VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-01570 Package ID: USCOURTS-cofc-1_19-vv-01570 Petitioner: Vanessa Morris Filed: 2019-10-09 Decided: 2024-12-02 Vaccine: influenza Vaccination date: 2017-10-04 Condition: Shoulder Injury Related to Vaccine Administration (SIRVA) / adhesive capsulitis Outcome: compensated Award amount USD: 502071 AI-assisted case summary: Vanessa Morris filed a petition alleging that she suffered a Shoulder Injury Related to Vaccine Administration (SIRVA) following an influenza vaccination on October 4, 2017. Initially, her claim was considered for the Vaccine Injury Table, but it was dismissed because her symptom onset occurred between 48 and 72 hours after vaccination, outside the Table's 48-hour window. The case then proceeded as an off-Table claim, where Ms. Morris had to prove causation-in-fact. She presented medical records and expert opinions from Dr. Naveed Natanzi and Dr. Eric Gershwin, who opined that her condition, adhesive capsulitis, could be caused by an inflammatory reaction following an intramuscular vaccine injection, even with an onset slightly outside the typical 48-hour window. The respondent did not contest the medical theory of causation or present alternative causes. After reviewing the evidence, the Special Master found that Ms. Morris had demonstrated by a preponderance of the evidence that her adhesive capsulitis was caused-in-fact by the flu vaccination. A subsequent decision awarded Ms. Morris $502,071.61 in compensation, which included $150,000.00 for pain and suffering, $4,439.57 for past unreimbursable expenses, and $347,632.04 for past lost wages. Theory of causation field: Off-Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_19-vv-01570-0 Date issued/filed: 2022-01-18 Pages: 8 Docket text: PUBLIC ORDER/RULING (Originally filed: 12/15/2021) regarding 30 Findings of Fact & Conclusions of Law, Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-01570-UNJ Document 33 Filed 01/18/22 Page 1 of 8 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 19-1570V UNPUBLISHED VANESSA MORRIS, Chief Special Master Corcoran Petitioner, v. Filed: December 15, 2021 SECRETARY OF HEALTH AND Special Processing Unit (SPU); HUMAN SERVICES, Findings of Fact; Onset; Influenza (Flu); Shoulder Injury Related to Respondent. Vaccine Administration (SIRVA); Table Claim Dismissal. Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for Petitioner. Benjamin P. Warder, U.S. Department of Justice, Washington, DC, for Respondent. FINDINGS OF FACT AND CONCLUSIONS OF LAW DISMISSING TABLE CLAIM1 On October 9, 2019, Vanessa Morris filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). Petitioner alleges that as a result of an influenza (“flu”) vaccine received on October 4, 2017, she suffered a shoulder injury related to vaccination (“SIRVA”) as defined on the Vaccine Injury Table (the “Table”). Petition (ECF No. 1) at Preamble. The case was assigned to the Special Processing Unit of the Office of Special Masters. 1 Because this unpublished opinion 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 opinion 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 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 1:19-vv-01570-UNJ Document 33 Filed 01/18/22 Page 2 of 8 For the reasons discussed below, I find that Petitioner’s Table SIRVA claim must be dismissed, because the evidentiary record does not support the conclusion that the requisite onset of her pain occurred within 48 hours following administration of the flu vaccine. I. Relevant Procedural History The Petition and supporting documentation were deemed to be sufficiently complete, and the matter was assigned to the SPU in October 2019. On January 12, 2021, Respondent completed his formal medical review of the case and invited litigative risk settlement discussions. ECF No. 20. Petitioner thereafter transmitted a settlement demand and supporting documentation on April 12, 2021. ECF No. 22.3 Respondent provided an offer on May 6, 2021, but the parties reached an impasse in their negotiations. ECF No. 23. On August 24, 2021, Respondent filed his Rule 4(c) Report contending that Petitioner had not established onset within 48 hours of vaccination, as required for a Table SIRVA. Respondent argued that within the medical records, Petitioner provided an incorrect date of vaccination on multiple occasions,4 and that she also provided inconsistent information regarding the onset of her left shoulder pain. Rule 4(c) Report (ECF No. 26) at 14. I then directed the parties to file briefs and any other evidence that would assist my resolution of the disputed issues. ECF No. 27. Petitioner filed a motion for a ruling on the record on October 6, 2021, ECF No. 28, to which Respondent filed a response on October 15, 2021, ECF No. 29. Petitioner did not file a reply. This matter is now ripe for adjudication. II. 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 Section 11(c)(1). A special master must consider, but is not bound by, any diagnosis, conclusion, judgment, 3 The case does not involve a workers’ compensation claim or a Medicaid lien. ECF No. 10. Petitioner initially reported that she was seeking an award for pain and suffering, out of pocket expenses, and lost wages She suggested that her lost wages were “complex” and required an expert economist (which request I deferred during the parties’ litigative risk settlement discussions). ECF Nos. 19-21. 4 However, Respondent recognized that there was preponderant evidence that Petitioner did receive the subject flu vaccine on October 4, 2017; that the vaccine was administered in her left deltoid, as alleged; and that the vaccine was intended for intramuscular administration. Rule 4(c) Report at 2; n. 2-3. 2 Case 1:19-vv-01570-UNJ Document 33 Filed 01/18/22 Page 3 of 8 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 & Human 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 & Human Servs., No. 03- 1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule does not always apply. In Lowrie, the special master wrote that “written records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent.” Lowrie, at *19. 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 & Human Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). The United States Court of Federal Claims has recognized that “medical records may be incomplete or inaccurate.” Camery v. Sec’y of Health & Human Servs., 42 Fed. Cl. 381, 391 (1998). The Court later 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 & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1335 (Fed. Cir. 2014). 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, 42 Fed. Cl. at 391 (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering such testimony must also be determined. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). 