VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-01890 Package ID: USCOURTS-cofc-1_17-vv-01890 Petitioner: Lorrie Jones Filed: 2017-12-06 Decided: 2025-02-21 Vaccine: Tdap; influenza; pneumococcal Vaccination date: 2016-10-25 Condition: shoulder injury related to vaccine administration (SIRVA) Outcome: compensated Award amount USD: 126590 AI-assisted case summary: On December 6, 2017, Lorrie Jones filed a petition alleging that a Tdap vaccination she received on October 25, 2016, caused a Shoulder Injury Related to Vaccine Administration (SIRVA). Ms. Jones, who was 51 years old at the time, also received influenza and pneumococcal vaccines in her other shoulder. She initially sought medical care for unrelated conditions and did not report shoulder pain until approximately three months post-vaccination, when she saw an orthopedist. Her medical records from an earlier visit with a neurologist noted no joint pain and normal shoulder examination findings. Ms. Jones's left shoulder pain progressed, leading to a diagnosis of impingement syndrome, osteoarthritis, and a rotator cuff tear. She underwent surgery for the rotator cuff tear and a bursectomy. Despite physical therapy, she continued to experience pain and limitations. Petitioner's experts, Dr. Clifford Colwell, Jr. and Dr. Uma Srikumaran, opined that her injury was consistent with SIRVA, proposing a mechanism involving an immune-mediated inflammatory reaction due to improper injection technique. Respondent's expert, Dr. Paul Cagle, argued against a Table SIRVA claim, citing the delayed onset of symptoms and the presence of pre-existing conditions like fibromyalgia and osteoarthritis that could explain her symptoms. He also questioned the MRI findings, suggesting they were consistent with age-related degeneration rather than acute inflammation. Special Master Herbrina Sanders, in a ruling on entitlement dated September 29, 2023, found that Ms. Jones did not meet the criteria for a Table SIRVA, primarily due to the delayed onset of symptoms and the potential explanation of her symptoms by pre-existing conditions. However, the Special Master determined that Ms. Jones had presented sufficient evidence for an off-Table SIRVA claim, establishing a medical theory, a logical sequence of cause and effect, and a proximate temporal relationship between the vaccination and her injury. The case then proceeded to damages. In a decision dated February 21, 2025, Special Master Herbrina D. S. Young awarded Ms. Jones $1,590.13 for out-of-pocket expenses and $125,000.00 for past pain and suffering, totaling $126,590.13. The Special Master noted that while Ms. Jones's injury was significant and required surgery, her delayed seeking of treatment and the lack of continuous medical documentation of ongoing post-surgical pain influenced the final award amount, distinguishing it from cases with higher awards. Theory of causation field: Tdap vaccine on October 25, 2016, age 51, with influenza and pneumococcal vaccines in the other shoulder, alleged SIRVA. COMPENSATED. Petitioner reported immediate pain to family, but medical documentation of shoulder pain appeared months later and respondent disputed entitlement. After entitlement/damages proceedings, compensation was awarded; award recorded as $126,590. Later attorney-fee decision did not change merits outcome. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_17-vv-01890-0 Date issued/filed: 2023-11-01 Pages: 23 Docket text: PUBLIC ORDER/RULING (Originally filed: 09/29/2023) regarding 51 Ruling on Entitlement. Signed by Special Master Herbrina Sanders. (rig) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 1 of 23 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: September 29, 2023 LORRIE JONES, No. 17-1890V Petitioner, Special Master Sanders v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Leah V. Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for Petitioner. Mitchell Jones, U.S. Department of Justice, Washington, DC, for Respondent. RULING ON ENTITLEMENT1 On December 6, 2017, Lorrie Jones (“Petitioner”) filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2018),2 alleging “injuries, including Shoulder Injury Related to Vaccine Administration (“SIRVA”), resulting from adverse effects of a tetanus/diphtheria (“Tdap”) vaccination she received on October 25, 2016.” Pet. at 1, ECF No. 1. After carefully analyzing and weighing all the evidence and testimony presented in this case in accordance with the applicable legal standards,3 I find that Petitioner has failed to provide preponderant evidence that the Tdap vaccine she received on October 25, 2016, caused her to suffer from a Table SIRVA. However, I do find preponderant evidence that Petitioner suffered 1 Because this Ruling contains a reasoned explanation for the special master’s action in this case, it will be posted on the United States Court of Federal Claims’ website in accordance with the E-Government Act of 2002. See 44 U.S.C. § 3501 note (2018) (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 the special master, upon review, agrees that the identified material fits within this definition, it will be redacted from public access. 2 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C. § 300aa-10-34. 3 While I have reviewed all of the information filed in this case, only those filings and records that are most relevant to the decision will be discussed. Moriarty v. Sec'y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally presume that a special master considered the relevant record evidence even though he does not explicitly reference such evidence in his decision.”) (citation omitted); see also Paterek v. Sec'y of Health & Hum. Servs., 527 F. App'x 875, 884 (Fed. Cir. 2013) (“Finding certain information not relevant does not lead to—and likely undermines—the conclusion that it was not considered.”). 1 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 2 of 23 from an off-Table local shoulder injury consistent with SIRVA. Accordingly, Petitioner is entitled to compensation. I. Procedural History Due to Petitioner’s SIRVA allegation, Petitioner’s case was originally assigned to the chief special master and the special processing unit. ECF No. 4. Petitioner filed a notice of intent to file on compact disc (“CD”) and her statement of completion on December 18, 2017. ECF Nos. 7–8. The CD contained Petitioner’s proof of vaccination, medical records, and a personal affidavit. Pet’r’s Exs. 1–7. On February 13, 2018, Petitioner filed a supplemental affidavit, her vaccine consent form, and a second statement of completion. Pet’r’s Exs. 8–9, ECF No. 10; ECF No. 11. Respondent filed his Rule 4(c) Report arguing that compensation is not appropriate in this case on November 1, 2018. Resp’t’s Report at 1, ECF No. 20. Petitioner filed an additional medical record on January 4, 2019. Pet’r’s Ex. 10, ECF No. 22-1. On January 13, 2019, Petitioner filed a second supplemental affidavit and her VAERS report. Pet’r’s Exs. 11–12, ECF No. 24. Respondent filed a status report on March 25, 2019, indicating his intention to continue to defend against Petitioner’s claim. ECF No. 26. The case was reassigned to me on April 9, 2019. ECF No. 28. Petitioner filed three witness affidavits on August 11, 2019. Pet’r’s Exs. 13–15, ECF No. 32. On September 9, 2019, Petitioner filed her first expert report from Clifford Colwell, Jr., M.D., Dr. Colwell’s C.V., and Dr. Colwell’s biography. Pet’r’s Exs. 16–18, ECF No. 34. Respondent filed his first expert report from Paul Cagle, M.D. on May 1, 2020. Resp’t’s Ex. A, ECF No. 40- 1. On September 8, 2020, Petitioner filed her first supplemental expert report from Dr. Colwell, along with medical literature. Pet’r’s Exs. 19–24, ECF No. 44. Respondent filed his first supplemental expert report from Dr. Cagle on January 11, 2021. Resp’t’s Ex. B, ECF No. 45-1. Petitioner filed an expert report from Uma Srikumaran, M.D. on March 29, 2021, along with medical literature. Pet’r’s Exs, 25–36, ECF No. 46. Respondent responded with a second supplemental report from Dr. Cagle on August 24, 2021. Resp’t’s Ex. C, ECF No. 49-1. On November 29, 2021, Petitioner filed a supplemental expert report from Dr. Srikumaran, along with his C.V. and medical literature. Pet’r’s Exs. 37–42, ECF No. 50. Respondent indicated via email on February 10, 2022, that he did not intend to file an additional expert report. Informal Comm., docketed Feb. 11, 2022.There have been no further submissions from either party. I am resolving Petitioner’s claim on the filed record. The Vaccine Act and Rules not only contemplate but encourage special masters to decide petitions on the papers where, in the exercise of their discretion, they conclude that doing so will properly and fairly resolve the case. See 42 U.S.C. 300aa § 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020); Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided cases on the papers in lieu of hearing and those decisions were upheld). Accordingly, this matter is now ripe for resolution. II. Factual History A. Medical Records 2 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 3 of 23 1. Pre-vaccination Medical Records Petitioner presented to her primary care provider (“PCP”), Ashleigh Brooke Teates, N.P., on May 13, 2016 to establish care. Pet’r’s Ex. 4 at 7. The record from that visit includes a medical history of hypothyroidism, seizures, migraines, chronic pain- fibromyalgia,4 GERD, and depression/anxiety. Id. Petitioner also had spinal fusion surgery in 2007. Id. N.P. Teates assessed Petitioner with unspecified hypothyroidism, fatigue, Vitamin D deficiency, dysthymic disorder, migraines, and insomnia. Id. at 9. 2. Vaccination and Post-Vaccination Medical Records On October 25, 2016, Petitioner received the Tdap vaccine at issue in this case in her left shoulder. Pet’r’s Ex. 1 at 1. She also received influenza and pneumococcal conjugate vaccines in her right shoulder. Id. She was fifty-one years old at the time of her vaccinations. Id. Petitioner’s first medical visit post vaccination was with her PCP on November 15, 2016. Pet’r’s Ex. 2 at 3. She was seen for routine lab work based on her medical history and did not mention shoulder pain or any other acute complaints. See id. at 3–4. On December 1, 2016, Petitioner saw neurologist Michael Becker, M.D. with chief complaints of migraine without aura and generalized convulsive epilepsy. Pet’r’s Ex. 5 at 1. Specifically, Petitioner reported worsening headaches “the past [four to five] months,” that manifest every two weeks as throbbing and pressure. Id. at 3. Petitioner also reported that her fibromyalgia manifested as “[three]-day flare-ups of pain once every [four] weeks lately.” Id. She described “[four] episodes of pain and tingling going up to the neck to the base of her skull, and also in the lower back during flare-ups[.]” Id. The medical record contains a detailed list of potential concerns. See id. Of note, Petitioner reported fatigue, nausea or vomiting, muscle pain or cramps and back pain. Id. She reported “no joint pain, no joint stiffness, no weakness of muscles or joints, [and] no cold extremities[.]” Id. Upon exam, Dr. Becker noted “[c]ervical Spine: no tenderness and decreased [range of motion (“ROM”)] (mildly on lateral rotation to either side).” Id. at 4. An extensive motor exam included the following left upper extremity findings: normal motor strength, abduction 5/5, internal rotation 5/5, and external rotation 5/5. Id. Petitioner saw orthopedist Donnis Harrison, M.D. approximately three months post vaccination on January 26, 2017. Pet’r’s Ex. 2 at 5. Petitioner self-referred with complaints of constant aching and throbbing in her left shoulder that was mild to moderate in severity but that “[was] aggravated by range of motion and certain movements.” Id. She reported that her “shoulder pain began after receiving the TDAP immunization.” Id. Petitioner further reported nonspecific joint pain, joint swelling, muscular weakness, muscle pain, back pain, and limitation of motion. Id. at 7. Upon inspection, Petitioner’s left shoulder was “tender[ ] to palpation over lateral aspect deltoid[,]” and she exhibited evidence of “pain with abduction past 90 degrees, active internal rotation: limited to sacrum, active forward elevation: > 150 degrees, [and] active external rotation: 45 to 65 degrees.” Id. Neer and Hawkins tests both also yielded positive results. Id. Dr. Harrison 4 Fibromyalgia is “pain and stiffness in the muscles and joints that either is diffuse or has multiple trigger points.” Dorland’s Illustrated Medical Dictionary 696 (33rd ed. 2020) [hereinafter “Dorland’s”]. 3 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 4 of 23 assessed Petitioner with “[i]mpingement syndrome5 of shoulder, left.” Id. at 8. Petitioner was given a steroid injection and prescribed physical therapy. Id. On January 31, 2017, Petitioner began physical therapy with Erin Moody, P.T. Pet’r’s Ex. 3 at 889. Petitioner reported to P.T. Moody that she first experienced “pain in the left shoulder following an injection she received by her pharmacy on October 25, 2016.” Id. She explained that the “pain and stiffness gradually progressed so she made an appointment with [an orthopedist].” Id. Petitioner noted that the steroid injection she received from Dr. Harrison helped, and P.T. Moody provided her with a home exercise plan. Id. at 889–890. During an emergency room visit on April 22, 2017, for unrelated bladder pain and diarrhea, Petitioner was noted to have “[g]ood range of motion in all major joints.” Id. at 775, 778. Petitioner returned to Dr. Harrison approximately five months after her evaluation with P.T. Moody, on June 13, 2017. Pet’r’s Ex. 2 at 17. Petitioner complained of renewed and more severe pain, following the month of relief that the steroid injection and physical therapy had provided. Id. She described the pain as “radiating into her neck and down into her elbow.” Id. Dr. Harrison administered a second steroid injection. Id. at 19–20. He also ordered an MRI, which showed “[m]oderate supraspinatus tendinosis6 with a chronic low-grade partial thickness bursal7 surface tear through the proximal supraspinatus tendon,” as well as mild-to-moderate acromioclavicular (“AC”) joint8 osteoarthrosis,9 moderate intra-articular biceps tendinosis, mild glenohumeral arthrosis, and small joint effusion. Id. Dr. Harrison saw Petitioner on July 7, 2017, for follow up in light of her MRI results. Id. at 27. He diagnosed her with impingement syndrome of the left shoulder, osteoarthritis of the left shoulder and AC joint, and an incomplete tear of the left rotator cuff. Id. at 29. On July 25, 2017, Dr. Harrison surgically repaired Petitioner’s left rotator cuff partial thickness tear. Id. at 31–32. He also performed extensive debridement of the bursal surface rotator cuff, as well as a distal clavicle resection and subacromial decompression with a partial acromioplasty.10 Id. at 31. The operative report noted that “a complete bursectomy11 was performed[.]” Id. at 32. On August 1, 2017, Petitioner was seen by Rachel Hines, P.T., for a physical therapy evaluation to rehabilitate her shoulder after surgery. Pet’r’s Ex. 6 at 1. Petitioner reported that 5 Impingement syndrome is “a type of overuse injury with progressive pathologic changes resulting from mechanical impingement by the acromion, coracoacromial ligament, coracoid process, or acromioclavicular joint against the rotator cuff[.]” Dorland’s at 1804. The rotator cuff is “a musculotendinous structure about the capsule of the shoulder joint[.]” Id. at 436. 6 Tendinosis, or tendinopathy, is “any pathologic condition of a tendon[.]” Dorland’s at 1852. 7 A bursa is “a sac or saclike cavity filled with a viscid fluid and situated at places in the tissues at which friction would otherwise develop.” Dorland’s at 258. 8 The AC joint is “the synovial joint between the acromion of the scapula and the acromial extremity of the clavicle[.]” Dorland’s at 156. 9 Osteoarthrosis, or 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.” Dorland’s at 1326. 10 Acromioplasty is “surgical removal of an anterior spur of the acromion to relieve mechanical compression of the rotator cuff during movement of the glenohumeral joint[.]” Dorland’s at 20. 