VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-01458 Package ID: USCOURTS-cofc-1_16-vv-01458 Petitioner: Denise Goring Filed: 2016-11-04 Decided: 2019-11-15 Vaccine: Tdap Vaccination date: 2015-10-19 Condition: shoulder injury related to vaccine administration (SIRVA) Outcome: compensated Award amount USD: 75200 AI-assisted case summary: On November 4, 2016, Denise Goring, a 60-year-old adult, filed a petition for compensation under the National Vaccine Injury Compensation Program. She alleged that she suffered a left shoulder injury, specifically Shoulder Injury Related to Vaccine Administration (SIRVA), caused by a Tetanus Diphtheria acellular Pertussis (Tdap) vaccination she received on October 19, 2015. On the same date, she also received influenza and shingles vaccines in her left arm. Ms. Goring reported experiencing immediate pain and inflammation in her left shoulder following the vaccinations, which worsened over the subsequent days, leading to significant pain and limited range of motion. She sought medical treatment, including physical therapy, which provided substantial relief, although some residual limitations persisted. The respondent, the Secretary of Health and Human Services, argued that the petition was filed before SIRVA was added to the Vaccine Injury Table, requiring Ms. Goring to prove causation-in-fact rather than relying on a presumed link. The parties also disputed whether the Tdap vaccine or the shingles vaccine was the cause of the injury. Chief Special Master Nora Beth Dorsey issued a ruling on entitlement on May 6, 2019, finding that Ms. Goring had established a prima facie case that the Tdap vaccine caused her SIRVA. The Special Master determined that the respondent bore the burden of proving that unrelated factors caused the injury and had not met this burden. This ruling was based on applying the Althen test for causation-in-fact, considering the SIRVA Qualifications and Aids to Interpretation (QAI) as persuasive, and finding that Ms. Goring met all three prongs of the Althen test: a medical theory connecting the vaccine and injury, a logical sequence of cause and effect, and a proximate temporal relationship. The Special Master also found that a lipoma on Ms. Goring's back was not a cause of her shoulder symptoms. Following the entitlement ruling, a decision on damages was issued on November 15, 2019. The Special Master awarded Ms. Goring $75,200.00 in damages. This award comprised $75,000.00 for pain and suffering and $200.00 for past unreimbursable medical expenses. The Special Master noted that Ms. Goring experienced moderate to severe symptoms for approximately six months, with substantial improvement after physical therapy, but retained some residual limitations. The award was based on prior SIRVA cases with similar symptom severity and duration, and it was determined that Ms. Goring did not meet the burden for future pain and suffering, nor was the cost of a specific exercise machine deemed reasonably necessary. Theory of causation field: Denise Goring, age 60, received a Tdap vaccine on October 19, 2015, along with influenza and shingles vaccines in the same left arm. She alleged a Shoulder Injury Related to Vaccine Administration (SIRVA) caused by the Tdap vaccine. The petition was filed on November 4, 2016, prior to SIRVA being added to the Vaccine Injury Table. The case was analyzed as an off-Table, causation-in-fact claim under the Althen standard. Petitioner's counsel was Isaiah Richard Kalinowski. Respondent's counsel was Voris Edward Johnson. Chief Special Master Nora Beth Dorsey ruled on entitlement on May 6, 2019, finding petitioner established a prima facie case under the Althen test (medical theory, logical sequence, proximate temporal relationship) and that the respondent failed to prove unrelated factors (a back lipoma or the shingles vaccine) caused the injury. The Special Master found the SIRVA QAI criteria persuasive for establishing the logical sequence of cause and effect. On November 15, 2019, the Special Master awarded $75,200.00, consisting of $75,000.00 for pain and suffering and $200.00 for past unreimbursable expenses. The award reflected moderate to severe symptoms for six months with significant improvement after physical therapy, but residual limitations. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_16-vv-01458-1 Date issued/filed: 2018-12-12 Pages: 6 Docket text: PUBLIC ORDER/RULING (Originally filed: 10/31/2018) regarding 65 Findings of Fact & Conclusions of Law ( Signed by Chief Special Master Nora Beth Dorsey. )(mpj) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-01458-UNJ Document 68 Filed 12/12/18 Page 1 of 6 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-1458V Filed: October 31, 2018 UNPUBLISHED DENISE GORING, Special Processing Unit (SPU); Fact Petitioner, Hearing; Findings of Fact; Onset; v. Site of Administration; Tetanus Diphtheria acellular Pertussis (Tdap) SECRETARY OF HEALTH Vaccine; Additional Non-covered AND HUMAN SERVICES, Vaccine; Shoulder Injury Related to Vaccine Administration (SIRVA); No Respondent. Other Condition or Abnormality Isaiah Richard Kalinowski, Maglio Christopher & Toale, PA, Washington, DC, for petitioner. Voris Edward Johnson, U.S. Department of Justice, Washington, DC, for respondent. FACT RULING1 Dorsey, Chief Special Master: On November 4, 2016, Denise Goring (“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”). Petitioner alleges that she suffered left shoulder injuries caused by vaccinations she received on October 19, 2015. Petition at 1-2. The case was assigned to the Special Processing Unit of the Office of Special Masters. For the reasons discussed below, the undersigned finds that petitioner’s Tetanus Diphtheria acellular Pertussis (“Tdap”) and shingles vaccines were administered in her left arm; that the onset of petitioner’s left shoulder injuries occurred within 48 hours of her October 19, 2015 vaccinations; and that a lipoma on petitioner’s 1 Because this unpublished ruling contains a reasoned explanation for the action in this case, the undersigned intends 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). 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, the undersigned agrees that the identified material fits within this definition, the undersigned 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 “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:16-vv-01458-UNJ Document 68 Filed 12/12/18 Page 2 of 6 back was incidental and was not a condition or abnormality that explained her symptoms. I. Procedural History Prior to Hearing On November 4, 2016, Ms. Goring filed her petition (ECF No. 1). On the same day, she filed medical records marked as Exhibits 1-6 (ECF No. 4). She filed additional medical records, Exhibit 7, and a Statement of Completion on November 28, 2016 (ECF Nos. 9 and 10). The initial status conference was held on January 10, 2017 and respondent was directed to file a status report concerning the completeness of the records and how respondent intended to proceed in this case (ECF No. 11). On February 3, 2017, petitioner filed an additional medical record marked as Exhibit 8 and an affidavit designated Exhibit 9 (ECF No. 12). On February 24, 2017, respondent filed a status report identifying missing records needed to determine respondent’s position in this case (ECF No. 13). On the same day, petitioner filed a status report in response concerning the medical records identified by respondent and stating that petitioner sent a demand letter to respondent on February 24, 2017 (ECF No. 14). On February 27, 2017, the undersigned issued a scheduling order directing respondent to file a status report proposing appropriate next steps (ECF No.15). From March to June 2017 the parties engaged in discussions attempting to informally resolve this matter (ECF Nos. 16-23). On July 20, 2017, petitioner filed a status report informing the court that the parties had been unable to resolve the matter informally and proposing that the court schedule a deadline for the filing of respondent’s Rule 4(c) Report (ECF No. 25). On July 21, 2017, petitioner filed additional medical records as Exhibit 10 (ECF No. 28). On August 10, 2017, respondent filed a Rule 4(c) Report (ECF No. 29). The court scheduled a status conference to discuss with the parties how to proceed. Before the status conference took place, on August 28, 2017, petitioner filed a motion for summary judgment (ECF No. 30). The August 28, 2017 status conference was cancelled, respondent filed a response to the summary judgment motion (ECF No. 31), and petitioner filed a reply (ECF No. 32). Petitioner filed an additional affidavit on September 20, 2017 (ECF No. 33). On October 4, 2017, the undersigned denied the summary judgment motion (ECF No. 34) and directed petitioner to file additional affidavits, medical records, and an expert report (ECF No. 35). On December 13, 2017, petitioner filed additional medical records, a detailed affidavit, and medical literature (ECF Nos. 39 and 40). Also on December 13, 2017, petitioner filed a status report and request for a status conference (ECF No. 41). On January 23, 2018, the undersigned held a status conference with counsel for both parties. On January 24, 2018, petitioner filed a status report confirming that she sent a detailed counter-offer to respondent (ECF No. 44). On February 1, 2018, the undersigned issued an order directing petitioner to obtain an expert report addressing a lipoma on petitioner’s back as an alternative cause of her shoulder condition. Scheduling Order, issued Feb. 1, 2018 (ECF No. 45). In the February 1, 2018 order, 2 Case 1:16-vv-01458-UNJ Document 68 Filed 12/12/18 Page 3 of 6 the undersigned further stated that absent additional evidence, the undersigned was inclined to rule that respondent had not met his burden of proving alternate causation, in this case whether a vaccine not covered by the Vaccine Act had caused petitioner’s injury. On April 24, 2018, petitioner filed medical records from Dr. Ellis Nam of Chicago Orthopaedics & Sports Medicine, S.C. (ECF No. 50-2). On May 30, 2018, petitioner filed a May 18, 2018 addendum to Dr. Nam’s earlier records (ECF No. 53-2). On May 30, 2018, the parties and OSM staff attorneys held a status conference to discuss how to proceed. On June 1, 2018, the undersigned issued an order determining that the case should proceed to a hearing to resolve the onset of petitioner’s symptoms, the site of administration of petitioner’s vaccinations, and whether a lipoma on petitioner’s back was a condition or abnormality that would explain her symptoms (ECF No. 54). A fact hearing was thereafter scheduled for September 18, 2018. II. Fact Hearing and Ruling A fact hearing was held in Washington, D.C., on September 18, 2018. Ms. Goring was the sole witness and she appeared in person with her attorney. At the conclusion of the hearing, the undersigned informed the parties that she intended to issue a ruling from the bench. The undersigned stated that her ruling would resolve the site of vaccine administration, whether the onset of petitioner’s symptoms occurred within 48 hours of vaccination, and the role of a lipoma on petitioner’s back. Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed on the Vaccine Injury Table (“Table”). See Vaccine Injury Table: Qualifications and Aids to interpretation. 42 C.F.R. § 100.3(c)(10). Although petitioner’s claim was filed before SIRVA was added to the Table, and thus cannot be found to be a Table SIRVA claim, the undersigned’s findings were informed by the Qualifications and Aids to Interpretation for SIRVA criteria used to evaluate such claims. The criteria are as follows: 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). Id.; 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). 3 Case 1:16-vv-01458-UNJ Document 68 Filed 12/12/18 Page 4 of 6 With these factors in mind, the undersigned made the following preliminary findings of fact: There are several issues that require this fact hearing today. They include -- the several fact issues, they include the site of administration, onset, and the role of the lipoma. First, as to the site of the tetanus and shingles vaccine injections, I find that they were administered into Petitioner's left arm. I base this on a number of medical record -- a number of pieces of medical record evidence. First, the Petitioner's Exhibit 1, the vaccine administration record shows that the Petitioner received three vaccines on October the 19th, 2015, including the TDaP vaccine. Secondly, Petitioner's Exhibit 3 at 42, Dr. Noriega charted at that visit, December 22nd of 2015, that the Petitioner had left arm pain after two shots. Similarly, Dr. Townsend documented that the Petitioner complained of left shoulder pain that began after receiving two immunizations in the left arm. That was documented January 26th, 2016. Exhibit 3 at page 326. Similarly, the Center for Progressive Health, that's the natural physician, documented on February the 2nd, 2016, left shoulder pain following tetanus and shingles shots in left deltoid in October. Exhibit 2 at pages 3 and 4. Additionally, that is consistent with the Petitioner's testimony here today. Also, the medical records by the physical therapist, Shawn White, Exhibit 5 at pages 54 and 56. All of these records are consistent, showing the Petitioner consistently reported to healthcare providers, different healthcare providers, who all documented that she received her tetanus and shingles vaccines and that they were administered in her left arm. For these reasons, I find the site of her tetanus and shingles vaccines to be her left deltoid. With regard to onset, I find that the onset of pain, the initial manifestation of pain in Petitioner began within 48 hours. I base this on a number of pieces of evidence. I think the strongest evidence is that written by Dr. Perrott on February 18th, 2016, when he documented "injections in left deltoid since October" and "since then" had pain in left shoulder region. Exhibit 14 at page 3. This is also documented by Dr. Noriega on December 22nd, 2015, at Exhibit 3 at page 42; however, he used the words "left arm pain after two shots." Similarly, Dr. Townsend Scott documented left shoulder pain that began after receiving two immunizations in the left arm. Exhibit 3 at 326. And, again, the Center for Progressive Health, "left shoulder pain following tetanus and shingles shots in left deltoid" in October. Exhibit 2 at pages 3 and 4. Additionally, I find that Petitioners' testimony here today to be consistent with a very detailed explanation as to the pain and then the weakness and reduced range of motion that she experienced. I find that her pain began within 48 hours of receiving the tetanus and shingles shots in her left arm. 4 Case 1:16-vv-01458-UNJ Document 68 Filed 12/12/18 Page 5 of 6 The next issue is the role of the lipoma. Ms. Goring was seen in the Mercy Hospital Emergency Room on January 19th, 2016, by Dr. Krishna [Raol] and Dr. Michael Joo . . . . On intake, Petitioner reported that she had been having left shoulder pain after she received two immunizations in that arm about two months ago. A CT of the chest was done which showed a large [fat] density mass deep to the left serratus anterior and latissimus dorsi muscles. The impression was "Fat density mass overlying the posteriolateral left chest wall to the same muscles, which likely represents a lipoma." The diagnosis was "Shoulder pain likely related to rotator cuff pathology, possibly related to large lipoma." And Ms. Goring was instructed to follow up with her PCP. Exhibit 3 at page 298. Ms. Goring did follow up and had additional evaluation. She saw Dr. Perrott on February 18th, 2016. Dr. Perrott diagnosed her with an incidental lipoma and noted that the Petitioner agrees that excision of this is unlikely to change her shoulder problem. He charted "Shoulder, questionable rotator cuff syndrome as cause of discomfort," and referred her to PT. Exhibit 14 at 3. Following that, she saw Dr. Nam in March, March 8th, 2018. Dr. Nam documented, "She is inquiring if a lipoma on her back resulted in her left shoulder condition. I believe her lipoma seen in her CT scan of her left upper back was unrelated to her left shoulder condition she developed after her vaccination." Exhibit 24 at page 3. Dr. Nam also documented an addendum on May 18th, 2018, in which he states: Patient has an incidental lipoma on her back which was unrelated to her left shoulder condition she developed as a result of the tetanus/shingles shot in her left shoulder on October 2015. The lipoma's location is not on her back and not on her left shoulder. They are in separate, distinct anatomical locations in her body. As a result, the lipoma has no relationship to her left shoulder and has no influence in Denise developing left shoulder pain after her injection she received in October 2015. Exhibit 24 at page 2. Thus, I find that Dr. Nam has clarified the condition of lipoma, which was raised as a possible issue by the emergency room physicians, and I find that his opinions are reasonable, valid, and credible, as well as persuasive, and, thus, I find, as Dr. Nam did, I find that his opinion that the lipoma is incidental and not related or causally related to her shoulder injury related to vaccine administration or shoulder injury, I find that it is not related. These are my opinions or my factual findings, and that is the end of my factual findings. 5 Case 1:16-vv-01458-UNJ Document 68 Filed 12/12/18 Page 6 of 6 Transcript of September 18, 2018 Hearing, ECF No. 63, at 82-86.3 III. Closing of the Record Regarding Entitlement Following the hearing, 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. 