Ashley Flanagan v. HHS - DPT, convulsions (2000)

On September 21, 1990, Veronica Flanagan filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986 on behalf of her daughter, Ashley Flanagan. Ashley, born September 4, 1980, received her third diphtheria-pertussis-tetanus (DPT) vaccination on March 26, 1981, after two prior DPT vaccinations without reported incident.

Within approximately six hours of the March 26, 1981 vaccination, Ashley experienced convulsions and was taken to the Stormont-Vail Emergency Room. She had a temperature of 101.2 degrees Fahrenheit, vomited, and appeared listless and unresponsive to verbal stimulation.

However, upon admission, she exhibited eye contact, rolled over, and attempted to crawl, appearing alert and happy. The attending physician, Dr.

David Kelly, initially considered a febrile convulsion and ruled out tuberous sclerosis (TS). Four days later, on March 30, 1981, Ashley underwent a neurological examination that yielded normal results.

Medical records noted depigmentation, and a CT scan was scheduled for a TS evaluation. Ashley's CT scan results on April 3, 1981, revealed the presence of tubers, indicating TS.

Her EEG on April 16, 1981, was normal. On May 22, 1981, Ashley was seen by Dr.

Joseph M. Stein for a neurological consultation, during which she had a second seizure with fever (103 degrees Fahrenheit).

Dr. Stein concluded this was a febrile seizure possibly related to her underlying TS, and Ashley was placed on Phenobarbital.

She was hospitalized until May 24, 1981, and a urine culture revealed pyelonephritis. From June through December 1981, Ashley experienced respiratory infections and a viral syndrome with fevers, vomiting, and weight loss.

During this period, her developmental and neurological milestones were noted as normal for her age. On January 5, 1982, Ashley received an MMR vaccination.

Ten days later, on January 15, 1982, she had a third seizure lasting 15 minutes, accompanied by a fever of 103 degrees Fahrenheit. Dr.

Gregory J. Van Sickle diagnosed TS and resolving viral syndrome, continuing Phenobarbital.

Ashley continued to experience illnesses and fevers through May 1983, with normal developmental and neurological examinations. In May 1983, she had a seizure lasting approximately an hour with a 106-degree fever.

By April 18, 1985, Ashley had experienced a total of five generalized seizures, the longest lasting 60 minutes. Her last seizure at that time had occurred 18 months prior.

A neurologist, Dr. R.E.

Baska, noted a short attention span, possibly due to Phenobarbital, but normal intelligence and neurological function, with normal EEG results. Ashley was off Phenobarbital by June 6, 1986, without issue, and her growth rate and examinations were normal, except for facial nodules associated with TS.

From January 1988 through 1989, Ashley's seizures became more frequent, exhibiting focal jerking, incontinence, and muttering, lasting 11 to 20 seconds. She was placed on Tegretol and later Depakote.

By June 23, 1989, she was having four to five seizures over a four-day period monthly. On November 11, 1989, Dr.

Van Sickle questioned if these predictable monthly seizures were hormonal. By April 24, 1990, the seizures had changed, lasting 30 seconds with shrill cries and arm movements, followed by headaches.

Dr. Baska evaluated Ashley again on March 6, 1991, noting at least one seizure weekly, sometimes four to eight daily, lasting a few seconds with specific movements and noises.

Her school performance and behavior had deteriorated. In June 1990, she began taking Diamox.

On June 15, 1991, Dr. Peter Huttenlocher, a pediatric neurologist and TS expert, recommended summer school, counseling, and medication trials, suggesting epilepsy surgery if seizure control did not improve, due to focal seizures and a tuber in the left temporal area.

Petitioner argued that the DPT, and at times MMR, vaccinations caused or significantly aggravated Ashley's seizure disorder and TS-related neurologic course. Petitioner's expert, Dr.

Marcel Kinsbourne, testified that DPT caused Ashley's seizures. Respondent's expert, Dr.

Gregory Holmes, testified that Ashley's neurologic impairment was due to TS, and that the DPT-related fever may have triggered an isolated febrile seizure without lasting neurologic significance. The Special Master denied entitlement after remand and further expert proceedings.

On review, Judge Miller sustained the denial on November 6, 2000, finding that the special master's reliance on Dr. Holmes' testimony was not arbitrary or capricious, that the burden of proof was not improperly allocated, and that the special master's legal reasoning was in accordance with the law, particularly citing the lengthy passage of time between vaccination and developmental delay as significant.

No vaccine-injury compensation was awarded.