G.C. v. HHS - Influenza, urticarial vasculitis (2019)
Case summary [AI summaries can sometimes make mistakes]
On July 23, 2015, Brynn Contino, on behalf of her minor child G.C., filed a petition alleging that G.C. developed urticarial vasculitis caused by an influenza vaccination received on December 3, 2013. Respondent was the Secretary of Health and Human Services.
Petitioner was represented by Lawrence R. Cohan of Anapol Weiss, and respondent was represented by Darryl R.
Wishard of the United States Department of Justice. Special Master Thomas L.
Gowen presided over the case. Petitioner did not allege a "Table" injury but rather sought to prove causation-in-fact.
The case involved expert testimony from Dr. Vera Byers for the petitioner and Dr.
Harry Schroeder for the respondent. Petitioner argued that G.C.'s prior episodes of hives in the late summer and early fall of 2013 were acute and allergic in nature, responding quickly to Benadryl.
Petitioner contended that the symptoms G.C. developed approximately five days after the December 3, 2013 flu vaccination—including a rash accompanied by swelling, bruising, and leg pain—were distinct from the earlier hives and represented the onset of urticarial vasculitis. Respondent argued that G.C.'s post-vaccination diagnosis was a natural progression of her pre-vaccination symptoms.
The medical records indicated G.C. was born on November 6, 2010. Prior to the vaccination, G.C. experienced episodes of hives in August and September 2013, which resolved within an hour of Benadryl treatment and were diagnosed as dermatographic urticaria.
After the December 3, 2013 vaccination, G.C. developed a rash, swelling, bruising, and leg pain starting around December 7-9, 2013. A skin biopsy on March 27, 2014, confirmed the diagnosis of urticarial vasculitis, showing granular deposition of IgM and C3 in superficial dermal blood vessels.
Dr. Byers proposed a theory of "bystander activation," suggesting that the flu vaccine stimulated G.C.'s innate immune system, leading to the release of cytokines that activated dormant autoreactive T and B cells, ultimately causing the autoimmune response of urticarial vasculitis.
Dr. Byers opined that the onset of symptoms five days post-vaccination was a medically acceptable temporal relationship, especially given G.C. had received prior flu vaccinations.
Dr. Schroeder argued that the pre- and post-vaccination rashes were similar and that the post-vaccination symptoms were likely due to a viral exanthem or a change in temperature, and he questioned the speed of the bystander activation theory.
However, the Special Master found that the medical records and testimony clearly distinguished the pre-vaccination hives from the post-vaccination symptoms of bruising, swelling, and joint pain, which were indicative of vasculitis. The Special Master concluded that the petitioner established a reliable medical theory connecting the flu vaccination to G.C.'s urticarial vasculitis, a logical sequence of cause and effect, and a proximate temporal relationship.
The Special Master ruled that G.C. was entitled to compensation, with damages to be determined separately. The decision was issued on September 5, 2019.
The award amount was $145,151.53.
Theory of causation
Petitioner G.C., a minor, received an influenza vaccine on December 3, 2013. Petitioner alleged this vaccine caused urticarial vasculitis. The Special Master found that G.C.'s prior episodes of hives in August and September 2013 were acute and allergic, responding to Benadryl. Post-vaccination, starting approximately five days after December 3, 2013, G.C. developed a rash with swelling, bruising, and leg pain, which was later diagnosed as urticarial vasculitis confirmed by skin biopsy showing IgM and C3 deposition. Petitioner's expert, Dr. Vera Byers, proposed a "bystander activation" theory, positing that the vaccine stimulated the innate immune system, releasing cytokines that activated dormant autoreactive T and B cells, leading to an autoimmune response. This theory was supported by medical literature and deemed a reputable explanation for vaccine-induced autoimmunity. The Special Master found a logical sequence of cause and effect, noting the distinct difference between pre- and post-vaccination symptoms (hives vs. rash with bruising, swelling, and pain). A medically acceptable temporal relationship was established, with symptom onset five days post-vaccination, considered appropriate given prior vaccine exposure and the nature of autoimmune responses. Respondent's expert, Dr. Harry Schroeder, argued the symptoms were similar and the post-vaccination episode was likely viral or environmental, but the Special Master found his assessment did not adequately account for the distinct post-vaccination symptoms and the established medical literature on vaccine-induced autoimmunity. The Special Master ruled in favor of entitlement, finding the flu vaccine was the cause-in-fact of G.C.'s urticarial vasculitis. The decision was issued by Special Master Thomas L. Gowen on September 5, 2019. Petitioner's counsel was Lawrence R. Cohan, and respondent's counsel was Darryl R. Wishard. The award amount was $145,151.53.
Source PDFs
USCOURTS-cofc-1_15-vv-00773