Zachary Hinkle v. HHS - DPT/DTP, encephalopathy (1995)

On May 18, 1994, Steven Frank, on behalf of Zachary Hinkle, filed a petition under the National Vaccine Injury Act. The petition alleged that Zachary suffered an "on-Table" encephalopathy following a Diphtheria-Pertussis-Tetanus (DPT) vaccination administered on May 20, 1992, and that his death on May 22, 1992, was a sequela of this injury.

The respondent filed a reply report requesting dismissal, asserting that the petitioner failed to demonstrate an on-Table injury and that the record indicated Zachary's death was caused by a viral respiratory illness unrelated to the vaccination. Special Master Laura D.

Millman denied compensation on February 14, 1995, deciding the case based on documentary evidence. Petitioner's counsel filed a motion for review, arguing that their expert, Dr.

William A. Cox, was the only one to identify a cause of death (DPT-related encephalopathy) and that respondent's experts had not offered an alternative explanation.

The government argued that the petitioner had not met the burden of proof. The court, presided over by Judge Horn, reviewed the special master's decision.

Zachary Hinkle was born prematurely on December 24, 1991, with respiratory distress and hyperbilirubinemia, requiring initial nursery treatment before discharge. He experienced several upper respiratory infections in early 1992.

On May 20, 1992, at approximately five months old, he received his first DPT and OPV #1 immunizations from Dr. Linda Schneider, after an exposure to chickenpox.

Following the vaccination, Zachary exhibited a mild febrile illness, upper respiratory symptoms, and irritability. His mother reported that by the early morning of May 22, his fever and congestion seemed to have resolved, he ate, and had a normal diaper.

He was found unresponsive and not breathing later that morning, around 10:00 a.m., and was pronounced dead on arrival at the hospital. The Medical Examiner's Certificate initially listed "Viral Respiratory Illness" as the immediate cause of death, with a later amendment.

The autopsy report noted pulmonary congestion, petechial hemorrhages, and congestion of the spleen and brain, listing viral respiratory illness as the cause of death, with inflammation throughout the respiratory tract. The special master denied compensation, finding that the petitioner had not met the burden of proof to establish an on-Table encephalopathy or that Zachary's death was a sequela of such an injury.

The special master noted that petitioner's expert, Dr. William A.

Cox, opined that Zachary had a DPT-related encephalopathy, citing morphologic changes in the brain and arguing the respiratory illness was insufficient to cause death. Respondent's expert, Dr.

Robert J. Baumann, stated Zachary did not have an encephalopathy linked to the DPT vaccination and attributed his irritability to an upper respiratory infection (URI), noting that Zachary's symptoms resolved hours before his death.

Respondent's other expert, Dr. Marie Valdes-Dapena, attributed the death to Sudden Infant Death Syndrome (SIDS) and stated Zachary did not have an encephalopathy, noting his minor respiratory illness would not have been expected to cause death.

The special master found that the medical records did not substantiate increased intracranial pressure, bulging fontanel, or convulsions, and that persistent inconsolable crying alone was insufficient to prove encephalopathy. Crucially, the special master found that Zachary had "recovered" from any reaction before his death, as he resumed normal functioning, eating, and sleeping.

The special master also noted that Dr. Cox failed to adequately address the cessation of symptoms hours before death and did not explain how Zachary's death was a result of encephalopathy, especially given the apparent recovery.

The court affirmed the special master's decision, finding it was not arbitrary, capricious, or contrary to law. The court held that the petitioner failed to establish an on-Table encephalopathy or causation, and therefore, the burden did not shift to the respondent to prove an alternative cause of death.

No compensation was awarded. Petitioner was represented by Steven Frank, and respondent was represented by counsel for the government.

The Special Master was Laura D. Millman, and the reviewing judge was Horn.