VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00959 Package ID: USCOURTS-cofc-1_20-vv-00959 Petitioner: Marla Miller Filed: 2020-08-03 Decided: 2023-07-03 Vaccine: influenza Vaccination date: 2017-11-14 Condition: left shoulder injury related to vaccine administration (SIRVA) Outcome: compensated Award amount USD: 82191 AI-assisted case summary: Marla Miller filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that she suffered a left shoulder injury related to vaccine administration (SIRVA) caused by the influenza vaccine she received on November 14, 2017. The court found that Ms. Miller was entitled to compensation, as her injury met the criteria for a Table SIRVA. She reported experiencing severe pain in her left arm immediately after the vaccination, waking up with excruciating pain that same night, and seeking medical treatment 16 days later. Her primary care physician diagnosed myositis, likely related to the vaccine, and she subsequently saw an orthopedist who diagnosed impingement syndrome. Ms. Miller underwent two cortisone injections and 24 physical therapy sessions over approximately ten months. The respondent initially contested the timing of the onset of symptoms, arguing it was not corroborated by contemporaneous medical records. However, the court found sufficient evidence, including Ms. Miller's affidavit and subsequent medical records, to establish that her pain began within 48 hours of vaccination, satisfying the Table criteria. The court awarded Ms. Miller $80,000.00 for pain and suffering and $2,191.80 for past unreimbursed out-of-pocket expenses, for a total award of $82,191.80. Theory of causation field: Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_20-vv-00959-0 Date issued/filed: 2022-06-16 Pages: 8 Docket text: PUBLIC ORDER/RULING (Originally filed: 04/29/2022) regarding 38 Ruling on Entitlement Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00959-UNJ Document 43 Filed 06/16/22 Page 1 of 8 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-0959V UNPUBLISHED MARLA MILLER, Chief Special Master Corcoran Petitioner, Filed: April 29, 2022 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Findings of Fact; Onset; Influenza HUMAN SERVICES, (Flu) Vaccine; Ruling on Entitlement; Table Injury; Shoulder Injury Related Respondent. to Vaccine Administration (SIRVA) Anne Carrion Toale, Maglio Christopher & Toale, PA, Sarasota, FL, for Petitioner. Mark Kim Hellie, U.S. Department of Justice, Washington, DC, for Respondent. FINDINGS OF FACT AND RULING ON ENTITLEMENT1 On August 3, 2020, Marla Miller 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 left shoulder injury related to vaccine administration (“SIRVA”) caused by the influenza (“flu”) vaccine she received on November 14, 2017. Petition at ¶¶2, 15. The case was assigned to the Special Processing Unit of the Office of Special Masters (the “SPU”). 1 Because this unpublished Ruling 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 Ruling 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 1:20-vv-00959-UNJ Document 43 Filed 06/16/22 Page 2 of 8 For the reasons discussed below, I find that Petitioner has satisfied the requirements of a Table SIRVA, and is therefore entitled to compensation under the Vaccine Act. I. Relevant Procedural History Soon after filing her petition on August 3, 2020, Ms. Miller filed seven medical record exhibits and a Statement of Completion. ECF No. 6-7. Petitioner continued to supplement the record with additional medical records. See ECF No. 13, 17. On October 4, 2021, Respondent filed a status report indicating that he was willing to engage in settlement discussions. ECF No. 21. After a short period of negotiation, however, the parties reached an impasse. ECF No. 26. Accordingly, on February 14, 2022, Petitioner filed a motion for a fact ruling on the issue of onset. ECF No. 30. In his Rule 4(c) Report (filed on March 16, 2022, in response to Petitioner’s motion), Respondent argued that Petitioner has failed to provide preponderant evidence that the onset of her pain occurred within 48 hours of her vaccination. Rule 4(c) Report at 5. Specifically, Respondent maintained that “although Petitioner claims that the onset of her symptoms was immediate, these claims were not corroborated by the contemporaneous medical records.” Id. at 6. Petitioner filed a reply on April 22, 2022 (“Rep.”). ECF 34. Petitioner’s Motion is now ripe for ruling. II. Relevant Factual History a. Pre-Vaccination Medical History Petitioner’s medical records from prior to her vaccination show no significant medical conditions, and specifically no injuries to or medical issues with her left shoulder, neck or arm. See Ex. 6. b. Post-Vaccination Medical History Petitioner received the flu vaccine in her left arm at Walgreens Pharmacy in Palm Springs, Florida on November 14, 2017. Ex. 4 at 5. She first sought medical treatment for her left shoulder pain from her primary care physician, Dr. Milena Jguenti, at Flagler Family Medicine, on November 30, 2017 - 16 days after her vaccination. Ex. 2 at 76. Dr. Jguenti reported that Petitioner complained of “pain in the L arm after flu vaccine 2 weeks 2 Case 1:20-vv-00959-UNJ Document 43 Filed 06/16/22 Page 