VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-02133 Package ID: USCOURTS-cofc-1_21-vv-02133 Petitioner: Sherri Pulsipher Filed: 2021-11-04 Decided: 2025-09-03 Vaccine: influenza Vaccination date: 2020-10-24 Condition: shoulder injury related to vaccine administration (SIRVA) Outcome: denied Award amount USD: AI-assisted case summary: Sherri Pulsipher, a 66-year-old woman, received an influenza vaccine on October 24, 2020. She alleged that within hours of the vaccination, she developed shoulder pain and limited range of motion, consistent with Shoulder Injury Related to Vaccine Administration (SIRVA). Ms. Pulsipher sought compensation under the National Vaccine Injury Compensation Program, first arguing that her condition qualified as a Table Injury. She contended that her injury met all four criteria for SIRVA, including onset within 48 hours and that her underlying osteoarthritis did not explain her symptoms, but was instead triggered by the vaccine. Alternatively, she argued for compensation under an "off-Table" claim, asserting that the vaccine caused her shoulder injury-in-fact. She presented expert testimony from Dr. Uma Srikumaran, who opined that the vaccine caused bursitis, which in turn activated her previously asymptomatic osteoarthritis. Respondent argued that Ms. Pulsipher failed to meet the criteria for a Table Injury, particularly the fourth criterion, as her osteoarthritis was a sufficient explanation for her symptoms. Respondent also contended that her "off-Table" claim failed because her medical theory was not sound or reliable, citing the lack of evidence linking vaccine-induced inflammation to osteoarthritis and the fact that her rotator cuff remained intact, separating the subacromial bursa from the glenohumeral joint. The Special Master denied Ms. Pulsipher's claim, finding she did not meet the fourth SIRVA criterion and that her "off-Table" claim lacked a reliable medical theory or a logical sequence of cause and effect. On appeal, the Court of Federal Claims affirmed the Special Master's decision, finding that Ms. Pulsipher waived her argument challenging the validity of the SIRVA regulation and that the Special Master correctly applied the Althen standard for actual causation. Therefore, Ms. Pulsipher was not entitled to compensation. Theory of causation field: Influenza vaccine on October 24, 2020, age 66, alleged SIRVA with shoulder pain within hours. DENIED. The Table theory failed because the record did not support all SIRVA criteria, and the off-Table theory also failed because petitioner did not prove vaccine causation by preponderant evidence. Special Master denied entitlement April 24, 2025; the Court of Federal Claims sustained denial on September 3, 2025. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_21-vv-02133-0 Date issued/filed: 2025-05-09 Pages: 18 Docket text: PUBLIC DECISION (Originally filed: 4/24/2025) regarding 37 DECISION of Special Master. Signed by Special Master Daniel T. Horner. (ksb) Service on parties made. -------------------------------------------------------------------------------- Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 1 of 18 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 21-2133V Filed: April 24, 2025 Special Master Horner SHERRI PULSIPHER, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Jimmy A. Zgheib, Zgheib Sayad, P.C., White Plains, NY, for petitioner. Rachelle Bishop, U.S. Department of Justice, Washington, DC, for respondent. DECISION1 On November 4, 2021, petitioner filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa, et seq. (2012),2 alleging that she suffered a Table Injury of a shoulder injury related to vaccine administration (“SIRVA”) as a result of an influenza (“flu”) vaccination she received on October 24, 2020. (ECF No. 1.) For the reasons set forth below, I conclude that petitioner is not entitled to compensation. I. Applicable Statutory Scheme Under the National Vaccine Injury Compensation Program, compensation awards are made to individuals who have suffered injuries after receiving vaccines. In general, to gain an award, a petitioner must make a number of factual demonstrations, including showing that an individual received a vaccination covered by the statute; 1 Because this document contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the document will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C. § 300aa-10, et seq. 1 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 2 of 18 received it in the United States; suffered a serious, long-standing injury; and has received no previous award or settlement on account of the injury. Finally – and the key question in most cases under the Program – the petitioner must also establish a causal link between the vaccination and the injury. In some cases, the petitioner may simply demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be shown that the vaccine recipient suffered an injury of the type enumerated in the “Vaccine Injury Table,” corresponding to the vaccination in question, within an applicable time period following the vaccination also specified in the Table. If so, the Table Injury is presumed to have been caused by the vaccination, and the petitioner is automatically entitled to compensation, unless it is affirmatively shown that the injury was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A); § 300aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B). As relevant here, the Vaccine Injury Table lists SIRVA as a compensable injury if it occurs within ≤48 hours of administration of a flu vaccine. § 300aa-14(a), amended by 42 C.F.R. § 100.3. Table Injury cases are guided by a statutory “Qualifications and aids in interpretation” (“QAI”), which provides more detailed explanation of what should be considered when determining whether a petitioner has actually suffered an injury listed on the Vaccine Injury Table. § 300aa-14(a). To be considered a Table SIRVA petitioner must show that his/her injury fits within the following definition: SIRVA manifests as shoulder pain and limited range of motion occurring after the administration of a vaccine intended for intramuscular administration in the upper arm. These symptoms are thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder resulting in an inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury and abnormalities on neurological examination or nerve conduction studies (NCS) and/or electromyographic (EMG) studies would not support SIRVA as a diagnosis . . . A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient’s symptoms (e.g. NCS/EMG or clinical evidence of 2 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 3 of 18 radiculopathy, brachial neuritis, mononeuropathies, and any other neuropathy). 42 CFR § 100.3(c)(10). Alternatively, if no injury falling within the Table can be shown, a petitioner could still demonstrate entitlement to an award by instead showing that the vaccine recipient’s injury or death was caused-in-fact by the vaccination in question. § 300aa-13(a)(1)(A); § 300aa-11(c)(1)(C)(ii). 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 v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321-22 (Fed. Cir. 2010) (quoting Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)); Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). To successfully demonstrate causation-in-fact, petitioner bears a burden to show: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal relationship between vaccination and injury. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. § 300aa-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 & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). A petitioner may not receive a Vaccine Program award based solely on her assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. § 300aa-13(a)(1). Cases in the Vaccine Program are assigned to special masters who are responsible for “conducting all proceedings, including taking such evidence as may be appropriate, making the requisite findings of fact and conclusions of law, preparing a decision, and determining the amount of compensation, if any, to be awarded.” Vaccine Rule 3(b)(1). Special masters must ensure each party has had a “full and fair opportunity” to develop the record. Vaccine Rule 3(b)(2). However, special masters are empowered to determine the format for taking evidence based on the circumstances of each case. Vaccine Rule 8(a); Vaccine Rule 8(d). Special masters are not bound by common law or statutory rules of evidence but must consider all relevant and reliable evidence in keeping with fundamental fairness to both parties. Vaccine Rule 8(b)(1). 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 3 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 4 of 18 death,” as well as the “results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.” § 300aa-13(b)(1)(A). The special master is required to consider all the relevant evidence of record, draw plausible inferences, and articulate a rational basis for the decision. Winkler v. Sec’y of Health & Human Servs., 88 F.4th 958, 963 (Fed. Cir. 2023) (citing Hines ex rel. Sevier v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)). II. Procedural History Based on the allegations in the petition, this case was initially assigned to the Chief Special Master as part of the Special Processing Unit (“SPU”), which is intended to expedite cases having a high likelihood of informal resolution. (ECF No. 10.) Petitioner filed medical records and other evidence marked as Exhibits 1-9 in November of 2021 and filed updated medical records marked as Exhibit 10 in September of 2022. (ECF Nos. 5, 15.) Respondent filed his Rule 4 Report in May of 2023. (ECF No. 19.) In his report, respondent contended that petitioner had neither satisfied the Table criteria for SIRVA nor demonstrated a shoulder injury caused-in-fact by her vaccination. (Id. at 10-13.) Although respondent did not contend petitioner had any prior clinical history of shoulder pain or dysfunction, he argued that petitioner did not meet any of the three other SIRVA criteria, asserting that onset of shoulder pain did not arise within 48 hours of vaccination, that her pain was not limited to her shoulder, and that it was otherwise explained by glenohumeral osteoarthritis. (Id. at 10-11.) With respect to causation-in- fact, respondent stressed the lack of a medical opinion to support such a claim, but also contended that a cause-in-fact analysis should likewise lead to the conclusion that petitioner’s shoulder pain was due to osteoarthritis. (Id. at 13.) Petitioner then filed an affidavit (Exhibit 11) and a motion for a ruling on the written record, seeking to be found entitled to compensation for a Table SIRVA. (ECF Nos. 20-21.) However, the Chief Special Master concluded that the motion was premature in that expert reports would likely be necessary. He found petitioner’s motion to be moot and reassigned the case to the undersigned for further litigation. (ECF No. 22.) Thereafter, the parties filed expert reports, with Uma Srikumaran, M.D., opining on petitioner’s behalf (ECF No. 24; Exs. 12-13) and Geoffrey Abrams, M.D., opining on respondent’s behalf (ECF No. 27; Exs. A-B). I then issued a Rule 5 Order providing the parties preliminary guidance on a particular fact issue (discussed further in the Factual History, below) and also posed specific questions to each party’s expert. (ECF No. 28.) I advised the parties that, once their experts responded to my questions, the case would likely be ripe for resolution based on written submissions pursuant to Vaccine Rule 8(d). (Id.) The parties filed supplemental expert reports (ECF Nos. 30-31; Exs. 14, C), and then petitioner moved for a ruling on the written record, which has been fully briefed (ECF Nos. 33, 35-36). 4 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 5 of 18 In her motion, petitioner asserts that she has met her burden of proof with respect to the requirements for a Table Injury of SIRVA. (ECF No. 33, pp. 14-24.) Alternatively, she argues that she should be found entitled to compensation for a shoulder injury caused-in-fact by her vaccination based on an Althen analysis. (Id. at 24-30.) In response, respondent contends that petitioner has not preponderantly demonstrated that she meets either the second or fourth SIRVA criteria (i.e., onset within 48 hours and that no other condition or abnormality explains her condition). (ECF No. 35, pp. 12-22.) Respondent further argues that petitioner has not presented a defined and recognized injury that would warrant an Althen analysis of causation-in-fact. (Id. at 27-28.) But, in any event, respondent contends that petitioner has not satisfied any of the three Althen prongs. (Id. at 28-34.) Of course, in her reply, petitioner seeks to rebut respondent’s contentions on all of these points. (ECF No. 36.) In light of the above, I have determined that the parties have had a full and fair opportunity to present their cases and that it is appropriate to resolve entitlement on the existing record. See Vaccine Rule 8(d); Vaccine Rule 3(b)(2); see also Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (noting that “special masters must determine that the record is comprehensive and fully developed before ruling on the record”). III. Factual History Petitioner received the flu vaccine at issue in her left deltoid on October 24, 2020. She was 66 years old at the time and respondent agrees she had no prior medical history of left shoulder pain, inflammation or dysfunction. (ECF No. 35, p. 2 (citing Ex. 1-2, 4; Ex. 5, pp. 33, 39-40, 126).) Petitioner, a hospice nurse, averred that she felt pain and burning in her left shoulder “within a few hours” of her vaccination, which worsened the next day, and she subsequently developed decreased shoulder mobility. (Ex. 11, p. 1.) However, she indicated that she attempted to manage her pain with Tylenol, NSAIDs, and rest for about three months, hoping the pain would resolve. (Id.) Petitioner’s initial post-vaccination medical encounter raised a factual issue. Petitioner initially presented to Certified Physician Assistant (P.A.-C) Rose on January 25, 2021, about three months post-vaccination. (Ex. 5, pp. 29-32.) The record documents a number of presenting complaints, but left shoulder pain was not among them. (Id. at 30.) However, petitioner filed an affidavit indicating not only that she did complain of left shoulder pain at this encounter, but also that P.A.-C Rose administered a steroid injection in her left shoulder. (Ex. 11, p. 1.) About a month later, on February 22, 2021, petitioner was seen by a sports medicine specialist, Dr. Kirk, for left shoulder pain. (Ex. 6, pp. 8-11.) Dr. Kirk specifically recorded that petitioner had previously been seen by P.A.-C Rose for her reported shoulder pain. (Id. at 8.) Petitioner was administered a steroid injection at her encounter with Dr. Kirk. (Id. at 10.) In my Rule 5 Order, I advised the parties that the history recorded by Dr. Kirk was sufficient to confirm petitioner’s recollection that she did report her shoulder pain to P.A.-C Rose on January 25, 2021, but that the record reflects that the complaint was 5 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 6 of 18 only incidentally discussed insofar as it was not listed among her chief complaints. (ECF No. 28, p. 2.) Additionally, the January 25, 2021 encounter record does not evidence the initial onset of her condition. (Id.) Petitioner’s recollection that she was administered a steroid injection by P.A.