3 Case 1:19-vv-01570-UNJ Document 33 Filed 01/18/22 Page 4 of 8 A special master may find that the first symptom or manifestation of onset of an injury occurred “within the time period described in the Vaccine Injury Table even though the occurrence of such symptom or manifestation was not recorded or was incorrectly recorded as having occurred outside such period.” Section 13(b)(2). “Such a finding may be made only upon demonstration by a preponderance of the evidence that the onset [of the injury] ... did in fact occur within the time period described in the Vaccine Injury Table.” Id. 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 § 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of Health & Human 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). III. Relevant Factual Evidence I have fully reviewed the evidence pertaining to the onset question, including all medical records, Respondent’s Rule 4(c) Report, and the parties’ briefs.5 find most relevant the following: • Upon receiving the subject vaccination, Ms. Morris was 58 years old. She was generally healthy, with no history of problems with her left shoulder. See, e.g., Ex. 2 at 22-26, 161-99; Ex. 7 at 3-9; Ex. 9 at 7-62; Ex. 10 at 7-78. • Petitioner was employed by Blue Cross Blue Shield in Arkansas. See, e.g., Ex. 4 at 6, 33; Ex. 5 at 52 (Petitioner’s self-identification as a “specialist”). • On October 4, 2017, a registered nurse administered the subject flu vaccine, which was intended for intramuscular administration, to Petitioner’s left deltoid. Ex. 1 at 1; Rule 4(c) Report at 2, n. 2-3. • While the vaccine record is from Freiderica Pharmacy & Compounding, Petitioner and a coworker recall that the vaccines were administered at their workplace’s breakroom. Exs. 13-14. 5 I recognize that Petitioner submitted two affidavits herself, as well as one from a coworker with recollections concerning the circumstances of their vaccinations in the workplace. Exs. 11, 13-14. These affidavits do not address the onset of Petitioner’s shoulder pain, however. 4 Case 1:19-vv-01570-UNJ Document 33 Filed 01/18/22 Page 5 of 8 • On November 8, 2017, Petitioner left a message for her primary care practice. Shawn Fells recorded that “since [Petitioner] received the flu shot in late October,” she had been experiencing pain at the injection site and difficulty moving her arm, and that she had taken Tylenol and Ibuprofen with no relief. Ex. 2 at 20. • The following day, November 9, 2017, a different individual, Nurse Jill Ashley, returned the call. Nurse Ashley memorialized in the record pertaining to this contact that Petitioner “had no pain in her arm for 2 days after her flu shot, but after the 2 days she has had a lot of pain…” Ex. 2 at 20 (emphasis added). Nurse Ashley also recorded that Petitioner had “read online that people have experienced this after the flu shot” and “discussed [that Petitioner’s pain] may or may not be related to inj.” Id. Nurse Ashley scheduled an appointment for the following Wednesday, November 15, 2017, for the primary care doctor, Rhodora Rhagavan, M.D., to assess Petitioner’s shoulder and discuss treatment options. Id. • At the November 15, 2017, appointment, Dr. Rhagavan recorded Petitioner’s history of “pain in her left arm from flu shot x6 weeks,” despite the application of ice, heat, electronic stimulation, and ibuprofen. Ex. 2 at 18. Dr. Rhagavan observed that Petitioner had restricted range of motion due to pain. Id. Dr. Rhagavan recorded that Petitioner’s left arm pain was a “vaccine reaction,” and referred her to physical therapy. Id. • Upon starting physical therapy on December 12, 2017, Petitioner reported “left upper arm and shoulder pain that began on October 11th after getting her flu shot.” Ex. 3 at 153. • Petitioner’s initial course of physical therapy consisted of nine visits. Ex. 3 at 153-81.6 On January 14, 2018, she self-discharged, planning to follow up with Dr. Rhagavan for additional testing and treatment options. Id. at 180-81. • On January 24, 2018, Petitioner followed up with Dr. Raghavan for continued pain in her left arm, which “started of [sic?] after receiving a flu vaccination in that arm,” and had been present “for about 4 months now.” Ex. 2 at 16. Petitioner’s left arm “hurt more than before” despite the non-steroidal anti- inflammatory medications (“NSAIDS”) and physical therapy. Id. Dr. Raghavan recorded that Petitioner’s pain was “chronic,” ordered an ultrasound, administered a Toradol injection, and prescribed Tramadol oral pain medications. Id. 6 The physical therapy sessions are out of order, but numbered, within Exhibit 5. The sessions were on December 12th, 14th, 19th, 21st, 27th, and 28th, 2017; and January 2nd, 4th, and 9th, 2018. 5 Case 1:19-vv-01570-UNJ Document 33 Filed 01/18/22 Page 6 of 8 • Dr. Raghavan referred Petitioner to a neurologist on January 25th, and prescribed gabapentin as a further intervention for her pain on February 1st, 2018. Ex. 2 at 14-15. • At their February 6, 2018, initial consult, the neurologist Julia McCoy, M.D., recorded: “[Petitioner] was in good health until October 11th, when she received a standard influenza injection at a local pharmacy. An IM injection in the left deltoid produced no immediate pain or significant change until the next day when the patient ‘developed sharp pains’ notably over the left deltoid with progressive pain in the proximal arm with pain on range of motion. The patient was given anti-inflammatories which did take the edge off and was given physical therapy for nine weeks which was not beneficial.” Ex. 2 at 155. Dr. McCoy’s impression was “influenza injection-induced adhesive capsulitis.” Id. at 155-57. An EMG nerve conduction study found no evidence for Parsonage-Turner syndrome. Id. at 157-60. Dr. McCoy recommended an MRI of the left shoulder and further evaluation by orthopedist Martin Siems, M.D. Id. at 157. • On February 22, 2018, at their initial consult, Dr. Siems recorded that Petitioner had left shoulder pain “since she received a flu shot this year.” Ex. 5 at 26. Petitioner’s pain and stiffness had persisted despite “nine weeks of physical therapy.” Id. Dr. Siems ordered an MRI to confirm his assessment of adhesive capsulitis and to rule out a rotator cuff tear. Id. • The February 28, 2018, MRI did not identify a rotator cuff tear or tendinopathy. The findings were consistent with adhesive capsulitis, mild acromioclavicular arthrosis, and minimal subacromial and subdeltoid bursitis. Ex. 5 at 57-58. • On March 12, 2018, Dr. Siems manipulated Petitioner’s left shoulder under anesthesia. Ex. 6 at 5; see also Ex. 5 at 21-25 (related medical appointments). • Later that day, Petitioner began treatment with a new physical therapist for the treatment of “adhesive capsulitis sustained as a result of receiving the flu shot 5 months ago.” Ex. 3 at 106. She ultimately underwent 40 physical therapy sessions through October 10, 2018. Id. at 20-152. • On July 3, 2018, orthopedic surgeon Jonathan Wyatt, M.D., met with Petitioner to discuss her left shoulder pain (recorded as being present for “several months,”) and plans for further surgical intervention. Ex. 5 at 15-17. • On August 3, 2018, Dr. Wyatt performed a left shoulder arthroscopy with capsular release, biceps tenotomy with limited debridement, subacromial decompression, and further manipulation of the left shoulder under anesthesia. 