K.T. v. HHS - MMR, Myoclonic-Astatic Epilepsy (MAE) / Epileptic Encephalopathy (EE) (2017)
Case summary [AI summaries can sometimes make mistakes]
On July 27, 2012, Alisha Dudenhoeffer, on behalf of her minor daughter K.T., filed a petition for compensation under the National Vaccine Injury Act of 1986. Petitioner alleged that K.T. developed Myoclonic-Astatic Epilepsy (MAE), also known as Doose Syndrome, and Epileptic Encephalopathy (EE) as a result of receiving the Measles-Mumps-Rubella (MMR) vaccine on August 6, 2009.
K.T. was born on August 1, 2008. Prior to the MMR vaccination, K.T. had a history of a febrile seizure in April 2009.
Following the MMR vaccine, K.T. began experiencing episodes of unresponsiveness, eye rolling, and arm limpness, which were diagnosed as seizures. Her condition was treated with various medications, including Keppra, Zonisamide, and Depakote.
Petitioner presented expert testimony from Dr. Yuval Shafrir, who theorized that the MMR vaccine could cause MAE through molecular mimicry, specifically by inducing antibodies against contactin-associated protein-like 2 (Caspr2).
Respondent presented expert testimony from Dr. Gregory Holmes, who opined that the MMR vaccine was not related to K.T.'s seizure episodes and that there was no credible evidence linking the MMR vaccine to autoimmune disease or epilepsy.
The Special Master, Lisa Hamilton-Fieldman, denied compensation on September 8, 2016. The Special Master found that while K.T. did have EE, Petitioner failed to establish a plausible medical theory linking the MMR vaccine to MAE and failed to demonstrate a logical sequence of cause and effect.
The court, Judge Patricia E. Campbell-Smith, affirmed the Special Master's decision on May 22, 2017, agreeing that Petitioner had not met her burden of proof under the Althen standard for causation-in-fact, particularly regarding the lack of a persuasive medical theory and a logical sequence of cause and effect.
The court noted that temporal proximity alone was insufficient to establish causation. The petition was ultimately denied.
Petitioner was represented by Clifford John Shoemaker of Shoemaker and Associates, and Respondent was represented by Darryl R. Wishard of the United States Department of Justice.
Theory of causation
Petitioner alleged that the MMR vaccine administered on August 6, 2009, caused K.T., a minor, to develop Myoclonic-Astatic Epilepsy (MAE) and Epileptic Encephalopathy (EE). Petitioner's expert, Dr. Yuval Shafrir, proposed a theory of molecular mimicry, suggesting that the MMR vaccine could trigger an autoimmune response where antibodies created against vaccine components mistakenly attack the body's own tissues, specifically targeting contactin-associated protein-like 2 (Caspr2), leading to epilepsy. Dr. Shafrir cited studies linking Caspr2 antibodies to epilepsy and developmental regression, and a study involving mice that showed elevated antibody binding to Caspr2 sequences similar to those in viruses. Respondent's expert, Dr. Gregory Holmes, countered that the proposed mechanism was speculative, citing limitations in the cited studies, including their focus on autism rather than epilepsy, the use of pertussis virus components (not in MMR), and artificial experimental conditions. Dr. Holmes stated there was no convincing evidence linking the MMR vaccine to epilepsy or MAE. The Special Master denied compensation, finding Petitioner failed to establish a plausible medical theory (Althen Prong 1) and a logical sequence of cause and effect (Althen Prong 2). The court affirmed, agreeing that the analytical gap between the proposed mechanism and the injury was too great and that temporal proximity alone was insufficient. The decision was issued by Special Master Lisa Hamilton-Fieldman on September 8, 2016, and affirmed by Judge Patricia E. Campbell-Smith on May 22, 2017. Petitioner was represented by Clifford John Shoemaker, and Respondent by Darryl R. Wishard.
Source PDFs
USCOURTS-cofc-1_12-vv-00477