64). The parties have been provided until December 7, 2018 to provide additional evidence concerning entitlement or any response to the court exhibits, and memoranda addressing the implications of petitioner’s receipt of a vaccine covered by the Vaccine Program and a non-covered vaccine in her injured arm. Id. Thereafter, the record will close and the undersigned will issue a decision or ruling on entitlement. IV. Conclusion In light of all of the above, and in view of the submitted evidence, including the medical records, credible witness testimony, and findings of fact, the undersigned finds that the site of administration of petitioner’s Tdap and shingles vaccinations was her left arm; that the onset of petitioner’s right shoulder injuries was within 48 hours of vaccination; and that petitioner’s back lipoma was incidental and not a condition or abnormality that would explain her symptoms. A scheduling order has been issued granting the parties until December 7, 2018 to submit any additional evidence on entitlement and allowing the parties to file memoranda of law addressing the implications of the fact that petitioner received both a vaccine covered by the Vaccine Program and a non-covered vaccine in her injured arm. (ECF No. 64). After the record closes, the undersigned intends to issue a decision or ruling on entitlement based on all the evidence submitted into the record, and consistent with the findings set forth in this ruling. IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 3 This ruling is not a verbatim transcript of the undersigned’s bench ruling. It includes minor changes for the purpose of readability. 6 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_16-vv-01458-2 Date issued/filed: 2019-08-20 Pages: 28 Docket text: PUBLIC DECISION (Originally filed: 05/06/2019) regarding 71 Ruling on Entitlement ( Signed by Chief Special Master Nora Beth Dorsey. )(mpj) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 1 of 28 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-1458V Filed: May 6, 2019 UNPUBLISHED DENISE GORING, Petitioner, Special Processing Unit (SPU); v. Ruling on Entitlement; Decision after Fact Hearing and Ruling; Causation- SECRETARY OF HEALTH AND In-Fact; Tetanus Diphtheria acellular HUMAN SERVICES, Pertussis (Tdap) Vaccine; Additional Non-covered Vaccine; Alternative Respondent. Causation Burden of Proof; Shoulder Injury Related to Vaccine Administration (SIRVA) Isaiah Richard Kalinowski, Maglio Christopher & Toale, PA, Washington, DC, for petitioner. Voris Edward Johnson, U.S. Department of Justice, Washington, DC, for respondent. RULING ON ENTITLEMENT1 Dorsey, Chief Special Master: On November 4, 2016, Denise Goring (“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”). Petitioner alleges that she suffered left shoulder injuries caused by vaccinations she received on October 19, 2015. Petition at 1 The undersigned intends to post this ruling on the United States Court of Federal Claims' website. This means the ruling will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material from public access. Because this unpublished ruling contains a reasoned explanation for the action in this case, undersigned is 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). 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 2 of 28 1-2. Petitioner received two vaccines, one covered and one non-covered, in the arm where she suffered an injury. The parties dispute whether this case may be analyzed as a Table case or petitioner must establish causation-in-fact; whether petitioner has established that a covered vaccine caused her injury; and who has the burden of proof as to whether factors unrelated to the covered vaccine caused her injury and whether this has been established in this case. For the reasons stated herein, the undersigned finds that, whether analyzed as a Table case or causation-in-fact case, the petitioner has established a prima facie case that she suffered a shoulder injury caused by a covered vaccine. The undersigned further determines that respondent has the burden of proof to show that unrelated factors caused petitioner’s injury and that he has not met this burden. I. Procedural History On November 4, 2016, Ms. Goring filed her petition (ECF No. 1). On the same day, she filed medical records marked as Exhibits 1-6 (ECF No. 4). The case was assigned to the Special Processing Unit of the Office of Special Masters. She filed additional medical records, Exhibit 7, and a Statement of Completion on November 28, 2016 (ECF Nos. 9 and 10). The initial status conference was held on January 10, 2017 and respondent was directed to file a status report concerning the completeness of the records and how respondent intended to proceed in this case (ECF No. 11). On February 3, 2017, petitioner filed an additional medical record marked as Exhibit 8 and an affidavit designated Exhibit 9 (ECF No. 12). On February 24, 2017, respondent filed a status report identifying missing records needed to determine respondent’s position in this case (ECF No. 13). On the same day, petitioner filed a status report in response concerning the medical records identified by respondent and stating that petitioner sent a demand letter to respondent on February 24, 2017 (ECF No. 14). On February 27, 2017, the undersigned issued a scheduling order directing respondent to file a status report proposing appropriate next steps (ECF No.15). From March to June 2017 the parties engaged in discussions attempting to informally resolve this matter (ECF Nos. 16-23). On July 20, 2017, petitioner filed a status report informing the court that the parties had been unable to resolve the matter informally and proposing that the court schedule a deadline for the filing of respondent’s Rule 4(c) Report (ECF No. 25). On July 21, 2017, petitioner filed additional medical records as Exhibit 10 (ECF No. 28). On August 10, 2017, respondent filed a Rule 4(c) Report (ECF No. 29) asserting that petitioner had not established entitlement to compensation. The court scheduled a status conference for August 28, 2017 to discuss with the parties how to proceed. Before the status conference took place, on August 28, 2017, petitioner filed a motion for summary judgment (ECF No. 30). The August 28, 2017 status conference was 2 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 3 of 28 cancelled. Respondent filed a response to the summary judgment motion (ECF No. 31), and petitioner filed a reply (ECF No. 32). Petitioner filed an additional affidavit on September 20, 2017 (ECF No. 33). On October 4, 2017, the undersigned denied the summary judgment motion (ECF No. 34) and directed petitioner to file additional affidavits, medical records, and an expert report (ECF No. 35). On December 13, 2017, petitioner filed additional medical records, a detailed affidavit, and medical literature (ECF Nos. 39 and 40). Also on December 13, 2017, petitioner filed a status report and request for a status conference (ECF No. 41). On January 23, 2018, the undersigned held a status conference with counsel for both parties. On January 24, 2018, petitioner filed a status report confirming that she sent a detailed counter-offer to respondent (ECF No. 44). On February 1, 2018, the undersigned issued an order directing petitioner to obtain an expert report addressing a lipoma on petitioner’s back as an alternative cause of her shoulder condition. Scheduling Order, issued Feb. 1, 2018 (ECF No. 45). In the February 1, 2018 order, the undersigned further stated that absent additional evidence, the undersigned was inclined to rule that respondent had not met his burden of proving alternative causation. Id. On April 24, 2018, petitioner filed medical records from Dr. Ellis Nam of Chicago Orthopaedics & Sports Medicine, S.C. (ECF No. 50-2). On May 30, 2018, petitioner filed a May 18, 2018 addendum to Dr. Nam’s earlier records (ECF No. 53-2). On May 30, 2018, the parties and OSM staff attorney held a status conference to discuss how to proceed. On June 1, 2018, the undersigned issued an order determining that the case should proceed to a hearing to resolve the onset of petitioner’s symptoms, the site of administration of petitioner’s vaccinations, and whether a lipoma on petitioner’s back was a condition or abnormality that would explain her symptoms (ECF No. 54). A fact hearing was thereafter scheduled for September 18, 2018. On September 18, 2018, a fact hearing was held in Washington, D.C. Transcript of Hearing held on September 18, 2019 (“Tr.”) (ECF No. 63). Ms. Goring was the sole witness and she appeared in person with her attorney. At the conclusion of the hearing, the undersigned issued a ruling from the bench. On the same day, the undersigned issued a scheduling order directing the parties to consult and determine whether, in light of the resolution of the disputed factual issues, they were able to resolve this matter through negotiations. Scheduling Order, issued Sept. 18, 2018 (ECF No. 60). On October 3, 2018, the parties filed a joint status report stating that they had attempted in good faith to resolve this matter but were unable to do so. Joint Status Report, filed Oct. 3, 2018 (ECF No. 61). On October 31, 2018, the undersigned issued a fact ruling memorializing the bench ruling. Fact Ruling, 2018 WL 6539219 (Fed. Cl. Spec. Mstr. Oct. 31, 2018) (ECF No. 65). The undersigned first determined that petitioner’s Tetanus Diphtheria acellular 3 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 4 of 28 Pertussis (“Tdap”) and shingles vaccines were administered in her left arm. Id. at *3. Next, the undersigned determined that the onset of petitioner’s left shoulder injuries occurred within 48 hours of her October 19, 2015 vaccinations. Id. at *4.3 Finally, the undersigned determined that a lipoma on petitioner’s back was incidental and not a condition or abnormality that explained her symptoms. Id. On October 31, 2018, the undersigned issued a scheduling order filing as court exhibits two articles pertaining to causation of vaccine-related shoulder injuries. Scheduling Order, issued Oct. 31, 2018 (ECF No. 64). These articles are: S. 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. 64). In the October 31, 2018 scheduling order, the parties were given until December 7, 2018 to provide additional evidence concerning entitlement or any response to the court exhibits, and to file memoranda addressing the implications of petitioner’s receipt of a vaccine covered by the Vaccine Program as well as a non-covered vaccine in her injured arm. Id. After that time, the parties were informed, the record concerning entitlement would close and the undersigned intended to issue a decision or ruling concerning entitlement. Id. In addition, the undersigned informed the parties that as previously indicated in a February 1, 2018 scheduling order (ECF No. 45), the undersigned was inclined to rule in this case that respondent had the burden of proving alternative causation and had not met that burden. Scheduling Order, issued Oct. 31, 2018 (ECF No. 64). The undersigned cited the decision of the United States Court of Appeals for the Federal Circuit in Walther v. Sec’y of Health and Human Servs., 485 F. 3d 1146 (Fed. Cir. 2007), as establishing that once petitioner has established a prima facie case, the government bears the burden of establishing alternative causation by a preponderance of the evidence. Id. The undersigned noted that she had previously applied the reasoning set forth in Walther to find, in a case where a petitioner received both a covered and non-covered vaccine in the injured arm, that the government bears the burden of establishing that the non-covered vaccine caused the injury.4 Id. The undersigned informed the parties that absent additional evidence, she was inclined to rule in this case that petitioner had established a prima facie case and respondent had 3 The October 31, 2018 fact ruling contained a typographical error in the conclusion, stating that onset of petitioner’s right shoulder injuries was within 48 hours of vaccination. Id. at *4. As the remainder of the fact ruling makes clear, petitioner’s injuries were to her left, not right, shoulder. 4 The previous decision involving this issue is Zebofsky v. Sec’y of Health & Human Servs., No. 15- 1084V, 2017 WL 7051381 (Fed. Cl. Spec. Mstr. Sept. 28, 2017) (applying Walther and determining that respondent had not provided evidence to establish an alternative cause of petitioner’s injury in a case also involving two vaccines, one covered and one non-covered, in the same arm). No motion for review was filed following the decision. 4 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 5 of 28 not met his burden of proving that the non-covered vaccine, rather than the covered vaccine, caused petitioner’s injury. Id. Finally, in the October 31, 2018 scheduling order, the undersigned noted that respondent had, in his Rule 4(c) Report, appeared to argue that petitioner alleged that a flu vaccine in her right shoulder had caused a SIRVA in her left shoulder.5 Id. The undersigned noted that in a February 1, 2018 scheduling order (ECF No. 45), the undersigned indicated that while the petition may have been ambiguous as to which vaccine was alleged to have caused petitioner’s injury, it appeared that the claim was based on the Tdap vaccine. Id. The undersigned invited the parties to file additional evidence on this matter as well. Id. On December 4, 2018, petitioner filed a motion for summary judgment (ECF No. 66). On December 7, 2018, respondent filed a response to the court’s October 31, 2018 scheduling order (ECF No. 67). On December 13, 2018, respondent filed a response to petitioner’s December 4 summary judgment motion (ECF No. 69). On December 20, 2018, petitioner filed a reply (ECF No. 70). This case is now ripe for a decision on petitioner’s second summary judgment motion and a ruling on entitlement. II. Factual History Denise Goring was 60 years old when she received influenza, Tetanus Diphtheria acellular Pertussis (“Tdap”), and shingles vaccines at a Department of Defense installation in Texas on October 19, 2015. Petitioner’s Exhibit (“Pet. Ex.”) 1 at 1; Pet. Ex. 11 at 1; Pet. Ex. 15 at 1. The Vaccine Administration Record filed as Pet. Ex. 1 lists all three of these vaccines as having been given on that date, and lists the manufacturer and lot number, but does not list the vaccination sites. Pet. Ex. 1. Petitioner asserts in her detailed fact affidavit that the influenza vaccination was administered in her right arm, while the Tdap and shingles vaccinations were administered in her left arm. Pet. Ex. 15 at ¶ 2. She states that she remembers which vaccinations were administered into which arm because of the circumstances of their administration. Pet. Ex. 15 at ¶ 3. Specifically, she states that she went to the clinic that day only to receive a flu shot, which the technician injected into her right shoulder first. Id. However, after administering the flu shot, the technician inquired how long it had been since petitioner had a tetanus booster. Id. at ¶ 4. Petitioner asserts that the technician convinced her to have a tetanus, or Tdap, shot, which she administered into petitioner’s upper left arm since she had already administered a flu shot into petitioner’s right shoulder. Id. As petitioner and the 5 Respondent’s argument is somewhat difficult to follow but appears to be that because petitioner’s initial affidavit mentioned only the arm of vaccination of her flu shot, which was administered into her right arm, that meant that petitioner was alleging that a flu shot in her right arm caused a SIRVA in her left shoulder. To the extent that this is respondent’s interpretation, the undersigned does not agree with respondent that petitioner asserts a flu shot in her right arm caused a SIRVA in her left shoulder. 5 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 6 of 28 technician continued to talk, the technician persuaded her to get a shingles vaccination as well, which was administered into petitioner’s left arm. Id. at ¶ 5. Petitioner states that because of these circumstances, she is confident that she accurately recalls which vaccinations were administered into which arm. Id. at ¶ 6. On October 19, 2015, petitioner also presented to Dr. Judy Rattan in the optometry clinic at Randolph Air Force Base for an eye exam. Pet. Ex. 4 at 209. Prior to the October 19, 2015 vaccinations, petitioner had no prior history of shoulder pain or shoulder injury. See generally Pet. Ex. 3, Pet. Ex. 4, Pet. Ex. 7. Petitioner states in her detailed affidavit that she began to experience “distinct pain and inflammation swelling almost immediately” after the vaccines were administered. Pet. Ex. 15 at ¶ 7. Petitioner testified that at the moment of injection, she “didn’t feel anything on my right side where my flu shot was . . . I felt like a tingling on my left side . . . . . [after the administration of] both the tetanus and the shingles [vaccines].” Tr. 10- 11. She testified that she began to experience soreness in her left shoulder “immediately pretty much after she administered those two [tetanus and shingles vaccines] in my left arm . . . what kind of startled me, I noticed that it was kind of inflamed.” Tr. 11. Petitioner states that the pain began before she left the clinic, that she inquired about it and was told it was normal and would go away. Pet. Ex. 15 at ¶ 7. Petitioner states that the area surrounding the injection site on her upper left arm was noticeably swollen by the time she returned to the place where she was staying in Texas. 6 Id. Petitioner’s detailed affidavit states that the day following the vaccine “the pain [in her left arm] became so bad, I knew there was a problem.” Id. at ¶ 8. Petitioner states that she telephoned the clinic and was again assured that the pain was normal and would go away. Id. Petitioner states that by the second day after vaccination, the pain remained and she also had difficulty with movement in her left arm. Id. at ¶ 9. Petitioner states that she again called the clinic and was told not to worry and that the pain could be expected to continue for the next two weeks before going away. Id. In her detailed affidavit, petitioner states that by one week following vaccination, she “could not move my left arm nearly at all, and it was basically incapacitated from that point onward.” Id. at ¶ 10. She states that she “could barely lift my arm to comb my hair, and could hardly use my left hand at all.” Id. After two weeks passed and she was still in pain, she called the facility again but “they again dismissed my concerns, stating that sometimes it can take even longer for the pain to go away.” Id. at ¶ 11. She states that she “could see that the staff at the clinic were not taking this injury seriously [and] decided I needed to set up an appointment with my doctor in Chicago for when I returned there from Texas.” Id. 6 At the hearing, petitioner explained that she lives in Chicago but visits San Antonio twice a year to visit her grown children and that while she is there she sees her dentist and medical providers. Tr. 55. 