VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00559 Package ID: USCOURTS-cofc-1_18-vv-00559 Petitioner: Wanda Rodgers Filed: 2018-04-18 Decided: 2022-02-01 Vaccine: influenza Vaccination date: 2016-09-13 Condition: Shoulder injury related to vaccine administration (SIRVA) Outcome: compensated Award amount USD: 120658 AI-assisted case summary: Wanda Rodgers filed a petition alleging that she suffered shoulder injuries related to vaccine administration (SIRVA) in both her right and left shoulders, caused by the influenza and Tdap vaccines she received on September 13, 2016. The court found that her injuries met the criteria for Table SIRVAs. The medical records indicated that Ms. Rodgers experienced pain in both arms shortly after vaccination, which persisted for approximately ten months. She sought treatment, including multiple cortisone injections, and her right shoulder MRI showed degenerative tearing. The respondent argued that her pain was not limited to the injection site and that she had prior conditions that could explain her symptoms. However, the court found that her prior conditions, such as brachial venous occlusion and lipomas, did not explain the shoulder pain. The court determined that Ms. Rodgers' injuries satisfied the Table SIRVA definition, including the requirement of no prior shoulder pain that would explain the symptoms and that the pain occurred within 48 hours of vaccination. The case proceeded to damages, where the parties could not agree on an amount. The court awarded Ms. Rodgers $117,500.00 for pain and suffering and $3,158.26 for past unreimbursable expenses, for a total award of $120,658.26. The court noted that while Ms. Rodgers suffered bilateral injuries, her pain was generally less severe than in some other SIRVA cases, and she experienced significant relief from injections. The court also considered that she had unrelated pain during the period of her injury. Theory of causation field: Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_18-vv-00559-0 Date issued/filed: 2020-04-14 Pages: 8 Docket text: PUBLIC ORDER/RULING (Originally filed: 03/11/2020) regarding 36 Findings of Fact & Conclusions of Law, Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:18-vv-00559-UNJ Document 39 Filed 04/14/20 Page 1 of 8 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 18-0559V UNPUBLISHED WANDA RODGERS, Chief Special Master Corcoran Petitioner, Filed: March 11, 2020 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Findings of Fact; Site of Vaccination HUMAN SERVICES, Tetanus Diphtheria acellular Pertussis (Tdap) Vaccine; Influenza Respondent. (Flu) Vaccine; Shoulder Injury Related to Vaccine Administration (SIRVA) Isaiah Richard Kalinowski, Maglio Christopher & Toale, PA, Washington, DC, for petitioner. Mallori Browne Openchowski, U.S. Department of Justice, Washington, DC, for respondent. FINDINGS OF FACT1 On April 18, 2018, Wanda Rodgers 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 shoulder injuries related to vaccine administration (“SIRVAs”) in both right and left shoulders casually related to the influenza (“Flu”) and tetanus, diphtheria, acellular pertussis (“Tdap”) vaccinations which she received on September 13, 2016. Petition at ¶¶ 3, 14, 17. Petitioner maintains that the 1 Because this unpublished fact 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 fact 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 “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:18-vv-00559-UNJ Document 39 Filed 04/14/20 Page 2 of 8 vaccine record, which indicates she received both vaccinations in her left deltoid, is erroneous, and that in fact she received one vaccination in each arm. Petition at ¶ 3; see Exhibit 1 at 65 (vaccine record). The case was assigned to the Special Processing Unit of the Office of Special Masters. For the reasons discussed below, I find Petitioner received one vaccination in her left deltoid, and the other vaccination in her right deltoid. I. Relevant Procedural History Shortly after filing her petition, Ms. Rodgers filed her medical records and a statement of completion. Exhibits 1-4 and Statement of Completion, filed Apr. 19, 2018, ECF Nos. 4-5. Following the initial status conference, she filed her affidavit. Exhibit 5, filed July 30, 2018, ECF No. 11. On March 1, 2019, Respondent filed a status report indicating he believed additional medical records were outstanding -- specifically physical therapy (“PT”) records and additional documentation regarding the sites of vaccination. ECF No. 19. On May 6, 2019, Petitioner filed her PT records and updated medical records from her orthopedist. Exhibits 6-7, ECF No. 21. Petitioner also filed a document titled “Objections” arguing that Respondent improperly included his request for additional documentation regarding the sites of vaccination in a status report and requesting that Respondent be required to file his Rule 4(c) report. ECF No. 22. A call was scheduled for May 23, 2019. During the call, the parties discussed how best to handle the issue regarding the sites of vaccination in this case. Petitioner was allowed time to provide any additional evidence she could obtain regarding the administration of the vaccinations alleged as causal and to state her preference regarding the next step in the case. Order, issued May 24, 2019, ECF No. 23. In the order, it was noted that Respondent would be allowed to provide his preference thereafter. Id. On August 8, 2019, Petitioner filed additional evidence, obtained from the vaccine administrator, Petitioner’s primary care provider (“PCP”) Dr. Katzen, regarding the general practice followed by personnel at the clinic when administering two vaccinations, the method by which vaccine records are created, documentation of calls Petitioner made to the clinic in October and November 2016, and a duplicate copy of the medical record for Petitioner’s visit to the clinic on October 4, 2016. Exhibit 8, ECF No. 28. Thereafter, the staff attorney contacted the parties by email correspondence regarding their preferred next step. The parties agreed that Petitioner should file a motion, requesting a factual finding regarding the sites of vaccination. Order, issued Aug. 12, 2019, ECF No. 30. On October 15, 2019, Petitioner filed her motion for a factual finding with a supporting memorandum attached. Motion for Finding of Fact Regarding Injection Site, ECF No 31; Petitioner’s Memorandum of Law in Support of Petitioner’s Motion for Finding 2 Case 1:18-vv-00559-UNJ Document 39 Filed 04/14/20 Page 3 of 8 of Fact Regarding Injection Site, ECF 31-1. Approximately one month later, on November 14, 2019, Respondent filed his response. Respondent’s Response to Petitioner’s Motion for Ruling on the Record (“Res. Response”), ECF No. 33. On November 26, 2019, Petitioner filed a reply. Petitioner’s Reply Memorandum in Support of Petitioner’s Motion for Finding of Fact Regarding Injection Site, ECF No. 34. II. Issue At issue is whether the vaccines alleged as causal in this case were administered, one in each arm, as Petitioner alleges, or both in her left deltoid as indicated in the vaccine record. Both vaccines are covered by the Vaccine Program, and Petitioner alleges that she suffered SIRVAs in both shoulders. 42 C.F.R. § 100.3(a) I., II., XIV. (2017) (most recent Vaccine Table including the Flu and Tdap vaccines). III. Authority Pursuant to Vaccine Act § 13(a)(1)(A), a petitioner must prove, by a preponderance of the evidence, the matters required in the petition by Vaccine Act § 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. § 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. 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 3 Case 1:18-vv-00559-UNJ Document 39 Filed 04/14/20 Page 4 of 8 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). 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.” § 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). IV. Finding of Fact I make this finding after a complete review of the record to include all medical records, affidavits, testimony, expert reports, respondent’s Rule 4 report, and additional evidence filed. Specifically, I base the finding on the following evidence: • On September 13, 2016, at an appointment with her PCP, Petitioner received the Flu and Tdap vaccinations. Exhibit 1 at 65. • On October 4, 2016, Petitioner called the clinic of her PCP (Dr. Katzen), where she received the vaccinations in question, complaining of soreness in both arms after receiving the Flu and Tdap vaccinations the prior month. Exhibit 8 at 2. Petitioner first spoke to an individual who reported Petitioner “still cannot bring her arm over her head without pain since her last vaccines 3 weeks ago.” Id. The call was routed another individual at the clinic. After 4 Case 1:18-vv-00559-UNJ Document 39 Filed 04/14/20 Page 5 of 8 speaking to Petitioner, this individual noted Petitioner “c/o[3] soreness on both arms from when she got the Flu and Tdap vaccine on 9-13-16” and “can’t sleep cause no matter which side she turns, her arms hurt.” Id. (emphasis added). Petitioner’s PCP indicated that he wished to see Petitioner. Id. • At her appointment that same day, Petitioner repeated her complaint of pain in both arms after receiving the Flu and Tdap vaccinations on September 2016.4 Exhibit 1 at 2 (indicating “c/o both arms are very painful”). When examining Petitioner, Dr. Katzen observed that she had bilateral tautness and pain. Exhibit 1 at 3 (indicating “B/l[5] deltoid taut and painful”). • Petitioner called her PCP three more times during the month on October 7, 13, and 27, 2016. Exhibit 8 at 8-12. The notes from the October 27, 2016 call indicate Petitioner wished “to speak with staff about her injection site[6]” and that she had come “in for her flu and Tdap shot and then discovered pain in her shoulders after her injections were given.” Id. at 8. • When visiting her surgeon, Dr. Rivera, on November 8, 2016, Petitioner indicated she wished to postpone surgery on her right medial arm and right medial knee masses[7] because she was having soreness from immunizations. Exhibit 2 at 12-13. • Petitioner called her PCP again on November 10, 2016. Exhibit 8 at 7. On that call, Petitioner “stated her arms/shoulder pain is about the same, not better.” Id. (emphasis added). • At her initial visit with Dr. Campbell at Southwest Arthritis Research Group on February 1, 2017, Petitioner indicated that, after receiving the Flu and Tdap vaccinations in October or November, “she developed swelling in her lateral shoulders (near injection sites) and pain in her shoulders.” Exhibit 3 3 The abbreviation “c/o” can stand for the phrase “complains of”. MEDICAL ABBREVIATIONS at 141 (16th ed. 2020). 4 The exact date in this record is listed as September 16, 2016. Exhibit 1 at 2. However, as noted earlier in this ruling, the correct date of vaccination is September 13, 2016. Exhibit 1 at 65. 5 It appears this abbreviation stands for “bilateral”. MEDICAL ABBREVIATIONS at 89 (indicating the abbreviation “BL” can mean bilateral). 