6 Case 1:19-vv-01570-UNJ Document 33 Filed 01/18/22 Page 7 of 8 Ex. 5 at 39-41; see also id. at 8-15 and Ex. 12 at 16-18 (follow up appointments with Dr. Wyatt). • At their last known follow-up appointment on June 25, 2019, Dr. Wyatt recorded that Petitioner’s left shoulder had improved following surgery and physical therapy, but she had continued pain and limitations in range of motion. She would continue with NSAIDs, topical treatments, and stretching exercises, and would follow up with Dr. Wyatt as needed. Ex. 12 at 15-16. IV. Findings of Fact I acknowledge that the standard applied to resolving onset for an alleged SIRVA is liberal, and will often permit a determination in a petitioner’s favor, especially in the absence of fairly contemporaneous and direct statements within the petitioner’s medical records to the contrary. However, not every case can be so preponderantly established. Ultimately, the resolution of such fact issues involves weighing different items of evidence against the overall record. Here, Petitioner’s post-vaccination onset claims (which do eventually tend to report immediate pain) are offset against a record created very near-in-time to vaccination – and this record does not support Petitioner’s claim. Specifically, the second post-vaccination record - from the November 9, 2017, telephone encounter with Nurse Ashley - specifically refutes the existence of pain for the first two days after vaccination, placing onset instead at “after the two days.” Ex. 2 at 20. The record from the day immediately before (the first record reporting pain) vaguely references pain “since” the receipt of the vaccine – and although this is not inconsistent with an allegation of immediate pain, it is also consistent with the second record, which identifies a particular, later onset. Id. Thereafter, on November 15, 2017, Petitioner reported a six-week history of shoulder pain, which dates back precisely to October 4, 2017. Ex. 2 at 18. However, that record does not mention the vaccination, and could represent a more approximate timeframe. Compare, e.g., Ex. 2 at 16 (January 24, 2018, history of shoulder pain “for about 4 months now,” which would relate back to before vaccination). Other records contain a history of shoulder pain either “since” or beginning within the first two days after vaccination. However, these were generally created later in time, and contain other inconsistencies. See, e.g., Ex. 2 at 20 (dating vaccination in “late” October); Ex. 3 at 153 (providing that the vaccination occurred on October 11th); Ex. 2 at 155 (providing the same incorrect date, and that the vaccination occurred “at a local pharmacy” rather than at Petitioner’s workplace). 7 Case 1:19-vv-01570-UNJ Document 33 Filed 01/18/22 Page 8 of 8 Overall, the most contemporaneous and specific record was that created by Nurse Ashley, which provides that onset occurred beyond 48 hours after vaccination. Petitioner has provided me no reason not to conclude that this medical record is correct, and she has not provided “consistent, clear, cogent, and compelling” testimony – or other evidence – in rebuttal. Camery v. Sec’y of Health & Human Servs., 42 Fed. Cl. 381, 391 (1998) (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998). And while other records are consistent with post- vaccination pain, they do not merit more weight than a specific and far closer-in-time record. Accordingly, there is not preponderance evidence of onset within 48 hours. 42 C.F.R. § 100.3(a)(I)(C). Nevertheless, the record does support onset having occurred shortly after vaccination – e.g., within the first 72 hours – and seemingly, all other criteria for a Table SIRVA claim. Therefore, Petitioner very likely has a viable non-Table claim. To that end, I urge the parties to make one final brief attempt at settlement – as I would anticipate that even after transfer, Petitioner’s claim could prove meritorious despite her inability to meet one Table element. Conclusion Petitioner has not preponderantly established that the onset of her shoulder pain occurred within 48 hours of vaccination. Accordingly, Petitioner’s Table SIRVA claim is dismissed. Petitioner shall file a joint status report addressing her conveyance of a revised settlement demand for her off-Table claim, and the parties’ efforts towards informal resolution, by no later than Friday, January 14, 2022. If the parties do not report progress in their efforts, the matter will likely be transferred out of the SPU. IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 8 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_19-vv-01570-1 Date issued/filed: 2023-08-07 Pages: 12 Docket text: PUBLIC ORDER/RULING (Originally filed: 7/11/2023) regarding 44 Ruling on Entitlement. Signed by Special Master Daniel T. Horner. (ksb) Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 1 of 12 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 19-1570V Filed: July 11, 2023 PUBLISHED Special Master Horner VANESSA MORRIS, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for petitioner. Benjamin Patrick Warder, U.S. Department of Justice, Washington, DC, for respondent. RULING ON ENTITLEMENT1 On October 9, 2019, petitioner, Vanessa Morris, filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012),2 alleging that she suffered a “Shoulder Injury Related to Vaccine Administration” or “SIRVA” following an influenza (“flu”) vaccination she received on October 4, 2017. (ECF No. 1.) For the reasons set forth below, I conclude that petitioner is 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 special master’s action in this case, it will be posted on the United States Court of Federal Claims’ website in accordance with the E- Government Act of 2002. See 44 U.S.C. § 3501 note (2012) (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 the special master, upon review, agrees that the identified material fits within this definition, it will be redacted 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-10-34. 1 Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 2 of 12 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); § 300 aa- 11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B). As relevant here, the Vaccine Injury Table lists a Shoulder Injury Related to Vaccine Administration or “SIRVA” as a compensable injury if it occurs within 48 hours of vaccine administration. § 300aa-14(a) as amended by 42 CFR § 100.3. Table Injury cases are guided by statutory “Qualifications and aids in interpretation” (“QAIs”), which provide more detailed explanation of what should be considered when determining whether a petitioner has actually suffered an injury listed on the Vaccine Injury Table. 