6 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 7 of 28 Petitioner asserts that she does not have records from October or November documenting her injury because her concerns were not taken seriously initially and because she was unable to obtain an appointment when she sought evaluation and treatment. Pet. Ex. 15 at ¶ 21. In her detailed affidavit, petitioner states that she called her primary care physician in Chicago seeking an appointment before the end of November, but the soonest she could obtain an appointment was in late December. Pet. Ex. 15 at ¶ 12. Petitioner states that she was finally able to see Dr. Karen Noriega on December 22, 2015. Id. at ¶ 13. On December 22, 2015, petitioner presented to Dr. Karen Noriega at Mercy Hospital and Medical with a chief complaint of “LT [left] ARM PAIN AFTER 2 SHOTS x 2 MONTHS; GETTTING WORST.” Pet. Ex. 3 at 42. In the same paragraph, the visit notes state that she complained of “left arm pain after shingles vaccination 10/2015 in texas military base, pt [patient] feels pain is worsening where she cannot lift her left arm over her head.” Id. While the medical record reflects that petitioner attributed her pain to her shingles vaccination, petitioner testified that she “mentioned all three” vaccines that she had received. Tr. 21. On examination, her left arm was found to have decreased range of motion and tenderness to deep palpation. Id. at 45. She could not lift her left arm above her head and her left arm was weaker than her right arm. Id. Dr. Noriega ordered a CT scan of petitioner’s left shoulder. Id. Petitioner states that Dr. Noriega prescribed pain medication and referred her for an MRI; however, her insurance declined coverage for the MRI because she had not first had an x-ray. Pet. Ex. 15 at ¶ 14. On January 19, 2016, petitioner presented to the emergency room at Mercy Hospital and Medical Center with a chief complaint of left arm pain. Pet. Ex. 3 at 278. She complained of left shoulder pain “ongoing since 10/2015, states she first felt pain after she received vaccine for shingles. Since then has had significant pain and has experienced limited range of motion of LUE [left upper extremity, or arm] and shoulder. Id. at 298. On examination, she was found to have mild tenderness to palpation and limited range of motion in her left shoulder. Id. She was given shoulder x-rays, which did not identify any fracture or dislocation. Id. at 294. She was also given a chest CT, which noted a fat density mass “which likely represents a lipoma.” Id. at 296. The examining physician found that the pain was reproducible with range of motion of the left shoulder. She was diagnosed with left shoulder pain not otherwise specified, left posterior chest wall lipoma, and possible adrenal lipoma. The [doctor] noted that the pain was “chronic in nature since 10/2015 limiting movement” and determined that the shoulder pain was “likely related to rotator cuff pathology, possibly related to large lipoma.” Pet. Ex. 3 at 298. Petitioner was discharged and directed to follow up with her primary care physician. Id. Petitioner states that the “lipoma was on my back and side, essentially, below my shoulder and scapula . . . not near my shoulder.” Id. Petitioner asserts that the lipoma 7 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 8 of 28 “has been present on my back for about 15 years, and has never caused me adverse symptoms or concern.” Pet. Ex. 15 at ¶ 18. In her detailed affidavit, executed on December 11, 2017, petitioner asserts that “[t]o this day, the Lipoma is still on my back.” Pet. Ex. 15 at ¶ 20. She asserts that as her injury developed and later improved, the lipoma has remained there. Id. On January 26, 2016 petitioner presented to Dr. Kimberly Townsend-Scott. Pet. Ex. 3 at 326. At this visit, she complained of left shoulder pain that she reported began after receiving two immunizations in her left arm. Id. Petitioner reported having been seen in the emergency room for this and directed to follow up with her doctor, but reported she was unable to get an appointment with her primary doctor, Dr. Dhir, until March 2016. Id. She was diagnosed with left arm pain, lipoma, adrenal mass, and hypertension. Id. at 331. Dr. Townsend-Scott referred her to surgery for evaluation and possible excision of the lipoma. Id. at 332. For her shoulder pain, Dr. Townsend-Smith discussed physical therapy if excision of the lipoma did not provide relief. Id. On February 2, 2016, petitioner was seen by Dr. Nicholas Leroy at the Center for Progressive Health. Pet. Ex. 2 at 3-4; Tr. 74. The visit notes reflect that petitioner was seen for left shoulder pain following tetanus and shingles shots in her left deltoid in October. Pet. Ex. 2 at 4. Petitioner reported that she could not raise her left arm above horizontal. She reported fever and night sweats since the vaccinations. Id. On examination, she was found to be severely restricted in internal and external rotation in her left shoulder. She was found to have tenderness in her left deltoid muscle, left subscapularis muscle, and left infraspinatus muscle. Id. Dr. Leroy assessed petitioner as having left “rot. [rotator] cuff syndrome 2° [secondary] to Oct 2015 vaccine shots [in left] deltoid.” Id. at 3. Myofascial release for rotator cuff or physical therapy was recommended. Id. On February 18, 2016, petitioner presented to Dr. Andrew Perrott. Pet. Ex. 14 at 3. She reported that she had injections in her left deltoid in October and since then had pain in her left shoulder region, particularly with certain movements. Id. She had a deep-seated lipoma of the left chest wall, but it was not tender. Id. On physical examination, petitioner was found to have restriction in left shoulder movement with abduction of about 60 degrees and extension of 90 degrees. Id. at 4. Dr. Perrott diagnosed petitioner with an “incidental lipoma” and noted that petitioner “agrees that excision of this [is] unlikely to change [her] shoulder problem.” Id. He added, “Shoulder ? rotator cuff syndrome as cause of her discomfort.” Id. Dr. Perrott discussed referral to an orthopedist or physical therapy and petitioner stated that she would like to try physical therapy first. Id. Dr. Perrott ordered physical therapy consultation and treatment. Id. at 7. On March 28, 2016, petitioner underwent an initial physical therapy evaluation for her left shoulder pain. Pet. Ex. 5 at 54. She reported that in the end of October 2015 she had tetanus and shingles vaccines in her left arm and after two weeks the pain in 8 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 9 of 28 her left shoulder increased. Id. She reported noticing tissue changes in her left shoulder following the shot and having pain. Id. She initially had pain at rest in her left shoulder, but at the time of evaluation she experienced pain only with movement. Id. at 56. She reported limited range of motion when putting her arm behind her back and reaching over her head. Id. On examination, she was found to have limited and painful range of motion and reduced strength in her left shoulder. Id. at 55. She had tenderness to palpation over the insertion of her left deltoid and her upper trapezius muscle and positive signs on Hawkins and Kennedy impingement tests. Id. On April 18, 2016, petitioner presented to Universal City Family Practice in Universal City, TX, to follow up on labs. Pet. Ex. 7 at 3. The visit notes are handwritten and difficult to read. There appears to be a mention of her left shoulder problem, but the notes are unclear as to what was discussed or recommended. Id. at 4. On November 7, 2016, petitioner was seen by Dr. Kokebie for a rheumatology consultation with a chief complaint of right wrist and right knee pain. Pet. Ex. 10 at 1. Petitioner reported that her right knee pain started in August after a car accident. Id. Petitioner reported that the right wrist pain “started 2 months ago since she was favoring her right arm due to tetanus and zoster vaccines in the left shoulder [which] was [very] painful.” Id. On March 8, 2018, petitioner presented to Dr. Ellis Nam of Chicago Orthopaedics and Sports Medicine, S.C. for examination. Pet. Ex. 23 at 3. She reported left shoulder pain that began “2 years ago, October 2015, after she had a tetanus/shingles shot in her left shoulder. No prior problems left shoulder prior to the injection.” Id. Dr. Nam assessed petitioner as having left shoulder pain following tetanus and shingles vaccinations in October 2015, with “possible [rotator] cuff tear.” Id. at 4. He recommended an MRI of the left shoulder to rule out a rotator cuff tear, but noted that petitioner did not want a left shoulder MRI. Id. Dr. Nam noted that petitioner inquired whether a lipoma on her back resulted in her shoulder condition. He stated, “I believe her lipoma seen in her ct scan of her left upper back was unrelated to her left shoulder condition she developed after her vaccination.” Id. On May 18, 2018, Dr. Nam added an addendum to petitioner’s medical records. Pet. Ex. 24. On May 30, 2018, petitioner filed Exhibit 24 and Exhibit 25, the curriculum vitae of Ellis Kevin Nam, M.D. Exhibit 25 was labeled in CM/ECF as “Expert CV” (ECF No. 53). In Exhibit 24, Dr. Nam stated: Patient has an incidental lipoma on her back which was unrelated to her left shoulder condition she developed as a result of the tetanus/shingles shot in her left shoulder on October, 2015. The lipoma’s location is on her back and NOT on her left shoulder. They are in separate distinct anatomic locations in her body. As a result, the lipoma has no relationship to her left shoulder and has no influence in [petitioner] developing left shoulder pain after her injection she received on October, 2015. 9 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 10 of 28 Pet. Ex. 24 at 1. III. Parties’ Arguments a. Petitioner’s Arguments In her summary judgment motion filed on December 4, 2018 (“Petitioner’s Second MSJ”) (ECF No. 66-1), petitioner asserts that she has satisfied the requirements of § 13 of the Vaccine Act by establishing the factual matters set forth in § 11(c)(1). Specifically, petitioner asserts that she has shown that she received the Tdap vaccine, which is set forth in the Table; received the vaccine in the United States; sustained a SIRVA as described in the QAI within the time set forth in the Table; suffered the residual effects of her injury for more than six months after vaccination; and has not previously collected an award or settlement of a civil action for damages for such vaccine-related injury. Petitioner asserts that respondent has not met the burden required by § 13(a)(1)(B) to rebut petitioner’s proof establishing entitlement because respondent has not filed any evidence to meet this burden. Petitioner asserts that she has established that the Table criteria for SIRVA are met. In short, petitioner argues that respondent bears the burden of proof of demonstrating the shoulder injury was caused by the shingles vaccination rather than the Tdap vaccination, and that respondent has not met this burden. b. Respondent’s Arguments Respondent argues that because the petition in this case was filed prior to SIRVA being added to the Table, petitioner is not entitled to a presumption of causation and must prove that the vaccine actually caused her SIRVA. Respondent’s December 7, 2018 Brief in Response to October 31, 2018 Scheduling Order (“Respondent’s December 7, 2018 Brief), filed Dec. 7, 2018, at *2 (ECF No. 67). Respondent asserts that petitioner must establish by preponderant evidence that the Tdap vaccination, rather than the shingles vaccine, was the cause of her SIRVA. Id. at 2-3. Respondent asserts that “there is no evidentiary basis for [the undersigned] to conclude that the Tdap vaccine was more likely than the shingles vaccine to have caused petitioner’s SIRVA, and indeed any such finding to that effect would constitute legal error.” Id. at 3. Respondent acknowledges that petitioner could re-file her petition to allege a Table SIRVA claim but asserts that because she has not done so, “her claim therefore must be analyzed under the legal standards in effect on the date her petition was filed.” Id., at *2 n.2. Respondent asserts that because the intramuscular administration of any vaccine could potentially cause a SIRVA, it is reasonable to infer in this case that the non-covered vaccination alone, in this case shingles, caused petitioner’s SIRVA. Respondent’s Opposition to Petitioner’s Second Motion for Summary Judgment (“Respondent’s Opposition to Second MSJ”), filed Dec. 13, 2018, at *2 (ECF No. 69). 10 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 11 of 28 Respondent cites Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986), for the proposition that, in evaluating a summary judgment motion, all justifiable inferences should be drawn in favor of the non-movant. Id. Respondent asserts that petitioner cannot show that the covered vaccination more likely than not caused her SIRVA and thus “there is a genuine dispute as to a material fact that precludes summary judgment for petitioner.” Id. Respondent declined to submit evidence concerning entitlement. Respondent’s December 7, 2018 Brief at *1 n.1 (ECF No. 67) (“Respondent elects not to submit any additional evidence at this time, because he is not the burdened party and because, as explained herein, the record evidence currently fails to satisfy petitioner’s burden of proof as a matter of law”) (emphasis added). IV. Summary Judgment Standards for Adjudication and Analysis Pursuant to Vaccine Rule 8(d), a special master may decide a case based on a summary judgment motion. If a summary judgment motion is filed, Rule of the Court of Federal Claims (“RCFC”) 56(a) applies and allows the court to decide a claim on summary judgment “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” “The party moving for summary judgment ‘bears the burden of demonstrating absence of all genuine issues of material fact.’” Jay v. Sec’y of Health and Human Servs., 998 F.2d 979, 982 (Fed. Cir. 1993) (quoting SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1116 (Fed.Cir.1985) (en banc)). If the evidence presented is insufficient to permit a reasonable factfinder to find in favor of the nonmoving party, there is no genuine issue of material fact. Jay, 998 F.2d at 982 (citing Anderson, 477 U.S. at 249). “The summary judgment inquiry in essence is whether the evidence presents a sufficient disagreement of fact to require submission to the factfinder or whether it is ‘so one-sided that one party must prevail as a matter of law.’” Id. The existence of a dispute as to a legal issue does not preclude the entry of summary judgment. See Howes v. Medical Components, Inc., 814 F.2d 638, 643 (Fed. Cir. 1987) (in patent case, stating that claim construction is a question of law and “the mere existence of a dispute as to that legal issue does not preclude summary judgment”). In the October 31, 2018 fact ruling, the undersigned resolved several disputed factual issues, including the site of administration of petitioner’s October 19, 2015 vaccinations, the onset of her shoulder injury, and whether a lipoma on her back caused her shoulder symptoms. Respondent appears to assert that whether a non-covered vaccination, shingles, caused petitioner’s injury is a disputed material fact that precludes summary judgment. However, respondent concedes that “the record evidence establishes, at best, that the Tdap vaccine and the shingles vaccine were both equally likely to have caused 11 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 12 of 28 petitioner’s SIRVA.” Respondent’s December 7, 2018 Brief at *1-2 (ECF No. 67) (emphasis added). Respondent has offered no proof to demonstrate that the non-covered shingles vaccine was more likely than the Tdap vaccine to have caused petitioner’s SIRVA or that the Tdap vaccine did not cause petitioner’s SIRVA. Thus, the evidence is insufficient to permit a reasonable factfinder to find in respondent’s favor. Therefore, under the Jay standard, there is no genuine issue of material fact in this case and summary judgment is appropriate. Moreover, with respect to the “fact” that respondent asserts is disputed, the undersigned has made all factual findings that can be made on this issue based on the evidence in the record, and the remaining issues pertain to the legal implications of the facts that have been found. All that remains to be resolved concerning entitlement in this case are the following issues: whether petitioner’s case may be analyzed as a Table case or petitioner must establish causation in fact; whether petitioner has established causation under the appropriate standard; and how to analyze the effect of a potential alternative cause and who bears the burden of proof on a potential alternative cause pursuant to § 13(a)(1)(B). There are no remaining issues of material fact. Thus, this case is appropriate for resolution on summary judgment.7 The court previously informed the parties that on December 7, 2018, “the record in this matter with regard to entitlement will close and a ruling or decision will issue thereafter.” Scheduling Order, issued Oct. 31, 2018 (ECF No. 64). The parties have had ample opportunity to submit evidence and arguments on the issue of entitlement. The undersigned has fully considered the issues raised in Petitioner’s Second MSJ [ECF Nos. 66, 66-1], Respondent’s Opposition to Second MSJ [ECF No. 69], petitioner’s reply (“Petitioner’s Reply, Second MSJ”) [ECF No. 70], and Respondent’s December 7, 2018 Brief [ECF No. 67]. For the reasons described below, the undersigned finds that petitioner is entitled to compensation. V. Legal Standard for Establishing Causation In order to establish entitlement to compensation under the Vaccine Act, a petitioner must demonstrate, by a preponderance of evidence, all matters required under Section 11(c)(1). § 13(a)(1)(A). In determining whether a petitioner has done so, the special master or court should consider the record as a whole. § 13(a)(1). Petitioner’s allegations must be supported by medical records or by medical opinion. Id. 7 Even if summary judgment were not appropriate, this is a case where a motion for a ruling on the record could have been filed and granted in petitioner’s favor. See Vaccine Rule 8(d) (allowing a special master to decide a case on the basis of written submissions). The parties have fully briefed the disputed issues concerning entitlement in the summary judgment motion papers and respondent’s December 7, 2018 brief. Thus, the undersigned determines that it is appropriate to determine entitlement. 