VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-01152 Package ID: USCOURTS-cofc-1_21-vv-01152 Petitioner: Alison Stiegler Filed: 2021-04-02 Decided: 2025-04-18 Vaccine: Tdap Vaccination date: 2018-04-04 Condition: postural orthostatic tachycardia syndrome (POTS) and chronic fatigue syndrome (CFS) Outcome: denied Award amount USD: AI-assisted case summary: Alison Stiegler received a Tdap vaccine on April 4, 2018. She filed a petition alleging that this vaccine caused her to develop Postural Orthostatic Tachycardia Syndrome (POTS) and Chronic Fatigue Syndrome (CFS). The case proceeded as an off-Table claim, meaning Ms. Stiegler had to prove causation. The Chief Special Master initially expressed skepticism about the claim, noting that POTS claims related to other vaccines, like the HPV vaccine, had been consistently rejected. He invited Ms. Stiegler to present a more persuasive theory specifically linking the Tdap vaccine to POTS. Ms. Stiegler filed a brief and cited medical literature, including studies on the HPV vaccine and POTS, and a case report about tetanus infection. She also argued a molecular mimicry theory. The respondent argued that Ms. Stiegler never received a formal diagnosis of POTS or CFS and failed to establish causation. The Chief Special Master ultimately denied entitlement, finding that Ms. Stiegler failed to establish a persuasive medical theory that the Tdap vaccine can cause POTS or CFS. He noted that the literature regarding the HPV vaccine and POTS had been repeatedly rejected and that the evidence specific to the Tdap vaccine was insufficient, relying heavily on a single case report. He also found the molecular mimicry argument unconvailing. Ms. Stiegler appealed this decision, arguing the Chief Special Master dismissed her claim improperly and abused his discretion by denying entitlement without allowing expert reports. The Court of Federal Claims affirmed the denial, finding that the Chief Special Master did not dismiss the case under Rule 12(b)(6) but rather ruled on the record after determining it was fully developed. The court also found no abuse of discretion in denying expert reports, as Ms. Stiegler had ample opportunity to present her case and failed to offer new evidence or arguments that had not already been rejected in prior cases. The court also denied Ms. Stiegler's motion for interim attorneys' fees and instructed the Special Master on how to handle fees related to certain improper filings. Theory of causation field: Tdap vaccine on April 4, 2018, adult exact age not stated, alleged to cause POTS and chronic fatigue syndrome. DENIED. Petitioner advanced an immune-mediated off-Table theory; respondent disputed diagnosis, mechanism, and logical sequence. The Special Master denied entitlement, and the Court of Federal Claims denied review on April 18, 2025. Later attorney-fee decision did not change the merits outcome. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_21-vv-01152-0 Date issued/filed: 2024-11-05 Pages: 19 Docket text: PUBLIC DECISION (Originally filed: 10/10/2024) regarding 86 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (af) Service on parties made. -------------------------------------------------------------------------------- Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 1 of 19 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 21-1152V * * * * * * * * * * * * * * * * * * * * * * * * * * Chief Special Master Corcoran * ALISON STIEGLER, * * Filed: October 10, 2024 Petitioner, * * v. * * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Andrew Downing, Downing, Allison, & Jorgenson, Phoenix, Arizona, for Petitioner. Sarah Duncan, U.S. Department of Justice, Washington, DC, for Respondent. DECISION DENYING ENTITLEMENT1 On April 2, 2021, Alison Stiegler filed a Petition under the National Vaccine Injury Compensation Program (the “Vaccine Program”),2 alleging that she developed Postural Orthostatic Tachycardia Syndrome (“POTS”) and chronic fatigue syndrome (“CFS”) as a result of receiving the tetanus, diphtheria, and acellular pertussis (“Tdap”) vaccine on April 4, 2018. ECF No. 1 (“Petition”). 1 This Decision will be posted on the United States Court of Federal Claims’ website in accordance with the E- Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published Ruling’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the entire Decision will be available to the public in its current form. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”). All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa. Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 2 of 19 On October 2, 2023, I held a status conference, after which I ordered Petitioner to file a brief explaining the theory offered in this case. ECF No. 68. On January 19, 2024, Petitioner filed that brief. ECF No. 69 (“Brief”). Two months later, on March 25, 2024, I issued another order reiterating the preliminary view (based on my experience adjudicating POTS claims) that the Petition was not tenable, and expressing my willingness to entertain dismissal. ECF No. 72. Respondent has now formally moved to dismiss the claim, and both sides have had an opportunity to weigh in on the matter. See Respondent’s Rule 4(c) Report (ECF No. 73) and associated Motion to Dismiss, filed April 30, 2024 (ECF No. 74) (collectively, “Mot.”); Petitioner’s Response, filed July 2, 2024 (ECF No. 81) (“Opp.”); Petitioner’s Motion for Oral Argument, filed July 8, 2024 (ECF No. 82); Respondent’s Reply, filed July 15, 2024 (ECF No. 83) (“Reply”); Respondent’s Response to Motion for Oral Argument, filed July 18, 2024 (ECF No. 84); Petitioner Reply in Support of Motion for Oral Argument, filed July 24, 2024 (ECF No. 85). Having reviewed the record and all associated filings, I hereby deny an entitlement award. Although this case involves the Tdap vaccine, Petitioner relies heavily on the contention that the human papillomavirus vaccine (“HPV”) can cause POTS. But claims involving an alleged HPV/POTS association have been routinely rejected in numerous prior Program cases as lacking reliable scientific support sufficient to meet the preponderant burden of proof. Otherwise, Petitioner offers minimal, unpersuasive evidence specific to a purported Tdap/POTS association, and does not advance sufficient basis to entertain further a CFS claim based on the same facts. I. Factual Background Pre-Vaccination History In the three years prior to her vaccination, Ms. Stiegler saw medical providers for multiple symptoms that continued after she received the Tdap vaccine. Thus, in October 2015, she presented to the emergency room (“ER”) complaining of shortness of breath with diffuse chest tightness and increased stress at work, and was diagnosed with a panic attack, given Ativan, and prescribed albuterol for wheezing. Ex. 13 at 12, 15. In December 2015, Petitioner presented to the ER and reported she had been experiencing almost daily abdominal discomfort or pain since April 2015, and reported that at times it went up to her chest and shoulders and was accompanied by shortness of breath. Id. at 56-59. She was diagnosed with gastritis versus gastroesophageal reflux disease with an anxiety component. Id. 2 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 3 of 19 Vaccination and Subsequent Manifestations of Symptoms On April 4, 2018, Petitioner received the Tdap vaccine after stepping on a nail three days earlier. Ex. 13 at 140-41, 150, 153. At the appointment, she complained of mild, intermittent headaches for the past month, fever, chills and stomach pain. Id. at 140-41. She also complained of pain after injuring her knee doing jujitsu the day before. Id. She was diagnosed with a likely tension headache, likely flu infection, a puncture wound, and a knee sprain or meniscal injury. Id. at 142. Over the next several months, Petitioner continued to report to her primary care physician (“PCP”) complaining of chronic headaches and pain in her knee, ankle, and hand from jujitsu. Ex. 6 at 7-8, 17, 49, 59-61. In August 2018 (four months post-vaccination), Petitioner presented to her PCP complaining of sciatic back pain that had worsened the day before, adding that she had been experiencing comparable symptoms for several years. Ex. 6 at 66. On October 31, 2018, more than six months post-vaccination, Petitioner saw her PCP and reported three weeks of unusual fatigue. Ex. 6 at 108. Her exam was normal, but during the appointment, she began sobbing and reported that she continuously checked her phone, calendar, and tasks, thinking something was wrong or would happen. Id. at 110. She reported that she had not slept well for a while because she would think about needing to wake up and urinate, which prevented her from sleeping, and that her periods were becoming irregular. Id. The differential diagnoses included likely obsessive-compulsive disorder with anticipatory anxiety, vitamin deficiency, endocrine issue, and psychosomatic complaints. Id. Thus, by this date, Petitioner was not reporting symptoms that might reflect POTS. Treatment in 2020 and Beyond Throughout 2019, Petitioner went to the ER three times for matters unrelated to the present case. Ex. 7 at 2-3; Ex. 30 at 7, 11. During her third visit on September 15, 2019, Petitioner complained of back pain, chest pain/pressure and shortness of breath for two weeks. Ex. 5 at 37. She also reported that she had experienced palpitations while watching TV that night. Id. at 89. She was diagnosed with nonspecific chest pain, lumbosacral strain, and left shin pain. Id. at 95. In the following year, she had additional ER visits, where she complained of shortness of breath, hyperventilation, and chest pain/tightness. Ex. 5 at 122-25, 174, 176, 198. On April 27, 2020, Petitioner had a telehealth visit with a gastroenterologist (“GI doctor”). Ex. 19 at 2. She reported that that she recently had difficulty breathing and explained that she never had this issue before. Id. She also complained of five years of bloating, which she controlled by avoiding certain foods. Id. The GI doctor diagnosed her with mixed irritable bowel syndrome (“IBS”) and advised her to follow up with her PCP and OB-GYN regarding her other symptoms. 3 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 4 of 19 Id. at 3-4. On April 30, 2020, Petitioner had a follow-up appointment with her GI doctor, who noted that her only finding after multiple ER and clinical visits was gallstones. Id. at 6-8. Petitioner became extremely upset during this appointment, and the GI doctor recommended she go to the ER where the doctor’s colleagues could evaluate her. Id. The surgical consult at the hospital recommended that Petitioner have her gallbladder removed but Petitioner declined. Ex. 4 at 14- 15. Thus, as of two years post-vaccination, Petitioner had not reported the kinds of symptoms that would be classically reflective of POTS, but instead constituted a variety of nonspecific complaints. See, e.g., Ex. 19 at 18, 21. On June 12, 2020, Petitioner presented to a chiropractor because she was “feeling ‘out of whack,’” wanted “a neurological assessment to address any areas of imbalance,” “suspect[ed] autoimmunity,” and was having numbness, tingling, and headaches. Ex. 27 at 11. She saw the chiropractor six more times through July 8, 2020. Id. at 5-10. On June 19, 2020, a week later, Petitioner presented to a new PCP for an annual exam and reported that she was feeling well and had no specific complaints. Ex. 25 at 2. Nevertheless, Petitioner sought treatment from a variety of other specialists through that summer, reporting concerns or asking about potential diagnoses that could not be confirmed. See generally Ex. 9 at 2; Ex. 10 at 7; Ex. 22 at 7; Ex. 25 at 3, 23; Ex. 8 at 13; Ex. 29 at 51. These efforts continued into the fall, and some treaters eventually proposed that the subjective and unsubstantiated nature of Petitioner’s complaints could reflect a psychologic rather than physical issue. Ex. 8 at 3-5, 31, 85. The closest Petitioner has come to a POTS diagnosis occurred in the context of a cardiologic visit in March 2021 (now three years post-vaccination). Ex. 16 at 8. She reported to the treater that when she stood or lied down, she had intermittent episodes where her heart raced, her symptoms would thereafter last a few seconds to hours, were sometimes associated with shortness of breath, and that these episodes began the year before. Id. at 8, 9. Petitioner felt that she might have POTS and was very flexible, might be double jointed, and have Ehlers-Danlos syndromes. Id. On exam, Petitioner had a heart murmur, but no cyanosis and her joints were normal. Id. at 9. The cardiologist diagnosed her with palpitations, chest discomfort, a heart murmur, abnormal EKG, shortness of breath, likely hypermobility syndrome, and shortness of breath. Id. at 6, 9. Petitioner thereafter continued to seek medical assistance for many different complaints and symptoms. In her affidavit, Petitioner reported a myriad of symptoms (unrelated to her CF and POTS claims) that she attributes to the Tdap vaccine, including chemical smell sensitivity, loss of height, low blood pressure, becoming a magnet for animals, an allergic reaction to sandflies, and fibrocystic breast disease. Ex. 1 at 6, 7. 4 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 5 of 19 II. Procedural History As noted above, the case was initiated in April 2021. On October 2, 2023, I held a status conference and explained my reasons for doubting Petitioner’s theory that POTS is predominantly autoimmune and can be caused by certain vaccines. I acknowledged, however, that I had yet to adjudicate a case in which Petitioner alleges that the Tdap vaccine specifically caused POTS, and I found it conceivable that a causation theory involving the Tdap vaccine could be different from other claims. I thus ordered Petitioner to file a brief explaining the theory offered in this case. After Petitioner did so, Respondent filed a Rule 4(c) Report and moved to dismiss the claim. In the course of briefing the topic, Petitioner also briefed the propriety of oral argument. No expert reports have been filed, and the motion to dismiss is now ripe for resolution. III. Parties’ Arguments Petitioner3 Petitioner argues that POTS is an autoimmune disease that can be triggered by the Tdap vaccine via molecular mimicry. Brief at 5, 20.4 She contends that recent research supports the conclusion that autoimmunity is a widely-accepted cause of POTS, rendering the Program’s previous conclusion – that POTS is not autoimmune – outdated. Id. at 1. And, she maintains, patients with POTS often report an immunological trigger (like vaccination) prior to their onset of symptoms, which is a feature of autoimmune disease. Id. at 2; Opp. at 38. In support, Petitioner cites several items of literature – although most were submitted in other cases alleging POTS as a vaccine injury, but deemed unreliable or unpersuasive.5 Brief at 2- 4, 8-9; Opp. at 40-41. In particular, she cites several articles that discuss a purported connection between POTS and the HPV vaccine. Brief at 5-7 (citing6 S. Blitshteyn, Postural Tachycardia Syndrome Following Human Papillomavirus Vaccination, 21 European J. of Neurology 135 (2014) (filed as pages 103-07 of ECF No. 71) (“Blitshteyn”); R. Chandler et al., Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster of Reports in VigiBase, 40 Drug Saf. 3 My summary of Petitioner’s arguments draws from both Petitioner’s initial filing in response to my concerns about the claim’s viability, as well as her later brief opposing Respondent’s dismissal motion. 4 Although, as noted above, Petitioner has also alleged CFS as an injury in this case, her briefing has little to say about it. She simply references the same molecular mimicry theory, claiming that impairment of certain adrenergic receptors allegedly implicated in an autoimmune form of POTS can lead to symptoms of CFS. Opp. at 53. 5 For a review of these papers and articles, see generally A.F. v. Sec’y of Health & Hum. Servs., No. 19-446V, 2023 WL 251948, at *7, *15 n. 22, *23 (Fed. Cl. Spec. Mstr. Jan. 18, 2023). 6 Petitioner did not properly file the 39 articles cited in her Brief as separate and individual exhibits, but instead simply included them in an appendix. ECF No. 71. I will therefore reference the page numbers of the relevant submission in citing to these items of literature. 