42 CFR § 100.3(c). To be considered a “Table SIRVA,” petitioner must show that 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 radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 2 Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 3 of 12 42 CFR § 100.3(c)(10). Alternatively, if no injury falling within the Table can be shown, the petitioner may still demonstrate entitlement to an award by showing that the vaccine recipient’s injury was caused-in-fact by the vaccination in question. § 300aa-13(a)(1)(A); § 300aa- 11(c)(1)(C)(ii). To so demonstrate, a petitioner must show that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly ex rel. Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (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). In particular, a petitioner must show by preponderant evidence: (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 in order to prove causation-in-fact. 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 must establish their claim by a “preponderance of the evidence”. § 300aa-13(a). That is, a petitioner must present evidence sufficient to show “that the existence of a fact is more probable than its nonexistence . . . .” Moberly, 592 F.3d at 1326 n.2. Proof of medical certainty is not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). However, 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). Once a petitioner has established their prima facie case, the burden then shifts to respondent to prove, also by preponderant evidence, that the alleged injury was caused by a factor unrelated to vaccination. Althen, 418 F.3d at 1278 (citations omitted); § 300aa- 13(a)(1)(B). II. Procedural History Petitioner filed medical records marked as Exhibits 1-10 and an affidavit marked as Exhibit 11 at the time she filed her petition. (ECF No 1.) The case was initially assigned to the Special Processing Unit (“SPU”) based on the allegations of the petition. (ECF No. 8.) Additional medical records and affidavits marked as Exhibits 12-14 were filed in January and February of 2020. (ECF Nos. 11-13.) The parties attempted settlement, but reached an impasse as of May of 2021. (ECF No. 23.) Respondent filed his Rule 4 Report on August 24, 2021. (ECF No. 26.) Respondent primarily raised the issue that petitioner had not established onset of her condition within 48 hours of vaccination as required for a Table SIRVA. (Id. at 13-14.) Respondent additionally observed that no expert report had been filed to support any cause in fact claim as of the time of filing. (Id. at 14.) On December 15, 2021, the Chief Special Master issued a finding of fact. (ECF No. 30; see also Morris v. Sec’y of Health & Human Servs., No. 19-1570V, 2021 WL 6504390 (Fed. Cl. Spec. Mstr. Dec. 15, 2021).) The Chief Special Master concluded 3 Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 4 of 12 that onset of petitioner’s shoulder pain was outside of 48 hours, but within 72 hours, of her vaccination. (Id. at 8.) Accordingly, he dismissed petitioner’s Table claim and urged the parties to explore informal resolution of the remaining off-Table claim. (Id.) As of January 14, 2022, the parties again reported they were unable to resolve the case. (ECF No. 31.) It was then reassigned to the undersigned on January 19, 2022. (ECF No. 34.) Thereafter, petitioner filed an expert report by Naveed Natanzi, DO, on February 17, 2022. (ECF No. 35; Exs. 15-37.) Petitioner filed a further report by Eric Gershwin, M.D., on May 9, 2022. (ECF No. 38; Exs. 38-43.) I allowed respondent an opportunity to file a responsive expert report; however, on June 10, 2022, respondent indicated that he did not believe filing a responsive expert report would be productive and instead requested that the case by resolved based on the existing record. (ECF No. 39.) Petitioner filed a motion for a ruling on the written record on August 23, 2022. (ECF No. 41.) Respondent filed his response on November 4, 2022. (ECF No. 43.) Petitioner did not file any reply. 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 this issue without a hearing. See Vaccine Rule 8(d); Vaccine Rule 3(b)(2); 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”). Accordingly, this matter is now ripe for resolution. III. Factual History Petitioner received the flu vaccine at issue in this case in her left arm on October 4, 2017. (Ex. 1.) Respondent agrees that she had no prior history of left shoulder problems. (ECF No. 43, p. 4 (citing Ex. 2, pp. 22-23, 25-26, 161-199; Ex. 7, pp. 3-9; Ex. 9, pp. 7-62; Ex. 10, pp .7-78).) Because the question of onset has already been resolved in a separate published ruling, this fact summary does not repeat all of the medical record entries that were discussed in the prior finding of fact with respect to onset. For a more detailed discussion of onset, see Morris, supra, at 2021 WL 6504390. Per that fact finding, petitioner began experiencing left shoulder pain between 48 to 72 hours after her vaccination. On November 8, 2017, petitioner called her primary care provider reporting pain in her left arm since receiving the flu vaccination. (Ex. 2, p. 20.) She reported being unable to move her arm. (Id.) Petitioner subsequently presented to Dr. Ragahavan on November 15, 2017. (Id. at 18-19.) Dr. Ragahaven’s physical exam confirmed limited range of motion due to pain, but no weakness. Dr. Ragahaven assessed “left arm pain” attributed to a “vaccine reaction” and referred petitioner to physical therapy. (Id. at 18- 19.) Petitioner’s physical therapy evaluation further confirmed her restricted range of motion. (Ex. 3, pp. 153-55.) She was discharged from physical therapy on January 14, 2018, with minimal improvement. (Id. at 180-81.) 4 Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 5 of 12 Petitioner returned to Dr. Ragahaven on January 24, 2018, reporting that physical therapy had worsened her pain. (Ex. 2, pp. 16-17.) An ultrasound was negative for any mass or fluid collection and the radiologist recommended an MRI to evaluate for Parsonage-Turner Syndrome. (Ex. 8, p. 139.) Dr. Ragahaven referred petitioner to a neurologist on January 25, 2018. (Ex. 2, p. 15.) Petitioner presented to neurologist Julia McCoy, M.D. on February 6, 2018. (Ex. 2, pp. 155-60.) Petitioner denied numbness, tingling, or radiating symptoms. (Id. at 155.) She did have decreased range of motion. (Id.) Dr. McCoy diagnosed “influenza injection induced adhesive capsulitis” and not Parsonage-Turner Syndrome. (Id. at 157.) She referred petitioner to an orthopedist. (Id.) Petitioner then presented to orthopedist Martin Siems, M.D., on February 22, 2018. (Ex. 5, pp. 26-27.) X-ray imaging showed mild acromioclavicular joint arthrosis and a small inferior head spur. (Id. at 26.) Dr. Siems diagnosed adhesive capsulitis and a possible rotator cuff tear. (Id.) An MRI was ordered to rule out a