-C Rose cannot reasonably be credited, especially in light of the injection being documented as occurring at her encounter with Dr. Kirk. (Id.) I offered the parties an opportunity to develop the record on this issue, but they advised in a joint status report that they would accept my finding on this issue as is. (ECF No. 29.) At her February 22, 2021 encounter with Dr. Kirk, petitioner presented with a chief complaint of left shoulder pain, which she indicated “has been present for about 4 months and occurred after she got a flu shot.” (Ex. 6, p. 8.) She described her pain as a 6 out of 10 and characterized it as “aching, burning, intermittent, [and] stabbing.” (Id.) The pain, which was noted to be worse later in the day, radiated down the arm and worsened with activity, such as lifting. (Id.) She also described symptoms of stiffness, tenderness, and weakness. (Id.) On physical exam, inspection of the left shoulder was normal, but range of motion was mildly restricted in all planes. (Id. at 9.) She had moderate tenderness with palpation over the lateral aspect of the shoulder and mild tenderness over the anterior and posterior shoulder. (Id.) She also had mild pain and weakness on abduction and external rotation, as well as positive impingement tests (Neer’s, Hawkin’s, and empty can). (Id.) X-rays showed no acute abnormalities, but did show moderately severe glenohumeral joint space narrowing and small osteophytes at the humeral head. (Id.) Petitioner was diagnosed with both rotator cuff impingement syndrome and primary glenohumeral osteoarthritis. (Id. at 10.) However, Dr. Kirk felt petitioner’s presentation, which was not focal to the glenohumeral joint, favored impingement as the explanation for her symptoms. (Id.) He intended to see how petitioner responded to treatment for impingement. (Id.) Petitioner was administered a therapeutic injection into her subacromial bursa, with a recommendation for a further injection into her glenohumeral joint if she did not experience relief. (Id.) Petitioner then had several encounters with P.A.-C Rose in March of 2021 and an emergency department encounter in April of 2021 for epigastric abdominal pain. Shoulder pain was not documented at any of these encounters. (Ex. 5, pp. 22-29; Ex. 7, pp. 16-19.) Her March 8, 2021 encounter with P.A.-C Rose indicated, under Review of Systems, that petitioner had no complaints of muscle pain or weakness and, under Physical Exam, that she had normal strength and tone and normal range of motion in all extremities. (Id. at 28-29.) Her emergency department encounter also documented full range of motion. (Ex. 7, p. 16.) Shortly thereafter, petitioner established care with a new provider, P.A.-C Briggs. (Ex. 5, p. 15.) Petitioner had a number of complaints, including muscle cramps and generalized pain, but shoulder pain was not specifically discussed and she had a normal musculoskeletal exam. (Id. at 15-18.) A normal musculoskeletal exam was also noted during a May 4, 2021 follow up regarding her epigastric pain. (Id. at 13, 15, 62.) Petitioner returned to Dr. Kirk on May 5, 2021. (Ex. 6, p. 55.) Dr. Kirk recorded substantially the same history he had recorded on February 22, 2021, and additionally 6 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 7 of 18 noted that petitioner did not find the steroid injection to have been helpful “at all.” (Id.) Physical exam was substantially the same. (Compare id. at 55-56, with id. at 9.) Although Dr. Kirk did not remove impingement from his assessment, he now considered it a lesser diagnosis and favored osteoarthritis as the primary source of her symptoms, given that the subacromial injection had not provided any relief. (Id. at 56.) Dr. Kirk ordered a left shoulder MRI and advised petitioner to continue strengthening and range of motion exercises. (Id.) Petitioner deferred a recommended glenohumeral joint injection. (Id.) Petitioner underwent an MRI of the left shoulder on May 13, 2021. (Id. at 53-54.) The impression from the radiologist was: (1) Severe glenohumeral osteoarthritis with a small joint effusion with synovitis; (2) Supraspinatus moderate tendinosis involving the interstitial and critical zone fibers with tearing; (3) Subscapularis and infraspinatus tendinosis; and (4) Moderate acromioclavicular osteoarthritis. (Id. at 54.) Based on his review of the MRI results, Dr. Kirk recommended a reverse shoulder replacement due to the severe arthritis and rotator cuff pathology and referred her to Dr. Parry. (Ex. 6, p. 51.) However, petitioner’s insurance denied coverage unless petitioner first underwent physical therapy (Id. at 34), which she began on June 4, 2021 (Id. at 34, 37). (She also had unrelated medical encounters in the interim.) At her physical therapy evaluation, petitioner attributed her shoulder pain to her vaccination, though onset is not specifically detailed. (Id. at 37.) Petitioner reported that she was still mostly able to complete her duties as a hospice nurse, as well as her activities of daily living; however, she did have difficulty reaching up or reaching forward. (Id.) Petitioner was worried about developing a frozen shoulder. (Id.) When petitioner first consulted with Dr. Parry on June 7, 2021, he recorded that her condition “came on suddenly without known injury,” but noted that “[s]he started noticing her pain after she received her flu shot in that arm.” (Id. at 34.) Petitioner complained that the physical therapy was too painful to continue. (Id. at 34, 36.) It was noted that petitioner would continue with the plan for surgery. (Id. at 36.) Petitioner underwent a reverse total shoulder arthroplasty on June 16, 2021. (Ex. 5, p. 160.) The preoperative diagnosis was rotator cuff arthropathy, which did not change postoperatively. (Id.) Although Dr. Kirk had initially recommended surgery in part due to petitioner’s severe arthritis, Dr. Parry’s operative report did not include arthritis as among the indications for the procedure. (Id.) (However, as discussed below, both parties’ experts explain that the shoulder replacement was indicated due to petitioner’s osteoarthritis. (Ex. 14, pp. 2-3; Ex. C, p. 3.)) At her two-week postoperative follow up, petitioner was still using a sling, but reported progressively less pain since the surgery. (Ex. 6, p. 94.) At her six week follow up, petitioner reported that she was no longer taking any pain medication and was advised that she could discontinue use of the sling. (Id. at 99, 101.) Petitioner was advised to be cautious, but was told she could continue to expect improvement over 12-18 months. (Id. at 101-02.) Petitioner attended postoperative physical therapy from July 27, 2021, until September 2, 2021. (Ex. 8.) At the conclusion of physical therapy, petitioner had active range of motion that was within normal limits, but her flexion remained limited and she continued to complain of soreness and weakness, especially with overhead exercises. (Id. at 45.) 7 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 8 of 18 At her final post-operative follow up on September 7, 2021, about three months after her surgery, petitioner was reportedly “totally amazed” at her results. (Ex. 6, p. 107.) She was doing well and was instructed to follow up again at the one-year mark. (Id.) In her later affidavit, petitioner averred that she still had limited range of motion at this encounter, though she “was generally satisfied with [her] progress” at that time. (Ex. 11, p. 3.) About one year following her surgery, petitioner returned to care complaining of a “few months” of pain that radiated into her neck and down her arm, though she denied numbness or tingling. (Ex. 10, p. 6.) Petitioner did not recall injuring her shoulder. (Id.) After x-ray and physical exam, there was no concern that her shoulder replacement had been loosening. (Id. at 8.) She was started on an anti-inflammatory medication, and physical therapy was recommended. (Id.) However, petitioner confirmed in her affidavit that she did not pursue this physical therapy, opting instead for home exercises (Ex. 11, p. 3), and no further medical records have been filed. As of May 17, 2023, petitioner avers that she still has pain and dysfunction of her left shoulder that does cause difficulty with her activities of daily living. (Id.) She feels her left shoulder “will never be the same again.” (Id.) IV. Expert Opinions a. Uma Srikumaran, M.D., for petitioner3 Based on his review of petitioner’s history, Dr. Srikumaran believes petitioner had no relevant history of shoulder pain or dysfunction and that her shoulder pain began within 48 hours of her vaccination. (Ex. 12, pp. 5-6.) He acknowledges that petitioner’s initial presentation included a report of pain that “radiate[d] down the arm,” but contends that, due to the complexity of the shoulder’s interconnectivity to adjacent parts of the body, injury to the shoulder joint can result in pain complaints relative to the surrounding musculature, including the arm. (Id. at 7 (alteration in original).) Thus, he opines that 3 Dr. Srikumaran received his medical degree from Johns Hopkins University School of Medicine (“Johns Hopkins”) in 2005, before going on to complete an internship in general surgery and orthopedic surgery and a residency in orthopedic surgery at Johns Hopkins Hospital in 2006 and 2010, respectively. (Ex. 13, p. 1.) From there, Dr. Srikumaran completed a fellowship in shoulder surgery at Harvard, Massachusetts General Hospital in 2011, before returning to Johns Hopkins as an assistant professor of orthopedic surgery that same year. (Id. at 1-2.) He was elevated to associate professor of orthopedic surgery in 2019. (Id. at 2.) Dr. Srikumaran worked briefly as an assistant team physician for the Baltimore Orioles, the Medical Director at Howard County Johns Hopkins Orthopedic Surgery, the chair of the Department of Orthopedic Surgery and the Medical Director of the Joint Academy at Howard County General Hospital, and the Medical Director of the Musculoskeletal Service Line-Columbia. (Id.) He currently maintains positions as the Director of the Shoulder Fellowship in the Department of Orthopedic Surgery at Johns Hopkins, Medical Director of Johns Hopkins Ambulatory Surgery Center, and Vice Chair-Quality, Safety, and Service in the Department of Orthopedic Surgery at Johns Hopkins. (Id.) Dr. Srikumaran is a board- certified orthopedic surgeon, and he maintains an active medical license in Maryland. (Id. at 16.) Throughout his career, Dr. Srikumaran has, among other things, authored over 100 pieces of original research, 8 review articles, 5 case reports, and over 50 book and book chapters. (Id. at 2-13.) 8 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 9 of 18 an isolated report of pain extending down into the arm is not incompatible with SIRVA, stressing that at the same encounter at which petitioner reported this radiating pain, she was diagnosed as having rotator cuff impingement syndrome. (Id. (citing Ex. 6, pp. 8, 10).) Accordingly, he opines that petitioner’s history is consistent with the first three table requirements for a SIRVA. (Id. at 5.) Dr. Srikumaran stresses that patients should be trusted when they are able to identify a trigger for shoulder pain. (Id. at 6.) Regarding the fourth criterion, Dr. Srikumaran acknowledges that it is “important to address the petitioner’s underlying glenohumeral arthritis.” (Ex. 12, p. 7.) As a degenerative condition, it takes decades to develop. (Id.) Yet, petitioner was asymptomatic prior to vaccination. (Id.) According to Dr. Srikumaran, in many patients, shoulder arthritis can remain silent until a trigger causes activation of pain. (Id.) In this case, he opines that petitioner initially suffered vaccine-related inflammation of the bursal and synovial tissue, noting that Dr. Kirk initially favored impingement syndrome, rather than glenohumeral arthritis, as the source of her pain. (Id. at 7-8 (citing Ex. 6, p. 60).) Petitioner’s inflamed bursal and synovial tissue then in turn triggered her previously asymptomatic glenohumeral arthritis to become painful, even though it did not cause it. (Id. at 8.) Thus, Dr. Srikumaran opines that petitioner’s condition satisfies all four of the criteria for a Table SIRVA. (Id.) Dr. Srikumaran opines that this understanding is consistent with the evolution of Dr. Kirk’s assessment from initially attributing petitioner’s pain primarily to impingement syndrome to later attributing it primarily to osteoarthritis. (Ex. 14, p. 2.) Even if petitioner’s subacromial injection had offered some relief, the fact that her osteoarthritis was becoming aggravated would explain why her pain continued, with the arthritic pain overcoming the pain from the bursitis. (Id.) Additionally, the fact that petitioner’s subsequent MRI showed no evidence of buritis would also be consistent with the notion that the subacromial injection had been effective. (Id.) He surmises that, if it had been done earlier, it would have shown bursitis. (Id. at 4.) Dr. Srikumaran indicates that “I believe her initial conglomerate of symptoms was consistent with subacromial bursitis and impingement syndrome.” (Id.) However, he notes that “impingement syndrome is a generalized term and can be secondary to many physiologic causes that affect the subacromial space such as subacromial bursitis (which the petitioner had physical exam findings of), rotator cuff tendinitis, calcific tendinitis and even glenohumeral arthritis.” (Id.) Dr. Srikumaran explains that shoulder joint replacement such as petitioner underwent is an “excellent surgery” for patients with moderate to severe osteoarthritis. (Ex. 14, pp. 2-3.) He opines that it was “appropriately indicated” in petitioner’s case. (Id. at 3.) “When her symptoms and physical exam findings are taken together with the level of arthritis identified on MRI, the best surgical option is a shoulder replacement,” even though a more limited bursectomy would have been the appropriate treatment to remove the vaccine irritant. (Id.) However, in his opinion, although the surgery was indicated because of petitioner’s chronic arthritis, the initiating event was still the 9 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 10 of 18 vaccination. In effect, he opines that petitioner’s surgery, while in treatment of her osteoarthritis, is not informative of the initial cause of her condition.4 Dr. Srikumaran also suggests that petitioner’s shoulder condition can be shown to have been caused-in-fact by her vaccination. (Ex. 12, pp. 8-9.) He presents a theory of causation whereby the injection of vaccine antigen into the subacromial bursa leads to an inflammatory response that can activate pathologic changes in the subacromial space, biceps tendon, glenohumeral joint, and/or capsulitis. (Id. (citing Marko Bodor & Enoch Montalvo, Vaccination-Related Shoulder Dysfunction, 25 VACCINE 585 (2007) (Ex. 12, Tab D); S. Atanasoff et al., Shoulder Injury Related to Vaccine Administration (SIRVA), 28 VACCINE 8049 (2010) (Ex. 12, Tab A), L.H. Martín Arias et al., Risk of Bursitis and Other Injuries and Dysfunctions of the Shoulder Following Vaccinations, 35 VACCINE 4870 (2017) (Ex. 12, Tab B); C. Trollmo et al., Intra-Articular Immunization Induces Strong Systemic Immune Response in Humans, 82 CLINICAL & EXPERIMENTAL IMMUNOLOGY 384 (1990) (Ex. 12, Tab S); D. C. Dumonde & L. E. Glynn, The Production of Arthritis in Rabbits by an Immunological Reaction to Fibrin, 43 BRIT. J. EXPERIMENTAL PATHOLOGY 373 (1962) (Ex. 12, Tab G); Julia R. Hirsiger et al., Chronic Inflammation and Experimental Matrix-Specific Autoimmunity Following Inadvertent Periarticular Influenza Vaccination, 124 J. AUTOIMMUNITY 102714 (2021) (Ex. 12, Tab N)).5 Following on from this theory, Dr. Srikumaran’s explanation of a logical sequence of cause and effect mimics his discussion of petitioner’s condition relative to the fourth SIRVA criterion. (Id. at 9.) Asked whether there is any evidence to suggest that vaccination can aggravate osteoarthritis, Dr. Srikumaran indicated that the Dumonde study, which is a rabbit model study, is the only available evidence to suggest that an immunologic reaction to antigenic material can result in arthritis. (Ex. 14, p. 4 (discussing Dumonde & Glynn, supra, at Ex. 12, Tab G).) However, when taken with the other literature of record showing various changes in joint tissue following vaccination, Dr. Srikumaran opines that the evidence shows that the inflammatory response to vaccination is capable of infiltrating all areas of the shoulder and that underlying arthritis can be affected by vaccination injuries. (Id. at 5.) 