VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-01008 Package ID: USCOURTS-cofc-1_20-vv-01008 Petitioner: Victor Johnson Filed: 2020-08-13 Decided: 2024-05-07 Vaccine: influenza Vaccination date: 2017-09-20 Condition: Shoulder Injury Related to Vaccine Administration (SIRVA) Outcome: compensated Award amount USD: 65000 AI-assisted case summary: Victor Johnson, a 59-year-old adult, filed a petition on August 13, 2020, alleging that he suffered a Shoulder Injury Related to Vaccine Administration (SIRVA) in his right shoulder following an influenza vaccination received on September 20, 2017. Initially, he pursued a "Table Injury" claim, which was dismissed. He then amended his petition to assert a claim based on "causation-in-fact." The respondent, the Secretary of Health and Human Services, argued that the petitioner's symptoms were primarily due to carpal tunnel syndrome, which is not vaccine-related, and that any rotator cuff tear was an incidental finding. The public decision does not detail the petitioner's specific symptoms beyond initial reports of arm pain, stiffness, muscle twitching, and later numbness and tingling in his fingers. Medical records indicated a diagnosis of carpal tunnel syndrome, but also a rotator cuff tear. Petitioner's expert, Dr. Naveed Natanzi, opined that the vaccination caused a SIRVA-like injury, including rotator cuff pathology, and that carpal tunnel syndrome could not explain the shoulder pain. Respondent's experts, Dr. Pria Anand and Dr. Paul Cagle, argued that carpal tunnel syndrome could present with shoulder pain and that the rotator cuff tear was likely an incidental finding unrelated to the vaccine. Special Master Daniel T. Horner issued a ruling on entitlement on December 20, 2023, finding that the petitioner was entitled to compensation because the vaccination was a substantial factor in causing his shoulder injury. The Special Master concluded that the petitioner met the "causation-in-fact" standard under the Althen standard, establishing a medical theory connecting the vaccination to the injury, a logical sequence of cause and effect, and a proximate temporal relationship. The Special Master also found that the respondent did not prove the injury was caused by a factor unrelated to the vaccine. Subsequently, on May 7, 2024, a decision awarding damages was issued. Victor Johnson was awarded a lump sum of $65,000.00 in pain and suffering, payable by check to him, as compensation for his vaccine-related shoulder injury. Leigh Finfer represented the petitioner, and Parisa Tabassian represented the respondent. Theory of causation field: Petitioner Victor Johnson, age 59, received an influenza vaccine on September 20, 2017, and subsequently developed shoulder pain and other symptoms. His Table claim for SIRVA was dismissed, and the case proceeded on a causation-in-fact theory. Petitioner's expert, Dr. Naveed Natanzi, opined that the flu vaccination caused a SIRVA-like injury, including rotator cuff pathology, via needle overpenetration and subsequent inflammatory response, and that carpal tunnel syndrome, also diagnosed, did not explain the shoulder pain. Respondent's experts, Dr. Pria Anand and Dr. Paul Cagle, argued that carpal tunnel syndrome could cause shoulder pain and that the rotator cuff tear was an incidental finding unrelated to the vaccine, asserting no scientific link between vaccination and carpal tunnel syndrome. Special Master Daniel T. Horner found that petitioner met the Althen standard for causation-in-fact, establishing a medical theory (vaccine injection causing rotator cuff injury), a logical sequence of cause and effect (lack of prior shoulder pain, post-vaccination onset of symptoms, diagnosis of rotator cuff pathology), and a proximate temporal relationship (symptoms perceived within hours to a day post-vaccination, with shoulder pain noted in subsequent medical visits). The Special Master concluded that the respondent did not prove the injury was caused by a factor unrelated to the vaccine. Petitioner was awarded $65,000.00 for pain and suffering. Attorneys: Leigh Finfer for petitioner, Parisa Tabassian for respondent. Special Master: Daniel T. Horner. Decision Dates: Entitlement Ruling December 20, 2023; Damages Decision May 7, 2024. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_20-vv-01008-0 Date issued/filed: 2022-05-20 Pages: 4 Docket text: PUBLIC ORDER/RULING (Originally filed: 04/07/2022) regarding 28 Findings of Fact & Conclusions of Law Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-01008-UNJ Document 31 Filed 05/20/22 Page 1 of 4 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-1008V UNPUBLISHED VICTOR JOHNSON, Chief Special Master Corcoran Petitioner, Filed: April 7, 2022 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Findings of Fact; Onset; Influenza HUMAN SERVICES, (Flu) Vaccine; Shoulder Injury Related to Vaccine Administration Respondent. (SIRVA) Leigh Finfer, Muller Brazil, LLP, Dresher, PA, for Petitioner. Parisa Tabassian, U.S. Department of Justice, Washington, DC, for Respondent. FINDINGS OF FACT AND CONCLUSIONS OF LAW DISMISSING TABLE CASE1 On August 13, 2020, Victor Johnson filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). Petitioner alleged that a flu vaccine he received on September 20, 2017, caused him to suffer the Table injury of “Shoulder Injury Related to Vaccine Administration” (“SIRVA”). Petition filed August 13, 2020, ECF No. 1. The case was assigned to the Special Processing Unit of the Office of Special Masters (the “SPU”). 1 Because this unpublished fact ruling contains a reasoned explanation for the action in this case, I am required to post it on the United States Court of Federal Claims' website in accordance with the E- Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the fact ruling will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:20-vv-01008-UNJ Document 31 Filed 05/20/22 Page 2 of 4 I. Relevant Procedural History – Order to Show Cause Respondent filed his Rule 4(c) Report on October 18, 2021, setting forth objections to compensation in this case. ECF No. 23. In sum, Respondent asserted that Petitioner could not meet three of the four QAI requirements for a Table case, because (a) Petitioner’s pain was not limited to the shoulder in which he received the vaccine, (b) Petitioner’s medical records do not document that he suffered shoulder pain within 48 hours of his vaccination; and (c) Petitioner’s medical records document another condition, carpal tunnel syndrome, that could explain his symptoms. Id. at 7-9 (citing 42 C.F.R. § 100.3(c)(10)). Respondent, further argued that Petitioner could not meet the evidentiary requirements for a causation-in-fact, non-Table claim and therefore his claim should be dismissed in the entirety. Id. at 9-10. On October 25, 2021, I issued an Order to Show Cause, as it appeared based upon my review that at a minimum Petitioner would not be able to establish a Table SIRVA claim, and therefore, I would likely dismiss his Table claim. ECF No. 24. But I also advised Petitioner that he might be able to establish an off-Table or causation in-fact claim, and that if he wished to proceed with causation-in-fact claim he should file an amended Petition. On November 23, 2021, Petitioner filed an Amended Petition, alleging a “Non- Table” SIRVA claim, and a Status Report in response to my Order to Show Cause, indicating that Petitioner “consent[s] to the dismissal of his Table SIRVA case” and “plans to proceed with a non-Table SIRVA claim.” ECF Nos. 25-26. Respondent has stated he has no objection to the dismissal of Petitioner’s Table Claim, obviating the need for a reply brief. See Informal Communication dated December 21, 2022. II. Analysis