Earleen Bean-Sasser v. HHS - Hepatitis B, rheumatoid arthritis (2016)

Earleen Bean-Sasser filed a petition on May 9, 2013, alleging that a hepatitis B (HepB) booster vaccination she received on May 11, 2010, after a patient blood exposure while working as a nurse, caused her to develop rheumatoid arthritis (RA). She alleged onset of symptoms approximately 11 hours after the vaccination.

The respondent, the Secretary of Health and Human Services, denied causation. Special Master Christian J.

Moran presided over the case. The petitioner presented Dr.

Ernest N. Charlesworth, an immunologist, as an expert.

The respondent presented Dr. Robert W.

Lightfoot, Jr., a rheumatologist. Special Master Moran found Dr.

Lightfoot's opinion more persuasive, citing his extensive experience in treating RA. The Special Master concluded that Ms.

Bean-Sasser likely already had RA at the time of vaccination or had accumulated significant risk factors, including a genetic predisposition, a history of smoking, and a prior diagnosis of carpal tunnel syndrome in 2004, making RA essentially inevitable. The Special Master determined that no persuasive medical theory supported causation by the HepB vaccine.

Ms. Bean-Sasser's medical history included an uncle with RA, a history of smoking (varying reports suggest 10-16 years of smoking one pack per day or half pack per day), and a diagnosis of carpal tunnel syndrome in 2004.

She received the HepB booster on May 11, 2010, after a blood exposure incident. Approximately 11 hours later, she experienced pain in her left wrist, followed by pain and swelling in both wrists and her right shoulder.

Tests revealed she was positive for rheumatoid factor (RF) antibody. She was diagnosed with polyarthritis by her primary care provider, Dr.

Paul Windham, who noted the temporal proximity to the vaccine as "serendipity." Further testing confirmed RA. Treating physicians offered differing opinions.

Dr. Robert Blau believed the vaccine was related to her RA, citing literature and genetic susceptibility.

Dr. Paul Utz, a rheumatologist, stated her antibodies likely existed prior to vaccination but suggested the vaccine might have triggered systemic disease if she was in the presymptomatic phase.

Dr. William Reeder also noted the potential link between RA and immune stimulation from vaccines.

Special Master Moran's decision, issued on April 5, 2016, denied compensation. He found that Dr.

Lightfoot's opinion, that Ms. Bean-Sasser was suffering from RA before vaccination, was persuasive, particularly given her risk factors.

He noted that the lack of a diagnosis before vaccination did not preclude an earlier onset, as RA can exist pre-clinically. He also addressed the medical theory prong, finding Ms.

Bean-Sasser's presented theory, which evolved during the hearing to involve toll-like receptors, lacked persuasive support and was not generally accepted in the scientific community. He also noted an epidemiological study that failed to find a statistically significant association between the HepB vaccine and RA.

Ms. Bean-Sasser filed a motion for review with the U.S.

Court of Federal Claims. Senior Judge Robert J.

Yock reviewed the Special Master's decision. In an opinion and order issued on June 28, 2016, the court affirmed the Special Master's decision.

The court found that the Special Master's factual determination that Ms. Bean-Sasser's RA was present prior to vaccination was not arbitrary or capricious, giving deference to the Special Master's weighing of expert testimony, particularly the experience of Dr.

Lightfoot over Dr. Charlesworth.

The court also found that the Special Master did not err in rejecting the petitioner's medical theory under the first prong of the Althen test, noting that a prior case (Capizzano) did not bind the Special Master due to different evidentiary records and that the petitioner's expert theory lacked sufficient support and reliability. The court concluded that Ms.

Bean-Sasser failed to demonstrate a legally probable theory of causation-in-fact. The petition was denied.