Claudia Rotoli v. HHS - Hepatitis B, autoimmune hepatitis (2009)

Claudia Rotoli, born January 25, 1969, received three doses of the hepatitis B vaccine in preparation for enrollment in a medical assistant program: October 10, 1994 (dose 1), November 9, 1994 (dose 2), and May 1, 1995 (dose 3). Eleven days after her first dose, she experienced coughing, congestion, fever, and extreme weakness.

Approximately two months after her second dose, she was treated for a prolonged upper respiratory infection, bronchitis, and conjunctivitis. Around the time of her third dose, she began having right upper quadrant pain.

Blood work on May 9, 1995 showed elevated ALT; Ms. Rotoli had not developed antibodies to the hepatitis B surface antigen.

A June 1995 ANA test was positive. A liver biopsy on June 29, 1995 revealed chronic active hepatitis with fibrosis and moderate necrosis.

In July 1995, Dr. Katz diagnosed Ms.

Rotoli with autoimmune hepatitis (AIH) and began treatment with prednisone and Imuran. She subsequently developed Sjögren's disease (1996), systemic lupus erythematosus (1997), and CNS lupus (1998).

She was removed from a liver transplant list after her lupus diagnosis and was terminally ill at the time of the litigation. This case was one of five consolidated cases in which petitioners alleged that the hepatitis B vaccine caused them to develop AIH.

Joint hearings were held in September 2007 and March 2008. The special master denied all five claims in September and October 2008, basing the rejection primarily on a nine-page section devoted to questioning the credibility and truthfulness of petitioners' expert, Dr.

Joseph A. Bellanti, a Professor of Microbiology, Immunology, and Pediatrics at Georgetown University Medical Center and Director of Georgetown's International Center for Interdisciplinary Studies of Immunology.

Petitioners sought review of the special master's decisions. The Court of Federal Claims, Judge Firestone, consolidated the five motions for review and heard oral argument on July 22, 2009.

Judge Firestone ruled that the special master's decisions were not in accordance with law under Andreu v. Secretary of HHS, 569 F.3d 1367 (Fed.

Cir. 2009), which held that a special master may not cloak rejection of an expert medical theory under the rubric of a credibility determination. The special master's error permeated the entire causation analysis of all five cases, making it impossible to review separately.

Accordingly, rather than remanding, the court issued its own findings of fact and conclusions of law. The court found that the petitioners satisfied Althen prong one, establishing a medical theory causally connecting the hepatitis B vaccine with AIH.

The court accepted Dr. Bellanti's opinions that the hepatitis B virus is known to cause AIH and that the vaccine therefore may also cause AIH, and that the mechanism could involve CD4+ T-regulatory cell dysfunction in genetically susceptible individuals, as supported by the Longhi article in the Journal of Hepatology (2004).

The respondent's experts argued that a paucity of direct epidemiological evidence precluded a finding of medical theory; the court rejected that argument as inconsistent with Andreu and Althen. For Ms.

Rotoli specifically, the court found that she also satisfied Althen prong three (proximate temporal relationship). Dr.

Bellanti testified that a medically acceptable adverse reaction window is approximately 14 to 40 days after vaccination. Ms.

Rotoli's first symptoms appeared 11 days after her first dose, within that range. The court rejected Dr.

Koff's argument that the fibrosis visible in the June 1995 biopsy must have predated the vaccination, because the Huppertz article documented a case in which fibrosis developed within 14 to 16 weeks of onset. Having satisfied all three Althen prongs and with the government having failed to establish an alternative cause, Ms.

Rotoli was found entitled to compensation. Damages proceedings were to follow.