VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_22-vv-00477 Package ID: USCOURTS-cofc-1_22-vv-00477 Petitioner: Patricia Stewart-Robinson Filed: 2022-04-28 Decided: 2024-10-08 Vaccine: influenza Vaccination date: 2019-09-25 Condition: multiple sclerosis Outcome: unclear Award amount USD: AI-assisted case summary: On April 28, 2022, Patricia Stewart-Robinson filed a petition under the National Vaccine Injury Compensation Program alleging that an influenza vaccine administered on September 25, 2019, caused her to develop transverse myelitis (TM) and subsequently multiple sclerosis (MS). Ms. Stewart-Robinson, who was 53 years old at the time of vaccination, began experiencing numbness and tingling in her lower extremities approximately two weeks after receiving the vaccine. Her symptoms progressed, leading to hospitalization where she was initially diagnosed with TM. However, subsequent testing and clinical evaluations over the following months led to a diagnosis of MS. The respondent, the Secretary of Health and Human Services, opposed an award of compensation, arguing that MS is unlikely to be caused by the flu vaccine and that the medical record indicated Ms. Stewart-Robinson's TM was an initial symptom of MS, not a separate injury. The Special Master, Chief Special Master Brian H. Corcoran, granted the respondent's motion to dismiss. He concluded that Ms. Stewart-Robinson's TM was not a distinct injury but rather the first manifestation of MS, and that MS is not likely vaccine-caused. He based this decision on his prior experience with similar cases, stating that he had never found MS to be a vaccine injury and was highly skeptical of such claims, and that he expected any expert report would likely repeat arguments he had previously rejected. He dismissed the case before Ms. Stewart-Robinson could submit an expert report to support her causation theory. Ms. Stewart-Robinson sought review of this decision. On October 8, 2024, Judge Molly R. Silfen of the U.S. Court of Federal Claims found that the Special Master had abused his discretion by prematurely dismissing the case and denying Ms. Stewart-Robinson the opportunity to present expert testimony. The court noted that while Special Masters can rely on their expertise, they cannot exclusively rely on prior cases to dismiss a claim without allowing the petitioner to fully develop their case, especially in off-Table injury claims where expert testimony is often crucial. The court emphasized that each case must be evaluated on its own merits and that denying the opportunity to submit an expert report prevented Ms. Stewart-Robinson from fully presenting her case. The court granted Ms. Stewart-Robinson's motion for review, vacated the Special Master's decision, and remanded the case to the Special Master to allow Ms. Stewart-Robinson the opportunity to present her case, including expert testimony. The ultimate outcome of the case remains to be determined. Theory of causation field: Patricia Stewart-Robinson, age 53, received an influenza vaccine on September 25, 2019. Approximately two weeks later, she developed symptoms of numbness and tingling in her lower extremities, which progressed and led to hospitalization. She was initially diagnosed with transverse myelitis (TM), but later diagnosed with multiple sclerosis (MS). Ms. Stewart-Robinson alleged that the flu vaccine caused her TM and subsequently MS. The Special Master dismissed the claim, finding that TM was an initial symptom of MS and that MS is not likely vaccine-caused, relying heavily on his prior experience with similar cases and denying the petitioner the opportunity to submit expert testimony. On review, the Court of Federal Claims found that the Special Master abused his discretion by prematurely dismissing the case and denying the petitioner the opportunity to present expert evidence, particularly in an off-Table injury claim where expert testimony is often essential for establishing causation. The court remanded the case to the Special Master to allow Ms. Stewart-Robinson to fully present her case, including expert testimony. The case is ongoing. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_22-vv-00477-1 Date issued/filed: 2024-04-29 Pages: 17 Docket text: PUBLIC DECISION (Originally filed: 4/1/2024) regarding 41 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (ag) Service on parties made. -------------------------------------------------------------------------------- Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 1 of 17 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 22-477V * * * * * * * * * * * * * * * * * * * * * * * * * * PATRICIA STEWART-ROBINSON, * * Petitioner, * Chief Special Master Corcoran * v. * Filed: April 1, 2024 * SECRETARY OF HEALTH AND * HUMAN SERVICES * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Renee Gentry, Law Office of Renee J. Gentry, Washington, DC, for Petitioner. Alexa Roggenkamp, U.S. Department of Justice, Washington, DC, for Respondent. ENTITLEMENT DECISION1 On April 28, 2022, Patricia Stewart-Robinson filed a petition for compensation under the National Vaccine Injury Compensation Program (the “Program”).2 She alleges that an influenza (“flu”) vaccine that she received caused her to develop what was eventually diagnosed as multiple sclerosis (“MS”)—although her initial presentation was suggestive of another injury that is typically monophasic and self-limiting, transverse myelitis (“TM”). Respondent’s Rule 4(c) Report opposed an award of compensation, arguing that it is unlikely the flu vaccine can cause MS—the proper, ultimate diagnosis applicable to Petitioner, as 1 Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public in its present form. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the Act”]. Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix). Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 2 of 17 the medical record indicates. Rule 4(c) Report, dated December 1, 2022 (ECF No. 20) (“Mot.”).3 I later informed Petitioner that although I doubted that my concerns about the claim’s viability could be overcome, I would allow her the opportunity to set forth arguments against dismissal, and she has done so. Petitioner’s Opposition, dated September 29, 2023 (ECF No. 40) (“Opp.”). Now, for the reasons stated below, I grant Respondent’s motion to dismiss. I. Factual Background Petitioner’s prior medical history was significant for anemia, gastroesophageal reflux disorder, epigastric pain, and gastric bypass surgery. Ex. 6 at 32; see also Exs. 10 and 16. Of note, she was briefly hospitalized in January 2017 for fatigue and dizziness, which was attributed to her anemia. See Ex. 10 at 182–255. And a year prior to vaccination, she received treatment for reported pain to the touch on the left side of the head. Ex. 16 at 8. However, there is no record evidence of any pre-vaccination neurologic events, or imaging relevant to her symptoms. Vaccination and October 2019 Hospitalization On September 25, 2019, Petitioner (who was 53 at the time) received the flu vaccine at an appointment with Linke Ma, M.D., her primary care provider (“PCP”). Ex. 3 at 2. She was also at this time treated for iron deficiency anemia and vitamin D deficiency. Id. Almost three weeks later, on October 13, 2019, Petitioner saw Munif Hussain, D.O., now complaining of paresthesia and tingling in both legs that began seven days prior (meaning October 6, 2019—eleven days after vaccination) and that was lasting all day. Ex. 4 at 5. She also reported that she did not feel the sensation of urinating at times and had difficulty sensing her rectum when wiping. Id. at 5–6. She denied back pain, fever, headache, weakness, recent trauma or illness, or abdominal pain, however. Id. at 5. On examination, Petitioner displayed decreased sensation below her knees and lower back, as well as decreased strength in both lower legs, although reflexes were present and normal. Id. at 5–6. Dr. Hussain sent her to an emergency department (“ED”) for additional evaluation. Id. at 6. That same day, Ms. Stewart-Robinson went to the Brooklyn Hospital Center. Ex. 5 at 12. She informed emergency care treaters that she had for three days (meaning since October 10, 2019) been experiencing bilateral numbness from the waist down, plus chills, difficulty walking, neck pain, and pain in her legs that she rated five out of ten. Id. at 2, 12. She also identified the vaccination as when she had started to experience changes in how she felt, noting specifically that in the three prior days she had felt ascending changes in sensation in her lower extremities that 3 Filed concurrently with the Rule 4(c) Report was Respondent’s Motion to Dismiss—but the latter is a one-page document that contains no specific arguments separate from the Rule 4(c) Report. I therefore treat the Rule 4(c) Report herein as Respondent’s actual “motion,” since it sets forth the substantive grounds offered for dismissal. 2 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 3 of 17 progressed to numbness. Id. at 12. Consistent with her examination by Dr. Hussain, examination at the ED revealed decreased sensation in Petitioner’s lower extremities, but normal sensation to her abdomen, back, face, and upper extremities. Id. at 12–13. She also denied pain and difficulty walking, but admitted to difficulty sensing the position of her feet. Id. at 14. Petitioner remained hospitalized until October 20, 2019. Ex. 5 at 32. MRIs performed of the cervical spine in this timeframe initially showed no evidence of MS, but did reveal a mild T2 prolongation measuring six by five by two-and-a-half millimeters at the base of the odontoid process, a second slight T2 prolongation measuring four millimeters at the mid-C3 level, and a third slight T2 prolongation in the lower cervical and upper thoracic cord—all of which were thought suggestive of the presence of a mild demyelinating disorder (although only the prolongation seen at C1-C2 showed enhancement—meaning it was likely a newer/active lesion).4 Id. at 108, 217. Thoracic spine MRIs taken the same dates showed prolongations at T1-T2 and T3- T4 and an approximately 23-millimeter protrusion at T3-T4, none of which showed enhancement. Id. at 108, 218. A CT of petitioner’s head showed no evidence of infarction, however, and a later MRI of the brain showed no abnormal enhancement. Id. at 124, 189, 219, 280. And Cerebrospinal fluid testing was negative for oligoclonal bands, an MS biomarker. Id. at 427. Petitioner’s discharge diagnosis was bilateral lower extremity weakness. Id. at 33. After discharge, Ms. Stewart-Robinson went back to see Dr. Ma on October 23, 2019. Ex. 6 at 25. By this time, she was still experiencing bilateral extremity weakness and an unsteady gait, as well as numbness in the lower extremities and pelvic area ataxia. Id. On examination, however, she had full strength in all extremities, and pulses in all extremities were within normal limits. Id. at 26. Dr. Ma increased Petitioner’s neuropathic pain medication and advised her to follow up with a neurologist plus engage in physical therapy. Id. That same day (during a call with Dr. Ma), Petitioner confirmed she had received a TM diagnosis after hospitalization, and expressed the concern that her September vaccination had been causal. Id. at 28. Dr. Ma did not comment on the accuracy of that concern, but instead proposed consultation with a neurologist. Id. Suspicion of MS (and Later Confirmation of Diagnosis) On October 25, 2019, Petitioner saw neurologist Eliz Agopian, M.D., at which time she reported the symptoms of lower extremity numbness and tingling that had resulted in her prior hospitalization. Ex. 7 at 4. The numbness had now ascended to her lower torso, although she denied bowel or bladder incontinence and was not experiencing leg or upper body weakness. Id. On examination, Ms. Stewart-Robinson displayed sensory loss at C2-C3 areas and impaired balance, but her muscle strength was intact and her deep tendon reflexes were all rated at 2+. Id. at 6. Dr. 4 In an MS patient, imaging enhancement typically reveals the presence of new lesions (as opposed to old lesions which are considered “non-enhancing”). See Taylor v. Sec'y of Health & Human Servs., No. 13-700V, 2018 WL 2050857, at * 21 & n. 4 (Fed. Cl. Spec. Mstr. Mar. 9, 2018). 