6 Although this entry uses the singular site, instead of sites, it also references to two vaccination. Exhibit 8 at 8. Thus, it appears the use of the singular site was a simple mistake. 7 When she received the vaccinations alleged as causal in this case, Petitioner was visiting her PCP for follow-up regarding these two masses. Exhibit 1 at 62. At that visit, she indicated she had these lipomas for five years, that the lipoma on her knee was increasing in size and painful, and that the lipoma on her right arm hurt when she exercised. She requested this surgical referral at that visit. Id. A lipoma is “a benign, soft, rubbery, encapsulated tumor of adipose tissue, usually composed of mature fat cells.” DORLAND’S ILLUSTRATED MEDICAL DICTIONARY (“DORLAND’S”) at 1063 (32th ed. 2012). 5 Case 1:18-vv-00559-UNJ Document 39 Filed 04/14/20 Page 6 of 8 at 7. She indicated she “was diagnosed with cellulitis and treated with bactrim.” Id. • When Petitioner was first seen by an orthopedist on April 5, 2017, she indicated “[s]he had vaccines in both shoulders back in September.” Exhibit 4 at 5. She described her pain as immediate, present for six months. The orthopedist, Dr. Flanagin, opined that Petitioner’s “[s]ymptoms seem consistent with SIRVA” and injected both shoulders with lidocaine and Kenalog. Id. at 7-8. • At her initial PT appointment, Petitioner reported that both her shoulders became swollen after receiving the Flu and Tdap vaccinations. Exhibit 7 at 13, 17. This history is included in the medical records from each subsequent session. Id. at 20, 23, 26, 29, 32, 35, 38, 41, 47, 50, 53. • Petitioner’s PCP provided written responses to questions posed by Petitioner’s counsel. According to these written responses, the clinic’s policy is to administer vaccines in both shoulders when administering more than one vaccine. Exhibit 8 at 1. Furthermore, the vaccination administration site “is documented in an electronic health record, with a ‘drop down’ box, where the person administering the vaccination selects the administration location.” Id. The above medical entries show Petitioner consistently reported pain and/or soreness in both shoulders after receiving the Flu and Tdap vaccinations. Although Petitioner generally referred to the location of her symptoms, rather than the injections themselves, the inference that she received the vaccinations in both shoulders is clear. At her April 5, 2017 visit to her orthopedist, Petitioner specifically stated that the September vaccinations were administered in both shoulders. Exhibit 4 at 5. At a February 1, 2017 visit to Dr. Campbell she described her bilateral swelling as occurring “near site injections”. Exhibit 3 at 7. Petitioner made five of these representations within 60 days of vaccination, to individuals at her PCP’s clinic where she received the vaccines. The documentation regarding these complaints contain no evidence that individuals at the clinic disagreed with or attempted to contradict Petitioner’s representation that she received the vaccines alleged as causal in both shoulders. Furthermore, when seen by her PCP on October 4, 2016, 21 days after vaccination, he observed tautness and pain in both shoulders. Exhibit 1 at 3. Respondent argues that the histories provided by Petitioner in the more contemporaneously created medical records should be given little weight since they are derived from information provided by Petitioner. Res. Response at 6. Respondent seems to argue these histories should be afforded the same weight as later allegations made by a petitioner in a vaccine proceeding. Id. (quoting § 13(a)(1) (“the spcial master . . . may not make such a finding . . . based on the claims of a petitioner alone, unsubstantiated by medical record or medical opinion”). However, the Federal Circuit has stated that “[m]edical records, in general, warrant consideration as trustworthy evidence . . . [as they] contain information supplied to or by health professionals to facilitate diagnosis and 6 Case 1:18-vv-00559-UNJ Document 39 Filed 04/14/20 Page 7 of 8 treatment of medical conditions.” Cucuras, 993 F.2d at 1528 (emphasis added). Thus, the Circuit has instructed that greater weight should be accorded to this information even when the information is provided by Petitioner. The record evidence, by contrast, is somewhat thinner in supporting administration having only occurred in one arm -- although the document that says so is the vaccine record itself. Exhibit 1 at 65. But Petitioner has offered persuasive arguments for why this record should not be taken at face value. As indicated in the documentation provided by Petitioner’s PCP, in filing out a vaccine administration record, the administrator would note the site of vaccination in an electronic record, using a “drop down” box. This method of documentation requires less effort on the part of the administrator than other methods, such as a written notation or requirement to circle left or right deltoid. Given that Petitioner received two vaccinations that day, it is reasonable to infer that the administrator mistakenly clicked the “drop down” box for left deltoid both times. It is unlikely that the vaccine administrator or Petitioner would have noticed this type of mistake. Additionally, Petitioner’s PCP has noted the general practice at his clinic is to administer one vaccine in each arm. Exhibit 8 at 1. Although Petitioner was experiencing lipomas on her right arm and knee which had existed for five years, the location of the mass on her right arm should not have caused the vaccine administrator to deviate from this general practice. As noted in the medical records from Petitioner’s surgeon, Dr. Rivera, the lipomas were located on the medial right arm and medial right knee. Medial means “pertaining to the middle; closer to the median plane or the midline of a body or structure.” DORLAND’S at 1118. Thus, it appears Petitioner’s lipomas were located lower on her arm, possibly on the inner part of her elbow and the inner side of her right knee. This placement would not have caused the vaccine administrator to avoid injecting Petitioner’s right shoulder. In fact, the medical record from that September 13, 2016 visit indicates Petitioner’s blood pressure was taken on her right arm. Exhibit 1 at 63. Additionally, it appears that Petitioner received an influenza vaccination in her right upper arm in October 2012, at a time when her lipomas were most likely present. Exhibit 1 at 90. There is one other entry (from the record of Petitioner’s October 4, 2016 call to her PCP) which would support the proposition that Petitioner received both vaccines in her left deltoid. This record is from the individual who first answered Petitioner’s call, and indicates Petitioner purported that she could not raise her arm (singular) due to the vaccines she received. Exhibit 8 at 2. However, that entry is contradicted by the note from the individual to whom the call was transferred and history provided by Petitioner at the visit later that same day. Those entries clearly indicate Petitioner complained of soreness and pain in both shoulders. Exhibit 1 at 2; Exhibit 8 at 2, 4. Accordingly, I find there is preponderant evidence to establish the two vaccinations alleged as causal in this case were administered on September 13, 2016, one in Petitioner’s left deltoid and one in Petitioner’s right deltoid. V. Scheduling Order Given my finding of fact regarding the site of Petitioner’s vaccinations, Respondent should evaluate and provide his current position regarding the merits of Petitioner’s case. 7 Case 1:18-vv-00559-UNJ Document 39 Filed 04/14/20 Page 8 of 8 Respondent shall file a Status Report regarding his current position by no than Friday, April 10, 2020. IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 8 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_18-vv-00559-1 Date issued/filed: 2021-10-13 Pages: 16 Docket text: PUBLIC ORDER/RULING (Originally filed: 09/09/2021) regarding 57 Ruling on Entitlement Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 1 of 16 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 18-0559V UNPUBLISHED WANDA RODGERS, Chief Special Master Corcoran Petitioner, Filed: September 9, 2021 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Entitlement; Table Injury; Ruling on HUMAN SERVICES, the Record Without Hearing; Influenza (Flu) Vaccine; Tetanus, Respondent. Diphtheria, acellular Pertussis (“Tdap”) Vaccine; Shoulder Injury Related to Vaccine Administration (SIRVA) Isaiah Richard Kalinowski, Maglio Christopher & Toale, PA, Washington, DC, for Petitioner. Mallori Browne Openchowski, U.S. Department of Justice, Washington, DC, for Respondent. RULING ON ENTITLEMENT1 On April 18, 2018, Wanda Rodgers 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 alleged that she suffered shoulder injuries related to vaccine administration (“SIRVAs”) in both right and left shoulders which meet the criteria for Table 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 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 2 of 16 SIRVAs and were casually related to the influenza (“flu”) and tetanus, diphtheria, acellular pertussis (“Tdap”) vaccines she received on September 13, 2016. Petition at ¶¶ 3, 14, 17. The case was assigned to the Special Processing Unit of the Office of Special Masters (the “SPU”). Based on the record as a whole and for the reasons discussed below, I find Petitioner suffered two SIRVAs - one in each shoulder - which satisfy the Table SIRVA definition. Furthermore, I find by preponderant evidence that Petitioner is entitled to compensation under the Vaccine Act. I. Relevant Procedural History From April through July 2018, Ms. Rodgers filed the affidavit and medical records required under the Vaccine Act. Exhibits 1-5, ECF Nos. 4, 11; see Section 11(c). During the remainder of 2018 and 2019, the parties discussed a factual issue regarding the site of vaccination,3 and Petitioner filed additional documentation and updated medical records. Exhibits 6-8, ECF Nos. 21, 28; Status Reports, ECF Nos. 19, 24, 29; Status Conference held May 23, 2019. On March 11, 2020, I issued a fact ruling, finding the two vaccines Petitioner received had been administered one in each arm, as she alleged. ECF No. 36. During March through August 2020, the parties attempted to reach an informal settlement in the case. See, e.g., Status Report, ECF No. 44. On August 26, 2020, they informed me they had reached an impasse in their settlement discussions. Status Report, ECF No. 45. On October 30, 2020, Respondent filed his Rule 4(c) Report, setting out his objections to compensation. ECF No. 47. On January 6, 2021, I held a call with the parties to discuss entitlement. See Scheduling Order, issued Jan. 6, 2021, ECF No. 48. After providing my initial impressions regarding the arguments made by Respondent in his Rule 4(c) Report, I outlined a briefing schedule. I informed Petitioner’s counsel that, if I was unable to resolve entitlement in favor of Petitioner, I would be transferring the case out of SPU. Id. The parties completed their briefing on March 24, 2021. ECF Nos. 49-52, 55-56. 