Case Model: Werderitsh
Werderitsh v. Secretary of Health and Human Services,
Office of Special Masters, No. 99-319V
Filed: May 26, 2006
- Hepatitis B vaccine
- Multiple sclerosis (MS)
- Entitled to compensation
Petitioner Dorothy Werderitsh alleged that the two hepatitis B vaccinations that she received on November 11 and December 16, 1992, caused her multiple sclerosis (MS).
Special Master Millman found that petitioner demonstrated that her MS was caused in fact by or significantly aggravated by those vaccinations, and thus that she was entitled to reasonable compensation.
This was one of four paradigm cases tried as part of the Hepatitis B-Neurological Demyelinating Omnibus Proceeding, and was to represent those petitioners with multiple sclerosis (MS).
The reasoning of the Special Master exhibits the following features:
- It discusses proof of a scenario of significant aggravation;
- It assesses autoimmune reaction as a plausible medical theory (Prong 1 of Althen);
- It assesses the probative value of a small study with no statistically significant results, but low power;
- It discusses challenge/rechallenge evidence of causation in a specific case;
- It assesses the argument that epidemiologic evidence is necessary to prove causation; and
- It discounts lack of supporting evidence from treating physicians.