11 A bursectomy is “excision of a bursa.” Dorland’s at 260. 4 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 5 of 23 her shoulder pain began after receiving a vaccine in October of 2016. Id. Petitioner returned to Dr. Harrison on August 14, 2017, for a post-surgery follow-up. Pet’r’s. Ex. 2 at 34. She complained of increased left shoulder pain and numbness radiating down her arm. Id. Petitioner was prescribed a Medrol12 dose pack and advised to alter her activity. Id. at 36. Dr. Harrison believed that Petitioner’s ulnar nerve may have been irritated by her sling. Id. He advised Petitioner to follow up in two months. Id. On October 5, 2017, Petitioner completed physical therapy. Pet’r’s Ex. 6 at 51. Her discharge record noted that she was no longer functionally limited and was able to complete all of her movements without deviation and all activities of daily living with good strength. Id. at 51–52. B. Affidavits Petitioner filed three personal affidavits in this case. Pet’r’s Exs. 7, 8, 11. In her initial November 10, 2017 affidavit, Petitioner described “enormous pain in the area [of her upper left shoulder] where [her vaccine] was injected.” Pet’r’s Ex. 7 ¶ 1. She wrote that she thought the pain would go away in time, but “hours turned into days, then weeks[,] and then months.” Id. Petitioner described her appointment with Dr. Harrison on January 26, 2017. Id. ¶ 2. Despite the steroid injection and physical therapy exercises, “the pain became worse[,] and [she] experienced weakness, throbbing and some numbness.” Id. After several months, Petitioner made another appointment for June 13, 2017, which ultimately led to shoulder surgery. Id. ¶ 3. Petitioner described physical therapy following her surgery and noted that it helped a lot before she was discharged. Id. ¶ 5. She noted that her shoulder continued hurting sometimes, but she said before the surgery, she “could not do any of [her] daily duties in the house.” Id. ¶ 6. Petitioner explained that she could not “cook, clean, do the laundry, raise [her] arms to put on clothes/bra, wash [her] hair, get into or out of [her] bathtub, or do the dishes.” Id. She continued that she is responsible for the care of her disabled son. Id. Petitioner “know[s] that [her] shoulder will never be 100 percent[, and she was still] unable to “reach all the way behind [her] back.” Id. She stated that because of her pre-existing fibromyalgia, “the pain from her shoulder had a huge impact on [her].” Id. ¶ 7. Petitioner signed her second affidavit on January 12, 2018. Pet’r’s Ex. 8 at 1, ECF No. 10- 1. She explained that she intentionally did not express to Dr. Becker, her neurologist, that she was experiencing shoulder pain on December 21, 2016. Id. ¶ 1. This was “[b]ecause shoulders are not Dr. Becker’s area of expertise.” Id. She added that he “only treats [her] for [her] problems concerning neurology issues.” Id. In Petitioner’s third affidavit, signed January 13, 2019, she reiterated that she felt “intense pain” at the time of the injection. Pet’r’s Ex. 11 ¶ 1, ECF No. 24-1. She continued that “[b]y the next day the pain was so severe that [she] felt like [her] arm was about to fall off.” Id. Petitioner noted that she has “several serious medical conditions that are unrelated to the pain in [her] left shoulder.” Id. ¶ 2. She noted that the record from her November 15, 2016 PCP appointment does not mention the pain from her left shoulder or the “several of the other chronic medical conditions [she] suffered from.” Id. Petitioner wrote: The lack of notes related to [her] shoulder should not be interpreted as [her] not having shoulder pain at that time. The fact is that [her] pain was severe and intense. 12 Medrol, or methylprednisolone, is a synthetic glucocorticoid. Dorland’s at 1137. 5 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 6 of 23 By the next day after receiving the shot, [she] was unable to lift or move [her] arm at all without pain. The pain was so bad that on December 27, 2016, [she] filed a VAERS report. Id. Petitioner’s VAERS report has an adverse event onset date of October 26, 2016. Id.; Pet’r’s Ex. 12 at 1, ECF No. 24-2. She stated that she filed the report because she wanted to “notify someone in the government about the debilitating pain that the shot had caused.” Pet’r’s Ex. 11 ¶ 2. She stated that she “filed that VAERS report long before [she] ever knew anything about filing a claim in the Vaccine Program.” Id. Petitioner also provided additional information about her December 2016 visit to Dr. Becker. Id. ¶ 3. She explained that appointments with Dr. Becker are typically limited to fifteen minutes, and she “did not want to burden [him] with [her] shoulder, especially when [she] was there to be seen for other serious conditions.” Id. Petitioner conceded that the record notes she did not have joint pain. Id. She explained that “[t]he pain in [her] shoulder was never mentioned during [their] time together, and Dr. Becker did not conduct an examination of [her] left shoulder on that day.” Id. In addition to Petitioner’s personal affidavits, she submitted affidavits from her husband, signed April 2, 2019, and her mother and sister, signed April 12, 2019. Pet’r’s Exs. 13–15. All three of the affidavits focus on the onset of Petitioner’s pain. See id. Petitioner’s husband, Lt. Col. Daniel Jones, recounted a phone call he received on October 25, 2016, during which Petitioner described extreme pain in her left arm, immediately post vaccination. Pet’r’s Ex. 13 at 1, ECF No. 32-1. Petitioner also told him that the vaccination site in her left arm was higher than the one in her right. Id. Lt. Col. Jones remembered that it was hurricane season, a busy time for him, and he was concerned about her ability to manage without him. Id. He noted that “[s]he still does home physical therapy because she still has some minor issues, . . . [b]ut, that excruciating pain was fixed with the surgery.” Id. He stated that his wife’s “shoulder was fine before she went to receive these vaccines.” Id. Petitioner’s mother’s affidavit was brief. See Pet’r’s Ex. 14 at 1, ECF No. 32-2. Petitioner’s mother, Linda Langston, “verif[ied] that [Petitioner] called [her] on October 25, 2016, and told [her] about the events that took place earlier in the day.” Id. Petitioner told her that the pain was immediate and excruciating. Id. Ms. Langston remembered that she and Petitioner discussed that they “had just celebrated [Ms. Langston’s] birthday the weekend prior and that is was a good thing that [Petitioner] waited to get the vaccines until afterward.” Id. Petitioner’s mother said that “[P]etitioner ha[d] never complained with shoulder pain before.” Id. She added that Petitioner “explained her pain [as] the worst she[ had] ever experienced.” Id. Lana Hardwick is Petitioner’s sister, and she provided the third witness affidavit. Pet’r’s Ex. 15 at 1, ECF No. 32-3. Ms. Hardwick also stated that Petitioner called her on the date of her vaccination, October 25, 2016, complaining of terrible pain in her left arm after the shot. Id. She recalled that Petitioner was hopeful the pain would resolve on its own. Id. Ms. Hardwick related the dated back to “three days after [her] mother’s birthday.” Id. She noted that her “sister was forced to undergo a painful shoulder surgery and go through a painful recovery that included physical therapy which was not easy on her.” Id. Ms. Hardwick also stated that Petitioner did not have left shoulder problems prior to her vaccination and that Petitioner told her that the Tdap 6 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 7 of 23 vaccine was given higher up on her left arm than the vaccines administered in Petitioner’s right arm the same day. Id. III. Expert Reports A. Petitioner’s Expert, Clifford W. Colwell, Jr., M.D. Clifford W. Colwell, Jr., M.D., is a board-certified orthopaedic surgeon, who received his undergraduate degree from Williams College and his medical degree from the University of Michigan. Pet’r’s Ex. 17 at 1, 3, ECF No. 34-2. Dr. Colwell’s postdoctoral training includes an internship and general surgery residency at the University of Michigan, followed by a residency in orthopaedic surgery at the Hospital for Special Surgery in New York and a trauma fellowship at Los Angeles County Hospital. Id. at 1. He currently serves as the medical director of the Shiley Center for Orthopaedic Research and Education at Scripps Clinic in California, as a clinical professor at the University of California, San Diego School of Medicine in the Department of Orthopaedics and Rehabilitation, and as an adjunct clinical professor at The Scripps Research Institute in the Department of Basic Science and Clinical Research. Id. at 2. Previously, Dr. Colwell was chief of the Orthopaedic Division at Scripps Clinic and Director of the Lower Extremity Reconstruction Fellowship Program, and he was also the team physician for the San Diego Padres. Pet’r’s Ex. 16 at 1, ECF No. 34-1. During this time, he treated numerous professional athletes for “severe shoulder injuries requiring both extensive diagnostic testing as well as non-surgical and surgical treatment modalities.” Id. After review of Petitioner’s medical record, Dr. Colwell concluded that Petitioner “meets the defined definitions of SIRVA, as outlined by the Vaccine Injury Compensation Program[.]” Id. He did not find any “indication that [Petitioner] had any previous history of left shoulder pain, inflammation, or dysfunction of the affected shoulder prior to her [Tdap] vaccination on October 25, 2016[,]” in Petitioner’s medical records. Id. Dr. Colwell acknowledged that Petitioner did not complain to a medical provider until “about three months” post vaccination; however, he opined “that her shoulder pain began within 48 hours” of her vaccination. Id. He noted that “all medical records that address the issue of onset consistently note that [Petitioner’s] shoulder pain began when she received her [Tdap] vaccine on October 25, 2016.” Id. at 2. Dr. Colwell also relied on Petitioner’s December 27, 2016 VAERS report and witness affidavits, which Dr. Colwell described as “entirely consistent with the medical records and indicate that [Petitioner’s] pain began when she received the [Tdap] vaccine.” Id. Continuing through the Table SIRVA requirements, Dr. Colwell did not believe that a single complaint of non-specific pain that radiated to Petitioner’s neck and elbow on June 13. 2017, was in any way related to her diagnosed left shoulder impingement. Id. Petitioner’s symptom improvement following a cortisone shot and then shoulder surgery provided further evidence to Dr. Colwell that her injury was consistent with SIRVA. Id. Dr. Colwell finally noted that “no other condition or abnormality is present that would explain [Petitioner’s] symptoms.” Id. at 3. In Dr. Colwell’s supplemental expert report, he reiterated his conclusion that Petitioner meets the four criteria for a Table SIRVA. Pet’r’s Ex. 19 at 1, ECF No. 44-1. However, he supplemented his opinion regarding the nature of Petitioner’s Table SIRVA symptom onset and injury and provided a biological mechanism for an off-Table vaccine-related shoulder injury. Dr. 7 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 8 of 23 Colwell opined that Petitioner’s June 2017 “MRI showed evidence of moderate supraspinatus tendinosis, a partial thickness rotator cuff tear, and biceps tendinosis, all consistent with a Table SIRVA injury.” Id. at 2. Discussing causation-in-fact, Dr. Colwell cited a 2010 Atanasoff et al.13 article that “provides support for the theory that antigenic material from the vaccine that is injected into synovial tissues results in an immune mediated inflammatory reaction.” Id. (citing Pet’r’s Ex. 21 at 1, ECF No. 44-3). Dr. Colwell also cited the Bodor and Montalvo14 article that found an inflammatory post-vaccination response in two patients caused shoulder pain. Id. at 3 (citing Pet’r’s Ex. 20, ECF No. 44-2). The authors “hypothesize that in both of [their] two cases, vaccine was injected in the subdeltoid bursa[, which is] contiguous with the subacromial bursa [and] led to subacromial bursitis, bicipital tendonitis, and inflammation of the shoulder capsule.” Pet’r’s Ex. 20 at 2. They cautioned against vaccinations “in the upper third of the deltoid muscle,” and they identified subacromial bursitis, bicipital tendonitis, and adhesive capsulitis as consistent a diagnosis of “vaccination-related shoulder dysfunction.” Id. at 3. Dr. Colwell cited the Institute of Medicine,15 which concluded that “[t]he evidence convincingly supports a causal relationship between the injection of a vaccine and deltoid bursitis.” Pet’r’s Ex. 19 at 3 (citing Pet’r’s Ex. 22 at 7, ECF No. 44-4). Although Dr. Colwell maintained that Petitioner suffered from a Table SIRVA, he noted that “[a] very recent investigation by Hesse et al[.],16 a large case series based on Vaccine Program claims, adds further support and reliability to the general theory of causation of SIRVA.” Id. (citing Pet’r’s Ex. 24, ECF No. 44-6). The investigation identified post-vaccination, musculoskeletal injuries that present as shoulder pain, “followed by rotator cuff problems and bursitis. Common findings on MRI included tendonitis/osis/inopathy, rotator cuff tears and bursitis.” Pet’r’s Ex. 24 at 6. The authors concluded that these injuries, in the case of “true SIRVA is likely preventable.” Id. Vaccine administrators were advised that “care should be taken to ensure that the injection is placed in the thick, centrally located portion of the deltoid muscle, away from the upper third of the deltoid where the risk of over penetration in the underlying structures of the shoulder is greatest.” Id. at 6–7. Dr. Colwell further noted that the Atanasoff article “indicated onset could be as late as 4 days after vaccination[,] and Arias stated onset could be as delayed as much as 7-60 days after vaccination.” Pet’r’s Ex. 19 at 2. Specifically the Atanasoff article reported pain onset “as occurring less than 24 h after vaccination in 93% and occurred immediately following injection in 53% of [cases.]” Pet’r’s Ex. 21 at 2. Arias et al.17 noted a latency period for six of eight patients with “increasing severity [of] pain starting within the first 24 h or few days (4-7 days) post- vaccination, and 2 reported pain within 2 months.” Pet’r’s Ex. 23 at 3, ECF No. 44-5. They also noted that patients experienced pain “of increasing severity” over time. Id. In conclusion, Dr. 13 S. Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA), 28 VACCINE 8049 (2010). 14 Marko Bodor & Enoch Montalvo, Vaccination-related shoulder dysfunction, 25 VACCINE 585 (2007). 15 K. Stratton et al. (eds.), Institute of Medicine, Adverse Effects of Vaccines, Evidence and Causality, 618 (2012). 16 Elizabeth M. Hesse et al., Shoulder Injury Related to Vaccine Administration (“SIRVA”): Petitioner claims to the National Vaccine Injury Compensation Program, 2010–2016, 38 VACCINE 1076 (2020). 17 L.H. Martín Arias et al., Risk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations, 35 VACCINE 4870 (2017). 