False-Positive Cancer Test Leads to $16.2 Million Verdict for Washington Woman

In January 1998, Jennifer Rufer was 22 years old and living in Spanaway, Washington, when she went to the University of Washington Medical Center for irregular bleeding. Doctors administered Abbott Laboratories' AxSYM BHCG assay, a test designed to detect the hormone HCG. The results came back sharply elevated, suggesting she had gestational trophoblastic disease, a form of cancer that can follow pregnancy.

What followed was eight months of aggressive treatment based on those readings. Rufer underwent four months of chemotherapy. When HCG levels on Abbott's test remained between 250 and 350, far above the normal threshold of five, her physicians proceeded with a hysterectomy. Tissue removed during the surgery showed no cancer. Months later, doctors removed a section of lung tissue. That too came back clean. In January 1999, UW physicians finally concluded that a natural blood substance in Rufer's system had been triggering false positives in the Abbott test from the start, a phenomenon that researchers had documented in roughly ten percent of the population. Yale University consultants later confirmed she had almost certainly never had cancer.

Rufer, her husband David, and their legal team -- Paul Luvera, Andrew Hoyal, Joel Cunningham, and David Beninger of Luvera Barnett Brindley Beninger -- filed suit in King County Superior Court in November 1999 against Abbott Laboratories and the University of Washington Medical Center. The products liability claims against Abbott centered on the company's package insert, which the plaintiffs argued failed to adequately warn clinicians that the test could produce false positives in patients with certain naturally occurring blood proteins. Abbott had received at least 67 such complaints before Rufer's case. The malpractice claims against UWMC focused on whether the medical center should have caught the diagnostic error sooner, given that imaging scans had repeatedly shown no tumor and pathology results had repeatedly shown no cancer.

The jury returned a verdict of $16.2 million and apportioned fault equally between Abbott Laboratories and UWMC, holding each responsible for half the judgment. Rufer told reporters afterward that her greatest loss was the ability to have children: 'I can't have kids, and I desperately want to have a family.'

Abbott appealed, and the case reached the Washington Supreme Court in 2005. The court's decision focused on two procedural issues, court-record sealing standards and the calculation of post-judgment interest during the appeal period, and the justices ruled against Abbott on both. The $16.2 million verdict itself was not disturbed.