Expert & witness evidence · On the timeline
Statement
11 Nov 2025
11 Nov 2025
Statements filed for the claimants
Watt — key documents on FDA vaccine non-regulation
Katherine Watt (expert nominated by the claimants)
Filed for the claimants · every defendant denies the claims; the court has not ruled
In 30 seconds
A five-page annotated list of historical records Watt says show US vaccine regulation is a show rather than real control. It supports her wider argument about how vaccines reached Europe.
Cheat sheet
- Lists documents from 1910 to 2022 — JAMA articles, 1924 House hearings, a 1958 HHS lawyer's paper, a 1962 NIH memo, court cases and FDA papers.
- Watt reads the 1902 Virus-Toxin law as licensing clean labs, not testing products; this is her interpretation.
- Cites the 1962 NIH order that batch release relied on manufacturers' own data, not lab testing.
- Quotes the US Supreme Court in Bruesewitz v. Wyeth (2011) on the FDA's lack of written safety criteria.
- Ends with a 2021 FDA notice on antibody tests and a 2022 FDA inspection report on a German Pfizer supplier.
Key passages · underlined
The real purpose of the 1902 Virus-Toxin law was to create initial false public confidence in vaccines.
[T]here has not been since the enactment of the statute in 1902 any litigation directly involving its application or interpretation; no one has been penalized for its violation
Design defects…do not merit a single mention in the [1986 National Childhood Vaccine Injury Act] or the FDA’s regulations. Indeed, the FDA has never even spelled out in regulations the criteria it uses to decide whether a vaccine is safe and effective for its intended use.
Every defendant denies the claims, and the court has not ruled on them. Allegations are the claimants' pleaded positions, quoted as theirs. This is analysis and commentary, not legal advice. Interest of Justice is not a party to the case.