VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-01977 Package ID: USCOURTS-cofc-1_19-vv-01977 Petitioner: Terry Klausen Filed: 2019-12-30 Decided: 2023-03-06 Vaccine: influenza Vaccination date: 2019-01-07 Condition: Shoulder Injury Related to Vaccine Administration (SIRVA) Outcome: compensated Award amount USD: 60000 AI-assisted case summary: Terry Klausen filed a petition alleging he suffered a Shoulder Injury Related to Vaccine Administration (SIRVA) after receiving an influenza vaccine on January 7, 2019. Mr. Klausen died on December 1, 2021, from causes unrelated to the vaccination, and his wife, Carolyn Klausen, was substituted as the petitioner. The case proceeded as a Table injury claim for SIRVA, which requires onset within 48 hours of vaccination. The court previously found that Mr. Klausen's shoulder pain began within 48 hours of vaccination. The respondent argued that entitlement should be denied, questioning the situs of the vaccination and the onset timeframe. However, the court found sufficient evidence that the vaccine was administered in the right shoulder and that the onset of pain was within 48 hours, thus granting entitlement. For damages, the petitioner sought $95,000 for pain and suffering, while the respondent proposed $60,000. Considering the severity and duration of the injury, the petitioner's delay in seeking treatment, and comparing the case to prior SIRVA awards, the court awarded $60,000 for pain and suffering. Theory of causation field: Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_19-vv-01977-0 Date issued/filed: 2021-07-06 Pages: 8 Docket text: PUBLIC ORDER/RULING (Originally filed: 06/02/2021) regarding 27 Findings of Fact & Conclusions of Law,,, Scheduling Order,,, Order on Motion for Ruling on the Record,, Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-01977-UNJ Document 29 Filed 07/06/21 Page 1 of 8 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 19-1977V UNPUBLISHED TERRY KLAUSEN, Chief Special Master Corcoran Petitioner, Filed: June 2, 2021 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Findings of Fact; Onset; Influenza HUMAN SERVICES, (Flu) Vaccine; Shoulder Injury Related to Vaccine Administration Respondent. (SIRVA) David John Carney, Green & Schafle LLC, Philadelphia, PA, for Petitioner. Lynn Christina Schlie, U.S. Department of Justice, Washington, DC, for Respondent. FINDINGS OF FACT AND CONCLUSIONS OF LAW1 On December 30, 2019, Terry Klausen 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 he suffered a right shoulder injury related to vaccine administration (“SIRVA”) caused by an influenza (“flu”) vaccine administered to him on January 7, 2019. Petition at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters. The parties have now sought a determination of facts bearing on the adequacy of Petitioner’s showing on certain elements of his claim. 1 Because this unpublished fact ruling contains a reasoned explanation for the action in this case, I am 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). This means the fact 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, 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 1:19-vv-01977-UNJ Document 29 Filed 07/06/21 Page 2 of 8 For the reasons discussed below, I find that there is a preponderance of evidence that the onset of Petitioner’s injury, specifically shoulder pain, occurred within 48 hours of his vaccine. I. Relevant Procedural History On August 17, 2020, Respondent filed a status report containing his counsel’s preliminary assessment of the case. In that status report, Respondent noted certain records may be missing, and that certain issues may require additional factual development, including the site of vaccination and the onset of Petitioner’s injury. (ECF No. 20).3 During a status conference held on September 2, 2020, I noted that the question of whether the onset of Petitioner’s shoulder injury fits within the Table SIRVA timetable remained open. Respondent also indicated that there were gaps in the medical records for the months following Petitioner’s vaccination and requested that Petitioner file his insurance benefits statement spreadsheet to ensure that all relevant medical records had been offered in the matter. I ordered the parties to file briefs for a factual ruling to determine onset, adding that after that issue is resolved, the question of additional unfiled records could be resolved. Petitioner filed his Motion for Ruling on the Record, along with a letter from the vaccine administrator (Exhibit (“Ex.”) 10) and Medicare Statement Notices (Ex. 11), on October 2, 2020. Motion for Finding of Fact (“Pet. Mot”), (ECF No. 24). Respondent filed his response on November 2, 2020. Respondent’s Response to Petitioner’s Motion for Finding of Fact (“Res. Resp.”).4 II. Petitioner’s Medical Records Petitioner received a flu vaccine on January 7, 2019. Ex. 6 at 7. The vaccination record states the vaccine was administered in Petitioner’s “deltoid” but does not specify the right or left arm. However, a letter from Petitioner’s primary care physician, Dr. Kewal Aggarwal, stated that it was common practice in his office to give the flu shot in the right deltoid. Ex. 10. 