VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-01003 Package ID: USCOURTS-cofc-1_21-vv-01003 Petitioner: Evelyn Gonzalez Filed: 2021-02-26 Decided: 2024-11-08 Vaccine: meningococcal conjugate Vaccination date: 2019-07-30 Condition: right shoulder injury related to vaccine administration (SIRVA) Outcome: denied Award amount USD: AI-assisted case summary: Evelyn Gonzalez, an 18-year-old, filed a petition for compensation under the National Vaccine Injury Compensation Program on February 26, 2021, alleging that a meningococcal conjugate vaccine administered on July 30, 2019, caused a right shoulder injury related to vaccine administration (SIRVA). Ms. Gonzalez claimed immediate and persistent pain following the vaccination, which worsened as she began playing college volleyball. She sought treatment and was diagnosed with SIRVA, bursitis, and tendinopathy. The case proceeded as a Table claim, with the central issue being whether her injury met the Vaccine Act's severity requirement of lasting more than six months. Respondent argued that medical records from November 2019 indicated Ms. Gonzalez had returned to normal activity and had no complaints of shoulder pain, and that there was a significant gap in treatment until September 2020. Respondent further contended that renewed pain in September 2020 was likely due to a new athletic injury sustained while serving a volleyball. The Chief Special Master agreed, finding that Ms. Gonzalez's shoulder pain appeared to have resolved by August 2019 and that the subsequent pain was likely due to an athletic injury, thus failing to meet the six-month severity requirement. Ms. Gonzalez sought review of this decision, arguing that the Chief Special Master failed to consider all evidence, including her affidavit and an expert's opinion. The reviewing court affirmed the dismissal, finding the Chief Special Master's decision was not arbitrary and capricious, as he had considered the relevant evidence and rationally concluded that the injury did not meet the six-month severity requirement. The court noted that while Ms. Gonzalez claimed continued pain and sought treatment for other ailments, the contemporaneous medical records, particularly those from athletic trainers indicating a return to normal activity and a subsequent athletic injury, carried more weight. The court found that the evidence did not preponderate in favor of a finding that the SIRVA injury continued for more than six months. Theory of causation field: Petitioner Evelyn Gonzalez, age 18, received a meningococcal conjugate vaccine on July 30, 2019. She alleged a right shoulder injury related to vaccine administration (SIRVA). The case was filed under the National Vaccine Injury Compensation Program. The core issue was whether the injury met the Vaccine Act's severity requirement of lasting more than six months. Respondent argued that medical records from November 2019 indicated a return to normal activity and no complaints of shoulder pain, with a subsequent gap in treatment until September 2020, and that renewed pain in September 2020 was likely due to an athletic injury. The Chief Special Master dismissed the petition, finding the injury did not persist for more than six months, a finding affirmed by the reviewing court. The court found the Chief Special Master's decision was not arbitrary and capricious, giving weight to contemporaneous medical records indicating a return to normal activity and a subsequent athletic injury, despite petitioner's affidavit and Dr. Peter Chalmers' opinion suggesting continued symptoms. No specific mechanism of injury was detailed in the public decision. The petition was denied. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_21-vv-01003-0 Date issued/filed: 2024-06-07 Pages: 11 Docket text: PUBLIC DECISION (Originally filed: 05/06/2024) regarding 34 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (tlf) Service on parties made. -------------------------------------------------------------------------------- Case 1:21-vv-01003-KCD Document 37 Filed 06/07/24 Page 1 of 11 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 21-1003V EVELYN GONZALEZ, Chief Special Master Corcoran Petitioner, v. Filed: May 6, 2024 SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Jonathan Joseph Svitak, Shannon Law Group, P.C., Woodridge, IL, for Petitioner. James Vincent Lopez, U.S. Department of Justice, Washington, DC, for Respondent. DECISION DISMISSING PETITION1 On June 13, 2022, Evelyn Gonzalez filed an amended petition2 for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.3 (the “Vaccine Act”). Petitioner alleges that she suffered a right shoulder injury related to vaccine administration (“SIRVA”) as a result of a meningococcal conjugate vaccine she received on July 30, 2019. Amended Petition at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters. 1 Because this unpublished Decision contains a reasoned explanation for the action in this case, I am required to post it on the United States Court of Federal Claims' website in accordance with the E- Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), 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 Petitioner filed the original petition on February 26, 2021. 3 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:21-vv-01003-KCD Document 37 Filed 06/07/24 Page 2 of 11 For the reasons discussed below, I find that Petitioner cannot show she suffered the residual effects of her right-sided shoulder injury for more than six months – and therefore the Petition warrants dismissal, since all Vaccine Act claims must meet the severity requirement. I. Relevant Procedural History Ms. Gonzalez filed the first version of her petition and medical record exhibits on February 26, 2021, with an amended Petition in June 2022. ECF Nos. 1, 22-23. On November 7, 2022, after reviewing the records in the case, Respondent filed his report pursuant to Vaccine Rule 4(c) and a Motion to Dismiss. ECF Nos. 28-29. Respondent argued therein that Petitioner had not shown that the symptoms from her injury lasted for more than six months. Rule 4(c) Report at 10. Respondent noted that just three and a half months after vaccination, Ms. Gonzalez was evaluated by athletic trainer Olivia Hartman, ATC, at NEU Sports Medicine. Ex. 3 at 2. The athletic trainer noted Petitioner had “been back to normal activity” since August 24, 2019, and had “not complained of any shoulder pain or decreased ROM.” Id. The treatment note related to Petitioner’s shoulder was closed at that time. Id. Then for the next approximately 10 months, from November 12, 2019, to September 30, 2020, there is no record of Petitioner receiving treatment for her right shoulder. Additionally, Respondent argued, onset of Ms. Gonzalez’s right shoulder pain in September 2020 was not SIRVA-related, but rather the result of a new injury that occurred while serving a volleyball at practice. Ex. 3 at 13. Thus, Petitioner’s shoulder pain appeared to have resolved in the summer of 2019 – and did not persist for the requisite six months after vaccination to establish the severity requirement under 42 U.S.C. § 300aa-11(c)(D)(i). Id. Petitioner filed a response to the Motion to Dismiss (“Response”) along with an affidavit from one of Ms. Gonzalez’s treating providers, Dr. Peter Chalmers, who stated that he believed Petitioner’s vaccine contributed to “some of the symptoms” she reported in early 2021. Ex. 14 at 1. The parties have briefed the issues in dispute (Motion to Dismiss and Rule 4(c) Report “Motion” and “Response”) and have requested that I issue a ruling. My findings are presented below. 2 Case 1:21-vv-01003-KCD Document 37 Filed 06/07/24 Page 3 of 11 II. Issue At issue is whether Petitioner continued to suffer the residual effects of the SIRVA for more than six months. 