VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-00301 Package ID: USCOURTS-cofc-1_19-vv-00301 Petitioner: Ryan Farrell Filed: 2019-02-26 Decided: 2025-12-10 Vaccine: tetanus-diphtheria-acellular pertussis (Tdap) Vaccination date: 2017-02-15 Condition: neuromyelitis optica (NMO) Outcome: compensated Award amount USD: 210000 AI-assisted case summary: On February 26, 2019, Ryan Farrell filed a petition alleging that a Tdap vaccine administered on February 15, 2017 caused neuromyelitis optica. He was a 41-year-old electric lineman who received the vaccine after cutting his finger at work. About three weeks later, after a flu-like illness, Mr. Farrell developed left-eye vision loss, urinary difficulty, and lower-extremity numbness and tingling. Imaging showed optic nerve and spinal cord involvement, and he was diagnosed with likely neuromyelitis optica. His treatment course included steroids and later Rituxan. The case included an expert hearing and extensive competing evidence about immune triggering and relapse/onset timing. Petitioner relied on treating neurologists including Dr. Salvatore Napoli and Dr. Michael Levy, while respondent relied on experts including Dr. He and Dr. Cohen. The entitlement ruling credited petitioner's theory that Tdap could trigger NMO in this clinical setting. On December 10, 2025, the court awarded $210,000.00 as interim compensation for pain, suffering, and emotional distress through September 1, 2025, with additional future compensation issues left open. Theory of causation field: Tdap vaccine February 15, 2017 at age 41 causing NMO. COMPENSATED. Onset about 21 days later with left eye vision loss, urinary difficulty, and lower-extremity numbness/tingling after flu-like illness; optic nerve and spinal cord imaging supported likely NMO; treated with steroids/Rituxan. Petitioner experts/treaters Dr. Salvatore Napoli and Dr. Michael Levy; respondent experts included Dr. He and Dr. Cohen. Entitlement July 29, 2025; interim damages December 10, 2025. Award $210,000.00 interim pain/suffering/emotional distress through September 1, 2025. Petition filed February 26, 2019. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_19-vv-00301-0 Date issued/filed: 2025-08-20 Pages: 19 Docket text: PUBLIC ORDER/RULING (Originally filed: 07/29/2025) regarding 137 Ruling on Entitlement. Signed by Special Master Christian J. Moran. (jjb) Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 1 of 19 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS * * * * * * * * * * * * * * * * * * * * * RYAN FARRELL, * * No. 19-301V * Special Master Christian J. Moran Petitioner, * v. * * Filed: July 29, 2025 SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * Leah VaSahnja Durant and Glenn MacLeod, Law Offices of Leah V. Durant, PLLC, Washington, D.C., for Petitioner; Elizabeth Andary and Emily Hanson, United States Dep’t of Justice, Washington, D.C., for Respondent. PUBLISHED RULING FINDING ENTITLEMENT TO COMPENSATION1 Ryan Farrell alleges that a tetanus, diphtheria, and acellular pertussis (“Tdap”) vaccine caused him to suffer from neuromyelitis optica (“NMO”). Pet., filed Feb. 26, 2019. The Secretary disputes Mr. Farrell’s entitlement to compensation. Both parties have supported their positions with reports and oral testimony from expert witnesses and argued through memorandum. 1 Because this ruling contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the ruling will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the parties have 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. Any changes will appear in the document posted on the website. Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 2 of 19 A review of the evidence and arguments shows that Mr. Farrell is entitled to compensation. The granting of entitlement is based upon petitioner establishing with preponderant evidence that the Tdap vaccine caused the NMO. The reasoning is set forth below. I. Facts2 Mr. Farrell was born in 1976. He worked as an electric lineman. While working, he cut his finger. Exhibit 6 at 15-16. As a result, he received the allegedly causal Tdap vaccine on Wednesday, February 15, 2017. Id. Due to an “inability to see out of his left eye, difficulty urinating and lower extremity numbness and tingling in the setting of a recent illness,” Mr. Farrell sought care at Needham Emergency Room on Wednesday, March 8, 2017. Exhibit 5 at 10. Mr. Farrell informed the medical staff that “over the weekend he developed what sounds like a flulike illness associated with cough, congestion, malaise and subjective chills.” Id. Testing for various infectious agents was negative. Id. at 11, 17. Mr. Farrell was admitted to the hospital. Id. at 5, 8. While in the hospital, Mr. Farrell underwent two MRIs. An MRI of his head showed a hyperintense signal in the left optic nerve. Exhibit 3 at 8 (March 9, 2017) and an MRI of his cervical and thoracic spine showed a hyperintense signal from C5-6 to C7-T1. Id. Based upon these results he was diagnosed with “likely” “neuromyelitis optica.” Id. This diagnosis was reached despite a lack of antibodies typically found in NMO patients. Mr. Farrell was treated with Solu-Medrol for five days and rapidly improved. He was discharged on March 13, 2017. Exhibit 3 at 8-9. When out of the hospital, Mr. Farrell saw a neurologist, Jacob Sloane. Dr. Sloane’s impression was that Mr. Farrell suffered from NMO. Exhibit 3 at 205. The experts retained for this litigation agree with the diagnosis of NMO. Dr. Sloane prescribed Rituxan. Rituxan “is an anti-CD19 monoclonal antibody that targets B cells that have that receptor.” Tr. at 106. This drug “binds to that receptor on the B cell and creates kind of a cellular toxicity, so that depletes that B cell.” Id. 2 Relatively few medical records contribute to assessing whether Mr. Farrell is entitled to compensation. Thus, the recitation of medical records is short. For a longer presentation of medical records, see Pet'r's Pre-Hearing Br. at 2-6; Resp't's Pre-Hearing Br. at 1-7. 2 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 3 of 19 The course of Mr. Farrell’s NMO over the next few months is generally not relevant to determining whether the Tdap vaccine caused the NMO. However, after approximately six months, Mr. Farrell sought a second opinion from a neurologist, Dr. Salvatore Napoli. Exhibit 4 at 2 (Dec. 19, 2017). Dr. Napoli obtained a history in which Mr. Farrell got cut, received a tetanus vaccine, and, three weeks later, developed vision and bladder trouble. Id. Dr. Napoli wrote that the “implication of this [tetanus] injection is unknown.” Id. at 4. Dr. Napoli assessed Mr. Farrell as suffering from multiple sclerosis and NMO. He also prescribed medications. Id. Dr. Napoli saw Mr. Farrell in December 2017, January 2018, February 2018, and March 2018. Exhibit 4 at 6-33. On March 8, 2018, Mr. Farrell reported concerns about his current medication (Cymbalta) and his job. Id. at 34. Dr. Napoli stated: “I do believe the patient is disabled from all gainful employment. I also agree that it is more likely than not that the DTaP vaccine may have triggered the onset of his NMO subtype of demyelinating disease.” Id. at 35. Dr. Napoli saw Mr. Farrell once more in March 2018 and twice in April 2018. Exhibit 4 at 38-51. Then following these appointments, Mr. Farrell saw medical professionals less frequently. Mr. Farrell returned to Dr. Napoli on January 11, 2019. Dr. Napoli again assessed him as suffering from neuromyelitis optica. Exhibit 44 at 108. Dr. Napoli said that it was “more probable than not” that Mr. Farrell’s “neuromyelitis optica and fulminant demyelination was triggered by” his “tetanus vaccination.” Id. Dr. Michael Levy saw Mr. Farrell in January 2021, February 2021, June 2021, December 2021, and February 2023. Exhibit 43 at 4, 15, 25, 32; Exhibit 51 at 4. On January 27, 2021, Dr. Levy authorized an ambulatory referral to external physical therapy for Mr. Farrell from Massachusetts General Hospital Neurology Virtual Department. Exhibit 43 at 32. On February 23, 2021, Dr. Levy saw Mr. Farrell virtually for a new patient consult. Id. at 25-27. On June 15, 2021, Dr. Levy saw Mr. Farrell again and assessed that Mr. Farrell was “a 45[-year-old] gentlemen with seronegative, monophasic neuromyelitis optica in 2017 following a vaccination.” Id. at 15. Dr. Levy advised Mr. Farrell to follow-up in about six months. Id. at 18. On December 7, 2021, Mr. Farrell returned to see Dr. Levy in- person. Id. at 4, 9. Dr. Levy assessed Mr. Farrell’s diagnosis as “remains seronegative NMO, likely due to a vaccine injury.” Id. at 5. On February 14, 2023, Mr. Farrell returned to see Dr. Levy and Dr. Anderson. Exhibit 51 at 4. Mr. Farrell reported at this visit that he weaned off Lyrica and still feels the neuropathy 3 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 4 of 19 in his feet. Id. at 1. Dr. Levy and Dr. Anderson reported that Mr. Farrell’s “neurological function is improving. He is exercising every day and walking. He eats well and feels healthy. He feels some sensation feelings in his hands that comes and goes.” Id. Mr. Farrell was advised to follow up in two years. Id. at 4. A record from January 13, 2021 indicates that Mr. Farrell had an “acute flare of neuromyelitis optica syndrome.” Exhibit 46 at 23. A more recent record states that Mr. Farrell has improved and nearly returned to his baseline. Exhibit 51 at 1 (Feb. 14, 2023). II. Procedural History Mr. Farrell initiated this case by filing a petition on February 26, 2019. He periodically submitted medical records. The Secretary evaluated this material and recommended that compensation be denied. Resp’t’s Rep., filed pursuant to Vaccine Rule 4, on March 12, 2020. In the Secretary’s view, Dr. Napoli’s January 28, 2019 letter was insufficient to establish that the tetanus vaccine caused Mr. Farrell’s NMO. Id. at 9-10. Mr. Farrell intended to obtain additional reports, either from Dr. Napoli or from an expert retained for the purpose of this litigation. Accordingly, proposed instructions were issued on March 24, 2020 and became final on April 16, 2020. The parties developed evidence from experts over the next few years. For Mr. Farrell, Dr. Napoli wrote two reports: Exhibit 12, filed October 26, 2020; and Exhibit 39, filed June 4, 2021. Dr. Levy also wrote two reports: Exhibit 34, filed May 14, 2021; and Exhibit 41, filed November 23, 2021.3 The Secretary’s pair of experts wrote a total of five reports. Dr. He’s reports are Exhibit A, filed March 1, 2021; Exhibit E, filed October 5, 2021; and Exhibit 3 Dr. Napoli is a board-certified neurologist, currently working as the medical director and president of the Neurology Center of New England. Exhibit 52 at 2. Dr. Napoli has written several publications in the field of neurology and demyelinating diseases, including NMO. Id. at 7. Dr. Levy is a world-class authority in NMO with over 15 years of clinical and research expertise in the treatment of NMO. Exhibit 53. Dr. Levy was the director of the NMO Clinic at the Johns Hopkins Hospital from 2009-2019. Id. at 2. Dr. Levy managed over 425 patients with NMO while he was at Johns Hopkins. Id. at 32. Dr. Levy currently sees about 160 patients with NMO. Tr. at 130. 