rotator cuff tear. (Id.) A left shoulder MRI of February 28, 2018, showed mild acromioclavicular joint arthritis, subacromial bursitis, and mild thickening of the inferior joint capsule suggestive of adhesive capsulitis. (Id. at 57-58.) Dr. Siems performed a left shoulder manipulation under general anesthesia on March 12, 2018. (Ex. 6, p.5) The postoperative diagnosis was adhesive capsulitis. (Id. at 5.) Petitioner continued to be symptomatic and continued to seek treatment. On July 3, 2018, petitioner had a surgical consultation with Jonathan Wyatt, M.D. (Ex. 5, pp. 15-17.) He diagnosed adhesive capsulitis, biceps tendonitis, and impingement. (Id. at 16.) On August 9, 2018, Dr. Wyatt performed an arthroscopic capsular release, biceps tenotomy, subacromial decompression, and manipulation under anesthesia. (Id. at 39- 41.) The postoperative diagnoses were adhesive capsulitis, biceps tendinitis, and impingement. (Id. at 39.) Although this did not resolve petitioner’s symptoms, the underlying nature of petitioner’s condition was not revisited in any of her subsequent treatment records. IV. Expert Reports a. Dr. Natanzi Dr. Natanzi opines that inadvertent overpenetration of a vaccine needle into the subacromial bursa can result in an exaggerated immune response that in turn leads to inflammation of the structures of the shoulder joint, resulting in, inter alia, bursitis and adhesive capsulitis. (Ex. 15, pp. 8-9.) These types of post-vaccination injuries have been collected into the phenomenon known as “Shoulder Injury Related to Vaccine Administration” or “SIRVA,” which he acknowledges does not constitute a medical diagnosis in itself. (Id. at 7.) Based on his own review of the medical records, Dr. Natanzi opines that petitioner experienced onset of shoulder pain within 48 hours of her vaccination; however, he stresses no two patients are exactly alike and that the 48-hour period represents merely a “typical” timeframe. Thus, given the finding of a 72-hour 5 Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 6 of 12 onset in this case, he confirms that in his opinion an onset of 72 hours should not preclude attributing a shoulder injury to vaccination. (Id. at 7-8.) Dr. Natanzi opines that petitioner’s own specific diagnosis of adhesive capsulitis is consistent with SIRVA literature and that her MRI finding of bursitis is a further hallmark of the pathologic process believed to be involved in SIRVA. (Id. at 8.) He concludes that “[g]iven the outlined temporal relationship of symptoms to the vaccine, the subjective and objective signs of a SIRVA, and the absence of any pre-vaccination shoulder dysfunction, it is more likely than not that the influenza vaccination on 10/4/17 caused Ms. Morris’ left shoulder dysfunction.” (Id. at 9.) b. Dr. Gershwin Dr. Gershwin endorses Dr. Natanzi’s analysis. (Ex. 38, p. 4.) He further asserts that based on his review of literature “[t]he development of symptoms from inflammation are obviously individually determined and the literature supports onset within days, not carved in a concrete 48-hour window.” (Id. at 3.) Dr. Gershwin explains that, although its etiology is still considered unknown, it is generally accepted that adhesive capsulitis is a progressive condition in which inflammation is believed to eventually lead to fibrosis, resulting in a clinical presentation of pain and reduced range of motion of the shoulder. (Id. at 3-4.) He explains that a prior rat study showed that adhesive capsulitis can develop in as little as five days. (Id. at 3.) Dr. Gershwin opines that petitioner’s own history, including her lack of prior shoulder dysfunction, symptom onset within five days of vaccination, MRI evidence including bursal fluid, and ultimate diagnosis of adhesive capsulitis, all support the conclusion that petitioner suffered vaccine-caused adhesive capsulitis. (Id. at 5.) V. Party Contentions a. Petitioner’s Motion Petitioner asserts that she has preponderantly satisfied the Althen test for causation-in-fact based on her medical history and the opinions of her two experts. (ECF No. 41.) She asserts that her two experts have presented a medical theory under Althen prong one demonstrating that adhesive capsulitis is an inflammatory condition that can be caused by vaccination. (Id. at pp. 10-12.) Regarding Althen prong two, petitioner notes that her primary care physician, Dr. Ragahaven, diagnosed petitioner as having had an adverse vaccine reaction and her treating neurologist, Dr. McCoy, opined petitioner’s adhesive capsulitis was due to her vaccination. (Id. at p. 12 (citing Ex. 2, pp. 18-19, 157).) Regarding Althen prong three, petitioner asserts that 48 hours is when post-vaccination shoulder injuries “commonly” occur and is “not an absolute.” (Id. at 14.) Petitioner lists several citations she asserts show some patients reported SIRVA at 3 or 4 days post vaccination. (Id. (citing Ex. 18, p. 2; Ex. 31, p. 1; Ex. 32, p. 2; Ex. 33, p. 2; Ex. 34, p. 2).) Petitioner stresses that respondent has not come forward with any evidence to suggest that it is unreasonable for her experts to opine that vaccine causation at 72 hours post-vaccination is appropriate. (Id. at 16.) 6 Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 7 of 12 b. Respondent’s Response Respondent’s motion response focuses exclusively on whether petitioner has established a medically reasonable temporal relationship between her vaccination and onset of adhesive capsulitis. (ECF No. 43.) Respondent asserts that petitioner’s experts provided inconsistent opinions on this point, leaving petitioner unable to meet her burden of proof. (Id. at 15-16.) Whereas Dr. Natanzi opined that petitioner’s symptoms began “well within 48 hours,” consistent with respondent’s regulatory rulemaking, Dr. Gershwin opined that onset within five days is appropriate. (Id. at 14- 15.) Respondent is further critical of Dr. Gershwin’s opinion because, according to respondent, the literature he has cited demonstrates a minimum latency of five days for adhesive capsulitis, which is incompatible with the three-day onset in this case. (Id. at 16.) VI. Discussion a. Table SIRVA As noted above, the Chief Special Master previously issued a finding of fact determining that onset of petitioner’s shoulder pain occurred 72 hours post-vaccination and dismissing petitioner’s Table SIRVA claim. (ECF No. 30; 2021 WL 6504390.) The Chief Special Master’s ruling is not binding on me. Godfrey v. Sec’y of Health & Human Servs., 2015 WL 10710961, at *9 (Fed. Cl. Spec. Mstr. Oct. 27, 2015) (noting that “[g]enerally, special masters may change or revisit any ruling until judgment enters, even if the case has been transferred.”); see also Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998), aff’d, 191 F.3d 1344 (Fed. Cir. 1999) (special masters are not bound by their own or other special masters’ decisions). However, upon review of that finding of fact as well as the record as a whole, I agree with the analysis and conclusion of the prior finding of fact and adopt it as my own. b. Causation-in-Fact i. Althen Prong One 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 (citations omitted). 