4 Dr. Srikumaran offers the analogy of a car tire. A worn tire tread may not come to attention on its own if it is not causing any problems. However, if a driver runs over a nail, the tire may deflate quickly, bringing the tire to a mechanic’s attention. Due to the presence of the worn tread, the mechanic may recognize the need to replace the tire altogether, rather than perform a more limited repair to patch the puncture; however, the nail was still nonetheless the cause of the deflated tire. According to Dr. Srikumaran, petitioner’s chronic arthritis is equivalent to the worn tire tread, while her vaccination plays the same role as the nail. A bursectomy would be equivalent to repairing the puncture, whereas petitioner’s joint replacement is equivalent to a tire replacement that simply obviated the need to repair the puncture. (Ex. 14, p. 3.) 5 These are the publications Dr. Srikumaran cited in a case-specific discussion of his theory of causation. At the end of his first report, he also included a broader, generic discussion of a theory by which vaccination can lead to SIRVA. That discussion cited additional literature. (Ex. 12, pp 10-15.) Although I have reviewed that literature, it is not necessary to separately address it. 10 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 11 of 18 b. Geoffrey Abrams, M.D., for respondent6 Based on his review of petitioner’s history, Dr. Abrams opines that petitioner’s shoulder pain is likely explained by her imaging-confirmed arthritis and that a SIRVA is an unlikely diagnosis. (Ex. A, p. 4.) Dr. Abrams stresses that arthritis is a very common cause of shoulder pain, especially in those over 50 years of age. (Id. (citing Claudio Chillemi & Vincenzo Franceschini, Shoulder Osteoarthritis, ARTHRITIS, Jan. 2013, at 1 (Ex. A, Tab 1)).) It is a slow process that takes years to develop. (Id.) He disagrees that patients can reliably identify a trigger for arthritic symptoms. While this may be true for traumatic events, such as falls or accidents, it is not necessarily true of shoulder pain more broadly. Most patients are unable to recall a specific triggering event. (Id.) Dr. Abrams stresses that “everyday activities (i.e. carrying groceries, sleeping on the shoulder, and other normal activities which patients do not recognize as traumatic) can initiate pain from shoulder arthritis.” (Id.) In petitioner’s case, he urges that the reliability of her recollection that her shoulder pain began following vaccination should be questioned in light of her delay in seeking treatment. (Id. at 6-7.) He notes that petitioner’s initial x-rays showed osteophytes, which could not have developed within the four months between the time of petitioner’s vaccination and her x-rays. (Id. at 4.) Dr. Abrams opines that the following points support arthritis as the cause of petitioner’s shoulder pain: • Findings on physical exam of range of motion “mildly restricted through all planes”; and • No significant positive response to a subacromial steroid injection; and • X-ray and MRI findings of “severe osteoarthritis”; and • A lack of any finding of subacromial/subdeltoid bursitis upon MRI; and • Her reverse shoulder replacement surgery, which confirms Dr. Kirk believed arthritis to be the source of her pain. (Ex. A, pp. 4-5 (citing Ex. 6, pp. 9, 54; Ex. 5, p. 55); Ex. C, p. 3.) Dr. Abrams endorses Dr. Kirk’s conclusion as the treating orthopedist that the failure of petitioner’s subacromial injection to alleviate her symptoms pointed away from subacromial inflammation and toward osteoarthritis as the source of petitioner’s pain. 6 Dr. Abrams received his medical degree from the University of California, San Diego, in 2007, before going on to complete a surgical internship in the Department of General Surgery at Stanford University Hospital and Clinics in 2008, as well as a residency in the Department of Orthopedic Surgery also at Stanford University Hospital and Clinics in 2012. (Ex. B, p. 1.) Dr. Abrams went on to complete a fellowship in orthopedic sports medicine at Rush University Medical Center, where he also worked as a clinical instructor, in 2013. (Id.) From there, Dr. Abrams worked as an assistant physician at the Veterans Administration Hospital, Palo Alto; an assistant professor at Stanford University School of Medicine; and Director of Lacob Sports Medicine Clinic at Stanford University School of Medicine. (Id.) He is a board-certified orthopedic surgeon, and he maintains an active medical license in California. (Id. at 2.) Throughout his career, Dr. Abrams has authored over 150 peer-reviewed publications and abstracts, nearly 30 podium and poster presentations, 5 commentaries, and 26 book chapters. (Id. at 2- 22.) 11 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 12 of 18 (Ex. A, p. 5 (citing Ex. 6, pp. 9, 56).) He disagrees with Dr. Srikumaran’s suggestion that the source of petitioner’s pain changed between her initial February orthopedic evaluation and her later evaluation, stressing that the physical exam findings, which he opines support osteoarthritis, remained essentially the same at both encounters. (Id.) He also explains that signs of impingement cannot be equated to a diagnosis of bursitis, as Dr. Srikumaran does. (Ex. C, pp. 3-4.) Dr. Abrams indicates that “[s]houlder exams can be variable from patient to patient and also from examiner to examiner. The fact that [petitioner] had pre-existing arthritis makes her susceptible to many positive exam findings, including those associated with impingement and bursitis.” (Id.) Other objective evidence is necessary to distinguish the cause of positive impingement signs and, here, that objective evidence, including petitioner’s MRI and lack of response to a subacromial injection, points away from bursitis. (Id. at 4.) Dr. Abrams acknowledges that “arthritis itself is an inflammatory condition, so once the process is initiated it can often lead to chronic symptoms and pain.” (Ex. A, p. 4 (footnote omitted) (citing Michelle Xiao et al., Inflammatory Mechanisms in the Development of Osteoarthritis (unpublished manuscript) (Ex. A, Tab 2)).) However, he characterizes the suggestion of post-vaccination bursitis initiating arthritic pain as “not a known clinical entity” and disagrees that the inflammatory response in SIRVA can move from the subacromial space to other areas of the shoulder, such as the rotator cuff and glenohumeral joint. (Id. at 5.) He explains that the supraspinatus tendon presents a barrier between the subacromial and intra-articular spaces and, in petitioner’s case, her MRI showed that she had no significant tearing of the rotator cuff, meaning it is unlikely antigenic material could have reached the intra-articular space where her arthritis was located. (Ex. C, pp. 2-3.) Without any antigenic material within the intra-articular space, there would be no biological mechanism for the vaccine to cause inflammation in that area. (Id. at 5.) Dr. Abrams stresses that both the Dumonde and Trollmo studies cited by Dr. Srikumaran involved intra-articular injections. (Id. at 4 (citing Dumonde & Glynn, supra, at Ex. 12, Tab G; C. Trollmo et al., supra, at Ex. 12, Tab S).) Accordingly, they do not constitute evidence that an intra-muscular injection could lead to joint arthrosis. (Id.) V. Analysis a. Table Injury of SIRVA As discussed above, petitioner is entitled to a presumption of causation if she can establish that her injury arose within 48-hours of vaccination and meets the specific criteria that define what constitutes a Table “SIRVA.” 42 CFR § 100.3(c)(10). Under the Vaccine Act, a petitioner bears the burden of demonstrating the factual underpinnings of her claim by a preponderance of the evidence. § 300aa-13(1)(a). Thus, she must demonstrate each of the four SIRVA QAI criteria by preponderant evidence. In this case, I find that petitioner cannot meet the fourth SIRVA QAI criterion, and this is therefore dispositive of her Table claim. 12 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 13 of 18 The fourth SIRVA criterion requires that “[n]o other condition or abnormality is present that would explain the patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, and any other neuropathy).” 42 CFR § 100.3(c)(10)(iv). This element of petitioner’s showing “requires consideration of a petitioner’s medical condition as a whole.” Record v. Sec’y of Health & Human Servs., No. 21-1312V, 2025 WL 868957, at *6 (Fed. Cl. Feb. 26, 2025). However, while the “other condition or abnormality” at issue must qualify as an explanation for the petitioner’s symptoms, it “need not be a better or more likely explanation.” French v. Sec’y of Health & Human Servs., No. 20-0862V, 2023 WL 7128178, at *6 (Fed. Cl. Spec. Mstr. Sept. 27, 2023). Indeed, a petitioner may fail to meet the fourth SIRVA criterion even where there is clinical evidence of an alternative condition that falls short of a definitive diagnosis. Durham v. Sec’y of Health & Human Servs., No. 17-1899V, 2023 WL 3196229, at *14 (Fed. Cl. Spec. Mstr. May 2, 2023) (noting that the regulation cites “clinical evidence of” various conditions). However, respondent does not defeat a Table SIRVA claim “simply by noting the presence of shoulder dysfunction beyond deltoid bursitis.” Grossman v. Sec’y of Health & Human Servs., No. 18-00013V, 2022 WL 779666, at *16 (Fed. Cl. Spec. Mstr. Feb. 15, 2022). Because SIRVA is itself broadly defined as an unspecified musculoskeletal injury affecting the shoulder (42 C.F.R. § 100.3(c)(10)), alternative explanations based on conditions or abnormalities intrinsic to the shoulder raise a potentially more difficult question. See Lang v. Sec’y of Health & Human Servs., No. 17-995V, 2020 WL 7873272, at *12-13 (Fed. Cl. Spec. Mstr. Dec. 11, 2020); see also Durham, 2023 WL 3196229, at *14 n.11. A finding that a petitioner has arthritis affecting the shoulder does not per se preclude a finding that a Table SIRVA exists. Lang, 2020 WL 7873272, at *13. Rather, in that context the question is “whether petitioner’s own clinical history indicates that her shoulder pathology wholly explains her symptoms independent of vaccination.” Id.; see also, e.g., Molina v. Sec’y of Health & Human Servs., No. 20- 845V, 2024 WL 4223393, at *8 (Fed. Cl. Spec. Mstr. Aug. 15, 2024) (finding that petitioner’s diagnosis of calcific tendinitis precluded a Table SIRVA under the fourth SIRVA criterion because it is “a condition that can in itself present with acute onset of shoulder pain”). Ultimately, where the presence of another condition is apparent, petitioner bears the burden of proving that the condition nonetheless “would not explain” her symptoms. Durham, 2023 WL 3196229, at *14. Here, petitioner’s treating orthopedist, Dr. Kirk, initially found that petitioner had evidence of both impingement syndrome affecting her subacromial space and glenohumeral osteoarthritis. (Ex. 6, p. 10.) He first felt that her symptoms were more likely the result of her impingement syndrome (Id.); however, after her condition failed to respond to a subacromial steroid injection, he concluded that her glenohumeral osteoarthritis was the more likely cause of her shoulder pain (Id. at 56). On respondent’s behalf, Dr. Abrams agrees with this conclusion. (Ex. A, p. 5.) Additionally, while Dr. Srikumaran proposes an initiating role for bursitis, he ultimately opines that any bursitis that was present would have resolved between petitioner’s February and May 2021 orthopedic encounters, and that her pain from that point forward was due to osteoarthritis. (Ex. 12, pp. 7-8.) Both parties’ experts agree that petitioner’s ultimate 13 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 14 of 18 treatment for her condition – her reverse shoulder replacement – was indicated due to the presence of osteoarthritis that failed conservative treatment measures. (Ex. 14, pp. 2-3; Ex. C, p. 3.) Given all this, petitioner cannot reasonably assert that her glenohumeral osteoarthritis “would not” explain her symptoms. Dr. Srikumaran nonetheless opines that petitioner’s osteoarthritis would not wholly explain her clinical history absent the additional involvement of her vaccination. However, this is not persuasive on this record. Dr. Srikumaran’s opinion is based on the speculative assumption that petitioner suffered transitory (vaccine-caused) bursitis that fully responded to treatment and therefore evaded any detection apart from petitioner’s initial signs of impingement upon physical examination. Importantly, however, both experts explain that impingement signs are not specific to bursitis and can be caused by a number of conditions, including glenohumeral osteoarthritis, which Dr. Kirk identified as additionally present from the time of petitioner’s first encounter. (Ex. 14, p. 4; Ex. C, pp. 3-4.) Moreover, Dr. Abrams stresses that petitioner’s physical exam findings were substantially the same at both her February and May 2021 orthopedic encounters – that is, both before and after the subacromial injection Dr. Srikumaran posits as an explanation for the disappearance of petitioner’s bursitis. (Ex. A, p. 5.) Even accepting that what Dr. Srikumaran proposes is possible, Dr. Abrams is persuasive in stressing that impingement signs cannot be merely equated with bursitis and that an actual diagnosis of bursitis should have some objective confirmation, which is entirely lacking in this case. (Ex. C, pp. 3-4; Ex. A, p. 5.) Therefore, given the lack of any other supporting evidence and the presence of confirmed glenohumeral osteoarthritis, bursitis is not a likely explanation for petitioner’s signs of impingement. Finally, the fact that petitioner’s pain first arose in the post-vaccination period is not dispositive. Although both experts agree that the degenerative changes underlying osteoarthritis develop over years (Ex. 12, p. 7; Ex. A, p. 4), onset of pain does not necessarily likewise occur gradually. Dr. Abrams explained that “everyday activities (i.e. carrying groceries, sleeping on the shoulder, and other normal activities which patients do not recognize as traumatic) can initiate pain from shoulder arthritis” even as the majority of patients cannot identify the trigger of their pain. (Ex. A, p. 4.) Although Dr. Srikumaran sought to defend the reliability with which petitioner identified her own vaccination as a trigger for her pain, he did not dispute this broader understanding of osteoarthritis onset as discussed by Dr. Abrams. (Ex. 14, pp. 1-2.) To be clear, this consideration is not to be confused with petitioner’s separate burden of demonstrating under the second SIRVA criterion that her pain arose within 48 hours of vaccination. Even assuming arguendo that petitioner met her burden of proof under the second criterion, the issue here would still be that she has not preponderantly demonstrated that the pattern of onset she experienced is incompatible with glenohumeral osteoarthritis being the explanation for her symptoms irrespective of her vaccination. For all these reasons, petitioner has not preponderantly demonstrated the presence of a Table SIRVA. 