Heavenly S. Lee v. HHS - DTaP, Dandy-Walker Variant, Vermian Hypoplasia, Cerebral Dysgenesis, Diffuse Cortical Atrophy, Thinning Corpus Callosum, Microcephaly, Seizure Disorder, Encephalopathy (2020)
Case summary [AI summaries can sometimes make mistakes]
On July 18, 2013, Ginger M. Martin and Catherine J.
O’Quin, as representatives of the Estate of Heavenly S. Lee, filed a petition for compensation under the National Vaccine Injury Compensation Program on behalf of Heavenly S.
Lee, a minor child. The petition alleged that DTaP, Hib, IPV, and Prevnar vaccines administered on August 2, 2010, and September 28, 2010, caused Heavenly to suffer seizures and encephalopathy associated with brain atrophy, leading to seizure disorder, microcephaly, and developmental delays.
An amended petition also alleged that the vaccinations significantly aggravated a pre-existing Dandy-Walker Variant. Special Master Mindy Michaels Roth issued a decision on October 27, 2020, denying entitlement to compensation.
The public decision details that Heavenly was born with severe congenital brain anomalies, including Dandy-Walker variant, cerebral dysgenesis, vermian hypoplasia, diffuse cortical atrophy, and thinning of the corpus callosum. Medical records indicated a failure to thrive and a declining head circumference from birth, predating the vaccinations.
Experts for both sides agreed that Heavenly had significant congenital brain malformations. Petitioners' expert, Dr.
Lawrence Steinman, opined that the DTaP vaccine components, specifically pertussis toxin and aluminum adjuvant, caused neuronal death and aggravated her condition. Respondent's experts, Dr.
Mark Holmes and Dr. Michael McGeady, concluded that Heavenly's neurological deficits were due to her congenital brain malformations, which were present in utero and not caused or aggravated by the vaccines.
Dr. Weldon Mauney, a treating neurologist, also opined that the DTaP vaccine caused a static encephalopathy, but his opinion was found to be based on questionable facts and inconsistent with the medical records.
The Special Master found that the petitioners failed to establish a sound medical theory connecting the vaccine to the alleged injuries, a logical sequence of cause and effect, or a proximate temporal relationship. The court found that Heavenly's congenital abnormalities were present from birth and that there was no documented adverse reaction following the vaccinations.
The Special Master noted that the evidence did not support a logical sequence of cause and effect or a proximate temporal relationship. Heavenly passed away on January 2, 2020, but her death was attributed to her congenital conditions, not the vaccines.
The petition was denied as petitioners failed to meet their burden of proof for causation. The decision was issued by Special Master Mindy Michaels Roth.
Theory of causation
Petitioners alleged that DTaP, Hib, IPV, and Prevnar vaccines administered on August 2, 2010, and September 28, 2010, caused Heavenly S. Lee's seizures, encephalopathy, microcephaly, and developmental delays, and significantly aggravated a pre-existing Dandy-Walker Variant. Petitioners' expert, Dr. Lawrence Steinman, opined that pertussis toxin and aluminum adjuvant in the DTaP vaccine caused neuronal death and aggravated Heavenly's condition. Respondent's experts, Dr. Mark Holmes and Dr. Michael McGeady, concluded Heavenly's neurological deficits were due to congenital brain malformations present in utero, not vaccine-related. Special Master Mindy Michaels Roth found petitioners failed to establish a sound medical theory, a logical sequence of cause and effect, or a proximate temporal relationship. The Special Master noted Heavenly's congenital abnormalities predated vaccinations and no adverse reaction was documented post-vaccination. The petition was denied. Attorneys for petitioner were Richard Gage and Richard Gage, P.C. Attorney for respondent was Claudia Gangi. Special Master was Mindy Michaels Roth. Decision date: October 27, 2020.
Source PDFs
USCOURTS-cofc-1_13-vv-00486