VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00855 Package ID: USCOURTS-cofc-1_20-vv-00855 Petitioner: Craig Fisher Filed: 2020-07-14 Decided: 2024-06-03 Vaccine: influenza Vaccination date: 2018-01-19 Condition: brachial neuritis Outcome: denied Award amount USD: AI-assisted case summary: Craig Fisher, a 67-year-old male, received an influenza vaccine on January 19, 2018. He alleged that he developed brachial neuritis, also known as Parsonage-Turner Syndrome, following the vaccination. Mr. Fisher had a significant past medical history including obesity, diabetes, heart disease, and kidney disease, and had recently undergone surgery for a hernia just prior to receiving the vaccine. He reported onset of severe left arm pain two days after vaccination, which he attributed to the flu shot. His primary care physician diagnosed him with left upper extremity pain, and later diabetic polyneuropathy, while a neurologist suspected carpal tunnel syndrome and cervical radiculopathy based on EMG/NCS testing. Mr. Fisher's expert, Dr. Peter-Brian Andersson, opined that Mr. Fisher suffered from vaccine-induced brachial neuritis, arguing that molecular mimicry could explain the causal link and that surgery was not a plausible cause. Respondent's experts, Dr. Brian Callaghan and Dr. Andrew MacGinnitie, disagreed. Dr. Callaghan concluded that Mr. Fisher's symptoms did not meet the criteria for brachial neuritis and were better explained by his pre-existing conditions like diabetic neuropathy, carpal tunnel syndrome, and cervical radiculopathy. Dr. MacGinnitie focused on causation, finding no reliable mechanism linking the flu vaccine to brachial neuritis and suggesting the prior surgery was a more likely trigger. The Chief Special Master denied Mr. Fisher's claim, finding that he failed to establish by a preponderance of evidence that he suffered from brachial neuritis, noting the lack of contemporaneous medical support for this diagnosis and that the EMG results were more consistent with other conditions. The Court of Federal Claims affirmed this decision on review, finding the Chief Special Master appropriately weighed the evidence and did not err in his legal conclusions. Theory of causation field: Off-Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_20-vv-00855-1 Date issued/filed: 2024-06-03 Pages: 25 Docket text: PUBLIC DECISION (Originally filed: 12/04/2023) regarding 69 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 1 of 25 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-855V * * * * * * * * * * * * * * * * * * * * * * * * * * CRAIG FISHER, * Chief Special Master Corcoran * Petitioner, * Filed: December 4, 2023 v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Andrew D. Downing, Downing, Allison & Jorgenson, for Petitioner. Madelyn Weeks, U.S. Dep’t of Justice, Washington, DC, for Respondent. ENTITLEMENT DECISION1 On July 14, 2020, Craig Fisher filed a petition for compensation under the National Vaccine Injury Compensation Program (the “Vaccine Program”).2 Petition (ECF No. 1) (“Pet.”). Petitioner alleges that he suffered from brachial neuritis3 following an influenza (“flu”) vaccine administered on January 19, 2018. Pet. at 1. A two-day Entitlement Hearing took place on April 13–14, 2023. Now, having reviewed the record and considered the expert testimony heard at trial, I deny entitlement, because the claimed injury has not been preponderantly established. 1 Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Ruling will be available to the public in its present form. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the Act”]. Individual section references hereafter will be to Section 300aa of the Act (but will omit the statutory prefix). 3 As the experts who testified in this matter agreed, brachial neuritis can also be termed neuralgic amyotrophy or Parsonage-Turner Syndrome, interchangeably. Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 2 of 25 I. Factual Background Prior to vaccination, Petitioner had a past medical history significant for obesity, diabetes mellitus with circulatory complication, acute abdominal pain syndrome, atrial fibrillation, coronary artery disease, chronic renal disease, hypertension, and sleep apnea. Ex. 3 at 13–14. On January 12, 2018, Petitioner presented to St. Francis Hospital for epigastric pain. Ex. 3 at 4. Petitioner underwent an abdominal CT which showed “findings consistent with small bowel obstruction with [a] transition point in a left lower anterior abdominal wall hernia which demonstrate[d] fat stranding indicating incarceration.” Id. at 13. The next day, Petitioner underwent a laparotomy with release of the small bowel obstruction and a ventral hernia repair. Id. at 15. Petitioner remained in the hospital until January 19, 2018, and was discharged with diagnoses including acute respiratory failure, hypokalemia, and ventral hernia repair. Ex. 3 at 82, 120; Ex. 2 at 7. Before being discharged, Petitioner received a flu vaccine in his left deltoid. Ex. 2 at 5. Two days later, on January 21, 2018, Mr. Fisher was seen by a St. Francis home health care nurse for post-surgery aftercare. Ex. 7 at 10–73. At this time, he reported that he had not monitored his blood sugar levels, since they had improved after losing more than two hundred pounds. Id. at 34. He also stated that he was “planning to return to work in [the] near future.” Id. at 34. However, Petitioner did not at this time report any left shoulder or arm pain. Id. Onset of Arm Pain and Treatment On January 23, 2018, Mr. Fisher saw his primary care physician (“PCP”), Patrick Murphy, M.D., at Warren Clinic South Memorial, with complaints of “severe [left] arm pain from [the] [f]lu vaccine [four] days ago,” and noting that the “pain began [two] days after the injection.” Ex. 9 at 235. Upon examination, Petitioner exhibited “tenderness [in his] left upper arm with no redness, warmth or firmness.” Id. at 241. Dr. Murphy’s assessment was left upper extremity pain and recommended Petitioner begin pain relief medication. Id. The following day (January 24, 2018), Petitioner had a second home health care visit. Ex. 7 at 41. Mr. Fisher now reported left arm pain ranging 3/10—noting that within the last twenty- four hours, his pain had ranged from 0 to 6/10. Id. Petitioner described his pain as acute, intermittent, and exacerbated by movement. Id. Petitioner had another home health care visit on January 31, 2018, at which time he reiterated what he previously had reported. Id. at 60. And on February 7, 2018, Petitioner had yet another home health care visit, at which time he stated that “he [had] been released by the doctor to return back to work and want[ed] to be discharged, he [wa]s no longer home-bound and no longer ha[d] a skilled need.” Id. at 73. 2 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 3 of 25 On March 30, 2018, Petitioner visited Dr. Murphy for treatment of his diabetes and hypertension. Ex. 9 at 246. A review of systems indicated left hand numbness and the assessment was diabetes mellitus with circulatory complication, including chronic diabetic polyneuropathy. Id. at 254–57. Three months later, on July 3, 2018, Petitioner saw Dr. Murphy for management of his chronic conditions. Ex. 4 at 5–15. Petitioner’s physical exam was normal, and Dr. Murphy’s assessment included diabetic polyneuropathy. Id. at 12. Petitioner again saw Dr. Murphy on August 23, 2018, for urinary frequency and left arm pain. Id. at 20. At this visit, Petitioner reported that his onset of arm pain occurred in January 2018, due to an injection reaction. Id. Petitioner noted that the pain was in his “[l]eft upper arm to [his] fingers,” and further described the pain as aching and moderate, with numbness in his second and third fingers. Id. A review of systems was positive for numbness, and Dr. Murphy’s assessment included chronic polyneuropathy. Id. Over the next ten months, Petitioner saw Dr. Murphy six times for ongoing management of his chronic conditions plus several other complaints, including bilateral ear pain and heartburn. Ex. 4 at 60, 70, 90, 106, 117, 126. Subsequent Treatment Petitioner saw neurologist Brooke McQueen, M.D., on September 24, 2019 (now more than a year and a half since the relevant vaccination), reporting “numbness, tingling, burning, and pins and needle sensation in the [left extremity] . . . [that] started about a year ago after the flu shot [in January 2018] . . ..” Ex. 4 at 141. Petitioner noted numbness and tingling in his left hand, specifically in his second and third digits, and noted that his PCP thought the flu vaccination “hit a nerve” but that the pain would improve over time. Id. Dr. McQueen suspected that Petitioner might have carpal tunnel syndrome (“CTS”) versus residual median sensory neuropathy from the flu vaccine. Dr. McQueen ordered electromyography (“EMG”)4 and nerve conduction study (“NCS”)5 tests—the results showing bilateral CTS and chronic cervical radiculopathy, with the left side worse than the right for both conditions. Id. at 160; Ex. 8 at 14–16, 20–25. Six months later, on March 24, 2020, Petitioner had a telehealth appointment with Dr. 4 “Electromyography” is defined as “an electrodiagnostic technique for recording the extracellular activity (action potentials and evoked potentials) of skeletal muscles at rest, during voluntary contractions, and during electrical stimulation; performed using any of a variety of surface electrodes, needle electrods, and devices for amplifying, transmitting, and recording the signals. Electromyography, https://www.dorlandsonline.com/dorland/definition?id=15854&searchterm=electromyography (last visited Dec. 4, 2023). 5 “Nerve Conduction Study” is defined as “a diagnostic test that evaluates the function of [the] peripheral nerves. [It] can help detect the presence and extent of peripheral nerve damage.” Nerve Conduction Study, https://my.clevelandclinic.org/health/treatments/24821-nerve-conduction-study (last visited Dec. 4, 2023). 3 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 4 of 25 McQueen, at which time he complained of continued “numbness/tingling in [his] left hand/fingers” and noted “some numbness, tingling, burning/sharp/electrical pain,” in several of his left fingers Ex. 4 at 163. Upon examination, Petitioner exhibited normal range of motion with mild atrophy in the left thenar region. Id. at 174. Dr. McQueen’s assessment included: “1) Neuropathy, 2) Cervical radiculopathy, 3) Bilateral carpel tunnel syndrome, 4) Neuropathic pain of hand, left.” Id. at 175. Dr. McQueen also documented that Petitioner showed “mild pinched nerves in the neck; bilateral C5 and C7 on the left, nothing to do at this time, likely age related, may consider neck imaging in the future.” Id. at 176. It was recommended that Petitioner wear wrist splints at night to help with his CTS. Id. II. Witness Testimony A. Petitioner’s Witnesses 1. Craig Fisher Petitioner was the only fact witness to testify. See generally Tr. at 8–57. He began his testimony addressing his pre-vaccination history, which he characterized as uneventful. Tr. at 9. Petitioner acknowledged that he had struggled with his weight, but that in the months leading up to his January 2018 vaccination, he had lost approximately one hundred pounds. Id. at 9–10. Petitioner also briefly discussed his hospitalization prior to receipt of the flu vaccine on January 19, 2018. Tr. at 11–14. Around October-November 2017, he had been experiencing some intermittent stomach pain and underwent a H. Pylori6 test—the result of which was positive. Tr. at 11. Petitioner’s treating physician prescribed him some antibiotics to treat the H. Pylori. Id. Petitioner recalled getting ready to leave for an out-of-town convention when his stomach pain became a bigger concern. Id. at 12–13. His ex-wife advised him to go to the nearby emergency care clinic so that a CT scan could be performed to see if something more was going on—and after receiving such a scan, he was told that he needed to go to the hospital for further evaluation and care. Id. at 13. Once there, he was immediately prepped for surgery as it appeared he had a herniated intestine. Id. at 13. Petitioner remained in the hospital for a week following his surgery and was discharged on January 19, 2018. Id. at 14. Petitioner recalled that before being discharged, he was advised to receive a flu vaccine, since contracting the flu after intestinal surgery could cause several complications. Tr. at 14. He had received the flu vaccine “pretty regularly” in the past, and while he had not planned to get one 6 “Helicobacter Pylori” is defined as “a species that causes gastritis and peptic ulcers and is also associated with gastric cancer. Formerly called ‘Campylobacter pylori.’” Helicobacter Pylori, Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=80297&searchterm=Helicobacter+pylori (last visited Dec. 4, 2023). 4 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 5 of 25 that year, he decided to do so in order to avoid any potential complications. Id. at 15. Two days after, on January 21, 2018, however, Petitioner woke up with an aching pain in his left upper arm so severe he worried he was having a heart attack. But an exam performed during a visit from his home health care team did not confirm this as the explanation for his pain. Id. at 16. On January 23, 2018, Petitioner had a regularly-scheduled appointment with his PCP, Dr. Murphy—at which time he was seeking additional treatment options for his pain, as it had gotten to the point where it was keeping him awake at night. Tr. at 20–21. Petitioner further noted that he had not taken any pain medication since his hernia surgery (out of concerns for avoiding dependency on it), but that “[the pain] was more than [he] could bear,” and that he was “desperately looking for a solution.” Id. at 21–22. Then, on or about January 30, 2018, Petitioner began experiencing a numbness/tingling sensation in his index finger which eventually spread to his middle finger, thumb, and half of his left hand. Tr. at 27. He further testified that the pain in his shoulder “was horrible,” and that “the only relief [he] found was icing it down” or scheduling massage appointments. Id. Over the course of the next seven to eight months, Petitioner reported to Dr. Murphy on several different occasions, since his symptoms persisted—and remain to this day. Id. at 32–33. He eventually sought a neurology referral from Dr. Murphy at an August 2018 appointment but noted that he was unable to schedule a consult until approximately a year later, on September 24, 2019. Id. at 34. Petitioner concluded his testimony by briefly emphasizing that the injury had negatively impacted his ability to work—noting that he eventually had to transition to a half-time position approximately six months following vaccination. Tr. at 37. Although he was hoping to return to a full-time position, it was “difficult to focus” due to the lack of sleep from the pain. Id. 2. Peter-Brian Andersson, M.D. Dr. Andersson, a clinical neurologist, prepared two written reports for Petitioner and testified in support of the contention that Petitioner suffered brachial neuritis caused by his receipt of the flu vaccine. See generally Tr. at 59–179; Report, dated Feb. 18, 2022, filed as Ex. 10 (ECF No. 26-1) (“Andersson First Rep.”); Report, dated Dec. 18, 2022, filed as Ex. 42 (ECF NO. 41-1) (“Andersson Second Rep.”). Dr. Andersson received his medical degree from the University of Cape Town, South Africa, in 1986, as well as an honors degree in Medical Biochemistry in 1988. Tr. at 59–60; Curriculum Vitae, filed as Ex. 11 (ECF NO. 26-2) (“Andersson CV”) at 1. Thereafter, Dr. Andersson received a Ph.D. equivalent in experimental pathology from the University of Oxford, United Kingdom in 1991. Tr. at 61; Andersson CV at 1. He later became a college lecturer in Immunology at Christ Church, University of Oxford. Id. Dr. Andersson then completed his 5 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 6 of 25 residency in neurology, followed by a fellowship in Neuroimmunology and Multiple Sclerosis