VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-00451 Package ID: USCOURTS-cofc-1_17-vv-00451 Petitioner: Larry Wolford Filed: 2017-03-29 Decided: 2022-08-05 Vaccine: influenza Vaccination date: 2015-11-11 Condition: right shoulder injury related to vaccine administration (SIRVA) Outcome: compensated Award amount USD: 71971 AI-assisted case summary: On March 29, 2017, Larry Wolford filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that an influenza vaccine administered on November 11, 2015, caused a right shoulder injury related to vaccine administration (SIRVA). Mr. Wolford, who was 53 years old at the time of vaccination, reported experiencing aching and stiffness the evening of the vaccination, with pain disturbing his sleep and worsening over the next day or two. He testified that the administering nurse felt the needle "tighten up" and "jerk" during administration. His wife corroborated that the nurse commented on the "jerk" and warned of soreness. Mr. Wolford began using a compression sock as a sling and found relief with Tylenol, ibuprofen, and Icy Hot. He was unable to comb his hair due to restricted arm movement. Due to Dr. Patel's unavailability, Mr. Wolford did not see another medical provider until February 16, 2016, approximately 97 days after vaccination, when he presented to chiropractor Dr. Jarrod Thacker with severe shoulder and arm pain. Dr. Thacker diagnosed impingement syndrome and bursitis, providing exercises and stretches. Mr. Wolford continued treatment with Dr. Thacker through November 2016. An MRI of his right shoulder on March 1, 2016, showed changes consistent with impingement syndrome or bursitis. Orthopedist Dr. Jamie Varney, whom Mr. Wolford saw on April 18, 2016, diagnosed impingement syndrome and bursitis, noting that while MRIs showed chronic tendinopathy and bursitis, it was unlikely the flu shot caused the damage, suggesting pre-existing conditions and a downward sloping acromion. Dr. Varney administered a cortisone injection. Petitioner's experts, Dr. Jeffrey Boyd and Dr. Tony Korman, opined that the flu vaccine caused Mr. Wolford's SIRVA through an immune-mediated inflammatory reaction due to unintentional injection into synovial tissues. They noted that pre-existing conditions could be aggravated by vaccination. Respondent's expert, Dr. Paul Cagle, opined that the flu vaccination did not cause Mr. Wolford's symptoms, attributing them to pre-existing conditions and occupational history, and questioning whether a standard needle could over-penetrate the deltoid muscle. Special Master Nora Beth Dorsey issued a Ruling on Entitlement on July 9, 2021, finding that Mr. Wolford proved by a preponderance of the evidence that the flu vaccine caused his right shoulder injury, satisfying all three prongs of the Althen test. A separate damages decision was issued on August 5, 2022. The Special Master awarded Mr. Wolford $70,000.00 for pain and suffering and $1,971.85 for out-of-pocket medical expenses, totaling $71,971.85. Theory of causation field: Larry Wolford, age 53, received an influenza vaccine on November 11, 2015. He alleged and proved by a preponderance of the evidence that the vaccine caused a right shoulder injury related to vaccine administration (SIRVA), specifically impingement syndrome and bursitis. Petitioner's experts, Dr. Jeffrey Boyd and Dr. Tony Korman, proposed a mechanism involving unintentional injection of antigenic material into synovial tissues, leading to an immune-mediated inflammatory reaction and subsequent bursitis and impingement syndrome, consistent with the "Off-Table" theory for SIRVA. They argued that pre-existing conditions, while present, were asymptomatic prior to vaccination and were aggravated by the vaccine. Respondent's expert, Dr. Paul Cagle, disagreed, attributing the symptoms to pre-existing conditions and occupational history, and questioning the likelihood of needle over-penetration. Special Master Nora Beth Dorsey found that Mr. Wolford satisfied the three prongs of the Althen test: a sound medical theory (supported by Atanasoff et al. and respondent's own recognition of SIRVA as a vaccine-related injury), a logical sequence of cause and effect (onset of symptoms within 48 hours of vaccination, with a clear progression of shoulder pain and limitations despite pre-existing conditions), and a proximate temporal relationship (symptoms beginning the evening of vaccination). The Special Master awarded $70,000.00 for pain and suffering and $1,971.85 for out-of-pocket medical expenses, totaling $71,971.85. Petitioner was represented by Isaiah Richard Kalinowski and Kyle Edward Pozza. Respondent was represented by Kyle Edward Pozza. Special Master Nora Beth Dorsey issued the entitlement ruling on July 9, 2021, and the damages decision on August 5, 2022. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_17-vv-00451-0 Date issued/filed: 2019-10-17 Pages: 13 Docket text: PUBLIC ORDER/RULING (Originally filed: 07/08/2019) regarding 56 Findings of Fact & Conclusions of Law Signed by Special Master Nora Beth Dorsey. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 1 of 13 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 17-0451V Filed: July 8, 2019 UNPUBLISHED LARRY WOLFORD, Special Processing Unit (SPU); Fact Petitioner, Hearing; Findings of Fact; Onset; v. Post-Hearing Briefing Not Required; Influenza (Flu) Vaccine; Shoulder SECRETARY OF HEALTH Injury Related to Vaccine AND HUMAN SERVICES, Administration (SIRVA); No Other Condition or Abnormality Respondent. Isaiah Richard Kalinowski, Maglio Christopher & Toale, PA, Washington, DC, for petitioner. Kyle Edward Pozza, U.S. Department of Justice, Washington, DC, for respondent. FACT RULING1 Dorsey, Chief Special Master: On March 29, 2017, Larry Wolford (“petitioner”) 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 he suffered a right shoulder injury caused by an influenza (“flu”) vaccination he received on November 11, 2015. Petition at 1-2. The case was assigned to the Special Processing Unit of the Office of Special Masters. 1 Because this unpublished ruling contains a reasoned explanation for the action in this case, the undersigned intends 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). 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, the undersigned agrees that the identified material fits within this definition, the undersigned 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 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 2 of 13 For the reasons discussed below, the undersigned finds that the onset of petitioner’s right shoulder injury occurred within 48 hours of his November 11, 2015 vaccination. I. Procedural History The petition in this case was filed on March 29, 2017. On January 16, 2018, respondent filed a Rule 4(c) report indicating that respondent did not consider this case to be appropriate for compensation (ECF No. 26). Respondent asserted that petitioner had not established that the onset of his symptoms began within 48 hours of his vaccination. Respondent further argued that petitioner had pre-existing cervical and upper thoracic issues and that his pain was not limited to his right shoulder. Specifically concerning onset, respondent argued: Petitioner did not seek medical care for his alleged vaccine injury until February 16, 2016, over three months post-vaccination. When he did present to chiropractor Jarrod Thacker, DC, petitioner said that his right arm pain began one week after receiving a flu vaccination in November 2015. Ex. 5 at 3. As a result, the medical records do not establish that petitioner suffered the first symptoms or manifestation of onset of a shoulder injury within 48 hours of the November 2015 flu vaccination. Respondent’s Rule 4(c) report at 5. On February 20, 2018, petitioner filed Exhibit 11, Affidavit of Larry Wolford, and Exhibit 12, Affidavit of Patty Wolford (ECF No. 28). On October 23, 2018, petitioner filed Exhibit 13, Expert Opinion of Jeffrey Boyd, M.D., Regarding Larry Wolford (ECF No. 38). On November 28, 2018, the parties and an OSM staff attorney held a telephonic status conference to discuss how to proceed. At the parties’ request, the undersigned scheduled a videoconference fact hearing on the issue of onset for May 14, 2019. Pre-Hearing Order, issued Dec. 7, 2018 (ECF No. 39). Approximately two weeks before the hearing, on April 29, 2019, respondent filed a status report requesting a pre-hearing status conference. Respondent’s Status Report, filed April 29, 2019 (ECF No. 44). Respondent noted that he had requested telephone records from petitioner that had not yet been filed. Id. On the same day, petitioner filed a status report indicating that he had been making efforts to obtain these records. Petitioner’s Status Report, filed April 29, 2019 (ECF No. 45). On April 30, 2019, a telephonic status conference was held with counsel for both parties and an OSM staff attorney. Following the status conference, the undersigned issued an order directing petitioner to file a motion for a subpoena and the records. Scheduling Order, issued April 30, 2019 (ECF No. 47). The undersigned stated that other than the items listed in the order, evidence not filed by the date set for the record on onset to close would not be admitted absent compelling circumstances. Id. 2 Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 3 of 13 On May 1, 2019, petitioner filed Pet. Ex. 21, a declaration from the custodian of records for Dinkar Patel, M.D., indicating that no phone records were produced. Pet. Ex. 21 at 2. On June 5, 2019, petitioner filed Pet. Ex. 22, containing phone records with several calls highlighted. Pet. Ex. 22 at 6-7. On May 14, 2019, the undersigned held a fact hearing on the issue of onset. The petitioner, Larry Wolford, and his wife, Patty Wolford, were witnesses and appeared via videoconference with petitioner’s attorney. On May 23, 2019, the undersigned held a telephonic status conference with the parties. Isaiah Kalinowski appeared on behalf of petitioner, and Kyle Pozza appeared on behalf of respondent. During the status conference, the undersigned indicated that if it was acceptable to the parties, she would issue an oral ruling as to onset during the status conference. Mr. Kalinowski agreed to this approach. Mr. Pozza stated that he thought that there would be briefing before a ruling was issued. The undersigned responded that onset was a factual issue and that the undersigned did not need briefs to resolve onset. The undersigned then proceeded to state her ruling on onset as well as the supporting evidence. The undersigned indicated that the ruling would be memorialized in writing. Following the May 23, 2019 status conference, the undersigned issued a scheduling order directing petitioner to file additional medical records, an expert report, social security disability records, and employment records. Scheduling Order, issued May 24, 2019 (ECF No. 51). On June 12, 2019, respondent filed a status report concerning the May 24, 2019 scheduling order. Respondent’s Status Report, filed June 12, 2019 (ECF No. 55). In his status report, respondent’s counsel noted that during the May 23, 2019 status conference he stated that post-hearing briefing would be appropriate. Id. Respondent noted that the May 24, 2019 scheduling order did not reference respondent’s request for post-hearing briefing. Id. II. Evidence from Medical Records, Affidavits, and Hearing Testimony While the undersigned has reviewed the entire record, because this ruling concerns only onset, only evidence relevant to onset is summarized herein. On November 11, 2015, petitioner was seen by his primary care physician, Dr. Dinkar Patel. Pet. Ex. 4 at 34. The record indicates chief complaints of diabetes mellitus and hypercholesterolemia. Id. Under “History of Present Illness,” the record indicates that petitioner complained of backache, came in for check up on blood sugar, had itching and rash on his right arm, and wanted the flu vaccine. Id. Petitioner testified that he had not previously had the flu vaccine, but that there were advertisements on television that “if you had sugar [diabetes] it would be bad on you if you didn’t take it . . . so I went up there . . . just to take a shot.” Transcript of May 14, 2019 Hearing (“Tr.”) at 15-16, 88. The record documents, “Flu vaccine given. No 3 Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 4 of 13 reaction noted.” Pet. Ex. 4 at 35. Petitioner’s detailed immunization record indicates that his flu shot on this date was administered intramuscularly into his right deltoid. Pet. Ex. 10. At the hearing, petitioner testified that when the vaccine was administered, the nurse “said she felt it tighten up on me, so I don’t know where she did or what, but she said she felt it tighten up on me.” Tr. at 17. He explained that “when she pulled the needle out, she said it tightened up on her . . . she felt it jerk, the muscle tightened up and everything.” Id. at 109-10. Petitioner testified that he began experiencing aching and stiffness the evening of the vaccination. Id. at 19. He testified that the shoulder pain disturbed his sleep and awoke him at night beginning the first night following the vaccination. Id. at 35. He had to start driving with one hand “[r]ight after the vaccine.” Id. at 36. He explained that a day or two later he developed a stabbing pain. Id. at 26. He then made a “sleeve,” or sling, out of a compression sock that, when worn as a sleeve, warmed his arm and reduced his discomfort. Id. at 19-20, 26, 31-33. When asked why he did not go to the emergency room, petitioner testified, “[p]robably because they’d probably tell her to give you a pain shot and stuff, and I didn’t want no more shots in the arm.” Id. at 117; see also id. at 123 (“they’d probably want to administrate a shot . . . I didn’t want no more shots”). He thought they would probably “say they want you to go to another doctor . . . so don’t make no difference.” Id. He further explained that a couple of days after vaccination, he did not go to the emergency room because “it would get better with treating – with my treating myself, Tylenol, ibuprofen . . . [and] I’d go ahead and everything and put the sleeve on it too, so it would make it, like I say, feel a little better.” Id. at 118. He added that he also used Icy Hot during this time. Id. at 119. Petitioner testified that his wife usually took care of making medical appointments and filling out medical forms. Tr. at 27, 152-53. He testified that his wife also usually did more of the talking than him. Id. at 152. Petitioner testified that at some point he asked his wife to start calling doctors to see if he could be examined, but that he did not recall exactly when that was. Id. at 44. He testified that “it’s hard to see doctors anymore” and that “he’s hard to see and so, but you ought to hang on to what doctor you got right now.” Id. at 121-22. Petitioner testified that he lives in a remote area and his primary care physician’s office is 35 minutes away. Id. at 15. At the hearing, Ms. Wolford testified that “when she [the nurse in Dr. Patel’s office] gave him [petitioner] his shot she just kind of – I guess laughed a little bit and said he’d probably get sore because I felt it jerk.” Id. at 157-58; see also id. at 199. Ms. Wolford testified that she was present during the entire visit with Dr. Patel on November 11, 2015 when petitioner received his flu shot and that she also received a flu shot during this visit. Id. at 157. She testified that the nurse who administered the vaccine was named Lynette but that she did not know the nurse’s last name. Id. at 199. The 4 Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 5 of 13 vaccine administration record indicates that the vaccine was administered by Lynette Gibson. Pet. Ex. 10. Ms. Wolford testified, “after we got home, he was complaining with it being sore, just like sore, a dull, aching sore, and – but he thought, you know, it was just normal.” Tr. at 158. She testified that she did not call Dr. Patel’s office that day about her husband’s pain because the nurse “said it was going to get sore, so he just thought it would be normal.” Id. at 201. She testified that the soreness did not go away but worsened. Id. at 158-59. She stated that the next day, “he just all of a sudden would be hollering, ouch, and grabbing to his arm.” Id. at 159. However, she testified that he “thought it was just normal from the shot, you know, because she said he’d get sore.” Id. Ms. Wolford testified that petitioner used Icy Hot, ibuprofen, and Tylenol for the pain, and made a sleeve to put on to lessen his pain. Id. at 159. She testified that as time went on in November and December, petitioner would “treat it for a while and then it would go away, and it’d like just come back . . . . I remember him propping it up on, like, a pillow to ease the pain. And I think we took rolled-up quilts, too, to put up under his arm to hold it up where it was sore.” Id. at 160. She recalled seeing him “trying to comb his hair, and he couldn’t get his arm up over his head to comb his hair, like he was having trouble moving his arm.” Id. at 161. She could not recall when she observed this but stated that it was before April 2016 and possibly before February 2016. Id. at 161, 173-74. Ms. Wolford testified that she was not sure when she first called Dr. Patel’s office, but believes it was sometime around mid-November or Thanksgiving. Tr. at 162- 63, 202. She testified that she was told that Dr. Patel “was out of the country at that time” and that he would be gone for a month. Id. at 163, 205. Petitioner’s phone records indicate that calls were made from a number registered to petitioner to the same number in Grundy, VA, (276) 935-6444, 20 times between November 20-24, 2015 and twice on January 15, 2016. Pet. Ex. 22 at 6-7. The phone records also indicate that two calls were made to (276) 935-8620 in Grundy, VA on January 11, 2016. Pet. Ex. 22 at 7. There is no evidence in the record of who these phone numbers belong to. The main number