4 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 5 of 19 G, filed January 24, 2022. Dr. Cohen’s reports are Exhibits C, filed March 1, 2021; and Exhibit F, filed October 5, 2021.4 After the experts were finished with disclosing their opinions in writing, the parties were directed to argue their positions through memoranda. Order, issued March 11, 2022. The parties did. Mr. Farrell submitted his primary brief on June 28, 2022, and his reply brief on January 3, 2023. Between those submissions, the Secretary offered his assessment through a brief filed on October 12, 2022. A review of the evidence and arguments suggested that oral testimony was appropriate, and the parties were instructed to determine mutually convenient dates for a hearing. Order, issued March 7, 2024. The hearing took place in Boston, Massachusetts on October 3-4, 2024. An order to show cause was issued on October 18, 2024 and advised that, based upon the evidence and arguments, Mr. Farrell was tentatively found to be entitled to compensation and specified topics that the parties should address in their post-hearing briefs. Respondent filed his post-hearing brief on February 3, 2025. Petitioner filed his response to respondent’s brief on April 18, 2025. Respondent did not submit a reply. The case is ready for adjudication. III. Standards for Adjudication A petitioner is required to establish his case by a preponderance of the evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence standard requires a “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 v. Sec’y of 4 Dr. He is a professor of immunology in the department of immunology at Duke University Medical Center. Exhibit A at 1. Dr. He’s research areas include human immune responses to viral infections, including influenza, HIV, HBV, and HCV. Id. Dr. He has served as a review expert for the NIH Study Section Cellular and Molecular Immunology-B and an ad hoc member for the NIH Biodefense Study Section. Id. at 1-2. Dr. Cohen holds certifications in clinical neurophysiology and neuromuscular disease. Exhibit C at 1. Dr. Cohen is a professor and chair of the department of neurology at the Geisel School of Medicine and the Dartmouth Hitchcock Medical Center. Id. Dr. Cohen had a clinical practice for 39 years, diagnosing and treating an average of 10 patients a year for MS and about two to three patients a year for NMO. Id. 5 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 6 of 19 Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Distinguishing between “preponderant evidence” and “medical certainty” is important because a special master should not impose an evidentiary burden that is too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed. Cir. 2009) (reversing special master's decision that petitioners were not entitled to compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (disagreeing with dissenting judge's contention that the special master confused preponderance of the evidence with medical certainty). IV. Causation Because the Vaccine Injury Table does not associate the Tdap vaccine with NMO, Mr. Farrell must pursue a claim that the Tdap vaccine was the cause-in-fact of the NMO. See Pet’r’s Pre-Hearing Br. at 7-8. For causation-in-fact claims, a petitioner bears a burden “to show by preponderant evidence that the vaccination brought about [the vaccinee’s] injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). A. Althen Prong One – Medical Theory Mr. Farrell’s brief discussed a medical theory of molecular mimicry to explain how the Tdap vaccine can cause NMO. See Pet’r’s Pre-Hearing Br. at 8- 11. In support of his claim, Mr. Farrell relies upon an epidemiologic study and opinions from two experts specializing in diagnosing and treating NMO, Dr. Napoli and Dr. Levy. 1. Epidemiologic Study Mr. Farrell meets his burden of proof largely due to a supporting epidemiologic study. For a lengthy discussion of the value of epidemiologic studies in the Vaccine Program, see Tullio v. Sec’y of Health & Hum. Servs., No. 15-51V, 2019 WL 7580149, at *5-8 (Fed. Cl. Spec. Mstr. Dec. 19, 2019), mot. for rev. denied, 149 Fed. Cl. 448, 475 (2020). Epidemiology is concerned with 6 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 7 of 19 whether a causal relationship exists between an agent and a disease.5 The first question epidemiology addresses is whether an association exists between exposure to the agent and disease. GREEN, supra note 5, at 566. “An association between exposure to an agent and disease exists when they occur more frequently than one would expect by chance.” Id. In support of his claim, Mr. Farrell advanced medical articles, including an epidemiological study conducted by Dr. Levy and his colleagues in 2018. Exhibit 37 (Mealy).6 The Mealy study is a multi-center retrospective analysis of patients with NMOSD for whom immunization history and clinical records from disease onset were available. Id. at 78. The study identified that the concern with vaccines involves the potential risk of non-specific immune activation in patients with immune-mediated diseases. In this study, we investigated the association of a relapse occurring within 30, 60, and 90 days of a vaccination and compared it with the association of a relapse occurring within randomly selected dates. The goal was to determine if vaccines increase the risk of an NMOSD relapse. Id. at 79 (internal citation omitted). Relapses were defined “across all centers as a new or worsening acute neurologic symptom lasting at least 24 [hours], associated with a change in exam localizing to the CNS and not explainable by fever, infection or metabolic condition.” Id. Ninety patients that met the 2015 diagnostic criteria for NMOSD received a total of 211 vaccinations and experienced 340 relapses. Id. The study compared the likelihood of a relapse occurring within 30, 60, and 90 days of a vaccine with the likelihood of a relapse occurring within each time point of a randomly generated date. Id. The study found that the “rate of vaccine-associated relapses within 30, 60, and 90 days was significantly higher than the likelihood of a relapse spontaneously occurring within each of the given time frames (p = 0.034, 0.01, 5 Michael D. Green, et al., Reference Guide on Epidemiology, in REFERENCE MANUAL ON SCIENTIFIC EVIDENCE 566 (3d ed. 2011). 6 Maureen A. Mealy, et al., Vaccines and the association with relapses in patients with neuromyelitis optica spectrum disorder, 23 MULTIPLE SCLEROSIS & RELATED DISORDERS 78-82 (2018), filed as Exhibit 37. 7 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 8 of 19 0.016, respectively) among patients who were not on preventative immunotherapy only.” Id. at 78. The study suggested that “there may be a risk of vaccination- associated relapses among untreated neuromyelitis optica spectrum disorder patients, however immunosuppressive therapy at time of vaccine may abort the risk.” Id. Ninety-five percent of relapses documented in the study were characterized as myelitis and/or optic neuritis. Id. at 79. Additionally, it was noted that “Five of the attacks were at the disease onset and eleven occurred later in the disease course.” Id. Two of the five attacks that were at the disease onset were associated with the Td and Tdap vaccines. Id. at 80. In analyzing the results, vaccines were associated with relapses in patients with NMOSD who were not on preventative immunotherapy, with the highest association occurring during the first 30 days after a vaccine. Id. at 80. The authors acknowledged that While the number of patients available in our cohort of a rare disease does not enable us to make any conclusions about specific vaccines, the data in MS largely mirror that in NMOSD, such that, overall, there appears to be no increased risk of relapses associated with vaccinations. However, the MS literature does not separately analyze the impact that disease modifying therapy may have on this association. Interestingly, most studies examining the relationship between MS onset and tetanus vaccination administration suggest that the vaccine may play a preventative role in MS development, and while less evidence supports this, some data suggest the same of the diphtheria vaccine. This contrasts with our findings of a disproportionate relationship between the tetanus + / - diphtheria vaccine and a subsequent relapse. Given the low number of patients receiving this vaccine in our cohort, more investigation is warranted, but this may be a result of the differing immunopathogenic mechanisms that distinguish MS from NMOSD. Id. at 80-81 (internal citation omitted). The number of observed relapses that occurred within 30 days of a vaccine in the untreated NMOSD study population was outside the range of expectation. Id. at 81. The authors also acknowledged that the study was limited by the inherent biases that exist in retrospective data analyses and thus, lacked rigorous controls. “Selection bias was minimized through the wide inclusion of any patients for 8 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 9 of 19 whom detailed vaccinations and clinical records were available, regardless of frequency of follow-up at each participating center.” Id. at 82. At the hearing, Dr. Levy explained the significance of this article in supporting a medical theory causally connecting the Tdap vaccine and NMO. In Dr. Levy’s words, the significance [of this article] is that we’d heard from a lot of our patients that they believe that their disease was linked to vaccines. So what we did was we said, okay, we’ll take your event and we’ll line up all of your relapses with all of your other vaccines and see if there is a random pattern of vaccines associated with relapses or if there is a more specific pattern of potential causation. And what we found is that statistically there were more events of relapses occurring after -- immediately after, 30 days, 60 days, or 90 days after a vaccine then would be accounted for by just random activity. So statistically, it does seem to be linked. Tr. at 147-48. Even though the article title uses the word “relapses,” Dr. Levy explained that five of the patients in the study were “new onset” of the disease. Tr. at 150, 153. The Secretary disputed that the Mealy article constituted epidemiological evidence that supported Mr. Farrell’s theory. The Secretary argued, even if the Mealy article constituted epidemiological evidence, that its weight is undermined because it contains a methodological flaw in that the subject population was selected based on a pre-existing suspicion that the subjects had suffered vaccine- related relapses. Resp’t’s Post-Hearing Br. at 16. The Secretary argued that the Mealy article, while it “may be somewhat probative with regard to vaccines generally as triggers for relapse in cases of NMO, it does not provide epidemiological support for petitioner’s contention that the Tdap vaccine specifically can cause NMO.” Id. at 17 (emphasis in original). The Secretary argued that this article merits little weight in determining whether Mr. Farrell has met the required standards under prong one. However, when Dr. Levy was questioned about the