VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-01536 Package ID: USCOURTS-cofc-1_19-vv-01536 Petitioner: De’Ann Zastrow Filed: 2019-10-03 Decided: 2022-06-27 Vaccine: influenza Vaccination date: 2017-11-28 Condition: Shoulder Injury Related to Vaccine Administration (SIRVA) Outcome: entitlement_granted_pending_damages Award amount USD: AI-assisted case summary: De’Ann Zastrow filed a petition under the National Vaccine Injury Compensation Program on October 3, 2019, seeking compensation for a Shoulder Injury Related to Vaccine Administration (SIRVA) allegedly resulting from an influenza vaccine she received on November 28, 2017. Petitioner alleged that the vaccination caused a SIRVA, characterized by reduced range of motion. The respondent, the Secretary of Health and Human Services, initially filed a report. On March 15, 2022, the Special Master had previously ruled that Petitioner experienced reduced range of motion following the flu vaccine. Subsequently, on April 15, 2022, the Respondent filed an amended Rule 4(c) Report. In this amended report, the Respondent conceded that, in light of the Special Master's Findings of Fact and the submitted medical record evidence, the Division of Vaccine Injury Compensation Programs (DICP) concluded that Petitioner suffered SIRVA as defined by the Vaccine Injury Table. The Respondent further stated that, based on the record and subject to the right to appeal the Findings of Fact, the Respondent did not dispute that Petitioner had satisfied all legal prerequisites for compensation under the Act. The Respondent requested that the issue of entitlement be decided based on the existing record. Special Master Katherine E. Oler, considering the Respondent's position and the evidence of record, ruled that Petitioner was entitled to compensation. The case was therefore entitled, pending a decision on damages. David J. Carney represented the Petitioner, and Camille M. Collett represented the Respondent. The public decision does not describe the specific onset of symptoms, diagnostic tests performed, treatments received, or the specific mechanism of injury. Theory of causation field: Petitioner De’Ann Zastrow received an influenza vaccine on November 28, 2017, and subsequently alleged a Shoulder Injury Related to Vaccine Administration (SIRVA). The Respondent, Secretary of Health and Human Services, conceded in an amended Rule 4(c) Report that Petitioner suffered SIRVA as defined by the Vaccine Injury Table and satisfied the legal prerequisites for compensation. Special Master Katherine E. Oler ruled on June 27, 2022, that Petitioner was entitled to compensation based on the Respondent's concession and the existing record. The theory of causation relied upon the Vaccine Injury Table for SIRVA. The public decision does not detail specific medical experts, the mechanism of injury beyond the Table definition, or the breakdown of damages awarded, as entitlement was granted pending damages. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_19-vv-01536-0 Date issued/filed: 2022-06-27 Pages: 2 Docket text: PUBLIC ORDER/RULING (Originally filed: 4/18/2022) regarding 49 Ruling on Entitlement. Signed by Special Master Katherine E. Oler. (sl) Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-01536-UNJ Document 54 Filed 06/27/22 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 19-1536V (not to be published) * * * * * * * * * * * * * * * * * * * * * * * * * * * * DE’ANN ZASTROW, * * Filed: April 18, 2022 Petitioner, * * * v. * Ruling on Entitlement; Influenza (“flu”) * Vaccine; Shoulder Injury Related to SECRETARY OF HEALTH AND * Vaccine Administration (SIRVA) HUMAN SERVICES, * * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * * David J. Carney, Green & Schafle LLC, Philadelphia PA, for Petitioner. Camille M. Collett, U.S. Department of Justice, Washington, DC, for Respondent. RULING ON ENTITLEMENT1 On October 3, 2019, De’Ann Zastrow (“Petitioner”) filed a petition, seeking compensation under the National Vaccine Injury Compensation Program (“the Vaccine Program”).2 Pet., ECF No. 1. Petitioner alleged that she suffered a Shoulder Injury Related to Vaccine Administration (“SIRVA”) as a result of the influenza (“flu”) vaccination she received on November 28, 2017. 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 1:19-vv-01536-UNJ Document 54 Filed 06/27/22 Page 2 of 2 On March 15, 2022, I ruled that Petitioner experienced reduced range of motion following receipt of the flu vaccine. ECF No. 46 at 2. On April 15, 2022, Respondent filed an amended Rule 4(c) Report. Amended Resp’t’s Rep., ECF No. 48. In the Amended Rule 4(c) Report, Respondent stated that “in light of the Special Master’s Findings of Fact, and medical record evidence submitted in this case, DICP has concluded that petitioner suffered SIRVA as defined by the Vaccine Injury Table.” Amended Resp’t’s Rep at 6. Respondent further stated that “based on the record as it now stands and subject to his right to appeal the Findings of Fact, respondent does not dispute that petitioner has satisfied all legal prerequisites for compensation under the Act. 42 U.S.C. § 300aa-13”. Id. Respondent requested that I decide the issue of entitlement based on the existing record. Id. at 7. 