VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-01560 Package ID: USCOURTS-cofc-1_21-vv-01560 Petitioner: Erik Koonce Filed: 2021-07-09 Decided: 2024-07-29 Vaccine: influenza Vaccination date: 2018-10-17 Condition: Guillain-Barré syndrome and Bell's palsy Outcome: compensated Award amount USD: 107614 AI-assisted case summary: Erik Koonce, a 50-year-old pilot, filed a petition on July 9, 2021, alleging that an influenza vaccine administered on October 17, 2018, caused him to develop Guillain-Barré syndrome (GBS) and Bell's palsy. Mr. Koonce alleged entitlement to compensation under the Vaccine Injury Compensation Program. The Secretary of Health and Human Services initially contested entitlement, arguing that Mr. Koonce did not meet the regulatory definition of GBS due to a lack of objective limb weakness. However, the Secretary later conceded entitlement, and the case proceeded to the determination of damages. Mr. Koonce first experienced symptoms on November 7, 2018, approximately one day after vaccination, reporting facial numbness and left facial droop, which was diagnosed as Bell's palsy. He was treated with prednisone and showed improvement. Around November 23, 2018, he developed numbness and weakness in his feet that ascended his legs. He sought hospital treatment on November 30, 2018, where a lumbar puncture revealed elevated protein levels consistent with GBS. He was diagnosed with Miller Fisher variant of GBS and received intravenous immunoglobulin (IVIG) therapy, after which his symptoms improved. His treating neurologists, including Dr. John Khoury, Dr. Richard Buckler, and Dr. Eric Lancaster, provided diagnoses of GBS or symptoms suggestive of GBS. Dr. Lancaster's report noted that Mr. Koonce had a limited form of GBS with less disability than usual. Regarding Bell's palsy, Dr. Lancaster observed subtle synkinesis on the left side of Mr. Koonce's face in June 2019, indicating the condition lasted more than six months. Special Master Christian J. Moran issued a ruling on January 3, 2024, finding Mr. Koonce entitled to compensation for both GBS, as a Table injury, and Bell's palsy. The case then proceeded to damages. In a decision dated July 29, 2024, Special Master Moran awarded Mr. Koonce a total of $107,614.03. This award included $70,000 for pain and suffering related to GBS, $27,000 for pain and suffering related to Bell's palsy, $10,494.43 for lost earnings, and $119.60 for unreimbursed expenses. The award was to be paid as a lump sum. Petitioner counsel was Laura J. Levenberg of Muller Brazil, and respondent counsel was Sarah B. Rifkin of the United States Department of Justice. Theory of causation field: Petitioner Erik Koonce, age 50, received an influenza vaccine on October 17, 2018. He alleged that the vaccine caused Guillain-Barré syndrome (GBS) and Bell's palsy. Mr. Koonce sought compensation under the Vaccine Injury Compensation Program. The Special Master found that Mr. Koonce satisfied the criteria for an on-Table GBS injury, with diagnoses from treating neurologists including Dr. John Khoury, Dr. Richard Buckler, and Dr. Eric Lancaster, and medical records showing elevated spinal fluid protein consistent with GBS. The Special Master also found that Mr. Koonce's Bell's palsy met the severity requirement, lasting more than six months with observed subtle synkinesis. The Secretary of Health and Human Services initially contested entitlement based on a lack of objective limb weakness for GBS but later conceded entitlement. The case proceeded to damages, and Special Master Christian J. Moran awarded $107,614.03, comprising $70,000 for GBS pain and suffering, $27,000 for Bell's palsy pain and suffering, $10,494.43 for lost earnings, and $119.60 for expenses. Petitioner counsel was Laura J. Levenberg, and respondent counsel was Sarah B. Rifkin. The decision date was July 29, 2024. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_21-vv-01560-0 Date issued/filed: 2024-01-25 Pages: 11 Docket text: PUBLIC ORDER/RULING (Originally filed: 1/3/24) regarding 53 Ruling on Entitlement Signed by Special Master Christian J. Moran. (dksc) Service on parties made. (Main Document 55 replaced on 1/29/2024 to correct Petitioner's first name.) (fm). -------------------------------------------------------------------------------- Case 1:21-vv-01560-UNJ Document 55 Filed 01/25/24 Page 1 of 11 CORRECTED In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS * * * * * * * * * * * * * * * * * * * * * * ERIK KOONCE, * * No. 21-1560V Petitioner, * Special Master Christian J. Moran * v. * * Filed: January 3, 2024 SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * Laura J. Levenberg, Muller Brazil, Dresher, PA, for petitioner; Sarah B. Rifkin, United States Dep’t of Justice, Washington, DC, for respondent. RULING FINDING ENTITLEMENT TO COMPENSATION1 Erik Koonce alleges that an influenza (“flu”) vaccine harmed him and seeks compensation via three avenues. First, Mr. Koonce argues that he developed a neurologic disorder, Guillain-Barré syndrome, and seeks the benefit of a presumption of causation via the Vaccine Injury Table. Second, Mr. Koonce supports a claim that the flu vaccine was the cause-in-fact of his Guillain-Barré 1 Because this Ruling contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the Ruling will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the parties have 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. Any changes will appear in the document posted on the