at the University of California, San Francisco. Tr. at 62; Andersson CV at 1. In addition to completing the previously mentioned fellowship, Dr. Andersson also completed a Neuromuscular fellowship at Oregon Health Sciences University as well as at Stanford University. Id. He is licensed to practice medicine in California, and he is board certified by the American Board of Psychiatry and Neurology and the American Board of Electrodiagnostic Medicine. Tr. at 62–63; Andersson CV at 1. He has published several articles on the topic of neurology and immune-mediated diseases, and has treated over a hundred cases of brachial neuritis, as well as thousands of cases for cervical radiculopathy, ulnar neuropathy, and carpal tunnel syndrome. Tr. at 64; Andersson CV at 2. Dr. Andersson began his testimony with a brief overview of Petitioner’s pre-vaccination history—emphasizing that upon his admission to the hospital on January 12, 2018, he had not been experiencing any numbness, arthralgias, or myalgias (making his post-vaccination condition meaningful by contrast). Tr. at 70; Ex. 3 at 114–15. Dr. Andersson then provided an explanation of brachial neuritis and its associated symptoms. Tr. at 71. Brachial neuritis is an inflammatory condition with “an acute onset that affects the brachial plexus and related nerves and at times roots.” Id. at 71–72. He identified several distinctive factors associated with brachial neuritis: striking severity; striking distribution; striking persistence; apparent lack of cause; and associated neurogenic features—all of which were observed in Petitioner, according to Dr. Andersson. Tr. at 72–73; Andersson First Rep. at 7–8. Dr. Andersson analyzed each factor relevant to the diagnosis, maintaining that Petitioner’s brachial neuritis was more likely a vaccine-induced sensory form of brachial neuritis rather than cervical radiculopathy or CTS. Tr. at 137–38; Andersson First Rep. at 7–8. Dr. Andersson emphasized Petitioner’s reported widespread distribution of severe pain, sudden onset, and intractability as distinctive of brachial neuritis—further noting Petitioner’s initial concern that he was suffering a heart attack, his inability to sleep, and the ineffectiveness of pain medication. Tr. at 134; Andersson First Rep. at 7–8. Dr. Andersson next explained that brachial neuritis is typically a “patchy syndrome,” but that Petitioner exhibited “very widespread, yet very severe [pain], and brachial neuritis does that.” Tr. at 135. Moreover, Petitioner’s pain not only began without any apparent cause, but it never seemed to improve. Id. at 135–36. Dr. Andersson further commented on the persistence of Petitioner’s pain—noting that “other structures that have a differential for casing pain, when they [are] musculoskeletal, they generally exacerbate or relive, depending on your position or movement,” but Petitioner did not experience later reduction in symptoms. Id. at 137–38. Accordingly, Dr. Andersson opined, brachial neuritis was the only diagnosis that would unify all of Petitioner’s presenting symptoms. Id. Brachial neuritis can be triggered by an activation of the immune system—including, but 6 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 7 of 25 not limited to, infection, vaccination, or recovery from surgery. Tr. at 75, 78–79; Anderson First Rep. at 10; J. LJspeert et al., Neuralgic Amyotrophy, 34 Current Opinion Neurology 605, 608 (2021), filed as Ex. 15 (ECF No. 27-4) (“LJspeert”) (finding that “any immune-related factor can trigger NA, including infection, vaccination, immunotherapy such as interferon or immune- checkpoint inhibitors, recovery from surgery, pregnancy or childbirth, trauma or psychological distress”); G. Suarez et al., Immune Brachial Plexus Neuropathy: Suggestive Evidence for an Inflammatory-Immune Pathogenesis, 46 Neurology 559, 560 (1996), filed as Ex. 19 (ECF No. 27- 8). However, Dr. Andersson hesitated to endorse the opinion that surgery can be a mechanism of injury for brachial neuritis—arguing that the literature is simply unclear as to the degree of association. Tr. at 77–78. To explain the mechanistic immune process that would result in brachial neuritis, Dr. Andersson provided testimony regarding the distinctions between a primary and secondary immune response. The primary immune response occurs in “a naïve host who [is] generating an immune response for the first time,” whereas “in the secondary, there is a memory” or a “recall of that original immune response in the T and the B cells [] [and] plasma cells.” Tr. at 80. An individual’s secondary immune response would become more rapid as well as more vigorous when an individual encountered antigens again, in subsequent exposures—and as Dr. Andersson explained, this is not only exactly what vaccination is predicated on, but likely explains the nature of Petitioner’s immune response to the flu vaccine he received. Id. at 81; Andersson First Rep. at 11–12. In support of his opinion that Petitioner’s brachial neuritis was likely mediated by a secondary/adaptive immune process, Dr. Andersson offered several items of literature. Tr. at 83; Andersson First Rep. at 11–12; See, e.g., F. Vriesendorp et al., Anti-Peripheral Nerve Myelin Antibodies and Terminal Activation Products of Complement in Serum of Patients with Acute Brachial Plexus Neuropathy, 50 Arch. Neurology 1301, 1303 (1993), filed as Ex. 23 (ECF No. 28-2) (“Vriesendrop”) (supporting the notion that complement-dependent, antibody-mediated demyelination may participate in the initial peripheral nerve damage or augment an ongoing process based on the detection of anti-PNM antibodies and complement activation products in three patients with brachial plexus neuropathy). Some items were case reports. A. Hamati-Haddad & F. Fenichel, Brachial Neuritis following Routine Childhood Immunization for Diphtheria, Tetanus, and Pertussis (DTP): Report of Two Cases and Review of the Literature, 99 Pediatrics 602 (1997), filed as Ex. 32 (ECF No. 29-1) (reporting two cases of brachial neuritis following receipt of the tetanus toxoid vaccination in adults); S. Queler et al., Parsonage-Turner Syndrome following COVID-19 Vaccination: MR Neurography, 302 Radiology 84, 85 (2022), filed as Ex. 33 (ECF No. 29-2) (“Queler”) (reporting onset of Parsonage-Turner syndrome post-vaccination within 28 days and as early as the same day as immunization). Dr. Andersson also opined that the timeframe in which Petitioner’s brachial neuritis began 7 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 8 of 25 was consistent with an adaptive/secondary immune-mediated process. He noted that when an individual is exposed to viral antigenic material to which he or she has previously been exposed, an immune-mediated process can occur more rapidly. Tr. at 93. As Dr. Andersson explained, an individual will “have a host who has an immune system primed and ready to go, . . . and now they have an antigenic trigger from a vaccination that will generate a response to this vaccine.” Id. In so responding, the immune system has also “activated clones of cells that were memory cells, [] so the effect is now to generate a host attack . . . and this attack is going to be severe [and rapid] because the immune response is secondary.” Id. P. Tsairis et al., Natural History of Brachial Plexus Neuropathy, 27 Arch Neurology 109, 111 (1972), filed as Ex. 16 (ECF No. 27-5) (“Tsairis”) (finding that “the most striking feature of this disease was the rapid onset of pain usually followed by muscle weakness or paralysis”). Thus, he deemed an onset of two to three days post-vaccination to be medically acceptable. B. Respondent’s Witnesses 1. Brian Callaghan, M.D. Dr. Callaghan, a neuromuscular specialist in treatment of neuropathies like brachial neuritis, prepared two written reports for Respondent and testified for Respondent in support of the contention that there is not a causal association between the flu vaccine and brachial neuritis. See generally Tr. at 181–281; Report, dated June 2, 2022, filed as Ex. A (ECF No. 31-1) (“Callaghan First Rep.”); Report, dated Feb. 19, 2023, filed as Ex. E (ECF No. 44-1) (“Callaghan Second Rep.”). Dr. Callaghan received his undergraduate degree from the University of Michigan in 1999, his medical degree from the University of Pennsylvania in 2004, and his Masters in Science from the University of Michigan in 2011. Curriculum Vitae, filed as Ex. B (ECF No. 31-2) (“Callaghan CV”) at 1; Tr. at 183–84. He became a clinical lecturer at the University of Michigan Health System’s Department of Neurology in 2009 and has been an Associate Professor of Neurology there since 2018. Callaghan CV at 1; Tr. at 182. He is licensed to practice medicine in Michigan, and he is board certified by the American Board of Psychiatry and Neurology and the American Board of Electrodiagnostic Medicine. Id. Dr. Callaghan has published mover than 120 articles and medical book chapters, with a majority focusing on neuropathy, and including the appropriate diagnostic evaluation and treatment of neuropathy. Callaghan CV at 14–24; Callaghan First Rep. at 1; Tr. at 186. Dr. Callaghan has averred that he has treated more than 50 patients with brachial neuritis. Callaghan Rep. at 1. Dr. Callaghan began his testimony addressing the rarity of both brachial neuritis and pure sensory brachial neuritis—noting that in his fifteen years as a neurologist, he has treated only a handful of cases for brachial neuritis, but has never seen a case of pure sensory brachial neuritis. 8 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 9 of 25 Tr. at 189. He defined brachial neuritis to be “a syndrome characterized by pain, followed by weakness and atrophy, that usually occurs in one limb and evolves over a series of months.” Id. He then briefly addressed the diagnostic criteria for brachial neuritis—emphasizing that “in the absence of neurographic studies, [diagnosis] requires weakness in [the] muscles supplied by more than one peripheral nerve, and then EMG and nerve conduction studies need to localize injury to the brachial plexus.” Id. at 191; Callaghan First Rep. at 4–5. This kind of testing was in fact critical to the diagnosis. Tr. at 206. Dr. Callaghan testified that he agreed with Petitioner’s treating physicians: Petitioner neither suffered from brachial neuritis nor from a pure sensory form of the condition, but instead more likely suffered from diabetic neuropathy, cervical radiculopathy, and/or CTS. Id. at 194. Indeed, there was no mention, even as part of a differential diagnosis, of brachial neuritis in treater records, and he was never formally so diagnosed. Id. at 195. Rather, Petitioner’s diagnosis was consistent with the symptoms he had reported to his treating physicians, and Dr. Callaghan emphasized that the nature of those symptoms, as well as the pain involved, were common to diabetic neuropathy, cervical radiculopathy, or CTS.7 Id. at 197–98. He would have made the same diagnoses as Petitioner’s treating physicians did, and would not have considered a pure sensory form of brachial neuritis as explanatory, given the record. Id. at 209. Dr. Callaghan went on to identify why Petitioner’s reported symptoms plus exam and testing findings did not satisfy the diagnostic criteria for brachial neuritis. Tr. at 215; Callaghan First Rep. at 5. For example, Petitioner never reported weakness in the affected arm, nor was it demonstrated on exam—thus not meeting criterion two. Id. Additionally, Petitioner did not display motor, sensory, and reflex deficiencies upon examination. The degree of pain Petitioner was reporting was not a factor favoring a brachial neuritis diagnosis, since actual severity of these conditions often did not correlate with complained-of pain levels. Id. Moreover, Petitioner’s symptoms did not appear to be widespread, but instead were isolated to his left upper extremity and three left hand fingers. Id. at 221–22. According to Dr. Callaghan, patients suffering from brachial plexus injuries typically experience more widespread symptoms. Id. The EMG/NCS testing performed in this case was also not confirmatory for a brachial neuritis diagnosis, in Dr. Callaghan’s view. The relevant testing revealed “things that are super common and completely describe the patient’s symptoms, and so cervical radiculopathy at those levels and a carpal tunnel syndrome would be exactly expected to give the symptoms that [Petitioner] presented with.” Tr. at 206, 216. The results did not confirm the existence of the kind of dysfunction that could be attributed to the brachial plexus. Callaghan First Rep. at 5. Petitioner’s EMG/NCS results were also consistent with some bilateral injuries, specifically on the left side, as well as cervical radiculopathy at C5 and C7 spine levels. Id. at 206–07. 7 Dr. Callaghan defined CTS as “a mechanical injury of the median nerve in the carpal tunnel itself,” deeming it not only the most common neuropathy, but particularly prevalent for patients with diabetes. Tr. at 200. 9 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 10 of 25 Petitioner’s past medical history, Dr. Callaghan opined, suggested a credible alternative explanation for Petitioner’s symptoms. That history was significant for diabetes, making Petitioner more prone to “every peripheral nerve manifestation.” Tr. at 196 (emphasis added). Diabetes, Dr. Callaghan explained, can often cause a form of polyneuropathy or increase an individual’s risk of radiculopathy, and can even lead to an increased chance of developing mononeuropathies, including carpal tunnel syndrome. Id. There was even other evidence consistent with the conclusion that such processes were already under way. Petitioner suffered from C5/C7 radiculopathy, which Dr. Callaghan described as an “injury to the nerve roots in the neck”—noting that C5 typically causes pain that travels down the arm, and oftentimes involves the shoulder and the first few digits whereas C7 usually involves the middle finger. Id. at 196–97. Petitioner’s diagnosis was consistent with the symptoms Petitioner reported to his treating physicians—and in fact, in Dr. Callaghan’s opinion the pain Petitioner described could equally implicate the existence of a diabetic neuropathy, cervical radiculopathy, or CTS. Id. at 197–98. Dr. Callaghan then briefly discussed several post-vaccination visits with Petitioner’s treating physicians—but focused specifically on his visits with Dr. McQueen in 2019-20. Tr. at 203. By this time (18-plus months post-vaccination), Petitioner was describing pain in the left upper arm that traveled down into his fingers and hand accompanied by numbness in his second and third fingers. But in Dr. Callaghan’s view, such symptoms were fully consistent with Petitioner’s prior diagnosis of C5/C7 radiculopathy and carpal tunnel syndrome. Id. In addition to disputing the propriety of a brachial neuritis diagnosis, Dr. Callaghan denied that the flu vaccine could likely cause the condition. Callaghan First Rep. at 5–6. In so doing, he addressed Dr. Andersson’s effort to analogize the autoimmune process deemed to be possibly triggered by the flu vaccine, resulting in GBS. In Dr. Callaghan’s view, GBS and brachial neuritis were wholly-distinct illnesses (even if both are peripheral nerve injuries), since GBS affects “the myelin or covering of the nerve,” whereas brachial neuritis is “an injury to the blood vessels that supply the nerve.” Tr. at 222 (emphasis added). They otherwise have different underlying pathologies, require different forms of treatment, and result in separate kinds of impacts to the body. Id. As a result, Dr. Callaghan deemed Dr. Andersson’s assertion that brachial neuritis essentially operates the same way as GBS to amount to a be “huge leap of faith.” Id. at 223. Dr. Callaghan further maintained that he could find no reliable literature support establishing a likely causal link between the flu vaccine and brachial neuritis. Id. at 223–24. 