Guest Commentary

Michael L. Junk, Hollingsworth LLP

On January 18, 2011, the United States District Court for the Western District of Arkansas (Volpe, M.J.) issued an order excluding the expert/opinion testimony offered by Dr. Donald F. Austin on behalf of the plaintiffs in the In re: Prempro Products Liability Litigation.

The court’s decision is remarkable first because it recognized that Dr. Austin’s opinions contradicted not only the plaintiffs’ longstanding medical- and scientific-causation case, but they also contradicted Dr. Austin’s prior testimony for the plaintiffs in the same litigation.

According to the court, “[s]ince the inception of the litigation” (Slip Op. at 5) the plaintiffs had trumpeted the results of a certain study which showed an association between long-term use of Prempro and an increased risk of breast cancer.  Among numerous other experts, Dr. Austin had himself endorsed the findings and methodology of this study.  “Accordingly, th[e] Court ha[d] consistently found that the . . . study is the most significant and reliable study for considering the risk of breast cancer from Prempro.”  (Slip Op. at 6.)  Importantly, the study found no increased risk of breast cancer associated with short-term Prempro use (i.e., 3 years or less).

In a move not all that unfamiliar to many mass tort litigators, the plaintiffs’ litigation strategy apparently evolved, and so notwithstanding their prior reliance upon this crucial study to prove that long-term use of Prempro causes breast cancer, the plaintiffs asked Dr. Austin to offer an opinion about an increased risk of breast cancer associated with short-term use of Prempro.  To render such an opinion, however, Dr. Austin would – and did – have to back away from many aspects of his prior testimony endorsing the results and methodology of what the court viewed as the definitive study concerning the risk of breast cancer associated with Prempro use.

The court was not impressed with this tactic:  “Although Plaintiffs have relied on [the study] as the definitive study for establishing a causal connection between [Prempro] use and breast cancer, they make great strides in this short-term use litigation to criticize the . . . study as unreliable.  Plaintiffs’ newfound criticism is not persuasive.”  (Slip Op. at 7.)  The court went on to cite specific examples of Dr. Austin’s praise for the study – and then turned this testimony squarely against the doctor to demonstrate the inherent unreliability of his short-term use opinions.  For example, the court noted that Dr. Austin had previously testified that the study was important in evaluating the risk of breast cancer associated with the duration of use of Prempro; thus, these statements belied his later testimony that the study was unable to evaluate risk related to duration of use.  (See Slip Op. at 7.)  Similarly, Dr. Austin’s prior testimony established that among all of the available evidence the study had the greatest statistical power to detect an association between breast cancer and Prempro use; consequently, his subsequent testimony to the contrary was unreliable.  (See Slip Op. at 7.)

Ultimately, the court found that in reaching his conclusions Dr. Austin failed to follow the same scientific methodology to which he purportedly subscribed.  As the court explained:

Dr. Austin is the proponent of the expert testimony, and he is obliged to present reliable studies and a consistent methodology to support his opinions.  Furthermore, it is Dr. Austin’s responsibility . . . to reliably establish his position while adhering to the rules he sets out;  that is, using only studies that have enough power, are precise, involve the same drugs [as those at issue], and closely track [Prempro] use.

(Slip Op. at 18.)

Interestingly, the court also took a dim view of the “process” that rendered Dr. Austin’s opinions.  The doctor admitted that “his short-term use report was written in about five hours at the behest and [with the] assistance of Plaintiffs’ counsel.”  (Slip Op. at 8.)  His “testimony also revealed that the process was driven largely by the lawyers.”  (Slip Op. at 9.)  From this, the court concluded that Dr. Austin’s “opinions were hastily formed in an attempt to overcome overwhelmingly reliable evidence to the contrary.  Given Plaintiffs’ enormous reliance on the [definitive] study in this litigation, . . . this criticism developed over the course of hours is not only inconsistent, but illogical.”  (Slip Op. at 9.)