website. Case 1:21-vv-01560-UNJ Document 55 Filed 01/25/24 Page 2 of 11 syndrome with the report from an expert. Third, Mr. Koonce maintains that the flu vaccine was the cause-in-fact of a different condition, Bell’s palsy. The Secretary contends that Mr. Koonce is not entitled to compensation. The Secretary’s position is advanced by arguments from attorneys. The Secretary has not presented evidence from an expert he retained for this litigation. As discussed below, Mr. Koonce is entitled to compensation. Thus, the case will proceed to damages. I. Events in Mr. Koonce’s Life2 In October 2018, Mr. Koonce was 50 years old. His medical history does not contribute to resolving his claim for compensation. He received a flu vaccine on October 17, 2018. Exhibit 1. On November 8, 2018, Mr. Koonce reported that he had numbness in his face and left facial droop, starting one day earlier. Exhibit 3 at 57. The doctor in the emergency room diagnosed Mr. Koonce as suffering from Bell’s palsy. He was prescribed a tapered course of prednisone. Id. at 60. In a follow-up with his primary care doctor (Christine Dacier), Mr. Koonce essentially repeated this history. Exhibit 2 at 33 (Nov. 14, 2018). Dr. Dacier also diagnosed Bell’s palsy and recommended another appointment in a week. Id. In the return appointment, Mr. Koonce told Dr. Dacier that he “continued to improve.” Exhibit 2 at 31 (Nov. 20, 2018). Movement in his face was increased. Dr. Dacier stated that Mr. Koonce is “medically stable to return to work as a pilot.” Id. On about November 23, 2018, Mr. Koonce developed numbness and weakness in his feet and ascending his legs for which he sought treatment in an 2 Mr. Koonce’s medical history is presented relatively summarily. For a more complete account, see Resp’t’s Second Am. Report, filed Mar. 24, 2023, at 3-10, and Pet’r’s Mot. for a Ruling on the Record, filed July 17, 2023, at 2-4. 2 Case 1:21-vv-01560-UNJ Document 55 Filed 01/25/24 Page 3 of 11 emergency room on November 30, 2018. Exhibit 4 at 29. He stated the weakness started after he completed his course of steroids. A physical examination, however, did not detect any weakness in his lower extremities. Yet, Mr. Koonce had decreased sensation from his feet to his mid-shins. Id. at 30. Mr. Koonce was admitted to the hospital. Mr. Koonce remained in the hospital for four days. A neurologist, John Khoury, examined Mr. Koonce. Dr. Khoury stated “Hopefully this is just a steroid induced Neuropathy but given the recent [Bell’s] palsy it is possible this is a Miller Fisher Variant of GBS.” Id. at 444. Dr. Khoury recommended that if Mr. Koonce’s symptoms worsened or if he lost his ankle reflexes, Mr. Koonce should have a lumbar puncture. Whether Mr. Koonce’s symptoms did worsen, or he lost his ankle reflexes is not clear. Regardless, Mr. Koonce underwent a lumbar puncture on December 1, 2018. The results showed an elevated protein level without an elevated blood count. Exhibit 4 at 108. Doctors interpreted these results as “consistent with GBS.” Id. at 10, 250, 311. Mr. Koonce continued to report that he felt weak, although the examination did not detect weakness or a loss of reflexes. Id. at 10. The doctors ordered intravenous immunoglobulin therapy (“IVIG”) and Mr. Koonce had four sessions while in the hospital. After 4 days of IVIG, Mr. Koonce’s symptoms improved. At discharge, Mr. Koonce’s diagnosis was the Miller Fisher syndrome. Id. at 10-12 (Dec. 4, 2018 discharge report). He was instructed to follow-up with his primary care physician. Mr. Koonce returned to Dr. Dacier and reported his recent diagnosis of GBS. Mr. Koonce also described new symptoms, including fever, chills, fatigue. Exhibit 2 at 28 (Dec. 20, 2018). Mr. Koonce also reported continued numbness from the knees down. Next, Mr. Koonce saw a neurologist, Richard Buckler. Dr. Buckler stated Mr. Koonce’s “symptoms and examination [were] suggestive of Guillain-Barré syndrome in view of the paresthesias, [left-sided] facial droop and depressed deep 3 Case 1:21-vv-01560-UNJ Document 55 Filed 01/25/24 Page 4 of 11 tendon reflexes in the upper extremities and an elevated CSF protein of 210.” Exhibit 31 at 8 (Dec. 26, 2018). Mr. Koonce returned to see the neurologist who had cared for him in the hospital, Dr. Khoury, on January 7, 2019. Exhibit 5 at 9. Dr. Khoury memorialized Mr. Koonce’s previous complaints and hospitalization. Dr. Khoury noted that after IVIG treatment, Mr. Koonce’s bilateral leg numbness had improved. Mr. Koonce denied any weakness and reported some numbness in his toes. Mr. Koonce walked normally and could stand on either foot without difficulty. Dr. Khoury assessed Mr. Koonce with “post viral GBS.” Id. at 10. Dr. Khoury stated that because Mr. Koonce was “doing great,” “no additional therapy [was] needed at this time.” Id. Dr. Khoury cleared Mr. Koonce “to work without restriction.” Id. In April 2019, Mr. Koonce saw both his neurologist (Dr. Khoury) and his primary care doctor (Dr. Dacier). He was not having neurologic problems. See Exhibit 5 at 7, Exhibit 2 at 20. But, in May 2019, Mr. Koonce told his other neurologist, Dr. Buckler, that his numbness had worsened. Exhibit 31 at 12. Mr. Koonce sought another opinion regarding his neurologic problems from Eric Lancaster at Penn Medicine on June 21, 2019. Exhibit 6 at 11. (As discussed below, the views of Dr. Lancaster contribute to the determination that Mr. Koonce is entitled to compensation.) Dr. Lancaster obtained a history from Mr. Koonce, in which Mr. Koonce informed Dr. Lancaster he had ascending numbness but “Never became weak” and “Still had reflexes.” Id. at 12. In the first hospitalization, Mr. Koonce had a high protein. Apparently, Mr. Koonce was unclear about the diagnosis “Miller Fisher vs. GBS.” Id. Through electronic medical records, Dr. Lancaster reviewed various documents, including the “Abington hospital admission records. Discharge diagnosis was GBS” and Dr. Khoury’s notes from January 7, 2019 and April 1, 2019 in which Dr. Khoury diagnosed GBS. Exhibit 6 at 13. For current problems, Mr. Koonce stated that “his feet are still tingling and numb and he feels it up to his knees. No convincing symptoms in hands. Face never became weak since the first attack of Bell's Palsy.” Id. at 18. 