2. Andrew MacGinnitie, M.D. Dr. MacGinnitie, an allergist/immunologist, prepared two written reports for Respondent and testified for Respondent, opining that there is no causal connection between the flu vaccine and the neurologic problems Petitioner suffered (however they are defined). See generally Tr. at 280–342; Report, dated May 31, 2022, filed as Ex. C (ECF No. 31-3) (“MacGinnitie First Rep.”); Report, dated Feb. 15, 2023, filed as Ex. F (ECF No. 44-2) (“MacGinnitie Second Rep.”). 10 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 11 of 25 Dr. MacGinnitie received his bachelor’s degree from Yale University and then attended the University of Chicago, Pritzker School of Medicine, where he received both an M.D. and a Ph.D. from the Department of Pathology. Curriculum Vitae, filed as Ex. D (ECF No. 31-4) (“MacGinnitie CV”) at 1; Tr. at 281–82. Thereafter, he completed a residency in pediatrics in the Boston Combined Residency Program, a joint venture of Boston Children’s Hospital and Boston Medica Center, followed by an Allergy/Immunology fellowship at Boston Children’s Hospital. Id.; MacGinnitie First Rep. at 1–2. Dr. MacGinnitie is an Associate Professor Pediatrics at Harvard Medical School, as well as the Clinical Chief for the Division of Immunology at Boston Children’s Hospital where he directs clinical operations for Allergy/Immunology, Rheumatology and Dermatology. MacGinnitie CV at 1–2; MacGinnitie First Rep. at 1; Tr. at 283–84. He is board certified in both Pediatrics and Allery and Clinical Immunology. MacGinnitie CV at 11; Tr. at 281. Dr. MacGinnitie has averred that he treats approximately 1,700 patients annually, and has extensive experience in caring for both children and adults with a variety of immunologic diseases, such as reactions to vaccines. MacGinnitie First Rep. at 2. Dr. MacGinnitie began his testimony by noting that he would not be offering an opinion on the diagnosis of brachial neuritis, deferring on that issue to Dr. Callaghan. Tr. at 286–87. Instead, Dr. MacGinnitie provided his view as to whether there likely exists a reasonable mechanism by which the flu vaccine could trigger brachial neuritis (and finding that there was not). Id. at 287. In so opining, Dr. MacGinnitie provided an explanation for the concept of molecular mimicry (which Dr. Andersson’s theory appeared to rely upon). Tr. at 287–89. He explained that the immune system has two responsive “arms”: the innate response, which immediately responds to antigenic exposure, sometimes involving or promoting inflammation, and then the second, adaptive response—i.e., the targeting of specific epitopes, typically proteins, on infections such as bacteria or viruses. Tr. at 288. Dr. MacGinnitie allowed that Petitioner’s receipt of the flu vaccine would implicate the secondary, adaptive response, since the immune system would likely recognize the flu antigens from prior vaccine exposures (despite differences in the vaccine from year to year). Tr. at 302–03. Dr. MacGinnitie agreed with Dr. Andersson’s explanation of molecular mimicry as involving the secondary/adaptive response, and occurring where “there’s some immune stimulus, typically thought of to be an infection—but could be vaccination or environmental exposure—and there is an antigen or epitope [that is] recognized by [the] immune system [and] is similar in structure to a human protein,” later resulting in the production of antibodies that recognize, and attack, both the foreign antigen as well as the similar human protein. Tr. at 287–88. In Dr. MacGinnitie’s experience, four criteria must be demonstrated8 if molecular mimicry is to be 8 I note that the criteria Dr. MacGinnitie discusses do not constitute elements of the legal test Petitioner must satisfy to meet his burden of proof. But they do stand as the kinds of factors that the scientific community would consider significant in whether molecular mimicry deserves explanatory weight, and I therefore evaluate them only in that 11 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 12 of 25 credibly invoked as an explanatory mechanism for a disease process. L. Peterson & R. Fujinami, Molecular Mimicry, 13 (Yehuda Shoenfeld et al. eds., 2nd ed. 2007) (“Peterson and Fujinami”). These are the “similarity between a host epitope and an epitope of a microorganism or environmental agent; detection of antibodies or T cells cross-reactive with both epitopes in patients with the autoimmune disease; epidemiological link between exposure to the environmental agent or microbe and development of autoimmune disease; and reproducibility of autoimmunity in an animal model following sensitization with the epitopes, infection with the microbe or exposure to the environmental agent.” Tr. at 290; MacGinnitie Second Rep. at 1. Peterson Fujinami at 13. In this case, molecular mimicry could not be demonstrated to be a reliable explanation for how the flu vaccine could cause brachial neuritis. In particular, Dr. MacGinnitie noted, the first and second criteria for deeming molecular mimicry an apt explanation for an immune-mediated process were absent. Tr. at 16. Thus, Dr. Andersson had failed to identify any homology between flu vaccine antigenic amino acid sequences and the human nerve proteins which would presumably be targeted. Id. at 288–89. Without establishing a specific basis for an errant cross-attack through the identification of some homology one could essentially maintain that “really anything that stimulates [an individual’s] immune system could cause any autoimmune disease”—which he maintained is not a very robust and convincing application. Id. at 295. Moreover, Dr. Andersson had not specified whether the immune response elicited B cells or T cells in carrying out its disease-causing process. Id. at 289, 292. And no cross-reactive antibodies or T cells that might theoretically drive an autoimmune process had been identified. Dr. MacGinnitie also felt it significant that little medical literature supported a causal relationship between the flu vaccine and brachial neuritis. Tr. at 296. He noted that, in conducting his own research for purposes of this hearing, he had found nothing so supportive except for a “handful of case reports [for] influenza and other vaccines but no epidemiologic studies that show a connection.” Id. There was otherwise, Dr. MacGinnitie maintained, no reason to deem the vaccine Petitioner received as more likely causal than several other potential explanations for Petitioner’s symptoms evident from the medical record. He noted, for example, that “some infections could trigger inflammation in an organ leading to autoimmunity without any evidence of molecular mimicry.” Tr. at 309. Although there are “significant safeguards in the immune system to protect against autoimmunity,” such mechanisms can be breached either through genetic mutations or other mechanisms. Tr. at 309. Surgery is another common preceding event for brachial neuritis, “roughly on the order of magnitude [as] vaccination.” Id. at 310. Here, eight to nine days prior to development of symptoms argued to reflect brachial neuritis, Petitioner had undergone surgery to repair an incarcerated hernia—which “would make that a much more plausible trigger of brachial neuritis than vaccination.” Id. In fact, Dr. MacGinnitie stressed, surgery is a “significant immune stimulus”—noting that damage-associated molecular patterns are released by damaged cells, and regard (since they provide some insight into why an expert might not deem molecular mimicry to stand as a persuasive explanation for an immune-mediated injury). 12 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 13 of 25 that when an individual undergoes any type of surgery or experiences trauma, “patients have a significant inflammatory response.” Id. at 311. Dr. MacGinnitie also opined that Petitioner’s onset date was inconsistent with Dr. Andersson’s proposed theory, and its reliance on molecular mimicry. An onset of 40 hours post- vaccination “is too fast for an adaptive immune response, which would be required for molecular mimicry.” Tr. at 289–90. This was true in his view even though he agreed that Petitioner (having been exposed to prior versions of the flu vaccine) would likely have a shorter adaptive response. Id. at 302–03. The adaptive response would take three days or more to manifest antibodies capable of the kind of cross-reaction implicated by molecular mimicry. Tr. at 298. III. Post-Hearing Reports After the hearing, I informed the parties that although it appeared Petitioner primarily relied on a theory involving an adaptive immune response as mediating the alleged brachial neuritis, it seemed as if Dr. Andersson had allowed for an innate response as also potentially driving brachial neuritis (and that this might be more consistent with the fast, post-vaccination onset of Petitioner’s symptoms). Thus, the parties were afforded a final opportunity to submit a single supplemental report addressing whether brachial neuritis can be caused by an innate immune response. Both sides offered a report from one expert. See Dr. Andersson Report, dated June 15, 2023, (ECF No. 67-1) (“Andersson Supp. Rep.”); Dr. MacGinnitie Report, dated June 13, 2023 (ECF No 66-1) (“MacGinnitie Supp. Rep.”). Dr. Andersson’s Post-Hearing Report Dr. Andersson first acknowledged that although he had referred to the innate immune response as pathogenic at hearing, he did not use that specific term in his reports. He nevertheless emphasized that “brachial neuritis is an immune mediated condition and as such it has two potential pathogenic mechanisms by which it is affected”—the adaptive and innate responses. Andersson Supp. Rep. at 1. In this report, Dr. Andersson addressed each system and discussed their respective relevance to Petitioner’s alleged injury and claim. Id. As Dr. Andersson noted, “[t]he pathophysiology of NA remains uncertain, although it often suggests an auto-immune origin such as in Guillain-Barré syndrome.” Andersson Supp. Rep. at 1; P. Seror, Neuralgic Amyotrophy: An Update, 84 Joint Bone Spine 153, 156 (2017), filed as Ex. 43 (ECF No. 38-1). He further noted that even if the timing of onset from vaccination to injury in this case (two days) was relatively rapid for an adaptive immune response, such timing did not rule out an adaptive-mediated path. Andersson Supp. Rep. at 1. Indeed, because Petitioner had previously been exposed to the flu vaccine, an immune memory-oriented response had likely occurred, and it would happen in a shorter timeframe. Id. However, Dr. Andersson also opined that brachial neuritis could be the result of an aberrant innate immune response. The innate response “is the body’s first line of defense against pathogens 13 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 14 of 25 entering the body and it responds in the same way to all foreign substances.” Andersson Supp. Rep. at 2. Studies discussing histopathologic evidence relevant to brachial neuritis had observed “[i]ncreased levels of complement9 C5-C9 and decreased levels of C3,” as well the “presence of “local inflammatory infiltrates, severe pain caused by the release of inflammatory mediators and ischemia of the nervi nervorum, and acute damage to the paranodal regions of large nerve fibers.’” Id.; J. Van Eijk et al., Neuralgic Amyotrophy: An Update on Diagnosis, Pathophysiology, and Treatment, 53 Muscle & Nerve 337, 340 (2016), filed as Ex. 18 (ECF No. 27-7); LJspeert at 4. Additionally, Dr. Andersson relied on statements made in the LJspeert article, which argued that essentially any factor that provokes the innate immune response can constitute an immunological trigger. Andersson Second Supp. Rep. at 2; LJspeert at 4. In fact, it might be difficult to differentiate the contributions of the innate versus adaptive immune response in attempting to identify the primary impetus for brachial neuritis. As Dr. Andersson noted, “the histopathology of brachial plexitis as inflammatory and the deposition of complement that is the [contribution of the] innate immune system” meant that the innate arm was likely also important to the disease process. Andersson Supp. Rep. at 2; Andersson Second Rep. at 11. The evidence of complement activation in brachial neuritis was “further evidence that an acute onset of symptoms within just a couple of days following a trigger is due to an innate immune-mediated response.” Id. Dr. Andersson thus maintained that an innate immune response could lead to the development of brachial neuritis through an “acute, nonspecific, immune- mediated inflammatory response triggered by localized inflammation, complement cascade, and localized lymphocytic infiltration”—all present in Petitioner’s case. Id. at 3. Dr. Andersson concluded his final report with a comment on whether Petitioner’s pre- vaccination hernia surgery could explain his injury. Although he could not dispute the fact of the surgery, Dr. Andersson maintained that there was a lack of an explanatory mechanism by which the surgery could have caused his brachial neuritis, adding that an interval of eight days post- surgery (January 13-21) would exclude the possibility that immune stimulation due to surgery was explanatory. Dr. MacGinnitie’s Post-Hearing Report Dr. MacGinnitie began his supplemental report with a brief overview of the nature of the innate and adaptive immune responses—noting that “innate immunity involves defense mechanisms that are not specific for any single pathogen, while the adaptive immune response can generate a near infinite number of receptors, capable of recognizing almost any protein or other molecules.” MacGinnitie Supp. Rep. at 2–6. Although the two arms of the immune response might work together to cause brachial neuritis, the adaptive arm better “explained” the disease’s 9 “Complement” is defined as “the entire functionally related system comprising at least 20 distinct serum proteins, their cellular receptors, and related regulatory proteins that is the effector not only of immune cytolysis but also of other biologic functions including anaphylaxis, phagocytosis, opsonization, and hemolysis.” Complement, Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=10705&searchterm=complement (last visited on Dec. 4, 2023). 14 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 15 of 25 pathogenic process, even if the innate arm also played a role. Id. at 6.10 Indeed, although complement is released via the innate immune response, the articles Dr. Andersson relied on also discussed the presence of both anti-myelin antibodies and complement activation—suggesting that an innate response might only occur after the adaptive immune response produces autoantibodies that instigate the disease initially. Id.; Vriesendrop at 1303. Other, more recent literature also illustrated the coordinated role the innate and adaptive immune responses play in the development of autoimmune diseases. MacGinnitie Supp. Rep. at 9; G. Wigerbald et al., Neutrophil Extracellular Traps in Systemic Autoimmune and Autoinflammatory Diseases, 23 Nat. Rev. Immunology 274 (2023).11 Dr. MacGinnitie therefore denied that an innate immune response alone could cause brachial neuritis. MacGinnitie Supp. Rep. at 10. Because the innate response is not antigen- specific, it is unlikely that “generalized inflammation could trigger the organ-specific autoimmunity seen in [brachial neuritis] (or pure sensory BN).” Id. Dr. MacGinnitie acknowledged one case report cited by Dr. Andersson involving a patient who developed symptoms of brachial neuritis within approximately 13 hours after receiving the Covid-19 vaccine, but emphasized the limitations of relying on such case reports. Id.; Queler at 1. In addition, the flu vaccine is generally not a strong stimulus for the innate immune response, especially since “the majority of influenza vaccines administered in the US are unadjuvanted, including the one [Petitioner] received, where adjuvants are materials added to vaccines specifically to trigger the innate immune system.” MacGinnitie Supp. Rep. at 11. An innate response also could not explain a purely sensory form of brachial neuritis. MacGinnitie Supp. Rep. at 11. In almost all of the literature discussing an immune mediated pathology for brachial neuritis, the adaptive immune response was discussed. Id. Moreover, innate immunity is not antigen-specific, and thus “innate immune activation would not explain symptoms limited to the peripheral nervous system.” Id. He concluded by reiterating his prior point that the timeframe for Petitioner’s onset was too rapid to be attributed to an adaptive response. Id. IV. Procedural History As noted above, this claim was initiated in July 2020, and the matter was originally designated as a “Special Processing Unit” (the “SPU”) case, based on anticipation that the claim was likely to settle. ECF Nos. 1, 4. All medical records with and an amended Statement of Completion were filed by December 2020. ECF No. 14. Respondent filed his Rule 4(c) Report contesting Petitioner’s right to compensation on June 16, 2021. ECF No. 21, and the matter was subsequently transferred out of SPU to my regular docket. Thereafter, expert reports were filed, 10 Dr. MacGinnitie disagreed with Dr. Andersson’s contention, however, that macrophages are only involved in the innate immune response. As a result, Dr. Andersson’s point about histopathology findings relating to brachial neuritis was supportive of both arms playing a role. MacGinnitie Supp. Rep. at 6. 