42 C.F.R. § 100.3(a) XV.B. (Meningococcal vaccines); Section 11(c)(1)(D)(i) (statutory six-month requirement). III. Authority Pursuant to Vaccine Act Section 13(a)(1)(A), a petitioner must prove, by a preponderance of the evidence, the matters required in the petition by Vaccine Act Section 11(c)(1). A special master must consider, but is not bound by, any diagnosis, conclusion, judgment, test result, report, or summary concerning the nature, causation, and aggravation of petitioner’s injury or illness that is contained in a medical record. Section 13(b)(1). “Medical records, in general, warrant consideration as trustworthy evidence. The records contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an extra premium. These records are also generally contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Accordingly, where medical records are clear, consistent, and complete, they should be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03- 1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule does not always apply. “Written records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent.” Murphy v. Sec’y of Health & Hum. Servs., No. 90-882V, 1991 WL 74931, *4 (Fed. Cl. Spec. Mstr. April 25, 1991), quoted with approval in decision denying review, 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed.Cir.1992)). And the Federal Circuit recently “reject[ed] as incorrect the presumption that medical records are accurate and complete as to all the patient’s physical conditions.” Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). The United States Court of Federal Claims has outlined four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person’s failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional’s failure to document everything reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v. Sec’y of Health & Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1335 (Fed. Cir. 2014). 3 Case 1:21-vv-01003-KCD Document 37 Filed 06/07/24 Page 4 of 11 The Court has also said that medical records may be outweighed by testimony that is given later in time that is “consistent, clear, cogent, and compelling.” Camery v. Sec’y of Health & Hum. Servs., 42 Fed. Cl. 381, 391 (1998) (citing Blutstein v. Sec’y of Health & Hum. Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering such fact testimony must also be determined. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). The special master is obligated to fully consider and compare the medical records, testimony, and all other “relevant and reliable evidence contained in the record.” La Londe, 110 Fed. Cl. at 204 (citing Section 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is within the special master’s discretion to determine whether to afford greater weight to medical records or to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such determination is rational). IV. Finding of Fact I make the findings after a complete review of the record to include all medical records, affidavits, Respondent’s Rule 4(c) report, and additional evidence filed. Specifically, I base the findings on the following evidence:  Petitioner’s medical history is unremarkable for any shoulder symptoms or injuries prior to the date of vaccination. See generally Ex. 10.  Petitioner (age 18) received an intramuscular meningococcal conjugate vaccine on July 30, 2019, at the office of her primary care provider located in Solana Beach, California. Ex. 10 at 190-95. The vaccination record states that the vaccine was administered in her right shoulder. Id. She received the vaccination in preparation for attending college as an incoming freshman at Northeastern University in Boston, Massachusetts. Ex. 3 at 2; Ex. 1 at 5.  Fifteen days after vaccination, on August 14, 2019, Ms. Gonzalez presented to sports medicine specialist Dr. Michael Beasley at the Boston Children’s Hospital, Sports Medicine Division for an initial evaluation for “[r]ight shoulder pain.” Ex. 2 at 4-5. Petitioner reported that “[s]he felt that the injection was higher than normal and had immediate pain upon administration of the injection. Since then[,], her pain [h]as persisted and gotten worse since she started playing volleyball at school…” Id. at 4. On exam, Ms. Gonzalez had tenderness to palpation of her right deltoid and 4 Case 1:21-vv-01003-KCD Document 37 Filed 06/07/24 Page 5 of 11 pain with abduction, flexion, and internal rotation of her right shoulder. Id. at 5. Dr. Beasley’s assessment stated “[w]e suspect that her pain is likely secondary to shoulder injury related to vaccine administration (SIRVA)[,] which is a well[-]recognized inflammatory response noted after administration of vaccines higher than normal in the deltoid region. . . . She does have some evidence of a possible nerve irritation from the administration of the vaccine given her symptoms of numbness and tingling.” Id. He ordered an MRI. Id.  On August 14, 2019, Ms. Gonzalez underwent an MRI of her right deltoid that showed a “[f]ocal complex fluid collection within the subdeltoid bursa, consistent with inflammatory bursitis,” and “[l]ow grade supraspinatus, infraspinatus, and subscapularis tendinopathy.” Ex. 2 at 7. Dr. Beasley reviewed the MRI that day and noted it “does seem to show subdeltoid bursitis likely consistent with an injury related to her shoulder immunization, and without significant evidence of other structural concerns.” Id. at 5.  On August 15, 2019, 16 days after vaccination, Ms. Gonzalez was evaluated by athletic trainer Kate Delude at Northeastern, who noted that “Patient is a freshman volleyball athlete. Prior to coming to campus[,] she received her mandatory meningitis [sic] immunization on 7/30/19. The operator injected her hitting shoulder. She reported that after the injection she ha[d] almost zero ROM in her shoulder. She now has almost full ROM but has pain. She sat out the first day of practice then played the next 3 days.” Ex. 2 at 7.  In an email from Dr. Beasley to the athletic trainer, Dr. Beasley advised that Ms. Gonzalez’s shoulder “looks as suspected like just inflammation from injection of subdeltoid bursa, surrounding tissue.” Id. Dr. Beasley’s recommendation was to limit Petitioner, as much as possible, from overhead activity and treat with ice. Id. The athletic trainer’s plan was for Ms. Gonzalez to “not participate in volleyball activities” and engage in bike conditioning and lower body lifting. Id.  On August 21, 2019, 22 days after vaccination, Ms. Delude again evaluated Ms. Gonzalez. Ex. 3 at 2. Ms. Gonzalez had been able to play volleyball that day with the restriction of no overhead activity. Id. She reported “one instance where she had pain but overall [said] she felt really good,” with “no pain after practice.” Id. The plan was to participate in practice again without overhead activity. Id. 5 Case 1:21-vv-01003-KCD Document 37 Filed 06/07/24 Page 6 of 11  On November 12, 2019, approximately three and a half months after vaccination, Ms. Gonzalez was evaluated by athletic trainer Olivia Hartman, ATC, at Northeastern University Sports Medicine. Ex. 3 at 2. Hs. Hartman noted, “Athlete has been back to normal activity since I came on as the volleyball athletic trainer 8/24. Athlete has not complained of any shoulder pain or decreased ROM. Note will be closed at this time.” Id.  For the next approximately 10 months, from November 12, 2019, to September 30, 2020, there is no record of Ms. Gonzalez receiving treatment of her right shoulder. In her affidavit, Ms. Gonzalez stated that “[w]hen [she] returned to [NEU] in January 2020 after the holiday break, [she] reported right shoulder pain, weakness and limited range of motion to [her] coach and trainers.” Ex. 1 at 3. She further stated in her affidavit that when she returned home in March 2020, due to Covid-19, she had “right shoulder pain when reaching, pulling, or lifting.” Id. She stated she took over-the-counter medications for pain, stretched, and iced her shoulder, and did home physical therapy. During this ten-month period, Ms. Gonzalez also had periodic follow ups with her primary care provider related to monitoring of isotretinoin therapy for acne and did not report any right shoulder issues. Ex. 10 at 141-88.  On September 30, 2020, approximately 14 months after vaccination, on September 30, 2020, Ms. Gonzalez had a virtual consultation with athletic trainer Mike McKenney, MS, ATC, at Northeastern University Sports Medicine. Ex. 3 at 13. Mr. McKenney noted Petitioner’s history as follows: “[she] believes she hurt her [r]ight shoulder last night during practice, her serving shoulder. She describes a very abbreviated warm-up prior to full serves that consisted of throwing the ball 3 times to a partner and then going into full serves. She was able to demonstrate almost full shoulder flexion and abduction overhead, but discomfort was present. . . . She has not been keeping up with the preventative exercises they were taught last year, but I advised she could continue with those if they were below the shoulder and not past neutral in [internal rotation]/[external rotation].” Petitioner was advised to follow up the next day for an in-person evaluation. Id.  