3 of 8 ago” and noted restricted range of motion. Id (emphasis added). Dr. Jguenti diagnosed Petitioner with myositis, “most likely related to reaction to vaccine injection,” and recommended topical heat application and Voltaren gel. Id. Ms. Miller returned to her primary care physician on December 19, 2017 for follow- up treatment for her left arm pain. Ex. 2 at 71. Nurse Practitioner Joann Fritsch, noted that Petitioner had previously been seen for “L arm pain that started following a flu injection.” Id. at 74 (emphasis added). She prescribed a Medrol Dosepak and ordered an MRI to further evaluate. Id. at 71. On December 27, 2017, Petitioner alerted NP Fritsch that her insurance had denied coverage for the MRI and that xrays needed to be ordered first. Id. at 70. Petitioner had xrays of her left upper arm on December 29, 2017 and an MRI on January 8, 2018, both of which were normal. Id. at 85-86, 88. Following her MRI, Petitioner requested a referral to an orthopedist. Id. at 68. The next year, Ms. Miller presented to orthopedist, Dr. David Gay, on March 23, 2018, for an evaluation of her left shoulder. Ex. 5 at 54. Dr. Gay recorded that Petitioner now reported the date of onset as November 14, 2017, and the context of her injury as “received a flu shot.” Id. Dr. Gay found reduced range of motion and positive impingement signs and diagnosed impingement syndrome of the left shoulder. Id. at 56. Dr. Gay gave Petitioner a cortisone injection and noted “significant improvement with post-injection exam.” Id. Petitioner returned to Dr. Gay on May 7, 2018. Id. at 52. He noted improvement from the initial injection, performed a second cortisone injection, and referred Petitioner to physical therapy for six weeks. Id. at 53-54. Petitioner began physical therapy on May 14, 2018. Ex. 1 at 78. On her intake form, Ms. Miller responded to the question “how and when the injury/disorder occurred” with “Nov. 14, 2017 from a flu shot.” Id. at 23. At her initial evaluation, she reported “left upper arm pain since a flu shot last November that became excruciating.” Id. at 78. She described pain with reaching and tightness at rest. Id. Upon examination, Petitioner exhibited “limited shoulder mobility and lateral shoulder pain with all active motions of the shoulder, limited strength and motor control.” Id. at 79. Petitioner attended a total of 24 PT sessions and then returned to Dr. Gay for a follow up appointment on September 26, 2018. Ex. 1; Ex. 5 at 50. Dr. Gay noted that she had completed “12 weeks of PT with significant improvement.” Id. at 51. Petitioner still had pain with range of motion. Id. He explained that “there may be an additional 4-6 months of improvement” but recommended no additional treatment. Id. at 52. There is nothing in the record as it currently stands to show Petitioner has since obtained further treatment of her left shoulder pain. 3 Case 1:20-vv-00959-UNJ Document 43 Filed 06/16/22 Page 4 of 8 c. Relevant Affidavit Testimony Ms. Miller’s Declaration, filed at Exhibit 12, describes the onset of her left shoulder pain in detail. Specifically, she stated that she “told the pharmacist at the time of the vaccine that it hurt when he gave it to” her. Ex. 12 at ¶2. She remembered waking up “in the middle of the night in excruciating pain (10/10)” and being unable to “put any weight on [her] arm.” Id. She explained that she saw her doctor “after 2 weeks had passed because the pain wouldn’t let up.” Id. Ms. Miller described her pain as “severe” for the first six months after her vaccination, until she began physical therapy. Id. at ¶5. She described her limitations in “performing many activities for around 9-10 months.” Id. at ¶4. III. Findings of Fact A. 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). The Federal Circuit has said that 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, 2005 WL 6117475, at *19. 4 Case 1:20-vv-00959-UNJ Document 43 Filed 06/16/22 Page 5 of 8 The United States Court of Federal Claims has recognized, however, 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). Thus, 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). 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 not only the medical records, testimony, but also 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 & 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). Indeed, as the Federal Circuit recently stated, although later oral testimony that conflicts with medical records is less reliable, it is appropriate for a special master to credit a petitioner’s lay testimony where is does not conflict with contemporaneous records. Kirby v. Sec’y of Health & Human Servs., 997 F.3d 1378, 1382-84 (Fed. Cir. 2021). 5 Case 1:20-vv-00959-UNJ Document 43 Filed 06/16/22 Page 6 of 8 B. Analysis At issue is whether Petitioner’s first symptom or manifestation of onset after vaccine administration occurred within 48 hours as set forth in the Vaccine Injury Table and the second QAI for a Table SIRVA. 