of the clinic where Dr. Patel practices in Grundy, VA is (276) 935-2148. See, e.g., Pet. Ex. 9 at 1. Petitioner’s wife testified that petitioner did not see another doctor in the practice because Dr. Patel had “been his doctor for years. He’s the only one he sees” and they planned to “wait for him to come back.” Tr. at 163-64. She testified that she did not initially look for other doctors because petitioner was treating himself and the pain was coming and going. Id. at 164. In a later record, Dr. Patel included a note stating: Patient states he came to see me in Nov 2015, I seen him on 11-11-15 but 5 Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 6 of 13 he came again to see me and I was out of town and he seen Jerry Thacker for right shoulder pain and received physical therapy. Pet. Ex. 7 at 5 (ECF No. 5-8); see also Pet. Ex. 9 at 5 (handwritten version of similar note).3 Ms. Wolford testified that eventually she started calling other doctors in the area that she identified by going through a phone book. Tr. at 164. She could not recall the names of the offices she called but stated that there were “a few” and that “they couldn’t get him in because . . . they wanted a referral or where it was the holidays and stuff, they wanted it two or three months down the road.” Id. at 185. Petitioner’s wife testified that they did not go to the emergency room because “he was already treating himself anyways. If he went to the emergency room, they just wouldn’t probably have done no more than what he’s already done.” Id. at 185. She testified that there are not many medical providers in the area. Id. at 203. She contacted the office of chiropractor Dr. Thacker and was told that he could see petitioner. Id. at 165. She could not recall the interval between when she called Dr. Thacker’s office and when petitioner was first seen by Dr. Thacker, but said that “it wasn’t that long. Probably a couple of days . . . they got him in quick.” Id. On February 16, 2016, petitioner presented to chiropractor Jarrod Thacker, DC for an examination. Pet. Ex. 5 at 3. The record states: Patient presents with severe upper thoracic/right shoulder/arm/elbow thumb pain. Patient explains the pain started after receiving a flu shot in November 2015. Patient has pain daily 4/5 times a day made worse with certain movements. Pain ranges from 2-8/10 on a pain scale. Onset: acute, one week after flu shot was administered. Cause of symptoms: flu shot. Pet. Ex. 5 at 3. On examination, Dr. Thacker found that petitioner presented with “severe guarding of the neck and right shoulder.” Id. Dr. Thacker treated petitioner to relieve pain, decrease inflammation, and to improve function, strength, and range of motion. Id. at 4. Petitioner was given shoulder exercises and stretches for impingement syndrome. Id. Petitioner testified that when he saw Dr. Thacker, he told him the reason for his visit was his arm and the flu shot. Tr. at 45. He testified that he did not tell Dr. Thacker when the pain began but that his wife did. Id. at 47. Petitioner testified that the notation stating the onset was one week after the flu shot is not accurate. Id. at 49, 127-28. On cross-examination, respondent’s counsel asked whether petitioner told Dr. 3 Pet. Ex. 7 may be found at ECF No. 5-8. Because Pet. Ex. 7 is not paginated, the reference to page 5 above refers to the page of the PDF when downloaded from CM/ECF. 6 Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 7 of 13 Thacker that the onset of his right shoulder pain was acute and was one week after the flu vaccine was administered. Id. at 128. Petitioner initially responded “yes,” but then immediately added, “If that’s what – is that what acute means? What does acute mean?” Id. Respondent’s counsel then asked if petitioner told Dr. Thacker that his right shoulder pain began one week after the flu shot was given to him, and petitioner replied “No, no, no. No, no, no, no.” Id. Ms. Wolford testified that “the first time he [petitioner] seen Dr. Thacker, he told Dr. Thacker that it – it got sore that day he took the shot and then it got worse that week.” Id. at 206-07. On February 29, 2016, petitioner saw Dr. Patel with chief complaints of diabetes mellitus and hypercholesterolemia. Pet. Ex. 4 at 36. The record further indicates that he had “neck pain, numbness in right arm.” Id. In relation to the neck pain and right arm numbness, the record indicates that he was “[b]eing followed by chiropractor.” Id. He was assessed as having “neck pain with probable degenerative disc disease c spine cervical radicular syndrome right side” as well as osteoarthritis and non-insulin dependent diabetes mellitus II. Id. at 37. The plan indicated that Dr. Patel “[a]dvised mri of the c spine, Patient states chiropractor is going to do it.” Id. At the hearing, petitioner testified that he told Dr. Patel that the shoulder pain began “[w]hen his nurse had give me the shot, the flu shot.” Tr. at 65. Ms. Wolford testified that she recalled petitioner “telling him [Dr. Patel] that his – he was having some trouble out of his arm after the shot, after he took that shot . . . he told him that his shoulder had been giving him some trouble since he had the shot.” Id. at 169. On April 11, 2016, petitioner was seen by Dr. Patel. Pet. Ex. 4 at 38. The record indicates that he presented for a check of his blood sugar and that he had “right shoulder pain with restricted shoulder movements. Multiple joint pains.” Id. He was assessed as having “right shoulder pain etiology to be determined,” osteoarthritis, acute bronchitis, and diabetes mellitus II without complication. Id. at 39. The record indicates that Dr. Patel. “[a]dvised mri of the right shoulder and Patient is being followed by Dr. Jarrod Thacker.” Id. Dr. Patel recommended that petitioner restrict his activity and continue physical therapy. Id. On April 18, 2016, petitioner was seen by orthopedist Dr. Jamie Varney, MD. Pet. Ex. 2 at 3. The record indicated that the visit was due to right shoulder pain and that he stated that “the symptoms began as the result of started hurting after flu shot.” Id. On examination, petitioner was found to have positive signs on the Hawkins and Neer’s impingement tests and the cross body test for shoulder joint pathology. Id. at 5. Dr. Varney’s records indicate that he “[d]iscussed that it is unlikely that the flu shot actually caused any damage to his shoulder” and noted that an MRI showed chronic tendinopathy with some tendinitis and bursitis and a downward sloping acromion “that causes rotator cuff impingement”. Id. at 7. Dr. Varney considered that the “[p]revious injection [which appears to refer to the flu shot] may have caused some inflammation of his underlying problems.” Id. Dr. Varney administered a steroid injection into petitioner’s right shoulder subacromial space. Id. at 6-7. 7 Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 8 of 13 Dr. Varney’s records include an Orthopedic Information Sheet filled in by hand. Pet. Ex. 2 at 10-13. Petitioner and his wife both testified that the handwriting on the form belongs to petitioner’s wife. Tr. at 73, 175. The completed form indicates that the appointment was for an injury from a flu shot that occurred at Dr. Patel’s office on November 11, 2015. Pet. Ex. 2 at 11. The “reason for visit” response indicates pain in right shoulder, numbness in thumb. Id. In response to a question about when symptoms started, the answer is “same night got sore.” Id. Petitioner’s wife confirmed this statement in her testimony. Tr. at 175. At the hearing, petitioner was questioned about why he accepted a steroid injection from Dr. Varney but avoided going to the emergency room because he did not want another shot. Petitioner testified that the steroid injection “was supposed to help my pain go and everything, but he did make my sugar go up.” Tr. at 135. He further explained that the shot from Dr. Varney was “in the side of the shoulder . . . . It wasn’t straight right here up front . . . . I told him I didn’t want to take it there.” Id. at 136. Petitioner testified that he would not have agreed to the injection if Dr. Varney had tried to put it in the front of his deltoid. Id. at 137. Petitioner submitted an expert report from Jeffrey Boyd, M.D., a practicing diagnostic radiologist specializing in musculoskeletal radiology. Pet. Ex. 13 at 1. Dr. Boyd stated, “it is my opinion to a reasonable degree of probability that Mr. Wolford’s MRI findings are consistent with having suffered from a SIRVA, for which the onset of injury occurred four months prior to the scan.” Id. at 6. Petitioner’s MRI was done on March 1, 2016, meaning that four months prior to the MRI would be early November. Pet. Ex. 3 at 2. III. Legal Standard 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 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.” Vaccine Act § 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. 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. Vaccine Act § 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 8 Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 9 of 13 also generally contemporaneous to the medical events.” Curcuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). IV. Finding of Fact To establish a Table SIRVA claim, a petitioner must establish, inter alia, that petitioner’s pain occurred within 48 hours of vaccination. See Vaccine Injury Table; Qualifications and Aids to Interpretation, 42 C.F.R. § 100.3(c)(10). The parties dispute whether this criterion is met in this case. In his Rule 4(c) report, respondent argued that petitioner had not established that the onset of his symptoms occurred within 48 hours of vaccination. Respondent cited the fact that petitioner did not seek medical care for his asserted vaccine injury until over three months after vaccination, on February 16, 2016, and that at this visit he reported that his right arm pain began one week after his November 2015 flu vaccination. Respondent’s Rule 4(c) report, filed Jan. 16, 2018, at 5 (ECF No. 26). During the May 23, 2019 status conference, the undersigned ruled that the onset of petitioner’s symptoms occurred on the evening of November 11, 2015, the night of the day on which petitioner received his flu vaccination. The undersigned bases her ruling on the following evidence. First, on the handwritten orthopedic information sheet, completed by Ms. Wolford, it states that the injury date was 11-11-15, lists as the injury “flu shot,” and in response to the pre-printed question of when the symptoms started states “same night got sore.” Pet. Ex. 2 at 11. Second, Dr. Varney’s note for petitioner’s April 18, 2016 visit indicates “Larry states that the symptoms began as the result of started hurting after flu shot.” Pet. Ex. 2 at 3. This evidence is supported by the testimony of petitioner and Ms. Wolford that the nurse told him it would probably be sore, that petitioner’s pain began the evening of the day he received the vaccine, and that the pain disturbed his sleep during that first night. Tr. at 17-19, 35, 157-59. Third, the note of chiropractor Dr. Thacker dated February 16, 2016 states, “Patient explains the pain started after receiving a flu shot in November 2015.” Pet. Ex. 5 at 3. This record further indicates that the onset was “acute, one week after flu shot was administered.” Id. At the hearing, Ms. Wolford testified that her husband reported to Dr. Thacker that his shoulder “got sore that day he took the shot and then it got worse that week.” Tr. at 206-07. Dr. Thacker’s note indicating that onset was acute and within one week is consistent with Ms. Wolford’s explanation of the pain. The undersigned found that Ms. Wolford’s explanation for why Dr. Thacker’s note noted onset of one week was reasonable. Although petitioner initially responded “yes” to respondent’s counsel’s question about whether he reported to Dr. Thacker that the onset was acute, one week after the flu shot, after obtaining clarification and being asked simply whether he reported that the onset was one week after the flu shot, petitioner emphatically responded that this was not correct. Fourth, petitioner and his wife testified in their affidavits and at the hearing that petitioner’s pain began on the evening of the flu vaccine, November 11, 2015. 9 Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 10 of 13 Specifically, Pet. Ex. 11 at ¶¶ 6-7 and the testimony of petitioner and his wife during the hearing support a finding that the onset of petitioner’s symptoms was the evening of November 11, 2015. Petitioner testified that when the vaccine was administered, the nurse “said she felt it tighten up on me, so I don’t know where she did or what, but she said she felt it tighten up on me.” Tr. at 17. Petitioner testified that he began experiencing aching and stiffness the evening of the vaccination. Tr. at 19. He testified that the shoulder pain disturbed his sleep and awoke him at night beginning the first night following the vaccination. Tr. at 35. Although Mr. Wolford’s testimony was difficult to understand, he consistently placed the onset of his symptoms at the evening of the vaccination. Ms. Wolford’s testimony also consistently placed onset of petitioner’s symptoms as occurring by the evening of the day the vaccine was administered. Ms. Wolford recalled that when the nurse gave petitioner his shot, “she just, kind of like said, he’d probably be a little sore because I felt it jerk.” Tr. at 157. She recalled the first name of the nurse who administered the vaccine, which is supported by the vaccine administration record. She testified, “after we got home, he was complaining with it being sore, just like sore, a dull, aching sore, and – but he thought, you know, it was just normal.” Tr. at 158. She testified that she did not call Dr. Patel’s office that day about her husband’s pain because the nurse “said it was going to get sore, so he just thought it would be normal.” Tr. at 201. Dr. Boyd’s expert report found that petitioner’s MRI findings were consistent with him having suffered a SIRVA in early November. This provides further support for the undersigned’s finding that petitioner’s onset occurred soon after his November 11, 2015 vaccination. Respondent places great weight on the fact that petitioner did not seek medical care for approximately three months after vaccination. The undersigned notes that a delay in seeking care is not uncommon in SIRVA cases and is not dispositive. See Cooper v. Sec’y of Health and Human Servs., No. 16-1387V, 2018 WL 1835179, at *6 (Fed. Cl. Spec. Mstr. Jan. 18, 2018) (“the undersigned does not find a delay in treatment of several months to be dispositive in and of itself regarding the question of onset in a SIRVA case such as this”); see also Tenneson v. Sec’y of Health & Human Servs., No. 16-1664V, 2018 WL 3083140 (Fed. Cl. Spec. Mstr. Mar. 30, 2018); Ray v. Sec’y of Health and Human Servs., No. 16-1388V, 2018 WL 7051571, at *6 (Fed. Cl. Spec. Mstr. Dec. 17, 2018) (citing Cooper). The Vaccine Act “does not mandate that the time of first onset be determined by the earliest entry” in the medical records. Lopez v. Sec’y of Health & Human Servs., No. 90-12V, 1990 WL 293414 (Cl. Ct. Spec. Mstr. Dec. 10, 1990). In this case, petitioner and Ms. Wolford testified that they live in a remote area with few doctors. They testified that the nurse told petitioner that the injection site may be painful as she had noted it “jerk” when she administered the vaccine. They testified that because it was anticipated that petitioner’s shoulder would be sore, petitioner did not pursue medical treatment immediately. They testified that when petitioner did 10 Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 11 of 13 attempt to obtain care, his primary care physician was away for an extended period of time. The phone records filed by petitioner demonstrate that numerous calls were made from their phone number to two numbers in Grundy, VA between the date of vaccination and the date when petitioner first saw Dr. Thacker. The lack of record evidence establishing who these phone numbers belong to limits the value of this piece of evidence. Nonetheless, these phone records serve to bolster the testimony of petitioner and his wife. Petitioner and his wife testified that, because these events took place over the holidays, other doctors were unable to fit him in promptly. During this time, petitioner self-treated to alleviate his pain by using over the counter medications and a homemade sling made from a sock. Under these circumstances, the undersigned finds that a three-month delay in receiving medical treatment is reasonable and does not cast doubt on whether petitioner’s injury occurred within 48 hours of vaccination. Respondent also emphasizes that Dr. Thacker’s record indicates that the onset of petitioner’s symptoms occurred one week after the flu vaccination. While Dr. Thacker’s record does state that onset was one week after the flu vaccine, that is not dispositive. The Vaccine Act contemplates that a record may incorrectly record onset or fail to record onset and provides that: The special master or court may find the first symptom or manifestation of onset or significant aggravation of an injury, disability, illness, condition, or death described in a petition 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. Vaccine Act § 13(b)(2) (emphasis added) Thus, the exact circumstances present in this case are contemplated by the Vaccine Act. The fact that a medical record does not record onset or records a time of onset outside of the Table provisions does not automatically eliminate the possibility that a petitioner can establish a Table claim. Rather, petitioner may still prove a Table claim if he demonstrates, by a preponderance of the evidence, that onset occurred within the time set forth in the Table. In this case, petitioner has done so. The undersigned found that Ms. Wolford’s explanation, that petitioner reported to Dr. Thacker onset of pain the evening of November 11, 2015 and reported that the symptoms worsened