Jeffrey W. Sprenger v. HHS - Pneumococcal, Guillain-Barré Syndrome (2023)
Case summary [AI summaries can sometimes make mistakes]
On February 22, 2018, Jeffrey W. Sprenger filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that he suffered Guillain-Barré Syndrome (GBS) as a result of a pneumococcal conjugate (Prevnar 13) vaccination he received on April 12, 2017.
He also initially alleged a shingles vaccine received on the same date and a flu vaccination from October 9, 2016, were causative, but later focused his claim solely on the Prevnar 13 vaccine. The respondent, the Secretary of Health and Human Services, argued against compensation.
The Special Master, Nora Beth Dorsey, found that Mr. Sprenger provided preponderant evidence that the Prevnar 13 vaccine caused his GBS, satisfying the criteria outlined in Althen v.
Secretary of Health & Human Services. The diagnosis of GBS was not disputed.
The core dispute was causation. Mr.
Sprenger's claim was based on the theory of molecular mimicry, positing that components of the Prevnar 13 vaccine could trigger an autoimmune response targeting the myelin sheath of peripheral nerves, leading to GBS. He presented expert testimony from Dr.
Lawrence Steinman, who detailed two potential mechanisms for this molecular mimicry: one involving homology between phosphoglycerol in the vaccine and phospholipids in the myelin sheath, and another involving homology between the CRM197 protein carrier in the vaccine and Contactin-1, a protein found in humans. Dr.
Steinman cited various studies and his own research to support these theories. Petitioner's treating physician, Dr.
Jose Diaz, opined that Mr. Sprenger's GBS was most likely secondary to the vaccinations received on April 12, 2017.
Respondent's experts, Dr. Dara G.
Jamieson and Dr. You-Wen He, contested causation.
Dr. Jamieson argued there was no epidemiological evidence linking Prevnar 13 to GBS and suggested Petitioner's prior respiratory infections were a more likely cause.
Dr. He initially acknowledged molecular mimicry as a potential mechanism but later challenged its validity, arguing that sequence similarity alone is insufficient and that infections provide a stronger immune stimulus.
He also emphasized the IOM criteria for molecular mimicry, which he argued were not met. However, the Special Master found Dr.
Steinman's theories to be sound and reliable, supported by foundational evidence and accepted in prior Vaccine Program cases. The Special Master also found a logical sequence of cause and effect, noting the absence of identified infectious or alternative causes in the medical records and the opinions of treating physicians Dr.
Diaz and Dr. Atta Rehman associating the vaccination with the GBS onset.
The temporal relationship was also deemed appropriate, with symptom onset approximately two weeks after vaccination, consistent with the molecular mimicry theory and established timeframes for GBS following vaccination. The Special Master concluded that Mr.
Sprenger met all three prongs of the Althen test and was entitled to compensation, with damages to be determined in a separate order. Petitioner was represented by Cary Michael Toland of Herrman and Herrman, PLLC, and Respondent was represented by Ryan Daniel Pyles of the U.S.
Department of Justice.
Theory of causation
Petitioner Jeffrey W. Sprenger, age 59, received a Prevnar 13 vaccine on April 12, 2017. He developed Guillain-Barré Syndrome (GBS). Petitioner's claim was based on the theory of molecular mimicry, as opined by expert Dr. Lawrence Steinman. Dr. Steinman proposed two mechanisms: (1) homology between phosphoglycerol in Prevnar 13 serotypes 18C and 23F and phospholipids in the human myelin sheath, and (2) homology between the CRM197 protein carrier in Prevnar 13 and Contactin-1, a protein found in humans. Dr. Steinman cited studies showing antibodies to phospholipids in GBS patients and homology between CRM197 and human proteins. Petitioner's treating physician, Dr. Jose Diaz, opined the GBS was most likely secondary to the April 12, 2017 vaccinations. Respondent's experts, Dr. Dara G. Jamieson and Dr. You-Wen He, contested causation, citing lack of epidemiological evidence, the possibility of prior infections as triggers, and challenging the molecular mimicry theory. The Special Master found Dr. Steinman's theory sound and reliable, supported by foundational evidence and accepted in prior cases. The Special Master found a logical sequence of cause and effect, noting the absence of identified alternative causes in the medical records and the opinions of treating physicians associating the vaccination with GBS. A proximate temporal relationship was established, with symptom onset approximately two weeks post-vaccination, consistent with the molecular mimicry theory and established timeframes. Petitioner was granted entitlement, with damages pending. Attorneys: Cary Michael Toland for Petitioner; Ryan Daniel Pyles for Respondent. Special Master: Nora Beth Dorsey. Decision Date: November 14, 2023.
Source PDFs
USCOURTS-cofc-1_18-vv-00279