Harvard Davis v. HHS - Influenza, Guillain-Barré Syndrome (“GBS”) and chronic inflammatory demyelinating polyneuropathy (“CIDP”) (2022)
Case summary [AI summaries can sometimes make mistakes]
Harvard Davis filed a petition on October 14, 2014, alleging that an influenza vaccine administered on August 19, 2013, caused him to develop Guillain-Barré Syndrome (GBS) and chronic inflammatory demyelinating polyneuropathy (CIDP). Mr.
Davis, born June 12, 1957, had a significant medical history including hypertension, uncontrolled Type 2 diabetes with peripheral neuropathy and vascular complications, multiple spinal surgeries, and suspected spinal cord compression. Following the vaccine, he reported widespread body pain, stiffness, weakness, and difficulty with movement, with symptoms worsening over several weeks.
Multiple physicians provided differing diagnoses, including GBS, CIDP, myopathy, and other neuropathies, with some physicians prescribing treatments such as steroids and IVIG. The case involved extensive expert testimony regarding the potential link between the flu vaccine and CIDP through theories of molecular mimicry and molecular mimics like Contactin-1 and Neurofascin.
Petitioner's expert, Dr. Lawrence Steinman, opined that the influenza vaccine triggered an immune-mediated inflammatory reaction, potentially through molecular mimicry, leading to CIDP, and that Mr.
Davis's comorbidities exacerbated the condition. Respondent's expert, Dr.
Vinay Chaudhry, contended that Mr. Davis's symptoms were more consistent with his comorbidities, particularly diabetes, and that the medical evidence did not support a diagnosis of CIDP.
Special Master Mindy Michaels Roth found that Mr. Davis's evidence was sufficient to demonstrate that the flu vaccine was a substantial triggering factor for probable CIDP.
The Special Master noted that Mr. Davis's comorbidities complicated the assessment of his ongoing debility but concluded that the vaccine, in combination with these comorbidities, was a substantial factor in causing his current disability.
The case proceeded on an entitlement track, and the Special Master ruled in favor of the petitioner for entitlement to compensation, with the matter to proceed to damages.
Theory of causation
Petitioner Harvard Davis, age 56, received an influenza vaccine on August 19, 2013, and subsequently developed symptoms consistent with probable CIDP. Petitioner's expert, Dr. Lawrence Steinman, proposed two theories of causation: 1) molecular mimicry involving antigangliosides, where components of the influenza vaccine (specifically H1N1) share structures with antigens in peripheral nerves, triggering an autoimmune response; and 2) molecular mimics Contactin-1 and Neurofascin, proteins found in the vaccine component A/Victoria/361/2011, which have homology with nerve proteins and can cause neuroinflammatory disease. Dr. Steinman cited studies on molecular mimicry in GBS and animal models showing homology can trigger paralysis. Respondent's expert, Dr. Vinay Chaudhry, disputed the diagnosis of CIDP, arguing that the petitioner's symptoms were primarily due to his significant comorbidities, particularly Type 2 diabetes with neuropathy, and that the EMG/NCS studies did not meet the EFNS criteria for CIDP. Dr. Chaudhry also noted that the specific molecular mimics cited by Dr. Steinman were rare in CIDP cases and petitioner's presentation did not align with those findings. Special Master Mindy Michaels Roth found Dr. Steinman's theory of molecular mimicry plausible for establishing a link between the flu vaccine and CIDP, satisfying Prong I of the Althen test. Regarding Prong II, the Special Master found that while petitioner's comorbidities contributed to his condition, the vaccine acted as a substantial factor, particularly in combination with his diabetes, leading to a "catastrophic downhill course." The onset of symptoms, reported as early as the day after vaccination and progressing over weeks, satisfied Prong III. The Special Master concluded that the petitioner had established a prima facie case for entitlement to compensation for probable CIDP, and respondent had not proven an alternative sole cause. The case was ruled in favor of entitlement, pending damages.
Source PDFs
USCOURTS-cofc-1_14-vv-00978