3 The vaccine record indicates that Petitioner received both the flu and Tdap vaccines in her left deltoid. Exhibit 1 at 65. 2 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 3 of 16 II. Relevant Factual History The medical records show Petitioner suffered prior conditions, including brachial venous occlusion,4 which caused pain down her arms (Exhibit 1 at 102), and cervical radiculopathy (id. at 61). See id. at 8-150. At the September 13, 2016 visit to her primary care provider (“PCP”) when she received the flu and Tdap vaccinations alleged as causal, Petitioner sought a surgical referral for the removal of lipomas5 on her right arm and knee. Exhibit 1 at 62, 65. Indicating they had existed for approximately five years, she described the lipoma on her knee as increasing in size and the lipoma on her right arm as “hurting when working out.” Id. at 62. Less than a month later, on October 4, 2016, Petitioner called the clinic of her PCP (Dr. Kevin Katzen), where she received the vaccinations in question, complaining of soreness in both arms after receiving the flu and Tdap vaccines during the prior month. Exhibit 8 at 2. Petitioner first spoke to an individual who reported Petitioner “still cannot bring her arm over her head without pain since her last vaccines 3 weeks ago.” Id. The call was routed to another individual at the clinic. After speaking to Petitioner, this individual noted Petitioner “c/o[6] soreness on both arms from when she got the Flu and Tdap vaccine on 9-13-16” and “can’t sleep cause no matter which side she turns, her arms hurt.” Exhibit 8 at 2. Petitioner’s PCP indicated that he wished to see Petitioner. Id. At her appointment that same day, Petitioner repeated her complaint of pain in both arms after receiving the flu and Tdap vaccinations in September 2016.7 Exhibit 1 at 2 (indicating “c/o both arms are very painful”). When examining Petitioner, Dr. Katzen observed no warmth or swelling but bilateral tautness and pain. Id. at 3 (indicating “B/l[8] deltoid taut and painful”). Petitioner called her PCP three more times during that month, on October 7, 13, and 27, 2016. Exhibit 8 at 8-12. The notes from the October 27, 2016 call indicate 4 Brachial venous occlusion is the blockage of blood flow through the veins in the upper arm. DORLAND’S ILLUSTRATED MEDICAL DICTIONARY (“DORLAND’S”) at 244, 1311, 2046 (32th ed. 2012). 5 A lipoma is “a benign, soft, rubbery, encapsulated tumor of adipose tissue, usually composed of mature fat cells.” DORLAND’S at 1063. 6 The abbreviation “c/o” can stand for the phrase “complains of”. MEDICAL ABBREVIATIONS at 141 (16th ed. 2020). 7 The exact date in this record is listed as September 19, 2016. Exhibit 1 at 2. However, as noted earlier in this Ruling, the correct date of vaccination is September 13, 2016. Exhibit 1 at 65. 8 It appears this abbreviation stands for “bilateral”. MEDICAL ABBREVIATIONS at 89 (indicating the abbreviation “BL” can mean bilateral). 3 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 4 of 16 Petitioner wished “to speak with staff about her injection site[9]” and that she had come “in for her flu and Tdap shot and then discovered pain in her shoulders after her injections were given.” Exhibit 8 at 8. During these calls, Petitioner requested additional and stronger antibiotics to rid her of the cellulitis she was experiencing and referenced a cortisone injection she claims to have received at the October 4, 2016 urgent care appointment with her PCP. Id. at 8, 11. Although there is no reference to a cortisone injection in the record from the October 4, 2016 visit (see Exhibit 1 at 2-7), in her affidavit, Petitioner claims her PCP “agreed to provide steroid injections at no charge in order to appease [her].” Exhibit 5 at ¶ 9. When visiting her surgeon, Dr. Julio Rivera, on November 8, 2016, Petitioner indicated she wished to postpone surgery on her right medial arm and right medial knee masses because she was having soreness from immunizations. Exhibit 2 at 12-13. Petitioner called her PCP again on November 10, 2016. Exhibit 8 at 7. On that call, Petitioner “stated her arms/shoulder pain is about the same, not better.” Id. She described the pain as worse when she was still and lying down but better as long as she is moving during the day. Id. She indicated she was unaware that Keflex10 had been prescribed for her and thus, had not yet picked it up. Exhibit 8 at 7. At her initial visit with Dr. Carmen Campbell at Southwest Arthritis Research Group on February 1, 2017, between four to five months post-vaccination, Petitioner indicated that, after receiving the flu and Tdap vaccines in October or November, “she developed swelling in her lateral shoulders (near injection sites) and pain in her shoulders.” Exhibit 3 at 7. She further indicated that she “was diagnosed with cellulitis and treated with bactrim.” Id. In addition to pain in her shoulder joints, Petitioner reported pain in her thumbs which radiated up her arms, pain in her wrists, and ten to fifteen minutes of stiffness in the mornings. To treat these symptoms, Petitioner indicated that she takes Advil pm at night which “partially alleviates her symptoms,” uses a gel in the morning, but has not attended physical therapy (“PT”). Id. Dr. Campbell indicated that she suspected Petitioner’s thumb and wrist pain was caused by underlying osteoarthritis, adding that she would evaluate that premise after reviewing x-rays of these areas. Exhibit 3 at 9. Regarding Petitioner’s shoulder pain, Dr. Campbell opined that its etiology was “unclear.” Id. She listed differential causes of rotator 9 Although this entry uses the singular site, instead of sites, it also references to two vaccination. Exhibit 8 at 8. Thus, I previously found that the use of the singular site was a simple mistake. Fact Ruling at 5 n.6, ECF No. 36. 10 Keflex is a cephalosporin antibiotic used to treat a wide variety of bacterial infections. See https://www.webmd.com/drugs/2/drug-6859/keflex-oral/details (last visited Aug. 31, 2021). 4 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 5 of 16 cuff tendinopathy, bursitis, and osteoarthritis, noting that Petitioner’s presentation would be atypical for rheumatoid arthritis. She prescribed x-rays and indicated she would consider an MRI of Petitioner’s right shoulder if needed. Id. On March 10, 2017, Petitioner underwent an MRI of her right shoulder which revealed partial tearing of the supraspinatus and subscapularis tendons, degenerative tearing of the superior labrum, mild AC joint arthrosis, and mild subacromial subdeltoid bursitis. Exhibit 4 at 31. On April 4, 2017, Petitioner returned to the rheumatologist, Dr. Campbell. Exhibit 3 at 10. Noting that Petitioner “continues to experience bilateral shoulder pain,” Dr. Campbell addressed the “multiple structural abnormalities” shown on Petitioner’s March 10, 2017 right shoulder MRI. Id. Upon examination, she observed limitations in Petitioner’s range of motion, noted as greater for her right shoulder than left. Id. at 11. Petitioner also reported intermittent stiffness bilaterally in her thighs. Id. at 10. Dr. Campbell referred Petitioner to an orthopedist for her shoulder pain and structural abnormalities on the MRI and prescribed PT for Petitioner’s bilateral thigh/hip tightness. Id. at 12. When Petitioner was first seen by an orthopedist on April 5, 2017, she indicated “[s]he had vaccines in both shoulders back in September . . . [and] started having pain immediately after that.” Exhibit 4 at 6. She described her pain as constant, immediate, and present for six months, adding that it was worse on her right side than left. She indicated her pain increased with activity, work, and lifting anything over 25 pounds and decreased with hot showers. She reported that her rheumatologist had prescribed antibiotics which did not help, that she had undergone an MRI, and that she had no prior injections or surgeries on either shoulder. Id. The orthopedist, Dr. Brody Flanagin, observed Petitioner was experiencing “tenderness over her coracoid process bilaterally, . . . bicipital groove, and rotator interval, . . . essential[ly] normal active and passive ROM in all planes bilaterally, . . . [and] [p]ain but no significant weakness with resisted rotator cuff strength testing.” Exhibit 4 at 7. Regarding the cause of Petitioner’s shoulder pain, Dr Flanagin opined that Petitioner’s “[s]ymptoms seem consistent with SIRVA.” Id. at 8. He injected both shoulders with lidocaine and Kenalog. Id. at 7-8. At a follow-up appointment with Dr. Flanagin on May 24, 2017, Petitioner reported significant pain relief after the injections she received in early April. Exhibit 4 at 4. Although her pain had returned, again worse on the right side, she indicated that she still felt “about 5 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 6 of 16 40% better.” Id. She acknowledged that her shoulder pain had worsened after she began working out and swimming. Id. Upon examination, Dr. Flanagan observed the same areas of tenderness previously seen on the right shoulder but not left, “full elevation and rotation in all planes, [and] [m]ild pain without weakness on resisted rotator cuff strength training bilaterally.” Exhibit 4 at 5. Because the April injections were administered approximately six weeks earlier, Dr. Flanagan recommended that he hold off on another set of injections and that Petitioner attend PT for both shoulders. Id. It appears Petitioner did not pursue PT in 2017. Instead, she returned to Dr. Flanagan on July 5, 2017 for another set of injections, reporting a few months of relief after the April injections. Exhibit 4 at 2. Dr. Flanagan again injected both shoulders with the same solution of lidocaine and Kenalog. He discussed a left shoulder MRI or right shoulder surgery as logical next steps. Id. at 3. On July 11, 2017, Petitioner called Dr. Flanagan’s office, complaining of a lack of pain relief. Exhibit 6 at 16. She was advised to wait a few days and informed that an MRI of her left shoulder would be ordered if needed. Id. at 17. After responding that she did not want to pursue a left shoulder MRI due to financial issues, Petitioner asked if she should try ice and heat for her soreness and pain – she was advised to do so. Id. at 18. Petitioner did not require additional treatment until February 2019. During this time, she contacted Dr. Flanagan’s office only once in October 2017, to request paperwork exempting her from receiving the flu vaccine. Exhibit 6 at 15. When seen again by Dr. Flanagan on February 6, 2019, Petitioner exhibited no tenderness, or issues with her ROM. Exhibit 6 at 11-12. Dr. Flanagan noted that she “[s]eems to have more clicking and popping in the shoulder than real pain.” Id. at 12. He recommended PT for rotator cuff strengthening. Id. At her initial PT appointment on February 20, 2019, Petitioner reported that both her shoulders became swollen after receiving the flu and Tdap vaccinations. Exhibit 7 at 13, 17. This history is repeated in the record from each subsequent session. Id. at 20, 23, 26, 29, 32, 35, 38, 41, 47, 50, 53. On the intake form, Petitioner reported pain at a level of two out of ten only in her right shoulder. Id. at 10. After attending twelve PT sessions, Petitioner was discharged on April 10, 2019. In these PT records, it was noted that, although she “kept reporting that her bicipital groove was painful,” Petitioner’s current pain was in her glenohumeral joint, following the head of her humerus. Id. at 55. 