5 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 6 of 19 81 (2017) (filed as pages 133-42 of ECF No. 71) (“Chandler”); J. Schofield & J. Hendrickson, Autoimmunity, Autonomic Neuropathy, and the HPV Vaccination: A Vulnerable Subpopulation, Clin. Ped. 1 (2018) (filed as pages 119-122 of ECF No. 71) (“Schofield”); L. Brinth et al., Orthostatic Intolerance and Postural Tachycardia Syndrome as Suspected Adverse Effects of Vaccination Against Human Papilloma Virus, 33 Vaccine 2602 (2015) (filed as pages 81-84 of ECF No. 71) (“Brinth”)). But these articles also have been considered in prior cases, and thus do not represent new or updated “takes” on the alleged POTS-HPV vaccine association that render a causal relationship more likely. See, e.g., C.F. v. Sec’y of Health & Hum. Servs., No. 15-731V, 2023 WL 2198809 at *15, *17-19, *32 (Fed. Cl. Spec. Mstr. Jan. 20, 2023). Petitioner also maintains other vaccines could be causal of POTS, even if the HPV vaccine remains the most common and likely trigger. For example, several case studies have reported patients developing POTS within weeks of receiving the COVID vaccine. Brief at 5 (citing P. TV et al., Postural Orthostatic Tachycardia Syndrome-like Symptoms Following COVID-19 Vaccination: An Overview of Clinical Literature, 31 Hum Antibodies, 9-17 (2023) (filed as pages 69-77 of ECF No. 71) (“TV et al.”); Opp. at 38 (citing C. Pena et al., Autoimmunity in Syndromes of Orthostatic Intolerance: An Updated Review, 14 J. Pers. Med., 2 (2024), filed as Ex. 37 (ECF No. 79)). But the COVID vaccine is not at issue herein (nor could it be, as it is not at present a Program-covered vaccine). Turning to the alleged relationship between the Tdap vaccine and POTS/CFS, Petitioner claims that the tetanus wild bacterium has been frequently connected to autonomic dysfunction. Brief at 17 (citing Won Seo et al., Autonomic Instability in Severe Tetanus: A Case Report; 23 Ann. Clin. Neurophysiology 117-120 (2021) (filed as pages 394-97 of ECF No. 71) (“Won Seo”) (individual patient case report). Petitioner thus assumes that the impact of the Tdap vaccine’s tetanus toxoid component (which is understood not to be equivalent to a wild tetanus infection, and thus inherently less dangerous) can also cause autonomic dysfunction. To prove that the Tdap vaccine can cause POTS (or CFS for that matter), Petitioner points to the mechanism of molecular mimicry, in which the body produces autoantibodies in response to a vaccine’s antigens that then (due to similarity between the antigens and self-tissue structures or components) erroneously cross-react, attacking the body. Brief at 9; Opp. at 47. Interference with the Alpha-1 adrenergic receptor (found on the surface of sympathetic nerve cells) is suspected to be causative of POTS. Opp. at 47. Antibodies generated in response to the Tdap vaccine bind to these receptors, due to sequence homology between Tdap vaccine peptide components and those found in the adrenergic receptors. Id. at 54. To prove this, Petitioner’s counsel conducted a UnitProt analysis between tetanus toxoid and the human antigen target of the Alpha-1 adrenergic receptor. Id. The results of the analysis revealed that there are nine homologous amino acids in the 6 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 7 of 19 run of twelve, and seven in a linear match. Id. at 57. This homology, Petitioner argues, is sufficient to support the theory that Petitioner developed POTS via molecular mimicry. Id.7 As independent support for this causal theory, Petitioner referenced several items of literature. Opp. at 50-51 (citing A. Fedorowski et al., Antiadrenergic Autoimmunity in Postural Tachycardia Syndrome, 19 Europace 1211 (2017) (filed as pages 268-76 of ECF No. 71); H. Li et al., Autoimmune Basis for Postural Tachycardia Syndrome, 3 J. Am. Heart. Ass’n. 2 (2014) (filed as pages 257-66 of ECF No. 71); W. Gunning et al., Postural Orthostatic Tachycardia Syndrome is Associated with Elevated G-Protein Coupled Receptor Autoantibodies, 8 J. Am. Heart Assoc. 1–10 (2019)) (filed as pages 311-320 of ECF No. 71)). But I have reviewed all these articles in previous cases and found them to be unpersuasive. A.F. v. Sec'y of Health & Hum. Servs., No. 19- 446V, 2023 WL 251948 at *5, *24 (Fed. Cl. Spec. Mstr. Jan. 18, 2023). Respondent At the outset, Respondent disputes that Petitioner ever suffered from either POTS or CFS. Mot. at 26. Petitioner never received either diagnosis from a treater, nor has she undergone testing sufficient to meet the diagnostic criteria for these conditions. Id. At most, Petitioner expressed concern that she might have POTS in March 2021, but her cardiologist did not diagnose her with the condition or order further testing. Id. And when Petitioner reported fatigue to various providers, she reported only brief periods of fatigue at sporadic times, and thus her complaints in this regard were too nonspecific to amount to the conclusion she actually had CFS. Id. at 27. Moreover, Respondent argues, even if Petitioner could show that she suffered from POTS and/or CFS, Petitioner cannot establish causation. Mot. at 27. In particular, Petitioner has failed to provide convincing evidence that POTS has an autoimmune basis. Id. at 30. Respondent observes that most of Petitioner’s cited literature has already been evaluated and rejected in previous Vaccine Program cases. Mot. at 28. And any new medical literature offered by Petitioner does not constitute preponderant evidence that POTS is an autoimmune condition. Id. at 30. One such article, for example, merely suggests that patients with POTS can also suffer from antiphospholipid syndrome,8 which Petitioner does not have. Id. (discussing H.A. Noureldine et al., Postural Tachycardia Syndrome (POTS) and Antiphospholipid Syndrome (APS): What Do We Know So Far?, 178 Rev Neurol (Paris) 306-314 (2022) (filed as pages 38-41 of ECF No. 71)). Another only suggests a possible genetic/inherited character for POTS, as opposed to it 7 Although in most cases an expert in immunology and/or molecular biology would be called for to perform this homology analysis, counsel attempts to do so here – but given the posture of the case, I do not fault the effort (even if I ultimately do not find that it aided Petitioner’s claim in the least). 8 “Antiphospholipid syndrome” is defined as “a multisystem inflammatory disorder characterized by the presence of circulating antiphospholipid antibodies with thrombosis.” Antiphospholipid syndrome, Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=110221&searchterm=antiphospholipid+syndrome (last visited Oct. 2, 2024). 7 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 8 of 19 commonly being the product of an autoimmune process. Id. at 30 (discussing J.R. Boris et al., Family History of Associated Disorders in Patients with Postural Tachycardia Syndrome, 30 Cardiol. Young 388-394 (2020) (filed as pages 44-67 of ECF No. 71)). Other items of literature offered by Petitioner purport to establish indirect evidence of POTS’s autoimmune character, by noting that IVIG9 treatments (known to ameliorate some autoimmune disease processes) are effective for POTS. Mot. at 30 (discussing J.R. Schofield et al., Intravenous Immunoglobulin Therapy in Refractory Autoimmune Dysautonomias: A Restrospective Analysis of 38 Patients, 26 Am. J. Ther. 570-582 (2019) (filed as pages 374-86 of ECF No. 71); B. Rodriguez et al., Immunomodulatory Treatment in Postural Tachycardia Syndrome: A Case Series, 28 Eur. J. Neurol. 1692-1697 (2021) (filed as page 372 of ECF No. 71)). But a different, recently-published article has confirmed that in a group of patients with POTS who received IVIG versus a placebo, there was no statistically-significant difference in response. Id. (discussing S. Vernino et al., Randomized Controlled Trials of Intravenous Immunoglobulin for Autoimmune Postural Orthostatic Tachycardia Syndrome (iSTAND), 102 J. of Nuerol. 153-163 (2024), filed as Ex. B (ECF No. 75-2) (of the study’s 30 participants, 16 received IVIG treatment and 14 received albumin. The participants received eight infusions over the course of twelve weeks. While the IVIG patients had a slightly higher response rate, the difference was not statistically significant.)). Beyond the foregoing, Respondent argues that Petitioner has not offered sufficient preponderant evidence to prove that the Tdap vaccine can itself likely cause POTS (regardless of its autoimmune character). Mot. at 28. Again, Respondent notes that most of Petitioner’s literature offered for this proposition has already been rejected in prior decisions, and the new articles are equally unconvincing. Id. at 29-30. One article merely discusses self-reported antecedent events in a three-month time frame – and does not otherwise conclude that any vaccine can cause POTS. Id. at 29 (discussing B. Shaw et al., The Face of Postural Tachycardia Syndrome – Insights From a Large Cross-Sectional Online Community-Based Survey, 286 J. of Intern Med. 438-448 (2019) (filed as pages 12-22 of ECF No. 71). Another – TV et al. – discusses patients who were never formally diagnosed with POTS. Id. at 30. And the vast majority of Petitioner’s evidence involves the HPV rather than Tdap vaccine. Id. at 28. The only evidence Petitioner offers to link the Tdap vaccine to POTS is a single case study in which a patient who was diagnosed with a life-threatening tetanus infection developed various symptoms that the Petitioner claims are POTS symptoms – severe neck muscle spasms, high blood pressure, sinus tachycardia, fever, and myoclonic leg movement. Id. at 32 (referencing Won Seo). That case study thus does not involve the Tdap vaccine, nor does it even mention POTS. Id. 9 “Intravenous Immunoglobulin (IVIG)” is defined as “[a] therap[y] prepared from a pool of immunoglobulins (antibodies) from the plasma of thousands of healthy donors. Immunoglobulins are made by the immune system of healthy people for the purpose of fighting infections…IVIG/SCIG work in different ways to prevent the body from attacking itself and to decrease several types of inflammation in the body.” IVIG, https://rheumatology.org/patients/intravenous-immunoglobulin-ivig (last visited Oct. 2, 2024). 8 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 9 of 19 Finally, Respondent denies that the Tdap vaccine can cause POTS/CFS via molecular mimicry. Mot. at 31. Petitioner’s brief merely provided purportedly significant homologies between tetanus toxoid and the Alpha-1 adrenergic receptor, but no corroborative evidence suggesting that these homologies are likely capable of resulting in an immune-mediated form of POTS. Id. at 32.10 IV. Applicable Legal Standards A. Petitioner’s Overall Burden in Vaccine Program Cases To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table— corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table 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).11 Petitioner does not assert a Table claim, nor does there exist such a claim for POTS (or autonomic disfunction generally) or CFS as the injury – regardless of the vaccine at issue. 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 10 Furthermore, Respondent argues, Petitioner has failed to provide evidence with respect to the “did cause” causation prong – that the Tdap vaccine caused or significantly aggravated her alleged POTS or CFS. Mot. at 33. Thus, no medical provider attributed Petitioner’s condition to the Tdap vaccine. Id. Instead, Petitioner’s complaints were deemed associated with a variety of other causes, including sports injuries, IBS, and anxiety. Id. And Petitioner’s symptoms did not develop within a medically acceptable timeframe. Id. at 34. She first reported unusual fatigue in October 2018, nearly four months after the vaccination, and she did not report symptoms associated with orthostatic change until July 2020. Id. Although these arguments all underscore the overall weakness of the claim (and would likely lead to its dismissal even if the “can cause” prong had been satisfied), my focus is on Petitioner’s inability to show the Tdap vaccine can cause POTS in the first place, and therefore I do not include determinations specific to these other points in my analysis. 11 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). 9 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 10 of 19 only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. Section 13(a)(1). In attempting to establish entitlement to a Vaccine Program award of compensation for a Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen v. Sec’y of Health and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal relationship between vaccination and injury.” Each Althen prong requires a different showing and is discussed in turn along with the parties’ arguments and my findings. Under Althen prong one, petitioners must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or scientifically certain.” Id. at 549. 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 Kalajdzic v. Sec’y of Health & Hum. Servs., No. 2023-1321, 2024 WL 3064398, at *2 (Fed. Cir. June 20, 2024) (arguments “for a less than preponderance standard” deemed “plainly inconsistent with our precedent” (citing Moberly, 592 F.3d at 1322)); Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); 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”), aff’d, 2024 WL 2873301 (Fed. Cir. June 7, 2024) (unpublished). 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). Petitioners may offer a variety of individual items of evidence in support of the first Althen prong, and are not obligated to resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec'y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325–26). No one 10 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 11 of 19 “type” of evidence is required. Special masters, despite their expertise, are not empowered by statute to conclusively resolve what are essentially thorny scientific and medical questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act's preponderant evidence standard.” Andreu, 569 F.3d at 1380. Nevertheless, even though “scientific certainty” is not required to prevail, the individual items of proof offered for the “can cause” prong must each reflect or arise from “reputable” or “sound and reliable” medical science. Boatmon, 941 F.3d at 1359–60. The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec'y of Health & Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions and views of the injured party's treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly trustworthy evidence, since they are created contemporaneously with the treatment of the patient. Cucuras v. Sec'y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). However, medical records and/or statements of a treating physician's views do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec'y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases. The views of treating physicians should also be weighed against other, contrary evidence also present in the record—including conflicting opinions among such individuals. Hibbard v. Sec'y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians' conclusions against each other), aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec'y of Health & Hum. Servs., No. 06–522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den'd, 100 Fed. Cl. 344, 356–57 (2011), aff'd without opinion, 475 F. App’x. 765 (Fed. Cir. 2012). The third Althen prong requires establishing a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the 11 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 12 of 19 phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disorder's etiology, it is medically acceptable to infer causation.” de Bazan v. Sec'y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine can cause an injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec'y of Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl. 353 (2012), aff'd mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Hum. Servs., No. 11– 355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den'd (Fed. Cl. Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir. 2014). B. Law Governing Analysis of Fact Evidence The process for making determinations in Vaccine Program cases regarding factual issues begins with consideration of the medical records. Section 11(c)(2). The special master is required to consider “all [ ] relevant medical and scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability, injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then required to weigh the evidence presented, including contemporaneous medical records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (determining that it is within the special master's discretion to determine whether to afford greater weight to contemporaneous medical records than to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such determination is evidenced by a rational determination). As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95 Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his contemporaneous medical records, the special master's decision to rely on petitioner's medical records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum. Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked propositions explains why such records deserve some weight: (i) sick people visit medical professionals; (ii) sick people attempt to honestly report their health problems to those professionals; and (iii) medical professionals record what they are told or observe when examining their patients in as accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum. Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to 12 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 13 of 19 conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”). Accordingly, if the medical records are clear, consistent, and complete, then they should be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records are often found to be deserving of greater evidentiary weight than oral testimony—especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)). However, the Federal Circuit has also noted that there is no formal “presumption” that records are accurate or superior on their face when compared to other forms of evidence. Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which compelling oral testimony may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination regarding a witness's credibility may be required when determining the weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). When witness testimony is offered to overcome the presumption of accuracy afforded to contemporaneous medical records, such testimony must be “consistent, clear, cogent, and compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs., No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and completeness of medical records, the Court of Federal Claims has listed four possible 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 13 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 14 of 19 result of a rational determination. Burns, 3 F.3d at 417. C. Consideration of Medical Literature Both parties filed numerous items of medical and scientific literature in this case, but not every filed item factors into the outcome of this Decision. While I have reviewed all the medical literature submitted in this case, I discuss only those articles that are most relevant to my determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“[w]e generally presume that a special master considered the relevant record evidence even though he does not explicitly reference such evidence in his decision”) (citation omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. Appx. 875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the conclusion that it was not considered”). D. Disposition of Case Without Hearing I am resolving Petitioner’s 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 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 should be evident from the foregoing, this claim has any number of deficiencies that would make early dismissal appropriate. In particular, it is clear from the record as it stands that Petitioner would unlikely be able to substantiate either claimed injury – she was never formally diagnosed with POTS or CFS,12 and it does not appear from her medical history that testing 12 Petitioner’s alleged CFS injury was particularly unsupported by the record. The first Vaccine Program case to find a causal link between a vaccine and CFS was Jane Doe/52 v. Sec'y of Dep't of Health & Hum. Servs., 2009 WL 5206199 at *16 (Fed. Cl. Spec. Mstr. Dec. 15, 2009), and it provides a good contrast into the kind of presentation that might reflect the existence of CFS. Within three days of receiving the hepatitis B vaccine, the Jane Doe/52 petitioner 14 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 15 of 19 necessary to confirm either was performed.13 Moreover, the timeframe between when the vaccination occurred and when Petitioner could arguably claim either injury manifested was more than a year, and thus facially far too long to be causally related. Disposition of this claim, however, primarily turns on the first Althen prong, which requires a claimant to provide a “persuasive medical theory” demonstrating that the vaccine received can cause or significantly aggravate the type of injury alleged. Althen, 418 F.3d at 1278. While a “persuasive medical theory” does not need to meet the standard of medical or scientific certainty (and may be supported by a variety of items of circumstantial or indirect proof), it must still be sound and reliable. Boatmon, 941 F.3d at 1351. POTS is a circulation disorder characterized by a group of symptoms (not including hypotension) that sometimes occur when a person assumes an upright position, including tachycardia, tremulousness, lightheadedness, sweating, and hyperventilation. The condition is seen more often in women than in men, and its etiology is uncertain. “Postural orthostatic tachycardia syndrome,” Dorland's Medical Dictionary Online, https://www.dorlandsonline.com /dorland/definition?id=111236 (last visited Sep. 25, 2024). As I have concluded in numerous prior cases, POTS is most commonly not attributable to an autoimmune process. See e.g., C.F., 2023 WL 2198809, at *32; E.S. v. Sec'y of Health & Hum. Servs., No. 17-480V, 2020 WL 9076620, at *43 (Fed. Cl. Spec. Mstr. Nov. 13, 2020), mot. for review den’d, 154 Fed. Cl. 149 (2021). Rather, POTS usually results from “deconditioning” (physical changes in the body caused by physical inactivity and/or an extremely sedentary lifestyle), hypovolemia (inadequate intake of fluids), or cardiac atrophy (a condition that occurs when the heart muscles waste away). C.F., 2023 WL 2198809, at *30. While some evidence has emerged in recent years that a small subset of POTS cases might have an autoimmune basis, this is the exception to the rule. E.S., 2020 WL 9076620, at *43. And the independent medical or scientific evidence that would support the possibility of an autoimmune version of the condition is scant and incomplete – and certainly does not point to vaccination as a triggering factor. Id. developed flu-like symptoms, malaise, low back pain, sore throat, lymph node swelling, musculoskeletal pain, and extreme exhaustion – she was eventually bedridden. Id. at *2. These symptoms lasted for two years before the petitioner was ultimately diagnosed with chronic fatigue syndrome. Id. But the symptoms Petitioner complains of that might arguably reflect CFS involved sporadic reports of intermittent, transient fatigue. Mot. at 27. Otherwise, the record only includes medical chart code references to CFS (Opp. at 37), and that diagnosis is not set forth as a treater conclusion, based on clinical presentation or test results. 13 In previous cases, for example, I have noted that the tilt table test (in which an individual’s orthostatic readings are continuously taken while the subject is secured to a flat tale that is then titled up), is the “gold standard” for diagnosing POTS. See Yalacki v. Sec'y of Health & Hum. Servs., No. 14-278V, 2019 WL 1061429 at *5, *35 (Fed. Cl. Jan. 31, 2019), mot. for review den’d, 146 Fed. Cl. 80 (2019). Petitioner’s health care providers never ordered a tilt table test for her. 15 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 16 of 19 Petitioner, however, insists that POTS is predominantly an autoimmune disease that can be triggered by vaccination. Brief at 5. To prove this theory, Petitioner relies heavily on arguments involving the HPV vaccine. Id. But I have repeatedly found such arguments unpersuasive – and I have reached this conclusion after hearings, as well as evaluation of large amounts of relevant independent medical and scientific literature. See, e.g., C.F., 2023 WL 2198809, at *36 (there is not preponderant evidence of a reliable medical theory causally connecting Petitioner’s HPV vaccine to her POTS); Hughes v. Sec'y of Health & Hum. Servs., No. 16-930V, 2021 WL 839092, at *30 (Fed. Cl. Spec. Mast. Jan. 4, 2021) (finding that Petitioner was unable to preponderantly demonstrate that the HPV vaccine can cause POTS); Otto v. Sec'y of Health & Hum. Servs., No. 16-1144, 2020 WL 4719285, at *2 (Fed. Cl. Spec. Mstr. June 17, 2020) (finding Petitioner’s causation theory – that the HPV vaccine can cause POTS – unreliable and unsupported by sufficient scientific/medical evidence); E.S., 2020 WL 9076620, at *42 (ruling that Petitioner has not established that the HPV vaccine or flu vaccine can cause POTS). And my conclusion does not reflect merely my own view on the subject – for no special masters have ever found POTS is caused by the HPV vaccine. Kelly v. Sec'y of Health & Hum. Servs., No. 21-827V, 2024 WL 3498199, at *9 (Fed. Cl. Spec. Mstr. June 26, 2024). Petitioner nevertheless relies heavily on this discredited association between POTS and the HPV vaccine – and to do so, she offers an abundance of literature that I have previously rejected as unreliable or unpersuasive. See e.g., C.F., 2023 WL 2198809, at *15, *17-19, *32 (discussing Blitshteyn, Chandler, Schofield, and Brinth). Accordingly, she makes as a centerpiece of her causation argument in this case a contention that itself is insufficiently preponderant – and one that numerous prior cases directly address. Because of this – and given the obvious point that the HPV vaccine is not at issue in any event – these arguments do nothing to advance Petitioner’s position. This leaves open (if barely) the possibility that the Tdap vaccine could be shown to be causal of POTS in a way the HPV vaccine has not been in past matters. But (and despite due opportunity herein, via the briefing of this matter) the only evidence offered specific to the relevant vaccine is a single case study, in which a patient with a life-threatening tetanus infection developed POTS-like symptoms (Won Seo). Brief at 17-18. Won Seo says nothing about the Tdap vaccine, and did not involve a POTS diagnosis either. None of the other filed materials involve either the Tdap vaccine or its constituent wild analogs. To compensate for the fact that no medical literature preponderantly supports her causal theory, Petitioner invokes the general theory of molecular mimicry. Brief at 20. She argues that there is significant homology between peptide components of the Tdap vaccine and Alpha-1 adrenergic receptor, allowing for the possibility that an antibody-driven cross-reaction could occur and ultimately cause POTS. Id. But I have consistently held that establishing homology is not enough to prove that molecular mimicry constitutes a likely mediating mechanism for a vaccine- triggered injury. See Sullivan v. Sec'y of Health & Hum. Servs., No. 10-398V, 2015 WL 1404957, 16 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 17 of 19 at *17-18, n. 30 (Fed. Cl. Spec. Mstr. Feb. 13, 2015) (while the law does not require Petitioner to “prove” homology in a Program case, mere assertion that HPV strain shares sequences with human body such that molecular mimicry might occur resulting in injury was by itself insufficient to satisfy burden); see also Yalacki v. Sec'y of Health & Hum. Servs., No. 14-278V, 2019 WL 1061429, at *34 (Fed. Cl. Spec. Mstr. Jan. 31, 2019), mot. for review den'd, 146 Fed. Cl. 80 (2019) (commenting on petitioner's theory that the Hep B vaccine could trigger a pathogenic process resulting in an autoimmune attack, but finding that it was “not enough for a claimant to invoke the concept of molecular mimicry” as petitioner needed to “cite to evidence, circumstantial or otherwise, suggesting reason to find it plausible that the proposed autoimmune cross-reaction triggered by the relevant vaccine does occur”). Put simply, the fact that molecular mimicry has been deemed applicable to some autoimmune diseases, or has scientific reliability as a mechanism in certain circumstances, does not mean the mechanism is applicable across the board to any vaccine injury claim. McKown v. Sec'y of Health & Hum. Servs., No. 15-1451V, 2019 WL 4072113, at *50 (Fed. Cl. Spec. Mstr. July 15, 2019) (“merely chanting the magic words ‘moleculary mimicry’ in a Vaccine Act case does not render a causation theory scientifically reliable, absent additional evidence specifically tying the mechanism to the injury and/or vaccine in question.”); see also Deshler v. Sec'y of Health & Hum. Servs., No. 16-1070V, 2020 WL 4593162, at *20 (Fed. Cl. Spec. Mstr. July 1, 2020) (“though molecular mimicry is a generally accepted scientific principle, mere invocation of the scientific term does not carry a petitioner’s burden in a Program case.”). Thus, there is insufficient evidence offered herein connecting the Tdap vaccine to POTS – even less than what is offered to connect the HPV vaccine to POTS (but which has been repeatedly rejected in prior well-reasoned decisions). And nothing new has been identified from the medical or scientific community that would provide a basis for allowing this claim to continue. The same is true for any putative association between CFS and the Tdap vaccine. As noted, it is not evident that Petitioner ever had CFS. And even if she had properly received such a diagnosis, and the record supported it, claimants in the Vaccine Program have been routinely unsuccessful in arguing that vaccines can cause CFS. See e.g., Skinner-Smith v. Sec'y of Health & Hum. Servs., No. 14-1212V, 2022 WL 4116896 (Fed. Cl. Spec. Mstr. Aug. 15, 2022), reconsideration denied, 2022 WL 13461862 (Fed. Cl. Spec. Mstr. Sept. 9, 2022) (nothing in the record to support the conclusion that the Tdap vaccine can cause immune dysregulation leading to CFS); Johnson v. Sec. of Health & Human Servs., No. 14-254V, 2018 WL 2051760 (Fed. Cl. Spec. Mstr. Mar. 23, 2018) (denying entitlement in case alleging CFS and POTS caused by HPV vaccination); D'Angiolini v. Sec'y of Health & Hum. Servs., No. 99-5788V, 2014 WL 1678145 (Fed. Cl. Spec. Mstr. March 27, 2014) (denying entitlement for adverse reaction, including CFS, 17 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 18 of 19 allegedly caused by hepatitis B vaccine).14 These decisions do not control the disposition of this case, but they underscore why (and in the absence of some independent basis for reevaluation) rejection of this causal theory would be reasonable. My determination to dismiss the case comes relatively early in the matter’s existence, and before substantial expert input was sought, but is a reasonable outcome in light of the claim’s very- evident deficiencies. Special masters are empowered to decide what discovery is needed to resolve a given matter. 42 U.S.C. § 300aa–12(d)(3)(B); see also Felix v. Sec'y of Health & Hum. Servs., 172 Fed. Cl. 626, 632 (2024) (“[n]ot all vaccine cases merit expert witness testimony”). They also have “wide discretion in determining whether to conduct an evidentiary hearing.” Kreizenbeck., 945 F.3d at 1365; see also Oliver v. Sec'y of Health & Hum. Servs., 900 F.3d 1357, 1364 n.6 (Fed. Cir. 2018) (holding that “Chief Special Master acted within her discretion in denying” the petitioner's request for a hearing). What matters at bottom is whether a claimant has been afforded “a full and fair opportunity to present [their] case and creat[e] a record sufficient to allow review of the special master's decision” through medical evidence and proffered affidavits in accordance with Vaccine Rule 3(b)(2). See, e.g., K.A. v. Sec'y of Health & Hum. Servs., 164 Fed. Cl. 98, 115– 19 (2022) (decision to deny requests to retain and present particular expert witness did not deprive the parties of “a full and fair opportunity to present his case” or otherwise amount to an abuse of discretion), aff'd, No. 23-1315, 2024 WL 2012526 (Fed. Cir. May 7, 2024) (per curiam) (table). Relying on my extensive experience with POTS cases, I noted a glaring problem with this claim early on in its existence, and one that I expected would render the claim untenable. But before I dismissed the matter, I invited the Petitioner to attempt to address my concerns – in particular by offering whatever independent evidence she could that would suggest this claim would fare better than similar prior matters, and thus should be allowed to progress. In reaction, Petitioner filed extensive medical records and briefs to support her claim, along with a lengthy appendix of medical and scientific articles. Yet this effort amounted to repeating what has been rejected in numerous prior Program matters regarding the HPV vaccine and POTS. And she otherwise has offered scant evidence specific to the Tdap vaccine, despite ample opportunity to do so. Under such circumstances, it cannot be said that Petitioner has been deprived of a chance to prove a claim that is so self-evidently unlikely to succeed. 