14 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 15 of 18 b. Shoulder Injury Caused-in-Fact by Vaccination Even having failed to meet the specific requirements for a Table Injury of SIRVA, petitioner could still demonstrate, pursuant to the Althen test, that her shoulder injury was nonetheless caused-in-fact by her vaccination. However, I do not find that petitioner has met her preponderant burden of proof under either Althen prongs one (a medical theory of causation) or two (a logical sequence of cause and effect). Under Althen prong one, petitioner 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 (quoting Pafford v. Sec’y of Health & Human Servs., No. 01- 0165V, 2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff’d, 64 Fed. Cl. 19 (2005), aff’d, 451 F.3d 1352 (Fed. Cir. 2006)). Such a theory must only be “legally probable, not medically or scientifically certain.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549-49 (Fed. Cir. 1994). Petitioner 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 & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1325-26 (Fed. Cir. 2006)). However, “[a] petitioner must provide a ‘reputable medical or scientific explanation’ for [her] theory. While it does not require medical or scientific certainty, it must still be ‘sound and reliable.’” Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019) (citation omitted) (quoting Knudsen, 35 F.3d at 548-49). Dr. Srikumaran theorizes that an inflammatory reaction in the subacromial space, consistent with what is generally believed to occur in the context of SIRVA, can ultimately spread to affect the glenohumeral space to aggravate osteoarthritis from an asymptomatic state to a painful state. (Ex. 12, pp. 8-9.) This theory initially appears intuitive insofar as Dr. Abrams agrees that arthritis is inflammatory and can be activated to become chronically painful by otherwise ordinary daily events. (Ex. A, p. 4.) Moreover, it has been observed that needle penetration into the glenohumeral space is possible given its proximity to the deltoid muscle. (Martín Arias et al., supra, at Ex. 12, Tab B, p. 5). However, while the SIRVA literature filed in this case indicates that a small percentage (5.2%) of SIRVA sufferers do have MRI findings of glenohumeral arthritis (Elisabeth M. Hesse et al., Shoulder Injury Related to Vaccine Administration (SIRVA): Petitioner Claims to the National Vaccine Injury Compensation Program, 2010-2016, 38 VACCINE 1076 (2020) (Ex. 12, Tab K, p. 5 tbl.5)), it does not suffice without more to demonstrate that glenohumeral arthritis is a pain generator among these individuals, rather than an incidental finding. Based on the case series by Bodor and Montalvo, it has been observed that SIRVA can affect the glenohumeral space. (Atanasoff et al., supra, at Ex. 12, Tab A, p. 2 (citing Bodor & Montalvo, supra, at Ex. 12, Tab D).) However, both of the Bodor and Montalvo subjects had issues with “multiple shoulder structures,” including the glenohumeral joint, but also beyond the glenohumeral joint, and neither subject was diagnosed with active osteoarthritis in particular. (Bodor & Montalvo, supra, at Ex. 12, Tab D, pp. 2-3.) Instead, the literature suggests that when a vaccine is inadvertently injected into the glenohumeral space, it results in “an intense 15 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 16 of 18 immune and inflammatory response” that leads to damage and dysfunction such as edema, erosion, and necrosis (Martín Arias et al., supra, at Ex. 12, Tab B, pp. 5-6), which is a different presentation than simple activation of preexisting osteoarthritis. After Dr. Srikumaran initially raised this theory based primarily on an animal model study (namely, the study by Dumonde and Glynn), my Rule 5 order prompted him, in light of Dr. Abrams’s competing opinion that it did not represent any known clinical entity, to identify what evidence is available to indicate that vaccinations can activate glenohumeral osteoarthritis in humans. (ECF No. 28, p. 3.) In response, he indicated that the Dumonde study “is the only study of its kind to demonstrate production of arthritis as the result of antigenic material.” (Ex. 14, p. 4.) Thus, although the Dumonde study is not the only evidence Dr. Srikumaran cites, it is the linchpin of his theory. Accord Clark v. Sec’y of Health & Human Servs., No 18-813V, 2022 WL 16635681, at *26 (Fed. Cl. Spec. Mstr. Feb. 7, 2022) (noting in a prior SIRVA case that “[n]one of the literature filed in this case supports the idea that those investigating acute post-vaccination shoulder injuries suspected an autoimmune etiology to explain their findings of acute shoulder pain whereas the literature Dr. Axelrod cites purporting to show potential molecular mimics within joint tissue involves the separate context of chronic conditions such as rheumatoid arthritis and osteoarthritis” (footnote omitted)). However, the purpose of the Dumonde study, which was conducted in 1961, was to develop an animal model of experimental immune-mediated arthritis resembling rheumatoid arthritis at a time when it remained uncertain whether rheumatoid arthritis was an immune disease. (Dumonde & Glynn, supra, at Ex. 12, Tab G, pp. 1, 14.) The authors concluded that they had experimentally provoked an arthritis in the subject rabbits that “bears a striking resemblance to rheumatoid arthritis.” (Id. at 16.) Especially given that time has borne out the hypothesis that rheumatoid arthritis is an autoimmune condition, Dr. Srikumaran has not substantiated that the Dumonde findings are informative with respect to osteoarthritis. Moreover, even where rheumatoid arthritis has been accepted as an autoimmune condition, petitioners have not necessarily been persuasive in seeking to demonstrate that it can be caused by the flu vaccine. E.g., Casazza v. Sec’y of Health & Human Servs., No. 17-947V, 2023 WL 6214984, at *13 (Fed. Cl. Spec. Mstr. Aug. 30, 2023) (explaining that petitioner’s expert was unpersuasive as to Althen prong one where he “presented a description of the autoimmune process involved in [rheumatoid arthritis] that does not itself implicate vaccines, a separate concept by which any vaccine might in general contribute to autoimmunity without respect to any specific context, and precious little that could tie the two together”). Additionally, Dr. Abrams observes that a significant limitation of the Dumonde study vis-à-vis Dr. Srikumaran’s theory is that the study’s findings resulted from intra- articular injections. (Ex. C, p. 4 (discussing Dumonde & Glynn, supra, at Ex. 12, Tab G, p. 12).) Thus, in that study, the findings resulted from direct exposure to inflammatory antigenic material. (Id.) However, that is not what Dr. Srikumaran hypothesizes in this case. Moreover, as noted above, the SIRVA literature otherwise correlates needle penetration of the glenohumeral joint with more severe damage than simply activation of 16 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 17 of 18 pre-existing ostoearthritis. (Martín Arias et al., supra, at Ex. 12, Tab B, p. 5.) The Dumonde findings do not readily support Dr. Srikumaran’s theory that inflammation stimulated by antigenic material within the subacromial bursa would spread to the separate glenohumeral space, especially given that the two spaces are separated by the supraspinatus tendon as Dr. Abrams otherwise observes. (Ex. C, pp. 2-5.) Thus, even if one accepted the Dumonde study as some evidence supporting the notion that an antigenic challenge could activate osteoarthritis, it would still fail to provide evidence supporting any interplay between post-vaccination bursitis and glenohumeral osteoarthritis. Accordingly, I cannot conclude that petitioner has presented a reliable theory of causation under Althen prong one to implicate her flu vaccination as a cause of her symptoms of glenohumeral osteoarthritis. The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human 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 significant weight. Andreu, 569 F.3d at 1375; Capizzano, 440 F.3d at 1326 (stating that “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’” (alteration in original) (quoting Althen, 418 F.3d at 1280)). However, medical records and/or statements of a treating physician’s views do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. See § 300aa-13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 745 n.67 (2009) (stating that “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”). Ultimately, petitioner may support her claim either through her medical records or by expert opinion. § 300aa-13(a)(1). Here, Dr. Srikumaran’s explanation of a logical sequence of cause and affect purporting to implicate petitioner’s vaccination as a cause of her condition is essentially the same as his explanation as to why her diagnosed osteoarthritis should not prevent her from demonstrating the table requirements for SIRVA. (Compare Ex. 12, pp. 7-8, with id. at 9.) Accordingly, the same reasoning that prevents petitioner from meeting the Table requirements (see section V.a., supra), equally hinders her demonstration of causation-in-fact. In particular, as explained above, Dr. Srikumaran’s predicate assumption that petitioner initially suffered bursitis, as called for by his theory of causation, is unsupported speculation. Moreover, under Althen prong two, treating physician opinions carry significant weight. Here, however, although petitioner reported her post-vaccination onset of shoulder pain to Dr. Kirk, he never opined that her condition was vaccine caused. Additionally, once petitioner’s condition failed to resolve 17 Case 1:21-vv-02133-EGB Document 38 Filed 05/09/25 Page 18 of 18 following a subacromial injection, he explicitly opined that petitioner’s osteoarthritis was the more likely cause of her pain. (Ex. 6, p. 56.) And, finally, even if Dr. Srikumaran’s theory were correct, Dr. Abrams further questions whether any sequence of cause and effect would be possible in petitioner’s own case, given that she had no full thickness rotator cuff tear that could potentially expose the glenohumeral space to the inflammatory response purportedly beginning within the subacromial space. (Ex. C, pp. 2-5.) For all these reasons, petitioner has not presented preponderant evidence of a logical sequence of cause and effect demonstrating that her vaccine was a cause of her shoulder pain. Even assuming arguendo that petitioner met her burden of proof under Althen prong three by demonstrating that onset of her shoulder pain occurred shortly after her vaccination, her failure to meet her burden of proof under Althen prongs one and two is dispositive. Veryzer v. Sec’y of Health & Human Servs., 100 Fed. Cl. 344, 356 (2011) (explaining that a “temporal relationship alone will not demonstrate the requisite causal link and that petitioner must posit a medical theory causally connecting the vaccine and injury”), aff’d per curiam sub nom. Veryzer v. United States, 475 F. App’x 765 (Fed. Cir. 2012); Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355, 1364-65 (Fed. Cir. 2012) (holding the special master did not err in resolving the case pursuant to prong two when respondent conceded that petitioner met prong three). VI. Conclusion Petitioner has my sympathy for what she has endured. However, considering the record as a whole under the standards applicable in this program, petitioner has not preponderantly established either that her October 24, 2020 flu vaccination resulted in a Table SIRVA or alternatively caused-in-fact a shoulder injury. Accordingly, petitioner is not entitled to compensation. Therefore, this case is dismissed.7 IT IS SO ORDERED. s/Daniel T. Horner Daniel T. Horner Special Master 7 In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter judgment accordingly. 18 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_21-vv-02133-1 Date issued/filed: 2025-12-09 Pages: 27 Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) re: 45 Order on Motion for Review, Judge Vaccine Order/Opinion Signed by Senior Judge Eric G. Bruggink. (jpk1) Service on parties made. -------------------------------------------------------------------------------- Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 1 of 27 In the United States Court of Federal Claims No. 21-2133 (Filed: September 3, 2025) (Re-issued: December 9, 2025)1 * * * * * * * * * * * * * * * * * * * * * * * * * SHERRI PULSIPHER, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * Isaiah Kalinowski, Fairfax, VA, and Jimmy A. Zgheib, White Plains, NY, for plaintiff. Rachelle P. Bishop, Trial Attorney, United States Department of Justice, Civil Division, for defendant, with whom were Brett A Shumate, Assistant Attorney General, C. Salvatore D’Alessio, Director, Heather L. Pearlman, Deputy Director, and Colleen C. Hartley, Assistant Director. OPINION BRUGGINK, Senior Judge. In this vaccine appeal, petitioner argues that the Special Master’s decision was not in accordance with law regarding her Shoulder Injury Related to Vaccine Administration (“SIRVA”) claim. Petitioner first argues that the regulatory provision the Special Master relied upon to deny her Table Injury claim is invalid, because it conflicts with the burden shifting framework of the National Vaccine Injury Compensation Program (“the Vaccine Act”). Petitioner also argues that the Special Master incorrectly 1 This opinion was originally issued under seal pursuant to Vaccine Rule 18(b) to afford the parties the opportunity to propose appropriate redactions. The opinion appears as in the original because no redactions were proposed. 1 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 2 of 27 applied the legal standards set forth in Althen in denying her actual causation claim. Because petitioner failed to raise her regulatory challenge before the Special Master, we find she has waived that argument. We also conclude that the Special Master did not err in his application of Althen. Accordingly, we deny petitioner’s motion for review and affirm the Special Master’s decision. BACKGROUND I. The Vaccine Act The Vaccine Act allows individuals to seek compensation from the federal government for injuries caused by certain vaccines. 42 U.S.C. § 300aa-11(b)(1)(A). Injured individuals can file a petition with the Office of Special Masters against the U.S. Department of Health and Human Services (“HHS”), seeking an award for their vaccine-related injuries. 42 U.S.C. § 300aa-11(a)(1). Under the Vaccine Act, a petitioner can recover under two distinct legal frameworks: (a) by establishing a “Table Injury”; or (b) by establishing that their injury was actually caused by a vaccine referenced in the Vaccine Act. 42 U.S.C. § 300aa-11(c)(1)(C). Both frameworks are discussed below. a. Establishing a Table Injury A petitioner is presumed to have experienced a vaccine-caused injury if the circumstances of their injury meet the qualifications of the Vaccine Injury Table—a creature of the Vaccine Act. 42 U.S.C. § 300aa- 11(c)(1)(C)(i). If a petitioner sufficiently shows she was administered a vaccine listed on the Table, and that she experienced an injury associated with that vaccine within the enumerated time limit, she has established a Table Injury and has a prima facie entitlement to compensation. 