{"package_id":"USCOURTS-cofc-1_08-vv-00650","decision_granule_id":"USCOURTS-cofc-1_08-vv-00650-1","petitioner_identifier":"I.R.","is_minor":1,"age_at_vaccination":1.0,"age_unit_raw":"years","vaccine_type":"ProQuad","vaccination_date":"2005-12-30","condition_raw":"significant aggravation of a mitochondrial disorder","condition_category":"developmental_delay_regression","autism_spectrum_adjacent":1,"outcome":"denied","award_amount_usd":null,"decision_date":"2018-12-04","extraction_version":"gemini-v2","extracted_at":"2026-04-30T04:35:43.795837+00:00","number_of_concurrent_vaccines":1,"dose_number":1,"time_to_onset_days":9,"theory_of_causation":"ProQuad (MMRV) + COMVAX (Hib+HepB) vaccines administered on December 30, 2005 (12-month visit) allegedly caused significant aggravation of a pre-existing mitochondrial disorder, leading to autism spectrum disorder (ASD) and developmental regression. Petitioners' experts (Drs. Niyazov, Wilson, Zimmerman) opined that I.R. had a mitochondrial disorder, that his autism manifested post-vaccination with regression, and that vaccines could trigger mitochondrial dysfunction. Respondent's experts (Drs. Wiznitzer, Cohen, McCandless) opined that I.R. showed signs of autism prior to vaccination, that no regression occurred, and that no mitochondrial disorder or vaccine-related causation was established. Chief Special Master Dorsey found that I.R.'s autism manifested prior to vaccination, based on retrospective video analysis by Dr. Wiznitzer, and that no regression occurred, as indicated by contemporaneous medical records. The Special Master also found no evidence of immune suppression or mitochondrial disorder, citing normal muscle biopsy results, the heterozygous nature of the POLG mutation, and the lack of supporting clinical and biochemical evidence. The petition was denied on all grounds, failing to meet the Althen and Loving standards. Attorneys for petitioners: Anne C. Toale. Attorney for respondent: Ryan D. Pyles. Decision date: December 4, 2018. Outcome: Denied.","is_death":0,"date_of_death":null,"petition_filed_date":"2008-09-15","case_summary":"On September 15, 2008, Eric and Jeanna Reed filed a petition under the National Vaccine Injury Compensation Program on behalf of their minor child, I.R. The petition alleged that I.R. suffered a significant aggravation of a mitochondrial disorder due to the ProQuad vaccine administered on December 30, 2005, which led to autism spectrum disorder. The petition was initially part of the Omnibus Autism Proceeding. After the test cases in that proceeding were rejected, the Reeds filed an amended petition, and later a second amended petition, refining their theory to focus on the significant aggravation of a mitochondrial disorder. An entitlement hearing was held, and on December 4, 2018, Chief Special Master Nora Beth Dorsey issued a decision denying the petition.\n\nI.R. was born on December 29, 2004. His early life was marked by frequent illnesses, including colic, gastroesophageal reflux, and respiratory colds. On December 30, 2005, at one year of age, I.R. received the ProQuad (measles, mumps, rubella, varicella) and COMVAX (Haemophilus influenzae type B and hepatitis B) vaccines. Approximately one week later, I.R. developed a fever and rash, which his pediatrician attributed to a normal reaction to the ProQuad vaccine. Following this, I.R. experienced a series of illnesses, including roseola, pityriasis rosea, and ear infections, leading to the insertion of ear tubes in May 2006. Despite these issues, I.R.'s 15-month and 18-month well-child visits noted him as healthy with no developmental concerns. The first documented developmental concern, a speech delay, was noted at I.R.'s 27-month visit in March 2007. Subsequent evaluations described a \"lack of progression\" rather than regression, and I.R. was diagnosed with autistic disorder in October 2007, later revised to PDD-NOS, reflecting developmental progress. \n\nPetitioners presented expert testimony from Dr. Dmitriy Niyazov, who opined that I.R. had a mitochondrial disorder exacerbated by vaccines; Dr. Kaitlyn Wilson, who conducted a retrospective video analysis and found autism markers appearing after vaccination; and Dr. Andrew Zimmerman, a pediatric neurologist who supported the causation theory. Petitioners also cited a POLG gene test showing a \"predicted deleterious\" mutation and a Morava criteria score of 7, suggesting a \"probable\" mitochondrial disorder.\n\nRespondent's experts, Dr. Max Wiznitzer and Dr. Bruce Cohen, presented a different view. Dr. Wiznitzer's retrospective video analysis identified signs of autism in I.R.'s videos from before the December 2005 vaccination, including hyporesponsiveness to pain. He found Dr. Wilson's analysis less persuasive, particularly regarding the timing of I.R.'s developmental issues. Dr. Cohen and Dr. Shawn McCandless, both experts in mitochondrial disorders, disputed the existence of a mitochondrial disorder in I.R., citing normal muscle biopsy results, the heterozygous nature of the POLG mutation, and the lack of other clinical indicators. They also disputed the theory that vaccines cause mitochondrial dysfunction leading to autism.\n\nChief Special Master Dorsey found that I.R.'s autism manifested prior to vaccination, based on Dr. Wiznitzer's analysis of home videos, which identified early signs of autism, including hyporesponsiveness to pain, that Dr. Wilson had not adequately accounted for. The Special Master also found no evidence of true regression, noting that contemporaneous medical records consistently described a \"lack of progression.\" Furthermore, the Special Master found no evidence of immune suppression or dysfunction, nor a mitochondrial disorder or dysfunction. The POLG mutation was deemed not disease-causing in its heterozygous state, and other biochemical and clinical findings were not considered sufficient to diagnose a mitochondrial disorder. The medical literature cited by petitioners did not establish a causal link between mitochondrial dysfunction and autism, or between vaccination and autism. \n\nOn December 4, 2018, Chief Special Master Dorsey issued a 131-page decision denying the petition, finding that petitioners failed to establish causation under the Althen standard and the Loving \"significant aggravation\" framework. The petition was dismissed without compensation.","is_minor_inferred":1,"is_pediatric_broad":1,"special_master":"Nora Beth Dorsey","petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":"Anne Carrion Toale","petitioner_attorney_firm":"Maglio, Christopher & Toale; Maglio Christopher and Toale","petitioner_attorney_location":"Sarasota, FL","adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":"|anne-toale|","firm_canonical_key":"maglio-christopher-and-toale","package_title":"REED et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_08-vv-00650","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_08-vv-00650.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_08-vv-00650.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_08-vv-00650-0","title":"REED et al v. 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(am) Service on parties made.","date_issued":"2019-01-02","pdf_url":"https://api.govinfo.gov/packages/USCOURTS-cofc-1_08-vv-00650/granules/USCOURTS-cofc-1_08-vv-00650-1/pdf","pdf_bytes":1168959,"triage_decision":"keep","triage_reason":"docketText matches keep keyword 'decision of special master'","download_status":"ok","registry_pdf_url":"https://vicp-registry.org/pdf/USCOURTS-cofc-1_08-vv-00650/USCOURTS-cofc-1_08-vv-00650-1"},{"granule_id":"USCOURTS-cofc-1_08-vv-00650-2","title":"REED et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 05/21/2019) regarding 212 DECISION of Special Master - Fees. Signed by Chief Special Master Nora Beth Dorsey. (am) Service on parties made.","date_issued":"2019-06-17","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"fees-only decision (attorney compensation)","download_status":"skipped"}]}