Alison Stiegler v. HHS - Tdap, postural orthostatic tachycardia syndrome (POTS) and chronic fatigue syndrome (CFS) (2025)

Filed 2021-04-02Decided 2025-04-18Vaccine Tdap
denied

Case summary [AI summaries can sometimes make mistakes]

Alison Stiegler received a Tdap vaccine on April 4, 2018. She filed a petition alleging that this vaccine caused her to develop Postural Orthostatic Tachycardia Syndrome (POTS) and Chronic Fatigue Syndrome (CFS).

The case proceeded as an off-Table claim, meaning Ms. Stiegler had to prove causation.

The Chief Special Master initially expressed skepticism about the claim, noting that POTS claims related to other vaccines, like the HPV vaccine, had been consistently rejected. He invited Ms.

Stiegler to present a more persuasive theory specifically linking the Tdap vaccine to POTS. Ms.

Stiegler filed a brief and cited medical literature, including studies on the HPV vaccine and POTS, and a case report about tetanus infection. She also argued a molecular mimicry theory.

The respondent argued that Ms. Stiegler never received a formal diagnosis of POTS or CFS and failed to establish causation.

The Chief Special Master ultimately denied entitlement, finding that Ms. Stiegler failed to establish a persuasive medical theory that the Tdap vaccine can cause POTS or CFS.

He noted that the literature regarding the HPV vaccine and POTS had been repeatedly rejected and that the evidence specific to the Tdap vaccine was insufficient, relying heavily on a single case report. He also found the molecular mimicry argument unconvailing.

Ms. Stiegler appealed this decision, arguing the Chief Special Master dismissed her claim improperly and abused his discretion by denying entitlement without allowing expert reports.

The Court of Federal Claims affirmed the denial, finding that the Chief Special Master did not dismiss the case under Rule 12(b)(6) but rather ruled on the record after determining it was fully developed. The court also found no abuse of discretion in denying expert reports, as Ms.

Stiegler had ample opportunity to present her case and failed to offer new evidence or arguments that had not already been rejected in prior cases. The court also denied Ms.

Stiegler's motion for interim attorneys' fees and instructed the Special Master on how to handle fees related to certain improper filings.

Theory of causation

Tdap vaccine on April 4, 2018, adult exact age not stated, alleged to cause POTS and chronic fatigue syndrome. DENIED. Petitioner advanced an immune-mediated off-Table theory; respondent disputed diagnosis, mechanism, and logical sequence. The Special Master denied entitlement, and the Court of Federal Claims denied review on April 18, 2025. Later attorney-fee decision did not change the merits outcome.

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