some citations omitted). Petitioner then moved for review. DISCUSSION Petitioner argues in the motion for review that the new Special Master could have considered the Langer-Gould study and erred by altogether refusing to do so. Pet.’s Brief at 4–5.6 I entirely agree. In Doles I, which related to the interpretation of Langer-Gould, I directed the original Special Master to “re-evaluate the medical evidence under the correct legal 6 The government argues that Petitioner forfeited that argument by failing to raise it before. Resp’t’s Brief at 10–11. That demands too much from Petitioner. Petitioner could not have objected to Doles I on remand because the original and new Special Masters were bound by this Court’s mandate. Doles I, 159 Fed. Cl. at 249; see also Banks v. United States, 741 F.3d 1268, 1276 (Fed. Cir. 2014) (discussing mandate rule). And she had no reason to object to Doles I in this Court after she prevailed on remand. Petitioner does not seem to have invited the new Special Master’s error. See Tr. at 7–8 (ECF 128). Petitioner was therefore within her rights in raising the argument in response to the Third Decision. - 6 - Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 7 of 12 and scientific standards.” Doles I, 159 Fed. Cl. at 249. Then in Doles II, which ordered reassignment, I provided that the new Special Master was to “review the record” in issuing a new decision. Doles II, 163 Fed. Cl. at 733. Langer-Gould is unquestionably part of the “medical evidence” within the case’s “record,” so the remand instructions in both Doles I and Doles II expressly called for review of Langer-Gould — for whatever significance the study might have, consistent with the mandate. See Contreras v. Sec’y of Health & Hum. Servs., 844 F.3d 1363, 1369 (Fed. Cir. 2017) (special masters must follow this Court’s instructions on remand); see also 42 U.S.C. § 300aa-12(e)(2)(C) (“[T]he United States Court of Federal Claims shall have jurisdiction to undertake a review of the record of the proceedings and may thereafter . . . remand the petition to the special master for further action in accordance with the court’s direction.”) (emphasis added). The new Special Master understood that she had been directed “to consider the record anew,” but for some reason thought that instruction did not include Langer- Gould, “any consideration [of which] would be improper.” Third Decision at 16 & n.11. The new Special Master attributed the purported exception to the “plain language” of Doles I. Id. at 16 n.11. Yet the new Special Master cited no actual language requiring such an extreme position. Although Doles I showed how the original Special Master misinterpreted Langer-Gould, that hardly means that “any consideration” of the study was off the table. Id. On the contrary; the Special Masters only had to ensure that their consideration of the study complied with “the correct legal and scientific standards.” Doles I, 159 Fed. Cl. at 249. The new Special Master thus misinterpreted the remand orders and performed an incomplete review of the record.7 The real question — addressed on my request in supplemental briefs — is whether the new Special Master’s error prejudiced Petitioner. This Court and the 7 Because Doles I and Doles II did not altogether forbid review of Langer-Gould, Petitioner’s arguments about legal relevance and this Court’s authority to exclude evidence presented to a special master are largely beside the point. See Pet.’s Brief at 4–17. I do not reach those arguments. Petitioner is plainly wrong, however, to the extent she argues that a special master’s interpretation of Langer-Gould is beyond this Court’s review. See id. at 15–19. Of course this Court can review interpretations of scientific studies: It is simply that the Court applies the deferential “arbitrary and capricious” standard when it does so. See Boatmon, 941 F.3d at 1358, 1362; J. v. Sec’y of Health & Hum. Servs., 155 Fed. Cl. 20, 47 (2021) (special master’s inaccurate interpretation of study was arbitrary and capricious); see also Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1381 (Fed. Cir. 2021) (requiring this Court to ensure special masters have “drawn plausible inferences and articulated a rational basis for the decision”) (quoting Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000)); Greene v. Sec’y of