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 (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 7 Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 8 of 12 reliable.’” Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019) (quoting Knudsen, 35 F.3d at 548-49). Dr. Natanzi opines that inadvertent overpenetration of a vaccine needle into the subacromial bursa can result in an exaggerated immune response that in turn leads to inflammation of the structures of the shoulder joint, resulting in, inter alia, bursitis and adhesive capsulitis. (Ex. 15, pp. 8-9.) Further to this, Dr. Gershwin explains that the pathogenesis of primary adhesive capsulitis likely stems at least in part from an inflammatory reaction that in turn leads to fibrotic changes. (Ex. 38.) Thus, he further endorses Dr. Natanzi’s opinion that the post-vaccination inflammatory process can lead to adhesive capsulitis. (Id. at 4.) These opinions are supported by various citations to relevant medical literature. Respondent agrees that adhesive capsulitis is the relevant injury that underlies petitioner’s claim. (ECF No. 43, p. 13.) However, he offers no argument refuting petitioner’s experts’ theory that vaccination can lead to adhesive capsulitis. Nor does he present any competing medical opinion to support such a view. In fact, two key pieces of literature cited by Dr. Natanzi informed respondent’s own regulatory rulemaking regarding SIRVA, namely Atanasoff, et al, and Bodor and Montalvo.3 Proposed Rulemaking, 2015 WL 4538923, at *45136. Special masters have observed with regard to SIRVA that “the very decision to add a claim [to the Vaccine Injury Table] reflects Respondent’s determination that valid science supports revising the Table.” E.g., L.J. v. Sec’y of Health & Human Servs., No. 17-59V, 2021 WL 6845593, at *14 (Fed. Cl. Spec. Mstr. Dec. 2, 2021). Regardless of respondent’s argument that the broader SIRVA concept is a creature of his own rulemaking, respondent cannot reasonably argue that these studies which he had already himself specifically endorsed are not persuasive as support for a medical theory of causation. Both Atanasoff and Bodor and Montalvo, support adhesive capsulitis specifically as among the conditions that can be causally related to vaccination. (Atanasoff, supra, at Ex. 18, p. 3; Bodor and Montalvo, supra, at Ex. 19, p. 2.) Thus, petitioner has satisfied Althen prong one by providing a sound and reliable medical theory demonstrating that a flu vaccination can cause adhesive capsulitis. ii. Althen Prong Three The third Althen prong requires establishing a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. A petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disorder's etiology, it is medically acceptable to infer causation.” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). 3 Atanasoff, et al., Shoulder injury related to vaccine administration (SIRVA), 28 VACCINE 8094 (2010) (Ex. 18); Bodor and Montalvo, Vaccine related shoulder dysfunction, 25 VACCINE 585 (2007) (Ex. 19). 8 Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 9 of 12 In stressing Dr. Natanzi’s opinion that petitioner suffered onset of shoulder pain within 48 hours of vaccination, respondent mischaracterizes his opinion. Although it is true that Dr. Natanzi assessed an earlier onset himself based on his own review of the records, he additionally addressed the Chief Special Master’s prior finding that onset occurred outside of 48 hours of vaccination. In that regard, he explained that although SIRVA typically does present within the first couple of days, as alluded to above, no two patients ever present a disease the same. Medical literature supports this, specifically Atanasoff et al., who cited a case where symptom presentation did not present until day four after vaccination. Even if I were to assume the alternative of pain beginning after 48 hours, it would not preclude me from making a SIRVA diagnosis. (Ex. 15, pp. 6-7.) I have previously found that the single outlier case from the Atanasoff study is not sufficient standing alone to support petitioner’s burden under Althen prong three, but I have also found that the overall focus of the body of relevant literature is on what is typical, meaning that the literature does not indicate that onset must fall precisely within 48 hours of vaccination to support causation-in-fact. Compare Clark v. Sec’y of Health & Human Servs., No. 18-813V, 2022 WL 16635681 (Fed. Cl. Spec. Mstr. Feb. 7, 2022) with Murray v. Sec'y of Health & Human Servs., No. 17-1357V, 2022 WL 17829797 (Fed. Cl. Spec. Mstr. Oct. 27, 2022); see also Pitts v. Sec’y of Health & Human Servs., No. 18-1512V, 2023 WL 2770943 (Fed. Cl. Spec. Mstr. Apr. 4, 2023).4 Indeed, the Federal Circuit holding in Paluck v. Secretary of Health & Human Services cautions against setting “hard and fast deadline[s]” for onset. See 786 F.3d 1373, 1383-84 (Fed. Cir. 2015) (stating that “[t]he special master further erred in setting a hard and fast deadline” for onset and noting that the medical literature filed in the case “do not purport to establish any definitive timeframe for onset of clinical symptoms.”). In this case, although he primarily cites to the Atanasoff outlier, Dr. Natanzi’s medical opinion with respect to onset is unrebutted by any other medical opinion from any treating physician or expert. It is also further complemented by Dr. Gershwin’s additional explanation of the pathogenesis of adhesive capsulitis. 4 Prior decisions by other special masters have also suggested that onset falling outside of the 48-hour Table window but within less than one week post-vaccination can support a cause-in-fact shoulder injury claim. Kuczarski v. Sec'y of Health & Human Servs., No. 20-0312V, 2023 WL 1777208, at *3-4 (Fed. Cl. Spec. Mstr. Feb. 6, 2023) (dismissing Table SIRVA claim but noting that “a causation-in-fact injury claim might still be tenable, based on an onset occurring a week after vaccination.”); Jewell v. Sec'y of Health & Human Servs., No. 16-0670V, 2017 WL 7259139, at * 3 (Fed. Cl. Spec. Mstr. Aug. 4, 2017) (finding entitlement for shoulder injury occurring 72 hours post-vaccination); but see C.C. v. Sec'y of Health & Human Servs., No. 17-708V, 2021 WL 2182817 (Fed. Cl. Spec. Mstr. Mar. 31, 2021) (finding onset of shoulder pain one-week post-vaccination did not satisfy Althen prong three because petitioner’s Althen prong one theory was based on the Vaccine Injury Table, which required a 48-hour onset); Porcello v. Sec'y of Health & Human Servs., No. 17-1255V, 2020 WL 4725507, at *9 (Fed. Cl. Spec. Mstr. June 22, 2020) (denying entitlement where petitioner failed to show onset “reasonably close” in time to vaccination where the only precise notation of onset indicated an 11-day latency). 