Devon Stapleford v. HHS - Varicella, seizure disorder with developmental delay (2009)

On January 31, 2003, Ka-thaleen Stapleford filed a petition under the National Vaccine Injury Compensation Program on behalf of her son, Devon Stapleford, alleging that the varicella vaccine administered on January 24, 2001, caused his seizure disorder and subsequent developmental delay. Devon, who was 13 months old at the time of vaccination, experienced his first seizure the morning after receiving the varicella and pneumococcal vaccines.

He was taken to the emergency room, where a seizure disorder was diagnosed, and he was discharged symptom-free. Three days later, he was readmitted after a grand mal seizure, and subsequent seizures occurred one to three times per week, leading to the initiation of anti-seizure medication.

Devon's mother also reported that he had experienced seizures the day after receiving DTP and HiB vaccines at an earlier visit. Over the following months, Devon began exhibiting signs of developmental delay, including speech difficulties and behavioral disturbances, and by 2002, his neurologist diagnosed him with "pervasive developmental delay" and "complex behavioral problems" similar to autism.

Devon's medical records indicated that his older brother had similar seizure and developmental problems, suggesting a potential familial or genetic component. The petition asserted an "off-table" claim, meaning it did not qualify for a presumption of causation and required proof by a preponderance of the evidence that the vaccine caused the injury.

The case involved competing expert testimony. Petitioner's expert, Dr.

Griesemer, acknowledged Devon's genetic predisposition to neurodevelopmental problems and stated that he likely would have experienced seizures and developmental issues even without the vaccine. However, Dr.

Griesemer argued that the varicella vaccine caused Devon's seizures to occur earlier than they otherwise would have, and that these early seizures themselves led to additional brain injury, resulting in a worse developmental outcome. Respondent's expert, Dr.

Snodgrass, also agreed that Devon was genetically predisposed but rejected the vaccine-as-trigger theory. Dr.

Snodgrass further testified that even if the vaccine had triggered the early seizures, they were not of a type or frequency sufficient to have caused or worsened Devon's later developmental problems. Special Master George Hastings denied compensation, finding that the petitioner failed to meet the three prongs of the Althen test for off-table claims.

The Special Master concluded there was no preponderant medical theory that the varicella vaccine can cause seizures, citing a lack of association in relevant epidemiological literature, including a postmarketing safety study. He also found no logical sequence of cause and effect, as none of Devon's treating physicians affirmatively attributed the seizures to the vaccine, with most stating the cause was unknown.

Furthermore, the Special Master found that petitioner's expert, Dr. Griesemer, failed to establish a medically acceptable temporal proximity, as he could not specify a timeframe after vaccination within which a vaccine-induced seizure would be expected.

The Special Master credited Dr. Snodgrass's testimony over Dr.

Griesemer's. The United States Court of Federal Claims, in an opinion by Judge Block, affirmed the Special Master's decision on October 19, 2009.

The court found that the Special Master had considered the relevant evidence, drawn plausible inferences, and articulated a rational basis for the decision, and that the decision was not arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. The court rejected the petitioner's arguments that the Special Master had impermissibly raised the standard of proof, failed to consider circumstantial evidence or treating physician opinions, required a mechanism of injury, or misinterpreted the respondent's expert testimony.

The court affirmed the Special Master's conclusion that the varicella vaccine did not cause Devon's injury and dismissed the petition with prejudice. Petitioner's counsel was not named in the provided text.

Respondent's counsel was not named in the provided text. The award amount was null.