K.E.L. v. HHS - DTaP, epileptic spasms, global developmental delay, acquired microcephaly, and encephalopathy (2023)
Case summary [AI summaries can sometimes make mistakes]
On February 1, 2017, Erik and Lisa Lindholm, on behalf of their minor son K.E.L., filed a petition for compensation under the National Vaccine Injury Compensation Program. They alleged that a DTaP vaccination administered on February 26, 2014, caused K.E.L. to develop epileptic spasms, global developmental delay, acquired microcephaly, and encephalopathy.
The Petitioners claimed that shortly after vaccination, K.E.L. experienced uncontrollable crying and jerking spells, followed by lethargy and developmental regression. Medical records indicated K.E.L. was diagnosed with infantile spasms around 10 months of age, with subsequent developmental delays and microcephaly.
The petition alleged a Table injury of encephalopathy within 72 hours of vaccination and alternatively, an "off-Table" claim for causation-in-fact. Respondent contested entitlement, arguing that no evidence supported a Table encephalopathy and that K.E.L.'s microcephaly predated the vaccination.
The case involved expert reports from Dr. L.
Douglas Wilkerson for the Petitioners, who opined that the vaccine likely caused K.E.L.'s condition, and Dr. Michael H.
Kohrman for the Respondent, who concluded that K.E.L.'s progressive microcephaly predated the vaccination and was the underlying cause of his infantile spasms. The Special Master, Katherine E.
Oler, found that the evidence did not demonstrate a Table encephalopathy, as the reported symptoms did not meet the Table's definition and were contradicted by contemporaneous medical records. Furthermore, the Special Master determined that Petitioners failed to establish causation-in-fact under the Althen test.
Specifically, the Special Master found no reliable medical theory linking the DTaP vaccine to K.E.L.'s condition, that K.E.L.'s microcephaly and abnormal brain development predated the vaccination, and that the onset of symptoms did not occur within a medically acceptable timeframe to infer causation. The public decision does not describe the specific mechanism of injury alleged by Petitioners or Respondent's specific arguments regarding the clinical story beyond the expert opinions.
The petition was denied. Petitioners were represented pro se at the time of the decision.
Respondent was represented by Mark Kim Hellie of the U.S. Department of Justice.
Theory of causation
Petitioners alleged that K.E.L., who received a DTaP vaccine on February 26, 2014, suffered from epileptic spasms, global developmental delay, acquired microcephaly, and encephalopathy. They pursued both a Table claim for encephalopathy within 72 hours of vaccination and an off-Table claim for causation-in-fact. Petitioners' expert, Dr. L. Douglas Wilkerson, opined that the DTaP vaccine likely caused K.E.L.'s condition, suggesting an "unspecified immune mechanism" and a temporal link between vaccination and symptom onset, though he acknowledged the exact mechanism was elusive and the onset difficult to pinpoint. Respondent's expert, Dr. Michael H. Kohrman, concluded that K.E.L.'s progressive microcephaly predated the vaccination and was the underlying cause of his infantile spasms and developmental delay, finding no evidence of vaccine causation and that the symptoms did not meet the Table definition of encephalopathy within the required timeframe. Special Master Katherine E. Oler denied the petition, finding that Petitioners failed to establish a Table encephalopathy due to lack of evidence and contradiction with medical records. For the off-Table claim, the Special Master found Petitioners failed to meet the Althen test: (1) Prong One (medical theory) was not met due to Dr. Wilkerson's conclusory opinions lacking a sound and reliable explanation of how the DTaP vaccine could cause the alleged injuries; (2) Prong Two (logical sequence of cause and effect) was not met as evidence indicated K.E.L.'s microcephaly and abnormal brain development predated the vaccination, and the Special Master found the elimination of other causes insufficient without more; and (3) Prong Three (proximate temporal relationship) was not met as the onset of symptoms was not established within a medically acceptable timeframe, with contemporaneous medical records indicating onset much later than alleged by Petitioners and their expert. The decision was issued on September 1, 2023, with Petitioners represented pro se and Respondent represented by Mark Kim Hellie.
Source PDFs
USCOURTS-cofc-1_17-vv-00154