42 U.S.C. § 300aa-14; 42 C.F.R. § 100.3(a); Shalala v. Whitecotton, 514 U.S. 268, 270– 71 (1995) (“[A] claimant may establish a prima facie entitlement to compensation . . . by meeting the requirements of what the Act calls the Vaccine Injury Table.”). Once a petitioner has established a prima facie Table Injury claim, the burden of proof then shifts to the government to show by a preponderance of the evidence that “the illness, disability, injury, or condition . . . is due to factors unrelated to the administration of the vaccine described in the petition”—in other words, that the petitioner’s injury was actually caused by something other than the vaccine at issue. 42 U.S.C. § 300aa-11(a)(1)(B); Shalala, 514 U.S. at 270–71. The Vaccine Act includes a section titled “Qualifications and Aids to 2 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 3 of 27 Interpretation” (“QAI”). 42 U.S.C. § 300aa-14(b); 42 C.F.R. § 100.3(c). This section more specifically defines the types of injuries covered under the Vaccine Injury Table and is supposed to be read in conjunction with the Table. 42 U.S.C. § 300aa-14(b). The Vaccine Act allows the Secretary of HHS to promulgate regulations that modify both the Vaccine Injury Table and the QAI. 42 U.S.C. § 300aa-14(c)(1); Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072, 1078 (Fed. Cir. 2020). Pertinent to the case at hand, in 2017, the Secretary promulgated a regulation adding SIRVA as an eligible Table Injury. 42 C.F.R. § 100.3(a). A petitioner can establish a SIRVA Table Injury by showing that she was administered a seasonal influenza (“flu”) vaccine, and that she experienced SIRVA within 48 hours of receiving that vaccine. Id. The QAI to that regulation states the following regarding SIRVA: A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient’s symptoms (e.g., NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 42 C.F.R. § 100.3(c)(10). b. Establishing Actual Causation If a petitioner was administered a vaccine listed on the Vaccine Injury Table but has not experienced a Table Injury (e.g., does not meet the QAI criteria for a SIRVA injury), causation is not presumed. Shalala, 514 U.S. at 3 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 4 of 27 1479; 42 U.S.C. § 300aa-11(c)(1)(C)(ii). Instead, the petitioner can only recover if she shows by a preponderance of the evidence that the Table vaccine was the actual cause of her injury. 42 U.S.C. § 300aa-11(c)(1)(C)(ii). The Federal Circuit articulated the elements for the off-table causation standard in Althen v. Sec’y of Health & Hum. Servs. To establish actual causation, the petitioner must show: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Once a petitioner satisfies all three Althen prongs, the burden of proof then shifts to the government to show, “also by a preponderance of [the] evidence, that the injury was in fact caused by factors unrelated to the vaccine.” Id. (internal citation omitted). II. Factual History On October 24, 2020, petitioner, Sherri A. Pulsipher, was administered a flu vaccine in her left shoulder at a pharmacy in Las Vegas, Nevada. Ex. 2 at 2–3; Ex. 11 at ¶ 2. She was 66 years old at the time. According to Ms. Pulsipher, within hours of receiving that vaccine, she started experiencing pain and burning in her left shoulder, which increased in intensity over the following weeks and was accompanied by decreased mobility. Ex. 1; Ex. 11 at ¶ 2. There is no evidence that petitioner experienced these left shoulder symptoms prior to vaccination. Petitioner did not immediately seek medical attention for her shoulder, but instead, for several months, self-treated her symptoms through rest and by taking over-the- counter-anti-inflammatories. Ex. 11 at ¶ 3. The record reflects a factual disagreement as to when petitioner first sought medical assistance for her shoulder pain. According to Ms. Pulsipher’s affidavit, she first sought medical assistance for her shoulder from Andrew Rose, a Certified Physician Assistant, on January 25, 2021, three months after the vaccination. Id. at ¶ 4. During that visit, petitioner informed Mr. Rose of her left shoulder symptoms, and he administered a steroid injection in Ms. Pulsipher’s left shoulder. Id. Contrary to Ms. Pulsipher’s affidavit, however, the documentation for petitioner’s visit with Mr. Rose does not reference any reported issues with her left shoulder— instead referencing a myriad of other unrelated medical issues, including generalized anxiety disorder, insomnia, depression, hypertension, and gastroesophageal reflux disease. Ex. 5 at 31. There is also no medical 4 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 5 of 27 documentation supporting petitioner’s claim that she received a steroid injection in her left shoulder. See generally id. at 29–32. About one month later, on February 22, 2021, Ms. Pulsipher visited Dr. Stephen Kirk, a sports medicine physician. Ex. 6 at 8–11. The documentation for that visit does reference her left shoulder pain. She described her pain as “aching, burning, intermittent, [and] stabbing,” and relayed additional symptoms such as “stiffness, tenderness, [and] weakness.” Id. at 8. Petitioner informed Dr. Kirk that her symptoms started after she received the flu shot in October. Id. Upon physical examination of Ms. Pulsipher’s left shoulder, Dr. Kirk observed that Ms. Pulsipher’s range of motion was mildly restricted in all planes of motion, she was moderately tender in the lateral part of her shoulder and mildly tender in the anterior and posterior parts of her shoulder, and that she experienced mild pain and weakness during the abduction external rotation of her shoulder. Id. at 9. After conducting several tests involving the movement of her arm and shoulder, Ms. Pulsipher tested positive for shoulder impingement.2 Id. Dr. Kirk also performed an x-ray of Ms. Pulsipher’s left shoulder. Id. That x-ray revealed that there was severe narrowing of the glenohumeral joint and that osteophytes (i.e., extra bone growth at the joint) were present at the humeral head. Ex. 6 at 9. Based on Ms. Pulsipher’s physical examination, Dr. Kirk diagnosed petitioner with left shoulder rotator cuff impingement syndrome. Id. at 10. Dr. Kirk noted that, although the x-ray supported a potential diagnosis of glenohumeral osteoarthritis, Ms. Pulsipher’s “symptoms do not seem to be focal to this presently,” and Dr. Kirk thus favored the impingement syndrome diagnosis. Id. He also noted, however, that he would “like to see how she does over the course of treatment to see how she responds to the impingement type treatment and whether or not she develops or presents with more glenohumeral pain in the future.” Id. Dr. Kirk administered a steroid injection into petitioner’s subacromial bursa that same day.3 Id. He determined that, if the subacromial bursa injection did not provide Ms. Pulsipher with significant relief, he “would strongly consider injecting the glenohumeral joint.” Id. 2 These tests are referred to as the Neer, Hawkins-Kennedy, and Empty Can tests. Ex. 6 at 9. 3 This is a part of the shoulder often associated with impingement syndrome. 5 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 6 of 27 On March 8, 2021, petitioner visited Mr. Rose again. The visit was for, among other things, epigastric abdominal pain. Ex. 5 at 25–27. No mention was made of her left shoulder symptoms, and, in fact, upon physical examination, Mr. Rose found “no malalignment or tenderness” to Ms. Pulsipher’s joints, bones, and muscles, and found “normal movement of all extremities.” Id. at 29. Mr. Rose instructed petitioner to avoid alcohol, caffeinated beverages, nicotine products, strenuous exercise, and large meals prior to bedtime. Id. The next day, on March 9, 2021, petitioner visited Mr. Rose again for a cough she was experiencing. Id. at 22, 24. Petitioner’s shoulder symptoms were once again not mentioned. Mr. Rose diagnosed Ms. Pulsipher with acute sinusitis (i.e., a sinus infection) and prescribed an antibiotic and cough suppressant. Id. at 25. On April 14, 2025, petitioner visited the Mesa View Regional Hospital Emergency Department for her epigastric abdominal pain. Ex. 7 at 16. Again, no shoulder symptoms were mentioned. Additionally, the emergency department physician, Dr. Jarrod Johnson, found “[f]ull, normal range of motion” during his physical examination. Id. Petitioner was administered and prescribed medication and was discharged that same day. Id. at 19. On April 21, 2021, petitioner began seeing another Certified Physician Assistant, Rodney Briggs, at the Mesa View Medical Group. Ex. 5 at 15. During her initial appointment with Mr. Briggs, petitioner reported various symptoms, including “[f]atigue, muscle cramps, generalized pain, headaches, confusion, memory impairment, [and] imbalance.” Id. at 17. She also reported her epigastric issues but did not report any abdominal pain. Id. Petitioner’s shoulder symptoms were not specifically mentioned, and Mr. Briggs recorded “normal movement of all extremities” during his physical exam. Id. at 18. Mr. Briggs scheduled Ms. Pulsipher for a follow-up appointment on May 4, 2021 with Dr. Soon Kim, a general surgeon at the Mesa View Medical group, regarding her epigastric condition. Id. At that appointment, no shoulder symptoms were mentioned. During Dr. Kim’s routine physical examination of petitioner’s joints, bones, and muscles, Dr. Kim recorded “no malalignment or tenderness and normal movement of all extremities.” Id. at 8–10. On May 5, 2021, petitioner returned to Dr. Kirk regarding her shoulder pain. She informed Dr. Kirk that the injection to her subacromial bursa “didn’t help her at all” and wanted to “see what she should do next[.]” Ex. 6 at 55. Dr. Kirk’s physical examination of Ms. Pulsipher’s left shoulder 6 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 7 of 27 was substantially the same as his examination in February—although his overall diagnosis differed. Id. at 55–56. Because the subacromial bursa injection failed to provide significant relief to Ms. Pulsipher’s shoulder pain, he considered glenohumeral osteoarthritis as the probable “primary source of her pain,” and considered impingement syndrome to be a “lesser diagnosis,” although he did not completely remove impingement syndrome as a potential diagnosis, as petitioner “still ha[d] some pain and weakness on abduction external rotation.” Id. at 56. Dr. Kirk and Ms. Pulsipher discussed a variety of treatment options, including an injection of the glenohumeral joint space; however, petitioner wanted a more advanced diagnostic of her shoulder before moving forward. Id. Dr. Kirk referred Ms. Pulsipher for an MRI of her left shoulder. Id. An MRI of petitioner’s left shoulder was conducted on May 13, 2021. Id. at 53–54. The radiologist, Dr. Don Williams, found, among other things, tendonitis in the rotator cuff, profound circumferential degeneration of the labrum in the glenohumeral joint, small glenohumeral osteophytes, and a small inferior clavicular head osteophyte. Id. There were no findings of subacromial bursitis (i.e., inflammation of the subacromial bursa). Ex. 6 at 54. Dr. Williams’s impressions was that petitioner was experiencing severe glenohumeral osteoarthritis, mild-to-moderate tendonitis in the rotator cuff area, mild tendonitis near the front of her shoulder blade, and moderate acromioclavicular osteoarthritis. Id. Dr. Kirk reviewed Ms. Pulsipher’s MRI results with Dr. Williams and met with petitioner that same day. Id. at 49– 52, 54. After reviewing Ms. Pulsipher’s MRI results, Dr. Kirk’s assessment was that petitioner had severe glenohumeral osteoarthritis and rotator cuff tendonitis. Id. at 51. He advised her that “the most appropriate next step in her treatment is to surgically treat the shoulder. A reverse shoulder replacement would be the most appropriate treatment choice given the severe arthritis and rotator cuff pathology present.” Id. A reverse shoulder replacement surgery was subsequently scheduled with Dr. Todd Parry, an orthopedic surgeon. Id. Ms. Pulsipher underwent shoulder replacement surgery on June 16, 2021. Ex. 5 at 160. Although Dr. Kirk advised petitioner to undergo surgery due, in part, to her glenohumeral osteoarthritis, the pre- and postoperative diagnosis on Dr. Parry’s operative report only mentioned “rotator cuff arthropathy.” Id. Approximately two weeks later, at the postoperative follow- up appointment, petitioner reported “progressively less pain over the last 7 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 8 of 27 several weeks,” and that “[s]he has worked with the physical therapist . . . as per the protocol and made reasonable progress,” although she was still using a shoulder sling. Ex. 6 at 94. At petitioner’s six-week follow-up appointment, she reported “not taking any pain medication,” and that she was “moving [her] shoulder a little more the past few days.” Id. at 99. Ms. Pulsipher was advised she could “discontinue use of the sling but continue to be cautious in regard to her activities.” Id. at 101. Petitioner underwent post-operative physical therapy for her shoulder between July 27, 2021 and September 2, 2021. See generally Ex. 8. At her last recorded appointment, she reported that “her shoulder is doing better.” Ex. 8 at 47. Her physical therapists noted that petitioner “has less fatigue after completing her exercises showing an increase in endurance,” that her “[upper extremity] strength has also increased but remains limited,” and that “[s]he had a slight increase in pain when performing [internal rotations] with [a] strap that decreased once the exercise was complete.” Id. On September 7, 2021, at petitioner’s three-month post-operative follow-up with Dr. Parry, petitioner stated that she was “‘totally amazed’ at her results thus far.” Ex. 6 at 107. It was recorded that she “shows great motion in the shoulder, having worked hard in physical therapy. X-rays taken today show that the components are perfectly aligned. She is well informed, is doing well, and will follow up . . . at the one year postop mark.” Id. Petitioner’s affidavit conforms with this information, as she states that, at the three-month mark, she was “generally satisfied with [her] progress.” Ex. 11 at ¶ 16. Unfortunately, at petitioner’s one-year post-op visit with Dr. Parry, she reported that “her shoulder has been causing her a lot of pain the last few months[,] [s]he does not remember injuring it at all,” and that “[t]he pain radiates into the neck and down the arm.” Ex. 10 at 6. A physical examination of her shoulder showed “a well-healed scar with no heat, redness or soft tissue swelling,” but that there was “weakness with internal and external rotation.” Id. at 8. An x-ray of petitioner’s left shoulder showed that, despite petitioner’s recorded symptoms, the “prosthesis appear[ed] well fixated without concern for loosening” and there was “no evidence of acute fracture or dislocation.” Id. Although Ms. Pulsipher was prescribed an anti- inflammatory and was recommended to once again attend physical therapy, she did not attend any further physical therapy sessions (she continued to perform at-home exercises, however). Id.; Ex. 11 at ¶¶ 17–19. 