title of the study referring to only relapses in the Mealy article, he testified that was “because we use ‘relapse’ too loosely.” Tr. at 177. Additionally, Dr. Levy testified that “But maybe even in my notes, I refer to Mr. Farrell’s attack as a relapse. I might have. It’s kind of a slip of the tongue, but it’s not – it’s not accurate to say it that way. . . . We should have been more correct in the title.” Id. Dr. Levy’s testimony and the 9 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 10 of 19 Mealy article persuasively explain how the theory of molecular mimicry explain how the Tdap vaccine can cause NMO. The presence of an epidemiologic study finding that vaccinations are associated with an increased incidence of a disease is strong evidence favoring an award of compensation. See In re Swine Flu Immunization Prods. Liab. Litig., 508 F. Supp. 897, 907 (D. Colo. 1981) (“Where, as here, the exact organic cause of a disease cannot be scientifically isolated, epidemiologic data becomes highly persuasive”), aff'd sub nom. Lima v. United States, 708 F.2d 502 (10th Cir. 1983); In re Agent Orange Prod. Liab. Litig., 611 F. Supp. 1223, 1239 (E.D.N.Y. 1985) (stating that in mass tort cases, “epidemiologic studies on causation assume a role of critical importance”), aff'd sub nom. In re Agent Orange Prod. Liab. Litig. MDL No. 381, 818 F.2d 187 (2d Cir. 1987). Epidemiologic studies often fail to detect an increased incidence, and special masters may consider the lack of a positive finding in an epidemiologic study in denying compensation. See Tullio. When the opposite occurs, a special master should also consider this evidence to determine where the weight of the evidence preponderates. Andreu v. Sec'y of Health & Hum. Servs., 569 F.3d 1367, 1380 (Fed. Cir. 2009) (“Medical literature and epidemiological evidence must be viewed, however, not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act's preponderant evidence standard.”). Here, the Mealy epidemiological study, while not required to support a claim, provides ample support for a reputable theory establishing how a Tdap vaccine can cause NMO. 2. Expert Opinions on Molecular Mimicry Dr. Napoli and Dr. Levy opined that molecular mimicry is a mechanism by which tetanus vaccines can cause NMO. Dr. Napoli and Dr. Levy provided persuasive evidence explaining the medical mechanism that is believed to cause NMO. Dr. Napoli explained that Vaccinations are composed of organic compounds of viral or bacterial origin. These are meant to stimulate an immune response when injected. If the antigen present on the vaccine shares any homologies with host antigen, then immune response will be directed at both the injected antigens and host antigen leading to an autoimmune response. This is known as molecular mimicry which is a well-known response in immunology (Lahesmaa et al. Clin Exp Immunol 1991 86(3): 399- 404). As previously noted, AQP-4 has been identified as the protein present in astrocytes which is the target for specific NMO antibodies. Molecular mimicry has been linked to the development of NMO due 10 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 11 of 19 to the similarity in epitopes of AQP-4 water channels and antigens, examples such as Hep B vaccination. Exhibit 12 at 6. Dr. Levy opined that The specific components of the Tdap vaccine are used in mouse models to trigger immune mediated neurological injury, especially the pertussis toxin (the “p” of the Tdap vaccine), which is hypothesized to transiently break down the blood brain barrier and permit the immune system to invade the nervous system. Molecular mimicry has been demonstrated in mouse models of neuromyelitis optica where immunization with the ABC water transporter of the Campylobacter bacterium that shares homology with the aquaporin-4 can recapitulate the human disease phenotype. Ex. 34 at 3. The Secretary argued that Mr. Farrell’s theory is not sufficiently detailed or specific to meet the requirements of prong one of Althen. In contesting Mr. Farrell’s claim, the Secretary submitted reports from Dr. He and Dr. Cohen. Exhibit A, E, G; Exhibit C, F. The Secretary also advanced testimony and articles arguing that recent evidence undermines the theory of molecular mimicry. The Secretary’s expert, Dr. He, opined that evidence of cross-reactivity alone does not support the conclusion that the Tdap vaccine can cause NMO because cross-reactivity happens constantly. Exhibit E at 6. Dr. He also testified that homology is not enough to establish molecular mimicry. Tr. at 276-78. Dr. He submitted three articles to support his opinion. Exhibit A, Tab 11 (Kanduc);7 Exhibit A, Tab 12 (Trost);8 Exhibit A, Tab 13 (Kusalik).9 These articles focus largely on amino acid sequences through the human proteome. The Secretary contended that evidence “of sequence homology and cross-reactivity are components of molecular mimicry, but do not demonstrate that a pathological outcome is likely, or even possible.” Resp’t’s Post-Hearing Br. 7 Darja Kanduc, et al., Massive peptide sharing between viral and human proteomes, 29 PEPTIDES 1755-66, 1755 (2008), filed as Exhibit A, Tab 11. 8 Brett Trost, et al., Bacterial peptides are intensively present throughout the human proteome, 1 SELF/NON-SELF 71-74, 71 (2010), filed as Exhibit A, Tab 12. 9 Anthony Kusalik, et al., Widespread and ample peptide overlapping between HCV and Homo sapiens proteomes, 28 PEPTIDES 1260-67, 1260 (2007), filed as Exhibit A, Tab 13. 11 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 12 of 19 at 20. However, Mr. Farrell’s experts and articles support preponderantly that molecular mimicry is a reliable theory, even if it is not accepted at a level of scientific certainty. Dr. Levy disagreed with Dr. He and testified that molecular mimicry is the best mechanism we have. We don’t really have another good explanation for why this would happen, but I should say it’s the basis of almost all of our neuroimmunological mechanisms. There has to be some reason the immune system makes this mistake. So molecular mimicry is the best explanation for why the immune system would make this mistake. Tr. at 155. Dr. Levy also testified that he thinks molecular mimicry is still “a very valid general mechanism.” Tr. at 157. 3. Assessment To the extent that the parties disagree, Mr. Farrell has provided sufficient, preponderant evidence to demonstrate a reputable medical theory that supports that Tdap vaccination can cause NMO through the mechanism of molecular mimicry. The Mealy epidemiological study, combined with the expert reports and testimonies of Mr. Farrell’s treating doctors tilts the evidence in Mr. Farrell’s favor, helping him establish his claim preponderantly. Unlike in some other cases that may rely on expert opinions and case studies to try and establish their claim to entitlement, the addition of an epidemiological study provides the level of preponderant support to demonstrate how molecular mimicry is a viable mechanism to establish how a Tdap vaccine can cause NMO. While epidemiological studies are not necessary to prove a successful claim in the Vaccine Program, here, this study provides enough support beyond vaguely raising molecular mimicry as a possible biological mechanism as to how a vaccine can cause a disease. Under the circumstances in which an epidemiologic study supports a finding that a vaccine can cause an injury and in which the Secretary has not meaningfully contested a proposed theory, an in-depth exploration of the theory is not required. The epidemiologic study persuasively shows that the Tdap vaccine can cause NMO. How that occurs---whether by molecular mimicry or some other means---is much less important than the showing that it does occur. See Lane v. Sec'y of 12 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 13 of 19 Health & Hum. Servs., No. 19-501V, 2024 WL 3584871, at *5 (Fed. Cl. Spec. Mstr. June 7, 2024). For these reasons, Mr. Farrell has met his burden of proof regarding prong one. Thus, the remaining Althen elements are considered. B. Althen Prong Three – Timing Althen’s third prong requires “a showing of a proximate temporal relationship between vaccination and injury.” 418 F.3d at 1278. The timing prong actually contains two parts. A petitioner must show the “timeframe for which it is medically acceptable to infer causation” and the onset of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed. Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013). The medically acceptable timeframe depends, at least in part, on the theory being offered. Langland v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 421, 443 (2013). Mr. Farrell argued that he has produced evidence showing a proximate temporal relationship between vaccination and onset of his NMO symptoms. Mr. Farrell presented opinions from Dr. Napoli and Dr. Levy regarding a timeframe from which an inference of causation is appropriate. Dr. Napoli opined that an onset of NMO symptoms occurring within five weeks and up to 10 weeks after vaccination is an appropriate timeframe for causation. Exhibit 12 at 7. Dr. Levy opined that “vaccine associated attacks” such as NMO “most often occur within the first 30 days from the jab, but can rarely occur 60 or even up to 90 days later in rare cases.” Exhibit 34 at 2. Dr. Napoli’s and Dr. Levy’s opinion that the onset of NMO 21 days post- vaccination is also supported by the Mealy article. Vaccine associated relapses were defined as those relapses that occurred “within 30, 60 or 90 days following an immunization.” Exhibit 37 (Mealy) at 79. For the second part of Althen prong three, Mr. Farrell argued that his NMO symptoms arose within the medically acceptable timeframe proposed by Dr. Napoli and Dr. Levy. Pet’r’s Post-Hearing Br. at 51. Dr. Napoli opined that “to a reasonable degree of medical certainty that the vaccination on February 15, 2017, more probably than not, caused and triggered symptoms that Mr. Farrell experienced after, with subsequent visit to Beth Israel Medical Center on March 8, 2017.” Exhibit 12 at 7. Dr. Levy agreed with Dr. Napoli that “the chronology 13 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 14 of 19 between the time of the vaccination and the onset of [NMO] symptoms 3 weeks later” was “well within the accepted time period for a vaccine induced neuro immunological injury.” Exhibit 34 at 4. Dr. Napoli’s and Dr. Levy’s opinion that the onset of NMO 21 days post- vaccination is also supported by the Mealy article. Vaccine associated relapses were defined as those relapses that occurred “within 30, 60 or 90 days following an immunization.” Exhibit 37 (Mealy) at 79. The 30-day time point was chosen as the primary analysis based on a large study that suggested there was no increased association of any CNS demyelination beyond 30 days from time of vaccine administration (Langer-Gould et al., 2014), and the analysis was extended in this study to 60- and 90-day time points based on case reports of temporality of vaccination to relapse in NMOSD beyond 30 days (Menge et al., 2012). Id. The Secretary disputed that Mr. Farrell provided any evidence to support that the Tdap vaccine can cause NMO in any timeframe, which makes it impossible to affix a time period in which it would be acceptable to infer vaccine causation. The Secretary argued that Dr. Napoli and Dr. Levy acknowledged in their testimony that their primary support for the causal theory is based simply on timing, which is insufficient to show a causal link between the Tdap vaccination and Mr. Farrell’s NMO. Resp’t’s Post-Hearing Br. at 30 citing Tr. at 26, 202. However, Mr. Farrell argued that the Secretary’s expert, Dr. He, conceded that the appropriate timing is met. Dr. He opined that Indeed, Mr. Farrell’s vaccination on February 15, 2017, and his symptoms after vaccination with subsequent visits at the Beth Israel Medical Center on March 8, 2017, are consistent with the temporal relationship between the receipt of Tdap vaccination and his NMO disease development (meaning that the time frame between the receipt of the vaccination and the development of NMO symptoms is medically possible). Exhibit A at 7; Tr. at 326. Here, Mr. Farrell has met the requirements of prong three of Althen with preponderant evidence. Mr. Farrell has established an acceptable medical theory 14 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 15 of 19 that NMO symptoms can develop within 30 days post-vaccination and that his symptoms did occur within 21 days post-vaccination. C. Althen Prong Two – Logical Sequence The remaining Althen prong requires a preponderant presentation of “a logical sequence of cause and effect showing that the vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. With respect to this prong, the Federal Circuit has instructed special masters to consider carefully the views of a treating doctor. Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (“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). Recommendations to avoid certain vaccines have been credited and have not been credited as indications of a causal role for a vaccine. Compare Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (stating given the testimony of a treating doctor, “the decision to withhold future administration of the pertussis vaccine provides little probative evidence of causation”); Gramza v. Sec’y of Health & Hum. Servs., 139 Fed. Cl. 309, 335-36 (2018) (ruling that the special master was not arbitrary in refraining from giving decisive weight to a note from a treating doctor advising “no future vaccination” when the treater wrote the note three years after the incident); and Bangerter v. Sec’y of Health & Hum. Servs., No. 14-1187V, 2022 WL 439535, at *29 (Fed. Cl. Spec. Mstr. Jan. 18, 2022) (although a recommendation to avoid future vaccinations has some value, this evidence does not carry petitioner’s burden on prong two when petitioner failed to meet prongs one and three) With Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1377 (Fed. Cir. 2008) (the opinion of a treating doctor to withhold future vaccines can be quite probative); and Robinson v. Sec’y of Health & Hum. Servs., No. 14-952V, 2021 WL 2371721, *1376-77 (Fed. Cl. Spec. Mstr. Apr. 12, 2021) (evidence that treating doctor withheld vaccines helps support prong two). Mr. Farrell argued that he has produced evidence of a logical sequence of cause and effect showing that the Tdap vaccination was the reason for Mr. Farrell’s NMO. Pet’r’s Post-Hearing Br. at 33-50. Mr. Farrell asserted that Dr. Napoli’s credible testimony reinforced Mr. Farrell’s claim “that the Tdap vaccine was a trigger and causative of the patient’s subsequent NMO.” Tr. at 33. Importantly, Dr. Napoli, as both an expert and treating physician, is afforded considerable weight when assessing a logical sequence of cause and effect. Dr. Napoli also 15 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 16 of 19 opined that it was “more probable than not that the [Tdap] vaccine may have triggered the onset of [Mr. Farrell’s] NMO subtype of demyelinating disease.” Exhibit 4 at 35. Mr. Farrell argued that Dr. Levy’s opinion on vaccine causation is based upon more than simply temporal relation and lack of alternative causes. Mr. Farrell asserted that Dr. Levy’s opinion is based on “solid scientific evidence, including numerous published peer reviewed scientific research and studies, including of his own epidemiologic studies (Mealy), as well as the specific facts and circumstances of Mr. Farrell’s illness.” Pet’r’s Post-Hearing Br. at 38 (emphasis in original). Dr. Levy opined that “The cause of [Mr. Farrell’s NMO] attack is most likely related to a vaccine Mr. Farrell received just prior to the attack on February 17, 2017.” Exhibit 34 at 2. Dr. Levy explained that Mr. Farrell’s “attack occurred starting 14 days after immunization. There is nothing else in Mr. Farrell’s prior history that could confound the chronological link such as the use of immunosuppressive medication or known autoimmune disease.” Id. Dr. Levy opined that In Mr. Farrell’s case, an aquaporin-4 antibody was not present at the time of the time suggesting that a different immunological antigen was the target in his case. Since March 2017, a new neurological target called myelin oligodendrocyte glycoprotein (MOG) was found to be to be present in up to 40% of patients with neuromyelitis optica who test negative for the aquaporin-4 antibody. At the time of Mr. Farrell’s attack, the MOG antibody test was not available. Notably, this antibody does not remain in circulation in the majority of patients beyond 6-12 months after an attack. Mr. Farrell tested negative for the MOG antibody when it became commercially available but that does not necessarily mean MOG was not the target of his attack. In my lab, we continue to search for additional neurological antigens of aberrant immune attacks. Id. at 3-4. Dr. Napoli testified that in his own practice, with a patient like Mr. Farrell, he “would not recommend [Mr. Farrell] get the Tdap vaccine, and I suspect 95 percent of providers would agree with that.” Tr. at 41. When asked whether he would advise Mr. Farrell to get a Tdap vaccine, Dr. Napoli stated that he would advise Mr. Farrell not to get “this specific vaccine, the Tdap.” Id. at 95. When Dr. Napoli was asked how he would advise Mr. Farrell if Mr. Farrell had stepped on a rusty nail, he testified that he would talk to Mr. Farrell’s team of doctors and 16 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 17 of 19 specialists to weigh the risks and benefits of vaccination, if he was on an immunosuppressant treatment. Id. So there may be the possibility that a team approach might say, hey, maybe you should get it, because the risk of having tetanus might be higher than NMO again, but we’re not sure what that risk is. And, ultimately, he’d have to make the decision, you know, if he wanted to do it. So in that scenario, it’s a great example of – how we approach in the offices that scenario, probably work as a team, bring in other providers involved in coming up with the benefits and also what could happen. Id. at 96. Similarly, Dr. Levy testified that he usually advises his patients “to receive a vaccine because all of my NMO patients are treated, and we know that treated patients who take vaccines have better outcomes.” Id. at 189. Dr. Levy, like Dr. Napoli, is one of Mr. Farrell’s treating physicians and Mr. Farrell argues that Dr. Levy’s testimony is entitled to significant weight. Pet’r’s Post-Hearing Br. at 37. The Secretary argued that Mr. Farrell’s causation theory is insufficient to prove a logical sequence of cause and effect. Resp’t’s Post-Hearing Br. at 24-26. The Secretary points to the progression of the strength of Dr. Napoli’s opinion regarding causation throughout the course of treatment. The Secretary asserted that because Dr. Napoli’s opinion progressed from “[t]he implication of [the Tdap] injection is unknown,” Exhibit 4 (December 19, 2017) at 2, to a few months later stating that it was “more probable than not that [the Tdap] vaccine may have triggered the onset of [Mr. Farrell’s] NMO subtype of demyelinating disease,” Id. (March 8, 2018) at 35, then to it was “more probable than not, that [Mr. Farrell’s] diagnosis [w]as related to the Tdap vaccination,” Exhibit 7 (September 6, 2018) at 1, and finally escalating his opinion to being “more likely than not triggered” by the February 2017 Tdap vaccination, Exhibit 9 (January 28, 2019) at 2, weakens the credibility of his opinion because it was written just under one month before Mr. Farrell filed his petition for vaccine compensation. Resp’t’s Post-Hearing Br. at 24-25. The Secretary argued that Dr. Napoli’s opinion did not provide anything other than temporal proximity to support his revised opinion. The Secretary maintained that Dr. Napoli’s opinion of vaccine causation should be assigned little weight. Resp’t’s Post-Hearing Br. at 25. 17 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 18 of 19 Similarly, the Secretary contended that Dr. Levy’s opinion that Mr. Farrell’s NMO was caused by the Tdap vaccine relies solely on the proximate temporal relationship and lack of other explanations is not sufficient to demonstrate causation. Resp’t’s Post-Hearing Br. at 26. The Secretary next argued that there were alternative causes reasonably raised in the record, even if the Secretary did not pursue a formal alternative cause argument. Id. The Secretary pointed to medical records that undercut Mr. Farrell’s claim of vaccine causation, specifically symptoms of a viral illness prior to his neurological disease onset, even if the specific infectious agent behind Mr. Farrell’s symptoms was not identified. Testimony from Dr. Cohen and Dr. He underscored the Secretary’s argument and opined that a wild pathogen causes a “much stronger” immunologic response than a Tdap vaccine. Tr. 290-92. The Secretary disputed whether Mr. Farrell has met his burden under prong two of Althen. Resp’t’s Post-Hearing Br. at 23-29. Mr. Farrell responded to Dr. He’s assertion that a flu-like illness was far more likely to have caused a “potent immunological stimulus,” triggering Mr. Farrell’s NMO as being nothing more than conjecture. See Exhibit G at 3; Pet’r’s Post-Hearing Br. at 39. Mr. Farrell argued that he was never diagnosed nor treated for an infectious illness prior to the onset of his NMO. Id. Mr. Farrell’s NMO started on March 3, 2017 or March 4, 2017. On March 8, 2017, Mr. Farrell’s doctor noted that he had a flu-like illness one week prior, placing the flu-like symptoms on March 1, 2017 at the earliest. Mr. Farrell argued that even if he had a “viral illness” on March 1, 2017, that would be too soon to have caused Mr. Farrell’s NMO two days later. See Exhibit 3 at 31; Tr. at 124-25, 181-82. Additionally, Mr. Farrell’s experts contended that all Mr. Farrell’s reported non- specific symptoms of a viral illness can also be associated with NMO. Tr. at 51, 161-63. Based on the record as a whole, it appears more likely than not that Mr. Farrell has established a logical sequence of cause and effect, supported by his treating doctors, that the Tdap vaccine caused his NMO. As such, Mr. Farrell has met his burden under prong two of Althen. D. Summary regarding Causation To establish the vaccine was the cause-in-fact of an injury, a petitioner must establish