11 I note, however, that Respondent did not file this item of literature. 15 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 16 of 25 and a two-day entitlement hearing was held on April 13-14, 2023. The parties have filed their supplemental expert reports addressing whether brachial neuritis can be caused by an innate immune response, and the matter is now ripe for resolution. V. Applicable Legal Standards A. Petitioner’s Overall Burden in Vaccine Program Cases To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table— corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).12 Petitioner does not herein assert a Table claim—nor could he, since the only Table claim for brachial neuritis involves tetanus-containing vaccines. For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. Section 13(a)(1). In attempting to establish entitlement to a Vaccine Program award of compensation for a Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen v. Sec'y of Health and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1) a 12 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. App’x. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13- 159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014). 16 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 17 of 25 medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal relationship between vaccination and injury.” Each Althen prong requires a different showing. Under Althen prong one, petitioners must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or scientifically certain.” Id. at 549. Petitioners may satisfy the first Althen prong without resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by statute to conclusively resolve what are essentially thorny scientific and medical questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed. Cl. at 245 (“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis in original)). In discussing the evidentiary standard applicable to the first Althen prong, the Federal Circuit has consistently rejected the contention that it can be satisfied merely by establishing the proposed causal theory’s scientific or medical plausibility. See Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of proof.” (citing Moberly, 592 F.3d at 1322)); see also Howard v. Sec'y of Health & Hum. Servs., 2023 WL 4117370, at *4 (Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance for nearly four decades”), appeal docketed, No. 23-1816 (Fed. Cir. Apr. 28, 2023). And petitioners always have the ultimate burden of establishing their overall Vaccine Act claim with preponderant evidence. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell v. United States, 133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s overall burden of proving causation-in-fact under the Vaccine Act” by a preponderance standard). The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu, 17 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 18 of 25 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly trustworthy evidence, since they are created contemporaneously with the treatment of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Medical records and statements of a treating physician, however, do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases. The views of treating physicians should be weighed against other, contrary evidence also present in the record—including conflicting opinions among such individuals. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012). The third Althen prong requires establishing a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable timeframe must align with the theory of how the relevant vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014). 18 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 19 of 25 B. Legal Standards Governing Factual Determinations The process for making determinations in Vaccine Program cases regarding factual issues begins with consideration of the medical records. Section 11(c)(2). The special master is required to consider “all [ ] relevant medical and scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability, injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then required to weigh the evidence presented, including contemporaneous medical records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (determining that it is within the special master's discretion to determine whether to afford greater weight to contemporaneous medical records than to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such determination is evidenced by a rational determination). As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95 Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his contemporaneous medical records, the special master's decision to rely on petitioner's medical records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum. Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked propositions explains why such records deserve some weight: (i) sick people visit medical professionals; (ii) sick people attempt to honestly report their health problems to those professionals; and (iii) medical professionals record what they are told or observe when examining their patients in as accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum. Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”). Accordingly, if the medical records are clear, consistent, and complete, then they should be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records are often found to be deserving of greater evidentiary weight than oral testimony—especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary 19 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 20 of 25 weight.”)). However, the Federal Circuit has also noted that there is no formal “presumption” that records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which compelling oral or written testimony (provided in the form of an affidavit or declaration) may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination regarding a witness's credibility is needed when determining the weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). When witness testimony is offered to overcome the presumption of accuracy afforded to contemporaneous medical records, such testimony must be “consistent, clear, cogent, and compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs., No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and completeness of medical records, the Court of Federal Claims has listed four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person's failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional's failure to document everything reported to her or him; (3) a person's faulty recollection of the events when presenting testimony; or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health & Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to afford greater weight to contemporaneous medical records or other evidence, such as testimony at hearing, there must be evidence that this decision was the result of a rational determination. Burns, 3 F.3d at 417. C. Analysis of Expert Testimony Establishing a sound and reliable medical theory often requires a petitioner to present expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). Under Daubert, the factors for analyzing the reliability of testimony are: 20 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 21 of 25 (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether there is a known or potential rate of error and whether there are standards for controlling the error; and (4) whether the theory or technique enjoys general acceptance within a relevant scientific community. Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95). In the Vaccine Program the Daubert factors play a slightly different role than they do when applied in other federal judicial settings, like the district courts. Typically, Daubert factors are employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health & Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88 Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not been employed at the threshold, to determine what evidence should be admitted, but instead to determine whether expert testimony offered is reliable and/or persuasive. Respondent frequently offers one or more experts in order to rebut a petitioner’s case. Where both sides offer expert testimony, a special master's decision may be “based on the credibility of the experts and the relative persuasiveness of their competing theories.” Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert's conclusion “connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum. Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on a particular expert's credibility, is part of the overall reliability analysis to which special masters must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26 (“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special masters are expected to consider the credibility of expert witnesses in evaluating petitions for compensation under the Vaccine Act”). 21 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 22 of 25 D. Consideration of Medical Literature Both parties filed medical and scientific literature in this case, but not all such items factor into the outcome of this decision. While I have reviewed all the medical literature submitted, I discuss only those articles that are most relevant to my determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072, 2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record evidence even though he does not explicitly reference such evidence in his decision”) (citation omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the conclusion that it was not considered”). ANALYSIS I. Treatment of Brachial Neuritis Claims Although the Vaccine Injury Table only provides for a claim of brachial neuritis after receipt of the tetanus vaccine, special masters have on many occasions found that other vaccines— including the flu vaccine—might also be causal of the condition. Morgan v. Sec’y of Health & Hum. Servs., No. 16-269V, 2023 WL 3984415 (Fed. Cl. Spec. Mstr. June 12. 2023) (finding two to three days post-intradermal influenza vaccination and the progression of pain and weakness over several days to be an acceptable temporal association); Abels v. Sec’y of Health & Hum. Servs., No. 18-558V, 2022 WL 2036101 (Fed. Cl. Spec. Mstr. May 6, 2022) (flu vaccine deemed causal of brachial neuritis). When adjudicating comparable claims, my decisions have turned less on whether the vaccine at issue could cause brachial neuritis, and more on whether onset occurred in a medically acceptable timeframe. See, e.g., Greene v. Sec’y of Health & Hum. Servs., No. 11-631V, 2019 WL 4072110 (Fed. Cl. Spec. Mstr. Aug. 2, 2019) (41-day onset after tetanus vaccine too long to be causal in Table claim), mot. for rev. den’d, 146 Fed. Cl. 655 (Fed. Cl. 2020), aff’d, 841 Fed. App’x. 195 (Fed. Cir. 2020); Garner v. Sec’y of Health & Human Servs., No. 15-063V, 2017 WL 1713184 (Fed. Cl. Mar. 24, 2017), mot. for rev. den’d, 2017 WL 3483352 (Fed. Cl. July 31, 2017) (dismissing claim that the Hepatitis A and B vaccines caused brachial neuritis, where claimant reported arm or shoulder pain 45 days post-vaccination). II. Petitioner has Not Preponderantly Established Brachial Neuritis as His Injury Here, as in many cases, disposition of the claim turns on its proper, evidence-supported characterization. Broekelschen, 618 F.3d at1350. Petitioner solely seeks to establish brachial 22 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 23 of 25 neuritis as his injury, and thus disposition of the case depends on the finding that this injury has preponderant evidentiary support. Unfortunately, the record does not support that conclusion.13 Dr. Callaghan made a number of reasonable and persuasive points suggesting a brachial neuritis diagnosis was not reflected by the medical record. First, he correctly observed that the proposed diagnosis was not corroborated by record evidence of contemporaneous treater support. In fact, arguably the best treater diagnostic opinion for the alleged brachial neuritis injury comes from Dr. McQueen’s exams of Petitioner—which occurred in September 2019 and then March 2020, and thus significantly after the vaccination and onset. And even the findings from those visits are more supportive of the diagnoses embraced by Dr. Callaghan. Second, Respondent successfully demonstrated that the criteria for brachial neuritis are not ultimately met given the facts of Petitioner’s medical history. Dr. Callaghan referred to the Table criteria in advancing this aspect of his opinion (see Callaghan First Rep. at 5), and although those elements are not controlling for this non-Table claim, they provide useful guidance for brachial neuritis’s elements. The criteria establishing a Table claim for brachial neuritis include: (i) Pain in the affected arm and shoulder is a presenting symptom and occurs within the specified time-frame; (ii) Weakness; a. Clinical diagnosis in the absence of nerve conduction and electromyographic studies requires weakness in muscles supplied by more than one peripheral nerve. b. Nerve conductions studies (NCS) and electromyographic (EMG) studies localizing the injury to the brachial plexus are required before the 13 Because the alleged injury lacks preponderant support, I need not conduct an Althen analysis. Lombardi v. Sec’y of Health & Hum. Servs., 656 F.3d 1343, 1353 (Fed. Cir. 2011). I note, however, that I would not have trouble finding on this record that the flu vaccine “can cause” brachial neuritis. Despite the reasonable objections made to the theory by Dr. MacGinnitie, the evidence offered was sufficiently preponderant on the question of vaccine causality for an Althen prong one finding in Petitioner’s favor. The timeframe prong under Althen presents a more difficult question, since onset occurred fairly close in time to vaccination, and thus is not consistent with an adaptive immune-mediated response. However, the immune memory arguments posited by Dr. Andersson have some persuasive value in the context of a brachial neuritis injury. In addition, although Respondent did effectively note the strong possibility that Petitioner’s surgery was a “factor unrelated” explanation for brachial neuritis (and I did not find persuasive Petitioner’s argument that surgery is only a risk due to positional effects—rather, surgery clearly could trigger an immune response as well), Respondent did not exclude the possibility of the vaccine as a substantial factor. Stone v. Sec'y of Health & Hum. Servs., 95 Fed. Cl. 233, 237 n.5 (2010). Of course, not establishing the alleged injury in this case is equivalent to failing to prove that the flu vaccine “did cause” it (meaning the second Althen prong is not established). The evidence—both from the record and based on expert submissions—heavily preponderates against the finding that Petitioner’s injury is best characterized as brachial neuritis. 