12 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 13 of 28 In addition to requirements concerning the vaccination received, the duration and severity of petitioner’s injury, and the lack of other award or settlement,8 a petitioner must establish that she suffered an injury meeting the Table criteria, in which case causation is presumed, or an injury shown to be caused-in-fact by the vaccination she received. § 11(c)(1)(C). The most recent version of the Table, which can be found at 42 C.F.R. § 100.3, identifies the vaccines covered under the Program, the corresponding injuries, and the time period in which the particular injuries must occur after vaccination. § 14(a). The injury alleged in this petition is a shoulder injury related to vaccine administration (“SIRVA”). Petition (ECF No. 1) at *1-3. SIRVA was added to the Vaccine Injury Table effective for petitions filed on or after March 21, 2017. The petition in this case was filed on November 4, 2016, four months prior to the effective date of the amendments adding SIRVA to the Table. If the petition in this case had been filed on or after March 21, 2017, as it could have been under the lookback provision in § 16(b), the parties agree that the revised Table would be applicable. See, e.g., respondent’s statement that “[r]espondent acknowledges that petitioner could dismiss the instant claim and re-file her petition to allege a Table SIRVA claim. However, she has not done so, and her claim therefore must be analyzed under the legal standards in effect on the date her petition was filed.” Respondent’s December 7, 2018 Brief at *2 n.2 (ECF No. 67). Because this case was filed prior to the effective date of the Table amendments, the parties dispute whether it may be analyzed as a Table case. In August 2017, the parties debated this issue in their submissions for and against the first summary judgment motion. This issue was also contested in respondent’s Rule 4(c) Report, Respondent’s December 7, 2018 Brief, and the submissions for and against the second summary judgment motion filed in December 2018. Both parties agree that pursuant to Vaccine Act § 14(c)(4), any Table modifications “shall apply only with respect to petitions for compensation under the Program which are filed after the effective date of such regulation.” See Petitioner’s First Motion for Summary Judgment, filed Aug. 28, 2017 (ECF No. 30-1), at *8; Respondent’s Response to First Motion for Summary Judgment, filed Aug. 30, 2017 (ECF No. 31), at *13. However, they differ in their view as to how respondent has implemented Table modifications in the past. Petitioner argues that this case should be treated as a Table case. In the Summary Judgment Motion filed on August 28, 2017 (ECF No. 30), petitioner asserted that respondent had a long-standing policy of applying Table changes without reference 8 In summary, a petitioner must establish that she received a vaccine covered by the Program, administered either in the United States and its territories or in another geographical area but qualifying for a limited exception; suffered the residual effects of her injury for more than six months, died from her injury, or underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or collected an award or settlement for her injury. See § 11(c)(1)(A)(B)(D)(E). 13 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 14 of 28 to whether the petition was filed before or after the Table changes took effect. Petitioner’s First Summary Judgment Motion, filed Aug. 28, 2017 (ECF No. 30-1). Petitioner argued that respondent has conceded many cases in recent years that would only have become Table injuries once the recent Table changes took effect in March 2017. Id. at *9-10. In his response to the first summary judgment motion, respondent stated that “had respondent determined that the facts of this case met the Table criteria, respondent would have conceded entitlement to compensation.” Response to First Motion for Summary Judgment, filed Aug. 30, 2017, at *14 (ECF No. 31). Yet in Respondent’s December 7, 2018 Brief, respondent asserted that because this case was filed before the Table amendments took effect, “petitioner may not take advantage of the benefits of presumed causation afforded to Table injury claims.” Respondent’s December 7, 2018 Brief at *2 (ECF No. 67). Respondent acknowledges that “petitioner could dismiss the instant claim and re-file the petition to allege a Table SIRVA claim. However, she has not done so, and her claim therefore must be analyzed under the legal standards in effect on the date her petition was filed.” Id. at n.2. Thus, respondent appears to have taken inconsistent positions, having earlier stated that if this case met Table criteria respondent would have conceded the case, yet now asserting that this case cannot be treated as a Table case because petitioner did not dismiss this case and file a new petition. While petitioner could have filed a new petition following the effective date of the Table amendments adding SIRVA to the Table,9 she did not. Petitioner’s assertion that respondent’s practice is to concede cases meeting Table criteria even if the petition was filed prior to the Table revision is supported by respondent’s earlier assertion that “had respondent determined that the facts of this case met the Table criteria, respondent would have conceded entitlement to compensation.” Respondent’s Response to First Motion for Summary Judgment, filed Aug. 30, 2017, at *14 (ECF No. 31). Nevertheless, the undersigned cannot ignore the clear language of § 14(c)(4) that Table modifications “shall apply only with respect to petitions for compensation” filed after the effective date of the Table revisions. Thus, the undersigned proceeds to analyze this case as if the March 21, 2017 revisions adding SIRVA to the Table do not expressly govern entitlement in this case. The undersigned finds that whether this is analyzed as a Table case or a causation-in-fact case, petitioner has established a prima facie case and respondent has not established that a factor unrelated to the Tdap vaccine caused petitioner’s SIRVA. For purposes of this ruling, the undersigned treats this case as a causation-in- 9 Section 11(b)(2) states that “[o]nly one petition may be filed with respect to each administration of a vaccine.” Nevertheless, § 16(b) creates an exception to this limitation in cases where the Table is revised and “the effect of such revision is to permit an individual who was not, before such revision, eligible to seek compensation under the Program, or to significantly increase the likelihood of obtaining such compensation.” 14 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 15 of 28 fact case subject to the standard set forth in Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). In a causation-in-fact case, the burden is on the petitioner to introduce evidence demonstrating that the vaccination actually caused the injury in question. Althen, 418 F.3d at 1278; Hines v. Sec’y of Health and Human Servs., 940 F.2d 1518, 1525 (Fed. Cir. 1991). The showing of “causation-in-fact” must satisfy the “preponderance of the evidence” standard, the same standard ordinarily used in tort litigation. § 13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that standard, the petitioner must show that it is “more probable than not” that the vaccination was the cause of the injury. Althen, 418 F.3d at 1279. The petitioner need not show that the vaccination was the sole cause or even the predominant cause of the injury or condition, but must demonstrate that the vaccination was a legal cause by showing that the vaccine was at least a “substantial factor” in causing the condition. Shyface v. Sec’y of Health and Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). If petitioner makes this showing, petitioner has established that the vaccine is a legal cause of the harm. Id. In Althen, the Federal Circuit articulated a three-part test incorporating requirements established in other decisions for demonstrating causation. The Althen court explained this “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). In finding causation, a 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.” Id. at 1280. Petitioner may establish a prima facie case that her injury was caused by a covered vaccine by satisfying the Althen test. Deribeaux v. Sec’y of Health and Human Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013). “Once a petitioner establishes her prima facie case by satisfying the Althen test, the burden then shifts to the respondent to show by a preponderance of the evidence that the injury is due to factors unrelated to the administration of the vaccine. Id. In determining whether a petitioner alleging a SIRVA has met the Althen criteria, the undersigned considers the Qualifications and aids to interpretation (“QAI”) included 15 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 16 of 28 in the revised Table for SIRVA to be persuasive regarding the factors necessary to demonstrate a logical sequence of cause and effect in a SIRVA case, even if the petition was filed prior to the effective date of the Table modification. Whether a petition alleging a SIRVA was filed before or after the effective date of the Table modification has no impact on the scientific or medical understanding of the injury or mechanism of injury. In either case, the same issues are relevant to assessing causation. The Table criteria and QAI are the very criteria that the Secretary of Health and Human Services has determined are relevant to causation in a SIRVA case. Thus, the SIRVA Table criteria and QAI provide a framework for assessing causation in SIRVA cases regardless of whether they are analyzed under the Table or the Althen factors. Therefore, the undersigned determines that in a case involving a SIRVA, the Table criteria and QAI are relevant to an analysis of whether a vaccine caused a SIRVA, regardless of whether the petition was filed before or after the date when the modification adding SIRVA to the Table became effective. In a case filed after the Table modification took effect, the analysis involves a straightforward determination of whether the Table and QAI criteria are met. In a case filed before the Table modification became effective, the analysis is slightly different but nevertheless involves application of the Table and QAI criteria. In such a case, the undersigned determines that the proper analysis is to apply Althen to determine whether a petitioner has proved her injury was caused in fact by the vaccination in question, and to use the Table and QAI as instructive in determining whether petitioner has met that burden. VI. Analysis of Causation Below, the undersigned first analyzes the three Althen prongs to determine whether petitioner has established a prima facie case that a covered vaccine caused her SIRVA. Next, because respondent asserts that a factor unrelated to the administration of a covered vaccine caused petitioner’s injury, the undersigned analyzes which party has the burden of proof with respect to the “factors unrelated” and whether that burden of proof has been met. For the reasons set forth below, the undersigned finds that petitioner has established that the Tdap vaccine was a substantial factor in causing her SIRVA. Next, the undersigned finds that pursuant to the Federal Circuit’s decision in Walther, the burden of proof with respect to “factors unrelated” to the administration of a covered vaccine is on respondent. Finally, the undersigned finds that respondent has not met his burden to demonstrate that an unrelated factor caused petitioner’s injury. Thus, the undersigned finds that petitioner has shown entitlement to compensation. a. Petitioner’s Prima Facie Case Petitioner may establish a prima facie case that her injury was caused by a covered vaccine by satisfying the Althen test. Deribeaux v. Sec’y of Health and Human Servs., 16 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 17 of 28 717 F.3d 1363, 1367 (Fed. Cir. 2013). “Once a petitioner establishes her prima facie case by satisfying the Althen test, the burden then shifts to the respondent to show by a preponderance of the evidence that the injury is due to factors unrelated to the administration of the vaccine.” Id. Therefore, the first step is to analyze whether petitioner has established the Althen prongs. For the reasons set forth below, the undersigned finds that she has. i. Althen Prong One Under Althen Prong One, there must be preponderant evidence of a medical theory causally connecting petitioner’s vaccination to her injury. In satisfaction of Althen Prong One, the undersigned takes judicial notice of the fact that respondent has added SIRVA to the Vaccine Injury Table for the influenza vaccine. See National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132, Notice of Proposed Rulemaking, July 29, 2015 (citing Atanasoff et al., Court Ex. I); see also Doe 21 v. Sec’y of Health and Human Servs., 88 Fed. Cl. 178 (July 30, 2009), rev’d on other grounds, 527 Fed. Appx. 875 (Fed. Cir. 2013) (holding that recognition of a link between vaccine and injury on the Vaccine Injury Table supports petitioner’s burden under Althen Prong One). In adding SIRVA to the Table, the Secretary of Health and Human Services determined that, for vaccines listing SIRVA as a Table injury,10 there is a sufficient causal connection between the administration of such vaccines and SIRVA to warrant adding SIRVA to the Table. In other words, the Secretary has determined that intramuscular administration of certain vaccines can cause SIRVA. Further, the literature and medical records filed in this case provide preponderant evidence of a medical causal theory. Atanasoff and Bodor set forth a proposed mechanism of injury, “the unintentional injection of antigenic material into synovial tissues resulting in an immune-mediated inflammatory reaction.” Atanasoff, Court Exhibit I at 1-3 (citing Bodor, Court Exhibit II). This occurs when the vaccine is “injected into the subdeltoid bursa . . . causing a robust local inflammatory and immune response” which leads to “bursitis, tendinitis, and inflammation of the shoulder capsule.” Id. at 2. Moreover, two of petitioner’s physicians opined that petitioner had a left shoulder injury due to the October 19, 2015 vaccines administered in her left deltoid. On February 2, 2016, Dr. Nicholas Leroy of the Center for Progressive Health examined petitioner due to left shoulder pain following tetanus and shingles vaccines in her left deltoid in October. Pet. Ex. 2 at 3-4. Dr. Leroy assessed petitioner as having left “rot. [rotator] cuff syndrome 2° [secondary] to Oct 2015 vaccine shots [in left] deltoid.” Id. at 3. 10 The undersigned notes that the shingles vaccine is not listed in the Table and thus SIRVA is not a Table injury for the shingles vaccine, while SIRVA is a Table injury for Tdap. However, the undersigned does not view this difference as dispositive. 17 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 18 of 28 In addition, after examining petitioner and ruling out a back lipoma as a cause of petitioner’s left shoulder condition, Dr. Ellis Nam assessed her with “Left shoulder pain, s/p [status post] tetanus/shingles injection on 10/2015.” Pet. Ex. 24 at 3. Dr. Nam described petitioner’s left shoulder condition as one that “she developed as a result of the tetanus/shingles shot in her left shoulder on October, 2015.” Pet. Ex. 24 at 2. Thus, petitioner has met Althen Prong One. ii. Althen Prong Two Under Althen Prong Two, petitioner must demonstrate a logical sequence of cause and effect showing that the vaccination was the reason for the injury. The undersigned determines that the SIRVA QAI criteria set forth a logical sequence of cause and effect and that by establishing that the QAI criteria are met, a petitioner may establish that Althen Prong Two has been met. The criteria under the QAI for SIRVA are as follows: 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). 82 Fed. Reg. 6303 (Qualifications and Aids to Interpretation for SIRVA). In light of the factual history described above, the undersigned finds that all four of the criteria listed in the QAI for SIRVA are satisfied by preponderant evidence in this case. 1. 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 Upon the undersigned’s review, nothing in petitioner’s prior medical history suggests any relevant history of pain, inflammation or dysfunction of petitioner’s left shoulder. 