42 C.F.R. § 100.3(a) XIV.B.; 42 C.F.R. § 100.3(c)(10)(ii) (required onset for pain listed in the QAI). Respondent argues that Petitioner has failed to provide preponderant evidence that the onset of her pain occurred within 48 hours of her vaccination. Rule 4(c) Report at 5. Specifically, Respondent maintains that “although Petitioner claims that the onset of her symptoms was immediate, these claims were not corroborated by the contemporaneous medical records.” Id. at 5, 6 (general references to pain “after” vaccination are insufficiently precise). In so arguing, Respondent seems to embrace the view that the only way Petitioner can show she experienced symptoms within 48 hours of vaccination is with contemporaneous records that state the date of onset with specificity. However, the very terms of Vaccine Act allow that a “special master … may find the first symptom … of an injury … occurred within the time period described in the Vaccine Injury Table even though the occurrence of such symptom … was not recorded” in contemporaneous medical records. 42 U.S.C. § 300aa-13(b)(2) (emphasis added). Ultimately, resolving how to weigh the evidence on such matters falls within the purview of the special masters. 42 U.S.C. § 300aa-13. In addition, the Program’s standard of preponderance means that this kind of fact issue can be (and often is) resolved in a petitioner’s favor despite a lack of specificity. Special masters weigh all items of evidence collectively – and although they may give some items more weight than others, it is the evidence in its totality that “moves the scale,” as it were. Thus, several reasonable and reliable pieces of evidence supporting a temporal onset claim may satisfy preponderance even if no single item specifically records onset being reported literally within the timeframe specified by the Table. Also relevant is the fact that (in SPU’s experience adjudicating SIRVA claims) injured petitioners often employ vague temporal language, based on their lack of awareness of the importance for Program purposes of specificity. This cannot reasonably be held against petitioners, any more than a delay in seeking treatment (based on the supposition that the shoulder pain will be transient) should be interpreted as weighing against a favorable finding. Taking all of the above into account, there is more than sufficient evidence in this case to support a finding of 48-hour post-vaccination onset as “more likely than not.” In multiple post-vaccination medical records, Petitioner consistently reported left shoulder pain in connection with her vaccination. See Ex. 1, 2, 5. Without fail, Petitioner attributed 6 Case 1:20-vv-00959-UNJ Document 43 Filed 06/16/22 Page 7 of 8 her injury to the flu vaccine she received on November 14, 2017. And Petitioner’s orthopedist and physical therapist noted the specific date in records on March 23, 2018, and May 14, 2018, respectively. Ex. 5 at 54; Ex. 1 at 78. Admittedly, the records from Petitioner’s first two visits for her left shoulder pain (which occurred closest in time to vaccination) are more vague, using language like “L arm pain after flu vaccine 2 weeks ago” (Ex. 2 at 76), or “L arm pain that started following a flu injection” (Id. at 71). But this language does not, when considered against other records, undermine the determination that Table onset was met. No record has been offered in which an onset clearly outside the relevant timeframe was indicated. In addition to the medical records, Petitioner provided affidavit testimony setting forth the immediate onset of pain at the time of vaccination, stating that she “told the pharmacist at the time of the vaccine that it hurt when he gave it to” her. Ex. 12 at ¶2. Petitioner went on to describe being awoken that same night in “excruciating pain (10/10).” Id. These witness statements provide enhancing, corroborative detail for the general notes recorded in the medical records. The Federal Circuit has held that it is appropriate to credit the lay testimony of a petitioner when said testimony does not conflict with the medical records. See Kirby v. Sec’y of Health & Human Servs., 997 F.3d 1378, 1384 (Fed. Cir. 2021) (affirming special master’s finding of severity based on petitioner’s testimony in the absence of contemporaneous medical records). Accordingly, I find there is preponderant evidence to establish the onset of Petitioner’s pain occurred within 48 hours of vaccination.3 IV. Requirements for Table SIRVA Because I have determined the onset of her left shoulder pain occurred within 48 hours of vaccination, Petitioner has fulfilled the second of the four QAI Table criteria. See 42 C.F.R. § 100.3(a)(XIV) (Table entry for SIRVA following influenza vaccine); 42 C.F.R. § 100.3(c)(10)(ii) (second QAI requirement). To establish that she suffered a Table SIRVA, Petitioner must satisfy the additional three QAI requirements. 42 C.F.R. § 100.3(c)(10)(i), (iii), (iv). Respondent has not contested Petitioner’s proof on the other QAI Table criteria. See Rule 4(c) Report. Further, the record in this case contains no indication that Petitioner suffered prior left shoulder issues or pain and reduced range of motion outside the left shoulder. See 42 C.F.R. § 100.3(c)(10)(i), (iii). Nor is there evidence of any other condition 3 I am aware of Petitioner’s frustration that these kinds of objections have held up resolution of the claim. While I deem Respondent’s position to be in good faith, and arising from facially-imprecise language from close-in-time records, Respondent should in future cases not permit this kind of objection to obstruct resolution of a claim that facially is otherwise likely to succeed as a Table claim. 