9 Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 10 of 12 Dr. Gershwin explains that, while the pathogenesis of adhesive capsulitis is not entirely clear, it likely involves an initial inflammatory process that results in the later development of fibrotic changes. (Ex. 38, pp. 3-4.) Based on a citation to a rat study, he suggests that the development of adhesive capsulitis takes at least five days. (Ex. 38, p. 3,5.) Combining this observation with the other literature regarding SIRVA, which places symptom onset within days of vaccination, he opines that it is medically reasonable for onset of manifestations of post-vaccination adhesive capsulitis to occur as late as five days post vaccination. (Id. at 5.) That is, Dr. Gershwin suggests that the fact that the underlying pathogenic process of adhesive capsulitis, inclusive of both inflammation and fibrotic changes, continues over the course of at least five days supports inter-patient variability in the initial outward manifestation of the condition. Thus, he characterizes a specific 48-hour period as “arbitrary.” (Id. at 2.) Respondent is critical of Dr. Gershwin’s opinion, because the onset of fibrosis in the animal study was at least five days, which is not compatible with the earlier onset in this case. However, respondent conflates the onset of symptomology, namely pain, which was found to be 3 days post-vaccination in this case, with the onset of fibrotic changes, as seen in the animals observed to suffer adhesive capsulitis as early as five days post exposure. Because Dr. Gershwin explains adhesive capsulitis to be a progressive condition, this is not necessarily a one-to-one comparison. Although petitioner experienced pain three days post-vaccination, nothing in the medical records is able to confirm whether she had fibrotic changes immediately upon the first manifestations of pain. For example, in one case report cited by Dr. Natanzi, the subject experienced pain within hours of vaccination, but additional signs of adhesive capsulitis developed progressively over a period of six weeks. (Barnes, et al, A “Needling” Problem: Shoulder Injury Related to Vaccine Administration, 25 J. OF THE AM. BOARD OF FAM. MED. 6 (Nov.-Dec. 2012) (Ex. 20).) Although adhesive capsulitis is this petitioner’s ultimate diagnosis, like the Barnes subject, petitioner’s February 28, 2018 MRI also confirmed that she had subacromial bursitis that could have additionally contributed to her overall presentation. (Ex. 5, pp. 24, 57-58.) Because respondent has opted not to present his own expert opinion, Dr. Natanzi’s and Dr. Gershwin’s expert medical opinions are unrebutted. I have considered respondent’s arguments suggesting that the opinions are facially inadequate, but do not find them persuasive. In particular, I do not agree that Dr. Natanzi’s and Dr. Gershwin’s opinions are inconsistent. Accordingly, petitioner has satisfied Althen prong three. iii. Althen Prong Two 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, 956 F.2d at 1148. In establishing that a vaccine “did cause” injury, the opinions and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (quoting Althen, 418 F.3d at 1280) (stating 10 Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 11 of 12 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’”). 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 Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 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, petitioner’s primary care physician initially felt she was suffering arm pain due to a vaccine reaction. (Ex. 2, pp. 18-19.) However, diagnosis remained unclear. In ruling out an alternative diagnosis of Parsonage-Turner Syndrome, petitioner’s neurologist specifically opined that petitioner was suffering adhesive capsulitis caused by her vaccine injection and referred petitioner to an orthopedist. (Id. at 157.) The orthopedist did not subsequently address the underlying cause of petitioner’s condition but did confirm the adhesive capsulitis diagnosis rendered by the neurologist. (Ex. 5, pp. 26-27.) Petitioner has also presented expert medical opinions from two physicians opining that her adhesive capsulitis was caused by her vaccination. On this record, all of these medical opinions are unrebutted. Moreover, respondent does not raise any issue with respect to preexisting shoulder dysfunction, identify any symptoms beyond the confines of the shoulder, or suggest the presence of any other condition or other trigger that could explain petitioner’s adhesive capsulitis. Although these factors overlap with the requirements for a Table SIRVA, they are also considerations relevant to assessing causation-in-fact based on the medical literature that has been filed in this case. Respondent’s sole argument that the timing of onset is not medically appropriate is not persuasive for the reasons discussed above. Thus, petitioner has satisfied Althen prong two. c. Factor Unrelated to Vaccination After petitioner has met her prima facie burden, respondent has the opportunity to identify a factor unrelated to vaccination as the true cause of the condition. § 300aa- 13(a)(1)(B). In this case, respondent has not identified any alternative cause for petitioner’s condition. Nor has he provided any medical opinion that could preponderantly support such a view. VII. Conclusion For all the reasons discussed above, after weighing the evidence of record within the context of this program, I find by preponderant evidence that petitioner suffered a 11 Case 1:19-vv-01570-UNJ Document 46 Filed 08/07/23 Page 12 of 12 shoulder injury, specifically adhesive capsulitis, caused-in-fact by her October 4, 2017 flu vaccination. A separate damages order will be issued. IT IS SO ORDERED. s/Daniel T. Horner Daniel T. Horner Special Master 12 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_19-vv-01570-2 Date issued/filed: 2024-12-02 Pages: 6 Docket text: PUBLIC DECISION (Originally filed: 11/5/2024) regarding 63 DECISION Stipulation/Proffer. Signed by Special Master Daniel T. Horner. (sh). Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-01570-UNJ Document 66 Filed 12/02/24 Page 1 of 6 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 19-1570V Filed: November 5, 2024 VANESSA MORRIS, Special Master Horner Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for petitioner. Benjamin Patrick Warder, U.S. Department of Justice, Washington, DC, for respondent. DECISION AWARDING DAMAGES1 On October 9, 2019, Vanessa Morris filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). Petitioner alleges that she suffered a shoulder injury related to vaccine administration (“SIRVA”) as a result of an influenza (“flu”) vaccine administered on October 4, 2017. (ECF No. 1) On July 11, 2023, a ruling on entitlement was issued, finding petitioner entitled to compensation for a shoulder injury caused-in-fact by her vaccination. (ECF No. 44.) On November 5, 2024, respondent filed a proffer on award of compensation (“Proffer”) indicating petitioner should be awarded $502,071.61, consisting of $150,000.00 for pain and suffering, $4,439.57 in past unreimbursable expenses, and $347,632.04 for past lost wages. (ECF No. 62.) In the Proffer, respondent represented that petitioner agrees with the proffered award. Id. Based on the record as a whole, I find that petitioner is entitled to an award as stated in the Proffer. 