Health & Hum. Servs., 146 Fed. Cl. 655, 665 (holding a special master’s findings of fact arbitrary and capricious where the “accuracy” was in dispute “rather than just the weight he placed on the evidence”), aff’d, 841 F. App’x 195 (Fed. Cir. 2020); 42 U.S.C. § 300aa- 12(e)(2) (granting this Court power to “set aside any of the findings of fact or conclusions of law of the special master found to be arbitrary, capricious, and abuse of discretion”) (emphasis added). - 7 - Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 8 of 12 Federal Circuit have ruled on a number of occasions that special master errors are not reversible unless the adverse party shows the error was prejudicial. See, e.g., Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1343 (Fed. Cir. 2010) (finding special master’s error harmless when “it did not affect the outcome of the proceeding”); Hines on Behalf of Sevier v. Sec’y of Dep’t of Health & Hum. Servs., 940 F.2d 1518, 1526–27 (Fed. Cir. 1991) (finding error harmless “because it did not change the outcome of the case”); see also A.Y. by J.Y. v. Sec’y of Health & Hum. Servs., 152 Fed. Cl. 588, 599 (2021); Johnson v. Sec’y of Health and Hum. Servs., 33 Fed. Cl. 712, 728–29 (1995); Cox v. Sec’y of Dept. of Health & Hum. Servs., 30 Fed. Cl. 136, 142–45 (1993). Here, the new Special Master helpfully explained why — if she had felt free to consider Langer-Gould — she would have concluded that it supported an award to Petitioner. Third Decision at 29 n.14.8 I would of course revisit my Doles I analysis of Langer-Gould if the new Special Master provided persuasive reasons to do so. But had she found for Petitioner for the reasons she set out, her decision would have been arbitrary and capricious. I therefore conclude that her error in wholly disregarding the study could not have prejudiced Petitioner. It is worth emphasizing at the outset that the new Special Master found Petitioner’s other evidence insufficient to show causation. Third Decision at 28–29. Petitioner has not argued that the new Special Master erred in that respect, so objections to the new Special Master’s treatment of the remaining evidence are forfeited. See RCFC App. B, Rule 24(b); Germaine v. Sec’y of Health & Hum. Servs., 155 Fed. Cl. 226, 228 n.3 (2021). Given that forfeiture, as a matter of law none of Petitioner’s other evidence — piecemeal or in any combination — is enough to show that her vaccinations caused her injuries. And because Petitioner has the burden to prove causation by a preponderance of the evidence, see, e.g., W.C., 704 F.3d at 1356, Petitioner can only show causation if Langer-Gould — the sole remaining piece of contested evidence — affirmatively supports it. The new Special Master provided two reasons for interpreting Langer-Gould to support Petitioner’s causation theory. I address them in turn. First, the new Special Master noted that because onset of MS after age 50 is unusual, “finding a study sufficiently powered to detect a statistically significant increase in MS onset in patients older than 60 would likely prove difficult.” Third 8 For that reason, Petitioner is wrong to cite Contreras, 844 F.3d at 1368, for the proposition that “failure to consider relevant evidence is, in and of itself, harmful error.” Pet.’s Supplemental Brief at 2. A petitioner is prejudiced when a special master ignores her medical theories and the evidence supporting them. Contreras, 844 F.3d at 1369. But because the new Special Master provided a proposed interpretation of Langer-Gould, this Court can consider whether her proposed interpretation would have changed the outcome of the case. - 8 - Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 9 of 12 Decision at 29 n.14.9 The new Special Master inferred on that basis that Langer- Gould’s findings of a “statistically significant increased risk of CNS acute demyelinating syndrome onset in patients under the age of 50 within 30 days of vaccination” could be extended to Petitioner’s MS. Id. There are several errors in that reading of Langer-Gould. To begin with, treating Langer-Gould as evidencing causation for that reason violates the rules of formal logic — specifically, by committing a fallacy referred to as “denying the antecedent.” Cf. TorPharm, Inc. v. Ranbaxy Pharm., Inc., 336 F.3d 1322, 1329 & n.7 (Fed. Cir. 2003) (“An invalid