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Prempro Ruling Offer Crash Course in Expert Testimony

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By Robyn Hagan Cain on July 27, 2012 4:03 PM

The Eighth Circuit Court of Appeals ruled last week that an Arkansas federal magistrate judge abused his discretion when he blocked expert testimony from a doctor on behalf of two Prempro users who developed breast cancer, reports CBS.

A study linked Prempro -- a combination hormone therapy drug marketed to treat symptoms of menopause -- to increased rates of breast cancer, heart attack and stroke in 2002.

Pamela Kuhn and Shirley Davidson, the lead plaintiffs in the litigation, were both prescribed Prempro. Kuhn took Prempro for 3 years and 28 days; Davidson took it for one year and nine months. Both women developed breast cancer and filed separate lawsuits against Wyeth, the manufacturer.

The complaints alleged, among other things, that Prempro use 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 who reviewed the matter concluded that Dr. Donald Austin’s opinion that short-term use of Prempro increases the risk of breast cancer was not sufficiently reliable to meet the Daubert admissibility standard.

Last Thursday, the Eighth Circuit Court of Appeals reversed that decision.

Federal Rule of Evidence (FRE) 702 states that the opinion of a qualified expert witness is admissible if:

  1. It is based on sufficient facts or data,
  2. It is the product of reliable principles and methods, and
  3. The expert has reliably applied the principles and methods to the facts of the case.

The expert’s scientific, technical, or specialized knowledge must also “assist the trier of fact to understand the evidence or determine a fact in issue.”

The district court acts as the gatekeeper for expert testimony, ensuring that “any and all scientific testimony or evidence admitted is not only relevant, but reliable.” The court is also required “to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.”

Here, the magistrate judge found that Dr. Austin failed to meet his burden “to present reliable science” to support his conclusion that a WHI study was unreliable. (The study said that breast cancer rates were lower among Prempro users than placebo patients.)

The Eighth Circuit Court of Appeals, however, concluded that the plaintiffs, (as the proponents of Dr. Austin’s testimony) did not have to disprove the WHI study’s finding. Instead, it was their burden to show that Dr. Austin arrived at his contrary opinion in a scientifically sound and methodological fashion.

As a result, the Eighth Circuit found 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.

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