4 Case 1:21-vv-01560-UNJ Document 55 Filed 01/25/24 Page 5 of 11 Dr. Lancaster’s impression was that: “Mr. Koonce has bell's palsy and then had an acute neuropathy. Since there was an LP showing high protein and normal CSF cell counts, it is hard to come up with any different cause tha[n] GBS for his symptoms. It does seem like he had a limited form of GBS with much less disability that is usual for GBS.” Id. at 19. Dr. Lancaster did not recommend any additional immune therapy. Dr. Lancaster recommended some tests for other causes of neuropathy. Dr. Lancaster ended his report with comments about the vaccine. Dr. Lancaster wrote: “We discussed vaccine causation. I disclosed that I have consulted for the vaccine injury compensation program. He is considering whether to apply for this program. I discussed my understanding of how these programs work.” Id. After some intervening medical appointments, Mr. Koonce visited with Dr. Lancaster via telemedicine on February 12, 2021. Exhibit 6 at 17. A primary purpose was to discuss vaccinations, particularly the Covid-19 vaccination. Dr. Lancaster wrote: “I would probably avoid a repeat flu shot but would not avoid other vaccines.” Id. at 19-20. The parties have not identified other medical records contributing to determining whether Mr. Koonce is entitled to compensation. See Pet’r’s Mot. at 4 (concluding with Dr. Lancaster’s Feb. 12, 2021 visit); Resp’t’s Second Amended Rep. at 10 (same). II. Procedural History Mr. Koonce began this case by submitting his petition on July 9, 2021. During the summer 2022, the parties attempted to resolve the case but were not successful. Pet’r’s Status Rep., filed Aug. 5, 2022. The Secretary recommended against compensation. The primary argument was that Mr. Koonce did not meet the definition of Guillain-Barré syndrome as set forth in the regulations because he did not have weakness in his limbs. Resp’t’s Rep., filed Sep. 23, 2022, at 10. The Secretary also maintained that Mr. Koonce failed to support any off-Table claim as he lacked a report from an expert. 5 Case 1:21-vv-01560-UNJ Document 55 Filed 01/25/24 Page 6 of 11 Mr. Koonce obtained a report from Joseph S. Jeret, a neurologist. Exhibit 14. Dr. Jeret asserted that Mr. Koonce “satisfies the Vaccine Injury Table criteria for GBS, but [not] the criteria for Miller-Fisher Syndrome.” Exhibit 14 at 7. Dr. Jeret opined that the flu vaccine was the cause-in-fact of Mr. Koonce’s Bell’s palsy. Id. at 7-9. The Secretary presented another report on March 13, 2023. The Secretary stated that “he will not continue to defend this case during further proceedings on entitlement before the Office of Special Masters, and requests a ruling on the record regarding petitioner’s entitlement to compensation.” Resp’t’s First Am. Report, filed Mar. 13, 2023, at 1. The Secretary’s analysis was confusing. The Secretary maintained that Mr. Koonce “has not met his burden of proof under the Vaccine Act for the reasons set forth in his initial Rule 4(c) Report.” Id. at 11. However, one reason the Secretary originally gave for declining to compensate Mr. Koonce was that Mr. Koonce did not have an expert report. While that statement was true in September 2022, it was not accurate in March 2023. The evidence, including Dr. Lancaster’s reports and Dr. Jeret’s report, were discussed in a March 14, 2023 status conference. The Secretary was directed to file an amended report. Order, issued March 14, 2023. The second amended report again recommended against an award of compensation. The Secretary addressed three claims. First, the Secretary argued that Mr. Koonce did not establish he suffered from Guillain-Barré syndrome as defined in the qualifications and aids to interpretation. Second Am. Report at 10- 12. The key point was the lack of limb weakness. Id. at 11, citing 42 C.F.R. § 100.3(c)(15)(ii)(A). Thus, according to the Secretary, Mr. Koonce was not entitled to a presumption of causation. Second, the Secretary argued that Mr. Koonce did not establish that he was entitled to compensation for his Bell’s palsy. The Secretary contended that Mr. Koonce’s Bell’s palsy did not last sufficiently long to meet the severity requirement. The Secretary did not challenge Mr. Koonce’s satisfaction of the Althen prongs for Bell’s palsy. Id. at 13-14. 6 Case 1:21-vv-01560-UNJ Document 55 Filed 01/25/24 Page 7 of 11 Third, the Secretary argued that Mr. Koonce did not establish that he was entitled to compensation for his Guillain-Barré syndrome as an off-Table claim. The key point was inconsistencies in Dr. Jeret’s report. Id. at 15. In this context, the Secretary did not discuss the reports from Dr. Lancaster. The Secretary also did not challenge Mr. Koonce’s satisfaction of the Althen prongs for Guillain- Barré syndrome. After being ordered to file a brief regarding entitlement, Mr. Koonce did so on July 17, 2023. The Secretary did not submit a response within the time permitted by the Vaccine Rules. Thus, Mr. Koonce’s motion is ready for adjudication. III. Standards for Adjudication A petitioner is required to establish his case by a preponderance of the evidence. 