VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-01467 Package ID: USCOURTS-cofc-1_15-vv-01467 Petitioner: Nyasha Walrond Filed: 2015-12-03 Decided: 2019-05-13 Vaccine: influenza Vaccination date: 2015-02-06 Condition: Guillain-Barré Syndrome (GBS) Outcome: dismissed Award amount USD: AI-assisted case summary: On December 3, 2015, Nyasha Walrond filed a petition alleging that she developed Guillain-Barré Syndrome (GBS) as a result of receiving an influenza vaccine on February 6, 2015. The respondent is the Secretary of Health and Human Services. Petitioner filed a statement of completion on April 8, 2016. The respondent initially indicated an intent to defend against the claim. Petitioner filed an expert report by Dr. Edwin Forman and supporting literature on March 24, 2017, and April 6, 2017, respectively. The respondent filed an expert report by Dr. Peter Bingham and a Rule 4(c) report on June 14, 2017. During a status conference on July 14, 2017, it was noted that medical records indicated the petitioner had positive Epstein Barr Virus (EBV) IgG and IgM tests between the time of vaccination and the GBS diagnosis. The petitioner was given an opportunity to file a responsive expert report, which she did on October 26, 2017, by Dr. Forman. The respondent then submitted a supplemental report by Dr. Hayley Gans. After further proceedings, including an informal attempt to resolve the case which reached an impasse in November 2018, a status conference was held on February 27, 2019. During this conference, Special Master Thomas L. Gowen indicated that the respondent's presented alternative cause (EBV) was not speculative, noting the documented occurrence of EBV and its temporal relationship with the GBS onset made it a more likely cause than the vaccination. Special Master Gowen recommended petitioner's counsel discuss the path forward with the client. On April 8, 2019, petitioner filed a motion to dismiss her claim, stating that an investigation of the facts and science supporting her case demonstrated she would be unable to prove entitlement to compensation. The petition did not allege a "Table injury." To prevail, petitioner needed to establish actual causation, requiring a medical theory, a logical sequence of cause and effect, and a medically acceptable temporal relationship between the vaccination and the injury, as outlined in Althen v. Sec’y of Health & Human Servs. The Special Master noted that the petitioner was ill with EBV between vaccination and GBS diagnosis, with elevated EBV IgM documenting the current nature of the infection. The Special Master found it more likely that the GBS occurred as a sequela of the EBV rather than the influenza vaccine. Finding insufficient evidence in the record for the petitioner to meet her burden, the Special Master dismissed the petition for insufficient proof. The Clerk of the Court was directed to enter judgment accordingly. Petitioner's counsel was Diana L. Stadelnikas. Respondent's counsel was Debra A. Begley. Special Master was Thomas L. Gowen. Theory of causation field: Petitioner Nyasha Walrond alleged Guillain-Barré Syndrome (GBS) following an influenza vaccine on February 6, 2015. This was an off-Table claim requiring proof of actual causation. Petitioner was represented by Diana L. Stadelnikas, and respondent was the Secretary of Health and Human Services, represented by Debra A. Begley. Petitioner filed expert reports from Dr. Edwin Forman and later Dr. Forman again. Respondent filed expert reports from Dr. Peter Bingham and Dr. Hayley Gans. Medical records showed positive Epstein Barr Virus (EBV) IgG and IgM tests between vaccination and GBS onset. Special Master Thomas L. Gowen noted the EBV infection and its temporal relationship to GBS made it a more likely cause than the vaccine. Petitioner subsequently filed a motion to dismiss her claim, conceding inability to prove entitlement. The Special Master found insufficient evidence to establish the vaccine caused the GBS, concluding EBV was the more likely cause, and dismissed the petition for insufficient proof on May 13, 2019. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_15-vv-01467-0 Date issued/filed: 2019-05-13 Pages: 3 Docket text: PUBLIC DECISION (Originally filed: 04/15/2019) regarding 77 DECISION of Special Master Signed by Special Master Thomas L. Gowen. (hs) Service on parties made. -------------------------------------------------------------------------------- Case 1:15-vv-01467-UNJ Document 78 Filed 05/13/19 Page 1 of 3 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: April 15, 2019 * * * * * * * * * * * * * NYASHA WALROND, * UNPUBLISHED * Petitioner, * No. 15-1467V * v. * Special Master Gowen * SECRETARY OF HEALTH * AND HUMAN SERVICES, * Denial Without Hearing; * Dismissal of Petition; * Petitioner’s Motion for Decision Respondent. * * * * * * * * * * * * * * * Diana L. Stadelnikas¸ Maglio Christopher and Toale, Sarasota, FL, for petitioner. Debra A. Begley, Department of Justice, Washington, D.C., for respondent. DECISION DISMISSING PETITION1 On December 3, 2015, Nyasha Walrond (“petitioner”) filed a petition in the National Vaccine Injury Compensation Program (“Vaccine Program”).2 Petitioner alleged that she developed Guillain-Barré Syndrome (“GBS”) as a result of receiving an influenza vaccine on February 6, 2015. Petition at ¶¶ 2 & 5. Petitioner filed a statement of completion on April 8, 2016. ECF No. 18. After an initial status conference on April 14, 2016, respondent filed a status report indicating he intended to defend against this claim. Respondent (“Resp.”) Status Report (ECF No. 20). 