VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00211 Package ID: USCOURTS-cofc-1_20-vv-00211 Petitioner: Trina Lower Filed: 2020-02-26 Decided: 2024-04-08 Vaccine: influenza Vaccination date: 2017-11-18 Condition: shoulder injury related to vaccine administration (SIRVA) Outcome: compensated Award amount USD: 81618 AI-assisted case summary: Trina Lower filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that she suffered a shoulder injury related to vaccine administration (SIRVA) caused by an influenza vaccine administered on November 18, 2017. The case was assigned to the Special Processing Unit of the Office of Special Masters. After settlement efforts failed, Petitioner was ordered to file a motion for a ruling on the record, which she did on August 15, 2022. Respondent filed a response on December 1, 2022. The Chief Special Master issued a ruling on entitlement on December 8, 2023, finding that Petitioner is entitled to compensation for a Table SIRVA. The ruling noted that Petitioner first reported left shoulder pain to her primary care physician approximately three weeks after the vaccination, associating the pain with the vaccine. Medical records showed ongoing pain, reduced range of motion, and several cortisone injections. The court found that Petitioner met the criteria for a Table SIRVA, including no prior history of shoulder problems, onset of pain within 48 hours of vaccination (though the medical records were vague, the court found preponderant evidence of onset within the timeframe), pain limited to the left shoulder, and no other condition explaining the symptoms. Respondent did not dispute most of these criteria. On April 8, 2024, a decision awarding damages was issued. Respondent filed a proffer on award of compensation, indicating Petitioner should be awarded $81,618.31, comprised of $80,000.00 for pain and suffering and $1,618.31 for out-of-pocket expenses. Petitioner agreed with the proffered award. The court awarded Petitioner a lump sum payment of $81,618.31. Theory of causation field: Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_20-vv-00211-0 Date issued/filed: 2024-01-12 Pages: 7 Docket text: PUBLIC ORDER/RULING (Originally filed: 12/08/2023) regarding 61 Ruling on Entitlement, Order on Motion for Ruling on the Record. Signed by Chief Special Master Brian H. Corcoran. (kle) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00211-UNJ Document 64 Filed 01/12/24 Page 1 of 7 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-211V UNPUBLISHED TRINA LOWER, Chief Special Master Corcoran Petitioner, Filed: December 8, 2023 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Entitlement to Compensation; Ruling HUMAN SERVICES, on the Record; Findings of Fact; Influenza (“Flu”); Shoulder Injury Respondent. Related to Vaccine Administration (SIRVA); Leigh Finfer, Muller Brazil, LLP, Dresher, PA, for Petitioner. Debra A. Filteau Begley, U.S. Department of Justice, Washington, DC, for Respondent. RULING ON ENTITLEMENT1 On February 26, 2020, Trina Lower 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 shoulder injury related to vaccine administration (“SIRVA”) caused by an influenza (“flu”) vaccine administered on November 18, 2017. Petition at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters. For the reasons set forth below, I find that Petitioner is entitled to compensation. 1 In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:20-vv-00211-UNJ Document 64 Filed 01/12/24 Page 2 of 7 I. Relevant Procedural History During the claim’s life, some effort was made at settlement, but the parties could not find agreement. Accordingly, Petitioner was ordered to file a motion for a ruling on the record, doing so on August 15, 2022. Motion for Ruling on the Record (“Mot.”), ECF No. 56. Respondent filed a response on December 1, 2022. Respondent’s Rule 4(c) Report and Response to Petitioner’s Motion for a Ruling on the Record (“Opp.”), ECF No. 60. The matter is ripe for resolution. II. Petitioner’s Medical Records Petitioner received a flu vaccine in her left shoulder on November 18, 2017, at her place of employment. Ex. 1 at 1. A little over three weeks later, she reported left shoulder pain to her primary care physician, Dr. Steven Tekippe, on December 11, 2018. Ex. 3 at 15. She associated the pain with the vaccination, and an examination revealed reduced range of motion. Id. A cortisone injection was administered. Id. On January 24, 2018, Petitioner returned to Dr. Tekippe, now reporting that she was pursuing a workers’ compensation claim due to her left shoulder injury “stemming from” the November 18 flu vaccine. Ex. 3 at 13. She also reported that the steroid injection helped, but her pain was returning. A second steroid injection was administered. Id. Petitioner next sought care on April 27, 2018, informing Dr. Tekippe that she had experienced “moderate improvement” since the last steroid injection, but still was feeling some pain. Ex. 3 at 11. She was assessed with bursitis, and a third injection was administered. Id. at 11. On June 27, 2018, Petitioner returned to Dr. Tekippe with reports of ongoing left shoulder pain she attributed to a flu vaccine. Ex. 3 at 8. She also reported right shoulder pain that could be the result of compensating for the left shoulder injury. Id. She was diagnosed with arthralgia of the left shoulder region and pain in the left shoulder. Id. Petitioner had an MRI on June 28, 2018, which showed impingement and minimal tendinopathy. Ex. 17 at 53. Petitioner began occupational therapy on December 18, 2018. Ex. 17 at 29. At the initial meeting, Petitioner reported that her symptoms “started after she received a flu shot last year in the left shoulder.” Id. Further, she stated that cortisone injections gave her “about 2 to 3 months” of relief. Id. She attended eleven sessions and was discharged on February 1, 2019, after making “excellent gains”. Id. at 28, 43. 