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ST. LOUIS - (Mealey's) In a 2-1 ruling July 26, the Eighth Circuit U.S. Court of Appeals reversed summary judgment in two Prempro bellwether cases that involve the risk of breast cancer in women who took the hormone replacement therapy drug for less than three years (Pamela Kuhn v. Wyeth, Inc., et al., No. 11-1809, Shirley Davidson v. Wyeth, et al., No. 11-1815, 8th Cir.).
(Opinion available. Document #28-120809-001Z.)
Pamela Kuhn took Prempro for three years and 28 days, and Shirley Davidson took it for one years and nine months. Kuhn argued that she took the drug for more than three years, but defendant Wyeth (now Pfizer Inc.) argued that she took it for less than three years.
Both plaintiffs developed breast cancer and filed separate lawsuits against Wyeth in the U.S. District Court for the Western District of Arkansas, where the Prempro multidistrict litigation is located, alleging that the drug increased the risk of breast cancer and that Wyeth failed to adequately warn of the risk.
Kuhn's and Davidson's cases were selected as bellwether cases on the issue of breast cancer caused by short-term use of Prempro. The plaintiffs named David F. Austin, M.D., an epidemiologist, as their expert on the issue of causation by short-term use of Prempro.
Joint Daubert Hearing
While Kuhn's and Davidson's cases were pending in the MDL, Wyeth was facing a trial in the District of Puerto Rico in a Prempro case that also involved short-term use. Since Wyeth planned to challenge the expert testimony in the Puerto Rico case, it suggested that the MDL court conduct a joint Daubert (Daubert v. Merrell Dow Pharmaceuticals, Inc. 509 U.S. 579 ) [enhanced version available to lexis.com subscribers] hearing.
Wyeth argued that there is no reliable scientific basis for plaintiff experts to conclude that taking Prempro for less than three years increased the risk of breast cancer. It added that the Women's Health Initiative (WHI), which found a link between Prempro and breast cancer, did not show that fewer than three years' use increased the risk and that studies that plaintiff experts relied on were methodologically flawed.
The plaintiffs argued that Prempro is a growth-promoting agent that causes cancer-susceptible cells to become cancerous, even with short-term use.
Magistrate Judge Joe J. Volpe granted Wyeth's motion to exclude Austin's testimony, finding that it was not sufficiently reliable to meet the admissibility standard of Daubert. The District Court adopted the recommendation and granted summary judgment.
Kuhn and Davidson appealed, arguing that the magistrate judge abused his discretion by precluding Austin's testimony and recommending summary judgment.
Magistrate Abused Discretion
In a 2-1 ruling the Eighth Circuit panel majority noted that the magistrate judge did not address Austin's testimony that women who took Prempro had lower recorded rates of breast cancer in the first two years, not three years. It said that although Austin distinguished between annual incidents of breast cancer and cumulative incidents, the magistrate judge addressed only the testimony about cumulative incidents.
"We conclude that the magistrate judge abused his discretion in deciding that Dr. Austin's criticisms of the WHI study were unfounded and inconsistent with his reliance on the study in other hormone therapy cases," the majority said. Citing Austin's testimony, the majority said, "In light of this testimony and its supporting evidence, Dr. Austin's reliance on the WHI study to prove general causation does not foreclose his opinion that the study did not accurately assess the risk of breast cancer associated with the short-term use of Prempro."
While Wyeth/Pfizer can challenge Austin's credibility based on his previous testimony, the majority said, "his previous reliance on and testimony regarding the WHI study does not render his opinion inadmissible, as it was not his burden to disprove the WHI's finding that short-term use of Prempro does not increase the risk of breast cancer."
Credibility, Not Admissibility
The majority said the magistrate judge erred in factoring in the haste in which Austin's opinion was written and the involvement of plaintiffs' counsel. It said those issues go to the credibility of Austin, not the admissibility of his opinion.
Austin's reliance on epidemiological studies compiled by plaintiffs' counsel and supporting observational studies "provide adequate foundation for Dr. Austin's testimony," the majority said.
"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," the majority said. It said the observational 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."
Wyeth/Pfizer also argued that Austin cherry-picked information from the observational studies. The majority rejected that: "There may be several studies supporting Wyeth's contrary position, but it is not the province of the court to choose between the competing theories when both are supported by reliable scientific evidence."
Because Austin's opinion is admissible, the majority reversed summary judgment. Also, the majority said it did not need to address Kuhn's argument that she used Prempro for more than three years.
The cases were remanded to the MDL court for further proceedings.
Circuit Judge Roger L. Wollman wrote the majority opinion. Joining him was Circuit Judge Raymond W. Gruender.
Circuit Judge James B. Loken dissented, saying the District Court's Daubert analysis was supported by the record and "properly focused on the gate-keeping function mandated by the Supreme Court and by [Federal] Rule [of Civil Procedure] 702."
Judge Loken said the majority applied an overly stringent review and failed to give the trial court's ruling deference.
Kuhn and Davidson are represented by Russell T. Abney, Ted G. Meadows and Navan J. Ward of Beasley Allen in Montgomery, Ala.; W. Gary Holt of Gary Holt & Associates in Little Rock, Ark.; Breean Walas of North Little Rock, Ark.; and Erik B. Walker of Hissey & Kientz in Austin, Texas.
Defense, Amicus Counsel
Wyeth/Pfizer is represented by Loren H. Brown and Christopher G. Campbell of DLA Piper in New York; Catherine M. Corless, Lyn Peoples Pruitt, Mary C. Way and Leigh A. Yeargan of Mitchell & Williams in Little Rock; David E. Dukes, Michael W. Hogue, John M. Jones of Nelson & Mullins in Columbia, S.C.; and F. Lane Heard III of Williams & Connolly in Washington, D.C.
Amicus Arkansas Trial Lawyers Association is represented by Brian G. Brooks of Greenbrier, Ark.
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