42 U.S.C. § 300aa-13(1)(a). The preponderance of the evidence standard requires a “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] 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). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Distinguishing between “preponderant evidence” and “medical certainty” is important because a special master should not impose an evidentiary burden that is too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed. Cir. 2009) (reversing a special master’s decision that petitioners were not entitled to compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (disagreeing with the dissenting judge’s contention that the special master confused preponderance of the evidence with medical certainty). 7 Case 1:21-vv-01560-UNJ Document 55 Filed 01/25/24 Page 8 of 11 IV. Analysis Part One – on-Table GBS Petitioners who establish that they received a vaccine listed on the Vaccine Table, suffered an injury listed on the Vaccine Table, and this injury occurred in the amount of time after a vaccine listed on the Vaccine Table are presumed to have established that the vaccine caused the injury. See Shalala v. Whitecotton, 514 U.S. 268, 270 (1995). Of these subsidiary components, the sole disputed item is whether Mr. Koonce suffered Guillain-Barré syndrome. Congress authorized special masters to award compensation based upon “medical records” or “medical opinion.” 42 U.S.C. § 300aa–13(a)(1). Medical records may be sufficient to establish that a vaccinee suffered an injury listed in the Vaccine Table. See Harrington v. Sec’y of Health & Hum. Servs., 139 Fed. Cl. 465, 469 (2018) (denying motion for review, in part, because petitioner did not establish that he suffered from GBS); Waterman v. Sec’y of Health & Hum. Servs., 123 Fed. Cl. 564, 573-74 (2015) (looking first to determine whether a treating doctor diagnosed a child-vaccinee with an encephalopathy before turning to reports from retained experts); Keith v. Sec’y of Health & Hum. Servs., 55 Fed. Cl. 791, 797 (2003) (denying motion for review and stating that “in the absence of clear, definitive medical records establishing this injury, a [petitioner] as actual manifestations of Brachial Neuritis”). Here, ample evidence shows that Mr. Koonce’s diagnosis of Guillain-Barré syndrome appears in “medical records” created by doctors who treated him. • Doctors at Abington Hospital interpreted the results of the spinal tap as “consistent with GBS.” Exhibit 4 at 10, 250, 311. • The discharge report from Abington Hospital stated that Mr. Koonce suffered from a subtype of Guillain-Barré syndrome, Miller Fisher syndrome. Exhibit 4 at 10-12 (Dec. 4, 2018 discharge report). • Neurologist Richard Buckler stated Mr. Koonce’s “symptoms and examination [were] suggestive of Guillain-Barré syndrome. Exhibit 31 at 8 (Dec. 26, 2018). • Neurologist John Khoury assessed Mr. Koonce with “post viral GBS.” Exhibit 5 at 10 (Jan. 7, 2019). 8 Case 1:21-vv-01560-UNJ Document 55 Filed 01/25/24 Page 9 of 11 • Neurologist Eric Lancaster wrote, “it is hard to come up with any different cause tha[n] GBS for his symptoms.” Exhibit 6 at 13 (June 21, 2019). In short, three neurologists diagnosed Mr. Koonce with Guillain-Barré syndrome. Dr. Khoury saw Mr. Koonce while he was hospitalized. Dr. Buckler saw Mr. Koonce shortly after he was discharged. Dr. Lancaster had the benefit of reviewing electronic medical records. The Secretary has not argued that any of these three doctors were mistaken or unreliable. Taken together, these reports constitute convincing evidence that Mr. Koonce had Guillain-Barré syndrome. Despite the reports from doctors who treated Mr. Koonce, the Secretary argues that he did not satisfy the regulatory definition of Guillain-Barré syndrome. In relevant part, the definition requires “Bilateral flaccid limb weakness and decreased or absent deep tendon reflexes in weak limbs.” 42 C.F.R. § 100.3(c)(15)(ii)(A); see also 80 Fed. Reg. 45132, 45145 (notice of proposed revisions to Vaccine Injury Table) (July 29, 2015). Although not spelled out, the Secretary’s position seems to be that “weakness” must be found by a doctor. Mr. Koonce’s subjective report of weakness (exhibit 4 at 29) apparently does not satisfy the Secretary. However, according to Dr. Jeret, a lack of objective confirmation is “not uncommon” because “bedside testing can easily miss minor weakness.” Exhibit 14 at 6. This opinion is not rebutted. Dr. Jeret’s opinion was that Mr. Koonce “satisfies the Vaccine Injury Table criteria for GBS.” Exhibit 14 at 7. Thus, Dr. Jeret is an additional neurologist who has stated that Mr. Koonce suffered from Guillain-Barré syndrome. To counter the opinions from four neurologists, the Secretary has not presented any evidence such as a report of a doctor retained for this litigation. The Secretary has not proposed any other diagnosis that would explain Mr. Koonce’s numbness and elevated protein at the end of November 2018. Although the Secretary does not bear the burden to propose an alternative diagnosis, the lack of evidence proposing an alternative diagnosis undermines the Secretary’s stance. 