three elements. The undersigned has reviewed all expert reports, articles, witness testimony, and briefs submitted by the parties. In this case, the evidence preponderates in Mr. Farrell’s favor. Mr. Farrell provided persuasive expert 18 Case 1:19-vv-00301-UNJ Document 141 Filed 08/20/25 Page 19 of 19 opinions, supported by reliable medical articles, to meet his burden on all three elements. The Secretary has not met his burden regarding alternative causation. V. Conclusion As evident in medical records and consistent with Mr. Farrell’s experts and treating doctors, Mr. Farrell has preponderantly established that he is entitled to compensation. A separate order regarding damages will issue. IT IS SO ORDERED. s/Christian J. Moran Christian J. Moran Special Master 19 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_19-vv-00301-1 Date issued/filed: 2025-12-10 Pages: 15 Docket text: PUBLIC DECISION (Originally filed: 10/28/2025) regarding 154 DECISION of Special Master. Signed by Special Master Christian J. Moran. (jjb) Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 1 of 15 CORRECTED1 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS * * * * * * * * * * * * * * * * * * * * * RYAN FARRELL, * * No. 19-301V * Special Master Christian J. Moran Petitioner, * v. * * Filed: October 28, 2025 SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * Leah VaSahnja Durant and Glenn MacLeod, Law Offices of Leah V. Durant, PLLC, Washington, D.C., for Petitioner; Elizabeth Andary and Emily Hanson, United States Dep’t of Justice, Washington, D.C., for Respondent. PUBLISHED DECISION AWARDING INTERIM COMPENSATION2 Ryan Farrell established that a tetanus, diphtheria, and acellular pertussis (“Tdap”) vaccine caused him to suffer from neuromyelitis optica (“NMO”). Entitlement Ruling, issued July 29, 2025, 2025 WL 2409187. He has sought an interim award of compensation for his pain, suffering, and emotional distress. The Secretary opposes an interim award, primarily upon legal (as opposed to factual) grounds. For the reasons explained below, Mr. Farrell is awarded $210,000.00. 1 This decision was corrected to include payment disbursement information. 2 Because this decision contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the parties have 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. Any changes will appear in the document posted on the website. Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 2 of 15 I. Facts3 Sources of information about Mr. Farrell’s condition come from three sources: medical records, his affidavits, and oral testimony from the experts retained. A. Medical Records Mr. Farrell was born in 1976. He worked as an electric lineman. While working, he cut his finger. Exhibit 6 at 15-16. As a result, he received the causal Tdap vaccine on Wednesday, February 15, 2017. Id. Due to an “inability to see out of his left eye, difficulty urinating and lower extremity numbness and tingling in the setting of a recent illness,” Mr. Farrell sought care at Needham Emergency Room on Wednesday, March 8, 2017. Exhibit 5 at 10. Mr. Farrell informed the medical staff that “over the weekend he developed what sounds like a flulike illness associated with cough, congestion, malaise and subjective chills.” Id. Testing for various infectious agents was negative. Id. at 11, 17. Mr. Farrell was transferred to a hospital in Boston. Id. at 11. In the emergency room at Beth Israel Deaconess Hospital, Mr. Farrell rated his pain as a six out of ten. Exhibit 3 at 27. Mr. Farrell also reported “pain with movement” during his initial consultation with a neurologist in the hospital. Id. at 48. Other problems included urine and stool retention. Based upon this presentation, the neurologist was concerned about various demyelinating conditions and admitted Mr. Farrell to the hospital. Id. While in the hospital, Mr. Farrell underwent two MRIs. An MRI of his head showed a hyperintense signal in the left optic nerve. Exhibit 3 at 8 (March 9, 2017). An MRI of his cervical and thoracic spine also showed a hyperintense signal from C5-6 to C7-T1. Id. Based upon these results he was diagnosed with “likely” “neuromyelitis optica.” Id. This diagnosis was reached despite a lack of antibodies typically found in NMO patients. The initial nurse’s assessment memorialized that Mr. Farrell complained of chronic and intermittent pain in his lower back at baselines. Exhibit 3 at 38. Mr. Farrell received occupational therapy and physical therapy. See id. at 54-58 (initial occupational therapy evaluation) and 65-68 (initial physical therapy evaluation). Mr. Farrell was treated with Solu- Medrol for five days and rapidly improved.4 He was discharged on March 13, 2017. Exhibit 3 at 8-9. At the time of discharge, Mr. Farrell could walk independently. Id. at 7. When out of the hospital, Mr. Farrell saw a neurologist, Jacob Sloane. Dr. Sloane’s impression was that Mr. Farrell suffered from NMO. Exhibit 3 at 205 (Mar. 16, 2017). The 3 A portion of the evidence summarized here repeats from the July 29, 2025 Entitlement ruling. However, this decision emphasizes the evidence showing Mr. Farrell’s pain, suffering, and emotional distress. 4 “Solu-Medrol” is a trademark for methyl-prednisolone sodium succinate. Dorland’s Illus. Med. Dict. 1703 (33rd ed.). Methylprednisolone, in turn, is an anti-inflammatory and immunosuppressant. Id. at 1137. 2 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 3 of 15 experts retained for this litigation agree with the diagnosis of NMO. Dr. Sloane prescribed Rituxan. Exhibit 3 at 206, 208.5 Mr. Farrell’s physical therapy, which started during the hospitalization, continued on an out-patient basis. Mr. Farrell attended physical therapy roughly once every other week for five sessions from March 17, 2017 to May 5, 2017. Exhibit 2 at 52-67. At the end of this period, Mr. Farrell reported that he had improved and was planning to return to work. Id. at 64. Mr. Farrell saw his neurologist, Dr. Sloane, in follow-up on June 15, 2017. Dr. Sloane documented that Mr. Farrell had returned to work as an electrician, working on power lines, but he is “clumsier, running into things/tripping or squeezing things too tightly in his hands.” Exhibit 3 at 216. Dr. Sloane also recorded that Mr. Farrell was continuing “to have pain in his lower back especially when he bends over. It is an electrical pain that shoots down his spine and into his legs. It is much worse in the heat.” Id. Dr. Sloane also explained how the disease was affecting Mr. Farrell: Overall, he has noted that he becomes very tired easily and has trouble getting out of bed. He feels depression and is having trouble sleeping. Also has low energy levels, decreased concentration. He does not want to take any medications for depression. He feels overwhelmed by the diagnosis but is slowly starting to adapt. Id. at 215. Although Mr. Farrell’s motor strength was normal, he had decreased sensation. Id. at 217. His gait was narrow based. Dr. Sloane ordered more imaging, which showed the previous lesions had resolved. Id. at 247-48 (July 6, 2017). In August, Mr. Farrell missed work due to illness. Exhibit 57 at 63. Apparently, he had a flare-up of symptoms in the hot weather. See Exhibit 2 at 68. In early August, he received three more infusions of Solu-Medrol. Exhibit 3 at 223-229. Dr. Sloane saw Mr. Farrell again on September 18, 2017. Exhibit 3 at 232. Dr. Farrell documented that Mr. Farrell was on short-term disability and would continue for “the full duration of several months allowable.” Id. at 233. A new problem was “pressure/achyness to the L foot sole.” Id. at 232. Dr. Sloane’s impression included that Mr. Farrell has “intermittent pain issues.” Id. at 235. Following this appointment with Dr. Sloane, Mr. Farrell resumed physical therapy. From September 22, 2017 to December 8, 2017, Mr. Farrell had five sessions. Exhibit 2 at 68-82. These records note, without much detail, that Mr. Farrell had pain. The final report is not particularly informative, stating that Mr. Farrell has good capacity for advancement. 5 Rituxan “is an anti-CD19 monoclonal antibody that targets B cells that have that receptor.” Tr. at 106. Rituxan is a trademark for a preparation of rituximab. Dorland’s at 1623. 3 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 4 of 15 Mr. Farrell returned to Dr. Sloane on December 14, 2017. Exhibit 3 at 242-45. Dr. Sloane recorded that “He is trying to get a more sedentary job so his health is not at risk.” Id. at 242. Generally, the December 14, 2017 record resembles the September 18, 2017 record, including a note that Mr. Farrell is having “intermittent pain issues.” Id. at 245. Dr. Sloane added a prescription for tramadol for pain control. Id.6 Mr. Farrell sought a second opinion about NMO from a neurologist, Salvatore Napoli. Exhibit 4 at 2 (Dec. 19, 2017). The history of present illness recounts that “The main issue now appears to be the pain.”7 More specifically, “he has cramping of the feet, he has [tightening] of his legs and feet” and “he will have severe pain of his lower back as well.” Id. Dr. Napoli’s examination more or less matched what Dr. Sloane had been finding. Dr. Napoli’s assessment included that Mr. Farrell “has residual pain in the lower extremities, spasticity, as well as difficulties with his gait. . . . Our plan will be to continue rituximab therapy or even transition to ocrelizumab.” Id. at 4. Dr. Napoli continued that Mr. Farrell’s “main issue of pain may also be related to spasticity so we will start him on baclofen and I will give him Vicodin as needed. . . We may also consider tizanidine or medicinal cannabinoid.” Id. In the next two appointments, Mr. Farrell continued to complain about pain, although the pain improved slightly. Exhibit 4 at 6-13. At the end of January 2017, Mr. Farrell had a flare of neck pain, which Dr. Napoli characterized as a Lhermitte’s-like phenomenon. Id. at 14-25. Mr. Farrell participated in another course of physical therapy in February 2018. Exhibit 42. He attended about five sessions. In the initial evaluation, the physical therapist obtained a history of Mr. Farrell’s neurologic problem. In this context, the therapist noted: “He is struggling with the mental health aspect of dealing with a disabling disease and feels overwhelmed with the treatment and prognosis.” Id. at 97. He reported becoming fatigued when walking 15 minutes. Id. He had a numbing pain in his both feet, which ranged from 3-7, and sharp pain in his cervical spine, which ranged from 3-7. Id. The last physical therapy appointment was on February 27, 2018. Id. at 38. Mr. Farrell appeared to have apologized for canceling sessions in the previous week, explaining, “‘The depression of all this is getting to be too much.’” The assessment also reflects this concern: “Pt notes extreme difficulty dealing with chronic pain, overwhelming nature of dealing with potential disability from work, mounting expenses.” Id. at 39. By the middle of February, Mr. Farrell was requesting that Dr. Napoli prescribe stronger medication for pain, such as oxycodone. Dr. Napoli gave him a one-month supply but stated that Mr. Farrell should seek assistance from pain management. Exhibit 4 at 27. Although the oxycodone helped, within about two weeks, Mr. Farrell reported “pain is all over but worse on the R side in both the arm and the leg, some burning quality.” Id. at 30 (Mar. 1, 2018). Dr. 6 “Tramadol hydrochloride” is an “opioid analgesic used for the treatment of moderate to moderately severed pain.” Dorland’s at 1920. 