{"package_id":"USCOURTS-cofc-1_14-vv-00257","decision_granule_id":"USCOURTS-cofc-1_14-vv-00257-2","petitioner_identifier":"Autumn Orm","is_minor":1,"age_at_vaccination":13.79,"age_unit_raw":"years","vaccine_type":"HPV","vaccination_date":"2011-08-30","condition_raw":"celiac disease","condition_category":"other","autism_spectrum_adjacent":0,"outcome":"denied","award_amount_usd":null,"decision_date":"2023-04-18","extraction_version":"gemini-v2","extracted_at":"2026-04-30T00:32:39.288993+00:00","number_of_concurrent_vaccines":1,"dose_number":1,"time_to_onset_days":null,"theory_of_causation":"Petitioner Autumn Orm alleged that the HPV vaccine administered on August 30, 2011, and November 22, 2011, caused her to develop celiac disease. Petitioner's experts, Dr. Aaron Lerner and Dr. Yehuda Shoenfeld, proposed that the vaccine's components, including the adjuvant alum, polysorbate 80, and yeast (Saccharomyces cerevisiae), or molecular mimicry involving the STAT3 protein, could trigger celiac disease. They suggested a temporal relationship where symptoms began weeks to months after vaccination. Respondent's expert, Dr. Chris A. Liacouras, opined that celiac disease is triggered by gluten and that Petitioner's symptoms, including fatigue and anemia, were indicative of the disease's natural progression, likely predating vaccination. Dr. Liacouras cited large-scale studies showing no increased risk of celiac disease post-HPV vaccination and explained that the development of anemia associated with celiac disease takes months to years. The Special Master, Nora Beth Dorsey, found Petitioner's expert theories lacked sufficient evidence, were conclusory, and often expressed as possibilities. The Special Master agreed with Dr. Liacouras that the evidence indicated the onset of Petitioner's celiac disease occurred prior to vaccination, failing the temporal relationship prong of the Althen test. The petition was denied.","is_death":0,"date_of_death":null,"petition_filed_date":"2014-04-02","case_summary":"On April 2, 2014, Autumn Orm, represented by Mark Theodore Sadaka, filed a petition under the National Vaccine Injury Compensation Program alleging that the human papillomavirus (HPV) vaccine (Gardasil) caused her to develop celiac disease. She received her first dose on August 30, 2011, and a second dose on November 22, 2011. The respondent was the Secretary of Health and Human Services, represented by Debra A. Filteau Begley. Initially, Ms. Orm alleged other conditions, but later narrowed her claim to celiac disease. The parties agreed that Ms. Orm suffers from celiac disease but disputed the onset of the illness and whether the HPV vaccination caused it. The Special Master, Nora Beth Dorsey, reviewed the evidence and found that Ms. Orm failed to prove by a preponderance of the evidence that the HPV vaccines caused her celiac disease, thus failing to satisfy the burden of proof under Althen v. Secretary of Health & Human Services. The petition was dismissed.\n\nMedical records indicated that Ms. Orm experienced symptoms such as fatigue starting in the summer of 2011. She received her first HPV vaccine on August 30, 2011, for hip pain. On January 5, 2012, she presented with shortness of breath, diarrhea, and abdominal pain, and was found to be severely anemic. Subsequent tests, including an elevated tissue transglutaminase (tTG) IgA antibody level and endoscopy with biopsy, led to a diagnosis of celiac disease on January 16, 2012. Her symptoms improved with a gluten-free diet. Ms. Orm's experts, Dr. Aaron Lerner and Dr. Yehuda Shoenfeld, proposed several mechanisms by which the HPV vaccine could have caused her celiac disease, including the adjuvant alum, polysorbate 80, yeast (Saccharomyces cerevisiae), and molecular mimicry involving the STAT3 protein. They opined that her symptoms began weeks to months after vaccination. However, the Special Master found these theories lacked sufficient foundational evidence, were conclusory, and often expressed as possibilities rather than probabilities. The cited literature did not directly support a link between the proposed vaccine components and celiac disease, and some studies involved oral ingestion rather than intramuscular injection. Furthermore, Dr. Lerner's proposed mechanisms were not supported by her treating physicians, and the medical literature he cited did not establish a causal link between alum, polysorbate 80, or S. cerevisiae and celiac disease.