Elizabeth Doles v. HHS - Tdap, significant aggravation of multiple sclerosis / CNS demyelination (2025)

On May 16, 2017, Elizabeth Doles filed a petition alleging that a polio vaccine administered on April 4, 2016, and a Tdap vaccine administered on April 22, 2016, caused her to suffer from Acute Disseminated Encephalomyelitis (ADEM). She later amended her petition to allege central nervous system (CNS) demyelination, best characterized as multiple sclerosis (MS), and that the vaccines either caused or significantly aggravated her condition.

The case proceeded as an off-Table claim, as ADEM and MS are not listed on the Vaccine Injury Table for these vaccines. Initially, Special Master Millman noted a conflict in diagnosis, suggesting MS was more likely than ADEM, and that symptoms appeared to begin around June 4, 2016.

Respondent's Rule 4(c) report recommended against compensation, citing an unclear diagnosis and failure to prove causation. Petitioner's treating physician, Dr.

Slavenka Kam-Hansen, opined that Petitioner suffered from ADEM caused by the vaccinations. However, another expert retained by Petitioner, Dr.

John G. Steel, opined that Petitioner had MS, not ADEM, and that the vaccines "unmasked" her underlying, asymptomatic MS or radiographically isolated syndrome (RIS), leading to an attack of focal myelitis or transverse myelitis (TM).

Dr. Steel argued that while vaccines do not typically cause MS in healthy individuals, they can trigger attacks in susceptible individuals with subclinical MS.

Respondent's expert, Dr. Subramaniam Sriram, agreed that Petitioner had MS but concluded the vaccines did not cause or exacerbate it, and that MS diagnosis precluded a separate diagnosis of TM.

Special Master Daniel T. Horner issued a ruling on entitlement on February 1, 2021, finding that Petitioner was entitled to compensation for a significant aggravation of her pre-existing MS, rather than a separate attack of TM.

He concluded that the medical evidence, including expert opinions from Dr. Steel and Dr.

Sriram, indicated Petitioner had pre-existing, clinically silent MS prior to vaccination. Special Master Horner relied on the Langer-Gould study, interpreting it as evidence that vaccines could aggravate subclinical autoimmunity into overt MS.

On review, Judge Stephen S. Schwartz vacated this decision, finding that the Special Master had misinterpreted the Langer-Gould study and that the parties had not been given a fair opportunity to address the Special Master's theory of significant aggravation of MS.

The case was remanded. On remand, the original Special Master again found entitlement for significant aggravation of MS, this time explicitly grounding the decision in Dr.

Steel's opinions. Judge Schwartz again vacated the decision, finding the Special Master's interpretation of Dr.

Steel's opinions inconsistent with his prior ruling and arbitrary and capricious, and reassigned the case to a new Special Master. The new Special Master, on September 20, 2023, found that Petitioner had not met her burden of proof for causation, specifically under Loving prong four/Althen prong one, and denied the petition.

She concluded that Petitioner had not provided a sound and reliable medical or scientific explanation for how the vaccines could have significantly aggravated her MS. While she noted that she would have found the Langer-Gould study supportive of Petitioner's theory if she had considered it, she ultimately found that the study's findings did not support causation in Petitioner's specific circumstances and that Petitioner's other evidence was insufficient.

Petitioner's motion for review of this decision was denied by Judge Schwartz, who sustained the Special Master's decision to deny the petition, finding that the Special Master's error in disregarding the Langer-Gould study was harmless because, even if considered, it would not have changed the outcome, and Petitioner's other evidence was insufficient. On October 5, 2021, Special Master Horner issued a decision awarding damages based on a stipulation.

Petitioner Elizabeth Doles was awarded a lump sum of $137,400.00, consisting of $135,000.00 for pain and suffering and $2,400.00 for past unreimbursable expenses. This award was based on the prior entitlement ruling that Petitioner's MS was significantly aggravated by the Tdap and polio vaccines.

The later supplemental record reflects the case's extended remand path. After multiple judge-review opinions and reassignment, a 2025 remand proffer again awarded Ms.

Doles $137,400.00, consisting of $135,000.00 for pain and suffering and $2,400.00 for past unreimbursable expenses.