A.P.M. v. HHS - DTaP, autistic regression, apraxia of speech, and Autism Spectrum Disorder (ASD) features (2016)

On April 17, 2008, Tisha Mette and Ryan R. Mette, parents and natural guardians of A.P.M., a minor, filed a petition seeking compensation under the National Vaccine Injury Compensation Program.

They alleged that the DTaP vaccine administered to A.P.M. on July 14, 2006, caused his autistic regression, leading to apraxia of speech and Autism Spectrum Disorder (ASD) features. The respondent, the Secretary of Health and Human Services, contested the claim.

An entitlement hearing was held on July 28-29, 2015. Petitioners' counsel was Robert Joel Krakow, and respondent's counsel was Lynn Ricciardella.

Special Master Brian H. Corcoran issued a decision on August 9, 2016, denying compensation.

The Special Master found that petitioners failed to establish that A.P.M. suffered from any form of cerebral folate deficiency, a critical component of their causation theory. The medical records showed A.P.M.'s cerebrospinal fluid (CSF) folate levels were within the normal range, and he did not exhibit the severe clinical features of infant-onset cerebral folate deficiency.

Petitioners' expert, Dr. Yuval Shafrir, conceded that A.P.M. did not have classic cerebral folate deficiency and proposed a novel, undelineated syndrome.

The Special Master also found the theory unreliable, noting the lack of scientific literature linking vaccines to the production of folate receptor blocking autoantibodies and the greater homology between bovine milk proteins and folate receptors, which petitioners' own literature supported. Furthermore, the Special Master found that the Althen prongs for causation were not met: Prong One (reliable and plausible theory) failed due to Dr.

Shafrir's lack of expertise in immunology and metabolic disorders, the unreliability of the proposed theory, and the contradictory evidence regarding bovine milk. Prong Two (logical sequence of cause and effect) failed because the contemporaneous medical records did not support the alleged post-vaccination reaction suggesting an autoimmune process, and the reported timing of A.P.M.'s regression varied.

Prong Three (medically acceptable temporal relationship) failed because the proposed timeframe was too broad and unsupported by specific medical understanding of the alleged autoimmune process. On August 9, 2016, Special Master Corcoran denied the claim, stating, "This is not a close case." Petitioners moved for review, and on July 26, 2017, Judge Victor Wolski of the Court of Federal Claims denied the motion, sustaining the Special Master's decision.

An interim award for attorney's fees and costs was made on December 21, 2015, totaling $190,093.42.