18 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 19 of 28 2. Pain occurs within the specified time-frame The question of when petitioner’s shoulder pain first manifested is one of the bases for respondent’s recommendation against compensation in this case. In his Rule 4(c) Report, respondent argued that the records did not establish that the onset of pain occurred within 48 hours of vaccination. Respondent’s Rule 4(c) Report at 7 n.2. At the hearing and in the subsequent October 31, 2018 fact ruling, however, the undersigned resolved this factual dispute. The undersigned found that the onset of petitioner’s injury occurred within 48 hours. This finding is supported by several pieces of evidence. On February 18, 2016, Dr. Perrott documented “injections in left deltoid since October” and “since then” pain in the left shoulder region. Pet. Ex. 14 at 3. On December 22, 2015, Dr. Noriega documented that petitioner reported “left arm pain after two shots,” Pet. Ex. 3 at 42. Dr. Townsend Scott also documented left shoulder pain that began after receiving two immunizations in the left arm. Pet. Ex. 3 at 326. The Center for Progressive Health documented that petitioner had “left shoulder pain following tetanus and shingles shots in left deltoid” in October. Pet. Ex. 2 at 3-4. At the hearing, petitioner testified that she experienced immediate soreness following vaccination. Tr. 11. She testified that she repeatedly called the clinic to report the pain and was told to give it some time to go away. Tr. 11-12. She testified that on the day after vaccination she had limited movement in her arm and was still in pain. Tr. 14. The undersigned finds that the preponderance of the evidence establishes that the onset of petitioner’s pain was within 48 hours after vaccination. 3. Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered The undersigned finds no evidence that petitioner’s pain and reduced range of motion extended beyond her left shoulder. Petitioner consistently reported pain in her left shoulder. While a physician theorized that a lipoma on her back could be related, another physician opined that the back lipoma was unrelated to petitioner’s shoulder pain. Moreover, petitioner testified that the lipoma has been on her back for 15 years and during that time has remained asymptomatic. The undersigned finds that the preponderance of the evidence establishes that petitioner’s pain and reduced range of motion were limited to the shoulder in which the intramuscular vaccine was administered. 4. No other condition or abnormality is present that would explain the patient’s symptoms (e.g. NCS/EMG or 19 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 20 of 28 clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy) The undersigned also finds no evidence of any condition or abnormality that would otherwise explain her symptoms. As noted above, the preponderance of the evidence establishes that petitioner’s back lipoma does not explain petitioner’s symptoms. 5. Additional considerations Moreover, separate and apart from the specific requirements of the QAI, as noted above, there are additional considerations that weigh in favor of finding that petitioner has satisfied the second prong of Althen. First, two of petitioner’s treating physicians opined that petitioner’s shoulder condition was vaccine-caused.11 See, e.g. Pet. Ex. 2 at 3; Pet. Ex. 24 at 1. “[T]reating physicians are likely to be in the best position to determine whether ‘a logical sequence of cause and effect show [s] that the vaccination was the reason for the injury.’ ” Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (quoting Althen, 418 F.3d at 1280). Second, the Federal Circuit’s adoption of the Restatement (Second) of Torts and analysis in Shyface supports a finding that the Tdap vaccine was a substantial factor in causing petitioner’s injury and thus the second Althen prong has been established. In Shyface, the Federal Circuit adopted the Restatement (Second) of Torts and ruled that “an action is the ‘legal cause’ of harm if that action is a ‘substantial factor’ in bringing about the harm, and [the] harm would not have occurred but for the action.” Shyface, 165 F.3d at 1352. In that case, petitioner’s expert testified that an infant’s death was caused by a high fever, which resulted from a combination of administration of a covered vaccine and an infection. Shyface, 165 F.3d at 1345-46. However, petitioner’s expert could not determine which of these two factors was more responsible. Id. Thus, the special master ruled against the petitioners, finding that “[p]etitioners evidence of a vaccine-related cause stands possibly in equipoise, but no better.” Id. at 1347 (quoting special master’s decision) (emphasis added). The Federal Circuit determined that evidence that the combination of the factors caused the death was sufficient to establish entitlement to compensation for a vaccine injury even if the vaccine was not the predominant cause, as long as it was a substantial factor. In determining whether it was a substantial factor, the Federal Circuit looked to the Restatement (Second) of Torts § 432(2), which states: If two forces are actively operating, one because of the actor’s negligence, the other not because of any misconduct on his part, and each of itself is sufficient to bring about harm 11 While a treating physician also considered petitioner’s back lipoma as a possible cause, Dr. Nam opined that the lipoma had no effect on petitioner’s shoulder condition, Pet. Ex. 24, and the undersigned has already ruled that the lipoma did not cause petitioner’s shoulder symptoms. 20 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 21 of 28 to another, the actor’s negligence may be found to be a substantial factor in bringing it about. Restatement (Second) of Torts § 432(2) (quoted in Shyface, 165 F.3d at 1352) (emphasis added). Applying the Restatement § 432(2) here, respondent agrees that based on the facts in this case “it is impossible to attribute causation to one vaccine or the other.” Respondent’s December 7, 2018 Brief at *2-3 (ECF No. 67). In addition, the covered vaccine, Tdap, itself was sufficient to bring about harm. Thus, under these circumstances, the undersigned finds that the Tdap vaccine was a substantial factor in causing petitioner’s injury. Thus, for all of the above reasons, the undersigned finds that petitioner has satisfied Althen Prong Two. iii. Althen Prong Three Under Althen Prong Three, there must be a proximate temporal relationship between vaccination and injury. In this case, both parties agree that the relevant medically accepted timeframe for onset of a SIRVA injury is within 48 hours of vaccination. As noted above, the undersigned found that the preponderance of the evidence supports a finding that the onset of petitioner’s SIRVA occurred within 48 hours of vaccination. Thus, petitioner has satisfied Althen Prong Three. Because petitioner has satisfied all three Althen prongs and thus established a prima facie case, the burden then shifts to respondent to prove, by a preponderance of the evidence, that petitioner’s injury was caused by factors unrelated to the administration of the Tdap vaccine. b. Factors Unrelated to Vaccination In determining entitlement to compensation, Vaccine Act § 13(a)(1) provides: Compensation shall be awarded under the Program to a petitioner if the special master or court finds on the record as a whole (A) that the petitioner has demonstrated by a preponderance of the evidence the matters required in the petition by section 300aa-11(c)(1) of this title; and (B) that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition. Vaccine Act § 13(a)(1) (emphasis added). 21 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 22 of 28 Respondent asserts that two factors unrelated to the covered Tdap vaccination may have contributed to petitioner’s injury. First, respondent asserts that petitioner’s back lipoma may have contributed to her injury. As noted above, the undersigned has previously found that the preponderance of the evidence does not support this contention. This finding is supported by Dr. Nam’s opinion that the lipoma was unrelated to petitioner’s shoulder condition as well as petitioner’s testimony, which the undersigned found credible. Second, respondent asserts that on the date of vaccination, petitioner received two vaccines in her injured arm, a Tdap vaccine and a shingles vaccine. As determined above, by establishing the Althen factors are met, petitioner has established a prima facie case that the Tdap vaccine caused her SIRVA. For the purpose of fully addressing respondent’s arguments, the undersigned analyzes this issue as a “factor unrelated to the administration of the vaccine” as well. With limited exceptions related to polio that are not applicable here, to be entitled to compensation a petition must assert an illness or injury caused by a vaccine set forth in the Vaccine Injury Table, 42 C.F.R. §100.3. Vaccine Act § 11(c)(1). The Tdap vaccine is listed in the Table, while the shingles vaccine is not. See, e.g., Duke v. Sec’y of Health and Human Servs., No. 15-473V, 2015 WL 4124547, at *2 (Fed. Cl. Spec. Mstr. June 12, 2015) (“The shingles vaccine is not listed on the Table and is therefore not covered by the Program” and noting the dismissal of previous petitions seeking compensation for injuries from the shingles vaccine). Respondent argues that petitioner has not established that the covered Tdap vaccine, rather than the non-covered shingles vaccine, caused her injury. The undersigned previously made a fact finding that petitioner received both the Tdap and shingles vaccinations in her injured left arm. In her petition, petitioner listed all three vaccines received on October 19, 2015. Petition, filed Nov. 4, 2016, at ¶ 3 (ECF No. 1). However, in her second summary judgment motion, petitioner asserts entitlement to compensation based on the tetanus, or Tdap, vaccine. Petitioner’s Second MSJ, filed Dec. 4, 2018, at 5 (ECF No. 66-1). In addition, the shingles vaccine is not a covered vaccine and petitioner asserts that the flu vaccine was administered into her right arm. Thus, the undersigned analyzes petitioner’s claim as asserting entitlement to compensation based on the Tdap vaccine, which is listed in the Table. Above, the undersigned determined that petitioner had shown by a preponderance of the evidence that the Tdap vaccine caused her SIRVA and thus made the showing required under § 13(a)(1)(A) to establish a prima facie case. Respondent asserts that petitioner testified that the vaccines were administered almost at the same time and that she felt tingling only after both were administered. Respondent’s December 7, 2018 Brief at *2-3 (ECF No. 67). Thus, respondent asserts that “at best, the evidence is in equipoise with respect to the Tdap and shingles vaccines as the cause of petitioner’s SIRVA.” Id. at *3. Respondent argues that it is petitioner’s burden to demonstrate that the Tdap vaccine was more likely to cause the 22 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 23 of 28 injury than the shingles vaccine and that because she cannot meet the burden, her claim must fail. As discussed above, the undersigned determines that petitioner has met her burden to demonstrate that the Tdap vaccine was a legal cause of her SIRVA and thus has established a prima facie case. Citing the Federal Circuit’s decision in Walther v. Sec’y of Health and Human Servs., 485 F.3d 1146 (Fed. Cir. 2007), petitioner asserts that under § 13(a)(1)(B), it is respondent’s burden to prove that the injury petitioner asserts is vaccine-related was actually caused by a factor unrelated to the vaccination. In other words, petitioner asserts that it is respondent’s burden to prove that the non-covered shingles vaccine caused the injury and that, unless he is able to do so, petitioner should prevail. Walther is strikingly similar in that it also involves the question whether petitioner’s injury was caused by a covered or non-covered vaccine. In Walther, the petitioner received four vaccines – tetanus-diphtheria (“Td”), yellow fever, and meningitis on July 31, 1997, and rabies on August 6, 1997. Of these four vaccines, only the Td vaccine was included in the Vaccine Injury Table. On August 7 and 8 she began experiencing trembling, weakness, and fatigue. She was ultimately diagnosed with post-vaccinal acute disseminated encephalomyelitis (“ADEM”). Petitioner’s expert testified that it was more likely than not that her ADEM was caused by the Td vaccine and that, for reasons specific to each vaccine, the other vaccines she received were unlikely to have caused her illness. The government primarily argued that petitioner did not suffer from ADEM, but also contended that even if she suffered from ADEM, it was not caused by the Td vaccine. The special master in Walther dismissed the petition, finding that Walther had not carried her burden to prove that her illness was caused by the Td vaccine, in part because she had not presented proof eliminating other potential causes for her injury. Walther, 485 F.3d at 1147.12 The petitioner unsuccessfully sought review in the Court of Federal Claims. On appeal at the Federal Circuit, petitioner argued that the special master “applied an incorrect standard requiring her to eliminate other potential causes in order to establish a prima facie case of causation.” Id. at 1148. The Federal Circuit ruled that while petitioner may use evidence eliminating other potential causes to help carry the burden on causation, petitioner does not bear the burden of eliminating alternative independent potential causes. Id. at 1150-52. The court ruled that once petitioner has established a prima facie case, “the government bears the burden of establishing alternative causation by a preponderance of the evidence.” Id. at 1151. The Federal Circuit noted that § 13(a)(1)(A) by its terms places the burden of proof on petitioner, while § 13(a)(1)(B) is silent with respect to burden of proof. Walther, 12 The special master’s decision in Walther was issued on July 29, 2005, the same day that the Federal Circuit issued its decision in Althen. The special master’s Walther decision thus had applied a different causation standard than that set forth in Althen. 23 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 24 of 28 485 F.3d at 1150-51. The court stated that a “plain reading of the statutory text [of subsection (B)] more naturally places the burden on the government to establish that there is an alternative cause by a preponderance of the evidence.” Id. at 1150. The court reasoned that assigning the burden of proof under subsection B to plaintiff “would essentially write § 300aa-13(a)(1)(B) out of the statute.” Id. The Walther court then looked to the Restatement (Second) of Torts, explaining that for purposes of causation a petitioner is treated as the equivalent of a tort plaintiff and the government as the equivalent of a tort defendant. The court noted that the Restatement (Second) of Torts § 433B(3) provided that in cases involving multiple independent potential causes, where harm has been caused by only one of them but there is uncertainty as to which one, “the burden is upon each such actor [tort defendant, or respondent in this case] to prove that he has not caused the harm.” Walther, 485 F.3d at 1151 (quoting Restatement (Second) of Torts § 433B(3) (1965)). Applying this to the Vaccine Act, the court stated that “the petitioner generally has the burden on causation, but when there are multiple independent potential causes, the government has the burden to prove that the covered vaccine did not cause the harm.” Id. The court determined that “in both Table and off-Table [causation-in-fact, or Althen, cases] cases the government bears the burden of establishing alternative causation by a preponderance of the evidence once the petitioner has established a prima facie case.”13 Id. Thus, in a case similar to this case, in that both involve the question of causation when a petitioner received multiple vaccines close in time, the Federal Circuit has addressed the very question at issue in this case and determined that the burden of proof with respect to alternative causes is on respondent. In another case, the Federal Circuit cited Walther and stated that “[o]nce the petitioner has established a prima facie case for entitlement to compensation and thus met her burden to prove causation-in-fact, the burden shifts to the government to prove ‘[by] a preponderance of the evidence that [petitioner’s injury] is due to factors unrelated to the administration of the vaccine described in the petition . . . . So long as the 13 This rationale has been followed by Special Masters in other cases. See, e.g., Heinzelman v. Sec’y of Health and Human Servs., No. 2007-01V, 2008 WL 5479123, at *17 (Fed. Cl. Spec. Mstr. Dec. 11, 2008) (concluding that petitioner’s “burden of proving ‘a logical sequence of cause and effect showing that the vaccination was the reason for the injury’ does not include the obligation to negate possible alternative causes” for her injury), mot. for rev. denied, 98 Fed. Cl. 808 (2011), aff’d on other grounds, 681 F.3d 1374 (Fed. Cir. 2012); Al-Uffi v. Sec’y of Health and Human Servs., No. 2013-956V, 2017 WL 1713113, at *19 (Fed. Cl. Spec. Mstr. Feb. 22, 2017) (“Because I find that Petitioner has established her prima facie case by a preponderance of the evidence, the burden now shifts to Respondent to prove by a preponderance of the evidence an alternative, unrelated cause” for petitioner’s condition) (citing Heinzelman); Deribeaux v. Sec’y of Health and Human Servs., No. 2005-306V, 2011 WL 6935504, at *33 (Fed. Cl. Spec. Mstr. Dec. 9, 2011) (assigning to respondent burden of proving that a factor unrelated to the vaccination caused the injury pursuant to § 13(a)(1)(B)), mot. for rev. denied, 105 Fed. Cl. 583 (2012), aff’d, 717 F.3d 1363 (Fed. Cir. 2013). 