3 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 4 of 17 Agopian reviewed prior imaging showing an enhancing lesion in the high cervical region but deemed the etiology of the lesion unclear, and proposed Petitioner be tested immediately to evaluate whether a vascular/infarction issue could be explanatory. Id. To that end, Petitioner returned to the ED later that day. Ex. 10 at 521. Her ED treatment provider noted Petitioner’s complaint of bilateral paresthesia for the prior four weeks (placing onset on or around September 27, 2019—two days after vaccination), but later also observed that Petitioner reported she had been experiencing a fluctuating “tightness/pulling sensation below the waist” for approximately six months (which, if accurate, would place onset on or about April 25, 2019—well prior to vaccination). Id. The provider also reported that Petitioner had already been evaluated for “MS among other neuro diseases.” Id. Petitioner declined to have another lumbar puncture and declined medication until she could see a neurologist. Id. at 523. Petitioner saw a second neurologist (Adina Alport, M.D.) at New York Presbyterian Brooklyn Methodist Hospital a few days later, and complained of a tightening sensation from her belly button on down, along with numbness in her legs and genitals. Ex. 8 at 3. Her balance was poor, and she required assistance with ambulation. Id. at 3, 7. Exam revealed normal muscle strength and tone but reduced sensation below the knees in both legs. Id. at 6–7. Dr. Alport specifically notes in the record from this visit that although Petitioner’s working diagnosis was TM of unknown etiology, MS or another central nervous system (“CNS”) demyelinating disease, neuromyelitis optica (“NMO”), could not be ruled out. Id. at 8. In early November, Petitioner underwent more spinal cord and brain imaging. A November 1, 2019 MRI of her thoracic spine showed a few hyperintense lesions located at the T3-T4, T8, and T9-T10 levels, with the T9-T10 lesion exhibiting enhancement. Ex. 8 at 9. In addition, a November 4, 2019 MRI of the cervical spine and brain showed approximately ten foci of signal change on the brain, the largest of which was suggestive of underlying demyelination (although no brain lesions appeared enhancing), plus some intramedullary lesions on the lower cervical spine which appeared demyelinating in nature. Id. at 18. Petitioner returned to New York Presbyterian Brooklyn Methodist Hospital neurology on November 4, 2019, where she reported to certified physician’s assistant Melissa Velez that she continued to experience numbness and tingling in her legs, plus some urinary complaints. Ex. 8 at 11. PA-C Velez noted that the imaging supported an MS diagnosis, though lumbar puncture results would be needed to confirm it. Id. at 15. Later that month, Petitioner attended several physical therapy appointments, and received Solumedrol (a glucocorticoid used to treat chronic inflammatory conditions, including MS)5 infusions as well. Ex. 15 at 2–14; Ex. 9 at 14. 5 See SOLU-MEDROL® (methylprednisolone sodium succinate for injection, USP), https://labeling.pfizer.com/showlabeling.aspx?id=648#:~:text=SOLU%2DMEDROL%20Sterile%20Powder%20is, %2C%20odorless%20hygroscopic%2C%20amorphous%20solid. (last accessed March 31, 2024) 4 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 5 of 17 Petitioner reported to PA-C Velez feeling a bit better after these treatments. Ex. 8 at 23. PA-C Velez later diagnosed Petitioner with a demyelinating disorder, possibly MS, although other rheumatological or autoimmune disorders could not be eliminated, and a repeat lumbar puncture was deemed necessary. Id. at 27. The lumbar puncture was performed on December 3, 2019, and cerebrospinal fluid collected at this time showed greater than five oligoclonal bands (clinical evidence supporting an MS diagnosis).6 Ex. 10 at 39–40. On December 12, 2019, Petitioner returned to her PCP, Dr. Ma. Ex. 6 at 20. She now reported that although her symptoms had improved, she continued to experience numbness in both feet, especially at night (with foot numbness the only issue revealed on exam). Id. at 20, 21. Dr. Ma noted that the etiology of her prior TM remained unknown, but could be related to an infection—or could suggest new-onset MS. Id. at 20. Petitioner also that month began a new round of physical therapy, informing the therapist that her symptoms had begun suddenly in October 2019 “after receiving a flu shot,” but that she had since been diagnosed with MS. Id. She indicated that her symptoms had now been diagnosed as MS. Id. She attended seven physical therapy sessions through March 13, 2020. Ex. 11 at 1–18. Treatment in 2020 and Beyond The medical records filed in this case establishing treatment received by Petitioner in 2020 to the present date confirm the propriety of the MS diagnosis—but do not reflect any findings that would make vaccine causation more, or less, likely. In early January 2020, Petitioner again saw PA-C Velez and complained of worsening foot numbness, gait issues, tingling, and some urinary frequency issues. Ex. 8 at 35, 39. Testing for NMO had been negative, but prior lumbar puncture results showed greater than five oligoclonal bands and an IgG index of 1.5, which PA-C Velez characterized as “highly suggestive of MS.” Id. at 39. PA-C Velez at this point formally included MS in her differential diagnosis (and did not mention TM), and it was agreed that Petitioner should begin a course of medication specific to treating MS. Id. at 39–40. By the spring, Petitioner’s symptoms had improved somewhat, although she continued to experience numbness and burning in her feet. Id. at 42. PA-C Velez deemed Petitioner’s MS to be “clinically stable” at this time. Id. at 47. Nevertheless, Petitioner’s symptoms and sequelae did not fully abate as time passed (more consistent with relapsing/remitting MS, rather than a monophasic, CNS demyelinating condition). In July 2020, Dr. Ma noted that Petitioner was best understood to have “MS of unknown etiology.” Ex. 6 at 13. The same view was expressed by a physical therapist who saw Petitioner that month 6 See Samuels v. Sec'y of Health & Hum. Servs., No. 17-071V, 2020 WL 2954953 (Fed. Cl. Spec. Mstr. May 1, 2020) (experts agreeing that oligoclonal bands confirm the presence of MS). 5 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 6 of 17 for home care. Ex. 12 at 13–25. And Petitioner informed PA-C Velez (at a July 20, 2020 visit) that she continued to experience stiffness in the lower extremities and numbness and burning in the bilateral feet—consistent with earlier that year. Ex. 8 at 56. PA-C Velez recommended repeat MRIs of the brain and cervical spine. Id. at 61. In September 2020, Ms. Stewart-Robinson returned to Dr. Ma, reporting some improvement but that she was still experiencing ongoing numbness in both feet. Ex. 6 at 5. Later that month, however, she began to feel some intermittent arm and head pain. Id. at 4. On September 23, 2020, she again saw PA-C Velez, after the pain became sharper and was associated with headaches. Ex. 8 at 63. She also noticed stiffness in her legs, especially in the morning, and numbness and burning in her feet. Id. The same issues lingered on into October, coupled with gait/balance improvements. Ex. 13 at 4. A brain MRI performed in this time period showed no significant interval change in petitioner’s white matter lesions. Id. at 61–62. The remaining medical records filed in this case (for treatment received through the middle of 2021) reveal ongoing, intermittent symptoms consistent with Petitioner’s experience in 2019- 20, with her receipt of the same treatments, plus additional PT, she underwent before. No records undermine the MS diagnosis, however, nor do they reflect treater thinking on an association between Petitioner’s medical issues and her receipt of the flu vaccine. II. Procedural History This case was initiated in April 2022, and at that time Petitioner was represented by different counsel. After the case was assigned to me, I held a status conference—and informed Petitioner right away that my prior experience with comparable cases suggested that a Vaccine Act claim that the flu vaccine can cause MS was unlikely to succeed. See Scheduling Order, dated July 28, 2022 (ECF No. 16). I therefore instructed Respondent to consider seeking dismissal of the claim after medical review and the filing of the Rule 4(c) Report. As noted above, Respondent moved for dismissal concurrently with the filing of his Rule 4(c) Report, both of which were submitted in December 2022. Thereafter, prior counsel withdrew from the case, and for a period of time it was a pro se matter until present counsel appeared in June 2023 (ECF No. 36). After holding a status conference, I reset the deadline for Petitioner’s response to the pending motion to dismiss, and Petitioner filed her brief at the end of September 2023. The matter is now ripe for resolution. III. Parties’ Arguments Respondent maintains that the medical record overall best supports MS as the proper diagnosis, not TM (which can be the first sign of MS). Mot. at 15. Even though treaters may have 6 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 7 of 17 initially viewed Petitioner’s presenting symptoms as consistent with TM, over time they embraced MS as the diagnosis—and the testing results (MRIs, lumbar punctures) plus other clinical findings are consistent with that diagnosis. Id. at 15–16. Furthermore (and relying somewhat on my own pronouncements made in the course of this case), Respondent contends that vaccine causation of MS is not preponderantly-established—as well as that the record itself does not support a finding the flu vaccine was likely causal of Petitioner’s MS. Id. at 16–17. As a result, a causation-in-fact claim is not tenable, and the matter warrants dismissal. Petitioner has offered a brief opposing dismissal. In summarizing the medical record, she focuses heavily on her initial presentation in October 2019, and the extent to which it was not at that time consistent with MS (even if later clinical and testing evidence is wholly consistent with it). See Opp. at 3–6. Otherwise, she explains that she was “initially diagnosed with TM and subsequently developed MS.” Id. at 8. TM is thus the injury she seeks to allege, and she maintains it cannot be reasonably conflated with her “ultimate MS diagnosis.” Id. at 16. TM. She maintains, is not only a distinct injury, but it understood to be separate even when a person suffering TM is later diagnosed with MS. Id. at 17.7 Based on this evidentiary construction, Petitioner reasons that her TM can be distinguished from her MS. At worst, it only increased her risk to develop MS—it was not an initial manifestation of it. Opp. at 15. She thus argues that she can meet the causation requirements to prove flu vaccine- caused TM, laying out how she has done so.8 Id. at 15, 18–22. Otherwise, Petitioner maintains “she need not prove a separate theory for causation for influenza vaccines and MS.” Id. at 18. And she argues that it is unfair to deny Petitioner the opportunity to offer expert testimony in support of her claim. Id. at 23. 7 Petitioner cites the National Multiple Sclerosis Society’s information page on TM, which states that “[i]n some people, transverse myelitis is the first symptom of an immune-mediated disease such as MS or NMOSD. Many individuals who have TM do not go on to develop MS.” Transverse Myelitis (TM) and Multiple Sclerosis, National Multiple Sclerosis Society, https://www.nationalmssociety.org/What-is-MS/Related-Conditions/Transverse-Myelitis (last accessed March 13, 2024). 8 Petitioner also contends at one point that an evidentiary standard of mere plausibility controls evaluation of the first causation prong. Opp. at 13. This argument is, however, contrary to the majority of Federal Circuit cases, and relies on a single recent Court of Federal Claims decision, and it has not been since embraced by numerous other Court decisions. See Howard v. Sec'y of Health & Hum. Servs., 2023 WL 4117370, at *4 (Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance for nearly four decades”), appeal docketed, No. 23-1816 (Fed. Cir. Apr. 28, 2023). And in any event, the case does not turn on whether it is merely plausible that TM is vaccine-caused, but instead whether TM is the preponderantly-supported characterization of her injury. 7 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 8 of 17 IV. Applicable Law A. Standards for Vaccine Claims To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table— corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).9 There is no Table claim available involving the flu vaccine and either TM or MS. For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. Section 13(a)(1). In attempting to establish entitlement to a Vaccine Program award of compensation for a Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal relationship between vaccination and injury.” Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the 9 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014). 8 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 9 of 17 type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or scientifically certain.” Knudsen, 35 F.3d at 549. Petitioners may satisfy the first Althen prong without resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by statute to conclusively resolve what are essentially thorny scientific and medical questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed. Cl. at 245. In discussing the evidentiary standard applicable to the first Althen prong, the Federal Circuit has consistently rejected the contention that it can be satisfied merely by establishing the proposed causal theory’s scientific or medical plausibility. See Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of proof” (citing Moberly, 592 F.3d at 1322)); see also Howard v. Sec'y of Health & Hum. Servs., 2023 WL 4117370, at *4 (Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance for nearly four decades”), appeal docketed, No. 23-1816 (Fed. Cir. Apr. 28, 2023). And petitioners always have the ultimate burden of establishing their overall Vaccine Act claim with preponderant evidence. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell v. United States, 133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s overall burden of proving causation-in-fact under the Vaccine Act” by a preponderance standard). The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly 9 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 10 of 17 trustworthy evidence, since they are created contemporaneously with the treatment of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Medical records and statements of a treating physician, however, do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases. The views of treating physicians should be weighed against other, contrary evidence also present in the record—including conflicting opinions among such individuals. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review denied, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012). The third Althen prong requires establishing a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable timeframe must align with the theory of how the relevant vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012), aff’d mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review denied, (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014). B. Law Governing Analysis of Fact Evidence The process for making determinations in Vaccine Program cases regarding factual issues begins with consideration of the medical records. Section 11(c)(2). The special master is required to consider “all [] relevant medical and scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability, injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then 10 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 11 of 17 required to weigh the evidence presented, including contemporaneous medical records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (determining that it is within the special master's discretion to determine whether to afford greater weight to contemporaneous medical records than to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such determination is evidenced by a rational determination). As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95 Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his contemporaneous medical records, the special master's decision to rely on petitioner's medical records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum. Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked propositions explains why such records deserve some weight: (i) sick people visit medical professionals; (ii) sick people attempt to honestly report their health problems to those professionals; and (iii) medical professionals record what they are told or observe when examining their patients in as accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum. Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”). Accordingly, if the medical records are clear, consistent, and complete, then they should be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records are often found to be deserving of greater evidentiary weight than oral testimony—especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir. 1992), cert. denied, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)). However, the Federal Circuit has also noted that there is no formal “presumption” that records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which compelling oral testimony may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak 11 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 12 of 17 or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination regarding a witness's credibility is needed when determining the weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). When witness testimony is offered to overcome the presumption of accuracy afforded to contemporaneous medical records, such testimony must be “consistent, clear, cogent, and compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs., No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and completeness of medical records, the Court of Federal Claims has listed four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person's failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional's failure to document everything reported to her or him; (3) a person's faulty recollection of the events when presenting testimony; or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health & Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to afford greater weight to contemporaneous medical records or other evidence, such as testimony at hearing, there must be evidence that this decision was the result of a rational determination. Burns, 3 F.3d at 417. C. Standards for Ruling on the Record I am resolving this claim on the filed record. The Vaccine Act and Rules not only contemplate but encourage special masters to decide petitions on the papers where (in the exercise of their discretion) they conclude that doing so will properly and fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided case on the papers in lieu of hearing and that decision was upheld). I am simply not required to hold a hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health & Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health & Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991). ANALYSIS As in many Program cases, determination of the relevant injury is critical to this claim’s success. Broekelschen, 618 F.3d at 1346. Although this is not because Petitioner’s diagnosis 12 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 13 of 17 herein is in dispute. On the contrary, it is not disputed that Petitioner was properly diagnosed with MS. Rather, the question presented is whether the claim can be narrowed only to focusing on TM as the alleged injury. It is in this regard that diagnosis is important, because the Program has treated TM very differently from MS. Moreover, Petitioner expressly is not attempting to prove her MS was vaccine-caused. Opp. at 15. Rather, she argues the flu vaccine caused her to incur TM—and at most allows that her experiencing TM increased her risk of MS, although she does not purport to explain how her subsequent MS diagnosis relates otherwise. TM presents usually as a one-time, monophasic (hence non-recurring) CNS injury— although it can leave lasting deficiencies in a patient who has experienced it.10 MS, by contrast, is typically chronic, featuring relapses or even worsening progression. Porch v. Sec'y of Health & Hum. Servs., No. 17-802V, 2023 WL 21875, at *21 (Fed. Cl. Spec. Mstr. Jan. 3, 2023); Samuels v. Sec'y of Health & Hum. Servs., No. 17-071V, 2020 WL 2954953, at *18-19 (Fed. Cl. May 1, 2020). MS can also be subclinical for long periods of time, with its characteristic lesions seen often only after clinical manifestations. Samuels, 2020 WL 2954953, at *18. And it is not well- understood what causes MS in the first place—with far more evidence linking vaccines to acute, self-limiting illnesses (like TM) than to MS. Id. at 21. Thus, even if both involve nerve demyelination, MS and TM are not congruent illnesses. Indeed, MS is a far more ominous diagnosis, since its course can prove significantly debilitating over time, whereas TM resolves faster. TM has often been deemed a compensable vaccine injury, as evidenced by numerous prior Program decisions. See, e.g., Raymo v. Sec’y of Health & Human Servs., No. 11-654V, 2014 WL 1092274, at *23 (Fed. Cl. Spec. Mstr. Feb. 24, 2014) (finding causal relationship between flu vaccine and TM). But I have observed a distinction between acute demyelinating injuries that cause sudden and abrupt injury to the central nervous system, like TM or acute disseminated encephalomyelitis (“ADEM”), and those that are chronic, relapsing/remitting, and/or progressive, like MS. See e.g., Morgan v. Sec'y of Health & Hum. Servs., No. 15-1137V, 2019 WL 7498665, at *16 (Fed. Cl. Spec. Mstr. Dec. 4, 2019), mot. for review den’d, 148 Fed. Cl. 454 (2020), aff'd, 850 F. App'x 775 (Fed. Cir. 2021); Samuels v. Sec'y of Health & Hum. Servs., No. 17-071V, 2020 WL 2954953, at *18 (Fed. Cl. Spec. Mstr. May 1, 2020) (MS with first presenting symptom ADEM).11 10 See S. PLOTKIN ET AL., PLOTKIN’S VACCINES t874 (7th ed. 2018) (listing flaccid diplegia and atrophy as sequalae between 3 months and one year after occurrence). 11 The Vaccine Program recognizes the distinction between monophasic, self-limiting diseases and those that are chronic/relapsing in other injury contexts as well. For example, while Guillain-Barré syndrome (an acute peripheral nervous system demyelinating disease) after receipt of the flu vaccine is a Table claim, chronic inflammatory demyelinating polyneuropathy, or “CIDP,” (what is often mischaracterized as “chronic GBS”) is not. Nieves v. Sec'y of Health & Hum. Servs., No. 18-1602V, 2023 WL 3580148, at *n43 (Fed. Cl. Spec. Mstr. May 22, 2023), mot. for 13 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 14 of 17 Thus, the flu vaccine has not consistently (or credibly) been linked to chronic and relapsing-remitting CNS illnesses. Doles v. Sec'y of Health & Hum. Servs., 167 Fed. Cl. 525, 533 (2023) (ruling that study showing a link between vaccines and acute, non-MS demyelinating conditions could not be inferred to support a theory linking vaccines and MS), appeal docketed, No. 17-642 (Fed. Cir. Sep. 25, 2023); Wei-Ti Chen v. Sec’y of Health & Human Servs., No. 16- 634V, 2019 WL 2121208, at *22 (Fed. Cl. Spec. Mstr. Apr. 19, 2019) (insufficient evidence was provided to support a causal connection between the flu vaccine and petitioner’s subsequent development of neuromyelitis optica spectrum disorder, which is chronic and relapsing/remitting like MS); Hunt v. Sec’y of Health & Human Servs., No. 12-232V, 2015 WL 1263356, at *15 (Fed. Cl. Spec. Mstr. Feb. 23, 2015) (denying entitlement where MS was the alleged injury, but the causation evidence related to ADEM) mot. for review den'd, 123 Fed.Cl. 509 (2015). Existing medical and scientific literature simply, and more compellingly, is supportive of the finding that a vaccine could cause a one-time injury (even if it results in secondary, lingering sequelae)—not a chronic and persistent condition that unpredictably waxes and wanes, long after the vaccine’s initial impact has occurred. Equally important is the fact that TM can often constitute the initial presenting symptom of MS, with subsequent flares occurring later in time. This is consistent with one commonly- accepted diagnostic criteria for MS—that it requires proof of two manifestations (e.g., lesions or symptoms) separated by time and “space” (meaning a second manifestation/flare impacting the body elsewhere). Hunt, 2015 WL 1263356, at *11 (noting that an MS diagnosis traditionally requires “at least two events disseminated in time and space” (internal quotation marks omitted)). Thus, when what initially appears to be TM is followed by subsequent neurologic symptoms or other corroborating proof of a more chronic condition, the claimant’s actual injury is not limited to the initially-diagnosed TM—and TM is no longer a diagnostically-correct classification for the injured party’s presentation. Pek v. Sec'y of Health & Hum. Servs., No. 16-0736V, 2020 WL 1062959, at *16 (Fed. Cl. Spec. Mstr. Jan. 31, 2020) (“I note that in prior cases I have generally observed a distinction between acute demyelinating injuries that cause sudden and abrupt injury to the CNS (e.g., TM), and those that are chronic, relapsing/remitting, and/or progressive, like MS”). Even if the individual’s first symptoms manifestations fit the diagnostic criteria for TM but not MS (as Petitioner observes in her briefing), a petitioner’s later health history may provide medical details missing at the start, subsequently illuminating the true, chronic nature of the injury. review den’d, 167 Fed. Cl. 422 (2023) In fact, I have noted in prior cases that the evidence associating CIDP with the flu vaccine is significantly less robust than what links the vaccine to GBS. Mason v. Sec'y of Health & Hum. Servs., No. 17-1383V, 2022 WL 600415, at *22 (Fed. Cl. Spec. Mstr. Feb. 4, 2022) (contrasting the strength of evidence supporting a link between the flu vaccine and CIDP versus that supporting a link to GBS). At bottom, chronic versions of a disease involve different biological inputs and immunologic “errors” that impact physiologic processes differently from a one-time, transient, acute “hit” to the immune system that a vaccine might trigger. Houston v. Sec'y of Health & Hum. Servs., No. 18-420V, 2021 WL 4259012, at *16 (Fed. Cl. Spec. Mstr. Aug. 19, 2021) (discussion of the differences in pathogenesis between GBS and CIDP). 