Mario Caruso v. HHS - Influenza, acute disseminated encephalomyelitis (2018)
Case summary [AI summaries can sometimes make mistakes]
Mario Caruso, a 64-year-old adult, filed a petition for compensation under the National Vaccine Injury Compensation Program on October 18, 2017, alleging that he developed acute disseminated encephalomyelitis (ADEM) as a result of receiving a trivalent influenza vaccine on October 16, 2012. Petitioner's family reported noticing behavioral changes, fatigue, and vision difficulties starting around November 2012.
Mr. Caruso sought medical attention in late January 2013 for gait problems, diagnosed as dizziness and a gait disorder.
Subsequent MRIs in March 2013 revealed multifocal signal abnormalities consistent with demyelination, and ADEM became the confirmed diagnosis. The case proceeded to an entitlement hearing.
Special Master Brian H. Corcoran issued a decision on October 18, 2017, denying entitlement.
The Special Master found that Mr. Caruso failed to meet his burden of proof for causation.
Specifically, the decision noted that the onset of symptoms, occurring approximately two months after vaccination (late December 2012), was too temporally distant to be medically acceptable for vaccine-induced ADEM, citing scientific literature suggesting a shorter onset window. Furthermore, the Special Master determined that Mr.
Caruso's presentation was an atypical, halting form of ADEM, which differed from the acute onset typically associated with vaccine-induced cases, and that reliable science linking vaccines to ADEM did not apply to his circumstances. Petitioner Mario Caruso filed a motion for review of this decision.
On April 6, 2018, Senior Judge Loren A. Smith of the U.S.
Court of Federal Claims issued an opinion denying the motion for review. The court upheld the Special Master's findings, agreeing that Mr.
Caruso had not met his burden of proof under the Althen criteria, particularly regarding the proximate temporal relationship and the logical sequence of cause and effect for an atypical presentation of ADEM. The court found no arbitrary or capricious action by the Special Master in weighing the evidence, including fact testimony and medical records, and affirmed the denial of compensation.
Theory of causation
Petitioner Mario Caruso, aged 64, received an influenza vaccine on October 16, 2012, and alleged developing acute disseminated encephalomyelitis (ADEM). The claim was for a "Non-Table Injury." Petitioner's counsel was Joseph Pepper and Ronald Craig Homer. Respondent's counsel was Darryl Wishard. Special Master Brian H. Corcoran denied entitlement on October 18, 2017. The court, Senior Judge Loren A. Smith, denied petitioner's motion for review on April 6, 2018. Petitioner's expert was Dr. Carlo Tornatore, who opined ADEM was triggered by the flu vaccine via molecular mimicry or B and T cell activation, suggesting onset within a month, and citing the Poser study for a longer onset window. Respondent's expert was Dr. Thomas Leist, who opined the symptoms were not ADEM or, if they were, not vaccine-caused, citing literature (Rowhani-Rahbar, Noorbakhsh, Tenembaum) supporting a 5-28 day, or at most 42-day, interval for vaccine-induced ADEM. The Special Master found the first Althen prong (medical theory) satisfied, acknowledging prior cases linking flu vaccines to ADEM. However, the Special Master found the second prong (logical sequence) not met due to Mr. Caruso's "atypical ADEM" with a halting, non-acute onset, distinguishing it from the acute form discussed in literature. The third prong (proximate temporal relationship) was also not met, as the earliest medically supported onset was late December 2012 (approx. 60 days post-vaccination), exceeding the 2-42 day window cited in Rowhani-Rahbar and other literature. The court affirmed the Special Master's denial, finding no arbitrary action in weighing evidence and upholding the conclusion that petitioner failed to meet the burden of proof, particularly regarding the temporal proximity and atypical presentation of the injury.
Source PDFs
USCOURTS-cofc-1_15-vv-00200