7 Case 1:20-vv-00959-UNJ Document 43 Filed 06/16/22 Page 8 of 8 or abnormality that would explain the left shoulder pain she experienced. See 42 C.F.R. § 100.3(c)(10)(iv). Thus, Petitioner has satisfied all QAI criteria for a Table SIRVA. V. Additional Requirements for Entitlement Because Petitioner has satisfied the requirements of a Table SIRVA, she need not prove causation. Section 11(c)(1)(C). However, she must satisfy the other requirements of Section 11(c) regarding the vaccination received, the duration and severity of her injury, and the lack of other award or settlement. Section 11(c)(A), (B), and (D). The vaccine record shows Petitioner received the flu vaccine in her left arm at a Walgreens Pharmacy in Florida. Ex. 4 at 5; see Section 11(c)(1)(A) (requiring receipt of a covered vaccine); Section 11(c)(1)(B)(i) (requiring administration within the United States or its territories). Additionally, Petitioner has stated that she has not filed any civil action or received any compensation for her vaccine-related injury, and there is no evidence to the contrary. Ex. 3 at ¶4; See Section 11(c)(1)(E) (lack of prior civil award). Finally, the medical records show that more than six months after vaccination, Petitioner continued to suffer the residual effects of her SIRVA. See Section 11(c)(1)(D)(i) (statutory six-month requirement). Petitioner received her vaccination on November 14, 2017. Ex. 4 at 5. Thereafter, she received continuing treatment, with no significant gaps, through at least September 26, 2018, a period of just over ten months. Ex. 1, 2, 5. Thus, Petitioner has satisfied all requirements for entitlement under the Vaccine Act. VI. Conclusion Based on the entire record in this case, I find that Petitioner has provided preponderant evidence satisfying all requirements for a Table SIRVA. Petitioner is entitled to compensation in this case. A separate damages order will be issued. IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 8 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_20-vv-00959-1 Date issued/filed: 2023-07-03 Pages: 10 Docket text: PUBLIC DECISION (Originally filed: 06/01/2023) regarding 52 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (kle) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00959-UNJ Document 53 Filed 07/03/23 Page 1 of 10 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-0959V UNPUBLISHED MARLA MILLER, Chief Special Master Corcoran Petitioner, Filed: June 1, 2023 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Decision Awarding Damages; Pain HUMAN SERVICES, and Suffering; Influenza (Flu) Vaccine; Shoulder Injury Related to Respondent. Vaccine Injury (SIRVA) Anne Carrion Toale, Maglio Christopher & Toale, PA, Sarasota, FL, for Petitioner. Mark Kim Hellie, U.S. Department of Justice, Washington, DC, for Respondent. DECISION AWARDING DAMAGES1 On August 3, 2020, Marla Miller 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 from a shoulder injury related to vaccine administration (“SIRVA”) as a result of an influenza (“flu”) vaccine she received on November 14, 2017. Petition at ¶1, 15. The case was assigned to the Special Processing Unit of the Office of Special Masters. For the reasons discussed below, and after hearing argument from the parties, I find that Petitioner is entitled to compensation in the amount of $82,191.80, representing 1 Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), 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 1:20-vv-00959-UNJ Document 53 Filed 07/03/23 Page 2 of 10 $80,000.00 for actual pain and suffering, plus $2,191.80 for past unreimbursed out-of- pocket expenses. I. Relevant Procedural History Approximately 14 months after this case was initiated, Respondent indicated that he wished to engage in settlement discussions. ECF No. 21. After two months of negotiations, however, the parties reached an impasse and Petitioner filed a Motion for a Fact Ruling. ECF No. 26, 30. A ruling on entitlement was issued on April 29, 2022, finding that Petitioner was entitled to compensation for her SIRVA injury. ECF No. 38. After a short period of additional negotiation, the parties were able to resolve only the award for past unreimbursed out-of-pocket expenses to be paid to Petitioner. ECF No. 44. Petitioner then filed a Motion for Ruling on damages (“Mot.”), Respondent filed a responsive memorandum (“Repl.”), and Petitioner filed a reply (“Repl.”). ECF No. 45-48. I subsequently proposed that the parties be given the opportunity to argue their positions at a motions hearing, at which time I would decide the disputed damages issues. ECF. No. 50. That hearing was held on May 26, 2023,3 and the case is now ripe for a determination. II. Relevant Medical History A complete recitation of the facts can be found in the Petition, the parties’ respective pre-hearing briefs, and in Respondent’s Rule 4(c) Report. Petitioner received a flu vaccine in her left arm on November 14, 2017, in Palm Coast, Florida. Ex. 4 at 4-5. She