VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-01426 Package ID: USCOURTS-cofc-1_17-vv-01426 Petitioner: Lindsey Lally Filed: 2017-10-04 Decided: 2021-05-10 Vaccine: Tdap Vaccination date: 2016-08-08 Condition: Shoulder Injury Related to Vaccine Administration (SIRVA) Outcome: compensated Award amount USD: 76529 AI-assisted case summary: Lindsey Lally filed a petition seeking compensation under the National Vaccine Injury Compensation Program after receiving a Tetanus-Diphtheria-acellular-Pertussis (Tdap) vaccine on August 8, 2016. She alleged that she suffered a Shoulder Injury Related to Vaccine Administration (SIRVA). The initial ruling on entitlement found that her left arm pain occurred within 48 hours of vaccination. The respondent, the Secretary of Health and Human Services, did not contest entitlement, advising that Ms. Lally had satisfied the criteria for SIRVA under the Vaccine Injury Table and Qualifications and Aids to Interpretation. The case proceeded as a Table claim. Subsequently, the parties reached a proffer agreement for damages. The court adopted this proffer, awarding Ms. Lally a total of $76,529.44. This amount included $75,000.00 for pain and suffering and $1,529.44 for past unreimbursable expenses related to her vaccine-related injury. The award was made as a lump sum payment to Ms. Lally. Theory of causation field: Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_17-vv-01426-0 Date issued/filed: 2019-10-11 Pages: 4 Docket text: PUBLIC ORDER/RULING (Originally filed: 7/24/2019) regarding 39 Findings of Fact & Conclusions of Law Signed by Special Master Nora Beth Dorsey. (ypb) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-01426-UNJ Document 44 Filed 10/11/19 Page 1 of 4 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 17-1426V Filed: July 24, 2019 UNPUBLISHED LINDSEY LALLY, Petitioner, Special Processing Unit (SPU); Fact v. Ruling; Onset; Tetanus Diphtheria acellular Pertussis (Tdap) Vaccine; SECRETARY OF HEALTH AND Shoulder Injury Related to Vaccine HUMAN SERVICES, Administration (SIRVA) Respondent. Amber Diane Wilson, Maglio Christopher & Toale, PA, Washington, DC, for petitioner. Robert Paul Coleman, III, U.S. Department of Justice, Washington, DC, for respondent. FACT RULING1 Dorsey, Chief Special Master: On October 4, 2017, 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 that she suffers from a left shoulder injury related to vaccine administration (“SIRVA”), resulting from a Tetanus-Diphtheria-acellular Pertussis (“Tdap”) vaccine administered on August 8, 2016. 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 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 1:17-vv-01426-UNJ Document 44 Filed 10/11/19 Page 2 of 4 For the reasons discussed below, the undersigned finds the onset of petitioner’s shoulder injury related to vaccine administration (“SIRVA”) occurred within 48 hours of vaccination. Specifically, petitioner suffered pain within 48 hours of vaccination. I. Relevant Procedural History In support of her claim, petitioner filed medical records (Exs. 1-3, 5-7, 9), her own affidavit (Ex. 4), and an affidavit from her friend and former co-worker, Deidre Ryan- Delaney (Ex. 10). Deadlines for respondent to report his position in the case were set following the November 6, 2017 initial status conference. Orders, ECF Nos. 9, 11, 14, 16, 19. On July 6, 2018, respondent reported that he intended to contest entitlement. ECF No. 21. Respondent filed his Rule 4(c) report contesting entitlement on September 4, 2018. ECF No. 24. The undersigned ordered respondent to file an amended report addressing petitioner’s evidence in greater detail. Order, ECF No. 25. Respondent filed an amended Rule 4(c) report on October 23, 2018. Resp.’s Am. Rep., ECF No. 27. In his amended report, respondent argued that petitioner had not met her burden of establishing that the onset of her alleged shoulder injury occurred within 48 hours of her August 8, 2016 Tdap vaccination. Id. at 4-6. A status conference was held on November 26, 2018 to discuss resolving the parties’ onset dispute by fact ruling. Order, ECF No. 28. Thereafter, the undersigned reviewed the evidence and determined that a fact hearing would not be necessary. Order, ECF No. 32. A schedule for concurrent briefing without responses was set. Id. The parties filed their briefs on June 4, 2019. Pet.’s Mot., ECF No. 38; Resp.’s Brief, ECF No. 37. The matter is now ripe. II. Issue At issue is whether petitioner’s first symptom or manifestation of onset after vaccine administration was within 48 hours as set forth in the Vaccine Injury Table. 