24 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 25 of 28 petitioner has satisfied all three prongs of the Althen test, she bears no burden to rule out possible alternative causes.” de Bazan v. Sec’y of Health and Human Servs., 539 F. 3d 1347, 1352 (Fed. Cir. 2008). “Once causation is established, the petitioner is entitled to compensation unless the government can show by a preponderance of the evidence that the injury is due to factors unrelated to the vaccine, i.e., an alternative cause.” Porter v. Sec’y of Health and Human Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011). Pursuant to the reasoning set forth in Walther, the tort defendant, or respondent here, has the burden of proving that the non-covered vaccine, rather than the covered vaccine, caused petitioner’s injury. Respondent has offered no evidence, other than the fact that petitioner received a non-covered vaccine, to meet this burden. Respondent asserts that the evidence as to which vaccine – Tdap or shingles – caused petitioner’s SIRVA is, at best, in equipoise. There is evidence showing that each vaccine was administered, but no evidence showing that either was more likely than the other to have caused petitioner’s SIRVA. However, the analysis is not either/or, as respondent suggests. Instead, the first inquiry is whether petitioner has established a prima facie case that the Tdap caused her injury; the undersigned has found that she has. The next inquiry is whether respondent has established by a preponderance of the evidence that a factor unrelated to the Tdap caused petitioner’s injury; the undersigned finds that he has not. Respondent argues that a more recent Federal Circuit case, Stone v. Sec’y of Health and Human Servs., 676 F.3d 1373, 1380 (Fed. Cir. 2012), “has limited the approach articulated in Walther, which presumably allows the special masters to ignore relevant evidence in the record when determining whether petitioners have met their burden of proving vaccine-causation by a preponderance of the evidence.” Respondent’s December 7, 2018 Brief at *2 (ECF No. 67). The undersigned disagrees with respondent’s characterization of Walther. Walther does not permit a special master to ignore evidence. Rather, Walther addressed the issue of burden of proof on alternative causes. With respect to Stone, the court in that case agreed that with “factors unrelated” evidence, “a special master may not require the petitioner to shoulder the burden of eliminating all possible alternative causes in order to establish a prima facie case.” Stone, 676 F.3d at 1380 (emphasis added). Nevertheless, in Stone, the Federal Circuit also stated that prior decisions support “the commonsense proposition that evidence of other possible sources of injury can be relevant not only to the ‘factors unrelated’ defense, but also to whether a prima facie showing has been made that the vaccine was a substantial factor in causing the injury in question.” Id. at 1379-80. The court further stated that “in some cases a sensible assessment of causation cannot be made while ignoring the elephant in the room – the presence of compelling evidence of a different cause for the injury in question.” Id. at 1380. 25 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 26 of 28 The undersigned notes that in Walther, the alternative causes asserted by respondent were four non-covered vaccines that petitioner received close in time to the sole covered vaccine she received. Respondent’s position was that each of the non- covered vaccines represented a biologically plausible explanation for her condition. In contrast, in Stone, the asserted alternative cause was a genetic mutation that respondent’s expert, who the special master found persuasive, testified was the sole cause of petitioner’s illness. Thus, one distinction between these cases is that Walther deals with a situation where, as in this case, respondent is raising the simple fact of a non-covered vaccination as an alternative cause, whereas in Stone, respondent also presented persuasive expert testimony as to a genetic etiology. In a case where a petitioner has received multiple vaccines, some listed in the Table and some not listed in the Table, in the same arm or other site, and is injured, it is somewhat difficult to reconcile the approaches of Walther and Stone. In such cases, as in this case, there may be little or no proof as to which vaccine or vaccines caused the injury. In such circumstances, the determination as to who has the burden of proof with respect to alternative causation may be dispositive. One cohesive reading of Walther and Stone is that Walther applies in a situation where respondent simply identifies a possible alternative cause with nothing more, whereas Stone is relevant in a case where respondent presents an alternative cause and evidence that the finder of fact finds persuasive enough to defeat petitioner’s prima facie case. This reading was suggested in Heinzelman v. Sec’y of Health and Human Servs., No. 07-01V, 2008 WL 5479123 (Fed. Cl. Spec. Mstr. Dec. 11, 2008), mot. for rev. denied, 98 Fed. Cl. 808 (2011), aff’d on other grounds, 681 F.3d 1374 (Fed. Cir. 2012) (“Assuming that the Federal Circuit actually created a distinction between situations in which the government challenged the persuasive value of petitioner’s evidence on a particular prong and situations in which the government put forth a particular agent as the cause of petitioner’s injury, then the distinction is important”). Applying this reading to the facts of this case, Walther would govern because respondent has offered no evidence at all, much less persuasive evidence, to demonstrate that the non-covered shingles vaccine is more likely the cause of petitioner’s injury than the covered Tdap vaccine. The undersigned interprets Walther as supporting a ruling in favor of petitioner if petitioner establishes a prima facie case and respondent does not establish by preponderant evidence that the injury was caused by an unrelated factor. Therefore, the undersigned determines that petitioner has established a prima facie case that her SIRVA was caused by her Tdap vaccination. The undersigned further finds that respondent has not met his burden of showing that the non-covered shingles vaccine, rather than the covered Tdap vaccine, caused petitioner’s SIRVA. See Suffolk Tech., LLC v. AOL Inc., 753 F.3d 1358, 1367 (Fed. Cir. 2014) (affirming grant of summary judgment and placing on non-moving party the burden of presenting 26 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 27 of 28 evidence to undermine moving party’s showing that there are no genuine issues of material fact). Respondent argues that “it would be error for the Chief Special Master to ignore the fact that petitioner received an uncovered shingles vaccine in the same arm, and at the same time, as the covered Tdap vaccine when deciding whether petitioner has shown that the Tdap vaccine is the more likely cause of her SIRVA” (ECF No. 67 at *5). Respondent is mistaken. First, the undersigned need not decide that the Tdap vaccine is the more likely cause of petitioner’s SIRVA. The undersigned finds that petitioner has established a prima facie case that a covered vaccine, Tdap, caused her SIRVA. Pursuant to Walther, once petitioner has established a prima facie case, the burden shifts to respondent to demonstrate that an unrelated factor caused the injury, and respondent has offered no proof to meet this burden. Second, the undersigned has not ignored that petitioner received a non-covered shingles vaccine in the same arm as she received her Tdap vaccine. The undersigned made this fact finding both at the end of the fact hearing and in a subsequent written fact ruling. However, respondent has the burden to prove that the shingles vaccine rather than the Tdap vaccine caused petitioner’s SIRVA, and respondent has not offered any proof beyond mere administration of a non-covered vaccine and thus has not met his burden. Respondent asserts in a footnote that petitioner initially attributed her injury to the shingles vaccine. Respondent’s Response to October 31, 2018 Scheduling Order, filed Dec. 7, 2018, at *3 n.3 (ECF No. 67). Petitioner’s medical records indicate in some notes that her pain began after a shingles vaccination and in other records that it began after receiving shingles and tetanus, or Tdap, vaccines, or simply after two immunizations, in her left arm. These statements are not inconsistent with each other and would not support a finding that petitioner attributed her injury solely to the shingles vaccine. Petitioner testified that she mentioned all three vaccines that she received to her medical providers. The undersigned found petitioner to be a credible witness and finds that the medical records are not inconsistent with petitioner’s testimony. In this case, whether analyzed as a Table case or as a causation-in-fact case, petitioner has established a prime facie case that a covered vaccine, Tdap, caused her SIRVA. Respondent has not established that a factor unrelated to the Tdap vaccine, either a back lipoma or a shingles vaccine, caused petitioner’s injury. The issue of causation in this case is a close one. Keeping in mind that “close calls regarding causation are resolved in favor of injured claimants,” Althen, 418 F.3d at 1280, the undersigned determines that petitioner is entitled to compensation. 27 Case 1:16-vv-01458-UNJ Document 78 Filed 08/20/19 Page 28 of 28 VII. Conclusion Thus, for all the foregoing reasons, the undersigned finds that petitioner is entitled to compensation. Accordingly, the undersigned GRANTS petitioner’s motion for summary judgment (ECF No. 66) and rules that petitioner is entitled to compensation. IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 28 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_16-vv-01458-3 Date issued/filed: 2019-11-15 Pages: 15 Docket text: PUBLIC DECISION (Originally filed: 08/23/2019) regarding 79 DECISION of Special Master Signed by Special Master Nora Beth Dorsey. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 1 of 15 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-1458V Filed: August 23, 2019 UNPUBLISHED DENISE GORING, Petitioner, Special Processing Unit (SPU); v. Decision Awarding Damages; Pain and Suffering; Tetanus Diphtheria SECRETARY OF HEALTH AND acellular Pertussis (Tdap) Vaccine; HUMAN SERVICES, Shoulder Injury Related to Vaccine Administration (SIRVA) Respondent. Isaiah Richard Kalinowski, Maglio Christopher & Toale, PA, Washington, DC, for petitioner. Voris Edward Johnson, U.S. Department of Justice, Washington, DC, for respondent. DECISION AWARDING DAMAGES1 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.,2 (the “Vaccine Act”). Petitioner alleges that she suffered a left shoulder injury related to a tetanus, diptheria, acellular pertussis (“Tdap”) vaccination she received on October 19, 2015.3 Petition at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters. 1 The undersigned intends to post this decision on the United States Court of Federal Claims' website. This means the decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material from public access. Because this unpublished decision contains a reasoned explanation for the action in this case, undersigned is 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). 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). 3 Petitioner received three vaccinations on October 19, 2015: Tdap, shingles, and influenza. Petitioner’s exhibit (“Ex.”) 1 at 1. Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 2 of 15 For the reasons described below, the undersigned finds that petitioner is entitled to an award of damages in the amount $75,200.00, representing compensation in the amount of $75,000.00 for actual pain and suffering and $200.00 for past unreimbursable expenses. I. Relevant Procedural History4 Petitioner filed a petition for compensation for a shoulder injury related to vaccine administration (“SIRVA”). (ECF No. 1). Respondent submitted a Rule 4(c) report on August 10, 2017 asserting that petitioner had not established entitlement to compensation due to an inadequate onset period for a SIRVA injury, uncertainty of the vaccination site, and an alternate cause for petitioner’s shoulder injury. (ECF No. 29). The undersigned held a fact hearing on September 18, 2018 with petitioner as the sole witness. Goring v. Sec’y of Health & Human Serv., No. 16-1458V, 2018 WL 6539219, *2 (Fed. Cl. Spec. Mstr. Oct. 31, 2018). The undersigned found that petitioner’s Tdap and shingles vaccines were administered to her left arm and the onset of petitioner’s left shoulder injuries occurred within 48 hours of her October 19, 2015 vaccinations. Id at *1. The undersigned further ruled that a lipoma on petitioner’s back was not a condition that explained her left shoulder symptoms. Id. On May 6, 2019, the undersigned determined that petitioner was entitled to compensation since she established that she suffered a shoulder injury caused by a covered vaccine and respondent did not show that unrelated factors caused her injury. Ruling on Entitlement at 2 (ECF No 78). On May 7, 2019, the parties were ordered to discuss the appropriate amount of compensation in this case. (ECF No. 72). Petitioner filed a joint status report on June 6, 2019 indicating the parties were unable to agree on the amount of damages. (ECF No. 73). On June 27, 2019, the undersigned ordered each party to file briefs to be considered in a decision awarding compensation. (ECF No. 74). The parties have filed their respective briefs and this case is now ripe for a determination regarding an award of damages. (ECF Nos. 76, 77). II. Relevant Medical History Petitioner received three vaccines on October 19, 2015 including a Tdap vaccine in her left shoulder. Ex. 1 at 1, Goring, 2018 WL 6539219 at *3. Petitioner’s prior medical history does not include any mention of left shoulder problems and is not otherwise relevant to her claim. 4 The undersigned adopts the comprehensive procedural history set forth in the Ruling on Entitlement issued on May 6, 2019. (ECF No. 78). 2 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 3 of 15 Although petitioner asserted in an affidavit that she experienced painful symptoms almost immediately, she was not seen by a medical provider for the pain until December 22, 2015 when she presented to her primary care physician, Karen Noriega, M.D. at Mercy Hospital. Ex. 3 at 42. Petitioner complained to Dr. Noriega of left arm pain after receiving vaccinations two months ago, stating that the “pain is worsening where she cannot lift her left arm over her head.” Id. Petitioner described an “aching” pain and rated it at 6 on a pain scale of 1 to 10. Id. at 49. Dr. Noriega examined petitioner and found she had decreased range of motion (“ROM”) in her left shoulder and tenderness to deep palpation. Id. at 45. Dr. Noriega diagnosed her with left arm pain and ordered a CT scan of petitioner’s left shoulder. Id. On January 19, 2016, petitioner presented to the emergency room (“ER”) at Mercy Hospital and Medical Center with a chief complaint of left arm pain. Ex. 3 at 278. She described significant left shoulder pain and limited range of motion that started when she received a vaccination in October 2015. Id. at 298. It was noted in the record that she was previously seen for left shoulder symptoms. Id. At the prior visit, a CT was ordered but not completed due to insurance issues. Id. On examination at the ER, the internal and external rotation of petitioner’s left shoulder was noted to be limited due to pain. Ex. 3 at 298. A left shoulder x-ray revealed only mild degenerative joint changes and a chest CT showed a lipoma on her back. Id. The examining physician determined that petitioner had “shoulder pain likely related to rotator cuff pathology, possibly related to large lipoma” and suggested she continue with pain medications. Id. Petitioner was discharged and directed to follow up with her primary care physician. Id. at 296. Petitioner followed up with another physician at Mercy Hospital, Kimberly Townsend-Scott, M.D., on January 26, 2016, complaining of left shoulder pain. Ex. 3 at 326. Dr. Townsend-Scott reviewed the test results from the ER visit and referred petitioner to a surgeon for evaluation and possible excision of the lipoma. Id. She suggested physical therapy (“PT”) if petitioner’s symptoms continued following surgery. Id. at 332. On February 2, 2016, petitioner sought treatment from an individual she described as a “natural doctor” at the Center for Progressive Health. Transcript of Fact Hearing (“Tr.”) 42. At that visit she reported she could not raise her left arm above horizontal. Ex. 2 at 4. The provider assessed her as having left rotator cuff syndrome secondary to the vaccines in the left shoulder. Id. at 3. In response to Dr. Townsend-Scott’s recommendation, petitioner saw a surgeon, Andrew Perrott, M.D., on February 18, 2016. Ex. 14 at 3. Dr. Perrott examined her and concluded that excision of the lipoma was “unlikely to change shoulder problem.” Id. at 4. Dr. Perrott noted restrictions in petitioner’s left shoulder movements with abduction limited to 60 degrees. Id. He proposed that rotator cuff syndrome might be the cause of her discomfort and recommended a referral to either an orthopedist or physical therapy. Id. Petitioner told him she would like to try physical therapy first and Dr. Perrott placed the order. Id. at 4, 7. 