3 Respondent also requested records for three years prior to vaccination and insurance benefit statements confirming there are no other pre-vaccination records. Id. Petitioner was ordered to file those records in an August 25, 2020 Scheduling order. (ECF No. 21). That same day, Petitioner’s counsel contacted the Court objecting to filing these records, arguing that the Vaccine Rules do not require these records and they are not relevant in this case. 4 Respondent’s counsel noted that medical personnel at DICP has not yet reviewed this case or provided a medical analysis. Id. at 11. 2 Case 1:19-vv-01977-UNJ Document 29 Filed 07/06/21 Page 3 of 8 Four months later, on April 8, 2019, Petitioner first complained of right shoulder pain to Dr. Aggarwal. Ex. 6 at 6.5 At that time, Petitioner reported right shoulder pain “when playing ‘Bowling’ in ‘Wii.’” Id. There is no mention of when the pain specifically began, or its trigger, however. Petitioner again saw Dr. Aggarwal on July 8, 2019. There is no mention of shoulder pain at that time. Ex. 6 at 3-4. Indeed, Petitioner had a physical examination at this time, which noted that Petitioner “does not appear to be in any acute distress.” Id. at 3. On August 13, 2019, Petitioner presented to Dr. Zubair Sarmast at Insight Orthopedics with complaints of right arm pain. Ex. 2 at 12. The record indicates that Petitioner’s pain began in January of 2019 after a flu shot. Id. Petitioner’s pain was worsening at that time with decreased range of motion, and he was assessed with “unspecified rotator cuff tear or rupture of right shoulder, not specified as traumatic.” Id. at 13. An X-ray showed degenerative changes of the right shoulder, “which could indicate chronic rotator cuff disease.” Id. at 14. Petitioner again saw Dr. Sarmast for a follow-up after an ultrasound exam on September 3, 2019.6 According to Dr. Sarmast, the ultrasound “did show a high-grade partial tear of his supraspinatus tendon. He has a pacemaker and is unable to tolerate MRI. He had pain in his shoulder develop after a flu shot in 2019.” Ex. 2 at 7. At that time, Petitioner reported some improvement in his pain, and received a steroid injection in his right shoulder. Id. On October 10, 2019, Petitioner began physical therapy for shoulder pain, neck pain, and upper arm pain. Ex. 3 at 3. His intake form indicates that his injury occurred “Jan 2019” and the activity prior to his condition was “received flu shot”. Ex. 2 at 12. The assessment at that time was “right shoulder pain consistent with rotator cuff pathology leading to subacromial impingement….” Id. at 18. At a follow-up examination with Dr. Sarmast, a second steroid injection was administered to Petitioner on October 29, 2019. Ex. 2 at 4, 6. Thereafter, between October 10, 2019 and January 16, 2020, Petitioner attended 16 physical therapy sessions. Ex. 5 at 3. Petitioner next saw Dr. Sarmast on December 10, 2019 for a follow-up regarding his right shoulder. Ex. 3 at 1-2. At that time, Petitioner exhibited reduced range of motion and expressed an interest in further injections but not surgery or further therapy. Id. 5 Petitioner’s Medicare Part B Summary Notices indicate there are numerous visits to the Michigan Institute of Urology and Oncology & Hematology, PC. Ex. 11. Respondent correctly notes that none of those records have been submitted (Res. Br. at 2, n.1), although their relevance to this claim has not been established. 6 Records of the ultrasound examination are referenced (see Ex. 11 at 119) but have not been filed. 3 Case 1:19-vv-01977-UNJ Document 29 Filed 07/06/21 Page 4 of 8 III. Affidavits Petitioner submitted four affidavits in support of his claim, including his own (Ex. 1); an affidavit from his daughter, Joani Stapleton (Ex. 7); an affidavit from his daughter, Shellie Forgione (Ex. 8); and an affidavit from his daughter, Jeani Noelle (Ex. 9). Petitioner’s affidavit states that he received a flu vaccine on January 7, 2019 in his right shoulder. Ex. 1 at 2. He also states that he began to notice “discomfort and pain” in that shoulder as he left the office. Id. at 3. “[L]ess than two days later, the pain and discomfort persisted and even worsened.” Id. The pain persisted over the next several months, and he was told by Dr. Aggarwal that the pain would improve over time. Id. at 4. He further stated that “Over the next couple of months, I had very little to no use of my right arm and shoulder.” Id. at 3. This severe description of his