over the week following the flu shot, provides a reasonable explanation for Dr. Thacker’s recorded time of onset. See, e.g., Stevens v. Sec’y of Health & Human Servs., 90-221V, 1990 WL 608693, at *3 (Cl. Ct. Spec. Mstr. 1990) 11 Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 12 of 13 (noting that clear, cogent, and consistent testimony can overcome missing or contradictory medical records). Based on the undersigned’s review of the record as a whole, in particular the portions cited herein, the undersigned finds that that the fact that (1) petitioner did not receive medical care until three months after vaccination and (2) the medical record from petitioner’s February 16, 2016 appointment with Dr. Thacker lists onset as one week after the flu shot, do not establish that the onset of petitioner’s shoulder pain did not occur within 48 hours of vaccination. After a review of all evidence, the undersigned finds that petitioner has established, by a preponderance of the evidence, that the onset of his shoulder pain occurred within 48 hours of his November 11, 2015 flu vaccination. V. Respondent’s Request for Post-Hearing Briefing The undersigned acknowledges that during the May 23, 2019 status conference and in his June 12, 2019 status report, respondent indicated an interest in post-hearing briefing. The undersigned determines that there is sufficient record evidence for a ruling on the record on onset and that, in this case, briefing would not be helpful in evaluating the evidence and determining the factual issue of onset. Pursuant to Vaccine Rule 8(a), a special master is required “to determine the format for taking evidence and hearing argument based on the specific circumstances of each case and after consultation with the parties.” Vaccine Rule 8(a). “In any matter not specifically addressed by the Vaccine Rules, the special master or the court may regulate the applicable practice, consistent with these rules and with the purpose of the Vaccine Act, to decide the case promptly and efficiently.” Vaccine Rule 1(b). In conducting proceedings, a special master is responsible for “endeavoring to make the proceedings expeditious, flexible, and less adversarial, while at the same time affording each party a full and fair opportunity to present its case.” Vaccine Rule 3(b)(2). The Vaccine Rules do not provide for routine briefing on factual issues and do not require or contemplate post-hearing briefing. Rather, the rules provide special masters with considerable flexibility in determining the appropriate procedures on a case by case basis. In so doing, the special master is to select procedures that are consistent with the program’s goal of making proceedings expeditious and less adversarial while ensuring that all parties are given the opportunity to present their case. In other cases, special masters have made onset rulings in other cases without post-hearing briefing. See, e.g., Sherbine (Tinley) v. Sec’y of Health and Human Servs., No. 17-0413, 2018 WL 5276612 (Fed. Cl. Spec. Mstr. Sept. 5, 2018); Brown v. Sec’y of Health and Human Servs., No. 13-766, 2015 WL 4626797 (Fed. Cl. Spec. Mstr. July 14, 2015) (issuing ruling on onset following fact hearing without briefing); see also Caron v. Sec’y of Health and Human Servs., No. 15-0777, 2016 WL 7664309 (Fed. Cl. Spec. Mstr. Dec. 14, 2016) (resolving onset without post-hearing briefing, although onset was briefed prior to hearing). 12 Case 1:17-vv-00451-UNJ Document 59 Filed 10/17/19 Page 13 of 13 In this case, respondent filed his Rule 4(c) report contesting entitlement based in part on concerns about onset nearly 18 months ago. Both parties have had ample opportunity to present their case since that time. In this case in particular, the undersigned finds that the record contains sufficient evidence to make a ruling on onset without the need for briefs. Thus, the undersigned determines that post-hearing briefs are not necessary or appropriate in this case. VI. Conclusion In light of all of the above, and in view of the submitted evidence, including the medical records, witness testimony, and affidavits, the undersigned finds that the onset of petitioner’s right shoulder injuries was within 48 hours of vaccination. IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 13 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_17-vv-00451-1 Date issued/filed: 2021-08-03 Pages: 20 Docket text: PUBLIC ORDER/RULING (Originally filed: 7/9/2021) regarding 80 Ruling on Entitlement. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made. (Main Document 83 replaced on 9/20/2021 to correct petitioner's counsel firm and location) (sw). -------------------------------------------------------------------------------- Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 1 of 20 CORRECTED In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: July 9, 2021 * * * * * * * * * * * * * * * * * * * * * * * * * LARRY WOLFORD, * PUBLISHED * Petitioner, * No. 17-451V * v. * Special Master Nora Beth Dorsey * SECRETARY OF HEALTH * Ruling on Entitlement; Causation-in-Fact; AND HUMAN SERVICES, * Influenza (“Flu”) Vaccine; Shoulder Injury * Related to Vaccine Administration Respondent. * (“SIRVA”). * * * * * * * * * * * * * * * * * * * * * * * * * * Isaiah Richard Kalinowski, Maglio Christopher and Toale, PA, Washington, DC, for petitioner. Kyle Edward Pozza, U.S. Department of Justice, Washington, DC, for respondent. RULING ON ENTITLEMENT1 On March 29, 2017, Larry Wolford (“petitioner”) filed a petition for compensation under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42 U.S.C. § 300aa-10 et seq. (2012).2 Petitioner alleges that he suffered a right shoulder injury as the result of an influenza (“flu”) vaccination administered on November 11, 2015. Petition at 1- 3 (ECF No. 1). 1 Because this Ruling contains a reasoned explanation for the action in this case, the undersigned is 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, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material from public access. 2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to -34 (2012). All citations in this Ruling to individual sections of the Vaccine Act are to 42 U.S.C. § 300aa. Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 2 of 20 After carefully analyzing and weighing the evidence presented in this case in accordance with the applicable legal standards, the undersigned finds that petitioner has provided preponderant evidence that the flu vaccine caused his right shoulder injury, which satisfies his burden of proof under Althen v. Secretary of Health & Human Services, 418 F.3d 1274, 1280 (Fed. Cir. 2005). Accordingly, petitioner is entitled to compensation. I. PROCEDURAL HISTORY Petitioner filed his petition on March 29, 2017, alleging that he sustained a right shoulder injury caused by a flu vaccine administered on November 11, 2015. Petition at 1-3. The early procedural history from March 2017 through June 2019 was set forth in the undersigned’s Fact Ruling and will not be repeated here. Fact Ruling dated July 8, 2019, at 2-3 (ECF No. 56). Thereafter, this case was removed from the Special Processing Unit (“SPU”). Petitioner filed additional documentation between August and December 2019. Pet. Exs. 30-32. On March 20, 2020, petitioner filed an expert report from Dr. Tony Korman. Pet. Ex. 33. Respondent filed an expert report from Dr. Paul Cagle on July 27, 2020. Resp. Ex. A. On September 22, 2020, petitioner filed a memorandum in support of petitioner’s entitlement to compensation. Memorandum in Support of Petitioner’s Entitlement to Compensation (“Pet. Memo.”), filed Sept. 22, 2020 (ECF No. 75). Respondent filed his response on November 13, 2020. Respondent’s Response to Pet. Motion for Ruling on the Record (“Resp. Response”), filed Nov. 13, 2020 (ECF No. 78). Petitioner filed a reply on December 1, 2020. Reply Memo. in Support of Pet. Entitlement to Compensation (“Pet. Reply”), filed Dec. 1, 2020 (ECF No. 79). This matter is now ripe for adjudication. II. FACTUAL HISTORY A. Pre-Vaccination Medical History Petitioner’s pre-vaccination medical history is significant for non-insulin dependent diabetes mellitus, diabetic neuropathy, weakness, fatigue, numbness in hands and legs, backache, multiple joint pains, gastroesophageal reflux disease, depression, and osteoarthritis. Pet. Ex. 4 at 4-5, 7, 16, 26, 28. On November 9, 2005, while working in the coal mines as a fine clean coal operator, petitioner injured his lower back when lifting 55 gallon wood barrels. Pet. Ex. 31 at 9-10, 19, 59. In his worker’s compensation claim,3 he explained that by November 14, the pain was so severe he sought medical treatment. Id. at 10. At the time he filed his claim on April 27, 2006, he was undergoing physical therapy, taking pain medications, and unable to return to work. Id. at 10-11. 3 In his 2006 workers compensation claim, petitioner indicated he filed another worker’s compensation claim in 1985 after cutting his leg with a chainsaw. Pet. Ex. 31 at 11. 2 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 3 of 20 According to petitioner’s workers compensation file and social security records, petitioner’s complaints of multiple joint pain began in 2005. Pet. Ex. 31 at 141; Pet. Ex. 32 at 167. Petitioner was diagnosed with osteoarthritis.4 Id. In physical therapy records from 2005, petitioner reported a history of osteoarthritis in right hip and knee. Pet. Ex. 32 at 110. No records indicate that petitioner had right shoulder pain prior to vaccination. B. Post-Vaccination Medical History The Fact Ruling set forth a summary of petitioner’s medical records, affidavits, and hearing testimony relative to onset of his right shoulder injury. See Fact Ruling at 3-8. Only the relevant portions will be repeated here. In the Fact Ruling, the undersigned found the onset of petitioner’s right shoulder injury was within 48 hours of vaccination. Id. at 13. On November 11, 2015, at fifty-three years old, petitioner was seen by his primary care physician, Dr. Patel. Pet. Ex. 4 at 34. Current medications included Ultram,5 Cymbalta,6 and Neurontin.7 Id. at 34-35. Chief complaints were diabetes mellitus and hypercholesterolemia. Id. at 34. Petitioner also complained of backache and itching and rash on his right arm. Id. He came for a check up on his blood sugar and wanted a flu vaccine. Id. Physical examination by Dr. Patel revealed tenderness in lower back, dermatitis on right arm, and normal range of motion. 4 Osteoarthritis is “a noninflammatory degenerative joint disease seen mainly in older persons, characterized by degeneration of the articular cartilage, hypertrophy of bone at the margins, and changes in the synovial membrane,” and “[i]t is accompanied by pain.” Osteoarthritis, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=35780 (last visited June 23, 2021). 5 Ultram is a trademark for tramadol hydrochloride, “an opioid analgesic used for the treatment of moderate to moderately sever pain following surgical procedures and oral surgery.” Ultram, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id= 51748 (last visited June 23, 2021); Tramadol Hydrochloride, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=50542 (last visited June 23, 2021). 6 Cymbalta, a trademark for duloxetine hydrochloride, is used for “the relief of pain in diabetic neuropathy.” Cymbalta, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/ dorland/definition?id=12214 (last visited June 23, 2021); Duloxetine Hydrochloride, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=15011 (last visited June 23, 2021). 7 Neurontin, or gabapentin, is used to treat and manage postherpetic neuralgia, or “persistent burning pain and hyperesthesia along the distribution of a cutaneous nerve.” Neurontin, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id= 33803 (last visited June 23, 2021); Gabapentin, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=19523 (last visited June 23, 2021); Postherpetic Neuralgia, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/ dorland/definition?id=92490 (last visited June 23, 2021). 3 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 4 of 20 Id. At this visit, Ms. Lynette Gibson administered a flu vaccine in petitioner’s right deltoid. Pet. Ex. 10 at 1. Dr. Patel documented, “Flu Vaccine given. No reaction noted.” Pet. Ex. 4 at 35. At the fact hearing, petitioner testified that when the vaccine was administered, the nurse “said she felt it tighten up on [him], so [he did not] know where she did or what, but she said she felt it tighten up on [him].” Tr. 17. He explained that “when she pulled the needle out, she said it tightened up on her . . . she felt it jerk, the muscle tightened up and everything.” Tr. 109-10. Ms. Wolford testified that “when [the nurse] gave [petitioner] his shot she just kind of—I guess laughed a little bit and said he’d probably get sore because [she] felt it jerk.” Tr. 157-58, 199. Ms. Wolford testified that she was present during the entire visit with Dr. Patel on November 11, 2015 when petitioner received his flu shot and that she also received a flu shot during this visit. Tr. 157. Petitioner testified that he began experiencing aching and stiffness the evening of the vaccination. Tr. 19. His shoulder pain disturbed his sleep and woke him up at night beginning the first night following the vaccination. Tr. 35. He had to start driving with one hand “[r]ight after the vaccine.” Tr. 36. He explained that a day or two later he developed a stabbing pain. Tr. 26. Ms. Wolford testified that after they got home, petitioner complained of his shoulder being “sore, a dull, aching sore,” but they thought it was normal. Tr. 158. She testified that she did not call Dr. Patel’s office that day about petitioner’s pain because the nurse “said it was going to get sore, so he just thought it would be normal.” Tr. 201; see also Tr. 159. She explained, however, the soreness did not go away but worsened. Tr. 158-59. The day after vaccination, “[petitioner] just all of a sudden would be hollering, ouch, and grabbing to his arm.” Tr. 159. Petitioner explained that he made a “sleeve,” or sling, out of a compression sock that, when worn as a sleeve, warmed his arm and reduced his discomfort. Tr. 19-20, 26, 31-33. His pain also got better with Tylenol, ibuprofen, and Icy Hot. Tr. 118-19. Ms. Wolford also testified to these facts. Tr. 159. Ms. Wolford testified that as time went on in November and December 2015, petitioner would “treat it for a while and then it would go away, and it’d like just come back . . . . [She] remember[ed] him propping it up on, like, a pillow to ease the pain.” Tr. 160. They also did this with other items like quilts. Id. Ms. Wolford recalled seeing petitioner “trying to comb his hair, and he couldn’t get his arm up over his head to comb his hair, like he was having trouble moving his arm.” Tr. 161. She could not recall when she observed this but stated that it was before April 2016 and possibly before February 2016. Tr. 161, 173-74. Ms. Wolford testified that she was not sure when she first called Dr. Patel’s office, but believed it was sometime around mid-November or Thanksgiving. Tr. 162-63, 202. She testified that she was told that Dr. Patel “was out of the country at that time” and that he would 4 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 5 of 20 be gone for a month.8 Tr. 163, 205. Petitioner’s wife testified that petitioner did not see another doctor in the practice because Dr. Patel had “been his doctor for years. He’s the only one he sees” and they planned to “wait for him to come back.” Tr. 163-64. She testified that she did not initially look for other doctors because petitioner was treating himself and the pain was coming and going. Tr. 164. Ms. Wolford testified that eventually she started calling other doctors in the area that she identified by going through a phone book. Tr. 164. She could not recall the names of the offices she called but stated that there were “a few” and that “they couldn’t get him in because . . . they wanted a referral or where it was the holidays and stuff, they wanted it two or three months down the road.” Tr. 185. She contacted the office of chiropractor Dr. Jarrod Thacker and was told that he could see petitioner. Tr. 165. She could not recall the interval between when she called Dr. Thacker’s office and when petitioner was first seen by Dr. Thacker, but said that “it wasn’t that long. Probably a couple of days . . . they got him in quick.” Id. Petitioner presented to Dr. Thacker on February 16, 2016 with “severe upper thoracic/right shoulder/arm/elbow thumb pain” that “started after receiving a flu shot in November 2015.” Pet. Ex. 5 at 3. Petitioner noted onset as “acute, one week after flu shot was administered.”9 Id. Petitioner reported “pain daily 4/5 times a day [and] made worse with certain movements. Pain ranges from 2-8/10 on a pain scale.” Id. Pain was described as “achy, burning, dull, sharp, stiff, throbbing,” and moderate. Id. Petitioner further reported numbness in right hand, severe spasms in right cervical paraspinal and right trapezius, right upper extremity weakness, and decreased cervical motion. Id. He indicated he was only able to lift 25 pounds and his sleep was affected. Id. On physical examination, Dr. Thacker wrote petitioner “presents with severe [guarding] of the neck and right shoulder.” Id. Petitioner had decreased range of motion. Id. Dr. Thacker treated petitioner to relieve pain, decrease inflammation, and to improve function, strength, and range of motion. Id. at 4. Petitioner was given shoulder exercises and stretches for impingement syndrome. Id. Petitioner returned to Dr. Thacker numerous times from February to November 2016. Pet. Ex. 5 at 6-56; Pet. Ex. 6 at 2-22, 24-32. During the February 24, 2016 visit, Dr. Thacker wrote “[a] MRI consult was discussed with [petitioner] because progression not optimal. 