2 Case 1:20-vv-00211-UNJ Document 64 Filed 01/12/24 Page 3 of 7 On May 3, 2019, Petitioner returned to Dr. Tekippe with complaints of left shoulder pain she attributed to “an injury…stemming from an injection for influenza.” Ex. 3 at 6. She was assessed with bursitis and received another cortisone injection. Id. at 6-7. On November 20, 2019, Petitioner again complained of shoulder pain “related to previous injection for flu immunization” and received another steroid injection. Ex. 6 at 9. Petitioner submitted an affidavit in support of her claim. Ex. 7. Therein, she states that she received a flu vaccine on October 26, 2018, and suffered the residual effects of her injury for mor than six months. III. Fact Findings and Ruling on Entitlement Pursuant to Vaccine Act Section 13(a)(1)(A), a petitioner must prove, by a preponderance of the evidence, the matters required in the petition by Vaccine Act Section 11(c)(1). In addition to requirements concerning the vaccination received, the duration and severity of petitioner’s injury, and the lack of other award or settlement,3 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. Section 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. Section 14(a). Pursuant to the Vaccine Injury Table, a SIRVA is compensable if it manifests within 48 hours of the administration of an influenza vaccine. 42 C.F.R. § 100.3(a)(XIV)(B). 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; 3 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). 3 Case 1:20-vv-00211-UNJ Document 64 Filed 01/12/24 Page 4 of 7 (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient’s symptoms (e.g., NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 42 C.F.R. § 100.3(c)(10). A special master must consider, but is not bound by, any diagnosis, conclusion, judgment, test result, report, or summary concerning the nature, causation, and aggravation of petitioner’s injury or illness that is contained in a medical record. Section 13(b)(1). “Medical records, in general, warrant consideration as trustworthy evidence. The records contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an extra premium. These records are also generally contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Accordingly, where medical records are clear, consistent, and complete, they should be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03- 1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, the Federal Circuit has recently “reject[ed] as incorrect the presumption that medical records are always accurate and complete as to all of the patient’s physical conditions.” Kirby v. Sec'y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). Medical professionals may not “accurately record everything” that they observe or may “record only a fraction of all that occurs.” Id. Medical records may be outweighed by testimony that is given later in time that is “consistent, clear, cogent, and compelling.” Camery v. Sec’y of Health & Hum. Servs., 42 Fed. Cl. 381, 391 (1998) (citing Blutstein v. Sec’y of Health & Hum. Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering such testimony must also be determined. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). A. Factual Findings Regarding a Table SIRVA After a review of the entire record, I find that a preponderance of the evidence demonstrates that Petitioner has satisfied the QAI requirements for a Table SIRVA. 4 Case 1:20-vv-00211-UNJ Document 64 Filed 01/12/24 Page 5 of 7 1. Petitioner Had No Prior Left Shoulder Condition or Injury that would Explain her Symptoms The first requirement for a Table SIRVA is a lack of problems associated with the affected shoulder prior to vaccination that would explain the symptoms experienced after vaccination. 42 C.F.R. § 100.3(c)(10)(i). Respondent does not dispute that Petitioner meets this criterion, and I find that she has demonstrated a lack of history of pain, inflammation, or dysfunction of her left shoulder that would explain her symptoms. 