6 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 7 of 16 III. Legal Standard for Entitlement Before compensation can be awarded under the Vaccine Act, a petitioner must demonstrate, by a preponderance of evidence, all matters required under Section 11(c)(1). Section 13(a)(1)(A). In making this determination, the special master or court should consider the record as a whole. Section 13(a)(1). Petitioner’s allegations must be supported by medical records or by medical opinion. Id. In addition to requirements concerning the vaccination received, the duration and severity of petitioner’s injury, and the lack of other award or settlement,11 a petitioner must establish that she suffered an injury meeting the Table criteria, in which case causation is presumed, or an injury shown to be caused-in-fact by the vaccination she received. Section 11(c)(1)(C). The most recent version of the Table, which can be found at 42 C.F.R. § 100.3, identifies the vaccines covered under the Program, the corresponding injuries, and the time period in which the particular injuries must occur after vaccination. Section 14(a). Pursuant to the Vaccine Injury Table, a SIRVA is compensable if it manifests within 48 hours of the administration of an influenza vaccine. 42 C.F.R. § 100.3(a)(XIV)(B). The criteria establishing a SIRVA under the accompanying QAI are as follows: Shoulder injury related to vaccine administration (SIRVA). 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 (even if the condition causing the neurological abnormality is not known). A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: 11 In summary, a petitioner must establish that she received a vaccine covered by the Program, administered either in the United States and its territories or in another geographical area but qualifying for a limited exception; suffered the residual effects of her injury for more than six months, died from her injury, or underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or collected an award or settlement for her injury. See Section 11(c)(1)(A)(B)(D)(E). 7 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 8 of 16 (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 42 C.F.R. § 100.3(c)(10). If, however, petitioner suffered an injury that either is not listed in the Table or did not occur within the prescribed time frame, she must prove that the administered vaccine caused injury to receive Program compensation. Section 11(c)(1)(C)(ii) and (iii). In such circumstances, petitioner asserts a “non-Table or [an] off-Table” claim and to prevail, petitioner must prove her claim by preponderant evidence. Section 13(a)(1)(A). The Federal Circuit has held that to establish an off-Table injury, petitioner must “prove . . . that the vaccine was not only a but-for cause of the injury but also a substantial factor in bringing about the injury.” Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1351 (Fed. Cir 1999). The received vaccine, however, need not be the predominant cause of the injury. Id. at 1351. The Federal Circuit has indicated that a petitioner “must show ‘a medical theory causally connecting the vaccination and the injury’” to establish that the vaccine was a substantial factor in bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). It added that "[t]here must be a ‘logical sequence of cause and effect showing that the vaccination was the reason for the injury.’” Id. The Federal Circuit subsequently reiterated these requirements in a three-pronged test set forth in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Under this test, a petitioner is required to show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the 8 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 9 of 16 vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury. Id. All three prongs of Althen must be satisfied. Id. Circumstantial evidence may be considered, and close calls regarding causation must be resolved in favor of the petitioner. Id. at 1280. IV. Summary of the Parties’ Arguments In his Rule 4(c) Report, filed on October 30, 2020, Respondent argues that Petitioner has not established that she suffered bilateral Table SIRVA Injuries because she has failed to show that the onset of her pain occurred within 48 hours, or that her “pain was limited to the arm in which the vaccine was given.” Rule 4(c) Report at 6; see 42 C.F.R. § 100.3(c)(10)(ii)-(iii) (two QAI criteria in question). In her motion for a ruling on the record as it currently stands, filed in February 2021, Petitioner argues in response that she has provided sufficient proof to establish that she suffered both left and right shoulder injuries meeting the Table definition for SIRVA or which, in the alternative, were caused by the vaccines she received. Motion for Findings of Fact and Conclusions of Law Regarding Entitlement to Compensation (“Motion”) at 7- 21, ECF No. 51. To further support her arguments, she filed medical literature and a supplemental declaration. Exhibits 12-31, ECF Nos. 49-50, 52. Respondent contests Petitioner’s assertions. Respondent’s Response to Pet. Motion (“Opp.”) at 1, ECF No. 55. Incorporating the arguments set forth in his Rule 4(c) Report, Respondent asserts that Petitioner had failed to satisfy the two QAI criteria previously discussed, as well as a third criteria mentioned for the first time in the response. Id. at 1-2. Specifically, Respondent argues that Petitioner has failed to establish that she had no history of prior shoulder pain which would explain her current condition. Id. at 2; see 42 C.F.R. § 100.3(c)(10)(i). It appears Respondent believes he addressed this additional QAI criteria in the Rule 4(c) Report, as he cites to pages in his Rule 4(c) Report and provides no further argument on the issue. Opp. at 2.12 12 In her reply, Petitioner responded to a Respondent criticism of a characterization made by Petitioner in her supplemental declaration which is not germane to the issue of entitlement. Reply Memorandum in Support of Pet. Motion, ECF No. 56; see Opp. at 2; Exhibit 31 at 10 (Petitioner’s declaration). 9 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 10 of 16 V. Finding of Fact: Onset As the Federal Circuit has stated, contemporaneous medical records are deemed to “warrant consideration as trustworthy evidence.” Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). In this case, Petitioner’s contemporaneously created medical records contain preponderant evidence supporting a factual finding that the onset of Petitioner’s bilateral shoulder pain occurred within 48 hours of vaccination - an issue directly bearing on entitlement in this case. Respondent argues that the onset descriptions provided by Petitioner in the contemporaneously created medical records are too imprecise to establish the Table onset, such as the description of pain “within minutes” found in Petitioner’s affidavit. Rule 4(c) Report at 6 (comparing an entry created three weeks post-vaccination reporting pain since vaccination at Exhibit 8 at 2 with an entry in Petitioner’s affidavit at Exhibit 5 at ¶ 2, stating her pain began within minutes of vaccination). However, I find this to be a specious distinction. As early as three weeks post-vaccination, Petitioner complained of “soreness on both arms from when she got the Flu and Tdap vaccine [sic].” Exhibit 8 at 2 (emphasis added). Further, she described an inability to raise her arms overhead “without pain since her last vaccines 3 weeks ago.” Id. (emphasis added). During the remainder of October, she was seen by her PCP once and called him on three other occasions complaining of her continued pain. Exhibit 1 at 2-7; Exhibit 8 at 8-12. When seen by an orthopedist, on April 4, 2017, Petitioner reported that she “started having pain immediately after” her September vaccinations. Exhibit 4 at 6 (emphasis added). Coupled with the lack of any entries describing a delayed onset, such proof is sufficient to establish that Petitioner’s bilateral shoulder pain began immediately after she received the flu and Tdap vaccines. VI. Entitlement As previously stated in Section III, a petitioner suffering a shoulder injury following receipt of the flu vaccine is entitled to compensation under the Vaccine Act if she can establish by preponderant evidence that her injury satisfies the definition for a Table SIRVA or was caused-in-fact by the flu vaccine she received. Section 11(c)(1)(C). In her Petition, Ms. Rodgers advances both types of claim. A. Table Injury: SIRVA As stated in the previous section, I find there is sufficient evidence to establish that the onset of Petitioner’s bilateral shoulder pain was immediate, and thus, within 48 hours 10 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 11 of 16 as required by the Vaccine Injury Table and accompanying SIRVA QAI. 42 C.F.R. § 100.3(a)(XIV)(B); 42 C.F.R. § 100.3(c)(10)(ii). Additionally, Respondent does not dispute that Petitioner’s alleged SIRVAs meet the fourth QAI criteria, and there is a scarcity of evidence showing an alternative cause for Petitioner’s bilateral shoulder pain. 42 C.F.R. § 100.3(c)(10)(iv). Thus, I find that Petitioner has satisfied this fourth QAI requirement as well and will limit my discussion to the remaining two QAI criteria. 1. Prior Shoulder Pain The first QAI criteria requires that a petitioner have “[n]o 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.” 42 C.F.R. § 100.3(c)(10)(i) (emphasis added). Although Respondent disputes that Petitioner has satisfied this criteria, he advances no specific argument and fails to identify the prior pain, inflammation or dysfunction upon which he relies. Thus, I have considered the only two possibilities: 1) the right arm pain caused by the venous occlusion Petitioner suffered in 2012; and 2) the right arm pain which occurred when working out and was caused by the lipoma existing on Petitioner’s medial arm at the time of vaccination. In her motion, Petitioner addresses only the first possibility. Underscoring the nature, timing, and resolution of the venous occlusion she suffered in 2012, Petitioner argues that the “thrombotic condition . . . could not have caused the injuries to [her] shoulder in 2016 and the years that follow.” Motion at 10. I credit Petitioner’s argument regarding the differing types of injuries involved. It is unlikely that the venous occlusion Petitioner experienced would explain the bilateral shoulder pain she later suffered. Similarly, due to its location, the lipoma which existed on Petitioner’s right arm at the time of vaccination would not explain her post-vaccination right shoulder pain. As I discussed when determining the site of Petitioner’s vaccinations,13 the lipoma was located 13 I determined that, located in Petitioner’s right medial arm, the lipoma would not have prevented the vaccine administrator from following the usual procedure of injecting two vaccine in both arms. Fact Ruling at 7. 