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 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Case 1:19-vv-01570-UNJ Document 66 Filed 12/02/24 Page 2 of 6 Pursuant to the terms stated in the attached Proffer, I award petitioner a lump sum payment of $502,071.61, representing $150,000.00 in compensation for pain and suffering, $4,439.57 in compensation for past unreimbursable expenses, and $347,632.04 in compensation for past lost wages, in the form of a check payable to petitioner. This amount represents compensation for all damages that would be available under § 15(a). The clerk of the court is directed to enter judgment in accordance with this decision.3 IT IS SO ORDERED. s/Daniel T. Horner Daniel T. Horner Special Master 3 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. 2 CCaassee 11::1199--vvvv--0011557700--UUNNJJ DDooccuummeenntt 6626 FFiilleedd 1112//0052//2244 PPaaggee 13 ooff 46 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS ) VANESSA MORRIS, ) ) Petitioner, ) ) No. 19-1570V (ECF) v. ) Special Master Horner ) SECRETARY OF HEALTH ) AND HUMAN SERVICES, ) ) Respondent. ) ) RESPONDENT’S PROFFER ON AWARD OF COMPENSATION On October 9, 2019, Vanessa Morris (“petitioner”) filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34, as amended (“Vaccine Act”), alleging a left shoulder injury related to vaccine administration (“SIRVA”), as defined in the Vaccine Injury Table (“Table”), resulting from her receipt of an influenza (“flu”) vaccination on October 4, 2017. ECF No. 1 at 1. On August 24, 2021, respondent filed his Rule 4(c) report, in which he argued that petitioner had failed to demonstrate that she suffered a SIRVA. ECF No. 26. On October 6, 2021, petitioner filed a motion for a factual ruling (“MFFR”). ECF No. 28. In the MFFR, petitioner moved the Court to find that she suffered a left SIRVA with an onset that occurred within forty-eight hours after her receipt of the vaccination. Id. at 1. On October 15, 2021, respondent filed his response to petitioner’s MFFR. ECF No. 29. On December 15, 2021, Chief Special Master Corcoran issued his Findings of Fact and Conclusions of Law Dismissing Table Claim (“FOF”), in which he dismissed petitioner’s SIRVA Table claim. ECF No. 30. On January 18, 2022, Chief Special Master Corcoran issued a Transfer CCaassee 11::1199--vvvv--0011557700--UUNNJJ DDooccuummeenntt 6626 FFiilleedd 1112//0052//2244 PPaaggee 24 ooff 46 Order – Special Processing Unit (“Transfer Order”), through which he transferred this case out of the SPU. ECF No. 32. Pursuant to the Notice of Reassignment issued on January 19, 2022, this case was reassigned to Special Master Horner. ECF No. 34. On February 17, 2022, petitioner filed the report of one of her experts, Naveed Natanzi, D.O. Petitioner’s Exhibit (“Ex.”) 15. On May 9, 2022, petitioner filed the report of her other expert, Eric Gershwin, M.D. Ex. 38. Respondent elected not to file responsive expert reports in this case. See ECF No. 39. On August 23, 2022, petitioner filed her motion for ruling on the record (“MFROR”). ECF No. 41. On November 4, 2022, respondent filed his response to petitioner’s MFROR. ECF No. 43. On July 11, 2023, Special Master Horner issued his Ruling on Entitlement, in which he found that petitioner was entitled to compensation, as she had demonstrated by preponderant evidence that she had suffered an injury to her left shoulder, specifically adhesive capsulitis, that was caused-in-fact by her receipt of the flu vaccination on October 4, 2017.1 ECF No. 44. Also on July 11, 2023, Special Master Horner issued a Damages Order. ECF No. 45. I. Items of Compensation A. Pain and Suffering Respondent proffers that petitioner should be awarded $150,000.00 for pain and suffering. See 42 U.S.C. § 300aa-15(a)(4). Petitioner agrees. B. Past Unreimbursable Expenses Evidence supplied by petitioner documents that she incurred past unreimbursable expenses pertaining to her vaccine-related injury. Respondent proffers that petitioner should be 1 The parties have no objection to the amount of the proffered award of damages. However, respondent reserves his right, pursuant to 42 U.S.C. § 300aa-12(f), to seek review of Special Master Horner’s July 11, 2023 Ruling on Entitlement, finding petitioner entitled to an award under the Vaccine Act. This right accrues following the issuance of the damages decision. 2 CCaassee 11::1199--vvvv--0011557700--UUNNJJ DDooccuummeenntt 6626 FFiilleedd 1112//0052//2244 PPaaggee 35 ooff 46 awarded past unreimbursable expenses in the amount of $4,439.57. See 42 U.S.C. § 300aa- 15(a)(1)(B). Petitioner agrees. C. Lost Wages Evidence supplied by petitioner documents that she incurred past lost wages pertaining to her vaccine-related injury. Respondent proffers that petitioner should be awarded past lost wages in the amount of $347,632.04. See 42 U.S.C. § 300aa-15(a)(3)(A). Petitioner agrees. These amounts represent all elements of compensation to which petitioner is entitled under 42 U.S.C. § 300aa-15(a). Petitioner agrees. II. Form of the Award Petitioner is a competent adult. Evidence of guardianship is not required in this case. Respondent recommends that the compensation provided to petitioner should be made through a lump sum payment as described below and requests that the Special Master’s decision and the Court’s judgment award the following:2 a lump sum payment of $502,071.61, in the form of a check payable to petitioner. III. Summary of Recommended Payment Following Judgment Lump sum payable to petitioner, Vanessa Morris: $502,071.61 Respectfully submitted, BRIAN M. BOYNTON Principal Deputy Assistant Attorney General C. SALVATORE D’ALESSIO Director Torts Branch, Civil Division 2 Should petitioner die prior to entry of judgment, the parties reserve the right to move the Court for appropriate relief. In particular, respondent would oppose any award for future lost earnings and future pain and suffering. 3 CCaassee 11::1199--vvvv--0011557700--UUNNJJ DDooccuummeenntt 6626 FFiilleedd 1112//0052//2244 PPaaggee 46 ooff 46 HEATHER L. PEARLMAN Deputy Director Torts Branch, Civil Division LARA A. ENGLUND Assistant Director Torts Branch, Civil Division /s/ Benjamin P. Warder BENJAMIN P. WARDER Trial Attorney Torts Branch, Civil Division U.S. Department of Justice P.O. Box 146, Ben Franklin Station Washington, DC 20044-0146 Telephone: (202) 532-5464 DATE: November 5, 2024 Email: Benjamin.P.Warder@usdoj.gov 4