E.A. v. HHS - Varicella, seizure disorder, cerebral injury, Major Neurocognitive Disorder, athetosis, chorea, and/or neurologic, psychiatric, and physical impairments (2024)
Case summary [AI summaries can sometimes make mistakes]
On June 30, 2016, E.A., a 16-year-old female, filed a petition for compensation under the National Vaccine Injury Compensation Program. She alleged that a varicella vaccination administered on July 2, 2013, caused or aggravated seizure disorder, cerebral injury, Major Neurocognitive Disorder, athetosis, chorea, and/or neurologic, psychiatric, and physical impairments.
The petitioner was represented by counsel at the time of filing, but counsel later withdrew. The petitioner, proceeding pro se with the assistance of her mother, faced numerous procedural delays due to personal and family hardships.
The respondent filed a Motion to Dismiss on March 4, 2020, arguing that the petitioner failed to prove causation-in-fact. The petitioner's mother, who is a registered nurse, provided much of the medical history and evidence, and also submitted her own "expert opinion." The Special Master reviewed extensive medical records detailing the petitioner's complex pre-vaccination history, which included learning disabilities, attention deficits, sensory processing issues, and possible developmental delays.
Following the vaccination, the petitioner experienced various symptoms, including tremors, behavioral changes, and alleged seizures. Multiple medical providers evaluated the petitioner.
Some noted potential links to the vaccine based on timing, while others identified alternative explanations or found no definitive evidence of vaccine causation. The Special Master considered expert reports from both sides, including opinions from Dr.
Juan Lacayo and Dr. Lawrence McKean for the petitioner, and Dr.
Max Wiznitzer for the respondent. Dr.
Wiznitzer concluded that there was no evidence the vaccine caused or aggravated any of the petitioner's conditions and that many alleged injuries were not supported by objective medical records or were pre-existing. The Special Master found that the petitioner failed to establish a defined and recognized injury caused by the vaccine and did not meet the three prongs of the Althen test for off-Table claims, specifically lacking a reputable medical theory, a logical sequence of cause and effect, and a proximate temporal relationship.
Consequently, the petition was dismissed. Petitioner counsel was E.A. pro se, respondent counsel was Alexis B.
Babcock, and Special Master was Mindy Michaels Roth.
Theory of causation
Petitioner alleged an off-Table injury, claiming the July 2, 2013 varicella vaccination caused seizure disorder, cerebral injury, Major Neurocognitive Disorder, athetosis, chorea, and/or neurologic, psychiatric, and physical impairments. The petitioner's mother, acting as her representative, submitted extensive medical records and her own "expert opinion," citing Dr. Juan Lacayo and Dr. Lawrence McKean as supporting physicians. Dr. Lacayo opined that the vaccine "can be the causation of her symptomology" and that immunocompromised patients are at higher risk from live vaccines, listing potential adverse events from the vaccine insert. Dr. McKean stated the petitioner had primary immune deficiency and suffered an "adverse reaction to the Varicella Zoster (Shingles) vaccine" with a subsequent decline in cognitive function and neurological symptoms, noting the petitioner's inability to mount an immune response to the vaccine. The mother argued that live vaccines are contraindicated in immunocompromised individuals and proposed theories involving molecular mimicry and residual DNA ingredients. Respondent's expert, Dr. Max Wiznitzer, concluded that no evidence supported a vaccine-related injury, finding that alleged injuries were pre-existing, unsupported by objective medical records, or had alternative explanations such as psychogenic disorder or ADHD. Dr. Wiznitzer also noted that the petitioner's alleged anaphylaxis was not supported by ER records, her tremor predated the vaccine, and her diagnoses of epilepsy, encephalitis, and myasthenia gravis lacked objective evidence or were diagnosed years after vaccination. The Special Master found that the petitioner failed to establish a defined and recognized injury and did not meet the three prongs of the Althen test: (1) a reputable medical theory connecting the vaccine to the injury, (2) a logical sequence of cause and effect, and (3) a proximate temporal relationship. The opinions of Drs. Lacayo and McKean were deemed conclusory and based on temporal association and inaccurate history, while the mother's submissions were not considered expert testimony. The petition was dismissed.
Source PDFs
USCOURTS-cofc-1_16-vv-00785