1 Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this decision contains a reasoned explanation for the action in this case, I intend to post it on the website of the United States Court of Federal Claims. The court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. Before the decision is posted on the court’s website, each party has 14 days to file a motion requesting redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). “An objecting party must provide the court with a proposed redacted version of the decision.” Id. If neither party files a motion for redaction within 14 days, the decision will be posted on the court’s website without any changes. Id. 2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended at 42 U.S.C. §§300aa-10 et seq. (hereinafter “Vaccine Act” or “the Act”). Hereafter, individual section references will be to 42 U.S.C. §300aa of the Act. Case 1:15-vv-01467-UNJ Document 78 Filed 05/13/19 Page 2 of 3 Petitioner filed an expert report by Dr. Edwin Forman on March 24, 2017 and supporting literature on April 6, 2017. See Petitioner (“Pet.”) Notice of Filing Expert Report (ECF No.35) & Medical Literature (“Lit.”) (ECF No. 36). On June 14, 2017 respondent filed an expert report by Dr. Peter Bingham and the Rule 4(c) report. See Resp. Notice of Filing Expert Report (ECF No. 39) & Resp. Report (ECF No. 40). The undersigned held a Rule 5 Status Conference on July 14, 2017. See Scheduling Order, issued July 14, 2017 (ECF No. 41). During the Rule 5 status conference, I observed that the medical records indicated that petitioner had positive Epstein Barr Virus (“EBV”) IgG and IgM tests between the time she received the flu vaccine and the time she was diagnosed with GBS. Id. The undersigned gave petitioner the opportunity to file a responsive expert report. On October 26, 2017, petitioner submitted an additional expert report by Dr. Forman. ECF No. 46. Respondent then submitted a supplemental report by Dr. Hayley Gans. Resp. Notice of Filing Expert Report (ECF No. 51). After another status conference held on March 28, 2018, the parties attempted to resolve this case informally, but reached an impasse in November 2018. Resp. Status Report (ECF No. 66). Respondent requested a status conference to determine how to proceed. Id. As requested by respondent, the undersigned held a status conference on February 27, 2019. Scheduling Order (ECF No. 68). During the status conference, I indicated that respondent’s alternative cause was not speculative. The well documented occurrence of EBV in the records and the temporal relationship with the onset of petitioner’s GBS tends to make the alternative cause more likely than the more remote immunization. I recommended petitioner’s counsel discuss with her client on how to proceed. Id. On April 8, 2019, petitioner filed the present motion to dismiss her claim, indicating that “an investigation of the facts and science supporting her case has demonstrated to petitioner that she will be unable to prove that she is entitled to compensation in the Vaccine Program.” Motion for a Decision Dismissing Petition (ECF No. 75). A petitioner must establish entitlement to compensation in the Vaccine Program through one of two ways. The first way is to establish that he or she suffered a “Table injury,” i.e., that he or she received a vaccine listed on the Vaccine Injury Table and subsequently developed a corresponding injury within a corresponding period of time. § 300aa-11(c)(1). The second way is to establish that the vaccine actually caused the onset or significant aggravation of a condition in the vaccinee. § 300aa-13(a)(1)(A). To prove actual causation, petitioner must present: (1) a medical theory; (2) a logical sequence of cause and effect; and (3) a medically acceptable temporal relationship between the vaccination and the injury. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). In the present cast, petitioner does not allege a Table injury. Thus, to prevail on entitlement, petitioner must establish that the flu vaccine she received is the actual cause of her injuries. Under the Vaccine Act, a petitioner may not be awarded compensation based solely on the petitioner's claims. Rather, the petition must be supported by either medical records or by the opinion of a competent physician. § 300aa-13(a)(1). As discussed above, petitioner was quite ill with EBV in the intervening time between the 2 Case 1:15-vv-01467-UNJ Document 78 Filed 05/13/19 Page 3 of 3 vaccination and the diagnosis of GBS. See Pet. Ex. 2 at 533. The presence of elevated EBV IgM documented the current nature of that infection. Thus, it appears more likely that petitioner’s GBS occurred as a sequela of the EBV rather than the influenza vaccine. In this case, there is insufficient evidence in the record for petitioner to meet her burden under the Act or Althen. Petitioner’s claim therefore cannot succeed and in accordance with her motion, must be dismissed for insufficient proof. Thus, this case is dismissed for insufficient proof. The Clerk of the Court shall enter judgment accordingly. IT IS SO ORDERED. s/Thomas L. Gowen Thomas L. Gowen Special Master 3