On October 1, 2020, Ms. Gonzalez was evaluated in person by Mr. McKenney at Northeastern Sports Medicine for right shoulder pain. Ex. 3 at 12-13. On exam, she had full range of motion, but posterior pain with external rotation and flexion past 90 degrees. Id. There was no pain with palpation. Id. There was weakness with external rotation, but no other major strength deficit. Id. The assessment was that Petitioner “may have strained 6 Case 1:21-vv-01003-KCD Document 37 Filed 06/07/24 Page 7 of 11 the [internal rotation] group of her [rotator cuff].” Id. Ms. Gonzalez was advised regarding a home exercise program, and overhead volleyball hitting was restricted. Id.  From October 1, 2020, through November 11, 2020, Ms. Gonzalez continued to participate in volleyball practice, with activity restrictions, and received rehabilitation and therapy from the athletic trainers at Northeastern University Sports Medicine. Ex. 3 at 12.  On November 17, 2020, Ms. Gonzalez returned to Dr. Corrado, who suspected a “labral or rotator cuff pathology” and ordered an MRI arthrogram. Ex. 3 at 12.  On November 30, 2020, Ms. Gonzalez underwent a right shoulder MRI arthrogram at Tufts Medical Center that showed a “[f]ocal full thickness tear of the anterior fibers of the supraspinatus muscle” and a “[l]ow-grade articular surface fraying of the posterior fibers of the supraspinatus.” Ex. 2 at 11; Ex. 7 at 6-7.  On December 11, 2020, Ms. Gonzalez was evaluated by athletic trainer Christen Chiesa at Northeastern University Sports Medicine. Ex. 3 at 10-11. Petitioner had a history of “[right] shoulder pain since late September.” Id. Ms. Gonzalez reported that “she can think of a couple instances where this could have occurred, one of which was serving the volleyball.” Id. Petitioner had pain rated 1-7/10. Id. Her past medical history related to her shoulder included “subacromial bursitis.” Id.  Approximately 16 ½ months after vaccination, on December 14, 2020, orthopedic surgeon Dr. Ramappa evaluated Ms. Gonzalez at Beth Israel Deaconess Medical Center. Ex. 5 at 10-12. Dr. Ramappa noted Petitioner’s history: 20 year[-]old healthy volleyball player who presents with [right] shoulder pain that began in September 2020. She experienced pain during a serve and has since had difficulty controlling her arm. Her shoulder pain and weakness has worsened since the onset of the injury. She took 1.5 [weeks] off from volleyball, but she has been actively playing with her pain. She has not performed formal PT. Her pain is worsened with overhead activity and washing her hair. She has a history of shoulder bursitis. Id. On exam, Ms. Gonzalez had full ROM and strength, with pain and positive impingement signs. Id. Dr. Ramappa noted the prior MRI demonstrated “a partial thickness supraspinatus tear with intratendinous cyst.” Id. The assessment was “[right] shoulder impingement, partial thickness 7 Case 1:21-vv-01003-KCD Document 37 Filed 06/07/24 Page 8 of 11 [supraspinatus] tear.” Id. Dr. Ramappa and petitioner discussed different treatment options, and Petitioner elected to proceed with PT. Id.  From December 18, 2020, to January 30, 2021, Petitioner participated in additional rehabilitation and therapy from the athletic trainers at NEU Sports Medicine. Ex. 3 at 3-9.  On January 25, 2021, Ms. Gonzalez had a telephone consultation with Dr. Ramappa and reported continued pain in her shoulder despite attending PT. Ex. 5 at 13. Petitioner advised that she would follow up to discuss treatment options. Id.  Over a year and a half after vaccination, on February 4, 2021, Petitioner had a telehealth consultation with Peter Chalmers, M.D., a shoulder, and elbow specialist at the University of Utah Health Orthopedics Center. Ex. 6 at 154-56. Dr. Chalmers noted Petitioner’s right shoulder pain and stiffness “began in October [2020] associated with volleyball.” Id. He also noted Ms. Gonzalez “had some pain before due to a (meningococcal) vaccine in August of 2019.” Id. Petitioner denied “pain radiating down to the hand, neck pain, or numbness.” Id. The assessment was a “right partial thickness cuff tear and biceps tendonitis.” Id. Petitioner elected to proceed with surgery. Id.  On February 12, 2021, Ms. Gonzalez underwent a right shoulder arthroscopic debridement and biceps tenodesis, performed by Dr. Chalmers. Ex. 6 at 49-57. Dr. Chalmers’ operative findings included a type II superior labrum from anterior to posterior (“SLAP”) tear and posterosuperior fraying consistent with internal impingement. Id. There was also significant tenosynovitis in the humeral groove of the biceps tendon. Id.  On February 26, 2021, two weeks after surgery, Ms. Gonzalez had her initial post-operative PT session. Pet. Ex. 6 at 29-34. At this session, Petitioner reported the following history: “[Patient] [r]eports over the past 1.5 years [] off and on [right] shoulder pain associated with collegiate volleyball. [Patient] [r]eports an injection, rest through summer, injury in Oct 2020 with a serve and progressive symptoms of pain and episodes of drastic pain.” Id. at 29.  On March 4 and 12, 2021, Petitioner attended additional post-surgical PT sessions at the University of Utah Health Orthopedics Center. Ex. 6 at 15- 8 Case 1:21-vv-01003-KCD Document 37 Filed 06/07/24 Page 9 of 11 25. On March 4, 2021, Petitioner reported she felt like she had “turned a corner.” Id. at 22. On March 12, 2021, she reported “feeling better each week” and having no problems with her HEP. Id. at 15.  On April 4, 2021, Petitioner saw Dr. Chalmers for a post-operative consultation. Ex. 6 at 9-11. Petitioner was “[d]oing great so far” and her pain was well controlled. Id.  On April 26, 2021, Petitioner had an initial evaluation for PT at The Training Room in California. Ex. 11 at 107-11. Her reported pain was 0-5/10. Id. The goal was to return to volleyball during the August 2021 preseason. Id.  On May 20, 2021, three months after surgery, Ms. Gonzalez had a post- operative telehealth consultation with Dr. Chalmers regarding her right shoulder. Ex. 6 at 3-4. Petitioner was “[d]oing great” and her “pre-operative pain [was] resolved.” Id.  According to the most recent records filed as of July 17, 2021, Petitioner was still in PT at The Training Room, having completed 29 sessions. X. 11 at 20-22. V. Analysis - Six Month Sequela In order to state a claim under the Vaccine Act, a petitioner must establish the “severity” requirement demonstrating that the vaccinee has either: (i) suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the administration of the vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered such illness, disability, injury, or condition from the vaccine which resulted in inpatient hospitalization and surgical intervention. §11(c)(1)(D). In this case, to satisfy the Vaccine Act’s severity requirement, Ms. Gonzalez must show that she suffered symptoms of her alleged SIRVA beyond January 30, 2020. Respondent argues that Petitioner has failed to meet her burden on this point. In support, Respondent notes that on November 12, 2019 (approximately three and a half months after vaccination), Ms. Gonzalez was evaluated by athletic trainer Olivia Hartman, ATC, at NEU Sports Medicine who stated that Petitioner had “been back to normal activity” 9 Case 1:21-vv-01003-KCD Document 37 Filed 06/07/24 Page 10 of 11 since August 24, 2019, and had “not complained of any shoulder pain or decreased ROM.” Id. The treatment note related to Petitioner’s shoulder was closed at this time. Response at 9-10. Then for the next approximately ten months (from November 12, 2019, to September 30, 2020 – meaning past the severity “cutoff of late January 2020) there is no record of Petitioner receiving treatment for her right shoulder. Id. In effect, as Respondent argues, Ms. Gonzalez’s shoulder pain appears to have mostly resolved by August 2019. She thereafter had minimal treatment through November 2019, when she ceased medical care for the injury. During this time, Petitioner actively participated in the “intense condition” associated with playing Division I college volleyball. Ex. 9 at 19. Complaints of renewed pain after September 2020 seem more likely the product of an athletic injury. On September 30, 2020, for example, Petitioner’s athletic trainer noted that Ms. Gonzalez “believes she hurt her [r]ight shoulder last night during practice, her