8 In a later record, Dr. Patel included a note stating, “[petitioner] states he came to see me in Nov[ember] 2015, I [saw] him on 11-11-15 but he came again to see me and I was out of town and he [saw] Jerry Thacker for right shoulder pain and received physical therapy.” Pet. Ex. 7 at 5; see also Pet. Ex. 9 at 5 (handwritten version of similar note). 9 Petitioner testified that the notation stating the onset was one week after the flu shot is not accurate. Tr. 49, 127-28, 206-07. 5 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 6 of 20 [Petitioner] would need to visit PCP (Dr. D Patel) to obtain order form [for] R shoulder MRI.”10 Pet. Ex. 5 at 13. On February 29, 2016, petitioner returned to Dr. Patel’s office11 with a chief complaint of diabetes mellitus and hypercholesterolemia. Pet. Ex. 4 at 36. Under review of systems, petitioner complained of neck pain and numbness in right arm and reported seeing a chiropractor. Id. Physical examination revealed tenderness in back of neck with painful neck movements, no stiffness in neck, and normal range of motion. Id. Assessment included “neck pain with probable degenerative disc disease c spine,” “cervical radicular syndrome right side,” and osteoarthritis. Id. at 37. Petitioner was advised to have an MRI of his cervical spine done.12 Id. An MRI of petitioner’s right shoulder was conducted on March 1, 2016. Pet. Ex. 3 at 2. Diagnosis was listed as shoulder pain and soreness after flu shot. Id. The impression was “[s]omewhat inferiorly projecting acromion process with mild increased signal intensity changes in the subacromial bursa could represent impingement syndrome[13] or from bursitis. [14] Study otherwise is negative for rotator cuff tear.” Id. Dr. Thacker’s examinations in March and April 2016 “show[ed] minimal to no improvement in [petitioner’s] subjective or objective complaints/findings.” Pet. Ex. 5 at 24, 48. Dr. Thacker discussed a referral to an orthopedist for an injection. Id. 10 Dr. Thacker’s additional patient notes regarding petitioner’s shoulder MRI are as follows: 4-7-16: Appointment with patient PCP was set up for 4-13-16 to obtain order for right shoulder MRI. Patient progress not showing expected results. Patient still suffering from severe pain when certain motions are sought (Mostly overhead/abduction/adduction to R shoulder). 4/14/16: Patient had follow up visit with PCP to get a MRI on R shoulder. 4/28/16: Patient was referred to orthopedist for consultation of cortisone injection into right shoulder. Injection was administered by Dr. Varney at PMC. Pet. Ex. 5 at 2. 11 It is not clear from the record who petitioner saw during this visit. 12 No records were provided indicating petitioner received a cervical spine MRI. Based on the medical records, it appears petitioner received only a right shoulder MRI. 13 Impingement syndrome results from “mechanical impingement by the acromion, coracoacromial ligament, coracoid process, or acromioclavicular joint against the rotator cuff.” Impingement Syndrome, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/ dorland/definition?id=110796 (last visited July 6, 2021). 14 Bursitis is “inflammation of a bursa.” Bursitis, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=7315 (last visited July 6, 2021). 6 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 7 of 20 Petitioner returned to Dr. Patel’s office15 on April 11, 2016. Pet. Ex. 4 at 38. Petitioner complained of “right shoulder pain with restricted shoulder movements” as well as multiple joint pain. Id. Physical examination revealed right shoulder tenderness with marked restricted movements and normal range of motion. Id. Assessment included “right shoulder pain etiology to be determined.” Id. at 39. Under plan, the record indicates “[a]dvised mri of the right shoulder and [petitioner] is being followed by Dr. [] Thacker.” Id. Petitioner was instructed to continue physical therapy. Id. On April 18, 2016, petitioner saw orthopedist Dr. Jamie Varney at Pikeville Medical Center complaining of right shoulder pain. Pet. Ex. 2 at 3, 7. Petitioner stated “the symptoms have been chronic non-traumatic,” occur intermittently, and “began . . . after flu shot.” Id. at 3. He described the pain as “piercing” and reported additional pain in his right thumb. Id. at 3, 12. He indicated his “symptoms are aggravated by daily activities and reaching overhead,” but are “relieved by physical therapy.” Id. At the time of the visit, petitioner reported his symptoms were moderate and his pain was a 2/10. Id. at 3, 11. In a handwritten orthopedic information sheet completed on April 18, 2016,16 petitioner related his injury back to the flu vaccine received on November 11, 2015 and listed his reason for visit as “pain in right shoulder [and] numbness in thumb.” Id. at 11. For when his symptoms started, he wrote “same night got sore.” Id. He also described the pain as stabbing and noted it “randomly” goes from 2/10 to 8/10. Id. Physical examination revealed positive signs on Hawkins and Neer’s tests and the cross body test for shoulder joint pathology. Pet. Ex. 2 at 5. Range of motion in petitioner’s left shoulder was normal, but there was “pain in impingement arc” noted with regard to petitioner’s right shoulder. Id. at 6. Elbow and wrist range of motion in both extremities was normal. Id. Upper extremity strength was normal except for “mild decreased right supraspinatus due to pain.” Id. Neurovascular upper extremity examination was normal, although petitioner reported “some decreased sensation on the inner aspect of his thumb.” Id. Assessment was impingement syndrome and bursitis of right shoulder. Id. Petitioner received a cortisone injection in the subacromial space in his right shoulder. Id. Dr. Varney stated, “it is unlikely that the flu shot actually caused any damage to his shoulder. MRIs . . . show[] chronic tendinopathy of supraspinatus with some tendinitis and bursitis. Also has a downward sloping acromion that causes rotator cuff impingement. Previous injection may have [] caused some inflammation of his underlying problems.”17 Id. at 7. Petitioner was advised to continue home exercises and physical therapy and ice and take anti-inflammatories as needed. Id. On August 16, 2016, petitioner returned to Dr. Patel for diabetes mellitus and hypercholesterolemia. Pet. Ex. 7 at 2. Petitioner did not complain of shoulder pain at this visit. See id. Physical examination revealed normal range of motion. Id. 15 Again, it is not clear from the record who petitioner saw during this visit. 16 Petitioner and his wife both testified that the handwriting on the form belongs to petitioner’s wife. Tr. 73, 175. 17 Dr. Varney does not define “previous injection.” It appears, however, based on the context of the note, that Dr. Varney was referring to the flu vaccination. 7 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 8 of 20 On July 21, 2016, petitioner saw Dr. Thacker who noted petitioner “re-injured right shoulder after hanging drywall for 4 hours [on] 7/18/16.” Pet. Ex. 6 at 17. Petitioner saw Dr. Patel on October 4, 2016, complaining of “rash on the arm with itching backache, numbness in legs. Came for check up on blood sugar. Cough, chest congestion.” Pet. Ex. 7 at 4. On physical examination, range of motion was normal. Id. Dr. Patel noted petitioner saw Dr. Thacker for right shoulder pain and received physical therapy. Id. at 5. Petitioner complained of diabetes mellitus, hypercholesterolemia, multiple join pain, numbness in legs, and a cough during a visit to Dr. Patel on December 7, 2016. Pet. Ex. 7 at 6. Petitioner did not complain of right shoulder pain during this visit. See id. Range of motion was normal on physical examination. Id. Petitioner saw Dr. Patel next on March 9, 2017. Pet. Ex. 9 at 1-2. No complaints of right shoulder pain were noted. See id. Physical examination revealed normal range of motion. Id. at 1. “Right elbow region pain” and “normal range of motion” were noted in petitioner’s next visit to Dr. Patel on June 14, 2017. Id. at 3-4. No additional medical records were provided. III. EXPERT REPORTS A. Petitioner’s Expert, Dr. Jeffrey Boyd 1. Background and Qualifications Dr. Boyd is a practicing diagnostic radiologist specializing in musculoskeletal radiology. Pet. Ex. 13 at 1. He is board certified in diagnostic radiology. Id. Dr. Boyd received his B.A. in Biochemistry in 2001 and his M.D. in 2005 from the University of Mississippi. Pet. Ex. 14 at 1. Thereafter, he completed an internship in internal medicine, residency in diagnostic radiology, and a fellowship in musculoskeletal radiology. Id. He holds licenses in Kentucky, Indiana, Mississippi, Tennessee, and Arkansas. Id. 2. Opinion Dr. Boyd opined that more likely than not petitioner’s November 11, 2015 flu vaccination caused petitioner to experience a shoulder injury related to vaccine administration (“SIRVA”), which he continues to suffer from. Pet. Ex. 13 at 8. For support that a flu vaccine can cause a SIRVA, Dr. Boyd cited Atanasoff et al.18 Pet. Ex. 13 at 5. In Atanasoff et al., the authors identified thirteen cases filed in the database of claims submitted to the Vaccine Program between 2006 to 2010 where “vaccine administration led to significant shoulder pain and dysfunction.” Pet. Ex. 15 at 1-2. Based on their 18 S. Atanasoff et al., Shoulder Injury Related to Vaccine Administration (SIRVA), 28 Vaccine 8049 (2010). 8 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 9 of 20 investigation, the authors’ proposed mechanism “is the unintentional injection of antigenic material into synovial tissues resulting in an immune-mediated inflammatory reaction.” Id. at 1. “[T]he rapid onset of pain with limited range of motion following vaccination . . . is consistent with a robust and prolonged immune response.” Id. at 3. The authors noted that some of their MRI findings “may have been present prior to vaccination and became symptomatic as a result of vaccination-associated synovial inflammation. Other findings such as fluid collections, localized tendon inflammation, and bursitis are more consistent with the vaccine needle over- penetration mechanism.” Id. at 3-4. Dr. Boyd agreed with the March 1, 2016 right shoulder MRI findings and opined that the findings are consistent with a SIRVA injury. Pet. Ex. 13 at 3, 6. He acknowledged that petitioner’s findings of mild tendinopathy in his supraspinatus and infraspinatus tendons, mild degenerative changes in his acromioclavicular joint, and lateral downsloping of his acromial process are consistent with normal aging and a labor-intensive career. Id. at 6. Although “arthrosis of the acromioclavicular joint and a lateral downsloping acromion can predispose [] subacromial impingement and inflammation in the bursa,” Dr. Boyd opined that it did not in petitioner’s case because petitioner was asymptomatic prior to his flu vaccination. Id. at 6-7. Petitioner’s MRI showed inflammation of the subacromial/subdeltoid bursa, which Dr. Boyd believed was most likely the source of petitioner symptoms. Id. at 7. He found “no evidence of any other internal derangement of the shoulder to explain [petitioner’s] symptoms.” Id. at 3. Knowing that petitioner received a vaccine in the right shoulder and that he was asymptomatic prior to vaccination, Dr. Boyd opined that “SIRVA would have to be included as a leading differential consideration for the source of his bursal inflammation.” Id. Dr. Boyd opined that the placement of injection “may likely” have affected petitioner. Pet. Ex. 13 at 7. He cited to the administering nurse’s note that documented a “jerk” upon administration and that fact that she warned petitioner of a likelihood of soreness due to the abnormality in administration. Id. With regard to onset, Dr. Boyd opined that petitioner consistently attributed the onset of his systems to his November 2015 flu vaccination. Pet. Ex. 13 at 7. Such a timeframe is consistent with the SIRVA medical literature. Id. at 7-8. Dr. Boyd found petitioner’s initial pain due to direct needle trauma and petitioner’s worsening pain due to persistent immune-mediated inflammatory response. Id. at 8. Petitioner’s injury is further consistent with a SIRVA diagnosis because he suffered from pain and limited or painful range of motion in his right shoulder. Pet. Ex. 13 at 7. He opined that petitioner’s reduced range of motion is consistent with subacromial/subdeltoid bursitis, which can occur after a SIRVA, but not with a radiculopathy. Id. at 8. Dr. Boyd found no evidence to support a neurologic etiology. Pet. Ex. 13 at 8. Nor did he find any evidence of another condition to explain petitioner’s pain or loss of range of motion in his shoulder. Id. He opined petitioner had no prior injury or chronic condition that could explain his symptoms, and there was no other contemporaneous injury other than vaccination to explain his symptoms. Id. 9 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 10 of 20 B. Petitioner’s Expert, Dr. Tony M. Korman 1. Background and Qualifications Dr. Korman is the Director of Infectious Diseases and Director of Microbiology at Monash Health as well as an Adjunct Clinical Professor and Microbiologist at Monash University in Australia. Pet. Ex. 33 at 2; Pet. Ex. 34 at 1. He received his Bachelor of Medicine in 1988, then completed an internship, residency, and multiple fellowships from 1989 to 1997. Pet. Ex. 34 at 3. He has authored or co-authored numerous publications, participates as a reviewer for multiple journals, and is a member of various committees and societies. Id. at 4-40, 47, 53-54. 2. Opinion Dr. Korman opined that petitioner, more likely than not, developed subacromial bursitis and impingement syndrome as a direct result of, and within 12 hours of, his flu vaccination. Pet. Ex. 33 at 4-5. Like Dr. Boyd, Dr. Korman cited to Atanasoff et al. for support of the proposed mechanism of injury in SIRVA cases. Pet. Ex. 33 at 2-3. He explained the mechanism is “the unintentional injection of antigenic material into synovial tissues resulting in an immune- mediated inflammatory reaction.” Id. (quoting Pet. Ex. 15 at 1). Dr. Korman added that “[a] robust and prolonged reaction may be the response of a sensitised population who have had antigenic exposure from previous vaccination or previous infection.” Id. at 4. An “[u]nintentional injection into the synovial bursa or the glenohumeral joint can induce an intense immune and inflammatory response in the shoulder capsule and bursitis.” Id. Dr. Korman also discussed how SIRVA can be associated with vaccine administration technique. Pet. Ex. 33 at 4. For example, vaccines have been reported to have been administered “very high” in the arm, between 1 and 3 cm from the acromion. Id. Dr. Korman cited to Bodor and Montalvo19 as evidence that vaccines have been “unintentionally delivered into the subdeltoid bursa or glenohumeral joint space because of its proximity to the deltoid muscle.” Id. In Bodor and Montalvo, the authors examined two patients with shoulder pain and weakness following vaccination and hypothesized that the “vaccine was injected into the subdeltoid bursa, causing a robust local immune and inflammatory response.” Pet. Ex. 18 at 1-2. They explained, “[g]iven that the subdeltoid bursa is contiguous with the subacromial bursa, this led to subacromial bursitis, bicipital tendonitis, and inflammation of the shoulder capsule,” as well as “adhesive capsulitis.” Id. at 2. Because multiple structures within the shoulder were involved in both patients, Bodor and Montalvo found this suggested “a primary inflammatory etiology rather than a mechanical overuse problem.” Id. at 3. The authors concluded that “the diagnosis of vaccination-related shoulder dysfunction . . . [should] be considered in patients presenting with shoulder pain and weakness following a vaccine injection.” Id. 19 Marko Bodor & Enoch Montalvo, Vaccination-Related Shoulder Dysfunction, 25 Vaccine 585 (2007). 10 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 11 of 20 With regard to petitioner’s shoulder injury, Dr Korman opined petitioner had no prior history of shoulder pain or limitations with range of motion. Pet. Ex. 33 at 4. Dr. Korman found petitioner’s shoulder MRI showing subacromial bursitis or impingement syndrome was consistent with a SIRVA. Id. He found petitioner’s complaints of shoulder pain when reaching overhead to be associated with the injury suffered by petitioner. Id. at 5. Additionally, although petitioner had some improvement in his pain after a corticosteroid injection in April 2016, he continued to experience limited range of motion through August 2016. Id. Dr. Korman concluded that petitioner continues to suffer from his shoulder injury. Id. at 6. Additionally, Dr. Korman opined there was no other condition to explain petitioner’s pain and loss of range of motion. Pet. Ex. 33 at 4. Although there is an entry from Dr. Thacker stating petitioner reinjured his shoulder after hanging drywall, Dr. Korman noted that petitioner testified that he had not hung drywall for 20 years. Id. at 5. Assuming Dr. Thacker’s record is accurate, he found Dr. Thacker determined this was a “re-injury” to the SIRVA injury. Id. Thus, he opined it was “reasonable to conclude that this ‘re-injury’ would not have occurred were it not for the earlier vaccination and the resultant shoulder injury, which could have been aggravated by rigorous use, and activities like hanging drywall certainly comport with that description.” Id. Dr. Korman also opined that petitioner suffered a typical SIRVA, where a previously asymptomatic shoulder condition is aggravated by an injection of a flu vaccine into the bursa, which was accompanied by secondary neurologic symptoms due to the effect and possible additional trauma to axillary nerve. Pet. Ex. 33 at 5. He found petitioner’s injury was not neurologic, “even if there were second-order neurologic symptoms that arose after the shoulder was injured by the vaccination.” Id. Dr. Korman found “[p]ain or numbness in the neck and hand on the side where [petitioner’s] vaccination was administered is readily attributable to direct injury to the axillary nerve and/or as a secondary effect from the immobilization and guarding of the arm after the injury first occurred.” Id. Thus, he concluded that “[r]egardless of the precise etiology of [petitioner’s] neurologic symptoms,” petitioner’s symptoms and clinical course are consistent with a SIRVA. Id. He cited medical literature to support the proposition that direct nerve injuries can occur due to needle trauma. Pet. Ex. 33 at 5. For example, Cook20 developed an evidence-based protocol for safe vaccine administration into the deltoid muscle “by making anthropometric measurements of the surface anatomical landmarks” in 536 adults and “mapping the position of structures potentially injured by vaccine administration in relation to these landmarks.” Pet. Ex. 24 at 1, 3. Cook found injections administered in certain locations “have the potential to cause injury to the subdeltoid/subacromial bursa and/or the anterior branch of the axillary nerve with the arm in the neutral position.” Id. at 4. Cook also determined the radial nerve can be compromised when vaccines are administered outside the recommended area. Id. Dr. Korman found the short onset interval between vaccination and pain, along with the lack of an alternative etiology, to be “convincing evidence linking [petitioner’s] shoulder pain associated with subacromial bursitis and vaccine administration.” Pet. Ex. 33 at 5. Thus, for all 20 Ian F. Cook, An Evidence Based Protocol for the Prevention of Upper Arm Injury Related to Vaccine Administration (UAIRVA), 7 Human Vaccines 845 (2011). 