symptoms, however, is inconsistent with the record evidence establishing that he only sought treatment in April 2019 -- four months after his vaccination. Petitioner’s daughter, Shellie Forgione, stated in her affidavit that she lives with her father and recalls that her father received his flu vaccine in January 2019, although she does not specify the precise date. Ex. 8 at 2. Further, Ms. Forgione recalled that her father commented that his vaccine hurt the same day he received it. Id. Additionally, she asked her father to play a bowling video game the next day after his vaccination, but he declined because his arm hurt. Ex. 8 at 4. Ms. Forgione’s affidavit also states that Petitioner could not use his arm for the remainder of the week and could not lift even small objects like towels or plates. Id. at 2. If so, however, it is unclear why Petitioner waited several months more for treatment. Petitioner also submitted affidavits from his two other daughters providing additional information regarding the onset of his shoulder pain. Joani Stapleton noted that she saw her father at the end of January, who told her at the time that he had shoulder pain from getting a flu shot “a few weeks ago.” Ex. 7 at 2. Ms. Stapleton also stated that in early February of 2019 she saw Petitioner “to borrow some moving blankets. [Petitioner] went to pick up 2 blankets and was unable to do so. [Petitioner] explained to me that his arm would not let him pick up the blankets.” Id. Jeani Noelle stated that the week after Petitioner received his vaccine, he stated his arm was still bothering him. Ex. 9 at 1. IV. Issue At issue is whether the onset of Petitioner’s pain occurred within 48 hours after vaccination, as set forth in the Vaccine Injury Table and Qualifications and Aids to 4 Case 1:19-vv-01977-UNJ Document 29 Filed 07/06/21 Page 5 of 8 Interpretation (“QAI”) for a Table SIRVA claim. 42 C.F.R. § 100.3(c)(10)(ii) (required onset for pain listed in the QAI). V. Authority 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). 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 & Human 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 & Human Servs., No. 03- 1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule does not always apply. In Lowrie, the special master wrote that “written records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent.” Lowrie, 2005 WL 6117475, at *19. The United States Court of Federal Claims has recognized that “medical records may be incomplete or inaccurate.” Camery v. Sec’y of Health & Human Servs., 42 Fed. Cl. 381, 391 (1998). The Court later outlined 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 & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1335 (Fed. Cir. 2014). The Court has also said that medical records may be outweighed by testimony that is given later in time that is “consistent, clear, cogent, and compelling.” Camery, 42 Fed. Cl. at 391 (citing Blutstein v. Sec’y of Health & Human 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 & Human Servs., 569 5 Case 1:19-vv-01977-UNJ Document 29 Filed 07/06/21 Page 6 of 8 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). A special master may find that the first symptom or manifestation of onset of 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.” Section 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. The special master is obligated to fully consider and compare the medical records, testimony, and all other “relevant and reliable evidence contained in the record.” La Londe, 110 Fed. Cl. at 204 (citing Section 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is within the special master’s discretion to determine whether to afford greater weight to medical records or to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such determination is rational). VI. Finding of Fact The following fact finding is based on a complete review of the record, including all medical records, affidavits, and additional evidence filed. Specifically, I highlight the following:  Petitioner received a flu vaccine on January 7, 2019. Ex. 6 at 7.  On April 8, 2019, Petitioner first noted he was experiencing right shoulder pain, but without specifying the onset. Ex. 6 at 6.  Petitioner again saw Dr. Aggarwal on July 8, 2019. There is no mention of shoulder pain at that time. Ex. 6 at 3-4. Indeed, Petitioner had a physical examination at this time, which noted that Petitioner “does not appear to be in any acute distress.” Id. at 3.  On August 13, 2019, Petitioner reported right shoulder pain that began after a January 2019 flu shot. Ex. 2 at 12.  On September 3, 2019, Petitioner again complained of shoulder pain that developed after his January flu shot. Ex. 2 at 7. 