23 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 24 of 25 diagnosis can be made if weakness is limited to muscles supplied by a single peripheral nerve. (iii) Motor, sensory, and reflex findings on physical examination and the results of NCS and EMG studies, if performed, must be consistent in confirming that dysfunction is attributable to the brachial plexus; and (iv) No other condition or abnormality is present that would explain the vaccine recipient’s symptoms. 42 C.F.R.§ 100.3(a), (c)(6). As Dr. Callaghan noted, Petitioner never exhibited symptoms or examination findings indicating weakness in the left arm compared to the right arm despite two visits to his neurologists and several to his PCP. Callaghan First Rep. at 5; Tr. at 206–209; 220–21. Weakness is a central feature of brachial neuritis, yet evidence of it is absent in this medical record. See, e.g., Tsairis at 111. The record also lacked evidence of “motor, sensory, reflexes findings, and EMG/NCS studies confirming dysfunction in the brachial plexus.” Callaghan First Rep. at 5. Rather, EMG and NCS testing were supportive of CTS and radiculopathy. Id. These conditions were all explanatory for Petitioner’s complaints. Id. at 7; Callaghan Second Rep. at 2 (“Petitioner’s symptoms of left shoulder pain and numbness, tingling, and burning in the 1-3 digits of the left hand are exactly the type of symptoms one would expect from a left C5 radiculopathy as demonstrated on the EMG/NCS”). That diagnostic testing was not supportive of brachial neuritis, as the contemporaneous record established. See Ex. 8 at 14-16 (EMG confirming bilateral CTS and chronic cervical radiculopathy). Finally, the characterization of Petitioner’s injury as an especially uncommon, pure sensory form of brachial neuritis was effectively rebutted by Dr. Callaghan as lacking record evidence substantiation. Callaghan Second Rep. at 1. No treater so diagnosed Petitioner. In addition, the EMG/NCS testing did not reveal injury to sensory nerves (as would be expected in a pure sensory form of brachial neuritis), but instead was (again) fully consistent with CTS, cervical radiculopathy, and neuropathy (all of which were the diagnoses made by Petitioner’s treating physicians). Dr. Andersson was a qualified and competent expert, fully capable of offering an opinion on the neurologic issues in dispute, and he made many credible points in Petitioner’s favor. The case was certainly reasonably disputed. But his contentions about the appropriateness of a brachial neuritis diagnosis were ultimately lacking in sufficient record support. 24 Case 1:20-vv-00855-KCD Document 79 Filed 06/03/24 Page 25 of 25 CONCLUSION Petitioner has not established the alleged brachial neuritis injury with sufficient preponderant evidence, and therefore is not entitled to an award of compensation. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.14 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 14 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices renouncing their right to seek review. 25 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_20-vv-00855-2 Date issued/filed: 2024-06-13 Pages: 30 Docket text: JUDGE VACCINE REPORTED OPINION 75 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Judge Kathryn C. Davis. (KS) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 1 of 30 IN THE UNITED STATES COURT OF FEDERAL CLAIMS ___________________________________ ) CRAIG FISHER, ) ) Petitioner, ) No. 20-855 ) v. ) Filed: May 23, 2024 ) SECRETARY OF HEALTH AND ) Re-issued: June 13, 2024 HUMAN SERVICES, ) ) Respondent. ) ___________________________________ ) OPINION AND ORDER Petitioner Craig Fisher (“Petitioner”) seeks review of a decision denying compensation under the National Vaccine Injury Compensation Program (“Vaccine Act”), 42 U.S.C. § 30aa-10 et seq. Petitioner filed a petition for compensation alleging that he suffered from pure sensory brachial neuritis caused by the influenza vaccine. On December 4, 2023, the Chief Special Master denied Petitioner’s claim, finding that Petitioner had not established by a preponderance of evidence that he suffered the claimed injury. Before the Court is Petitioner’s Motion for Review of the Chief Special Master’s entitlement decision pursuant to Rules 23 and 24 of the Vaccine Rules of the United States Court of Federal Claims (“Vaccine Rules”). For the reasons discussed below, the Court DENIES Petitioner’s Motion.  The Court issued this opinion under seal on May 23, 2024, and directed the parties to file any proposed redactions by June 6, 2024. As the parties do not propose any redactions, the Court reissues the opinion publicly in full. Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 2 of 30 I. BACKGROUND A. Petitioner’s Medical History Prior to Vaccination At the time of the alleged injury, Petitioner was 67 years old with no history of medical issues involving his back, shoulder, or elbow prior to vaccination. Pet’r’s Ex. 1, ¶¶ 1, 6, ECF No. 6-1. On January 12, 2018, Petitioner was admitted to the hospital for epigastric pain. Id. ¶¶ 2–3. Petitioner underwent emergency surgery for a hernia and was hospitalized for one-week post- surgery. Id. Records from this time indicate that Petitioner had numerous comorbidities, including diabetes, atrial fibrillation, coronary artery disease, chronic renal disease, hypertension, and sleep apnea. Pet’r’s Ex. 3 at 5, ECF No. 6-3. Records from physical examinations on January 13, 2018, while Petitioner was hospitalized, indicate that his extremities were “normal,” and his neurological system showed “normal motor and sensory” functions. Id. at 12. Petitioner was discharged from the hospital on January 19, 2018. ECF No. 6-1, ¶ 3. Just prior to leaving the hospital, upon recommendation of the charge nurse, Petitioner received the flu vaccine in his left deltoid. Id. Petitioner had received flu shots in the past without any complications. Pet’r’s Ex. 4 at 141, ECF No. 6-4. B. Petitioner’s Onset of Symptoms and Treatment On January 21, 2018, two days after vaccination, Petitioner alleges that he awoke with a severe pain in his left upper arm. ECF No. 6-1, ¶ 4. Records from a home health care nurse’s visit do not indicate that he experienced any left shoulder or arm pain, though the notes mention anxiety and fatigue. Pet’r’s Ex. 7 at 6, 9, 10, ECF No. 6-7. On January 23, 2018, Petitioner visited his primary care physician, Dr. Patrick Murphy, and complained of “severe arm pain from [the] [f]lu vaccine [four] days ago.” Pet’r’s Ex. 9 at 235, ECF No. 22-1. Dr. Murphy diagnosed Petitioner with left upper extremity pain and prescribed pain relief medication. Id. at 234, 241. On January 2 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 3 of 30 24 and 31, 2018, Petitioner received additional in-home health care visits related to his surgery. ECF No. 6-7 at 40, 59. At both visits, Petitioner described his left arm pain as an “ache” that was exacerbated by physical activity. Id. at 41, 60. On February 7, 2018, Petitioner informed the home health care nurse that his doctor approved his return to work, that he was “no longer home bound,” and that he did not have a “skilled need” for in-home care. Id. at 73. On March 30, 2018, Petitioner saw Dr. Murphy for routine management of his diabetes, hypertension, and hyperlipidemia conditions. ECF No. 22-1 at 246–47. At this visit, Petitioner exhibited left hand numbness, and Dr. Murphy diagnosed him with diabetes mellitus with circulatory complication and chronic diabetic polyneuropathy. Id. at 252, 245–46. On July 3, 2018, Petitioner again saw Dr. Murphy for management of his chronic conditions. ECF No. 6-4 at 5. At this visit, Dr. Murphy recorded Petitioner’s physical exam as normal, and included diabetic polyneuropathy in his assessment of Petitioner’s conditions. Id. at 11, 6. On August 23, 2018, Petitioner returned to see Dr. Murphy for urinary frequency and left arm pain. Id. at 20. Petitioner reported that the onset of arm pain occurred in January 2018 due to an “injection reaction.” Id. Petitioner described the pain as located in his “left upper arm to fingers,” that it was a “moderate” and “aching” pain, and that he felt numbness in his second and third fingers. Id. Among other conditions, Dr. Murphy’s assessment of Petitioner again included diabetic polyneuropathy. Id. On October 4, 2018, Petitioner saw Dr. Murphy for a diabetes follow up appointment. Id. at 32. The record from this visit lists the flu vaccine as an allergen for Petitioner. Id. at 35. Almost one year later, on September 24, 2019, Petitioner saw Dr. Brooke McQueen, a neurologist. Id. at 141. Dr. McQueen recorded the history of Petitioner’s left arm pain and noted that he “presented to the clinic with complaints of numbness, tingling, burning, and pins and needle sensation” in his left arm that started “after the flu shot.” Id. At this visit, Petitioner reported to 3 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 4 of 30 Dr. McQueen that Dr. Murphy “thought the injection hit a nerve in the arm when he got the flu shot and that this would improve [with] time.” Id. Dr. McQueen diagnosed Petitioner with neuropathy and suspected that Petitioner might have carpal tunnel syndrome (“CTS”). Id. at 160. Dr. McQueen ordered an electromyography test (“EMG”) test. Id. The EMG results showed that Petitioner had CTS and chronic cervical radiculopathy, with the left side worse than the right for both conditions.1 Pet’r’s Ex. 8 at 13–14, ECF No. 13-1. On March 24, 2020, Petitioner had a telemedicine appointment with Dr. McQueen. ECF No. 6-4 at 163. Petitioner complained of numbness and “tingling, burning/sharp/electrical pain” in some of his left fingers. Id. at 164. Dr. McQueen noted that Petitioner had “no reported weakness in the left arm . . . [or] left hand.” Id. at 164–65. Considering these symptoms and the results of Petitioner’s EMG test, Dr. McQueen diagnosed Petitioner with: “1. Neuropathy; 2. Cervical radiculopathy; 3. Bilateral carpal tunnel syndrome; 4. Neuropathic pain of hand, left.” Id. at 163; see id. at 175. In addition, Dr. McQueen reported that Petitioner had “mild pinched nerves in the neck” but that there was “nothing to do at this time, likely age related.” Id. at 176. Dr. McQueen advised Petitioner that “likely he will have some permanent residual deficits from his nerve injury” and that he should wear wrist splints at night for his CTS. Id. In a sworn statement dated July 1, 2020, Petitioner describes his pain as persistent and that the Naproxen and hydrocodone prescribed by Dr. Murphy did not provide relief. ECF No. 6-1, ¶ 5. Petitioner reports that he must either ice the area of pain, take a hot shower, or seek massage therapy to find some “temporary relief.” Id. ¶ 6. 1 Petitioner’s EMG test, performed on September 27, 2019, included nerve conduction studies. Pet’r’s Ex. 8 at 13–14, ECF No. 13-1. These studies are referred to separately by the parties in their briefing materials and by the experts in their reports as “NCS” tests. The Court’s references to Petitioner’s “EMG test” are inclusive of the NCS tests performed as part of the September 27, 2019, EMG test. 4 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 5 of 30 C. Procedural History On July 14, 2020, Petitioner filed a petition with the Office of Special Masters requesting compensation under the Vaccine Act. See ECF No. 1. Petitioner alleges that after he received the influenza vaccine, he developed chronic pain and neuropathy. Id. ¶¶ 14–15. Petitioner’s case was initially assigned to the Special Processing Unit (“SPU”) based on the Office of Special Masters’ anticipation that the claim was likely to settle. See Notice, ECF No. 4; SPU Initial Order, ECF No. 10. On December 10, 2020, Petitioner filed a Statement of Completion notifying the court that he had filed all outstanding relevant medical records. See ECF No. 14. On June 16, 2021, Respondent filed its Rule 4(c) Report, disputing Petitioner’s claims and requesting the court dismiss the matter. See ECF No. 21. On August 17, 2021, the matter was removed from the SPU due to issues raised in Respondent’s Rule 4 report and was reassigned to the Chief Special Master’s regular docket. See Order, ECF No. 24. Petitioner proceeded to file his expert reports (ECF Nos. 26, 41, 67) and supporting medical literature (ECF Nos. 27–29, 38). Respondent filed its expert reports (ECF Nos. 31, 44, 66) and supporting medical literature (ECF Nos. 37, 49) as well. A two-day Entitlement Hearing was held on April 13–14, 2023. See Minute Entry (Apr. 14, 2024). The Chief Special Master issued an Entitlement Decision on December 4, 2023, denying the Petition because Petitioner did not establish his claimed injury by a preponderance of evidence. Entitlement Dec. at 1, ECF No. 69. On January 2, 2024, Petitioner filed the present Motion for Review, and on January 24, 2024, Respondent filed its Response. See ECF Nos. 70, 73. On January 31, 2024, Petitioner filed a Motion for Leave to File Petitioner’s Reply in Support of Motion for Review. See ECF No. 74. 5 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 6 of 30 D. Expert Opinions In reaching his decision, the Chief Special Master reviewed Petitioner’s medical records and eight expert reports filed by three different experts: three reports filed by Petitioner’s expert and five reports filed by Respondent’s two experts. See generally Pet’r’s Ex. 10, ECF No. 26-1; Pet’r’s Ex. 42, ECF No. 41-1; Pet’r’s Ex. 53, ECF No. 67-1; Resp’t’s Ex. A, ECF No. 31-1; Resp’t’s Ex. C, ECF No. 31-3; Resp’t’s Ex. E, ECF No. 44-1; Resp’t’s Ex. F, ECF No. 44-2; Resp’t’s Ex. G, ECF No. 66-1. 1. Petitioner’s Expert Reports Petitioner retained one expert, Dr. Peter-Brian Andersson, a clinical neurologist who has treated over one hundred cases of brachial neuritis.2 ECF No. 69 at 5–6; ECF No. 26-1 at 1–2. In his first report, Dr. Andersson reviewed Petitioner’s medical history and summarized Petitioner’s EMG test from September 27, 2019. ECF No. 26-1 at 2–6. Dr. Andersson noted the “paucity of abnormalities, including for carpal tunnel syndrome and cervical radiculopathy” in Petitioner’s records and concluded that the EMG test showed that “these conditions [we]re not explanatory” of Petitioner’s symptoms. Id. at 6. Specifically, Dr. Andersson asserted that the numbness in Petitioner’s fingers was not consistent with CTS or cervical radiculopathy, rebutting the treating physicians’ diagnoses. Id. at 8–9. Instead, Dr. Andersson diagnosed Petitioner with neuralgic amyotrophy (an “equivalent” term to brachial plexitis and brachial plexitis neuropathy) “to a reasonable medical probability.” Id. at 7. According to Dr. Andersson, only this diagnosis can account for the entirety of Petitioner’s symptoms, all of which he characterized as “striking.” Id. at 7–8. The factors he considered relevant to the diagnosis included: severity of the pain, apparent lack of a cause of the pain, distribution (wide) of the pain, time course (sudden severe 2 Dr. Andersson’s CV is found at Pet’r’s Ex. 11, ECF No. 26-2. 