B.P. v. HHS - DTaP, encephalopathic developmental regression into autism, as well as immunoglobulin deficiencies, exacerbated by underlying mitochondrial dysfunction (2017)
Case summary [AI summaries can sometimes make mistakes]
On January 27, 2014, Christina E. Pope, on behalf of her minor son B.P., filed a petition seeking compensation under the National Vaccine Injury Compensation Program.
The petition alleged that the Diphtheria Tetanus acellular-Pertussis (DTaP) and pneumococcal conjugate (PCV) vaccines B.P. received on May 11, 2011, caused him to develop an encephalopathic developmental regression into autism, along with immunoglobulin deficiencies, exacerbated by underlying mitochondrial dysfunction. Petitioner's counsel was Richard Gage.
Respondent's counsel was Lynn E. Ricciardella.
Special Master Brian H. Corcoran presided over the case.
The Special Master reviewed the medical records and expert reports. Petitioner contended that B.P. experienced immediate adverse reactions post-vaccination, including fever and irritability, and subsequently lost developmental milestones.
However, contemporaneous medical records did not corroborate these claims, indicating normal development for the period following the vaccinations. Concerns about B.P.'s development, including possible developmental delay and autism, were first noted in the medical records in January 2012, approximately eight months after the vaccinations.
Petitioner's experts, Dr. Harum and Dr.
Kinsbourne, proposed theories linking the vaccines to B.P.'s condition, suggesting aggravation of an underlying mitochondrial disorder. Respondent's expert, Dr.
Cohen, opined that B.P. did not have a mitochondrial illness or dysfunction and that his condition was more consistent with idiopathic autism. The Special Master found that the medical evidence did not support a diagnosis of mitochondrial dysfunction or disease, and that B.P. did not experience an acute post-vaccination reaction or regression.
The Special Master also found that Petitioner's causation theory lacked reliability and was not supported by persuasive expert testimony or medical literature, and that the alleged onset of symptoms was too far removed from the vaccination date to establish a medically acceptable temporal relationship. Ultimately, the Special Master granted Respondent's motion to dismiss, finding that Petitioner had not met her burden of proof under the Althen standard for establishing causation-in-fact.
The case was dismissed without an award.
Theory of causation
Petitioner alleged that the DTaP and PCV vaccines administered on May 11, 2011, to minor B.P. caused an encephalopathic developmental regression into autism, immunoglobulin deficiencies, and exacerbated mitochondrial dysfunction. Petitioner's experts, Dr. Harum and Dr. Kinsbourne, proposed that the vaccines aggravated a pre-existing, subclinical mitochondrial disorder, leading to oxidative stress and subsequent autistic regression. Dr. Harum's report summarized medical records without providing a clear causation theory, while Dr. Kinsbourne posited that the vaccines interfered with B.P.'s mitochondrial function by increasing oxidative stress, leading to clinical manifestation of autism. Respondent's expert, Dr. Bruce Cohen, opined that B.P. did not have a mitochondrial illness or dysfunction and that his condition was consistent with idiopathic autism. Dr. Cohen found no evidence of mitochondrial disease or dysfunction based on extensive testing and clinical presentation, and he disagreed that the vaccines were a substantial factor in B.P.'s autism. The Special Master, Brian H. Corcoran, found that the medical records did not support a diagnosis of mitochondrial dysfunction or disease, nor did they show an acute post-vaccination reaction or regression. The Special Master determined that Petitioner's causation theory was not supported by reliable expert testimony or medical literature, and the alleged onset of symptoms was not within a medically acceptable temporal relationship to the vaccination. The case was dismissed for failure to meet the Althen standard for causation-in-fact. The theory of causation was deemed 'Off-Table'.
Source PDFs
USCOURTS-cofc-1_14-vv-00078