11 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 12 of 20 the reasons stated above, Dr. Korman concluded that more likely than not, petitioner’s flu vaccination caused his shoulder injury. Id. at 4-5. C. Respondent’s Expert, Dr. Paul J. Cagle 1. Background and Qualifications Dr. Cagle is a board-certified orthopaedic surgeon. Resp. Ex. A at 1. He currently works as an Assistant Professor and Associate Program Director in the Department of Orthopaedic Surgery at the Icahn School of Medicine at Mount Sinai. Id. He received his B.S. in Biology from St. Ambrose University in 2004 and his M.D. from Loyola University in 2008. Resp. Ex. B at 2. Thereafter, he completed an orthopaedic surgery residency at the University of Minnesota, a shoulder and elbow fellowship at Mount Sinai Hospital, and a shoulder fellowship in France. Id. Dr. Cagle has received various honors, has co-authored various publications, and held multiple leadership and professional membership positions throughout his career. Id. at 2-3, 11- 14. 2. Opinion Dr. Cagle opined that petitioner’s bursitis, shoulder pain and range of motion, neck pain, back pain, and cervical spine and neck pain are not correlated with or caused by the flu vaccination at issue. Resp. Ex. A at 4. Dr. Cagle based his opinion on three reasons:21 (1) no information regarding needle size or technique were provided and it is not conceivable that a standard needle would have over penetrated petitioner’s deltoid muscle; (2) petitioner’s preexisting conditions can explain petitioner’s symptoms; and (3) petitioner’s MRI findings do not support a SIRVA. Id. at 3-4. First, Dr. Cagle found the most common mechanism associated with SIRVA is “over penetration of the vaccination injection needle causing a mechanical injury and/or over penetration leading to the injection of the vaccine antigen/adjuvant into the bursa/tissue causing an immune reaction.” Resp. Ex. A at 3. For this to occur, he opined that a long needle or inappropriate technique must have been used. Id. Dr. Cagle noted that in petitioner’s case, no information regarding needle size or technique were provided. Id. Assuming the needle used on petitioner was the standard needle length of one inch, he opined that “it is not conceivable how a standard needle would have led to an over penetration event” based on the medical literature and petitioner’s weight on the date of vaccination (220 lbs or 100 kg). Id. Dr. Cagle explained that the “Centers for Disease Control and Prevention guidelines recommend a 1-inch (25mm) needle length for all patients except women over 200 [lbs], males over 260 lbs (113 kg)[,] and newborns.” Id. 21 Dr. Cagle also opined there is no evidence associating vaccination with the onset of petitioner’s shoulder injury within 48 hours. Resp. Ex. A at 3. However, because the undersigned previously issued a ruling finding petitioner’s onset was within 48 hours of vaccination, this issue is not addressed in this Ruling. 12 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 13 of 20 Dr. Cagle also cited to Poland et al.22 and Koster et al.23 to support his proposition that a needle over one inch would be necessary to penetrate the bursa. Resp. Ex. A at 3. In Poland et al., the authors conducted a study of 220 people, 126 women and 94 men, to determine the optimal needle length for deltoid intramuscular immunization in healthy adults. Resp. Ex. A, Tab 27 at 1. They found a one-inch needle sufficient to allow at least 5 mm of muscle penetration in men between 60-118 kg. Id. at 3. Koster et al. examined 141 subjects between the ages of 11 and 15, 55% being female, to determine appropriate needle length for intramuscular injection. Resp. Ex. A, Tab 28 at 1. They found a one-inch needle appropriate for subjects between 60 and 70kg. Id. at 4. They also determined that “body weight is an excellent predictor of required needle length.” Id. Notably, this study examined adolescents, and not adults. Id. at 1. And because only seven subjects weighed more than 70 kg, the authors made no recommendations for this group. Id. at 4. Next, Dr. Cagle opined that petitioner had a “long standing and well documented history” of joint and back pain that could explain petitioner’s pain. Resp. Ex. A at 3-4. Dr. Cagle cited to medical records from Dr. Patel and Dr. Thacker as support. Id. He noted Dr. Patel’s diagnosis of peripheral neuropathy “clearly explain[s] why [petitioner] was having numbness in his hand as documented during his visits with [Dr. Thacker].” Id. at 3. Additionally, Dr. Thacker documented a long standing history of cervical pain,24 which Dr. Cagle opined is an “additional and common reason for hand numbness” and “demonstrates a self-reported history of episodic pain . . . off and on for year” that is associated with petitioner’s strenuous job. Id. at 4. Thus, Dr. Cagle opined that given petitioner’s “long standing episodic history of joint and back pain,” he disagreed with Dr. Korman that no other explanation exists to explain petitioner’s symptoms. Id. He added that Dr. Korman did not explain how petitioner’s numbness that Dr. Korman associated with the bursitis is different than petitioner’s years of documented numbness. Id. Lastly, Dr. Cagle opined that petitioner’s MRI findings do not support a finding of SIRVA. Resp. Ex. A at 4. The MRI showed a downsloping acromion, which has been found to cause bursitis and impingement syndrome. Id. Thus, he found petitioner was predisposed to shoulder bursitis and impingement syndrome due to his “bony morphology” and “occupational history of heavy work.” Id. Dr. Cagle concluded that the combination of petitioner’s bony morphology and occupational work explains the etiology of petitioner’s shoulder issues. Id. 22 Gregory A. Poland et al., Determination of Deltoid Fat Pad Thickness: Implications for Needle Length in Adult Immunization, 277 JAMA 1709 (1997). 23 Michael Philip Koster et al., Needle Length for Immunization of Early Adolescents as Determined by Ultrasound, 124 Pediatrics 667 (2009). 24 Dr. Thacker’s record does not document a long standing history of cervical pain. See Pet. Ex. 5 at 3. Dr. Thacker documented, “[petitioner] has suffered from upper thoracic pain for many years. [Petitioner] explain[ed] that he has worked throughout his life in strenuous job setting that have placed above normal amounts of tension stress to upper thoracic spine.” Id. 13 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 14 of 20 Dr. Cagle concluded that petitioner’s flu vaccination did not cause petitioner’s symptoms. Resp. Ex. A at 4. He found petitioner’s medical records documented his history of joint pain and his MRI supports a finding that petitioner was predisposed to bursitis due to the shape of his shoulder and occupation. Id. IV. DISCUSSION A. Standards for Adjudication The Vaccine Act was established to compensate vaccine-related injuries and deaths. § 10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as a simple, fair and expeditious means for compensating vaccine-related injured persons. The Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty and generosity.’” Rooks v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 1, 7 (1996) (quoting H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344). Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The preponderance standard requires a petitioner to demonstrate that it is more likely than not that the vaccine at issue caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, petitioner must prove that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)); see also Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). The received vaccine, however, need not be the predominant cause of the injury. Shyface, 165 F.3d at 1351. A petitioner who satisfies this burden is entitled to compensation unless respondent can prove, by a preponderance of the evidence, that the vaccinee’s injury is “due to factors unrelated to the administration of the vaccine.” § 13(a)(1)(B). B. Factual Issues A petitioner must prove, by a preponderance of the evidence, the factual circumstances surrounding his claim. § 13(a)(1)(A). To resolve factual issues, the special master must weigh the evidence presented, which may include contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special master must decide what weight to give evidence including oral testimony and contemporaneous medical records). Contemporaneous medical records are presumed to be accurate. See Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). To overcome the presumptive accuracy of medical records, a petitioner may present testimony which is “consistent, clear, cogent, and compelling.” Sanchez v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec’y of Health & Hum. Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). 14 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 15 of 20 There are situations in which compelling testimony may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“[L]ike any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking.”); Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005 WL 6117475, at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005) (“[W]ritten records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent.” (quoting Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992))). Ultimately, a determination regarding a witness’s credibility is needed when determining the weight that such testimony should be afforded. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). Despite the weight afforded medical records, special masters are not bound rigidly by those records in determining onset of a petitioner’s symptoms. Valenzuela v. Sec’y of Health & Hum. Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see also Eng v. Sec’y of Health & Hum. Servs., No. 90-1754V, 1994 WL 67704, at *3 (Fed. Cl. Spec. Mstr. Feb. 18, 1994) (Section 13(b)(2) “must be construed so as to give effect also to § 13(b)(1) which directs the special master or court to consider the medical records (reports, diagnosis, conclusions, medical judgment, test reports, etc.), but does not require the special master or court to be bound by them”). C. Causation To receive compensation through the Program, petitioner must prove either (1) that he suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a vaccine that he received, or (2) that he suffered an injury that was actually caused by a vaccination. See §§ 11(c)(1), 13(a)(1)(A); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1319-20 (Fed. Cir. 2006). Because petitioner’s claim predates the inclusion of SIRVA on the Table, he must prove his claim by showing that his injury was caused-in-fact by the vaccination in question. § 11(c)(1)(C)(ii). To do so, petitioner must establish, by preponderant evidence: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278. The causation theory must relate to the injury alleged. The petitioner must provide a sound and reliable medical or scientific explanation that pertains specifically to this case, although the explanation need only be “legally probable, not medically or scientifically certain.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Petitioner cannot establish entitlement to compensation based solely on his assertions; rather, a vaccine claim must be supported either by medical records or by the opinion of a medical doctor. § 13(a)(1). In determining whether petitioner is entitled to compensation, the special master shall consider all material in the record, including “any . . . conclusion, [or] medical judgment . . . which is contained in the record regarding . . . causation.” § 13(b)(1)(A). The undersigned must 15 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 16 of 20 weigh the submitted evidence and the testimony of the parties’ proffered experts and rule in petitioner’s favor when the evidence weighs in his favor. See Moberly, 592 F.3d at 1325-26 (“Finders of fact are entitled—indeed, expected—to make determinations as to the reliability of the evidence presented to them and, if appropriate, as to the credibility of the persons presenting that evidence.”); Althen, 418 F.3d at 1280 (noting that “close calls” are resolved in petitioner’s favor). V. CAUSATION ANALYSIS A. Althen Prong One Under Althen Prong One, petitioner must set forth a medical theory explaining how the received vaccine could have caused the sustained injury. Andreu, 569 F.3d at 1375; Pafford, 451 F.3d at 1355-56. Petitioner’s theory of causation need not be medically or scientifically certain, but it must be informed by a “sound and reliable” medical or scientific explanation. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also Knudsen, 35 F.3d at 548; Veryzer v. Sec’y of Health & Hum. Servs., 98 Fed. Cl. 214, 223 (2011) (noting that special masters are bound by both § 13(b)(1) and Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”). If petitioner relies upon a medical opinion to support his theory, the basis for the opinion and the reliability of that basis must be considered in the determination of how much weight to afford the offered opinion. See Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (“The special master’s decision often times is based on the credibility of the experts and the relative persuasiveness of their competing theories.”); Perreira v. Sec’y of Health & Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (stating that an “expert opinion is no better than the soundness of the reasons supporting it” (citing Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl. 1980))). The mechanism for a SIRVA injury is well described in the medical literature filed in this case. In Atanasoff, the authors propose that the causal mechanism “is the unintentional injection of antigenic material into synovial tissues resulting in an immune-mediated inflammatory reaction.” Pet. Ex. 15 at 1. They found “rapid onset of pain with limited range of motion following vaccination . . . is consistent with a robust and prolonged immune response.” Id. at 3. MRI findings supported the conclusion that shoulder impairments, such as rotator cuff tears, “may have been present prior to vaccination and became symptomatic as a result of vaccination- associated synovial inflammation.” Id. Similarly, Bodor and Montalvo proposed that a “vaccine was injected into the subdeltoid bursa, causing a robust local immune and inflammatory response.” Pet. Ex. 18 at 1-2. They found multiple structures within the shoulder involved, which suggested “a primary inflammatory etiology rather than a mechanical overuse problem.” Id. at 3. Further, when proposing the addition of SIRVA to the Vaccine Table, respondent discussed the mechanism by which this injury is caused. See National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132, 45137 (July 29, 2015). 16 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 17 of 20 The undersigned takes judicial notice of the fact that respondent has added SIRVA after receipt of an intramuscularly administered flu vaccine to the Table. Such recognition of the causal association between vaccine and injury has been held to support the establishment of the theory required by the first Althen prong. See Doe 21 v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 178, 193 (2009), rev’d on other grounds, 527 F. App’x. 875 (Fed. Cir. 2013). Moreover, petitioner submitted the expert opinions of Drs. Boyd and Korman who provided a sound and reliable medical and scientific theory of causation supported by medical literature. In summary, Dr. Korman explained that the “injection of antigenic material into synovial tissues [can result] in an immune-mediated inflammatory reaction,” leading to “[a] robust and prolonged reaction” and the development of subacromial bursitis and impingement syndrome. Pet. Ex. 33 at 3-4. For all of the above reasons, the undersigned finds petitioner has provided by preponderant evidence a sound and reliable theory that the flu vaccine administered intramuscularly can cause SIRVA, and therefore, petitioner has satisfied the first Althen prong. B. Althen Prong Two Under Althen Prong Two, petitioner must prove by a preponderance of the evidence that there is a “logical sequence of cause and effect showing that the vaccination was the reason for the injury.