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 2: USCOURTS-cofc-1_19-vv-01536-1 Date issued/filed: 2022-06-27 Pages: 7 Docket text: PUBLIC ORDER/RULING (Originally filed: 3/15/2022) regarding 46 FINDINGS OF FACT Regarding RANGE OF MOTION. Signed by Special Master Katherine E. Oler. (sl) Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-01536-UNJ Document 55 Filed 06/27/22 Page 1 of 7 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 19-1536V Filed: March 15, 2022 * * * * * * * * * * * * * * * * * * * * * * * * * * DE’ANN ZASTROW * * Petitioner, * Findings of Fact; Range of Motion; SIRVA v. * (Not to be Published) * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * David Carney, Green & Schafle, LLC, Philadelphia, PA, for Petitioner Camille Collett, U.S. Department of Justice, Washington, DC, for Respondent RULING ON RANGE OF MOTION1 Oler, Special Master: On October 3, 2019, De’Ann Zastrow (“Ms. Zastrow” or “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” or “Program”). The petition alleges that the Petitioner developed a left shoulder injury related to vaccine administration (“SIRVA”) as a result of the flu vaccine she received on November 28, 2017. Pet. at 1, ECF No. 1. 1 Because this unpublished Ruling contains a reasoned explanation for the action in this case, I intend 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). This means the Ruling will be available to anyone with access to the internet. 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 whole Ruling will be available to the public. Id. 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). 1 Case 1:19-vv-01536-UNJ Document 55 Filed 06/27/22 Page 2 of 7 After carefully considering the evidence presented in this case, to include the medical records, Petitioner’s affidavit, and the expert report authored by Petitioner’s expert, Dr. Naveed Natanzi, I find that Petitioner did experience reduced range of motion after her receipt of the flu vaccine. I. Procedural History Petitioner filed her petition on October 3, 2019. Pet., ECF No. 1. Ms. Zastrow filed supporting medical records on October 14, 2019 (Exs. 1, 3, 4, 5), an affidavit (Ex. 2), and a statement of completion on that same day. ECF No. 7. Respondent filed a status report on January 20, 2021 indicating that “petitioner’s claim may be appropriate for informal settlement.” ECF No. 20. The parties engaged in settlement discussions for the next several months. On May 7, 2021, Petitioner filed a status report indicating that despite ongoing negotiations, the parties remained too far apart in their positions. ECF No. 24. Accordingly, Chief Special Master Corcoran set a deadline for Respondent to file his Rule 4 Report. Respondent filed his Rule 4(c) Report on July 30, 2021. Resp’t’s Rep. ECF No. 28. Respondent argued that this case is not appropriate for compensation because the medical records do not reflect that Petitioner met the qualifications and aids to interpretation (“QAI”) for SIRVA because “the left upper extremity pain that [Petitioner] experienced was not limited to the shoulder in which the flu vaccine was administered, and, at times, radiated down to her left hand or up into her neck.” Resp’t’s Rep. at 5. Respondent further contended that there is no evidence that “petitioner had range of motion deficits in her left shoulder post vaccination.” Id. This case was transferred out of the SPU to my docket on August 11, 2021. ECF No. 29. I held a status conference on August 17, 2021 where I asked counsel to explain why their settlement negotiations had not progressed. The parties indicated that “Respondent was not convinced that Petitioner’s injury met the QAI criteria to qualify as a table SIRVA claim, given that Respondent believes that Petitioner did not suffer from reduced range of motion or pain that was limited to the left shoulder.” Scheduling Order dated August 19, 2021; ECF No. 32. The parties agreed that Petitioner would file an expert report. Id. Petitioner filed an expert report on September 22, 2021. Ex. 7. On December 17, 2021, Respondent filed a status report indicating that “it would be helpful to have the Special Master’s preliminary thoughts, particularly on specific factual elements in this case, to include whether petitioner’s affidavit is sufficient to establish deficits in petitioner’s shoulder range-of-motion that are not documented in petitioner’s medical records.” ECF No. 41. I conducted a status conference on January 10, 2022. See Order dated January 12, 2022; ECF No. 42. During this status conference, I told the parties that I credited Petitioner’s affidavit 2 Case 1:19-vv-01536-UNJ Document 55 Filed 06/27/22 Page 3 of 7 along with medical records as support for the fact that Petitioner experienced reduced range of motion after her flu vaccine. Id. at 1. I gave Respondent a deadline of February 15, 2022 to file a status report indicating how he would like to proceed. Id. at 2. Respondent filed a status report on February 15, 2022 asking that I “issue Findings of Fact regarding petitioner’s range of motion deficits.” ECF No. 43. I held a status conference with the parties on March 1, 2022, where we discussed several matters, to include whether the parties would prefer that I issue a ruling on entitlement or a fact ruling. ECF No. 44. Respondent filed a status report reiterating his request that I rule on Petitioner’s range of motion deficits and indicated that “resolution of this issue would render the case ripe for resolution.” ECF No. 45. Petitioner did not object to this course of action. The matter is now ripe for a factual determination. II. Petitioner’s Medical Records that Discuss her Range of Motion Petitioner received her flu vaccine on November 28, 