8 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 9 of 23 Colwell reiterated that he “believe[s Petitioner’s] onset was within 48 hours of vaccination, [but he argued in the alternative based on the filed literature that] she meets the timing requirement of actual causation even if her onset was later than 48 hours.” Pet’r’s Ex. 19 at 3. B. Petitioner’s Expert, Uma Srikumaran, M.D. Uma Srikumaran, M.D. is a board-certified orthopaedic surgeon and an associate professor at the Johns Hopkins University School of Medicine in the Department of Orthopaedic Surgery, Shoulder Division. Pet’r’s Ex. 25 at 1, ECF No. 46-1. He received his undergraduate degree from Northwestern University and obtained his medical degree from Johns Hopkins. Pet’r’s Ex. 38 at 1, ECF No. 50-2. Dr. Srikumaran then completed an internship and residency in orthopaedic surgery before obtaining master’s degrees in business administration and public health, also from Johns Hopkins. Id. He has served as assistant team physician for the Baltimore Orioles and, in addition to teaching, now serves as the Shoulder Fellowship Director at Johns Hopkins, as Chair of Orthopaedic Surgery for the Howard County General Hospital, and as the Medical Director of the Johns Hopkins Musculoskeletal Service Line at the Columbia, Maryland site. Id. at 2. Dr. Srikumaran has “published numerous articles in the field of shoulder surgery, [but he has] not published specifically related to shoulder injuries related to [v]accination [a]dministration [ ].” Pet’r’s Ex. 25 at 1. His practice over the last five years includes “10–12 patients with shoulder dysfunction after vaccination[.]” Id. Overall Dr. Srikumaran sees “approximately 2500–3000 patients for shoulder issues and [performs] 400–500 shoulder surgeries annually.” Id. In support of his opinion that Petitioner suffered a Table SIRVA, Dr. Srikumaran went through the requirements in his expert report. See id. at 6–10. Dr. Srikumaran noted that Petitioner had fibromyalgia flares pre vaccination. Id. at 6. However, Dr. Srikumaran did not believe that Petitioner’s post-vaccination symptoms were consistent with her pre-existing injury. Id. Specifically, Dr. Srikumaran stated that Petitioner’s “fibromyalgia flares were documented to include the areas of the neck and radiating to the base of the skull, along with lower back [ ].” Id. (citing Pet’r’s Ex. 5 at 3). Furthermore, Dr. Srikumaran noted that pre vaccination, Petitioner only suffered “mild decreased cervical spine ROM with lateral rotation bilaterally [ ].” Id. (citing Pet’r’s Ex. 5 at 4, 7, 11, 15, 24, 28, 32, 36). Petitioner’s June 13, 2017 complaint of radiating neck and elbow pain is explained by Dr. Srikumaran as “shoulder pathology [ ] affecting [Petitioner’s] surrounding musculature and causing increased pain in the adjacent tissues of the cervical spine and upper arm to her elbow.” Id. at 7. Dr. Srikumaran also noted that Petitioner consistently related her shoulder pain to her vaccine, and her witness statements all corroborate an immediate onset of shoulder pain post vaccination. Id. Furthermore, “[t]here are no documents available to [Dr. Srikumaran] that would call into question [Petitioner’s] statements and [her] very consistent medical reports.” Id. at 9. In his experience, [t]he vast majority of patients do not have their pain (outside of acute traumas/emergency room situations) evaluated within 48 hours.” Id. Dr. Srikumaran explained that many people believe that the pain will recede with time and “try several over the counter remedies for many weeks or months before seeking professional evaluation (particularly when they expert there is to be some pain as after any vaccination.” Id. He also noted the costs of seeking medical 9 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 10 of 23 care and how a patient’s pain tolerance level can impact when medical care is ultimately sought. Id. Dr. Srikumaran shared the opinion of Respondent’s expert that Petitioner’s MRI findings are “consistent with degenerative conditions,” but he noted that they “disagree on several points.” Id. at 8. He noted that Petitioner’s “MRI was obtained after [Petitioner] had received a second corticosteroid injection in the subacromial space.” Id. Therefore, “[i]t is reasonable that a successful injection into the subacromial space given less than two weeks prior to an MRI would reduce inflammation in the bursal tissue to a level that was not easily detectable.” Id. This chronology is in addition to a bursectomy, which indicates that bursitis “was thought to be causing or contributing to pain and inflammation.” Id. Dr. Srikumaran argued that “the vast majority of the population in their 50s will have ‘chronic degenerative conditions’ in their shoulder that are readily detectable on MRI scans[,] and they are most likely to be asymptomatic.” Id. Petitioner’s symptoms were not explained by a chronic condition in Dr. Srikumaran’s opinion. Id. Dr. Srikumaran asserted that “[v]accination did not cause these degenerative conditions, but [it] was the trigger that instigated inflammation of the surrounding structures and tissues, causing symptoms consistent with impingement syndrome (a term that is commonly used in cases of SIRVA injury.” Id. at 8–9. He noted that “there were no other injuries or activities in this time period that provide an alternate explanation, i.e.[,] another trigger like a fall or unusual event . . . .” Id. at 9–10. After Dr. Srikumaran characterized of Petitioner’s injury as a Table SIRVA, he also noted that “the criteria for causation in fact are also met[.]” Id. at 11. He relied on the filed articles and echoed Dr. Colwell’s explanation that injury results from “an immune mediated response of inflammation related to antigens injected into the bursal tissue, likely from poor technique related to various factors (site, needle choice, angle and location of injection, not accounting for patient size variation).” Id. Dr. Srikumaran asserted that Petitioner’s injection site was “inadvertently near the bursa or rotator cuff tendon[, and this] led to a strong immune mediated inflammatory reaction, causing bursitis and tendinitis.” Id. at 12. After reiterating the appropriate temporal relationship between Petitioner’s vaccination and pain onset, Dr. Srikumaran briefly noted that Petitioner was asymptomatic pre vaccination. Id. He concluded that Petitioner’s “current condition is well documented in the medical records[,] and the time course of events supports that she had a significant aggravation of a condition that existed prior to vaccination.” Id. The supplemental report issued by Dr. Srikumaran did not contain any new arguments. See Pet’r’s Ex. 37, ECF No. 50-1. He repeated that Petitioner’s change in symptom characterization between when she described her fibromyalgia neck pain pre vaccination and when she described her shoulder pain post vaccination was the key factor for his determination that Petitioner’s shoulder symptoms were due to her vaccination rather than her fibromyalgia. Id. at 1. Dr. Srikumaran also again mentioned Petitioner’s consistent account that her shoulder pain began immediately after her vaccination. See id. at 1, 5. After acknowledging that “cervical spine pain and shoulder pain can be difficult to diagnose and differentiate from one another[,]” Dr. Srikumaran argued that “a complete consideration of the historical details, their timing, in conjunction with the associated exam and diagnostic test findings is critical for evaluation and management.” Id. at 1. He explained that in 10 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 11 of 23 this case, “the most likely mechanism” explaining Petitioner’s neck pain in June of 2017 is that Petitioner attempted to mitigate her shoulder pain “by adjusting [her] shoulder girdle[,]” leading to neck spasms and pain and “causing [her] neck condition (disc degeneration/arthritis) to become symptomatic or worsen.” Id. at 3. Dr. Srikumaran maintained his opinion that Petitioner’s “symptoms of impingement improve and worsen over the course of her treatment[] and depend on medications and injections targeted at removing inflammation.” Id. at 4. In support of his contention that Petitioner had bursitis, Dr. Srikumaran noted that the record did not include the MRI images, but only the report, which did not state whether Petitioner’s bursa was abnormal or even mention it at all. Id. There is, however, a record of Petitioner’s complete bursectomy, “indicating that there was a significantly inflamed bursa which the surgeon felt needed to be removed.” Id. C. Respondent’s Expert, Paul J. Cagle, M.D. Paul J. Cagle, M.D. is a board-certified orthopaedic surgeon and an assistant professor and associate program director in the Department of Orthopaedic Surgery at the Icahn School of Medicine at Mount Sinai. Resp’t’s. Ex. A at 1.18 Currently, Dr. Cagle’s practice “focuses on the shoulder, representing approximately 95% or more of the patients and pathology [he] treat[s].” Id. His professional memberships include the American Shoulder and Elbow Surgeons, the American Academy of Orthopaedic Surgeons, and the American Orthopaedic Association. Id. In his initial export report, Dr. Cagle identified problems with Petitioner’s “timing, the mechanism and actual injury.” Id. at 2–3. He noted that “there is no medical record, except for her reporting, establishing a 48[-]hour link between the vaccination event and the onset of shoulder pain.” Id. Dr. Cagle further noted that Petitioner does have medical records that document examinations “by two providers who did not document shoulder pain but did document a normal shoulder exam.” Id. at 4. Specially, Dr. Cagle cited that Dr. Becker conducted a system review on December 1, 2016, including “a shoulder exam that demonstrates 5/5 shoulder strength in abduction, internal rotation and external rotation [ ].” Id. at 1 (citing Pet’r’s Ex. 5 at 1–4). Dr. Cagle’s second point of contention is that “the actual injury mechanism [was] never establish[ed].” Id. at 3. He stated that Petitioner was diagnosed with shoulder impingement, but he argued that “the [June 30, 2017] MRI findings in this case are actually in stark contradiction to the published SIRVA literature.” Id. Dr. Cagle explained that SIRVA patients have increased bursal fluid as evidence of local inflammation. Id. In Petitioner’s case, there was “no significant joint effusion or bursitis, and there is notation of chronic shoulder conditions consisting of a chronic rotator cuff tearing and chronic labral tears [ ].” Id. (citing Pet’r’s Ex. 2 at 23–24). Dr. Cagle reasoned that Petitioner’s “MRI findings represent typical age[-]related degenerative change.” Id. He cited several studies indicating that “people over the age of 50 years old can have asymptomatic rotator cuff tears[]” and that “demonstrate[] that over 50% of individuals with an asymptomatic rotator cuff tear will become symptomatic in an average of 2.8 years.” Id. Dr. Cagle opined that it is “highly likely[,]” given that Petitioner is over 50, that she suffered from “an underlying rotator cuff tear that predated the injection[.]” Id. 18 Respondent did not file Dr. Cagle’s CV in this case, but he frequently submits expert reports on SIRVAs and similar injuries in the Program. 11 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 12 of 23 Lastly, Dr. Cagle argued that “there is no explanation as to what structure(s) was/were injured or how this injury occurred.” Id. Dr. Colwell did not discuss overpenetration, and Dr. Cagle argued that Petitioner is “well within the safe weight range (77.7 kg on 1/26/17), it is not conceivable how a standard needled [sic] would have let to an overpenetration event.” Id. at 4. Dr. Cagle’s supplemental report was specifically focused on onset and clinical presentation. See Resp’t’s Ex. B at 1–2. He disputed Dr. Colwell’s description of Petitioner’s complaints as consistent and noted that post vaccination, Petitioner “had a documented normal shoulder exam[.]” Id. at 1. Furthermore, Dr. Cagle opined that “it does not make any sense that [Petitioner] would selectively not mention [her shoulder pain] immediately after the injection but then mention it every time after [January 26, 2017].” Id. He did not find “support for the less than 48[-]hour time table necessary to qualify for a [Table] SIRVA.” Id. In direct response to Dr. Colwell’s reliance on Petitioner’s MRI results, Dr. Cagle noted that “Dr. [Colwell] selectively ignores the findings of AC joint arthrosis (joint degeneration) and glenohumeral arthrosis (joint degeneration).” Id. In doing so, Dr. Cagle argued that Dr. Colwell incorrectly attributed Petitioner’s rotator cuff tendinosis to SIRVA, even in “the absence of a bursal fluid signal.” Id. at 1–2. Dr. Cagle explained that an increase in bursal fluid is an indicator of the acute inflammation seen “in the SIRVA literature.” Id. at 1. He concluded that “[w]ithout a significant bursal fluid increase, the logical interpretation of the MRI findings are that these are all consistent with chronic degenerative changes.” Id. at 2. Following Dr. Srikumaran’s report, Dr. Cagle responded in a second supplemental report. Resp’t’s Ex. C, ECF No. 49-1. Dr. Cagle noted that Dr. Srikumaran attributed Petitioner’s increased pain “in the adjacent tissues of the cervical spine and upper arm to her elbow[]” to her shoulder injury. Id. at 1 (quoting Pet’r’s Ex. 25 at 7). He questioned why Dr. Srikumaran’s theory “could[ not] be reciprocal.” Id. Dr. Cagle asserted that “[i]t is just as likely that pain in the cervical region could cause pain in the surrounding musculature of the shoulder.” Id. He continued that “[f]ibromyalgia in the cervical [ ] region could have caused associated pain in the shoulder region[,]” and in this case, “[f]ibromyalgia is a [documented] preexisting condition that can explain the symptoms.” Id. Dr. Cagle also disputed Dr. Srikumaran’s suggestion that Petitioner’s cortisone injection “provided complete resolution of the bursal inflammation to a point that no trace of it was demonstrated on the MRI[.]” Id. at 2. He asserted that this line of reasoning does not account for “how a cortisone injection is capable of capable of clearing up all MRI signs of inflammation but simultaneously not improving clinical symptoms.” Id. Dr. Cagle then explicitly stated that “[i]t is in conflict to state in one paragraph that inflammation in the subacromial space was alleviated by a cortisone injection and then subsequently to state that impingement syndrome (inflammation in the subacromial space) was present.” Id. Finally, Dr. Cagle noted that Dr. Srikumaran did not address the shoulder exam done by Dr. Becker on December 1, 2016, which yielded normal results, in his analysis on Petitioner’s shoulder injury onset. Id. at 3. IV. Applicable Statutory Scheme 12 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 13 of 23 The Vaccine Act provides petitioners with two avenues to receive compensation for their injuries resulting from vaccines or their administration. First, a petitioner may demonstrate that she suffered a “Table” injury—i.e., an injury listed on the Vaccine Injury Table that occurred within the provided time period. § 11(c)(1)(C)(i). “In such a case, causation is presumed.” Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006); § 13(a)(1)(B). The Vaccine Injury Table lists a Shoulder Injury Related to Vaccine Administration or “SIRVA” as a compensable injury if it occurs within 48 hours of administration of a vaccination. § 300aa-14(a) as amended by 42 CFR § 100.3. Table injury cases are guided by statutory “Qualifications and Aids in Interpretation” (“QAIs”), which provide more detailed explanation of what should be considered when determining whether a petitioner has actually suffered an injury listed on the Vaccine Injury Table. See 42 CFR § 100.3(c). To be considered a “Table SIRVA,” a petitioner must show that her injury fits within the following definition: SIRVA manifests as shoulder pain and limited [ROM] occurring after the administration of a vaccine intended for intramuscular administration in the upper arm. These symptoms are thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder resulting in an inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal structures of the shoulder (e.g., tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury and abnormalities on neurological examination or nerve conduction studies (NCS) and/or electromyographic (EMG) studies would not support SIRVA as a diagnosis . . . . A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced [ROM] are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient's symptoms (e.g., NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 42 CFR §100.3(c)(10). Alternatively, if a petitioner is unable to establish a Table claim, she may bring an “off- Table” claim. § 11(c)(1)(C)(ii). An “off-Table,” or causation-in-fact, claim requires that the petitioner “prove by a preponderance of the evidence that the vaccine at issue caused the injury.” Capizzano, 440 F.3d at 1320; see § 300aa-13(a)(1)(A); see § 11(c)(1)(C)(ii)(II). A petitioner must show that the vaccine was “not only a but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly ex rel. Moberly v. Sec'y of Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (quoting Shyface v. Sec'y of Health & Hum. Servs., 165 F.3d 1344, 13 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 14 of 23 1352–53 (Fed. Cir. 1999)); Pafford v. Sec'y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006) (citations omitted). In the seminal case of Althen v. Sec’y of of Health & Hum. Servs., the Federal Circuit set forth a three-pronged test to determine whether a petitioner has established a causal link between a vaccine and the claimed injury. See 418 F.3d at 1278–79. The Althen test requires petitioners to set forth: “(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.” Id. at 1278. To establish entitlement to compensation under the Program, a petitioner is required to establish each of the three prongs of Althen by a preponderance of the evidence. See id. Under the first prong of Althen, a petitioner must offer a scientific or medical theory that answers in the affirmative the question: “can the vaccine[] at issue cause the type of injury alleged?” See Pafford v. Sec’y of Health & Hum. Servs., No. 01-0165V, 2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), mot. for rev. denied, 64 Fed. Cl. 19 (2005), aff’d, 451 F.3d 1352 (Fed. Cir. 2006). To satisfy this prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or scientifically certain.” Id. at 548–49. Petitioners are not required to identify “specific biological mechanisms” to establish causation, nor are they required to present “epidemiologic studies, rechallenge[] the presence of pathological markers or genetic disposition, or general acceptance in the scientific or medical communities.” Capizzano, 440 F.3d at 1325 (quoting Althen, 418 F.3d at 1280). Scientific and “objective confirmation” of the medical theory with additional medical documentation is also unnecessary. Althen, 418 F.3d at 1278–81; Moberly, 592 F.3d at 1322. However, as the Federal Circuit has made clear, “simply identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of proof.” LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (citing Moberly, 592 F.3d at 1322). Rather, “[a] petitioner must provide a reputable medical or scientific explanation that pertains specifically to the petitioner’s case.” Moberly, 592 F.3d at 1322. In general, “the statutory standard of preponderance of the evidence requires a petitioner to demonstrate that the vaccine more likely than not caused the condition alleged.” LaLonde, 746 F.3d at 1339. Furthermore, establishing a sound and reliable medical theory connecting the vaccine to the injury often requires a petitioner to present expert testimony in support of her claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). The Supreme Court’s opinion in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), requires that courts determine the reliability of an expert opinion before it may be considered as evidence. “In short, the requirement that an expert’s testimony pertain to ‘scientific knowledge’ establishes a standard of evidentiary reliability.” Id. at 590 (citation omitted). Thus, for Vaccine Act claims, a “special master is entitled to require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592 F.3d at 1324. The Daubert factors are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health & Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“[U]niquely in this Circuit, the Daubert factors have been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of expert testimony already admitted.”). Nothing requires the acceptance of an expert’s conclusion “connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too great an analytical gap between the data 14 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 15 of 23 and the opinion proffered.” Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 743 (2009) (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). Under the second prong of Althen, a petitioner must prove that the vaccine actually did cause the alleged injury in a particular case. See 418 F.3d at 1279. The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Id. at 1278; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). A petitioner does not meet this obligation by showing only a temporal association between the vaccination and the injury; instead, the petitioner “must explain how and why the injury occurred.” Pafford, 2004 WL 1717359, at *4 (emphasis in original). The special master in Pafford noted petitioners “must prove [ ] both that [the] vaccinations were a substantial factor in causing the illness . . . and that the harm would not have occurred in the absence of the vaccination.” See 2004 WL 1717359, at *4 (citing Shyface, 165 F.3d at 1352). A reputable medical or scientific explanation must support this logical sequence of cause and effect. Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed Cir. 1993) (citation omitted). Nevertheless, “[r]equiring epidemiologic studies . . . or general acceptance in the scientific or medical communities . . . impermissibly raises a claimant’s burden under the Vaccine Act and hinders the system created by Congress . . . .” Capizzano, 440 F.3d at 1325–26. “[C]lose calls regarding causation are resolved in favor of injured claimants.” Althen, 418 F.3d at 1280. In Program cases, contemporaneous medical records and the opinions of treating physicians are favored. Capizzano, 440 F.3d at 1326 (citing Althen, 418 F.3d at 1280). Indeed, when reviewing the record, a special master must consider the opinions of treating physicians. Id. This is because “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.’” Id. (quoting Althen, 418 F.3d at 1280). In addition, “[m]edical records, in general, warrant consideration as trustworthy evidence. The records contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an extra premium. These records are also generally contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). While a special master must consider these opinions and records, they are not “binding on the special master or court.” § 300aa-13(b)(1). Rather, when “evaluating the weight to be afforded to any such . . . [evidence], the special master . . . shall consider the entire record . . . .” Id. To satisfy the third Althen prong, a petitioner must establish a “proximate temporal relationship” between the vaccination and the alleged injury. Althen, 418 F.3d at 1281. This “requires preponderant proof that the onset of symptoms occurred within a timeframe for which, given the medical understanding of the disorder’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). Typically, “a petitioner’s failure to satisfy the proximate temporal relationship prong is due to the fact that onset was too late after the administration of a vaccine for the vaccine to be the cause.” Id. However, “cases in which onset is too soon” also fail this prong; “in either case, the temporal relationship is not such that it is medically acceptable to conclude that the vaccination and the injury are causally linked.” Id.; see also Locane v. Sec’y of Health & Hum. Servs., 685 15 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 16 of 23 F.3d 1375, 1381 (Fed. Cir. 2012) (“[If] the illness was present before the vaccine was administered, logically, the vaccine could not have caused the illness.”). Although a temporal association alone is insufficient to establish causation, under the third prong of Althen, a petitioner must show that the timing of the injury fits with the causal theory. See Althen, 418 F.3d at 1278. The special master cannot infer causation from temporal proximity alone. See Thibaudeau v. Sec’y of Health & Hum. Servs., 24 Cl. Ct. 400, 403–04 (1991); see also Grant, 956 F.2d at 1148 (“[T]he inoculation is not the cause of every event that occurs within the ten[-]day period . . . [w]ithout more, this proximate temporal relationship will not support a finding of causation.” (quoting Hasler v. United States, 718 F.2d 202, 205 (6th Cir. 1983))). Once a petitioner has established her prima facie case, the burden then shifts to Respondent to prove, also by preponderant evidence, that the alleged injury was caused by a factor unrelated to vaccination. Althen, 418 F.3d at 1278 (citations omitted); § 300aa-13(a)(1)(B). The Vaccine Act requires Respondent to establish that the factor unrelated to the vaccination is the more likely or principal cause of the injury alleged. Deribeaux v. Sec'y of Health & Hum. Servs., 717 F.3d 1363, 1369 (Fed. Cir. 2013). Such a showing establishes that the factor unrelated, not the vaccination, was “principally responsible” for the injury. See § 300aa-13(a)(2)(B). The factor unrelated must be the “sole substantial factor[;]” therefore, Respondent must establish that the factor unrelated, not the vaccination, actually caused the injury alleged. See de Bazan, 539 F.3d at 1354. V. Discussion In the present case, the parties are unable to agree on any material fact or legal conclusion, save that Petitioner’s Tdap vaccination occurred on October 25, 2016. Petitioner maintains that she suffered a left-sided shoulder injury that satisfies the QAI criteria for a SIRVA. Alternatively, Petitioner also submitted evidence of causation through her expert reports and medical literature. Although not explicitly alleged, one of Petitioner’s experts characterized Petitioner’s shoulder injury as “a significant aggravation of a condition that existed prior to vaccination.” Pet’r’s Ex. 25 at 12. Dr. Srikumaran did not elaborate on this contention aside from conclusions that Petitioner meets the additional factors for significant aggravation. Id. Specifically, Dr. Srikumaran noted that Petitioner was asymptomatic prior to her vaccination and that her current condition is “well documented in the medical records[,]” establishing a clear “significant aggravation[.]” Id. Dr. Cagle, however, disputed the characterization of the claim as on-Table, the timing of onset, and the nature of Petitioner’s symptoms. He also argued that there is an alternate cause for Petitioner’s symptoms that is a pre-existing condition. After a thorough review of the record, I find that Petitioner has not presented preponderant evidence of a Table claim because she is unable to satisfy the QAI criteria. However, Petitioner has submitted evidence of a theory of causation, a logical sequence of cause and effect, and an appropriate temporal relationship for an off-Table shoulder injury. I find that Petitioner has presented preponderant evidence that she suffered an off- Table injury to her left shoulder that was caused by the administration of her Tdap vaccine. A. Table Claim i. History of Pain, Inflammation, or Dysfunction 16 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 17 of 23 Petitioner underwent spinal surgery in 2007, and she also has a history of fibromyalgia, migraines, and seizures. Pet’r’s Ex. 4 at 7. Petitioner’s expert Dr. Srikumaran argued that Petitioner’s pre-vaccination fibromyalgia pain is distinguishable from her alleged shoulder injury because her “fibromyalgia flares were documented to include the areas of the neck and radiating to the base of the skull, along with lower back [ ].” Pet’r’s Ex. 25 at 6. In contrast, Petitioner reported that post vaccination, she suffered severe and intense pain in her left shoulder that “became [,] and [she] experienced weakness, throbbing and some numbness.” Pet’r’s Ex. 7 ¶ 2. Respondent’s expert did not contend that Petitioner complained of shoulder pain during her pre- vaccination treatment for fibromyalgia, although ultimately, Dr. Cagle asserted that “[f]ibromyalgia is a preexisting condition that can explain [Petitioner’s shoulder] symptoms.” Resp’t’s Ex. C at 1. The first QAI criterion specifically refers to “history of pain, inflammation or dysfunction of the affected shoulder[.]” 42 CFR §100.3(c)(10). There is no evidence that Petitioner suffered from left shoulder pain prior to vaccination. Therefore, I find that Petitioner has satisfied the first of the QAI criteria that she had no pre-vaccination history of pain, inflammation, or dysfunction of the affected shoulder. ii. 48-Hour Symptom Onset While it is true that Petitioner consistently related her shoulder pain to her October 25, 2016 Tdap vaccination, it is also true that she did not report her injury to a medical provider for approximately three months post vaccination. Petitioner’s experts presented opinion evidence and medical evidence to explain why a patient would wait for such an extended period of time to seek treatment for the type of severe pain that Petitioner complained of. Petitioner’s personal and witness affidavits are also compelling evidence that Petitioner’s pain was related to her vaccination. However, despite Petitioner’s failure to mention her shoulder pain to her PCP and neurologist during regularly scheduled visits related to her pre-existing conditions, Petitioner’s medical records are not silent on the condition of Petitioner’s shoulder during this time. Dr. Cagle noted that during Petitioner’s visit with Dr. Becker on December 1, 2016, Petitioner underwent “a shoulder exam that demonstrate[d] 5/5 shoulder strength in abduction, internal rotation and external rotation.” Resp’t’s Ex. A at 1 (citing Pet’r’s Ex. 5 at 4). That record noted that Petitioner had decreased ROM (mildly to either side).” Pet’r’s Ex. 5 at 4 (emphasis added). Dr. Becker also noted that Petitioner reported “no joint pain, joint stiffness, [and] no weakness of muscles or joints[.]” Id. at 3. In her affidavit, Petitioner explained that these routine medical visits are only fifteen minutes, that “[t]he pain in [her] shoulder was never mentioned during [their] time together, and that Dr. Becker did not conduct an examination of [her] left shoulder on that day.” Pet’r’s Ex. 11 ¶ 3. Petitioner’s account of her December 1, 2016 medical visit with Dr. Becker is in direct contradiction with the extensive and contemporaneous treater record. Often, petitioners are able to show that medical records contain inaccuracies. This is especially true with respect to the medical and patient history parts of the record, which are often a cut-and-paste from prior visits, and the complaint history, which can be a series of boxes hastily checked post visit. This case contains the results of an examination that Petitioner attested never occurred. Furthermore, Petitioner suggested that her report to Dr. Becker that she was experiencing no joint pain was, unintentionally or otherwise, fabricated. In evaluating whether elements of a claim have been met, 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. Medical records created contemporaneously with the events they describe are generally 17 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 18 of 23 trustworthy because they “contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions,” where “accuracy has an extra premium.” Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378 (Fed. Cir. 2021) (citing Cucuras, 993 F.2d at 1528). This is based on the linked proposition that (i) sick people visit medical professionals; (ii) sick people honestly report their health problems to those professionals; and (iii) medical professionals record what they are told or observe when examining their patients in as accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825 at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) mot. for rev. denied, 142 Fed. Cl. 247, 251-52 (2019), vacated on other grounds and remanded, 809 Fed. Appx. 843 (Fed. Cir. Apr. 7, 2020). However, there is no presumption that medical records are accurate and complete as to all the patient’s physical conditions. Kirby, 997 F.3d at 1383. Where there are inconsistencies, special masters are within their discretion to award contemporaneous medical records greater weight than later conflicting testimony. See Cucuras, 993 F.2d at 1528 (holding that the special master’s reliance on contemporaneous medical records over conflicting oral testimony given after the fact was not arbitrary or capricious); see also Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that the decision of whether to accord greater weight to contemporaneous medical records or later given testimony is “uniquely within the purview of the special master”). Indeed, contemporaneous medical records are generally found to be deserving of greater evidentiary weight than oral testimony – especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also 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), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“It has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)). However, there are situations in which compelling oral 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) (“Written records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent.”) (quoting Murphy, 23 Cl. Ct. at 733)). 