recalled that she took Tylenol the same day for pain and that she woke that night with excruciating pain (10/10). Ex. 12 at ¶2. On November 30, 2017 (16 days post-vaccination), Petitioner presented to her primary care physician (“PCP”) with complaints of pain in her left arm after her flu vaccine two weeks prior. Ex.2 at 76. On exam, Petitioner had tenderness over the deltoid muscle (injection site) and, although she had normal/full passive range of motion without pain, she was unable to perform active range of motion due to pain. Id. Her treater diagnosed myositis and prescribed Voltaren gel. Id. She recommended that Petitioner use heat and return in a week if it had not resolved. Id. 3 At the end of the hearing held on May 26, 2023, I issued an oral ruling from the bench on damages in this case. That ruling is set forth fully in the transcript from the hearing, which is yet to be filed with the case’s docket. The transcript from the hearing is, however, fully incorporated into this Decision. 2 Case 1:20-vv-00959-UNJ Document 53 Filed 07/03/23 Page 3 of 10 Petitioner returned to her PCP on December 19, 2017 for her annual exam and reported no improvement in her left arm pain. Ex. 2 at 74. She was prescribed a Medrol Dosepak and an MRI was ordered. Id. at 71. Petitioner stated that the Voltaren gel and Medrol Dosepak reduced her pain to 5-7/10, but that it returned after the course of steroids ended. Ex. 12 at ¶2. Petitioner was unable to immediately get an MRI because her insurance required that she have x-rays first. Ex. 2 at 70. She had x-rays of her left humerus and shoulder on December 29, 2017. Both were normal. Id. at 85-86. She had an MRI of her left humerus on January 8, 2018, which was also normal. Id. at 88. On March 28, 2018, Petitioner presented to an orthopedist reporting moderate, aching pain from her flu shot. Ex. 5 at 54-55. On exam, she had reduced range of motion and positive impingement signs. Id. at 56. The treater diagnosed impingement syndrome and administered a cortisone injection. Id. Petitioner returned to the orthopedist less than two months later, on May 7, 2018, reporting improvement since the previous injection. Ex. 5 at 52-53. That treater administered a second cortisone injection and referred Petitioner to physical therapy. Id. at 53-54. On May 14, 2018, Petitioner presented for an initial physical therapy evaluation. Ex. 1 at 25. Petitioner reported pain after her flu shot that “became excruciating.” Id. She noted that the oral steroids had helped but did not last and that she had had two cortisone injections. Id. She reported that she felt pain of 7/10 while reaching and 2/10 soreness at rest. Id. Petitioner attended a total of 24 PT sessions through August 15, 2018. Id. at 28- 78. By July 27, 2018 (after more than two months of PT), Petitioner reported 65% improvement, but that she still had difficulty reaching for her seatbelt. Id. at 39. At her last visit on August 15, 2018 (after three months of PT), Petitioner reported that the only pain remaining was in the back of her shoulder. Id. at 29. Petitioner returned to the orthopedist on September 26, 2018. Ex. 5 at 50. She reported significant improvement from PT, but still had pain with range of motion (although the pain was much better). Id. at 51. On exam, Petitioner’s range of motion had improved and impingement testing was negative. Id. The treater explained that it may take 4-6 more months “if it follows the normal course for frozen shoulder.” Id.at 52. He did not recommend additional intervention. Petitioner did not seek further medical treatment for her shoulder pain. Ex. 12 at ¶3. She stated that after six more months, her shoulder was “much better” with only occasional pain. Id. 3 Case 1:20-vv-00959-UNJ Document 53 Filed 07/03/23 Page 4 of 10 III. The Parties’ Arguments a. Petitioner Ms. Miller seeks an award in the total amount of $92,191.80 consisting of $90,000.00 as compensation for her pain and suffering, plus $2,191.80 for past unreimbursable out-of-pocket expenses (a sum that Respondent does not contest). Mot. at 2, 9. To support her pain and suffering request, Petitioner stressed that her SIRVA injury caused her severe pain and required a significant course of treatment, including two cortisone injections, 24 physical therapy treatments, and over a year to resolve. Id. at 10. During the hearing and in her brief, Petitioner discussed prior SIRVA cases that involved injured claimants with similar fact patterns, and thus argued that an award of $90,000.00 in pain and suffering was reasonable and appropriate given that her circumstances were comparable. b. Respondent Respondent maintains that a pain and suffering award of only $57,500.00 is appropriate, because Petitioner “sustained a comparatively minor injury and received conservative treatment.” Resp. at 4-5. Respondent argued that Ms. Miller’s treatment consisted of two steroid injections and physical therapy, but no narcotic medications or surgery. Id. at 5. Respondent distinguished Petitioner’s cited prior SIRVA case and presented other SIRVA cases as support for his proposed award. Resp. at 5-6. IV. Legal Standard Compensation awarded pursuant to the Vaccine Act shall include “[f]or actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000.” Section 15(a)(4). Additionally, a petitioner may recover “actual unreimbursable expenses incurred before the date of judgment awarding such expenses which (i) resulted from the vaccine- related injury for which the petitioner seeks compensation, (ii) were incurred by or on behalf of the person who suffered such injury, and (iii) were for diagnosis, medical or other remedial care, rehabilitation . . . determined to be reasonably necessary.” Section 15(a)(1)(B). The petitioner bears the burden of proof with respect to each element of 4 Case 1:20-vv-00959-UNJ Document 53 Filed 07/03/23 Page 5 of 10 compensation requested. Brewer v. Sec’y of Health & Hum. Servs., No. 93-0092V, 1996 WL 147722, at *22-23 (Fed. Cl. Spec. Mstr. Mar. 18, 1996). There is no mathematic formula for assigning a monetary value to a person’s pain and suffering and emotional distress. I.D. v. Sec’y of Health & Hum. Servs., No. 04-1593V, 2013 WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May 14, 2013) (“[a]wards for emotional distress are inherently subjective and cannot be determined by using a mathematical formula”); Stansfield v. Sec’y of Health & Hum. Servs., No. 93-0172V, 1996 WL 300594, at *3 (Fed. Cl. Spec. Mstr. May 22, 1996) (“the assessment of pain and suffering is inherently a subjective evaluation”). Factors to be considered when determining an award for pain and suffering include: 1) awareness of the injury; 2) severity of the injury; and 3) duration of the suffering. I.D., 2013 WL 2448125, at *9 (citing McAllister v. Sec’y of Health & Hum. Servs., No 91-1037V, 1993 WL 777030, at *3 (Fed. Cl. Spec. Mstr. Mar. 26, 1993), vacated and remanded on other grounds, 70 F.3d 1240 (Fed. Cir. 1995)). I may also consider prior pain and suffering awards to aid my resolution of the appropriate amount of compensation for pain and suffering in this case. See, e.g., Doe 34 v. Sec’y of Health & Hum. Servs., 87 Fed. Cl. 758, 768 (2009) (finding that “there is nothing improper in the chief special master’s decision to refer to damages for pain and suffering awarded in other cases as an aid in determining the proper amount of damages in this case.”). And, of course, I may rely on my own experience (along with that of my predecessor Chief Special Masters) adjudicating similar claims.4 Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (noting that Congress contemplated that the special masters would use their accumulated expertise in the field of vaccine injuries to judge the merits of individual claims). Although pain and suffering in the past was often determined based on a continuum, as Respondent argues, that practice was cast into doubt by the Court several years ago. See Graves v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 579 (Fed. Cl. 2013). The Graves decision maintained that to do so resulted in “the forcing of all suffering awards into a global comparative scale in which the individual petitioner’s suffering is compared to the most extreme cases and reduced accordingly.” Id. at 589-90. Instead, Graves assessed pain and suffering by looking to the record evidence, prior pain and suffering awards within the Vaccine Program, and a survey of similar injury claims outside of the Vaccine Program. Id. at 593-95. Under this alternative approach, the statutory cap merely cuts off higher pain and suffering awards – it does not shrink the magnitude of all 4 From July 2014 until September 2015, the SPU was overseen by former Chief Special Master Vowell. For the next four years, until September 30, 2019, all SPU cases, including the majority of SIRVA claims, were assigned to former Chief Special Master Dorsey, now Special Master Dorsey. In early October 2019, the majority of SPU cases were reassigned to me as the current Chief Special Master. 5 Case 1:20-vv-00959-UNJ Document 53 Filed 07/03/23 Page 6 of 10 possible awards as falling within a spectrum that ends at the cap. While Graves does not control the outcome of this case, it provides logical guidance that bears on how pain and suffering is calculated. V. Prior SIRVA Compensation Within SPU5 A. Data Regarding Compensation in SPU SIRVA Cases SIRVA cases have an extensive history of informal resolution within the SPU. As of January 1, 2022, 2,371 SPU SIRVA cases have been resolved since the inception of SPU on July 1, 2014. Compensation was awarded in 2,306 of these cases, with the remaining 65 cases dismissed. Of the compensated cases, 1,339 SPU SIRVA cases involved a prior ruling that petitioner was entitled to compensation. In only 88 of these cases was the amount of damages determined by a special master in a reasoned decision. As I have previously stated, the written decisions setting forth such determinations, prepared by neutral judicial officers (the special masters themselves), provide the most reliable precedent setting forth what similarly-situated claimants should also receive.6 1,223 of this subset of post-entitlement determination, compensation-awarding cases, were the product of informal settlement - cases via proffer and 28 cases via stipulation. Although all proposed amounts denote an agreement reached by the parties, those presented by