2017. Ex. 1 at 79. On January 24, 2018, Petitioner saw NP Kontia Grant for left shoulder pain following her flu shot on November 28, 2017. Ex. 1 at 83. The HPI notes that it was difficult for Petitioner to lift her left arm. Id. The musculoskeletal portion of the exam indicates Petitioner had “Normal range of motion, Normal strength, No tenderness, No swelling.” Id. at 85. On April 12, 2018, Petitioner visited Kelly Purcell, D.O. Ex. 1 at 95. During this visit, Petitioner complained of left arm pain that began after her flu shot in November of 2018. Id. She described the pain as sharp and stabbing and stated that it was present all the time. Id. The musculoskeletal portion of the exam notes “Normal range of motion, Normal strength, left arm tender diffusely with palpation.” Id. at 97. Petitioner attended an initial physical therapy evaluation on June 12, 2018. Ex. 4 at 2. The record notes that “[p]ain is constant, pain worsens with lifting, pulling, dressing, work demands as a seamstress.” Id. On exam, petitioner’s range of active motion was measured at 180˚. Id. However, this same record notes that “Patient presents with losses in - ROM [range of motion] – Strength”. Id. at 4. The same record indicates that her losses resulted in functional limitations, which include “pain with reaching across body and putting on clothing”, “pain with lifting objects”, and “increased pain with pulling activities.” Id. Id. 3 Case 1:19-vv-01536-UNJ Document 55 Filed 06/27/22 Page 4 of 7 III. Portions of Petitioner’s Affidavit that Pertain to her Range of Motion In her affidavit filed on October 14, 2019, Petitioner averred that she continues to experience “severe pain, discomfort and decreased range of motion in my left shoulder.” Ex. 2 at 2. Petitioner noted that her decreased range of motion began within one week of vaccination, and that it continued to worsen in January of 2018. Id. at 3. She also stated that she has difficulty reaching for objects, raising her arm, carrying objects, and getting changed. Id. at 2. Petitioner averred that her shoulder injury has affected her life. She stated: “I cannot pick up objects, reach for objects, get a good night of sleep, play with my grandchildren, or perform my job functions without being in severe pain.” Id. at 4. IV. Expert Opinion that Pertains to Range of Motion Petitioner filed an expert report from Dr. Naveed Natanzi, a board-certified specialist in physical medicine and rehabilitation and pain management. Ex. 7. With respect to range of motion, Dr. Natanzi opined “I do believe there was a shoulder injury which was causing obvious pain and likely some limitation or at least pain with range of motion, given descriptions within the affidavit of pain with lifting, getting dressed, etc.” Ex. 7 at 9. Finally, Dr. Natanzi concluded that Petitioner’s presentation meets all the QAI criteria for SIRVA. Id. at 10-11. V. Legal Standards Regarding Fact Finding Petitioner bears the burden of establishing her claim by a preponderance of the evidence. 42 U.S.C. § 300aa-13(1)(a). A petitioner must offer evidence that leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he or she] may find in favor of the party who has the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted). In order to make a determination concerning factual issues, such as the timing of onset of petitioner’s alleged injury, the special master should first look to the medical records. “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.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993); Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2006 WL 3734216, at *8 (Fed. Cl. Spec. Mstr. Nov. 29, 2006). Medical records created contemporaneously with the events they describe are presumed to be accurate and complete. Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed. Cl. 598, 608 (2010). Contemporaneous medical records generally merit greater evidentiary weight than oral testimony; this is particularly true where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d, 968 F.2d 1226 (Fed. Cir. 1992)(citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“It has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight”)). 4 Case 1:19-vv-01536-UNJ Document 55 Filed 06/27/22 Page 5 of 7 However, there are situations in which compelling oral testimony may be more persuasive than written records--for instance in cases where records are found to be incomplete or inaccurate. Campbell, 69 Fed. Cl. at 779 (“like any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“Written records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733). When witness testimony is used to overcome the presumption of accuracy afforded to contemporaneous medical records, such testimony must be “consistent, clear, cogent, and compelling.” Sanchez v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec’y of Health & Hum. Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and completeness of medical records, the Court of Federal Claims has listed four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person’s failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional’s failure to document everything reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v. Sec’y of Health & Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). A special master making a determination whether to afford greater weight to contemporaneous medical records or other evidence, such as testimony at a hearing must have evidence suggesting the decision was a rational determination. Burns by Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993). In order for Petitioner to succeed on a Table SIRVA claim, he must show that his claim meets the Table criteria for a SIRVA. The Qualifications and Aids to Interpretation (“QAI”) further specify: A vaccine recipient shall be considered to have suffered a 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). 