14 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 15 of 17 The individual, in retrospect, did not suffer from TM, despite evidence supporting the diagnosis at first glance. Given the above, I have never found entitlement in a case where a Petitioner’s initial presenting illness may have appeared to be an acute event (like TM or ADEM), but later turned out to be the first manifestation of MS.12 Such claimants have simply been unable to establish preponderantly that (a) the MS could have been caused by vaccination in the first place, or (b) the vaccine likely caused the acutely-presenting first symptom, but then that initial adverse event was also the “but for” cause of the petitioner’s subsequently-diagnosed chronic condition (as opposed to a first manifestation of the subsequent illness). See Pek, 2020 WL 1062959, at *16; Maciel v. Sec'y of Health & Hum. Servs., No. 15-362V, 2018 WL 6259230, at *23 (Fed. Cl. Spec. Mstr. Oct. 12, 2018), mot. for review denied (Fed. Cl. Apr. 1, 2019); L.Z. v. Sec'y of Health & Hum. Servs., No. 14-920V, 2018 WL 5784525, at *18 (Fed. Cl. Spec. Mstr. Aug. 24, 2018). Here, the record preponderantly establishes a number of facts undermining causality. Most significantly, the record establishes that Petitioner experienced MS—not a single, self-limiting occurrence of TM. Ex. 8 at 39–40 (official diagnosis of MS and beginning of MS-specific treatment plan). No treaters proposed that TM characterizes Petitioner’s overall course, even if they reasonably believed at the outset of her presentation that Petitioner had TM. Rather, and after time progressed and Petitioner’s course lengthened, it was concluded that what appeared to be TM was a first/initial MS flare, with Petitioner ultimately receiving an MS diagnosis that has preponderant record support. Id. Based on such a record, I cannot find (drawing upon my experience as a special master in deciding prior, comparable cases) that the flu vaccine could have caused it—or was responsible for an isolated “case” of TM that preceded it but morphed into MS for unrelated reasons. Petitioner’s TM was the presenting component of a greater condition—so 12 Admittedly, a few special masters have gone in the opposite direction, and granted compensation in MS cases— finding either direct causality or aggravation of preexisting, if subclinical, MS. See, e.g., Gardner v. Sec'y of Health & Hum. Servs., No. 17-1851V, 2023 WL 9288070 (Fed. Cl. Spec. Mstr. Dec. 21, 2023); Robinson v. Sec'y of Health & Hum. Servs., No. 14-952V, 2021 WL 2371721, at *25 (Fed. Cl. Spec. Mstr. Apr. 12, 2021); Hitt v. Sec'y of Health & Human Servs., No. 15-1283V, 2020 WL 831822, at *9–10 (Fed. Cl. Spec. Mstr. Jan. 24, 2020). However, the significant aggravation cases are distinguishable factually, since it has usually been conceded or found therein that the individual in question likely had at least “subclinical” MS before vaccination—something not contended in this case. And in any event (and disregarding the fact that I am not bound by the decisions of other special masters), I do not (based on my own experiencing deciding such claims) concur that the transient impact of a single vaccine could likely worsen MS—since MS flares are known to be triggered by a large number of transient occurrences (heat, stress, an infection, etc.), but those triggers are not deemed directly responsible for the entirety of a claimant’s subsequent disease (which will inherently feature remitting/relapsing occurrences of symptoms). Otherwise, my review of those contrary decisions does not reveal any reasoned efforts to grapple with the distinctions between acute and chronic injuries, or the acknowledged fact that what initially may seem to be a one- time event proves otherwise. Rather, the assumption in these decisions appears to have been that if a vaccine can cause one kind of CNS autoimmune demyelinating injury, it can cause another. 15 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 16 of 17 because she does not seek to prove her MS was vaccine-caused (except as a secondary matter at most),13 she cannot prevail. Because I am opting to dismiss the claim even before Petitioner has had the chance to offer expert support for her claim, I will explain why such input would not alter the outcome. As noted, I am drawing upon my expertise ruling on comparable claims in which a single, one-time demyelinating event did not capture the claimant’s actual illness—even if at first glance it appeared otherwise. In such similar petitions, I have heard live testimony on the question and/or reviewed lengthy expert reports. I therefore have sufficient familiarity with the subject to expect that any evidence submitted herein would likely repeat prior arguments I have considered but rejected. Moreover, special masters are empowered to determine how best to resolve a claim, and in what manner—including whether to allow discovery at all. Section 12(d)(3)(B)(“[t]here may be no discovery in a proceeding on a petition other than the discovery required by the special master”); Kreizenbeck, 945 F.3d at 1363. Matters do not run on automatic pilot, with claimants setting the terms for what discovery and evidence will be permitted, and/or how long the process to generate those materials will take. In addition, experts are not de rigueur in every single Vaccine Act case. And here, a medical expert could not gainsay the medical/scientific fact that TM and MS are distinguishable—and that TM can constitute an initial MS presenting symptoms, in the unfortunate case that an individual’s neurologic symptoms subsequently progress or deteriorate. As a result, in this matter I am confronted with a causation theory that I have evaluated repeatedly before, in matters where I was required to exhaustively review medical and scientific evidence on questions of causation. There is no call for repeating this exercise solely because the claimant is different. I am also unlikely to revisit my prior determinations on the subject absent some critical or new item of evidence that justifies reconsideration—and Petitioner has pointed to no new science or medical discoveries that would support the conclusion that an initial, vaccine- caused MS flare, first manifesting as TM, in turn is likely casual of MS writ large.14 The overall record herein strongly supports an MS diagnosis, for the reasons set forth above—and contemporaneous treaters in fact revised their diagnostic views accordingly, as time 13 I would, however, still dismiss the claim even if Petitioner had advanced the alternative theory that her MS was vaccine-caused, relying on the reasoning from prior cases. See, e.g., Pek, 2020 WL 1062959. 14 While claimants often protest that finding this kind of evidence is difficult (and thus that to “require” it is to demand certainty of proof, despite the Program’s preponderance standard), I note that in many other recent cases, claimants have cited some new scientific studies about an observed link between the Epstein-Barr virus (“EBV”) and MS. See, e.g., Nieves, 2023 WL 3580148, at *20. But these new studies are usually offered to bulwark causation theories involving molecular mimicry. They do not tend to make it more likely than not that the flu virus—let alone the vaccine intended to ward against it—would also likely cause MS. Indeed—there are, to my knowledge, no comparable studies whatsoever linking the flu virus to MS in the same manner (nor is there even an EBV vaccine). Thus, the EBV-oriented evidence only underscores the absence of comparable evidence that could be referenced in this case. 16 Case 1:22-vv-00477-MRS Document 44 Filed 04/29/24 Page 17 of 17 progressed and testing and other clinical evidence came in. As a result, the fact that the flu vaccine “can cause” TM does not assist Petitioner—for TM does not accurately describe her overall injury, or even an injury apart from her later-diagnosed MS.15 It is for these reasons that dismissal is warranted. CONCLUSION Petitioner’s injury herein is not limited to TM. Rather, her initial TM was itself a first MS flare—and I have repeatedly found that MS is not likely vaccine-caused. Accordingly, she cannot establish entitlement to an award of damages, and I must DISMISS the claim.16 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 15 While it is conceivable that an individual could experience TM due to vaccination, and then years later suffer MS independently, the record herein is not consistent with such an occurrence. Instead, it suggests the disease process that seemed to cause TM was rapidly progressing in real time, with treaters coming to the determination that MS was the injury less than four months after the TM diagnosis. 16 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their right to seek review. 17 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_22-vv-00477-2 Date issued/filed: 2024-10-08 Pages: 25 Docket text: RE-DOCKETED FOR ADMINISTRATIVE PURPOSES JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) (originally filed 09/20/2024) granting 42 motion for review of 41 decision of Special Master and remanding. Signed by Judge Molly R. Silfen. (jt1) Service on parties made. -------------------------------------------------------------------------------- Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 1 of 25 In the United States Court of Federal Claims PATRICIA STEWART-ROBINSON, Petitioner, v. No. 22-477 V (Filed: October 8, 2024) SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Renée J. Gentry, The Law Office of Renée J. Gentry, Washington, D.C., for petitioner. Eleanor A. Hanson, Torts Branch, Civil Division, United States Department of Justice, Washing- ton, D.C., for respondent. OPINION AND ORDER Granting Ms. Stewart-Robinson’s Motion for Review SILFEN, Judge. Patricia Stewart-Robinson filed a petition under the National Childhood Vaccine Injury Act of 1986 (Vaccine Act) seeking compensation for injuries that she alleges resulted from a flu vaccine: transverse myelitis and multiple sclerosis.1 Relying on his prior experience and expertise, the special master held that Ms. Stewart-Robinson’s earlier transverse myelitis diagnosis was only an initial presenting symptom of multiple sclerosis, not a separate illness, and that her medical records did not reflect a link between the flu vaccine and her multiple sclerosis diagnosis. He 1 This opinion was originally issued under seal. The parties had no proposed redactions. The court reissues this opinion publicly. 