Rose Capizzano v. HHS - Hepatitis B, rheumatoid arthritis (2004)

Rose Capizzano, a nurse at Westerly Hospital in Westerly, Rhode Island, received her second hepatitis B vaccination on May 3, 1998, at the age of 31. Immediately following that vaccination, she developed a serum sickness-type illness, consisting of a rash on her abdomen and stiff, painful joints.

She did not receive the third vaccination in the series. Beginning in October 1998 — approximately five months after the vaccination — she sought evaluation from rheumatologists.

Over the following years, she was evaluated by multiple physicians, and by June 2000 at least one physician had reported a diagnosis of "inflammatory arthritis post vaccination." In March 2003, her rheumatologist confirmed a diagnosis of rheumatoid arthritis (RA). Ms.

Capizzano's case was one of five cases selected from approximately twenty-two hepatitis B and RA petitions pending before the Court of Federal Claims to serve as representative "test cases" addressing the general question of whether the hepatitis B vaccine can cause RA. The other test cases were Ashby v.

HHS, Analla v. HHS, Ryman v.

HHS, and Manville v. HHS.

At a consolidated two-day hearing held in June 2003, the Chief Special Master received testimony from expert witnesses on both sides. Petitioner's expert, Dr.

David Bell — a rheumatologist with a Royal College Fellowship from the Canadian equivalent of Board Certification, who had conducted research and published in the area of RA — offered a scientific mechanism by which the hepatitis B vaccine could cause RA in susceptible individuals. Respondent's experts included an immunologist, a rheumatologist, and a biostatistician, who challenged the proposed mechanism.

Based on the evidence at the consolidated hearing, Chief Special Master Golkiewicz concluded that the hepatitis B vaccine can cause RA in theory. However, in separate individual decisions, including a decision issued on June 8, 2004, the Chief Special Master denied compensation to Ms.

Capizzano for failure to prove individual causation-in-fact. The Chief Special Master found that Ms.

Capizzano had not established a "rechallenge" — adverse symptoms following one dose and recurring after a subsequent dose — because she had received only two doses and had refused the third. He found that there was no epidemiological evidence linking hepatitis B vaccination to RA, and that Dr.

Bell's proposed causal mechanism had a critical missing piece in the sequence identified by respondent's expert Dr. Zweiman.

He also found that the statements in Ms. Capizzano's medical records bearing on causation amounted only to a temporal history rather than independent causal opinions from treating physicians, and that VAERS reports were unreliable for establishing causation.

Senior Judge Merow, writing for the Court of Federal Claims on December 7, 2004, sustained the Chief Special Master's decision and denied the motion for review. The court adopted the analysis from the contemporaneously issued Manville v.

HHS opinion as to the general issues applicable to all five test cases, including the rejection of the Stevens five-prong causation framework in favor of Federal Circuit precedent. On the merits, the court affirmed that a temporal relationship between the vaccine and the RA onset, while present, was insufficient to establish causation under Grant v.

HHS, 956 F.2d 1144 (Fed. Cir. 1992) and Shyface v.

HHS, 165 F.3d 1344 (Fed. Cir. 1999), given the statistical reality that some individuals who receive hepatitis B vaccinations would develop RA anyway.

Ms. Capizzano had not produced rechallenge evidence, epidemiological evidence, or independent medical opinion linking the vaccine to her RA.

Her treating physicians' records were limited to a recitation of her reported temporal history, with the exception of a brief, inconclusive workers' compensation statement from Dr. Virginia Parker — who also noted that vaccination-associated arthritis is generally associated with live vaccines rather than recombinant hepatitis B vaccine.

No treating physician testified at the hearing. The Chief Special Master's findings were not arbitrary, capricious, or an abuse of discretion.