argument of the general form: If p, then q. Not p. Therefore, not q.”). I reasoned in Doles I that “[t]he fact that the Langer-Gould study shows no association relevant to [Petitioner] means that it does not evidence causation[.]” Doles I, 159 Fed. Cl. at 248. In other words: If no association, then no causation. But say, for argument, that the new Special Master is right that the lack of a statistical association in Langer-Gould between vaccinations and MS in older patients could be the result of lack of statistical power. That would call into question the premise that Langer-Gould shows no association between vaccinations and MS. But it cannot follow, logically, that Langer-Gould does show causation. It can only mean — as I pointed out in Doles I — that Langer-Gould does not disprove an association if there is other evidence to establish it. Id. The new Special Master, again, found that Petitioner’s other evidence does not prove causation, so the Special Master’s critique of Langer-Gould’s statistical power does not help. Now suppose instead that what the new Special Master meant to say was that because Langer-Gould shows an association between vaccines and demyelinating conditions for some demographics and post-vaccination timeframes, there is probably an association between vaccines and MS in Petitioner’s demographic and timeframe, even though the study lacks statistical power to identify it. That reasoning is essentially identical to the mistaken interpretation of the original Special Master. 9 The new Special Master did not explain why she thought that Langer-Gould lacked statistical power sufficient to detect an association between vaccination and MS onset in patients older than 60. See Third Decision at 29 n.14; Fed. Jud. Ctr., Reference Manual on Scientific Evidence 254 (3d ed. 2011) (“Power is the chance that a statistical test will declare an effect when there is an effect to be declared.”). But where Langer-Gould lacked statistical power, the investigators acknowledged it explicitly. Langer-Gould at 1512 (describing the study as “underpowered” with respect to “detecting associations with rare forms of CNS ADS (pediatric ADS and ADEM), uncommon exposures (single- antigen HepB vaccine), … small select subgroups (symptom onset within 180 days following HPV vaccine in young women)[, and] risk of CNS ADS following HepB vaccination in early childhood”). The investigators did not say that the study was underpowered as to older patients, only that “the number of older individuals was relatively small[.]” Id. The new Special Master’s view that Langer-Gould was underpowered as to Petitioner’s demographic is thus not only unexplained, but inconsistent with the investigators’ own description of their study. Nonetheless, giving the new Special Master every possible benefit of the doubt, I shall assume arguendo that she was right. - 9 - Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 10 of 12 The new Special Master overlooks the fact that Langer-Gould does not show an association between vaccines and MS for anybody: not in Petitioner’s demographic, not in any demographic, and not within any time period after vaccination. Id. at 247. As noted in Doles I, the statistical association observed in Langer-Gould was between vaccinations and demyelinating conditions other than MS. Id. Statistical power has nothing to do with it, for Langer-Gould found no association between vaccines and MS even for demographics where statistical power is not in question. Perhaps there are times when an association in one circumstance is enough to infer an association in another, notwithstanding statistical evidence to the contrary. To be minimally rational, though, such an inference must be grounded in evidence.10 See Germaine, 155 Fed. Cl. at 227–28 (citing Knudsen, 35 F.3d at 549, and Boatmon, 941 F.3d at 1360). Why infer that a short-term association between vaccinations and non-MS demyelinating conditions in young patients can be generalized to MS, in older patients, longer after vaccination? The Special Master’s discussion of Langer- Gould merely assumes the inference rather than explaining or justifying it. Third Decision at 29 n.14. Whatever the outer limits might be on the new Special Master’s discretion, she had to start from something, somewhere. Inferring that a vaccine can cause a