Arthur L. Trollinger v. HHS - Pneumococcal, Guillain-Barré syndrome (2023)

On April 14, 2016, Arthur L. Trollinger filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that the Prevnar-13 pneumococcal vaccine he received on July 17, 2015, caused him to develop Guillain-Barré syndrome (GBS).

Mr. Trollinger, then 68 years old, experienced symptoms including loss of feeling in his hands and weakness and numbness in his legs approximately ten days after vaccination.

He was diagnosed with GBS and received treatment, including IVIG and rehabilitation. Petitioner was represented by Nancy Routh Meyers of Turning Point Litigation, and Respondent was represented by Mallori Browne Openchowski of the U.S.

Department of Justice. Petitioner presented expert reports from Dr.

Lawrence Steinman, who proposed a theory of molecular mimicry, suggesting that components within the pneumococcal vaccine, specifically phosphoglycerol, could mimic structures in the nerve's myelin sheath, triggering an autoimmune response leading to GBS. Dr.

Steinman's theory evolved over the course of the litigation, initially focusing on phospholipids and later on phosphoglycerol found in some of the vaccine's polysaccharide antigens. He also explored potential mimicry involving the vaccine's CRM protein conjugate and the role of the alum adjuvant.

Respondent presented expert reports from Dr. Timothy Vartanian and Dr.

J. Lindsay Whitton.

Dr. Vartanian questioned the diagnosis of GBS, highlighting discrepancies in nerve conduction studies and suggesting alternative causes like hyponatremia.

Both Dr. Vartanian and Dr.

Whitton contested Dr. Steinman's causation theory, arguing that the evidence did not establish a reliable link between the pneumococcal vaccine and GBS.

Dr. Whitton specifically critiqued the molecular mimicry theory, noting the lack of scientific support for pneumococcus infection causing GBS, the difference between gram-positive bacteria like pneumococcus and gram-negative bacteria associated with GBS, and the speculative nature of the proposed mimicry mechanism involving phosphoglycerol and the vaccine's conjugate.

He also argued that the scientific literature cited by Dr. Steinman was either specific to multiple sclerosis or did not establish a causal link for GBS.

Chief Special Master Brian H. Corcoran denied entitlement, finding that Petitioner failed to establish by a preponderance of the evidence that the pneumococcal vaccine can cause GBS or did so in his case.

The Special Master concluded that Petitioner's causation theory, particularly the molecular mimicry argument, lacked sufficient specificity and reliable scientific support when applied to the pneumococcal vaccine, distinguishing it from the established link between the flu vaccine and GBS. The Special Master found Dr.

Whitton's critiques persuasive and noted that Dr. Steinman's theory had a "one-size-fits-all quality" that strained to apply flu vaccine science to the pneumococcal vaccine context.

Petitioner sought review of the Chief Special Master's decision. Judge Eleni M.

Roumel of the U.S. Court of Federal Claims affirmed the Special Master's decision, denying entitlement.

The Court found that the Chief Special Master correctly applied the preponderance of the evidence standard to the Althen prongs and did not err in evaluating Petitioner's expert or considering the molecular mimicry theory. The Court concluded that the Chief Special Master's factual findings and legal analyses were in accordance with binding precedent and did not reflect arbitrary or capricious reasoning.

The Court affirmed the denial of entitlement, finding that Petitioner had not established by a preponderance of the evidence that the pneumococcal vaccine can cause GBS.