14 At best, a special master in one case found that the petitioner preponderantly established the influenza vaccine as a cause of chronic fatigue syndrome. Bryan v. Sec'y of Health & Hum. Servs., No. 14-898V, 2020 WL 7089841 at *1 (Fed. Cl. Spec. Mstr. Oct. 9, 2020). But Skinner-Smith noted that what was arguably true of the flu vaccine has not been shown to be applicable to the Tdap vaccine. Skinner-Smith, 2022 WL 4116896., at *35. 18 Case 1:21-vv-01152-ZNS Document 87 Filed 11/05/24 Page 19 of 19 CONCLUSION Petitioner cannot substantiate her claim that the Tdap vaccine can cause POTS or CFS. I therefore must DENY entitlement in this case. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.15 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 15 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices renouncing their right to seek review. 19 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_21-vv-01152-1 Date issued/filed: 2025-05-13 Pages: 16 Docket text: REPORTED OPINION. Signed by Judge Zachary N. Somers. (ah) Service on parties made. -------------------------------------------------------------------------------- Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 1 of 16 In the United States Court of Federal Claims No. 21-1152 (Filed Under Seal: April 18, 2025)∗ (Reissued: May 13, 2025) * * * * * * * * * * * * * * * * * * * * ALISON STIEGLER, * * Petitioner, * * v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * Courtney C. Jorgenson, Siri & Glamstad, LLP, of Phoenix, AZ, for Petitioner, Sarah C. Duncan, Trial Attorney, with whom were Debra A. Filteau Begley, Senior Trial Attorney, Heather L. Pearlman, Deputy Director, C. Salvatore D’Alessio, Director, and Brett A. Shumate, Acting Assistant Attorney General, Torts Branch, Civil Division, U.S. Department of Justice, of Washington, D.C., for Respondent. OPINION AND ORDER SOMERS, Judge. Petitioner filed a motion for review challenging the chief special master’s decision denying her entitlement to compensation for Postural Orthostatic Tachycardia Syndrome (“POTS”) and Chronic Fatigue Syndrome (“CFS”) allegedly caused by the Tetanus, Diphtheria, Acellular Pertussis (“Tdap”) vaccine. See Stiegler v. Sec’y of Health & Hum. Servs., No. 21- 1152, 2024 WL 4678300 (Fed. Cl. Spec. Mstr. Oct. 10, 2024). Specifically, Petitioner contends that the chief special master’s decision was not in accordance with law, because he dismissed her claim under Rule 12(b)(6) of the Rules of the U.S. Court of Federal Claims (“RCFC”) and failed to abide by the legal standard for dismissal under that rule. Additionally, Petitioner asserts that the chief special master’s denial of entitlement without allowing Petitioner to file expert reports ∗ On April 18, 2025, the Court issued this opinion and order under seal in accordance with Rule 18(b) of the Vaccine Rules (Appendix B) of the U.S. Court of Federal Claims. The Court provided the parties 14 days to proposed redactions. The parties did not propose any redactions, and, accordingly, the Court reissues this opinion in its original form with a few minor stylistic and typographical corrections. Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 2 of 16 to substantiate her claim constitutes an abuse of discretion. Petitioner also seeks interim attorneys’ fees. As explained in greater detail below, the Court denies Petitioner’s motion for review. First, the chief special master did not dismiss Petitioner’s claim pursuant to RCFC 12(b)(6), but instead denied entitlement due to Petitioner’s failure to assert the causal theory necessary for an alleged “off-Table” injury. In other words, the chief special master was not required to follow the legal standard for dismissal under RCFC 12(b)(6) because he did not dismiss Petitioner’s claim pursuant to that rule. Second, the chief special master’s decision to deny entitlement without consideration of expert reports was not an abuse of discretion because the chief special master determined that the record was comprehensive and fully developed before doing so. Finally, the Court remands to the chief special master Petitioner’s motion for interim attorneys’ fees for a reasonableness analysis in accordance with the instructions provided below. BACKGROUND A. Factual History Petitioner received the Tdap vaccine at issue in this case on April 4, 2018. ECF No. 1, ¶ 2. However, Petitioner has an extensive relevant medical history dating to before her vaccination. According to the medical records filed, Petitioner first went to the emergency room on October 9, 2015, complaining of shortness of breath, chest tightness, and increased stress at work. See ECF No. 30-5 at 12. She was diagnosed as having had a panic attack and prescribed medication to mitigate these symptoms. Id. at 15. About three months later, Petitioner presented again to the emergency room, complaining of almost daily abdominal pain she claims she had experienced continuously since April 2015. Id. at 56. Petitioner described the abdominal pain as discomfort that “gets so bad sometimes it goes up into her shoulders and into her chest” and was accompanied by shortness of breath. Id. She was diagnosed with suspected gastritis or gastroesophageal reflux disease (“GERD”), along with an anxiety component. Id. at 57. Over two years later, on April 4, 2018, Petitioner presented to the emergency room complaining of a headache, flu-like symptoms, knee pain from a jiu-jitsu injury, and a puncture wound on her foot from stepping on a nail three days earlier. Id. at 140–41. On that day, Petitioner received the Tdap vaccine. Id. at 153. She was diagnosed with a tension headache, likely flu infection, puncture wound, and a possible knee sprain or meniscal injury. Id. at 142. Throughout the next several months, Petitioner repeatedly visited her primary care physician complaining of chronic headaches and various injuries to her knee, ankle, and hand from jiu-jitsu. See, e.g., ECF No. 9-3 at 6–8, 109. During a consultation on October 31, 2018, Petitioner began crying and her physician noted that Petitioner “continuously checks her phone, her tasks, her callander [sic], thinking something is wrong or something . . . will happen” and that she “drink[s] lots of water and she anticipates she will wake up and urinate while sleeping, [preventing] her from sleeping to the point that she has not been having a good sleep for a while.” Id. at 109. Her physician diagnosed her with likely obsessive-compulsive disorder with anticipatory anxiety, vitamin deficiency, or other conditions. Id. 2 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 3 of 16 In 2019, Petitioner presented to the emergency room numerous times. See, e.g., ECF No. 9-4 at 2–3; ECF No. 59-1 at 11; ECF No. 9-2 at 36. During one visit, on September 15, 2019, Petitioner complained of heart palpitations, lower back pain, chest pain, and shortness of breath. ECF No. 9-2 at 36–39. On April 27, 2020, Petitioner complained to a physician in a telehealth appointment about difficulty breathing and that she had experienced stomach bloating for the past five years. ECF No. 31-3 at 2. The physician assessed her as suffering from possible mixed irritable bowel syndrome. Id. at 3. Three days later, on April 30, 2020, following further gastro-intestinal evaluation, Petitioner was diagnosed with gallstones but declined removal surgery. Id. at 7–8. On June 12, 2020, Petitioner visited a chiropractor, complaining that she felt “out of wack [sic],” and was experiencing numbness, tingling sensations, and headaches. ECF No. 35-7 at 11. She had six follow-up visits with the chiropractor through July 8, 2020. Id. at 5–10. Petitioner consulted with a variety of other doctors for the remainder of the summer. See, e.g., ECF No. 30-1 at 2; ECF No. 30-2 at 7; ECF No. 35-2 at 7; ECF No. 35-5 at 3, 23; ECF No. 9-5 at 13; ECF No. 58-2 at 51. On March 25, 2021, nearly three years after receiving the Tdap vaccination, Petitioner presented to a cardiologist complaining of intermittent episodes of heart palpitations when she stood up or lay down. ECF No. 30-8 at 8. The cardiologist noted that Petitioner “said that she may have POTS.” Id. The cardiologist assessed her as having heart palpitations and chest discomfort. Id. at 9. Nonetheless, Petitioner attributes various symptoms—chemical smell sensitivity, loss of height, low blood pressure, becoming a magnet for animals, an allergic reaction to sandflies, and fibrocystic breast disease—to her Tdap vaccination. ECF No. 28-1, ¶¶ 19–25. B. Procedural History Petitioner filed her petition and filed a statement of completion on December 27, 2021. ECF No. 33. After Petitioner amended her petition, ECF No. 36, and filed an updated statement of completion, ECF No. 64, her case was activated from Pre-Assignment Review and randomly assigned to the chief special master. ECF No. 65. On October 2, 2023, the chief special master held a status conference. After the conference, the chief special master issued a scheduling order outlining his impressions of Petitioner’s initial case. ECF No. 68. The chief special master stated that he has “heard many claims arguing that a different vaccine (HPV) causes POTS or other forms of dysautonomia. But none have succeeded.” Id. at 1. The chief special master further stated that he had “yet to adjudicate a case in which a petitioner allege[d] that the Tdap vaccine specifically caused POTS,” remarking that it is “wholly conceivable that a causation theory involving this vaccine could be qualitatively different from what [he has] heard so often before.” Id. However, the chief special master decided that Petitioner ought to “evaluate whether a more persuasive and preponderantly-supported causation theory”—specific to the Tdap vaccine causing POTS— could be mounted, before delving into the medical facts of Petitioner’s case. Id. at 1–2. Accordingly, the chief special master provided Petitioner “an opportunity to file a brief (along with any helpful literature—especially more recently-published items) setting forth and 3 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 4 of 16 explaining the theory to be offered in this case.” Id. at 2. The chief special master stated that Petitioner may “consult with an expert . . . although no expert report should yet be filed or obtained . . . .” Id. On January 19, 2024, Petitioner filed the requested brief. ECF No. 69. In that brief, Petitioner attempted to establish the association between POTS and autoimmunity by arguing that the HPV vaccine has been shown to cause POTS. Id. at 17. Petitioner stated that the “HPV vaccine is much more likely to trigger POTS versus other vaccines.” Id. Petitioner also argued that vaccination is a trigger of POTS, asserted a molecular mimicry argument, and noted the relationship between adrenergic receptors and POTS before arguing that the Tdap vaccine can induce POTS. See generally id. at 1–17. In response to the chief special master’s order, Petitioner cited three medical articles that she claims establish that POTS can be triggered by vaccination. See id. at 15 (citing Hongliang Li et al., Autoimmune Basis for Postural Tachycardia Syndrome, J. AM. HEART. ASS’N., Jan. 2014, at 2 (“Li”)); id. at 17–18 (citing Seung Won Seo et al., Autonomic Instability in Severe Tetanus: A Case Report, 23 ANN. CLIN. NEUROPHYSIOLOGY 117 (2021) (“Seung Won Seo”)); id. at 11, 16–17 (citing Steven Verino et al., Postural Orthostatic Tachycardia Syndrome (POTS): State of the Science and Clinical Care from a 2019 National Institutes of Health Expert Consensus Meeting, AUTONOMIC NEUROSCIENCE: BASIC & CLINICAL, Nov. 2021, at 1 (“NIH consensus”)). In a subsequent scheduling order, the chief special master stated that despite Petitioner’s efforts to substantiate her claim, his “initial views about the claim’s scientific and medical weakness have only been confirmed by Petitioner’s filings.” ECF No. 72 at 1. The chief special master placed no weight on Petitioner’s argument associating POTS with the HPV vaccine, stating that he has “evaluated [that theory] repeatedly in prior cases—and rejected [it].” Id. The chief special master was also unpersuaded by Petitioner’s arguments regarding the association between Tdap and POTS, remarking that Petitioner’s evidence included only a “case report (a kind of evidence not deemed to merit much weight generally)” and that Petitioner unfoundedly presumed that her “form of POTS was the uncommon, anti-adrenergic version that has not been established in this case . . . [to] be relevant or applicable.” Id. at 3. The chief special master further criticized Petitioner’s reliance on homology and molecular mimicry arguments as such methods are, in his view, “never sufficient to establish causation.” Id. In sum, the chief special master stated that his “preliminary but informed view” was that Petitioner’s claim was “not tenable,” noting that if Petitioner “seeks to keep this claim alive, a far better showing associating the relevant vaccine and POTS must be made.” Id. at 3–4 (emphasis omitted). The chief special master subsequently ordered Respondent to file a Rule 4(c) Report “so that Petitioner is fully informed of [Respondent’s] response to her contentions” and invited Respondent to move to dismiss the claim. Id. On April 30, 2024, Respondent filed a Rule 4(c) Report and moved to dismiss Petitioner’s claim. ECF No. 73; ECF No. 74. After responsive briefing on the motion, the chief special master denied Petitioner entitlement to compensation, finding that Petitioner could not “substantiate her claim that the Tdap vaccine can cause POTS . . . .” Stiegler, 2024 WL 4678300, at *14. According to the chief special master, “[d]isposition of this claim . . . primarily turns on the first Althen prong, which requires a claimant to provide a ‘persuasive medical theory’ demonstrating that the vaccine received can cause or significantly aggravate the type of 4 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 5 of 16 injury alleged.” Id. at *11 (quoting Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005)). At the outset, Petitioner’s repeated argument that the HPV vaccine could cause POTS was unavailing to the chief special master, who stated that he has “repeatedly found such arguments unpersuasive . . . [having] reached this conclusion after hearings, as well as evaluation of large amounts of relevant independent medical and scientific literature.” Id. Furthermore, the chief special master noted that Petitioner, after spending most of her briefing establishing a connection between the HPV vaccine and POTS, only filed one unpersuasive case study to support her theory that the Tdap vaccine can cause POTS. Id. at *12 (“[T]he only evidence offered specific to the relevant vaccine is a single case study, in which a patient with a life-threatening tetanus infection developed POTS-like symptoms ([Seung Won Seo]) . . . . [Seung] Won Seo says nothing about the Tdap vaccine and did not involve a POTS diagnosis either.”). The chief special master also found unpersuasive Petitioner’s repeated molecular mimicry and homology arguments. Id. (“But I have consistently held that establishing homology is not enough to prove that molecular mimicry constitutes a likely mediating mechanism for a vaccine-triggered injury.”). In total, according to the chief special master, there was “insufficient evidence offered [by petitioner] connecting the Tdap vaccine to POTS—even less than what [was] offered to connect the HPV vaccine to POTS (but which has been repeatedly rejected in prior well-reasoned decisions).” Id. at *13. For this reason, and because “nothing new [was] identified from the medical or scientific community that would provide a basis for allowing this claim to continue,” the chief special master denied entitlement. Id. On November 8, 2024, Petitioner timely filed a motion for review. ECF No. 88. Respondent filed a response to Petitioner’s motion on December 20, 2024. ECF No. 95. Petitioner moved the Court for leave to file a reply brief, ECF No. 96, which the Court denied, ECF No. 97. Hours later, Petitioner filed a motion for reconsideration, ECF No. 98, and the reply brief, ECF No. 99, despite the Court’s instruction not to do so. The Court struck the brief from the record and ordered Petitioner’s former counsel1 to show cause as to why he should not be sanctioned for filing a brief despite this Court’s denial of leave to do so. ECF No. 100. Petitioner’s former counsel responded to the Court’s show cause order that day. ECF No. 101. About a week later, on January 7, 2025, Petitioner filed a motion for interim attorneys’ fees, ECF No. 102, and Respondent filed an opposition to that motion on January 21, 2025. ECF No. 103. The Court held oral argument on February 6, 2025. DISCUSSION A. Legal Standard In 1986, Congress established the National Vaccine Injury Compensation Program to provide a no-fault compensation program for those with vaccine-related injuries. Bruesewitz v. Wyeth LLC, 562 U.S. 223, 228 (2011); see 42 U.S.C. § 300aa-10 et seq. (“the Vaccine Act”). The Vaccine Act distinguishes between so-called “Table injuries,” for which causation is presumed when a designated condition follows the administration of a select vaccine within a certain period of time, see 42 U.S.C. §§ 300aa-11(c), 300aa-14, and all other injuries alleged to be 1 On January 24, 2025, Petitioner’s counsel, Courtney Jorgenson, filed an unopposed motion to substitute attorney of record, ECF No. 105, thereby replacing Petitioner’s former counsel, Andrew Downing, as attorney of record in this case. 5 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 6 of 16 caused by a vaccine, known as “off-Table injuries,” “for which causation must be proved in each case.” Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010). Here, Petitioner’s asserted injuries—POTS and CFS allegedly caused by the Tdap vaccine—are “off-Table” injuries. See 42 U.S.C. § 300aa-14. Accordingly, to prove causation for an off-Table injury, Petitioner 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.” Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). In Althen v. Secretary of Health & Human Services, the Federal Circuit promulgated a three-step test to guide petitions alleging off-Table injuries. 418 F.3d at 1278. Under Althen, to successfully demonstrate causation, a petitioner must advance “a medical theory causally connecting the vaccination and the injury,” illustrate “a logical sequence of cause and effect showing that the vaccination was the reason for the injury,” and establish a “proximate temporal relationship between vaccination and injury.” Id. Under the Vaccine Act, judges of this Court review decisions issued by special masters upon a petitioner’s filing of a motion for review. 42 U.S.C. § 300aa-12(e)(1). The Court reviews a special master’s findings of fact under the “arbitrary and capricious” standard, legal questions under the “not in accordance with law” standard, and discretionary rulings for “abuse of discretion.” Munn v. Sec’y of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992); see Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1358 (Fed. Cir. 2019). Pertinent to this case, the Court reviews a special master’s case management decisions—which are discretionary rulings—under the “abuse of discretion” standard. Stewart-Robinson v. Sec’y of Health & Hum. Servs., 173 Fed. Cl. 567, 575 (2024). “Special masters have broad discretion to determine how to best manage the cases before them.” Bello v. Sec’y of Health & Hum. Servs., 158 Fed. Cl. 734, 748 (2022). As Judge Kaplan has noted, Rule 3(b) of Appendix B of the Rules of the U.S. Court of Federal Claims (“Vaccine Rules”) “states that ‘[t]he special master is responsible for conducting all proceedings’ and ‘shall determine the nature of the proceedings, with the goal of mak[ing] the proceedings expeditious, flexible, and less adversarial.’” Id. (alteration in original). Furthermore, “under Vaccine Rule 8(a), the special master has discretion to ‘determine the format for taking evidence and hearing argument based on the specific circumstances of each case and after consultation with the parties.’” Id. (quoting Vaccine Rule 8(a)). Vaccine Rule 8(d) also “expressly states that ‘[t]he special master may decide a case on the basis of written submissions without conducting an evidentiary hearing.’” Id. (alteration in original) (quoting Vaccine Rule 8(b)). Such a decision is referred to as a “ruling on the record.” See, e.g., id.; Kreizenbeck v. Secy’ of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020). However, a special master’s discretion in ruling on the record is not without limitation. Vaccine Rule 8(b) mandates that special masters “consider all relevant and reliable evidence” and ensure that all proceedings are “governed by principles of fundamental fairness to both parties.” Special masters must also “determine that the record is comprehensive and fully developed before ruling on the record.” Kreizenbeck, 945 F.3d at 1366. But so long as the special master follows these general principles, decisions regarding the management of a case are left to his or her discretion and are “subject to reversal only under the highly deferential abuse of discretion standard.” Bello, 158 Fed. Cl. at 748 (citing Kreizenbeck, 945 F.3d at 1364). 6 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 7 of 16 B. Analysis Petitioner essentially makes two arguments in her motion for review. First, Petitioner argues that, because the chief special master dismissed her petition pursuant to RCFC 12(b)(6) and did not adhere to the legal standards for applying that rule, the chief special master’s decision is not in accordance with law. See ECF No. 91 at 18. Alternatively, Petitioner argues that the chief special master’s ruling on the record without allowing Petitioner to file expert reports constitutes an abuse of discretion. See id. at 35. Petitioner separately seeks award of interim attorneys’ fees. The Court will address these three issues in turn. 1. The Chief Special Master Did Not Dismiss Petitioner’s Case Under RCFC 12(b)(6). Petitioner argues that the chief special master dismissed her petition under RCFC 12(b)(6). ECF No. 91 at 18. For this reason, Petitioner contends that the chief special master had to draw “every inference in favor of Ms. Stiegler” under this rule and, because he did not do so, his finding that she failed to meet her initial burden of proof was not in accordance with law. Id. at 33. Petitioner feels she was “deprived of an opportunity to prove her case” and that there is “no legal reason that a 12(b)(6) motion should have been successful under the facts of this case, the pleadings filed, and the evidence presented.” Id. at 39. Respondent argues that the chief special master did not dismiss the case pursuant to RCFC 12(b)(6); rather, “after soliciting and reviewing significant evidence, [he] determined there was insufficient evidence of a causal theory.” ECF No. 95 at 10. In furtherance of this argument, Respondent notes that, if a court dismisses a case for failure to state a claim, it generally considers “only the allegations contained in the complaint, exhibits attached to the complaint[,] and matters of public record.” Id. at 11 (alteration in original) (quoting Pension Benefit Gaur. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir. 1993)). Here, according to Respondent, the chief special master “invited petitioner to attempt to address . . . concerns” he had with Petitioner’s case and “carefully considered petitioner’s submissions, including ‘extensive medical records and briefs to support her claim, along with a lengthy appendix of medical and scientific articles’ before determining that petitioner could not meet her burden.” Id. (quoting Stiegler, 2024 WL 4678300, at *14). Respondent argues that this constitutes a ruling on the record rather than an RCFC 12(b)(6) dismissal. See id. at 11–12. “[S]pecial masters have jurisdiction to rule on motions to dismiss,” W.J. v. Sec’y of Health & Hum. Servs., 93 F.4th 1228, 1243 (Fed. Cir. 2024), and the legal standard special masters must follow in ruling on such motions are no different than they are for judges. See Felix v. Sec’y of Health & Hum. Servs., 172 Fed. Cl. 626, 632 (2024). Therefore, “in ruling upon a motion to dismiss, the special master must accept as true the facts asserted by the petitioner in determining whether the claim for relief under the Vaccine Act is both ‘sufficient’ and ‘plausible on its face.’” Id. (quoting W.J., 93 F.4th at 1235). Here, both the chief special master’s opinion and the parties’ subsequent briefing make clear that this case was not dismissed under RCFC 12(b)(6). Particularly illustrative is the fact 7 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 8 of 16 that neither the chief special master’s decision nor the parties’ briefs reference the petition itself. If this were an RCFC 12(b)(6) dismissal, discussion of the petition itself would be central to the chief special master’s decision—and certainly to Petitioner’s challenge of the decision as not in accordance with law—because the RCFC 12(b)(6) standard looks to the factual allegations of the complaint or, in this case, the petition. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (“To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” (emphasis added)); see also Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (“While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff’s obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief’ requires more than labels and conclusions . . .” (first alteration in original) (emphasis added) (citation omitted)). However, instead of referencing her barebones amended petition, Petitioner argues that, given the “facts of this case, the pleadings filed, and the evidence presented,”2 there is no legal basis with which the chief special master could have granted an RCFC 12(b)(6) dismissal. ECF No. 91 at 39. In furtherance of this argument, Petitioner relies on Herren v. Secretary of Health & Human Services, No. 13-1000V, 2014 WL 3889070 (Fed. Cl. Spec. Mstr. July 18, 2014). In Herren, the special master, in summarizing Warfle v. Secretary of Health & Human Services, stated that special masters must draw “all inferences from the available evidence in petitioner’s favor” when deciding a motion to dismiss. Id. at *2 (citing Warfle, No. 05-1399V, 2007 WL 760508, at *2 (Fed. Cl. Spec. Mstr. Feb. 22, 2007)). Therefore, Petitioner argues, “[d]rawing all inferences from the available evidence in [Petitioner]’s favor, she has far surpassed her burden to survive the motion to dismiss.” ECF No. 91 at 33. However, Herren misapplies the RCFC 12(b)(6) legal standard. As explained above, when deciding on a motion to dismiss, the Court looks to the factual allegations of the complaint—or in vaccine cases, the petition3—and assumes all such allegations in the non- moving party’s favor. Iqbal, 556 U.S. at 678; Twombly, 550 U.S. at 555. The Court does not look to the “available evidence” as Herren states or construe any such evidence in the non- moving party’s favor. 2014 WL 3889070, at *2. For this reason, Petitioner’s reliance on Herren is unpersuasive. Although the chief special master invited Respondent to move to dismiss the case and used language suggesting dismissal under RCFC 12(b)(6) in his decision,4 see Stiegler, 2024 WL 4678300, at *3 (“the motion to dismiss is now ripe for resolution”), the chief special master’s decision to deny Petitioner entitlement to compensation is better characterized as a ruling on the 2 The Court takes Petitioner’s reference to “pleadings filed” to mean briefs filed by both parties and not “pleadings” in the formal use of the term (i.e., a complaint and an answer). 3 Bass v. Sec’y of Health and Hum. Servs., 12-135V, 2012 WL 3031505, at *5 (Fed. Cl. Spec. Mstr. June 22, 2012) (“Here, [petitioner’s] initial petition is vulnerable to a [RCFC 12(b)(6)] motion to dismiss for failure to state a claim because it lacks adequate factual allegations.” (emphasis added)). 4 The Court cautions the chief special master against using language suggesting dismissal when ruling on the record. “Dismissal” as a term is generally understood to mean adjudication under RCFC 12. In cases in which the chief special master is not adjudicating a case under RCFC 12, he should not use the term “dismissal” as such use sows confusion among litigants and leads to unnecessary litigation, which depletes the Court’s limited resources. 8 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 9 of 16 record than as an RCFC 12(b)(6) dismissal when reading the decision in its entirety and considering the arguments asserted by the parties both before the chief special master and this Court. For these reasons, the chief special master did not dismiss Petitioner’s case pursuant to RCFC 12(b)(6) and was not required to draw inferences in Petitioner’s favor. Therefore, on this ground, his decision was in accordance with law and not violative of the RCFC 12(b)(6) legal standard. 2. The Chief Special Master Did Not Abuse His Discretion When He Denied Entitlement Without Providing Petitioner an Opportunity to File Expert Reports. Petitioner and Respondent discuss at great length whether Petitioner had POTS and the proper onset for that disease. See ECF No. 91; ECF No. 95. But that is not what is at issue in this petition for review. The chief special master did not premise his decision on diagnosis or onset arguments. Instead, the chief special master denied entitlement because Petitioner failed to establish a causal theory under Althen prong 1. Stiegler, 2024 WL 4678300 at *11; ECF No. 91 at 38 (“Petitioner is not appealing Althen Prong 2 because the Chief Special Master did not make a determination regarding Althen Prong 2.”). Specifically, the issue before the Court is whether the chief special master abused his discretion when he denied entitlement without providing Petitioner an opportunity to file expert reports. Petitioner argues that she should have been permitted to file expert reports before the chief special master rendered a decision. ECF No. 91 at 31. According to Petitioner, an expert witness would have been able to “provide discussion of [Petitioner’s submitted medical] articles within an expert report detailing causation.” Id. at 38. Petitioner argues that such expert testimony would better establish her causal theory and would, therefore, alleviate the chief special master’s skepticism of her case. See id. at 38–39. For this reason, according to Petitioner, the chief special master’s ruling on the record without considering expert reports was an abuse of discretion. Id. Conversely, Respondent contends that the chief special master had the authority to rule on the record without expert testimony as long as he determined that the record was “comprehensive and fully developed” before so doing. ECF No. 95 at 11 (quoting Kreizenbeck, 945 F.3d 1366). Respondent further argues that, because of the “absence of new, reliable medical or scientific evidence specific to the Tdap vaccine and in consideration of his prior experience in similar cases,” the chief special master was within his discretion to determine that “he did not need expert reports to assist in his adjudication of the case.” Id. at 19. “Special masters have broad discretion to determine how to best manage the cases before them.” Bello, 158 Fed. Cl. at 748. So long as special masters “consider all relevant and reliable evidence,” ensure that all proceedings are “governed by principles of fundamental fairness to both parties,” and determine that “the record is comprehensive and fully developed before ruling on the record,” id. (quoting Kreizenbeck, 945 F.3d at 1366), decisions regarding the management of a case are left to his discretion and are “subject to reversal only under the highly deferential abuse of discretion standard.” Id. (citing Kreizenbeck, 945 F.3d at 1364). 