9 Case 1:21-vv-01560-UNJ Document 55 Filed 01/25/24 Page 10 of 11 Accordingly, Mr. Koonce has demonstrated that he suffered from Guillain- Barré syndrome. He has also satisfied the other elements to be awarded compensation for Guillain-Barré syndrome.3 V. Analysis Part 2: off-Table Bell’s Palsy As to whether Mr. Koonce should receive compensation for his Bell’s palsy, the parties differ. Through Dr. Jeret, Mr. Koonce alleges that the flu vaccine caused him to develop Bell’s palsy. Exhibit 14 at 7-8. The Secretary argued that the Bell’s palsy resolved so quickly that Mr. Koonce cannot satisfy the Vaccine Act’s severity requirement. Second Am. Rep. at 13. The Secretary did not contend that Mr. Koonce’s evidence failed to fulfill the Althen prongs. In reply, Mr. Koonce identified a June 21, 2019 medical record in which Dr. Lancaster stated that the left side of Mr. Koonce’s face showed “‘subtle synkinesis.’” Pet’r’s Mot. at 19, quoting Exhibit 6 at 12. Here, although Mr. Koonce’s Bell’s palsy was not severe, the Bell’s palsy has lasted more than six months. See Exhibit 14 at 5 (Dr. Jeret’s report, linking the subtle facial synkinesis to Bell’s palsy). Thus, Mr. Koonce has demonstrated that he fulfills the Vaccine Act’s severity requirement. Other than severity, the Secretary did not interpose any reason to deny compensation for Bell’s palsy. Thus, Mr. Koonce is entitled to compensation. See Vaccine Rule 4(c)(1) (requiring the Secretary to set forth “a full and complete statement of its position as to why an award should or should not be granted”). VI. Conclusion Mr. Koonce has demonstrated that he is entitled to compensation for Bell’s palsy and Guillain-Barré syndrome. An order regarding the process for quantifying the compensation to which he is entitled will be issued shortly. 3 Given that Mr. Koonce established his claim for compensation based upon the Vaccine Injury Table, an analysis of Mr. Koonce’s alternative theory that the flu vaccine was the cause- in-fact of his Guillain-Barré syndrome is superfluous. 10 Case 1:21-vv-01560-UNJ Document 55 Filed 01/25/24 Page 11 of 11 Any questions regarding this ruling may be directed to my law clerk, Debbie Chu, at (202) 357-6360. IT IS SO ORDERED. s/Christian J. Moran Christian J. Moran Special Master 11 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_21-vv-01560-1 Date issued/filed: 2024-07-29 Pages: 10 Docket text: PUBLIC DECISION (Originally filed: 07/08/2024) regarding 64 DECISION of Special Master Signed by Special Master Christian J. Moran. (ceo) Service on parties made. -------------------------------------------------------------------------------- Case 1:21-vv-01560-UNJ Document 68 Filed 07/29/24 Page 1 of 10 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS * * * * * * * * * * * * * * * * * * * * * * ERIK KOONCE, * * No. 21-1560V Petitioner, * Special Master Christian J. Moran * v. * * Filed: July 8, 2024 SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * Laura J. Levenberg, Muller Brazil, Dresher, PA, for petitioner; Sarah B. Rifkin, United States Dep’t of Justice, Washington, DC, for respondent. DECISION AWARDING COMPENSATION1 Erik Koonce established that an influenza (“flu”) vaccine caused him to develop two different conditions, Guillain-Barré syndrome and Bell’s palsy. The parties dispute the amount of compensation to which Mr. Koonce is entitled. For the reasons explained below, a reasonable amount of compensation is $107,614.03. 1 Because this decision contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the parties have 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. Any changes will appear in the document posted on the website. Case 1:21-vv-01560-UNJ Document 68 Filed 07/29/24 Page 2 of 10 I. Events in Mr. Koonce’s Life2 In October 2018, Mr. Koonce was 50 years old. His medical history does not contribute to resolving his claim for compensation. He was employed as a pilot. See Exhibit 3 at 57. He received a flu vaccine on October 17, 2018. Exhibit 1. On November 8, 2018, Mr. Koonce reported that he had numbness in his face and left facial droop, starting one day earlier. Exhibit 3 at 57. The doctor in the emergency room diagnosed Mr. Koonce as suffering from Bell’s palsy. He was prescribed a tapered (12-day) course of prednisone. Id. at 60. In a follow-up with his primary care doctor (Christine Dacier), Mr. Koonce essentially repeated this history. Exhibit 2 at 33 (Nov. 14, 2018). Mr. Koonce stated that the “left side of his face ‘felt frozen.’” Id. Dr. Dacier also diagnosed Bell’s palsy and recommended another appointment in a week. Id. In the return appointment, Mr. Koonce told Dr. Dacier that he “continued to improve.” Exhibit 2 at 31 (Nov. 20, 2018). Movement in his face was increased. Dr. Dacier stated that Mr. Koonce is “medically stable to return to work as a pilot.” Id. On about November 23, 2018, Mr. Koonce developed numbness and weakness in his feet and ascending his legs for which he sought treatment in an emergency room on November 30, 2018. Exhibit 4 at 29. He stated the weakness started after he completed his course of steroids. A physical examination, however, did not detect any weakness in his lower extremities. Yet, Mr. Koonce had decreased sensation from his feet to his mid-shins. Id. at 30. Mr. Koonce was admitted to the hospital. 2 Mr. Koonce’s medical history is presented relatively summarily. For a more complete account, see Resp’t’s Second Am. Report, filed Mar. 24, 2023, at 3-10, and Pet’r’s Mot. for a Ruling on the Record, filed July 17, 2023, at 2-4. 