A federal appeals court has sided with two women who developed breast cancer after taking the hormone therapy drug Prempro. The women alleged that Wyeth failed to adequately warn that the use of Prempro increased their risk of breast cancer.
The 8th U.S. Circuit Court of Appeals said a federal magistrate judge abused his discretion when he blocked expert testimony from a doctor on behalf of Pamela Kuhn and Shirley Davidson.
Pamela Kuhn and Shirley Davidson were prescribed Prempro, a hormone therapy drug comprised of estrogen and progestin. Kuhn took Prempro for three years and twenty-eight days; Davidson took it for one year and nine months. Both women developed breast cancer and filed separate lawsuits against Wyeth in the Western District of Arkansas.
Prempro is used to treat symptoms of menopause, including vasomotor symptoms and vaginal atrophy.
The complaints alleged, among other things, that the use of Prempro increased the risk of breast cancer and that Wyeth failed to adequately warn of the drug’s adverse effects. Both cases were transferred to the Multidistrict Litigation proceedings in the Eastern District of Arkansas, where Wyeth moved to preclude any expert testimony that Prempro use increases breast cancer risk when taken for three years or less.
The magistrate judge sided with Wyeth and precluded testimony from Doctor Donald Austin who said that short-term use of Prempro increases the risk of breast cancer.
Dr. Austin, the plaintiff’s expert witness, contended that short-term use of Prempro causes breast cancer, and his opinion ultimately relied on three observational studies to support his conclusions; the Calle study, the Million Women Study, and the Fournier study.
The magistrate judge analyzed each study separately and concluded that the studies failed to reliably support Dr. Austin’s position. On appeal, Kuhn and Davidson argued that the magistrate judge usurped the role of factfinder and that any problems with the studies go to the weight of the evidence, not to the studies’ validity.
Wyeth responded that the magistrate judge properly determined that the studies were insufficient to support Dr. Austin’s opinion because there existed too great an analytical gap between the underlying studies and Dr. Austin’s opinion.
Dr. Austin’s testimony is admissible because the studies upon which he relied were sufficient to support his opinion that short-term use of Prempro increases the risk of breast cancer. Taken together, the Calle study and the foreign studies constitute appropriate validation of and good grounds for Dr. Austin’s opinion. The studies’ limitations may be presented to the jury, and Dr. Austin’s reliance on the studies may be tested through the traditional means of cross examination and presentation of contrary evidence.
“We conclude that the magistrate judge abused his discretion in precluding Dr. (Donald) Austin’s expert testimony, and thus we reverse and remand for further proceedings,” Judge Roger Wollman wrote for two members of the three-judge panel.
Judge James Loken dissented.
Wyeth is now a subsidiary of Pfizer Inc., which spokesman Chris Loder said is considering its legal options.
The district court’s ruling “was well supported by the evidence, which included findings from the Women’s Health Initiative (WHI) showing no evidence that Prempro use for three years or less increases the risk of breast cancer,” Loder said in a statement.