NORA BETH DORSEY, Chief Special Master.
On April 4, 2017, petitioner filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.,
After filing her petition, petitioner filed medical records marked as Exhibits 1 to 9 on April 14, 2017. (ECF No. 7.) Affidavits by petitioner were filed as Exhibits 10 and 11. (ECF No. 8.) Additional records were filed as Exhibits 12 to 14 on May 15, 2017. (ECF No. 10.)
The initial status conference was held with the staff attorney managing this case on June 23, 2017. (ECF No. 13.) At that time, respondent's counsel indicated that her client intended to defend the case, stressing that petitioner did not seek treatment for her alleged SIRVA until six months after her vaccination. (Id.) Respondent requested further evidence corroborating petitioner's affidavit which described reasons, including ongoing dental care, for her delay in seeking treatment. (Id.)
On August 7, 2017, petitioner filed dental records as Exhibits 15 to 17. (ECF No. 14.) On August 21, 2017, petitioner filed a supplemental affidavit as Exhibit 18 and witness affidavits as Exhibits 19 (Michael Gurney) and 20 (Diane Edmond). (ECF No. 17.) She also filed a copy of her paid leave report as Exhibit 21. (ECF No. 18.)
A further status conference was held with the staff attorney managing this case on September 21, 2017. (ECF No. 21.) At that time, respondent indicated that petitioner's supplemental filings did not alter respondent's position in the case. (Id.)
Respondent filed his Rule 4(c) Report on October 31, 2017. (ECF No. 22.) Respondent contended that petitioner's injury could not constitute a Table Injury SIRVA, because there is no documentation showing that petitioner exhibited symptoms of SIRVA within 48 hours of vaccine administration and none of her medical records describe her pain as occurring within 48 hours of vaccination. (Id. at 8.) With regard to a potential cause-in-fact claim, respondent argued that petitioner failed to provide evidence of a logical sequence of cause and effect, that she had no medical or expert opinion to support her claim, and that petitioner's medical records contradict or are insufficient to prove a temporal association between her injury and her vaccination. (Id. at 9.)
Thereafter, a video fact hearing was set for March 13, 2018.
Subsequently, the undersigned held a post-hearing status conference on April 3, 2018. (ECF No. 38.) At that time the undersigned indicated that "she finds petitioner to be a credible witness and that her testimony is credible and reasonable regarding her delay in seeking treatment of her shoulder injury. Although the delay in seeking treatment could be a factor in assessing petitioner's damages, it does not defeat petitioner's claim." (Id. at 1) Nonetheless, the undersigned indicated that expert opinion would be necessary to address the significance, if any, of potential aggravating incidents discussed in petitioner's testimony as well as symptoms of numbness, tingling, and neck pain described in petitioner's testimony.
Petitioner filed updated medical records as Exhibit 26 on May 21, 2018. (ECF No. 41.) She filed an expert report by Marco Bodor, M.D., on May 24, 2018, as Exhibit 27, with supporting literature marked as "Tabs" A to D. Dr. Bodor's curriculum vitae was filed as Exhibit 28.
On August 29, 2018, respondent filed a responsive expert report by Robert Brophy, M.D., as Exhibit A, with supporting materials filed as "Tabs" 1 and 2. Dr. Brophy's curriculum vitae was filed as Exhibit B.
Thereafter, respondent requested an opportunity to file a further response to petitioner's supplemental expert report and requested a hearing. (ECF No. 56.) The undersigned allowed respondent the opportunity to file the requested response, but declined to proceed with a hearing, indicating that "[a]t this time the undersigned does not believe that a further hearing will be necessary to resolve entitlement in this case."
Respondent filed a supplemental expert report by Dr. Brophy on December 19, 2018. (ECF No. 58.)
Petitioner filed a motion for a ruling on the record on February 27, 2019. (ECF No. 60.) Respondent's response was due by March 13, 2019, but respondent filed no response.
Accordingly, this case is now ripe for the undersigned's ruling on entitlement.
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, such as the present one, the petitioner may seek simply to 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 by the government that the injury was caused by some factor other than the vaccination.
As relevant here, effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed on the Vaccine Injury Table ("Table"). See National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, Final Rule, 82 Fed. Reg. 6294, Jan. 19, 2017; National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, Delay of Effective Date, 82 Fed. Reg. 11321, Feb. 22, 2017 (delaying the effective date of the final rule until March 21, 2017). The criteria under the QAI are as follows:
82 Fed. Reg. 6303 (Qualifications and Aids to Interpretation for SIRVA); see also National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132, Notice of Proposed Rulemaking, July 29, 2015 (citing Atanasoff S, Ryan T, Lightfoot R, and Johann-Liang R, 2010, Shoulder injury related to vaccine administration (SIRVA), Vaccine 28(51):8049-8052).