given condition based solely on a study that does not show an association between vaccines and that condition, in circumstances like Petitioner’s — only other conditions, in other circumstances — without any other evidence is arbitrary and capricious. See, e.g., Olaf M. Dekkers, The Long and Winding Road to Causality, 34 European J. of Epidemiology 533 (2019) (“[T]he fundamental prerequisite before judging causality is the presence of an association. ... In short: no causation without association.”); see also Paluck v. Sec’y of Health & Hum. Servs., 786 F.3d 1373, 1380 (Fed. Cir. 2015) (“Where, as here, a special master … makes factual inferences wholly unsupported by the record, the Court of Federal Claims is not only authorized, but obliged, to set aside the special master’s findings of fact and conclusions of law.”); Nussman v. Sec’y of Health & Hum. Servs., 83 Fed. Cl. 111, 120 (2008) (special master must explain rationale for decision); Broekelschen, 618 F.3d at 1345 (special master cannot find causation without “reputable medical or scientific explanation that pertains specifically to the petitioner’s case”). 10 Imagine a study showing that University of Minnesota graduates — presumably because of a solid education and good work habits — enjoy heightened opportunities in employment generally, but not as pearl divers in Tahiti. No sensible person would infer that Golden Gophers probably also have advantages in pearl diving, whatever the sample sizes might be. The likelier conclusion would be that Tahitian pearl diving is a special situation where a University of Minnesota bachelor’s degree has limited usefulness. - 10 - Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 11 of 12 Second, the new Special Master pointed to Langer-Gould’s “broadly stated conclusion that ‘vaccines (like infections) may accelerate the transition from subclinical to overt autoimmunity in patients with existing disease,’” a conclusion the Special Master said “provides strong support for Petitioner’s theory that the vaccines she received did just that.” Third Decision at 29 n.14. Assume — for a moment — that the new Special Master fairly characterized Langer-Gould’s conclusions. Scientific studies have to be interpreted on their own terms qua scientific studies, just as courts treat other genres of written material. See ONY, Inc. v. Cornerstone Therapeutics, Inc., 720 F.3d 420, 496–97 (2d. Cir 2013); Partington v. Bugliosi, 56 F.3d 1147, 1154–55 (9th Cir. 1995); Ollman v. Evans, 750 F.2d 970, 983–84 (D.C. Cir. 1984); see also Anya Bernstein, Legal Corpus Linguistics and the Half-Empirical Attitude, 106 Cornell L. Rev. 1397, 1439–40 (2021) (explaining that different categories of language should be read and interpreted in different ways). The real conclusions of a scientific study are found in its data, not in the accompanying verbiage. If the authors of a scientific study describe their findings in ways that the data do not support, the data control. Cf. Jarvis v. Sec’y of Dept. of Health & Hum. Servs., 99 Fed. Cl. 47, 61 (2011) (holding, in the context of litigation experts, that scientific opinions need not be credited where “there is simply too great an analytical gap between the data and the opinion proffered”) (citing Cedillo, 617 F.3d at 1339 (Fed. Cir. 2010) (itself citing Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997))). At a minimum, courts should avoid interpreting investigators’ remarks in ways that contradict the study’s actual findings. Here — at the risk of beating a dead horse — Langer-Gould found no association between vaccinations and MS, so it would be arbitrary and capricious to treat the investigators’ words as showing such an association where the data do not. Besides, the new Special Master misunderstood what the Langer-Gould investigators said about their findings. Here is the full paragraph containing the language she quoted: Findings from the present study show no long-term association of vaccines with an increased risk of MS and other CNS ADS. In younger patients, we observed a short-term increase in risk after vaccination of any type, which suggests that vaccines (like infections) may accelerate the transition from subclinical to overt autoimmunity in patients with existing disease. We found no association between HepB vaccination and an increased risk of