serving shoulder. . . . She has not been keeping up with the preventative exercises they were taught last year.” Ex. 3 at 13. From that date forward, Ms. Gonzalez’s right shoulder symptoms are consistently associated with playing volleyball. Ex. 3 at 13 (On October 1, 2020, athletic trainer Mike McKenney’s assessment was that Petitioner “may have strained the [internal rotation] group of her [rotator cuff].”); Ex. 3 at 10-11 (On December 11, 2020, athletic trainer Christen Chiesa noted Petitioner’s history of “[right] shoulder pain since late September,” and Petitioner reported “she can think of a couple instances where this could have occurred, one of which was serving the volleyball”); Ex. 5 at 10-12 (On December 14, 2020, orthopedic surgeon Dr. Ramappa noted Petitioner’s history of “[right] shoulder pain that began in September 2020,” which was attributed to a serve); Ex. 6 at 154-56 (On February 4, 2021, shoulder and elbow specialist Dr. Chalmers noted Petitioner’s history of right shoulder pain and stiffness that “began in October [sic] [2020] associated with volley[]ball”); id. at 29-34 (On February 26, 2021, at an initial PT evaluation, Petitioner reported an “injury in Oct[ober] [sic] 2020 with a serve and progressive symptoms of pain and episodes of drastic pain”). There is no mention in any of these notes of a vaccine-related injury. Thus, the initial 10-month treatment gap from November 12, 2019, to September 30, 2020, is the most pertinent period of time for evaluation of the six-month severity requirement. In many cases, a treatment gap that overlaps with the deadline for the six-month severity “endpoint,” measured from the date of onset, does not bar a finding of severity. See e.g., Law v. Sec'y of Health & Hum. Servs., No. 21-0699V, 2023 WL 2641502, at *5 (Fed. Cl. Mar. 27, 2023); Kilgore v. Sec'y of Health & Hum. Servs., No. 21-1390V, 2023 WL 7130175, at *6 (Fed. Cl. Sept. 29, 2023); Grieshop v. Sec'y of Health & Human Servs., No. 14-119, 2015 WL 4557620, at *5–6 (Fed. Cl. Spec. Mstr. June 5, 2015). A failure to seek treatment during such a gap does not inherently mean an individual’s SIRVA-related pain has ceased, since claimants often live with the pain, based upon the expectation it 10 Case 1:21-vv-01003-KCD Document 37 Filed 06/07/24 Page 11 of 11 will subside, or because of the reasonable desire to avoid unnecessary treatment. Claimants also may in that timeframe see medical professionals for unrelated concerns, where they would not logically mention an unrelated physical issue. See e.g., Rowe v. Sec'y of Health & Hum. Servs., No. 17-1182V, 2020 WL 6281742, at *3 (Fed. Cl. Sept. 24, 2020). And the length of the gap also bears on how much weight it should be given. Here, however, the mix of evidence preponderates against a favorable severity finding. In particular, I give weight to the fact that the Petitioner was able to engage in a strenuous exercise program associated with playing college volleyball despite her pain (activity that would reasonably be expected to prove difficult to perform for anyone, but especially an individual with a persistent shoulder injury). Moreover, after this training, Petitioner obtained treatment on several occasions for pain impacting her elsewhere in her body – but not for her shoulder. See e.g., Ex. 10 at 141-88. This not only suggests the shoulder was not then an issue, but also that she had the opportunity to seek treatment – and did so readily for issues bothering her. And finally, the gap itself, and what transpired during it, allows for other factors to have caused the pain to return – independent of the vaccination. All of the above is unsupportive of severity in this case. Accordingly, the record does not preponderate in favor of the conclusion that Petitioner’s SIRVA likely continued during this gap – and thus Petitioner cannot establish that she suffered the residual effects of her left shoulder injury for more than six months. VI. CONCLUSION Under the Vaccine Act, to be compensable, the vaccine injury alleged must either persist for more than six months or require inpatient hospitalization and surgical intervention. § 11(c)(1)(D)(i). In this case, the record does not contain medical records or a medical opinion sufficient to demonstrate that Petitioner is entitled to compensation. For these reasons, Petitioner’s claim for compensation is denied and this case is dismissed. The Clerk shall enter judgment accordingly.4 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 4 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing the right to seek review. 11 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_21-vv-01003-1 Date issued/filed: 2024-11-08 Pages: 19 Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) re: 39 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Judge Kathryn C. Davis. (jg) Service on parties made. -------------------------------------------------------------------------------- Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 1 of 19 IN THE UNITED STATES COURT OF FEDERAL CLAIMS ___________________________________ ) EVELYN GONZALEZ, ) ) Petitioner, ) No. 21-1003 ) v. ) Filed: October 24, 2024 ) SECRETARY OF HEALTH AND ) Re-issued: November 8, 2024* HUMAN SERVICES, ) ) Respondent. ) ___________________________________ ) OPINION AND ORDER Petitioner Evelyn Gonzalez seeks review of a decision dismissing her petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq. (“Vaccine Act”). Ms. Gonzalez alleges that she suffered a shoulder injury caused by the administration of a meningococcal vaccine (“meningitis vaccine”). On May 6, 2024, the Chief Special Master denied Ms. Gonzalez’s claim and dismissed her petition, finding that she had not established by a preponderance of evidence that her injury lasted long enough to meet the severity requirement under the Vaccine Act. In accordance with Rules 23 and 24 of the Vaccine Rules of the United States Court of Federal Claims (“Vaccine Rules”), Ms. Gonzalez filed a Motion for Review of the Chief Special Master’s Decision Dismissing Petition. For the reasons discussed below, the Chief Special Master’s decision was not arbitrary and capricious or contrary to law. Therefore, the Court DENIES Ms. Gonzalez’s Motion. * The Court issued this opinion under seal on October 24, 2024, and directed the parties to file any proposed redactions by November 7, 2024. As the parties do not propose any redactions, the Court reissues the opinion publicly in full. Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 2 of 19 I. BACKGROUND A. Ms. Gonzalez’s Medical History, Onset of Symptoms, and Diagnosis On July 30, 2019, when Ms. Gonzalez was 18 years old, she received a meningitis vaccine in her right deltoid.1 Pet’r’s Ex. 10 at 193, ECF No. 14-1. In an affidavit, she states that before receiving the vaccination, she had “no history of pain, inflammation or dysfunction in [her] right shoulder.” Pet’r’s Ex. 1 ¶ 6, ECF No. 1-3. At the time of vaccination, she had been preparing for her freshman year at Northeastern University in Boston, where she would be a member of the women’s volleyball team. Id. ¶ 9. Ms. Gonzalez claims that upon receiving the vaccine, she felt “immediate severe pain” in her right shoulder that was so acute she thought she would faint. Id. ¶ 5. She reports that she was unable to sleep that night due to the pain. Id. ¶ 7. When Ms. Gonzalez arrived at Northeastern, she missed the first several volleyball practices due to shoulder pain. Id. ¶¶ 10–11. On August 14, 2019, she visited the team physician at Boston Children’s Hospital and was seen by Dr. Michael Beasley. Id. ¶ 12. Dr. Beasley examined her right shoulder and ordered an MRI. Id. Based on the examination, he suspected that her shoulder was inflamed due to “shoulder injury related to vaccine administration (SIRVA),” which is “a well recognized inflammatory response noted after administration of vaccines higher than normal in the deltoid region.” Pet’r’s Ex. 2 at 5, ECF No. 1-4. According to an MRI specialist, the MRI scan demonstrated a “focal fluid collection deep to the lateral aspect of the deltoid” that appeared to be “within the subdeltoid bursa.” Id. at 7. The specialist also noted that the right shoulder had “mild to moderate tendinosis of the supraspinatus tendon, without a partial or full thickness tear,” as well as “mild tendinosis of the 1 Ms. Gonzalez also received a human papillomavirus (“HPV”) vaccine on the same