Based on the record as a whole, including the medical records, testimony, witness statements, and expert reports with supporting literature, the undersigned finds preponderant evidence that petitioner suffered a Table SIRVA. As noted above, the undersigned found petitioner credible in her testimony regarding the onset of her condition, but felt that expert opinion was necessary to speak to what, if any, significance could be attributed to two possible aggravating incidents as well as petitioner's testimony that she experienced tingling and neck pain. Upon review of the expert reports filed in this case, the undersigned is persuaded that the evidence of record does not suggest that any of these factors defeat petitioner's claim.
The facts at issue in this case need not be repeated at length. Petitioner received an influenza vaccination in her left deltoid at her primary care physician's office on October 1, 2015. (Ex. 1, p. 2.) Neither petitioner's testimony nor her medical records indicate any history of prior shoulder complaints or symptoms. On March 31, 2016, petitioner presented to her primary care doctor complaining of "[left] shoulder limitations severe pain, want to know if the flu shot she [had] could of [sic.] had a reaction." (Ex. 2, p. 4.) An orthopedist later diagnosed her with adhesive capsulitis. (Ex. 4, pp. 1-5.) An MRI conducted April 15, 2017, showed "[f]ocal superficial partial thickness undersurface tear involving the region of the posterior fibers of the supraspinatus tendon and anterior fibers of the supraspinatus tendon. There is nonspecific subcortical cystic change noted at this level within the humeral head. There is mild subacromial/subcortical bursitis. Non-detached tear of the superior anterior to posterior labrum." (Ex. 12, pp. 7-8.) Prior to seeking treatment for her shoulder pain, petitioner testified that she experienced two possible aggravating incidents, a fall on the stairs and pain when pulling on a car fender. (See, e.g. Tr. 16-18, 71-72.) Additionally, petitioner testified that she experienced neck pain as well as tingling in her fingers and a strange sensation similar to the squeezing of an elastic band. (See, e.g. Tr. 12-13, 69, 72.)
Pursuant to the Vaccine Act, the special master may find the time period for the first symptom or manifestation of onset required for a Table injury is satisfied "even though the occurrence of such symptom or manifestation was not recorded or was incorrectly recorded as having occurred outside such a period." § 13(b)(2). "Such a finding may be made only upon demonstration by a preponderance of the evidence that the onset . . . occurred within the time period described in the Vaccine Injury Table." Id.; accord Tenneson v. HHS, No. 16-1664V, 2018 WL 3083140, at *5 (Fed. Cl. Spec. Mstr. Mar. 30, 2018) (finding, despite prior records indicating non-tender extremities, that "respondent unreasonably dismisses petitioner's contemporaneous treatment records since the records were not created contemporaneously with the onset of petitioner's shoulder pain.").
Based on a review of the testimony and medical records in this case, the undersigned finds preponderant evidence that the onset of petitioner's shoulder pain occurred within 48 hours of vaccination. Although petitioner waited almost six months before seeking treatment, her first treatment record explicitly attributed her pain to her flu vaccination. Specifically, as noted above, on March 31, 2016, petitioner's primary care physician recorded a history of "[left] shoulder limitations severe pain, want to know if the flu shot she [had] could of [sic.] had a reaction." (Ex. 2, p. 4.) Her orthopedic records were less precise; however, her physical therapist recorded that petitioner "presents with long [history of] left shoulder pain that she relates to a flu shot." (Ex. 3, p. 4.) Additionally, petitioner submitted an affidavit by Dr. Marc Wladis, a cataract surgeon and petitioner's employer. (Ex. 22; Tr. 5.) Dr. Wladis recalled that petitioner "noticed significant pain in her shoulder area immediately after receiving the shot." (Id.)
Dr. Wladis also indicated that he spoke with petitioner about her shoulder pain after her vaccination and that he urged her to be patient and that her symptoms would likely resolve with time. (Ex. 22.) In addition, petitioner described other reasons why she delayed seeking treatment. In the undersigned's experience, this is not unusual among those experiencing a SIRVA. See, e.g. Cooper, 2018 WL 1835179, *2 (noting that petitioner described a delay in seeking treatment due to an extended trip to Vietnam and care for her ailing mother); Marino v. HHS, 16-622V, 2018 WL 2224736, at *2 (Fed. Cl. Spec. Mstr. Mar. 26, 2018) (noting a delay in seeking treatment due to a busy work schedule and difficulty making appointments); Almanzar v. HHS, No. 16-340V, 2017 WL 8220616, at *3 (Fed. Cl. Spec. Mstr. Dec. 21, 2017) (noting delay in treatment due to difficulty scheduling appointments and snow storms); Knauss v. HHS, 16-1372V, 2018 WL 3432906 (Fed. Cl. Spec. Mstr. May 23, 2018)(noting three month delay in seeking treatment without a specified reason).