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1278). “Petitioner must show that the vaccine was the ‘but for’ cause of the harm . . . or in other words, that the vaccine was the ‘reason for the injury.’” Pafford, 451 F.3d at 1356 (internal citations omitted). In evaluating whether this prong is satisfied, the opinions and views of the vaccinee’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“[M]edical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.’” (quoting Althen, 418 F.3d at 1280)). Medical records are generally viewed as trustworthy evidence, since they are created contemporaneously with the treatment of the vaccinee. Cucuras, 993 F.2d at 1528. The petitioner need not make a specific type of evidentiary showing, i.e., “epidemiologic studies, rechallenge, the presence of pathological markers or genetic predisposition, or general acceptance in the scientific or medical communities to establish a logical sequence of cause and effect.” Capizzano, 440 F.3d at 1325. Instead, petitioner may satisfy his burden by presenting circumstantial evidence and reliable medical opinions. Id. at 1325-26. With regard to the second Althen prong, the undersigned finds there is a preponderance of evidence in the record to support a logical sequence of cause and effect showing the November 11, 2015 flu vaccination to be the cause of petitioner’s right shoulder pain. See Althen, 418 F.3d at 1278. Petitioner received the flu vaccine at issue on November 11, 2015. The first time he was seen by a medical doctor was on February 29, 2016, at Dr. Patel’s office. While earlier records reference neck pain, the focus soon became petitioner’s right shoulder pain. A shoulder MRI 17 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 18 of 20 was ordered, and performed on March 1, 2016. The MRI of petitioner’s right shoulder showed “[s]omewhat inferiorly projecting acromion process with mild increased signal intensity changes in the subacromial bursa [that] could represent impingement syndrome or [] bursitis.” Pet. Ex. 3 at 2. Dr. Thacker’s records continued to document decreased range of motion in March and April 2016. Pet. Ex. 5 at 24, 48. Dr. Patel’s office, on April 11, 2016, documented right shoulder tenderness with marked restricted movements and normal range of motion. Pet. Ex. 4 at 38. Assessment included “right shoulder pain etiology to be determined.” Id. at 39. Additional visits to Dr. Patel in 2016 and 2017 revealed normal range of motion on physical examination. Pet. Ex. 7 at 2, 4, 6; Pet. Ex. 9 at 1, 3-4. For each of these visits, however, petitioner presented to Dr. Patel for issues other than his right shoulder pain. It is reasonable that petitioner would not discuss his right shoulder pain during these visits when he presented for other reasons and was also seeing Dr. Thacker during most of 2016 for his shoulder issues. On April 18, 2016, petitioner saw orthopedist Dr. Jamie Varney. Pet. Ex. 2 at 3, 7. Physical examination revealed positive signs on Hawkins and Neer’s tests and the cross body test for shoulder joint pathology. Id. at 5. “[P]ain in impingement arc” was noted in petitioner’s right shoulder. Id. at 6. Upper extremity strength was normal except for “mild decreased right supraspinatus due to pain.” Id. Assessment was impingement syndrome and bursitis of right shoulder. Id. Based on a review of all of the records in context, while petitioner’s treating physicians may have initially documented concerns with the neck or cervical spine, they soon thereafter focused on his right shoulder as the primary problem. Dr. Patel initially considered degenerative disease of cervical spine; however, it does not appear he ever ordered a cervical spine MRI. The medical records do not include any such study, and only an MRI of petitioner’s right shoulder was performed. Additionally, Dr. Thacker’s records show his primary concern was petitioner’s right shoulder pain and pathology, not the cervical spine. Likewise, Dr. Varney’s records focus on petitioner’s shoulder. Thus, based on all of the evidence, the undersigned finds petitioner developed a SIRVA, specifically impingement syndrome and bursitis, consistent with Dr. Varney’s assessment. This finding is also consistent with the evidence presented by petitioner and his experts. Respondent’s expert, Dr. Cagle opined that petitioner had a “long standing and well documented history” of joint and back pain that could explain petitioner’s pain. Resp. Ex. A at 3-4. He found Dr. Patel’s diagnosis of peripheral neuropathy explains petitioner’s hand numbness. Id. at 3. Additionally, he found Dr. Thacker’s documentation of a long standing history of cervical pain an “additional and common reason for hand numbness.” Id. at 4. However, Dr. Thacker’s record does not document a long standing history of cervical pain. See Pet. Ex. 5 at 3. Instead, Dr. Thacker documented, “[petitioner] has suffered from upper thoracic pain for many years. [Petitioner] explain[ed] that he has worked throughout his life in strenuous job setting that have placed above normal amounts of tension stress to upper thoracic spine.” Id. 18 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 19 of 20 Dr. Cagle also opined petitioner was predisposed to shoulder bursitis and impingement syndrome due to his “bony morphology” and “occupational history of heavy work.” Resp. Ex. A at 4. Thus, he attributed petitioner’s shoulder issues to his bone structure and work history. Id. Petitioner’s experts disagreed. Dr. Boyd found no evidence to support a neurologic etiology and no evidence of another condition to explain petitioner’s pain or loss of range of motion in his shoulder. Pet. Ex. 13 at 8. He opined petitioner had no prior injury or chronic condition that could explain his shoulder symptoms, and there was no other contemporaneous injury other than vaccination to explain his symptoms. Id. Likewise, Dr. Korman found no other condition to explain petitioner’s shoulder pain and loss of range of motion. Pet. Ex. 33 at 4. He opined petitioner’s complaints of numbness were more likely than not a result of his SIRVA. Id. at 5. He found petitioner’s injury was not neurologic, “even if there were second-order neurologic symptoms that arose after the shoulder was injured by the vaccination.” Id. The “[p]ain or numbness in the neck and hand on the side where [petitioner’s] vaccination was administered is readily attributable to direct injury to the axillary nerve and/or as a secondary effect from the immobilization and guarding of the arm after the injury first occurred.” Id. And therefore, “[r]egardless of the precise etiology of [petitioner’s] neurologic symptoms,” petitioner’s symptoms and clinical course are consistent with a SIRVA. Id. The undersigned acknowledges that petitioner had a history of back and joint pain, diabetic neuropathy, and a labor-intensive job. However, Atanasoff et al. stated that in many cases, conditions including “impingement syndrome, rotator cuff tear, biceps tendonitis, osteoarthritis[,] and adhesive capsulitis[,] . . . may cause no symptoms until provoked by trauma or other events.” Pet. Ex. 15 at 3. The authors concluded that “some of the MRI findings . . . may have been present prior to vaccination and became symptomatic as a result of vaccination- associated synovial inflammation.” Id. Here, petitioner may have had pre-existing pathology, but he was not symptomatic until after vaccination. While petitioner’s job and pre-vaccination history may have made it more likely for him to have suffered a shoulder injury, the undersigned finds that it was not an alternative cause, or factor unrelated to vaccination, which caused petitioner’s symptoms. As Dr. Boyd explained, petitioner’s shoulder symptoms began only after vaccination, which is further supported by Atanasoff et al. Thus, the undersigned finds petitioner’s vaccination was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface, 165 F.3d at 1352-53). In conclusion, the undersigned finds petitioner has proven by preponderant evidence a logical sequence of cause and effect and has satisfied the second Althen prong. C. Althen Prong Three Althen Prong Three requires petitioner to establish a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to mean a “medically acceptable temporal relationship.” Id. The petitioner must offer 19 Case 1:17-vv-00451-UNJ Document 83 Filed 08/03/21 Page 20 of 20 “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disease’s etiology, it is medically acceptable to infer causation-in- fact.” de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable time frame must also coincide with the theory of how the relevant vaccine can cause the injury alleged (under Althen Prong One). Id.; Koehn v. Sec’y of Health & Hum. Servs., 773 F.3d 1239, 1243 (Fed. Cir. 2014); Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013). As stated above, the undersigned found the onset of petitioner’s right shoulder pain occurred within 48 hours of vaccination. The timing of onset shows a proximate temporal relationship between vaccination and injury. See Althen, 418 F.3d at 1278. The undersigned finds the evidence discussed in the prior Fact Ruling establishes that the flu vaccine caused petitioner’s shoulder injury within the time frame required. The temporal association is appropriate given the mechanism of injury. Thus, petitioner has satisfied the third Althen prong. D. Alternative Causation Because the undersigned concludes that petitioner has established a prima facie case, petitioner is entitled to compensation unless respondent can put forth preponderant evidence “that [petitioner’s] injury was in fact caused by factors unrelated to the vaccine.” Whitecotton v. Sec’y of Health & Hum. Servs., 17 F.3d 374, 376 (Fed. Cir. 1994), rev’d on other grounds sub nom., Shalala v. Whitecotton, 514 U.S. 268 (1995); see also Walther v. Sec’y of Health & Hum. Servs., 485 F.3d 1146, 1151 (Fed. Cir. 2007). As discussed above in the analysis related to Althen Prong Two, the undersigned found the respondent failed to establish evidence to show that petitioner’s SIRVA injury was caused by a source other than his vaccination. Thus, respondent did not prove by a preponderance of evidence that petitioner’s injury is “due to factors unrelated to the administration of the vaccine.” § 13(a)(1)(B). VI. CONCLUSION Based on the record as a whole and for the reasons discussed above, the undersigned finds there is preponderant evidence to satisfy all three Althen prongs and to establish petitioner’s November 11, 2015 flu vaccination caused his right shoulder injury. Thus, the undersigned finds that petitioner has established by preponderant evidence that he is entitled to compensation. A separate damages order will issue. IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Special Master 20 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_17-vv-00451-2 Date issued/filed: 2022-08-05 Pages: 16 Docket text: PUBLIC DECISION (Originally filed: 7/11/2022) regarding 107 DECISION of Special Master. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 1 of 16 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: July 11, 2022 * * * * * * * * * * * * * * * * * * * * * * * * * LARRY WOLFORD, * PUBLISHED * Petitioner, * No. 17-451V * v. * Special Master Nora Beth Dorsey * SECRETARY OF HEALTH * Damages Decision; Influenza (“Flu”) AND HUMAN SERVICES, * Vaccine; Shoulder Injury Related to Vaccine * Administration (“SIRVA”). Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Isaiah Richard Kalinowski, Bosson Legal Group, Fairfax, VA, for petitioner. Kyle Edward Pozza, U.S. Department of Justice, Washington, DC, for respondent. DAMAGES DECISION1 On March 29, 2017, Larry Wolford (“petitioner”) filed a petition for compensation under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42 U.S.C. § 300aa-10 et seq. (2012).2 Petitioner alleges that he suffered a right shoulder injury related to vaccine administration (“SIRVA”) as the result of an influenza (“flu”) vaccination administered on November 11, 2015. Petition at 1-3 (ECF No. 1). On July 9, 2021, the undersigned issued a ruling on entitlement, finding that petitioner was entitled to compensation. Ruling on Entitlement dated July 9, 2021 (ECF No. 80). 1 Because this Decision contains a reasoned explanation for the action in this case, the undersigned is 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, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material from public access. 2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to -34 (2012). All citations in this Decision to individual sections of the Vaccine Act are to 42 U.S.C. § 300aa. Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 2 of 16 The parties were unable to resolve damages and requested that the Court enter a schedule for damages briefs. Since then, the parties’ briefs have been filed. After consideration of all of the evidence, and for the reasons described below, the undersigned finds that petitioner is entitled to $70,000.00 for actual pain and suffering, and $1,971.853 for out-of-pocket medical expenses, for a total award of $71,971.85. I. PROCEDURAL HISTORY Petitioner filed his petition on March 29, 2017, alleging that he sustained a right shoulder injury caused by a flu vaccine administered on November 11, 2015. Petition at 1-3. The early procedural history from March 2017 through July 2021 was set forth in the undersigned’s Fact Ruling and Ruling on Entitlement and will not be repeated here. See Fact Ruling dated July 8, 2019, at 2-3 (ECF No. 56); Ruling on Entitlement at 2. Thereafter, the parties engaged in settlement discussions but were not able to resolve this matter informally. Petitioner’s (“Pet.”) Status Report (Rept.”), filed Feb. 8, 2022 (ECF No. 98). The parties agreed to submit the issue of pain and suffering to the Court’s resolution by briefing. Joint Status Rept., filed Feb. 16, 2022 (ECF No. 100). On March 4, 2022, petitioner filed a memorandum of law regarding damages. Pet. Opening Memorandum of Law Regarding Damages (“Pet. Mem.”), filed Mar. 4, 2022 (ECF No. 103). Respondent filed his response on May 2, 2022. Respondent’s Brief on Damages (“Resp. Br.”), filed May 2, 2022 (ECF No. 105). Petitioner filed a reply on May 9, 2022. Pet. Reply Memorandum of Law Regarding Damages (“Pet. Reply Mem.”), filed May 9, 2022 (ECF No. 106). This matter is now ripe for adjudication. II. FACTUAL HISTORY4 A. Pre-Vaccination Medical History Petitioner’s pre-vaccination medical history is significant for non-insulin dependent diabetes mellitus, diabetic neuropathy, weakness, fatigue, numbness in hands and legs, backache, multiple joint pains, gastroesophageal reflux disease, depression, and osteoarthritis. Pet. Ex. 4 at 4-5, 7, 16, 26, 28. No records indicate that petitioner had right shoulder pain prior to vaccination. 3 The parties agreed on the total out-of-pocket expenses in the amount of $1,971.85. Respondent’s Brief on Damages (“Resp. Br.”), filed May 2, 2022, at 2, 2 n.1 (ECF No. 105). 4 In the interest of efficiency, this summary is taken from relevant portions of the undersigned’s Ruling on Entitlement. See Ruling on Entitlement at 2-8. 2 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 3 of 16 B. Post-Vaccination Medical History The Fact Ruling set forth a summary of petitioner’s medical records, affidavits, and hearing testimony relative to onset of his right shoulder injury. See Fact Ruling at 3-8. Only the relevant portions will be repeated here. In the Fact Ruling, the undersigned found the onset of petitioner’s right shoulder injury was within 48 hours of vaccination. Id. at 13. On November 11, 2015, at fifty-three years old, petitioner was seen by his primary care physician, Dr. Dinkar Patel. Pet. Ex. 4 at 34. Current medications included Ultram, Cymbalta, and Neurontin. Id. at 34-35. Chief complaints were diabetes mellitus and hypercholesterolemia. Id. at 34. Petitioner also complained of backache and itching and rash on his right arm. Id. He came for a check up on his blood sugar and wanted a flu vaccine. Id. Physical examination by Dr. Patel revealed tenderness in lower back, dermatitis on right arm, and normal range of motion. Id. At this visit, Ms. Lynette Gibson administered a flu vaccine in petitioner’s right deltoid. Pet. Ex. 10 at 1. Dr. Patel documented, “Flu Vaccine given. No reaction noted.” Pet. Ex. 4 at 35. At the fact hearing, petitioner testified that when the vaccine was administered, the nurse “said she felt it tighten up on [him].” Transcript (“Tr.”) 17. He explained that “when she pulled the needle out, she said it tightened up on her . . . she felt it jerk, the muscle tightened up and everything.” Tr. 109-10. Ms. Wolford testified that “when [the nurse] gave [petitioner] his shot she just kind of—I guess laughed a little bit and said he’d probably get sore because [she] felt it jerk.” Tr. 157-58, 199. Ms. Wolford testified that she was present during the entire visit with Dr. Patel on November 11, 2015 when petitioner received his flu shot and that she also received a flu shot during this visit. Tr. 157. Petitioner testified that he began experiencing aching and stiffness the evening of the vaccination. Tr. 19. His shoulder pain disturbed his sleep and woke him up at night beginning the first night following the vaccination. Tr. 35. He had to start driving with one hand “[r]ight after the vaccine.” Tr. 36. He explained that a day or two later he developed a stabbing pain. Tr. 26. Ms. Wolford testified that after they got home, petitioner complained of his shoulder being “sore, a dull, aching sore,” but they thought it was normal. Tr. 158. She testified that she did not call Dr. Patel’s office that day about petitioner’s pain because the nurse “said it was going to get sore, so he just thought it would be normal.” Tr. 201; see also Tr. 159. She explained, however, the soreness did not go away but worsened. Tr. 158-59. The day after vaccination, “[petitioner] just all of a sudden would be hollering, ouch, and grabbing to his arm.” Tr. 159. Petitioner explained that he made a “sleeve,” or sling, out of a compression sock that, when worn as a sleeve, warmed his arm and reduced his discomfort. Tr. 19-20, 26, 31-33. His pain also got better with Tylenol, ibuprofen, and Icy Hot. Tr. 118-19. Ms. Wolford also testified to these facts. Tr. 159. Ms. Wolford testified