1 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 2 of 25 dismissed the case based on those conclusions, without providing Ms. Stewart-Robinson with an opportunity to submit an expert report. Ms. Stewart-Robinson seeks review of that dismissal, arguing that the special master abused his discretion and erred as a matter of law. Special masters may—and are expected to— rely on their experience and expertise when deciding Vaccine Act cases. But here the special mas- ter abused his discretion by relying exclusively on his prior experience to presume that any expert report would have no merit. That process denied Ms. Stewart-Robinson the chance to present her case. This court grants Ms. Stewart-Robinson’s motion for review and remands the case to the special master to provide Ms. Stewart-Robinson with an opportunity to present her case. I. Background A. Ms. Stewart-Robinson’s medical history On September 25, 2019, Ms. Stewart-Robinson received a flu vaccine administered by her primary care physician, Dr. Linke Ma. ECF No. 1 at 1 [¶4]; ECF No. 7-3 at 2 (vaccination record). Approximately two weeks later, around October 10, Ms. Stewart-Robinson began to experience changes in sensation and numbness in her lower body and feet. ECF No. 1 at 1 [¶5]. A few days later, the numbness had extended upward to her hips, so she visited an urgent care center. Id. at 1-2 [¶¶5-6]; ECF No. 7-4 (urgent care records). The urgent care center doctor examined her and referred her to the Brooklyn Hospital Center emergency department for further evaluation. ECF No. 1 at 1-2 [¶¶5-6]. The Brooklyn Hospital admitted Ms. Stewart-Robinson for inpatient treatment on Octo- ber 13. ECF No. 1 at 2 [¶6]; Exhibit 5 to the Complaint at 1 (Brooklyn Hospital records). The Brooklyn Hospital doctor noted that Ms. Stewart-Robinson had numbness and loss of sensation up to her waist and that Ms. Stewart-Robinson had received a flu vaccine two weeks before. 2 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 3 of 25 Exhibit 5 to the Complaint at 12-13. Before and during her hospital stay, Ms. Stewart-Robinson also experienced sweating and fevers. Exhibit 5 to the Complaint at 19; ECF No. 1 at 2 [¶6]. The numbness and weakness in her lower body grew, and she could not walk without a walker. ECF No. 1 at 2 [¶7]; see Exhibit 5 to the Complaint at 34. The hospital ran magnetic resonance imaging (an MRI) and a spinal tap before administering steroids and supplements. ECF No. 1 at 2 [¶7]; Exhibit 5 to the Complaint at 34. The MRI “showed segments of demyelination” but was not con- clusive. Exhibit 5 to the Complaint at 33. At that time, a diagnosis of multiple sclerosis (MS) “was ruled out.” ECF No. 9-3 at 3. The hospital discharged her about a week later. Exhibit 5 to the Complaint at 1, 32-35; ECF No. 1 at 2 [¶7]. A few days after her discharge, Ms. Stewart-Robinson had a follow-up appointment with Dr. Ma. ECF No. 1 at 2 [¶8]; ECF No. 9-1 at 25-26 (primary care physician records). Dr. Ma noted that Ms. Stewart-Robinson still needed assistance to walk and continued to experience neuropathy (numbness, weakness, and pain) in both legs. ECF No. 1 at 2 [¶8]; ECF No. 9-1 at 26. Dr. Ma added that a cerebrospinal fluid analysis test, conducted after Ms. Stewart-Robinson’s hospital MRI, “was not consistent with MS.” ECF No. 9-1 at 25. Dr. Ma advised her to continue taking supplements and to begin physical therapy. ECF No. 1 at 2 [¶8]; ECF No. 9-1 at 26. Ms. Stewart-Robinson then had a neurological consultation with Dr. Adina Alport at the New York Presbyterian Brooklyn Methodist Hospital. ECF No. 1 at 2 [¶10]; ECF No. 9-3 at 3-8 (neurology consultation records). Dr. Alport reported that Ms. Stewart-Robinson’s functionality had significantly declined. ECF No. 1 at 2 [¶10]; ECF No. 9-3 at 8. Dr. Alport gave Ms. Stewart- Robinson a working diagnosis of transverse myelitis (TM)—a demyelinating condition—but stated that neither MS nor neuromyelitis optica—which are also demyelinating conditions—could be ruled out. ECF No. 1 at 2 [¶10]; ECF No. 9-3 at 8. After additional testing, Dr. Alport formally 3 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 4 of 25 diagnosed Ms. Stewart-Robinson with a demyelinating disorder. ECF No. 9-3 at 15, 27; ECF No. 1 at 2 [¶11]. Ms. Stewart Robinson had further testing (ECF No. 1 at 2 [¶11]), which showed “[l]esions … due to transverse myelitis” or a “demyelinating disorder.” ECF No. 9-4 at 5. About a month later, another physician, Dr. Laura Watson, confirmed Dr. Alport’s findings and diag- nosed Ms. Stewart Robinson with “[a]cute transverse myelitis in [a] demyelinating disease of the central nervous system.” ECF No. 9-5 at 11, 31 (Brooklyn Methodist Hospital records); ECF No. 1 at 3 [¶12]. In another follow-up appointment, Dr. Ma recorded the neurologist’s TM diagnosis and discussed with Ms. Stewart-Robinson the possible causes, explaining that it was still unclear whether infection, idiopathy, or vaccination had caused her condition. ECF No. 9-1 at 27-28. In early January 2020, Ms. Stewart-Robinson had a follow-up appointment with Dr. Alport. ECF No. 1 at 3 [¶15]; ECF No. 9-3 at 29-34. Dr. Alport determined that Ms. Stewart-Robinson’s latest test was “highly suggestive of MS.” ECF No. 1 at 3 [¶15]; ECF No. 9-3 at 29, 33. Ms. Stewart-Robinson began seeing Dr. Alport regularly and received treatment to minimize her symp- toms related to MS and TM. ECF No. 1 at 3 [¶¶15-18]; see ECF No. 9-3 at 35-69. About nine months later, Dr. Alport reported that although Ms. Stewart-Robinson had tingling, numbness, and itching symptoms, her gait instability was improving, and her MS was clinically stable. ECF No. 1 at 3 [¶18]; ECF No. 9-3 at 63-64, 68. B. The procedural background of this case On April 28, 2022, Ms. Stewart-Robinson filed a petition with the Office of Special Mas- ters in the Court of Federal Claims. ECF No. 1. She alleged that she has both TM and MS, that the flu vaccine she received in September 2019 directly caused her TM and MS, and that the residual effects, complications, and symptoms she continues to experience will require medical care in the 4 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 5 of 25 future. ECF No. 1 at 3-4 [¶¶19-21]. Ms. Stewart-Robinson sought compensation for her medical injuries following her 2019 flu vaccination. Id. at 4 [¶¶20-23]. The special master assigned to the case held a status conference. See ECF No. 16 (order summarizing status conference); ECF No. 18 (transcript of status conference). The special master noted that, although Ms. Stewart-Robinson’s doctor initially diagnosed her with TM, it appeared that “her initial, post-vaccination TM was the first presenting symptom of MS, rather than a single, independent event.” ECF No. 16 at 1. “[W]here TM is followed by subsequent, recurring neuro- logic symptoms or other corroborating proof of a more chronic condition,” he explained, “the claimant’s actual injury is more than the initially-diagnosed TM.” Id. at 2. Thus, he concluded, MS was “really the injury” that Ms. Stewart-Robinson alleged. ECF No. 18 at 7:3-4. Relying on his prior experience with similar cases, the special master said that Ms. Stewart- Robinson’s claim was unlikely to succeed because, although TM “injuries are often successfully established [under the Vaccine Act], and credibly so, [MS claims] are not with respect to the flu vaccine.” ECF No. 16 at 1-2 (citing examples); see ECF No. 18 at 4:11-13 (“I have never found that MS is a vaccine injury and I’m highly skeptical of the theory.”); id. at 6:18-7:16 (expressing his skepticism of Ms. Stewart-Robinson’s claim but noting that his initial reaction was “only based on the petition, so [he] could be wrong”). The special master’s initial impression was that Ms. Stewart-Robinson “faces an uphill effort in establishing that any vaccine might initiate a chroni- cally-aberrant immune process over a lengthy time period resulting in an MS diagnosis—even if she might under other circumstances prove that the flu vaccine could cause a single, monophasic and acute demyelinating injury like TM.” ECF No. 16 at 2; ECF No. 18 at 4:11-13. Despite his skepticism, the special master noted that Ms. Stewart-Robinson’s theory that she “got MS later, but the TM was vaccine-caused and it’s unrelated” “might be possible, in some context” and that 5 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 6 of 25 it “isn’t a completely untenable situation.” ECF No. 18 at 4:14-20. He also agreed that it is very difficult to distinguish between TM and MS. Id. at 6:8-13. Thus, the special master directed the parties to submit briefs addressing whether there was a specific and credible distinction between Ms. Stewart-Robinson’s case and previous cases in- volving MS and the flu vaccine. ECF No. 18 at 4:23-5:8; ECF No. 16 at 2. The special master told Ms. Stewart-Robinson’s counsel at the time that, in opposing the government’s brief, Ms. Stewart- Robinson could refine her theory of causation, consult with an expert, and include a declaration summarizing a future full report. ECF No. 18 at 5:9-22. According to the special master, that dec- laration should articulate a causation theory and explain why the special master “should disregard other cases that involve [MS] as the injury.” Id. at 5:16-19. The government moved to dismiss Ms. Stewart-Robinson’s petition for failing to present a prima facie case that the flu vaccine was the actual cause of either her TM or her MS diagnoses. ECF No. 21 (motion to dismiss under Rules of the Court of Federal Claims, Appendix B, Vaccine Rule 4(c) (“Vaccine Rule 4(c)”)); ECF No. 20 at 16-18 (Vaccine Rule 4(c) report). The govern- ment argued that “a preponderance of the medical evidence of record establishes that the condition initially diagnosed as TM was a manifestation of petitioner’s MS, not a separate diagnosis.” ECF No. 20 at 16. Even if TM were a distinct diagnosis, according to the government, Ms. Stewart- Robinson “failed to provide a sound and reliable medical theory connecting” her diagnosis to the flu vaccine. Id. The government noted that none of Ms. Stewart-Robinson’s medical providers “posited a link, except a temporal one, between the vaccine and her resultant condition” and that the record did not otherwise include evidence of causation. Id. at 17. The government mirrored the special master’s skepticism that the flu vaccine could cause a chronic demyelinating condition like MS, as opposed to a temporary demyelinating condition like TM. Id. at 16-17. 6 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 7 of 25 After the government moved to dismiss, Ms. Stewart-Robinson’s counsel withdrew from the case, and she proceeded without a lawyer. ECF Nos. 28, 29. Before Ms. Stewart-Robinson’s response to the government’s motion was due, the special master held another status conference. ECF No. 35. He reiterated that his “prior experience with this sort of claim suggests … that it is unlikely to succeed.” Id. at 1. But, he told her, she could “try to defend her case.” Id. To do that, he encouraged her to seek counsel and to “look carefully at the relevant documents to determine if she could provide credible support for her claim.” Id. He also told her that she could look for an expert to provide a report for her case and that the vaccine program would reimburse her at the end of the case for the cost of the expert. Id. Ms. Stewart-Robinson retained new counsel (ECF Nos. 36, 37), and the special master held a third status conference, which was not recorded (see docket entry from July 13, 2023). Ms. Stew- art-Robinson alleges that, at that status conference, the special master told her that she “would not be allowed to get an expert” (ECF No. 40 at 2), and he “limit[ed] her presentation of her case to solely her medical records” (id. at 19). See also ECF No. 50 at 4:22-25, 17:10-18:4. According to Ms. Stewart-Robinson, at that status conference the special master also told her that “he would not pay an expert in this matter and that Counsel would need to file a brief outlining the theory of causation in response to the Motion to Dismiss.” ECF No. 40 at 2. But, according to Ms. Stewart- Robinson, the special master said that “Counsel may file literature and that she may ‘consult’ with an expert in a limited capacity and that could be reimbursed.” Id.; ECF No. 50 at 69:22-70:5, 71:3- 23; see also ECF No. 50 at 46:17-24 (government’s counsel agreeing that at the July status con- ference the special master told Ms. Stewart-Robinson’s counsel that she could consult with an expert and file medical literature). Ms. Stewart-Robinson alleges that the special master agreed to pay for one hour of consultation with an expert. ECF No. 50 at 69:22-24. 