{"package_id":"USCOURTS-cofc-1_12-vv-00551","decision_granule_id":"USCOURTS-cofc-1_12-vv-00551-2","petitioner_identifier":"R.P.A.","is_minor":1,"age_at_vaccination":10.5,"age_unit_raw":"years","vaccine_type":"Flu Mist","vaccination_date":"2009-09-28","condition_raw":"acute hepatitis resulting in liver failure and a liver transplant","condition_category":"other","autism_spectrum_adjacent":0,"outcome":"compensated","award_amount_usd":278160,"decision_date":"2016-10-07","extraction_version":"gemini-v2","extracted_at":"2026-04-30T02:43:03.590050+00:00","number_of_concurrent_vaccines":1,"dose_number":null,"time_to_onset_days":10,"theory_of_causation":"Petitioners alleged that the Flu Mist vaccine administered on September 28, 2009, to R.P.A., then 10.5 years old, caused acute hepatitis, liver failure, and a liver transplant. Petitioners' expert, Dr. Joseph A. Bellanti, proposed that the vaccine triggered an autoimmune reaction via cell-mediated injury, possibly through molecular mimicry, innocent bystander effect, or polyclonal activation, leading to apoptosis of liver cells. Respondent's expert, Dr. Stephen J. McGeady, disagreed, stating no plausible medical theory linked the vaccine to the liver failure and that the pathology did not support an immune or viral cause. Special Master Laura D. Millman found Dr. Bellanti's testimony credible and ruled that the Flu Mist vaccine was a substantial factor in causing R.P.A.'s hepatitis and liver failure, satisfying the Althen standard for entitlement. The case was an off-Table claim. The parties stipulated to damages, resulting in an award of $278,160.63, including $225,000.00 for pain and suffering, $9,408.00 for future medical expenses, and $43,752.63 for past unreimbursable expenses.","is_death":0,"date_of_death":null,"petition_filed_date":"2016-04-21","case_summary":"On August 30, 2012, Patrick J. Agnew and Constance M. Agnew, parents of R.P.A., a minor, filed a petition under the National Childhood Vaccine Injury Act. They alleged that the Flu Mist vaccine, which R.P.A. received on September 28, 2009, caused him to develop acute hepatitis, leading to liver failure and a liver transplant on October 26, 2009. The petitioners were represented by law students from the George Washington School of Law Vaccine Injury Clinic, with attorneys Renée J. Gentry and Clifford J. Shoemaker serving as instructors. The respondent was represented by Alexis B. Babcock. Special Master Laura D. Millman presided over the case. \n\nR.P.A., born March 30, 1999, received the Flu Mist vaccine on September 28, 2009. Approximately ten days later, on October 13, 2009, his mother reported stomach aches, vomiting, and yellow eyes to his pediatrician, Dr. Deborah Zinck, who diagnosed likely viral hepatitis. R.P.A. was admitted to Rhode Island Hospital on October 15, 2009, with a diagnosis of acute hepatitis. Doctors considered Epstein Barr virus, non-typeable viral hepatitis, and autoimmune hepatitis. An ultrasound showed signs of acute hepatitis. He was discharged but returned on October 17, 2009, with vomiting, jaundice, dark urine, and abdominal pain. He was transferred to Yale New Haven Hospital on October 20, 2009, with acute and subacute necrosis of the liver and listed for a liver transplant. Doctors assessed him with acute liver failure, considering infectious or autoimmune etiology. His parents expressed concern about a link to the Flu Mist vaccine. A VAERS search for acute liver failure associated with Flu Mist vaccine yielded no cases. On October 26, 2009, R.P.A. underwent a liver transplant. Pathology of his removed liver revealed fulminant hepatic necrosis without clear evidence of etiology, and no viral inclusions were found. \n\nPetitioners' expert, Dr. Joseph A. Bellanti, an immunologist, testified that the Flu Mist vaccine activated R.P.A.'s immune system, which was misdirected to his liver, causing cell-mediated injury through mechanisms like molecular mimicry, innocent bystander injury, or polyclonal activation. He stated that this process could lead to apoptosis (programmed cell death) without inflammation, consistent with the pathology findings. He noted that the 10-day interval between vaccination and symptom onset was a classic period for inducing an immune reaction. \n\nRespondent's expert, Dr. Stephen J. McGeady, an immunologist, testified that there was no plausible medical theory connecting the Flu Mist vaccine to R.P.A.'s liver failure. He stated that the pathology did not support an immune or viral cause, and that apoptosis without inflammation is a normal cellular process, not a pathological one. He noted the absence of immunologically relevant cells and cytokines in R.P.A.'s liver and that there had been no reported cases of liver failure linked to Flu Mist vaccine in the medical literature. \n\nSpecial Master Millman found Dr. Bellanti's testimony credible, noting his extensive expertise. She concluded that the Flu Mist vaccine could cause an autoimmune reaction via a cell-mediated process leading to hepatitis and liver failure, even if rare. She found that petitioners proved a logical sequence of cause and effect, with a 10-day interval between vaccination and symptom onset, satisfying the three prongs of the Althen standard for entitlement. \n\nFollowing the entitlement ruling, the parties stipulated to damages. On June 20, 2016, Special Master Millman issued a decision awarding R.P.A. a total of $278,160.63. This award comprised a lump sum of $234,408.00 for pain and suffering ($225,000.00) and future medical expenses ($9,408.00), payable to R.P.A.'s guardians/conservators. An additional lump sum of $43,752.63 was awarded for past unreimbursable expenses, payable to Patrick Agnew and Constance Agnew. A subsequent decision on October 7, 2016, confirmed the award after Constance M. Agnew was made the sole petitioner.","is_minor_inferred":1,"is_pediatric_broad":1,"special_master":"Laura D. Millman","petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":"Tatiana Cody; Kelly Marco; Maureen Urbina; Renee J. Gentry","petitioner_attorney_firm":null,"petitioner_attorney_location":"Washington, DC","adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":"|tatiana-cody|kelly-marco|maureen-urbina|renee-gentry|","firm_canonical_key":null,"package_title":"AGNEW et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_12-vv-00551","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_12-vv-00551.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_12-vv-00551.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_12-vv-00551-0","title":"AGNEW et al v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC ORDER/RULING (Originally filed: 03/30/2016) regarding 61 Ruling on Entitlement Signed by Special Master Laura D Millman. 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