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). When witness testimony is offered to overcome the presumption of accuracy afforded to contemporaneous medical records, such testimony must be “consistent, clear, cogent and compelling.” Sanchez, 2013 WL 1880825 at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs., No. 90-2808V, 1998 WL 408611 at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and completeness of medical records, the Court of Federal Claims has listed four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person’s failure to recount to the medical professional everything that happened 18 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 19 of 23 during the relevant time period; (2) the medical professional’s failure to document everything reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. LaLonde v. Sec’y of Health & Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to afford greater weight to contemporaneous medical records or other evidence, such as hearing testimony, there must be evidence that this decision was the result of a rational determination. Burns, 3 F.3d at 417. In the present case, I must weigh Petitioner’s presented lay witness testimony: her personal affidavit and the affidavits of her family members, against the December 1, 2016 medical record from Dr. Becker’s office. Petitioner alleged that she failed to recount her pain to Dr. Becker. However, that still does not explain the results of his physical exam, which are inconsistent with Petitioner’s account of excruciating pain such that “the next day after receiving the shot, [she] was unable to lift or move [her] arm at all without pain.” Pet’r’s Ex. 11 ¶ 2. Furthermore, it is surprising that Petitioner would be experiencing that degree of pain during an exam and not relay her condition to the doctor in real time. This is especially surprising given that Petitioner reported four “episodes of pain and tingling” between her neck and her skull and in her lower back related to her fibromyalgia during this appointment. See Pet’r’s Ex. 5 at 3. There is no assertion that Dr. Becker failed to document Petitioner’s reported condition or that there was an accounting of nonexistent symptoms. That leaves Petitioner’s faulty recollection of the events. See LaLonde, 110 Fed. Cl. at 203–04. I do not see how this record can be reconciled with Petitioner’s described level of shoulder pain that began several weeks prior to this visit and continued beyond her filing of a VAERS report on December 27, 2016. Petitioner stated that she filed the VAERS report because she wanted to “notify someone in the government about the debilitating pain that the shot had caused.” Pet’r’s Ex. 11 ¶ 2. At that point, Petitioner relayed her shoulder pain back to her vaccination, and she was consistent from that point on. There is therefore preponderant evidence that sometime between December 1 and 27, 2016, Petitioner was experiencing severe shoulder pain that she attributed to her vaccination. Petitioner has not established by preponderant evidence that she experienced pain with the specified time-frame of 48 hours. However, Petitioner has established that she experienced her shoulder pain, documented it, and related it back to her vaccination within two months post vaccination. iii. Nature of Symptoms Prior to her vaccination, Petitioner was being treated by her neurologist, Dr. Becker, for migraines and seizures. See generally Pet’r’s Ex. 5. She was also being treated for fibromyalgia. See Pet’r’s Ex. 4 at 7.19 These ailments led to complaints by Petitioner of headaches, back pain, and neck pain, but there is no indication in the record pre vaccination that she was treated for shoulder pain. Post vaccination, Petitioner reported to her orthopaedist on January 26, 2017, that in addition to her shoulder pain, she was suffering from back pain. Pet’r’s Ex. 2 at 7. Notably, she was assessed with left shoulder impingement. Id. at 27. During a physical therapy session on June 13, 2017, Petitioner described the pain “radiating into her neck and into her neck and down into her elbow.” Id. at 17. This is consistent with Dr. Srikumaran’s opinion that Petitioner’s “shoulder pathology is affecting the surrounding musculature and causing increased pain in the adjacent 19 It does not appear that Dr. Becker generally treated Petitioner’s fibromyalgia. See generally Pet’r’s Ex. 5. 19 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 20 of 23 tissues of the cervical spine and upper arm to her elbow.” See Pet’r’s Ex. 25 at 7. Petitioner had complaints of pain in areas other than her shoulder, and these complaints were specifically connected to her shoulder pain. Therefore, she is unable to establish by preponderant evidence that her pain is limited to the shoulder where she received her injection. iv. Lack of Alternative Condition The last QAI criterion prohibits compensation for a Table SIRVA if any alternative condition is present that could explain Petitioner’s symptoms. Petitioner is also unable satisfy this requirement. After a review of Petitioner’s medical records, affidavits, expert reports, and medical literature, I find that there is preponderant evidence that Petitioner’s post-vaccination symptoms could be explained by fibromyalgia. Fibromyalgia is defined by Dorland’s Illustrated Medical Dictionary as “pain and stiffness in the muscles and joints that either is diffuse or has multiple trigger points.” Dorland’s at 696. Petitioner’s fibromyalgia would explain Petitioner’s shoulder symptoms by nature of the condition. In fact, Drs. Srikumaran and Cagle agreed that it is often difficult when treating patients to discern whether cervical pain or shoulder pain came first, as the two areas are connected and interrelated. While it is not clear that Petitioner’s shoulder pain was caused by her fibromyalgia, the existence of her fibromyalgia precludes her from establishing that she suffered from a Table SIRVA. Petitioner has not presented preponderant evidence that she suffered from a Table SIRVA. Table claims carry a presumption because they are unhindered by previous similar injury, additional symptoms indicative or other conditions, and timing concerns. They are streamlined, and often resolve without medical expert reports or opinions to rule out other diagnoses. In cases where other issues are present, cases proceed more deliberately. It is Petitioner’s burden to overcome those complications using the parameters set forth in Althen. While it is true that the QAI criteria set the parameters for a Table claim, failure to meet the standard for presumption does not disqualify Petitioner’s assertion that she did in fact suffer a vaccine-caused shoulder injury, notwithstanding her fibromyalgia diagnosis. In this case, Petitioner has presented evidence that her shoulder injury was caused-in-fact by her vaccination. Therefore, I will complete an Althen analysis. B. Causation-in-fact i. Althen Prong One: General Causation Theory SIRVA is a well-known phenomenon in the Program, but petitioners must present a causation theory in all off-Table cases. Dr. Srikumaran relied on the filed articles and echoed Dr. Colwell’s explanation of the mechanics of a shoulder injury caused by vaccination. He concisely summarized that injury results from “an immune mediated response of inflammation related to antigens injected into the bursal tissue, likely from poor technique related to various factors (site, needle choice, angle and location of injection, not accounting for patient size variation).” Pet’r’s Ex. 25 at 11. Dr. Colwell provided medical literature support via the 2010 Atanasoff et al. article that “provides support for the theory that antigenic material from the vaccine that is injected into synovial tissues results in an immune mediated inflammatory reaction.” Pet’r’s Ex. 19 at 2 (citing Pet’r’s Ex. 21 at 1). The Bodor and Montalvo article also cautioned against vaccinations “in the upper third of the deltoid muscle,” and they identified subacromial bursitis, bicipital tendonitis, 20 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 21 of 23 and adhesive capsulitis as consistent a diagnosis of “vaccination-related shoulder dysfunction.” Pet’r’s Ex. 20 at 3. Dr. Cagle did not directly contradict this reasoning. See generally Resp’t’s Exs. A–C. Petitioner has presented preponderant evidence that the Tdap vaccine can cause an off-Table shoulder injury related to vaccination, and she has therefore satisfied prong one of Althen. ii. Althen Prong Two: Specific Causation Petitioner stated that she believes her Tdap vaccine was administered in her upper left shoulder, and her husband and sister asserted that Petitioner reported that her Tdap vaccine was administered higher in her left arm than the vaccines she received in her right arm. Pet’r’s Ex. 7 ¶ 1; Pet’r’s Ex. 13 at 1; Pet’r’s Ex. 15 at 1. Petitioner recounted increasing pain in her left shoulder that decreased her range of motion and made it impossible to perform everyday tasks. See Pet’r’s Ex. 7 ¶ 6. Petitioner did not report her pain immediately to her doctor, and her medical record documents a normal shoulder exam approximately five weeks post vaccination. However, Petitioner did begin to seek treatment for her shoulder pain, and she consistently described her injury as vaccine-caused, even submitting a VAERS report. Her treaters administered steroid injections, and Petitioner underwent physical therapy based on a shoulder impingement diagnosis before she was referred for shoulder surgery. Although Petitioner’s treaters did not attribute her injury to her vaccination, neither did they attribute it to fibromyalgia. Her symptoms and course of treatment are consistent with a shoulder injury related to vaccination. Dr. Cagle identified preponderant evidence in the record that Petitioner suffered wear-and-tear injury from old age. However, there is nothing in the record that suggests that her osteoarthritis was symptomatic prior to her vaccination. Additionally, there is no evidence presented that Petitioner could not suffer from osteoarthritis that was further irritated by her vaccine. Petitioner has presented preponderant evidence that her vaccine was administered higher in the upper left arm, near the bursa or rotator cuff tendon leading to an inflammatory reaction and pain. Although Dr. Srikumaran briefly referenced significant aggravation, he only highlighted that Petitioner was asymptomatic pre vaccination and that, despite no prior history of shoulder complaints, Petitioner required surgery post vaccination. These facts are not enough to establish a significant aggravation claim. Petitioner’s but-for causation claim is stronger, given that Petitioner is alleging, based on the pleadings and the injury mechanism, that the new symptom/injury was caused by the vaccine injection. iii. Althen Prong Three: Temporal Relationship During the Table claim analysis, I found that Petitioner has not presented preponderant evidence that her injury manifested within 48 hours of her vaccination. The record contains preponderant evidence that Petitioner was examined by a treater approximately five weeks post vaccination, and her neurologist found normal motor strength, abduction, and rotation. Pet’r’s Ex. 5 at 4. Furthermore, the medical record noted that Petitioner did not report joint pain. Id. at 3. It is possible that Petitioner could have been experiencing pain at that time that did not rise to the level of manifesting during her exam, although this would be inconsistent with Petitioner’s description of her pain as severe. It is also possible that as Petitioner stated, she did not discuss her shoulder pain at that time because she was there to treat other conditions. She described her other conditions as serious, but it is curious why her inability to “do any of [her] daily duties,” including cooking, 21 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 22 of 23 cleaning, dressing, and caring for her disabled son would not be considered serious. See Pet’r’s Ex. 7 ¶ 6. As discussed earlier, I find that Petitioner presented preponderant evidence that she was experiencing shoulder pain within two months of her vaccination. However, the medical record does not support severe shoulder pain prior to her December 1, 2016 doctor’s visit. The Arias article noted that although six of eight of the patients in the study experienced pain within the first four to seven days, two patients reported their pain to medical providers within two months. Pet’r’s Ex. 23 at 3. Dr. Cagle did not dispute that off-Table SIRVA pain could manifest within two months post vaccination. The Arias article also describes that pain as increasing in severity. Id. These cases are more consistent with Petitioner’s, where she described immediate pain, but the record does not provide contemporaneous evidence of that until several weeks later, within two months. Petitioner has presented preponderant evidence in the form of medical literature that explains how the timing and presentation of her shoulder pain related to vaccination is appropriate. C. Alternative Causation Dr. Cagle suggested that Petitioner’s fibromyalgia could be the cause-in-fact of Petitioner’s shoulder’s symptoms. See Resp’t’s Ex. C at 1. However, Dr. Cagle did not adequately explain the shift in Petitioner’s fibromyalgia pain from her neck and back to her left shoulder. He also did not identify in the record where Petitioner conflates her fibromyalgia pain with the shoulder pain that she alleges is vaccine-caused. There is much debate between the experts on the significance of a lack of bursal fluid or signs of inflammation. Dr. Cagle argued that without an increase in bursal fluid, Petitioner lacks the necessary signs of post-vaccination inflammation. However, he did not address Petitioner’s bursectomy, which provides a strong indication of bursal abnormality. There also appears to be a chicken versus egg conundrum in terms of the shoulder pain exacerbating cervical spine pain or vice versa. Dr. Cagle implied that if Petitioner has fibromyalgia or any chronic diffuse pain condition, she cannot ever establish that post-vaccination shoulder pain is related to vaccination. In this case, I find that Petitioner was able to establish that she experienced symptoms that are not consistent with her previously reported fibromyalgia pain. Another potential cause identified by Dr. Cagle was the natural wear-and-tear of osteoarthritis. Again, he did not provide explanation as to why Petitioner’s asymptomatic osteoarthritis became painful and severe enough to require surgery shortly after she received a vaccination. I do not find that the asserted alternative causes fit Petitioner’s clinical picture by a preponderant standard. Therefore, I do not find that Respondent has overcome Petitioner’s causation prima facie case. VI. Conclusion After considering the entire record, Petitioner has established by preponderant evidence that she suffered from an off-Table shoulder injury as the result of her October 25, 2016 Tdap vaccination. Accordingly, Petitioner is entitled to compensation. This case shall proceed to damages.20 IT IS SO ORDERED. 20 In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter judgment accordingly. 