MARIA TORRES, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.
No. 19-540V
In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS
Filed: June 3, 2025
Special Master Horner
Case 1:19-vv-00540-UNJ Document 97 Filed 06/30/25 Page 1 of 13
Dorian Hurley, U.S. Department of Justice, Washington, D.C., for respondent.
RULING ON ENTITLEMENT1
On April 11, 2019, petitioner filed a petition under the
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. 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 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.
As relevant here, the Vaccine Injury Table lists SIRVA as a compensable injury if it occurs within ≤48 hours of administration of a flu vaccine.
SIRVA manifests as shoulder pain and limited range of motion occurring after the administration of a vaccine intended for intramuscular administration in the upper arm. These symptoms are thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder resulting in an inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury and abnormalities on neurological examination or nerve conduction studies (NCS) and/or electromyographic (EMG) studies would not support SIRVA as a diagnosis .... A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following:
- 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;
- Pain occurs within the specified time-frame;
Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and - 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, and any other neuropathy).
Alternatively, if no injury falling within the Table can be shown, a petitioner could still demonstrate entitlement to an award by instead showing that the vaccine recipient‘s injury or death was caused-in-fact by the vaccination in question.
For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof.
Cases in the Vaccine Program are assigned to special masters who are responsible for “conducting all proceedings, including taking such evidence as may be appropriate, making the requisite findings of fact and conclusions of law, preparing a decision, and determining the amount of compensation, if any, to be awarded.” Vaccine Rule 3(b)(1). Special masters must ensure each party has had a “full and fair opportunity” to develop the record. Vaccine Rule 3(b)(2). However, special masters are empowered to determine the format for taking evidence based on the circumstances
II. Procedural History
Based on the allegations in the petition, this case was initially assigned to the Chief Special Master as part of the Special Processing Unit (“SPU“), which is intended to expedite cases having a high likelihood of informal resolution. (ECF No. 6.) Petitioner filed medical records marked as Exhibits 1-6, an affidavit marked as Exhibit 7, and a Statement of Completion in April of 2019. (ECF Nos. 7-8.) About a year later, respondent completed a preliminary medical review and determined that additional records, namely the record of an independent medical exam (“IME“), were needed. (ECF No. 22.) Petitioner then filed disability records in November and December of 2020. (ECF Nos. 34, 36; Exs. 8-10.)
On May 25, 2021, respondent filed his Rule 4 Report, recommending against compensation. (ECF No. 44.) Regarding petitioner‘s Table SIRVA claim, respondent contended that a biceps tendon tear constituted a condition or abnormality that would otherwise explain petitioner‘s symptoms under the fourth SIRVA QAI criterion. (Id. at 8.) Respondent did not address petitioner‘s alternative cause-in-fact claim apart from noting her preponderant burden of proof in that context. (Id. at 7-8.)
Thereafter, the case was reassigned out of the SPU and to another special master. (ECF Nos. 45-46.) Petitioner then filed additional evidence in June and August of 2021 and an expert report by orthopedic surgeon Benjamin Busfield, M.D., in March of 2022. (ECF No. 47, 49, 56; Exs. 11-16.) Respondent filed a responsive expert report by orthopedic surgeon Brian Feeley, M.D., in July of 2022. (ECF No. 60; Exs. A-B.) Petitioner filed a supplemental expert report by Dr. Busfield in October of 2022. (ECF No. 64; Exs. 17-20.)
On March 20, 2023, respondent filed an amended Rule 4 Report. (ECF No. 72.) Based on review of the parties’ expert reports, respondent conceded that petitioner‘s biceps tear was likely “an incidental finding.” (Id. at 10 (quoting Ex. A, p. 4).) However, respondent‘s expert concluded that petitioner more likely suffered biceps tendinitis, unrelated to any SIRVA and without reduced range of motion. (Id. at 9-10.) Thus,
On April 29, 2024, petitioner filed a motion for a ruling on the written record, seeking a finding that she is entitled to compensation for her alleged SIRVA. (ECF No. 84.) Within her motion, petitioner primarily addressed her allegation of a Table Injury of SIRVA, but she also argued that she could meet her burden of proof for causation-in-fact and that, following either analysis, respondent could not demonstrate her injury to be due to factors unrelated to her vaccination. (Id.) Respondent filed his response on July 12, 2024. (ECF No. 86.) Respondent argued that petitioner cannot meet her burden of proof relative to either a Table SIRVA or a shoulder injury caused-in-fact by her vaccination. Accordingly, respondent stressed that the burden of proof does not shift to him to affirmatively demonstrate a factor unrelated to vaccination as the cause of petitioner‘s injury. (Id.) Petitioner filed her reply on August 19, 2024. (ECF No. 90.)
