{"package_id":"USCOURTS-cofc-1_98-vv-00619","decision_granule_id":"USCOURTS-cofc-1_98-vv-00619-cl6662997","petitioner_identifier":"Paul A. Viscontini","is_minor":1,"age_at_vaccination":13.0,"age_unit_raw":"years","vaccine_type":"Hepatitis B","vaccination_date":"1995-12-07","condition_raw":"Crohn's disease","condition_category":"other","autism_spectrum_adjacent":0,"outcome":"denied","award_amount_usd":null,"decision_date":"2012-02-28","extraction_version":"gemini-v2","extracted_at":"2026-04-30T14:31:20.686662+00:00","number_of_concurrent_vaccines":1,"dose_number":1,"time_to_onset_days":3,"theory_of_causation":"Petitioner Paul A. Viscontini, born September 17, 1982, received the Hepatitis B vaccine on December 7, 1995, January 11, 1996, and July 31, 1996. He alleged that the vaccine caused his Crohn's disease, diagnosed in November 1996. This was an off-Table claim. Petitioner's experts, Drs. Bellanti and Solny, proposed an \"environmental-trigger theory\" suggesting the Hepatitis B vaccine could trigger Crohn's disease in predisposed individuals. Respondent's expert, Dr. Warner, found no scientific evidence to support this. Special Master Moran applied the Althen test, requiring a medical theory, logical sequence of cause and effect, and proximate temporal relationship. Applying Daubert standards, the Special Master found the petitioner's theory lacked testing, peer review, and general acceptance, and appeared developed for litigation. He also found the temporal relationship between vaccination and symptom onset, as documented in medical records, was not proximate. The Court of Federal Claims affirmed the denial, finding that while the Special Master should have considered petitioner's testimony regarding symptom onset, it would not have altered the outcome as the first two Althen prongs were not met. Petitioner's counsel was Paul A. Viscontini. Respondent's counsel is not named. Special Master was Christian J. Moran. The decision date was February 28, 2012. Compensation was denied.","is_death":0,"date_of_death":null,"petition_filed_date":"1998-07-29","case_summary":"Paul A. Viscontini, born September 17, 1982, received the first dose of the Hepatitis B vaccine on December 7, 1995, at age thirteen. He reported mild flu-like symptoms shortly after this first dose. After receiving the second dose on January 11, 1996, he experienced more severe symptoms including abdominal pain and vomiting. His mother testified that these symptoms began within days of the second dose, but medical records documenting these specific complaints were not created until later, with a diagnosis of Crohn's disease being made in November 1996. A third dose was administered on July 31, 1996. Paul's mother filed a petition on his behalf on July 29, 1998, alleging the Hepatitis B vaccine caused his Crohn's disease. The case proceeded as an off-Table claim, requiring proof of causation. Petitioner's experts, Joseph A. Bellanti, M.D., and Meyer Solny, M.D., proposed theories that the vaccine could trigger Crohn's disease. Dr. Bellanti initially theorized that individuals with ASCA antibodies could have an immunologic response triggered by yeast antigens in the vaccine, but later shifted to an \"environmental-trigger theory\" where the vaccine could be an environmental trigger for individuals with a deficient immune system and genetic predisposition. Respondent's expert, Andrew S. Warner, M.D., challenged these theories, noting a lack of scientific evidence. Special Master Christian J. Moran applied the Althen test, requiring a medical theory connecting the vaccine and injury, a logical sequence of cause and effect, and a proximate temporal relationship. The Special Master applied Daubert standards to evaluate the experts' theories. He found Dr. Bellanti's environmental-trigger theory lacked testing, peer review, and general acceptance within the scientific community. He also noted that Dr. Bellanti's theory appeared to be developed for litigation and that he could not identify what in the vaccine acted as a trigger. The Special Master found that petitioner failed to satisfy Althen's first prong (medical theory) due to the unreliability of the proposed theory. Regarding Althen's second prong (logical sequence of cause and effect), the Special Master noted that the lack of a reliable medical theory precluded satisfying this prong, and also found that petitioner's mother's testimony about symptom onset was not substantiated by medical records. The Special Master also addressed the challenge-rechallenge argument, finding it weakened by the timing of the doses and symptom onset. For Althen's third prong (proximate temporal relationship), the Special Master accepted, \"without critical evaluation,\" that symptoms within three to seven days of vaccination would be medically acceptable for inferring causation. However, he found that petitioner's abdominal symptoms did not begin until late January 1996, more than seven days after the first and second doses, and the Crohn's disease diagnosis occurred in mid-February 1996, also outside the accepted timeframe. The Special Master concluded that petitioner failed to satisfy all three prongs of the Althen test and denied compensation. The Court of Federal Claims reviewed the Special Master's decision. The court agreed that the Special Master should have credited petitioner's and his mother's testimony regarding symptom onset, even without contemporaneous medical records, as this would have potentially satisfied Althen's third prong. However, the court affirmed the Special Master's denial of compensation, finding that even if the temporal relationship prong were satisfied, petitioner would still fail to satisfy the first two prongs. The court found the Special Master's application of the Daubert factors and his credibility determinations were not arbitrary or capricious and did not impose an elevated evidentiary burden. The court concluded that the Special Master applied the correct legal standard and that the decision denying compensation was neither arbitrary nor capricious, affirming the denial.","is_minor_inferred":1,"is_pediatric_broad":1,"special_master":"Christian J. Moran","petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":"Clifford J. Shoemaker","petitioner_attorney_firm":"Shoemaker & Associates","petitioner_attorney_location":"Vienna, VA","adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":"|clifford-shoemaker|","firm_canonical_key":"shoemaker-and-associates","package_title":"Viscontini v. Secretary of Health & Human Services","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_98-vv-00619","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_98-vv-00619.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_98-vv-00619.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_98-vv-00619-cl6662997","title":"Viscontini v. Secretary of Health & Human Services","docket_text":"lead-opinion","date_issued":"2012-02-28","pdf_url":"https://www.courtlistener.com/opinion/6779331/viscontini-v-secretary-of-health-human-services/","pdf_bytes":null,"triage_decision":"keep","triage_reason":"recovered via CL opinion 6662997 (html_with_citations)","download_status":"ok","registry_pdf_url":"https://vicp-registry.org/pdf/USCOURTS-cofc-1_98-vv-00619/USCOURTS-cofc-1_98-vv-00619-cl6662997"},{"granule_id":"USCOURTS-cofc-1_98-vv-00619-cl-extra-854583","title":"Paul A. Viscontini v. Secretary of Health and Human Services","docket_text":"Supplementary opinion from CourtListener cluster 854583","date_issued":"2013-02-12","pdf_url":null,"pdf_bytes":null,"triage_decision":"keep","triage_reason":"CL supplement: Paul A. Viscontini v. Secretary of Health and Human Services","download_status":"ok","registry_pdf_url":"https://vicp-registry.org/pdf/USCOURTS-cofc-1_98-vv-00619/USCOURTS-cofc-1_98-vv-00619-cl-extra-854583"}]}