3 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 4 of 15 Petitioner reported to physical therapy (“PT”) on March 28, 2016 for an initial evaluation. Ex. 5 at 54. She rated her pain at a 7/10 and described having pain with movement. Id. The physical therapist, Shawn White, P.T., assessed her with left shoulder ROM limitations. Her flexion ROM was limited to “86 degrees with pain” and her abduction ROM was limited to “60 degrees with pain.” Id. at 55. Mr. White rated petitioner’s left upper extremity strength as only “fair” and noted she had tenderness with palpation over the left deltoid insertion and upper trapezius muscle. Id. He noted she had positive signs on Hawkins and Kennedy impingement tests. Id. In his overall assessment, Mr. White wrote that petitioner had “difficulty with ADLs and functional task[s] of reaching, washing hair, pulling and carrying items that are 10 lbs. or more.” Id. at 56. Petitioner returned to see Mr. White on April 26, 2016. Ex. 5 at 20. She initially reported moderate pain, rating it as 5/10. Id. She experienced some pain relief and increased ROM in her left shoulder flexion and abduction as a result of the session. Id. at 21. On April 28, 2016, she rated her pain at 1/10 but she denied improvement with left shoulder ROM. Id. at 22. Mr. White instructed her to perform shoulder exercises and stretches at home. Id. On May 3, 2016, petitioner reported decreased pain and improved range of motion at PT. Ex. 5 at 30. She rated her left shoulder pain at 0/10 on May 5, 2016 and said she only had pain with strenuous activity. Id. at 32. Petitioner reported on May 10, 2016 that she was “now able to take her coat off without pain in her [left] shoulder” although Mr. White noted that she had pain during the PT session. Id. at 34. On May 19, 2016, petitioner told Mr. White she had pain above her left clavicle over the weekend, but it decreased when she rubbed the spot. Id. at 38. Mr. White noted she also had pain with manual therapy during the session and she seemed to have increased fluid in her left shoulder compared to previous sessions. Id. at 38. She rated her pain level at 1/10 when she returned to PT on May 24, 2016 but by June 7, 2016, she again reported a pain score of 0/10. Id. at 39, 5. Petitioner attended a total of 12 PT sessions with Mr. White and was discharged on June 9, 2016. Ex. 5 at 7-57. At the final PT session, petitioner said she was feeling well with no left shoulder pain. Id. at 7. Her active ROM had improved but was still limited to 95 degrees in flexion and 93 degrees in abduction. Id. at 8. Mr. White noted the following in the discharge assessment: Upon discharge patient is able to perform increased ADLs including ease in putting on bra, zipping dresses, and donning jackets. Patient has increased ROM of [left] shoulder compared to initial evaluation in shoulder flexion and abduction. Patient has decreased pain of 0/10 in [left] shoulder compared to a 7/10 achy pain in the shoulder during initial evaluation on March 28, 2016. Patient showed a decrease in functional limitations with Shoulder Pain and Disability Index from 86.9% to 79% upon discharge. Patient is now [independent] with [home exercise program] and instructed to continue 4 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 5 of 15 home exercises and stretches to continue to decrease functional impairment in [left] shoulder. Id. at 9. Petitioner mentioned her left shoulder condition at appointments with several other providers but did not receive treatment. For example, she presented to Universal City Family Practice on April 18, 2016 to follow up on some unrelated labs. Ex. 7 at 3. The notes from the visit were handwritten and are difficult to read but there seems to be a notation about a left shoulder problem. Id. at 4. It appears no treatment was suggested for the left shoulder. Id. On November 7, 2016, petitioner was seen by a rheumatologist, Rediet Kokebie, M.D., for right wrist and right knee pain. Ex. 10 at 1. Petitioner attributed the right wrist pain to overuse of the right arm to protect the vaccine-injured left shoulder. Dr. Kokebie did not address the left shoulder condition other than to note petitioner’s account. Id. at 1, 2. Finally, petitioner sought an evaluation of her left shoulder pain and her back lipoma from an orthopedist, Ellis Nam, M.D., on March 8, 2018. Ex. 23 at 3. Dr. Nam noted her history of left shoulder pain after a vaccination and that she had PT for about three months that helped her pain. Dr. Nam added that she still had some weakness and loss of range of motion. Id. After examining petitioner, Dr. Nam found her shoulder area nontender, determined that she had good passive ROM but positive impingement, and noted a weak rotator cuff. Id. at 4. He assessed her with left shoulder pain, status post vaccination in October 2015, with a possible cuff tear. He recommended an MRI to rule out a rotator cuff tear, but she elected not to proceed. Id. at 4. III. Testimony and Affidavit Petitioner described her vaccination experience and her subsequent left shoulder pain and suffering in an affidavit filed in this case. Ex. 15. She also testified at length at a fact hearing on September 18, 2018 about her attempts to obtain treatment for the left shoulder injury and her current limitations. Petitioner recalled in her affidavit that she experienced pain and inflammation almost immediately after receiving the vaccinations in her left arm. Ex. 15 at 2. She asked the clinic technician about the pain and was advised it was normal and would subside in a couple of days. Id. at 2; Tr. 11. She noticed swelling around the injection site after she left the clinic. Ex. 15 at 2. The pain worsened the following day and she had difficulty moving her arm. Ex. 15 at 2. She called the clinic and was told it might take a couple of weeks to resolve. Id. at 2-3. Petitioner stated in her affidavit that in the week following the vaccinations, she “could not move [her] left arm nearly at all, and it was basically incapacitated from that point onward.” Ex. 15 at 3. She called the clinic after two weeks because the pain and immobility had continued. Id. She was told again that the symptoms should go away. 5 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 6 of 15 Id. Petitioner testified that she took aspirin and wore an “ion bracelet” and an “impulse stimulator” to ease the pain that she described as “unbearable.” Tr. 15. She contacted her primary care physician, Dr. Noriega, but could not schedule an appointment until late December. Id at 15-16. When petitioner saw Dr. Noriega on December 22, 2015, she could not lift her left arm which interfered with dressing and bathing. Tr. 18. Dr. Noriega referred her for a test, but it was not covered by insurance. Ex. 15 at 3. Petitioner became frustrated with the pain, sleeplessness, and immobility of her left arm so she went to the emergency room on January 19, 2016. Ex. 15 at 3-4; Tr. 23. The CT scan showed a lipoma on petitioner’s back leading to uncertainty regarding her diagnosis and she was discharged with pain medication and instructions to return if symptoms worsened. Ex. 15 at 4; Tr. 24. Petitioner testified that she went to the Center for Progressive Health in February 2016 and paid out of pocket because she was determined to find out what was going on with her left shoulder. Tr. 42. The “natural doctor” at the center told her that she had an issue with her rotator cuff. Id. Petitioner’s left arm was still painful with limited functioning when she went to the PT evaluation on March 28, 2016. Tr. 38. She could not get in the tub, reach her pots and pans, put on a necklace, or fasten her bra. Tr. 38-39. The PT helped petitioner with the pain, and she regained use of her arm although she still has limitations. Tr. 45. Petitioner testified that she purchased an exercise device called the Euro Shaper in order to exercise at home because she was concerned about going to the gym and further injuring her shoulder. Tr. 43. She expressed a belief that the device would assist in healing her shoulder condition but acknowledged that it was not prescribed or recommended by her physicians. Tr. 43, 68. The date of the purchase was May 23, 2016. Ex. 26 at 2. Petitioner testified that she sought out Dr. Nam in 2018 to clarify whether the lipoma was the cause of her symptoms and he told her she had a rotator cuff tear and should get an MRI. She chose not to get an MRI because the left shoulder pain was gone, and she wanted to forget about it. Tr. 51. Petitioner described her experience as pain that she would not wish “on [her] worst enemy, because it took [her] through hell.” Tr. 53. She also testified that currently she “can do everything practically that [she] used to” except for reaching for her pots and pans. Tr. 48-49. Upon request from the undersigned at the fact hearing, petitioner demonstrated that the flexion and abduction range of motion of her left arm was limited to 90 degrees or less. She was unable to reach the back of her bra strap with her left hand. Tr. 80-81. The undersigned determined at the hearing that petitioner’s testimony was consistent and credible as to the pain, weakness, and reduced range of motion that she experienced. Tr. 84. 6 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 7 of 15 IV. The Parties’ Arguments Petitioner proposes damages in the amount of $100,000.00 for her actual pain and suffering and $1,300.00 in unreimburseable expenses including $200.00 for a medical appointment at the Center for Progressive Health and $1,100.00 for an item of “rehabilitation exercise equipment.” Memorandum of Law in Support of Petitioner’s Motion for Finding of Fact Regarding Damages (“Pet. Mem.”) at 4 (ECF No. 76). Petitioner did not make a claim for lost wages. In support of the amount suggested for her pain and suffering, petitioner makes passing reference to the Court’s rulings on damages over the last year but cites no cases. Pet. Mem. at 5. Petitioner also emphasizes that she continues to experience “residual deficits in strength, range of motion, and ability with her left arm, as was visually demonstrated at the fact hearing.” Id. Respondent argues that petitioner should be awarded $50,000.00 as compensation for her actual pain and suffering. Respondent’s Brief on Damages (“Res. Brief”) at 1 (ECF No. 77). To justify this lower amount, respondent emphasizes that petitioner did not obtain medical care until almost two months after the causal vaccination, took no pain medications other than aspirin, and was treated with ten PT sessions after which her left shoulder was significantly improved.5 Respondent further asserts that petitioner’s SIRVA was not severe and to the extent that it has not resolved, is only mildly limiting at present. Res. Brief at 8. Respondent compares petitioner’s SIRVA to those suffered by petitioners in Knauss and Crefasi.6 Res. Brief at 9. He argues the facts in this case are most like those in Knauss where the petitioner was awarded $60,000.00 for pain and suffering. Id. Respondent also relies on a syncope case involving a fractured skull, purportedly for context.7 Id. at 8-9. V. Legal Standard Compensation awarded pursuant to the Vaccine Act shall include “[f]or actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000.” § 15(a)(4). Additionally, petitioner may recover “actual unreimbursable expenses incurred before the date of judgment award such expenses which (i) resulted from the vaccine-related injury for which petitioner seeks compensation, (ii) were incurred by or on behalf of the person who suffered such injury, 5 Petitioner had 12 sessions of physical therapy. See Ex. 5 at 5-57. 6 Knauss v. Sec’y of Health & Human Servs., No. 16-1372V, 2018 WL 3432906 (Fed. Cl. Spec. Mstr. May 23, 2018) (awarding $60,000.00 for pain and suffering and $170.00 in unreimbursable medical expenses); Crefasi v. Sec’y of Health & Human Serv., No. 15-166V, 2015 WL 5166283 (Fed. Cl. Spec. Mstr. Aug. 12, 2015) (awarding $50,000.00 pursuant to proffer). 7 H.S. v. Sec’y of Health & Human Serv., No. 14-1057V, 2015 WL 6155891 (Fed. Cl. Spec. Mstr. Sept. 25, 2015) (awarding $60,000.00 for pain and suffering). 7 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 8 of 15 and (iii) were for diagnosis, medical or other remedial care, rehabilitation . . . determined to be reasonably necessary.” § 15(a)(1)(B). Petitioner bears the burden of proof with respect to each element of compensation requested. Brewer v. Sec’y of Health & Human Servs., No. 93-0092V, 1996 WL 147722, at *22-23 (Fed. Cl. Spec. Mstr. Mar. 18, 1996). There is no formula for assigning a monetary value to a person’s pain and suffering and emotional distress. I.D. v. Sec’y of Health & Human Servs., No. 04- 1593V, 2013 WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May 14, 2013) (“Awards for emotional distress are inherently subjective and cannot be determined by using a mathematical formula”); Stansfield v. Sec’y of Health & Human Servs., No. 93-0172V, 1996 WL 300594, at *3 (Fed. Cl. Spec. Mstr. May 22, 1996) (“the assessment of pain and suffering is inherently a subjective evaluation”). Factors to be considered when determining an award for pain and suffering include: 1) awareness of the injury; 2) severity of the injury; and 3) duration of the suffering. I.D., 2013 WL 2448125, at *9 (quoting McAllister v. Sec’y of Health & Human Servs., No 91-1037V, 1993 WL 777030, at *3 (Fed. Cl. Spec. Mstr. Mar. 26, 1993), vacated and remanded on other grounds, 70 F.3d 1240 (Fed. Cir. 1995)). The undersigned may also look to prior pain and suffering awards to aid in her resolution of the appropriate amount of compensation for pain and suffering in this case. See, e.g., Doe 34 v. Sec’y of Health & Human Servs., 87 Fed. Cl. 758, 768 (2009) (finding that “there is nothing improper in the chief special master’s decision to refer to damages for pain and suffering awarded in other cases as an aid in determining the proper amount of damages in this case.”). And, of course, the undersigned may also rely on her own experience adjudicating similar claims.8 Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (noting that Congress contemplated the special masters would use their accumulated expertise in the field of vaccine injuries to judge the merits of individual claims). Importantly, however, it must also be stressed that pain and suffering is not determined based on a continuum. See Graves v. Sec’y of Health & Human Servs., 109 Fed. Cl. 579 (2013). In Graves, Judge Merrow rejected the special master’s approach of awarding compensation for pain and suffering based on a spectrum from $0.00 to the statutory $250,000.00 cap. Judge Merrow noted that this constituted “the forcing of all suffering awards into a global comparative scale in which the individual petitioner’s suffering is compared to the most extreme cases and reduced accordingly.” Graves, 109 Fed. Cl. at 590. Instead, Judge Merrow assessed pain and suffering by looking to the record evidence, prior pain and suffering awards within the Vaccine Program, and a survey of similar injury claims outside of the Vaccine Program. Id. at 595. VI. Prior SIRVA Compensation 8 From July 2014 until September 2015, the SPU was overseen by former Chief Special Master Vowell. Since that time, all SPU cases, including the majority of SIRVA claims, have remained on the undersigned’s docket. 8 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 9 of 15 A. History of SIRVA Settlement and Proffer9 SIRVA cases have an extensive history of informal resolution within the SPU. As of July 1, 2019, 1,170 SIRVA cases have informally resolved10 within the SPU since its inception in July of 2014. Of those cases, 689 resolved via the government’s proffer on award of compensation, following a prior ruling that petitioner is entitled to compensation.11 Additionally, 462 SPU SIRVA cases resolved via stipulated agreement of the parties without a prior ruling on entitlement. Among the SPU SIRVA cases resolved via government proffer, awards have typically ranged from $75,325.00 to $124,442.25.12 The median award is $96,223.27. Formerly, these awards were presented by the parties as a total agreed upon dollar figure without separately listed amounts for expenses, lost wages, or pain and suffering. Since late 2017, the government’s proffer has included subtotals for each type of compensation awarded. Among SPU SIRVA cases resolved via stipulation, awards have typically ranged from $50,000.00 to $95,000.00.13 The median award is $70,000.00. In most instances, the parties continue to present the stipulated award as a total agreed upon dollar figure without separately listed amounts for expenses, lost wages, or pain and suffering. Unlike the proffered awards, which purportedly represent full compensation for all of petitioner’s damages, stipulated awards also typically represent some degree of litigative risk negotiated by the parties. B. Prior Decisions Addressing SIRVA Damages 9 Prior decisions awarding damages, including those resolved by settlement or proffer, are made public and can be searched on the U.S. Court of Federal Claims website by keyword and/or by special master. On the court’s main page, click on “Opinions/Orders” to access the database. All figures included in this order are derived from a review of the decisions awarding damages within the SPU. All decisions reviewed are, or will be, available publicly. All figures and calculations cited are approximate. 10 Additionally, 36 claims alleging SIRVA have been dismissed within the SPU. 11 Additionally, there have been 19 prior cases in which petitioner was found to be entitled to compensation, but where damages were resolved via a stipulated agreement by the parties rather than government proffer. 12 Typical range refers to cases between the first and third quartiles. Additional outlier awards also exist. The full range of awards spans from $25,000.00 to $1,845,047.00. Among the 19 SPU SIRVA cases resolved via stipulation following a finding of entitlement, awards range from $45,000.00 to $1,500,000.00 with a median award of $115,772.83. For these awards, the first and third quartiles range from $90,000.00 to $160,502.39. 13 Typical range refers to cases within the second and third quartiles. Additional outlier awards also exist. The full range of awards spans from $5,000.00 to $509,552.31. Additionally, two stipulated awards were limited to annuities, the exact amounts of which were not determined at the time of judgment. 9 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 10 of 15 In addition to the extensive history of informal resolution, the undersigned has also issued 19 reasoned decisions as of the end of May of 2019 addressing the appropriate amount of compensation in prior SIRVA cases within the SPU.14 i. Below-median awards limited to past pain and suffering In 11 prior SPU cases, the undersigned has awarded compensation for pain and suffering limited to compensation for actual or past pain and suffering that has fallen below the amount of the median proffer discussed above. These awards for actual pain and suffering ranged from $60,000.00 to $90,000.00.15 These cases have all included injuries with a “good” prognosis, albeit in some instances with some residual pain. All of these cases had only mild to moderate limitations in range of motion and MRI imaging likewise showed only evidence of mild to moderate pathologies such as tendinosis, bursitis, or edema. The duration of injury ranged from six to 29 months and, on average, these petitioners experienced approximately 14 months of pain. Significant pain was reported in these cases for up to eight months. However, in approximately half of the cases, these petitioners subjectively rated their pain as six or below on a ten-point scale. Petitioners who reported pain in the upper end of the ten- point scale generally suffered pain at this level for three months or less. Approximately one-half were administered one to two cortisone injections. Most of these petitioners 14 An additional case, Young v. Sec’y of Health & Human Servs., No. 15-1241V, was removed from the SPU due to the protracted nature of the damages phase of that case. In that case the undersigned awarded $100,000.00 in compensation for past pain and suffering and $2,293.15 for past unreimbursable expenses. 