42 C.F.R. § 100.3(a) I.C & II.C. (2017) (Tdap vaccination). Additionally, the Qualifications and aids to interpretation (“QAI”) for a Table SIRVA requires that a petitioner’s pain occur within this same time frame, 48 hours. 42 C.F.R. § 100.3(c)(10). III. Authority Pursuant to Vaccine Act § 13(a)(1)(A), a petitioner must prove, by a preponderance of the evidence, the matters required in the petition by Vaccine Act § 11(c)(1). A special master may find that the first symptom or manifestation of onset of 2 Case 1:17-vv-01426-UNJ Document 44 Filed 10/11/19 Page 3 of 4 an injury occurred “within the time period described in the Vaccine Injury Table even though the occurrence of such symptom or manifestation was not recorded or was incorrectly recorded as having occurred outside such period.” Vaccine Act § 13(b)(2). “Such a finding may be made only upon demonstration by a preponderance of the evidence that the onset [of the injury] . . . did in fact occur within the time period described in the Vaccine Injury Table.” Id. 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. Vaccine Act § 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.” Curcuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). IV. Finding of Fact The undersigned makes the finding after a complete review of the record to include all medical records, affidavits, testimony, expert reports, respondent’s Rule 4 report, and additional evidence filed. Specifically, the undersigned bases the finding on the following evidence: • Petitioner received the Tdap vaccine in her left deltoid on August 8, 2016. Ex. 1 at 1; Ex. 2 at 41; Ex. 9 at 9. • Petitioner avers that when receiving her August 8, 2016 Tdap vaccine, the administering nurse stuck the needle into petitioner’s arm twice causing significant and immediate pain. Ex. 4 at 1-2. • Petitioner emailed her primary care physician on November 28, 2016 stating that during administration of Tdap vaccine, she “jerked [her] arm back and it came out before it was complete. The nurse then did it again.” Ex. 5. Petitioner reported that she “had the usual pain afterwards, but [she] still ha[s] pain in [her] arm at the injection spot and it seems to be getting worse.” Id. • On December 8, 2016, petitioner was seen by Anthony K. Park, M.D., a doctor at petitioner’s PCP’s office, with complaints of left shoulder pain that petitioner related to the Tdap vaccination of August 8, 2016. Ex. 2 at 60. Petitioner reported that her left shoulder hurt immediately after vaccination, and that she experienced some bruising for one and one-half weeks. Id. • Petitioner began physical therapy on January 12, 2017. Ex. 2 at 75. During this session, petitioner reported that her left shoulder pain began “after getting her TDAP shot.” Id. at 75. • Petitioner went for an orthopedic consult on April 25, 2017. Ex. 3 at 5. The history from this appointment indicates that petitioner “associated shoulder pain with Tdap given last year.” Id. 3 Case 1:17-vv-01426-UNJ Document 44 Filed 10/11/19 Page 4 of 4 • Petitioner had a phone consultation with orthopedist Dr. David Yi on July 25, 2017 discussing her treatment options. Ex. 7 at 6. The record from this consultation notes that petitioner “has had L shoulder pain for 1+ yr, coincided with tetanus shot.” Id. The above medical entries are consistent with petitioner’s affidavit testimony that her pain began at the time she received the Tdap vaccine on August 8, 2016. Petitioner’s former co-worker and friend, Ms. Ryan-Delaney, also recalls petitioner complaining of shoulder pain starting upon receipt of the Tdap vaccination in August 2016. Ex. 10. The undersigned finds the sworn testimony of petitioner and her witness to be credible and in agreement with the contemporaneously created treatment records. As such, the undersigned finds preponderant evidence that the onset of petitioner’s left shoulder injury occurred within 48 hours of her August 8, 2016 Tdap vaccination. V. Scheduling Order Respondent shall file a status report by Thursday, September 5, 2019, indicating whether he is interested in exploring an informal resolution of petitioner’s claim. IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 4 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_17-vv-01426-1 Date issued/filed: 2020-12-04 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 10/9/2020) regarding 59 Ruling on Entitlement. Signed by Special Master Katherine E. Oler. (sl) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-01426-UNJ Document 61 Filed 12/04/20 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 17-1426V (not to be