8 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 9 of 27 Petitioner claims that she continues to experience pain and dysfunction in her left shoulder “to this day,” and that she has “difficulty with activities of daily living involving [her] left shoulder.” Ex. 11 at ¶ 19. Despite the treatment she has received, she believes that her “left shoulder will never be the same again.” Id. III. Procedural History Ms. Pulsipher filed her petition in the Office of Special Masters on November 4, 2021, requesting compensation under the Vaccine Act for SIRVA allegedly caused by the flu vaccine. The parties filed their respective expert reports and medical literature between August 9, 2023, and February 23, 2024. a. Petitioner’s Expert Opinion Petitioner’s expert, Dr. Uma Srikumaran, Associate Professor in the Department of Orthopedic Surgery at Johns Hopkins University, stated in his expert report that the record supports Ms. Pulsipher’s SIRVA claim under both legal frameworks of the Vaccine Act. Ex, 12 at 1, 5, 8–9. First, Dr. Srikumaran stated that both Ms. Pulsipher’s medical records and sworn statements satisfy all four QAI requirements of a SIRVA Table Injury claim. Id. at 5. He highlighted that there was no indication from Ms. Pulsipher’s medical records that she had any prior history of pain or dysfunction in her left shoulder. Id. Additionally, her pain is consistently documented as limited to her left shoulder. Id. Although petitioner’s appointment with Mr. Rose in January did not reference any shoulder pain or steroid injection, Dr. Srikumaran credited petitioner’s affidavit that her symptoms occurred within 48 hours of vaccination. Id. Moreover, although her appointment with Mr. Rose occurred several months after Ms. Pulsipher was administered a flu vaccine, Dr. Srikumaran noted that “the vast majority of patients do not have their pain . . . evaluated within 48 hours,” and that “[m]ost people are hopeful things will improve with time and basic measures and try several over the counter remedies for many weeks or months before seeking professional evaluation.” Id. at 6. In addressing the last requirement of a SIRVA Table Injury—that petitioner must show that no other condition or abnormality is present that would explain the symptoms—Dr. Srikumaran acknowledged the petitioner’s underlying glenohumeral osteoarthritis, and that the “condition takes decades to develop.” Ex. 12 at 7. He opined, however, that her 9 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 10 of 27 glenohumeral osteoarthritis did not explain her symptoms, as “it was completely asymptomatic prior to her vaccination.” Instead, the administered vaccination “caused, or ‘triggered,’ a previously asymptomatic chronic condition to become painful.” Id. at 7–8. Second, Dr. Srikumaran stated that petitioner’s claim also meets the requirements for actual causation. Id. at 8. Dr. Srikumaran’s medical theory of causation was that Ms. Pulsipher received the flu vaccine inadvertently near the subacromial bursa, which resulted in an inflammatory reaction, causing bursitis. Id. at 8–9. Bursitis then led to the activation of painful glenohumeral arthritis, which had previously been asymptomatic. Id. To support his medical theory, Dr. Srikumaran pointed to a 2010 article involving research from the Department of Health and Human Services and the University of Kentucky School of Medicine, showing that 46% of Vaccine Act claims involving shoulder pain and dysfunction between 2006 and 2010 also involved vaccines that were administered high in the deltoid, and 93% of those patients experienced pain and limited range of motion within 24 hours of vaccine administration. Ex. 12 at 11. He also cited a 2007 article by Bodor and Montalvo, showing two cases of “shoulder pain, decreased range of motion, and weakness after vaccine injection,” in which “both cases involved injections ‘high’ . . . into the deltoid muscle with symptoms beginning two days after injection.” Id. at 10; Ex. 12, Tab D. The authors to that study hypothesized that the administered vaccine “was injected into the subacromial bursa, ‘causing a robust local immune and inflammatory response.’” Ex. 12, Tab D at 2. Dr. Srikumaran then went on to cite a host of scientific literature supporting the notion that vaccines—in particular, the poor administration of vaccines—have “the potential for inducing a prolonged immune-mediated inflammatory reaction,” leading to the “[r]isk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations.” Ex. 12 at 8–9; see also Ex. 12, Tab A. In his attempt to connect vaccine-caused inflammation to arthritis, Mr. Srikumaran cited one 1962 study, the Dumonde study, where an immunological reaction caused by the injection of antigenic material in rabbits produced arthritis. Ex. 12 at 9, 11; Ex. 12, Tab G; Ex. 14 at 4. Dr. Srikumaran, however, admitted that “[t]he production of arthritis in rabbits secondary to an immunological reaction observed and documented in the Dumonde study is the only of its kind to demonstrate production of arthritis as the result of antigenic material.” Ex. 14 at 4. 10 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 11 of 27 Dr. Srikumaran then went on to explain how petitioner’s case conformed with his medical theory of causation. According to Dr. Srikumaran, petitioner’s initial symptoms were not only consistent with left shoulder impingement syndrome, but also with subacromial bursitis (although he also mentions that impingement syndrome is a generalized term and can be secondary to, among other things, glenohumeral arthritis as well). Ex. 12 at 13; Ex 14 at 4. During petitioner’s initial appointment with Dr. Kirk, she was administered a steroid injection to her subacromial bursa, which addressed her bursitis—evidenced by the fact that her May 13 MRI findings found no subacromial bursitis in her left shoulder. Ex. 14 at 2. Despite the fact the steroid injection was successful in reducing petitioner’s subacromial inflammation, during the time between vaccine administration and the steroid injection, the inflammation in her subacromial bursa spread to her glenohumeral joint, which activated her preexisting yet asymptomatic glenohumeral arthritis. Id. According to Dr. Srikumaran, this explains why petitioner was still feeling pain in her shoulder after the steroid injection to her subacromial bursa, as well as Dr. Kirk’s second diagnosis, favoring glenohumeral osteoarthritis over impingement syndrome as the likely diagnosis. Id. b. Respondent’s Expert Opinion Respondent’s expert, Dr. Geoffrey D. Abrams, Professor of Orthopedic Surgery at the Stanford School of Medicine, stated that petitioner’s medical record and history “confirmed diagnosis of shoulder arthritis [as] a more likely source of her shoulder pain than SIRVA.” Ex. A at 1, 4. In support of his conclusion, Dr. Abrams noted that “[s]houlder arthritis is a very common cause of shoulder pain, with an increasing incidence as patients age and is seen most commonly in those over 50 years of age.” Id. at 4. Arthritis development, especially in the shoulder, “is a slow process and takes years for clinical symptoms to express themselves.” Id. He mentioned that, although there is indeed a period where arthritis is present prior to symptoms, “everyday activities (i.e., carrying groceries, sleeping on the shoulder, and other normal activities which patients do not recognize as traumatic) can initiate pain from shoulder arthritis.” Id. As a result, “it is exceedingly common (the great majority) for patients with underlying arthritis as a cause of their shoulder pain to not recall any specific event which they can attribute to the onset of their symptoms.” Id. Moreover, in response to Dr. Srikumaran’s medical theory connecting vaccine-caused inflammation to arthritis pain, Dr. Abrams stated, “the ability 11 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 12 of 27 of a vaccination to ‘trigger’ symptoms related to arthritis is not a known clinical entity,” and that “a vaccination would be unlikely to affect the intra- articular space of the shoulder, where the arthritis is located,” because “the rotator cuff . . . provides a barrier between the subacromial and intra-articular spaces.” Id. at 5; Ex. C at 2–3. Dr. Srikumaran also cited a position statement from the American Academy of Orthopedic Surgeons (“AAOS”), stating that “vaccination administered to the shoulder is unlikely to cause or contribute to common shoulder pathologies such as . . . glenohumeral arthritis.” Ex. A- 3 at 3; Ex. A at 7–8. Regarding Ms. Pulsipher’s medical record, Dr. Abrams pointed out that petitioner’s first visit to a health care provider post-vaccination produced no documentation regarding her shoulder symptoms or any administered steroid injection to petitioner’s shoulder. Ex. A at 5–6. Although Dr. Abrams stated that he has seen medical record errors before, he also stated that “[t]he chance that the provider not only failed to record that the petitioner reported shoulder pain as well as also failed to report that an injection was given is improbable.” Id. at 6. Additionally, though it is possible that those who experience SIRVA may not seek medical care for their shoulder pain within the first 48 hours, it is unusual for a patient to not seek medical care for their pain for several months after the occurrence. Id. Instead, Dr. Abrams suggested that petitioner’s recounting of the circumstances surrounding her vaccination are likely “susceptible to distortion,” as “memory has proven unreliable in recollection of facts surrounding an event, particularly as the duration of time passes from the event occurrence,” potentially resulting in the “retrospective attribution of musculoskeletal pain to some prior event.” Id. at 7. Dr. Abrams noted that it was not until petitioner’s visit with Dr. Kirk on February 22, 2021 that her shoulder symptoms and steroid injection were first recorded; and although Dr. Kirk recorded an initial diagnosis of impingement syndrome, according to Dr. Abrams, positive examination findings of impingement syndrome are not only independently associated with bursitis, but also with pre-existing arthritis. Id. at 4–5; Ex. C at 3–4. Dr. Abrams also stated that “the mechanism of SIRVA centers around injection of antigenic material into the subacromial space, with resulting inflammation (and therefore clinical symptoms) in the shoulder area,” but that there was no indication from petitioner’s MRI that there was any significant tearing in her rotator cuff that could have possibly allowed any inflammation in the subacromial space to affect the arthritis-affected space. 12 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 13 of 27 Ex. C at 2. Furthermore, petitioner claimed she did not experience any pain relief from the steroid injection administered by Dr. Kirk, which Dr. Abrams asserted contradicts a SIRVA diagnosis. Id. at 3–4. According to Dr. Abrams, with such an injection, one would “expect to see at least some inflammatory reaction or ‘bursitis’ . . . on the MRI”; however, petitioner’s MRI results indicated “no subacromial/subdeltoid bursitis.” Ex. A at 5; Ex. 6 at 54. Alternatively, the February 22 (pre-injection) and May 5 (post-injection) appointments with Dr. Kirk consistently showed petitioner’s mild range of motion, the February 22 x-ray of petitioner’s shoulder showed small osteophytes present (which Dr. Abrams described as the “hallmark of joint arthritis”), and the May 13 MRI findings showed “severe glenohumeral osteoarthritis,” which all support the opinion that petitioner’s shoulder pain was independently caused by her pre-existing osteoarthritis. Ex. A at 4–5. c. Parties’ Arguments Before the Office of Special Masters, petitioner argued that she had demonstrated a Table Injury, because (1) she had no history of pain, inflammation or dysfunction in her left shoulder before receiving the flu vaccination; (2) the onset of her pain occurred within 48 hours of vaccine administration; (3) her symptoms were limited to the left shoulder; and (4) no other condition or abnormality was present that would explain her symptoms. Regarding the last QAI prong, petitioner argued that, although medical evidence of petitioner’s underlying osteoarthritis was present, it did not wholly explain petitioner’s shoulder symptoms, as the progression of arthritis symptoms is slow and the medical records in this case show petitioner experienced sudden shoulder symptoms after vaccination. Thus, according to petitioner, Dr. Srikumaran’s explanation of events—that the vaccination caused an inflammatory reaction which triggered petitioner’s arthritis symptoms—is more consistent with the medical record. Petitioner alternatively claimed recovery under an actual causation theory. First, petitioner stated that Dr. Srikumaran’s medical theory (Althen prong one) is sound, because it is generally accepted that administering a vaccine inadvertently into the rotator cuff can cause an inflammatory response; and because it is widely recognized that osteoarthritis may cause no symptoms until aggravated by another event. Second, to support a logical sequence of cause and effect (Althen prong two), petitioner pointed to Dr. Srikumaran’s opinion that petitioner likely experienced inflammation due to 13 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 14 of 27 inadvertent administration of the flu vaccine near her subacromial bursa, causing bursitis, which eventually aggravated her previously asymptomatic osteoarthritis. Third, petitioner claimed that a proximate temporal relationship (Althen prong three) exists between the vaccination and her injuries, arguing that her records demonstrate that she consistently placed the onset of her condition within 48 hours of vaccination and reported the onset of her symptoms “after” or “suddenly after” the October 24, 2020 vaccination. Before the Special Master, respondent countered that petitioner cannot recover under a Table Injury claim, because the record does not establish that her pain began within 48 hours of vaccination. Although petitioner signed an affidavit alleging that she started feeling her shoulder symptoms within 48 hours of vaccine administration, she did not report her shoulder pain to Mr. Rose until January 25, 2021—more than 3 months post- vaccination. Moreover, respondent pointed out that petitioner’s medical encounter with Mr. Rose showed no documentary evidence of shoulder complaints or treatment. It was not until her first appointment with Dr. Kirk on February 22 that there was documentary evidence showing her shoulder complaint and subsequent treatment. Petitioner also had a number of medical appointments in which she did not mention her shoulder symptoms, instead raising a variety of other medical issues, including, among other things, depression, sinus infection, and epigastric pain. Thus, respondent argued that petitioner’s affidavit regarding the onset of her symptoms within the 48-hour window and the circumstances of her initial appointment with Mr. Rose should be given less deference due to its contradiction by the documentary evidence. Respondent also argued that petitioner has not established the fourth QAI requirement for a SIRVA Table Injury claim—that no other condition or abnormality is present that could explain petitioner’s symptoms—because petitioner’s arthritis independently explains her symptoms. Respondent referenced petitioner’s x-ray and MRI findings that confirmed petitioner’s moderate-to-severe osteoarthritis, including the presence of osteophytes, which could not have developed within only several months of vaccination. Moreover, petitioner’s lack of relief from her shoulder symptoms after receiving the subacromial steroid injection and her MRI finding of “[n]o subacromial/subdeltoid bursitis” points away from SIRVA. According to respondent, petitioner’s physical exam findings pre- and post-steroid injection both show “mild” restriction on all planes, suggesting the cause of her shoulder pain was the same between both visits. 