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In re Taxotere (Docetaxel) Products Liability Litigation

United States District Court, E.D. Louisiana

August 14, 2019

IN RE TAXOTERE (DOCETAXEL) PRODUCTS LIABILITY LITIGATION This document relates to Barbara Earnest, 16-17144

         SECTION: “H” (5)

          ORDER AND REASONS

          JANE TRICHE MILAZZO UNITED STATES DISTRICT JUDGE

         Before the Court is Plaintiff's Motion to Exclude Expert Testimony that Relies Upon Defendants' Employee Dr. Michael Kopreski (Doc. 6160). The Court heard oral argument on July 25, 2019. For the following reasons, the Motion is DENIED.

         BACKGROUND

         Plaintiffs in this multidistrict litigation (“MDL”) are suing several pharmaceutical companies that manufactured and/or distributed a chemotherapy drug, Taxotere or docetaxel, [1] that Plaintiffs were administered for the treatment of breast cancer and other forms of cancer. Plaintiffs allege that the drug caused permanent alopecia-in other words, permanent hair loss. Plaintiffs bring claims of failure to warn, negligent misrepresentation, fraudulent misrepresentation, and more.

         The first bellwether trial of Plaintiff Barbara Earnest (“Plaintiff”) is set to begin September 16, 2019. In the instant Motion, Plaintiff moves to exclude expert testimony that relies on a certain analysis conducted by Dr. Michael Kopreski. Dr. Kopreski is a former employee of Sanofi who provided deposition testimony as Sanofi's 30(b)(6) witness. Defendants have not proffered Dr. Kopreski himself as an expert, but several of Sanofi's designated experts rely on Dr. Kopreski's post hoc analysis of alopecia adverse events in the Taxotere clinical study, TAX 316.

         TAX 316 was a 1997 Sanofi clinical trial testing the efficacy of Taxotere in the treatment of adjuvant breast cancer. As part of the trial, participants were followed for 10 years after their treatment. During this period, researchers tracked ongoing adverse events, including alopecia. The study, as reported to the FDA, concluded that roughly 4 percent of the participants experienced “ongoing alopecia.”

         In conjunction with this litigation and in response to a 30(b)(6) deposition notice, Dr. Kopreski performed a re-analysis of the TAX 316 data as it relates to ongoing alopecia. His updated analysis reports that less than 1 percent of patients experienced “persistent alopecia.” Three of Defendants' experts-Dr. John Glaspy, Dr. Janet Arrowsmith, and Mr. Justin Victoria-rely on the findings of Dr. Kopreski in the expert opinions they intend to render at trial.

         LEGAL STANDARD

         The admissibility of expert testimony is governed by Federal Rule of Evidence 702, which provides as follows:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:
(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and ...

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