Olivia Bender v. HHS - Meningococcal, transverse myelitis (2019)

Filed 2011-10-19Decided 2019-01-23Vaccine Meningococcal
denied

Case summary [AI summaries can sometimes make mistakes]

Olivia Bender, a 14-year-old, filed a petition on October 19, 2011, alleging that she developed transverse myelitis (TM) as a result of receiving the meningococcal (Menactra) and Hepatitis A vaccines on May 29, 2009. On July 10, 2009, 42 days after vaccination, Ms.

Bender experienced a sudden loss of sensation in her legs, leading to her collapse and subsequent diagnosis of TM. Initial medical evaluations and MRIs confirmed TM.

However, initial treaters mistakenly diagnosed TM secondary to a mycoplasma infection based on erroneous lab results. Further specialist consultations, including by Dr.

Douglas Kerr, a neurologist with expertise in TM, suggested an unknown etiology and did not link the condition to the vaccines. Petitioner's experts, Dr.

Vera Byers (immunologist) and Dr. Chone Ken Chen (pediatric neurologist), proposed that the vaccines caused TM through immunological mechanisms such as bystander activation or epitope spreading, arguing that the vaccines provoked pro-inflammatory cytokines.

Respondent's experts, Dr. Timothy Lotze (pediatric neurologist) and Dr.

Thomas Forsthuber (immunologist), countered that these mechanisms were not scientifically supported for TM causation and that the vaccines were not linked to TM in medical literature. They also argued that the 42-day interval between vaccination and onset was too long to be medically acceptable.

Special Master Brian H. Corcoran initially denied entitlement, finding Petitioner failed to prove causation under the Althen standard, deeming her experts less persuasive and their theories lacking reliable support.

The Court of Federal Claims granted Petitioner's motion for review, finding the Special Master had misconstrued Dr. Byers' testimony regarding molecular mimicry.

On remand, Special Master Corcoran again denied entitlement, finding Petitioner failed to establish a scientifically reliable and plausible causation theory, that her experts were less persuasive than Respondent's, that the timeframe was too long, and that there was insufficient evidence for the second Althen prong. The Court of Federal Claims, in an opinion by Senior Judge Mary Ellen Coster Williams, affirmed the Special Master's decision on remand, finding that the Special Master reasonably evaluated the expert testimony and evidence, and that Petitioner failed to meet her burden of proof on all three Althen prongs.

The case was ultimately denied as Petitioner failed to meet her burden of proof for vaccine causation.

Theory of causation

Off-Table. Petitioner alleged that the meningococcal and Hepatitis A vaccines administered on May 29, 2009, caused transverse myelitis (TM) which manifested on July 10, 2009 (42 days post-vaccination). Petitioner's experts, Dr. Vera Byers and Dr. Chone Ken Chen, proposed that the vaccines caused TM through immunological mechanisms like bystander activation or epitope spreading, arguing that the vaccines provoked pro-inflammatory cytokines. Dr. Byers conceded molecular mimicry was not a primary mechanism but suggested individualized molecular mimicry or epitope spreading. Respondent's experts, Dr. Timothy Lotze and Dr. Thomas Forsthuber, countered that these mechanisms were not scientifically supported for TM causation and that the vaccines were not linked to TM in medical literature. They also argued the 42-day interval was not medically acceptable. Special Master Brian H. Corcoran denied entitlement, finding Petitioner failed to prove causation under the Althen standard, deeming her experts less persuasive and their theories lacking reliable support, and that the temporal relationship was not medically acceptable. The Court of Federal Claims affirmed the denial on review, agreeing that the Special Master reasonably evaluated the expert testimony and evidence, and that the proposed causal mechanisms were not sufficiently established, nor was the temporal relationship definitively proven. Petitioner's counsel was Bruce W. Slane. Respondent's counsel was Lara Englund. Special Master was Brian H. Corcoran. The case was denied.

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