MS or other CNS demyelination up to 3 years after vaccination, which is reassuring. Our results for HPV vaccine are inconclusive given the small number of cases and the paucity of previous studies on the topic. Our findings reconcile the anecdotal clinical reports of a CNS ADS onset shortly after vaccination with the larger body of - 11 - Case 1:17-vv-00642-SSS Document 139 Filed 09/20/23 Page 12 of 12 epidemiologic literature showing no long-term increased risk of MS or other forms of CNS ADS following vaccination. Our findings do not warrant any change in vaccine policy. Langer-Gould at 1512. In context, the “broadly stated conclusion” the new Special Master relied upon turns out to be a mirage. Third Decision at 29 n.14. The language she quoted was in fact limited to “short-term” effects in “younger patients,” rather than broadly generalizable, and does not mention MS. Langer-Gould at 1512. The investigators recited that they found “no long-term association of vaccines with an increased risk of MS[.]” Id. They also said that while their data were consistent with “anecdotal clinical reports of a CNS ADS onset shortly after vaccination,” the data also corroborated “the larger body of epidemiologic literature showing no long-term increased risk of MS or other forms of CNS ADS following vaccination.” Id. All of this is consistent with the underlying data, as analyzed in Doles I: There might be an association between vaccinations and non-MS demyelinating conditions soon after vaccination in younger patients, but there is no evidence of one with MS, in older patients, later post-vaccination. The new Special Master was of course correct that the standard in vaccine cases “is not one of scientific certainty, ‘nor must the findings of the Court meet the standards of the laboratorian.’” Third Decision at 29 n.14 (quoting Bunting, 931 F.2d at 873). The Vaccine Act does not require a diagnosis of a petitioner’s condition or certain proof of its etiology. But where a study cannot rationally be read to support a petitioner’s theory of causation, it would be arbitrary and capricious to do so. Because the new Special Master’s interpretation of Langer-Gould would have been arbitrary and capricious, her erroneous exclusion of the study from her analysis was harmless. CONCLUSION For the foregoing reasons, Petitioner’s motion for review is DENIED. The decision of the new Special Master is SUSTAINED. The Clerk is directed to enter judgment accordingly. IT IS SO ORDERED. s/ Stephen S. Schwartz STEPHEN S. SCHWARTZ Judge - 12 - ================================================================================ DOCUMENT 6: USCOURTS-cofc-1_17-vv-00642-7 Date issued/filed: 2025-08-06 Pages: 6 Docket text: PUBLIC DECISION (Originally filed: 07/11/2025) regarding 150 DECISION on Remand Proffer. Signed by Special Master Nora Beth Dorsey. (aevw) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-00642-SSS Document 153 Filed 08/06/25 Page 1 of 6 CORRECTED In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: July 11, 2025 * * * * * * * * * * * * * * * ELIZABETH DOLES, * * Petitioner, * No. 17-642V * v. * Special Master Dorsey * SECRETARY OF HEALTH * Damages Award on Remand; Proffer; AND HUMAN SERVICES, * Multiple Sclerosis (“MS”); Significant * Aggravation; Tetanus Diphtheria Acellular Respondent. * Pertussis (“Tdap”) Vaccine; Polio Vaccine. * * * * * * * * * * * * * * * * Joseph Vuckovich, Maglio Christopher & Toale, P.A., Washington, DC, for Petitioner. Catherine Stolar, U.S. Department of Justice, Washington, DC, for Respondent. DECISION ON REMAND AWARDING DAMAGES BASED ON PROFFER1 On May 16, 2017, Elizabeth Doles (“Petitioner”) filed a petition under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42 U.S.C. § 300aa-10 et seq. (2018)2 alleging that she suffered acute disseminated encephalomyelitis (“ADEM”) as a result of her receipt of the polio vaccination on April 4, 2016 and/or the tetanus, diphtheria, and pertussis (“Tdap”) vaccination on April 22, 2016. Petition at ¶¶ 1, 5-7 (ECF No. 1.) On July 5, 2019, Petitioner amended her petition, now alleging that the vaccinations she received in April of 2016 caused her central nervous system (“CNS”) demyelination best categorized as multiple 1 Because this Decision contains a reasoned explanation for the action in this case, the undersigned is required to post it on the United States Court of Federal Claims’ website and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc in accordance with the E- Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the Decision will be available to anyone with access to the Internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material from public access. 