Rebecca Golub v. HHS - IPV/Polio, HIB meningitis with seizure disorder, developmental delay, and cortical damage (1999)

Rebecca Golub, born July 14, 1972, received diphtheria-pertussis-tetanus (DPT) and oral polio (OPV) vaccinations on September 14, 1972. Her parents, Ralph J. and Adrienne M.

Golub, sought compensation under the National Childhood Vaccine Injury Act of 1986 for injuries their daughter allegedly suffered as a result of these vaccinations, specifically Hemophilus Influenza Type B (HIB) meningitis, which they claimed led to a seizure disorder, developmental delay, and cortical damage. The public decision does not describe the specific counsel involved in the case.

According to the petition, on September 18, 1972, Rebecca began feeding poorly. The following day, she became lethargic and developed a fever of 104.8 degrees Fahrenheit.

On September 20, 1972, her pediatrician referred her to Children's Hospital Medical Center. There, doctors observed a bulging fontanelle and a stiff neck.

Spinal fluid testing confirmed HIB meningitis. Rebecca was hospitalized and treated with high doses of ampicillin and Decadron.

Despite treatment, she experienced generalized seizures, shock, and disseminated intravascular coagulation. She was discharged on October 21, 1972, and subsequently suffered from seizure disorder, developmental delay, and cortical damage.

The public decision does not detail the specific medical tests performed beyond the initial spinal fluid analysis, nor does it describe the specific treatments administered beyond ampicillin and Decadron, or the long-term management of her conditions. Petitioners' expert, Dr.

Leon D. Sabath, testified that the DPT and OPV vaccinations more likely than not caused Rebecca's HIB meningitis and subsequent neurological injuries.

Dr. Sabath proposed a theory of "antigen-induced, transient immunosuppression," suggesting that vaccine antigens temporarily lower a child's immune defenses for about two weeks, making a child already colonized with HIB hyper-susceptible to fulminant infection.

He cited animal studies, a human study involving tetanus toxoid immunization and T-cell changes, an untranslated German article, and his own unpublished abstract examining children with purulent meningitis. Dr.

Sabath opined that Rebecca was likely asymptomatically carrying HIB before vaccination and that the vaccine antigens, rather than community exposure, triggered the immune change allowing HIB to become invasive. He reasoned that community exposure was unlikely given that Rebecca stayed home with her mother and siblings.

Respondent's expert, Dr. W.

Paul Glezen, disagreed, testifying that there was no evidence of increased HIB risk following DPT vaccination and citing studies that found no consistent relationship between DPT immunization and later invasive bacterial disease. He stated that Rebecca's illness was typical for an infant her age, as bacterial meningitis risk is greater in young infants, and that serious infections can occur in unvaccinated children.

Dr. Glezen criticized Dr.

Sabath's supporting studies as irrelevant, not applicable to human bacterial disease, or methodologically flawed. He suggested that Rebecca's infection was more likely due to the natural dissipation of maternal antibodies by the time she was two months old, coinciding with the natural disappearance of protective antibodies.

The Special Master denied compensation, finding that the petitioners had not proven causation-in-fact under the standard set forth in Grant v. Secretary of the Department of Health & Human Services.

While acknowledging Dr. Sabath's theory as plausible, the Special Master found the supporting evidence unpersuasive and credited Dr.

Glezen's testimony and literature. The Special Master applied a two-step analysis: first, whether vaccines can cause hyper-vulnerability to HIB, and second, if so, whether they did in Rebecca's case.

The Special Master found petitioners failed the first step, deeming the animal studies and the AIDS study irrelevant, and giving little weight to Dr. Sabath's unpublished abstract due to its lack of peer review and general acceptance.

The Special Master also found that even if the first step were met, petitioners failed the second step, as there was no direct medical evidence or biological markers to show that the vaccinations caused Rebecca's susceptibility, and other antigen exposures were possible. Judge Roger B.

Andewelt affirmed the denial on August 30, 1999. The court held that the Special Master had appropriately weighed conflicting expert testimony, found Dr.

Glezen more persuasive, reasonably gave little weight to Dr. Sabath's unpublished abstract, and did not abuse discretion by declining further discovery into unpublished research concerning adenylate cyclase removal from the pertussis vaccine.

No compensation was awarded.