2 Case 1:21-vv-01560-UNJ Document 68 Filed 07/29/24 Page 3 of 10 Mr. Koonce remained in the hospital for four days. A neurologist, John Khoury, examined Mr. Koonce. Dr. Khoury stated “Hopefully this is just a steroid induced Neuropathy but given the recent [Bell’s] palsy it is possible this is a Miller Fisher Variant of GBS.” Exhibit 4 at 444. Dr. Khoury recommended that if Mr. Koonce’s symptoms worsened or if he lost his ankle reflexes, Mr. Koonce should have a lumbar puncture. Whether Mr. Koonce’s symptoms did worsen, or he lost his ankle reflexes is not clear. Regardless, Mr. Koonce underwent a lumbar puncture on December 1, 2018. The results showed an elevated protein level without an elevated blood count. Exhibit 4 at 108. Doctors interpreted these results as “consistent with GBS.” Id. at 10, 250, 311. Mr. Koonce continued to report that he felt weak, although the examination did not detect weakness or a loss of reflexes. Id. at 10. The doctors ordered intravenous immunoglobulin therapy (“IVIG”) and Mr. Koonce had four sessions while in the hospital. After four days of IVIG, Mr. Koonce’s symptoms improved. At discharge, Mr. Koonce’s diagnosis was GBS with Miller Fisher variant. Exhibit 4 at 10-12 (Dec. 4, 2018 discharge report). He was instructed to follow-up with his primary care physician. Mr. Koonce returned to Dr. Dacier and reported his recent diagnosis of GBS. Mr. Koonce also described new symptoms, including fever, chills, fatigue. Exhibit 2 at 28 (Dec. 20, 2018). Mr. Koonce also reported continued numbness from the knees down. Next, Mr. Koonce saw a neurologist, Richard Buckler. Dr. Buckler stated Mr. Koonce’s “symptoms and examination [were] suggestive of Guillain-Barré syndrome in view of the paresthesias, [left-sided] facial droop and depressed deep tendon reflexes in the upper extremities and an elevated CSF protein of 210.” Exhibit 31 at 8 (Dec. 26, 2018). Although Dr. Buckler recommended more studies (an EMG/NCS and an MRI of the cervical spine), it appears that Mr. Koonce did not undergo this workup. In a January 3, 2019 appointment with Dr. Dacier, Mr. Koonce reported that the numbness in his feet was “a little better.” Exhibit 2 at 22. He also said that he 3 Case 1:21-vv-01560-UNJ Document 68 Filed 07/29/24 Page 4 of 10 had exercised in a gym the previous day. Dr. Dacier stated that his gait was normal. Mr. Koonce returned to see the neurologist who had cared for him in the hospital, Dr. Khoury, on January 7, 2019. Exhibit 5 at 9. Dr. Khoury memorialized Mr. Koonce’s previous complaints and hospitalization. Dr. Khoury noted that after IVIG treatment, Mr. Koonce’s bilateral leg numbness had improved. Mr. Koonce denied any weakness and reported some numbness in his toes. Mr. Koonce walked normally and could stand on either foot without difficulty. Dr. Khoury assessed Mr. Koonce with “post viral GBS.” Id. at 10. Dr. Khoury stated that because Mr. Koonce was “doing great,” “no additional therapy [was] needed at this time.” Id. Dr. Khoury cleared Mr. Koonce “to work without restriction.” Id.3 In April 2019, Mr. Koonce saw both his neurologist (Dr. Khoury) and his primary care doctor (Dr. Dacier). He was not having neurologic problems. See Exhibit 5 at 7, Exhibit 2 at 20. But, in May 2019, Mr. Koonce told his other neurologist, Dr. Buckler, that his numbness had worsened over the past month. Exhibit 31 at 12. Mr. Koonce sought another opinion regarding his neurologic problems from Eric Lancaster at Penn Medicine on June 21, 2019. Exhibit 6 at 11. Dr. Lancaster obtained a history from Mr. Koonce, in which Mr. Koonce informed Dr. Lancaster he had ascending numbness but “Never became weak” and “Still had reflexes.” Id. at 12. In the first hospitalization, Mr. Koonce had a high protein. Apparently, Mr. Koonce was unclear about the diagnosis “Miller Fisher vs. GBS.” Id. Through electronic medical records, Dr. Lancaster reviewed various documents, including the “Abington hospital admission records. Discharge diagnosis was GBS” and Dr. Khoury’s notes from January 7, 2019 and April 1, 2019 in which Dr. Khoury diagnosed GBS. Exhibit 6 at 13. 3 Mr. Koonce asserts that he missed five months of work without identifying any evidence to support this statement. Pet’r’s Br. at 7; Pet’r’s Reply at 2. 4 Case 1:21-vv-01560-UNJ Document 68 Filed 07/29/24 Page 5 of 10 For current problems, Mr. Koonce stated that “his feet are still tingling and numb and he feels it up to his knees. No convincing symptoms in hands. Face never became weak since the first attack of Bell's Palsy.” Exhibit 6 at 18. Dr. Lancaster’s impression was that: “Mr. Koonce has bell's palsy and then had an acute neuropathy. Since there was an LP showing high protein and normal CSF cell counts, it is hard to come up with any different cause tha[n] GBS for his symptoms. It does seem like he had a limited form of GBS with much less disability that is usual for GBS.” Exhibit 6 at 19. Dr. Lancaster did not recommend any additional immune therapy. Dr. Lancaster recommended some tests for other causes of neuropathy. After some intervening medical appointments, Mr. Koonce visited with Dr. Lancaster via telemedicine on February 12, 2021. Exhibit 6 at 17. A primary purpose was to discuss vaccinations, particularly the Covid-19 vaccination. Dr. Lancaster wrote: “I would probably avoid a repeat flu shot but would not avoid other vaccines.” Id. at 19-20. Mr. Koonce reported that he had ongoing numbness from his feet to his knees. Id. at 17. Yet, Mr. Koonce could also sprint around the court when he played racquetball. Id. The parties have not identified other medical records contributing to determining whether Mr. Koonce is entitled to compensation. See Pet’r’s Mot., filed May 13, 2024 at 4 (concluding with Dr. Lancaster’s Feb. 12, 2021 visit); Resp’t’s Resp., filed June 14, 2024 at 12 (same). II. Procedural History Mr. Koonce began this case by submitting his petition on July 9, 2021. During the summer of 2022, the parties attempted to resolve the case but were not successful. Pet’r’s Status Rep., filed Aug. 5, 2022. 