VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_13-vv-00677 Package ID: USCOURTS-cofc-1_13-vv-00677 Petitioner: MWS Filed: 2013-09-13 Decided: 2016-04-05 Vaccine: DTap Vaccination date: 2010-09-17 Condition: acute encephalopathy, seizure disorder, ataxia, apraxia, dysarthria, autism-like symptoms, developmental regression and delay, and other neurological conditions Outcome: dismissed Award amount USD: AI-assisted case summary: On September 13, 2013, Donna and Brian Smith, parents of a minor child identified as MWS, filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986. They alleged that Diphtheria, Tetanus, Pertussis (DTap), Haemophilus Influenzae Type B (Hib), Inactivated Polio (IPV), and Pneumococcal Conjugate (PCV) vaccinations administered on September 17, 2010, and Hepatitis A (Hep A) and seasonal influenza (Flu) vaccinations administered on December 17, 2010, caused MWS to suffer from an acute encephalopathy. The alleged resulting symptoms included a seizure disorder, ataxia, apraxia, dysarthria, autism-like symptoms, developmental regression and delay, and other neurological conditions. Petitioners also alternatively alleged that the September 17, 2010 vaccinations caused MWS to develop cerebral folate deficiency, an autoimmune injury, or aggravated a pre-existing condition, such as a metabolic disorder or mild speech delay, leading to marked developmental regression. After an investigation, the petitioners concluded they could not prove entitlement to compensation and filed a motion to dismiss their own petition on March 9, 2016. Special Master Lisa Hamilton-Fieldman noted that to receive compensation, a petitioner must prove either a "Table Injury" corresponding to a vaccination or that an injury was actually caused by a vaccine. The record did not contain evidence of a Table Injury, nor did it include a medical expert's opinion or other persuasive evidence indicating that MWS's injuries were caused by the vaccinations. The Special Master found the medical records insufficient to establish entitlement and that no medical opinion had been offered in support. Consequently, the petition was dismissed for insufficient proof on April 5, 2016. Theory of causation field: Petitioners alleged that DTap, Hib, IPV, and PCV vaccines administered on September 17, 2010, and Hep A and Flu vaccines administered on December 17, 2010, caused MWS to suffer an acute encephalopathy, resulting in seizure disorder, ataxia, apraxia, dysarthria, autism-like symptoms, developmental regression and delay, and other neurological conditions. Alternative theories included vaccine-induced cerebral folate deficiency, autoimmune injury, or aggravation of a pre-existing condition (metabolic disorder or mild speech delay) leading to developmental regression. The Special Master found no evidence of a "Table Injury" and no persuasive medical evidence or expert opinion establishing that the vaccines caused MWS's alleged injuries. The petition was dismissed for insufficient proof. Attorneys for petitioners were Robert Krakow, Law Office of Robert J. Krakow, P.C. Attorney for respondent was Linda Renzi, United States Department of Justice. Special Master was Lisa Hamilton-Fieldman. Decision date was April 5, 2016. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_13-vv-00677-0 Date issued/filed: 2016-04-05 Pages: 3 Docket text: PUBLIC DECISION (Originally filed: 03/09/2016) regarding 53 DECISION of Special Master. Signed by Special Master Lisa Hamilton-Fieldman. (jb) Copy to parties. -------------------------------------------------------------------------------- Case 1:13-vv-00677-UNJ Document 54 Filed 04/05/16 Page 1 of 3 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 13-677 Filed: March 9, 2016 * * * * * * * * * * * * * * * * * * * * * * * * * UNPUBLISHED DONNA SMITH and BRIAN SMITH, * Parents of MWS, a minor, * * Special Master Hamilton-Fieldman Petitioners, * * v. * Petitioners’ Motion for Dismissal * Decision; Diphtheria, Tetanus, SECRETARY OF HEALTH * Pertussis (“DTap”), Haemophilus AND HUMAN SERVICES, * Influenzae Type B (“Hib”), * Inactivated Polio (“IPV”), Respondent. * Pneumococcal Conjugate (“PCV”), * Hepatitis A (“Hep A”), Influenza * * * * * * * * * * * * * * * * * * * * * * * * * (“Flu”) Vaccinations; Acute