and Findings of Fact The criteria for establishing a Table SIRVA are as follows: Shoulder injury related to vaccine administration (SIRVA). SIRVA manifests as shoulder pain and limited range of motion occurring after the administration of a vaccine intended for intramuscular administration in the upper arm. These symptoms are thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder resulting in an inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury and abnormalities on neurological examination or nerve conduction 2 Case 1:20-vv-01008-UNJ Document 31 Filed 05/20/22 Page 3 of 4 studies (NCS) and/or electromyographic (EMG) studies would not support SIRVA as a diagnosis (even if the condition causing the neurological abnormality is not known). A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 42 C.F.R. § 100.3(c)(10). As explained in my Order to Show Cause, at a minimum, Petitioner cannot establish that he suffered a Table SIRVA injury, given that his post-vaccination arm pain was not limited to his shoulder, but was consistently described as including: numbness in his fingers and hands, and paresthesia of the right upper extremity. See, e.g., Ex. 2 at 45, 49; Ex. 4 at 6; Ex. 5 at 32, 60. Additionally, Petitioner has offered no additional evidence or argument to the contrary and has consented to the dismissal of his Table SIRVA claim. ECF No. 26. Accordingly, for the above stated reasons I find3 that Petitioner has failed to demonstrate the Table requirements for SIRVA (42 C.F.R. § 100.3(c)(10)), and hereby dismiss Petitioner’s Table SIRVA claim. III. Transfer from SPU In light of the instant ruling, I will proceed with transferring Petitioner’s case out of SPU and will randomly reassign the case to a special master to conduct further proceedings to establish whether Petitioner has demonstrated an off-Table case for SIRVA. 3 I make these findings after a complete review of the record, including all medical records, affidavits, and all other additional evidence and filings from the parties. 3 Case 1:20-vv-01008-UNJ Document 31 Filed 05/20/22 Page 4 of 4 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 4 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_20-vv-01008-1 Date issued/filed: 2024-01-17 Pages: 16 Docket text: PUBLIC ORDER/RULING (Originally filed: 12/20/2023) regarding 44 Ruling on Entitlement. Signed by Special Master Daniel T. Horner. (ksb) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 1 of 16 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-1008V Filed: December 20, 2023 Special Master Horner VICTOR JOHNSON, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Leigh Finfer, Muller Brazil, LLP, Dresher, PA, for petitioner. Parisa Tabassian, U.S. Department of Justice, Washington, DC, for respondent. RULING ON ENTITLEMENT1 On August 13, 2020, petitioner filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10, et seq. (2018),2 alleging that he suffered the Table Injury of Shoulder Injury Related to Vaccine Administration (“SIRVA”) in his right shoulder following an influenza (“flu”) vaccination that he received on September 20, 2017. (ECF No. 1.) On November 21, 2021, an amended petition was filed adding a claim based on causation-in-fact. (ECF No. 25.) For the reasons set forth below, I conclude that petitioner is entitled to compensation for a shoulder injury caused-in-fact by his vaccination. 1 Because this document contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the document will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C. § 300aa-10, et seq. 1 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 2 of 16 I. Applicable Statutory Scheme Under the National Vaccine Injury Compensation Program, compensation awards are made to individuals who have suffered injuries after receiving vaccines. In general, to gain an award, a petitioner must make a number of factual demonstrations, including showing that an individual received a vaccination covered by the statute; received it in the United States; suffered a serious, long-standing injury; and has received no previous award or settlement on account of the injury. § 300aa-11(c). Finally – and the key question in most cases under the Program – the petitioner must also establish a causal link between the vaccination and the injury. In some cases, the petitioner may simply demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be shown that the vaccine recipient suffered an injury of the type enumerated in the “Vaccine Injury Table,” corresponding to the vaccination in question, within an applicable time period following the vaccination, which is also specified in the Table. If so, the Table Injury is presumed to have been caused by the vaccination, and the petitioner is automatically entitled to compensation, unless it is affirmatively shown that the injury was caused by some factor other than the vaccination. See § 300aa- 13(a)(1); § 300 aa-11(c)(1)(C)(i); § 300aa-14(a). As relevant here, the Vaccine Injury Table lists a SIRVA as a compensable injury if it occurs within 48 hours of vaccine administration. See § 300aa-14(a), amended by 42 CFR § 100.3. Table Injury cases are guided by statutory “Qualifications and aids in interpretation” (“QAIs”), which provide more detailed explanation of what should be considered when determining whether a petitioner has actually suffered an injury listed on the Vaccine Injury Table. 42 CFR § 100.3(c). To be considered a “Table SIRVA,” petitioner must show: (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient's symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 42 CFR § 100.3(c)(10). In this case, petitioner’s Table claim was already dismissed for, at a minimum, failing to meet the third of these requirements. (ECF No. 28.) To alternatively show actual causation or “causation in fact,” petitioner must satisfy the “preponderance of the evidence” standard, the same standard ordinarily used in tort litigation. § 300aa-13(a)(1)(A); see also Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1279 (Fed. Cir. 2005); Hines v. Sec’y of Health & Human Servs., 2 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 3 of 16 940 F.2d 1518, 1525 (Fed. Cir. 1991). Under that standard, the petitioner must show that it is “more probable than not” that the vaccination caused the alleged injury. Althen, 418 F.3d at 1279. The petitioner need not show that the vaccination was the sole cause of the injury or condition but must demonstrate that the vaccination was a “substantial factor” and a “but for” cause. Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). This standard has been interpreted to require “proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury;” the logical sequence must be supported by “reputable medical or scientific explanation, i.e., evidence in the form of scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278; Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). A petitioner may not receive a Vaccine Program award based solely on his or her assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. § 300aa-13(a)(1); § 300aa-11(c). In what has become the predominant framing of this burden of proof, the Althen court described the “causation-in-fact” standard, as follows: Concisely stated, Althen’s burden is to show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal relationship between vaccination and injury. If Althen satisfies this burden, she is “entitled to recover unless the [government] shows, also by a preponderance of the evidence, that the injury was in fact caused by factors unrelated to the vaccine.” Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner need not necessarily supply evidence from medical literature supporting petitioner’s causation contention, so long as the petitioner supplies the medical opinion of an expert. Id. at 1279-80. That expert’s opinion must be “sound and reliable.” Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. 2019). The Althen court also indicated, however, that a Program fact finder may rely upon “circumstantial evidence,” which the court found to be consistent with the “system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants.” Althen, 418 F.3d at 1280. Once a petitioner has established a 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 (citation omitted); § 300aa-13(a)(1)(B). II. Procedural History As noted above, petitioner initially asserted a Table injury. (ECF No. 1.) The case was assigned to the Chief Special Master as part of the Special Processing Unit or “SPU.” (ECF Nos. 8-9.) Petitioner filed an affidavit and medical records marked as Exhibits 1-13. (ECF Nos. 1, 17, 19.) A Statement of Completion was filed on April 27, 2021. (ECF No. 20.) 3 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 4 of 16 Respondent filed his Rule 4 Report on October 18, 2021. (ECF No. 23.) Regarding any Table claim, respondent argued (1) that petitioner’s pain and reduced range of motion was not limited to the affected shoulder, (2) that the record is not consistent regarding the requisite period of onset, and (3) that petitioner’s condition is otherwise explained by carpal tunnel syndrome. (Id. at 7-8.) Regarding causation-in- fact, respondent argued the record cannot support petitioner’s claim absent an expert report. (Id. at 8-10.) Thereafter, the Chief Special Master issued an Order to Show Cause why petitioner’s Table claim should not be dismissed. (ECF No. 24.) The Chief Special Master afforded petitioner an opportunity to amend his petition to include a cause-in-fact claim, which he did. (Id.; see also ECF No. 25.) Petitioner then consented to dismissal of his Table claim. (ECF No. 26.) After petitioner’s Table claim was dismissed (ECF No. 28), the case was reassigned to the undersigned (ECF Nos. 29-30). Petitioner filed an expert report to support his cause-in-fact claim in August of 2022. (ECF No. 33; Exs. 14-36.) Respondent filed responsive expert reports in November of 2022. (ECF Nos. 35-36; Exs. A-B.) Thereafter, petitioner requested an opportunity to file a supplemental report by his expert and to then brief the question of his entitlement to compensation. (ECF No. 37.) Petitioner filed a supplemental expert report on February 7, 2023 (ECF No. 38; Ex. 37) and a brief pursuant to Vaccine Rule 8(d) on February 21, 2023. (ECF No. 40.) Respondent filed a responsive brief accompanied by a supplemental report by one of his experts. (ECF Nos. 41-42; Ex. C.) Petitioner filed a reply on May 3, 2023. (ECF No. 43.) In light of the above, I have determined that the parties have had a full and fair opportunity to present their cases and that, given the parties’ assent, it is appropriate to resolve entitlement on the existing record. See Vaccine Rule 8(d); Vaccine Rule 3(b)(2); see also Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (noting that “special masters must determine that the record is comprehensive and fully developed before ruling on the record”). Accordingly, this matter is now ripe for resolution. III. Factual History a. As Reflected in the Medical Records Petitioner was 59 years old at the time of the vaccination at issue, which was administered in his right shoulder on September 20, 2017, at a primary care provider appointment. (Ex. 1, p. 6.) At that time, he was presenting for evaluation of coughing up blood as well as reporting left elbow tenderness that was likely due to soft tissue calcifications as observed on x-ray. (Id. at 6-9; Ex 2, p. 40.) Prior to the vaccination, petitioner also had a history of intermittent right elbow pain. (Ex. 9, pp. 6-8.) 4 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 5 of 16 Three days later, petitioner’s wife called the primary care provider to report that petitioner was experiencing a vaccine reaction. (Ex. 3, pp. 8-9.) Petitioner was reportedly negative for a number of symptoms of a vaccine reaction, such as fever, shortness of breath, or disorientation. (Id. at 8.) The “main symptom” reported was “twitching to the arm” with additional bumps and itching around the injection site. (Id.) Petitioner reportedly denied any pain but did report stiffness. (Id. at 9.) Petitioner was advised to use a cold compress and Tylenol as needed and to follow up if symptoms did not resolve. (Id.) Approximately two months later, on November 30, 2017, a further call from petitioner’s wife was documented. (Ex. 2, p. 45.) She was seeking to have petitioner’s next primary care appointment advanced for several reasons, including “after 2 months, he is still having trouble with his right arm, that began after his flu shot. His fingers still tingle and go numb if he does not move his hand and fingers.” (Id.) Petitioner was seen by his primary care provider for “arm pain” on December 18, 2017. (Ex. 2, pp. 48-49.) On exam, petitioner had adequate grip and his radial pulses and sensation were intact in his right upper extremity. (Id. at 48.) However, he had paresthesia of the right upper extremity the differential diagnosis for which was “reportedly post injection vs cervical radiculopathy.” (Id. at 49.) An EMG was ordered. (Id.) Petitioner presented for his EMG on January 18, 2018, with a pre-procedure diagnosis of paresthesia of the right upper extremity. (Ex. 4, pp. 6-8.) The history indicates petitioner presented “with complaints of numbness in the thumb, index and middle finger since a flu shot last fall. Brief neurological exam shows normal strength and reflexes in the upper extremities.” (Id. at 8.) The study demonstrated “mild median neuropathy at the wrists bilaterally, worse on the right” with no evidence of denervation. (Id.) The day after petitioner’s EMG, his wife called his primary care provider seeking “something for pain of right arm.” (Ex. 2, p. 54.) She noted that he cannot sleep. (Id.) The assessment following the EMG was that petitioner had bilateral carpal tunnel syndrome, though without any “prominent” abnormalities, unrelated to his vaccine injection. (Id.; Ex. 4, p. 6.) A wrist split was recommended and gabapentin was prescribed for nerve pain. (Ex. 2, p. 54.) About four months later, petitioner’s wife called his primary care provider seeking a referral for an orthopedic evaluation. (Ex. 2, p. 65.) She explained that petitioner’s right shoulder had been bothering him since September. (Id. at 64.) The requested referral was provided. (Id.) Petitioner then saw an orthopedist on June 6, 2018. (Ex. 5, pp. 15-18.) At that time petitioner complained of severe right shoulder pain, increasing with reaching, that began 8 months prior. (Id. at 15.) Petitioner did not complain of instability or weakness. (Id.) Upon physical exam, petitioner was negative for any acromioclavicular joint or biceps tenderness but was positive for subacromial space tenderness. (Id. at 17.) He had a positive cross body test and signs of subacromial impingement. (Id.) External rotation was 25 degrees and petitioner could reach L1 on internal rotation. (Id.) Light touch was intact. (Id.) X-ray showed no glenohumeral arthritis but did show changes suggestive of chronic tendonitis. (Id.) Petitioner was diagnosed with rotator cuff tendonitis. (Id.) A follow up ultrasound and a cortisone injection were recommended. (Id.) 5 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 6 of 16 Petitioner underwent an ultrasound of his right shoulder on August 24, 2018. (Ex. 6, pp. 7-8.) Petitioner had a mild amount of fluid in his biceps tendon and his subscapularis tendon had thickening