On September 10, 2024, the case was reassigned to the undersigned. (ECF No. 92.) The following day, the parties confirmed via a Joint Status Report that they believed the case remained ripe for resolution based on petitioner‘s pending motion. (ECF No. 93.)
In light of the above, I have determined that the parties have had a full and fair opportunity to present their cases and that 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“).
III. Factual History
Petitioner received the vaccination at issue in her left shoulder on October 18, 2016, at her place of employment. (Ex. 1, pp. 3-4; Ex. 3, p.20.) She was 27 years old at the time and had a history of an employment-related back injury in July of that year, for which she had previously been on modified duty and referred to physical therapy. (Ex. 3, pp. 7-10.)
About six days post-vaccination, on October 24, 2016, petitioner presented to occupational health. (Ex. 3, p. 20.) She reported that she did not think her flu vaccination had been administered correctly. She experienced “a lot of pain” in her left shoulder accompanied by numbness, tingling, and shooting pain affecting her neck and arm. (Id.) By the time of this encounter, her numbness and shooting pain had resolved, but her shoulder remained sore. She also reported difficulty with range of motion due to the pain, which was improving, as well as crepitus. (Id.) Physical exam was normal
About two weeks later, on November 8, 2016, petitioner sought the opinion of a physical medicine and rehabilitation specialist, Dr. Bajaj, regarding her left shoulder pain. (Ex. 2, p. 12.) Petitioner provided substantially the same history she had provided at her initial occupational health encounter, though it was recorded in greater detail. (Id.) However, she reported that her pain, though it had been improving, began to come back around November 4, but without trauma or injury. (Id. at 12-13.) As of her November 8 encounter, petitioner‘s pain was located on the anterior aspect of the left shoulder and around to the anterior and lateral midarm. She also continued to have cracking and popping with movement. The pain was dull at rest, sharp with movement, ranging from 6-8 on a 10-point scale, and with no numbness or tingling. (Id. at 13.) On physical exam, petitioner had slightly reduced range of motion relative to her opposite shoulder with flexion and abduction, but not internal or external rotation, though she reported pain with all of these maneuvers. (Id. at 15.) She did not have tenderness to palpation, except behind the shoulder. (Id. at 16.) She tested positive for signs of impingement (Neer and Hawkins tests5) and was negative for signs of biceps pathology (speed‘s test6). (Id.) Dr. Bajaj suspected a SIRVA and recommended an MRI to evaluate the shoulder pathology. Given the earlier radiating pain and numbness, he also felt an EMG/NCS would be appropriate to rule out any neuropathy. (Id. at 17.)
On November 14, 2016, petitioner completed the recommended EMG/NCS, which showed mild ulnar neuropathy across the wrist, but no evidence of any brachial plexopathy or radiculopathy. (Ex. 2, p. 26.) Petitioner completed the recommended
Thereafter, petitioner pursued physical therapy between December of 2016 and May of 2017. (Ex. 2, pp. 139-412.) She continued to follow up with Drs. Bajaj and Garbis and had a steroid injection into her left shoulder on February 21, 2017. (Id. at 49, 57, 65, 73.) After failing conservative measures, on June 19, 2017, petitioner underwent a left shoulder arthroscopy with debridement and a left open biceps tenodesis. (Id. at 82, 413.) Petitioner‘s post-operative diagnosis was biceps tendinopathy. During surgery, it was observed that petitioner had inflammatory tissue at the rotator interval anteriorly extending down to the biceps groove as well as some, albeit minimal, inflamed bursa in the subacromial space. (Id. at 413-14.)