6 Case 1:19-vv-01977-UNJ Document 29 Filed 07/06/21 Page 7 of 8  Petitioner reported that his shoulder pain began after an injury in January of 2019 when he started physical therapy in October of 2019. Ex. 2 at 12. Overall, the evidence offered in support of Petitioner's onset allegation is not especially robust, and Respondent has raised reasonable questions about the matter. Nevertheless, I find that the above items of evidence collectively establish (if weakly) that Mr. Klausen’s shoulder pain most likely began within 48 hours of receiving the January 7, 2019 flu vaccine. While some of Petitioner's medical records do not reflect a precise date of onset, instead including vague temporal references (i.e., “…in January of 2019 after a flu shot.”), he consistently linked the development of his shoulder pain to his vaccination, albeit later in his treatment process. See, e.g., Ex. 2 at 7 (stating his shoulder pain developed after a flu shot in 2019); Ex. 2 at 12 (stating his pain began in January of 2019 after a flu shot). The delay in seeking treatment is relevant to overall severity (and undercuts claims about the degree of pain he was living with) but does not prevent me from finding onset as alleged. Certainly, there are no intervening records that rebut such a determination. The July 2019 record is not wholly consistent with Petitioner’s onset allegations, but it perhaps only underscores that Petitioner’s pain was not so acute throughout the relevant time period (another point bearing mostly on damages). That the onset of Petitioner’s injury was within 48 hours of his vaccine is further supported by Petitioner's own declarations, as well as the affidavits of his daughters which describe the onset of Petitioner's condition in greater detail. In particular, Ms. Forgione’s affidavit states that she recalled when Petitioner’s received his vaccination because they live together. Further, she recalled his pain began immediately following the vaccine. These records are sufficient to establish onset consistent with the Table’s requirements. Although this is a close call, petitioners are accorded the benefit of close calls in the Vaccine Program. Roberts. v. Sec'y of Health & Human Servs., No. 09-427V, 2013 WL 5314698, at *10 (Fed. Cl. Spec. Mstr. Aug. 29, 2013). VII. Conclusion In view of the evidence of record, I find that there is preponderant evidence that the onset of Petitioner’s injury, specifically shoulder pain, was within 48 hours of his vaccine. 7 Case 1:19-vv-01977-UNJ Document 29 Filed 07/06/21 Page 8 of 8 VIII. Scheduling Order Petitioner should proceed with preparing a settlement demand, with supporting documentation, for Respondent’s consideration. Petitioner shall also file the records that were identified in Respondent’s responsive motion as set forth below. I have reviewed Respondent’s argument as to why these records are necessary and agree that Petitioner should file them. As there is no routine discovery in Vaccine cases, it is imperative that Petitioner file all outstanding medical records to avoid undue delay in resolving this case. Accordingly, the following is ORDERED: (1) Petitioner shall file the following medical records by Friday, July 16, 2021: i. Petitioner’s Medicare Part B Summary Notices indicate there are numerous visits to the Michigan Institute of Urology and Oncology & Hematology, PC. Ex. 11. Respondent correctly notes that none of those records have been submitted (Res. Br. at 2, n.1). Petitioner shall file these records dating from the three years prior to the vaccination at issue in this case to the present. ii. Records of the ultrasound examination as are referenced in Ex. 11 at 119 from Regional Medical Imaging, P.C. iii. All updated medical records, including any records created after January 16, 2020. (2) Respondent shall file, by no later than Friday, July 16, 2021, a status report indicating his position in light of this ruling. I strongly encourage the parties to discuss an informal resolution of this case. (3) Additional proceedings will be set after the information in this Order is filed. IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 8 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_19-vv-01977-1 Date issued/filed: 2023-03-06 Pages: 9 Docket text: PUBLIC ORDER/RULING (Originally filed: 02/02/2023) regarding 55 Ruling on Entitlement, DECISION of Special Master, Order on Motion for Ruling on the Record ( Signed by Chief Special Master Brian H. Corcoran. )(mpj) Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-01977-UNJ Document 63 Filed 03/06/23 Page 1 of 9 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 19-1977V UNPUBLISHED CAROLYN KLAUSEN, administrator of Chief Special Master Corcoran the ESTATE OF TERRY KLAUSEN, Filed: February 2, 2023 Petitioner, v. Special Processing Unit (SPU); Entitlement to Compensation; Table SECRETARY OF HEALTH AND Injury; Decision Awarding Damages; HUMAN SERVICES, Pain and Suffering; Influenza (Flu) Vaccine; Shoulder Injury Related to Respondent. Vaccine Administration (SIRVA) David John Carney, Green & Schafle, LLC, Philadelphia, PA, for Petitioner. Austin Joel Egan, U.S. Department of Justice, Washington, DC, for Respondent. RULING ON ENTITLEMENT AND DECISION AWARDING DAMAGES1 On December 30, 2019, Terry Klausen filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”), alleging that he suffered a Shoulder Injury Related to Vaccine Administration (“SIRVA”) as a result of an influenza (“flu”) vaccine he received on January 7, 2019. Petition, ECF No. 1 at 1. On December 1, 2021, Mr. Klausen died due to causes unrelated to the vaccination at issue in this case. Petitioner’s Exhibit (“Ex.”) 20. His wife, Carolyn Klausen, was appointed administrator of his estate and substituted as the petitioner in this case. (ECF No. 49-50).The case was assigned to the Special Processing Unit of the Office of Special Masters (the “SPU”). 1 Although I have not formally designated this Decision for publication, I am required to post it on the United States Court of Federal Claims' website in accordance with the E-Government Act of 2002, because it contains a reasoned explanation for my determination. 44 U.S.C. § 3501 note (2012) (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 (2012). Case 1:19-vv-01977-UNJ Document 63 Filed 03/06/23 Page 2 of 9 For the reasons described below, and after holding a brief hearing on entitlement and damages in this matter, I find that Petitioner is entitled compensation, and I award damages in the total amount of $60,000.00, for actual pain and suffering. I. Relevant Procedural History Early in the development of this case, it became evident that the issue of onset would need to be resolved. On June 2, 2021, after the parties briefed the issue, I issued a Findings of Fact and Conclusions of Law finding that there was preponderant evidence that Mr. Klausen’s shoulder pain began within 48 hours of vaccination. ECF No. 27 (“Onset Fact Finding”). Thereafter, Respondent filed a status report requesting that the deadline to file the Rule 4(c) Report be suspended while the parties explored settlement. ECF No. 30. After several months of settlement discussions, the parties reached an impasse. Petitioner requested the opportunity to file a motion for ruling on the record and a brief in support of damages. This request was granted, and a scheduling order was entered. ECF No. 42. On December 14, 2021, Petitioner filed a Motion for Ruling on Record and Brief in support of Damages (“Motion”), arguing that Petitioner had established entitlement to compensation for a SIRVA injury, and requesting $95,000.00 for Mr. Klausen’s pain and suffering. ECF No. 44. Petitioner specifically asserted that the evidence in the record preponderantly established that Mr. Klausen received a vaccine in his right shoulder on January 7, 2019, that his shoulder injury began within 48 hours of receiving the vaccine, and that he was therefore entitled to compensation. Id. Respondent filed a Response to Petitioner’s Motion on January 19, 2022 (“Response”) recommending that entitlement to compensation be denied under the terms of the Vaccine Act. ECF No. 46. Respondent argued that Petitioner had not established that the onset of Mr. Klausen’s pain occurred with the specified timeframe (despite my fact finding to the contrary), nor had Petitioner submit preponderant evidence that Mr. Klausen received the causal flu vaccine in his right shoulder as the petition alleged. Id. at 8-11. Petitioner filed his Reply on February 2, 2022. ECF No. 47. This case was set for an expedited “Motions Day” hearing, at which time I would decide the disputed issues based on all evidence filed to date and any oral argument from counsel. The Motions Day hearing took place on January 27, 2023. Minute Entry dated January 27, 2023. After the argument, I orally ruled on Petitioner’s entitlement to compensation and made a damages determination as well. This Decision memorializes those findings/determinations. 2 Case 1:19-vv-01977-UNJ Document 63 Filed 03/06/23 Page 3 of 9 II. Factual Findings and Ruling on Entitlement A. Legal Standards Before compensation can be awarded under the Vaccine Act, a petitioner must demonstrate, by a preponderance of evidence, all matters required under Section 11(c)(1), including the factual circumstances surrounding his claim. Section 13(a)(1)(A). In making this determination, the special master or court should consider the record as a whole. Section 13(a)(1). Petitioner’s allegations must be supported by medical records or by medical opinion. Id. To resolve factual issues, the special master must weigh the evidence presented, which may include contemporaneous medical records and testimony. See Burns v. Sec'y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special master must decide what weight to give evidence including oral testimony and contemporaneous medical records). Contemporaneous medical records are presumed to be accurate. See Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). To overcome the presumptive accuracy of medical records testimony, a petitioner may present testimony which is “consistent, clear, cogent, and compelling.” Sanchez v. Sec'y of Health & Human Servs., No. 11–685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec'y of Health & Human Servs., No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). 