5 Case 1:21-vv-01560-UNJ Document 68 Filed 07/29/24 Page 6 of 10 Mr. Koonce was found to be entitled to compensation. Ruling, issued Jan. 3, 2024. The parties were not able to resolve the amount of compensation for pain and suffering.4 Mr. Koonce proposed that a reasonable amount of pain and suffering is $160,000 for Guillain-Barré syndrome and $60,000 for Bell’s Palsy. Pet’r’s Mot.., filed May 13, 2024 at 10. In contrast, the Secretary proposed a “holistic” amount of compensation for pain and suffering is $70,000. Resp’t’s Resp., filed June 13, 2024, at 2.5 Mr. Koonce defended his proposal. Pet’r’s Reply, filed June 20, 2024. With the submission of the reply, the case is ready for adjudication. III. Standards for Adjudication A petitioner is required to establish his case by a preponderance of the evidence. 42 U.S.C. § 300aa-13(1)(a). The preponderance of the evidence standard requires a “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] 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). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Distinguishing between “preponderant evidence” and “medical certainty” is important because a special master should not impose an evidentiary burden that is 4 The parties agree that $10,494.43 was a reasonable amount of compensation for lost earnings. The parties’ cooperation in resolving this component is appreciated. 5 To support his position of proposing a single amount of compensation for two different conditions, the Secretary cited Pappas v. Sec’y of Health & Hum. Servs., No. 21-1690V, 2023 WL 7298437 (Fed. Cl. Spec. Mstr. Oct. 6, 2003), and Miller v. Sec’y of Health & Hum. Servs., No. 21-1559V, 2023 WL 2474322 (Fed. Cl. Spec. Mstr. Mar. 13, 2023). Resp’t’s Resp. at 13 n.7. The relevance of Pappas and Miller for this proposition is not readily apparent. In both cases, the chief special master determined the amount of compensation for Guillain-Barré syndrome and the decisions do not suggest that the petitioners were suffering from conditions other than Guillain-Barré syndrome. 6 Case 1:21-vv-01560-UNJ Document 68 Filed 07/29/24 Page 7 of 10 too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed. Cir. 2009) (reversing a special master’s decision that petitioners were not entitled to compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (disagreeing with the dissenting judge’s contention that the special master confused preponderance of the evidence with medical certainty). The Vaccine Act states that compensation shall include “For actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000.” 42 U.S.C. § 300aa–15(a)(4). Factors relevant to this element of compensation are “[(1)] the ability to understand the injury, i.e., the injured’s mental faculties are intact; [(2)] the degree of severity of the injury; and [(3)] the potential number of years the individual is subjected to the injury.” 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). IV. Analysis Part One – Compensation for Guillain-Barré Syndrome Mr. Koonce recognizes that his “condition was on the mild end of severity in GBS cases.” Pet’r’s Br. at 7; accord Resp’t’s Resp. at 9. Several factors contribute to a characterization of mildness. For example, Mr. Koonce’s hospitalization was relatively short (four-days). Because he improved so rapidly, Mr. Koonce was not required to stay in the hospital to receive his fifth (and final) IVIG treatment. During the hospitalization, his treating doctors did not detect any weakness. He also did not have trouble with walking or respirating, two difficulties that often accompany Guillain-Barré syndrome. Mr. Koonce’s improvement during his hospitalization allowed him to be discharged home, as opposed to a rehabilitation facility. Rehabilitation was not required because, in part, Mr. Koonce was independent in bathing, dressing, walking, and climbing stairs. Exhibit 4 at 17. After leaving the hospital, he did not attend physical therapy. The January 7, 2019 record from Dr. Khoury states that Mr. Koonce was “doing great” and “no additional therapy needed.” Exhibit 5 at 9. This medical 7 Case 1:21-vv-01560-UNJ Document 68 Filed 07/29/24 Page 8 of 10 record, which was created approximately one month after Mr. Koonce was hospitalized, shows that Mr. Koonce’s Guillain-Barré syndrome did not last long. Any residual symptoms, such as the numbness reported to Dr. Lancaster in February 2021, did not interfere with physical activities such as playing racquetball. The duration and intensity of pain and suffering affect the amount of compensation for the pain and suffering. Fortunately for Mr. Koonce, the duration was relatively short and the intensity was mild. Accordingly, a reasonable amount of pain and suffering for Mr. Koonce’s pain and suffering is $70,000. V. Analysis Part Two – Compensation for