42 C.F.R. § 100.3(c)(10). 5 Case 1:19-vv-01536-UNJ Document 55 Filed 06/27/22 Page 6 of 7 VI. Findings of Fact Petitioner has the burden of demonstrating the facts necessary for entitlement to an award by a preponderance of the evidence. § 300aa-12(a)(1)(A). Under that standard, the existence of a fact must be shown to be “more probable than its nonexistence.” In re Winship, 397 U.S. 358, 371 (1970) (Harlan, J., concurring). The question to be resolved is whether Petitioner experienced loss of range of motion after her November 28, 2017 flu vaccine. Range of motion is defined as “the range, measured in degrees of a circle, through which a joint can be extended and flexed.”3 After careful examination of the record as a whole, I find there is preponderant evidence that Petitioner did experience a loss of range of motion in her left shoulder. In arriving at this determination, I place significant weight on Petitioner’s affidavit, wherein she described a “decreased range of motion that affected [her] daily life and [her] work.” Ex. 2 at 3. Petitioner averred that she “went back to [her] family doctor in January 2018 because [her] left shoulder was still in severe pain and [her] range of motion was continuing to get worse.” Id. Petitioner described that her “shoulder pain and decreased range of motion w[ere] also affecting [her] ability to earn a living by doing [her] upholstery work. [She] ha[s] to lift furniture and be hands-on, and [she] feel[s] like [she] can only do the work with one arm.” Id. at 4. Petitioner goes beyond simply stating that she experienced reduced range of motion -- she provides specific examples of how this reduction manifested itself in her life. She describes difficulty reaching for objects. Id. at 2. She further states, “I could barely raise my left arm just a few weeks after getting the flu shot.” Id. at 3. These descriptions, in particular the extreme difficulty raising her arm, describe a reduced range of motion. Although reduced range of motion is not well documented in Petitioner’s medical records, one record does note that “Patient presents with losses in - ROM - Strength”. Ex. 4 at 4. This same record indicates that her losses have resulted in functional limitations, which include “pain with reaching across body and putting on clothing”, “pain with lifting objects”, and “increased pain with pulling activities.” Id. Additionally, the medical record from January 24, 2018, notes that it was difficult for Petitioner to lift her left arm. Ex. 1 at 83. Although Petitioner’s range of motion was recorded as normal during this visit, the fact that lifting her arm was difficult implies that this movement caused pain, and further that Petitioner was not able to move her shoulder joint normally without experiencing pain. Petitioner has also provided evidence of her reduced range of motion through the opinion of Dr. Natanzi. Dr. Natanzi opined that Petitioner likely had some limitation with range of motion. Ex. 7 at 9. Ultimately, he concluded that Petitioner’s presentation meets all the QAI criteria for SIRVA. Id. at 10-11. This opinion inherently includes the fact that Petitioner experienced reduced range of motion. I find that Dr. Natanzi’s expert report helps Petitioner to meet her burden in this case. 3 Range of motion, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/ definition?id=102065 (last accessed March 14, 2022). 6 Case 1:19-vv-01536-UNJ Document 55 Filed 06/27/22 Page 7 of 7 VII. Conclusion In short, I find that Petitioner’s affidavit, her medical records, and the expert opinion of Dr. Natanzi work in concert to provide preponderant evidence that Petitioner experienced loss of range of motion in her left shoulder. The following is therefore ORDERED: By April 14, 2022, Respondent shall file an Amended Rule 4 Report based on the facts articulated in this ruling. IT IS SO ORDERED. s/ Katherine E. Oler Katherine E. Oler Special Master 7 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_19-vv-01536-2 Date issued/filed: 2023-05-01 Pages: 8 Docket text: PUBLIC DECISION (Originally filed: 3/20/2023) regarding 62 DECISION Awarding Damages. Signed by Special Master Katherine E. Oler. (emh) Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-01536-UNJ Document 68 Filed 05/01/23 Page 1 of 8 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 19-1536V (not to be published) * * * * * * * * * * * * * * * * * * * * * * * * * * * * DE’ANN ZASTROW, * * Filed: March 20, 2023 Petitioner, * * * v. Damages Decision; Pain and Suffering; * * Influenza (“Flu”) Vaccine; Shoulder SECRETARY OF HEALTH AND * Injury Related to Vaccine Administration * HUMAN SERVICES, (“SIRVA”). * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * * David Carney, Green & Schafle LLC, Philadelphia, PA, for Petitioner Camille Collett, U.S. Department of Justice, Washington, DC, for Respondent DECISION AWARDING DAMAGES1 On October 3, 2019, De’Ann Zastrow (“Petitioner”) filed a petition seeking compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq. (“the Vaccine Program”).2 Pet., ECF No. 1. Petitioner alleges she suffered from a shoulder injury related to vaccine administration (“SIRVA”) as a result of the influenza (“flu”) vaccination she received on November 28, 2017. Pet. at 1. 