CK v. HHS - DTaP, afebrile infantile spasms and a non-Table chronic encephalopathy (2020)
Case summary [AI summaries can sometimes make mistakes]
On September 11, 2015, Maryellen and Nicholas Kottenstette filed a petition on behalf of their daughter, CK, alleging that the DTaP, Hib, IPV, and Prevnar vaccines administered on October 2, 2012, caused her to develop infantile spasms and a chronic encephalopathy. CK, who was approximately four months old and behind on her immunizations, received her two-month vaccines on this date.
The first episodes of abnormal movements began within hours of vaccination. A video of these movements, observed by Dr.
Irina Anselm, was consistent with infantile spasms, and an EEG showed hypsarrhythmia. CK was prescribed ACTH, and her parents were advised to avoid further immunizations for six months.
Initially, Special Master Laura D. Millman ruled in favor of the petitioners on entitlement in December 2017, relying on the ten-hour onset of symptoms and literature suggesting vaccines could trigger infantile spasms in susceptible children.
A damages award was subsequently made, but the respondent sought review. The Court of Federal Claims vacated the entitlement decision in February 2020, finding the legal standard and evidentiary basis unclear, and remanded the case for a renewed analysis under the Althen standard.
On remand, Special Master Horner denied compensation. The petitioners argued that the DTaP vaccine could lower the seizure threshold and, in CK's case, triggered infantile spasms early enough to cause severe psychomotor regression.
Their theory involved DPT/DT infantile spasm literature, ACTH response, corticotropin-releasing hormone, and an innate immune-response "double hit" mechanism. Special Master Horner found the evidence insufficient to establish that DTaP can cause infantile spasms or that it did so in CK.
Judge Richard A. Hertling denied the petitioners' motion for review and sustained the denial on August 11, 2020.
The final outcome was a denial of compensation. Following the denial, the petitioners sought review of Special Master Horner's decision.
Judge Hertling denied the motion for review, sustaining the Special Master's decision. The judge found that the petitioners had not met their burden of proof under the Althen test, particularly regarding the link between the DTaP vaccine and infantile spasms, and the evidence presented was insufficient to establish causation.
The public record does not describe the specific clinical course after the denial of compensation.
Theory of causation
Petitioners alleged that DTaP, Hib, IPV, and Prevnar vaccines administered on October 2, 2012, to four-month-old CK caused afebrile infantile spasms and a non-Table chronic encephalopathy. The first episodes of rhythmic movements began approximately ten hours after vaccination, with no fever, fussiness, or postictal state. An EEG showed hypsarrhythmia, and ACTH was prescribed. Special Master Millman initially granted entitlement, finding a causal link based on early onset and vaccine trigger literature. This decision was vacated and remanded by the Court of Federal Claims for reconsideration under the Althen standard. On remand, Special Master Horner denied compensation, finding insufficient evidence that DTaP can cause infantile spasms or did so in CK. Petitioners' theory involved DTaP lowering the seizure threshold, triggering early infantile spasms via stress/CRH/innate immune "double hit" mechanisms, citing Dr. Marcel Kinsbourne and DPT/DT studies. Respondent challenged the applicability of DPT studies to DTaP and the causal showing. Judge Hertling sustained the denial, finding the evidence insufficient to establish causation under the Althen test. The final outcome was denial of compensation. Attorneys for petitioners included John F. McHugh. Attorneys for respondent included Camille M. Collett and Voris E. Johnson. Special Master Millman issued the initial entitlement decision and damages award, while Special Master Horner issued the final denial on remand, and Judge Hertling reviewed and sustained the denial.
Source PDFs
USCOURTS-cofc-1_15-vv-01016