Timothy Koller v. HHS - Pneumococcal, Guillain-Barré Syndrome (Miller-Fisher variant) (2021)
Case summary [AI summaries can sometimes make mistakes]
On April 6, 2016, Timothy Koller filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that the pneumococcal conjugate vaccine (Prevnar 13) he received on May 13, 2015, caused him to develop Guillain-Barré Syndrome (GBS), specifically the Miller-Fisher variant. The respondent, the Secretary of Health and Human Services, initially intended to defend against the claim.
Petitioner's expert, Dr. Lawrence Steinman, proposed a theory of molecular mimicry, suggesting that a component of the Prevnar 13 vaccine, phosphoglycerol, could trigger an immune response that cross-reacts with phospholipids in the myelin sheath, leading to demyelination and GBS.
Respondent's expert, Dr. Thomas Leist, argued that the vaccine was not a recognized cause of GBS and that Dr.
Steinman's theory was speculative. The Special Master, Thomas L.
Gowen, reviewed the evidence, including medical records and expert testimony. The factual history detailed Mr.
Koller's presentation of symptoms approximately 12-14 days after vaccination, starting with left-sided facial weakness and progressing to diplopia and generalized weakness. Medical records from multiple treating physicians, including Dr.
Dallas Bogner, Dr. Thomas G.
Mattio, Dr. Steven W.
Huder, Dr. Riess Sagers, Dr.
Scott G. Powley, and Dr.
Gizell Larson, associated the onset of his GBS with the pneumococcal vaccination. Diagnostic tests, including an MRI and lumbar puncture, revealed findings consistent with GBS.
Petitioner underwent plasmapheresis treatment. The Special Master found that petitioner had established a sound and reliable theory of causation through molecular mimicry, a logical sequence of cause and effect, and a medically acceptable temporal relationship between the vaccination and the onset of his GBS symptoms.
The court found that Dr. Steinman's theory, supported by the Prevnar-13 patent, the Chang et al. article, and the Ho et al. study, was persuasive.
While Dr. Leist raised concerns about the lack of direct literature linking Prevnar 13 to GBS and the speculative nature of the molecular mimicry theory involving sugar moieties, the Special Master found that the petitioner met the burden of proof.
The Special Master concluded that Timothy Koller is entitled to compensation, and a separate damages order would be issued. Petitioner was represented by Maximillian J.
Muller of Muller Brazil, LLP, and respondent was represented by Dhairya D. Jani of the U.S.
Department of Justice.
Theory of causation
Petitioner Timothy Koller, aged 65, received a Prevnar 13 vaccine on May 13, 2015, and subsequently developed Guillain-Barré Syndrome (GBS), Miller-Fisher variant, approximately 12-14 days later. Petitioner's expert, Dr. Lawrence Steinman, proposed an "off-Table" theory of causation based on molecular mimicry. Dr. Steinman posited that the phosphoglycerol component, essential for the immunogenicity of certain polysaccharides in the Prevnar 13 vaccine (specifically serotypes 18C, 11A, and 15B, as supported by the vaccine's patent and the Chang et al. article), mimics the phosphoglycerol head group of phospholipids found in the myelin sheath. This molecular mimicry, Dr. Steinman argued, triggers an autoimmune response where antibodies generated against the vaccine's phosphoglycerol cross-react with the myelin's phospholipids, leading to demyelination and GBS. This theory was further supported by the Ho et al. study, which indicated that autoantibodies in Multiple Sclerosis patients target the phosphoglycerol head group of myelin phospholipids, and the Gilburd et al. study, which found antiphospholipid antibodies in GBS patients. Respondent's expert, Dr. Thomas Leist, contended that the theory was speculative, lacked direct scientific literature linking Prevnar 13 to GBS, and that phospholipids are not components of the vaccine. However, the Special Master found Dr. Steinman's theory to be sound and reliable, supported by a logical sequence of cause and effect, and a medically acceptable temporal relationship (12-14 days post-vaccination). The Special Master found that petitioner established entitlement to compensation, with damages to be determined separately. Attorneys involved were Maximillian J. Muller for the petitioner and Dhairya D. Jani for the respondent. Special Master Thomas L. Gowen issued the ruling on October 29, 2021.
Source PDFs
USCOURTS-cofc-1_16-vv-00439