14 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 15 of 27 Regarding petitioner’s alternative actual causation theory for recovery, respondent asserted that petitioner has not established a persuasive or reliable medical theory under Althen prong one. This is because, where, as with petitioner, the rotator cuff is largely intact, it is unlikely that any inflammation in the subacromial bursa would spread to the intra-articular space (where petitioner’s osteoarthritis is located), as the two spaces are separated by the rotator cuff. Although respondent recognized the existence of medical literature supporting the fact that vaccination can cause inflammation, respondent claims that petitioner fails to cite any credible medical literature linking vaccine-caused inflammation to arthritis. In fact, the AAOS specifically refutes this theory. Thus, respondent claimed petitioner’s medical theory is without any indicia of reliability. Respondent also claimed that, even if petitioner’s medical theory is sound, under Althen prong two, petitioner has failed to establish a logical sequence of events comporting with that medical theory. This is because petitioner’s MRI failed to show any signs of bursitis; the steroid injection in petitioner’s left shoulder offered no pain relief; petitioner’s rotator cuff was intact; both Dr. Kirk and Dr. Williams attributed petitioner’s shoulder pain to osteoarthritis; and the parties agree that osteoarthritis is a slow-developing condition, that petitioner had osteoarthritis before her vaccination, and that it is exceedingly common for arthritis symptoms to be triggered by everyday activities. For Althen prong three, respondent claimed that petitioner had not established a proximate temporal relationship between her vaccination and her alleged injury. Although petitioner alleges her shoulder symptoms began within 48 hours of receiving the flu vaccine, the medical record does not support this notion. Respondent highlights that petitioner first reported her symptoms several months after the vaccination. As a result, respondent argued that petitioner had not satisfied by a preponderance of the evidence her actual causation theory. d. Special Master Findings Special Master Daniel T. Horner filed his decision on April 24, 2025, ruling against petitioner under both frameworks of compensation. See generally Pulsipher v. Sec’y of Health & Hum. Servs., No. 21-2133V, 2025 WL 1364203 (Fed. Cl. Spec. Mstr. Apr. 24, 2025). In finding that petitioner failed to establish a SIRVA Table Injury, Special Master Horner found that, even if petitioner met the second QAI 15 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 16 of 27 criterion—that pain occurred within the 48-hour time period—she did not meet the fourth QAI criterion—that no other condition or abnormality could explain petitioner’s symptoms. Id. at *11. More specifically, Special Master Horner determined that petitioner had not “preponderantly demonstrated that the pattern of onset she experienced is incompatible with glenohumeral osteoarthritis being the explanation for her symptoms irrespective of her vaccination.” Id. According to Special Master Horner, this was because of the following evidence: Dr. Kirk concluded that glenohumeral osteoarthritis was the more likely cause of petitioner’s shoulder pain; signs of impingement syndrome are not specific to bursitis and may be caused by other conditions, including osteoarthritis; petitioner’s physical exam findings between February 22, 2021, and May 5, 2021 were substantially the same, indicating the same condition was present in both instances; and that arthritis symptoms can occur as a result of normal everyday activities, which patients may not recognize as the trigger of their pain. Id. Because petitioner had failed to satisfy the fourth QAI criterion for a SIRVA injury, she could not recover under a Table Injury claim. Id. at *10–11. Special Master Horner also found that petitioner had not established actual causation under Althen prongs one and two. Id. at *11. He recognized that petitioner may satisfy prong one—that petitioner proffer a reputable medical theory—“without resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory.” Pulsipher, 2025 WL 1364203 at *11 (citing Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009)). He also noted, however, that a petitioner must nonetheless “provide a ‘reputable medical or scientific explanation’ for [her] theory. While it does not require medical or scientific certainty, it must still be ‘sound and reliable.’” Id. (quoting Boatman v. Sec’y of Health and Human Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019)). After reviewing the medical literature submitted by petitioner, he noted that only 5.2% of SIRVA claimants have MRI findings of glenohumeral arthritis, and he determined that, “it does not suffice without more to demonstrate that glenohumeral arthritis is a pain generator among these individuals, rather than an incidental finding.” Id. at *12; Ex. 12, Tab K at 5. Special Master Horner further noted that the 1962 Dumonde study is the “only study of its kind to demonstrate production of arthritis as the result of antigenic material.” Pulsipher, 2025 WL 1364203 at *12. Moreover, the specific type of arthritis provoked in that study, according to its authors, bore “a striking resemblance to rheumatoid arthritis,” which is an autoimmune 16 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 17 of 27 condition—not a degenerative condition (such as osteoarthritis). Id. As a result, Special Master Horner found that “Dr. Srikumaran has not substantiated that the Dumonde findings are informative with respect to osteoarthritis.” Id. Moreover, Special Master Horner stated that, even if the Dumonde study was some evidence supporting the connection between an antigenic injection and osteoarthritis, this would still not support petitioner’s medical theory, because, as Dr. Abrams points out, the subacromial bursa and glenohumeral joint are still separated by the rotator cuff. Id. at *12. Thus, petitioner did not satisfy prong one of Althen. Id. at *13. Regarding the second Althen prong—establishing a logical sequence of cause and effect—Special Master Horner found that “the same reasoning that prevents petitioner from meeting the Table requirements . . . equally hinders her demonstration of causation-in-fact.” Id. His analysis emphasized that “treating physician opinions carry significant weight,” and that the treating physician in petitioner’s case, Dr. Kirk, “never opined that her condition was vaccine caused” and “explicitly opined that petitioner’s osteoarthritis was the more likely cause of her pain.” Id. Even if Dr. Srikumaran’s medical theory of causation was generally correct regardless of Dr. Kirk’s opinion, Special Master Horner contemplated “whether any sequence of cause and effect would be possible in petitioner’s own case, given that she had no full thickness rotator cuff tear that could potentially expose the glenohumeral space to the inflammatory response purportedly beginning within the subacromial space.” Id. Thus, petitioner did not satisfy Althen prong two either. Id. at *14. e. Appeal to this Court Petitioner filed her motion for review of Special Master Horner’s decision on May 27, 2025, arguing that the Special Master’s decision was not in accordance with law. In support of her motion, petitioner first argues that the regulation the Special Master relied upon in denying petitioner’s Table Injury—the fourth QAI criterion for a SIRVA Table Injury—was promulgated without authority, as it conflicts with the burden-shifting framework of the Vaccine Act. Petitioner next argues that the Special Master applied the wrong legal standard in Althen prong one by allegedly requiring petitioner to provide medical literature to support her medical theory and in Althen prong two by requiring petitioner to show in her chain of causation that the flu vaccine was the sole or superseding cause over osteoarthritis for her shoulder symptoms. 17 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 18 of 27 Respondent filed its response to petitioner’s motion on June 25, 2025, arguing that: (1) petitioner waived her statutory authority argument, because it was not first raised before the Office of Special Masters; (2) the Secretary, in any event, acted within his authority in promulgating the fourth QAI criterion; (3) even in the event the Secretary exceeded his authority, the petitioner has no meaningful relief, as the court cannot sever the fourth criterion from the rest of the rule; (4) Special Master Horner did not require petitioner to provide medical literature but merely reviewed the medical literature provided by the parties; and (5) Special Master Horner did not require petitioner to show that the flu vaccine was the sole or superseding cause of her shoulder symptoms. On August 6, 2025, we directed petitioner to file a reply solely addressing whether petitioner waived her statutory authority argument before this court, given that she had not first raised it before the Office of Special Masters. Petitioner filed her reply on August 13, 2025, claiming that she had indeed raised that argument before the Office of Special Masters, and that, even if it had not been raised below, waiver is discretionary and ought not be applied in these circumstances. Oral argument was held on August 18, 2025. DISCUSSION I. Jurisdiction and Standard of Review The Court of Federal Claims has jurisdiction under 42 U.S.C. § 300aa- 12(d)(3)(A) to review decisions made by the Office of Special Masters regarding petitions under the Vaccine Act. See also Shaw v. Sec’y of Health & Hum. Servs., 609 F.3d 1372, 1375 (Fed. Cir. 2010); Terran ex rel. Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1307 (Fed. Cir. 1999). We may set aside findings of fact or conclusions of law made by the special master that we find “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B); see also Munn v. Sec’y of Dep’t of Health & Hum. Servs., 970 F.2d 863, 867–68 (Fed. Cir. 1992). The special master’s determinations of law are reviewed de novo, Demore v. Sec’y of Health & Hum. Servs., 175 Fed. Cl. 756, 760 (2025), and the special master’s findings of fact are reviewed for clear error. Rus v. Sec’y of Health & Hum. Servs., 129 Fed. Cl. 672, 678 (2016). In doing so, we may issue our own findings of fact and conclusions of law or remand the petition to the special master for further action. 42 U.S.C. § 300aa- 12(e)(2)(B)–(C). After reviewing the record before us, we cannot grant petitioner’s 18 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 19 of 27 motion. We reject her Table Injury claim, because petitioner failed to raise her statutory authority argument before the Special Master. We reject her actual causation claim, because she has not demonstrated that Special Master Horner erred in his application of Althen. II. Petitioner Has Waived Her Statutory Authority Argument Petitioner first argues that the fourth QAI criterion for a SIRVA Table Injury was promulgated by the Secretary without authorization, because the provision conflicts with the burden of proof framework contemplated by the Vaccine Act. More specifically, as the provision requires petitioner to show that “[n]o other condition or abnormality is present that would explain the patient’s symptoms,” petitioner is essentially required to prove that the vaccine actually caused her symptoms in order to show a valid SIRVA Table Injury. According to petitioner, a requirement to prove actual causation for a Table Injury runs contrary to the Vaccine Act, because meeting the vaccination, injury, and timeframe requirements of the Injury Table is intended to create a presumption of causation. The QAI is only supposed to limit the scope of what constitutes an injury under the Act, not increase the petitioner’s burden of proof. Under the Table Injury framework, it is not until the burden of proof shifts to the government that the government must prove that petitioner’s symptoms were actually caused by “factors unrelated to the administration of the vaccine.” Thus, according to petitioner, Special Master Horner’s decision regarding petitioner’s failure to establish a Table Injury, which wholly relied on the provision at issue, should be set aside, as it was not in accordance with law. We note that respondent makes several substantive counterarguments to petitioner’s statutory authority argument. As a threshold matter, however, we must first address respondent’s procedural counterargument—that petitioner waived her statutory authority argument by not first raising it before the Special Master. For the reasons below, we agree with respondent that the issue was not preserved and is therefore waived. Rule 8(f) of the Vaccine Rules makes it clear that “[a]ny fact or argument not raised specifically in the record before the special master will be considered waived and cannot be raised by either party in proceedings on review of a special master’s decision.” Vaccine Rule 8(f)(i). Indeed, consistent with this rule, the Federal Circuit has routinely held that arguments not made before the special master are waived on appeal. Davis v. Sec’y of Health & Hum. Servs., 409 F. App’x 342, 344 (Fed. Cir. 2011) (“Because 19 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 20 of 27 [petitioner] points to nothing in the record establishing that [her] arguments . . . were adequately presented to the special master, we decline to consider those arguments on appeal.”); Weddel v. Sec’y of Dep’t of Health & Hum. Servs., 23 F.3d 388, 390 n.2 (Fed. Cir. 1994) (“The government correctly observes that [petitioner] failed to raise before the [s]pecial [m]aster the . . . arguments they now press.”); Jay v. Sec’y of Dep’t of Health & Hum. Servs., 998 F.2d 979, 983 n.4 (Fed. Cir. 1993) (finding that, because petitioner did not raise an issue before the special master, “[w]e thus conclude, as did the Claims Court, that it was abandoned.”). This court’s holdings are consistent. E.g., Austin v. Sec’y of Health & Hum. Servs., 141 Fed. Cl. 268, 277 (2018), aff’d, 818 F. App’x 1005 (Fed. Cir. 2020); Hellenbrand-Sztaba v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 222, 225 (1996), aff’d, 106 F.3d 426 (Fed. Cir. 1997); McMillan v. Sec’y of Health & Hum. Servs., 26 Cl. Ct. 357, 358–59 (1992). The general rule that a court will not consider issues not first raised at the initial adjudicatory forum is rooted in sound policies: It ensures finality in litigation by limiting the appealable issues to those a lower court had an opportunity to, and did, address. The rule also conserves judicial resources because it prevents parties from undoing a lower court’s efforts—sometimes spanning years of litigation—based on an error that a lower court could have considered and corrected. In the same regard, the rule discourages parties from inviting an alleged error below only to raise it on appeal. HTC Corp. v. IPCom GmbH & Co., KG, 667 F.3d 1270, 1281–82 (Fed. Cir. 2012). In her reply brief here, petitioner argues that she indeed raised the statutory authority issue before the Special Master, quoting the following language from her reply brief before the Special Master: “[I]n presenting her prima facie case under the Vaccine Injury Table, petitioner does not bear any burden of proving causation generally or to show that her shoulder pathology can be directly related to her vaccination as causal. It would be incompatible with the very idea of the Vaccine Injury Table to hold petitioner to a burden of proving causation to establish a Table Injury.” 