Julie F. Terran v. HHS - DPT, seizure episode, afebrile seizures, seizure activity, seizure disorder, encephalopathy, mentally retarded (1998)
Case summary [AI summaries can sometimes make mistakes]
Julie F. Terran, born February 10, 1992, filed a petition for compensation under the National Childhood Vaccine Injury Act on July 12, 1995, on behalf of her daughter, Julie F.
Terran. Julie received her third DPT vaccination on August 10, 1992, at six months old.
The day after vaccination, Julie experienced a seizure episode, followed by four more afebrile seizures the next day. She was hospitalized from August 12-14, 1992, during which she had another seizure.
In total, she experienced approximately twelve minutes of seizure activity in the week following vaccination, with seizures continuing for the next year. Prior to vaccination, medical tests, including an MRI on May 18, 1992, showed no brain abnormalities, and a follow-up by a pediatric neurosurgeon determined her pre-immunization neurological condition to be unremarkable except for moderate strabismus.
After vaccination, MRIs in May and August 1993 showed no structural pathology. On September 13, 1993, her pediatrician noted her as "well appearing" and "neurologically intact." However, in November 1993, her doctor noted a borderline passing score on the Denver Developmental Screening Test, and she is currently mentally retarded, with seizures continuing.
The petitioner argued that the DPT vaccine caused Julie's seizure disorder and encephalopathy, and that recent revisions to the Vaccine Injury Table should not apply retroactively. The Special Master denied compensation.
The petitioner filed a motion for review of the Special Master's decision. The court reviewed the Special Master's decision under an "arbitrary and capricious" standard.
The court addressed the petitioner's arguments regarding the constitutionality of the Table revisions, the validity of the Table regulations, and the retroactive application of the Table modifications. The court found that it lacked jurisdiction to hear the constitutional claim.
It also noted that challenges to the Table regulations must be made in a court of appeals within sixty days of promulgation, which did not occur. Regarding retroactivity, the court found that the Vaccine Act expressly states that revisions apply to petitions filed after the effective date of the regulations, and that the presumption against retroactivity did not apply as Julie did not have a vested right to compensation until a final judgment.
The court then addressed the petitioner's causation in fact argument, focusing on the testimony of Dr. Menkes, a pediatric neurologist.
The Special Master applied the Daubert standard to evaluate the reliability of Dr. Menkes' theory that pertussis toxin can cause seizure disorder and encephalopathy.
The Special Master concluded that Dr. Menkes' theory was not sufficiently reliable, citing lack of human testing, no publication, unknown error rate, and limited support within the scientific community.
The court affirmed the Special Master's application of Daubert, finding it was not arbitrary or capricious to deem the theory unreliable. The Special Master also considered the Institute of Medicine (IOM) reports.
The court found that the IOM report established a causal relationship between DPT vaccination and febrile seizures, but Julie experienced afebrile seizures. The IOM report also addressed chronic nervous system dysfunction meeting National Childhood Encephalopathy Study (NCES) criteria, but Julie did not meet the criteria for acute encephalopathy or complicated seizures.
The court affirmed the Special Master's finding that the petitioner failed to establish causation under the IOM report. The court also rejected the petitioner's argument that the Special Master failed to rule on her clinical explanation of causation, finding that temporal association alone is insufficient and that evidence showing an absence of other causes does not meet the petitioner's affirmative duty to show actual causation.
The court denied the petitioner's motion for review and affirmed the Special Master's denial of compensation. The court directed the clerk to enter judgment accordingly.
Theory of causation
Petitioner alleged that the third DPT vaccination administered on August 10, 1992, to Julie F. Terran, who was six months old, caused her seizure disorder and encephalopathy. The petitioner argued for causation in fact, presenting the theory of Dr. Menkes, a pediatric neurologist, who posited that pertussis toxin could enter a child's brain and cause seizure disorder and potential evolution to retardation. The Special Master applied the Daubert standard to assess the reliability of Dr. Menkes' theory, finding it lacked general acceptance, peer review, testing on humans, and had an unknown error rate, concluding it was not sufficiently reliable. The court affirmed this finding, noting it was not arbitrary or capricious. The Special Master also reviewed the Institute of Medicine (IOM) reports, which found a causal link between DPT and febrile seizures, but not afebrile seizures as experienced by Julie. The IOM also addressed chronic nervous system dysfunction meeting NCES criteria, which Julie did not meet. The court affirmed the Special Master's conclusion that causation was not established under the IOM report. The petitioner's claim was denied by the Special Master and the denial was affirmed by the court. Petitioner's counsel was not named. Respondent's counsel was not named. Special Master Abell presided. The court decision date was July 10, 1998. The case was an "Off-Table" claim, as the petitioner conceded no Table injury under the revised Table and argued causation in fact.
Source PDFs
USCOURTS-cofc-1_95-vv-00451