Mary Maloney v. HHS - Pneumococcal, Guillain-Barré Syndrome (2022)

Petitioner Mary Maloney, age 89, received a Prevnar 13 vaccine on July 7, 2017, and subsequently developed Guillain-Barré Syndrome (GBS). Petitioner did not allege a Table injury, thus requiring proof of causation-in-fact. Petitioner's experts, Drs. Steven Sykes and Lawrence Steinman, opined that the Prevnar 13 vaccine caused Maloney's GBS. Dr. Steinman proposed two molecular mimicry theories: (1) homology between phosphoglycerol in vaccine serotypes 18C and 23F and phospholipids in the human myelin sheath, supported by studies showing human antibodies targeting phosphoglycerol in the 23F component and evidence that myelin phospholipids are targeted in autoimmune diseases like MS and GBS; and (2) homology between the CRM197 protein carrier in the vaccine and Contactin-1, a protein found in humans, supported by sequence homology and T-cell responses to diphtheria toxin regions. Dr. Sykes supported the molecular mimicry mechanism and cited case reports of GBS following pneumococcal vaccines. Petitioner's treating physicians also noted an association between the vaccine and GBS. Respondent's experts, Drs. Vinay Chaudhry and Lindsay Whitton, disputed the diagnosis of GBS and the causation theory, arguing a lack of epidemiological evidence for vaccine-induced GBS, that gangliosides, not phospholipids, are the primary targets in GBS, and that the proposed molecular mimics were not sufficiently supported. Special Master Nora Beth Dorsey found preponderant evidence for GBS diagnosis and for causation, accepting the molecular mimicry theory, particularly the phosphoglycerol mechanism, as sound and reliable, citing supporting studies and prior program decisions. The Special Master found a logical sequence of cause and effect, noting treating physicians' statements linking the vaccine to the GBS and the lack of evidence for alternative causes. A medically acceptable temporal relationship of one to two weeks post-vaccination was also established. Maloney was found entitled to compensation, with damages to be determined separately. Attorneys involved were Jeffrey S. Pop for petitioner and Colleen Clemons Hartley for respondent. Special Master Nora Beth Dorsey issued the ruling on April 11, 2022.