2. Onset of Petitioner’s Injury Occurred within Forty-Eight Hours of her Vaccination The medical records preponderantly establish onset of injury close-in-time to vaccination. Petitioner first reported shoulder pain twenty-three days after her November 18, 2018, vaccination, and associated her shoulder pain with the earlier vaccination. Ex. 3 at 15. Thereafter, Petitioner continued to link her shoulder pain temporally to the flu vaccine. See Ex. 3 at 13 (record from January 24, 2018, stating that Petitioner’s shoulder injury “stem[ed] from” the flu vaccination); Ex. 3 at 8 (record from June 27, 2018, reporting ongoing shoulder pain Petitioner attributed to the flu vaccine); Ex. 17 at 29 (record from December 18, 2018, stating that Petitioner’s symptoms “started after she received a flu shot last year in the left shoulder”). Respondent argues that Petitioner’s statements are vague, failing to identify a specific onset date for her shoulder symptoms. Opp. at 6-7. Even so, a finding of Table- consistent onset can be made based on such a record. Program petitioners are not required to marshal records setting forth with chronographic specificity the precise day and hour that their onset manifested. As noted above, Petitioner consistently linked her shoulder pain to the November 18, 2018, flu vaccine – whereas there are no records suggesting an onset outside of 48-hours post-vaccination. Further, the relevant medical records show that Petitioner reported shoulder pain in a relatively timely manner in comparison to the date of vaccination Thus, Petitioner first began to complain of shoulder pain within approximately three weeks of the vaccine, and did not attribute her pain to any other injury or cause. It is common for SIRVA petitioners to delay seeking treatment, thinking the injury will resolve on its own, especially since patients are often told by medical providers at the time of vaccination to expect some soreness and pain for a period of time after. And individuals also often misconstrue the nature of their injury, and therefore fail to inform treaters of all specific facts relevant to onset until later. Here, the added detail of onset did not “wait” for months before being 5 Case 1:20-vv-00211-UNJ Document 64 Filed 01/12/24 Page 6 of 7 provided, but began to be reported in a reasonable time post-vaccination. And Petitioner affirmatively and repeatedly linked her shoulder pain to the flu vaccine. Accordingly, there is preponderant evidence that establishes the onset of Petitioner’s left shoulder pain more likely than not occurred within 48-hours of vaccination. 3. Petitioner’s Pain was Limited to her Left Shoulder Respondent does not contest this aspect of Petitioner’s claim, and there is nothing in the records to suggest otherwise. 4. There is No Evidence of Another Condition or Abnormality The last criteria for a Table SIRVA state that there must be no other condition or abnormality which would explain a petitioner’s current symptoms. 42 C.F.R. § 100.3(c)(10)(iv). Respondent does not contest this aspect of Petitioner’s claim, and there is nothing in the records to suggest that any such condition or abnormality exists. B. Other Requirements for Entitlement In addition to establishing a Table injury, a petitioner must also provide preponderant evidence of the additional requirements of Section 11(c). Respondent does not dispute that Petitioner has satisfied these requirements in this case, and the overall record contains preponderant evidence to fulfill these additional requirements. The record shows that Petitioner received a flu vaccine intramuscularly on November 18, 2018, in the United States. Ex. 1 at 1; see Section 11(c)(1)(A) (requiring receipt of a covered vaccine); Section 11(c)(1)(B)(i)(I) (requiring administration within the United States or its territories). There is no evidence that Petitioner has collected a civil award for her injury. Ex. 7; Section 11(c)(1)(E) (lack of prior civil award). Based upon all of the above, Petitioner has established that she suffered a Table SIRVA. Additionally, she has satisfied all other requirements for compensation. I therefore find that Petitioner is entitled to compensation in this case. Conclusion In view of the evidence of record, I find that there is preponderant evidence that Petitioner satisfies the QAI requirements for a Table SIRVA. Further, based on the evidence of record, I find that Petitioner is entitled to compensation. 6 Case 1:20-vv-00211-UNJ Document 64 Filed 01/12/24 Page 7 of 7 Accordingly, the parties shall file a Joint Status Report by January 4, 2024, indicating whether a brief attempt at settlement discussions would be productive. IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 7 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_20-vv-00211-1 Date issued/filed: 2024-04-08 Pages: 5 Docket text: PUBLIC DECISION (Originally filed: 03/01/2024) regarding 67 DECISION Stipulation/Proffer Signed by Chief Special Master Brian H. Corcoran. (nh) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00211-UNJ Document 68 Filed 04/08/24 Page 1 of 5 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-211V TRINA LOWER, Chief Special Master Corcoran Petitioner, Filed: March 1, 2024 v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Leigh Finfer, Muller Brazil, LLP, Dresher, PA, for Petitioner. Debra A. Filteau Begley, U.S. Department of Justice, Washington, DC, for Respondent. DECISION AWARDING DAMAGES1 On February 26, 2020, Trina Lower 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 shoulder injury related to vaccine administration (“SIRVA”) as a result of an influenza vaccine administered on November 18, 2017. Petition at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters. On December 8, 2023, a ruling on entitlement was issued, finding Petitioner entitled to compensation for a SIRVA. On February 26, 2024, Respondent filed a proffer on award of