6 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 7 of 30 onset), persistence of the pain, and associated neurogenic features (severity, constancy, absence of musculoskeletal association). See id. In addition, Dr. Andersson described how Petitioner’s case meets the legal standard for causation in a Vaccine Act case. Dr. Andersson opined that the process of “molecular mimicry”3 can cause brachial neuritis by activating an immune response and potentially causing a vaccination-induced neuropathic injury. Id. at 10–13. Dr. Andersson further opined that he “d[id] not find any other explanations for why Petitioner contracted neuralgic amyotrophy [other] than vaccination” and that the “timing correlates” between vaccination to onset of Petitioner’s symptoms. Id. at 14. Dr. Andersson filed two supplemental reports, one in rebuttal to Respondent’s experts’ reports and another that elaborates on whether brachial neuritis can be caused by an innate immune response. See ECF Nos. 41-1, 67-1. In his rebuttal, Dr. Andersson specifically objected to Respondent’s expert’s opinion on Petitioner’s EMG test results, stating that the expert “fail[ed] to reject a diagnosis of brachial plexitis” and that the “[EMG] study was hamstrung by its limitations.” ECF No. 41-1 at 3. Dr. Andersson also rebutted Respondent’s expert’s opinion disputing that the flu vaccine can cause Petitioner’s claimed injury, asserting that the expert ignored the record and held Petitioner’s expert (Dr. Andersson) to a higher bar than himself. Id. at 10. In his report discussing innate immune responses to a vaccine, Dr. Andersson first noted that although the timeframe from vaccination to onset of symptoms in Petitioner was rapid, “a memory adaptive response” can explain Petitioner’s sudden symptoms. ECF No. 67-1 at 1. Even 3 Dr. Andersson described “molecular mimicry” as a process that happens when “‘cross reacting’ homologies that are shared between a foreign antigen and brachial plexus tissues result in an antibody mediated and or cytotoxic T cell mediated ‘friendly fire’ attack on the host.” ECF No. 67-1 at 1. 7 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 8 of 30 so, Dr. Andersson also explained that “any factor” including vaccination can “provok[e] the innate immune system [and] can serve as the immunological trigger” for the injury.4 Id. at 2. Furthermore, Dr. Andersson asserted that there is “no mechanism” by which Petitioner’s surgery just days prior to receiving the vaccine could be the cause of his injury. Id. at 3. 2. Respondent’s Expert Reports Respondent retained two experts: Dr. Brian C. Callaghan, a neuromuscular specialist with expertise in the treatment of neuropathies like brachial neuritis, and Dr. Andrew MacGinnitie, an immunologist who is the Clinical Director for the Division of Immunology at Boston Children’s Hospital and an Associate Professor of Pediatrics at Harvard Medical School.5 ECF No. 69 at 8, 11. Dr. Callaghan characterized brachial neuritis as “rare” and estimated he has seen over 50 patients with the condition. ECF No. 31-1 at 1. In his first report, Dr. Callaghan agreed with Petitioner’s treating physicians’ diagnoses of neuropathy, cervical radiculopathy, and CTS. Id. at 4. Dr. Callaghan disagreed with Petitioner’s brachial neuritis claim because Petitioner did not exhibit all the symptoms for the condition according to the Act’s Vaccine Injury Table (“Table”). Id. at 4–5. He noted that Petitioner’s EMG test “revealed injury to the median nerve (carpal tunnel syndrome) and the cervical nerve roots (C5 and C7 radiculopathies) and not the brachial plexus.” Id. at 5. As to causation, Dr. Callaghan asserted that available medical data points to infections (rather than vaccines or surgery) as being “by far the most common antecedent event prior to 4 Dr. Andersson explained that activation of complement (a component of the innate immune system that defends against foreign pathogens) in brachial neuritis “provides further evidence that an acute onset of symptoms within just a couple of days following a trigger is due to an innate immune-mediated response.” ECF No. 67-1 at 2. 5 Dr. Callaghan’s CV is found at Resp’t’s Ex. B, ECF No. 31-2. Dr. MacGinnitie’s CV is found at Resp’t’s Ex. D, ECF No. 31-4. 8 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 9 of 30 brachial neuritis.” Id. Dr. Callaghan also disagreed with Dr. Andersson’s molecular mimicry theory—linking vaccines to the onset of brachial neuritis, based on similarities between brachial neuritis and Guillain-Barre Syndrome (“GBS”)—because there is no reliable evidence to support this claim and because brachial neuritis and GBS are distinct neurologic diseases. Id. at 6. Dr. Callaghan concluded that there is “insufficient evidence to support a causal relationship between” the flu vaccine and brachial neuritis. Id. at 7. In rebuttal to Dr. Andersson’s report, Dr. Callaghan reiterated his original assessment of Petitioner’s diagnosis and his disagreement with Dr. Andersson’s causation analogy to GBS, and he provided further explanation of EMG test results generally. See ECF No. 44-1. According to Dr. Callaghan, findings of cervical radiculopathy and CTS on an EMG test are indicative of a “severe” occurrence of those conditions “affecting the motor nerves in addition to the sensory nerves” (rebutting Dr. Andersson’s contention that Petitioner’s EMG results for these conditions were “minimal”). Id. at 2. Dr. Callaghan also disputed Dr. Andersson’s conclusion that Petitioner suffered from pure sensory brachial neuritis because such a diagnosis would be a “rare presentation of an already uncommon disease,” and supporting evidence is lacking in Dr. Andersson’s report. Id. at 1. Dr. MacGinnitie’s first report focused on the causation theory offered by Dr. Andersson rather than Petitioner’s alleged injury. ECF No. 31-3 at 5. Dr. MacGinnitie asserted that Dr. Andersson did not provide specifics on how “molecular mimicry” (i.e., “cross-reactivity between vaccine and human antigens”) could cause an immune response leading to Petitioner’s symptoms. Id. at 6. In addition, Dr. MacGinnitie rebutted Dr. Andersson’s analogy to vaccine causation in cases of GBS because Dr. Andersson provided “no evidence that similar cross-reactivity exist[s] between influenza vaccine components and human nervous tissue.” Id. Dr. MacGinnitie also 9 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 10 of 30 explained why the timeframe between Petitioner’s receipt of the vaccine and onset of symptoms did not support a causal link to the vaccine. Id. at 7–8. Rather, he pointed to Petitioner’s abdominal surgery, a few days prior to receiving the vaccine, as the likely cause of his later symptoms. Id. at 8. In rebuttal to Dr. Andersson’s report, Dr. MacGinnitie reiterated his conclusions from his first report. See ECF No. 44-2. Dr. MacGinnitie provided diagnostic criteria for establishing a causative relationship between a vaccine and an injury via molecular mimicry and concluded that Dr. Andersson did not provide supporting evidence meeting these criteria. Id. at 1–2. Furthermore, Dr. MacGinnitie noted that the timing of the onset of Petitioner’s symptoms is “incompatible with an adaptive immune response” and again pointed to his surgery a few days prior as a more likely potential cause of Petitioner’s injury. Id. at 2. Dr. MacGinnitie also filed a supplemental report elaborating on whether an innate immune response can cause brachial neuritis. See ECF No. 66-1. Here, Dr. MacGinnitie provided an explanation of the innate and adaptive arms of the immune system and how these responses work together to cause brachial neuritis. Id. at 2–9. Dr. MacGinnitie noted that infections and vaccinations activate both the innate and adaptive immune response; however, he opined that “few physicians would consider onset of symptoms [less than] 48 hours after vaccination as consistent with a sound theory of a vaccine being causative.” Id. at 8. Accordingly, Dr. MacGinnitie asserted that an innate immune response is not a plausible cause of brachial neuritis, and an influenza vaccination is not a strong stimulus for the innate immune response. Id. at 10. E. The Entitlement Decision On December 4, 2023, the Chief Special Master issued his Entitlement Decision, in which he denied Petitioner’s claim. ECF No. 69 at 1. Specifically, the Chief Special Master held that 10 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 11 of 30 Petitioner had not met his burden to show his alleged injury by preponderant evidence. Id. at 25. Because Petitioner did not sufficiently prove his alleged injury, the Chief Special Master did not perform the three-prong causation analysis set forth in Althen v. Secretary of Health and Human Services, 418 F.3d 1274 (Fed. Cir. 2005). Id. at 23 n.13. In reaching his decision, the Chief Special Master reviewed the testimony, reports, and supporting literature offered by both Petitioner’s and Respondent’s fact and expert witnesses. With respect to Petitioner’s expert witness, the Chief Special Master noted Dr. Andersson’s explanation of brachial neuritis and its associated symptoms. Id. at 6. He also summarized Dr. Andersson’s opinions as to Petitioner’s purported immune response to the vaccine that resulted in his alleged injury and the timeframe within which Petitioner’s symptoms arose as being “consistent with an adaptive/secondary immune-mediated process.” Id. at 6–8. The Chief Special Master also provided an overview of Respondent’s first expert witness’s testimony regarding the diagnostic criteria for brachial neuritis. Id. at 9. The Chief Special Master noted Dr. Callaghan’s conclusion that Petitioner’s symptoms did not meet these criteria and that Petitioner’s past medical history was more likely an explanation for Petitioner’s symptoms. Id. at 9–10. The Chief Special Master likewise reviewed Respondent’s second expert witness’s testimony about whether there is a causal connection between the flu vaccine and the type of problems suffered by Petitioner. Id. at 10. The Chief Special Master then observed that while Dr. MacGinnitie agreed with Dr. Andersson’s explanation of an adaptive immune response to a vaccine and the relation of “molecular mimicry” to this response, Dr. MacGinnitie ultimately did not agree that molecular mimicry explained how the flu vaccine could cause brachial neuritis. Id. at 11–12. 11 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 12 of 30 Finally, the Chief Special Master summarized the parties’ supplemental reports submitted after the Entitlement Hearing “addressing whether brachial neuritis can be caused by an innate immune response.” Id. at 13. The Chief Special Master noted Dr. Andersson’s opinion that brachial neuritis could result from an innate immune response “through an ‘acute, nonspecific, immune-mediated inflammatory response triggered by localized inflammation, complement cascade and localized lymphocytic infiltration[,]’” which were “all present in Petitioner’s case.” Id. at 14. The Chief Special Master observed that, conversely, Dr. MacGinnitie denied that an innate immune response alone could cause brachial neuritis. Id. at 15. Rather, Dr. MacGinnitie had asserted that “the majority of influenza vaccines administered in the U.S. are unadjuvanted, including the one [Petitioner] received, where adjuvants are materials added to vaccines specifically to trigger the innate immune system.” Id. After reviewing the medical evidence and expert opinions, the Chief Special Master provided an overview of how the Office of Special Masters treats brachial neuritis claims. Id. at 22. The Chief Special Master acknowledged that even though the Table only provides for a claim of brachial neuritis after receipt of the tetanus vaccine, some special masters have found that other vaccines, including the flu vaccine, may also cause the condition. Id. The Chief Special Master tempered this potential finding of a causal link with the weight he generally affords to evidence of the onset of symptoms within a medically acceptable timeframe. Id. With this context, the Chief Special Master then proceeded to explain why Petitioner’s claimed injury was not sufficiently supported by the evidence and why disposition of the case depended upon such finding. Id. at 22– 24. First, the Chief Special Master found that Petitioner’s alleged injury was “not corroborated by record evidence of contemporaneous treater support.” Id. at 23. Rather, he found that the 12 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 13 of 30 records from Petitioner’s visits to his neurologist, Dr. McQueen, were more supportive of the diagnoses embraced by Respondent’s expert witness—i.e., CTS, chronic cervical radiculopathy, and neuropathy. Id. at 23, 24. Second, the Chief Special Master agreed with Respondent’s expert’s analysis regarding the criteria for a brachial neuritis claim, which he found to be lacking in Petitioner’s case. Id. at 23– 24. Specifically, he found Dr. Callaghan had demonstrated that Petitioner’s symptoms meet only one (“pain in the affected arm and shoulder”) of the four criteria that would establish a Table Claim for brachial neuritis.6 Id. The Chief Special Master reiterated Dr. Callaghan’s findings that Petitioner did not show symptoms of “weakness,” nor did his “motor, sensory, reflexes findings, and EMG/NCS studies confirm[] dysfunction in the brachial plexus,” and there were other “condition[s] or abnormalit[ies]” present, specifically the EMG test was supportive of CTS and radiculopathy diagnoses. Id. at 23–24. Finally, the Chief Special Master found that Petitioner had failed to provide preponderant evidence establishing that his injury was the “especially uncommon, pure sensory form of brachial neuritis.” Id. at 24. Consistent with Dr. Callaghan’s report, the Chief Special Master found that “no treater so diagnosed Petitioner.” Id. Furthermore, the EMG testing Petitioner underwent “did not reveal injury to sensory nerves (as would be expected in a pure sensory form of brachial neuritis),” but instead was “consistent” with the same findings made by Petitioner’s treating physicians—namely, CTS, cervical radiculopathy, and neuropathy. Id. Accordingly, the Chief Special Master denied Petitioner’s claim for entitlement to compensation because his alleged injury lacked preponderant evidentiary support. Id. at 25. 6 The Chief Special Master acknowledged that the Table criteria for a brachial neuritis claim are “not controlling” in this off-Table matter, nonetheless they “provide useful guidance for brachial neuritis’s elements.” ECF No. 69 at 23. 13 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 14 of 30 F. The Motion for Review On January 2, 2024, Petitioner timely filed a Motion for Review of the Entitlement Decision. See ECF No. 70. Petitioner asks the Court to remand his claim to the Chief Special Master with instructions to find that Petitioner met his burden to preponderantly prove the alleged injury and to “conduct further proceedings consistent with this determination.” Pet’r’s Mem. of Objs. in Supp. of Mot. for Rev. at 24, ECF No. 71. Specifically, Petitioner claims that the Chief Special Master arbitrarily and capriciously elevated his burden to demonstrate a rare injury. Id. at 15. He also claims the Chief Special Master arbitrarily and capriciously elevated his burden to show that the treating physicians made the exact same diagnosis as Petitioner’s expert witness and that the treating physicians correctly diagnosed Petitioner with a rare illness.7 Id. at 19. Petitioner’s Motion for Leave to File a Reply and the proposed Reply In Support of Motion for Review reiterate arguments found in his Motion for Review. See ECF Nos. 74, 74-1. On January 24, 2024, Respondent filed its response to Petitioner’s Motion for Review, arguing that the Chief Special Master’s determination was not arbitrary or capricious because he appropriately considered all relevant evidence, including opinions of the parties’ experts, and discussed why the evidence supported his findings. Resp’t’s Resp. to Pet’r’s Mot. for Rev. at 14– 16, ECF No. 73. In addition, Respondent argues that the Chief Special Master appropriately considered the contemporaneous medical records when determining that Petitioner had not established a diagnosis of brachial neuritis, the claimed injury. Id. at 17. Because Petitioner had 7 Although Petitioner frames his questions presented as involving the arbitrary and capricious standard, the Motion argues that the Chief Special Master committed errors of law, which would be reviewed under the “not in accordance with law” standard. See Vinesar v. Sec’y of Health & Hum. Servs., 170 Fed. Cl. 681, 691 (2024). Since a misapplication of the burden of proof would be considered a legal error, the remainder of the opinion refers to the arguments as such. Ultimately, however, the substance of the arguments relates to the Chief Special Master’s weighing of evidence, and thus the Court will also apply the arbitrary and capricious standard. 