VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-00630 Package ID: USCOURTS-cofc-1_15-vv-00630 Petitioner: C.B. Filed: 2015-05-23 Decided: 2016-06-16 Vaccine: Gardasil Vaccination date: 2012-06-20 Condition: irregular heart rate and syncopy, adrenal gland insufficiency, autonomic dysfunction, chronic nausea, hand and foot tremors, hand discoloration, anxiety, headaches, and depression Outcome: dismissed Award amount USD: AI-assisted case summary: Wendy Early filed a petition on May 23, 2015, on behalf of her minor child, C.B., alleging that a Gardasil vaccination received on June 20, 2012, caused C.B. to suffer from irregular heart rate and syncope, adrenal gland insufficiency, autonomic dysfunction, chronic nausea, hand and foot tremors, hand discoloration, anxiety, headaches, and depression. The Special Master's decision notes that the information in the record did not show entitlement to an award under the National Vaccine Injury Compensation Program. On May 23, 2016, the petitioner moved to dismiss the petition, stating that an investigation demonstrated an inability to prove entitlement to compensation. To receive compensation, a petitioner must prove either a "Table Injury" corresponding to the vaccination or that the vaccination actually caused the alleged injuries. The record did not contain evidence of a "Table Injury," nor did it contain persuasive evidence that the Gardasil vaccine caused C.B.'s alleged injuries. The decision emphasizes that claims cannot be based solely on the petitioner's assertions but must be supported by medical records or a competent physician's opinion, neither of which were sufficiently provided in this case. Consequently, the case was dismissed for insufficient proof. The Special Master was Thomas L. Gowen. Petitioner's counsel was Larry D. Wright. Respondent's counsel was Debra A. Filteau Begley. The decision was issued on June 16, 2016. Theory of causation field: Petitioner C.B. received a Gardasil vaccination on June 20, 2012. The petition alleged that this vaccination caused irregular heart rate and syncope, adrenal gland insufficiency, autonomic dysfunction, chronic nausea, hand and foot tremors, hand discoloration, anxiety, headaches, and depression. The case was dismissed on June 16, 2016, by Special Master Thomas L. Gowen, upon petitioner's motion to dismiss due to an inability to prove entitlement. The dismissal was based on the lack of evidence of a "Table Injury" and insufficient proof that the Gardasil vaccine actually caused the alleged injuries. The public decision does not describe the specific mechanism of causation, name any medical experts, or detail the evidence presented. Petitioner's counsel was Larry D. Wright, and respondent's counsel was Debra A. Filteau Begley. The award amount was $0 as the case was dismissed. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_15-vv-00630-0 Date issued/filed: 2016-06-16 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 05/23/2016) regarding 22 DECISION of Special Master (Signed by Special Master Thomas L. Gowen.)(mpj) Copy to parties. -------------------------------------------------------------------------------- Case 1:15-vv-00630-UNJ Document 23 Filed 06/16/16 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 15-630V Filed: May 23, 2016 [Not to be published] * * * * * * * * * * * * * * * * * * * * * WENDY EARLY, on behalf of * minor child, C.B., * * Petitioner, * Dismissal; Gardasil; v. * Autonomic Dysfunction; Syncopy; * Adrenal Gland Insufficiency; * Irregular Heart Rate; Headaches; SECRETARY OF HEALTH * Chronic Nausea; Depression; AND HUMAN SERVICES, * Hand and Foot Tremors; Anxiety. * Respondent. * * * * * * * * * * * * * * * * * * * * * * Larry D. Wright, Wright & Fisher, LLC, Kansas City, MO, for petitioner. Debra A. Filteau Begley, United States Department of Justice, Washington, DC for respondent. DECISION1 Gowen, Special Master: On June 19, 2015, petitioner filed a petition on behalf of her minor child, C.B., for compensation in the National Vaccine Injury Compensation Program [“the Program”],2 alleging that a Gardasil vaccination received on June 20, 2012, caused C.B. to suffer irregular heart rate and syncopy, adrenal gland insufficiency, autonomic dysfunction, chronic nausea, hand and foot tremors, hand discoloration, anxiety, headaches, and depression. Petition at Preamble, filed June 1 Because this unpublished decision contains a reasoned explanation for the action in this case, the undersigned intends to post this decision 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). In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to delete medical or other information, that satisfies the criteria in § 300aa-12(d)(4)(B). Further, consistent with the rule requirement, a motion for redaction must include a proposed redacted decision. If, upon review, I agree that the identified material fits within the requirements of that provision, I will delete such material from public access. 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, 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. 1 Case 1:15-vv-00630-UNJ Document 23 Filed 06/16/16 Page 2 of 2 19, 2015. The information in the record, however, does not show entitlement to an award under the Program. On May 23, 2016, petitioner moved for a decision dismissing this petition, stating that “[a]n investigation of the facts and science supporting Petitioner’s claim has demonstrated that Petitioner will be unable to prove she is entitled to compensation in the Vaccine Program.” Motion Dismissing the Petition at ¶ 1, filed May 23, 2016. To receive compensation under the Program, petitioner must prove either (1) that C.B. suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—corresponding to the vaccination, or (2) that C.B. suffered an injury that was actually caused by the vaccination. See §§ 13(a)(1)(A) and 11(c)(1). An examination of the record did not uncover any evidence that C.B. suffered a “Table Injury.” Further, the record does not contain persuasive evidence indicating that C.B.’s alleged injuries was caused by the Gardasil vaccine. Under the Act, petitioner may not be given a Program award based solely on the petitioner’s claims alone. Rather, the petition must be supported by either medical records or by the opinion of a competent physician. § 13(a)(1). In this case, because there are insufficient medical records supporting petitioner’s claim, a medical opinion must be offered in support. Petitioner, however, has offered no such opinion that supports a finding of entitlement. Accordingly, it is clear from the record in this case that petitioner has failed to demonstrate either that C.B. suffered a “Table Injury” or that the injuries were “actually caused” by the Gardasil vaccination. Thus, this case is dismissed for insufficient proof. The Clerk shall enter judgment accordingly. IT IS SO ORDERED. / Thomas L. Gowen Thomas L. Gowen Special Master 2