stipulation derive more from compromise than any formal agreement or acknowledgment by Respondent that the settlement sum itself is a fair measure of damages. Of course, even though any such informally-resolved case must still be approved by a special master, these determinations do not provide the same judicial guidance or insight obtained from a reasoned decision. But given the aggregate number of such cases, these determinations nevertheless “provide some evidence of the kinds of awards received overall in comparable cases.” Sakovits, 2020 WL 3729420, at *4 (emphasis in original). The remaining 967 compensated SIRVA cases were resolved via stipulated agreement of the parties without a prior ruling on entitlement. These agreements are often 5 All figures included in this decision are derived from a review of the decisions awarding compensation within the SPU. All decisions reviewed are, or will be, available publicly. All figures and calculations cited are approximate. 6 See, e.g., Sakovits v. Sec’y of Health & Hum. Servs., No. 17-1028V, 2020 WL 3729420, at *4 (Fed. Cl. Spec. Mstr. June 4, 2020) (discussing the difference between cases in which damages are agreed upon by the parties and cases in which damages are determined by a special master). 6 Case 1:20-vv-00959-UNJ Document 53 Filed 07/03/23 Page 7 of 10 described as “litigative risk” settlements, and thus represent a reduced percentage of the compensation which otherwise would be awarded. Due to the complexity of these settlement discussions, many which involve multiple competing factors, these awards do not constitute a reliable gauge of the appropriate amount of compensation to be awarded in other SPU SIRVA cases. The data for all groups described above reflect the expected differences in outcome, summarized as follows: Damages Proffered Stipulated Stipulated7 Decisions by Damages Damages Agreement Special Master Total Cases 88 1,223 28 967 Lowest $40,757.91 $25,000.00 $45,000.00 $5,000.00 1st Quartile $70,950.73 $70,000.00 $90,000.00 $42,500.00 Median $95,974.09 $90,000.00 $122,886.42 $60,390.00 3rd Quartile $125,269.46 $116,662.57 $161,001.79 $88,051.88 Largest $265,034.87 $1,845,047.00 $1,500,000.00 $550,000.00 B. Pain and Suffering Awards in Reasoned Decisions In the 88 SPU SIRVA cases which required a reasoned damages decision, compensation for a petitioner’s actual or past pain and suffering varied from $40,000.00 to $210,000.00, with $94,000.00 as the median amount. Only five of these cases involved an award for future pain and suffering, with yearly awards ranging from $250.00 to $1,500.00.8 In cases with lower awards for past pain and suffering, many petitioners commonly demonstrated only mild to moderate levels of pain throughout their injury course. This lack of significant pain is often evidenced by a delay in seeking treatment – over six months in one case. In cases with more significant initial pain, petitioners experienced this greater pain for three months or less. All petitioners displayed only mild to moderate limitations in range of motion (“ROM”), and MRI imaging showed evidence of mild to moderate pathologies such as tendinosis, bursitis, or edema. Many petitioners suffered from unrelated conditions to which a portion of their pain and suffering could be attributed. These SIRVAs usually resolved after one to two cortisone injections and two months or 7 Two awards were for an annuity only, the exact amounts which were not determined at the time of judgment. 8 Additionally, a first-year future pain and suffering award of $10,000.00 was made in one case. Dhanoa v. Sec’y of Health & Hum. Servs., No. 15-1011V, 2018 WL 1221922 (Fed. Cl. Spec. Mstr. Feb. 1, 2018). 7 Case 1:20-vv-00959-UNJ Document 53 Filed 07/03/23 Page 8 of 10 less of physical therapy (“PT”). None required surgery. The duration of the injury ranged from six to 30 months, with most petitioners averaging approximately nine months of pain. Although some petitioners asserted residual pain, the prognosis in these cases was positive. Only one petitioner provided evidence of an ongoing SIRVA, and it was expected to resolve within the subsequent year. Cases with higher awards for past pain and suffering involved petitioners who suffered more significant levels of pain and SIRVAs of longer duration. Most of these petitioners subjectively rated their pain within the upper half of a ten-point pain scale and sought treatment of their SIRVAs more immediately, often within 30 days of vaccination. All experienced moderate to severe limitations in range of motion. MRI imaging showed more significant findings, with the majority showing evidence of partial tearing. Surgery or significant conservative treatment, up to 95 PT sessions over a duration of more than two years and multiple cortisone injections, was required in these cases. In four cases, petitioners provided sufficient evidence of permanent injuries to warrant yearly compensation for future or projected pain and suffering. VI. Appropriate Compensation in this SIRVA Case a. Awareness of Suffering Awareness of suffering is not typically a disputed issue in cases involving SIRVA – and it does not appear to be here. Based on the circumstances of this case, I find