Elijah McLeod v. HHS - Tdap, multiple sclerosis (2015)

On April 10, 2012, Jacqueline S. Hunt, as legal guardian for minor Elijah McLeod, filed a petition for compensation under the National Childhood Vaccine Injury Act.

The petition alleged that Tdap, varicella, and meningococcal vaccines administered on April 20, 2011, caused Elijah to develop acute disseminated encephalomyelitis (ADEM) and multiple sclerosis (MS), or significantly aggravated a pre-existing condition. The respondent, the Secretary of Health and Human Services, disagreed with the petitioner's claims.

Petitioner was represented by Daniel Pfeifer of Pfeifer, Morgan & Stesiak, and respondent was represented by Tara J. Kilfoyle and Heather L.

Pearlman from the U.S. Department of Justice.

Special Master Christian J. Moran presided over the case.

Elijah McLeod, born in 1999, began experiencing symptoms prior to vaccination. Reports indicated that in the fall of 2010, he started using his right hand more than his left, and in February 2011, he began experiencing double vision.

He did not seek medical attention for these issues at the time. Following the April 20, 2011 vaccinations, Elijah became ill, experiencing vomiting, dizziness, and unsteadiness.

He was seen in the emergency room on April 21 and April 22, 2011, where initial assessments noted a localized reaction and later revealed areas of hypodensity in his brain via CT scan. He was hospitalized, and an MRI on April 23, 2011, showed abnormalities interpreted as likely ADEM, with multiple sclerosis considered less likely.

A lumbar puncture revealed oligoclonal bands in his cerebrospinal fluid (CSF). He was treated with steroids and physical therapy and discharged on April 29, 2011, with a diagnosis consistent with ADEM, though MS remained a differential diagnosis.

Subsequent MRIs and clinical evaluations in May and June 2011 showed evolving demyelinating lesions. By August 2011, an MRI showed progression of white matter disease with more lesions, leading Dr.

David Mattson, Elijah's treating neurologist, to declare a diagnosis of multiple sclerosis. Dr.

Mattson opined that the vaccinations caused Elijah's ADEM and MS. The Secretary retained Dr.

Subramanian Sriram as an expert, who opined that Elijah's symptoms predated the vaccinations and that the vaccines did not cause or worsen his MS. Dr.

Sriram noted that the oligoclonal bands found in Elijah's CSF 48 hours post-vaccination indicated that his MS likely predated the vaccinations, as antibody production typically takes longer. The Special Master found that Elijah had experienced clinical symptoms of multiple sclerosis, including hand weakness and double vision, prior to the vaccinations.

The presence of oligoclonal bands in his CSF also indicated immune dysregulation before vaccination. Consequently, the Special Master determined that the claim could only proceed as one of significant aggravation, not new onset causation.

The Special Master further found that the petitioner failed to prove by a preponderance of the evidence that the vaccines significantly aggravated Elijah's multiple sclerosis. The medical theories presented by Dr.

Mattson (molecular mimicry and bystander activation) were found unpersuasive, and epidemiological studies did not support a link between the vaccines and MS. The Special Master also found that the timing of symptom onset was not medically acceptable to infer causation, as the earliest neurological symptoms appeared within one day of vaccination, which was deemed too soon for an immune-mediated process to develop, even with pre-existing immune dysregulation.

On review, the Court of Federal Claims, Judge Lydia Kay Griggsby presiding, agreed that the Special Master had committed some procedural errors in the analysis of the causation-in-fact claim, specifically by making a preliminary diagnosis of pre-existing MS before fully applying the Althen framework and by not fully considering all evidence related to ADEM. However, the Court found these errors to be harmless because, even with a corrected analysis, the petitioner had not met her burden of proof for either causation-in-fact or significant aggravation.

The Court affirmed the Special Master's denial of compensation. Subsequently, on October 14, 2015, Special Master Christian J.

Moran issued a decision regarding attorneys' fees and costs. Although compensation was denied, the petition was deemed to have been brought in good faith with a reasonable basis.

Petitioner's counsel, Pfeifer Morgan & Stesiak, sought $92,500.00 for attorneys' fees and costs, an amount to which the respondent did not object. The Special Master awarded this amount.