\n\nRespondent's expert, Dr. Chris A. Liacouras, a pediatric gastroenterologist, opined that celiac disease is an immune-mediated disorder triggered by gluten ingestion and that Ms. Orm's symptoms and diagnosis were consistent with the natural progression of the disease, likely beginning before her vaccination. Dr. Liacouras cited numerous large-scale safety studies that did not show an increased risk of celiac disease following HPV vaccination. He also argued that the symptoms of celiac disease, particularly anemia, take months or years to develop, and Ms. Orm's symptoms, such as fatigue and shortness of breath, likely began before her vaccination. Dr. Liacouras's opinion was supported by the fact that Ms. Orm's symptoms improved with a gluten-free diet, indicating gluten as the trigger. Respondent's other expert, Dr. Eric Lancaster, also critiqued the molecular mimicry theory, noting that short amino acid sequence matches can occur by chance and that evidence did not support the ASIA theory related to alum adjuvants.\n\nThe Special Master agreed with Respondent's expert, finding that Ms. Orm failed to establish a medically acceptable temporal relationship between the vaccination and the onset of her celiac disease. The evidence indicated that her symptoms, such as shortness of breath and leg weakness, appeared around September 10, 2011, which was shortly after her August 30, 2011 vaccination. However, Dr. Liacouras persuasively explained that the pathological process of celiac disease, leading to anemia and its symptoms, takes a significant amount of time to develop, likely months or years. The Special Master concluded that Ms. Orm's illness followed a chronic course, and her symptoms, particularly the severe anemia diagnosed in January 2012, likely began before her vaccination. Therefore, Ms. Orm failed to meet the preponderance of the evidence standard for all three prongs of the Althen test. Consequently, her petition was denied.","is_minor_inferred":0,"is_pediatric_broad":1,"special_master":"Nora Beth Dorsey","petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":"Mark Theodore Sadaka","petitioner_attorney_firm":"Law Offices of Sadaka Associates, LLC","petitioner_attorney_location":"Englewood, NJ","adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":"|mark-sadaka|","firm_canonical_key":"law-offices-of-sadaka-associates","package_title":"ORM v. SECRETARY OF HEALTH AND HUMAN SERVICES","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_14-vv-00257","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_14-vv-00257.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_14-vv-00257.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_14-vv-00257-0","title":"ORM v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 5/21/19) regarding 203 DECISION of Special Master - Interim Attorneys' Fees. Signed by Special Master Christian J. Moran. (MRG) Service on parties made.","date_issued":"2019-06-14","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"fees-only decision (attorney compensation)","download_status":"skipped"},{"granule_id":"USCOURTS-cofc-1_14-vv-00257-1","title":"ORM v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 3/29/2022) regarding 291 DECISION of Special Master - Interim Attorney's Fees. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made.","date_issued":"2022-04-25","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"fees-only decision (attorney compensation)","download_status":"skipped"},{"granule_id":"USCOURTS-cofc-1_14-vv-00257-2","title":"ORM v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 3/24/2023) regarding 310 DECISION of Special Master. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made.","date_issued":"2023-04-18","pdf_url":"https://api.govinfo.gov/packages/USCOURTS-cofc-1_14-vv-00257/granules/USCOURTS-cofc-1_14-vv-00257-2/pdf","pdf_bytes":628998,"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_14-vv-00257/USCOURTS-cofc-1_14-vv-00257-2"},{"granule_id":"USCOURTS-cofc-1_14-vv-00257-3","title":"ORM v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 4/2/2024) regarding 317 DECISION of Special Master - Fees. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made.","date_issued":"2024-04-29","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"fees-only decision (attorney compensation)","download_status":"skipped"}]}