Vera Analla v. HHS - Hepatitis B, rheumatoid arthritis (2006)

Vera Analla was born on April 7, 1949, and worked as a nurse. By her own account, she had been healthy and active before receiving hepatitis B vaccinations — she jogged, danced, bowled, and attended exercise classes three times per week.

She had never been hospitalized except for childbirth, and had no family history of rheumatoid arthritis (RA), though her mother had Systemic Lupus Erythematosus (SLE). Beginning in August 1989 — before any vaccination — Ms.

Analla developed right carpal tunnel syndrome, which her doctor relieved by surgery in November 1989. Ms.

Analla received her first hepatitis B vaccination on September 8, 1989, without adverse reaction. She received her second vaccination on October 12, 1989; according to her own affidavit, her joints began to feel stiff the next day, and by the evening of October 13 her hands were frozen in a half-open position.

She refused the third hepatitis B vaccination because of her increased arthritic activity. Despite her reported acute post-vaccination onset, Ms.

Analla did not visit her primary physician, Dr. Donald Binz, until March 6, 1990 — approximately five months after the second vaccination.

At that visit, Dr. Binz's notes recorded complaints of "swollen and painful joints." At a follow-up visit on March 20, 1990, Dr.

Binz noted a "6-week history of arthralgias," placing the onset of joint symptoms in approximately early February 1990. When Ms.

Analla visited rheumatologist Dr. Ronald Wepprich on April 26, 1990, however, Dr.

Wepprich recorded a "14-month history of multiple joint discomfort" dating the onset to January 1989 — before any vaccination. The same letter from Dr.

Wepprich stated that Ms. Analla "had been well prior to onset of polyarthritis in January 1990." The medical records thus contained three contradictory onset dates: January 1989, October 13, 1989, and early February 1990.

Ms. Analla filed her petition for compensation on August 4, 1999, within two years of the August 6, 1997 revision that added hepatitis B to the Vaccine Injury Table.

Her case was one of five "test cases" selected to address the general question of whether the hepatitis B vaccine can cause RA — along with Capizzano, Ryman, Manville, and Ashby. In Capizzano v.

HHS, Chief Special Master Golkiewicz concluded, based on the evidence at a consolidated hearing, that the hepatitis B vaccine can cause RA in theory. However, in separate individual decisions, the Chief Special Master denied compensation to each petitioner for failure to prove causation-in-fact.

In Ms. Analla's case, the Chief Special Master applied a five-factor causation framework — requiring evidence such as epidemiological studies showing a relative risk greater than two, rechallenge events, pathological markers, general acceptance in the medical community, and a demonstrated biologic link — and found that none of the five criteria were satisfied.

The Chief Special Master's initial June 2004 decision was sua sponte remanded by Judge Horn for greater factual detail; the amended decision with more extensive findings was issued on October 22, 2004. Three of the other test cases had already been affirmed on review before the Court of Federal Claims at the time of this opinion.

Judge Wheeler, writing for the Court of Federal Claims on March 8, 2006, affirmed the Chief Special Master's amended decision and denied the petition for review. The court rejected the five-prong causation framework from Stevens v.

HHS, 2001 WL 387418 (Fed.Cl. Spec.

Mstr. 2001), on the authority of Althen v. HHS, 418 F.3d 1274 (Fed.

Cir. 2005), which the Federal Circuit had issued in July 2005 after the Chief Special Master's decision. The court similarly rejected the Chief Special Master's five specific evidence criteria as too restrictive, noting that demanding epidemiological studies, rechallenge events, or pathological markers was likely impossible for any petitioner and departed from the Vaccine Act's intent that close calls be resolved in favor of claimants.

However, applying the correct preponderance-of-the-evidence standard from Althen and its antecedents, the court found that the Chief Special Master's error was harmless: even under the proper standard, petitioner had not established that the hepatitis B vaccine caused her RA. The record was contradictory and inconclusive as to when Ms.

Analla's RA actually began. She had not seen a doctor within the one-to-five week causation window identified by her own expert witness, Dr.

Bell, as the expected interval for vaccine-induced RA onset. Her treating physicians' records established only that she had RA — a fact not in dispute — but contained no contemporaneous statements attributing the RA to the vaccination.

The court also found that VAERS reports had been properly discounted, and that petitioner's objections amounted to a disagreement with the Chief Special Master's weighing of the evidence, which was not arbitrary, capricious, or an abuse of discretion.