11 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 12 of 16 on Petitioner’s right medial arm,14 causing right arm pain which is clearly distinguishable from the right shoulder pain she suffered post-vaccination. I find that neither the prior right arm pain caused by venous occlusion Petitioner suffered in 2012 nor the right arm pain when working out caused by the lipoma existing at the time of vaccination would qualify as pain, inflammation or dysfunction which would explain Petitioner’s post-vaccination. Thus, I find Petitioner had satisfied this QAI criteria. 2. Location of Petitioner’s Pain The last QAI criteria to be satisfied involves the location of Petitioner’s pain and limited range of motion. To qualify for a Table SIRVA, a petitioner’s pain and reduced range of motion must be limited to the shoulder in which the vaccine was administered. 42 C.F.R. § 100.3(c)(10)(iii). When addressing this QAI criteria, Respondent emphasizes the lack of uniformity regarding the symptoms Petitioner experienced in her right and left shoulders, specifically mentioning that the symptoms Petitioner experienced in her left shoulder were milder and emphasizing the fact that a left shoulder MRI was never performed. Rule 4(c) Report at 6-7. Respondent also references the history Petitioner provided to the rheumatologist in which she also complained of pain in her wrists and thumbs which radiated up her arms, and the statement by Petitioner’s rheumatologist, Dr. Campbell, indicating that he “suspected a ‘multi-factorial’ process was causing [P]etitioner’s symptoms.” Id. at 7 (citing Exhibit 3 at 9). Citing language in the introductory paragraph of the SIRVA QAI, Petitioner maintains that this requirement regarding location applies only to symptoms experienced at the onset or manifestation of a SIRVA. Motion at 11. She distinguishes the symptoms Petitioner later reported, such as the pain Petitioner experienced in her wrists and fingers, from “her initial complaints of symptoms which were clearly limited to her shoulders, which is where her symptoms manifested.” Id. at 11-12. Petitioner criticizes Respondent’s arguments as an overly narrow interpretation of the criteria, characterizing them as requiring Petitioner to be free from all other pain. Id. at 12. I do not accept Petitioner’s characterization regarding the timing of this requirement - that it applies only to the initial symptoms a petitioner suffers. Indeed, the requirements for a Table SIRVA mandate only that a petitioner’s pain occur within 48 14 Medial means “pertaining to the middle; closer to the median plane or the midline of a body or structure.” DORLAND’S at 1118. Thus, it appears Petitioner’s lipoma was located lower on her arm, possibly on the inner part of her elbow. 12 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 13 of 16 hours or vaccination15 - not that they also immediately experience reductions in range of motion, which often lag after the initial injury by weeks or months. It would be illogical for a requirement which applied to a petitioner’s decreased range of motion, as well as pain, to be limited in the manner Petitioner asserts. However, I find the portion of Petitioner’s argument regarding unrelated areas of pain persuasive, and agree that this QAI criteria does not prevent a petitioner with simultaneous areas of pain due to unrelated conditions from also meeting the Table SIRVA definition. In this case, the medical records clearly establish that Petitioner suffered from pain in numerous areas caused by multiple unrelated conditions, both prior to and following vaccination. And Dr. Campbell’s suspicions that Petitioner’s bilateral shoulder and thumb/wrist pain were multi-factorial supports this premise. Exhibit 3 at 9. Dr. Campbell opined that Petitioner’s finger and wrist pain was likely due to osteoarthritis, but proposed other possibilities for the source of her bilateral shoulder pain - including rotator cuff tendinopathy and bursitis. Regarding the possibility that the bilateral shoulder pain was due to rheumatoid arthritis, Dr. Campbell, a rheumatologist, opined that Petitioner’s “[p]resentation would be atypical for RA.” Id. The one entry cited by Respondent, regarding pain in Petitioner’s wrists and fingers, is not sufficient to prevent her from satisfying this criteria.16 Respondent’s argument regarding the lack of uniformity in the severity of Petitioner’s symptoms is similarly unpersuasive. In proposing the Table addition of SIRVA, Respondent discussed the scientific evidence regarding the means by which this injury is caused – and in so doing specifically referenced the article also filed by Petitioner in this case. See National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132, 45136-37 (July 29, 2015); S. Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA), 28 Vaccine 8049 (2010), filed as Exhibit 12, ECF No. 49-2 (“Atanasoff”). As noted in Atanasoff, many of the patients studied may have had prior conditions such as rotator cuff tears which became symptomatic following the improper vaccine injection. Atanasoff at 8051. Indeed, the right shoulder MRI Petitioner underwent in early March 2017 revealed significant degenerative changes, which may account for the greater severity of symptoms Petitioner experienced in her right shoulder. Exhibit 3 at 41. Although this assumption cannot be confirmed due to the lack of a left shoulder MRI, I do not need to know the basis for the difference in severity. Given that Petitioner’s shoulder conditions prior to vaccination are likely to differ, proof of mirror-image severity in the rare case of a bilateral SIRVA after two vaccinations 15 See Portee v. Sec’y of Health & Human Servs., No. 16-1552V, 2018 WL 5284599 (Fed. Cl. Spec. Mstr. Sept. 14, 2018) for further discussion regarding this issue. 16 Of course, distinguishing SIRVA-related pain from pain attributable to a different injury bears heavily on damages – and Petitioner in this case must make sure to draw such distinctions when seeking damages. 13 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 14 of 16 cannot be the standard, as Respondent seems to propose. Regarding the more relevant issue, the type of symptoms suffered, the descriptions Petitioner provided throughout the medical records of her symptoms were identical. The record in this case shows that in multiple entries, especially those created closer in time to vaccination, Petitioner consistently reported pain and difficulties with movement which was confined to both shoulders. E.g., Exhibit 1 at 4. Petitioner has satisfied this remaining QAI requirement. She has established, by preponderant evidence, that both of her shoulder injuries meet the Table SIRVA definition. B. Causation-in-Fact: SIRVA Although a detailed discussion of Petitioner’s causation-in-fact claim is not required, it is worth noting that the record also contains evidence likely sufficient to satisfy the three-pronged Althen test for both shoulder injuries. See Althen, 418 F.3d at 1278. I have previously taken judicial notice of the fact that Respondent has added SIRVA after receipt of an intramuscularly administered seasonal influenza vaccine to the Vaccine Injury Table as evidence of the causal link between vaccine and injury needed to satisfy the first Althen prong. Lesher v. Sec’y of Health & Human Servs., No. 17-1076V, 2020 WL 4522381, at *11 (Fed. Cl. Spec. Mstr. July 2, 2020) (citing Doe 21 v. Sec'y of Health & Human Servs., 88 Fed. Cl. 178, 193 (2009), rev’d on other grounds, 527 Fed. Appx. 875 (Fed. Cir. 2013)). Regarding the second Althen prong, Petitioner’s orthopedist opined Petitioner’s bilateral shoulder pain seemed consistent with SIRVA. Exhibit 4 at 8. In establishing that a vaccine “did cause” an injury, the opinions and views of the injured party’s treating physicians are entitled to some weight. Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). Finally, given that Petitioner has satisfied the onset required for a Table SIRVA, she would, no doubt, have no difficulty establishing the medically acceptable time frame needed for actual causation. C. Additional Requirements for Entitlement Even though she has established that she suffered Table SIRVAs in both shoulder following her September 13, 2016 vaccinations, Petitioner must satisfy the additional requirements in Section 11(c) regarding the vaccinations received, the duration and severity of petitioner’s injury, and the lack of other award or settlement. Section 11(c)(A), (B), and (D). The vaccine record shows the flu and Tdap vaccines were administered to Petitioner on September 13, 2016, at her PCP’s clinic in Texas. Exhibit 1 at 65; see Section 11(c)(1)(A) (requiring receipt of a covered vaccine); Section 11(c)(1)(B)(i) 14 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 15 of 16 (requiring administration within the United States or its territories). Although the vaccine record indicated both vaccines were administered in Petitioner’s left deltoid, I previously found there was preponderant evidence showing the vaccines were administered one in each arm as Petitioner alleges. Fact Ruling, issued Mar. 11, 2020, ECF No. 36. Additionally, there is no evidence that Petitioner has collected a civil award for her injury. See Section 11(c)(1)(E) (lack of prior civil award). Regarding the six-month severity requirement, the medical records show Petitioner complained of bilateral shoulder pain, with only short periods of relief due to steroid injections, from vaccination until early July 2017. Exhibit 6 at 16-18. When first seen by an orthopedist on April 5, 2017, prior to her first steroid injections, Petitioner reported pain which was as constant, immediate, and present for more than six months. Exhibit 4 at 6. In order to meet this requirement, Petitioner must establish that her symptoms occurred beyond March 13, 2017. Despite reporting a greater level of pain in her right shoulder, Petitioner clearly indicated she was suffering from bilateral shoulder pain. E.g., id. Thus, I find that the medical records show that more than six months after vaccination, Petitioner continued to suffer the residual effects of both SIRVAs. See Section 11(c)(1)(D)(i) (statutory six-month requirement). Petitioner has satisfied all requirements for