9 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 10 of 16 Additionally, under Vaccine Rule 8(e), special masters have a duty to manage cases in a manner that forwards “Congress’s objective of making [Vaccine Program] proceedings expeditious, flexible, and less adversarial.” Cox v. Sec’y of Health & Hum. Servs., 30 Fed. Cl. 136, 148 (1993); see also Stewart-Robinson, 173 Fed. Cl. at 576 (quoting Vaccine Rule 3(b)(2)). To better perform this duty, special masters may rely on their experience in previous cases as they “have the expertise and experience to know the type of information that is most probative of a claim.” Doe v. Sec’y of Health & Hum. Servs., 76 Fed. Cl. 328, 339 (2007). This duty becomes particularly salient when considering the increasing backlog of cases within the Vaccine Program. The program sees many cases alleging that a vaccination caused POTS. Specifically, according to one study, since 1998, petitioners filed 102 POTS-related cases. Waqar Waheed, et al., Do Vaccines Cause Postural Orthostatic Tachycardia Syndrome? Review of Cases in the National Vaccine Injury Compensation Program, PEDIATRIC NEUROLOGY, Dec. 2024 at 229, 232 (“Waheed”). Of those 102 cases, the special masters determined that POTS, among other conditions, could have been caused by immunization in only one case.5 Id. at 233. According to the study, in no other case has a special master determined that POTS was caused by immunization. Id. With this background in mind, the chief special master viewed Petitioner’s initial case with skepticism. After an initial review of the proffered evidence, the chief special master essentially asked: “What do you have that’s new on this well-settled topic?” Petitioner responded to this inquiry by filing medical articles purportedly supporting two arguments. First, according to Petitioner, “POTS is an autoimmune disease that [can be] triggered by vaccination.” ECF No. 69 at 2; id. at 2–9. In furtherance of this argument, Petitioner argued in great length and cited articles stating that the HPV vaccine can cause POTS. See id. at 2–9. Second, Petitioner asserts, the Tdap vaccine can induce POTS, as evidenced by other immunizations causing autoimmune disease and by searching the “UniProt” database to conduct a molecular mimicry test performed by Petitioner’s former counsel. Id. at 17–20. However, Petitioner’s arguments are not new. Of the 102 POTS cases adjudicated by the special masters, petitioners alleged the HPV vaccine caused POTS in 71 cases. Waheed at 233. Furthermore, like Petitioner here, petitioners made the arguments that immunization induces autoimmune disease and that molecular mimicry between a vaccine and neural tissue results in POTS in 85.7% and 78.6% of all POTS cases, respectively. Id. at 233–34. Despite these statistics and the chief special master’s own experience in adjudicating cases in which vaccination-caused POTS was alleged, the chief special master fully considered Petitioner’s arguments and cited authorities. Regarding Petitioner’s first argument, the chief special master personally concluded in numerous prior cases that POTS is most commonly not attributable to an autoimmune process. Stiegler, 2024 WL 4678300, at *11 (listing cases). Petitioner’s reliance on articles establishing that the HPV vaccine can cause POTS was unpersuasive, as the chief special master has “previously rejected as unreliable or unpersuasive” 5 Dunbar v. Sec’y of Health & Hum. Servs., No. 98-627V, 2007 WL 2844826 (Fed. Cl. Spec. Mster. Sept. 14, 2007). The petitioner there argued that his hepatitis B vaccination caused various conditions such as encephalopathy, POTS, autoimmune hepatitis, neuropathy, and lupus-like syndrome. See id. at *27. The special master awarded entitlement finding that the petitioner proved “a prima facie case of causation in fact and but for the hepatitis B vaccinations, he would not have had the conditions he currently has . . . .” Id. at *28. 10 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 11 of 16 the very articles Petitioner cites for this proposition. Id. at *12 (citing C.F. v. Sec’y of Health & Hum. Servs., No. 15-731V, 2023 WL 2198809, at *15, *17–19, *32 (Fed. Cl. Spec. Mstr. Jan. 20, 2023). Because the chief special master previously scrutinized these articles and found them unpersuasive, his disregard for their propositions in this case does not constitute an abuse of discretion. Turning to Petitioner’s second argument, the chief special master similarly discredited in a previous case the Seung Won Seo case study which, Petitioner purports, is evidence that the Tdap vaccine can induce POTS. According to the chief special master, the Seung Won Seo case study is not relevant as it “says nothing about the Tdap vaccine[] and did not involve a POTS diagnosis either.” Stiegler, 2024 WL 4678300, at *12. The chief special master has discretion to determine the relevancy of evidence, which is reviewed under the abuse of discretion standard. See Contreras v. Sec’y of Health & Hum. Servs., 844 F.3d 1363, 1368 (Fed. Cir. 2017); Bello, 158 Fed. Cl. at 748 (“To be sure, special masters are obligated to ‘consider all relevant and reliable evidence’. . .” (quoting Vaccine Rule 8(b))). His decision here—that the Seung Won Seo case study is not relevant—does not constitute an abuse of discretion. The Seung Won Seo case study merely chronicled one patient’s POTS-like symptoms that developed after a life- threatening tetanus infection without mentioning any vaccine, let alone the Tdap vaccine. Perhaps recognizing the weakness of her case on the existing record, Petitioner focuses her petition for review on the chief special master’s decision to deny entitlement without allowing her to file expert reports. Petitioner essentially argues that she cannot analyze what was new in her claim without expert reports. See ECF No. 91 at 30–31. For this reason, she argues, her denial of entitlement without the ability to file expert reports constitutes an abuse of discretion because she did not have an opportunity to fully present her case. See id. But, in this case, the chief special master gave Petitioner a full and fair opportunity to present written evidence and argument. The chief special master afforded Petitioner numerous extensions of time to submit her affidavits, medical records, and authorities, and she ultimately filed a statement of completion, certifying that all supporting records had been submitted, after amending her petition. See ECF No. 36. Additionally, the chief special master explicitly gave Petitioner a chance to address the typical shortcomings presented in cases in which claimants attempt to prove that a vaccine can cause POTS. He cautioned Petitioner, stating that in his experience many claimants argued “that a different vaccine (HPV) causes POTS . . . [b]ut none have succeeded.” ECF No. 68 at 1. Recognizing that it is “wholly conceivable” that the Tdap vaccine may cause POTS under the causation theory claimed here, id., the chief special master gave Petitioner two more chances to develop her case. The first was ordering Petitioner to file brief regarding her causal theory. ECF No. 69. Second, after Petitioner asserted arguments in that brief that the chief special master had previously determined to be unpersuasive, the chief special master afforded Petitioner yet another opportunity to establish her case by ordering Respondent to file a Rule 4(c) Report and allowing Petitioner to respond that report. ECF No. 72 at 3–4. In her response, Petitioner once again largely repeated arguments and cited articles that the chief special master already discredited. Moreover, Petitioner’s argument that expert reports are imperative to establishing her case is unpersuasive. Petitioner emphasizes in her petition for review two articles—Li and the 11 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 12 of 16 NIH consensus report—about which an expert witness could have “conduct[ed] a more comprehensive medical search and opine[d]” and could have “provide[d] discussion of these articles within an expert report detailing causation.” See ECF No. 91 at 38. Petitioner relies on the Li article to argue that there is a homological correlation between Tdap vaccination and the onset of POTS because the adrenergic receptor mentioned in that study is the “same receptor that Petitioner demonstrated molecular mimicry with the Tdap vaccination received by Ms. Stiegler.” Id. at 31 (emphasis omitted). However, no expert report was needed to explain this argument to the chief special master, who not only determined in previous cases that “establishing homology is not enough to prove that molecular mimicry constitutes a likely mediating mechanism for a vaccine-triggered injury,” see Stiegler, 2024 WL 4678300 at *12 (listing cases), but has also considered this very article in a previous case and determined that it was unreliable. A.F. v. Sec’y of Health & Hum. Servs., No. 19-446V, 2023 WL 251948, at *5–6 (Fed. Cl. Spec. Mstr. Jan. 18, 2023) (“But Li[]’s authors admitted that demonstrated cardiovascular changes had some problems when compared to humans, since rabbits are quadrupeds.”). Similarly, Petitioner contends that the NIH consensus report establishes certain triggers for POTS, one of which may be “immunological stressors such as viral infection.” ECF No. 91 at 28 (quoting the NIH consensus report at 2). It is worth noting at the outset that the NIH consensus report Petitioner filed is a 2021 article explaining the state of POTS research from a 2019 NIH expert consensus meeting. See NIH consensus report at 2. Since that time, as Respondent notes, studies conducted contemporaneously with the NIH consensus report in 2019 have faced scrutiny from more-recently-published articles.6 ECF No. 83 at 6 n.4, 7–9. Furthermore, Petitioner’s above quote from the article demonstrates that the NIH consensus report discusses viral infection, not a vaccine, as an “immunological stressor” that could cause POTS. NIH consensus report at 2. The chief special master was within his discretion to determine that this article is of limited relevance to Petitioner’s argument that the Tdap vaccine can cause POTS. In short, the chief special master could determine the unreliability and lack of relevancy of this article on its face without expert reports. Although the chief special master originally stated that he would not permit expert reports to be filed, he stated that Petitioner “may consult with an expert” and report back. ECF No. 68 at 2. While it is unclear to what extent Petitioner consulted with an expert, it is clear that Petitioner never moved for leave to file an expert report, despite a subsequent scheduling order stating that adjudication of this case was imminent.7 ECF No. 72 at 3–4 (“If Petitioner seeks to keep the claim alive, a far better showing associating the relevant vaccine and POTS must be made.”). Therefore, though not dispositive, Petitioner argues that the chief special abused his discretion by “denying” her something she never formally requested. Instead of explaining to 6 See, e.g., Juliette Hall, et al., Detection of G Protein-Coupled Receptor Autoantibodies in Postural Orthostatic Tachycardia Syndrome Using Standard Methodology, 146 CIRCULATION, 613, 620 (2022) (calling into question the results of previous POTS studies that did not properly include a control group against which to compare data). 7 Petitioner’s former counsel seemingly has no problem pushing the envelope when it comes to filings. Before this Court, Petitioner’s former counsel filed a motion for leave to file a reply brief, ECF No. 96, which the Court denied, ECF No. 97. Despite this lack of leave, Petitioner’s former counsel filed the reply brief anyway, ECF No. 99, which the Court struck and for which the Court issued a show cause order. ECF No. 100. 12 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 13 of 16 the chief special master specially how an expert report would establish a causal theory under Althen prong 1, Petitioner asserted that an expert report would merely affirm Petitioner’s fruitless arguments or establish her diagnosis and onset of POTS. See ECF No. 81 at 37 (“Petitioner’s filing of an expert report would further explain the diagnostic criteria of POTS . . . and would explain why Ms. Stiegler’s case meets the diagnostic criteria.”). Put differently, rather than explaining the utility of expert reports in establishing a causal theory or formally moving for leave to file an expert report, Petitioner filed medical articles and asserted causal theories that the chief special master has repeatedly discredited in previous cases. As demonstrated above, the chief special master reviewed Petitioner’s medical authorities and arguments in various prior cases and drew upon those conclusions to inform his decision to deny entitlement to compensation. To be sure, if these medical articles were relevant and the chief special master had not reviewed them in previous cases, his decision to deny entitlement without reviewing an expert report could constitute an abuse of discretion. But that is not the case here. Instead, the chief special master generously asked for new evidence to revive Petitioner’s weak initial case, which was based on studies that the chief special master and other special masters have repeatedly seen and rejected in the past. Instead of providing any new studies or evidence, Petitioner responded by providing medical literature and asserting causal theories the chief special master himself has repeatedly deemed insufficient to move the Althen needle. For this reason, the chief special master decided that that the record was “comprehensive and fully developed” after Petitioner’s repeated failure to present anything new. See Kreizenbeck, 945 F.3d at 1366 (“As a result, special masters must determine that the record is comprehensive and fully developed before ruling on the record.”). Recognizing that expert reports would only delay the inevitable, the chief special master denied entitlement without consideration of such reports. This is not an abuse of discretion. In addition to alleging that the Tdap vaccine caused POTS, Petitioner argues that her vaccination caused CFS. However, Petitioner spent virtually no time in her brief or at oral argument developing this argument or even mentioning CFS beyond a mere reference to the condition while speaking to POTS. In other words, there is nothing before this Court, and there was minimal support before the chief special master, to develop Petitioner’s CFS claim beyond conclusory statements. For example, Petitioner does not explain to this Court what the chief special master supposedly got wrong regarding CFS or allege that the chief special master did not allow her to develop this claim. For these reasons, the Court finds that Petitioner has waived any arguments regarding CFS and will not consider Petitioner’s CFS claims. Rodriguez v. Dep’t of Veterans Affs., 8 F.4th 1290, 1305 (Fed. Cir. 2021) (“An issue that is merely alluded to and not developed as an argument in a party’s brief is deemed waived.”); Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1250 n.2 (Fed. Cir. 2008) (“A skeletal ‘argument,’ really nothing more than an assertion, does not preserve a claim[.]” (quoting United States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991))); Bauer v. United States, No. 24-287L, 2025 WL 1064205, at *4 (Fed. Cl. Apr. 9, 2025) (“When an argument is not fully developed in briefing, this Court—absent unusual circumstances—ordinarily finds a forfeiture . . . .”). In sum, Petitioner brings a claim to the Vaccine Program that has been routinely heard and consistently rejected by the special masters. Recognizing the familiar allegations of Petitioner’s claims from his adjudication of identical arguments and authorities in previous cases, 13 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 14 of 16 the chief special master ordered Petitioner to present something new before progressing this case any further. Petitioner failed to do so. In the interests of fairness to the parties and expediency of proceedings, the chief special master’s subsequent decision to deny entitlement without considering expert reports does not constitute an abuse of discretion. 