consistent with tendinosis, without evidence of a tear. (Id. at 7.) His supraspinatus tendon had a full thickness tear with a bony irregularity. (Id.) His subacromial bursa was minimally thickened. (Id.) He had mild acromioclavicular osteoarthritis. (Id.) There was no sizeable glenohumeral effusion. (Id.) A dynamic evaluation showed normal range of motion and no evidence of subacromial or subcoracoid impingement. (Id.) The impression was full-thickness tear of the supraspinatus tendon, subscapularis tendinosis without a tear, and mild acromioclavicular joint osteoarthritis. (Id.) Petitioner began physical therapy for chronic right shoulder pain about two weeks later. (Ex. 5, pp. 30-35.) Petitioner presented with limited function due to his right shoulder full thickness rotator cuff tear. (Id. at 30.) In particular, he complained of difficulty with sleeping and lifting. (Id. at 32.) He complained of “R shoulder pain that began about a year ago. It began after a flu shot.” (Id.) His pain is characterized as intermittent and radiating to the upper arm. (Id.) He also reported having numbness and tingling in his first three digits. (Id.) Upon evaluation, petitioner had range of motion within functional limits and with no increase in pain. (Id. at 33.) He had normal strength, but pain with resisted abduction and tenderness to palpation. (Id.) Light touch sensations and reflexes were within normal limits. (Id. at 34.) Cervical spinal and shoulder special tests were all negative. (Id. at 34.) It was noted that petitioner had a stable and uncomplicated presentation with good rehab potential, but that he had poor understanding of his condition and poor self-management skills. (Id. at 31.) The goals of physical therapy were to decrease pain, increase flexibility, posture, and stabilization. (Id. at 31.) Twelve sessions over eight weeks were recommended. (Id.) On November 1, 2018, petitioner contacted his primary care provider seeking pain medication for ongoing shoulder pain he attributed to his vaccination. (Ex. 2, p. 68.) He was prescribed a muscle relaxant. (Id.) However, shortly thereafter, on November 12, 2018, he presented to the emergency department with a complaint of “right arm pain that has been ongoing for one year,” and which he again attributed to his flu vaccination, though the record misstates that the vaccination was administered in December. (Ex. 13, pp. 8-9.) Petitioner reported that his pain was located in his right shoulder, arm, and hand. (Id. at 9.) He indicated it was waxing and waning, shooting and sharp, and radiated to his fingers. (Id.) The pain was reportedly worsened by movement and relieved by nothing. (Id.) Petitioner also had numbness and decreased sensation in a medial distribution but had normal range of motion of the shoulder. (Id. at 11.) Both he and his wife asserted that the carpal tunnel diagnosis was unlikely because petitioner had no reason to have carpal tunnel syndrome, and both were “adamant” that his condition resulted from the flu vaccination. (Id. at 12.) The emergency physician felt petitioner had signs and symptoms consistent with neuromuscular right arm pain and expressed suspicion regarding “RSD” (presumably rejection sensitive dysphoria) but diagnosed only “pain of right upper extremity.” (Id. at 11-12.) Petitioner returned to his primary care provider two days later, on November 6 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 7 of 16 14, 2018, for chronic right arm pain that he indicated started “the next day” following his flu vaccination. (Ex. 2, p. 74-75.) He was referred to neurology and a pain clinic given his pain and paresthesia. (Id. at 75.) Petitioner also saw his orthopedist on November 14, 2018. (Ex. 5, pp. 65-69.) Petitioner complained of persistent right shoulder pain that he attributed to his flu vaccination. (Id. at 65-66.) In particular, petitioner complained of pain worse at night and with reaching. (Id. at 65.) The orthopedist re-reviewed the prior EMG and confirmed it showed only evidence of carpal tunnel syndrome but noted that it did not examine the axillary nerve, which could reveal a radiculopathy. (Id.) Absent that, the orthopedist’s “working diagnosis” remained rotator cuff tear. (Id. at 66.) He ordered a follow up EMG of the axillary nerve to clarify the diagnosis and to have further follow up after that. (Id. at 69.) The axillary nerve EMG was normal. (Ex. 4, pp. 9-11.) Petitioner did not return for follow up care until October of 2019. (Ex. 12, pp. 194-95.) (In the interim, petitioner pursued physical therapy for a left shoulder injury related to a fall. (Id. at 170-71.)) The orthopedist attributed the lack of follow up after the axillary nerve EMG to a miscommunication. (Id. at 194.) Petitioner had no numbness or tingling and had full range of motion, but with some discomfort and some impingement with abduction. (Id.) It was noted that petitioner was able to do heavy lifting, but that he continued to have difficulty with overhead reaching. (Id. at 95.) The orthopedist’s final diagnosis was supraspinatus rotator cuff tear for which he recommended surgery. (Id.) It was also suggested that petitioner seek a second opinion. (Id.) The second orthopedist to whom petitioner was referred ordered a right shoulder MRI, which was completed on November 12, 2019. (Id. at 210-11.) The impression was (1) moderate to significant diffuse rotator cuff tendinosis involving the supraspinatus and infraspinatus tendon with a full-thickness tear of the anterior supraspinatus; (2) significant subscapular tendinosis with fraying; (3) significant proximal long head biceps tendinosis; and (4) mild degenerative acromioclavicular joint and glenohumeral joint osteoarthritis. (Id. at 211.) However, no further treatment records were filed. b. As Reflected in Petitioner’s Affidavit Petitioner avers that he had not suffered any injury to his right shoulder prior to administration of the flu vaccination at issue. (Ex. 11, ¶ 5.) He states: The day after receiving the vaccine, I told my wife that my right arm didn’t feel right. My arm was painful and stiff, and it felt like my muscle was “jumping.” On September 23, 2017, my wife spoke to a nurse at Henry Ford Medical Center and relayed my symptoms. We were told to apply a warm compress on the muscle where it was twitching. (Id. at ¶ 4.) 7 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 8 of 16 Petitioner indicates that he continues to experience pain and reduced strength in his right arm. (Id. at ¶ 7.) IV. Expert Reports a. Petitioner’s expert, Naveed Natanzi, D.O.3 Dr. Natanzi cites several medical records which he indicates support onset of “an atypical sensation and pain in [petitioner’s] shoulder beginning the day after vaccination.” (Ex. 14, p. 7 (citing Ex. 3, p. 8; Ex. 2, pp. 48, 74; Ex. 5, p. 15).) Whereas petitioner had no prior history of right shoulder complaints, his post-vaccination presentation included difficulty reaching, pain upon palpation, and impingement. (Id. (citing Ex. 5, p. 15; Ex. 12, p. 19).) MRI confirmed a rotator cuff tear, which Dr. Natanzi indicates is commonly seen in SIRVA. (Id. (citing Ex. 13, p. 211).) Dr. Natanzi agrees that petitioner also suffered carpal tunnel syndrome that arose independent of his vaccination and that resulting injury. (Id. at 7-8.) He asserts that this explained petitioner’s discomfort in his right hand. (Id. at 8.) Dr. Natanzi does not assert that vaccination in the shoulder can cause carpal tunnel syndrome. (Id.) Conversely, “there is no way [carpal tunnel syndrome] can be the cause of [petitioner]’s shoulder pain . . . [q]uite simply, the presence of [carpal tunnel syndrome], which is an issue of the wrist, has no bearing on the possibility of a vaccine needle