date. Pet’r’s Ex. 10 at 193, ECF No. 14-1. The HPV vaccine, however, is not at issue in this case. 2 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 3 of 19 infraspinatus and subscapularis tendons.”2 Id. Dr. Beasley recommended that Ms. Gonzalez continue physical therapy with the team trainers and refrain from overhead activity. ECF No. 1- 3 ¶ 12. B. Initial Treatment, Continued Symptoms, and Follow-up Treatment Following Dr. Beasley’s instructions, Ms. Gonzalez returned to the team trainers and began therapy exercises. Id. ¶ 14. On August 21, 2019, 22 days after vaccination, she returned to practice but did not do any overhead activity. Id. ¶ 15. That same day, team trainer Kate Delude evaluated Ms. Gonzalez. Pet’r’s Ex. 3 at 2, ECF No. 1-5. The trainer noted that Ms. Gonzalez participated in volleyball practice that day and reported “one instance where she had pain but overall [said] she felt really good,” with “no pain after practice.” Id. By the end of August, her pain had improved slightly, and she played volleyball and participated in practices “despite continued pain and discomfort.” ECF No. 1-3 ¶ 16. Toward the end of the season, however, Ms. Gonzalez stated that her shoulder weakened and became “more and more painful.” Id. Even so, on November 12, 2019, approximately three and a half months after vaccination, team trainer Olivia Hartman evaluated Ms. Gonzalez and noted, “Athlete has been back to normal activity since I came on as the volleyball athletic trainer 8/24. Athlete has not complained of any shoulder pain or decreased [range of motion].” ECF No. 1-5 at 2. The season ended later that month, and Ms. Gonzalez returned home to Solana Beach, California, for winter break. Pet’r’s Ex. 12 ¶ 10, ECF No. 31-1. While home, Ms. Gonzalez visited her primary care doctor for additional vaccines but, according to Ms. Gonzalez, requested that she receive them in her thigh because her right shoulder was still in pain. ECF No. 14-1 at 2 A “bursa” is defined as “a sac or sac-like cavity filled with a viscid fluid and situated at places in the tissues at which friction would otherwise develop.” Bursa, Dorland’s Medical Dictionary 258 (33d ed. 2020). “Tendinosis” is defined as “any pathologic condition of a tendon.” Id. at 1852. 3 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 4 of 19 65; ECF No. 31-1 ¶ 10. Ms. Gonzalez further reports that when she returned to Northeastern in January 2020, she told the team trainers that she was still experiencing pain and discomfort. ECF No. 31-1 ¶ 11. She planned to perform daily resistance band exercises to strengthen her shoulder. Id. When Northeastern’s campus closed in March 2020 due to the COVID-19 pandemic, Ms. Gonzalez again returned home to California. Id. ¶ 12. While home, she did not play volleyball. Id. She instead rested and performed a daily stretching, icing, and heating regimen. Id. Returning to campus in August 2020, she played volleyball until the end of September. Id. ¶¶ 14–15. However, on September 29, 2020, she informed the trainers that she felt a “sharp pain” in her right shoulder during team service drills. Id. ¶ 15. The trainers worked with her on therapy and stretching exercises for two months before recommending that she see the team physician at Boston Children’s Hospital. Id. The team physician, Dr. Gian-Michel Corrado, examined Ms. Gonzalez, noting that her “pain began insidiously in the context of being a hitting volleyball player.” Pet’r’s Ex. 13 at 13, ECF No. 31-2. Of the “multitude” of possible causes, “the most concerning” to Dr. Corrado was a “labral tear or rotator cuff tear.” Id. Dr. Corrado ordered an MRI. Id.; see ECF No. 1-3 ¶ 22. At a follow-up appointment on December 7, 2020, Dr. Corrado explained that the MRI showed a rotator cuff tear and recommended that Ms. Gonzalez see a shoulder specialist. Id. ¶ 24; see ECF No. 1-4 at 13; ECF No. 31-2 at 11. Ms. Gonzalez then saw specialist Dr. Arun Ramappa at Beth Israel Deaconess Medical Center on December 14, 2020. ECF No. 31-1 ¶ 17. After reviewing the MRI results, Dr. Ramappa recommended physical therapy. Id. Not seeing improvement after several months of therapy, on February 4, 2021, Ms. Gonzalez sought a second opinion from Dr. Peter Chalmers at the University of Utah Orthopaedics Center. Id. ¶ 19. Dr. Chalmers, an orthopedic surgeon, 4 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 5 of 19 examined her, reviewed her MRI, and recommended surgery. Pet’r’s Ex. 6 at 156, ECF No. 10- 1. On February 12, 2021, Dr. Chalmers performed the surgery, an outpatient procedure comprised of a “right shoulder arthroscopic extensive intraarticular debridement,” id. at 53, including a “subacromial bursectomy,” id. at 55; debridement of an “area of bursa on the bursal side of the anterior supraspinatus,” id.; and a “right open biceps tenodesis,” id. at 53. Dr. Chalmers provided an affidavit for purposes of the litigation stating that Ms. Gonzalez’s immunization injury “more likely than not” contributed to the symptoms that she reported to him in February 2021. Pet’r’s Ex. 14 ¶ 6, ECF No. 33-1. C. Procedural History On February 26, 2021, Ms. Gonzalez filed a petition with the Office of Special Masters seeking compensation under the Vaccine Act, 42 U.S.C. § 300aa-11(c). Pet. at 1, ECF No. 1. She alleged that the administration of the HPV vaccine, the meningitis vaccine, or both, caused her to develop SIRVA. Id. Ms. Gonzalez filed an amended petition in June 2022, clarifying her factual assertions and narrowing her claim to the meningitis vaccine. Am. Pet. at 1, ECF No. 23- 1. On November 7, 2022, Respondent filed his Rule 4(c) report and moved to dismiss the case, arguing that Ms. Gonzalez failed to demonstrate that her injury lasted for more than six months, as is necessary to meet the Vaccine Act’s “severity” requirement. See Resp’t’s Mot. to Dismiss, ECF No. 28; Resp’t’s Rule 4(c) Report, ECF No. 29. Ms. Gonzalez filed a response on December 23, 2022, asserting that the record shows her symptoms persisted throughout the 2019 volleyball season and into 2020, as she applied ice and heat treatments, took over-the-counter pain medications, and continued to experience pain during the offseason. Pet’r’s Resp. to Resp’t’s Mot. to Dismiss at 9–10, ECF No. 32. She also filed additional medical records, a 5 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 6 of 19 supplemental affidavit, and the affidavit from Dr. Chalmers. See Pet’r’s Ex. 7–9, ECF No. 12; ECF No. 14; ECF No. 31-1; ECF No. 33-1. D. The Entitlement Decision On May 6, 2024, the Chief Special Master issued his Decision Dismissing Petition, denying Ms. Gonzalez’s request for compensation and dismissing her case. Dec. Dismissing Pet. at 1–2, ECF No. 34. The Chief Special Master held that Ms. Gonzalez had not met her burden of showing that she suffered the residual effects of SIRVA for more than six months and that, under the Vaccine Act’s severity requirement, her petition must therefore be dismissed. Id.; see 42 U.S.C. §§ 300aa-11(c)(1), 300aa-13(a)(1)(A). In reaching his decision, the Chief Special Master stated that he reviewed the complete record, including all medical records, affidavits, Respondent’s Rule 4(c) report, and additional evidence filed. ECF No. 34 at 4. He summarized the statutory severity requirement, which a petitioner must meet to state a claim for compensation under the Vaccine Act, explaining that Ms. Gonzalez had to demonstrate that she either: (i) suffered the residual effects or complications of the injury for more than six months after receiving the vaccine, (ii) died from receiving the vaccine, or (iii) suffered an injury from the vaccine that resulted in inpatient hospitalization and surgical intervention. Id. at 9 (citing 42 U.S.C. § 300aa-11(c)(1)(D)). The Chief Special Master then considered Ms. Gonzalez’s allegation that she suffered residual effects or complications of SIRVA for more than six months. See id. at 2. In this case, given the date of vaccination, Ms. Gonzalez needed to show that she suffered SIRVA symptoms beyond January 30, 2020. Id. at 9. The Chief Special Master noted that Ms. Gonzalez was evaluated on November 12, 2019, by a team trainer who stated that Ms. Gonzalez had “been back to normal activity” since August 24, 2019, and had “not complained of any shoulder pain or 6 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 7 of 19 decreased [range of motion].” Id. at 9–10 (citation omitted). He