compensation (“Proffer”) indicating Petitioner should be awarded $81,618.31 (comprised of $80,000.00 for pain and suffering and $1,618.31 for out-of-pocket expenses). Proffer at 2. In the Proffer, Respondent represented that Petitioner agrees 1 Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the 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, I agree that the identified material fits within this definition, I will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2018). Case 1:20-vv-00211-UNJ Document 68 Filed 04/08/24 Page 2 of 5 with the proffered award. Id. Based on the record as a whole, I find that Petitioner is entitled to an award as stated in the Proffer. Pursuant to the terms stated in the attached Proffer, I award Petitioner a lump sum payment of $81,618.31 (comprised of $80,000.00 for pain and suffering and $1,618.31 for out-of-pocket expenses) in the form of a check payable to Petitioner. This amount represents compensation for all damages that would be available under Section 15(a). The Clerk of Court is directed to enter judgment in accordance with this decision.3 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 3 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing the right to seek review. 2 Case 1:20-vv-00211-UNJ Document 68 Filed 04/08/24 Page 3 of 5 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS __________________________________________ ) TRINA LOWER, ) ) Petitioner, ) ) No. 20-211V (ECF) v. ) Chief Special Master Corcoran ) SECRETARY OF HEALTH ) AND HUMAN SERVICES, ) ) Respondent. ) RESPONDENT’S PROFFER ON AWARD OF COMPENSATION On February 26, 2020, Trina Lower (“petitioner”) filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to 34 (“Vaccine Act” or “Act”), alleging that she suffered a shoulder injury related to vaccine administration (“SIRVA”), as defined in the Vaccine Injury Table, following administration of an influenza vaccine on November 18, 2017. ECF # 1 (Petition). On December 1, 2022, the Secretary of Health and Human Services (“respondent”) filed a combined Vaccine Rule 4(c) Report recommending against compensation and Response to Petitioner’s Motion for a Ruling on the Record.1 ECF # 60. One year later, on December 8, 2023, Chief Special Master Corcoran issued a Ruling on Entitlement which included a factual finding that petitioner’s shoulder pain began within 48 hours of her November 18, 2017 vaccination. ECF # 61. Based on that factual finding, and respondent’s acknowledgement that all other requirements for a Table SIRVA claim 1 Respondent explained that petitioner’s most contemporaneous medical records contain only vague references to onset and do not specifically put the onset of her shoulder pain within the 48- hour Vaccine Table timeframe for SIRVA, and recommended that petitioner’s request for a ruling on the record be denied. Other than onset, respondent agreed that all other SIRVA requirements were met. See ECF # 60; 42 C.F.R. § 100.3(c)(10). Case 1:20-vv-00211-UNJ Document 68 Filed 04/08/24 Page 4 of 5 were met, the Chief Special Master concluded that petitioner was entitled to compensation for a Table SIRVA claim.2 See id. I. Items of Compensation Based on the evidence of record, respondent proffers that petitioner should be awarded a total of $81,618.31, for all damages, which includes $80,000.00 representative of pain and suffering, and $1,618.31 representative of out-of-pocket medical and related expenses. These amounts represent all elements of compensation to which petitioner would be entitled under 42 U.S.C. § 300aa-15(a). Petitioner agrees. II. Form of the Award Petitioner is a competent adult. Evidence of guardianship is not required in this case. Respondent recommends that the compensation provided to petitioner should be made through a lump sum payment as described below, and requests that the Chief Special Master’s damages decision and the Court’s judgment award the following: a lump sum payment of $81,618.31 in the form of a check payable to petitioner.3 Petitioner agrees. Respectfully submitted, BRIAN M. BOYNTON Principal Deputy Assistant Attorney General C. SALVATORE D’ALESSIO Director Torts Branch, Civil Division 2 Respondent has no objection to the amount of the proffered award of damages set forth herein. Assuming the Chief Special Master issues a damages decision in conformity with this proffer, respondent waives his right to seek review of such damages decision. However, respondent reserves his right, pursuant to 42 U.S.C. § 300aa-12(e), to seek review of the Chief Special Master’s December 8, 2023, entitlement decision. 3 Should petitioner die prior to the entry of judgment, respondent would oppose any award for future medical expenses, future pain and suffering, and future lost wages, and the parties reserve the right to move the Court for appropriate relief. Case 1:20-vv-00211-UNJ Document 68 Filed 04/08/24 Page 5 of 5 HEATHER L. PEARLMAN Deputy Director Torts Branch, Civil Division DARRYL R. WISHARD Assistant Director Torts Branch, Civil Division S/ DEBRA A. FILTEAU BEGLEY DEBRA A. FILTEAU BEGLEY Senior Trial Attorney Torts Branch, Civil Division U.S. Department of Justice P.O. Box 146 Benjamin Franklin Station Washington D.C. 20044-0146 Tel: (202)616-4181 Dated: February 26, 2024 Debra.Begley@usdoj.gov