2019 WL 664495 (Fed. Cl. Spec. Mstr. Jan. 22, 2019). A separate reasoned ruling addressed the amount awarded. 2019 WL 396981 (Fed. Cl. Spec. Mstr. Jan. 4, 2019). 15 These cases are: Bruegging v. Sec’y of Health & Human Servs., No. 17-0261V, 2019 WL 2620957 (Fed. Cl. Spec. Mstr. May 13, 2019) (awarding $90,000.00 for actual pain and suffering and $1,163.89 for actual unreimbursable expenses); Pruett v. Sec’y of Health & Human Servs., No. 17-0561V, 2019 WL 3297083 (Fed. Cl. Spec. Mstr. Apr. 30, 2019) (awarding $75,000.00 for actual pain and suffering and $944.63 for actual unreimbursable expenses); Bordelon v. Sec’y of Health & Human Servs., No. 17- 1892V, 2019 WL 2385896 (Fed. Cl. Spec. Mstr. Apr. 24, 2019) (awarding $75,000.00 for actual pain and suffering); Weber v. Sec’y of Health & Human Servs., No. 17-0399V, 2019 WL 2521540 (Fed. Cl. Spec. Mstr. Apr. 9, 2019) (awarding $85,000.00 for actual pain and suffering and $1,027.83 for actual unreimbursable expenses); Garrett v. Sec’y of Health & Human Servs., No. 18-0490V, 2019 WL 2462953 (Fed. Cl. Spec. Mstr. Apr. 8, 2019) (awarding $70,000.00 for actual pain and suffering); Attig v. Sec’y of Health & Human Servs., No. 17-1029V, 2019 WL 1749405 (Fed. Cl. Spec. Mstr. Feb. 19, 2019) (awarding $75,000.00 for pain and suffering and $1,386.97 in unreimbursable medical expenses); Dirksen v. Sec’y of Health & Human Servs., No. 16-1461V, 2018 WL 6293201 (Fed. Cl. Spec. Mstr. Oct. 18, 2018) (awarding $85,000.00 for pain and suffering and $1,784.56 in unreimbursable medical expenses); Kim v. Sec’y of Health & Human Servs., No. 17-0418V, 2018 WL 3991022 (Fed. Cl. Spec. Mstr. July 20, 2018) (awarding $75,000.00 for pain and suffering and $520.00 in unreimbursable medical expenses); Knauss v. Sec’y of Health & Human Servs., No. 16-1372V, 2018 WL 3432906 (Fed. Cl. Spec. Mstr. May 23, 2018) (awarding $60,000.00 for pain and suffering and $170.00 in unreimbursable medical expenses); Marino v. Sec’y of Health & Human Servs., No. 16-0622V, 2018 WL 2224736 (Fed. Cl. Spec. Mstr. Mar. 26, 2018) (awarding $75,000.00 for pain and suffering and $88.88 in unreimbursable medical expenses); Desrosiers v. Sec’y of Health & Human Servs., No. 16-0224V, 2017 WL 5507804 (Fed. Cl. Spec. Mstr. Sept. 19, 2017) (awarding $85,000.00 for pain and suffering and $336.20 in past unreimbursable medical expenses). 10 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 11 of 15 pursued physical therapy for two months or less and none had any surgery. The petitioners in Weber and Garrett attended PT for five and four months respectively, but most of the PT in Weber focused on conditions unrelated to the petitioner’s SIRVA. Several of these cases (Knauss, Marino, Kim, and Dirksen) included a delay in seeking treatment. These delays ranged from about 42 days in Kim to over six months in Marino. ii. Above-median awards limited to past pain and suffering Additionally, in five prior SPU cases, the undersigned has awarded compensation limited to past pain and suffering falling above the median proffered SIRVA award. These awards have ranged from $110,000.00 to $160,000.00.16 Like those in the preceding group, prognosis was “good.” However, as compared to those petitioners receiving a below-median award, these cases were characterized either by a longer duration of injury or by the need for surgical repair. Four out of five underwent some form of shoulder surgery while the fifth (Cooper) experienced two full years of pain and suffering, eight months of which were considered significant, while seeking extended conservative treatment. On the whole, MRI imaging in these cases also showed more significant findings. In four out of five cases, MRI imaging showed possible evidence of partial tearing.17 No MRI study was performed in the Cooper case. During treatment, each of these petitioners subjectively rated their pain within the upper half of a ten-point pain scale and all experienced moderate to severe limitations in range of motion. Moreover, these petitioners tended to seek treatment of their injuries more immediately. Time to first treatment ranged from five days to 43 days. Duration of physical therapy ranged from one to 24 months and three out of the five had cortisone injections. 16 These cases are: Reed v. Sec’y of Health & Human Servs., No. 16-1670V, 2019 WL 1222925 (Fed. Cl. Spec. Mstr. Feb. 1, 2019) (awarding $160,000.00 for pain and suffering and $4,931.06 in unreimbursable medical expenses); Knudson v. Sec’y of Health & Human Servs., No. 17-1004V, 2018 WL 6293381 (Fed. Cl. Spec. Mstr. Nov. 7, 2018) (awarding $110,000.00 for pain and suffering and $305.07 in unreimbursable medical expenses); Cooper v. Sec’y of Health & Human Servs., No. 16-1387V, 2018 WL 6288181 (Fed. Cl. Spec. Mstr. Nov. 7, 2018) (awarding $110,000.00 for pain and suffering and $3,642.33 in unreimbursable medical expenses); Dobbins v. Sec’y of Health & Human Servs., No. 16-0854V, 2018 WL 4611267 (Fed. Cl. Spec. Mstr. Aug. 15, 2018) (awarding $125,000.00 for pain and suffering and $3,143.80 in unreimbursable medical expenses); Collado v. Sec’y of Health & Human Servs., No. 17- 0225V, 2018 WL 3433352 (Fed. Cl. Spec. Mstr. June 6, 2018) (awarding $120,000.00 for pain and suffering and $772.53 in unreimbursable medical expenses). 17 In Reed, MRI showed edema in the infraspintaus tendon of the right shoulder with a possible tendon tear and a small bone bruise of the posterior humeral head. In Dobbins, MRI showed a full-thickness partial tear of the supraspinatus tendon extending to the bursal surface, bursal surface fraying and partial thickness tear of the tendon, tear of the posterior aspects of the inferior glenohumeral ligament, and moderate sized joint effusion with synovitis and possible small loose bodies. In Collado, MRI showed a partial bursal surface tear of the infraspinatus and of the supraspinatus. In Knudson, MRI showed mild longitudinally oriented partial-thickness tear of the infraspinatus tendon, mild supraspinatus and infraspinatus tendinopathy, small subcortical cysts and mild subcortical bone marrow edema over the posterior-superior-lateral aspect of the humeral head adjacent to the infraspinatus tendon insertion site, and minimal subacromial-subdeltoid bursitis. 11 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 12 of 15 iii. Awards including compensation for both past and future pain and suffering In three prior SPU SIRVA cases, the undersigned has awarded compensation for both past and future pain and suffering.18 In two of those cases (Hooper and Binette), petitioners experienced moderate to severe limitations in range of motion and moderate to severe pain. The Hooper petitioner underwent surgery while in Binette petitioner was deemed not a candidate for surgery following an arthrogram. Despite significant physical therapy (and surgery in Hooper), medical opinion indicated that their disability would be permanent. In these two cases, petitioners were awarded above-median awards for actual pain and suffering as well as awards for projected pain and suffering for the duration of their life expectancies. In the third case (Dhanoa), petitioner’s injury was less severe than in Hooper or Binette; however, petitioner had been actively treating just prior to the case becoming ripe for decision and her medical records reflected that she was still symptomatic despite a good prognosis. The undersigned awarded an amount below-median for actual pain and suffering, but, in light of the facts and circumstances of the case, also awarded projected pain and suffering. VII. Appropriate Compensation in this SIRVA Case A. Past Pain and Suffering In this case, awareness of the injury is not in dispute. The record reflects that at all relevant times petitioner was a competent adult with no impairments that would impact her awareness of her injury. Therefore, the undersigned’s analysis will focus principally on the severity and duration of petitioner’s injury. Petitioner received a vaccine on October 19, 2015 and suffered pain in her left shoulder that was immediate and severe. Ex. 15 at 2-3. She testified that she tried to obtain medical attention for the painful symptoms within days and weeks of the vaccination but was unable to see her primary care physician until two months after the vaccination. Tr. 12-13. She described how she took measures on her own to obtain relief from the pain by taking aspirin and wearing an “ion bracelet” and an “impulse stimulator.” Tr. 15. She testified that the pain “took [her] through hell” and she would not wish it “on [her] worst enemy.” Tr. 53. When petitioner’s primary care physician proved unhelpful in diagnosing and treating her left shoulder, she went to the emergency room to find out what was wrong 18 These cases are: Dhanoa v. Sec’y of Health & Human Servs., No. 15-1011V, 2018 WL 1221922 (Fed. Cl. Spec. Mstr. Feb. 1, 2018) (awarding $85,000.00 for actual pain and suffering, $10,000.00 for projected pain and suffering for one year, and $862.15 in past unreimbursable medical expenses); Binette v. Sec’y of Health & Human Servs., No. 16-0731V, 2019 WL 1552620 (Fed. Cl. Spec. Mstr. Mar. 20, 2019) (awarding $130,000.00 for actual pain and suffering, $1,000.00 per year for a life expectancy of 57 years for projected pain and suffering, and $7,101.98 for past unreimbursable medical expenses); and Hooper v. Sec’y of Health & Human Servs., No. 17-0012V, 2019 WL 1561519 (Fed. Cl. Spec. Mstr. Mar. 20, 2019) (awarding $185,000.00 for actual pain and suffering, $1,500.00 per year for a life expectancy of 30 years for projected pain and suffering, $37,921.48 for lost wages). 12 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 13 of 15 and to obtain relief from the pain. Ex. 15 at 3-4; Ex. 3 at 278, 298. When that effort was also unsuccessful, she paid out of pocket to see a “natural doctor.” Tr. 42. Finally, she saw a surgeon who recommended physical therapy which ultimately resolved the pain. Ex. 14 at 4; Tr. 45. Petitioner described moderate to severe pain in her left shoulder to her medical providers from December 2015 through April 2016. She rated her pain as 6/10 to Dr. Noriega on December 22, 2015 and rated the pain as 7/10 at the PT evaluation on March 28, 2016. Ex. 3 at 49; Ex. 5 at 54. After several sessions of PT, she rated her pain as 5/10 on April 26, 2016. Ex. 5 at 55. Subsequently her pain mostly resolved as a result of PT and home exercise program. She reported pain levels of 0-1/10 at PT in May and June 2016. Ex. 5 at 10, 41, She testified at the fact hearing on September 18, 2018 that the left shoulder pain had gotten better. Tr. 45. Petitioner also suffered from ROM restrictions in her left shoulder starting shortly after the vaccination. Ex. 15 at 3. She testified the restrictions were severe and interfered with dressing, bathing, and cooking. Tr. 38-39. PT helped with the restricted ROM but, upon discharge, the physical therapist recommended continued home exercises and stretches to keep improving. Ex. 5 at 9. At the fact hearing, petitioner demonstrated that she still could not move her left arm past 90 degrees in flexion and abduction. Tr. 80-81. Petitioner’s case is similar to the prior SPU cases with below-median awards for past pain and suffering. Petitioners in these cases tended to have moderate symptoms with good results from treatment and did not require surgery. The awards in these cases ranged from $60,000.00 to $90,000.00. Petitioner’s case is most like the facts found in Kim. The petitioner in Kim sought treatment 42 days after vaccination, had three months of significant pain (rated at 7-10/10), and her symptoms mostly resolved after 11 sessions of PT over several months. She had a good prognosis with some remaining pain and stiffness. The petitioner in Kim was awarded $75,000.00 in pain and suffering.19 Respondent primarily relies on Knauss to support his proposed award of $50,000.00. However, the petitioner in Knauss was awarded $60,000.00 and he rarely rated his pain higher than 1/10. 20 He continued swimming and performing yard work while undergoing treatment and went for extended periods of time without treatment. Id. This suggests his symptoms were milder and interfered less with his daily activities than the petitioner in the instant case. There is preponderant evidence to establish petitioner suffered moderate to severe symptoms of her SIRVA, including significant pain and limited ROM, for six months after vaccination. By the end of this period she showed substantial improvement. She completed PT on June 9, 2016 and was reporting no pain but some residual limitations in her ROM. Ex. 5 at 9. Although she complained of weakness and loss of motion in the left shoulder in a medical visit on March 8, 2018, she elected not to 19 Kim, 2018 WL 3991022, at *1-3 20 Knauss, 2018 WL 3432906 at *7-8. 13 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 14 of 15 undergo treatment for it. Ex. 23 at 4. Her active treatment for the left shoulder concluded on June 9, 2016, eight months after the vaccination. Looking at the totality of circumstances, including the severity of petitioner’s initial pain and suffering and limited ROM, the undersigned finds $75,000 to be an appropriate amount for petitioner’s pain and suffering. B. Future Pain and Suffering Petitioner mentions future pain and suffering in her brief as being compensable under the Vaccine Act without making a specific request or providing supporting evidence. Pet. Mem. at 5. Rather, petitioner emphasizes that she continues to experience residual deficits. She claims to have provided ample evidence of pain and suffering from the time of onset to the time of the fact hearing. Id. The record shows that petitioner obtained significant relief from physical therapy. She has not sought further treatment for her left shoulder since her discharge from PT other than a consultation in 2018. Ex. 5 at 9; Ex. 23 at 4. At that consult, an MRI was recommended, but petitioner elected not to proceed because her pain was gone. Id. The undersigned finds that petitioner has not met her burden of establishing by preponderant evidence that she is entitled to an award for future pain and suffering. C. Award for Past Unreimbursed Expenses Petitioner requests reimbursement for two expenses and provided receipts to support the request. Pet. Mem. at 4; Ex. 26 at 1-3. The first receipt is for a $200.00 payment to the Center for Progressive Health. Ex. 26 at 1. Petitioner testified at the fact hearing that she went to the Center for Progressive Health to obtain treatment for her left shoulder pain. Petitioner has submitted medical records documenting the visit. Tr. 42; Ex. 2 at 1-4. Respondent confirmed in his damages brief that he has no objection to this payment. Res. Brief at 10. Petitioner’s second receipt is for $1,100.00 for an item of exercise equipment called a Euro Body Shaper. Ex. 26 at 2-3. Petitioner claims in her damages brief that she purchased the item for the purpose of performing rehabilitation exercises at home “in order to recover from her injury in a safe environment.” Pet. Mem. at 4. Petitioner testified at the fact hearing that she bought the item because she could not go to the gym and exercise out of fear that someone would hit her shoulder. Tr. 43. She also testified that she believed the device would help her shoulder because it was supposed to “improve your blood circulation and lymphatic system.” Id. She conceded that she did not buy it at the recommendation of any of her medical providers. Id. Petitioner did not provide evidence, other than her own opinion, that the Euro Body Shaper was special equipment that was “reasonably necessary” for diagnosis, medical treatment, or rehabilitation of her injured left shoulder as required in § 15(a)(1)(B)(iii). Considering the above, the undersigned awards $200.00 in past unreimbursed expenses for the medical visit to the Center for Progressive Health. The undersigned 14 Case 1:16-vv-01458-UNJ Document 82 Filed 11/15/19 Page 15 of 15 finds that petitioner has not met her burden of establishing by preponderant evidence that the Euro Body Shaper was reasonably necessary for diagnosis, treatment, or rehabilitation of her left shoulder. VIII. Conclusion For all of the reasons discussed above and based on consideration of the record as a whole, the undersigned finds that $75,000.00 represents a fair and appropriate amount of compensation for petitioner’s actual pain and suffering.21 The undersigned also finds that petitioner is entitled to $200.00 in actual unreimbursable expenses. Based on the record as a whole and arguments of the parties, the undersigned awards petitioner a lump sum payment of $75,200.00 in the form of a check payable to petitioner, Denise Goring. 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.22 IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 21 Since this amount is being awarded for actual, rather than projected, pain and suffering, no reduction to net present value is required. See § 15(f)(4)(A); Childers v. Sec’y of Health & Human Servs., No. 96- 0194V, 1999 WL 159844, at *1 (Fed. Cl. Spec. Mstr. Mar. 5, 1999) (citing Youngblood v. Sec’y of Health & Human Servs., 32 F.3d 552 (Fed. Cir. 1994)). 22 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. 15