also noted that Ms. Gonzalez had minimal treatment through November 2019, when she ceased medical care for the injury. Id. at 10. Additionally, for the next 10 months, through September 2020, there is no record of Ms. Gonzalez receiving any treatment for her right shoulder. Id. As to the pain complained of in September 2020, the Chief Special Master observed that on September 30, 2020, the team trainer stated that Ms. Gonzalez “believes she hurt her [r]ight shoulder last night during practice, her serving shoulder . . . . She has not been keeping up with the preventative exercises they were taught last year.” Id. (citation omitted). He also noted that from “that date forward, Ms. Gonzalez’s right shoulder symptoms are consistently associated with playing volleyball.” Id. (citation omitted). Moreover, the Chief Special Master emphasized that in the six months following her vaccination Ms. Gonzalez was able to engage in a “strenuous exercise program” despite her pain and that she obtained treatment on multiple occasions for pain in areas other than her shoulder. Id. at 11. He therefore concluded that her “shoulder pain appears to have mostly resolved by August 2019” and that complaints of “renewed pain after September 2020 seem more likely the product of an athletic injury.” Id. at 10. The Chief Special Master acknowledged that a treatment gap does not bar a finding of severity but found that, here, “the mix of evidence preponderates against a favorable severity finding.” Id. at 10–11. E. The Motion for Review On June 4, 2024, Ms. Gonzalez timely filed a Motion for Review of the Chief Special Master’s Decision Dismissing Petition. Pet’r’s Mot. for Review at 1, ECF No. 35-1. Ms. Gonzalez asks the Court to set aside any of the Chief Special Master’s findings of fact and conclusions of law that are arbitrary, capricious, an abuse of discretion, or otherwise not in 7 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 8 of 19 accordance with law, and issue its own findings of fact and conclusions of law or remand the petition to the Chief Special Master for further proceedings. Id. Specifically, Ms. Gonzalez claims that the Chief Special Master erred by failing to consider the entire record, especially Ms. Gonzalez’s affidavit testimony averring that (a) she felt immense pressure to return to playing volleyball and played through her shoulder pain and discomfort until the season ended in November 2019, and that (b) in December 2019 she visited her primary care physician for a vaccine and asked to receive it in her thigh instead of her arm due to continuing shoulder pain. Id. at 8. She further claims that the Chief Special Master failed to consider Dr. Chalmers’ affidavit testimony and opinion that Ms. Gonzalez’s SIRVA contributed to the symptoms she suffered from in February 2021 prior to surgery, and he failed to compare her August 2019 MRI with her November 2020 MRI, which she argues show consistent findings and support Dr. Chalmers’ opinion. Id. at 8, 9. Moreover, Ms. Gonzalez claims that the Chief Special Master placed undue emphasis on notes from a team trainer stating that Ms. Gonzalez had “been back to normal activity” by August 2019 and “had not complained of any shoulder pain,” despite the fact that the contrary evidence just discussed undercut the finding that she was symptom-free in November 2019. Id. at 9. On June 27, 2024, Respondent filed his response to Ms. Gonzalez’s Motion for Review, arguing that the Chief Special Master’s decision should be affirmed because, under the deferential standard of review, Ms. Gonzalez has not shown that the decision was arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with law. Resp’t’s Resp. to Pet’r’s Mot. for Review at 1, 18, ECF No. 38. The decision should be upheld, Respondent argues, because the Chief Special Master’s findings are supported by ample record evidence. 8 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 9 of 19 II. LEGAL STANDARD A. The Court’s Standard of Review This Court has jurisdiction to review a special master’s entitlement decision upon the timely request of either party. 42 U.S.C. § 300aa-12(e)(2). Under the Vaccine Act, a court deciding a motion for review may: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or (C) remand the petition to the special master for further action in accordance with the court’s direction. Id. §§ 300aa-12(e)(2)(A)–(C); accord Vaccine Rule 27(a)–(c). The three standards of review in 42 U.S.C. § 300aa-12(e)(2)(B) “vary in application as well as degree of deference,” as each standard “applies to a different aspect of the judgment.” Munn v. Sec’y of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). When reviewing the special master’s factual findings, the Court applies the arbitrary and capricious standard. The scope of review is thus limited and highly deferential. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000); see Munn, 970 F.2d at 870 (review of a special master’s factual findings is “well understood to be the most deferential possible” (citations omitted)); see also Dougherty v. Sec’y of Health & Hum. Servs., 141 Fed. Cl. 223, 229 (2018) (“[S]pecial masters have broad discretion to weigh evidence and make factual determinations.”). The Court does “not reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses—these are all matters within the purview of the fact finder.” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011). In other words, the 9 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 10 of 19 Court should not “second guess the Special Master[’]s fact-intensive conclusions.” Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010) (quotations omitted) (quoting Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)). “If the special master has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely difficult to demonstrate.” Hines ex rel. Sevier v. Sec’y of Health & Hum. Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991). However, when a question of law is at issue—for example, a special master’s interpretation of the Vaccine Act—the Court applies the “not in accordance with law” standard, which is de novo review. See id. at 1527; Sanchez ex rel. Sanchez v. Sec’y of Health & Hum. Servs., 34 F.4th 1350, 1353 (Fed. Cir. 2022). The third and final standard of review, abuse of discretion, applies when the special master excludes evidence or otherwise limits the record upon which he relies. See Munn, 970 F.2d at 870 n.10. B. Burden of Proof for a Table Injury A petitioner may establish that a vaccine caused an alleged injury in one of two ways. See 42 U.S.C. § 300aa-11(c); Munn, 970 F.2d at 865. First, a petitioner who has received a vaccine listed on the Vaccine Act’s Injury Table (“Table”) may recover for any resulting illness, disability, injury, or condition that is also listed on the Table, or a significant aggravation thereof. 42 U.S.C. §§ 300aa-11(c)(1)(C)(i), 300aa-14; see Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1277–78 (Fed. Cir. 2005) (describing a “Table injury”). Second, a petitioner who has received a vaccine listed on the Table, but whose vaccine-related injury does not meet Table requirements, may recover under an “off-Table” theory. See 42 U.S.C. §§ 300aa-11(c)(1)(C)(ii), 300aa-13(a)(1)(A). 10 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 11 of 19 In a Table injury case, a petitioner must prove the injury by a preponderance of evidence. See id. § 300aa-13(a)(1)(A). To meet that burden, the petitioner must demonstrate that she meets five criteria. Specifically, the petitioner must show that (1) she received a Table vaccine, see id. § 300aa-11(c)(1)(A);3 (2) she received the vaccine in the United States or meets a limited exception, see id. § 300aa-11(c)(1)(B); (3) she either suffered a Table injury or died, see id. § 300aa-11(c)(1)(C); (4) she suffered the “residual effects or complications” from such injury for more than six months or that such injury led to “inpatient hospitalization and surgical intervention,” see id. § 300aa-11(c)(1)(D); and (5) she has not already collected civil damages via award or settlement for such injury, see id. § 300aa-11(c)(1)(E). III. DISCUSSION Ms. Gonzalez raises one basic objection to the challenged dismissal decision: that the Chief Special Master’s weighing, consideration, and discussion of evidence was arbitrary and capricious or otherwise not in accordance with law. Specifically, she contends that in finding her Table injury did not persist for more than six months, the Chief Special Master failed to consider or discuss certain relevant record evidence—for example, affidavits submitted by her and Dr. Chalmers—that purportedly supports her claim. ECF No. 35-1 at 7. Instead, Ms. Gonzalez contends that the Chief Special Master placed “undue emphasis” on the team trainer notes. Id. at 9. These failures, she argues, render arbitrary and capricious the Chief Special Master’s finding that the injury did not persist for more than six months. And as a corollary, Ms. Gonzalez contends his conclusion that she did not meet the statutory severity requirement was contrary to law. 3 For the list of Table vaccines, see 42 U.S.C. § 300aa-14(a) (initial list) and 42 C.F.R. § 100.3(a) (additional vaccines and injuries). 