{"package_id":"USCOURTS-cofc-1_03-vv-00620","decision_granule_id":"USCOURTS-cofc-1_03-vv-00620-cl6654792","petitioner_identifier":"Adela Quintana De Bazan","is_minor":0,"age_at_vaccination":49.0,"age_unit_raw":"years","vaccine_type":"Td","vaccination_date":"2000-04-19","condition_raw":"acute disseminated encephalomyelitis (ADEM)","condition_category":"encephalitis_encephalopathy","autism_spectrum_adjacent":0,"outcome":"unclear","award_amount_usd":null,"decision_date":"2006-05-15","extraction_version":"gemini-v2","extracted_at":"2026-04-30T14:30:22.128187+00:00","number_of_concurrent_vaccines":1,"dose_number":null,"time_to_onset_days":0,"theory_of_causation":"Td vaccination Apr 19, 2000 → ADEM onset ~11 hours post-vaccination. Estimated 5th-6th tetanus vaccination (prior sensitization → accelerated response). Petitioner now quadriplegic. Four treating physicians (Hansen, Adler, Humphries, Hoffman) opined causation. SM Abell Feb 7, 2006: DENIED (onset too soon; Dr. Sriram 10-14 day model; Dr. Hansen's PNS analogy rejected). CFC Judge Lettow May 15, 2006: REVERSED AND REMANDED — SM misapplied burden of proof; collapsed two-step §300aa-13(a)(1) analysis. Court independently found Althen prima facie case established. Remanded for government to prove alternative causation. DB petition_filed_date 2006-05-15 = wrong (case filed ~2003 per case number).","is_death":0,"date_of_death":null,"petition_filed_date":"2006-05-15","case_summary":"Adela Quintana De Bazan was an ostensibly healthy, active woman of approximately 49 years of age when she received a tetanus-diphtheria (Td) vaccination on the morning of April 19, 2000. Her medical history indicated that this was likely her fifth or sixth tetanus vaccination — she had been born and had had three children in Peru, where immunization of pregnant women against tetanus is routine, and her April 19, 2000 medical records recorded that she had received a tetanus booster approximately ten to eleven years earlier. At the time of the April 2000 vaccination, her medical records noted a sore throat, swelling on the left side of her neck, and nasal discharge, though the special master later found insufficient evidence that she was suffering from a viral or bacterial infection at that time.\n\nBy 9:00 that evening — approximately eleven hours after the vaccination — Ms. De Bazan began to experience soreness in her arms, numbness, and a general decline in health. By May 2, 2000, her symptoms had become so severe that she could no longer walk without assistance; she sought emergency medical attention and was hospitalized on May 8, 2000. She has remained hospitalized in a quadriplegic state since then. Both parties agreed that Ms. De Bazan's diagnosis was acute disseminated encephalomyelitis (ADEM), a disorder of the central nervous system in which the immune system attacks the myelin sheathing the nerves, and that her symptoms appeared approximately eleven hours after the vaccination.\n\nPetitioner's expert witness was Dr. Susan Hansen, her treating neurologist, who is Board-certified in neurology, electrodiagnostic medicine, and clinical neurophysiology and is affiliated with Stanford University's School of Medicine. Dr. Hansen testified that Td vaccine can cause ADEM, and that onset can occur within hours of vaccination, explaining this through (1) a molecular mimicry mechanism and (2) case reports of demyelinating disorders of the peripheral nervous system with onset within hours of vaccination, which she argued were analogous. Dr. Hansen's analysis was supported by the affidavits of three other treating physicians: Dr. Jacqueline Adler (tropical medicine; previously at UCSF School of Medicine), Dr. Sheila Humphries (internist, El Camino Hospital), and Dr. Ronald Hoffman (neurologist, Stanford and El Camino Hospital), each of whom examined Ms. De Bazan and concluded that the Td vaccination had caused her ADEM. Respondent's expert was Dr. Subramaniam Sriram, director of the multiple sclerosis clinic at Vanderbilt Medical Center, who testified based on animal models that a minimum of ten to fourteen days was necessary for the immune cascade underlying ADEM to develop after a vaccination.