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 he 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 a flu vaccine. 42 C.F. R. § 100.3(a)(XIV)(B). The criteria establishing a SIRVA under the accompanying QAI are as follows: 3 In summary, a petitioner must establish that he 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 his injury for more than six months, died from his 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 1:19-vv-01977-UNJ Document 63 Filed 03/06/23 Page 4 of 9 Shoulder injury related to vaccine administration (SIRVA). SIRVA manifests as shoulder pain and limited range of motion occurring after the administration of a vaccine intended for intramuscular administration in the upper arm. These symptoms are thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder resulting in an inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury and abnormalities on neurological examination or nerve conduction studies (NCS) and/or electromyographic (EMG) studies would not support SIRVA as a diagnosis (even if the condition causing the neurological abnormality is not known). A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 42 C.F.R. § 100.3(c)(10). B. Factual Finding Regarding QAI Criteria for Table SIRVA Respondent argues that Petitioner has failed to present evidence that Mr. Klausen received the flu vaccination at issue in this case in his right shoulder – the relevant situs for his injury - because the vaccination record contained no indication identifying the arm of administration, and therefore the claim could not succeed. Response at 8, 10-11. Respondent does, however, “acknowledge[] that [Mr. Klausen] consistently reported pain in his right arm throughout his medical records,” although he did not report pain “until months after vaccination.” Id. at 11. With respect to the issue of situs, I find that the evidence in the record supports a 4 Case 1:19-vv-01977-UNJ Document 63 Filed 03/06/23 Page 5 of 9 finding that Mr. Klausen’s January 7, 2019 vaccination was more likely than not administered to his right shoulder. In seeking care for his right shoulder injury, Mr. Klausen consistently reported that the vaccine had been administered in his right arm. There is not a single record indicating otherwise. All the treatment he received for his shoulder injury was administered to his right shoulder. And thereafter, he consistently related his right shoulder injury to the January 7, 2019, flu vaccine. See e.g., Ex. 2 at 12 (Mr. Klausen reports to Insight Orthopedics that his right shoulder “pain began in January of 2019 after a flu shot”); Ex. 3 at 3 (physical therapy intake form states the right shoulder injury occurred “Jan 2019” and the activity prior to his condition was “received flu shot.”); Ex. 5 at 3 (Mr. Klausen completed 16 physical therapy sessions for his right shoulder injury). And although not dispositive, Mr. Klausen obtained a letter from his primary care provider who administered the vaccine that stated that it was common practice in his office to give the flu shot in the right deltoid. Ex. 10. at 1. Accordingly, there is record support for the contention about the situs of administration, beyond Mr. Klausen’s own allegations. Respondent also seems to dispute the onset issue, i.e., that Mr. Klausen’s shoulder pain began within 48 hours of vaccination. But I have already resolved this issue in my prior ruling. See Findings of Fact and Conclusions of Law, issued June 2, 2021, ECF No. 27. Accordingly, that issue also cuts in Petitioner’s favor. I therefore find it more likely than not that the vaccination alleged as causal in this case was administered in Mr. Klausen’s right shoulder on January 7, 2019, and that the onset of his right shoulder pain was within 48 hours of vaccination. Accordingly, these elements of the claim have been met. C. Other Requirements for Entitlement As stated above, I find that Petitioner has satisfied all requirements for a Table SIRVA and is entitled to a presumption of causation. Even if a petitioner has satisfied the requirements of a Table injury or established causation-in-fact, he or she must also provide preponderant evidence of the additional requirements of Section 11(c), i.e., receipt of a covered vaccine, residual effects of injury