{"package_id":"USCOURTS-cofc-1_05-vv-01168","decision_granule_id":"USCOURTS-cofc-1_05-vv-01168-0","petitioner_identifier":"M.B.","is_minor":1,"age_at_vaccination":1.0,"age_unit_raw":"years","vaccine_type":"MMR","vaccination_date":null,"condition_raw":"pervasive developmental disorder (“PDD”), not otherwise specified, autism","condition_category":"ASD_autism","autism_spectrum_adjacent":1,"outcome":"dismissed","award_amount_usd":null,"decision_date":"2018-02-07","extraction_version":"gemini-v2","extracted_at":"2026-04-30T04:35:22.225963+00:00","number_of_concurrent_vaccines":2,"dose_number":null,"time_to_onset_days":370,"theory_of_causation":"Petitioners alleged that residual human DNA fragments and HERV-K endogenous retrovirus fragments contained in vaccines manufactured using human fetal cell lines (MMR II, varicella, hepatitis A) cause autism. The proposed mechanisms included insertional mutagenesis, retrograde axonal transport, microvesicle transport, and hematopoietic stem cell uptake, leading to brain cell disruption and autism. Dr. Theresa Deisher's \"change point study\" correlating autism prevalence with vaccine introductions was central to the theory. The theory was rejected by Chief Special Master Nora Beth Dorsey for failing to meet the Althen Prong One standard, specifically failing multiple Bradford Hill criteria, including lack of strength of association, consistency with other studies, specificity, temporal relationship, dose-response, coherence, effect of ceasing exposure, analogy, biological plausibility, and replication. The proposed mechanisms were found to be speculative and unsupported by preponderant evidence. The case was dismissed.","is_death":0,"date_of_death":null,"petition_filed_date":null,"case_summary":"This case was filed on behalf of M.B., a minor child, alleging that the MMR vaccine administered at approximately one year of age caused his autism. The petition was filed in 2005 by his parents, C.B. and C.B. The case was held in abeyance during the Omnibus Autism Proceeding (OAP). Following the OAP's rejection of the MMR-causes-autism and thimerosal theories, M.B.'s case was included in a \"mini-omnibus\" proceeding testing a new theory: that residual human DNA fragments and HERV-K (human endogenous retrovirus type K) fragments in vaccines manufactured using human fetal cell lines cause autism. Petitioners' counsel was John F. McHugh. Respondent's counsel was Traci R. Patton. The theory focused on vaccines such as MMR II, varicella, and hepatitis A. Petitioners' expert, Dr. Theresa Deisher, proposed that these DNA fragments could reach the brain via insertional mutagenesis, retrograde axonal transport, microvesicle transport, or hematopoietic stem cell uptake, leading to autism. She based this on a \"change point study\" correlating autism prevalence with vaccine introductions. Petitioners also presented Dr. Karin Burkhard as a corroborating expert, drawing analogies to PANDAS and citing diffusion tensor imaging studies. Respondent's experts included Dr. M. Daniele Fallin, Dr. Neal Halsey, and Dr. Dan Arking. The entitlement hearing was held in March 2016, with rebuttal testimony in May 2016. Chief Special Master Nora Beth Dorsey issued a decision on August 31, 2017, refiled in redacted form on February 7, 2018, dismissing the petition. The decision found that petitioners failed to meet the burden under Prong One of Althen v. Sec'y of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005). Chief Special Master Dorsey applied the Bradford Hill criteria to Dr. Deisher's theory and found it failed on multiple counts, including strength of association (lack of measurable correlation parameters), consistency (contradicted by numerous large epidemiological studies), specificity (study did not compare autism to other developmental disabilities), temporal relationship (autism susceptibility window is prenatal, not postnatal), dose-response (autism prevalence continued to rise after vaccine coverage plateaued), coherence (inconsistent with current understanding of autism etiology), effect of ceasing exposure (inconsistent country-level patterns in follow-up study), analogy (autism's closest known cause is a germline mutation, not postnatal DNA insertion), biological plausibility (proposed mechanisms were speculative), and replication (study had not been replicated). Methodological critiques included the use of an ecological study design, failure to account for changes in diagnostic criteria, reporting practices, access to services, stigma, paternal age, and decreasing age at diagnosis. Concerns were also raised about Dr. Deisher's potential conflicts of interest and the rejection of her NIH grant application due to methodological weaknesses. The decision concluded that the proposed mechanisms for DNA fragments reaching the brain were speculative and that the evidence did not support a causal link. The dismissal of M.B.'s case was part of a larger \"mini-omnibus\" proceeding involving 23 cases, all of which were dismissed on similar grounds.","is_minor_inferred":1,"is_pediatric_broad":1,"special_master":"Nora Beth Dorsey","petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":"John F. McHugh","petitioner_attorney_firm":"Law Office of John McHugh","petitioner_attorney_location":"New York, NY","adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":"|john-mchugh|","firm_canonical_key":"law-office-of-john-mchugh","package_title":"B. et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_05-vv-01168","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_05-vv-01168.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_05-vv-01168.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_05-vv-01168-0","title":"B. et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 08/17/2017) regarding 65 DECISION of Special Master. Signed by Chief Special Master Nora Beth Dorsey. (Attachments: # 1 Appendix A)(har) Service on parties made. Modified on 7/3/2019 to include the attachment(s) in the main document for posting to the court's website (da).","date_issued":"2018-02-07","pdf_url":"https://api.govinfo.gov/packages/USCOURTS-cofc-1_05-vv-01168/granules/USCOURTS-cofc-1_05-vv-01168-0/pdf","pdf_bytes":1306191,"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_05-vv-01168/USCOURTS-cofc-1_05-vv-01168-0"}]}