Frances Campbell v. HHS - Influenza, rheumatoid arthritis (2009)

Frances Campbell was born in August 1957. On December 4, 2003, she visited her primary care physician, Dr.

Thad Jackson, complaining of pain in both shoulders, her hip, and upper and lower back, and severely restricted use of her left shoulder. Dr.

Jackson noted that she appeared depressed because her pain had prevented her from activities she enjoyed, such as hunting and fishing. During that visit, she received both the trivalent influenza vaccine and the pneumococcal vaccine.

She had numerous pre-existing conditions, including osteoarthritis in multiple locations, three prior shoulder surgeries, non-alcoholic steatohepatitis with liver fibrosis, and positive antinuclear antibody tests dating to 2001. Approximately three to four days later — on December 7 or 8, 2003 — Ms.

Campbell was bumped by teenagers while leaving church, an event she described as quite painful. Within hours she began experiencing pain in her left arm radiating upward to the shoulder, then similar pain in her right arm accompanied by difficulty swallowing and chest heaviness.

Dr. Jackson admitted her to Grayling Mercy Hospital on December 8.

An orthopedist, Dr. Darius Divina, noted that her "left and right shoulders seem somewhat swollen and slightly warm to touch" and listed "acute inflammatory response to vaccine" as a condition to rule out.

Testing showed a positive ANA. She was discharged on December 10 with a diagnosis of "acute bilateral upper extremity inflammatory arthritis" of unknown cause.

Ms. Campbell returned to the emergency room on December 12 with pain extending to her left foot.

On December 19, Dr. Jackson admitted her to Munson Medical Center, noting in his records that her condition could represent "new rheumatologic disease versus possible reactivity due to her previous influenza vaccine." Rheumatologist Dr.

Karen Gilhooly evaluated her that day and stated that her differential diagnosis was, "in descending order of probability," "immunization related autoimmune phenomenon which will probably be transient" — while noting that the "possibility of long-lasting symptomatology is there." Neurologist Dr. Richard Ball agreed that Ms.

Campbell had a "rheumatological problem, probably precipitated/exacerbated by her recent Pneumovax/flu vaccines." By March 2004, Dr. Jackson was recording that she "had difficulty with an inflammatory arthritis after she received a flu vaccine" and had placed flu vaccine on her allergy list.

Dr. Gilhooly later diagnosed psoriatic arthritis before her death in an automobile accident in late 2004.

Ms. Campbell was eventually diagnosed with rheumatoid arthritis by a rheumatologist in Nevada after she moved there.

Ms. Campbell filed her petition on June 28, 2007.

She presented expert testimony from Dr. Arthur Brawer, a board-certified rheumatologist and internist in private practice since 1975, with academic appointments and approximately 15,000 new patients treated over his career.

Dr. Brawer's primary theory was that molecular mimicry caused the onset of Ms.

Campbell's rheumatoid arthritis: flu vaccine antigens cross-reacted with self-antigens on immunocompetent cells, triggering an inflammatory autoimmune response in a person genetically predisposed to rheumatoid arthritis. He supported the theory with case reports of patients who had developed rheumatoid arthritis following vaccinations.

The government's expert, Dr. Robert Lightfoot, a semi-retired rheumatologist who had held academic positions at Columbia, Cornell, Wisconsin, and Kentucky, offered two principal responses: that only live or attenuated vaccines (not the killed-virus flu vaccine) are capable of causing chronic arthritis; and that given 332 new rheumatoid arthritis diagnoses per day and 70 million flu vaccinations per year, statistical coincidence made the observed association meaningless.

The special master denied the petition on July 7, 2009, finding Dr. Lightfoot more credible than Dr.

Brawer based on Dr. Lightfoot's greater academic standing, less frequent litigation involvement, and the fact that Dr.

Brawer's opinions had not survived Daubert challenges in at least two prior cases. The special master then used this credibility finding — which he declared "virtually not reviewable on appeal" — as the primary basis for rejecting Ms.

Campbell's claim. He required Dr.

Brawer to prove specific biological mechanisms, dismissed the case reports as presenting only a "chronological picture," accepted Dr. Lightfoot's statistical argument without reservation, and found that the records of Ms.

Campbell's treating physicians were "not clear statements that the flu vaccine caused rheumatoid arthritis." He discounted Dr. Jackson's December 10, 2003 diagnosis of acute bilateral upper extremity inflammatory arthritis, dismissed Dr.

Gilhooly's records as ambiguous, and inferred that Ms. Campbell had not had rheumatoid arthritis within the first two weeks of vaccination because she had not shown synovitis in that period.

Judge Lettow, writing for the Court of Federal Claims on October 26, 2009, vacated the decision and remanded the case. The court found that the special master had committed legal error in multiple respects.

First, he had improperly used a credibility determination to shield his rejection of Dr. Brawer's medical theory from appellate review, in violation of the Federal Circuit's instruction in Andreu that credibility determinations are for assessing the candor of fact witnesses — not for evaluating whether an expert's medical theory is supported by the weight of the evidence.

Dr. Brawer's candor was not in dispute.

Second, requiring Dr. Brawer to prove specific biological mechanisms violated Knudsen's instruction that such a requirement would be inconsistent with the purpose of the Vaccine Program.

Third, case reports have evidentiary value in vaccine proceedings and may not be dismissed simply because they show only a temporal association. Fourth, the statistical coincidence argument was the same one the Federal Circuit had specifically rejected in the rheumatoid arthritis context in Capizzano.

Fifth, the special master had drawn every inference against petitioner from the treating physicians' records: Dr. Gilhooly's initial diagnosis of "post vaccination reactive arthritis" was a substantive medical assessment that could not be dismissed as ambiguous; both experts agreed that rheumatoid arthritis cannot be diagnosed until at least six to eight weeks of evaluation, making the absence of confirmed rheumatoid arthritis within two weeks legally irrelevant to whether the temporal relationship had been established; and Capizzano instructs that treating physicians' diagnoses are typically quite probative of Althen's second prong.

The special master had set aside the findings of every treating physician without adequate justification.