B.R. v. HHS - Tdap, Streptococcus pyogenes infection leading to sepsis and death (2023)
Case summary [AI summaries can sometimes make mistakes]
On April 4, 2011, Stephanie Roscoe, as representative of the estate of B.R., filed a petition under the National Vaccine Injury Compensation Program. B.R., an 11-year-old, received four vaccines—Hepatitis A, Tdap, Menactra, and HPV—on March 31, 2009.
Petitioner alleged that these vaccinations led to fever, pain, confusion, and ultimately death from Streptococcus pyogenes infection, sepsis, and necrotizing fasciitis. The respondent, the Secretary of Health and Human Services, argued against compensation.
The case involved extensive litigation, including a prior civil action for medical negligence. After a ruling on entitlement, the Special Master found that the petitioner had provided preponderant evidence that one or more of the vaccines caused B.R.'s infection and death, satisfying the Althen standard for causation.
The Special Master's decision was issued on June 8, 2020. Subsequently, a decision on damages was issued on November 14, 2022 (refiled in redacted form January 23, 2023).
The Special Master awarded $250,000 for pain and suffering and $250,000 for the death benefit, totaling $500,000. A key issue was whether this award was subject to a set-off from a prior civil settlement.
The Special Master ruled that the award was not subject to a set-off because there was insufficient evidence that the settlement proceeds were paid under an insurance policy, as required by the Vaccine Act. The respondent appealed this decision regarding the set-off.
On March 6, 2023, the Court denied the respondent's motion for review, affirming the Special Master's findings on both the allocation of the burden of proof for the set-off and the lack of evidence that the settlement was paid under an insurance policy. Petitioner's counsel was Richard Gage, and respondent's counsel was Kyle Edward Pozza.
Special Master Nora Beth Dorsey presided over the entitlement and damages rulings, and Senior Judge Edward J. Damich reviewed the set-off decision.
Theory of causation
Petitioner alleged that B.R., an 11-year-old, received Hepatitis A, Tdap, Menactra, and HPV vaccines on March 31, 2009. Within approximately 15 hours, B.R. developed hip pain and fever, progressing to necrotizing fasciitis and septic shock, leading to death on April 4, 2009. Petitioner's expert, Dr. Douglas Miller, opined that the vaccinations introduced Streptococcus pyogenes bacteria into B.R.'s bloodstream, which then spread hematogenously to the soft tissue of her hip and thigh, causing the infection. Dr. Miller supported this theory by citing medical literature describing how injections can serve as a portal of entry for bacteria, leading to remote site infections via bloodstream spread, even without a visible infection at the injection site. Respondent's expert, Dr. Sara Vargas, argued that for a vaccine to cause a distant infection, there must be an infection at the vaccination site, and suggested alternative sources like strep throat or a urogenital infection. However, the Special Master found insufficient evidence for these alternative sources, noting negative throat cultures and lack of other symptoms. The Special Master found Dr. Miller's theory sound and reliable, establishing a logical sequence of cause and effect and a proximate temporal relationship between the vaccinations and the onset of symptoms. The Special Master concluded that the petitioner proved by a preponderance of the evidence that the vaccines were a substantial factor in causing B.R.'s infection and death. The Special Master awarded $250,000 for pain and suffering and $250,000 for the death benefit, totaling $500,000, and ruled that this award was not subject to set-off from a prior civil settlement due to insufficient evidence that the settlement was paid under an insurance policy. This ruling was affirmed on review.
Source PDFs
USCOURTS-cofc-1_11-vv-00206