1 Although this Decision 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 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 Decision 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. 1 Case 1:19-vv-01536-UNJ Document 68 Filed 05/01/23 Page 2 of 8 For the reasons discussed in this Decision, I find that Petitioner is entitled to a pain and suffering award of $70,000. I. Relevant Procedural History I issued a Ruling on Entitlement on April 18, 2022, finding that Petitioner was entitled to compensation. Ruling on Entitlement, ECF No. 49. I then issued a damages order that same day. ECF No. 50. On July 25, 2022, the parties filed a joint status report indicating that damages could not be resolved informally given the demands exchanged. The parties did not request a damages hearing, and instead asked that I set a briefing schedule. ECF No. 57. On August 2, 2022, Petitioner filed a Motion for a Ruling on the Record for Petitioner’s Damages. ECF No. 58 (hereinafter “Petitioner’s Brief” or “Pet’r’s Br.”). On November 4, 2022, Respondent file a response. ECF No. 59 (hereinafter “Respondent’s Brief” or “Resp’t’s Br.”). On November 22, 2022, Petitioner filed a reply. ECF No. 60 (hereinafter “Petitioner’s Reply Brief” or “Pet’r’s Reply Br.”). The parties filed a joint status report on December 15, 2022, indicating that the record was complete. ECF No. 61. This matter is now ripe for a decision on damages. II. Medical History A. Medical Records At the time of vaccination, Petitioner was 48 years old and had a history of anxiety and arthritis. Ex. 1 at 75. Petitioner received her flu vaccine in her left shoulder on November 28, 2017. Id. at 79. On January 24, 2018, 57 days later, Petitioner saw NP Kontia Grant, reporting left arm pain secondary to the flu shot she received on November 28, 2017. Ex. 1 at 83. Petitioner stated that her pain was “achy” and that it started “in [her] upper arm and [went] down to [her] elbow.” Id. She reported that the pain sometimes woke her up at night and was worse first thing in the morning. Id. Petitioner had trouble lifting her left arm, but an examination revealed normal range of motion and strength and no tenderness or swelling. Id. at 85. NP Grant recommended Flexeril, and Petitioner responded that she wished to continue with Naproxen and Aspercreme. Id. at 85. On April 12, 2018, Petitioner visited Kelly Purcell, D.O. Ex. 1 at 95. During this visit, Petitioner complained of left arm pain that began after her flu shot in November of 2018.3 Id. She described the pain as sharp and stabbing and stated that it was present all the time. Id. She stated that Flexeril had not helped and that the pain radiated from her upper arm down to her hand. Id. The musculoskeletal portion of the exam notes “Normal range of motion, Normal strength, left arm tender diffusely with palpation.” Id. at 97. Dr. Purcell ordered a nerve conduction study (“NCS”) and gave Petitioner an injection of Toradol. Id. 3 The medical record for this April 2018 visit states that Petitioner had received her flu shot in November 2018. I presume this to be a typographical error. 2 Case 1:19-vv-01536-UNJ Document 68 Filed 05/01/23 Page 3 of 8 On May 1, 2018, Petitioner underwent an electromyography NCS of her left arm. Ex. 3 at 6. The results showed “incidental chronic left C8-T1 radiculopathy.” Id. On May 22, 2018, Petitioner saw Dr. Purcell regarding the NCS results. Ex. 1 at 100. Petitioner complained of ongoing left arm pain that was “sharp” and “stabbing,” and radiated from her upper arm or neck down to her hand. Id. Examination revealed normal range of motion and strength, as well as tenderness with palpation in the left arm. Id. at 102. Dr. Purcell diagnosed Petitioner with cervical radiculopathy. Id. She prescribed Neurontin and recommended a cervical MRI. Id. Petitioner underwent the cervical MRI on June 1, 2018. Id. at 103. The MRI showed “[m]inimal degenerative changes throughout the cervical spine without evidence of spinal canal narrowing or neural foraminal stenosis at any level.” Id. at 104. Moreover, there was a “normal appearance of the cervical spinal cord.” Id. Petitioner attended an initial physical therapy evaluation on June 12, 2018. Ex. 4 at 2. Petitioner complained of left arm pain after a flu shot in November 2017, as well as neck pain. Id. On exam, petitioner’s range of active motion was measured at 180˚. Id. However, this same record notes that “Patient presents with losses in - ROM [range of motion] – Strength”. Id. at 4. The record notes that “[p]ain is constant, pain worsens with lifting, pulling, dressing, work demands as a seamstress.” Id. The same record indicates that her losses resulted in functional limitations, which include “pain with reaching across body and putting on clothing,” “pain with lifting objects”, and “increased pain with pulling activities.” Id. On June 26, 2018, Petitioner returned to Dr. Purcell for a follow up on multiple issues, including left arm pain that was unchanged since her previous appointment. Ex. 1 at 106. Petitioner reported that steroids, NSAIDs, and Flexeril had not helped. Id. Petitioner attended 15 physical therapy (“PT”) sessions and was discharged in August 2018. Ex. 4. at 35. The PT discharge report reflects that Petitioner’s progress had “reached a plateau” and that