R.W. v. HHS - DTaP, encephalopathy, with an aggravation of feeding problems, dysphagia, lack of coordination, and sensory and speech disturbances (2016)
Case summary [AI summaries can sometimes make mistakes]
On April 24, 2014, Cassie and Richard Wolf filed a petition on behalf of their minor child, R.W., seeking compensation under the National Vaccine Injury Compensation Program. They alleged that the DTaP and influenza vaccines R.W. received on December 12, 2011, caused him to develop encephalopathy, leading to language and other developmental impairments.
R.W. was born on July 16, 2011. Feeding and swallowing problems were noted early in his life.
He received his first DTaP, Hib, and rotavirus vaccines on September 13, 2011, and his second DTaP, Hib, rotavirus, and first flu vaccine on December 16, 2011. Mrs.
Wolf asserted that R.W. seemed lethargic, had a fever, and vomited the day after the December 2011 vaccinations, and subsequently experienced gagging and coughing with solid foods. Medical records from January 2012 through early 2013 noted feeding issues, and by November 2012, R.W. failed a verbal skill developmental test, leading to a preliminary assessment of a language-related developmental disorder.
In February 2013, over a year after the vaccinations, a physician diagnosed R.W. with encephalopathy, unspecified, and global developmental delay, noting red flags for autism. Another treater in May 2013 concurred with the autism red flags and characterized his symptoms as neurological in origin, representing an encephalopathy.
Petitioners' experts, Dr. Phillip DeMio and Dr.
Harvey Cantor, opined that the vaccines caused R.W.'s neurological and developmental abnormalities, suggesting a mechanism involving proinflammatory cytokine expression. Respondent argued that the petitioners failed to meet their burden of proof, citing a lack of objective evidence of a vaccine reaction and a weak causation theory.
Special Master Brian H. Corcoran denied the petition, finding that the record lacked objective evidence of an encephalopathy at or around the time of vaccination.
The Special Master also found that the proposed causation theory involving cytokine expression had been repeatedly rejected in similar cases and that the alleged developmental problems predated or were not clearly linked to the vaccinations. The Special Master concluded that the court found no reliable medical theory or logical sequence of cause and effect to establish that the vaccines caused R.W.'s condition, and the temporal relationship was insufficient to prove causation.
The petition was denied.
Theory of causation
Petitioners alleged that the DTaP and influenza vaccines administered on December 12, 2011, caused R.W. to develop encephalopathy, leading to language and developmental impairments. Petitioners' experts, Dr. Phillip DeMio and Dr. Harvey Cantor, opined that the vaccines caused R.W.'s neurological and developmental abnormalities, suggesting a mechanism involving proinflammatory cytokine expression. Dr. DeMio suggested aluminum adjuvants and vaccine combinations could lead to a pathologic response damaging immune, neurologic, and metabolic systems. Dr. Cantor proposed proinflammatory cytokine expression post-vaccination as the pathophysiological mechanism, consistent with Mrs. Wolf's reports of R.W.'s immediate post-vaccination reaction. Respondent argued that petitioners failed to meet their burden of proof due to a lack of objective evidence of a vaccine reaction and a weak causation theory. Special Master Brian H. Corcoran denied the petition, finding a lack of objective evidence of an encephalopathy at or around the time of vaccination, that the cytokine expression theory had been repeatedly rejected in similar cases, and that the alleged developmental problems predated or were not clearly linked to the vaccinations. The Special Master concluded that the record lacked a reliable medical theory or logical sequence of cause and effect to establish vaccine causation, and the temporal relationship was insufficient. The petition was denied.
Source PDFs
USCOURTS-cofc-1_14-vv-00342