20 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 21 of 27 Pet’r’s Reply Br. at 4, Pulsipher v. Sec’y of Health & Hum. Servs., No. 21- 2133V, 2025 WL 1364203 (Fed. Cl. Spec. Mstr. Apr. 24, 2025) (quoting Lang v. HHS, No. 17-995V, 2020 WL 7873272, at *13 n.9 (Fed. Cl. Spec. Mstr. Dec. 11, 2020)). According to petitioner, although her filings before the Office of Special Masters do not explicitly mention the issue of statutory authority, the statutory authority argument she brings before us is a logical extension of the language used above—not a completely new argument.4 We disagree. Petitioner primarily relies on this court’s decision in Spahn v. Sec’y of Health & Hum. Servs., 138 Fed. Cl. 252 (2018). In Spahn, before the special master, the respondent argued that the special master had an independent duty to determine reasonable attorneys’ fees and costs and requested that the special master “exercise his discretion” in doing so. Id. at 260–61 (internal citations omitted). On the respondent’s appeal to this court, the respondent argued that the special master abused his discretion in determining a reasonable award for the petitioner, because he failed to make an independent finding regarding the reasonableness of fees and costs. Id. Respondent also argued on appeal, however, that the special master’s independent duty to determine reasonable fees and costs is rooted in Supreme Court and Federal Circuit caselaw. Id. at 261. The petitioner argued the respondent had waived his caselaw argument under Rule 8(f), as that specific argument was not first raised before the special master. Id. We rejected petitioner’s argument, however, writing that, although respondent did not specifically raise the additional supporting caselaw before the special master, “the Secretary’s argument in this regard simply expands upon the core argument that the Secretary did present to the special master.” Id. We find petitioner’s reliance on Spahn misplaced, as the statutory authority argument petitioner presents now is not rooted in the same “core argument” brought before the Special Master. Petitioner did indeed articulate the following legal standard: a petitioner generally has no obligation to prove causation when establishing a prima facie Table Injury. Petitioner cited this 4 “While ‘a waiver may occur if a party raises a new issue on appeal . . . [a] waiver will not necessarily occur . . . if a party simply presented new or additional arguments in support.’” O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1359–60 (Fed. Cir. 2008) (quoting CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1370–71 (Fed. Cir. 2002)). 21 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 22 of 27 standard, however, in support of her argument that she satisfied the fourth QAI criterion for a SIRVA Table Injury—not that the criterion was promulgated contrary to statutory authority. In the very next paragraph of petitioner’s reply brief, she quotes the fourth criterion, and states that the court must “conduct a ‘holistic examination of a petitioner’s complete clinical presentation’ and assess whether the preponderant evidence shows ‘either (a) that her history is entirely free of, for example, clinical evidence of [osteoarthritis], or (b) if not, that the [osteoarthritis] would not explain her symptoms.’” Pet’r’s Reply Br. at 4, Pulsipher v. Sec’y of Health & Hum. Servs., No. 21-2133V, 2025 WL 1364203 (Fed. Cl. Spec. Mstr. Apr. 24, 2025) (quoting Durham v. HHS, No. 17-1899V, 2023 WL 3196229, at *14 (Fed. Cl. May 2, 2023)). She then claimed, after going through the medical history, that she met the fourth criterion, as “no other condition or abnormality wholly explains [p]etitioner’s post vaccination left shoulder symptoms independent of vaccination.” Id. at 7. Claiming that the fourth QAI criterion for a SIRVA Injury was promulgated without authority and unlawfully relied on by the Special Master is not merely an extension of petitioner’s core argument mentioned above. Rather, it is a new argument addressing a completely different issue on appeal. Petitioner next relies on the Federal Circuit’s decision in Terran ex rel. Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1310–11 (Fed. Cir. 1999), as well as our decision in GHS HMO, Inc. v. United States, 76 Fed. Cl. 339, 368–72 (2007), aff’d, 536 F.3d 1293 (Fed. Cir. 2008), in arguing that challenges to a regulation’s statutory authority are exempt from the waiver doctrine. The issue in Terran, however, was whether the Vaccine Act required a petition challenging a regulation to be filed within 60 days of its promulgation (it did not)—not whether a petitioner presenting a regulatory challenge is exempt from raising their argument before the trial court first. Terran, 195 F.3d at 1310–11.5 5 The cases petitioner includes in her following string cite are similarly unhelpful. Pub. Citizen v. Nuclear Regul. Comm’n, 901 F.2d 147, 150–53 (D.C. Cir. 1990) (addressing whether petitioner’s challenge was barred by a statutory time limit); N.L.R.B. Union v. Fed. Lab. Rels. Auth., 834 F.2d 191, 195–97 (D.C. Cir. 1987) (same); Nat. Res. Def. Council v. Nuclear Regul. Comm’n, 666 F.2d 595, 601–03 (D.C. Cir. 1981) (same); Functional Music, Inc. v. F.C.C., 274 F.2d 543, 546–47 (D.C. Cir. 1958) (same); Eagle-Picher 22 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 23 of 27 Likewise, in GHS HMO, the issue was not whether a party could raise a new legal issue on appeal but whether contractors could object to a mandatory contract provision, incorporating an invalid regulation, after contract award and performance (which we ruled they could). GHS HMO, 76 Fed. Cl. at 368–72. Moreover, the general rule petitioner cites from that case pertaining to waiver is limited to contract law: “if government officials make a contract they are not authorized to make, in violation of a law enacted for the contractor’s protection, the contractor is not bound by estoppel, acquiescence, or failure to protest.” Id. at 370. Furthermore, our reasoning for that case partly relied on the fact that the plaintiffs’ objections to the contract provision at issue before award would have been futile, because the agency had already overridden similar objections from other interested parties in its rulemaking process. Id. at 372. Here, there is no indication that petitioner’s challenge to the fourth SIRVA QAI criterion would have been similarly futile before the Special Master.6 Petitioner next argues that, depending on the facts and circumstances of the case, we have discretion in deciding when to apply the waiver doctrine. Petitioner primarily relies on the Federal Circuit’s decision in Becton Dickinson & Co. v. C.R. Bard, Inc., 922 F.2d 792 (Fed. Cir. 1990). That case, however, is of no aid to petitioner. Petitioner specifically relies on the Federal Circuit’s language that the waiver doctrine “is, of course, not governed by a rigid rule but may as a matter of discretion not be adhered to where circumstances indicate that it would result in basically unfair procedure.” Id. at 800. The court in that case, however, decided not to apply its discretion to hear the unraised issue, noting that the plaintiff “had a full opportunity” to raise the issue before the lower court, but “[i]t chose not to do so.” Id. at 800. As in Becton Dickinson, we decline to hear petitioner’s statutory authority Indus., Inc. v. U.S. E.P.A., 759 F.2d 905, 911–19 (D.C. Cir. 1985) (addressing whether petitioner’s challenge was either moot or barred by a statutory review period). 6 Petitioner also briefly argues in her reply brief that she had “no reason to focus on the illegitimacy of the offending language in 42 C.F.R. § 100.3(c)(10)(iv), because there was no indication that the Special Master would rule against her on that basis.” Pet’r’s Reply Br. at 4. Petitioner’s obligation, however, was to either meet the regulatory test or challenge its application. She chose only to do the former, and it is now too late to choose the latter on review. 23 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 24 of 27 argument, because there is nothing in the record to suggest petitioner did not have a full opportunity to raise it before the Special Master.7 In sum, in accordance with longstanding precedent, as well as the rules of this court, petitioner has waived her argument regarding the validity of the fourth SIRVA QAI criterion, and we thus decline to address it.8 Because we find that waiver applies, we need not address respondent’s other counterarguments on the issue. III. The Special Master did not Err in His Application of Althen Petitioner next argues that the Special Master’s application of Althen was flawed under both prongs one and two. Petitioner’s prong one argument is that the Special Master erred in rejecting petitioner’s medical theory by requiring petitioner to support her theory with medical literature. Respondent counters that the Special Master did not require petitioner to support her 7 Petitioner also relies on the Federal Circuit’s decision in Ericsson Inc. v. TCL Commc’n Tech. Holdings Ltd., 955 F.3d 1317 (Fed. Cir. 2020). The issue in that case was whether an argument raised and denied before this court on summary judgment but not raised in a subsequent motion for judgment as a matter of law could be heard on appeal. Id. at 1320–21. The Federal Circuit decided not to apply the waiver doctrine to the appellant’s argument, noting that “this is not a typical waiver scenario in which we are asked to ‘consider an issue not passed upon below’” and placed significant weight in the fact that “the issue . . . was fully briefed, argued, and decided below.” Id. at 1322 (quoting Singleton v. Wulff, 428 U.S. 106, 120 (1976)). Contrary to Ericcson, petitioner does not raise an already argued issue on appeal—but a completely new issue. 8 Petitioner argues at the end of her reply brief that “principles of fundamental fairness” must be applied by the court when weighing the application of the waiver doctrine. It is clear, however, that the “principles of fundamental fairness” petitioner relies on apply to the admission of evidence. Horner for Horner v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 23, 26–29 (1996) (holding principles of fundamental fairness required reopening the evidentiary record to consider “newly found” evidence); see also Vaccine Rule 8(b)(1) (“In receiving evidence, the special master . . . must consider all relevant and reliable evidence governed by principles of fundamental fairness to both parties.”). No such evidentiary admissibility concern exists here. 24 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 25 of 27 medical theory with medical literature, but “thoroughly and thoughtfully analyzed the medical literature provided and determined that the record evidence failed to support petitioner’s theory.” Resp’t’s Resp. Br. at 16. We agree with respondent. To establish actual causation, petitioner must first “show a medical theory causally connecting the vaccination and the injury.” Althen, 418 F.3d at 1278 (internal citation omitted). The medical theory must demonstrate a “‘logical sequence of cause and effect’ . . . supported by ‘reputable medical or scientific explanation[,]’ i.e., ‘evidence in the form of scientific studies or expert medical testimony.’” Id. (quoting Grant v. Sec'y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed.Cir.1992)). A medical theory “need only be ‘legally probable, not medically or scientifically certain.” Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010) (quoting Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543, 548–49 (Fed.Cir.1994)). Likewise, a petitioner is “not required to show that the theory is generally accepted, and [s]he may demonstrate h[er] theory without resort to medical literature or epidemiological studies.” Bechel v. Sec'y of Health & Hum. Servs., 168 Fed. Cl. 602, 617 (2023); see also Althen, 418 F.3d at 1280 (“[B]y requiring medical literature, it contravenes section 300aa-13(a)(1)’s allowance of medical opinion as proof.”). We note, however, that “the medical theory must nonetheless be sound and reliable for a petitioner to prevail,” and the special master’s evaluation of a petitioner’s medical theory “is both a fact-specific inquiry and an exercise of his or her judgment to determine the relative weight of the evidence presented ‘in a field bereft of complete and direct proof of how vaccines affect the human body.’” Bechel, 168 Fed. Cl. at 618 (quoting Althen, 418 F.3d at 1280). Petitioner’s medical theory is that the inadvertent administration of the flu vaccine near her subacromial bursa resulted in inflammation, leading to bursitis in that area, which subsequently triggered symptoms in petitioner’s pre-existing yet asymptomatic osteoarthritis in her glenohumeral joint. In support of this theory, petitioner cites, in part, SIRVA injury claim statistics between 2010 and 2016, as well as the 1962 Dumonde study linking the injection of antigenic material in rabbits to the development of arthritis. Regarding petitioner’s use of medical literature, we do not find that the Special Master required petitioner to resort to medical literature in establishing her medical theory, but, rather, that the Special Master reviewed the medical literature submitted by petitioner and determined that it did not support petitioner’s theory. 25 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 26 of 27 In his decision, Special Master Horner was unconvinced by the SIRVA claim statistics petitioner cites, as those statistics only show that 5.2% of SIRVA claims between 2010 and 2016 showed MRI findings of glenohumeral arthritis. Additionally, the authors of that publication noted that many of the recorded MRI findings, including for glenohumeral arthritis, “are common in patients with and without shoulder pain and may not be related to vaccination.” Ex. 12, Tab K at 6. We cannot say the Special Master erred in concluding that these statistics show no more than incidental findings of osteoarthritis. Nor was the Special Master unreasonable in discounting the Dumonde study. The study was conducted over 60 years ago, and even Dr. Srikumaran acknowledged that it “is the only study of its kind to demonstrate production of arthritis as the result of antigenic material.” Ex. 14 at 4. Even assuming the reliability of the Dumonde study, Special Master Horner correctly points out that the authors of the study state that the induced arthritis bears a “striking” resemblance to rheumatoid arthritis, which is a distinct condition from the osteoarthritis suffered by petitioner. Ex. 12, Tab G at 16. Moreover, the Special Master determined that Dr. Srikumaran’s medical theory does not sufficiently link the flu vaccination to petitioner’s shoulder injury. He found that Dr. Srikumaran’s medical theory does not account for the fact that, because the rotator cuff operates as a barrier between the subacromial bursa (injection site) and the glenohumeral joint (osteoarthritis site), it is unlikely that, even if petitioner experienced inflammation at the injection site, that inflammation would have spread to the glenohumeral joint, thereby aggravating petitioner’s preexisting osteoarthritis. Given that petitioner’s medical records show that she had an intact rotator cuff, it was not unreasonable for the Special Master to conclude that petitioner’s medical theory failed to causally connect the vaccination to her injury. Because the Special Master correctly applied prong one, and because the petitioner must establish all three Althen prongs to succeed on her actual causation claim, we need not address the parties’ arguments under prong two. CONCLUSION Overall, petitioner has failed to establish that the Special Master’s decision was not in accordance with law. Because petitioner failed to raise her statutory authority argument before the Special Master, we find that argument waived. We also do not find that the Special Master erred in his 26 Case 1:21-vv-02133-EGB Document 50 Filed 12/09/25 Page 27 of 27 application of Althen. As a result, we deny petitioner’s motion for review and affirm the decision below. The Clerk of Court is directed to enter judgment accordingly. s/Eric G. Bruggink ERIC G. BRUGGINK Senior Judge 27