her left arm pain was ongoing. Id. The physical therapist noted that Petitioner’s prognosis was “excellent” provided that she continued with the home program as prescribed. Id. at 34. No further medical records relevant to my assessment on damages have been filed. B. Petitioner’s Affidavit On October 14, 2019, Petitioner filed an affidavit. ECF No. 6-6 (filed as Ex. 2) (hereinafter “Aff.”). In it, Petitioner stated that she began to have sharp pain in her left shoulder immediately after receiving the flu vaccine. Aff. at 2. She stated that, over the following weeks, the pain worsened and she began to experience decreased range of motion to the point that she consulted her primary care physician in January 2018. Id. at 3. Petitioner averred that her shoulder pain has interfered with her work as a furniture upholsterer because it is difficult to lift heavy objects and to raise her left arm over her head. Aff. at 3. She stated that she is “physically and mentally exhausted from this experience” and “afraid that [she] will not regain full function and a pain free life.” Id. at 4. 3 Case 1:19-vv-01536-UNJ Document 68 Filed 05/01/23 Page 4 of 8 C. Petitioner’s Supplemental Affidavit On March 16, 2022, Petitioner filed a supplemental affidavit. ECF No. 47-1 (filed as Ex. 11) (hereinafter “Supp. Aff.”). In it, Petitioner stated that the 15 PT sessions improved her symptoms somewhat, but that they never completely resolved. Supp. Aff. at 1. Petitioner stated that she “continue[s] to have pain, discomfort and decreased range of motion in my left shoulder, all of which affect my daily life, hobbies, and activities of daily living.” Id. at 2. Petitioner rated her pain as ranging between a 2 and 5 out of 10 on the pain scale. Id. Petitioner stated that her pain has been “severe and unrelenting” since November 2017 and that she has “suffered physically and emotionally as a result.” Supp. Aff. at 2. She described difficulty performing daily tasks and playing with her grandchildren and stated that she controls the pain with ice and over the counter medications. Id. Petitioner also stated that she has not returned to PT or to an orthopedist because it would be “futile” as she did not want to undergo surgery or cortisone injections. Id. at 3. III. Legal Standard There is no formula for assigning a monetary value to a person’s pain and suffering and emotional distress. See I.D. v. Sec’y of Health & Hum. Servs., No. 04-1593V, 2013 WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May 14, 2013), originally issued Apr. 19, 2013 (“Awards for emotional distress are inherently subjective and cannot be determined by using a mathematical formula.”); Stansfield v. Sec’y of Health & Hum. Servs., No. 93-172V, 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. See I.D., 2013 WL 2448125, at *9; McAllister v. Sec’y of Health & Hum. Servs., No 91-103V, 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). Compensation awarded pursuant to the Vaccine Act shall include “actual and projected pain and suffering and emotional distress from the vaccine-related injury… not to exceed $250,000.” § 15(a)(4). In determining an award for pain and suffering and emotional distress, it is appropriate to consider the severity of injury and awareness and duration of suffering. See I.D., 2013 WL 2448125, at *9-11, citing McAllister, 1993 WL 777030, at *3. In evaluating these factors, I have reviewed the entire record, including medical records, documentary evidence, and the affidavit submitted by Petitioner. IV. Prior SIRVA Compensation within SPU4 A. Data Regarding Compensation in SPU SIRVA Cases 4 All figures included in this decision are derived from a review of the decisions awarding compensation within the SPU. All decisions reviewed are, or will be, available publicly. All figures and calculations cited are approximate. 4 Case 1:19-vv-01536-UNJ Document 68 Filed 05/01/23 Page 5 of 8 SIRVA cases have an extensive history of informal resolution within the SPU. As of January 1, 2023, 3,031 SPU SIRVA cases have resolved since the inception of SPU on July 1, 2014. Compensation was awarded in 2,950 of these cases, with the remaining 81 cases dismissed. Of the compensated cases, 1,677 SPU SIRVA cases involved a prior ruling that petitioner was entitled to compensation. In only 148 of these cases was the amount of damages determined by a special master in a reasoned decision. As I have previously stated, the written decisions setting forth such determinations, prepared by neutral judicial officers (the special masters themselves), provide the most reliable precedent setting forth what similarly situated claimants should also receive.5 1,501 of this subset of post-entitlement determination, compensation-awarding cases were the product of informal settlement -- cases via proffer, and there were 28 cases via stipulation. Although all proposed amounts denote an agreement reached by the parties, those presented by stipulation derive more from compromise than any formal agreement or acknowledgment by Respondent that the settlement sum itself is a fair measure of damages. Of course, even though any such informally resolved case must still be approved by a special master, these determinations do not provide the same judicial guidance or insight obtained from a reasoned decision. But given the aggregate number of such cases, these determinations nevertheless “provide some evidence of the kinds of awards received overall in comparable cases.” Sakovits, 2020 