Lawrence Romine v. HHS - Pneumococcal, Guillain-Barre syndrome (GBS) (2026)
Case summary [AI summaries can sometimes make mistakes]
Lawrence Romine, born in 1951, received the Prevnar 13 vaccine on March 15, 2018, and alleges it caused him to develop Guillain-Barre syndrome (GBS). His symptoms began approximately 13 days later, around March 28, 2018.
Mr. Romine supported his claim with expert opinions suggesting a molecular mimicry theory, proposing that components of the Prevnar vaccine could cross-react with proteins or phospholipids in the nervous system, leading to GBS.
The Secretary of Health and Human Services opposed the claim, presenting expert opinions that refuted the proposed theories. The court reviewed extensive epidemiological studies which found no increased risk of GBS following pneumococcal vaccines and no association between Streptococcus pneumoniae infections and GBS.
The court also examined Dr. Steinman's molecular mimicry theories, including a protein-based theory involving CRM-197 and PMP22, and a phosphoglycerol-based theory.
The court found Dr. Steinman's methodology, particularly his use of the BLAST program with a lenient E-value, to be unreliable.
Furthermore, the court found insufficient evidence to support the proposed cross-reactivity between vaccine components and nervous system proteins or phospholipids. The court also noted the lack of general acceptance for the proposed theories within the scientific community and the difficulty in falsifying the molecular mimicry hypothesis.
Ultimately, the court concluded that Mr. Romine failed to establish a reliable theory of causation by a preponderance of the evidence and denied his claim for compensation.
Theory of causation
Prevnar 13 pneumococcal conjugate vaccine on March 15, 2018, age 67, followed by Guillain-Barre syndrome about 13 days later. DENIED. Petitioner relied on Dr. Steven Sykes and Dr. Lawrence Steinman, arguing molecular mimicry/cross-reactivity involving pneumococcal vaccine components, myelin proteins, and phospholipids. Respondent relied on Dr. James J. Sejvar and Dr. Richard Alexander, who emphasized the lack of reliable epidemiologic association between pneumococcal vaccination and GBS, the absence of wild pneumococcal infection preceding GBS, and the speculative nature of the proposed cross-reactivity. Special Master Moran found no persuasive reliable medical theory and no logical sequence proving the vaccine caused Mr. Romine's GBS. Decision filed March 13, 2026. Attorney: Jeffrey S. Pop.
Source PDFs
USCOURTS-cofc-1_19-vv-00468