entitlement under the Vaccine Act. D. Severity and Duration of Petitioner’s Pain and Suffering As I previously noted in this ruling, Petitioner suffered pain due to conditions unrelated to her SIRVAs both prior to and following vaccination. At the time of vaccination, she was suffering from right knee and arm pain attributed to lipomas in these areas. Exhibit 1 at 62. Furthermore, in early 2017, it was noted that Petitioner suffered from pain in her wrists and fingers, most likely due to osteoarthritis. Exhibit 3 at 7. Although these unrelated symptoms and conditions do not prevent Petitioner from establishing that she is entitled to compensation, they are relevant when determining the appropriate amount of compensation to be awarded. Furthermore, it appears Petitioner obtained significant relief from the steroid injections she received in early April and July 2017. For example, at her second orthopedic appointment in late May 2017, Petitioner characterized her overall condition as “feeling about 40% better.” Exhibit 4 at 4. Upon examination, the orthopedist observed that Petitioner had full range of motion and mild pain bilaterally. Id. at 5. In contrast, prior to this first set of steroid injections, Petitioner described her pain as moderate to severe. Id. at 6. Although Petitioner reported continued pain in July 2017, following the second set of steroid injections administered in early July 2017, she must have ultimately obtained relief because she did not return for treatment until almost 19 months later in 15 Case 1:18-vv-00559-UNJ Document 59 Filed 10/13/21 Page 16 of 16 early February 2019. See Exhibit 4 at 10 (regarding July 5, 2017 injections); Exhibit 6 at 16-18 (calls later in July 2017). At her first PT session in late February 2019, Petitioner complained of only right shoulder pain at a level of two out of ten. Exhibit 7 at 10. She attributed her symptoms to the vaccines she received in late 2016 (id. at 13), but the record as it currently stands does not support that assertion. When he examined Petitioner in early February 2019, her orthopedist, Dr. Flanagan, observed full range of motion and no tenderness. Exhibit 6 at 11-12. He indicated Petitioner “[s]eems to have more clicking and popping in the shoulder than real pain.” Id. at 12. At her PT discharge on April 10, 2019, it was noted that Petitioner reported pain in her bicipital groove as she experienced in 2016-17, but when asked to identify the location of her pain, pointed to her glenohumeral joint and head of her humerus. Exhibit 7 at 55. Given that Petitioner suffered from bilateral SIRVAs in 2016, the compensation awarded for the pain and suffering she experienced in 2016-17 is likely to be greater than for a petitioner who suffered a SIRVA in only one shoulder. However, as Petitioner herself acknowledges (Motion at 12), she also suffered unrelated pain during this time. Additionally, the pain Petitioner suffered in her left shoulder was less severe than what she experienced in her right shoulder, and she obtained significant relief from the steroid injections she received in 2017. The parties should consider all these factors when attempting to informally resolve the issue of damages in this case. VII. Conclusion Having reviewed the affidavits, medical records, and briefing in this case, I find that Petitioner has provided preponderant evidence to establish that she suffered Table SIRVAs in both her right and left shoulders. Petitioner is therefore entitled to compensation under the Vaccine Act. A damages order will be issued setting the next deadline in this case. IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 16 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_18-vv-00559-2 Date issued/filed: 2022-02-01 Pages: 13 Docket text: PUBLIC DECISION (Originally filed: 12/29/2021) regarding 65 DECISION of Special Master Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 1 of 13 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 18-0559V UNPUBLISHED WANDA RODGERS, Chief Special Master Corcoran Petitioner, Filed: December 29, 2021 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Decision Awarding Damages; Pain HUMAN SERVICES, and Suffering; Influenza (Flu) and Diphtheria, Tetanus, acellular Respondent. Pertussis (Tdap) Vaccines; Bilateral Shoulder Injuries Related to Vaccine Administration (SIRVAs) Isaiah Richard Kalinowski, Maglio Christopher & Toale, PA, Washington, DC, for Petitioner. Mallori Browne Openchowski, U.S. Department of Justice, Washington, DC, for Respondent. DECISION AWARDING DAMAGES1 On April 18, 2018, Wanda Rodgers 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 alleged that she suffered shoulder injuries related to vaccine administration (“SIRVAs”), in both right and left shoulders, both meeting the criteria for Table SIRVAs and casually related to the influenza (“flu”) and tetanus, diphtheria, acellular pertussis (“Tdap”) vaccines she received on September 13, 2016. Petition at ¶¶ 1 Because this unpublished Decision contains a reasoned explanation for the action in this case, I am required to post it on the United States Court of Federal Claims' website in accordance with the E- Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 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 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 2 of 13 3, 14, 17. The case was assigned to the Special Processing Unit of the Office of Special Masters, and although entitlement was decided in Petitioner’s favor, the parties could not agree on damages. For the reasons described below, I find that Petitioner is entitled to an award of damages in the amount of $120,658.26, representing compensation in the amount of $117,500.00 for actual pain and suffering, plus $3,158.26 for past unreimbursable expenses. I. Relevant Procedural History From April through July 2018, Ms. Rodgers filed the affidavit and medical records required under the Vaccine Act. Exhibits 1-5, ECF Nos. 4, 11; see Section 11(c). During the remainder of 2018 into 2019, the parties discussed a factual issue regarding the site of vaccination,3 and Petitioner filed additional documentation and updated medical records. Exhibits 6-8, ECF Nos. 21, 28; Status Reports, ECF Nos. 19, 24, 29; Status Conference held May 23, 2019. On March 11, 2020, I issued a fact ruling, finding the two vaccines Petitioner received had been administered one in each arm, as alleged. ECF No. 36. During March through August 2020, the parties attempted to reach an informal settlement in the case. See, e.g., Status Report, ECF No. 44. On August 26, 2020, they informed me they had reached an impasse in their settlement discussions. Status Report, ECF No. 45. After the parties briefed entitlement,4 I issued a ruling finding Petitioner had provided preponderant evidence to establish that she suffered Table SIRVAs in both her right and left shoulders, based on the two covered vaccines she had received. Ruling on Entitlement, issued Sept. 9, 2021, ECF No. 57. In the ruling, I cautioned the parties that in discussing damages they should consider factors such as Petitioner’s unrelated pain during this same time, the lower severity of her left shoulder injury in comparison to her right, and the significant relief obtained from steroid injections she received in 2017. I also observed that Petitioner had complained of only right shoulder pain by 2019, and that the record did not appear to support Petitioner’s assertions that this later right shoulder was related to her 2016 vaccinations. Id. at 16. Less than two months later, the parties informed me they had reached an impasse in their damages discussions and proposed consecutive briefing dates. Joint Status 3 The vaccine record indicates that Petitioner received both the flu and Tdap vaccines in her left deltoid. Exhibit 1 at 65. 4 ECF Nos. 51, 55-56. Along with her brief, Petitioner filed medical literature and an additional declaration. Exhibits 12-31, ECF Nos. 49-50, 52. 2 Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 3 of 13 Report, filed Nov. 1, 2021, ECF No. 61. The parties filed their briefs as proposed. ECF Nos. 62-64. The matter is now ripe for adjudication. II. 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 award such expenses which (i) resulted from the vaccine-related injury for which 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 compensation requested. Brewer v. Sec’y of Health & Human 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 & Human 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 & Human 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 (quoting McAllister v. Sec’y of Health & Human 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 & Human 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 my predecessor Chief Special Masters) adjudicating similar claims.5 Hodges v. Sec’y of 5 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. 3 Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 4 of 13 Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (noting that Congress contemplated 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. In Graves, Judge Merow rejected a special master’s approach of awarding compensation for pain and suffering based on a spectrum from $0.00 to the statutory $250,000.00 cap. Graves v. Sec’y of Health & Human Servs., 109 Fed. Cl. 579 (Fed. Cl. 2013). Judge Merow maintained that 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 590. Instead, Judge Merow 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 595. Under this alternative approach, the statutory cap merely cuts off higher pain and suffering awards – it does not shrink the magnitude of all possible awards as falling within a spectrum that ends at the cap. III. Prior SIRVA Compensation Within SPU6 A. Data Regarding Compensation in SPU SIRVA Cases SIRVA cases have an extensive history of informal resolution within the SPU. As of July 1, 2021, 2,097 SPU SIRVA cases have resolved since the inception of SPU on July 1, 2014. Compensation was awarded in 2,036 of these cases, with the remaining 61 cases dismissed. Of the compensated cases, 1,187 SPU SIRVA cases involved a prior ruling that petitioner was entitled to compensation. In only 69 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.7 6 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. 7 See, e.g., Sakovits v. Sec’y of Health & Human 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). 4 Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 5 of 13 1,092 of this subset of post-entitlement determination, compensation-awarding cases, were the product of informal settlement - cases via proffer and 26 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 849 compensated SIRVA cases were resolved via stipulated agreement of the parties without a prior ruling on entitlement. These agreements are often 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 Stipulated8 Decisions by Damages Damages Agreement Special Master Total Cases 69 1,092 26 849 Lowest $40,757.91 $25,000.00 $45,000.00 $5,000.00 1st Quartile $75,000.00 $70,000.00 $90,000.00 $45,000.00 Median $97,500.00 $90,350.00 $115,214.49 $65,000.00 3rd Quartile $125,360.00 $119,502.79 $158,264.36 $90,000.00 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 69 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 $95,500.00 as the median amount. Only five of these cases involved 8 Two awards were for an annuity only, the exact amounts which were not determined at the time of judgment. 