{"package_id":"USCOURTS-cofc-1_18-vv-00761","decision_granule_id":"USCOURTS-cofc-1_18-vv-00761-0","petitioner_identifier":"Raymond Bielak","is_minor":0,"age_at_vaccination":65.0,"age_unit_raw":"years","vaccine_type":"pneumococcal","vaccination_date":"2015-09-22","condition_raw":"Guillain-Barré syndrome","condition_category":"GBS","autism_spectrum_adjacent":0,"outcome":"denied","award_amount_usd":null,"decision_date":"2022-12-09","extraction_version":"gemini-v2","extracted_at":"2026-04-30T05:07:46.050384+00:00","number_of_concurrent_vaccines":1,"dose_number":null,"time_to_onset_days":1,"theory_of_causation":"Petitioner Raymond Bielak alleged that the pneumococcal vaccine (Prevnar-13) administered on September 22, 2015, caused his Guillain-Barré syndrome (GBS). Petitioner's experts, Dr. Sami Khella and Dr. Marc Serota, proposed a theory of molecular mimicry, suggesting that components of the pneumococcal vaccine, specifically phosphoglycerol groups in the capsular polysaccharide antigens, mimic structures in the peripheral nerve myelin, leading to an autoimmune attack. They cited literature indicating the presence of anti-phospholipid antibodies in GBS patients and proposed that antibodies generated against the vaccine's antigens could cross-react with myelin phospholipids. Respondent's experts, Dr. Robert Fujinami and Dr. Dara Jamieson, argued against this theory, emphasizing the lack of scientific support for a pneumococcal vaccine-GBS link, the differences in vaccine composition and mechanism compared to vaccines with established GBS associations (like the flu vaccine), and the possibility that the identified antibodies are a consequence rather than a cause of nerve damage. Dr. Fujinami, a key figure in molecular mimicry research, highlighted that the vaccine's T-cell dependent conjugate mechanism is less likely to induce pathogenic autoantibodies compared to T-cell independent vaccines, and that experimental models showed direct myelin immunization could be protective. Chief Special Master Brian H. Corcoran denied entitlement, finding Petitioner failed to establish by a preponderance of the evidence that the pneumococcal vaccine can cause GBS or that it did cause his GBS, citing insufficient scientific support for the proposed mechanism and the speculative nature of the proposed autoimmune process. The decision was issued on December 9, 2022. Petitioner was represented by Joseph Alexander Vuckovich and Respondent by Ronalda Elnetta Kosh.","is_death":0,"date_of_death":null,"petition_filed_date":"2018-05-31","case_summary":"On May 31, 2018, Raymond Bielak filed a petition seeking compensation under the National Vaccine Injury Compensation Program, alleging that the pneumococcal vaccine (Prevnar-13) he received on September 22, 2015, caused him to develop Guillain-Barré syndrome (GBS). Mr. Bielak was 65 years old at the time of vaccination. He reported experiencing malaise, myalgia, and fatigue approximately two weeks after vaccination, followed by numbness and tingling in his hands and feet. Medical evaluations confirmed absent reflexes and a diagnosis of GBS. Petitioner's experts, neurologist Sami Khella, M.D., and immunologist Marc Serota, M.S., M.D., Ph.D., opined that the pneumococcal vaccine could cause GBS through molecular mimicry, suggesting that components of the vaccine's antigens mimic structures in the nerve myelin, leading to an autoimmune attack. Dr. Khella focused on phospholipids in the myelin and the vaccine's phosphoglycerol component, while Dr. Serota proposed that antibodies generated against the vaccine's carbohydrate structures could interact with lipid/sugar structures on the myelin sheaths. Respondent's experts, neuroimmunologist Robert Fujinami, Ph.D., and neurologist Dara Jamieson, M.D., countered that the scientific evidence did not support a causal link between the pneumococcal vaccine and GBS. Dr. Fujinami, a pioneer in molecular mimicry theory, argued that the vaccine's mechanism and composition differ significantly from those associated with GBS, and that the proposed antibodies are likely a result, not a cause, of nerve damage. Dr. Jamieson emphasized the lack of epidemiological evidence and questioned the severity and direct causation of Mr. Bielak's GBS, noting his significant pre-existing medical conditions. The court reviewed extensive medical literature and expert testimony during a two-day entitlement hearing held from April 12-13, 2022. Ultimately, Chief Special Master Brian H. Corcoran found that Petitioner failed to establish by a preponderance of the evidence that the pneumococcal vaccine can cause GBS, particularly noting the lack of robust scientific support for the proposed mechanism and the distinction from the flu vaccine-GBS association. The court also found insufficient evidence to establish that the vaccine did cause Mr. Bielak's GBS. Therefore, the petition for entitlement was denied. Petitioner was represented by Joseph Alexander Vuckovich of Maglio Christopher & Toale, P.A., and Respondent was represented by Ronalda Elnetta Kosh of the U.S. Department of Justice.","is_minor_inferred":0,"is_pediatric_broad":0,"special_master":"Brian H. Corcoran","petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":"Joseph Alexander Vuckovich","petitioner_attorney_firm":"Maglio Christopher & Toale, P.A.","petitioner_attorney_location":"Washington, DC","adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":"|joseph-vuckovich|","firm_canonical_key":"maglio-christopher-and-toale","package_title":"BIELAK v. SECRETARY OF HEALTH AND HUMAN SERVICES","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00761","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00761.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00761.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_18-vv-00761-0","title":"BIELAK v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 12/09/2022) regarding 76 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (saj) Service on parties made.","date_issued":"2023-01-03","pdf_url":"https://api.govinfo.gov/packages/USCOURTS-cofc-1_18-vv-00761/granules/USCOURTS-cofc-1_18-vv-00761-0/pdf","pdf_bytes":633492,"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-00761/USCOURTS-cofc-1_18-vv-00761-0"},{"granule_id":"USCOURTS-cofc-1_18-vv-00761-1","title":"BIELAK v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 05/04/2023) regarding 84 DECISION of Special Master - Fees. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made.","date_issued":"2023-05-31","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"fees-only decision (attorney compensation)","download_status":"skipped"}]}