11 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 12 of 19 Having considered the arguments and record, the Court rejects Ms. Gonzalez’s objection. The Chief Special Master appropriately considered the whole record in reaching his factual findings. And based on those findings, he rationally concluded that Ms. Gonzalez’s injury did not persist for more than six months. Because this determination was within the Chief Special Master’s purview as factfinder, the Court declines to review his finding de novo. Accordingly, the Chief Special Master’s decision is upheld. A. The Chief Special Master’s Finding that Ms. Gonzalez’s Injury Did Not Persist for More Than Six Months Was Not Arbitrary and Capricious. Ms. Gonzalez challenges the Chief Special Master’s finding that her SIRVA injury did not last more than six months. In arguing that the Chief Special Master’s severity determination was arbitrary and capricious, Ms. Gonzalez notes that the Vaccine Act directs the special master to base his findings on “the record as a whole.” 42 U.S.C. § 300aa-13(a)(1). As discussed above, she asserts that the Chief Special Master failed to consider or even discuss her supplemental affidavit testimony, Dr. Chalmers’ affidavit testimony, or the purportedly consistent findings from her August 2019 and November 2020 MRIs. ECF No. 35-1 at 8–10. Instead, Ms. Gonzalez asserts that the decision unduly focused on team trainer notes suggesting, for example, that Ms. Gonzalez had been “back to normal activity” by August 2019. Id. at 9. The Court finds that the Chief Special Master’s decision was not arbitrary and capricious. Nothing in his decision suggests that he failed to “consider[] the relevant evidence of record.” Hines, 940 F.2d at 1528. On the contrary, the Chief Special Master affirmatively indicated that he based his findings on “a complete review of the record to include all medical records, affidavits, Respondent’s Rule 4(c) report, and additional evidence filed.” ECF No. 34 at 4. This representation is supported by his findings of fact, which provide a detailed summary of the evidence to include the testimony in Ms. Gonzalez’s initial affidavit and Dr. Chalmers’ affidavit, 12 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 13 of 19 as well as Ms. Gonzalez’s medical records and MRIs. See id. at 4–9. Although the decision does not expressly cite Ms. Gonzalez’s supplemental affidavit or refer to the vaccine she received in her thigh in December 2019, that does not in itself render the decision arbitrary and capricious. As judges of this court have recognized, a special master need not “‘discuss every piece of evidence or testimony in [his or] her decision.’” Simanski v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 407, 436 (2014) (quoting Snyder ex rel. Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 728 (2009)), aff’d, 601 F. App’x 982 (Fed. Cir. 2015). Indeed, Ms. Gonzalez’s own affidavits (both initial and supplemental) are the type of evidence that the Court presumes the Chief Special Master considered. See Hazlehurst v. Sec’y of Health & Hum. Servs., 604 F.3d 1343, 1352 (Fed. Cir. 2010). Ms. Gonzalez references no authority establishing that a special master presumptively fails to consider relevant parts of the record where, as here, he does not cite certain pieces of evidence that a petitioner finds important. She points to Cedillo to support her argument that the decision should have explicitly considered Dr. Chalmers’ and her affidavits, the December 2019 vaccine, and a comparison of her MRIs. See ECF No. 35-1 at 7–8 (citing Cedillo, 617 F.3d at 1345). But Cedillo establishes no such requirement. Rather, in that case, the United States Court of Appeals for the Federal Circuit upheld a special master’s decision, describing it as “careful and thorough.” Cedillo, 617 F.3d at 1345. The Court noted that the special master “stated his reasons for rejecting or discounting each item of evidence in which the petitioners relied,” id., but nowhere did it suggest that to satisfy judicial review he must always do so. In fact, Cedillo stated that a special master’s factual findings should be upheld if they are “based on evidence in the record that [is] not wholly implausible,” and the Court upheld the special master’s decision 13 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 14 of 19 because it was “rationally supported by the evidence, well-articulated, and reasonable.” Id. at 1338 (quoting Lampe, 219 F.3d at 1363); id. at 1349. Nor does Ms. Gonzalez reference authority that supports her related argument that the Chief Special Master’s decision should be set aside because he failed to explain why he rejected Dr. Chalmers’ affidavit testimony. See ECF No. 35-1 at 9–10. She concedes that special masters “are undoubtedly given discretion in determining the credibility of witnesses” but insists that they must discuss such determinations. In support of this argument, Ms. Gonzalez cites Elson ex rel. Hodge v. Secretary of Health and Human Services, 164 Fed. Cl. 633 (2023). In Elson, the special master rejected the petitioner’s testimony as a whole because of inconsistencies between certain statements and the medical record. Id. at 642–43. The court set aside the special master’s conclusion because in determining the reliability and credibility of the petitioner he failed to discuss numerous other medical records that were supportive of the particular testimony at issue. Id. at 646. Here, however, the only other medical records that Ms. Gonzalez points to are the MRIs, which the Chief Special Master considered and discussed. See ECF No. 34 at 5, 7. Moreover, Ms. Gonzalez does not explain how the Chief Special Master’s review of the MRIs was problematic, nor does she elaborate on her allegation that the MRI results were consistent and supportive of Dr. Chalmers’ opinion. See ECF No. 35-1 at 9; compare ECF No. 1-4 at 7 (August 2019 MRI report) with ECF No. 12-1 at 6–7 (November 2020 MRI report). Dr. Chalmers’ affidavit did not compare the two MRIs or even mention the August 2019 MRI. See generally ECF No. 33-1. To be sure, the Chief Special Master gave more “weight to the fact that [Ms. Gonzalez] was able to engage in a strenuous exercise program associated with playing college volleyball despite her pain.” ECF No. 34 at 11. He also gave more weight to a team trainer’s note 14 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 15 of 19 indicating that in August 2019 Ms. Gonzalez had been “back to normal activity,” id. at 9, and to a September 2020 note indicating that Ms. Gonzalez “believe[d] she hurt her [r]ight shoulder last night during practice,” id. at 10. But his weighing of these facts does not suggest that he ignored other facts. Indeed, the broad discretion to weigh evidence is “within the purview of [the special master as] the fact finder.” Porter, 663 F.3d at 1249; see R.J. ex rel. W.J. v. Sec’y of Health & Hum. Servs., 93 F.4th 1228, 1235 (Fed. Cir. 2024) (“It is within a special master’s discretion to weigh evidence.” (citation omitted)). The record demonstrates that the Chief Special Master exercised that discretion reasonably and drew plausible inferences from the facts. See Hines, 940 F.2d at 1528. In this instance, the Chief Special Master explained that contemporaneous team trainer records showed no evidence of pain, decreased range of motion, or treatment of Ms. Gonzalez’s shoulder from November 2019 onward. ECF No. 34 at 9–10. Notwithstanding her affidavit testimony describing continued pain, he noted a 10-month gap in any treatment related to her shoulder even though she presented for treatment of