5 Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 6 of 13 an award for future pain and suffering, with yearly awards ranging from $250.00 to $1,000.00.9 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 of 40 days to over six months. 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 less of physical therapy (“PT”). None required surgery. The duration of the injury ranged from six to 29 months, with petitioners averaging approximately nine months of pain. Although some petitioners asserted residual pain, the prognosis in these cases was positive. 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. In the fourth case involving an award of future pain and suffering, the petitioner provided evidence of an ongoing SIRVA expected to resolve within the subsequent year. IV. Appropriate Compensation for Petitioner’s Pain and Suffering In this case, awareness of the injury is not disputed. The record reflects that at all times Petitioner was a competent adult, with no impairments that would impact her awareness of her injury. Therefore, I analyze principally the severity and duration of Petitioner’s injury. In performing this analysis, I have reviewed the record as a whole, including all 9 Additionally, a first-year future pain and suffering award of $10,000.00 was made in one case. Dhanoa v. Sec’y of Health & Human Servs., No. 15-1011V, 2018 WL 1221922 (Fed. Cl. Spec. Mstr. Feb. 1, 2018). 6 Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 7 of 13 medical records and affidavits filed, plus the parties’ briefs and other pleadings. I also have taken into account prior awards for pain and suffering in both SPU and non-SPU SIRVA cases, and rely upon my experience adjudicating these cases. However, I base my ultimate determination on the specific circumstances of this case. A. The Parties’ Arguments The parties agree Petitioner should be awarded $3,158.26 for her unreimbursed medical expenses. Opening Memorandum of Law Regarding Damages (“Brief”) at 1, 15, ECF No. 62; Respondent’s Brief on Damages (“Opp.”) at 2 n.1, 11; ECF No. 63; Reply Memorandum Regarding Damages (“Reply Brief”), at 9, ECF No. 64. Thus, the only area of disagreement is regarding the amount of compensation which should be awarded for Petitioner’s pain and suffering. Emphasizing that Petitioner suffered bilateral SIRVAs caused by two vaccine administered on the same day, Petitioner requests a pain and suffering award of $165,000.00, representing $85,000.00 for her more severe right SIRVA and $80,000.00 for her left SIRVA. Brief at 1, 11. She stresses the short amount of time between vaccination and her initial complaint of shoulder pain, the difficulties she experienced sleeping, moving her arm, and performing her nursing duties, the fact that she canceled planned surgery to remove a lipoma, and the need for multiple cortisone injections to treat her pain. Id. at 12-13. Petitioner maintains that the results of her right shoulder MRI – showing degenerative tearing – provides further evidence that her shoulder pain was severe. She also insists that she continued to suffer the residual effects of both SIRVAs as late as 2019. Id. at 13. As general argument, Petitioner addresses the probative value of information contained in medical records – citing the rule articulated in Murphy, which she maintains is often overlooked, that information contained in medical records is more significant than what is omitted. Brief at 8-9 (citing Murphy v. Sec’y of Health & Human Servs. 23 Cl. Ct. 726, 773 (1991), aff’d, 968 F.2d 1226 (Fed. Cir. 1992), cert. denied sub nom. Murphy v. Sullivan, 113 S.Ct. 263 (1992)). Petitioner also criticizes any consideration of the amount of medical treatment sought as a factor to be weighed when determining the severity of Petitioner’s injury. However, she agrees with and advocates for comparisons to other Program awards when determining the appropriate amount of damages. Brief at 9-10. To support her requested award, Petitioner cites several decisions featuring lower awards - Johnson, George, and T.E.10 - arguing that her SIRVAs were more severe. Brief 10 Johnson v. Sec’y of Health & Human Servs., No. 18-1486V, 2021 WL 836891 (Fed. Cl. Spec. Mstr. Jan. 25, 2021) (awarding $65,000.00 for actual pain and suffering); George v. Sec’y of Health & Human Servs., No. 18-0426V, (Fed. Cl. Spec. Mstr. July 13, 2020) (awarding $67,000.00 for actual pain and suffering); 7 Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 8 of 13 at 13-14. She maintains the level of her pain and limited ROM was greater than that suffered by the Johnson petitioner; that her treatment was more significant than that required for the George petitioner – three cortisone injections as opposed to one; and that the duration of her injury was less than that suffered by the T.E. petitioner. Id. (citing Johnson, 2021 WL 836891, at *2, 7; George, 2021 WL 4692451, at *2; T.E., 2021 WL 2935751, at *3). Petitioner also argues that the MRI of her right shoulder showed evidence supporting a more severe SIRVA injury – degenerative tearing not seen on the T.E. petitioner’s MRI. Brief at 14 (citing T.E., 2021 WL 2935751, at *4). She maintains that Dhanoa provides “[t]he closest analog for evaluating each of the Petitioner’s two shoulder injuries.” Brief at 15 (citing Dhanoa, 2018 WL 1221922, at *7 (awarding $85,000.00 for actual pain and suffering and a one-year award of $10,000.00 for projected pain and suffering)). Although Respondent agrees that Petitioner’s “award is likely to be greater than a petitioner who experienced a SIRVA injury in only one shoulder” (Opp. at 9), he proposes the lesser sum of $117,500.00 for total pain and suffering. Id. at 2. He argues that Petitioner’s SIRVAs were less severe – involving gaps in treatment, descriptions of multi- factorial pain, and significant relief from administered cortisone injections. Id. at 8-9. Stressing that Petitioner’s injuries and treatment spanned the same period – which he estimates to be ten months, Respondent disagrees with Petitioner’s proposal that the two shoulder injuries “must be assessed separately, and then combined for one damages award.” Id. at 9. Discussing awards in four other cases (Rayborn, Knauss, Dagen, and Bossenbroek)11 (Opp. at 10-11), Respondent argues that “Petitioner’s course is similar to that outlined in the Rayborn and Dagen cases” (id. at 11). He asserts that the treatment and duration of Petitioner’s injury is comparable to that experienced by those petitioners, who received awards of $55,000.00 and $65,000.00, respectively. Id. Addressing the Federal Circuit’s holding in Graves, Respondent asserts that it is still proper to compare the severity of petitioners’ pain and suffering in Program cases. T.E. v. Sec’y of Health & Human Servs., No. 19-0633V, 2021 WL 2935751 (Fed. Cl. Spec. Mstr. May 7, 2021) (awarding $70,000.00 for actual pain and suffering). 11 Rayborn v. Sec’y of Health & Human Servs., No. 18-0226V, 2020 WL 5522948 (Fed. Cl. Spec. Mstr. Aug. 14, 2020) (awarding $55,000.00 for actual pain and suffering); Knauss v. Sec’y of Health & Human Servs., No. 16-1372V, 2018 WL 3432906 (Fed. Cl. Spec. Mstr. May 23, 2018) (awarding $60,000.00 for actual pain and suffering); Dagen v. Sec’y of Health & Human Servs., No. 18-0442V, 2019 WL 7187335 (Fed. Cl. Spec. Mstr. Nov. 6, 2019) (awarding $65,000.00 for actual pain and suffering); Bossenbroek v. Sec’y of Health & Human Servs., No. 17-0122V, 2020 WL 2510454 (Fed. Cl. Spec. Mstr. Apr. 3, 2020) (a non-SPU SIRVA cases in which $50,000.00 was awarded for actual pain and suffering and annual payments of $300.00 was awarded for projected pain and suffering). 8 Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 9 of 13 Opp. at 7 n.8. However, he also argues “that such awards, in the aggregate, have trended too high.” Id. at 9 n.10. Filed as an attachment to his damages brief, Respondent provides a list of 55 traditional tort system awards, noting that 75 percent of these awards are for $30,000.00 or less. Id. (citing Appendix A, ECF No. 63-1). In her responsive brief, Petitioner addresses these arguments, insisting that, although not perfect, Program awards “form a workable, organically developed system of analysis by which parties in the Program should evaluate damages.” Reply Brief at 7; see also id. at 4-7. She also criticizes Respondent’s reliance on statements I made in my Ruling on Entitlement, noting that the parties had not yet briefed the issue of damages at that time. Id. at 3. Stressing again the unique nature of her bilateral SIRVA injuries, Petitioner maintains that the award she seeks, twice the median amount for all SIRVA claims, “is a wholly reasonable amount.” Id. at 9. B. Analysis The guidance provided by the Graves decision is clear (although not controlling),12 and I have previously addressed the more general arguments about calculation of pain and suffering damages made by Respondent during expedited “Motions Day” hearings and in other damages decisions. I also have not previously given great weight to Respondent’s citation to pain and suffering determinations from traditional tort system state court cases, noting that Congress intended the “no-fault” system established in the Vaccine Program to be generous. H.R. REP. NO. 99-908, at 12-13 reprinted in 1986 U.S.C.C.A.N. 6344, 6353-54. Thus, Vaccine Program compensation will likely be greater than what is awarded in civil actions. Additionally, the descriptions of the traditional tort system cases proposed by Respondent often lack basic information needed for comparison. Rafferty v. Sec’y of Health & Human Servs., No. 17-1906V, 2020 WL 3495956, at *18 (Fed. Cl. Spec. Mstr. May 21, 2020). As a result, “SIRVA awards in the Vaccine Program are self-evidently more relevant and apposite.” Id. 1. Duration and Severity of SIRVA Injury13 A thorough review of the medical record reveals that Petitioner suffered moderate to severe SIRVA injuries in both shoulders following flu and Tdap vaccines administered in September 2016, obtained significant relief from cortisone injections administered in 12 See supra Section II (for further discussion). 13 A detailed factual history can be found in the Ruling on Entitlement issued on September 9, 2021. ECF No. 57. 