lasting six months, etc. See generally § 11(c)(1)(A)(B)(D)(E). But those elements are established or undisputed. I therefore find that Petitioner is entitled to compensation in this case. 5 Case 1:19-vv-01977-UNJ Document 63 Filed 03/06/23 Page 6 of 9 D. Damages a. The Parties’ Arguments Citing five4 prior damages determinations, Petitioner requests $95,000.00 in pain and suffering. Motion at 23. She asserts that Mr. Klausen’s course of treatment (including an MRI, five steroid injections,16 sessions of physical therapy, and a home exercise program with the assistance of his daughter who is a PT assistant until December 2021), is comparable to the aforementioned non-surgical SIRVA cases and warrants an award at that level. Motion at 1-2, 13-25. Respondent, by contrast, proposes an award of no more than $60,000.00 for pain and suffering. Response at 15-19. He argues that “the Court should consider [Mr. Klausen’s] significant delay in seeking treatment for right shoulder pain.” Id. at 16. Respondent cites to one case in particular – Knauss v. Sec’y of Health & Human Servs., No. 16-1372V, 2018 WL 343296 (Fed. Cl. Spec. Mstr. Ma 23, 2018) – in which the petitioner received $60,000.00 for pain and suffering stating that this is the more analogous case. Response at 11. b. Legal Standards for Damages Awards In another recent decision, I discussed at length the legal standard to be considered in determining damages and prior SIRVA compensation within SPU. I fully adopt and hereby incorporate my prior discussion in Sections II and III of Berge v. Sec’y Health & Human Servs., No. 19-1474V, 2021 WL 4144999, at *1-3. (Fed. Cl. Spec. Mstr. Aug. 17, 2021). In sum, compensation awarded pursuant to the Vaccine Act shall include “[f]or actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000.” Section 15(a)(4). The petitioner bears the burden of proof with respect to each element of compensation requested. Brewer v. Sec’y of Health & Human Servs., No. 93-0092V, 1996 WL 147722, at *22-23 (Fed. Cl. Spec. Mstr. Mar. 18, 1996). Factors to be considered when determining an award for pain and 4 Petitioner discusses the following cases in her Motion: Danielson v. Sec’y of Health & Human Servs., No. 18-1878V, 2020 WL 8271642, at *3 (Fed. Cl. Dec. 29, 2020)(Chief Special Master Corcoran); Selling v. Sec’y of Sec’y of Health & Human Servs., No. 16-0588v, 2021 WL 1292753 (Fed. Cl. Spec. Mstr. May 2, 2021) (Special Master Oler); Gentile v. Sec’y of Health & Human Servs., No. 16-0980v, 2020 WL 3618909, at *1-2 (Fed. Cl. Spec. Mstr., June 5, 2020) (Special Master Dorsey); Young v. Sec’y of Health & Human Servs., No. 15-1241V, 2019 WL 396981 (Fed. Cl. Spec. Mstr., Jan. 4, 2019) (Special Master Dorsey); Binette v. Sec’y of Health & Human Servs., No. 16-0731V, 2019 WL 1552620 (Fed. Cl. Spec. Mstr., Mar. 20 2019) (Special Master Dorsey). 6 Case 1:19-vv-01977-UNJ Document 63 Filed 03/06/23 Page 7 of 9 suffering include: 1) awareness of the injury; 2) severity of the injury; and 3) duration of the suffering. 5 c. Appropriate Compensation for Pain and Suffering In this case, awareness of the injury is not disputed. The record reflects that at all times Mr. Klausen was a competent adult with no impairments that would impact his awareness of his injury. Therefore, I analyze principally the severity and duration of his injury. When performing this analysis, I review the same record relied upon to determine entitlement, including the filed affidavits and medical records, written briefs, and argument at the Motions Day hearing. I have also considered prior awards for pain and suffering in both SPU and non-SPU SIRVA cases and rely upon my experience adjudicating these cases. Determination of pain and suffering is complicated by the fact that Mr. Klausen died during the pendency of this case (due to unrelated factors). I do consider and factor into my Decision that obtaining additional evidence from Mr. Klausen about his pain and suffering was not possible. However, I must rule on an award for pain and suffering on the record as it stands before me. Mr. Klausen’s only affidavit (dated December 30, 2019) states that prior to vaccination, he was healthy, active, and had no orthopedic shoulder injuries. Ex. 1 at 1. He stated that in the days after receiving the vaccine, he attempted to play the game Wii with his great grandchildren and noticed that he felt sharp pain in his shoulder while playing the bowling game. Id. at 3. But over the next couple of months, he had “very little to no use of my right arm and shoulder.” Id. He described that he could not pick up his grandchildren for fear of dropping them. Id. He finally saw a physician in April of 2019, approximately three months after vaccination, because his right shoulder “was not resolving like I thought it would.” Id. Mr. Klausen attended several weeks of