14 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 15 of 30 not met the initial burden of establishing the claimed injury, Respondent argues that the Chief Special Master was not required to perform an Althen analysis. Id. at 18. II. LEGAL STANDARD A. The Court’s Standard of Review This Court has jurisdiction to review a special master’s entitlement decision upon the timely request of either party. 42 U.S.C. § 300aa-12(e)(2). Under the Vaccine Act, the Court when deciding a motion for review may: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or (C) remand the petition to the special master for further action in accordance with the court’s direction. Id. §§ 300aa-12(e)(2)(A)–(C); accord Vaccine Rule 27(c). The standards of review set forth in 42 U.S.C. § 300aa-12(e)(2)(B) “vary in application as well as degree of deference” as each “standard applies to a different aspect of the judgment.” Munn v. Sec’y of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). The special master’s factual findings are reviewed under an arbitrary and capricious standard. Id. This scope of review is thus limited and highly deferential. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000); see Munn, 970 F.2d at 870 (review of a special master’s factual findings is “well understood to be the most deferential possible” (citations omitted)). “If the special master has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely difficult to demonstrate.” Hines ex rel. Sevier v. Sec’y of Dep’t of Health & Hum. Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991). When the Court’s review of a special master’s decision involves statutory construction or other legal issues, it applies the “not 15 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 16 of 30 in accordance with law” standard. Id. at 1527. The third standard of review, abuse of discretion, is applicable when the special master excludes evidence or otherwise limits the record upon which he relies. See Munn, 970 F.2d at 870 n.10. B. The Standard of Causation in Vaccine Cases The duty of a special master in a vaccine case is to determine, by a preponderance of evidence, whether the vaccine caused the alleged injury. Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010) (citing Andreu ex rel. Andreu v. Sec’y of Dep’t of Health & Hum. Servs., 569 F.3d 1367, 1382 (Fed. Cir. 2009)). A petitioner may establish that a vaccine caused an alleged injury in one of two ways. 42 U.S.C. § 300aa-11(c); see Munn, 970 F.2d at 865. First, a petitioner who has received a vaccine listed on the Table may recover for any resulting illness, disability, injury, or condition that is also listed on the Table, or a significant aggravation thereof. 42 U.S.C. §§ 300aa-11(c)(1)(C)(i), 300aa-14; see Althen, 418 F.3d at 1278 (describing a “Table injury”). Second, a petitioner who has received a vaccine listed on the Table, but whose vaccine-related injury does not meet Table requirements, may recover under an “off- Table” theory. See 42 U.S.C. §§ 300aa-11(c)(1)(C)(ii), 300aa-13(a)(1)(A). A petitioner’s establishment of an actual injury is a prerequisite to the causation determination. Broekelschen, 618 F.3d at 1346 (“[E]ach prong of the Althen [causation] test is decided relative to the injury . . . .”); see 42 U.S.C. § 300aa–11(a) (creating a cause of action for persons suffering a “vaccine-related injury”). In limited cases where the parties allege competing diagnoses, a special master must “first determine which injury was best supported” by the evidence in the record before proceeding to the Althen causation analysis. Broekelschen, 618 F.3d at 1346. This includes cases where “the injury itself is in dispute, [or] the proposed injuries differ significantly in their pathology, and the question of causation turns on which injury [the petitioner] 16 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 17 of 30 suffered.” Id. (quoting Kelley v. Sec’y of Health & Hum. Servs., 68 Fed. Cl. 84, 100–01 (2005)); see Lombardi v. Sec’y of Health & Hum. Servs., 656 F.3d 1343, 1352–53 (Fed. Cir. 2011) (an initial determination of the injury is necessary where there is “extreme disagreement among well- qualified medical experts”); Contreras v. Sec’y of Health & Hum. Servs., 107 Fed. Cl. 280, 294– 95 (2012). Importantly, if the special master determines that a petitioner did not establish his claimed injury by a preponderance of evidence, then the special master does not need to undertake the three-prong Althen causation analysis. Lombardi, 656 F.3d at 1353. In that scenario, the special master may deny the claim as an initial matter because the alleged injury is the “underpinning” of the petitioner’s claim. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011), aff’d, 698 F.3d 1355 (Fed. Cir. 2012). Assuming he meets that initial burden, a petitioner may make a prima facie case of entitlement to compensation under an off-Table theory by showing, by a preponderance of evidence, that a Table vaccine actually caused the petitioner to sustain that claimed illness, disability, injury, or condition which is not listed on the Table, or that first appeared outside the time limits set by the Table. 42 U.S.C. § 300aa-11(c)(1)(C)(ii); see Pafford v Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). For a petitioner to successfully recover for an off-Table claim, he or she must establish causation-in-fact. See 42 U.S.C. §§ 300aa- 11(c)(1)(C)(ii), 300aa-13(a)(1); Pafford, 451 F.3d at 1355. This requires “preponderant evidence both that [the] vaccination[] [was] a substantial factor in causing the illness, disability, injury or condition and that the harm would not have occurred in the absence of the vaccination.” Pafford, 451 F.3d at 1355 (citing Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999)). Although the vaccination “must be a ‘substantial factor’” in bringing about the injury, “it 17 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 18 of 30 need not be the sole factor or even the predominant factor.” Id. at 1357 (quoting Shyface, 165 F.3d at 1352–53). To make the showing that “the vaccination brought about [the] injury,” a petitioner must show: “(1) a medical theory causally linking the vaccine and the injury; (2) a logical sequence of cause and effect showing the vaccine was the reason for the injury; and (3) a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278. “[N]either a mere showing of a proximate temporal relationship between vaccination and injury, nor a simplistic elimination of other potential causes of the injury suffices, without more, to meet the burden of showing actual causation” under the three-factor test. Id. (citing Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144, 1149 (Fed. Cir. 1992)). Nor may the special master make a finding of causation based on the claims of a petitioner alone, which are not substantiated by medical records or by medical opinion. See 42 U.S.C. § 300aa-13(a)(1). Thus, the presentation of medical records or medical opinion supporting a claim is a prerequisite to recovery. Id. In off-Table cases, petitioners bear the burden to prove actual causation by a preponderance of evidence. Althen, 418 F.3d at 1278; see 42 U.S.C. § 300aa-11(c)(1)(A). The preponderant- evidence standard requires that a petitioner demonstrate proof “by a simple preponderance, of ‘more probable than not’ causation.” Althen, 418 F.3d at 1279 (citing Hellebrand v. Sec’y of Health & Hum. Servs., 999 F.2d 1565, 1572–73 (Fed. Cir. 1993)). This standard “‘simply requires the trier of fact to believe that the existence of a fact is more probable than its nonexistence.’” Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (quoting Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension T. for S. Cal., 508 U.S. 602, 622 (1993)). In evaluating the evidence put forth to meet the preponderance standard, the special master has discretion to determine the relative weight of the evidence presented, including 18 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 19 of 30 contemporaneous medical records and oral testimony. See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993); see also Hibbard, 698 F.3d at 1368. If a petitioner presents adequate evidence on the three essential aspects of causation, and thus makes a prima facie case for liability, the burden shifts to Respondent to prove, by a preponderance of evidence, an alternate cause of the alleged injury. Althen, 418 F.3d at 1278; de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). III. DISCUSSION Petitioner’s Motion raises two objections to the Chief Special Master’s decision. First, Petitioner contends that the Chief Special Master improperly elevated Petitioner’s burden of proof by requiring him to prove a rare injury with scientific certainty and by applying diagnostic criteria for a different injury. ECF No. 71 at 6, 18–19. Second, Petitioner contends that the Chief Special Master improperly elevated his burden of proof by requiring Petitioner’s treating physicians and expert witness to have made the same diagnosis—which in essence required the treaters to have correctly diagnosed a rare illness—and by improperly making his entitlement determination prior to shifting the burden of proof to Respondent to rebut Petitioner’s prima facie case. Id. at 6–7, 22– 24; ECF No. 74-1 at 2–3. Having considered the arguments and the record, the Court rejects both claims. The Chief Special Master did not commit an error of law, rather he followed clear Federal Circuit precedent in first determining the underlying injury, which was a matter in dispute and on which the Althen causation analysis was dependent. Broekelschen, 618 F.3d at 1350; ECF No. 69 at 22–23. In reaching his conclusion, the Chief Special Master properly weighed the evidence in the record, including the parties’ expert reports, fact and expert witness testimony, submitted literature, and Petitioner’s medical records, and made a rational determination of injury based on that evidence. 19 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 20 of 30 Burns, 3 F.3d at 417; ECF No. 69 at 23–25. Accordingly, the Chief Special Master’s decision is upheld. A. The Chief Special Master Did Not Make an Error of Law by Elevating Petitioner’s Burden of Proof. Petitioner alleges that the Chief Special Master made an error of law by determining that Petitioner did not meet his burden to prove that he suffers from pure sensory brachial neuritis. ECF No. 71 at 6, 14; see id. at 15 (alleging error because “[t]here is far too much evidence satisfying [his] initial burden”). According to Petitioner, the Chief Special Master erroneously elevated Petitioner’s burden in regard to the degree and type of proof he required. Id. at 15, 16, 18–19. The Court finds no error in the Chief Special Master’s application of the burden of proof and agrees with Respondent that Petitioner’s arguments are mere disagreements with the weight the Chief Special Master afforded the evidence. Petitioner emphasizes that an off-Table injury claim in the Vaccine Program “only” requires a showing of preponderant evidence satisfying the three prongs of the Althen causation analysis. Id. at 15. He further emphasizes that proving causation to a scientific certainty is not required. Id. at 16. Once satisfied, Petitioner contends that “the burden shifts to the Government to prove a more likely alternative explanation.” Id. at 15. Under this framework, Petitioner contends that given the amount of evidence supporting his expert’s opinion it was an “error of law to state that Petitioner ‘failed to meet his burden,’” and the burden should have shifted to Respondent per Althen. ECF No. 74-1 at 2; ECF No. 71 at 15, 24. As Petitioner correctly observes, the legal framework for vaccine cases is well established in Federal Circuit and Court of Federal Claims decisions that define the causation standard. ECF No. 71 at 17 (citing, e.g., Campbell v. Sec’y of Health & Hum. Servs., 90 Fed. Cl. 369, 380–81 (2009) (“‘[T]he purpose of the Vaccine Act’s preponderance standard is to allow the finding of causation in a field bereft of complete and 20 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 21 of 30 direct proof of how vaccines affect the human body.”); Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 549 (Fed. Cir. 1994) (“[T]o require identification and proof of specific biologic mechanisms would be inconsistent with the purpose and nature of the vaccine compensation program.”); Moberly, 592 F.3d at 1325 (“[T]he legal standard is preponderance of the evidence, not scientific certainty.” (citing Andreu, 569 F.3d at 1378))). Although Petitioner accurately describes the standard of proof for causation-in-fact, Petitioner overlooks clear Federal Circuit precedent in cases, like this one, where the alleged injury is disputed. See Broekelschen, 618 F.3d at 1346. Petitioner’s claim is analogous to the claim in Broekelschen where the petitioner also received the flu vaccine. Id. at 1342. Six weeks post- vaccination, the Broekelschen petitioner was hospitalized with severe pain in his chest, neck, arms, and left scapula. Id. Doctors recorded symptoms characteristic of both anterior spinal artery syndrome, a vascular condition, and transverse myelitis, an inflammatory response. Id. The petitioner filed for compensation under the Vaccine Act alleging that the flu vaccine caused him to suffer transverse myelitis. Id. at 1343. As is the case here, Respondent’s expert witness disagreed with the alleged injury and argued that the petitioner suffered from anterior spinal artery syndrome, not caused by the flu vaccine. Id. Due to the competing diagnoses, the special master first determined which diagnosis was best supported by evidence in the record before applying the Althen causation test. Id. at 1346. On appeal, the Federal Circuit held that “it was appropriate” for the special master to do so because “the special master could subsequently determine causation relative to the injury.” Id. The Court applies this same principle articulated in Broekelschen and will not deviate from the long-standing and well-established precedents. See, e.g., Lombardi, 656 F.3d at 1356; Hibbard, 698 F.3d at 1369; Contreras v. Sec’y of Health & Hum. Servs., 844 F.3d 1363, 1368 21 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 22 of 30 (Fed. Cir. 2017); see also O.M.V. v. Sec’y of Health & Hum. Servs., 157 Fed. Cl. 376, 385 (2021); Mager v. Sec’y of Health & Hum. Servs., 158 Fed. Cl. 136, 156 (2022). To do so would collapse the threshold requirement to prove existence of an injury by a preponderance of evidence with the standard of proof for causation-in-fact under Althen. Petitioner cannot avoid clear, binding precedent that requires a finding on the factual question of injury preceding the causation analysis and shifting of the burden to Respondent. Petitioner also highlights two other ways in which the Chief Special Master allegedly elevated Petitioner’s burden with regard to the degree and type of proof he required—i.e., his application of the diagnostic criteria and consideration of the treating physicians’ diagnoses. Neither objection is persuasive. As to the diagnostic criteria for the alleged injury, Petitioner contends that the Chief Special Master required a diagnosis of his injury that “check[s] every single box of a disease with varying presentations.” ECF No. 71 at 19. Because Petitioner did not demonstrate symptoms of “weakness,” Petitioner contends that the Chief Special Master “erroneously disregarded a pure sensory manifestation of brachial neuritis” and “used criteria for a different injury to exclude causation.” Id. at 18–19. The Chief Special Master does this, Petitioner alleges, despite Petitioner’s expert’s report and testimony explaining that “[t]he sensory form [of brachial neuritis] has no weakness.” Id. at 18 (emphasis omitted) (quoting ECF No. 41-1 at 10). Petitioner’s argument presumes that his expert’s testimony as to the significance of muscle weakness (or lack