over-penetrating its target and causing a shoulder injury.” (Id.) Dr. Natanzi opines that petitioner’s injury meets both the Table criteria for SIRVA and also the three-part Althen test for determining causation-in-fact. (Id. at 9-10.) To the extent that respondent’s orthopedic expert, Dr. Cagle, asserts that carpal tunnel syndrome can sometimes cause shoulder pain, Dr. Natanzi charges that the evidence supporting that assertion (two case series) is “weak.” (Ex. 37, p. 1 (discussing Yusuke Hagiwara, et al, “Idiopathic” Shoulder Pain and Dysfunction from Carpal Tunnel Syndrome and Cubital Tunnel Syndrome, 10 PLASTIC RECONSTRUCTIVE SURGERY: GLOB. OPEN e4114 (2022) (Ex. B, Tab 2); Bertram M. Kummel & George A. Zazani, Shoulder Pain as the Presenting Complaint in Carpal Tunnel Syndrome, 92 CLINICAL ORTHOPAEDICS & RELATED RESEARCH 227 (1973) (Ex. B, Tab 3)).) Moreover, the larger series cited by Dr. Cagle (Hagiwara, et al., supra, at Ex. B, Tab 2) screened out patients with MRI evidence of shoulder pathology such as rotator cuff tear. (Ex. 37, p. 2.) Thus, he contends that this hypothesis does not accord with petitioner’s own history. (Id. at 1- 2.) Specifically, Dr. Natanzi stresses the post-vaccination timing of onset for the shoulder pain and also disagrees that the observed rotator cuff tear was asymptomatic given the history and physical exam. (Id. at 1 (citing Ex. 5, p. 15; Ex. 12, p. 19).) If Dr. 3 Dr. Naveed Mayer Natanzi received is doctorate in osteopathy from Western University of Health Sciences. (Ex. 15, p. 2.) He is board certified in physical medicine and rehabilitation. (Id. at 1.) He currently works as a physician at VA Long Beach Healthcare System and is an attending physician at Pasadena Rehab Institute. (Id.) He is also the founder of the Regenerative Sports and Spine Institute. (Id.) He has written and sought publication for seven articles and has participated in the development of two research studies. (Id. at 3-4.) 8 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 9 of 16 Cagle’s proposed explanation was correct, one would expect a gradual onset, the lack of any inciting event, and moderate to severe carpal tunnel based on EMG. (Id. at 1.) b. Respondent’s expert, Pria Anand, M.D. 4 Dr. Anand’s report has the primary purpose of confirming petitioner’s carpal tunnel syndrome diagnosis and that his symptoms of paresthesias and numbness of his hand and fingers are due to that condition. (Ex. A, p. 5.) Dr. Anand does not assert that carpal tunnel syndrome would explain symptoms of shoulder pain; however, she doubts that the medical records support an immediate post-vaccination onset of shoulder pain. (Id.) She notes that SIRVA is not the only possible etiology for the type of pathologies observed on petitioner’s MRI. (Id.) Dr. Anand concludes that petitioner’s initial complaints that his arm “just didn’t feel right” and “my muscle was ‘jumping’” or “twitching and itching around site as well as some stiffness,” are not consistent with the shoulder pain typically observed in SIRVA. (Id. at 4 (citing Ex. 11, p. 1; Ex. 3, p. 8).) c. Respondent’s expert, Paul Cagle, M.D. 5 Dr. Cagle indicates that petitioner’s presentation “clearly demonstrates a picture of neurologic changes along the arm.” (Ex. B, p. 3.) He further notes that petitioner’s EMG confirmed the diagnosis in the wrist, but a subsequent EMG of the shoulder did not demonstrate shoulder axillary nerve involvement. (Id.) Therefore, petitioner’s medical history presents a condition isolated to the wrist rather than any shoulder injury. (Id.) Dr. Cagle acknowledges that a rotator cuff tear was also diagnosed, but opines that it was most likely an incidental, asymptomatic finding. (Id. at 4.) Dr. Cagle cites literature that he asserts demonstrates that carpal tunnel syndrome can present with shoulder pain. (Id. (citing Hagiwara, et al, supra, at Ex. B, Tab 2; Kummel & Zazani, supra, at Ex. B, Tab 3)).) Because Dr. Cagle opines that only carpal tunnel syndrome is present, he limits his discussion of vaccine causation to that condition. He opines there is no scientific link between vaccination and carpal tunnel syndrome. (Id.) He observes that the treating physicians characterized petitioner’s carpal tunnel syndrome as “not apparently related to injection.” (Id. (citing Ex. 2, p. 56).) In response to Dr. Natanzi’s criticism of the Hagiwara and Kummel and Zazanis papers as “weak” evidence, Dr. Cagle counters that the case series examined are comparable in scale to much of the available SIRVA literature. (Ex. C, p. 1.) He further 4 Dr. Pria Anand received her medical degree from Stanford University School of Medicine. (Ex. A, Tab 5, p. 1.) She is board certified in psychiatry and neurology. (Id.) She is currently an assistant professor in the Department of Neurology at Boston Medical Center at Boston University. (Id.) She has written 23 peer reviewed articles and one textbook chapter, and submitted seven editorials, seven reviews, and six case reports for publication. (Id. at 9-12.) 5 Dr. Paul J. Cagle Jr. received his medical degree from Loyola University Stritch School of Medicine in Chicago. (Ex. B, Tab 8, p. 1.) He is board certified in orthopaedic surgery and currently works as an associate professor at the Icahn School of Medicine in the Leni and Peter May Department of Orthopedics located in Mount Sinai. (Id.) He as published 60 peer reviewed articles and eight book chapters. (Id. at 3-10.) 9 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 10 of 16 stresses that Dr. Natanzi has not identified any conflicting literature. (Id.) By contrast, the literature demonstrates that asymptomatic rotator cuff tears are “a common occurrence” and “the simple presence of a rotator cuff tear does not indicate an injury or even a painful condition.” (Id. at 2.) V. Discussion a. Althen prong one Under Althen prong one, petitioner must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type of injury alleged. Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355-56 (Fed. Cir. 2006) (citations omitted). Such a theory must only be “legally probable, not medically or scientifically certain.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994). Petitioner may satisfy the first Althen prong without resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1325-26 (Fed. Cir. 2006)). However, “[a] petitioner must provide a ‘reputable medical or scientific explanation’ for [her] theory. While it does not require medical or scientific certainty, it must still be ‘sound and reliable.’” Boatmon, 941 F.3d at 1359 (quoting Knudsen, 35 F.3d at 548-49). Petitioner argues that her expert, Dr. Natanzi, has “articulated a logical medical theory causally connecting the September 20, 2017 flu vaccination to the resulting SIRVA-type injury. Dr. Natanzi describes a mechanism involving inadvertent overpenetration of the vaccination needle leading to an injury to the rotator cuff and inflammatory response, eventually leading to inflammation and pain in the rotator cuff tendons.” (ECF No. 40, p. 8 (citing Ex. 14, p. 8).) Petitioner also requests that the undersigned take judicial notice of respondent’s addition of SIRVA to the Vaccine Injury Table. (Id. (citing Doe 21 v. Sec’y of Health & Human Servs., 88 Fed Cl. 179, 198 (2009), rev’d on other grounds, 527 F.App’x. 875 (Fed. Cir. 2013).) In response, respondent argues that petitioner cannot succeed based on a “generic shoulder injury” and that respondent did not concede Althen prong one when he added “SIRVA” to the Vaccine Injury Table. (ECF No. 42, pp. 7-11.) Respondent argues it would be inappropriate to simply credit Dr. Natanzi’s ipse dixit and that his experts are better qualified to opine on the issues in this