Medical records generally "warrant consideration as trustworthy evidence." Cucuras v. HHS, 993 F.2d 1525, 1528 (Fed.Cir.1993). Notwithstanding that the precise onset is not recorded or that some records may be silent as to the cause of petitioner's shoulder pain, based on the record as a whole the undersigned finds preponderant evidence in petitioner's contemporaneous treatment records supporting her testimony linking the onset of her shoulder pain to her vaccination.
In addition, petitioner's claim is supported by expert opinion persuasively suggesting that petitioner suffered a SIRVA. Petitioner's expert, Dr. Bodor, opined that "[b]ased on my review of the records, including the 148-page transcript of March 29, 2018, Ms. Gurney sustained an injury to her shoulder at the time of her vaccination on October 1, 2015. This was caused by both needle trauma and an antigen-mediated inflammatory response followed by adhesive capsulitis (frozen shoulder), which appears to continue to the present time based on limitations of raising her arm and reaching when asked to do so during her hearing of March 29, 2018." (Ex. 27, p. 2.) Dr. Bodor further indicated that petitioner's later MRI showed abnormalities at the location of the infraspinatus-supraspinatus tendon insertion, which he opined is consistent with the manner of injection petitioner described in her testimony. (Ex. 27, p. 2.) Dr. Bodor opined that the manner of injection, combined with petitioner's low BMI
With regard to petitioner's testimony that she experienced tingling and neck pain, Dr. Bodor suggested that these symptoms may either be secondary to referred pain from needle trauma and inflammation or they may be secondary to the development of cervical radiculopathy as a result of petitioner compensating for her reduced range of motion in her shoulder. (Ex. 27, p. 3.) He noted, however, that numbness and tingling are non-specific in the setting of a normal neurological exam.
With regard to the fender pulling and staircase fall incidents described by petitioner, Dr. Bodor opined that these incidents would have been unlikely to cause petitioner pain if she had not already had a vaccine-related shoulder injury. (Ex. 27 at 3-4.) Additionally, both Dr. Bodor and Dr. Brophy opined that petitioner's superior anterior-posterior labral tear evidenced on her MRI was mostly likely a pre-existing condition rather than being caused by these incidents.
To the extent Dr. Brophy offered opinions contrary to those of Dr. Bodor, the undersigned found Dr. Brophy's reports less persuasive overall. Indeed, much of Dr. Brophy's reports are devoted to discussing the nature of adhesive capsulitis and whether it can be considered vaccine-caused in this or in any case. Specifically, Dr. Brophy opined that "Ms. Gurney suffered from a diagnosis of left shoulder adhesive capsulitis, most likely idiopathic. Idiopathic adhesive capsulitis, commonly known as frozen shoulder, has an overall incidence of 3 to 5 percent, peaking between the ages of 35 to 65 and more common in females than males." (Ex. A, p. 3.) He further opined that "there is limited evidence that a flu shot can cause adhesive capsulitis." (Id. at 4.) Although Dr. Brophy acknowledged that there is scientific literature linking the vaccination and the development of frozen shoulder, he indicated that "[t]he problem with these cases is that temporal association does not equate with causation." (Id.)
However, since Dr. Brophy's opinion is that petitioner's condition is better explained as idiopathic adhesive capsulitis, it necessarily fails to meet respondent's burden of showing the presence of a factor unrelated to vaccination. 13(a)(2)(A)(indicating that "the term `factors unrelated to the administration of the vaccine — does not include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition.") And, in any event, to establish a Table SIRVA, petitioner does not bear any burden to affirmatively prove that her adhesive capsulitis was caused by her vaccine. Her burden is to prove the elements of SIRVA as set forth in the QAI along with satisfying the timing requirements of the Vaccine Injury Table. Nothing in the QAI for SIRVA requires the presence of any specific orthopedic diagnosis and adhesive capsulitis is compatible with SIRVA. Significant in that regard, when proposing to add SIRVA to the Vaccine Injury Table, respondent specifically identified adhesive capsulitis or frozen shoulder syndrome as "diagnoses, beyond deltoid bursitis, that resulted in shoulder pain following vaccination." National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132, Notice of Proposed Rulemaking, July 29, 2015.
For all the foregoing reasons, the undersigned finds that petitioner has demonstrated by preponderant evidence that she suffered a SIRVA within the definition of the Vaccine Injury Table Qualification and Aids to Interpretation and that the first manifestation or symptom of her SIRVA occurred within 48 hours of her October 1, 2015 flu vaccination. Accordingly, petitioner is entitled to compensation for her SIRVA.