22 Case 1:17-vv-01890-UNJ Document 52 Filed 11/01/23 Page 23 of 23 s/Herbrina D. Sanders Herbrina D. Sanders Special Master 23 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_17-vv-01890-1 Date issued/filed: 2025-02-21 Pages: 12 Docket text: PUBLIC DECISION (Originally filed: 1/14/2025) regarding 70 DECISION of Special Master. Signed by Special Master Herbrina D S Young. (krt) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 1 of 12 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: January 14, 2025 * * * * * * * * * * * * * * * * LORRIE JONES, * No. 17-1890V * Petitioner, * Special Master Young * v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for Petitioner. Mitchell Jones, U.S. Department of Justice, Washington, DC, for Respondent. DECISION AWARDING DAMAGES1 On December 6, 2017, Lorrie Jones (“Petitioner”) filed a petition for compensation under the National Vaccine Injury Compensation Program (“Vaccine Program” or “Program”). 42 U.S.C. § 300aa-10 to 34 (2018). Petitioner alleged that she suffered “injuries, including [s]houlder [i]njury [r]elated to [v]accine [a]dministration (“SIRVA”), resulting from adverse effects of a tetanus/diphtheria (“Tdap”) vaccination she received on October 25, 2016.” Pet. at 1, ECF No. 1. I resolved Petitioner’s claim on the record and issued a Ruling on Entitlement on September 29, 2023. ECF No. 51. The case proceeded to damages, but the parties were unable to make progress on an amount for pain and suffering.2 For the reasons discussed below, and after considering the entire record and argument from the parties, I find that Petitioner is entitled to $1,590.13 in out- of-pocket expenses and a total pain and suffering award of $125,000.00. I. Relevant Procedural History Due to Petitioner’s SIRVA allegation, Petitioner’s case was originally assigned to the Chief Special Master and the special processing unit (“SPU”). ECF No. 4. Respondent filed his Rule 1 Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 Respondent does not contest the amount of out-of-pocket expenses requested. 1 Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 2 of 12 4(c) Report arguing that compensation is not appropriate in this case on November 1, 2018. Resp’t’s Report at 1, ECF No. 20. The case was reassigned to me on April 9, 2019. ECF No. 28. On September 11, 2019, Petitioner filed her first expert report from Clifford Colwell, Jr., M.D. Pet’r’s Ex. 16, ECF No. 34. Respondent filed his first expert report from Paul Cagle, M.D. on May 1, 2020. Resp’t’s Ex. A, ECF No. 40-1. On September 8, 2020, Petitioner filed her first supplemental expert report from Dr. Colwell, along with medical literature. Pet’r’s Exs. 19–24, ECF No. 44. Respondent filed his first supplemental expert report from Dr. Cagle on January 11, 2021. Resp’t’s Ex. B, ECF No. 45-1. Petitioner filed an expert report from Uma Srikumaran, M.D. on March 29, 2021, along with medical literature. Pet’r’s Exs, 25–36, ECF No. 46. Respondent responded with a second supplemental report from Dr. Cagle on August 24, 2021. Resp’t’s Ex. C, ECF No. 49-1. On November 29, 2021, Petitioner filed a supplemental expert report from Dr. Srikumaran, along with medical literature. Pet’r’s Exs. 37–42, ECF No. 50. Respondent indicated via email on February 10, 2022, that he did not intend to file an additional expert report. Informal Comm., docketed Feb. 11, 2022. I resolved Petitioner’s claim on the record and issued a Ruling on Entitlement on September 29, 2023. ECF No 51. The case has been in the damages phase since then. ECF No. 53. On August 1, 2024, I ordered the parties to brief the issue of damages as there had been no progress. ECF No. 65. It was noted that Respondent had failed to substantively participate in settlement negotiations. Id. Petitioner filed a brief on damages as well as a supplemental affidavit, medical records, and evidence of out-of-pocket expenses on September 3, 2024. Pet’r’s Br., ECF No. 66; Pet’r’s Exs. 43–45, ECF No. 67. Respondent filed his brief on October 3, 2024, and Petitioner filed a reply brief on November 4, 2024. Resp’t’s Br., ECF No. 68; Pet’r’s Reply, ECF No. 69. This matter is now ripe for adjudication on the issue of damages. II. Medical History On October 25, 2016, Petitioner received the Tdap vaccine at issue in this case in her left shoulder. Pet’r’s Ex. 1 at 1. She also received influenza and pneumococcal conjugate vaccines in her right shoulder. Id. She was 51 years old at the time of her vaccinations. Id. Petitioner’s first medical visit post vaccination was with her primary care provider (“PCP”) on November 15, 2016. Pet’r’s Ex. 2 at 3. She was seen for routine lab work based on her medical history and did not mention shoulder pain or any other acute complaints. See id. at 3–4. On December 1, 2016, Petitioner saw neurologist Michael Becker, M.D. with chief complaints of migraine without aura and generalized convulsive epilepsy. Pet’r’s Ex. 5 at 1. Specifically, Petitioner reported worsening headaches “the past [four to five] months,” that manifested every two weeks as throbbing and pressure. Id. at 3. Petitioner also reported that her fibromyalgia manifested as “[three]-day flare-ups of pain once every [four] weeks lately.” Id. She described “[four] episodes of pain and tingling going up to the neck to the base of her skull, and also in the lower back during flare-ups.” Id. The medical record contained a detailed list of potential concerns. See id. Of note, Petitioner reported fatigue, nausea or vomiting, muscle pain or cramps and back pain. Id. She reported “no joint pain, no joint stiffness, no weakness of muscles or joints, [and] no cold extremities.” Id. Upon examination, Dr. Becker noted “[c]ervical [s]pine: 2 Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 3 of 12 no tenderness and decreased [range of motion (“ROM”)] (mildly on lateral rotation to either side).” Id. at 4. An extensive motor examination included the following left upper extremity findings: normal motor strength, abduction 5/5, internal rotation 5/5, and external rotation 5/5. Id. Petitioner saw orthopedist Donnis Harrison, M.D. approximately three months post vaccination on January 26, 2017. Pet’r’s Ex. 2 at 5. Petitioner self-referred with complaints of constant aching and throbbing in her left shoulder that was mild to moderate in severity but that “[was] aggravated by range of motion and certain movements.” Id. She reported that her “shoulder pain began after receiving the T[dap] immunization.” Id. Petitioner further reported nonspecific joint pain, joint swelling, muscular weakness, muscle pain, back pain, and limitation of motion. Id. at 7. Upon inspection, Petitioner’s left shoulder was “tender[] to palpation over lateral aspect deltoid,” and she exhibited evidence of “pain with abduction past 90 degrees, active internal rotation: limited to sacrum, active forward elevation: > 150 degrees, [and] active external rotation: 45 to 65 degrees.” Id. Neer and Hawkins tests both also yielded positive results. Id. Dr. Harrison assessed Petitioner with “[i]mpingement syndrome of shoulder, left.” Id. at 8. Petitioner was given a steroid injection and prescribed physical therapy. Id. On January 31, 2017, Petitioner began physical therapy with Erin Moody, P.T. Pet’r’s Ex. 3 at 889. Petitioner reported to P.T. Moody that she first experienced “pain in the left shoulder following an injection she received by her pharmacy on October 25, 2016.” Id. She explained that the “pain and stiffness gradually progressed so she made an appointment with [an orthopedist].” Id. Petitioner noted that the steroid injection she received from Dr. Harrison helped, and P.T. Moody provided her with a home exercise plan. Id. at 889–90. During an emergency room visit on April 22, 2017, for unrelated bladder pain and diarrhea, Petitioner was noted to have “[g]ood range of motion in all major joints.” Id. at 775, 778. Petitioner returned to Dr. Harrison approximately five months after her evaluation with P.T. Moody, on June 13, 2017. Pet’r’s Ex. 2 at 17. Petitioner complained of renewed and more severe pain, following the month of relief that the steroid injection and physical therapy had provided. Id. She described the pain as “radiating into her neck and down into her elbow.” Id. Dr. Harrison administered a second steroid injection. Id. at 19–20. He also ordered magnetic resonance imaging (“MRI”), which showed “[m]oderate supraspinatus tendinosis with a chronic low-grade partial thickness bursal surface tear through the proximal supraspinatus tendon,” as well as mild- to-moderate acromioclavicular (“AC”) joint osteoarthrosis, moderate intra-articular biceps tendinosis, mild glenohumeral arthrosis, and small joint effusion. Id. Dr. Harrison saw Petitioner on July 7, 2017, for follow-up in light of her MRI results. Id. at 27. He diagnosed her with impingement syndrome of the left shoulder, osteoarthritis of the left shoulder and AC joint, and an incomplete tear of the left rotator cuff. Id. at 29. On July 25, 2017, Dr. Harrison surgically repaired Petitioner’s left rotator cuff partial thickness tear. Id. at 31–32. He also performed extensive debridement of the bursal surface rotator cuff, as well as a distal clavicle resection and subacromial decompression with a partial acromioplasty. Id. at 31. The operative report noted that “a complete bursectomy was performed.” Id. at 32. On August 1, 2017, Petitioner was seen by Rachel Hines, P.T., for a physical therapy evaluation to rehabilitate her shoulder after surgery. Pet’r’s Ex. 6 at 1. Petitioner reported that her 3 Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 4 of 12 shoulder pain began after receiving a vaccine in October 2016. Id. Petitioner returned to Dr. Harrison on August 14, 2017, for a post-surgery follow-up. Pet’r’s. Ex. 2 at 34. She complained of increased left shoulder pain and numbness radiating down her arm. Id. Petitioner was prescribed a Medrol dose pack and advised to alter her activity. Id. at 36. Dr. Harrison believed that Petitioner’s ulnar nerve may have been irritated by her sling. Id. He advised Petitioner to follow up in two months. Id. On October 5, 2017, Petitioner completed physical therapy. Pet’r’s Ex. 6 at 51. Her discharge record noted that she was no longer functionally limited and was able to complete all of her movements without deviation and all activities of daily living with good strength. Id. at 51–52. On January 8, 2018, five months after surgery, Petitioner returned to Dr. Harrison for left shoulder pain. Pet’r’s Ex. 45 at 12. Petitioner reported aching, but that her symptoms had improved since her last visit in October 2017. Id. It was also noted the physical therapy had helped improve her symptoms. Id. Physical examination of her left upper extremity revealed no tenderness or swelling, no joint instability, full ROM and full strength, and negative Neer and Hawkins tests. Id. at 14. The assessment was shoulder bursitis. Id. Dr. Harrison recommended Petitioner do gentle stretches and exercises of the shoulder and modify activities as needed. Id. at 14–15. III. Petitioner’s Statements3 In her initial November 10, 2017 declaration, Petitioner described “enormous pain in the area [of her upper left shoulder] where [her vaccine] was injected.” Pet’r’s Ex. 7 at ¶ 1. She wrote that she thought the pain would go away in time, but “hours turned into days, then weeks[,] and then months.” Id. Petitioner described her appointment with Dr. Harrison on January 26, 2017. Id. at ¶ 2. Despite the steroid injection and physical therapy exercises, “the pain became worse[,] and [she] experienced weakness, throbbing and some numbness.” Id. After several months, Petitioner made another appointment for June 13, 2017, which ultimately led to shoulder surgery. Id. at ¶ 3. Petitioner described physical therapy following her surgery and noted that it helped a lot before she was discharged. Id. at ¶ 5. She noted that her shoulder continued hurting sometimes, but she said before the surgery, she “could not do any of [her] daily duties in the house.” Id. at ¶ 6. Petitioner explained that she could not “cook, clean, do the laundry, raise [her] arms to put on clothes/bra, wash [her] hair, get into or out of [her] bathtub, or do the dishes.” Id. She continued that she is a homemaker and responsible for the care of her disabled son and also cares for her ailing mother. Id. Petitioner “know[s] that [her] shoulder will never be 100 percent,” and she was still unable to “reach all the way behind [her] back.” Id. She stated that because of her pre-existing fibromyalgia, “the pain from her shoulder had a huge impact on [her].” Id. at ¶ 7. This includes increased anxiety. Id. In Petitioner’s next declaration, signed January 13, 2019, she reiterated that she felt “intense pain” at the time of the injection. Pet’r’s Ex. 11 at ¶ 1. She continued that “[b]y the next day the pain was so severe that [she] felt like [her] arm was about to fall off.” Id. Petitioner noted that she has “several serious medical conditions that are unrelated to the pain in [her] left shoulder.” Id. at ¶ 2. She noted that the record from her November 15, 2016 PCP appointment does not mention the pain from her left shoulder or the “several of the other chronic medical conditions [she] suffered from.” Id. Petitioner wrote: 3 Only the portions relevant to damages are discussed herein. 4 Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 5 of 12 The lack of notes related to [her] shoulder should not be interpreted as [her] not having shoulder pain at that time. The fact is that [her] pain was severe and intense. By the next day after receiving the shot, [she] was unable to lift or move [her] arm at all without pain. The pain was so bad that on December 27, 2016, [she] filed a [Vaccine Adverse Event Reporting System (“VAERS”)] report. Id. Petitioner’s VAERS report has an adverse event onset date of October 26, 2016. Id.; Pet’r’s Ex. 12 at 1. She stated that she filed the report because she wanted to “notify someone in the government about the debilitating pain that the shot had caused.” Pet’r’s Ex. 11 at ¶ 2. She stated that she “filed that VAERS report long before [she] ever knew anything about filing a claim in the Vaccine Program.” Id. Petitioner submitted a supplemental declaration specific to ongoing pain. Pet’r’s Ex. 43 at ¶ 1. Petitioner again reiterated that upon receiving the Tdap vaccine on October 25, 2016, she felt “horrible, sharp pain” as soon as he received the injection. Id. at ¶ 2. She realized she needed help and saw Dr. Harrison where she was prescribed physical therapy, steroids, muscle relaxers, and an MRI. Id. at ¶ 3. Eventually it was determined that only surgery would correct the problem. Id. Petitioner averred the surgery itself and the postoperative time “was a different kind of agony and pain.” Id. She recalled going through physical therapy was “extremely difficult. The pain, weakness, nausea, light headedness, depression[,] and anxiety were at an all-time high.” Id. Although her postoperative time ended in 2017, she sought help from Dr. Harrison again in January 2018 for left shoulder pain. Id. She received either a steroid injection or a steroid dose pack. Id. Since her last appointment with Dr. Harrison, she fears she will need to return to her orthopedic doctor for her “acute pain flare-ups” where they could discover the hardware placed in her surgery could have slipped or something else has occurred. Id. at ¶ 4. These “flare-ups” come at any time, day or night, and affect her sleep. Id. As of the date of this declaration, August 28, 2024, Petitioner continues to experience weakness in her left arm on a daily basis. Id. at ¶ 5. She has aching and throbbing in her shoulder approximately once per week and she takes ibuprofen daily to alleviate the pain. Id. Doctors have cautioned her about taking ibuprofen because she has fatty liver disease, but it is “the only thing that calms things down” for her. Id. Petitioner has “trouble holding onto pots and pans, dishes and moving things in [her] kitchen. [She] love[s] to cook but need[s] the assistance of [her] husband quite often if [she] can’t hold something.” Id. Petitioner is also now fearful of getting other injections and vaccinations. Id. at ¶ 6. In addition to Petitioner’s personal statements, she submitted declarations from her husband, signed April 2, 2019, and her mother and sister, signed April 12, 2019. Pet’r’s Exs. 13– 15. All three of the declarations