Hayley Graves v. HHS - Pneumococcal, seizures, intractable seizures, status epilepticus, hypoxic encephalopathy, death (2011)

On September 16, 2002, petitioners Walter and Lisa Graves filed a petition for vaccine injury compensation under the National Childhood Vaccine Injury Act of 1986 on behalf of their daughter, Hayley Graves. Hayley, born November 4, 1999, received a Prevnar (pneumococcal conjugate) vaccination and a hepatitis B vaccination on August 8, 2000, at approximately nine months of age.

Two days later, on August 10, 2000, Hayley experienced uncontrollable seizures on the left side of her body. She was taken to Cook Children's Medical Center, where she was diagnosed with ongoing electrical seizure activity.

Despite extensive treatment with multiple anticonvulsant medications and supportive care in the pediatric intensive care unit, her seizures were unremitting. She was transferred to Hermann Hospital Epileptic Center on August 29, 2000, where she remained under specialized care for 26 days.

Hayley died on September 24, 2000. Her death certificate listed the immediate cause as status epilepticus and the underlying cause as intractable seizures.

The autopsy concluded she died from hypoxic encephalopathy following a seizure. The petitioners alleged that the Prevnar vaccine caused Hayley's seizures and death.

Petitioners' experts, immunologist Dr. Vera Byers and pediatric neurologist Dr.

Marcel Kinsbourne, proposed a theory that the Prevnar vaccine could trigger a biochemical cascade, producing interleukin-1 beta (IL-1β) and other cytokines, which are known seizure triggers. They suggested this process could occur within hours to two to three days after vaccination, with or without fever.

Hayley's treating pediatric neurologist, Dr. James Wheless, also opined that the Prevnar vaccine was associated with the onset of her intractable seizures and death.

Respondent's expert, Dr. Michael Kohrman, disagreed with the petitioners' causation theory, questioning whether IL-1β could cause seizures in the absence of a fever and arguing that the doses of IL-1β cited in the literature were far higher than what could have been present in Hayley's system.

Special Master Hastings issued two decisions denying compensation, first in Graves I (October 14, 2008) and again on remand in Graves II (September 21, 2010). The Special Master found that the petitioners had not proven by a preponderance of the evidence that Prevnar caused the onset of Hayley's seizures, particularly in the absence of a fever, and that the literature cited did not support the theory that IL-1β could cause seizures in the amounts potentially present in Hayley's system.

The Special Master also concluded that the Prevnar vaccine did not cause the intractability or duration of Hayley's seizures. The petitioners sought review of these decisions.

On July 5, 2011, the United States Court of Federal Claims, in an opinion by Senior Judge Merow, reversed the Special Master's decisions. The court found that the Special Master had set the burden of proof too high, improperly focusing on the absence of fever and according insufficient weight to the testimony of treating physician Dr.

Wheless. The court also found that the Special Master had improperly discounted the medical research underlying Dr.

Byers's theory regarding IL-1β and seizure duration. The court concluded that the petitioners had presented sufficient evidence of a medically plausible theory connecting Prevnar to the onset, duration, and intractability of Hayley's seizures.

The court reversed the denial of compensation and remanded the case to the Special Master for a determination of damages. The court noted that the Prevnar vaccine is covered under the Vaccine Injury Table, but this case proceeded as an off-table claim requiring proof of actual causation.