Dorothy T. Gray v. HHS - Influenza, Bickerstaff Brainstem Encephalitis (BBE) (2022)
Case summary [AI summaries can sometimes make mistakes]
On February 18, 2015, Dorothy Gray, born May 4, 1932, filed a petition for compensation under the National Vaccine Injury Compensation Program. She alleged that on October 11, 2011, she received a seasonal influenza vaccine and subsequently developed Bickerstaff Brainstem Encephalitis (BBE).
Mrs. Gray passed away from other causes on December 17, 2016, and her daughter, C.
Vanessa Randolph, continued the case as executor of her estate. The initial entitlement decision, issued by Chief Special Master Brian H.
Corcoran on November 12, 2021, denied entitlement. The decision found that while the flu vaccine could likely cause BBE within a medically acceptable timeframe, the petitioner had not proven by a preponderance of the evidence that the vaccine was the likely cause in Mrs.
Gray's specific case. The decision noted that Mrs.
Gray had an intervening urinary tract infection (UTI) and upper respiratory tract infection (URI) closer in time to her BBE onset, which could have been the cause. The petitioner's expert, Dr.
Lawrence Steinman, opined that the flu vaccine could cause BBE through the production of anti-ganglioside antibodies and molecular mimicry. The respondent's expert, Dr.
Timothy Vartanian, argued that an antecedent infection was a more likely cause and that the onset timeframe excluded vaccination. The Special Master determined that while the first and third Althen prongs (can cause and medically acceptable timeframe) were met, the second prong (did cause) was not preponderantly established due to the intervening infection and the temporal remoteness of the vaccination.
Despite the denial of entitlement, the parties later filed a notice of tentative settlement and a stipulation to resolve the appeal. On March 25, 2022, Chief Special Master Corcoran issued a decision awarding damages based on this stipulation.
The parties agreed to a settlement award of $25,000.00, payable as a lump sum to Petitioner as legal representative of the estate, representing compensation for all damages available under the Act. Petitioner was represented by Andrew Donald Downing of Van Cott & Talamante, PLLC.
Respondent was represented by Kelly Heidrich and later Alexis B. Babcock of the U.S.
Department of Justice.
Theory of causation
Petitioner Dorothy Gray, aged 79, received an influenza vaccine on October 11, 2011, and subsequently developed Bickerstaff Brainstem Encephalitis (BBE). Petitioner's expert, Dr. Lawrence Steinman, proposed that the flu vaccine could cause BBE by eliciting anti-ganglioside antibodies and through molecular mimicry, citing medical literature and in silico research. Respondent's expert, Dr. Timothy Vartanian, contended that an antecedent infection was a more likely cause and that the onset timeframe was too distant from vaccination. The Special Master, Brian H. Corcoran, denied entitlement, finding that while the vaccine could cause BBE (Althen prong one) and the onset was within a medically acceptable timeframe (Althen prong three, determined as November 23, 2011, 43 days post-vaccination), the petitioner failed to preponderantly prove the vaccine was the actual cause (Althen prong two). This failure was attributed to the presence of an intervening UTI/URI closer in time to the BBE onset and the lack of evidence of an aberrant immune response in the period immediately following vaccination. Despite the denial of entitlement, the parties stipulated to a settlement award of $25,000.00 for all damages, which the Special Master adopted as the decision awarding damages on March 25, 2022. Petitioner was represented by Andrew Donald Downing and Respondent by Kelly Heidrich and Alexis B. Babcock. The theory of causation was off-Table.