{"package_id":"USCOURTS-cofc-1_18-vv-00327","decision_granule_id":"USCOURTS-cofc-1_18-vv-00327-1","petitioner_identifier":"Janie Miller","is_minor":0,"age_at_vaccination":64.0,"age_unit_raw":"years","vaccine_type":"influenza","vaccination_date":"2016-10-01","condition_raw":"leukocytoclastic vasculitis","condition_category":"other","autism_spectrum_adjacent":0,"outcome":"denied","award_amount_usd":null,"decision_date":"2024-09-20","extraction_version":"gemini-v2","extracted_at":"2026-04-30T00:56:30.924923+00:00","number_of_concurrent_vaccines":1,"dose_number":null,"time_to_onset_days":12,"theory_of_causation":"Janie Miller, a 64-year-old woman, received an influenza vaccine on October 1, 2016. She alleged this vaccine caused leukocytoclastic vasculitis (LCV), which she argued subsequently led to deep vein thrombosis (DVT) and pulmonary embolism (PE). Petitioner's expert, Dr. Yehuda Shoenfeld, proposed several theories for vaccine-induced LCV, including molecular mimicry, viral invasion of endothelial cells, immune complexes, and adjuvants (formaldehyde and Triton X-100). Respondent's experts, Dr. Olajumoke Fadugba and Dr. Brendan Antiochos, contested these theories. The Special Master, Christian J. Moran, found that while the Monjazeb case report and the vaccine package insert provided some evidence that vaccines can cause vasculitis (Althen prong one), and the immune complex theory was not rebutted as a theory, Ms. Miller failed to demonstrate a logical sequence of cause and effect. Specifically, the Special Master found that Ms. Miller did not provide evidence that she actually had immune complexes, which was the only marginally passable theory from Dr. Shoenfeld that advanced to prong two. The public decision does not detail the specific peptides or molecular structures involved in the molecular mimicry theory, nor does it specify the exact diagnostic tests that would confirm immune complex deposition. The public decision does not detail the specific mechanism by which the vaccine might induce immune complexes. The Special Master denied compensation, finding Ms. Miller failed to meet the second prong of the Althen test by not proving a logical sequence of cause and effect. Judge Eleni M. Roumel affirmed this decision on September 20, 2024, agreeing that Ms. Miller did not provide sufficient evidence to establish causation, particularly the lack of testing for immune complexes and the absence of treating physician opinions linking the vaccine to her condition. The case was denied on the merits.","is_death":0,"date_of_death":null,"petition_filed_date":"2018-03-05","case_summary":"Janie Miller, born in 1952, filed a petition for vaccine compensation on March 5, 2018, alleging that an influenza vaccine administered on October 1, 2016, caused her to develop leukocytoclastic vasculitis (LCV). Approximately 12 days after vaccination, Ms. Miller noticed a sore on her right foot that developed into a rash on both feet. She was seen by an Advanced Practice Registered Nurse who noted petechiae on her feet and recommended an emergency room visit, which records do not confirm she attended. Ms. Miller later saw Dr. Douglas Thompson for the rash, which had been present for five days. Issues addressed during that visit included tiredness, high cholesterol, and type 2 diabetes. A punch biopsy performed on November 18, 2016, by Dr. Michael Chen, with findings interpreted by dermatopathologist Dr. Julia Cruz, were strongly suggestive of LCV. Ms. Miller was prescribed prednisone. In December 2016, she fainted and was hospitalized; her LCV lesions were healing. A rheumatologist, Dr. Kevin Schlessel, noted no obvious etiology for the LCV and no evidence of systemic vasculitis. In January 2017, Ms. Miller was hospitalized again after an ultrasound revealed deep vein thrombosis (DVT) and pulmonary embolism (PE). A radiologist later noted these events occurred in the setting of an acute inflammatory condition secondary to LCV and elevated BMI. Ms. Miller was placed on anticoagulation therapy and steroids. Petitioner's counsel was Louis P. McFadden, Jr. of McFadden Law Firm P.C. Respondent's counsel included Zoë Wade from the U.S. Department of Justice. Special Master Christian J. Moran issued a decision on March 7, 2024, denying compensation. Ms. Miller sought review of this decision, and Judge Eleni M. Roumel of the U.S. Court of Federal Claims issued a memorandum and order on September 20, 2024, denying the motion for review and sustaining the Special Master's decision. The public decision does not describe the specific mechanism of the vaccine's alleged causation or detail the specific peptides involved in the molecular mimicry theory. The public decision does not describe any specific diagnostic tests performed for immune complexes, nor does it detail the specific treatment protocols beyond prednisone and anticoagulation therapy. The public decision does not name treating physicians beyond those involved in her initial care and diagnosis of LCV and DVT/PE. The public decision does not mention any award amount as the claim was denied.","is_minor_inferred":0,"is_pediatric_broad":0,"special_master":"Christian J. Moran","petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":"Louis P. McFadden","petitioner_attorney_firm":"McFadden Law Firm","petitioner_attorney_location":"Northfield, NJ","adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":"|louis-mcfadden|","firm_canonical_key":"mcfadden","package_title":"MILLER v. SECRETARY OF HEALTH AND HUMAN SERVICES","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00327","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00327.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00327.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_18-vv-00327-0","title":"MILLER v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 03/07/2024) regarding 123 DECISION of Special Master Signed by Special Master Christian J. Moran. (ceo) Service on parties made.","date_issued":"2024-03-29","pdf_url":"https://api.govinfo.gov/packages/USCOURTS-cofc-1_18-vv-00327/granules/USCOURTS-cofc-1_18-vv-00327-0/pdf","pdf_bytes":342805,"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_18-vv-00327/USCOURTS-cofc-1_18-vv-00327-0"},{"granule_id":"USCOURTS-cofc-1_18-vv-00327-1","title":"MILLER v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"JUDGE VACCINE REPORTED OPINION (reissued for publication of 128 JUDGE VACCINE ORDER/OPINION denying 125 Petitioner's Motion for Review and sustaining 123 DECISION of Special Master). Signed by Judge Eleni M. Roumel. (cj) Service on parties made.","date_issued":"2024-09-20","pdf_url":"https://api.govinfo.gov/packages/USCOURTS-cofc-1_18-vv-00327/granules/USCOURTS-cofc-1_18-vv-00327-1/pdf","pdf_bytes":512634,"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_18-vv-00327/USCOURTS-cofc-1_18-vv-00327-1"}]}