9 Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 10 of 13 both shoulder in early April 2017, experienced lower levels of returned pain in late May 2017, and gained more lasting relief following another set of injections administered in July 2017.14 Petitioner did not return for further treatment until February 2019, and there is not sufficient evidence to show this later pain, reported only in the right shoulder, is related to the SIRVA injuries Petitioner suffered. In addition, this is not a case in which the petitioner required surgery. During this ten-month period, Petitioner consistently reported that her right shoulder pain was more severe than her left.15 She also described symptoms which appear unrelated to her SIRVA injuries, and her treating physicians indicated her overall condition was due to multiple factors. There is evidence showing Petitioner suffered from cervical radiculopathy and brachial venous occlusion prior to vaccination,16 was reporting pain due to lipomas in her right arm and left knee at the time of vaccination,17 and described pain and other symptoms more likely attributed to other conditions - such as osteoporosis, while experiencing her SIRVA injuries.18 Although the relief Petitioner experienced in early April 2017 was significant - an almost two-month reprieve followed by a return of mild pain and no limitation in ROM in 14 There is some evidence that Petitioner may have received cortisone injections without charge from her primary care provider (“PCP”) shortly after vaccination. Exhibit 8 at 11. However, sufficient documentation of these earlier injections has not been provided, and it appears they did not alleviate Petitioner’s initial pain. 15 At her first appointment with an orthopedist on April 5, 2017, Petitioner reported bilateral shoulder pain which was worse on her right side. Exhibit 4 at 6. An MRI of only her right shoulder was performed in early March 2017. Id. at 31. 16 Prior to vaccination, Petitioner suffered prior conditions, including brachial venous occlusion, which caused pain down her arms and cervical radiculopathy. Exhibit 1 at 102. X-rays, taken in 2012, revealed degenerative disc disease. Id. at 61. Brachial venous occlusion is the blockage of blood flow through the veins in the upper arm. DORLAND’S ILLUSTRATED MEDICAL DICTIONARY (“DORLAND’S”) at 244, 1311, 2046 (32th ed. 2012). 17 At the September 13, 2016 visit to her PCP when she received the flu and Tdap vaccinations alleged as causal, Petitioner sought a surgical referral for the removal of lipomas on her right arm and knee. Exhibit 1 at 62, 65. Indicating they had existed for approximately five years, she described the lipoma on her knee as increasing in size and the lipoma on her right arm as “hurting when working out.” Id. at 62. A lipoma is “a benign, soft, rubbery, encapsulated tumor of adipose tissue, usually composed of mature fat cells.” DORLAND’S at 1063. 18 At her initial visit with her rheumatologist on February 1, 2017, between four to five months post- vaccination, Petitioner reported pain in her thumbs which radiated up her arms, pain in her wrists, and ten to fifteen minutes of stiffness in the mornings. Exhibit 3 at 7. The rheumatologist indicated that she suspected Petitioner’s thumb and wrist pain was caused by underlying osteoarthritis, adding that she would evaluate that premise after reviewing x-rays of these areas. Regarding Petitioner’s shoulder pain, Dr. Campbell opined that its etiology was “unclear.” Id. At a later appointment on April 3, 2017, the rheumatologist prescribed PT for bilateral thigh/hip tightness Petitioner was experiencing. Id. at 12. 10 Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 11 of 13 late May,19 its effect is countered by the bilateral nature of Petitioner’s SIRVAs. Whether resulting in the severe pain levels reported initially or mild to moderate pain experienced later, Petitioner’s simultaneous SIRVA injuries undoubtedly posed considerable difficulties throughout this time. Thus, even considering the evidence of simultaneous unrelated pain, the pain and suffering attributable to her SIRVAs during this ten-month period should be considered substantial. However, as I previously stated, the record does not support Petitioner’s claim of continued pain related to her SIRVA injuries beyond July 2017. Ruling on Entitlement, issued Sept. 9, 2021, at 15-16. When Petitioner sought treatment again in early February 2019 - more than 19 months later and almost ten months after filing her claim, her orthopedist observed full range of motion, no tenderness, and symptoms which “[s]eems to have more clicking and popping in the shoulder than real pain.” Exhibit 6 at 12. Her PT records show she complained of only right shoulder pain at that time (Exhibit 7 at 10) and identified a different location for her current pain than what she reported in 2016-17.20 Although Petitioner correctly notes that the parties had not briefed the issue of damages at that time (Reply Brief at 3), she fails to acknowledge that she has provided no additional evidence to counter my earlier stated conclusion. Thus, I find the duration of Petitioner’s bilateral SIRVAs to be approximately ten months. 2. Comparison to Other Awards I agree that the three cases first mentioned by Petitioner (Johnson, George, and T.E.) provide examples of less severe pain and suffering that that experienced by the Petitioner herein. However, I disagree with Petitioner’s assertion that Dhanoa provides a comparable case for each of Petitioner’s SIRVA injuries individually, with only a $5,000.00 reduction for her lesser left SIRVA injury. The Dhanoa petitioner suffered a SIRVA which resulted in severe pain and significantly limited ROM for a longer duration than the injuries suffered by Petitioner. Dhanoa, 2018 WL 1221922, at *3-5, Additionally, the Dhanoa petitioner did not experience unrelated conditions which would have contributed to the pain and suffering she endured. Id. at *3. Although the Dhanoa petitioner showed 19 At a follow-up appointment with her orthopedist on May 24, 2017, Petitioner reported significant pain relief after the injections she received in early April. Exhibit 4 at 4. Although her pain had returned, again worse on the right side, she indicated that she still felt “about 40% better.” Id. She acknowledged that her shoulder pain had worsened after she began working out and swimming. Id. Upon examination, Dr. Flanagan observed the same areas of tenderness previously seen on the right shoulder but not left, “full elevation and rotation in all planes, [and] [m]ild pain without weakness on resisted rotator cuff strength training bilaterally.” Id. at 5. 20 At her PT discharge on April 10, 2019, it was noted that Petitioner reported pain in her bicipital groove as she experienced in 2016-17, but when asked to identify the location of her pain, pointed to her glenohumeral joint and head of her humerus. Exhibit 7 at 55. 11 Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 12 of 13 improvements after multiple injections and PT sessions, her progress was slow and steady, lacking the significant improvement shown by Petitioner in this case after her April and July 2017 injections. Id. at *4-5. The Dagen and Rayborn cases cited by Respondent provide better comparisons, but the durations of the petitioners’ SIRVAs in those cases were shorter. Rayborn, 2020 WL 5522948, at *11; Dagen, 2019 WL 7187335, at *10. Presumedly, Respondent offered an amount close to twice the awards in those cases to account for this difference, as well as the fact that Petitioner suffered two, virtually concurrent SIRVA injuries – at this time a relatively rare occurrence in the Vaccine Program. As the parties acknowledged, given the bilateral SIRVA injuries suffered by Petitioner, it is difficult to find an appropriate comparison. Most of the non-surgical cases involving awards of more than $100,000 feature a SIRVA which continued for at least several years. See, e.g., Fry v. Sec’y Health & Human Servs., No. 18-1091V, 2020 WL 8457671 (Fed. Cl. Spec. Mstr. Dec. 16, 2020) (involving a duration of more than four years and an award of $120,000.00 for actual pain and suffering). However, I find the Danielson case to be informative when considering Petitioner’s injury in its totality. That petitioner also suffered unrelated back and thoracic pain, but experienced a severe SIRVA and possible bone injury which improved slowly after multiple cortisone injections and seven months of PT. Danielson v. Sec’y of Health & Human Servs., No. 18-1878V, 2020 WL 8271642, at *3-4 (Fed. Cl. Spec. Mstr. Dec. 29, 2020) (awarding $110,000.00 for actual pain and suffering). Although the overall duration of the Danielson petitioner’s injury was greater – more than two years - he did not experience the unique difficulties associated with Petitioner’s dual injuries. Id. Despite requiring surgery to resolve her injury, the petitioner in Berge also experienced events and circumstances similar to Petitioner’s. Berge v. Sec’y of Health & Human Servs., No. 19-1474V, 2021 WL 4144999, at *5-6 (Fed. Cl. Spec. Mstr. Aug. 17, 2021) (awarding $115,000.00 for actual pain and suffering). For example, she suffered severe pain but a less significantly limited ROM for approximately nine months prior to surgery. And the Berge petitioner was suffering significant back and knee pain at the time of her injury. Berge, 2021 WL 4144999, at *6. The fact that Petitioner suffered injuries in both shoulders is offset by the Berge petitioner’s need for arthroscopic surgery. If Petitioner had experienced only a right shoulder injury, I would award a pain and suffering amount slightly more than the $65,000.00 awarded in Dagen, 2019 WL 7187335, at *10. Given that Petitioner suffered bilateral SIRVA injuries, however - albeit milder in the left than right shoulder - I find the amount proposed by Respondent, which is slightly higher than what was awarded in Danielson and Berge, to be appropriate in this case. 12 Case 1:18-vv-00559-UNJ Document 70 Filed 02/01/22 Page 13 of 13 Conclusion For all of the reasons discussed above and based on consideration of the record as a whole, I find that $117,500.00 represents a fair and appropriate amount of compensation for Petitioner’s actual pain and suffering.21 I also find that Petitioner is entitled to $3,158.26 in actual unreimbursable expenses. Based on the record as a whole and arguments of the parties, I award a lump sum payment of $120,658.26 in the form of a check payable to Petitioner. This amount represents compensation for all damages that would be available under Section 15(a). The clerk of the court is directed to enter judgment in accordance with this decision.22 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 21 Since this amount is being awarded for actual, rather than projected, pain and suffering, no reduction to net present value is required. See Section 15(f)(4)(A); Childers v. Sec’y of Health & Human Servs., No. 96- 0194V, 1999 WL 159844, at *1 (Fed. Cl. Spec. Mstr. Mar. 5, 1999) (citing Youngblood v. Sec’y of Health & Human Servs., 32 F.3d 552 (Fed. Cir. 1994)). 22 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. 13