focus on the onset of Petitioner’s pain. IV. Arguments Regarding Damages a. Petitioner’s Argument In Petitioner’s motion for damages, she requested $1,590.13 to cover past unreimbursed expenses (out-of-pocket expenses) and an award for past pain and suffering in the amount of 5 Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 6 of 12 $160,000.00.4 Pet’r’s Br. at 1. Petitioner focused on several factors for consideration, including multiple medical examinations and an MRI, arthroscopic shoulder surgery, at least two steroid injections, at least 18 physical therapy sessions, her pain years after vaccination, and the impact on her quality of life and mental health. Id. at 12. She cited other Program cases where damages were awarded at a comparable level to what Petitioner seeks here. Id. at 12–16. For example, Petitioner compared the facts of her case to Reed v. Sec’y of Health & Hum. Servs., No. 16-1670V, 2019 WL 1222925 (Fed. Cl. Spec. Mstr. Feb. 1, 2019) and argued that the cases are similar and therefore she should be awarded $160,000.00 in pain and suffering like the petitioner in Reed. Id. at 12–13. There, Ms. Reed was a single mother working full-time at the time of her injury. Reed, 2019 WL 1222925, at *10. She suffered severe shoulder pain from the time of vaccination until her shoulder surgery, a period of approximately six months. Id. at *15– 16. Ms. Reed remained in physical therapy following surgery (18 postoperative physical therapy sessions), and while her range of motion improved, her pain had not fully subsided two- and one- half years post vaccination. Id. During his time, she lost the ability to independently do activities of daily living and could not lift or play with her young grandsons. Id. at *10. Binette v. Sec’y of Health & Hum. Servs., No. 16-0731V, 2019 WL 1552620 (Fed. Cl. Spec. Mstr. July 8, 2019) was a non-surgical SIRVA case where the petitioner was awarded $130,000.00 in past pain and suffering. Pet’r’s Br. at 13–14. There, the petitioner had moderate to severe pain and episodes of severe pain for approximately two years after her injury, followed by a flare-up that lasted approximately 11 months. Binette, 2019 WL 1552620, at *13–14. She had two MRIs, five cortisone injections and multiple rounds of physical therapy but did not have surgery. Id. Petitioner here argued her case is more severe than Binette and should be awarded a higher amount of past pain and suffering than awarded in Binette because Petitioner experienced pain for longer than Ms. Binette, even with surgical intervention, and had more extensive treatment. Pet’r’s Br. at 14. Similarly, Dawson-Savard v. Sec’y of Health & Hum. Servs., No. 17-1238V, 2020 WL 4719291 (Fed. Cl. Spec. Mstr. July 14, 2020) was a nonsurgical SIRVA case where the petitioner was awarded $130,000.00 in past pain and suffering. Id. at 15. Unlike Ms. Dawson-Savard, Petitioner had to undergo surgical intervention, as well as physical therapy “to only obtain a sliver of the relief that Ms. Dawson-Savard was able to achieve.” Id. Therefore, Petitioner argued her award should be higher than that in Dawson-Savard. Id. In Rafferty v. Sec’y of Health & Hum. Servs., No. 17-1906V, 2020 WL 3495956 (Fed. Cl. Spec. Mstr. May 21, 2020) the petitioner was awarded $127,500.00 for past pain and suffering. Id. at 15. There, the petitioner had moderate to severe shoulder pain and underwent surgery. Rafferty, 2020 WL 3495956, at *15. After surgery she attended 21 physical therapy sessions. Id. at *16. The Chief Special Master noted that while Ms. Rafferty’s pain continued after surgery, she had “significant improvement” after surgery and that “[a]ny pain and suffering experienced by [Ms. Rafferty] after this point appears to be minimal. It certainly was not sufficient enough to require further medical care.” Id. Petitioner here argued she should be awarded more than what 4 Petitioner did not request an award of future pain and suffering. 6 Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 7 of 12 was awarded in Rafferty because Petitioner experienced a higher level of ongoing pain years after her surgery and has continued disruptions in her daily activities. Pet’r’s Br. at 15–16. In her reply to Respondent, Petitioner pointed out that Respondent did not contest the duration and severity of Petitioner’s injury or deny that Petitioner received extensive treatment. Pet’r’s Reply at 4. Petitioner reiterated that in addition to the medical records, the affidavits and declarations submitted provide important context. Id. For example, in her supplemental affidavit submitted on August 28, 2024 (almost eight years post vaccination), Petitioner stated that she still “experience[s] weakness in [her] left arm on a daily basis.” Id. at 5 (quoting Pet’r’s Ex. 43 at ¶ 5). Petitioner argued the cases cited by Respondent, in which a gap in treatment warranted a lower award of pain and suffering, are not comparable to the case at bar. Id. at 6 (citing Shelton v. Sec’y of Health & Hum. Servs., No. 19-279V, 2021 WL 2550093 (Fed. Cl. Spec. Mstr. May 21, 2021); Crawford v. Sec’y of Health & Hum. Servs., No. 19-0544V, 2024 WL 1045147 (Fed. Cl. Spec. Mstr. Feb. 5, 2024)). Two months after her vaccination, Petitioner filed a VAERS report noting her shoulder pain began within 25 hours of vaccination. Id. at 7. One month later, Petitioner saw Dr. Harrison for her shoulder pain. Id. And four days later, she began physical therapy. Id. Over the following months, Petitioner had multiple follow-up examinations and underwent surgery just eight months after her vaccination. Id. Petitioner contended the “record is clear that any treatment gaps in this case pale in comparison to those which were present in Shelton and Crawford.” Id. Moreover, Petitioner argued the severity and longevity of pain the petitioners experienced in Shelton and Crawford are distinguishable from Petitioner’s pain here. Id. at 8–9. b. Respondent’s Argument Respondent did not contest the $1,590.13 in out-of-pocket expenses requested by Petitioner. Resp’t’s Br. at 2 n.1. Respondent argued that Petitioner’s requested award of $160,000.00 is excessive. Id. at 2. But rather than recommending a specific dollar amount for the pain and suffering award, Respondent stated that Petitioner’s “overall injury was severe/unique, and an award consistent with awards in other cases of that nature would be reasonable, fair, and appropriate.” Id. at 10. Respondent proposed the Court should consider the 1) circumstances, 2) physical examinations, and 3) treatment/prognosis in determining a pain and suffering award in severe/surgical/unique cases. Id. at 12–14. For support, he cited SIRVA cases involving surgery or “special extenuating circumstances” that awarded more than $95,000.00 in pain and suffering. Id. at 13. In Shelton, the petitioner did not obtain treatment for five months after her vaccination, and then did not obtain any further treatment until over three months later. 2021 WL 2550093, at *7. Ms. Shelton’s SIRVA was “moderately severe,” and treatment involved an MRI, three cortisone injections, 26 physical therapy sessions, and surgery. Id. After her post-surgical physical therapy sessions, Ms. Shelton met all of her milestones and did not seek further treatment. Id. The Chief Special Master observed that “the fact that petitioner could cope with 7 Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 8 of 12 her injury for such a long period of time counsels in favor of a lower pain and suffering award.” Id. The petitioner was awarded $97,500.00 in pain and suffering. Id. at *9. Similarly, in Crawford, the petitioner did not seek treatment until four months after vaccination—and thereafter, there was a 20-month gap treatment. 2024 WL 1045147, at *23–24. Ms. Crawford had an MRI, three steroid injections, 65 physical therapy sessions, and surgery. Id. at *23. She reported she still experienced pain even after all of her treatment. Id. The Chief Special Master noted that Ms. Crawford’s gaps in treatment were “more reflective of a less-serious injury than the claimant’s personal proclivities with respect to medical care generally.” Id. at *24. The petitioner was awarded $105,000.00 in pain and suffering. Id. at *25. Respondent also cited Meyers v. Sec’y of Health & Hum. Servs., No. 20-779V, 2024 WL 706877 (Fed. Cl. Spec. Mstr. Jan. 12, 2024) in which the petitioner was awarded $125,000.00 for pain and suffering. Resp’t’s Br. at 14. There, the petitioner had two MRIs, four steroid injections, 21 physical therapy sessions, arthroscopic surgery, and her injury substantially resolved within 16 months. Id.; Meyers, 2024 WL 706877, at *4. Relying primarily on Shelton and Crawford, Respondent argued that significant delays in treatment and/or gaps in treatment signal a mild nature of injury and thus warrant a lower award of pain and suffering. Id. at 11. Like the petitioners in Shelton and Crawford, Respondent stated Petitioner here “had a significant, three-month delay before presenting to Dr. Harrison with complaints of left shoulder pain.” Id. at 14. But because Petitioner here received less injections and underwent less physical therapy than the petitioners in Shelton and Crawford, Respondent proposed it would be appropriate for Petitioner to receive a lower amount of pain and suffering than what was awarded in Shelton and Crawford. Id. Respondent did not respond to the cases cited by Petitioner. V. Legal Standard Compensation awarded pursuant to the Vaccine Act may include an award “[f]or actual and projected pain and suffering and emotional distress from the vaccine-related injury, . . . not to exceed $250,000.” § 15(a)(4). There is no precise 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: 1) awareness of the injury; 2) severity of the injury; and 3) duration of the suffering. I.D., 2013 WL 2448125, at *9 (quoting McAllister v. Sec’y of Health & 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)). A special master may also look to prior pain and suffering awards to aid in the resolution of the appropriate amount of compensation for pain and suffering in each 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 8 Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 9 of 12 in other cases as an aid in determining the proper amount of damages in this case”). And, of course, a special master may rely on his or her own experience adjudicating similar claims. Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (noting that Congress contemplated that 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, criticizing this as constituting “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 590. Instead, he found that pain and suffering should be assessed 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, applying the statutory cap only thereafter. Id. at 595. VI. Prior SIRVA Compensation a. Data Regarding Compensation in SPU SIRVA Cases SIRVA cases have an extensive history of informal resolution within the SPU. As of July 1, 2024, 4,138 SPU SIRVA cases have resolved since the inception of the SPU ten years before. Compensation has been awarded in the vast majority of cases (4,016), with the remaining 122 cases dismissed. Although this case was ultimately removed from the SPU, consideration of the SPU compensated cases can provide some insight on an appropriate damages award. Of the 4,138 compensated cases, 2,308 SPU SIRVA cases were the result of a reasoned ruling that the petitioner was entitled to compensation (as opposed to an informal settlement or concession). In only 235 of these cases was the amount of damages determined by a special master in a reasoned decision. The written decisions setting forth such determinations, prepared by neutral judicial officers (the special masters themselves), provide the most reliable precedent setting forth what similarly-situated claimants should also receive. 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). b. Pain and Suffering Awards in Reasoned Decisions In the 235 SPU SIRVA cases in which damages were the result of a reasoned decision, compensation for a petitioner’s actual or past pain and suffering varied from $35,000.00 to $215,000.00, with $85,000.00 as the median amount. Only ten of these cases involved an award for future pain and suffering, with yearly awards ranging from $250.00 to $1,500.00. 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 9 Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 10 of 12 significant pain is often evidenced by a petitioner’s delay in seeking treatment—over six months in one case. In cases with more significant initial pain, petitioners usually experienced this greater pain for three months or less. Most petitioners displayed only mild to moderate limitations in ROM. 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 mild to moderate SIRVAs usually resolved after one to two cortisone injections and two months or less of physical therapy. None required surgery. Except in one case involving very mild pain levels, the duration of the SIRVA injury ranged from six to thirty months, with most petitioners averaging approximately nine months of pain. Although some petitioners asserted residual pain, the prognosis in these cases was positive. Cases with higher awards for past pain and suffering involved petitioners who suffered more significant levels of pain and SIRVAs of longer duration. Most of these petitioners subjectively rated their pain within the upper half of a ten-point pain scale and sought treatment of their SIRVAs more immediately, often within thirty days of vaccination. All petitioners with significant pain also experienced moderate to severe limitations in ROM. 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—occasionally spanning several years—and multiple cortisone injections, were required in these cases. VII. Appropriate Compensation for Petitioner’s Pain and Suffering In this case, awareness of the injury is not disputed. The record reflects that at all times Petitioner was a competent adult with no impairments that would impact her awareness of her injury. Therefore, I will address the remaining factors to be considered when determining an award for pain and suffering: the severity and duration of Petitioner’s injury. A review of her medical records reveals that from the date of vaccination on October 25, 2016, until her surgery on July 25, 2017, a period of approximately eight months, Petitioner suffered from a moderate SIRVA. While Petitioner did not immediately seek medical attention after the alleged onset of her SIRVA and did not report shoulder pain or show signs of reduced ROM to her PCP and neurologist five weeks post vaccination, she submitted a VAERS report two months after her vaccination claiming onset was within 25 hours of vaccination, or October 26, 2016. One month after submitting the VAERS report and three months after vaccination, on January 26, 2017, Petitioner saw orthopedist Dr. Harrison for shoulder pain that began after vaccination. Petitioner received a steroid injection and began physical therapy. Despite waiting three months to seek medical attention, upon doing so, Petitioner regularly sought treatment for her SIRVA with no substantial gaps in treatment. After a second steroid injection and an MRI, surgical intervention was deemed necessary. She was diagnosed with impingement syndrome of the left shoulder, osteoarthritis of the left shoulder and AC joint, and an incomplete tear of the left rotator cuff. Dr. Harrison surgically repaired Petitioner’s left rotator cuff partial thickness tear and a complete bursectomy. Following her surgery, Petitioner reported increased shoulder pain. She had post-surgical physical therapy and was eventually discharged from physical therapy as she was no longer functionally limited. There are no medical records that document Petitioner’s pain past her 10 Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 11 of 12 postoperative physical therapy discharge in October 2017. In January 2018, Petitioner reported achiness in her left shoulder to Dr. Harrison, but also that her symptoms had improved. However, statements submitted from 2017 to 2024, by Petitioner and other witnesses, consistently suggest