Ann Roberts v. HHS - Prevnar, seizure disorder (2014)
Case summary [AI summaries can sometimes make mistakes]
On September 23, 2010, Ann Roberts, as the parent and natural guardian of M.R., a minor, filed a petition for compensation under the National Vaccine Injury Compensation Program. The petition alleged that the DTaP, Hib, MMR, and varicella vaccinations M.R. received on February 21, 2008, and a Prevnar vaccination on March 17, 2008, caused M.R. to suffer from a seizure disorder.
Respondent recommended against compensation. Petitioner's expert was Dr.
Dwight L. Lindholm, a pediatric neurologist, and respondent's experts were Dr.
Max Wiznitzer and Dr. Mark S.
Korson. A hearing was held, and on September 24, 2014, Chief Special Master Nora Beth Dorsey issued a Ruling on Entitlement, finding M.R. entitled to compensation.
The parties stipulated that the vaccines did not cause M.R.'s mitochondrial disorder. Petitioner's theory of causation was that the Prevnar vaccination triggered an autoimmune cross-reactivity response, leading to inflammation, blood-brain barrier disruption, and calcium influx into neurons, ultimately producing a seizure disorder.
Dr. Lindholm supported this theory, citing M.R.'s low IgA level and mitochondrial dysfunction as predisposing factors, the temporal relationship between the Prevnar vaccine and M.R.'s ataxia onset, M.R.'s positive response to steroids, and an elevated IgG index.
Respondent's expert, Dr. Wiznitzer, challenged this theory, arguing against the plausibility of an enhanced immune response and the lack of proven homology for cross-reactivity.
Dr. Wiznitzer also proposed Doose Syndrome as an alternative diagnosis, which Special Master Dorsey gave no weight as it was raised for the first time at the hearing and not supported by the medical records.
Special Master Dorsey found all three Althen prongs satisfied, concluding that Dr. Lindholm's theory was sound and reliable, supported by circumstantial evidence and a medically acceptable timeframe.
On April 26, 2016, Chief Special Master Dorsey issued a Decision Awarding Damages, awarding a total of $214,548.49. This included $160,000.00 for pain and suffering, $45,732.29 for past unreimbursable expenses, and $8,816.20 to satisfy the State of Kansas Medicaid lien.
No lost wages were awarded as M.R. was performing at grade level. The award was based on a proffer agreed upon by both parties.
Theory of causation
Petitioner M.R., a minor, received DTaP, Hib, MMR, and varicella vaccines on February 21, 2008, and a Prevnar vaccine on March 17, 2008. Petitioner alleged these vaccines caused a seizure disorder. Petitioner's expert, Dr. Dwight L. Lindholm, proposed a theory of autoimmune cross-reactivity (molecular mimicry), where antibodies generated against vaccine antigens cross-reacted with M.R.'s neural tissue, causing inflammation, blood-brain barrier disruption, and neuronal calcium influx, leading to seizures. Dr. Lindholm cited M.R.'s low IgA level and mitochondrial disorder as predisposing factors, the temporal onset of ataxia within 15-22 days post-Prevnar, M.R.'s dramatic response to steroids (Prednisone), and an elevated CSF IgG index (0.60) as evidence supporting causation. Respondent's expert, Dr. Max Wiznitzer, disputed the theory, questioning the plausibility of an enhanced immune response and the lack of proven homology for cross-reactivity. Dr. Wiznitzer also proposed Doose Syndrome as an alternative diagnosis, which was rejected by the Special Master. Special Master Nora Beth Dorsey found that petitioner satisfied the three Althen prongs for causation, accepting Dr. Lindholm's theory and evidence. The Prevnar vaccine was identified as the likely cause due to the proximate temporal relationship. The decision on entitlement was issued on September 24, 2014. A subsequent decision on damages on April 26, 2016, awarded $214,548.49, comprising $160,000.00 for pain and suffering, $45,732.29 for past unreimbursable expenses, and $8,816.20 for a Medicaid lien. Attorneys for petitioner were Lawrence Gene Michel, Kennedy Berkley, et al. Attorneys for respondent were Alexis B. Babcock, U.S. Department of Justice.
Source PDFs
USCOURTS-cofc-1_10-vv-00639