Denial of Entitlement; RA Following Hepatitis B Vaccination


Bean-Sasser v. HHS (Fed. Cl. Spec. Mstr. Apr. 5, 2016) (Moran, SM)

In this case, the special master denied entitlement for two reasons: 1) Petitioner’s theory under Althen prong 1 was not persuasive, and 2) Petitioner’s rheumatoid arthritis was preexisting.  Petitioner was asymptomatic at the time of the vaccine, although she had a history of carpal tunnel, which can be a presenting symptom.  Environmental factors are relevant in RA, Petitioner was a smoker which doubles the risk and is by far the most relevant environmental factor.  RA has a preclinical stage where people test positive for biomarkers of the disease.  Petitioner tested positive for RF antibodies, implicated in RA, 5 days after the vaccine, which was determined to be preexisting.  Although it was not guaranteed that Petitioner would develop RA, it was more likely than not.  Thus, Petitioner’s claim failed because her RA was preexisting.  A significant aggravation claim was not pursued.

Petitioner’s medical theory originally was that hepatitis B vaccine can cause immune complexes, also known as a Gel and Combs type III reaction.  At hearing, Petitioner’s expert opined that the hepatitis B vaccine can stimulate a part of the innate immune system, toll-like receptors, to produce pro-inflammatory cytokines that lead to RA.  The Special Master found that this theory was not reliable or persuasive.  There was no evidence that the theory was tested, that the theory was consistent with articles from peer-reviewed journals, or that the theory was generally accepted among immunologists or rheumatologists.  Moreover, epidemiological evidence undermined the persuasiveness.  Even if the theory were viable, Petitioner’s risk of developing RA from her other risk factors, genetics, and smoking, was much greater.

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