B.A. v. HHS - HPV, severe, chronic headaches and various other sequelae (2021)
Case summary [AI summaries can sometimes make mistakes]
On January 20, 2011, B.A. filed a claim in the National Vaccine Injury Compensation Program, alleging that the second and third doses of the HPV vaccine, administered on January 23, 2008, and June 3, 2008, respectively, caused severe, chronic headaches and other sequelae. B.A. was sixteen years old at the time of the second vaccination and seventeen at the time of the third.
Approximately nine to ten days after the second vaccination, B.A. began experiencing debilitating headaches, which worsened after the third vaccination. Her reported symptoms included severe headaches, fatigue, sensitivity to light and sound, joint and muscle pain, tremors, muscle spasms, depression, anxiety, cognitive deficits, and facial tics.
The public decision does not describe B.A.'s prior medical history in detail, other than noting intermittent headaches associated with sinus irritation, colds, and allergies prior to the vaccinations. The respondent opposed compensation, and presented expert testimony from Dr.
Thomas Leist, M.D. (neurology and immunology) and Dr. Edward Cetaruk, M.D. (toxicology).
Petitioner's expert, Dr. Lawrence Steinman, M.D. (neurology and immunology), proposed two theories of causation.
The first theory posited that B.A.'s symptoms were caused by acute disseminated encephalomyelitis (ADEM) due to molecular mimicry. The second theory proposed that the HPV vaccine's antigens and alum adjuvant activated pro-inflammatory cytokines and stimulated the trigeminal ganglion, leading to headaches.
Special Master Thomas L. Gowen, in a ruling on entitlement filed December 6, 2018, and refiled in redacted form on January 10, 2019, found that B.A. did not establish ADEM.
However, the Special Master concluded that the second theory of causation was sound and reliable and fit the facts of the case, finding a proximate temporal relationship and a logical sequence of cause and effect. The respondent did not establish a more likely alternative cause for B.A.'s symptoms.
Therefore, B.A. was found entitled to compensation. A subsequent decision on damages, filed November 2, 2021, awarded B.A. a lump sum payment of $1,826,255.62 for life care expenses, lost earnings, pain and suffering, and past unreimbursable expenses, along with an amount sufficient to purchase an annuity contract.
Petitioner was represented by Lisa A. Roquemore, and respondent was represented by Jennifer L.
Reynaud. Special Master Thomas L.
Gowen presided over both the entitlement and damages proceedings.
Theory of causation
Petitioner B.A., vaccinated with the HPV vaccine on January 23, 2008, and June 3, 2008, at age 16 and 17, alleged severe chronic headaches and other sequelae. Petitioner's expert, Dr. Lawrence Steinman, M.D., proposed two theories: 1) ADEM caused by molecular mimicry, and 2) activation of pro-inflammatory cytokines and the trigeminal ganglion by HPV vaccine antigens and alum adjuvant, leading to headaches. Respondent's experts, Dr. Thomas Leist, M.D., and Dr. Edward Cetaruk, M.D., opposed compensation. Special Master Thomas L. Gowen rejected the ADEM theory due to lack of objective evidence, but accepted the second theory, finding it sound and reliable. The Special Master determined that the HPV vaccine's antigens and alum adjuvant could stimulate the Nalp3 inflammasome pathway in the trigeminal ganglia, leading to severe headaches. This theory was supported by medical literature and the temporal proximity of B.A.'s symptoms to the vaccinations, including evidence of challenge-rechallenge. The Special Master found that respondent failed to establish a more likely alternative cause, such as a psychiatric component or PCOS. B.A. was awarded $1,826,255.62 in a lump sum and an annuity. Attorneys for petitioner were Lisa A. Roquemore and for respondent Jennifer L. Reynaud. Special Master Gowen issued the entitlement ruling on December 6, 2018 (redacted Jan 10, 2019) and the damages decision on November 2, 2021.