A.C.W. v. HHS - HPV, acute transverse myelitis (2019)
Case summary [AI summaries can sometimes make mistakes]
On December 15, 2015, Heidi and David White, parents of A.C.W. (referred to as A.W. in the decision), filed a petition alleging that the human papillomavirus (HPV) vaccine administered on July 30, 2013, caused their then 11-year-old daughter to develop acute transverse myelitis. A.W. received her third dose of the HPV vaccine on July 30, 2013.
Approximately 27 days later, on August 26, 2013, she experienced severe back pain, followed by weakness and sensory deficits in her limbs, leading to hospitalization. Her treating physicians at Boston Children's Hospital diagnosed her with acute transverse myelitis.
Petitioners presented expert testimony from Dr. Lawrence Steinman and Dr.
Marcel Kinsbourne, who supported the diagnosis of inflammatory transverse myelitis and proposed a theory of molecular mimicry, suggesting the HPV vaccine's components mimicked proteins in the spinal cord, triggering an autoimmune response. Respondent's expert, Dr.
Soe Mar, questioned the diagnosis, arguing that A.W. did not meet the strict criteria for inflammatory transverse myelitis due to a lack of certain inflammatory markers in diagnostic tests, and suggested alternative diagnoses like acute flaccid myelitis or a spinal cord stroke. Respondent's other expert, Dr.
Neil Romberg, also questioned the inflammatory nature of the diagnosis and suggested that any homology between the vaccine and spinal cord proteins was likely coincidental and could be attributed to exposure to common microbes. Special Master Thomas L.
Gowen reviewed the medical records, expert testimony, and medical literature. He found that A.W.'s treating physicians consistently diagnosed and treated her for inflammatory transverse myelitis, and that the evidence supported the theory of molecular mimicry as the cause.
The Special Master determined that petitioners met all three prongs of the Althen test for causation: a reputable scientific explanation (molecular mimicry), a logical sequence of cause and effect (onset of symptoms 27 days post-vaccination with no other identified cause and positive response to treatment), and a proximate temporal relationship (27 days post-vaccination, within the medically acceptable timeframe). Therefore, the Special Master found that the HPV vaccine was the cause-in-fact of A.W.'s injury and granted entitlement to compensation.
A separate order for damages was to be issued. Petitioner's counsel was Anthony M.
Carr of Shaheen & Gordon, P.A. Respondent's counsel was Adriana R.
Teitel of the U.S. Dept. of Justice.
Special Master Thomas L. Gowen issued the ruling on December 19, 2019.
Theory of causation
Petitioners alleged that the HPV vaccine administered on July 30, 2013, caused A.W. to develop acute transverse myelitis (ATM) through a theory of molecular mimicry. Petitioners' experts, Dr. Lawrence Steinman and Dr. Marcel Kinsbourne, opined that the L1 proteins in the Gardasil vaccine share amino acid sequences with myelin basic protein (MBP) and myelin oligodendrocyte glycoprotein (MOG), which are targets in autoimmune attacks on the spinal cord. Dr. Steinman's BLAST searches indicated sufficient homology between HPV antigens and MBP/MOG to trigger neuroinflammation. Petitioners argued that A.W.'s symptoms began 27 days post-vaccination, a medically acceptable timeframe, and that other causes were ruled out by treating physicians. Respondent's experts, Dr. Soe Mar and Dr. Neil Romberg, contested the diagnosis of inflammatory ATM, citing a lack of inflammatory markers (CSF pleocytosis, elevated IgG index, gadolinium enhancement) in A.W.'s initial tests, and suggested alternative diagnoses like acute flaccid myelitis or spinal cord stroke. Dr. Romberg argued that any protein homology was coincidental and likely due to common microbial exposures. Special Master Gowen found that A.W.'s treating physicians consistently diagnosed and treated her for inflammatory ATM, and that the medical literature supported the theory of molecular mimicry as a plausible mechanism, especially given the lack of evidence for alternative causes and the positive response to anti-inflammatory treatment. The Special Master concluded that petitioners met all three prongs of the Althen test, establishing causation-in-fact. Entitlement was granted, pending damages.
Source PDFs
USCOURTS-cofc-1_15-vv-01521