D.E. v. HHS - Pneumococcal, atypical Kawasaki disease (2024)

On April 14, 2017, Tara Elvira, on behalf of her minor child D.E., filed a petition under the National Childhood Vaccine Injury Act. The petition alleged that D.E. suffered atypical Kawasaki disease caused-in-fact or significantly aggravated by his pneumococcal conjugate vaccination received on February 26, 2015.

Petitioner was represented by Mark Theodore Sadaka of the Law Offices of Sadaka Associates, LLC, and respondent was represented by Adam Nemeth Muffett of the U.S. Department of Justice.

Special Master Daniel T. Horner issued the decision on December 3, 2024.

D.E., who was nine months old, received his third pneumococcal vaccine on February 26, 2015. Two days later, on February 28, 2015, he presented to the emergency department with fever, convulsions, and swollen lymph nodes.

He was hospitalized from February 28, 2015, to March 9, 2015, and diagnosed with atypical or incomplete Kawasaki disease. He was treated with high-dose aspirin and intravenous immunoglobulin (IVIG), and also received antibiotics for cervical lymphadenitis.

His cervical lymphadenopathy improved with treatment and was noted as "minimal" at discharge. A cardiology follow-up on March 26, 2015, indicated D.E. was symptom-free with no coronary artery dilation and doing well.

Subsequent medical records through June 2016 showed no further issues related to his Kawasaki disease, and no recurrence of cervical adenopathy was indicated. No medical records were filed after June 2016.

The petition alleged that the pneumococcal vaccine caused D.E.'s Kawasaki disease. Since Kawasaki disease is not listed on the Vaccine Injury Table, petitioner had to demonstrate causation-in-fact under the Althen test and satisfy the statutory severity requirement.

The severity requirement mandates that an injury must result in residual effects for more than six months, or death, or require inpatient hospitalization and surgical intervention. Petitioner initially argued that D.E.'s lumbar puncture during hospitalization constituted surgical intervention.

This argument was rejected by Special Master Millman. Petitioner then argued that D.E. met the severity requirement because he was restricted from receiving live-virus vaccines for thirteen months due to his IVIG treatment, which she contended indicated a weakened immune state.

Special Master Millman found this argument persuasive "at this juncture." Petitioner later argued that D.E. experienced persistent recurrent cervical adenopathy causally attributable to his Kawasaki disease. Finally, in light of the Federal Circuit's decision in Leming v.

Secretary of Health & Human Services, petitioner reasserted that the lumbar puncture met the definition of surgical intervention. Special Master Horner revisited Special Master Millman's preliminary ruling on the severity requirement, citing the Federal Circuit's decision in Wright v.

Secretary of Health & Human Services, which clarified that residual effects must be "suffered" and detrimental. The court found that the restriction from live-virus vaccines was due to the blunting effect of IVIG on vaccine efficacy, not immune suppression, and that this effect was not a "clinically significant immune suppression" that impacted D.E.'s health, as confirmed by petitioner's own expert, Dr.

M. Eric Gershwin.

Respondent's experts, Dr. Stacy B.

Strayer and Dr. Andrew MacGinnitie, persuasively explained that IVIG administration necessitates withholding live-virus vaccines to ensure efficacy, not due to safety concerns related to immunosuppression.

Petitioner's expert, Dr. Gershwin, agreed with this explanation.

Therefore, the court concluded that the restriction from live-virus vaccines did not constitute a residual effect lasting more than six months. Regarding recurrent cervical adenopathy, the court found that while D.E. had cervical adenopathy during his acute Kawasaki disease, it resolved with treatment.

Contemporaneous medical records and follow-up exams up to June 2016 showed no recurrence. Letters from Drs.

Duke Johnson and LeTrinh Hoang, filed much later, claimed persistent recurrent cervical adenopathy attributed to Kawasaki disease. However, the court found these letters lacked sufficient detail and were not supported by medical records.

Respondent's expert, Dr. Scott Yeager, opined that chronic lymphadenopathy is not a known long-term consequence of Kawasaki disease, which primarily affects arteries, and that cervical lymphadenopathy is common in childhood.

The court found Dr. Yeager's opinion more persuasive, concluding that petitioner failed to demonstrate that the alleged recurrent adenopathy was causally connected to D.E.'s Kawasaki disease.

Concerning the surgical intervention argument, the court applied the Leming decision, which clarified that any surgical act or measure taken to prevent harm or improve health qualifies if the patient is hospitalized. However, the court found that D.E.'s lumbar puncture, performed bedside with local anesthetic by a resident, without general anesthesia or specific surgical protocols, did not meet the definition of surgery as typically understood in prior case law and distinguished from the bone marrow biopsy in Leming.

The court found no preponderant evidence that the lumbar puncture constituted a surgery. Because D.E.'s injury did not meet the statutory severity requirement, the petition was dismissed.

However, the court also addressed the causation-in-fact requirement. Petitioner's expert, Dr.

Gershwin, acknowledged that the etiology of Kawasaki disease is enigmatic and that epidemiological studies have not established a causal link with vaccination, with some even suggesting a decreased risk. While Dr.

Gershwin posited that an antigenic challenge, including vaccination, could trigger an excessive immune response, the court found this theory lacked a specific mechanism and was not supported by sound medical or scientific explanation, especially given the consensus that Kawasaki disease is likely caused by excessive inflammation following infection. Respondent's experts, Dr.

MacGinnitie and Dr. Yeager, presented extensive epidemiological evidence showing no association or even a decreased risk of Kawasaki disease following vaccination.

They also noted that the seasonal clustering of Kawasaki disease cases is more consistent with an infectious cause. Dr.

MacGinnitie further argued that D.E.'s condition following his third pneumococcal dose was inconsistent with Dr. Gershwin's theory.

The court found that Dr. Gershwin's reliance on limited findings from studies that did not reach statistical significance, and his general assertion that vaccines provoke immune responses, were insufficient to establish a reputable medical theory under the first Althen prong.

Consequently, the court concluded that petitioner failed to demonstrate causation-in-fact. Ultimately, Special Master Horner found that petitioner failed to demonstrate by a preponderance of the evidence that D.E.'s Kawasaki disease was vaccine-caused or that the injury met the statutory severity requirement.

The petition was dismissed.