Donna Wagner v. HHS - MMR, arthropathy (1997)

Donna Wagner, age 39 at the time of vaccination, received a rubella vaccine on December 3, 1987. She filed a petition under the National Childhood Vaccine Injury Compensation Program alleging that the vaccine caused her to develop arthropathy.

Her case was part of the Omnibus Proceeding established to resolve a large group of rubella vaccine-arthritis/arthropathy claims. Under the Omnibus framework, petitioners were required to satisfy a six-element causation test; one element required petitioners to show there was no "other good explanation" for their symptoms.

The special master denied the petition. A central basis for the denial was that petitioner suffers from Sjogren's Syndrome — a chronic autoimmune condition — which the special master characterized as "another good explanation" for her arthropathic symptoms under element six of the Omnibus test.

The special master required petitioner to disprove Sjogren's Syndrome as the cause of her condition. Judge Bruggink, writing for the Court of Federal Claims on January 6, 1997, reversed the special master's decision and remanded for further proceedings.

The court's analysis centered on 42 U.S.C. § 300aa-13(a)(2)(A), which limits the circumstances under which the government may defeat a compensation claim: the statute permits the Secretary to defend on the ground that the injury was caused by "factors unrelated to the administration of the vaccine." The court held that Sjogren's Syndrome, a condition of unknown etiology, cannot lawfully be invoked as a § 13(a)(2)(A) defense because it is impossible to establish that a condition of unknown cause is "unrelated to" the vaccine — the required showing under the statute. When the cause of a condition is not known, the Secretary cannot demonstrate the "unrelated to" nexus that the statute demands.

By treating Sjogren's Syndrome as a valid § 13(a)(2)(A) defense and placing the burden on petitioner to disprove it, the special master had committed legal error: the six-part Omnibus test, as applied, improperly allocated the burden to petitioner to disprove a condition the Secretary had no statutory authority to invoke as a defense. The decision was reversed and the case remanded for reconsideration consistent with the court's opinion.