7 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 8 of 25 After the status conference, Ms. Stewart-Robinson submitted two published scientific stud- ies, as evidence of a link between flu vaccines and TM, in support of her causation theory. ECF Nos. 39-2, 39-3. She also responded to the government’s motion to dismiss, arguing that she had established causation by a preponderance of the evidence. ECF No. 40 at 15-16. She further argued that the special master did not give her a full and fair opportunity to present her case by preventing her from providing expert testimony and by limiting her to her medical records and published studies. Id. at 16, 19, 22-23. Ms. Stewart-Robinson also argued that the government had mischaracterized her general theory of causation. She alleged that “the vaccine was a substantial but-for factor in her develop- ment of TM and[,] based on the generally accepted science regarding TM/MS, her TM was a substantial but-for factor in the development of MS.” ECF No. 40 at 16, 20. She argued that the special master should not conflate the two diagnoses but treat each one as distinct, even after MS was diagnosed. Id. at 16-18, 20. She argued that she did not need to “prove a separate theory of causation” that the flu vaccine caused MS. Id. at 18. According to Ms. Stewart-Robinson, the special master should treat TM as “a clinically isolated” or separate syndrome. Id. at 15-16. Be- cause her TM diagnosis “remains clinically significant and may not be simply subsumed into her subsequent MS diagnosis,” Ms. Stewart-Robinson argued that this case particularly warranted giv- ing her an opportunity to present a full expert report in support of her causation theory. Id. at 18. The special master granted the government’s motion and dismissed Ms. Stewart-Robin- son’s case. ECF No. 41. The special master concluded that “TM does not accurately describe her overall injury, or even an injury apart from her later-diagnosed MS,” and “it is not disputed that [she] was properly diagnosed with MS.” Id. at 13, 17 (emphasis omitted). He stated that Ms. Stew- art-Robinson’s medical records supported her ultimate MS diagnosis but did not establish “an 8 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 9 of 25 association between [her] medical issues and her receipt of the flu vaccine,” either through direct evidence or through the opinions of her medical providers. Id. at 6. Procedurally, the special master dismissed Ms. Stewart-Robinson’s claim “even before [she] … had the chance to offer expert support for her claim.” ECF No. 41 at 16. He explained that expert “input would not alter the outcome.” Id. According to the special master, based on his “ex- pertise ruling on comparable claims in which a single, one-time demyelinating event did not cap- ture the claimant’s actual illness,” he had already “heard live testimony on the question and/or reviewed lengthy expert reports” in other cases. Id. The special master explained that he “therefore [had] sufficient familiarity with the subject to expect that any evidence submitted herein would likely repeat prior arguments [he had] considered but rejected.” Id. Without evidence that Ms. Stewart-Robinson ever had TM, and without evidence of a causal link between the vaccine and MS, the special master concluded that Ms. Stewart-Robinson had failed to establish a prima facie case. Id. at 17. Ms. Stewart-Robinson seeks review of the special master’s decision dismissing her case. ECF No. 42. She also requests that the court reassign the case to a different special master on remand. Id. at 19-20. The court held an oral argument on the motion for review. II. Discussion This court has jurisdiction to review a special master’s decision under the Vaccine Act. 42 U.S.C. § 300aa-12(e). On a motion for review, this court may uphold or set aside the special mas- ter’s findings of fact and conclusions of law or remand the petition to the special master for further action. 42 U.S.C. § 300aa-12(e)(2); accord Vaccine Rule 27. This court reviews the decision of a special master to determine whether it is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. 42 U.S.C. § 300aa- 9 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 10 of 25 12(e)(2)(B); Masias v. Secretary of Health and Human Services, 634 F.3d 1283, 1287 (Fed. Cir. 2011); accord Vaccine Rule 27. That standard is “well understood to be the most deferential pos- sible.” Munn v. Secretary of Health and Human Services, 970 F.2d 863, 870 (Fed. Cir. 1992). This court reviews the special master’s findings of fact to determine whether they are ar- bitrary or capricious. Hodges v. Secretary of Health and Human Services, 9 F.3d 958, 961 (Fed. Cir. 1993). “If the special master has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely diffi- cult to demonstrate.” Hines v. Secretary of Health and Human Services, 940 F.2d 1518, 1528 (Fed. Cir. 1991). The court, like the Federal Circuit, does “not reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses—these are all matters within the purview of the fact finder.” Porter v. Secretary of Health and Human Services, 663 F.3d 1242, 1249 (Fed. Cir. 2011); see Munn, 970 F.2d at 871-72 (explaining that the Federal Circuit and this court apply the same standard). This court reviews discretionary rulings, including case management decisions, for abuse of discretion. Munn, 970 F.2d at 870 n.10. That review “rarely come into play except where the special master excludes evidence.” Id. The court gives “no deference to the … Special Master’s determinations of law” and reviews legal questions de novo. Carson v. Secretary of Health and Human Services, 727 F.3d 1365, 1368 (Fed. Cir. 2013). Ms. Stewart-Robinson bears the burden to prove, by a preponderance of the evidence, that the flu vaccine caused her to develop the medical conditions she alleges. 42 U.S.C. § 300aa- 13(a)(1)(A); id. § 300aa-11(c)(1)(C); see Porter, 663 F.3d at 1249. To prove causation, she “must show that the vaccine was not only a but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly v. Secretary of Health and Human Services, 592 F.3d 1315, 10 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 11 of 25 1321 (Fed. Cir. 2010) (quotation marks omitted). Ms. Stewart-Robinson must support her allega- tions of causation with “a sound and reliable medical or scientific explanation,” but her explanation need only be “legally probable, not medically or scientifically certain.” Knudsen v. Secretary of Health and Human Services, 35 F.3d 543, 548-49 (Fed. Cir. 1994). She can also prove causation from “the circumstances of the particular case” without “hard and fast per se scientific or medical rules.” Id. Congress intended “close calls regarding causation [to be] resolved in favor of the in- jured claimants.” Althen v. Secretary of Health and Human Services, 418 F.3d 1274, 1280 (Fed. Cir. 2005). A. The special master abused his discretion by denying Ms. Stewart-Robinson the opportunity to file an expert report Ms. Stewart-Robinson argues that the special master violated her procedural rights under the Vaccine Act and Vaccine Rules 3 and 8, and abused his discretion, when he dismissed her case without letting her submit an expert report. ECF No. 42 at 10-14, 18-19. She asserts that the special master improperly relied on his experience in previous cases to determine that any expert report, regardless of its content, would be inadequate to establish causation in her case. Id. She adds that the special master initially encouraged her to retain an expert but then denied her request to provide an expert report. Id. at 13. She also argues that the special master’s reliance on facts developed in earlier cases amounts to an improper application of issue preclusion. Id. at 14-18. She argues that the special master therefore prematurely dismissed her case. Id. at 19. The government responds that the special master acted within his discretion in managing the proceeding. ECF No. 47 at 10-15. The government reads the Vaccine Act, rules, and case law not to require a special master to accept expert reports, such that a special master may dismiss a case on the initial written record alone. Id. at 12-15. Special masters, the government argues, may rely on their expertise, including from previous cases, to inform their decisionmaking. Id. 11 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 12 of 25 Special masters have broad discretion to manage and administer Vaccine Act cases. Burns v. Secretary of Health and Human Services, 3 F.3d 415, 417 (Fed. Cir. 1993); Vaccine Rule 3(b)(1). A special master must “endeavor[] to make the proceedings expeditious, flexible, and less adversarial, while at the same time affording each party a full and fair opportunity to present its case and creating a record sufficient to allow review of the special master’s decision.” Vaccine Rule 3(b)(2); see 42 U.S.C. § 300aa-12(d)(2)(D) (requiring the vaccine rules to “include the op- portunity for parties to submit arguments and evidence on the record without requiring routine use of oral presentations, cross examinations, or hearings”). The rules further direct the special master to “determine the format for taking evidence and hearing argument based on the specific circum- stances of each case and after consultation with the parties.” Vaccine Rule 8(a). But special masters’ discretion to administer Vaccine Act proceedings is not unlimited. Kreizenbeck v. Secretary of Health and Human Services, 945 F.3d 1362, 1366 (Fed. Cir. 2020). Special masters may not conduct proceedings “in a way that deprives a party of procedural rights provided by the Vaccine Act and the Vaccine Rules.” Simanski v. Secretary of Health and Human Services, 671 F.3d 1368, 1385 (Fed. Cir. 2012). Special masters “shall afford all interested persons an opportunity to submit relevant written information.” 42 U.S.C. § 300aa-12(d)(3)(B)(iv); see Burns v. Secretary of Health and Human Services, No. 90-953, 1992 WL 365410, at *2 (Fed. Cl. Spec. Mstr. Nov. 6, 1992), aff’d, 3 F.3d 415 (Fed. Cir. 1993) (special master had a duty to consider a medical expert report but had discretion to determine whether to supplement the record with additional affidavits). “The special master or court may not [award compensation] based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa-13(a)(1). Thus, special masters are required to “consider all relevant and reliable evi- dence” in the record, draw plausible inferences, and articulate a rational basis for their decisions. 12 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 13 of 25 Vaccine Rule 8(b)(1); Hines, 940 F.2d at 1528; see also Burns, 1992 WL 365410, at *2. When receiving evidence, the special master is “governed by principles of fundamental fairness to both parties.” Vaccine Rule (8)(b)(1). A special master may not rule on the record until he has deter- mined that “the record is comprehensive and fully developed.” Kreizenbeck, 945 F.3d at 1366. The special master abused his discretion in denying Ms. Stewart-Robinson an opportunity to file an expert report in this case. The government is correct that special masters may draw on and even substantially rely on their expertise and case law to resolve Vaccine Act cases. Doe v. Secretary of Health and Human Services, 76 Fed. Cl. 328, 338-39 (2007) (“One reason that pro- ceedings are more expeditious in the hands of special masters is that the special masters have the expertise and experience to know the type of information that is most probative of a claim.”); Munn, 970 F.2d at 868-71. Special masters would “be remiss in ignoring prior cases presenting similar theories or factual circumstances, along with the reasoning employed in reaching such de- cisions.” Simeone v. Secretary of Health and Human Services, No. 20-1375, 2023 WL 5286292, at *7 n.7 (Fed. Cl. Spec. Mstr. Feb. 24, 2023), review denied, decision aff’d, 167 Fed. Cl. 389 (2023). But special masters may not rely exclusively on the facts found in other similar vaccine cases to determine causation or make any ultimate determinations in a new case. Contreras v. Secretary of Health and Human Services, 107 Fed. Cl. 280, 308 (2012). A special master’s deci- sion must also account for the record in the pending case. E.g., Kalajdzic v. Secretary of Health and Human Services, No. 23-1321, 2024 WL 3064398, at *3 (Fed. Cir. June 20, 2024) (holding that the special master did not place undue weight on a previous decision because he analyzed and rejected expert testimony on case-specific grounds); O.M.V. v. Secretary of Health and Human Services, 157 Fed. Cl. 376, 388 (2021) (finding no error when the special master relied on 13 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 14 of 25 experience and case law in conjunction with medical literature and expert testimony to ultimately deny the petitioner’s claim). That is because each Vaccine Act case is unique and must be evaluated on its own merits. Contreras, 107 Fed. Cl. at 308; Campbell v. Secretary of Health and Human Services, 69 Fed. Cl. 775, 784 (2006). Causation in fact is “based on the circumstances of the particular case, having no hard and fast per se scientific or medical rules” because causation “under the Vaccine Act involves ascertaining whether a sequence of cause and effect is ‘logical’ and legally probable, not medically or scientifically certain.” Knudsen, 35 F.3d at 548-49. Furthermore, special masters are not bound by their own earlier decisions. Hanlon v. Secretary of Health and Human Services, 40 Fed. Cl. 625, 630 (1998), aff’d, 191 F.3d 1344 (Fed. Cir. 1999). Thus, the special master’s “acceptance of a theory in one case does not require him or her to accept the theory in subsequent cases involving similar facts or the same vaccine.” Rickett v. Secretary of Health and Human Services, 468 Fed. App’x 952, 959 (Fed. Cir. 2011). A “different evidentiary record can lead to different outcomes. To decide otherwise would effectively require special masters to ignore the impact of ever-chang- ing technological advances and medical breakthroughs that might discredit the plausibility of a formerly accepted theory.” Id. (citations omitted). Notably, in Moberly, 592 F.3d at 1325, expert reports distinguished two very similar cases that concerned the same injury and theory of causation. The special master in Moberly found that the petitioner’s expert lacked credibility and was unpersuaded by the expert’s theory of causation, whereas in the previous case the special master had relied on an expert report presenting the same theory. Id. Although the two expert reports conflicted, the Federal Circuit held that the special master did not need to resolve the conflict to decide causation. Id. Because “the legal standard is a preponderance of the evidence, not scientific certainty,” the special master had to decide whether 14 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 15 of 25 expert testimony was credible, reliable, and persuasive, not whether it was scientifically sound. Id. The Federal Circuit concluded that because of the experts, the records in the two cases were sig- nificantly different, so the result in the previous case did “not compel the same result” there. Id. Here, the special master impermissibly allowed his expertise and experience with similar cases to control the outcome of this case without considering a full record. ECF No. 41 at 12-17. Relying on other cases and Ms. Stewart-Robinson’s medical records, he concluded that Ms. Stew- art-Robinson’s earlier documented TM diagnosis was not a clinically isolated syndrome or a con- gruent illness, but only the “initial presenting symptom of MS.” Id. at 14-15 (emphasis omitted). Therefore, he concluded that she “experienced MS—not a single, self-limiting occurrence of TM”—and that “TM was the presenting component of a greater condition”; she did not have “an isolated ‘case’ of TM.” Id. at 15 (emphasis omitted). That was “despite evidence supporting the diagnosis at first glance.” Id. Because Ms. Stewart-Robinson did “not seek to prove her MS was vaccine-caused (except as a secondary matter at most),” he concluded that “she cannot prevail.” Id. at 16. The special master also concluded that the flu vaccine could not have caused MS. Id. at 16 n.13 (“I would, however, still dismiss the claim even if [Ms. Stewart-Robinson] had advanced the alternative theory that her MS was vaccine-caused, relying on the reasoning from prior cases.”). Those conclusions were premature. By dismissing the case without allowing Ms. Stewart- Robinson to present expert evidence rebutting his conclusions, the special master precluded Ms. Stewart-Robinson from developing the full record that he is required to consider (Vaccine Rule 8(b)(1)) and impeded her from fully presenting her case (Vaccine Rule 3(b)(2)). In stating that no viable expert report would support Ms. Stewart-Robinson’s theory, the special master presumed what any expert report might say and, in the process, determined the case’s overall merits. ECF No. 41 at 16 & n.13. But ruling on the merits of a case at the motion-to-dismiss stage is premature. 15 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 16 of 25 See Simanski, 671 F.3d at 1380, 1382-85 (remanding because the special master had prematurely ruled on the merits at “an early procedural stage,” and noting that when the government believes the petitioner’s evidence is insufficient to justify compensation under the Vaccine Act, “the proper course is for the [government] to move for summary judgment”).2 Refusing to allow an expert report was particularly detrimental here because “expert med- ical testimony is often very important” for demonstrating “proof of actual causation,” Broekelschen v. Secretary of Health and Human Services, 618 F.3d 1339, 1347 (Fed. Cir. 2010), and can be dispositive, Moberly, 592 F.3d at 1325. Further, the special master told Ms. Stewart- Robinson that she would have an opportunity to provide expert testimony (ECF No. 35 at 1) and later said that he was “unlikely to revisit [his] prior determinations on the subject” unless she presented “some critical or new item of evidence” such as new scientific studies “that would sup- port the conclusion that an initial, vaccine-caused MS flare, first manifesting as TM, in turn is likely [causal] of MS writ large” (ECF No. 41 at 16 (emphasis omitted)). Although the special master considered Ms. Stewart-Robinson’s medical records when concluding that Ms. Stewart-Robinson did not separately have TM (ECF No. 41 at 15), he did not address Ms. Stewart-Robinson’s specific theory of causation (id. at 12-17). Instead, he explained that, in his experience, no case or medical study has yet established that the flu vaccine could cause 2 Ms. Stewart-Robinson argues that the special master ordered the government to file a motion to dismiss, compounding her concern that the decision was premature because it was not even the government’s idea. ECF No. 42 at 11-12. While it appears to be rare that a special master might order such a motion, as opposed to issuing a show-cause order (see, e.g., Bello v. Secretary of Health and Human Services, No. 20-739, 2021 WL 5070179, at *1 (Fed. Cl. Spec. Mstr. Sept. 10, 2021)), the special master has wide discretion in choosing how to conduct proceedings (Burns, 3 F.3d at 417; Vaccine Rule 3(b)). And, on a review of the transcript and order, it does not appear that the special master ordered the government to file the motion, as opposed to simply discussing the timing of a possible motion to dismiss. ECF No. 18 at 4:23-5:8; ECF No. 16 at 2. 16 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 17 of 25 MS or that TM could lead to MS. Id. at 15 (“I have never found entitlement in a case where a Petitioner’s initial presenting illness may have appeared to be an acute event (like TM …), but later turned out to be the first manifestation of MS.”); id. at 16 n.14 (“[T]o my knowledge, [there are] no comparable studies whatsoever linking the flu virus to MS in the same manner.”). Because the special master has “sufficient familiarity with the subject,” he reasoned that he could “expect that any evidence submitted herein would likely repeat prior arguments [he had] considered but rejected” and thus that it would be impossible for any expert to present a credible report to the contrary. Id. at 16 (“[E]xpert support for her claim … would not alter the outcome.”). But contrary to the special master’s conclusion, as he noted, Vaccine Act cases do not unanimously reject Ms. Stewart-Robinson’s theory. Id. at 15 n.12 (“Admittedly, a few special masters have gone in the opposite direction, and granted compensation in MS cases—finding either direct causality or ag- gravation of preexisting, if subclinical, MS.”); see Hitt v. Secretary of Health and Human Services, No. 15-1283, 2020 WL 831822, at *9-11 (Fed. Cl. Spec. Mstr. Jan. 24, 2020). To support the conclusion that the flu vaccine cannot cause MS, the special master ex- plained that he was “confronted with a causation theory that [he has] evaluated repeatedly before, in matters where [he] was required to exhaustively review medical and scientific evidence on ques- tions of causation.” ECF No. 41 at 16. According to the special master, “[t]here is no call for repeating this exercise solely because the claimant is different.” Id. But the provisions of the Vac- cine Act require more. See Moberly, 592 F.3d at 1325. The special master relied on his knowledge of the medical literature, not to evaluate the persuasiveness of the record, but to preclude Ms. Stewart-Robinson from fully developing it. As the special master stated, “here, a medical expert could not gainsay the medical / scientific fact that TM and MS are distinguishable—and that TM can constitute an initial MS presenting 17 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 18 of 25 symptoms.” ECF No. 41 at 16 (emphasis omitted). He also dismissed the alternative theory that the flu vaccine could cause MS because he was not aware of any medical study supporting it. Id. at 16 n.14 (“[T]o my knowledge, [there are] no comparable studies whatsoever linking the flu virus to MS in the same manner.” (emphasis omitted)). But the special master also acknowledged that “it is not well-understood what causes MS in the first place—with far more evidence linking vac- cines to acute, self-limiting illnesses (like TM) than to MS.” Id. at 13. Ms. Stewart-Robinson’s theory of causation does not need to be medically or scientifically certain, only legally probable. Knudsen, 35 F.3d at 548-49. Thus, an expert report could conceivably meet that standard in this case. A special master may rely on an earlier case to reject an expert report for lack of credibility, but that decision must be based on “case-specific reliability grounds.” Kalajdzic, 2024 WL 3064398, at *3; see also Whitecotton v. Secretary of Health and Human Services, 81 F.3d 1099, 1108 (Fed. Cir. 1996) (explaining that special masters “have very wide discretion with respect to the evidence they would consider and the weight to be assigned that evidence,” but in evaluating weight the special master must consider the entire record). In Kalajdzic, 2024 WL 3064398, at *3, the petitioner had an opportunity to file an expert report. In this case, the special master did not allow an expert report explaining Ms. Stewart-Robinson’s theory. In Bello v. Secretary of Health and Human Services, 158 Fed. Cl. 734, 743-44, 748-49 (2022), which the government relies on (ECF No. 47 at 12-15), this court held that a special master did not abuse his discretion by refusing a petitioner’s requests for an evidentiary hearing and ad- ditional time to submit an expert report. But in Bello, the special master “gave Petitioners a full and fair opportunity to present written evidence and argument” by granting them more than one opportunity to clarify the written record beyond their initial submissions of medical records, 18 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 19 of 25 including “a chance to address the difficulties that are commonly presented when claimants at- tempt to prove that vaccines have caused” injuries. 