\n\nSpecial Master Thomas Abell denied compensation on February 7, 2006, concluding that the onset of Ms. De Bazan's symptoms occurred too soon after the vaccination to have been caused by it. He credited Dr. Sriram's model, rejected Dr. Hansen's testimony (finding her PNS analogy unconvincing and her testimony insufficiently rigorous under a Daubert analysis), and appeared to apply the legal framework of Pafford v. Secretary of HHS, 64 Fed. Cl. 19 (2005), which required the petitioner to disprove alternative causation as part of her prima facie showing.\n\nJudge Lettow, writing for the Court of Federal Claims on May 15, 2006, reversed the special master's decision and remanded. The court held that the special master had misapplied the statutory allocation of burdens of proof under 42 U.S.C. § 300aa-13(a)(1). The Vaccine Act creates a two-step inquiry: the petitioner first bears the burden of establishing a prima facie case of causation-in-fact under subparagraph (A); once that burden is met, the burden shifts to the government to prove by a preponderance of the evidence that the injury was caused by \"factors unrelated to the administration of the vaccine\" under subparagraph (B). The special master had effectively required Ms. De Bazan to both prove her prima facie case and disprove the government's model in a single step — an improper collapsing of the statutory analysis that the court found contrary to Althen v. Secretary of HHS, 418 F.3d 1274 (Fed. Cir. 2005), Capizzano v. Secretary of HHS, 440 F.3d 1317 (Fed. Cir. 2006), and Knudsen v. Secretary of HHS, 35 F.3d 543 (Fed. Cir. 1994). The court disagreed with Pafford to the extent it required petitioner to eliminate alternative causes as part of her prima facie case.\n\nIndependently reviewing the record, the court found that Ms. De Bazan had satisfied each of the three Althen causation elements by a preponderance. On the first prong (causal theory), the court found the molecular mimicry mechanism plausible and the case reports linking Td to demyelinating disorders probative, even though the occurrence was rare and below the level of scientific certainty. On the second prong (logical sequence of cause and effect), the court found that the opinions of all four treating physicians that the Td vaccination caused Ms. De Bazan's ADEM were circumstantial evidence sufficient under Capizzano to establish the logical sequence — treating physicians need not rely on epidemiologic evidence. On the third prong (proximate temporal relationship), the court found that the eleven-hour onset was consistent with petitioner's prior sensitization — given her estimated five or more prior tetanus vaccinations, prior exposure would accelerate the immune response — and with case reports of demyelinating disorders of the peripheral nervous system arising within hours of vaccination.\n\nHaving concluded that petitioner established a prima facie case, the court remanded to the special master to receive additional evidence and determine whether the government could prove by a preponderance of evidence that petitioner's ADEM was caused by factors unrelated to the vaccine.","is_minor_inferred":0,"is_pediatric_broad":0,"special_master":null,"petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":null,"petitioner_attorney_firm":null,"petitioner_attorney_location":null,"adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":null,"firm_canonical_key":null,"package_title":"De Bazan v. Secretary of the Department of Health & Human Services","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_03-vv-00620","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_03-vv-00620.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_03-vv-00620.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_03-vv-00620-cl6654792","title":"De Bazan v. Secretary of the Department of Health & Human Services","docket_text":"lead-opinion","date_issued":"2006-05-15","pdf_url":"https://www.courtlistener.com/opinion/6771874/de-bazan-v-secretary-of-the-department-of-health-human-services/","pdf_bytes":null,"triage_decision":"keep","triage_reason":"recovered via CL opinion 6654792 (html_with_citations)","download_status":"ok","registry_pdf_url":"https://vicp-registry.org/pdf/USCOURTS-cofc-1_03-vv-00620/USCOURTS-cofc-1_03-vv-00620-cl6654792"}]}