DAC v. HHS - DTP, autism spectrum disorder (2016)
Case summary [AI summaries can sometimes make mistakes]
On July 6, 2004, Darius and Teresita Canuto filed a petition under the National Vaccine Injury Compensation Program on behalf of their son, DAC, alleging that his DTP and DTaP vaccinations caused his autism spectrum disorder (ASD). DAC was born on July 17, 2000, in the Philippines.
He received his first two DTP vaccinations in the Philippines in September and November 2000. After relocating to California, DAC received his third DTaP vaccination in January 2001 and a fourth DTaP vaccination in December 2001.
DAC's pediatricians began noting potential developmental delays around August 2001, when he was one year old. By October 2003, he was diagnosed with severe expressive and receptive language disorder.
In March 2004, a developmental pediatrician diagnosed him with autism, citing delayed language skills, difficulty interacting with peers, and limited play. A March 2006 assessment confirmed the autism diagnosis.
The petitioners also alleged that DAC suffered post-vaccination seizures, but contemporaneous medical records did not document these. Petitioners' expert, Dr.
Mark Levin, opined that the DTP vaccinations caused DAC's autism, citing the temporal relationship between vaccination and onset and general increases in autism rates. Respondent's expert, Dr.
Max Wiznitzer, a pediatric neurologist, opined that DAC's developmental trajectory was typical for ASD and that there was no evidence of vaccine-induced encephalitis or encephalopathy. Special Master George L.
Hastings issued a decision on January 19, 2016, finding Dr. Wiznitzer more persuasive.
The Special Master concluded that the petitioners failed to establish causation under the three prongs of the Althen test, noting that Dr. Levin's report was unpersuasive, lacked scientific support, and contained factual errors regarding DAC's vaccination history.
The Special Master found that DAC's medical records did not support the alleged seizures and that his developmental trajectory was consistent with a natural autism diagnosis. The Court of Federal Claims, in an opinion and order dated May 3, 2016, affirmed the Special Master's decision, finding it was not arbitrary, capricious, or otherwise not in accordance with the law.
The court agreed that the Special Master had thoroughly considered the evidence, including expert testimony and medical records, and had rationally based the decision on the lack of demonstrated causation.
Theory of causation
Petitioners alleged that DAC's DTP and DTaP vaccinations caused his autism spectrum disorder (ASD). Petitioners' expert, Dr. Mark Levin, opined that the DTP vaccinations caused DAC's autism, citing a temporal relationship between vaccination and onset, and general increases in autism rates. He also suggested a link between vaccine-induced encephalitis/encephalopathy and autism. Respondent's expert, Dr. Max Wiznitzer, a pediatric neurologist, opined that DAC's developmental history was consistent with a typical ASD trajectory and that there was no evidence of encephalitis or encephalopathy. The Special Master found Dr. Wiznitzer more persuasive, concluding that Dr. Levin's report was unpersuasive, lacked scientific basis, and contained factual inaccuracies. The Special Master determined that petitioners failed to meet the Althen test for causation-in-fact, finding no credible medical theory, logical sequence of cause and effect, or proximate temporal relationship linking the vaccines to DAC's ASD. The Special Master noted the absence of contemporaneous medical records supporting alleged seizures and concluded that DAC's condition was not vaccine-related. The Court of Federal Claims affirmed the Special Master's decision, finding no arbitrary or capricious error in the rejection of the causation theory.
Source PDFs
USCOURTS-cofc-1_04-vv-01128