7 Some of Dr. Napoli’s records are written in all capital letters. This decision uses more traditional capitalization without specifically noting the alteration. 4 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 5 of 15 Napoli added another medication, Cymbalta.8 Although Dr. Napoli considered referring him to physical therapy, Mr. Farrell said that physical therapy is painful. Id. at 31. On March 8, 2018, Mr. Farrell reported concerns about the effectiveness of Cymbalta in controlling his pain. Exhibit 4 at 34. Dr. Napoli increased the dose of Cymbalta. Id. at 35. Dr. Napoli stated: “patient is disabled from all gainful employment.” Id. at 35. With the increase in oxycodone, Mr. Farrell’s pain improved from 8/10 to 6/10. Exhibit 4 at 38 (Mar. 16, 2018). In this visit, Mr. Farrell informed Dr. Napoli that he (Mr. Farrell) thinks he has not “ever returned to baseline after initial attack last March.” Id. at 39. Due to the continued pain, Dr. Napoli introduced a new medication, Acthar.9 Exhibit 4 at 42 (Mar. 20, 2018). Mr. Farrell returned to Dr. Napoli about two weeks later again stating he “has been in pain all the time.” Id. at 46. Dr. Napoli also documented that Mr. Farrell got “a pill from his friend. A urine test did show positive fentanyl.” Id. Dr. Napoli and his nurse practitioner, Stacey Murray, spoke to Mr. Farrell about their policy and planned to taper Mr. Farrell off oxycodone. Then, Mr. Farrell was expected to resume pain management. Id. at 47. About two weeks later, Mr. Farrell was promising to go to pain management. Exhibit 4 at 51 (Apr. 20, 2018). In the meantime, Mr. Farrell stated that “he has stopped taking opiate-based medications.” Id. Dr. Napoli advised that due to Mr. Farrell’s weakness, he should be on disability. Id.10 As Dr. Napoli had been recommending, Mr. Farrell saw a specialist in pain management, Sherif Algendy, on April 25, 2018. Exhibit 8. Mr. Farrell reported neck and lower back pain that averaged 7 out of 10 with a 10 being the worst pain. Id. at 1. The history reports that Mr. Farrell stopped oxycodone 24 days ago. The plan was to increase the dosage of Cymbalta. Another alternative was to try CBD. Id. at 3. Mr. Farrell returned to Dr. Napoli on January 11, 2019. Exhibit 44 at 108. The reason for this appointment was “NMO/letter.” Dr. Napoli recorded that although Mr. Farrell was “feeling improved,” “he is still having chronic issues, feet, hip, and back.” Id. Other specific problems included feeling squeezed like by a band, a difficulty with urination, a difficulty with moving his 8 Cymbalta is a trademark for duloxetine hydrochloride. Dorland’s at 452. Duloxetine hydrochloride, in turn, is a medication “used for the treatment of major depressive disorder and the relief of pain in diabetic neuropathy.” Id. at 566. 9 Acthar is a trademark for corticotropin. Dorland’s at 21. Corticotropin, in turn, stimulates the production of corticosteroids. Id. at 416-17. 10 A medical record from December 31, 2024 states that Mr. Farrell had a fentanyl overdose in 2021. In this context, Mr. Farrell reported that he had “past opioid addiction due to frequent pain in the setting of neuromyelitis optica.” Exhibit 55 at 45. Another December 2024 medical record suggests that opioid addiction occurred prior to 2021 as Mr. Farrell “detoxed in 2017.” Id. at 68. 5 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 6 of 15 bowels, and leg fatigue and weakness. Id. at 108. Dr. Napoli ordered labs and prescribed medications. This appointment with Dr. Napoli led to another course of physical therapy, which started on January 15, 2019. Exhibit 45 at 73. Mr. Farrell stated that he “feels like always being squeezed tight or wearing [a] belt.” Id. Before his injury, he walked 1-2 miles with a dog. Currently, he could walk about 0.25 miles and he tripped when he did not pick up his boots. He again reported pain in his back and both feet. The physical therapist observed problems with Mr. Farrell’s gait. Id. at 76. Mr. Farrell attended about 17 sessions of physical therapy at the beginning of 2019. He did not attend an appointment scheduled for May 22, 2019 because he planned to exercise at his house. Exhibit 45 at 3. In the previous session, which was May 1, 2019, he reported that his “walking is getting better and that he is getting more strength in his legs.” Id. at 7. Mr. Farrell returned to Dr. Napoli’s practice on May 16, 2019, when he saw Nurse Practitioner Murray. Exhibit 44 at 99. The chief complaint was: “Follow up NMO. SS [probably Social Security] hearing 5/21/2019.” Mr. Farrell reported that “he has been feeling ‘okay.’” Id. Mr. Farrell “continues to have ‘tightening’ sensations, occasionally described as electrical shock in the spine or in the legs. [T]his is intermittent but ‘when it happens it is severe.’” Id. The plan was continuing his medication, Ocrevus. Dr. Napoli and Ms. Murray supported his application for benefits because Mr. Farrell “can no longer perform his job function[s].” Id. at 100. Across the next approximately 18 months, Mr. Farrell returned to Dr. Napoli’s practice approximately every month. Exhibit 44 at 39-97. During this time, Mr. Farrell continued to receive various treatments. See, e.g., id. at 82 (Dec. 17, 20219 for Ocrevus), at 77 (May 6, 2020 for medical marijuana), at 63 (June 25, 2020 for Solumedrol), at 52 (July 13, 2020 for Rituximab), at 47 (Aug. 7, 2020 for Botox). Occasionally, Mr. Farrell reported exacerbations. See, e.g., id. at 56 (June 29, 2020). Mr. Farrell reported another exacerbation on December 31, 2020. Exhibit 44 at 36. Despite treatment, Mr. Farrell did not improve. Thus, on January 12, 2021, he sought care from the emergency department at Newton-Wellesley Hospital. Exhibit 46 at 3. He complained about lower abdominal pressure, including urinary retention and an inability to move his bladder. Medical personnel consulted neurologists at Massachusetts General Hospital. Dr. Michael Levy offered to admit Mr. Farrell to his service but no beds were available. Id. at 9. So, Mr. Farrell was admitted to Newton-Wellesley Hospital. While in the hospital, Mr. Farrell underwent a series of tests, including another round of MRIs. The MRI of the cervical spine and thoracic spine showed degenerative changes. Exhibit 46 at 41, 50. The doctor responsible for his treatment considered these results to be unrevealing. Id. at 23. Mr. Farrell was discharged on January 13, 2021. Id. at 23. On February 23, 2021, Dr. Levy saw Mr. Farrell virtually for a new patient consult. Exhibit 43 at 25-27. On June 15, 2021, Dr. Levy saw Mr. Farrell again and assessed that Mr. Farrell was “a 45[-year-old] gentlemen with seronegative, monophasic neuromyelitis optica in 6 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 7 of 15 2017 following a vaccination.” Id. at 15. Dr. Levy stated that Mr. Farrell “remains on rituximab which may be preventing future relapses.” Dr. Levy also memorialized that “Symptoms continue to flare periodically approximately twice per year.” Dr. Levy advised Mr. Farrell to follow-up in about six months. Id. at 18. On December 7, 2021, Mr. Farrell returned to see Dr. Levy in-person. Dr. Levy stated that Mr. Farrell has “been managed with high-dose steroids and rituximab.” Exhibit 43 at 3. Dr. Levy memorialized that “Mr. Farrell reports that he weaned off Lyrica and only uses marijuana and it works for him. He still feels the neuropathy in his feet, which is a little uncomfortable.” Id. “Currently, his neurological function is improving. He is exercising every day and walking. He eats well and feels healthy. He feels some sensation feelings in his hands that comes and goes.” Id. “For preventive treatment, Mr. Farrell previously used rituximab, last used in January in 2021. He is no longer using rituximab as there is no indication that he is at risk for recurrent disease.” Id. Mr. Farrell again expressed an interest in returning to work by, perhaps, using medical marijuana. Id. at 8. In between appointments with Dr. Levy in 2021, Mr. Farrell returned to Dr. Napoli’s practice. See Exhibit 50. Medical appointments in 2022 appear relatively infrequent. On June 22, 2022, Mr. Farrell saw Dr. Napoli. Mr. Farrell “reports feeling good. He hasn't been in the hospital in over a year which he feels really good about. He was stating that he did not have the greatest first few years when he was first diagnosed with MS but today he feels great. No complaints.”11 Exhibit 50 at 7. Under the history of present illness, Mr. Farrell denied “any new issues. He has been limited in his medicine use. He takes Lyrica as needed.” Dr. Napoli added that his “main symptoms are hip and neck pain. He has spasticity and leg pain and leg fatigue with any prolonged distance.” Id. Dr. Napoli recommended repeat MRIs. On February 14, 2023, Mr. Farrell returned to see Dr. Levy and Dr. Anderson. Exhibit 51 at 4. For the interval history, Mr. Farrell reported general improvement: Mr. Farrell states that he has been keeping active and feels that he has almost returned to his baseline. He is currently retired from his previous occupation. He still does not think his balance is where it needed to be to continue with that occupation. [Review of systems] was negative other than paresthesias in the feet at night, persistent urinary retention, and occasional "flashes" in his vision at night. He was even able to walk up 7 flights up for today's appt. He is not currently on any medications other than Adderall and occasional marijuana gummies at night for sleep. Id. at 2. Mr. Farrell was advised to follow up in two years. Id. at 4. The theme of general improvement is also reflected in an August 8, 2023 medical record prepared by a nurse practitioner in Dr. Napoli’s practice, Beverly Wang. Exhibit 50 at 5-6. Ms. 11 The reference to MS (or multiple sclerosis) is mistaken. 