WL 3729420, at *4 (emphasis in original). The remaining 1,273 compensated SIRVA cases were resolved via stipulated agreement of the parties without a prior ruling on entitlement. These agreements are often described as “litigative risk” settlements, and thus represent a reduced percentage of the compensation which otherwise would be awarded. Due to the complexity of these settlement discussions, many which involve multiple competing factors, these awards do not constitute a reliable gauge of the appropriate amount of compensation to be awarded in other SPU SIRVA cases. The data for all groups described above reflect the expected differences in outcome, summarized as follows: Damages Proffered Stipulated Stipulated6 Decisions by Damages Damages Agreement Special Master Total Cases 148 1,501 28 1,273 Lowest $40,757.91 $22,500.00 $45,000.00 $5,000.00 5 See, e.g., Sakovits v. Sec’y of Health & Hum. Servs., No. 17-1028V, 2020 WL 3729420, at *4 (Fed. Cl. Spec. Mstr. June 4, 2020) (discussing the difference between cases in which damages are agreed upon by the parties and cases in which damages are determined by a special master). 6 Two awards were for an annuity only, the exact amounts which were not determined at the time of judgment. 5 Case 1:19-vv-01536-UNJ Document 68 Filed 05/01/23 Page 6 of 8 1st Quartile $70,382.97 $65,000.00 $90,000.00 $40,000.00 Median $93,649.92 $85,000.00 $122,886.42 $56,250.00 3rd Quartile $125,000.00 $112,654.00 $161,001.79 $82,500.00 Largest $265,034.87 $1,845,047.00 $1,500,000.00 $550,000.00 B. Pain and Suffering Awards in Reasoned Decisions In the 148 SPU SIRVA cases which required a reasoned damages decision, compensation for a petitioner’s actual or past pain and suffering varied from $40,000.00 to $210,000.00, with $90,000.00 as the median amount. Only seven of these cases involved an award for future pain and suffering, with yearly awards ranging from $250.00 to $1,500.00.7 In cases with lower awards for past pain and suffering, many petitioners commonly demonstrated only mild to moderate levels of pain throughout their injury course. This lack of significant pain is often evidenced by a delay in seeking treatment – over six months in one case. In cases with more significant initial pain, petitioners usually experienced this greater pain for three months or less. Most petitioners displayed only mild to moderate limitations in range of motion (“ROM”), and MRI imaging showed evidence of mild to moderate pathologies such as tendinosis, bursitis, or edema. Many petitioners suffered from unrelated conditions to which a portion of their pain and suffering could be attributed. These SIRVAs usually resolved after one to two cortisone injections and two months or less of physical therapy (“PT”). None required surgery. Except in one case involving very mild pain levels, the duration of the SIRVA injury ranged from six to 30 months, with most petitioners averaging approximately nine months of pain. Although some petitioners asserted residual pain, the prognosis in these cases was positive. Cases with higher awards for past pain and suffering involved petitioners who suffered more significant levels of pain and SIRVAs of longer duration. Most of these petitioners subjectively rated their pain within the upper half of a ten-point pain scale and sought treatment of their SIRVAs more immediately, often within 30 days of vaccination. All experienced moderate to severe limitations in range of motion. MRI imaging showed more significant findings, with the majority showing evidence of partial tearing. Surgery or significant conservative treatment, up to 133 PT sessions - occasionally spanning several years, and multiple cortisone injections, were required in these cases. In six cases, petitioners provided sufficient evidence of permanent injuries to warrant yearly compensation for future or projected pain and suffering. V. Appropriate Compensation in this SIRVA Case Petitioner requests a pain and suffering award of $80,000, while Respondent argues for a pain and suffering award of $50,000. Both parties have provided a number of cases they believe are comparable to Petitioner’s. When performing this analysis, I reviewed the record as a whole, including the medical records and affidavits. I also take into account prior awards for pain and suffering in both SPU and non-SPU SIRVA cases. I base my decision as to the appropriate amount 7 Additionally, a first-year future pain and suffering award of $10,000.00 was made in one case. Dhanoa v. Sec’y of Health & Hum. Servs., No. 15-1011V, 2018 WL 1221922 (Fed. Cl. Spec. Mstr. Feb. 1, 2018). 6 Case 1:19-vv-01536-UNJ Document 68 Filed 05/01/23 Page 7 of 8 of damages on the particular facts and circumstances of this specific case. The parties do not dispute Petitioner’s awareness of her injury. 