case. (Id. at 11-15.) Under the heading of “medical theories,” respondent acknowledges that petitioner’s expert theorizes a direct causal relationship between needle overpenetration and rotator cuff injury; however, respondent’s only response is to stress that her experts disclaim the presence of any actual rotator cuff injury. (Id. at 15-17.) Based on my review of the record as a whole, Dr. Natanzi’s assertion that vaccine injection can lead to rotator cuff injury is not limited to his ipse dixit. Rather, he has cited several publications that have included rotator cuff tear and tendonitis among 10 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 11 of 16 the constellation of injuries that have been observed post-vaccination. (See Marko Bodor & Enoch Montalvo, Vaccination-Related Shoulder Dysfunction, 25 VACCINE 585 (2007) (Ex. 22); S. Atanasoff et al., Shoulder Injury Related to Vaccine Administration (SIRVA), 28 VACCINE 8049, 8050, 8051 (2010) (Ex. 16, p. 3); Naveed Natanzi, Frank Hebroni, & Marko Bodor, Teres Minor Injury Related to Vaccine Administration, 15 RADIOLOGY CASE REP. 552, 553 (2020) (Ex. 35, p. 2). For example, Atanasoff, et al, observed that Although shoulder dysfunction due to mechanical or overuse injury is always a diagnostic consideration, the rapid onset of pain with limited range of motion following vaccination in our series of patients is consistent with a robust and prolonged immune response within already-sensitized shoulder structures following injection of antigenic substance into the subacromial bursa or the area around the rotator cuff tendon. . . . In general, chronic shoulder pain with or without reduced shoulder joint function can be caused by a number of common conditions including impingement syndrome, rotator cuff tear, biceps tendonitis, osteoarthritis and adhesive capsulitis. In many cases, these conditions may cause no symptoms until provoked by trauma or other events . . . Reilly et al. reviewed a series of shoulder ultrasound and MRI studies obtained in asymptomatic persons past middle age and found partial or complete rotator cuff tears in 39% of those individuals. Therefore, some of the MRI findings in our case series, such as rotator cuff tears, may have been present prior to vaccination and became symptomatic as a result of vaccination-associated synovial inflammation. (Atanasoff et al., supra, at Ex. 16, p. 3.) While respondent contests whether such conditions were actually present in this case, those arguments are not germane to petitioner’s particular burden of proof under Althen prong one. Setting petitioner’s own history aside for purposes of general causation under Althen prong one, nothing in respondent’s brief or his experts’ opinions challenges that vaccination needle overpenetration can cause an inflammatory response that leads to symptomatic rotator cuff injury. Thus, Dr. Natanzi’s actual medical theory remains unrebutted on this record. Accordingly, petitioner has satisfied Althen prong one. b. Althen prong two The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant, 956 F.2d at 1148. In establishing that a vaccine “did cause” injury, the opinions and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1382-83; Capizzano, 440 F.3d at 1326 (quoting Althen, 418 F.3d at 1280) (stating that “medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a 11 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 12 of 16 ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”). However, medical records and/or statements of a treating physician’s views do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. See § 300aa- 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (stating that “there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and cannot be rebutted”). Ultimately, petitioner may support her claim either through her medical records or by expert opinion. See § 300aa-13(a)(1). Petitioner stresses that he had no prior history of shoulder pain and that just three-days post vaccination he complained (via his wife) of symptoms such as muscle twitching and stiffness around his injection site. (ECF No. 40, p. 9.) Although a nerve injury was initially suspected, treatment of that condition did not resolve petitioner’s pain and he ultimately sought an orthopedic assessment that confirmed a right shoulder injury. (Id.) Petitioner never wavered during treatment of his shoulder injury in dating his shoulder pain back to his vaccination and, as his expert opines, it would not be logical to blame his shoulder pain on his separately diagnosed carpal tunnel syndrome. (Id. at 9-10.) Respondent argues that carpal tunnel syndrome is the only condition petitioner suffered and that all three experts opining for both parties agree that carpal tunnel syndrome would not have been caused by vaccination. (ECF No. 42, p. 18.) Respondent stresses Dr. Anand’s opinion that petitioner’s initially reported symptoms were not typical of SIRVA as well as Dr. Cagle’s opinion that “the simple presence of a rotator cuff tear does not indicate an injury or even a painful condition.” (Id. (quoting Ex. C, p. 2).) Respondent argues that Dr. Cagle’s explanation of carpal tunnel syndrome leading to shoulder pain is more credible that Dr. Natanzi’s invocation of two separate conditions, namely carpal tunnel syndrome and a separate rotator cuff injury. (Id. at 15- 16.) The nature and timing of onset of petitioner’s reported post-vaccination symptoms is separately discussed under Althen prong three. However, even if finding petitioner has met his burden under Althen prong three, respondent would still argue that petitioner’s condition is explained solely by carpal tunnel syndrome, for which there is no opinion supporting vaccine causation. (ECF No. 40, pp. 17-19.) Respondent is unpersuasive in arguing that petitioner’s carpal tunnel syndrome diagnosis precludes him from demonstrating a logical sequence of cause and effect between his vaccination and his shoulder injury. First, respondent’s view is in conflict with the contemporaneous medical records. Petitioner’s orthopedist diagnosed a right shoulder condition, and ultimately recommended surgery, with full knowledge that petitioner had also been previously diagnosed with carpal tunnel syndrome. (Ex. 12, p. 195.) Although asymptomatic 12 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 13 of 16 rotator cuff pathology can sometimes be revealed incidentally on imaging, petitioner’s diagnosis was not based solely on imaging. Petitioner was seeking treatment for shoulder pain and his orthopedist also conducted a physical exam and took a history that he concluded was indicative of a rotator cuff pathology. (Ex. 5, p. 17.) While respondent’s expert, Dr. Cagle, stresses that it is possible for rotator cuff pathology to be asymptomatic, neither of respondent’s experts address the basis for the treating orthopedist’s actual diagnosis in this case. (Ex. B, p. 4.) Additionally, petitioner’s presentation is not necessarily consistent with what Dr. Cagle hypothesizes. While respondent is persuasive in contending that carpal tunnel syndrome can sometimes cause radiating pain, Dr. Natanzi is persuasive in observing that the Hagiwara case series hypothesized only that carpal tunnel syndrome may explain idiopathic shoulder pain. (Hagiwara, et al, supra, at Ex. B, Tab 2, p. 1.) In that regard, Hagiwara, et al., explicitly precluded any patient with any evidence of rotator cuff pathology. (Hagiwara, et al., supra, at Ex. B, Tab 2, p. 2.) Moreover, in both the Kummel and Zazanis and Hagiwara papers, carpal tunnel syndrome is hypothesized as the cause of shoulder pain because treatment of the carpal tunnel syndrome relieved symptoms, including those of the