that as time went on in November and December 2015, petitioner would “treat it for a while and then it would go away, and it’d like just come back . . . . [She] 3 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 4 of 16 remember[ed] him propping it up on, like, a pillow to ease the pain.” Tr. 160. They also did this with other items like quilts. Id. Ms. Wolford recalled seeing petitioner “trying to comb his hair, and he couldn’t get his arm up over his head to comb his hair, like he was having trouble moving his arm.” Tr. 161. She could not recall when she observed this but stated that it was before April 2016 and possibly before February 2016. Tr. 161, 173-74. Ms. Wolford testified that she was not sure when she first called Dr. Patel’s office, but believed it was sometime around mid-November or Thanksgiving. Tr. 162-63, 202. She testified that she was told that Dr. Patel “was out of the country at that time” and that he would be gone for a month.5 Tr. 163, 205. Petitioner’s wife testified that petitioner did not see another doctor in the practice because Dr. Patel had “been his doctor for years. He’s the only one he sees” and they planned to “wait for him to come back.” Tr. 163-64. She testified that she did not initially look for other doctors because petitioner was treating himself and the pain was coming and going. Tr. 164. Ms. Wolford testified that eventually she started calling other doctors in the area that she identified by going through a phone book. Tr. 164. She could not recall the names of the offices she called but stated that there were “a few” and that “they couldn’t get him in because . . . they wanted a referral or where it was the holidays and stuff, they wanted it two or three months down the road.” Tr. 185. She contacted the office of chiropractor Dr. Jarrod Thacker and was told that he could see petitioner. Tr. 165. She could not recall the interval between when she called Dr. Thacker’s office and when petitioner was first seen by Dr. Thacker, but said that “it wasn’t that long. Probably a couple of days . . . they got him in quick.” Id. Petitioner presented to chiropractor, Dr. Thacker, on February 16, 2016 with “severe upper thoracic/right shoulder/arm/elbow thumb pain” that “started after receiving a flu shot in November 2015.” Pet. Ex. 5 at 3. Petitioner noted onset as “acute, one week after flu shot was administered.”6 Id. Petitioner reported “pain daily 4/5 times a day [and] made worse with certain movements. Pain ranges from 2-8/10 on a pain scale.” Id. Pain was described as “achy, burning, dull, sharp, stiff, throbbing,” and moderate. Id. Petitioner further reported numbness in right hand, severe spasms in right cervical paraspinal and right trapezius, right upper extremity weakness, and decreased cervical motion. Id. He indicated he was only able to lift 25 pounds and his sleep was affected. Id. On physical examination, Dr. Thacker wrote petitioner “presents with severe [guarding] of the neck and right shoulder.” Id. Petitioner had decreased range of motion. Id. Dr. Thacker treated petitioner to relieve pain, decrease inflammation, and to improve function, strength, and range of motion. Id. at 4. Petitioner was given shoulder exercises and stretches for impingement syndrome. Id. 5 In a later record, Dr. Patel included a note stating, “[petitioner] states he came to see me in Nov[ember] 2015, I [saw] him on 11-11-15 but he came again to see me and I was out of town and he [saw] Jerry Thacker for right shoulder pain and received physical therapy.” Pet. Ex. 7 at 5; see also Pet. Ex. 9 at 5 (handwritten version of similar note). 6 Petitioner testified that the notation stating the onset was one week after the flu shot is not accurate. Tr. 49, 127-28, 206-07. 4 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 5 of 16 Petitioner returned to Dr. Thacker 27 times from February 18, 2016 to November 4, 2016. Pet. Ex. 5 at 6-56; Pet. Ex. 6 at 2-22, 24-32. During the February 24, 2016 visit, Dr. Thacker wrote “[a] [magnetic resonance imaging (“MRI”)] consult was discussed with [petitioner] because progression [was] not optimal. [Petitioner] would need to visit [primary care physician (“PCP”)] (Dr. D Patel) to obtain order form [for] R shoulder MRI.”7 Pet. Ex. 5 at 13. On February 29, 2016, petitioner returned to Dr. Patel’s office8 with a chief complaint of diabetes mellitus and hypercholesterolemia. Pet. Ex. 4 at 36. Under review of systems, petitioner complained of neck pain and numbness in right arm and reported seeing a chiropractor. Id. Physical examination revealed tenderness in back of neck with painful neck movements, no stiffness in neck, and normal range of motion. Id. Assessment included “neck pain with probable degenerative disc disease c spine,” “cervical radicular syndrome right side,” and osteoarthritis. Id. at 37. Petitioner was advised to have an MRI of his cervical spine done.9 Id. An MRI of petitioner’s right shoulder was conducted on March 1, 2016. Pet. Ex. 3 at 2. Diagnosis was listed as shoulder pain and soreness after flu shot. Id. The impression was “[s]omewhat inferiorly projecting acromion process with mild increased signal intensity changes in the subacromial bursa could represent impingement syndrome[10] or from bursitis.[11] Study otherwise is negative for rotator cuff tear.” Id. 7 Dr. Thacker’s additional patient notes regarding petitioner’s shoulder MRI are as follows: 4-7-16: Appointment with patient PCP was set up for 4-13-16 to obtain order for right shoulder MRI. Patient progress not showing expected results. Patient still suffering from severe pain when certain motions are sought (Mostly overhead/abduction/adduction to R shoulder). 4/14/16: Patient had follow up visit with PCP to get a MRI on R shoulder. 4/28/16: Patient was referred to orthopedist for consultation of cortisone injection into right shoulder. Injection was administered by Dr. Varney at PMC. Pet. Ex. 5 at 2. 8 It is not clear from the record who petitioner saw during this visit. 9 No records were provided indicating petitioner received a cervical spine MRI. Based on the medical records, it appears petitioner received only a right shoulder MRI. 10 Impingement syndrome results from “mechanical impingement by the acromion, coracoacromial ligament, coracoid process, or acromioclavicular joint against the rotator cuff.” Impingement Syndrome, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/ dorland/definition?id=110796 (last visited July 6, 2022). 11 Bursitis is “inflammation of a bursa.” Bursitis, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=7315 (last visited July 6, 2022). 5 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 6 of 16 Dr. Thacker’s examinations in March and April 2016 “show[ed] minimal to no improvement in [petitioner’s] subjective or objective complaints/findings.” Pet. Ex. 5 at 24, 48. Dr. Thacker discussed a referral to an orthopedist for an injection. Id. Petitioner returned to Dr. Patel’s office12 on April 11, 2016. Pet. Ex. 4 at 38. Petitioner complained of “right shoulder pain with restricted shoulder movements” as well as multiple joint pain. Id. Physical examination revealed right shoulder tenderness with marked restricted movements and normal range of motion. Id. Assessment included “right shoulder pain etiology to be determined.” Id. at 39. Under plan, the record indicates “[a]dvised mri of the right shoulder and [petitioner] is being followed by Dr. [] Thacker.” Id. Petitioner was instructed to continue physical therapy. Id. On April 18, 2016, petitioner saw orthopedist Dr. Jamie Varney at Pikeville Medical Center complaining of right shoulder pain. Pet. Ex. 2 at 3, 7. Petitioner stated “the symptoms have been chronic non-traumatic,” occur intermittently, and “began . . . after flu shot.” Id. at 3. He described the pain as “piercing” and reported additional pain in his right thumb. Id. at 3, 12. He indicated his “symptoms are aggravated by daily activities and reaching overhead,” but are “relieved by physical therapy.” Id. At the time of the visit, petitioner reported his symptoms were moderate and his pain was a 2/10. Id. at 3, 11. In a handwritten orthopedic information sheet completed on April 18, 2016,13 petitioner related his injury back to the flu vaccine received on November 11, 2015 and listed his reason for visit as “pain in right shoulder [and] numbness in thumb.” Id. at 11. For when his symptoms started, he wrote “same night got sore.” Id. He also described the pain as stabbing and noted it “randomly” goes from 2/10 to 8/10. Id. Physical examination revealed positive signs on Hawkins and Neer’s tests and the cross body test for shoulder joint pathology. Pet. Ex. 2 at 5. Range of motion in petitioner’s left shoulder was normal, but there was “pain in impingement arc” noted with regard to petitioner’s right shoulder. Id. at 6. Elbow and wrist range of motion in both extremities was normal. Id. Upper extremity strength was normal except for “mild decreased right supraspinatus due to pain.” Id. Neurovascular upper extremity examination was normal, although petitioner reported “some decreased sensation on the inner aspect of his thumb.” Id. Assessment was impingement syndrome and bursitis of right shoulder. Id. Petitioner received a cortisone injection in the subacromial space in his right shoulder. Id. Dr. Varney stated, “it is unlikely that the flu shot actually caused any damage to his shoulder. MRIs . . . show[] chronic tendinopathy of supraspinatus with some tendinitis and bursitis. Also has a downward sloping acromion that causes rotator cuff impingement. Previous injection may have [] caused some inflammation of his underlying problems.”14 Id. at 7. Petitioner was advised to continue home exercises and physical therapy and ice and take anti-inflammatories as needed. Id. 12 Again, it is not clear from the record who petitioner saw during this visit. 13 Petitioner and his wife both testified that the handwriting on the form belongs to petitioner’s wife. Tr. 73, 175. 14 Dr. Varney does not define “previous injection.” It appears, however, based on the context of the note, that Dr. Varney was referring to the flu vaccination. 6 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 7 of 16 On July 21, 2016, petitioner saw Dr. Thacker who noted petitioner “re-injured right shoulder after hanging drywall for 4 hours [on] 7/18/16.” Pet. Ex. 6 at 17. On August 16, 2016, petitioner returned to Dr. Patel for diabetes mellitus and hypercholesterolemia. Pet. Ex. 7 at 2. Petitioner did not complain of shoulder pain at this visit. See id. Physical examination revealed normal range of motion. Id. Petitioner saw Dr. Patel on October 4, 2016, complaining of “rash on the arm with itching backache, numbness in legs. Came for check up on blood sugar. Cough, chest congestion.” Pet. Ex. 7 at 4. On physical examination, range of motion was normal. Id. Dr. Patel noted petitioner was seeing Dr. Thacker for right shoulder pain and physical therapy. Id. at 5. Petitioner last saw Dr. Thacker on November 4, 2016. Pet. Ex. 6 at 30-32. There is no indication as to why this was petitioner’s last visit. Petitioner complained of diabetes mellitus, hypercholesterolemia, multiple joint pain, numbness in legs, and a cough during a visit to Dr. Patel on December 7, 2016. Pet. Ex. 7 at 6. Petitioner did not complain of right shoulder pain during this visit. See id. Range of motion was normal on physical examination. Id. Petitioner saw Dr. Patel next on March 9, 2017. Pet. Ex. 9 at 1-2. No complaints of right shoulder pain were noted. See id. Physical examination revealed normal range of motion. Id. at 1. “Right elbow region pain” and “normal range of motion” were noted in petitioner’s next visit to Dr. Patel on June 14, 2017. Id. at 3-4. No additional medical records were provided. III. PARTIES’ CONTENTIONS A. Petitioner’s Contentions Petitioner requests a pain and suffering award of $70,000.00. Pet. Mem. at 11; Pet. Reply Mem. at 10. Petitioner contends his “injury follows the more typical pattern in SIRVA cases.” Pet. Mem. at 11. Petitioner acknowledges that he first saw his treating chiropractor, Dr. Thacker, 97 days after vaccination. Pet. Mem. at 10. However, petitioner contends he first contacted his doctor nine days after vaccination, and “[t]he only reason [p]etitioner was not assessed and treated for his pain earlier was due to the unavailability of a doctor to see him.” Id. Petitioner argues this gap in onset and his first visit to a medical provider “is not indicative of the absence of pain and suffering and emotional distress.” Pet. Reply Mem. at 3. Petitioner also disputes respondent’s argument that petitioner’s shoulder and arm pain was not noted in visits later in 2016. Pet. Reply Mem. at 3. “Given that the shoulder injury was gradually improving without further acute incident, it is neither remarkable or relevant that Dr. 7 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 8 of 16 Patel did not further reference the injury in later visits.” Id. Petitioner contends his continued chiropractic visits are more instructive to the question of pain and suffering. Id. Additionally, at the fact hearing in 2019, petitioner testified he continued to suffer residual effects. Id. Citing Johnson, petitioner notes that in the lower end of the spectrum of SIRVA cases, pain and suffering awards average between $55,000.00 and $75,000.00. Pet. Mem. at 10 (citing Johnson v. Sec’y of Health & Hum. Servs., No. 18-1486V, 2021 WL 836891, at *5 (Fed. Cl. Spec. Mstr. Jan. 25, 2021)). Petitioners in those cases delayed seeking treatment, and their pain and limitations in range of motion remained mild to moderate. Id. (citing Johnson, 2021 WL 836891 at *5). Petitioner also notes mild cases typically resolve after one to two cortisone injections and two months or less of physical therapy, and pain lasted an average of nine months. Id. (citing Johnson, 2021 WL 836891 at *5). In Johnson, the petitioner suffered significant pain upon vaccination, but overall suffered a moderate SIRVA injury. Johnson, 2021 WL 836891 at *7. Petitioner took oral steroids, attended six physical therapy sessions, and received one cortisone injection, after which pain levels decreased. Id. “By six months after vaccination, [p]etitioner reported only minor discomfort with certain movements.” Id. Additionally, the special master noted petitioner “exhibited normal strength, and the reduction in [range of motion] was never significant,” and petitioner “had an unrelated condition which constituted an additional source of pain.” Id. at *7- 8. Given these facts, the special master awarded petitioner $65,000.00 in pain and suffering. Id. at *8. Along with Johnson, petitioner cited George v. Secretary of Health & Human Services, No. 18-0426V, 2020 WL 4692451 (Fed. Cl. Spec. Mstr. July 10, 2020) and T.E. v. Secretary of Health & Human Services, No. 19-0633V, 2021 WL 2935751 (Fed. Cl. Spec. Mstr. May 7, 2021) for support. Pet. Mem. at 11. The petitioner in George did not undergo surgery, received one cortisone injection, attended 40 sessions of physical therapy, and had an “initial course of treatment last[ing] approximately seven months.” George, 2020 WL 4692451 at *3. An MRI revealed minimal bursitis and mild tendinopathy of the infraspinatus tendon. Id. at *2. The special master found “[p]etitioner’s injury was on the ‘mild’ end of the spectrum” and awarded petitioner $67,000.00 in pain and suffering. Id. at *2-3. In T.E., petitioner did not undergo surgery, was treated with one cortisone injection, attended seven sessions of physical therapy, “experienced mild to moderate restrictions in her range of motion and pain with motion,” and did not seek further evaluation or treatment after six months post-vaccination. T.E., 2021 WL 2935751 at *4-6. The petitioner received two MRIs and an ultrasound, which her treating physician found did not show “signs of a high-grade partial thickness tear.” Id. at *5. The special master found the facts “support[d] a slightly below- median award” and awarded $70,000.00 in pain and suffering. Id. at *4, *6. Lastly, petitioner notes “[r]espondent failed to provide any comparable cases for the Court’s consideration of damages in this case” and failed to provide “any reference to reasoned authority” for respondent’s chosen offered amount. Pet. Reply Mem. at 5 (emphasis omitted). 8 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 9 of 16 Petitioner asserts “[r]espondent can offer no analogous case to support the amount proposed,” while “[p]etitioner’s reference to analogous damages rulings places this case within the broader context and backdrop of other cases properly adjudicated by this Court.” Id. at 10. B. Respondent’s Contentions Respondent argues that based on the facts of this case, petitioner should be awarded $30,000.00 for pain and suffering. Resp. Br. at 7. Respondent contends the medical records reflect a “relatively mild SIRVA injury.” Id. First, because petitioner did not see a medical provider for over three months, “[p]etitioner’s shoulder pain was not severe enough to require immediate treatment or hospitalization.” Id. Next, respondent asserts petitioner’s treatment was limited to chiropractic care and one cortisone injection, with treatment occurring within one year. Id. Respondent argues George and T.E. are not factually analogous to petitioner’s case. Resp. Br. at 8. In George, “petitioner presented to a medical provider three weeks after vaccination, and an MRI revealed minimal bursitis and mild tendinopathy,” while petitioner here “waited a little more than three months to seek treatment, and his orthopedist noted . . . [the] MRI . . . show[ed] chronic tendinopathy of supraspinatus with some tendinitis and bursitis.” Id. (internal quotations omitted). Respondent, citing Rayborn, notes “a longer delay in seeking initial treatment suggests petitioner’s pain was manageable and did not require immediate medical attention.” Id. (citing Rayborn v. Sec’y of Health & Hum. Servs., No. 18-0226V, 2020 WL 5522948, at *12 (Fed. Cl. Spec. Mstr. Aug. 14, 2020) (awarding $55,000.00 for actual pain and suffering)). Additionally, the petitioner in George attended forty physical therapy sessions, unlike petitioner here. Id. Regarding T.E., respondent asserts petitioner’s reliance is misplaced because T.E. “is a conceded case that does not discuss the age of petitioner or the time interval of her first appointment.” Id. Respondent concludes that “under the totality of the circumstances, an award of $30,000.00 for pain and suffering is just and fair compensation.” Resp. Br. at 8. Respondent does not cite to any factually analogous cases for support of such award. IV. LEGAL FRAMEWORK 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.” § 15(a)(4). Additionally, petitioner may recover “actual unreimbursable expenses incurred before the date of judgment,” including those that “(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.” § 15(a)(1)(B). Petitioner bears the burden of proof with respect to each element of compensation requested. Brewer v. Sec’y of Health & Hum. Servs., No. 93-0092V, 1996 WL 147722, at *22-23 (Fed. Cl. Spec. Mstr. Mar. 18, 1996). 