Trisha Estep v. HHS - DPT, encephalopathy with permanent neurological sequela, including mental retardation and developmental delays (1993)

Trisha Estep, an infant, received a diphtheria-pertussis-tetanus (DPT) vaccination on July 3, 1985. Several days after the vaccination, her behavior changed, characterized by inconsolable screaming and crying for months, sleeping no more than thirty minutes at a time, unresponsiveness, and disinterest in her surroundings.

Her pediatrician later observed developmental delays, and she ultimately suffered permanent neurological sequelae, including mental retardation and developmental delays. Trisha's mother filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that the DPT vaccine caused her to suffer an encephalopathy.

Special Master Paul T. Baird conducted two factual hearings and determined that Trisha had suffered an encephalopathy, with symptoms beginning four days post-vaccination.

Because this onset fell outside the three-day period specified in the Vaccine Injury Table, the claim required proof of actual causation. The Special Master found that the DPT vaccine can cause encephalopathy and that it more likely than not caused Trisha's condition.

He issued decisions awarding compensation on November 3, 1992, and January 26, 1993. The respondent, the Secretary of Health and Human Services, sought review, arguing that the petitioner had not presented a reputable medical or scientific explanation supporting causation.

The petitioner's experts, Dr. Mark R.

Geier and Dr. Thomas A.

Schweller, testified that the DPT vaccine can cause chronic encephalopathy. Dr.

Geier based his opinion on case reports, animal testing, the biological properties of the pertussis bacterium, controlled studies like the National Childhood Encephalopathy Study, and adverse event monitoring data. Dr.

Schweller testified that DPT can cause acute encephalopathy and that any agent causing acute encephalopathy can also cause chronic neurological damage. The respondent's expert, Dr.

Joel Herskowitz, disagreed that Trisha's injury was an encephalopathy but acknowledged that evidence suggests DPT can often cause acute encephalopathy and that many causes of acute encephalopathy can also lead to chronic damage. Judge Lawrence S.

Margolis affirmed the Special Master's award on June 25, 1993. The court held that the Special Master applied the correct causation-in-fact standard and reasonably found a reputable medical or scientific theory supporting a logical sequence of cause and effect.

The court also found that the Special Master was not obligated to treat the Institute of Medicine report as dispositive and had adequately explained the weight given to the expert testimony and other evidence. The public decision does not state the compensation amount awarded.