158 Fed. Cl. at 748. As in this case, the special master in Bello warned that claims like the one alleged are often unsuccessful. Id. But because of that, the special master in Bello “invited Petitioners to identify medical evidence” to distinguish and attempt to prove their claim. Id. The petitioners in Bello “had the opportunity” to clarify and complete the record but chose not to take advantage of that opportunity. Id. at 748-49 (In response to the special master’s order to show cause, the petitioners “took precisely the approach the [special master] warned them against.”). In comparison, the special master here did not give Ms. Stewart- Robinson an opportunity to clarify the record. After the special master gave her time to retain new counsel and recommended that she retain an expert to help her argue a difficult case (ECF No. 35 at 1), the special master then dismissed the case before giving her the chance to submit an expert report (ECF No. 41 at 16-17). The government also raises the court’s recent decision in Felix v. Secretary of Health and Human Services, No. 21-1728, 2024 WL 3807273 (Fed. Cl. Aug. 14, 2024). ECF No. 48. There, the court held that a special master did not abuse his discretion when he rejected the petitioners’ request to submit expert reports. Felix, 2024 WL 3807273, at *4. The government argues that the special master here likewise gave Ms. Stewart-Robinson a full opportunity to present her case, even without expert testimony, before dismissing the case. ECF No. 48 at 2-3. But Felix was a “table injury” case, whereas this case is an “off-table injury” case. Compare 2024 WL 3807273, at *1 with ECF No. 42 at 6. As the special master in Felix noted, “experts are not routine in [table injury] cases.” Felix v. Secretary of Health and Human Services, No. 21-1728, 2024 WL 2831368, at *1 n.3 (Fed. Cl. Spec. Mstr. Apr. 29, 2024); Guilliams v. Secretary of Health and Human Services, No. 11-716, 2012 WL 1145003, at *10 n.20 (Fed. Cl. Spec. Mstr. Mar. 14, 19 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 20 of 25 2012). In table injury cases, as long as the claims are “within the timetable and specifications of a Table injury … the statute does the heavy lifting—causation is conclusively presumed.” Hodges, 9 F.3d at 961. “By comparison, in off-Table injury cases, it is the preponderance standard, as opposed to operation of law, that does the ‘heavy lifting’ of establishing causation.” Althen, 418 F.3d at 1280 (quoting Hodges, 9 F.3d at 961). And the Vaccine Act requires different and more extensive evi- dence to show entitlement for off-table injuries. Compare 42 U.S.C. § 300aa-11(c)(1)(A), (B)(i) with § 300aa-11(c)(1)(C). Thus, expert reports are more common and are often essential to estab- lishing causation in off-table injury cases. Broekelschen, 618 F.3d at 1347; Lampe v. Secretary of Health and Human Services, 219 F.3d 1357, 1361 (Fed. Cir. 2000) (“As is often true in Vaccine Act cases based on a theory of actual causation, the expert medical testimony was important in this case.”). Relatedly, the motion to dismiss in Felix concerned whether the plaintiff had satisfied the severity requirement (42 U.S.C. § 300aa-11(c)(1)(D)), while here the motion to dismiss concerns causation (id. § 300aa-12(d)(3)(B)(iv)). It is harder to prove causation. In Felix, the court explained that witness statements noting that the injury had persisted for six months would have sufficed to establish severity. See 2024 WL 2831368, at *1 & n.3. Unlike the severity provision, the Vaccine Act’s causation provision requires the special master to “afford all interested persons an oppor- tunity to submit relevant written information … relating to any allegation in a petition [that the petitioner sustained, or had significantly aggravated, any off-table illness, disability, injury, or condition but which was caused by a vaccine on the Vaccine Injury Table].” 42 U.S.C. § 300aa- 12(d)(3)(B)(iv)(II) (incorporating § 300aa-11(c)(1)(C)(ii)); see generally 42 U.S.C. § 300aa- 12(d)(3)(B). Thus, although in Felix the special master had “satisfied the … procedural and 20 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 21 of 25 substantive requirements” without accepting an expert report (2024 WL 3807273, at *3-4), differ- ent procedural requirements apply to establish causation. The government analogizes the special master’s authority to prohibit an expert report in this case to special masters’ discretion over whether to hold evidentiary hearings. ECF No. 47 at 7, 12. Although expert reports, like evidence adduced in a hearing, are all evidence, the rules and case law treat them differently. Vaccine Rule 8(d) states that a “special master may decide a case on the basis of written submissions without conducting an evidentiary hearing.” See also 42 U.S.C. § 300aa-12(d)(3)(B)(v); Oliver v. Secretary of Health and Human Services, 900 F.3d 1357, 1364 n.6 (Fed. Cir 2018); Burns, 3 F.3d at 417. In contrast, the Vaccine Act states that special masters, “[i]n conducting a proceeding on a petition … shall afford all interested persons an opportunity to submit relevant written information.” 42 U.S.C. § 300aa-12(d)(3)(B)(iv). And before deciding to skip an evidentiary hearing, special masters must first determine that they have considered all the relevant evidence in the case. Kreizenbeck, 945 F.3d at 1366 (“[S]pecial masters must determine that the record is comprehensive and fully developed before ruling on the record.”); Vinesar v. Secretary of Health and Human Services, No. 18-440, 2023 WL 5427935, at *47-48 (Fed. Cl. July 28, 2023), review denied on other grounds, decision aff’d, 170 Fed. Cl. 681 (2024) (Federal Circuit appeal on other grounds pending). In Vinesar, the special master explained, in deciding not to hold an evidentiary hearing, that the petitioners “had ample opportunity to submit evidence supporting their position” and that, “from the [petitioners’] per- spective, they do not need any additional evidence.” Vinesar, 2023 WL 5427935, at *48. Unlike Vaccine Rule 8(d), there is no equivalent provision under the Vaccine Act or in the rules permitting the special master to prevent a party from filing a relevant written expert report. Although there is not much authority directly addressing how to decide a case without an expert 21 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 22 of 25 report, the Federal Circuit has implied that, under the plain language of the Vaccine Act and Vac- cine Rules, special masters have more discretion to skip a hearing than to prohibit expert reports. D’Tiole v. Secretary of Health and Human Services, 726 Fed. App’x 809, 812 (Fed. Cir. 2018) (affirming the special master’s discretion to accept and consider seven expert reports but decide the case without an evidentiary hearing). This court does not reweigh factual evidence or review the special master’s evaluation of that evidence. Porter, 663 F.3d at 1249. The problem here is that the special master did not allow the evidence—an expert report—to be submitted in the first place. And while a special master has wide discretion in case management decisions, a decision to exclude evidence can amount to an abuse of discretion. Munn, 970 F.2d at 870 n.10. This court and the Federal Circuit are “willing[] to reverse the decision of a special master when the special master has failed to adequately develop the record, failed to consider facts critical to the case, failed to give adequate consideration to a viable medical theory, or otherwise misapplied the law.” Snyder v. Secretary of Health and Human Services, 88 Fed. Cl. 706, 718 (2009); see Tebcherani v. Secretary of Health and Human Services, 55 Fed. Cl. 460, 477-479 (2003); Dickerson v. Secretary of Health and Human Services, 35 Fed. Cl. 593, 601-602 (1996). Notably, the rules do not require an extensive review of the evidence, and special masters are of course permitted and encouraged to rely on their expertise in adjudicating Vaccine Act cases. At the motion-to-dismiss stage, the special master is allowed to dismiss an implausible theory. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)); W.J. v. Secretary of Health and Human Services, 93 F.4th 1228, 1243 (Fed. Cir. 2024) (“[S]pecial masters have jurisdiction to rule on motions to dismiss.”), petition for certiorari dock- eted. 22 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 23 of 25 But here the special master acknowledged that Ms. Stewart-Robinson’s theory that she had both TM and MS “might be possible, in some context,” that it “isn’t a completely untenable situ- ation,” and that the special master was not “dealing with … something that’s well beyond the pale.” ECF No. 18 at 4:14-22. In at least one other case, a special master has accepted Ms. Stewart- Robinson’s theory, that the flu vaccine caused the petitioner’s MS that initially presented as TM. Hitt, 2020 WL 831822, at *9-11; see ECF No. 41 at 15 n.12 (acknowledging that other special masters have granted compensation in MS cases). Here, Ms. Stewart-Robinson should have the chance to submit an expert report. See Kreizenbeck, 945 F.3d at 1366 (A special master may not rule on the record until he has determined that “the record is comprehensive and fully developed.”). The special master abused his discretion when he dismissed Ms. Stewart-Robinson’s case on an incomplete record. Nothing in this opinion should be read to preclude the special master from coming to the same conclusion in this case after looking at all the evidence. And, indeed, nothing in this opinion precludes the special master from excluding an expert’s opinion as lacking credibility or scientific support under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). See Terran v. Secretary of Health and Human Services, 195 F.3d 1302, 1316 (Fed. Cir. 1999) (explaining that a special master may apply the Daubert framework in Vaccine Act cases to evaluate expert testi- mony). The special master could also limit the reimbursement of expert fees and costs if he deems the basis for hiring an expert unreasonable. See 42 U.S.C. § 300aa-15(e)(1) (permitting the special master to award “reasonable attorneys’ fees, and other costs, incurred” throughout the proceeding as long as “the petition was brought in good faith and there was a reasonable basis for the claim.”); ECF No. 50 at 24:23-25:13 (Ms. Stewart-Robinson’s counsel explaining that when a petitioner relies on a theory that lacks a reasonable basis, special masters typically inform the petitioner that 23 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 24 of 25 the court will not pay for the expert but do not prohibit expert reports). The special master need only allow Ms. Stewart-Robinson to present her evidence and address that evidence in making a decision.3 B. The court remands the case to the original special master On remand, this court ordinarily reassigns vaccine cases to the originally assigned special master. Contreras v. Secretary of Health and Human Services, 844 F.3d 1363, 1369 (Fed. Cir. 2017); see Liteky v. United States, 510 U.S. 540, 551 (1994) (“It has long been regarded as normal and proper for a judge to sit in the same case upon its remand, and to sit in successive trials in- volving the same defendant.”). Reassignment is limited to when it is necessary “to preserve the appearance of fairness.” See Alta Wind I Owner Lessor C v. United States, 897 F.3d 1365, 1382 (Fed. Cir. 2018). This court and the Federal Circuit reassign cases only when “the circumstances … are such that upon remand [the adjudicator] cannot reasonably be expected to erase the earlier impressions from his or her mind” or “where [an adjudicator] has repeatedly adhered to an erro- neous view after the error is called to his attention.” Contreras, 844 F.3d at 1369 (marks omitted). Adjudicators are presumed to be impartial. Aetna Life Ins. Co. v. Lavoie, 475 U.S. 813, 820 (1986). Ms. Stewart-Robinson argues that the special master’s comments—such as his being “un- likely to revisit [his] prior determinations on the subject absent some critical or new item of evi- dence that justifies reconsideration” (ECF No. 41 at 16)—“strongly imply that no evidence will change his mind” (ECF No. 42 at 19 (emphasis omitted)). But special masters are not precluded from relying on their experience and expertise in deciding a case. See Doe, 76 Fed. Cl. at 338-39. “[O]pinions held by judges as a result of what they learned in earlier proceedings” do not constitute 3 Because the special master abused his discretion, the court need not address Ms. Stewart-Robin- son’s issue preclusion argument (ECF No. 42 at 14-18). 24 Case 1:22-vv-00477-MRS Document 55 Filed 10/08/24 Page 25 of 25 bias or prejudice. Liteky, 510 U.S. at 551. It is okay—and even helpful—for a special master to preview for the parties that he is skeptical of certain parts of the case. That allows the parties to address those concerns in future briefing and arguments. Unlike cases where reassignment was justified, the special master here has not failed to follow any prior instructions (as in Contreras, 844 F.3d at 1369), shown any evidence of bias against this particular petitioner (as in Richardson v. Secretary of Health and Human Services, 89 Fed. Cl. 657, 660 (2009)), or inconsistently interpreted the evidence in this case (as in Doles v. Secretary of Health and Human Services, 163 Fed. Cl. 616, 618 (2023)). Instead, the problem here was a reluctance to examine the evidence in the first place. The court is confident that the special master will examine the evidence and impartially adjudicate Ms. Stewart-Robinson’s claim on remand. Ms. Stewart-Robinson has not overcome the presumption of impartiality afforded to the special master in this case. III. Conclusion For the reasons stated above, this court grants Ms. Stewart-Robinson’s motion for review and sets aside the special master’s decision dismissing the case. The court remands the case to the special master under Vaccine Rule 27(c). IT IS SO ORDERED. s/ Molly R. Silfen MOLLY R. SILFEN Judge 25