that Ms. Miller had full awareness of her pain and suffering. b. Severity and Duration of Pain and Suffering With respect to the severity and duration of the injury, Ms. Miller’s medical records and affidavit reveal a moderate, non-surgical SIRVA injury. Ms. Miller was treated by her PCP and an orthopedist, was prescribed steroid medication, had two cortisone injections, had x-rays and one MRI, and participated in 24 physical therapy sessions. She described moderate to severe pain (between 7/10 and 10/10) at the beginning of her injury, which reduced over the course of treatment. See Ex. 1 at 25; Ex. 12 at ¶2, 5. Ms. Miller treated her injury for approximately ten months with good results, although she described ongoing mild symptoms for an additional six months before full recovery. Ex. 12 at ¶4-5. All of the above suggest that the appropriate award in this case is “below median,” especially given the absence of any surgical intervention – and neither side has requested that the pain and suffering component to be awarded should exceed $100,000.00. Petitioner relied primarily on Bruegging v. Secretary of Health & Human Services, No 17-0261V, 2019 WL 2620957 (Fed. Cl. Spec. Mstr. May 13, 2019) in support of her 8 Case 1:20-vv-00959-UNJ Document 53 Filed 07/03/23 Page 9 of 10 proposed award. The Bruegging petitioner was awarded $90,000 in pain and suffering for a SIRVA injury that caused severe pain for 6-8 months and required two cortisone injections, an MRI and 12 sessions of occupational therapy. Id. at *1-2. Although Bruegging is a reasonable comparable decision, Ms. Miller’s severe pain moderated over the course of her treatment. Further, as Bruegging was decided several years ago (and at a time when there was a lesser body of reasoned decisions available for comparison), I give it somewhat less weight than more recent SIRVA decisions. Respondent cited two cases to support his proposed pain and suffering award of $57,500: Rayborn v. Secretary of Health & Human Services, No. 18-0226, 2020 WL 5522948 (Fed. Cl. Spec. Mstr. Aug. 14, 2020)9 and Lucchesi v. Secretary v. Health & Human Services, No. 19-0943, 2021 WL 5119145 (Fed. Cl. Spec. Mstr. Oct. 4, 2021). Resp. at 5-6. I find Lucchesi to be a fair comparable, but a bit low in result considering that Ms. Miller’s injury required significantly more PT. Further, Respondent bases his argument, at least in part, on the fact that the petitioners in Rayborn and Lucchesi had abnormal findings on their MRIs, while Ms. Miller’s MRI was normal. Resp. at 5-6. However, Ms. Miller had an MRI of her humerus only, and only x-ray imaging of her shoulder, which suggests any comparison of findings is not useful in determining Ms. Miller’s pain and suffering. In addition to the parties’ proposed comparable cases, I deem the present action to be factually similar to another recent case: Russano v. Secretary of Health & Human Servs., No. 18-0392V, 2020 WL 3639804 (Fed. Cl. Spec. Mstr. June 4, 2020). In Russano, a petitioner sought treatment for her SIRVA 17 days after her vaccination, initially rated her pain at 8/10 to 9/10, had one MRI and one cortisone injection, and did 23 sessions of physical therapy over an eight-month period. Id. at 1. Ms. Russano was awarded $80,000 in pain and suffering. Id. at *4. Although Ms. Miller had one additional cortisone injection and treated for a bit longer than Ms. Russano, Ms. Russano was a breast cancer survivor, which complicated her recovery from her SIRVA and justified a slightly higher pain and suffering award. Id. at 3-4. On balance, Russano provides a good comparable to Ms. Miller’s experience. Under such circumstances and considering the arguments presented by both parties at the hearing, a review of the cited cases, and based on the record as a whole, I find that $80,000.00 in compensation for past pain and suffering is reasonable and appropriate in this case. 9 The Rayborn petitioner was awarded $55,000 in pain and suffering after a treatment course consisting of an MRI, one cortisone injection and some occupational therapy after a four-month delay in seeking treatment. Rayborn, 2020 WL 5522948 at *2-3. It is clear that Ms. Miller’s injury was more severe than that of the Rayborn petitioner and there was no delay in seeking treatment, making Rayborn clearly distinguishable. 9 Case 1:20-vv-00959-UNJ Document 53 Filed 07/03/23 Page 10 of 10 c. Award for Past Unreimbursed Expenses Ms. Miller requests $2,191.80 in past unreimbursable expenses. Mot. at 2. Respondent does not dispute this sum (See Resp. at 1), and therefore Petitioner is awarded this sum without adjustment. CONCLUSION In light of all of the above, the I award Petitioner a lump sum payment of $82,191.80, (representing $80,000.00 for Petitioner’s actual pain and suffering and $2,191.80 for unreimbursable out-of-pocket expenses) in the form of a check payable to Petitioner, Marla Miller. This amount represents compensation for all damages that would be available under Section 15(a) of the Vaccine Act. Id. The clerk of the court is directed to enter judgment in accordance with this Decision.10 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 10 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. 10