thereof) was not in dispute. He highlights Dr. Andersson’s supplemental report, which asserted that “‘[t]he absence of weakness does not bear on the diagnosis of brachial plexitis.’” Id. (emphasis omitted). But Respondent’s expert provided a contrary opinion, testifying that “‘in the absence of neurographic studies, [diagnosis] requires weakness in [the] muscles 22 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 23 of 30 supplied by more than one peripheral nerve.’” ECF No. 69 at 9 (quoting Tr. at 191, ECF No. 63). Indeed, both parties’ experts laid out the differing factors they considered relevant to the diagnosis of Petitioner’s claimed injury. See id. at 6 (citing Tr. at 137–38) (Dr. Andersson), 9 (citing Tr. at 191) (Dr. Callaghan). The Chief Special Master considered each side’s evidence and applied the criteria provided by Respondent’s expert, which draws from the Table’s criteria. Id. at 23–24. The Chief Special Master acknowledged that the Table’s criteria for a brachial neuritis injury were not controlling in an off-Table claim, but nonetheless provided “useful guidance.” Id. at 23. It cannot be said, then, that he “disregarded” Petitioner’s evidence or claimed injury; he merely assigned a weight to Petitioner’s expert opinion different from that which Petitioner argued. As to treating physicians’ diagnoses, Petitioner contends that the Chief Special Master “set aside” Petitioner’s evidence and gave “great weight” to the contemporaneous diagnoses of Petitioner’s treating physicians (diabetic neuropathy, CTS, and cervical radiculopathy). ECF No. 71 at 19. He claims that in doing so the Chief Special Master “effectively overlooked” Dr. Andersson’s rebuttal of “alternate explanations” for Petitioner’s symptoms and prevented Dr. Andersson from disagreeing with or challenging the treating physicians’ diagnoses. Id. at 20; see id. at 22–23. The Entitlement Decision does not bear out that argument. ECF No. 69 at 6 (summarizing Dr. Andersson’s diagnosis), 24 (assessing Dr. Andersson’s diagnosis). Rather, consistent with Federal Circuit precedent, the Chief Special Master considered Petitioner’s contemporaneous medical records and weighed the evidence to determine the injury “best supported by the record.” Broekelschen, 618 F.3d at 1346 (a special master must “determine ‘based on the record evidence as a whole and the totality of the case, whether it has been shown by a preponderance of the evidence that a vaccine caused the [petitioner’s] injury’” (emphasis added) (quoting Andreu, 569 F.3d at 1382)); see ECF No. 69 at 22–24. 23 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 24 of 30 Petitioner’s reliance on Cloer v. Secretary of Health and Human Services for the proposition that requiring contemporaneous treater support of an alleged injury in a vaccine case goes against the intent of the Vaccine Program is misplaced.8 ECF No. 71 at 23 (citing Cloer v. Sec’y of Health & Hum. Servs., 654 F.3d 1322, 1332 n.4 (Fed. Cir. 2011)). In Cloer, the Court established at the outset that the petitioner suffered from multiple sclerosis. 654 F.3d at 1327. The issue in dispute was when the Vaccine Act’s statute of limitations was triggered. Id. at 1330. The petitioner argued that a “‘vaccine-related injury’ for purposes of the Vaccine Act and its statute of limitations cannot occur until the medical community at large understands and recognizes the causal relationship between the claimed injury and the administration of a vaccine.”9 Id. The Federal Circuit disagreed and instead allowed for non-objective circumstantial evidence in off- Table petitions to potentially establish the first links between a vaccine and an injury. Id. at 1332 n.4. Although Cloer provides support for Petitioner’s contention that a diagnosis by a contemporaneous treater is not required for a successful vaccine injury claim, this is not what the Chief Special Master required here. Instead, he weighed all the evidence, including the experts’ diagnoses and the treating physicians’ diagnoses, to determine whether Petitioner had presented preponderant proof of the alleged injury. Accordingly, the Court finds that the Chief Special Master did not commit an error of law by elevating Petitioner’s burden of proof. He properly determined as an initial matter that 8 In citing Cloer, Petitioner separately and interchangeably refers to contemporaneous treater support of the injury’s diagnosis and for causation of the injury, again collapsing the factual determination of the injury with the legal standard of causation-in-fact. Compare ECF No. 71 at 22 with id. at 23. 9 In addition, like Petitioner’s allegation that the Court is requiring “scientific certainty” of his claimed injury, the petitioner in Cloer initially argued that “no vaccine-related injury can occur before a clinically definite diagnosis is made.” Cloer, 654 F.3d 1322 at 1330. However, the petitioner abandoned this argument on appeal. Id. 24 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 25 of 30 Petitioner did not sufficiently prove his alleged injury by a preponderance of evidence. Petitioner’s objections to the Chief Special Master’s reliance on certain pieces of evidence, and not others, to reach that conclusion goes to the weight the Chief Special Master afforded the evidence. B. The Chief Special Master Appropriately Weighed the Evidence and Rationally Explained His Determination. Throughout his Motion, Petitioner disputes the Chief Special Master’s approach to weighing the evidence in the record. See, e.g., ECF No. 71 at 18 (the Chief Special Master “erroneously disregarded” certain evidence), 19 (assigned “great weight” to some evidence, while other evidence was “set aside”), 21 (“effectively overlooked” relevant evidence and “over- emphasized” other evidence). Giving broad deference to the Chief Special Master’s findings of fact, the Court finds no reason to disturb the decision because the Chief Special Master considered the relevant evidence and provided a rational basis for his factual determination regarding Petitioner’s alleged injury. See Lampe, 219 F.3d at 1360; Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011); Hines, 940 F.2d at 1528. Under the arbitrary and capricious standard, a special master has “broad discretion to weigh evidence and make factual determinations.” Dougherty v. Sec’y of Health & Hum. Servs., 141 Fed. Cl. 223, 229 (2018). When reviewing a special master’s factual findings, the Court will “not reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses—these are all matters within the purview of the fact finder.” Porter, 663 F.3d at 1249; Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010) (“[The Court’s] role is not to ‘second guess the Special Master[’]s fact-intensive conclusions’ particularly in cases ‘in which the medical evidence of causation is in dispute.’” (quoting Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993))). With respect to factual findings, “[r]eversible error is ‘extremely 25 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 26 of 30 difficult to demonstrate’ if the special master ‘has considered the relevant evidence of record, drawn plausible inferences[,] and articulated a rational basis for the decision.’” Loyd, Next Friend of C.L. v. Sec’y of Health & Hum. Servs., No. 2022-1371, 2023 WL 1878572, at *2 (Fed. Cir. Feb. 10, 2023) (quoting Hines, 940 F.2d at 1528). Petitioner’s Motion raises several objections to the weight the Chief Special Master gave to the evidence in the record. For example, Petitioner contends that the Chief Special Master “over-emphasiz[ed]” the “incidental findings” of his EMG test results, and by doing so moved the “goal posts” for a successful vaccine injury petition. ECF No. 71 at 21–22. In support of this argument, Petitioner cites Abels v. Secretary of Health and Human Services, arguing that a petitioner can prevail on a brachial neuritis claim even if his EMG test shows other potential diagnoses or “incidental findings.” Id. at 21 (citing Abels v. Sec’y of Health & Hum. Servs., No. 18-558V, 2022 WL 2036101, at *21 (Fed. Cl. May 6, 2022)). Petitioner’s reliance on Abels is misplaced. The dispositive issue in Abels was the temporal onset of injury, not the diagnosis of the injury itself. 2022 WL 2036101, at *1. There, the special master noted that Respondent’s expert “agreed that brachial neuritis is ‘the correct diagnosis,’” id. at *11, even though the petitioner’s EMG test results “showed changes consistent with either C5-6 radiculopathy or upper trunk plexopathy,” id. at *4. The special master found “strong support” for the petitioner’s claim of brachial neuritis because his “clinical course was consistent with the development of brachial neuritis after vaccination.” Id. at *18. Thus, in Abels, the appearance of C5-6 radiculopathy results on the petitioner’s EMG test was indeed uncorroborated “incidental” evidence that did not weigh in favor of the “correct” diagnosis. Id. at *4–5. Here, the Chief Special Master found that Petitioner’s so-called “incidental” findings of CTS and cervical radiculopathy on his EMG test was corroborated by other evidence in the record, 26 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 27 of 30 supporting the conclusion that Petitioner’s injury was not a rare pure sensory form of brachial neuritis. ECF No. 69 at 24 (“[T]he EMG/NCS testing did not reveal injury to sensory nerves (as would be expected in a pure sensory form of brachial neuritis), but instead was (again) fully consistent with CTS, cervical radiculopathy, and neuropathy (all of which were the diagnoses made by Petitioner’s treating physicians).”); ECF No. 31-1 at 4–5; see Burns, 3 F.3d at 417. Contrary to Petitioner’s objections, the Chief Special Master properly weighed witness testimony, expert reports, medical literature, and Petitioner’s contemporaneous medical records. The Chief Special Master observed that Petitioner’s expert, Dr. Andersson, identified and analyzed diagnostic factors associated with brachial neuritis, ECF No. 69 at 6 (citing ECF No. 26-1 at 7–8), and concluded that Petitioner’s injury was more likely a vaccine-induced sensory form of brachial neuritis rather than cervical radiculopathy or CTS, id. (citing ECF No. 26-1 at 8–9). The Chief Special Master noted that Dr. Andersson submitted literature in support of his opinion that Petitioner’s brachial neuritis was likely due to a secondary/adaptive immune process. Id. at 7. Finally, the Chief Special Master noted Dr. Andersson’s conclusion that the timeframe of the onset of the injury was consistent with an adaptive/secondary immune-mediated process. Id. at 7–8. The Chief Special Master also reviewed material submitted by Respondent’s experts.10 He observed that Dr. Callaghan also addressed the diagnostic criteria for brachial neuritis and concluded that “Petitioner neither suffered from brachial neuritis nor from a pure sensory form of 10 Respondent’s second expert, Dr. MacGinnitie, offered his opinion on causation theories (innate or immune response to the vaccine). His report and testimony are not further addressed in this opinion because they pertain solely to the issue of causation, and the dispositive issue here is the diagnosis of the injury. See ECF No. 69 at 11 (“Dr. MacGinnitie began his testimony by noting that he would not be offering an opinion on the diagnosis of brachial neuritis, deferring on that issue to Dr. Callaghan.” (citation omitted)); id. (“Dr. MacGinnitie provided his view as to whether there likely exists a reasonable mechanism by which the flu vaccine could trigger brachial neuritis[.]” (citation omitted)). 27 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 28 of 30 the condition, but instead more likely suffered from diabetic neuropathy, cervical radiculopathy, and/or CTS,” as he had been diagnosed by his treating physicians based on his reported symptoms. Id. at 9 (citations omitted) (noting that there was no mention of brachial neuritis in treater records). The Chief Special Master noted Dr. Callaghan’s explanation that a brachial neuritis diagnosis “requires weakness” in the associated muscles.11 Id. (citing ECF No. 31-1 at 4–5). Petitioner’s reported degree of pain, the fact that the symptoms did not appear to be widespread, and the fact that Petitioner’s EMG results did not show “dysfunction that could be attributed to the brachial plexus” were additional factors reviewed by the Chief Special Master that weighed against a brachial neuritis diagnosis. Id. (citing ECF No. 33-1 at 5). The Chief Special Master also weighed Dr. Callaghan’s conclusion that Petitioner’s past medical history was a more likely explanation for his symptoms and that Dr. Callaghan could find no reliable literature to support a likely causal link between the flu vaccine and brachial neuritis. Id. at 10. A special master is not required to cite every piece of submitted evidence; however, his decision must be supported by the evidence in the record. See Moriarty by Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016); see also Hines, 940 F.2d at 1528. In assessing the evidence, a special master may give more weight to contemporaneous medical records than to evidence offered later during litigation. Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1382 (Fed. Cir. 2021) (citing Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993)). Here, acknowledging that Dr. Andersson was well qualified and “made many credible points,” the Chief Special Master ultimately found Dr. Callaghan more persuasive. ECF No. 69 at 24. As such, the Chief Special Master concluded that (1) the claimed 11 See supra § III.A. The Chief Special Master did not “erroneously disregard[]” the claimed injury due to lack of reported weakness. ECF No. 71 at 18. The absence of weakness was one factor considered, as well as the lack of injury to sensory nerves. ECF No. 69 at 24. 28 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 29 of 30 injury was “not corroborated by record evidence of contemporaneous treater support,” id. at 23; (2) Petitioner did not meet the criteria for a brachial neuritis claim given the absence of muscle weakness and because Petitioner’s EMG testing “did not reveal injury to sensory nerves,” id. at 23–24; and (3) Dr. Callaghan effectively rebutted Petitioner’s claimed injury as lacking record evidence substantiation, id. at 23 (“[D]isposition of the case depends on the finding that this injury has preponderant evidentiary support. Unfortunately, the record does not support that conclusion.”). His assessment of the persuasiveness of the parties’ expert witnesses was a matter within in his discretion. See Moberly, 592 F.3d at 1325–26 (“Assessments as to the reliability of expert testimony often turn on credibility determinations, particularly in cases such as this one where there is little supporting evidence for the expert’s opinion.”). Accordingly, the Court finds that the Chief Special Master properly considered the evidence as a whole, supported his conclusions with citations to the record, and articulated a rational connection between the facts found and the determination made. See Hines, 940 F.2d at 1528. The Court will not “‘second-guess’” the decision’s “‘fact-intensive conclusions.’” Cedillo, 617 F.3d at 1338 (quoting Hodges, 9 F.3d at 961). IV. CONCLUSION The Court finds that the Chief Special Master’s examination of the record in Petitioner’s case, including the hearing testimony, expert reports, Petitioner’s contemporaneous medical records, and the literature submitted, resulted in a decision that was not “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B). The Chief Special Master’s Entitlement Decision is therefore affirmed, and Petitioner’s Motion for Review (ECF No. 70) is DENIED. In addition, Petitioner’s Motion for Leave to File Petitioner’s Reply in Support of Motion for Review (ECF No. 74) is GRANTED. 29 Case 1:20-vv-00855-KCD Document 84 Filed 06/13/24 Page 30 of 30 The Clerk of the Court shall enter JUDGMENT consistent with this Opinion. SO ORDERED. Dated: May 23, 2024 /s/ Kathryn C. Davis KATHRYN C. DAVIS Judge 30