Bell’s Palsy Both parties agree that the only reasoned decision awarding pain and suffering to a vaccinee who suffered Bell’s palsy is Sturdevant v. Sec’y of Health & Hum. Servs., No. 17-172V, 2024 WL 1045145 (Fed. Cl. Spec. Mstr. Feb. 12, 2024), mot. for rev. denied, 2024 WL 2755121 (Fed. Cl. May 3, 2024). See Pet’r’s Br. at 8; Resp’t’s Resp. at 15. However, Sturdevant tends to show an upper bound as Mr. Koonce concedes that he had “a more mild case of Bell’s palsy than the petitioner in Sturdevant.” Pet’r’s Br. at 9; accord Resp’t’s Resp. at 15. The acute portion of Mr. Koonce’s Bell’s palsy was relatively short. After receiving the flu vaccination on October 17, 2018, Mr. Koonce developed numbness in his face and left facial droop, starting November 7, 2018. Exhibit 3 at 57. Approximately two weeks later, after a course of medication, Mr. Koonce’s symptoms were significantly improved. Id. at 31 (Nov. 20, 2018). During the treatment for Guillain-Barré syndrome, Dr. Khoury stated Mr. Koonce’s “Bell[’s] palsy is gone.” Exhibit 5 at 7 (April 1, 2019). Under this chronology, the Secretary had a fair argument that Mr. Koonce was not entitled to compensation for the Bell’s palsy because it did not last longer than six months. See 42 U.S.C. § 300aa–11(c)(1)(D). However, on June 21, 2019, Dr. Lancaster detected “subtle synkinesis” on the left side of Mr. Koonce’s face upon examination. Exhibit 6 at 12. Dr. Lancaster’s observation stands in contrast with Mr. Koonce’s own experience as he informed Dr. Lancaster that he (Mr. Koonce) could “not see any difference” in his face. Id. 8 Case 1:21-vv-01560-UNJ Document 68 Filed 07/29/24 Page 9 of 10 Mr. Koonce lack of complaint to Dr. Lancaster about a distortion in his face is a foundation for the Secretary’s argument that the compensation should be reduced due to Mr. Koonce’s lack of awareness any distortion. Resp’t’s Resp. at 12-13. Mr. Koonce appears to overlook this argument. See Pet’r’s Reply at 2 (asserting that the Secretary “seems to not give any thoughts on the pain and suffering award for Petitioner’s Bell’s palsy diagnosis”). Under these circumstances, an appropriate amount of compensation for Mr. Koonce’s pain and suffering due to his Bell’s palsy is $27,000. VI. Additional Undisputed Items and Summary Besides seeking compensation for pain and suffering, Mr. Koonce seeks compensation for his lost earnings and for unreimbursed expenses. The parties agreed to compensation in the amount of $10,494.43 for lost earnings and $119.60 for out-of-pocket medical expenses. Accordingly, Mr. Koonce is awarded the following: Item Amount Compensation for pain and suffering associated with Guillain- $70,000.00 Barré syndrome: Compensation for pain and suffering associated with Bell’s $27,000.00 palsy Lost earnings $10,494.43 Unreimbursed expenses $119.60 TOTAL $107,614.03 9 Case 1:21-vv-01560-UNJ Document 68 Filed 07/29/24 Page 10 of 10 VII. Conclusion Mr. Koonce previously established that he is entitled to compensation. The evidence shows that a reasonable amount of compensation is $107,614.03. This amount shall be payable in a lump sum in the form of a check payable to petitioner. This amount constitutes compensation for all items listed in 42 U.S.C. § 300aa–15(a). The Clerk's Office is instructed to enter judgment in accord with this decision unless a motion for review is filed. Information about filing a motion for review, including the deadline, can be found in the Vaccine Rules, which are available on the website for the Court of Federal Claims. IT IS SO ORDERED. s/Christian J. Moran Christian J. Moran Special Master 10 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_21-vv-01560-cl-extra-10823306 Date issued/filed: 2025-03-14 Pages: 1 Docket text: Supplementary opinion from CourtListener cluster 10356718 -------------------------------------------------------------------------------- In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS ********************** ERIK KOONCE, * * No. 21-1560V Petitioner, * Special Master Christian J. Moran * v. * * Filed: February 20, 2025 SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * ********************** Laura J. Levenberg, Muller Brazil, Dresher, PA, for petitioner; Sarah B. Rifkin, United States Dep’t of Justice, Washington, DC, for respondent. UNPUBLISHED DECISION AWARDING ATTORNEYS’ FEES AND COSTS1 Pursuant to 42 U.S.C. § 300aa-15(e), petitioner has requested a total of $53,325.29 in attorneys’ fees and costs. The undersigned tentatively found that petitioner requested a reasonable amount and was entitled to the full amount requested. The undersigned allowed respondent an opportunity to comment. Respondent did not interpose any objections within the time permitted. 1 Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the parties have 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. Any changes will appear in the document posted on the website. Petitioner’s attorney, attorney staff, and expert have requested hourly rates that are consistent with the rates previously awarded and/or reasonable. The number of hours is reasonable. Thus, the amount requested is reasonable. Petitioner is awarded 53,325.29 to be paid through an ACH deposit to petitioner’s counsel’s IOLTA account for prompt disbursement. 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. 2 IT IS SO ORDERED. s/Christian J. Moran Christian J. Moran Special Master 2 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their right to seek review. 2