physical therapy to treat his “severe shoulder pain” and also received a cortisone injection since the shoulder pain was restricting his activities. Ex. 1 at 2. He stated that neither the physical therapy nor the cortisone injection relieved his pain. Id. Mr. Klausen described that he had difficulty reaching, raising his arm, carrying objects, and donning shirts. Id. He described that the pain often interrupted his sleep. Id. 5 I.D. v. Sec’y of Health & Human Servs., No. 04-1593V, 2013 WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May 14, 2013) (quoting McAllister v. Sec’y of Health & Human Servs., No 91-1037V, 1993 WL 777030, at *3 (Fed. Cl. Spec. Mstr. Mar. 26, 1993), vacated and remanded on other grounds, 70 F.3d 1240 (Fed. Cir. 1995)). 7 Case 1:19-vv-01977-UNJ Document 63 Filed 03/06/23 Page 8 of 9 I note that Mr. Klausen underwent an MRI of his right shoulder on August 13, 2019, which showed degeneration of the right shoulder (which may indicate chronic rotator cuff disease that likely predated the relevant vaccination). Ex. 2 at 14. He then reported to physical therapy on October 10, 2019, and attended a total of 16 physical therapy sessions to treat his right shoulder. Ex. 2 at 7; Ex. 4 at 2; Ex. 16 at 4-9; 19-20. Mr. Klausen received a total of five cortisone injections to his right shoulder to treat his pain. His medical records note that after physical therapy, Mr. Klausen had only regained 10% of normal function in his right shoulder, resulting in an overall 40% loss of function as of October 2020. Ex. 15 at 4. However, Mr. Klausen’s delay of three months in seeking treatment is not insignificant. Mr. Klausen stated in his affidavit that he had “very little to no use of my right arm and shoulder.” Ex. 1 at 3. If his right shoulder pain were as severe as he described, it is difficult to understand why he waited nearly three months to be seen. The medical records also indicate that the worst he rated his pain was 4/10. Ex. 15 at 4-5. The parties’ comparable case citations were reasonable, but not fully useful in helping me to calculate pain and suffering. In particular, Petitioner’s comparable cases featured pain and suffering awards well in excess of what is appropriate in a non-surgery SIRVA case like the present. And the parties also only cited to one SIRVA case that I decided in the context of SPU. While I certainly consider cases decided by other special masters for guidance, cases where I have already ruled in similar circumstances are particularly helpful, since it has been my goal in SPU (and in promulgating “Motions Day” as well) to fashion consistent results that might guide the parties in future damages disputes. I find that Petitioner’s SIRVA more closely resembles the injury suffered by the petitioner in Knauss. As here, the Knauss claimant did not undergo surgery. Both petitioners were in their 70s and delayed seeking treatment for their shoulder injuries for several months after vaccination. Knauss, 2018 WL 332906, at *2-4. Both petitioners underwent physical therapy and received steroid injections. And while Mr. Klausen may have endured a longer period of time of active pain, that evidence is not in the record and could not be further explored due to his death. Unfortunately, I must rule on the evidence before me. Under such circumstances, and considering the arguments presented by both parties, a review of the cited cases, and based on the record as a whole, I find that $60,000.00 in compensation for Mr. Klausen’s pain and suffering, akin to Knauss, is reasonable and appropriate in a non-surgery SIRVA case like the present. (I also note that Petitioner took considerable risk in litigating this claim, despite my comments in the Onset Fact Finding about delay in treatment impacting severity. (See Onset Fact Finding 8 Case 1:19-vv-01977-UNJ Document 63 Filed 03/06/23 Page 9 of 9 at 7). I well could have awarded even less in damages than Respondent proposed. Although I am not privy to the parties’ settlement discussions and their tenor, the failure to settle the case after my fact determination exposed Petitioner to the possibility of a diminished recovery. I will hope in the future that counsel take seriously my comments about severity in my fact determinations). E. Conclusion In light of all of the above, the I award a lump sum payment of $60,000.00, (for actual pain and suffering) in the form of a check payable to Petitioner. This amount represents compensation for all damages that would be available under Section 15(a) of the Vaccine Act. Id. This amount represents compensation for all damages that would be available under Section 15(a). The Clerk of the Court is directed to enter judgment in accordance with this Decision.6 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 6 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. 9