{"package_id":"USCOURTS-cofc-1_04-vv-01041","decision_granule_id":"USCOURTS-cofc-1_04-vv-01041-cl6661302","petitioner_identifier":"Amelia Stone","is_minor":1,"age_at_vaccination":0.33,"age_unit_raw":"years","vaccine_type":"DTaP","vaccination_date":null,"condition_raw":"Severe Myoe-elonic Epilepsy of Infancy (SMEI), also known as Dravet Syndrome","condition_category":"seizure_disorder","autism_spectrum_adjacent":1,"outcome":"unclear","award_amount_usd":null,"decision_date":"2010-05-17","extraction_version":"gemini-v2","extracted_at":"2026-04-30T14:30:31.940646+00:00","number_of_concurrent_vaccines":null,"dose_number":1,"time_to_onset_days":null,"theory_of_causation":"Petitioners alleged that the DTaP vaccination administered to Amelia Stone at approximately four months of age caused her Severe Myoclonic Epilepsy of Infancy (SMEI), also known as Dravet Syndrome. Petitioners' expert, Dr. Marcel Kinsbourne, initially supported this theory, stating the DTaP vaccination caused the SMEI. After new genetic research emerged, it was discovered that SMEI is caused by mutations in the SCN1A gene. Amelia tested positive for this mutation. Respondent's expert, Dr. Gerald Raymond, testified that the SCN1A gene mutation was the sole cause of Amelia's SMEI. Dr. Kinsbourne maintained that the DTaP vaccination triggered the seizure and lowered Amelia's seizure threshold. Special Master Golkiewicz found that the SCN1A gene mutation was a 'but for' and 'substantial factor' in causing Amelia's SMEI, denying compensation. The Court of Federal Claims, in reviewing the Special Master's decision, found that the Special Master applied an incorrect legal standard. The Court remanded the case, holding that the respondent must prove an unrelated factor, such as the SCN1A gene mutation, was the 'sole substantial factor' or 'principally responsible' for the injury, a higher burden than proving it was merely a 'but for' or 'substantial factor.' The Court noted that genetic mutations, even if not explicitly listed in the statute, can qualify as unrelated factors if they meet the 'principally responsible' standard. The case was remanded for application of the correct legal standard.","is_death":0,"date_of_death":null,"petition_filed_date":"2010-10-28","case_summary":"Petitioners Jennifer and Gary Stone filed a claim under the National Vaccine Injury Compensation Program on behalf of their daughter, Amelia Stone, who suffers from Severe Myoclonic Epilepsy of Infancy (SMEI), also known as Dravet Syndrome. SMEI is described as an epilepsy syndrome beginning in the first year of life in previously healthy children, resulting in long-lasting seizures associated with fever. Amelia received a DTaP vaccination approximately four months after her birth. Petitioners alleged this vaccination caused her SMEI. At an initial hearing, petitioners' expert, Dr. Marcel Kinsbourne, testified that the DTaP vaccination caused Amelia's SMEI. Respondent's expert, Dr. Michael Kohrman, testified that a genetic predisposition, such as a Chromosome 20 duplication, caused Amelia's SMEI. The Special Master initially found no reliable evidence that factors unrelated to the vaccination caused Amelia's seizure disorder. Subsequently, new genetic research indicated that SMEI is caused by mutations in the Sodium Channel 1α subunit gene (SCN1A). Amelia tested positive for this mutation. A second hearing was held. Respondent's genetics expert, Dr. Gerald Raymond, testified that Amelia's SCN1A gene mutation was the sole cause of her SMEI. Dr. Kinsbourne testified that while SMEI has a genetic component, the DTaP vaccination triggered the seizure and lowered Amelia's seizure threshold. Special Master Gary J. Golkiewicz denied compensation on April 15, 2010, finding that the respondent had demonstrated by a preponderance of the evidence that Amelia's SCN1A gene mutation was more likely than not the 'but for' and 'substantial factor' that caused her SMEI. The Court of Federal Claims, through Senior Judge Margolis, reviewed the Special Master's decision. The Court noted that petitioners had made a prima facie case for compensation. The burden then shifted to the respondent to prove an unrelated factor caused the injury. The Court found that the Special Master applied the incorrect legal standard. Under the Vaccine Act and precedent like de Bazan v. Sec'y of Health & Human Services, the respondent must prove that an unrelated factor was the 'sole substantial factor' or 'principally responsible' for the injury, not merely a 'but for' or 'substantial factor.' The Special Master's finding that the SCN1A mutation was a 'but for' and 'substantial factor' did not meet this higher threshold. The Court rejected respondent's argument that this was harmless error, stating that expert testimony is not a substitute for the Special Master's findings of fact. The Court also rejected respondent's argument that genetic mutations do not fall under the statutory definition of 'factors unrelated,' citing Finley v. Sec'y of Health & Human Servs., which established that the list of unrelated factors is non-exhaustive and that conditions with no known relation to the vaccine, if principally responsible, qualify. Therefore, the Court vacated the Special Master's decision and remanded the case for further proceedings consistent with the correct legal standard.","is_minor_inferred":1,"is_pediatric_broad":1,"special_master":"Laura D. Millman","petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":"Richard Gage","petitioner_attorney_firm":"Richard Gage, P.C.","petitioner_attorney_location":"Cheyenne, WY","adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":"|richard-gage|","firm_canonical_key":"richard-gage","package_title":"Stone v. Secretary of the Department of Health & Human Services","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_04-vv-01041","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_04-vv-01041.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_04-vv-01041.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_04-vv-01041-cl6661302","title":"Stone v. Secretary of the Department of Health & Human Services","docket_text":"lead-opinion","date_issued":"2010-10-28","pdf_url":"https://www.courtlistener.com/opinion/6777820/stone-v-secretary-of-the-department-of-health-human-services/","pdf_bytes":null,"triage_decision":"keep","triage_reason":"recovered via CL opinion 6661302 (html_with_citations)","download_status":"ok","registry_pdf_url":"https://vicp-registry.org/pdf/USCOURTS-cofc-1_04-vv-01041/USCOURTS-cofc-1_04-vv-01041-cl6661302"},{"granule_id":"USCOURTS-cofc-1_04-vv-01041-cl-extra-985647","title":"Jennifer Stone and Gary Stone, Parents and Next Friends of Amelia Stone, a Minor v. Secretary of Health and Human Services 0","docket_text":"Supplementary opinion from CourtListener cluster 985647","date_issued":"2013-06-07","pdf_url":null,"pdf_bytes":null,"triage_decision":"keep","triage_reason":"CL supplement: Jennifer Stone and Gary Stone, Parents and Next Friends of A","download_status":"ok","registry_pdf_url":"https://vicp-registry.org/pdf/USCOURTS-cofc-1_04-vv-01041/USCOURTS-cofc-1_04-vv-01041-cl-extra-985647"}]}