7 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 8 of 15 Wang memorialized that Mr. Farrell is currently not on any disease modifying therapy. He occasionally gets “pain in the neck or feet with weather changes.” Id. at 5. Although Dr. Napoli had recommended repeat MRIs in June 2022, Mr. Farrell had not gotten them. Mr. Farrell again deferred more MRIs. The plan was for follow up in six months. By the next appointment, which was by video on April 12, 2024, Mr. Farrell had not obtained another set of MRIs. Exhibit 50 at 3. Mr. Farrell reported “neuropathic pain in his bilateral feet; reports this returned about 3-4 weeks ago as he has been on his feet more at work.” Id. Dr. Napoli prescribed Lyrica and again ordered MRIs. At the end of December 2024, Mr. Farrell was hospitalized for significant cardiac problems. Exhibit 55 at 49. He received treatment for heart failure in 2025. Exhibit 55, passim. B. Affidavits Mr. Farrell submitted two affidavits, both filed relatively early in the litigation. In his first affidavit, which was signed on May 3, 2019, Mr. Farrell described his initial hospitalization in March 2017. Mr. Farrell “thought [he] might die.” Exhibit 10 ¶ 1. Mr. Farrell also recounted that he had difficulty returning to work and the “emotional and financial worries [he has] when this first happened and still have [are] difficult to describe. [His] role as the breadwinner, husband, & father was threatened.” Id. ¶ 2. He further averred that he “spend[s] many long, lonely days wondering if [his] life will ever get back to normal.” Id. ¶ 3. Mr. Farrell provided some general information about his potential damages in an affidavit that was also signed in May 2019. Exhibit 11. Mr. Farrell stated that activities that he could no longer enjoy included: playing with his children, driving long distances, walking long distances, running, and working in the yard. Id. ¶ 10. Although Mr. Farrell was invited to testify at the hearing, he did not testify. However, Mr. Farrell and his family attended the hearing. C. Testimony from Treating Doctors As discussed below, Mr. Farrell presented reports and oral testimony from Dr. Napoli and Dr. Levy. In particular, Dr. Napoli emphasized that Mr. Farrell wanted to return to work. Tr. 25- 27, 107-109. Dr. Napoli stated that Mr. Farrell “had scars to the battle that still remains.” Tr. 108. Dr. Napoli worried that problems with stamina might impair Mr. Farrell’s ability to work. Tr. 109. II. Procedural History12 Mr. Farrell initiated this case by filing a petition on February 26, 2019. The Secretary evaluated this material and recommended that compensation be denied. Resp’t’s Rep., filed pursuant to Vaccine Rule 4, on March 12, 2020. In the Secretary’s view, Dr. Napoli’s January 28, 12 A more extensive procedural history can be found in the July 29, 2025 Entitlement Ruling. 8 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 9 of 15 2019 letter was insufficient to establish that the tetanus vaccine caused Mr. Farrell’s NMO. Id. at 9-10. The parties developed evidence from experts over the next few years. For Mr. Farrell, Dr. Napoli wrote two reports: Exhibit 12, filed October 26, 2020; and Exhibit 39, filed June 4, 2021. Dr. Levy also wrote two reports: Exhibit 34, filed May 14, 2021; and Exhibit 41, filed November 23, 2021. The Secretary’s pair of experts wrote a total of five reports. Dr. He’s reports are Exhibit A, filed March 1, 2021; Exhibit E, filed October 5, 2021; and Exhibit G, filed January 24, 2022. Dr. Cohen’s reports are Exhibits C, filed March 1, 2021; and Exhibit F, filed October 5, 2021. Periodically, the topic of settlement was raised. On some occasions, the Secretary declined to explore an informal resolution. See Resp’t’s Status Rep., filed Jan. 27, 2020; Resp’t’s Status Rep., filed Aug. 6, 2021; Order, issued Mar. 11, 2022; Order, issued April 17, 2024; Order, issued Aug. 8, 2024.13 In any event, the parties did not reach a settlement, and the case proceeded to a hearing. After a hearing and briefing, Mr. Farrell was found entitled to compensation. Entitlement Ruling, issued July 29, 2025, 2025 WL 2409187.. As part of the process for determining the amount of damages, Mr. Farrell anticipates claiming a substantial amount of compensation for his lost earnings. See order, issued July 23, 2025. Whether this claim is justified to any extent remains undetermined. Mr. Farrell requested an award of compensation on an interim basis via the pending motion, filed on Aug. 28, 2025. Mr. Farrell presents essentially three points: (1) as a matter of law, interim awards of compensation are available to petitioners in the Vaccine Program; (2) as a matter of discretion, he should receive an interim award of compensation; and (3) an appropriate amount of compensation for his pain, suffering, and emotional distress is $250,000. The Secretary opposes and challenges each of the three points as discussed below. Resp’t’s Resp., filed Sep. 9, 2025. Mr. Farrell defended his request. Pet’r’s Reply, filed Sep. 26, 2025. With the submission of the reply, the motion is ready for adjudication. III. Analysis Part One: Are Interim Awards of Compensation Available to Petitioners in the Vaccine Program? Interim awards of compensation have happened before. The parties cite the same series of cases. See Pet’r’s Mot. at 2-3; Resp’t’s Resp. at 2-3. In chronological order, starting with the earliest, these are: Lerwick v. Sec’y of Health & Hum. Servs., No. 06-847V, 2014 WL 1897656 (Fed. Cl. Spec. Mstr. Apr. 16, 2014); Day v. Sec’y of Health & Hum. Servs., No. 12-630V, 2016 WL 3457749 (Fed. Cl. Spec. Mstr. May 31, 2016), mot. for rev. denied, 129 Fed. Cl. 450 (2016); Fairchild v. Sec’y of Health & Hum. Servs., No. 13-487V, 2017 WL 6892899 (Fed. Cl. Spec. Mstr. Dec. 1, 2017), mot. for rev. denied, 138 Fed. Cl. 29 (2018), app. dismissed, No. 2018-2320, 13 It appears that the Secretary may have communicated an offer. See Pet’r’s Status Rep., filed July 11, 2024. 9 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 10 of 15 2018 WL 11450386, at *1 (Fed. Cir. Dec. 28, 2018); and Schettl v. Sec’y of Health & Hum. Servs., No. 14-422V, 2020 WL 1912224 (Fed. Cl. Spec. Mstr. Mar. 25, 2020). The Secretary notes that these opinions do not create binding precedent. This is true. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1358 (Fed. Cir. 2019). On the other hand, the Secretary does not meaningfully engage with these opinions’ reasoning. For example, the Secretary contends that the “Vaccine Act does not contemplate multiple damages judgments in the same case.” Resp’t’s Resp. at 3. Yet, in those cases, multiple damages judgments were issued. Moreover, in two cases, the Secretary challenged a special master’s determination that interim awards of compensation are available by filing a motion for review. (The Secretary did not challenge the ruling finding entitlement to compensation.) In both cases (Day and Fairchild), the Court of Federal Claims, which reviewed the special master’s holding that the Vaccine Act allows for interim awards of compensation without deference, also held that petitioners may receive an interim award of compensation. Finally, to the extent that the Secretary were concerned about this interpretation, the Secretary could have appealed to the Federal Circuit. The Secretary took advantage of this option in Fairchild but then dismissed the appeal. Mr. Farrell makes a similar argument with respect to the Fairchild appeal to the Federal Circuit that the Secretary dismissed: If the Secretary wanted to maintain arguments against awards of compensation on an interim basis, it is incumbent on respondent to file a motion for review and, if necessary, to file an appeal so that judges can resolve the issue. Consistently raising an argument before special masters without taking the steps to obtain a definitive interpretation wastes resources of litigants and special masters. Pet’r’s Reply, at 3, citing Nuttal v. Sec’y of Health & Hum. Servs., No. 07–810V, 2011 WL 5926131, at *2 (Fed. Cl. Spec. Mstr. Nov. 4, 2011) (discussing the Secretary’s arguments against awarding attorneys’ fees and costs on an interim basis). In accord with the non-binding authorities cited above, the undersigned holds that awards of interim compensation are available to petitioners in the Vaccine Program. IV. Analysis Part Two: Is an Interim Award of Compensation Appropriate for Mr. Farrell? Although as a matter of statutory interpretation interim awards of compensation are consistent with the Vaccine Act, petitioners are not always entitled to an interim award. Instead, special masters exercise discretion in determining whether an award is appropriate. The parties differ. Mr. Farrell emphasizes that the litigation has been pending for more than six years (Pet’r’s Mot. at 2) and that a lack of gainful employment has made him “in dire 10 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 11 of 15 need of financial assistance” (Pet’r’s Mot. at 11). In contrast, the Secretary suggests that if interim awards of compensation are allowed, then they should be reserved for cases with extraordinary circumstances. Resp’t’s Resp. at 4, citing Day, 2016 WL 3457749, at *5. The Secretary argues that Mr. Farrell has not presented evidence documenting his financial circumstances and points out that he received a payment for his injury via a Workers’ Compensation claim. The Secretary also notes that the resolution of the damages portion of the case has not been protracted. Id. at 5. Finally, the Secretary suggests that the Secretary’s defense of the entitlement portion of the claim should weigh against an award of compensation on an interim basis because “a motion for review of the ruling on entitlement is being seriously contemplated.” Id. at 7. Although Day appears to be limit interim decisions awarding compensation to extraordinary circumstances, the undersigned is not sure that they should be so restricted. Three factors support making interim compensation decision more available. First, the general oft- repeated policy of the Vaccine Program is “to award compensation to vaccine-injured persons quickly.” Cottingham v. Sec’y of Health & Hum. Servs., 971 F.3d 1337, 1343 (Fed. Cir. 2020); accord Koston v. Sec’y of Health & Hum. Servs., 947 F.2d 157, 161 (Fed. Cir. 1992). An interim award, which delivers at least some compensation, more speedily is in accord with Congress’s purpose. Here, Mr. Farrell has qualified as someone who has demonstrated with preponderant evidence that a vaccine harmed him.14 Thus, resolution of the amount of compensation to which he is entitled should happen “quickly.” But this tends not to happen. The time for determining damages is the second reason supporting an interim award of compensation. The process for resolving damages when petitioners seek compensation for unreimbursed medical expenses via a life care plan and compensation for lost future earnings tends to take at least one year minimum. In the damages phase, the parties tend to cooperate. After a ruling finding entitlement in off-Table cases, most cases are resolved via a proffer. The parties deserve credit for reaching agreements with each other that minimize the number of issues in damages that the special masters are called upon to resolve. 14 Although the Secretary states that he might file a motion for review challenging the Entitlement Ruling, this factor plays almost no role in determining whether Mr. Farrell should be awarded compensation on an interim basis. The Secretary possesses a right to contest entitlement by seeking further review. But, the Secretary’s right does not prevent Mr. Farrell from exercising his right to seek an award of compensation on an interim basis. Moreover, if anything, the possibility that the Secretary might challenge the entitlement ruling seems to support an earlier decision awarding a portion of the compensation to which Mr. Farrell might be entitled. If the entitlement ruling were overturned sooner, then the parties would not devote so much time and resources to determining the amount of compensation. See, e.g., Dobrydnev v. Sec’y of Health & Hum. Servs., 566 Fed. App’x 976 (Fed. Cir. 2014) (reinstating a special master’s decision that petitioner was not entitled to compensation and reversing judgment awarding compensation). 