2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to -34 (2018) (“Vaccine Act” or “the Act”). All citations in this Ruling to individual sections of the Vaccine Act are to 42 U.S.C.A. § 300aa. 1 Case 1:17-vv-00642-SSS Document 153 Filed 08/06/25 Page 2 of 6 sclerosis (“MS”). Amended Petition at ¶¶ 1, 7 (ECF No. 44). Petitioner alleged that her condition was caused, or alternatively significantly aggravated, by her vaccinations. Id. at ¶ 10. On February 1, 2021, Special Master Horner issued a ruling finding Petitioner entitled to compensation. Ruling on Entitlement dated Feb. 1, 2021 (ECF No. 73). On October 4, 2021, Respondent filed a Proffer on Award of Compensation (“Proffer”), attached hereto as Appendix A. The next day, Special Master Horner issued a decision based on the Proffer. Decision Awarding Damages dated Oct. 5, 2021 (ECF No. 83). Subsequently, Respondent filed a motion seeking review of Special Master Horner’s February 1, 2021 Ruling on Entitlement. Respondent’s Motion for Review, filed Nov. 4, 2021, at 1 (ECF No. 86). On April 1, 2022, Judge Schwartz issued an opinion reversing and remanding Special Master Horner’s Ruling on Entitlement and vacating the Decision Awarding Damages. Opinion and Order dated April 1, 2022, at 10 (ECF No. 90). On June 24, 2022, Special Master Horner issued a decision again finding that Petitioner was entitled to compensation. Decision on Remand dated June 24, 2022, at 2 (ECF No. 102). Respondent again appealed. Respondent’s Motion for Review, filed July 22, 2022, at 1 (ECF No. 105). On December 16, 2022, Judge Schwartz issued an opinion vacating Special Master Horner’s June 24, 2022 Decision and remanding the case to a new special master. Opinion and Order dated Dec. 16, 2022, at 9 (ECF No. 113). On March 15, 2023, Special Master Oler issued a decision dismissing Petitioner’s petition. Decision on Remand dated Mar. 15, 2023, at 2 (ECF No. 129). Petitioner filed a motion for review. Petitioner’s Motion for Review, filed Apr. 14, 2023, at 1 (ECF No. 132). On August 30, 2023, Judge Schwartz denied Petitioner’s motion for review. Opinion and Order dated Aug. 30, 2023, at 12 (ECF No. 137). Petitioner appealed the denial to the United States Court of Appeals for the Federal Circuit. Notice of Docketing dated Sept. 21, 2023 (ECF No. 140). On April 23, 2025, the Federal Circuit found Petitioner entitled to compensation under the Vaccine Act, reinstated Special Master Horner’s February 1, 2021 Ruling on Entitlement, and remanded for a determination of damages. Doles v. Sec’y of Health & Hum. Servs., No. 2023-2404, 2025 WL 1177875, at *1 (Fed. Cir. Apr. 23, 2025). A formal mandate was issued on June 16, 2025. Mandate (ECF No. 144). Subsequently, on June 24, 2025, the case was remanded, and assigned to the undersigned. Order dated June 24, 2025 (ECF No. 154) (remanding case); Notice of Reassignment dated June 26, 2025 (ECF No. 147). On July 2, 2025, Respondent filed a joint status report stating the parties agreed damages should be award based on the October 4, 2021 Proffer. Joint Status Report, filed July 2, 2025 (ECF No. 149). The undersigned held a status conference on July 10, 2025 to confirm that the Proffer, which was agreed to in 2021, was still valid and represented appropriate compensation as agreed upon by the parties. See Minute Entry dated July 10, 2025. At the status conference, the parties confirmed that Petitioner and Respondent agree with the proffered award set out in 2021. Further, the parties confirmed that although the Proffer was filed on October 4, 2021, the Proffer accurately represents the damages available to Petitioner in 2025. 2 Case 1:17-vv-00642-SSS Document 153 Filed 08/06/25 Page 3 of 6 Based on the record as a whole, the undersigned finds that Petitioner is entitled to an award as stated in the Proffer. Pursuant to the terms stated in the attached Proffer, the undersigned awards Petitioner: (1) A lump sum payment of $137,400.00, representing compensation for $135,000.00 in pain and suffering and $2,400.00 in past unreimbursable expenses, in the form of a check payable to Petitioner. Proffer at 2-3. This amount represents all elements of compensation to which petitioner is entitled under § 15(a). Id. at 3. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court SHALL ENTER JUDGMENT herewith.3 IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Special Master 3 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of notice renouncing the right to seek review. 3 Case 1:17-vv-00642-SSS Document 153 Filed 08/06/25 Page 4 of 6 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS ) ELIZABETH DOLES, ) ) Petitioner, ) ) No. 17-642V v. ) Special Master Horner ) ECF SECRETARY OF HEALTH AND ) HUMAN SERVICES, ) ) Respondent. ) ) RESPONDENT’S PROFFER ON AWARD OF COMPENSATION On May 16, 2017, Elizabeth Doles (“petitioner”) filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (“Vaccine Act” or “Act”), alleging that her receipt of a polio vaccine and a tetanus, diphtheria, and acellular pertussis (“Tdap”) vaccine on April 4, 2016 and April 22, 2016, respectively, caused or significantly aggravated Acute Disseminated Encephalomyelitis. ECF No. 1, at 1-2. On April 24, 2018, the Secretary of Health and Human Services (“respondent”) filed a Rule 4(c) Report setting forth the reasons why petitioner was not entitled to compensation. ECF No. 21. On July 5, 2019, petitioner filed an amended petition, alleging that as a result of her April 4, 2016 and April 22, 2016 vaccinations, she “has suffered from central nervous system (CNS) demyelination.”1 ECF No. 44 at 2. On February 1, 2021, following briefing by both parties, the 1 In the amended petition, petitioner further alleged that “Dr. John Steel, a neurology expert retained by Petitioner, has opined that Petitioner’s neurological injuries are best characterized as multiple sclerosis (MS).” ECF No. 44 at 2. Case 1:17-vv-00642-SSS Document 153 Filed 08/06/25 Page 5 of 6 Special Master issued a Ruling on Entitlement finding petitioner entitled to compensation for a significant aggravation of MS.2 ECF No. 73. I. Items of Compensation A. Pain and Suffering Respondent proffers that petitioner should be awarded $135,000.00 in pain and suffering. See 42 U.S.C. § 300aa-15(a)(4). Petitioner agrees. B. Past Unreimbursable Expenses Evidence supplied by petitioner documents that she incurred past unreimbursable expenses related to her vaccine-related injury. Respondent proffers that petitioner should be awarded past unreimbursable expenses in the amount of $2,400.00. See 42 U.S.C. § 300aa- 15(a)(1)(B). Petitioner agrees. These amounts represent all elements of compensation to which petitioner is entitled under 42 U.S.C. § 300aa-15(a). Petitioner agrees. II. Form of the Award Petitioner is a competent adult. Evidence of guardianship is not required in this case. Respondent recommends that the compensation provided to petitioner should be made through a lump sum payment as described below and requests that the Special Master’s decision and the 2 The parties have no objection to the amount of the proffered award of damages set forth herein. However, respondent reserves his right, pursuant to 42 U.S.C. § 300aa-12(e), to seek review of the Special Master’s February 1, 2021 Ruling on Entitlement. This right accrues following issuance of the damages decision. 2 Case 1:17-vv-00642-SSS Document 153 Filed 08/06/25 Page 6 of 6 Court’s judgment award the following3: a lump sum payment of $137,400.00, in the form of a check payable to petitioner. Summary of Recommended Payments Following Judgment Lump sum payable to petitioner, Elizabeth Doles: $137,400.00 Respectfully submitted, BRIAN M. BOYNTON Acting Assistant Attorney General C. SALVATORE D’ALESSIO Acting Director Torts Branch, Civil Division HEATHER L. PEARLMAN Deputy Director Torts Branch, Civil Division DARRYL R. WISHARD Assistant Director Torts Branch, Civil Division /s/ Catherine E. Stolar CATHERINE E. STOLAR Trial Attorney Torts Branch, Civil Division U.S. Department of Justice P.O. Box 146 Benjamin Franklin Station Washington, D.C. 20044-0146 Tel.: (202) 353-3299 Fax: (202) 616-4310 Email: catherine.stolar@usdoj.gov DATED: October 4, 2021 3 Should petitioner 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 lost earnings and future pain and suffering. 3