pain in other parts of her body. Id. at 6, 10, 11. And he highlighted Ms. Gonzalez’s apparent ability to engage in a competitive, college-level volleyball program less than six months after vaccination. Id. at 10–11. As to the renewed pain experienced in September 2020, the Chief Special Master again relied on contemporaneous trainer notes indicating that Ms. Gonzalez hurt her shoulder while serving during practice, and both contemporaneous trainer notes and medical records after that date (including from visits with Dr. Chalmers) that associated the new pain with playing volleyball. See id. at 10. The Court finds no error in the Chief Special Master’s reliance on this evidence over Ms. Gonzalez’s and Dr. Chalmers’ contrary affidavit testimony. See Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993) (“[T]he Supreme Court counsels that oral testimony in 15 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 16 of 19 conflict with contemporaneous documentary evidence deserves little weight.”). Nor were his findings of fact based on this evidence implausible. Moreover, the Chief Special Master “articulated a rational basis” for his decision. Hines, 940 F.2d at 1528. As he explained, consistent with the findings, “the record does not preponderate in favor of the conclusion that [Ms. Gonzalez’s] SIRVA likely continued” after November 2019, ECF No. 34 at 11, and the complaints of pain that emerged “after September 2020 seem more likely the product of an athletic injury,” id. at 10. Ample record evidence supports this determination. See id. at 9–11. As a result, the Chief Special Master’s determination that Ms. Gonzalez did not establish the severity requirement was rational. Lastly, the Chief Special Master did not act arbitrarily and capriciously by placing “undue emphasis” on team trainer notes. Paluck v. Sec’y of Health & Hum. Servs., 786 F.3d 1373, 1383 (Fed. Cir. 2015). Ms. Gonzalez’s assertion to the contrary is essentially an extension of her argument that the Chief Special Master improperly weighed the facts. In Paluck, the Federal Circuit reversed a special master’s finding that the petitioner did not experience progressive neurodegeneration following vaccination. Id. The Court held that the record contained “no reasonable basis” for his finding; rather, “compelling evidence” supported the petitioner. Id. at 1382. The Court also found that the special master placed undue emphasis on evidence showing “relatively insignificant variations in muscle tone,” even though other evidence explained why those variations were immaterial. Id. at 1383 (“[B]ecause physical therapy can stretch muscles, the fact that K.P.’s muscle tone fluctuated during the period when he was receiving chiropractic therapy . . . did not mean that his overall condition was improving.” (citation omitted)). This lack of record evidence, combined with the “short shrift” 16 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 17 of 19 the special master gave evidence supporting the petitioner, made the decision arbitrary and capricious. Id. This case, however, is not like Paluck. The Court has little doubt that the Chief Special Master’s decision emphasized team trainer notes, but the emphasis he placed on them was far from undue. Instead, the Chief Special Master cited ample record evidence to support his determination that Ms. Gonzalez’s SIRVA lasted less than six months. See ECF No. 34 at 9–11. The evidence detailed in his decision, including the team trainer notes suggesting that Ms. Gonzalez had returned to normal activity in August 2019 and that she suffered an athletic injury to her shoulder in September 2020, demonstrates the rational basis for his determination. In pursuit of his duty to consider the whole record, the Chief Special Master considered these notes—in combination with other consistent evidence including contemporaneous medical records—and assessed their weight accordingly. The Court does not find his weighing irrational, and his decision therefore does not run afoul of the arbitrary and capricious standard. In sum, Ms. Gonzalez’s core dispute with the Chief Special Master appears to be a disagreement with the weight he assigned different pieces of evidence. As discussed above, allocating relative weight to evidence is a matter of fact-finding within the special master’s purview. It is therefore “extremely difficult to demonstrate” reversible error here, Hines, 940 F.2d at 1528, and ultimately Ms. Gonzalez does not clear that hurdle. For these reasons, the Court declines to set aside the Chief Special Master’s decision as arbitrary and capricious. B. The Court Declines to Review the Chief Special Master’s Severity Determination De Novo. Ms. Gonzalez further argues that, because the Chief Special Master failed to consider all the relevant evidence in the record, his conclusion that Ms. Gonzalez failed to satisfy the severity requirement is not in accordance with law. See ECF No. 35-1 at 10. Respondent responds that 17 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 18 of 19 this “attempt to cast the [severity determination] as a question of law under the ‘not in accordance with law’ standard” is “without merit” because such a determination is a factual finding. ECF No. 38 at 18. Ms. Gonzalez’s argument appears to be derivative of her core claim that the Chief Special Master’s weighing of evidence was erroneous. In any event, she challenges a quintessential finding of fact, not a legal conclusion. See Wyatt v. Sec’y of Health & Hum. Servs., 825 F. App’x 880, 886, 887 (Fed. Cir. 2020) (categorizing special master’s determination that an injury lasted more than six months as a factual finding); Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1381 (Fed. Cir. 2021) (applying arbitrary and capricious review to special master’s finding that injury lasted more than six months); id. at 1384 (holding “a reasonable fact finder could” evaluate Kirby’s testimony as special master did) (emphasis added)). Ms. Gonzalez does not contest that the Vaccine Act has a severity requirement that requires her injury to have lasted more than six months. See ECF No. 35-1 at 7, 9–10 (arguing that Ms. Gonzalez meets the severity requirement); ECF No. 23-1 ¶ 28 (alleging that Ms. Gonzalez sustained a right shoulder SIRVA injury for a period lasting “longer than six months”). Nor does she argue that she meets the severity requirement even if the Chief Special Master’s factual findings are correct—in other words, she does not contest his interpretation of the statute’s requirement. Cf., e.g., Wright v. Sec’y of Health & Hum. Servs., 22 F.4th 999, 1004–05 (Fed. Cir. 2022) (“The construction of ‘residual effects’ in the Vaccine Act is a question of law, which we review de novo.” (emphasis added) (citation omitted)). Her challenge, then, raises not a legal question, but a factual one. That means the decision receives arbitrary and capricious review. 18 Case 1:21-vv-01003-KCD Document 41 Filed 11/08/24 Page 19 of 19 Even if Ms. Gonzalez is implying that the severity determination here is based on a mere inference drawn from facts or the weighing of facts, the Court would still give this determination deference as a factual finding. The Federal Circuit has repeatedly held that such inferences and weighing are factual findings. See, e.g., Sanchez, 34 F.4th at 1354–55 (categorizing special master’s crediting of family testimony as factual finding); Kottenstette v. Sec’y of Health & Hum. Servs., 861 F. App’x 433, 439, 442 (Fed. Cir. 2021) (categorizing plausible inferences from record as factual findings); Lampe, 219 F.3d at 1360 (same); W.J., 93 F.4th at 1235 (categorizing special master’s exercise of “discretion to weigh evidence” as factual finding). Because it does not set aside the Chief Special Master’s findings of fact as arbitrary and capricious, the Court declines to replace those findings with its own. IV. CONCLUSION For the above reasons, the Court finds that the Chief Special Master’s examination of the record in Ms. Gonzalez’s case, including all medical records and affidavits, resulted in a decision that was not arbitrary and capricious or contrary to law. The Chief Special Master’s Decision Dismissing Petition is therefore affirmed, and Petitioner’s Motion for Review (ECF No. 35) is DENIED. The Clerk of the Court shall enter judgment consistent with this Opinion. SO ORDERED. Dated: October 24, 2024 /s/ Kathryn C. Davis KATHRYN C. DAVIS Judge 19