published) * * * * * * * * * * * * * * * * * * * * * * * * * * * * LINDSEY LALLY, * * Filed: October 9, 2020 Petitioner, * * * v. * Ruling on Entitlement; Tetanus- * Diphtheria-acellular-Pertussis (“Tdap”) SECRETARY OF HEALTH AND * Vaccine; Shoulder Injury Related to HUMAN SERVICES, * Vaccine Administration (SIRVA) * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * * Amber Wilson, Wilson Science Law, Washington, DC, for Petitioner. Christine Becer, U.S. Department of Justice, Washington, DC, for Respondent. RULING ON ENTITLEMENT1 On October 4, 2017, Lindsey Lally (“Petitioner”) filed a petition, seeking compensation under the National Vaccine Injury Compensation Program (“the Vaccine Program”).2 Pet., ECF No. 1. Petitioner alleges that she suffered a Shoulder Injury Related to Vaccine Administration (“SIRVA”) as a result of the Tetanus-Diphtheria-acellular-Pertussis (“Tdap”) vaccination she received on August 8, 2016. Pet. at 1. 1 Although this Ruling has been formally designated “not to be published,” it will nevertheless be posted on the Court of Federal Claims’ website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Ruling will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Ruling’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the Ruling in its present form will be available. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”). All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa. Case 1:17-vv-01426-UNJ Document 61 Filed 12/04/20 Page 2 of 2 On July 24, 2019, Special Master Dorsey ruled that the onset of Petitioner’s shoulder injury occurred within 48 hours of vaccination. ECF No. 39. On October 9, 2020, Respondent filed an amended Rule 4(c) Report. Amended Resp’t’s Rep., ECF No. 57. In the Amended Rule 4(c) Report, Respondent advised that “he will not defend this case on other grounds during further proceedings before the Office of Special Masters,” but reserved his right to appeal the factual finding. Amended Resp’t’s Rep. at 2. Respondent indicated that Petitioner “has otherwise satisfied the criteria set forth in the Vaccine Injury Table and the Qualifications and Aids to Interpretation (“QAI”) for SIRVA.” Id. Respondent requested that I decide the issue of entitlement based on the existing record. Id. In view of Respondent’s position and the evidence of record, I find that the Petitioner is entitled to compensation. IT IS SO ORDERED. s/ Katherine E. Oler Katherine E. Oler Special Master ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_17-vv-01426-2 Date issued/filed: 2021-05-10 Pages: 5 Docket text: PUBLIC DECISION (Originally filed: 3/24/2021) regarding 67 DECISION of Special Master - Proffer. Signed by Special Master Katherine E. Oler. (sl) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-01426-UNJ Document 73 Filed 05/10/21 Page 1 of 5 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 17-1426V (not to be published) * * * * * * * * * * * * * * * * * * * * * * * * * * * * LINDSEY LALLY, * * Filed: March 24, 2021 Petitioner, * * * v. * Entitlement; Decision by Proffer; * Damages; Tetanus-Diphtheria-Acellular SECRETARY OF HEALTH AND * Pertussis (“Tdap”) Vaccine; Shoulder HUMAN SERVICES, * Injury Related to Vaccine Administration * * (“SIRVA”). Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * * Amber Wilson, Wilson Science Law, Washington, DC, for Petitioner Christine Becer, U.S. Department of Justice, Washington, DC, for Respondent DECISION AWARDING DAMAGES1 On October 4, 2017, Lindsey Lally (“Petitioner”) filed a petition, seeking compensation under the National Vaccine Injury Compensation Program (“the Vaccine Program”).2 Pet., ECF No. 1. alleged that she developed a shoulder injury related to vaccine administration (“SIRVA”) as a result of receiving a tetanus-diphtheria-acellular pertussis vaccine on August 8, 2016. See Proffer at 1, ECF No. 66; see also Pet. On July 24, 2019, former Chief Special Master Dorsey issued Findings of Fact that found 1 Because this Decision contains a reasoned explanation for my actions in this case, I will 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 (2012). This means the Decision will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”). All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa. Case 1:17-vv-01426-UNJ Document 73 Filed 05/10/21 Page 2 of 5 Petitioner’s left arm pain occurred within 48 hours of vaccination. ECF No. 39. On October 8, 2020, Respondent filed an Amended Rule 4(c) Report, stating that, “While preserving his right to appeal the Chief Special Master’s Findings of Fact, respondent submits that petitioner has otherwise satisfied