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, my analysis will focus mainly on the severity and duration of Petitioner’s injury. The medical records and my prior factual ruling in this case establish that Petitioner suffers from a SIRVA injury with moderate levels of pain and limited range of motion that have persisted since her vaccination in November 2017. Petitioner’s affidavit states that her pain began immediately after vaccination, although her medical records show that she did not seek medical advice until nearly two months later. Compare Aff. at 2, Ex. 1 at 83. At the first appointment documenting her SIRVA injury, Petitioner told her medical provider, “The pain starts in my upper arm and goes down to my elbow. It’s achy. It’s hard to lift my arm. It wakes me up and hurts when I wake up in the morning[].” Ex. 1 at 83. On June 27, 2022, I issued a fact ruling finding that Petitioner suffered decreased range of motion in her shoulder due to the flu vaccine. ECF No. 55 at 2. I gave Petitioner’s affidavit “significant weight,” noting in particular her description of how her injury has impacted her ability to function in daily life. Id. at 6. Petitioner works as a furniture upholsterer and has difficulty lifting heavy objects and raising her left arm above her head. Supp. Aff. at 2. Petitioner also described the psychological toll that her SIRVA injury has taken on her. Her PT record reflects that, after 15 sessions, Petitioner was still experiencing some left arm pain and reduced strength, and that her improvement had reached a plateau. Ex. 4 at 35. Petitioner described feeling “physically and mentally exhausted” by her injury and that she feared that her pain would never fully resolve. Aff. at 4. (“I don’t believe there is much more I can do for my shoulder except to manage the pain and deal with it on a daily basis.”). Petitioner’s medical records and affidavits establish that the duration of her treatment was slightly less than seven months. Ex. 1 at 83 (Petitioner’s first visit to NP Grant on January 24, 2018); Ex. 4 at 35 (Petitioner’s discharge from PT on August 13, 2018). Although the duration of Petitioner’s treatment was shorter than in some other SIRVA cases, I find that Petitioner’s decision not to seek further treatment was reasonable in light of her physical therapist’s assessment that she had reached a plateau and that she should continue home exercises. Ex. 4 at 35. Petitioner continues to do exercises at home and manages her pain with over-the-counter medication and ice. Aff. at 4. Of the cases cited to by the parties, I have identified three that I find most comparable to the case at hand. In Vinocur, Special Master Dorsey awarded $70,000 in pain and suffering damages to a petitioner who showed that his pain and range of motion had steadily worsened until he began treatment. Vinocur v. Sec’y of Health & Hum. Servs., No. 17-598V, 2020 WL 1161173 *12, 16 (Fed. Cl. Jan. 31, 2020). The petitioner in Vinocur, like Petitioner here, attended 15 PT sessions and received one injection for pain. Id. at *6, 13. The petitioner in Vinocur also described ongoing trouble sleeping due to continuing pain in his shoulder. Id. at *14. The special master awarded the petitioner in Vinocur $70,000 in pain and suffering damages despite his delay of four and a half months in seeking treatment initially, a time period roughly twice as long as Petitioner’s 7 Case 1:19-vv-01536-UNJ Document 68 Filed 05/01/23 Page 8 of 8 57 days. Id. at *15-16. Respondent cites Rayborn v. Sec’y of Health & Hum. Servs., in which the petitioner received an award of $55,000 in pain and suffering damages. No. 18-0226V, 2020 WL 5522948, at *1 (Fed. Cl. Spec. Mstr. Aug. 14, 2020). The petitioner had begun experiencing shoulder pain immediately after vaccine administration and sought treatment when she began to experience issues with range of motion approximately four months later. Id. at *3-4. The petitioner in Rayborn received one cortisone injection and underwent 14 occupational therapy (“OT”) sessions, and experienced mild to moderate symptoms for a period of nine months. Id. at 12. Here, Petitioner received one shot of Toradol and underwent 15 PT sessions, but her symptoms have been moderate and continue to this day. See Aff. at 2; Supp. Aff. at 1-2. I find that the facts in Rayborn are comparable to Petitioner’s case, but that Petitioner’s pain was more severe and of longer duration. Petitioner also cites to Smallwood v. Sec’y of Health & Hum. Servs., No. 18-291V, 2020 WL 2954958 (Fed. Cl. Spec. Mstr. Apr. 29, 2020). In Smallwood, the special master awarded the petitioner $72,500 in pain and suffering damages where the injury was comparably severe to Petitioner’s here. Id. at *17-18. I note, however, that the petitioner in Smallwood underwent only seven PT sessions and realized a near complete resolution of his shoulder pain in PT. Id. (noting that, after seven PT sessions, the petitioner “was experiencing no pain, and only pain at a level of 4 out of 10 after a full day’s work.”). Like Petitioner here, the petitioner in Smallwood also reported that his pain interfered with his ability to work at a job involving physical labor. Id. at *5. I find that the facts in Smallwood are comparable to Petitioner’s case, but that the petitioner in Smallwood achieved better results from PT in fewer sessions. VI. Conclusion For the reasons discussed above, I find that $70,000 represents a fair and appropriate amount of compensation for Petitioner’s actual pain and suffering. Therefore, based on the record as a whole, I find the Petitioner is entitled to an award of: A lump sum in the amount of $70,000.00, which represents an award of pain and suffering, in the form of a check payable to Petitioner. This award represents compensation for all damages that would be available under 42 U.S.C. § 300aa-15(a). In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court is directed to enter judgment herewith.8 IT IS SO ORDERED. s/ Katherine E. Oler Katherine E. Oler Special Master 8 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by jointly filing notice renouncing their right to seek review. 8