Petitioner returned to physical therapy following her surgery, which she pursued from June to December of 2017. (Ex. 2, pp. 415-610, 648.) Petitioner continued to complain of pain and reduced range of motion. (See, e.g., Ex. 2, p. 98.) However, a disability claim was denied due to lack of support for any functional loss subsequent to October 27, 2017. (Ex. 10, pp. 64-65, 1084.)
a. Benjamin Busfield, M.D., for petitioner8
According to Dr. Busfield, the nature of petitioner‘s post-vaccination symptoms, the fact that symptoms occurred directly after vaccination, and the lack of any pre-existing symptoms affecting the shoulder, all point to petitioner‘s flu vaccine as the sole cause of her condition. Thus, he opines that Dr. Bajaj was correct in his initial assessment of SIRVA. (Ex. 14, p. 7.) He opines that petitioner satisfies all four of the Table SIRVA criteria. (Id. at 7-8.)
Dr. Busfield opines that the biceps tendon tear was only “an incidental finding” and that petitioner‘s SIRVA is represented by the separate finding of rotator interval inflammation observed during her surgery, which was sufficient to explain her pain. (Ex. 14, p. 8.) Dr. Busfield disagrees with respondent‘s expert‘s opinion that the inflammation around the rotator cuff is nonspecific and subjective. (Ex. 21, p. 3.) He states that
Rotator cuff inflammation indicates a pathologic process around the shoulder tendons, which is very specific. Rotator [cuff] interval inflammation is consistent with frozen shoulder and not biceps tendinitis, and I have never seen rotator [cuff] interval synovitis from isolated biceps tendinitis in my 15-year career. I see synovitis most commonly with significant rotator cuff pathology, past injury, and frozen shoulder.
(Id.) Moreover, Dr. Busfield stresses that petitioner‘s surgery included arthroscopic debridement in addition to tenodesis, confirming that the issue was not limited to biceps tendinitis. (Id.) To Dr. Busfield, the fact that Dr. Garbis‘s surgical report referenced the history of petitioner‘s vaccination under operative indications, confirms the understanding that petitioner‘s vaccination was felt to be relevant to the pathology at issue. (Id. at 4-5 (discussing Ex. 2, pp. 413-14).)
Dr. Busfield indicates that biceps tendinitis is rarely seen in isolation, noting that only 5% of patient with biceps tendinitis have primary biceps tendinitis. (Ex. 21, p. 4.) Instead, it is frequently associated with rotator cuff pathology, bursitis, labral pathology, or acromioclavicular joint pain. (Ex. 17, p. 4 (citing Douglas P. Beall et al., Association of Biceps Tendon Tears with Rotator Cuff Abnormalities: Degree of Correlation with Tears of the Anterior and Superior Portions of the Rotator Cuff, 180 AM. J. ROENTGENOLOGY 633 (2003) (Ex. 20)).) He further stresses that it is mostly seen in young athletes. (Ex. 17, p. 4; Ex. 21, p. 4.) Thus, Dr. Busfield concludes it is unlikely
Despite the focus in the medical records on a biceps pathology, Dr. Busfield stresses that petitioner‘s physical exam findings were more consistent with bursitis or frozen shoulder. (Ex. 17, p. 3.) In particular, he notes that Dr. Bajaj‘s initial evaluation documented pain radiating to the anterior and lateral mid-arm whereas biceps tendinitis classically affects the direct anterior aspect of the shoulder. (Id. (discussing Ex. 2, p. 13).) In that regard, Dr. Busfield stresses that petitioner‘s surgical findings noted inflammation affecting the anterior rotator cuff interval, which he opines is a pattern of inflammation consistent with SIRVA. (Ex. 21, pp. 2-3 (discussing Ex. 2, pp. 413-14).) Moreover, limitation in abduction and flexion was more consistent with bursitis and/or frozen shoulder. (Ex. 17, p. 3 (discussing Ex. 2, p. 13).) Petitioner was also observed to have signs of impingement and reduced range of motion on later physical exams. (Id. (discussing Ex. 2, pp. 34, 65, 414); see also Ex. 21, p. 2.)
