{"package_id":"USCOURTS-cofc-1_12-vv-00254","decision_granule_id":"USCOURTS-cofc-1_12-vv-00254-4","petitioner_identifier":"J.M.","is_minor":1,"age_at_vaccination":8.6,"age_unit_raw":"years","vaccine_type":"influenza","vaccination_date":"2009-10-01","condition_raw":"relapse of minimal change nephrotic syndrome with later relapses and strokes","condition_category":"other","autism_spectrum_adjacent":0,"outcome":"denied","award_amount_usd":null,"decision_date":"2018-12-20","extraction_version":"gemini-v2","extracted_at":"2026-04-30T04:37:37.863556+00:00","number_of_concurrent_vaccines":1,"dose_number":null,"time_to_onset_days":0,"theory_of_causation":"Influenza vaccine administered on October 1, 2009, allegedly caused a relapse of J.M.'s minimal change nephrotic syndrome (MCNS) and subsequent strokes. The theory proposed was that prior influenza vaccinations primed J.M.'s immune system, leading to an anamnestic immune response with proinflammatory cytokines upon receiving the 2009 flu shot, triggering the MCNS relapse and subsequent complications. Petitioner's experts included treating nephrologist Dr. Albert Quan and immunologist Dr. Joseph A. Bellanti. Respondent's experts were pediatric nephrologist Dr. Bernard S. Kaplan and immunologist Dr. Arnold I. Levinson. Key evidence included J.M.'s medical history, showing an initial MCNS diagnosis in September 2007, remission in February 2008, a first relapse in June 2009 (prior to the vaccine in question), and a second relapse around October 1-2, 2009. The defense emphasized that J.M. had tolerated previous flu vaccinations and that the relapse onset appeared to be before or contemporaneous with the October 1, 2009 vaccination. Special Master Laura D. Millman denied entitlement, finding MCNS to be a podocytopathy rather than a proven vaccine-triggered immune disease, rejecting the anamnestic response theory, and deeming the timing medically unacceptable. The Special Master's decision was upheld on review by Senior Judge Loren A. Smith. Entitlement was denied, and the petition was dismissed without award.","is_death":0,"date_of_death":null,"petition_filed_date":"2012-04-18","case_summary":"On April 18, 2012, Mark Miles, as legal representative for J.M., filed a petition under the National Childhood Vaccine Injury Act. The petition alleged that an influenza vaccine administered on October 1, 2009, caused J.M. to experience a second relapse of his minimal change nephrotic syndrome (MCNS), which subsequently led to further relapses and three strokes. J.M. was born on February 23, 2001. His medical history prior to the vaccination at issue showed no prior instances of vaccine-associated nephrotic syndrome. J.M. was diagnosed with MCNS in September 2007, treated with prednisone, and achieved remission by February 2008. Subsequent vaccinations, including an influenza vaccine in November 2008, did not trigger a relapse. J.M.'s first relapse occurred in June 2009, prior to the October 2009 vaccination. The timing of the second relapse became a critical issue. Medical records indicated that J.M. experienced increased urine protein and edema in the two weeks preceding an October 9, 2009 nephrology visit. Petitioner's affidavit suggested the relapse occurred immediately after the October 1, 2009 vaccination. Special Master Laura D. Millman found that the relapse onset timing was either before, contemporaneous with, or within approximately sixteen hours of the vaccination, which she deemed problematic for establishing causation. J.M. continued to experience relapses after October 2009, and in August 2011, he suffered multiple strokes, leading to left-sided paralysis and residual weakness. Petitioner's experts, Dr. Albert Quan (treating nephrologist) and Dr. Joseph A. Bellanti (immunologist), testified that the flu vaccine likely triggered the relapse and subsequent complications through an immune-mediated response. Respondent's experts, Dr. Bernard S. Kaplan (pediatric nephrologist) and Dr. Arnold I. Levinson (immunologist), disputed the immune-mediated theory, arguing that MCNS is a podocytopathy and that the timing was not indicative of vaccine causation. They also noted the lack of evidence linking flu vaccines to MCNS relapses or strokes. Special Master Millman denied the petition on June 28, 2018, finding petitioner's theory speculative and not supported by current medical understanding. She concluded that the timing was medically unacceptable and that the proposed mechanism of an anamnestic immune response was not supported. Consequently, the link between the vaccine and the subsequent strokes was not established. Senior Judge Loren A. Smith denied review of the Special Master's decision on December 20, 2018, affirming that the Special Master's findings regarding the nature of MCNS, the plausibility of the immune response, and the timing were not arbitrary or capricious. The petition was dismissed, and no award was granted.","is_minor_inferred":0,"is_pediatric_broad":1,"special_master":"Laura D. Millman","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":"MILES et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_12-vv-00254","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_12-vv-00254.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_12-vv-00254.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_12-vv-00254-0","title":"MILES et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION Signed by Special Master Laura D Millman. (tlj) Copy to parties.","date_issued":"2014-03-12","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"no decision/ruling/opinion signal in docketText","download_status":"skipped"},{"granule_id":"USCOURTS-cofc-1_12-vv-00254-1","title":"MILES et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 10/04/2017) regarding 104 DECISION of Special Master - Interim Attorney's Fees Signed by Special Master Laura D Millman. 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SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 9/7/2018) regarding 139 DECISION of Special Master - Interim Attorneys' Fees and Costs. Signed by Special Master Laura D. Millman. (ec) Service on parties made.","date_issued":"2018-10-02","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"fees-only decision (attorney compensation)","download_status":"skipped"},{"granule_id":"USCOURTS-cofc-1_12-vv-00254-4","title":"MILES et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"JUDGE VACCINE REPORTED OPINION re: 143 Order on Motion for Review. Signed by Senior Judge Loren A. Smith. (mr) Service on parties made.","date_issued":"2019-02-22","pdf_url":"https://api.govinfo.gov/packages/USCOURTS-cofc-1_12-vv-00254/granules/USCOURTS-cofc-1_12-vv-00254-4/pdf","pdf_bytes":320378,"triage_decision":"keep","triage_reason":"docketText matches keep keyword 'opinion'","download_status":"ok","registry_pdf_url":"https://vicp-registry.org/pdf/USCOURTS-cofc-1_12-vv-00254/USCOURTS-cofc-1_12-vv-00254-4"}]}