9 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 10 of 16 There is no formula for assigning a monetary value to a person’s pain and suffering and emotional distress. I.D. v. Sec’y of Health & Hum. Servs., No. 04-1593V, 2013 WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May 14, 2013) (“Awards for emotional distress are inherently subjective and cannot be determined by using a mathematical formula.”); Stansfield v. Sec’y of Health & Hum. Servs., No. 93-0172V, 1996 WL 300594, at *3 (Fed. Cl. Spec. Mstr. May 22, 1996) (“[T]he assessment of pain and suffering is inherently a subjective evaluation.”). Factors to be considered when determining an award for pain and suffering include: (i) awareness of the injury; (ii) severity of the injury; and (iii) duration of the suffering. I.D., 2013 WL 2448125, at *9 (quoting McAllister v. Sec’y of Health & Hum. Servs., No. 91-1037V, 1993 WL 777030, at *3 (Fed. Cl. Spec. Mstr. Mar. 26, 1993), vacated and remanded on other grounds, 70 F.3d 1240 (Fed. Cir. 1995)). The undersigned may look to prior pain and suffering awards to aid in the resolution of the appropriate amount of compensation for pain and suffering in this case. See, e.g., Doe 34 v. Sec’y of Health & Hum. Servs., 87 Fed. Cl. 758, 768 (2009) (finding that “there is nothing improper in the chief special master’s decision to refer to damages for pain and suffering awarded in other cases as an aid in determining the proper amount of damages in this case”). The undersigned may also rely on her experience adjudicating similar claims.15 Hodges v. Sec’y of Health & Hum. 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). Importantly, however, it must also be stressed that pain and suffering is not determined based on a continuum. See Graves v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 579 (2013). In Graves, Judge Merrow rejected the 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. Judge Merrow noted that this constituted “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.” Graves, 109 Fed. Cl. at 589-90. Instead, Judge Merrow 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. 15 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 the undersigned as the former Chief Special Master, now Special Master Dorsey. Since that time, SPU cases have been assigned to Chief Special Master Corcoran. 10 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 11 of 16 Although this case was removed from the Special Processing Unit (“SPU”) on September 30, 2019, the undersigned finds statistical data from SIRVA cases resolved in SPU to be informative, as they have an extensive history of informal resolution within the SPU.16 V. PRIOR SIRVA COMPENSATION WITHIN SPU A. Data Regarding Compensation in SPU SIRVA Cases SIRVA cases have an extensive history of informal resolution within the SPU. As of July 1, 2022, 2,723 SPU SIRVA cases have resolved since the inception of SPU on July 1, 2014. Compensation was awarded in 2,651 of these cases, with the remaining 72 cases dismissed. Of the compensated cases, 1,513 SPU SIRVA cases involved a prior ruling that petitioner was entitled to compensation. In only 114 of these cases was the amount of damages determined by a special master in a reasoned decision. These 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.17 1,371 of this subset of post-entitlement determination, compensation-awarding cases, were the product of informal settlement—cases via proffer and 28 cases via stipulation. Although all proposed amounts denote an agreement reached by the parties, those presented by stipulation derive more from compromise than any formal agreement or acknowledgment by respondent that the settlement sum itself is a fair measure of damages. Of course, even though any such informally-resolved case must still be approved by a special master, these determinations do not provide the same judicial guidance or insight obtained from a reasoned decision. But given the aggregate number of such cases, these determinations nevertheless “provide some evidence of the kinds of awards received overall in comparable cases.” Sakovits v. Sec’y of Health & Hum. Servs., No. 17-1028V, 2020 WL 3729420, at *4 (Fed. Cl. Spec. Mstr. June 4, 2020) (emphasis in original). The remaining 1,138 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 16 Prior decisions awarding damages, including those resolved by settlement or proffer, are made public and can be searched on the U.S. Court of Federal Claims’ website by keyword and/or by special master. On the Court’s main page, click on “Opinions/Orders” to access the database. All figures included in this Decision are derived from a review of the decisions awarding damages within SPU. All decisions reviewed are, or will be, available publicly. All figures and calculations cited are approximations. 17 See, e.g., Sakovits v. Sec’y of Health & Hum. Servs., No. 17-1028V, 2020 WL 3729420, at *4 (Fed. Cl. Spec. Mstr. June 4, 2020) (discussing the difference between cases in which damages are agreed upon by the parties and cases in which damages are determined by a special master). 11 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 12 of 16 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 Stipulated18 Decisions by Damages Damages Agreement Special Master Total Cases 114 1,371 28 1,138 Lowest $40,757.91 $25,000.00 $45,000.00 $5,000.00 1st Quartile $72,354.81 $67,472.00 $90,000.00 $40,000.00 Median $102,479.12 $86,927.85 $122,886.42 $60,000.00 3rd Quartile $125,343.45 $115,000.00 $161,001.79 $115,000.00 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 114 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 $100,000.00 as the median amount. Only five of these cases involved an award for future pain and suffering, with yearly awards ranging from $250.00 to $1,500.00.19 In cases with lower awards for past pain and suffering, many petitioners commonly demonstrated only mild to moderate levels of pain throughout their injury course. This lack of significant pain is often evidenced by a delay in seeking treatment—over six months in one case. In cases with more significant initial pain, petitioners experienced this greater pain for three months or less. All petitioners displayed only mild to moderate limitations in range of motion, 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. None required surgery. The duration of the injury ranged from six to 30 months, with most petitioners averaging approximately nine months of pain. Although some petitioners asserted residual pain, the prognosis in these cases was positive. Only one petitioner provided evidence of an ongoing SIRVA, and it was expected to resolve within the subsequent year. 18 Two awards were for an annuity only, the exact amounts which were not determined at the time of judgment. 19 Additionally, a first-year future pain and suffering award of $10,000.00 was made in one case. Dhanoa v. Sec’y of Health & Hum. Servs., No. 15-1011V, 2018 WL 1221922 (Fed. Cl. Spec. Mstr. Feb. 1, 2018). 12 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 13 of 16 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 133 physical therapy sessions over a duration of more than three years and multiple cortisone injections, was required in these cases. In four cases, petitioners provided sufficient evidence of permanent injuries to warrant yearly compensation for future or projected pain and suffering. VI. APPROPRIATE COMPENSATION IN THIS SIRVA CASE A. Actual Pain and Suffering In this case, awareness of the injury is not in dispute. The record reflects that at all times petitioner was a competent adult with no impairments that would impact his awareness of his injury. Therefore, the undersigned’s analysis will focus principally on the severity and duration of petitioner’s injury. When performing this analysis, the undersigned reviews the record as a whole, including the medical records, affidavits, testimony, and any expert opinions. The undersigned also takes into account prior awards for pain and suffering in both SPU and non-SPU SIRVA cases, as well as her experience adjudicating these cases. The undersigned bases her decision as to the appropriate amount of damages on the particular facts and circumstances of this specific case. The medical records establish that petitioner first sought treatment on February 16, 2016, 97 days after his vaccination on November 11, 2015. Respondent argues that this delay in seeking treatment is evidence that “[p]etitioner’s shoulder pain was not severe enough to require immediate treatment or hospitalization.” Resp. Br. at 7. However, the medical records and testimony at the fact hearing show petitioner had reasonable reasons for his delay in seeking treatment. For example, petitioner tried to see his primary care physician, Dr. Patel, but he was unavailable because he was out of the country. Additionally, petitioner tried to find another doctor, but as petitioner’s wife explained, “they couldn’t get him in because . . . they wanted a referral or where it was the holidays and stuff, they wanted it two or three months down the road.” Tr. 185. Thus, under these circumstances, the undersigned finds that petitioner has a reasonable explanation for his three-month delay in receiving medical treatment, and that this factor alone cannot be used to discount the severity of petitioner’s pain during that time. A review of the records reveals petitioner’s pain is described as significant from November 11, 2015, the date of vaccination, to April 2016, after petitioner received a cortisone injection. Beginning on the night of November 11, 2015, the date of vaccination, petitioner experienced aching and stiffness, and the pain woke him up during the night. A day or two later, he developed stabbing pain. 13 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 14 of 16 On February 16, 2016, petitioner saw chiropractor, Dr. Thacker for “severe upper thoracic/right shoulder/arm/elbow thumb pain” that “started after receiving a flu shot in November 2015.” Pet. Ex. 5 at 3. Petitioner reported “pain daily 4/5 times a day [and] made worse with certain movements. Pain ranges from 2-8/10 on a pain scale.” Id. Pain was described as “achy, burning, dull, sharp, stiff, throbbing,” and moderate. Id. Physical examination revealed “severe [guarding] of the neck and right shoulder” and decreased range of motion. Id. From February 18, 2016 to November 4, 2016, petitioner visited chiropractor Dr. Thacker 27 additional times for physical therapy. At the February 24, 2016 visit, Dr. Thacker noted “progression not optimal.” Pet. Ex. 5 at 13. An MRI of petitioner’s right shoulder was conducted on March 1, 2016, and the impression was “[s]omewhat inferiorly projecting acromion process with mild increased signal intensity changes in the subacromial bursa could represent impingement syndrome or from bursitis. Study otherwise is negative for rotator cuff tear.” Pet. Ex. 3 at 2. Dr. Thacker’s examinations in March and April 2016 “show[ed] minimal to no improvement in [petitioner’s] subjective or objective complaints/findings.” Pet. Ex. 5 at 24, 48. On April 7, 2016, Dr. Thacker wrote, “[p]atient progress not showing expected results. Patient still suffering from severe pain when certain motions are sought . . . .” Id. at 2. Dr. Thacker discussed a referral to an orthopedist for an injection. On April 11, 2016, at a visit to Dr. Patel, petitioner complained of “right shoulder pain with restricted shoulder movement.” Pet. Ex. 4 at 38. Physical examination revealed right shoulder tenderness with marked restricted movements. On April 18, 2016, petitioner saw orthopedist Dr. Varney, where petitioner reported “the symptoms have been chronic non-traumatic,” occur intermittently, and “began . . . after flu shot.” Pet. Ex. 2 at 3. He described the pain as “piercing” and “stabbing,” indicated his “symptoms are aggravated by daily activities and reaching overhead,” and noted the pain “randomly” goes from 2/10 to 8/10. Id. at 3, 11-12. At the time of the visit, petitioner reported his symptoms were moderate and his pain was a 2/10. Dr. Varney administered a cortisone injection. Dr. Varney stated “MRIs . . . show[] chronic tendinopathy of supraspinatus with some tendinitis and bursitis. Also has a downward sloping acromion that causes rotator cuff impingement.” Id. at 7. After the cortisone injection, petitioner continued to see Dr. Thacker until November 2016. Medical records filed after November 2016 do not document complaints of shoulder pain and physical examinations reveal normal range of motion. In summary, the evidence establishes that petitioner had significant pain for approximately five months, from his vaccination in November 2015 to his cortisone injection in April 2016. Petitioner’s period of treatment totals approximately one year, until November 2016. During this year, petitioner visited a chiropractor for physical therapy 28 times, underwent one MRI study, and received one cortisone injection. The undersigned finds petitioner’s visits to and treatment by a chiropractor is similar to that of a physical therapist. Petitioner’s medical 14 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 15 of 16 records show that his physician instructed petitioner to continue physical therapy with Dr. Thacker or referred to petitioner’s visits with Dr. Thacker as physical therapy. See Pet. Ex. 2 at 7; Pet. Ex. 4 at 39; Pet. Ex. 7 at 5. The undersigned has reviewed the cases cited by petitioner to support his position on the appropriate amount for an award of actual pain and suffering. The undersigned finds this case is similar to Johnson and George. The petitioner in Johnson took oral steroids, attended six physical therapy sessions, and received one cortisone injection, after which her pain levels decreased. Johnson, 2021 WL 836891 at *7. Similarly, petitioner here received one cortisone injection around five months after vaccination; however, petitioner here visited a chiropractor a total of 28 times, which is 22 more visits than the petitioner in Johnson. The Johnson petitioner also “reported only minor discomfort with certain movements” six months post-vaccination, while petitioner in this case continued to see a chiropractor until around one year post-vaccination. Id. Because of the petitioner’s additional visits to a chiropractor and extended treatment period, the undersigned finds an award greater than the Johnson petitioner received ($65,000.00) is appropriate. The petitioner in George, like petitioner here, did not undergo surgery and received one cortisone injection. George, 2020 WL 4692451 at *3. The petitioner in George attended more physical therapy sessions (40 total, 12 more than petitioner here); however, the “initial course of treatment lasted approximately seven months” in George, while petitioner’s lasted one year. Id. Additionally, an MRI in George revealed minimal bursitis and mild tendinopathy of the infraspinatus tendon, and petitioner’s MRI revealed “chronic tendinopathy of supraspinatus with some tendinitis and bursitis.” Id. at *2; Pet. Ex. 2 at 7. Given the longer treatment period and MRI differences, the undersigned finds an award greater than George ($67,000.00) appropriate. Based on a review of the entire record and consideration of the facts and circumstances presented here, as well as the cases cited by the parties, the undersigned awards $70,000.00 in compensation for petitioner’s pain and suffering. Petitioner does not seek compensation for future pain and suffering, and the evidence does not support such damages. B. Award for Past Unreimbursed Expenses Petitioner’s past unreimbursable medical expenses are uncontested. Both parties agree petitioner’s past unreimbursable medical expenses equals $1,971.85, and thus, the undersigned finds petitioner is entitled to receive an award of $1,971.85 for past unreimbursable medical expenses. VII. CONCLUSION In determining an award in this case, the undersigned does not rely on a single decision or case. Rather, the undersigned has reviewed the particular facts and circumstances in this case, giving due consideration to the circumstances and damages in other cases cited by the parties and other relevant cases, as well as her knowledge and experience adjudicating similar cases. 15 Case 1:17-vv-00451-UNJ Document 108 Filed 08/05/22 Page 16 of 16 For all the reasons discussed above, the undersigned awards the following compensation: A lump sum payment of $71,971.85, representing $70,000.00 for petitioner’s actual pain and suffering and $1,971.85 for related out-of-pocket medical expenses, in the form of a check payable to petitioner, Larry Wolford. This amount represents compensation for all damages available under § 15(a). The Clerk of Court is directed to enter judgment in accordance with this Decision.20 IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Special Master 20 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. 16