Dr. Busfield also disagrees with respondent‘s expert regarding the significance of petitioner‘s February 21, 2017 therapeutic injection. (Ex. 17, p. 2; Ex. 21, pp. 2-3.) Whereas Dr. Feeley opined that petitioner‘s partial response to that injection is consistent with biceps tendinitis as the source of her pain, Dr. Busfield opines that intra-articular injection is not a treatment for biceps tendinitis. Instead, it would be more likely that a partial response to a glenohumeral joint injection would be indicative of an issue, such as frozen shoulder, stemming from the adjacent subacromial space. In fact, Dr. Busfield suggests that Dr. Garbis‘s decision to utilize an injection into the joint may indicate that a shoulder pathology was suspected, given that this would be clinically appropriate for petitioner‘s reduced range of motion, but not otherwise indicated based on the clinical focus on the biceps tendon. (Ex. 17, pp. 2-3.)
Dr. Busfield additionally set forth an opinion based on causation in fact. (Ex. 14, pp. 9-11.) He theorizes that an intramuscular deltoid injection can penetrate the subacromial space, resulting in either mechanical trauma or an immune response leading to inflammation that results in bursitis and impingement and, with immobilization, secondary adhesive capsulitis. (Id. at 9-10 (citing Adam T Hexler et al., Management of Glenohumeral Synovitis Secondary to Influenza Vaccination, 7 SHOULDER & ELBOW 100 (2015) (Ex. 15); Patrick J. Messerschmitt et al., Progressive Osteolysis and Surface Chondrolysis of the Proximal Humerus Following Influenza Vaccination, 35 ORTHOPEDICS e283 (2012) (Ex. 16)).) Dr. Busfield opines that petitioner‘s onset of shoulder pain within 24 hours of vaccination is consistent with the expected timing pursuant to this theory and that her post operative finding of rotator cuff inflammation and the overall circumstances of her clinical history support a logical sequence of cause and effect supporting vaccine causation. (Id. at 10-11.)
Dr. Feeley opines that petitioner‘s post-vaccination clinical presentation is explained by biceps tendinitis, rather than a SIRVA. (Ex. A, p. 4.) Moreover, he opines that a vaccine injection would not be a cause of biceps tendinitis. (Id. at 5.) Dr. Feeley suggests that petitioner‘s physical examinations consistently documented anterior pain, as well as positive signs of biceps irritation. (Id. at 4, 9.) Additionally, her MRI did not detect any bursitis, a common finding in SIRVA. (Id. at 4.) Finally, her partial response to a glenohumeral joint injection and physical therapy also point to biceps tendinitis as the source of her pain. (Id. at 4-5.) Dr. Feeley agrees that petitioner‘s biceps tear is likely to be an incidental finding, but opines that the biceps tendinitis is nonetheless the primary source of pain given the consistency of her reports of biceps pain on exam and her positive Speed‘s and Yergason‘s tests. (Id. at 4, 9; see also Ex. C, pp. 1-2.) Biceps tendinitis was the indication for her surgery, and the surgical finding of inflammation around the rotator cuff is nonspecific, subjective, and likely to be sequela of the biceps tendinitis. (Ex. A, p. 9.) By contrast, indicators of frozen shoulder and/or impingement were not consistently seen. (Id. at 9-10.)
Regarding causation-in-fact, Dr. Feeley appears to agree that vaccinations involving needle overpenetration can cause an acute inflammatory response leading to subacromial bursitis, but disputes that this type of reaction could result in a rotator cuff tear. He opines that petitioner had no bursitis or subacromial fluid collection and only mild tendinopathy in the rotator cuff. (Ex. A, p. 8.) Stressing that rotator cuff pathology is common among those over the age of 50, Dr. Feeley suggests there is a high risk of erroneous attribution when vaccine administration is merely coincidental to common shoulder pathologies. (Id. at 8-9.) He disputes any direct causal relationship between deltoid trauma (without subacromial penetration) and adhesive capsulitis. (Id. at 10.)