11 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 12 of 15 These good-faith efforts from the parties necessarily take time. In general, neither petitioners nor respondent are necessarily at fault for time it takes to process damages. It is usually the case that complicated issues simply require the input of many busy professionals. Third, the time for processing damages hurts petitioners, who are awaiting compensation. The delay cannot be compensated because special masters cannot award interest. Edgar v. Sec’y of Health & Hum. Servs., 29 Fed Cl. 339, 344 (1993). The significance of a lack of interest can be illustrated in a chart based upon interest compounded once per year. Date Value to Mr. Value to Mr. Value to Mr. Compensation Amount Interest Farrell on Farrell on Farrell on Awarded Awarded Rate 11/1/2025 11/1/2026 11/1/2027 11/1/2025 $210,000 4% $210,000 $218,400 $227,136 11/1/2026 $210,000 4% none $210,000 $218,400 11/1/2027 $210,000 4% none none $210,000 The three different rows reflect three scenarios. The first row (compensation awarded on Nov. 1, 2025) reflects an award of interim compensation. The second row (compensation awarded on Nov. 1, 2026) reflects a potentially optimistic resolution of damages with the damages process taking about one year. The third row (compensation awarded on November 1, 2027) reflects a more protracted process. As this chart illustrates, an award of compensation to Mr. Farrell on an interim basis delivers money for his use and enjoyment more quickly and the earlier award of compensation results in a greater amount of money from his perspective. As someone who is entitled to compensation, Mr. Farrell should receive some compensation as quickly as possible. Thus, he is not required to demonstrate extraordinary circumstances.15 Therefore, awarding Mr. Farrell compensation on an interim basis is appropriate. V. Analysis Part Three: What Is A Reasonable Amount of Compensation for Pain, Suffering, and Emotional Distress? The Vaccine Act provides statutory guidance regarding awards for pain and suffering. 15 On the other hand, as a practical matter, limits on judicial resources may preclude interim awards of compensation routinely. In the roughly analogous circumstance of awards of attorneys’ fees and costs, sometimes special masters prioritize resolving amounts of final fees over resolving amounts of interim fees. This prioritization of some cases is an inevitable part of docket management. See Landis v. N. Am. Co., 299 U.S. 248, 255-55 (1936) (recognizing trial courts’ discretion to manage their dockets); Amado v. Microsoft Corp., 517 F.3d 1353, 1358 (Fed. Cir. 2008) (trial courts “are afforded broad discretion to control and manage their dockets, including the authority to decide the order in which they hear and decide issues pending before them”). 12 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 13 of 15 Compensation awarded under the Program to a petitioner under section 300aa-11 of this title for a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, shall include the following: . . . . (4) For actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000. 42 U.S.C. § 300aa-15. “Successful claimants receive compensation for medical, rehabilitation, counseling, special education, and vocational training expenses; diminished earning capacity; pain and suffering; and $250,000 for vaccine-related deaths.” Bruesewitz v. Wyeth LLC, 562 U.S. 223, 229 (2011). With respect to the amount of compensation, the parties’ advocacy could have been better. Mr. Farrell seeks the maximum amount. Pet’r’s Mot. at 13. However, he did not cite any analogous cases. The Secretary did not propose any amount as reasonable. See Resp’t’s Resp. at 7-8. The Secretary also fails to cite any comparable cases. Instead, the Secretary points out that a January 12, 2021 MRI of Mr. Farrell’s spine shows that he has developed degenerative changes. Id. at 8, citing Exhibit 46 at 41. Thus, the Secretary argues that an evaluation of Mr. Farrell’s pain and suffering should be deferred until the record is further developed by obtaining opinions from an expert. The Secretary’s contention that further development is required is misguided for at least two reasons. First, the record already contains the opinion of two experts, Doctors Napoli and Levy. To the extent that the Secretary wanted to counter these opinions, the Secretary has not shown that he has taken any steps to do so. For example, during the entitlement phase, the Secretary retained a neurologist, Dr. Cohen, and presumably, Dr. Cohen, remains available to comment upon whether problems Mr. Farrell experienced after January 2021, when the MRI detected degenerative changes, were attributable to NMO. Actually, Dr. Cohen agreed that Mr. Farrell has “had significant neurological deficits.” Tr. 234. The Secretary did not propose any schedule by which he might present the opinions of an expert. Mr. Farrell does not have to wait. Second, and more importantly, the Secretary’s argument appears to focus on the trees, not the forest. At the broad level, Mr. Farrell was diagnosed with NMO, and the Secretary does not dispute the diagnosis. See Exhibit C (Dr. Cohen’s report) at 5. The onset was in March 2017. This means that he has suffered from NMO for more than eight years. Although Mr. Farrell experienced other health problems during these eight years, none of those other problems eliminate NMO. Furthermore, there is ample information about Mr. Farrell’s physical and mental health from the NMO. The Secretary could have analyzed this evidence to propose an amount of compensation for the pain, suffering, and emotional distress that flowed from Mr. Farrell’s NMO. Except for citing the January 2021 MRI and one other record, the Secretary’s response to Mr. Farrell’s motion for an award for his pain, suffering, and emotional distress omits any discussion of Mr. Farrell’s medical records. The Secretary’s failure to propose a specific number may be interpreted as a waiver of any argument regarding the amount of the pain and suffering. See Vaccine Rule 8(f). 13 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 14 of 15 Highlights from the evidence about Mr. Farrell’s pain, suffering, and emotional distress include the following: • He was hospitalized for about five days in March 2017. Exhibit 3 at 7. • During this time, Mr. Farrell feared he might die. Exhibit 10 ¶ 1. • NMO affected Mr. Farrell’s mental well-being. Exhibit 3 at 215, Exhibit 42 at 97; see also Exhibit 50 at 7. • NMO complicated his employment. Thus, Mr. Farrell worried about the financial circumstances for his family and his himself.16 • From onset in March 2017 to about February 2021, Mr. Farrell’s problems waxed and waned for which he took a variety of medications. His symptoms flared about twice per year. Exhibit 43 at 15. • By the end of 2021, Mr. Farrell was taking relatively little medication to control his residual problems such as paresthesias. Exhibit 43 at 3, Exhibit 50 at 7. • Despite Dr. Napoli’s recommendation, Mr. Farrell did not obtain additional MRIs after June 2022. See Exhibit 50 at 3. This lack of follow up suggests that the neurologic problems were not weighing heavily on Mr. Farrell’s mind. In short, Mr. Farrell experienced four rough years (March 2017 to February 2021). But, the approximately 4.5 years from February 2021 to the present have been comparatively good. When considered as a whole, the evidence preponderantly supports an award for pain, suffering, and emotional distress at $210,000. This amount compensates for pain, suffering, and emotional distress incurred through September 1, 2025. Mr. Farrell remains eligible for an additional award of pain, suffering, and emotional distress incurred after September 1, 2025. 16 Mr. Farrell’s worries about his financial problems are noted. However, this aspect does not contribute significantly to the assessment of his pain, suffering, and emotional distress as the evidence is not complete. A family’s finances depend upon both money received and money spent. Mr. Farrell has presented negligible information about spending money. For the other side of the ledger concerning receiving money, Mr. Farrell’s evidence is also not complete. Although Mr. Farrell states that after his NMO, he has worked little (Pet’r’s Status Rep., filed Sep. 22, 2025), medical records refer to him working at least sometimes. See Exhibit 55 at 49, 60 (stating he worked until 2022), and 148. Further, Mr. Farrell received money through Workers’ Compensation. Exhibit 56 at 8. He also is receiving disability benefits through Social Security. Id. at 12. The statement that evidence about Mr. Farrell’s financial problems is “incomplete” does not mean that he has not worried about his finances. But, when a claim for pain, suffering, and emotional distress is based, in part, on financial problems due to a vaccine-related injury, more information about financial circumstances should be provided. 14 Case 1:19-vv-00301-UNJ Document 165 Filed 12/10/25 Page 15 of 15 Some of this post-September 1, 2025 pain, suffering, and emotional distress might include pain, suffering, and emotional distress that Mr. Farrell is expected to incur after the date of any judgment, which is usually termed “future pain and suffering.” This topic will be discussed at the next status conference. As just stated, the amount is based upon the evidence in Mr. Farrell’s case. The amount of past pain, suffering, and emotional distress also appears consistent with awards in cases with another demyelinating disease, Guillain-Barré syndrome. See, e.g.,Drcar v. Sec'y of Health & Hum. Servs., No. 21-1766V, 2024 WL 5266648 (Fed. Cl. Spec. Mstr. Nov. 14, 2024) (awarding $200,000 in pain and suffering); Fiumara v. Sec'y of Health & Hum. Servs., No. 23-138V, 2024 WL 4930694 (Fed. Cl. Spec. Mstr. Oct. 30, 2024) (awarding $197,500 in pain and suffering); Merchant v. Sec'y of Health & Hum. Servs., No. 20-0450V, 2022 WL 17819548 (Fed. Cl. Spec. Mstr. Nov. 7, 2022) (awarding $170,000 in pain and suffering). Although none of these cases match Mr. Farrell’s case perfectly, they illustrate how special masters have compensated people who have suffered from a demyelinating disease for about five years. VI. Conclusion Mr. Farrell established that his receipt of a vaccine caused him an injury. Congress created the Vaccine Program to compensate people like Mr. Farrell. Here, the evidence supports a finding that a reasonable amount of compensation for the pain, suffering, and emotional distress that Mr. Farrell has incurred is $210,000. A lump sum of $210,000 shall be paid through an ACH deposit to petitioner’s counsel’s IOLTA account for prompt disbursement to petitioner. The Clerk's Office is instructed to enter judgment in accord with this decision unless a motion for review is filed. Information about filing a motion for review, including the deadline, can be found in the Vaccine Rules, which are available on the website for the Court of Federal Claims. IT IS SO ORDERED. s/Christian J. Moran Christian J. Moran Special Master 15