shoulder. (Kummel & Zazains, supra, at Ex. B, Tab 3; Hagiwara et al., supra, at B, Tab 2.) Here, however, there is no evidence that any such phenomenon occurred. Petitioner was first treated for carpal tunnel syndrome and a shoulder pathology was explored only after petitioner complained that treatment for his carpal tunnel syndrome mainly gabapentin for neuropathic pain, did not provide relief.6 (Ex. 2, pp. 52-53, 64.) Kummel and Zazanis explain that shoulder pain related to carpal tunnel syndrome is a relatively rare presentation, with only 15% of patients’ carpal tunnel syndrome patients reporting pain radiating antidromically toward the neck and shoulder. (Kummel & Zazanis, supra, at Ex. B, Tab 3, p. 1.) Notably, while respondent’s orthopedist, Dr. Cagle, opines that petitioner’s carpal tunnel syndrome may explain his shoulder symptoms, respondent’s neurologist, Dr. Anand, conspicuously did not reach any similar conclusion. To the extent Dr. Anand questions whether petitioner’s earliest symptoms, inclusive of “stiffness” are consistent with a SIRVA-like presentation, the literature filed in this case indicates that rotator cuff lesions are “one of the most common known causes of secondary stiffness.” (Zein M. Saleh, Sami Faruqui, & Abdullah Foad, Onset of Frozen Shoulder Following Pneumococcal and Influenza Vaccinations, 14 J. CHIROPRACTIC MED. 285, 288 (2015) (Ex. 25, p. 4).) In light of the above, respondent is not persuasive in contending that petitioner’s right shoulder pain should be attributed to carpal tunnel syndrome instead of his confirmed rotator cuff pathology. Accordingly, petitioner’s lack of any prior history of shoulder pain, his separate showings under Althen prongs one and three, and Dr. Natanzi’s further supporting causal opinion supporting a logical sequence of cause and 6 In addition to pain medication, petitioner was recommended to wear a wrist brace. However, he later reported that he did not wear the wrist brace because he did not think the diagnosis of carpal tunnel syndrome was correct. (Ex. 13, p. 12.) 13 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 14 of 16 effect, are sufficient for petitioner to meet his burden of proof under Althen prong two by preponderant evidence. c. Althen prong three The third Althen prong requires establishing a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1278. A petitioner must offer “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 & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). In this case, petitioner’s expert, Dr. Natanzi, opines that it is medically reasonable to infer vaccine causation where onset of symptoms occurs within 48 hours of vaccination, the same period utilized by the Vaccine Injury Table for SIRVA. (Ex. 14, p. 10.) Respondent’s experts effectively agree. (Ex. A, p. 4; Ex. B, p. 4.) Petitioner argues that respondent has raised no concern regarding the onset of his symptoms. (ECF No. 40, p. 10.) Petitioner contends that his repeated attributions of his pain to his vaccination are sufficient to evidence that onset was within 48 hours of vaccination. (Id. (citing Williams v. Sec’y of Health & Human Servs., No. 17-1046V, 2020 WL 3579763, at *5 (Fed Cl. Spec. Mstr. Apr. 1, 2020).) However, in his motion response, respondent does challenge onset, arguing that petitioner’s initial symptom complaints (made via his wife) were muscle stiffness and twitching as well as numbness and tingling in the right hand and finger, which were instead attributable to his carpal tunnel syndrome. (ECF No. 42, pp. 20-21 (citing Ex. A, pp 4-5; Ex. B, pp. 4-5).) Thus, he contends the evidence indicates there was no shoulder pain within 48 hours of vaccination. (Id. at 20.) Respondent raises an important point in noting that petitioner’s earliest reported medical histories do not indicate that petitioner was experiencing shoulder pain. (ECF No. 42, p. 20 (citing Ex. 3, pp. 8-9; Ex. 2, p. 45).) In particular, the first report of a vaccine reaction, offered three days post-vaccination, explicitly denied petitioner was experiencing any pain. (Ex. 3, p. 9.) However, these first two reports deserve less weight than a contemporaneous record would normally receive, because the description of symptoms was offered by petitioner’s wife over the telephone. Thus, the resulting record does not memorialize any direct communication between petitioner and his physician. While petitioner avers in his affidavit that his initial presentation included pain, he explains that he much more vaguely “told [his] wife that [his] right arm didn’t feel right.” (Ex. 11, ¶ 4.) In that regard, the record does seem to reflect that petitioner struggled to articulate what he was experiencing. The evidence reflects petitioner resorting to vague or colloquial expressions of his symptoms, such as his shoulder being “not right” or “jumping” and his physical therapist recorded that he had a poor understanding of his own condition. (Ex. 3, p. 9; Ex. 11, Ex. 5, pp. 31.) In contrast, when petitioner did first present to his primary care provider in person for these complained of post-vaccination symptoms, arm pain was specifically recorded 14 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 15 of 16 and the resulting differential diagnosis was between a post injection phenomenon or cervical radiculopathy, both of which potentially implicate shoulder pain. (Ex. 2, p. 49.) Thereafter, when petitioner himself presented for care, the records were clearer in capturing that he was suffering shoulder pain that began after vaccination. (Ex. 4, pp. 6-8; Ex. 5, p. 32, 65; Ex. 2, p., 74; Ex. 13, pp. 8-9.) That the first such report of shoulder pain occurred a little over two months post-vaccination is not in itself unusual. See Flores v. Sec’y of Health & Human Servs., No. No. 20-1858V, 2023 WL 4248571, at *5 (Fed. Cl. Spec. Mstr. May 24, 2023) (granting entitlement based on a Table claim and finding that petitioner reported his pain more than two months post-vaccination which was “not immediately, but not wholly attenuated and untimely”); Davenport v. Sec’y of Health & Human Servs., No. 20-206V, 2023 WL 8598645, at *4 (Fed. Cl. Spec. Mstr. Nov. 8, 2023) (granting entitlement based on a Table claim and finding that even though petitioner first sought treatment “approximately two months after vaccination,” there was preponderant evidence that petitioner’s pain began 48 hours after vaccination based on medical records that “consistently link his shoulder pain” to his vaccination); Hutchens v. Sec’y of Health & Human Servs., No. 17-797V, 2021 WL 4267579 (Fed. Cl. Spec. Mstr. Aug. 31, 2021) (finding that petitioner preponderantly established that his pain began the day of his vaccination, even though he did not report pain to a doctor until two months after his vaccination). Considered as a whole, petitioner’s medical treatment records support that he started experiencing what he perceived as a vaccine reaction within hours to a day after his vaccination (Ex. 3, p. 8; Ex. 2, pp. 49, 74; Ex. 4, pp. 6-8; Ex. 5, pp. 32, 65; Ex. 13, pp. 8-9; Ex. 11, ¶ 4) and that, while the exact nature of this condition was not clearly expressed, it did include shoulder pain and stiffness from the outset. (Ex. 3, p. 9; Ex. 2, pp. 49, 54.) In light of the above, I conclude that petitioner has satisfied Althen prong three by preponderant evidence. d. Factor Unrelated Once petitioner has satisfied his own prima facie burden, respondent has the opportunity to demonstrate, also by a preponderance of the evidence, that petitioner’s injury was nonetheless caused by a factor unrelated to vaccination. §300aa- 13(a)(1)(B); § 300aa-13(a)(2); Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013). In order to meet his