Dr. Feeley explains biceps tendinitis as inflammation of the long head of the biceps tendon, which can cause the tendon sheath to thicken and sometimes result in tearing. Biceps tendinitis can be associated with rotator cuff tearing in patient‘s over 50 years of age and also appear in patients between ages 30-40. (Ex. A, p. 6.) “In most cases, damage to the biceps tendon is due to a lifetime of normal activities,” with age-related degeneration worsened by overuse. (Id.) Sports, as well as repetitive manual labor, can cause overuse damage. (Id.) Biceps tenodesis has a success rate of 90%. (Id.) In petitioner‘s case, however, Dr. Feeley opines that petitioner‘s failure to improve following surgery is consistent with secondary gain relative to her workers’
V. Analysis
a. Table Injury of SIRVA
As discussed above, petitioner is entitled to a presumption of causation if she can establish by preponderant evidence that her injury arose within 48-hours of vaccination and meets the four specific criteria under the QAI that define what constitutes a Table “SIRVA.”
The fourth SIRVA criterion requires that “[n]o 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, and any other neuropathy).”
However, respondent does not defeat a Table SIRVA claim “simply by noting the presence of shoulder dysfunction beyond deltoid bursitis.” Grossmann, 2022 WL 779666
Ultimately, petitioner‘s surgery confirmed both of the pathologies informing the competing expert opinions — biceps tendinitis, as well as inflammation and synovitis at the rotator cuff. (Ex. 2, pp. 413-14.) However, Dr. Busfield has filed literature demonstrating that some conceded SIRVA cases between July 2010 and December 2016 did include findings related to the biceps tendon on MRI. (Elisabeth 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) (Ex. 18, p. 5 tbl. 5).) Moreover, the same literature indicates that rotator cuff pathology is seen in 43% of SIRVA cases, and 13.9% of SIRVA patients were first diagnosed as having a rotator cuff problem. (Id. at 5 tbls. 4 & 5.) Accordingly, petitioner‘s rotator cuff pathology is compatible with SIRVA and her biceps finding is not necessarily confounding. Regarding clinical history, Dr. Feeley‘s description of biceps tendonitis as an age-related degenerative condition is not a good fit for this petitioner, given that she suffered her alleged SIRVA at only 27 years of age. (Ex. A, p. 6.) Given all this, Dr. Feeley is not persuasive on the whole in opining that biceps tendinitis is likely to be a complete explanation for petitioner‘s clinical presentation independent of vaccination.
Instead, when petitioner was first evaluated by a specialist, Dr. Bajaj, he concluded that her physical exam was consistent with a SIRVA based on her history and her physical examination. (Ex. 2, p. 17.) At that time, petitioner had reduced range of motion as well as positive Neer and Hawkins tests, suggestive of subacromial impingement. (Id. at 15-16.) By contrast, her speed‘s test, an indicator of biceps pathology, was negative at that time. (Id. at 16.) Consistent with Dr. Busfield‘s opinion, Dr. Bajaj characterized petitioner‘s presentation as “mimicking adhesive capsulitis.” (Id. at 17.) Accordingly, petitioner‘s initial presentation is not well explained by biceps tendinitis based on the treating physician‘s evaluation. Although petitioner‘s overall course subsequently presented mixed findings with respect to rotator cuff versus biceps pathology, this does not outweigh petitioner‘s initial presentation. Dr. Bajaj and Dr. Garbis both later assessed a bicipital tear based on MRI (Ex. 6, p. 37; Ex. 2, p. 36); however, both parties’ experts have ultimately concluded that this was an incidental
b. Factor Unrelated to Vaccination
Once petitioner has met her prima facie burden of proof, the burden shifts to respondent to demonstrate that petitioner‘s injury was caused by factor(s) unrelated to vaccination.
VI. Conclusion
After weighing the evidence of record, I find by preponderant evidence that petitioner suffered a Table Injury of SIRVA resulting from the flu vaccination she received on October 18, 2016. Accordingly, petitioner is entitled to compensation for her SIRVA. A separate damages order will be issued.
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master