Petitioner still experiences pain, difficulties with activities of daily living, and negative effects to her mental health. Her latest declaration submitted in August 2024, indicates she still experiences shoulder pain and flare-ups. She has trouble holding pots and pans in the kitchen and sometimes needs assistance cooking. To support the amount requested, Petitioner primarily relies on Reed in which the petitioner was awarded $160,000.00. While Petitioner and Ms. Reed had a similar clinical course and severity of pain, in Reed, the medical records show that the petitioner’s pain had not fully resolved after surgery, and she continued seeking treatment. Here, Petitioner was discharged from physical therapy with full functionality and did not return to a medical provider for her SIRVA until five months later, during which she reported her left shoulder was aching. There are no follow-up medical records thereafter. However, as evidenced in the affidavits and declarations, both petitioners had similar non-medical mitigating factors where their injuries impacted their personal lives such as caring for family members. Nonetheless, this does not overcome the lack of medical records reflecting ongoing post-surgical pain justifying a pain and suffering award equal to that awarded in Reed. Perhaps more analogous in that regard, is Petitioner’s citation to Rafferty where the petitioner had moderate to severe pain, underwent surgery, and received $127,500.00 in pain and suffering. The Chief Special Master noted that while Ms. Rafferty’s pain continued after surgery, she had “significant improvement” after surgery and that “[a]ny pain and suffering experienced by [Ms. Rafferty] after this point appears to be minimal. It certainly was not sufficient enough to require further medical care.” Rafferty, 2020 WL 3495956, at *16. This case is more akin to Petitioner’s post-surgical pain because while she consistently reported in her declarations ongoing pain, it did not appear the pain was severe enough to seek further medical care. Moreover, at the January 2018 visit with Dr. Harrison, it was noted Petitioner had improved since her last postoperative appointment. Additionally, the Roberson case, awarding $125,000.00 in pain and suffering, is also analogous to Petitioner’s case in that Mr. Roberson received two steroid injections prior to surgery and completed 21 physical therapy sessions post surgery with a good prognosis and nearly full ROM. Roberson v. Sec’y of Health & Hum. Servs., No. 19-90V, 2020 WL 5512542, at *4 (Fed. Cl. Spec. Mstr. Aug. 7, 2020).5 Unlike these cases, however, Petitioner did not seek immediate medical attention after the alleged onset of her shoulder pain. Thus, Respondent’s argument for a lower pain and suffering award based on the delay in seeking treatment is noteworthy. The Shelton petitioner did not seek treatment until five months after her vaccination and then did not obtain further treatment until three months later. And the Crawford petitioner, did not seek treatment until four months after vaccination and then had a 20-month gap in treatment. But here, once Petitioner did seek treatment three months post vaccination, her subsequent treatment was more consistent. For that reason, an award of pain and suffering higher than that awarded in Shelton and Crawford is appropriate. 5 Petitioner cited Roberson in her damages brief as an example of a surgical case awarding $125,000.00 in pain and suffering. Pet’r’s. Br. at 16. 11 Case 1:17-vv-01890-UNJ Document 72 Filed 02/21/25 Page 12 of 12 VIII. Conclusion After a careful and comprehensive review of the facts of this case and in consideration of all the arguments presented by both parties along with the relevant caselaw, I find that $125,000.00 in compensation for actual pain and suffering is reasonable in this case. I also find that Petitioner is entitled to $1,590.13 for out-of-pocket expenses. Therefore, I award a lump sum payment of $126,590.13 in the form of a check payable to Petitioner. This amount represents compensation for all damages that would be available under § 15(a). The Clerk of Court is directed to enter judgment in accordance with this Decision.6 IT IS SO ORDERED. s/Herbrina D. S. Young Herbrina D. S. Young Special Master 6 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. 12 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_17-vv-01890-cl-extra-11227475 Date issued/filed: 2025-12-18 Pages: 1 Docket text: Supplementary opinion from CourtListener cluster 10760890 -------------------------------------------------------------------------------- In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: November 21, 2025 * * * * * * * * * * * * * * ** LORRIE JONES, * * Petitioner, * No. 17-1890V * v. * Special Master Young * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * ** Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for Petitioner. Mitchell Jones, U.S. Department of Justice, Washington, DC, for Respondent. DECISION AWARDING ATTORNEYS’ FEES AND COSTS1 On December 6, 2017, Lorrie Jones (“Petitioner”) filed a petition for compensation under the National Vaccine Injury Compensation Program (“Vaccine Program” or “Program”). 42 U.S.C. § 300aa-10 to 34 (2018). Petitioner alleged that she suffered “injuries, including [s]houlder [i]njury [r]elated to [v]accine [a]dministration (“SIRVA”), resulting from adverse effects of a tetanus/diphtheria (“Tdap”) vaccination she received on October 25, 2016.” Pet. at 1, ECF No. 1. I resolved Petitioner’s claim on the record and issued a Ruling on Entitlement on September 29, 2023. ECF No. 51. I issued a damages decision on January 14, 2025. ECF No. 70. On July 11, 2025, Petitioner filed a final motion for attorneys’ fees and costs. Pet’r’s Mot., ECF No. 74. Petitioner requests a total amount of $83,511.32, representing $64,103.70 in attorneys’ fees and $19,407.62 in attorneys’ costs. Pet’r’s Mot. at 1. Petitioner also requests $60.50 of personal costs incurred in pursuit of her petition. Id. at 1–2. Respondent responded to the motion on July 11, 2025, stating that Respondent “is satisfied the statutory requirements for an award of attorneys’ fees and costs are met in this case.” Resp’t’s Resp. at 2, ECF No. 75. Petitioner filed a reply the same day. ECF No. 76. 1 Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 1 I. Reasonable Attorneys’ Fees and Costs The Vaccine Act permits an award of “reasonable attorneys’ fees” and “other costs.” § 15(e)(1). If a petitioner succeeds on the merits of his or her claim, the award of attorneys’ fees is automatic. Id.; see Sebelius v. Cloer, 133 S. Ct. 1886, 1891 (2013). However, a petitioner need not prevail on entitlement to receive a fee award as long as the petition was brought in “good faith” and there was a “reasonable basis” for the claim to proceed. § 15(e)(1). Here, I am satisfied that good faith and reasonable basis have been met in the instant case. Respondent has also not raised an objection regarding whether good faith and reasonable basis have been met. Accordingly, Petitioner is entitled to a final award of reasonable attorneys’ fees and costs. The Federal Circuit has approved the lodestar approach to determine reasonable attorneys’ fees and costs under the Vaccine Act. Avera v. Sec’y of Health & Hum. Servs., 515 F.3d 1343, 1348 (Fed. Cir. 2008). This is a two-step process. Id. First, a court determines an “initial estimate . . . by ‘multiplying the number of hours reasonably expended on the litigation times a reasonable hourly rate.’” Id. at 1347–48 (quoting Blum v. Stenson, 465 U.S. 886, 888 (1984)). Second, the court may make an upward or downward departure from the initial calculation of the fee award based on specific findings. Id. at 1348. It is “well within the special master’s discretion” to determine the reasonableness of fees. Saxton v. Sec’y of Health & Hum. Servs., 3 F.3d 1517, 1521–22 (Fed. Cir. 1993); see also Hines v. Sec’y of Health & Hum. Servs., 22 Cl. Ct. 750, 753 (1991) (“[T]he reviewing court must grant the special master wide latitude in determining the reasonableness of both attorneys’ fees and costs.”). Applications for attorneys’ fees must include contemporaneous and specific billing records that indicate the work performed and the number of hours spent on said work. See Savin v. Sec’y of Health & Hum. Servs., 85 Fed. Cl. 313, 316–18 (2008). Such applications, however, should not include hours that are “‘excessive, redundant, or otherwise unnecessary.’” Saxton, 3 F.3d at 1521 (quoting Hensley v. Eckerhart, 461 U.S. 424, 434 (1983)). Reasonable hourly rates are determined by looking at the “prevailing market rate” in the relevant community. See Blum, 465 U.S. at 895. The “prevailing market rate” is akin to the rate “in the community for similar services by lawyers of reasonably comparable skill, experience and reputation.” Id. at 895, n.11. Petitioners bear the burden of providing adequate evidence to prove that the requested hourly rate is reasonable. Id. A. Hourly Rate The decision in McCulloch provides a framework for consideration of appropriate ranges for attorneys’ fees based upon the experience of the practicing attorney. McCulloch v. Sec’y of Health & Hum. Servs., No. 09-293V, 2015 WL 5634323, at *19 (Fed. Cl. Spec. Mstr. Sept. 1, 2015), motion for recons. denied, 2015 WL 6181910 (Fed. Cl. Spec. Mstr. Sept. 21, 2015). The Court has since updated the McCulloch rates, and the Attorneys’ Forum Hourly Rate Fee Schedules can be accessed online.2 2 The OSM Fee Schedules are available at https://www.uscfc.uscourts.gov/osm-attorneys-forum-hourly- rate-fee-schedules. The hourly rates contained within the schedules are updated from the decision in McCulloch, 2015 WL 5634323. 2 Petitioner requests the following rates of compensation for her counsel: for Ms. Leah Durant, $365.00 per hour for work performed in 2017, $377.00 per hour for work performed in 2018, $380.00 per hour for work performed in 2019, $395.50 per hour for work performed in 2020, $420.00 per hour for work performed in 2021, $441.00 per hour for work performed in 2022, $463.00 per hour for work performed in 2023, $486.00 per hour for work performed in 2024, and $530.00 per hour for work performed in 2025; for Mr. Michael Milmoe, $464.00 per hour for work performed in 2019, $484.00 per hour for work performed in 2020, and $509.00 per hour for work performed in 2021; for Ms. Summer Abel, $260.00 per hour for work performed in 2020; for Mr. Christopher Williams, $325.00 per hour for work performed in 2021, $358.00 per hour for work performed in 2023, and $376.00 per hour for work performed in 2024; and for Mr. Mateo Forero- Norena, $385.00 per hour for work performed in 2024. Additionally, Petitioner requests paralegal rates ranging from $145.00 per hour to $203.00 per hour for work performed from 2017 to 2025. The rates requested are consistent with what counsel have previously been awarded for their work in the Vaccine Program; therefore, I will award the rates requested herein. B. Reasonable Number of Hours Attorneys’ fees are awarded for the “number of hours reasonably expended on the litigation.” Avera, 515 F.3d at 1348. Counsel should not include in their fee requests hours that are “excessive, redundant, or otherwise unnecessary.” Saxton, 3 F.3d at 1521 (quoting Hensley v. Eckerhart, 461 U.S. 424, 434 (1983)). It is well-established that billing for administrative or clerical tasks is not permitted in the Vaccine Program. See e.g., Rochester v. United States, 18 Cl. Ct. 379, 387 (1989) (stating that services that are “primarily of a secretarial or clerical nature . . . should be considered as normal overhead office costs included within the attorneys’ fee rates”); see also Isom v. Sec’y of Health & Hum. Servs., No. 94-770, 2001 WL 101459, at *2 (Fed. Cl. Spec. Mstr. Jan. 17, 2001) (agreeing with Respondent that tasks such as filing and photocopying are subsumed under overhead expenses); Walters v. Sec’y of Health & Hum. Servs., No. 15-1380V, 2022 WL 1077311, at *5 (Fed. Cl. Spec. Mstr. Feb. 23, 2022) (failing to award fees for the review of CM/ECF notifications and the organization of the file); McCulloch, 2015 WL 5634323, at *26 (noting that clerical and secretarial tasks should not be billed at all, regardless of who performs them). Upon review, I find the submitted billing entries and the total number of hours billed to be reasonable. However, I find reductions are necessary. Throughout litigation, Petitioner’s counsel consistently included filing documents in their billing entries. Additionally, most of these billing entries contained block billing, making it impossible to discern how much time was spent on noncompensable tasks. For example, Ms. Durant billed one entry for “[c]omplete research. Review and prepare evidence. Review and provide feedback on [P]etitioner’s expert report. Evaluate literature. Draft and file notice of filing. File expert report.” Pet’s’ Mot. at 8. It is well known in the Vaccine Program that billing for some administrative tasks (e.g., filing), even at a paralegal rate, is not permitted. See, e.g., Rochester, 18 Cl. Ct. at 387 (stating that services that are “primarily of a secretarial or clerical nature . . . should be considered as normal overhead office costs included within the attorneys’ fee rates”). Additionally, “[i]t is well 3 established that an application for fees and costs must sufficiently detail and explain the time billed so that a special master may determine, from the application and the case file, whether the amount requested is reasonable.” Mostovoy v. Sec’y of Health & Hum. Servs., No. 02-10V, 2016 WL 720969, at *6 (Fed. Cl. Spec. Mstr. Feb. 4, 2016) (citing Bell v. Sec’y of Health & Hum. Servs., 18 Cl. Ct. 751, 760 (1989)). Therefore, I find a 10%3 reduction reasonable. This results in a reduction of $9,615.56.4 C. Costs Like attorneys’ fees, a request for reimbursement of attorneys’ costs must be reasonable. Perreira v. Sec’y of Health & Hum. Servs., 27 Fed. Cl. 29, 34 (Fed. Cl. 1992). Petitioner requests a total of $19,407.62 in attorneys’ costs comprised of acquiring medical records, the filing fee, FedEx expenses, and expert services provided by Dr. Catherine Shaer, D. Cliff Colwell, and Dr. Uma Srikumaran. Petitioner also requests $60.50 in personal costs incurred from acquiring medical records. Petitioner has provided adequate documentation of all these expenses, and they appear reasonable in my experience. Accordingly, Petitioner is awarded the full amount of costs sought. II. Conclusion In accordance with the Vaccine Act, 42 U.S.C. §15(e) (2018), I have reviewed the billing records and costs in this case and find that Petitioner’s request for fees and costs is reasonable. Based on the above analysis, I find that it is reasonable to compensate Petitioner and her counsel as follows: Attorneys’ Fees Requested $64,103.70 (Reduction to Fees) ($6,410.37) Total Attorneys’ Fees Awarded $57,693.33 Attorneys’ Costs Requested $19,407.62 (Reduction to Costs) - Total Attorneys’ Costs Awarded $19,407.62 Total Attorneys’ Fees and Costs $77,100.95 Petitioner’s Costs Requested $60.50 (Reduction to Costs) - Total Petitioner’s Costs Awarded $60.50 3 With more than 15 years in the Vaccine Program, Ms. Durant should be aware of the expected billing practices, especially when she has been warned about block billing and billing for administrative tasks in the past. If counsel continues to block bill in the future, the reduction will be greater than 10%. 4 $64,103.70 x 10% = $6,410.37. 4 Accordingly, I award a lump sum in the amount of $77,100.95, representing reimbursement for Petitioner’s attorneys’ fees and costs, to be paid through an ACH deposit to Petitioners’ counsel’s IOLTA account for prompt disbursement. I also award a lump sum in the amount of $60.50, representing reimbursement for Petitioner’s personal costs incurred, to be paid through an ACH deposit to Petitioner’s counsel’s IOLTA account for prompt disbursement. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court is directed to enter judgment herewith.5 IT IS SO ORDERED. s/Herbrina D. S. Young Herbrina D. S. Young Special Master 5 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. 5