burden, respondent must demonstrate by preponderant evidence “that a particular agent or condition (or multiple agents/conditions) unrelated to the vaccine was in fact the sole cause (thus excluding the vaccine as a substantial factor).” de Bazan, 539 F.3d at 1354. As with petitioner’s burden under Althen, respondent must show a logical sequence of cause and effect linking the injury to the proposed factor unrelated. Deribeaux, 717 F.3d at 1369. It need not be scientifically certain but must be legally probable. Id. Here, respondent asserts that the burden should not shift to him because petitioner has not met his own prima facie burden of proof. (ECF No. 42, p. 21.) Respondent stresses that he is not the burdened party and that he may offer evidence to challenge petitioner’s case in chief without taking on the burden of proof. (Id.) 15 Case 1:20-vv-01008-UNJ Document 46 Filed 01/17/24 Page 16 of 16 For all the reasons discussed above, however, I have concluded that petitioner did meet his prima facie burden under Althen. Accordingly, it is necessary to additionally, albeit briefly, note that respondent did not meet his burden of proof. I have already examined under Althen prong two respondent’s contention that petitioner’s condition is explained solely by carpal tunnel syndrome. Although respondent has shown that carpal tunnel syndrome can cause shoulder pain in a minority of cases, he has not demonstrated that it would be appropriate to attribute petitioner’s own shoulder symptoms to his carpal tunnel syndrome given his own clinical history. Accordingly, respondent cannot meet his shifted burden of proof. VI. Conclusion After weighing the evidence of record within the context of this program, I find by preponderant evidence that petitioner suffered a shoulder injury caused-in-fact by his September 20, 2017 flu vaccination. A separate damages order will be issued. IT IS SO ORDERED. s/Daniel T. Horner Daniel T. Horner Special Master 16 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_20-vv-01008-2 Date issued/filed: 2024-05-07 Pages: 5 Docket text: PUBLIC DECISION (Originally filed: 4/8/2024) regarding 53 DECISION Stipulation/Proffer. Signed by Special Master Daniel T. Horner. (sh). Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-01008-UNJ Document 57 Filed 05/07/24 Page 1 of 5 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-1008V Filed: April 8, 2024 UNPUBLISHED VICTOR JOHNSON, Special Master Horner Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Leigh Finfer, Muller Brazil, LLP, Dresher, PA, for petitioner. Parisa Tabassian, U.S. Department of Justice, Washington, DC, for respondent. DECISION AWARDING DAMAGES1 On August 13, 2020, Victor Johnson, “petitioner,” filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). (ECF No. 1.) Petitioner filed an amended petition on November 23, 2021. (ECF No. 25.) Petitioner alleges that he suffered a shoulder injury related to vaccine administration (“SIRVA”) as a result of the influenza (“flu”) vaccine he received on September 20, 2017. (ECF Nos. 1, 25.) On December 20, 2023, a ruling on entitlement was issued, finding petitioner entitled to compensation. On April 8, 2024, respondent filed a proffer on award of compensation (“Proffer”) indicating petitioner should be awarded $65,000.00. (ECF No. 52, p. 2.) In the Proffer, respondent represented that petitioner agrees with the proffered award. Id. Based on the record as a whole, I find that petitioner is entitled to an award as stated in the Proffer. 1 Because this document contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the document will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Case 1:20-vv-01008-UNJ Document 57 Filed 05/07/24 Page 2 of 5 Pursuant to the terms stated in the attached Proffer, I award petitioner a lump sum payment of $65,000.00 in the form of a check payable to petitioner. This amount represents compensation for all damages that would be available under § 15(a). The clerk of the court is directed to enter judgment in accordance with this decision.3 IT IS SO ORDERED. s/Daniel T. Horner Daniel T. Horner Special Master 3 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing the right to seek review. 2 Case 1:20-vv-01008-UNJ Document 57 Filed 05/07/24 Page 3 of 5 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS VICTOR JOHNSON, Petitioner, v. No. 20-1008V Special Master Daniel T. Horner SECRETARY OF HEALTH AND ECF HUMAN SERVICES, Respondent. RESPONDENT’S PROFFER ON AWARD OF COMPENSATION On August 13, 2020, Victor Johnson (“petitioner”) filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986, as amended, 42 U.S.C. §§ 300aa-1 et seq. (“Vaccine Act”), alleging that as a result of receiving the influenza (“flu”) vaccine in his right shoulder on September 20, 2017, he suffered a shoulder injury related to vaccine administration (“SIRVA”). ECF No. 1. On October 18, 2021, respondent filed his Rule 4(c) Report recommending against compensation because petitioner had not established a Table1 SIRVA claim. ECF No. 23. On November 23, 2021, petitioner filed an amended petition asserting a non-Table claim. ECF No. 25 at 1. The court dismissed petitioner’s Table claim from the initial petition for compensation, allowing the case to proceed with a causation-in-fact, off-Table claim, on April 7, 2022. ECF No. 28. On December 20, 2023, the Court issued a Ruling on Entitlement finding that petitioner is entitled to compensation.2 ECF No. 44. Respondent now files this proffer regarding the 1 The Vaccine Injury Table is located at 42 C.F.R. § 100.3. 2 Respondent has no objection to the amount of the proffered award of damages set forth herein. Assuming the Special Master issues a damages decision in conformity with this proffer, 1 Case 1:20-vv-01008-UNJ Document 57 Filed 05/07/24 Page 4 of 5 amount of damages to be awarded. I. Items of Compensation Respondent proffers that petitioner should be awarded $65,000.00 in pain and suffering. See 42 U.S.C. § 300aa-15(a)(4). Petitioner agrees. This amount represents all elements of compensation to which petitioner is entitled under 42 U.S.C. § 300aa-15(a). Petitioner agrees. II. Form of the Award Petitioner is a competent adult. Evidence of guardianship is not required in this case. Respondent recommends that the compensation provided to petitioner should be made through a lump sum payment as described below and requests that the Special Master’s decision and the Court’s judgment award the following3: a lump sum payment of $65,000.00, in the form of a check payable to petitioner. III. Summary of Recommended Payments Following Judgment Lump sum payable to petitioner, Victor Johnson: $65,000.00 Respectfully submitted, BRIAN M. BOYNTON Principal Deputy Assistant Attorney General C. SALVATORE D’ALESSIO Director Torts Branch, Civil Division HEATHER L. PEARLMAN Deputy Director Torts Branch, Civil Division respondent waives his right to seek review of such damages decision. However, respondent reserves his right, pursuant to 42 U.S.C. § 300aa-12(e), to seek review of the Special Master’s December 20, 2023, entitlement decision. 3 Should petitioner die prior to entry of judgment, the parties reserve the right to move the Court for appropriate relief. In particular, respondent would oppose any award for future, unreimbursed expenses, future lost earnings and future pain and suffering. 2 Case 1:20-vv-01008-UNJ Document 57 Filed 05/07/24 Page 5 of 5 LARA A. ENGLUND Assistant Director Torts Branch, Civil Division s/ PARISA TABASSIAN PARISA TABASSIAN Trial Attorney Torts Branch, Civil Division U.S. Department of Justice P.O. Box 146 Benjamin Franklin Station Washington, D.C. 20044-0146 Tel: (202) 305-4035 Parisa.Tabassian@usdoj.gov Dated: April 8, 2024 3