{"package_id":"USCOURTS-cofc-1_08-vv-00284","decision_granule_id":"USCOURTS-cofc-1_08-vv-00284-3","petitioner_identifier":"A.P.M.","is_minor":1,"age_at_vaccination":1.5,"age_unit_raw":"years","vaccine_type":"DTaP","vaccination_date":"2006-07-14","condition_raw":"autistic regression, apraxia of speech, and Autism Spectrum Disorder (ASD) features","condition_category":"ASD_autism","autism_spectrum_adjacent":1,"outcome":"denied","award_amount_usd":null,"decision_date":"2016-08-09","extraction_version":"gemini-v2","extracted_at":"2026-04-30T04:35:40.275818+00:00","number_of_concurrent_vaccines":2,"dose_number":null,"time_to_onset_days":35,"theory_of_causation":"Petitioners alleged that the DTaP vaccine administered on July 14, 2006, caused A.P.M. to develop a form of cerebral folate deficiency (CFD) or a related syndrome, leading to autistic regression, apraxia of speech, and Autism Spectrum Disorder (ASD). The proposed mechanism involved molecular mimicry, where a five-amino-acid sequence in the pertussis component of the DTaP vaccine was homologous to the human folate receptor, prompting the immune system to produce autoantibodies that blocked folate transport to the brain. This was alleged to result in a milder, undelineated syndrome characterized by elevated folate receptor blocking autoantibodies. Petitioners' expert, Dr. Yuval Shafrir, proposed this theory, acknowledging A.P.M. did not have classic CFD and that no studies linked vaccines to the production of these autoantibodies. Respondent's expert, Dr. Max Wiznitzer, countered that A.P.M.'s CSF folate levels were normal, he lacked CFD symptoms, and that bovine milk, with 90% homology to folate receptors, was a more likely trigger for autoantibodies. Dr. Wiznitzer also argued a five-amino-acid sequence was insufficient for molecular mimicry. Special Master Corcoran denied the claim, finding no evidence of CFD, that the proposed syndrome lacked medical literature support, and that all three prongs of the Althen test for causation failed. The Court of Federal Claims affirmed this decision. The theory evolved from an initial Omnibus Autism Proceeding petition to focus solely on the DTaP vaccine's role in CFD. Key failures included the lack of CFD diagnosis (normal CSF folate, absence of severe symptoms), inadequate rebuttal of bovine milk's potential role, and failure to meet the Althen prongs regarding a reliable theory, logical sequence of cause and effect, and medically acceptable temporal relationship. The autoantibody test was performed four years post-vaccination, and Dr. Frye, a treating physician, misstated test results and progressively inflated characterizations of CSF folate levels. The decision was issued by Special Master Brian H. Corcoran on August 9, 2016, and affirmed by Judge Victor J. Wolski on July 26, 2017.","is_death":0,"date_of_death":null,"petition_filed_date":"2008-04-17","case_summary":"On April 17, 2008, Tisha Mette and Ryan R. Mette, parents and natural guardians of A.P.M., a minor, filed a petition seeking compensation under the National Vaccine Injury Compensation Program. They alleged that the DTaP vaccine administered to A.P.M. on July 14, 2006, caused his autistic regression, leading to apraxia of speech and Autism Spectrum Disorder (ASD) features. The respondent, the Secretary of Health and Human Services, contested the claim. An entitlement hearing was held on July 28-29, 2015. Petitioners' counsel was Robert Joel Krakow, and respondent's counsel was Lynn Ricciardella. Special Master Brian H. Corcoran issued a decision on August 9, 2016, denying compensation. The Special Master found that petitioners failed to establish that A.P.M. suffered from any form of cerebral folate deficiency, a critical component of their causation theory. The medical records showed A.P.M.'s cerebrospinal fluid (CSF) folate levels were within the normal range, and he did not exhibit the severe clinical features of infant-onset cerebral folate deficiency. Petitioners' expert, Dr. Yuval Shafrir, conceded that A.P.M. did not have classic cerebral folate deficiency and proposed a novel, undelineated syndrome. The Special Master also found the theory unreliable, noting the lack of scientific literature linking vaccines to the production of folate receptor blocking autoantibodies and the greater homology between bovine milk proteins and folate receptors, which petitioners' own literature supported. Furthermore, the Special Master found that the Althen prongs for causation were not met: Prong One (reliable and plausible theory) failed due to Dr. Shafrir's lack of expertise in immunology and metabolic disorders, the unreliability of the proposed theory, and the contradictory evidence regarding bovine milk. Prong Two (logical sequence of cause and effect) failed because the contemporaneous medical records did not support the alleged post-vaccination reaction suggesting an autoimmune process, and the reported timing of A.P.M.'s regression varied. Prong Three (medically acceptable temporal relationship) failed because the proposed timeframe was too broad and unsupported by specific medical understanding of the alleged autoimmune process. On August 9, 2016, Special Master Corcoran denied the claim, stating, \"This is not a close case.\" Petitioners moved for review, and on July 26, 2017, Judge Victor Wolski of the Court of Federal Claims denied the motion, sustaining the Special Master's decision. An interim award for attorney's fees and costs was made on December 21, 2015, totaling $190,093.42.","is_minor_inferred":1,"is_pediatric_broad":1,"special_master":"Brian H. Corcoran","petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":"Robert Joel Krakow","petitioner_attorney_firm":"Law Office of Robert J. Krakow, P.C.","petitioner_attorney_location":"New York, NY","adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":"|robert-krakow|","firm_canonical_key":"law-office-of-robert-j-krakow","package_title":"M. et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_08-vv-00284","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_08-vv-00284.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_08-vv-00284.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_08-vv-00284-0","title":"M. et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 12/21/2015) regarding 120 DECISION Interim Fees Stipulation. Signed by Special Master Brian H. Corcoran. (ag) Copy to parties.","date_issued":"2016-01-14","pdf_url":"https://api.govinfo.gov/packages/USCOURTS-cofc-1_08-vv-00284/granules/USCOURTS-cofc-1_08-vv-00284-0/pdf","pdf_bytes":251813,"triage_decision":"keep","triage_reason":"docketText matches keep keyword 'stipulation'","download_status":"ok","registry_pdf_url":"https://vicp-registry.org/pdf/USCOURTS-cofc-1_08-vv-00284/USCOURTS-cofc-1_08-vv-00284-0"},{"granule_id":"USCOURTS-cofc-1_08-vv-00284-1","title":"M. et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"JUDGE VACCINE REPORTED OPINION re: 146 Judgment Signed by Judge Victor J. Wolski. 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