3. Contempt of Court and Petitioner’s Motion for Interim Attorneys’ Fees On January 7, 2025, Petitioner filed a motion for interim attorneys’ fees totaling $99,501.58. ECF No. 102 at 12. Therein, Petitioner’s former counsel, Andrew Downing, informed the Court that he and his firm would no longer be able to represent Petitioner in this case because counsel “had the honor of being vetted for a Presidential appointment within [the] U.S. [Department of] Health and Human Services.” Id. at 2. In furtherance of this motion, Petitioner’s former counsel argues that this case was brought in good faith and that there was a reasonable basis for the claims asserted. Id. at 3. Respondent opposes the motion, arguing that Petitioner lacks a reasonable basis for her claims because Petitioner never established that she had POTS or CFS, has not “provided more than a scintilla of evidence” of general or specific causation evidence, and has not established a proximal temporal relationship between her vaccination and the onset of her injuries. ECF No. 103 at 17–20. The Vaccine Act permits a special master or the Court to award “as part of such compensation an amount to cover reasonable attorneys’ fees.” 42 U.S.C. § 300aa-15(e)(1)(A). The Federal Circuit has determined that section 300aa-15(e) contemplates awards of interim attorneys’ fees, as the statute applies to fees and costs “‘incurred in any proceeding on such petition,’ and not solely those fully adjudicated on the merits.” Cloer v. Sec’y of Health & Hum. Servs., 675 F.3d 1358, 1361 (Fed. Cir. 2012) (quoting 42 U.S.C. § 300aa-15(e)). This case, however, has now been fully adjudicated on the merits so there is no need to award “interim” fees. Moreover, as the Federal Circuit has observed, “[i]nterim fees are particularly appropriate in cases where proceedings are protracted and costly experts must be retained.” Avera v. Sec’y of Health & Hum. Servs., 515 F.3d 1343, 1352 (Fed. Cir. 2008). Here, the status of the case is not protracted (it is resolved) and no experts were retained (the inability to file expert reports was the main point of Petitioner’s motion for review). Furthermore, Petitioner made no showing of “undue hardship” or any other showing that “would justify an award of interim fees.” Id. Rather, Petitioner merely states that her former counsel’s “firm will be closing down” without tying that statement to any claim of undue hardship or other justification for award of interim fees. ECF No. 102 at 3. In other words, this statement is just that—a statement with no associated argument explaining why the closing of the firm necessitates or otherwise justifies the award of interim fees. Accordingly, Petitioner’s motion for interim attorneys’ fees is denied. The chief special master can assess the reasonableness of the fees sought in the “interim” along with any other fees sought after the issuance of this opinion. However, if fees and costs are to be awarded, the chief special master shall award fees with the following instructions regarding the reasonableness of a subset of those fees and Petitioner’s former counsel’s contempt of court. The chief special master shall not award any attorneys’ fees and costs incurred in relation to Petitioner’s motion for reconsideration (ECF No. 98), Petitioner’s stricken reply brief (ECF No. 99), or Petitioner’s 14 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 15 of 16 response to the Court’s show cause order (ECF No. 101). Denial of attorneys’ fees and costs for these filings is justified for two reasons. First, there was no reasonable basis for the filing of the motion for reconsideration or filing the reply brief after reconsideration was denied because the motion for reconsideration was frivolous and the filing of the reply brief was explicitly prohibited by the Court’s denial of leave to file the reply brief. In her motion for reconsideration, Petitioner argued that “leave of Court is not required” to file a reply brief because “based on [RCFC] 5.4, the Court has no statutory authority to deny a Reply on a motion for review.” ECF No. 98 at 1, 2. Petitioner has the rule here backwards. It is Petitioner that has no statutory right, nor a right under the RCFC or the Vaccine Rules, to file a reply brief. The Vaccine Act provides that if a motion for review is filed with the Court, “the other party shall file a response with the clerk of the United States Court of Federal Claims no later than 30 days after the filing of such motion.” 42 U.S.C. § 300aa- 12(e)(1)). In short, the Vaccine Act does not provide for a reply brief on a motion for review. This is clear because the time for the Court to decide a motion for review is tied to the response brief: “[t]he court shall complete its action on a petition within 120 days of the filing of a response under paragraph (1) excluding any days the petition is before a special master as a result of a remand under subparagraph (C).” Id. § 300aa-12(e)(2)(c). The only exception to this time limit is in cases in which remand to the special master is ordered. Id. A reply brief is simply not contemplated in the Vaccine Act. The Vaccine Rules similarly do not provide for a reply brief. See Vaccine Rule 28(a) (“The assigned judge must complete the review within 120 days after the filing of a response under Vaccine Rule 25 . . . .”); see also Vaccine Rule 25. Put simply, the Vaccine Act and the Vaccine Rules provide for a motion for review and a response to any such motion. A reply brief can only be filed by leave of the Court. Moreover, contrary to Petitioner’s assertion, the RCFC likewise do not provide the ability to file a reply brief, without leave of the Court, in a vaccine case. Petitioner tried to divine such a right through a highly strained reading of RCFC 5.4. See ECF No. 98. Petitioner argued that because RCFC 5.4(a)(4) provides that “[a] reply brief or memorandum must conform to the requirements of RCFC 5.4(a)(3),” Petitioner had the right to file a reply brief without leave of the Court. Id. at 1–2 (quoting RCFC Rule 5.4). But RCFC 5.4 does not provide any such right; rather, RCFC 5.4 provides the rule that governs the contents and length of a brief or memorandum, including a reply brief. The only application of RCFC 5.4 that would have been relevant here is if the Court had granted Petitioner’s motion for leave. The Court denied that motion; therefore, Petitioner did not have the right to file a reply brief under RCFC 5.4 or otherwise. This Court, like all federal courts, has inherent power “to control the disposition of the causes on its docket with economy of time and effort.” CliniComp Int’l, Inc. v. United States, 134 Fed. Cl. 736, 753 (2017) (quoting Landis v. N. Am. Co., 299 U.S. 248, 254–55 (1936)). Petitioner misses the mark in arguing that the Court is without the discretionary authority to control its own docket, and thus cannot deny leave for certain filings, simply because the RCFC contemplate the filing of reply briefs in certain instances. For this reason, Petitioner’s motion for reconsideration, ECF No. 98, and Petitioner’s stricken reply, ECF No. 99, along with the response to the Court’s show cause order, ECF No. 101, lack a reasonable basis and the chief 15 Case 1:21-vv-01152-ZNS Document 112 Filed 05/13/25 Page 16 of 16 special master may not award attorneys’ fees and costs incurred in connection with any of these filings. Even if there were a reasonable basis for these filings, denial of attorneys’ fees and costs related to the filing of a brief in direct contradiction of the Court’s denial of leave is a reasonable sanction for contempt. This goes as well for the closely related motion for reconsideration and the response to the Court’s show cause order. A court may assess attorneys’ fees as a sanction for the “willful disobedience of a court order.” Chambers v. NASCO, Inc., 501 U.S. 32, 45 (1991) (quoting Alyeska Pipeline Serv. Co. v. Wilderness Soc’y, 421 U.S. 240, 258 (1975)). To determine that a party acted in willful disobedience of an order, the Court “need not find that the party acted in bad faith.” Pyramid Real Estate Services, LLC v. United States, 95 Fed. Cl. 613, 623 (2010) (quoting Alyeska, 421 U.S. at 258)). Instead, the Court may find a “willful violation” when it determines that a party took an action that “it knew or should have known to be contrary to an express court order.” Pac. Gas & Elec. Co. v. United States, 82 Fed. Cl. 474, 483 (2008). Here, Petitioner moved the Court for leave to file a reply brief. See ECF No. 96. The Court denied such leave. ECF No. 97. Mere hours later, Petitioner’s filed the reply brief anyway, despite the Court’s instruction not to do so. ECF No. 99. It is readily apparent that Petitioner’s counsel knew filing this brief was “contrary to [the] express court order” denying him permission to file that brief. Pacific Gas & Elec. Co., 82 Fed. Cl. at 483. Therefore, the chief special master shall not award attorney’s fees for any work done on Petitioner’s stricken brief, ECF No. 99, motion for reconsideration, ECF No. 98, or response to the Court’s show cause order related to filing that brief, ECF No. 101, because denial of attorneys’ fees and costs is a reasonable sanction for Petitioner’s former counsel’s contemptuous filing of the reply brief. See 28 U.S.C. § 2521(b) (providing the Court with statutory contempt authority). CONCLUSION For the foregoing reasons, the Court finds that the chief special master adequately reviewed the record and determined that it was fully developed before denying entitlement. Therefore, his decision to deny entitlement without considering expert reports was not an abuse of discretion. In light of these conclusions, the chief special master’s decision denying entitlement is AFFIRMED and Petitioner’s motion for review is DENIED. Additionally, Petitioner’s motion for interim attorneys’ fees is DENIED, and the chief special master is instructed—if fees are sought and he determines any such fees are reasonable—to only award attorneys’ fees and costs in a manner that is consistent with the above instruction regarding contempt of court. The Clerk shall enter JUDGMENT accordingly. IT IS SO ORDERED. s/ Zachary N. Somers ZACHARY N. SOMERS Judge 16 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_21-vv-01152-cl-extra-11262261 Date issued/filed: 2026-02-17 Pages: 1 Docket text: Supplementary opinion from CourtListener cluster 10795604 -------------------------------------------------------------------------------- In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 21-1152V ************************* * ALISON STIEGLER, * Chief Special Master Corcoran * Petitioner, * Filed: January 21, 2026 * v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * ************************* Courtney C. Jorgenson, Siri & Glimstad, LLP, Phoenix, AZ, for Petitioner. Sarah C. Duncan, U.S. Department of Justice, Washington, DC, for Respondent. DECISION GRANTING IN PART MOTION FOR ATTORNEY’S FEES AND COSTS 1 On April 2, 2021, Alison Stiegler filed a petition under the National Vaccine Injury Compensation Program (the “Vaccine Program”). 2 Petitioner alleged that she developed Postural Orthostatic Tachycardia Syndrome (“POTS”) and chronic fatigue syndrome (“CFS”) as a result of receiving the tetanus, diphtheria, and acellular pertussis (“Tdap”) vaccine on April 4, 2018. Petition (ECF No. 1) at 1. After briefing, I issued a decision denying entitlement on October 10, 2024. See Decision, dated Oct. 10, 2024 (ECF No. 86) (“Decision”). Petitioner moved for review (ECF No. 88), but the motion was denied. See Judge Vaccine Order/Opinion, dated Apr. 18, 2025 (ECF No. 109) (“Vaccine Order”). While the Motion for Review was pending, Petitioner filed a Motion for Interim Attorney’s Fees and Costs in January 2025, seeking $99,501.58 ($97,701.00 in attorney’s fees, plus $1,800.58 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). in costs). See ECF No. 102 (“Interim Fees Motion”). This fees request sought reimbursement for work performed on the matter for the work of two law firms—the first (Van Cott & Talamante) which handled the matter from March 2021 (shortly before its initiation) to July 2022; and the second (Downing, Allison, & Jorgenson) that represented Petitioner from July 2022 to January 2025. See Ex. A (ECF No. 102-1) to Interim Fees Motion at 1–23, 77–90. Respondent filed his opposition to the motion on January 27, 2025, alleging that Petitioner’s claim lacked a reasonable basis. See Opposition, dated Jan. 27, 2025 (ECF No. 103). In the context of denying Petitioner’s Motion for Review, the Court denied the Interim Fees Motion, noting that the case “ha[d] been fully adjudicated on the merits so there [wa]s no need to award ‘interim fees.” Vaccine Order at 14. I was directed instead to resolve a final fees request—but in so doing, to “not award any attorneys’ fees and costs incurred in relation to Petitioner’s motion for reconsideration (ECF No. 98), Petitioner’s stricken reply brief (ECF No. 99), or Petitioner’s response to the Court’s show cause order (ECF No. 101).” Id.at 14–16. 3 Petitioner has now filed a motion for a final award of attorney’s fees and costs. Motion, dated June 18, 2025 (ECF No. 114) (“Final Fees Motion”). Petitioner seeks additional fees and costs incurred from January to June 2025 (along with what was previously requested in the interim fees request). Ex. 41 (ECF No. 115-1) at 1–6. Petitioner requests the additional sum of $19,818.42 ($17,841.50 in attorney’s fees, plus $1,976.92 in costs) for the work of the attorneys and staff at a third law firm. 4 Final Fees Motion at 6; Reply, dated July 2, 2025 (ECF No. 118) (“Reply”) at 8. Respondent reacted to the Final Fees Motion on July 1, 2025. See Response, dated July 1, 2025 (ECF No. 117) (“Resp.”). He argues that “[t]he objective evidence indicates that [P]etitioner neither began her case with a reasonable basis, nor did one emerge as her case progressed,” and thus her motion must be denied. Resp. at 19. In so arguing, Respondent maintains that Petitioner has failed to establish that she has POTS or CFS—emphasizing that no provider ever diagnosed her with either condition, and that she lacked any testing consistent with the diagnostic criteria for POTS or CFS. Id. At best, according to Respondent, “[P]etitioner reported fatigue for short periods of time at sporadic encounters after October 31, 2018 (more than six months after vaccination), and self-reported her own opinion that she had ‘features of abnormal thermoregulation along with clinical features of orthostatic hypotension’ to a rheumatologist in July 2020.’” Id. (referencing Ex. 10 at 7). Moreover, no treating provider ever attributed Petitioner’s condition to her receipt of 3 In briefing the Motion for Review, Petitioner had requested the opportunity to file a reply brief, although there is no reply as a matter of right or procedure under the Vaccine Rules. After that motion was denied, Petitioner went ahead and filed the reply—leading the Court to strike it and ordering the Petitioner to Show Cause why Petitioner’s former counsel should not be held in contempt of court for filing a reply brief after the Court specifically denied leave to do so, and while she had a motion for reconsideration of that order pending. See Order, dated Dec. 27, 2024 (ECF No. 100). 4 The common thread running through the appearance of each firm is a single attorney, who switched firms in 2022 and then withdrew from the case in 2025. 2 the Tdap vaccine, and that she only first reported “unusual fatigue” symptoms lasting for three weeks on October 31, 2018 - nearly six months post-vaccination. Id. at 23. In addition, Respondent argues that Petitioner’s claim was not supported by either medical opinion or her medical records. Resp. at 19, 20. He further submits that the late filing of Petitioner’s Exhibit 40 (a case report describing a case of a 40-year-old female who presented with symptoms suggestive of POTS following receipt of a dTap booster vaccination one week prior) should be given no weight in determining whether the claim had reasonable basis. Id. at 21–22. However, should I take this item of literature into account, Respondent nevertheless maintains that “this single case report does not satisfy [P]etitioner’s burden to establish reasonable basis for her claim.” Id. at 22. Petitioner filed a reply, insisting that her claim had both good faith and reasonable basis. Reply at 1. As support for reasonable basis, Petitioner notes that she provided extensive medical records and briefing to bulwark the main points of her case. For example, she maintains that her claimed injuries—POTS or CFS—can reflect an autoimmune response to an immune-mediated trigger, and that vaccination in general, as well as the specific vaccine she received, has been linked to her alleged injuries. Id. at 2. I. Applicable Legal Standards Motivated by a desire to ensure that petitioners have adequate assistance from counsel when pursuing their claims, Congress determined that attorney’s fees and costs may be awarded even in unsuccessful claims. H.R. REP. No. 99-908, at 22 preprinted in 1986 U.S.C.C.A.N. 6344, 6363; see also Sebelius v. Cloer, 133 S.Ct. 1886, 1895 (2013) (discussing this goal when determining that attorneys’ fees and costs may be awarded even when the petition was untimely filed). This is consistent with the fact that “the Vaccine Program employs a liberal fee-shifting scheme.” Davis v. Sec’y of health & Hum. Servs., 105 Fed. Cl. 627, 634 (2012). Indeed, it may be the only federal fee-shifting statute that permits unsuccessful litigants to recover fees and costs. However, Congress did not intend that every losing petition be automatically entitled to attorney’s fees. Perreira v. Sec’y of Health & Hum. Servs., 33 F.3d 1375, 1377 (Fed. Cir. 1994). And there is also a prerequisite to even obtaining fees in an unsuccessful case. The special master or court may award attorney’s fees and costs to an unsuccessful claimant only if “the petition was brought in good faith and there was a reasonable basis for the claim for which the petition was brought.” Section 15(e)(1). Reasonable basis is a prerequisite to a fee award for unsuccessful cases—but establishing it does not automatically require an award, as special masters are still empowered by the Act to deny or limit fees. James-Cornelius on behalf of E.J. v. Sec’y of Health & Hum. Servs., 984 F.3d 1374, 1379 (Fed. Cir. 2021) (“even when these two requirements are satisfied, a special master retains discretion to grant or deny attorneys’ fees”). 