Alexi Stoev v. HHS - HPV, complex regional pain syndrome (CRPS) to worsen (2023)
Case summary [AI summaries can sometimes make mistakes]
Alexi Stoev, born in April 2001, filed a petition on September 18, 2019, alleging that the Gardasil-9 (HPV-9) vaccine administered on September 19, 2016, caused a significant worsening of his pre-existing Complex Regional Pain Syndrome (CRPS). Alexi Stoev, who was nearly 14 years old at the time of vaccination, had initially developed CRPS in March 2015 following a tripping incident, which led to severe leg pain, difficulty walking, and reliance on mobility aids.
His condition had shown improvement with physical therapy over time. Approximately three weeks after receiving the HPV vaccine, Alexi reported a dramatic worsening of his CRPS symptoms, requiring him to use a wheelchair again.
His parents, both physicians, suspected the vaccine was the cause, citing medical literature suggesting a link between HPV vaccines and CRPS. The Secretary of Health and Human Services disputed this claim, arguing that Alexi had not presented a persuasive medical theory causally linking the vaccine to his condition or a logical sequence of cause and effect.
The Special Master, Christian J. Moran, reviewed extensive expert testimony and medical literature regarding the theory of molecular mimicry, which Alexi's experts proposed.
However, the Special Master found the case series cited by Alexi's experts to be unpersuasive and undermined by larger epidemiological studies from reputable organizations like the European Medicines Agency (EMA) and the World Health Organization (WHO), which found no causal link between HPV vaccines and CRPS. Furthermore, the Special Master found that Alexi's treating physicians, including his parents, did not provide a sufficiently persuasive basis for their opinion that the vaccine caused the flare-up, relying primarily on temporal proximity and discredited literature.
The Special Master also noted that evidence suggested Alexi's CRPS flare-up may have begun prior to the vaccination and that his condition did not appear to be autoimmune in nature, further weakening the proposed causation theory. Ultimately, the Special Master concluded that Alexi had not met his burden of proving by a preponderance of the evidence that the HPV vaccine caused or significantly aggravated his CRPS.
Therefore, his petition for compensation was denied. Petitioner was represented by Brian L.
Cinelli of Schiffmacher Cinelli Adoff LLP, and respondent was represented by Lynn Christina Schlie of the United States Department of Justice. The decision was issued on November 3, 2023.
Theory of causation
Petitioner alleged that the HPV vaccine aggravated his pre-existing Complex Regional Pain Syndrome (CRPS) through the theory of molecular mimicry. Petitioner's experts, including Dr. Robert Nickeson and Dr. Steven Stoev, proposed that the HPV vaccine could trigger an immune-mediated autonomic dysfunction in susceptible individuals due to homology between vaccine components and human proteins, leading to an autoimmune response. Petitioner's parents, both physicians, also suspected the vaccine based on temporal proximity and literature review. Respondent's experts, Dr. Carlos Daniel Rose and Dr. Stephen J. McGeady, argued against this theory, citing a lack of epidemiological evidence supporting a link between HPV vaccines and CRPS, questioning the biological plausibility of molecular mimicry as a mechanism for CRPS aggravation, and noting that petitioner's CRPS did not appear to be autoimmune in nature, citing normal inflammatory markers and lack of response to steroid treatment. The Special Master, Christian J. Moran, found the case series cited by petitioner unpersuasive and undermined by large-scale epidemiological studies from the EMA and WHO, which found no causal link between HPV vaccines and CRPS. The Special Master also found that the opinions of petitioner's treating physicians, including his parents, were not sufficiently persuasive, relying heavily on temporal proximity and discredited literature. The Special Master further noted that evidence suggested the flare-up began prior to vaccination and that the condition was not autoimmune. The petition was denied. Petitioner's counsel was Brian L. Cinelli, and respondent's counsel was Lynn Christina Schlie. The decision date was November 3, 2023.
Source PDFs
USCOURTS-cofc-1_19-vv-01433