NORA BETH DORSEY, Chief Special Master.
On November 4, 2016, petitioner filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.,
On November 4, 2017, along with her petition, petitioner filed medical records marked as exhibits 1-4. (ECF No. 1.) However, petitioner did not file a statement of completion until December 19, 2016. (ECF No. 9.) Subsequently, during the initial status conference held January 13, 2017, additional outstanding medical records were identified. (ECF No. 11.) Additional records and an amended statement of completion were filed on February 27, 2017. (ECF Nos. 12-13.)
On April 28, 2017, respondent filed his Rule 4(c) Report. (ECF No. 17.) Respondent recommended against compensation in this case. (Id.) Respondent argued, inter alia, that the evidence was insufficient to show a logical sequence of cause and effect or a temporal relationship between vaccination and injury because petitioner did not seek medical attention for her shoulder injury until nearly four months after her vaccination, the injection site was not included in her vaccination record, and she did not adequately describe to her doctors the relationship between her vaccination and her shoulder pain. (Id., p. 4.)
Additional records were filed on May 23, 2017. (ECF No. 19.) Thereafter, following a status conference held by the staff attorney managing this case, the undersigned concluded that the case was ripe for a fact hearing. (ECF No. 20.) In preparation for the hearing, petitioner filed additional evidence on August 30, 2017, September 8, 2017, and September 11, 2017. (ECF Nos. 25, 27-28.)
A fact hearing was held in Washington, D.C., on September 14, 2017. (See Transcript of Proceedings ("Tr.") at ECF No. 42.) Petitioner was the sole witness. At the conclusion of the hearing, the undersigned informed the parties that she intended to issue a preliminary ruling from the bench. (Tr. 51-52.) The parties consented. (Tr. 52.) The undersigned stated that her ruling would resolve (1) the site of administration of petitioner's vaccination, (2) whether the onset of petitioner's symptoms occurred within 48 hours of vaccination, and (3) whether petitioner sustained a shoulder injury related to vaccine administration ("SIRVA"). (Tr. 52-53.)
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). Although petitioner's claim was filed before SIRVA was added to the Table, and thus cannot be found to be a SIRVA Table injury, the undersigned's findings were informed by the criteria used to evaluate such claims. (See Tr. 52-55.) The criteria 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).
With these factors in mind, the undersigned made the following preliminary findings of fact:
The undersigned further concluded that:
Tr. 55.
Following the undersigned's preliminary ruling, respondent's counsel informed the undersigned of respondent's position that the record of the case lacked any expert or physician testimony regarding whether petitioner's injury was caused-in-fact by the vaccination. (Tr. 57.) In light of respondent's position, the undersigned took judicial notice of two articles pertaining to causation of vaccine-related shoulder injuries which were filed as court exhibits. These articles are: B. Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA), 28 Vaccine 8049 (2010), filed as Court Exhibit I, and M. Bodor and E Montalvo, Vaccination Related Shoulder Dysfunction, 25 Vaccine 585 (2007), filed as Court Exhibit II. (ECF No. 29.) Respondent was provided 30 days to provide any additional evidence regarding entitlement or any response to the court exhibits. (Id.) No further filings were made and the undersigned announced the record as to entitlement closed as of October 27, 2017. (ECF No. 45.)
A cause-in-fact injury is established when petitioner demonstrates by a preponderance of the evidence: (1) she received a vaccine set forth on the Vaccine Injury Table; (2) she received the vaccine in the United States; (3) she sustained or had significantly aggravated an illness, disease, disability, or condition caused by the vaccine; and (4) the condition has persisted for more than six months. § 13(a)(1)(A). To satisfy the burden of proving causation in fact, petitioner must establish each of three factors announced by the Federal Circuit in Althen v. Sec'y of Health & Human Servs. by preponderant evidence: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a proximate temporal relationship between vaccination and injury. 418 F.3d 1274, 1278 (Fed. Cir. 2005). Proof of medical certainty is not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).