Encephalopathy; Chronic Encephalopathy; Seizure Disorder; Neurological Conditions; Speech Delay; Developmental Regression, Autism-like Symptoms. Robert Krakow, Law Office of Robert J. Krakow, P.C., New York, NY, for Petitioners Linda Renzi, United States Department of Justice, Washington, DC, for Respondent. DECISION1 On September 13, 2013, Donna and Brian Smith (“Petitioners”) filed a petition, on behalf of their minor child MWS, for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 et seq. (2006) (“Vaccine Act”). In an amended Petition filed on November 20, 2015, Petitioners alleged that the Diphtheria, Tetanus, Pertussis (“DTap”), Haemophilus Influenzae Type B (“Hib”), Inactivated Polio (“IPV”), and Pneumococcal 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, codified as amended at 44 U.S.C. § 3501 and note (2012). In accordance with Vaccine Rule 18(b), a party 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, the undersigned agrees that the identified material fits within the requirements of that provision, such material will be deleted from public access. Case 1:13-vv-00677-UNJ Document 54 Filed 04/05/16 Page 2 of 3 Conjugate (“PCV”) vaccinations administered to MWS on September 17, 2010, and the Hepatitis A (“Hep A”) and seasonal influenza (“flu”) vaccinations administered to MWS on December 17, 2010, caused him to suffer from “an acute encephalopathy” either as a Table injury or caused-in- fact by the vaccines, that resulted in symptoms including a seizure disorder, ataxia, apraxia, dysarthria, autism-like symptoms, developmental regression and delay, and “other neurological conditions.” Amended Petition (“Amend. Pet.”) at 1-6. Alternatively, Petitioners’ Amended Petition alleged that the September 17, 2010 vaccinations caused MWS to develop cerebral folate deficiency, “an autoimmune injury,” “manifesting as the symptoms of developmental and behavioral regression.” Id. at 4-5. As an additional alternative theory, Petitioners alleged that the vaccinations “significantly aggravated [MWS’] preexisting condition, to wit: a metabolic disorder” or a “mild speech delay” resulting in “a marked developmental regression that occurred shortly after the vaccines were administered and was caused by them.” Id. at 5. The undersigned now finds that the information in the record does not show entitlement to an award under the Program. On March 9, 2016, Petitioners filed a Motion for a decision dismissing the petition. According to the Motion, “[a]n investigation of the facts and available science supporting petitioners’ case has demonstrated to petitioners that they will be unable to prove that they are entitled to compensation in the Vaccine Injury Compensation Program (“VICP”).” Motion, at 1. Petitioners further state that they understand that a dismissal decision will result in a judgment against them, and that such a judgment will end all of their rights in the Vaccine Program. To receive compensation under the Vaccine Act, Petitioner must prove either 1) that he suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table – corresponding to one of his vaccinations, or 2) that he suffered an injury that was actually caused by a vaccine. See §§ 300aa-13(a)(1)(A) and 300aa-11(c)(1). An examination of the record did not uncover any evidence that MWS suffered a “Table Injury.” Further, the record does not contain a medical expert’s opinion or any other persuasive evidence indicating that his injuries were caused by vaccinations. Under the Vaccine Act, a petitioner may not be awarded compensation based on the petitioner’s claims alone. Rather, the petition must be supported by either medical records or by the opinion of a competent physician. § 300aa-13(a)(1). In this case, because the medical records are insufficient to establish entitlement to compensation, a medical opinion must be offered in support. Petitioners, however, have offered no such opinion. 2 Case 1:13-vv-00677-UNJ Document 54 Filed 04/05/16 Page 3 of 3 Therefore, the only alternative remains to DENY this petition. Thus, this case is dismissed for insufficient proof. In the absence of a motion for review, the Clerk shall enter judgment accordingly. IT IS SO ORDERED. s/Lisa D. Hamilton-Fieldman Lisa D. Hamilton-Fieldman Special Master 3