3 As the Federal Circuit has explained, whether a discretionary fees award is appropriate involves two distinct inquiries, but only reasonable basis is at issue herein. 5 Reasonable basis is deemed “an objective test, satisfied through objective evidence.” Cottingham v. Sec’y of Health & Hum. Servs., 971 F.3d 1337, 1344 (Fed. Cir. 2020) (“Cottingham I”). The reasonable basis requirement examines “not at the likelihood of success [of a claim] but more to the feasibility of the claim.” Turner, 2007 WL 4410030, at *6 (quoting Di Roma v. Sec’y of Health & Hum. Servs., No. 90-3277V, 1993 WL 496981, at *1 (Fed. Cl. Spec. Mstr. Nov. 18, 1993)). The Federal Circuit recently explained “that a reasonable basis analysis is limited to objective evidence, and that subjective considerations, such as counsel’s subjective views on the adequacy of a complaint, do not factor into a reasonable basis determination.” James-Cornelius, 984 F.3d at 1379. Although clearly easier to meet than the preponderant standard required for compensation, “courts have struggled with the nature and quantum of evidence necessary to establish a reasonable basis.” Wirtshafter v. Sec’y of Health & Hum. Servs., 155 Fed. Cl. 665, 671 (Fed. Cl. 2021). “[I]t is generally accepted that ‘a petitioner must furnish some evidence in support of the claim.’” Id. Citing the prima facie elements of a successful claim described in Section 11(c)(1), the Federal Circuit recently instructed that the level of the objective evidence sufficient for a special master to find reasonable basis should be “more than a mere scintilla but less than a preponderance of proof.” Cottingham I, 971 F.3d at 1345–46. “This formulation does not appear to define reasonable basis so much as set its outer bonds.” Cottingham v. Sec’y of Health & Hum. Servs., 159 Fed. Cl. 328, 333 (Fed. Cl. 2022) (“Cottingham II”), aff’d without op., 2023 WL 754047 (Fed. Cir. Nov. 14, 2023). “[T]he Federal Circuit’s statement that a special master ‘could’ find reasonable basis based upon more than a mere scintilla does not mandate such a finding.” Cottingham II, 159 Fed. Cl. at 333 (citing Cottingham I, 971 F.3d at 1346). Furthermore, the issue of reasonable basis is not a static inquiry. The reasonable basis which existed when a claim was filed may cease to exist as further evidence is presented. Perreira, 33 F.3d at 1377. In Perreira, the Federal Circuit affirmed a special master’s determination that reasonable basis was lost after Petitioner’s “expert opinion, which formed the basis of the claim, was found to be unsupported by either medical literature or studies.” Id. at 1376. 5 Claimants must also establish that the petition was brought in good faith. Simmons v. Sec’y of Health & Hum. Servs., 875 F.3d 632, 635 (Fed. Cir. 2017) (quoting Chuisano v. Sec’y of Health & Hum. Servs., 116 Fed. Cl. 276, 289 (2014)). “[T]here ‘good faith’ requirement … focuses upon whether petitioner honestly believed he had a legitimate claim for compensation.” Turner v. Sec’y of Health & Hum. Servs., No. 99-0544V, 2007 WL 4410030, at *5 (Fed. Cl. Spec. Mstr. Nov. 30, 2007). But good faith is not disputed herein, and I do not ascertain evidence in the record calling it into question. 4 II. Fees are Appropriate for this Matter Here, and despite its readily-evident weakness, the claim had sufficient objective evidence to support Petitioner’s claim. In so finding, I emphasize the exceedingly-low bar that governs the reasonable basis inquiry. A finding of reasonable basis requires a mere scintilla of objective evidence to support a feasible claim—a burden that is much lower than the preponderance of evidence standard required for entitlement. It is also well-established that an expert report addressing causation is not necessary to show that a claim had reasonable basis. James-Cornelius v. Sec’y of Health & Hum. Servs., 984 F.3d 1374, 1379–80 (Fed. Cir. 2021). Further, as the Federal Circuit explained in James-Cornelius, affidavits or sworn statements may themselves stand as objective evidence that can be invoked in support of reasonable basis (as well as in establishing entitlement). Id. at 1380–81. The evidence filed herein shows that Petitioner received the subject vaccine on April 4, 2018. Pet. at 1. Over the next several months, Petitioner continued to report to her primary care physician (“PCP”) complaining of chronic headaches and pain in her knee, ankle, and hand from jujitsu. Decision at 3. And nearly six months post-vaccination, Petitioner returned to her PCP and reported three weeks of unusual fatigue. Id. Respondent correctly observes that, based on the medical records and despite dozens of different evaluations by different specialists, Petitioner was never diagnosed with POTS or CFS. But I can still find that Petitioner, if only barely, established a reasonable basis for her claim on the basis of objective medical records establishing that she sought treatment for difficult-to-explain symptoms. This is not a case where it is readily evident from the record that Petitioner had either nothing close to the alleged condition, or some other explanation clearly existed for it. In addition, I note that although during the course of litigating the matter I expressed reasoned skepticism (based on my experience with comparable cases involving POTS) that the claim could succeed, I permitted Petitioner to attempt to meet my doubts with independent evidence. Of course, Petitioner utterly failed to do so—but I am reluctant to equate Petitioner’s inability to establish grounds for entitlement with whether there was any legal possibility before that she could succeed. (I do not, however, deem her subsequently-filed literature or evidence to bulwark the claim’s validity after the fact—and the time to file such evidence (unless it is truly brand-new) is while the claim is still pending, not on appeal or in fees litigation. See Vaccine Order at 14). My determination that the case possessed a modicum of reasonable basis sufficient for a fees award does not mean I am forestalled from reducing the fees to be awarded. As noted below, I will do so in this case, which was never likely to succeed, and which was ultimately pursued to an unnecessary degree, resulting in a waste of judicial resources. Counsel who worked on this matter past and present must also going forward confront this fact: they have been repeatedly unable to prove that certain covered vaccines (HPV and not Tdap) can cause POTS; they are not 5 likely to do so in the future absent new scientific discoveries; and any such future cases they file despite this notice will result in swift dismissal and a finding the claim lacked reasonable basis. III. Calculation of Attorney’s Fees Only “reasonable” fees or costs may be awarded in the Program. Determining the appropriate amount of the fees award is a two-part process. The first part involves application of the lodestar method—“multiplying the number of hours reasonably expended on the litigation times a reasonable hourly rate.” Avera v. Sec’y of Health & Hum. Servs., 515 F.3d 1343, 1347–48 (Fed. Cir. 2008) (quoting Blum v. Stenson, 465 U.S. 886, 888 (1984)). The second part involves adjusting the lodestar calculation up or down to take relevant factors into consideration. Id. at 1348. This standard for calculating a fee award is considered applicable in most cases where a fee award is authorized by federal statute. Hensley v. Eckerhart, 461 U.S., 424, 429–37 (1983). An attorney’s reasonable hourly rate is determined by the “forum rule,” which bases the proper hourly rate to be awarded on the forum in which the relevant court sits (Washington, D.C., for Vaccine Program cases), except where an attorney’s work was not performed in the forum and there is a substantial difference in rates (the so-called “Davis” exception. Avera, 515 F.3d at 1348 (citing Davis Cty. Solid Waste Mgmt. & Energy Recovery Special Serv. Dist. v. U.S. Envtl. Prot. Agency, 169 F.3d 755, 758 (D.C. Cir. 1999)). A 2015 decision established the hourly rate ranges for attorneys with different levels of experience who are entitled to the forum rate in the Vaccine Program. See McCulloch v. Sec’y of Health & Hum. Servs., No. 09-293V, 2015 WL 5634323, at *19 (Fed. Cl. Spec. Mstr. Sept. 1, 2015). Petitioner requests the following rates for her attorneys and support staff, based on the years work was performed: 2021 2022 2023 2024 2025 Andrew $385.00 $445.00 $445.00 $485.00 $485.00 Downing (Attorney) Ann Allison -- -- $415.00 $435.00 -- (Attorney) Courtney $275.00 $325.00 $345.00 $375.00 $400.00 Jorgenson (Attorney) Paralegals $135.00 $135.00 $155.00 $175.00 $195.00 Interim Fees Mot. at 15–16; Final Fees Mot. at 2–6. The attorneys at Petitioner’s former counsel’s firm, as well as her current counsel’s firm, have been recognized to practice in forum, thus, entitling them commensurate rates established in McCulloch. See Rossiter v. Sec’y of Health & Hum. Servs., No. 20-1888V, 2023 WL 3778899, at *2 (Fed. Cl. Spec. Mstr. June 2, 2023). Accordingly, I will utilize the proposed rates. 6 Time billed to this matter, however, is another thing entirely. Simply put, even if this case had a modicum of reasonable basis, it was wasteful and improvident for counsel to incur six figures in fees and costs pursuing it. Counsel was well aware of the many prior decisions I had issued involving POTS, and the need to identify new medical or scientific evidence supporting a Tdap- POTS link if the case was to proceed. Not only did Petitioner fail to do so, however, but she then pursued an appeal which (due to counsel’s profligate filing conduct and disregard for the Vaccine Rules – not to mention the Orders of the Court) resulted in a partial fees sanction. 6 See Vaccine Order at 14–16 (stating that any attorneys’ fees and costs incurred in relation to the filing of Petitioner’s motion for reconsideration, stricken reply brief, or her response to the Court’s show cause order shall be denied). Otherwise, Petitioner should have had well in hand what medical or scientific authority supported her claim well before I first raised questions about the claim’s basis in October 2023 (ECF No. 68)—and certainly by the time of the Motion for Review, which was briefed a year later. It is recognized that special masters have the discretion to make across-the-board fees reductions in appropriate circumstances—not only in the interests of avoiding fees litigation becoming a secondary dispute, but in order to ensure reasonable time is spent on a matter. Humphries v. Sec’y of Health & Hum. Servs., No. 17-288V, 2021 WL 5444097, at *5 (Fed. Cl. Spec. Mstr. Oct. 26, 2021) (“Special masters need not engage in a line-by-line review of fees requests when making reductions, and in fact are permitted to make fair across-the-board cuts.” Cases unlikely to succeed may have reasonable basis, but that does not mean excessive time spent on such a case is inherently reasonable. And by and large, cases alleging POTS as a vaccine injury are not reasonably-advanced (and will remain so unless and until new medical research establishes a reliable link). For these reasons, a substantial percentage cut is called for in this case. I accordingly reduce all time billed to the matter by 50 percent. Application of the foregoing reduces the amount of fees to be awarded herein by $39,939.75 7 for Petitioner’s former counsel; and by $8,920.75 8 for Petitioner’s current counsel of record. I recognize that the percentage discount I have employed is larger than usual. But I deem it appropriate—especially in a case that barely meets the reasonable basis standard. Counsel improvidently pursued this matter, despite my warnings along the way that it likely was not 6 Taking into account the instructions set forth in the Vaccine Order, 42.7 hours (24 hours of work performed at $375.00/hour; 17.9 hours of work performed at $485.00/hour; and 0.8 hours of work performed at $175.00/hour) were billed in relation to Petitioner’s Motion for Reconsideration, Petitioner’s stricken Reply Brief, and Petitioner’s Response to the Court’s Show Cause Order. This results in a reduction of $17,821.50, and I have subtracted this amount from the total remainder that forms the basis for my discounted, final fees and costs award. 7 This amount is calculated as ($97,701.00 - $17,821.50) = $79,879.50; ($79,879.50 x 0.50) = $39,939.75. 8 This amount is calculated as ($17,841.50 x 0.50) = $8,920.75. 7 tenable. See Scheduling Order, dated Oct. 2, 2023 (ECF No. 68). And then appeal was taken on top of that. It is an abuse of the Program’s exceedingly-generous fees provisions to run up fees and costs in the six figures on a claim that appears facially weak, and then only proves to be so. The risk for taking on this work is properly placed on counsel, who will hopefully in future matters exercise greater care when pursuing flimsy causation theories based on limited objective proof. IV. Calculation of Attorney’s Costs Just as they are required to establish the reasonableness of requested fees, petitioners must also demonstrate that requested litigation costs are reasonable. Presault v. United States, 52 Fed. Cl. 67, 670 (2002); Perreira v. Sec’y of Dep’t of Health & Hum. Servs., 27 Fed. Cl. 29, 34 (1992). Reasonable costs include the costs of obtaining medical records and expert time incurred while working on a case. Fester v. Sec’y of Health & Hum. Servs., No. 10-243V, 2013 WL 5367670, at *16 (Fed. Cl. Spec. Mstr. Aug. 27, 2013). When petitioner fail to substantiate a cost item, such as by not providing appropriate documentation to explain the basis for a particular cost, special masters have refrained from paying the cost at issued. See, e.g., Gardner-Cook v. Sec’y of Health & Hum. Servs., No. 99-480V, 2005 WL 6122520, at *4 (Fed. Cl. Spec. Mstr. June 30, 2005). (A) Downing, Allison & Jorgenson Costs Petitioner seeks $1,800.58 in outstanding costs, including the filing fee, medical record retrieval costs, and postage costs. ECF No. 102-1 at 22–21; 89–90. All are commonly incurred in the Vaccine Program, and are reasonable herein. (B) Siri & Glimstad, LLP Costs Petitioner also seeks $1,976.92 in outstanding costs, including court filing fees, legal research charges, PACER costs, and costs associated with travel for oral argument. ECF No. 115-1 at 5. Such costs are typical in Program cases, and are reasonable herein. CONCLUSION Based on the foregoing, and in the exercise of the discretion afforded to me in determining the propriety of a fees award, I GRANT IN PART Petitioner’s Motion for Attorneys’ Fees and Costs. I award a total of $52,638.00, reflecting (a) $41,740.33 in attorneys’ fees and costs, to be paid through an ACH deposit to Petitioner’s former counsel, Andrew D. Downing’s, IOLTA account for prompt disbursement; and (b) $10,897.67 in attorneys’ fees and costs, to be paid through an ACH deposit to Petitioner’s counsel of record, Courtney C. Jorgenson’s, IOLTA account for prompt disbursement. 8 In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision. 9 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 9 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices renouncing their right to seek review. 9