Alessandra Giannetta v. HHS - Meningococcal, multiple sclerosis (2017)
Case summary [AI summaries can sometimes make mistakes]
On March 26, 2013, Sandro and Nancy Giannetta filed a petition for compensation on behalf of their then-minor child, Alessandra Giannetta, alleging that a meningococcal vaccination received on June 8, 2011, caused her to develop multiple sclerosis (MS). Alessandra Giannetta was 14 and one-half years old at the time of vaccination.
Petitioner's expert, Dr. Lawrence Steinman, proposed a theory of molecular mimicry, suggesting that components of the Menactra vaccine, specifically diphtheria toxoid and meningococcal polysaccharides, could trigger an autoimmune response in susceptible individuals, leading to MS.
Respondent's experts, Dr. Soe Mar and Dr.
Neal Halsey, argued against this theory, citing a lack of epidemiological studies and questioning the relevance of existing research. They attributed petitioner's initial symptoms to musculoskeletal issues or a viral illness.
The court found that petitioner established a plausible medical theory connecting the vaccine to MS through molecular mimicry and demonstrated a logical sequence of cause and effect with a proximate temporal relationship. The court accepted Dr.
Steinman's opinion that the vaccine acted as a trigger for MS in Ms. Giannetta, who may have had a predisposition due to her gender and family history.
The court ruled that the respondent failed to prove an alternative cause for her condition. Consequently, Ms.
Giannetta was found entitled to compensation, and the case proceeded to the damages phase. The Special Master was Mindy Michaels Roth.
Petitioner's counsel included Danielle Strait and Isaiah Kalinowski of Maglio Christopher and Toale, PA. Respondent's counsel included Jennifer Reynaud and Althea Davis of the U.S.
Dept. of Justice. The decision date was September 26, 2017.
Theory of causation
Petitioner Alessandra Giannetta, age 14.5, received the Menactra meningococcal vaccine on June 8, 2011. She developed symptoms of multiple sclerosis (MS), with onset alleged by petitioner's expert, Dr. Lawrence Steinman, to be in July 2011 (42-47 days post-vaccination), and by respondent's expert, Dr. Soe Mar, to be in January 2012. The Special Master, Mindy Michaels Roth, found that petitioner's symptoms began in July 2011, establishing a proximate temporal relationship. Dr. Steinman proposed a theory of molecular mimicry, positing that the meningococcal polysaccharides and diphtheria toxoid in the Menactra vaccine, due to structural similarities with components of the central nervous system (like contactin), could trigger an autoimmune response in a genetically predisposed individual, leading to demyelination and MS. He cited studies on glycan antibodies in MS patients and intrathecal synthesis of antibodies to diphtheria toxoid. Respondent's experts, Dr. Mar and Dr. Neal Halsey, argued that the scientific literature did not support a link between Menactra and MS, questioned the relevance of the cited studies (e.g., animal models, small sample sizes, lack of epidemiological data), and suggested alternative causes like musculoskeletal issues or viral illness. Dr. Mar specifically noted that the chiropractic records indicated peripheral nervous system involvement in July 2011, not central nervous system demyelination. Dr. Halsey emphasized the lack of epidemiological studies linking meningococcal vaccines to MS and distinguished MS from Guillain-Barré Syndrome (GBS), another vaccine-associated neurological condition. The Special Master found Dr. Steinman's theory biologically plausible and fitting the facts of the case, particularly the timing and petitioner's symptoms. The Special Master concluded that the respondent failed to prove an alternative cause for petitioner's MS. Entitlement to compensation was granted, with the case proceeding to damages. Petitioner's counsel: Danielle Strait and Isaiah Kalinowski. Respondent's counsel: Jennifer Reynaud and Althea Davis. Decision Date: September 26, 2017.
Source PDFs
USCOURTS-cofc-1_13-vv-00215