the criteria set forth in the Vaccine Injury Table and the Qualifications and Aids to Interpretation (“QAI”) for SIRVA.” Resp’t’s Am. Rep. at 2, ECF No. 57. Respondent also requested a ruling on the record regarding Petitioner’s entitlement to compensation. Id. In light of Respondent’s request, I issued a Ruling on Entitlement on October 9, 2020. ECF No. 59. Respondent filed a proffer on March 22, 2021 (ECF No. 66), agreeing to issue the following payments: 1. A lump sum payment of $76,529.44 paid in the form of a check to Petitioner; $75,000.00 for pain and suffering, and $1,529.44 for past unreimbursable expenses related to [Petitioner’s] vaccine-related injury. These amounts represent all elements of compensation for all damages that would be available under § 300aa-15(a). I adopt the parties’ proffer attached hereto, and award compensation in the amount and on the terms set forth therein. I, therefore, award compensation in the amount of a lump sum payment of $76,529.44, in the form of a check payable to Petitioner, Lindsey Lally. The Clerk of Court is directed to enter judgment in accordance with this decision.3 IT IS SO ORDERED. s/ Katherine E. Oler Katherine E. Oler Special Master 3 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party filing a notice renouncing the right to seek review. Case 1:17-vv-01426-UNJ Document 73 Filed 05/10/21 Page 3 of 5 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS ____________________________________ ) LINDSEY LALLY, ) ) Petitioner, ) ) No. 17-1426V v. ) Special Master Oler ) ECF SECRETARY OF HEALTH AND ) HUMAN SERVICES, ) ) Respondent. ) ____________________________________) RESPONDENT’S PROFFER ON AWARD OF COMPENSATION On October 4, 2017, Lindsey Lally (“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 a tetanus- diphtheria-acellular pertussis (“Tdap”) vaccine on August 8, 2016. Petition at 1. On October 8, 2020, the Secretary of Health and Human Services (“respondent”) filed an Amended Vaccine Rule 4(c) Report advising that, in light of former Chief Special Master Dorsey’s Findings of Fact ruling that the onset of petitioner’s left arm pain occurred within 48 hours of vaccination, and the medical evidence submitted in this case, respondent did not dispute that petitioner had satisfied all legal prerequisites for compensation under the Vaccine Act. Amended Rule 4(c) Report at 3 (ECF #57). On October 9, 2020, Special Master Oler issued a Ruling on Entitlement, finding that petitioner was entitled to vaccine compensation for her shoulder injury related to vaccine administration (“SIRVA”).1 See Ruling on Entitlement (ECF #59). 1 Respondent has no objection to the amount of the proffered award of damages set forth herein. Assuming the Special Master issues a damages decision in conformity with this proffer, Case 1:17-vv-01426-UNJ Document 73 Filed 05/10/21 Page 4 of 5 I. Items of Compensation A. Pain and Suffering Respondent proffers that petitioner should be awarded $75,000.00 for pain and suffering. See 42 U.S.C. § 300aa-15(a)(4). Petitioner agrees. B. Past Unreimbursable Expenses Evidence supplied by petitioner documents that she incurred past unreimbursable expenses related to her vaccine-related injury. Respondent proffers that petitioner should be awarded past unreimbursable expenses in the amount of $1,529.44. See 42 U.S.C. § 300aa- 15(a)(1)(B). Petitioner agrees. These amounts represent all elements of compensation to which petitioner is 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 Special Master’s decision and the Court’s judgment award the following2: a lump sum payment of $76,529.44, in the form of a check payable to petitioner. III. Summary of Recommended Payments Following Judgment Lump sum payable to petitioner, Lindsey Lally: $76,529.44 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 Special Master’s October 9, 2020, entitlement decision. 2 Should petitioner die prior to entry of judgment, the parties reserve the right to move the Court for appropriate relief. In particular, respondent would oppose any award for future lost earnings and future pain and suffering. 2 Case 1:17-vv-01426-UNJ Document 73 Filed 05/10/21 Page 5 of 5 Respectfully submitted, BRIAN M. BOYNTON Acting Assistant Attorney General C. SALVATORE D’ALESSIO Acting Director Torts Branch, Civil Division HEATHER L. PEARLMAN Acting Deputy Director Torts Branch, Civil Division DARRYL R. WISHARD Assistant Director Torts Branch, Civil Division s/Christine Mary Becer CHRISTINE MARY BECER 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) 616-3665 Christine.m.becer@usdoj.gov DATED: March 22, 2021 3