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In re Taxotere (Docetaxel) Products Liability Litigation

United States District Court, E.D. Louisiana

August 23, 2019

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

         SECTION: “H” (5)



         Before the Court is a Motion to Exclude Expert Testimony on Specific Causation (Doc. 6162) filed by Defendants Sanofi-Aventis U.S. LLC and Sanofi U.S. Services, Inc. (collectively, “Sanofi” or “Defendants”). The Court heard oral argument on the Motion on July 25, 2019. For the following reasons, the Motion is DENIED.


         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 or 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.[2] In the instant Motion, Defendants seek to exclude testimony on specific causation, arguing that, under Daubert, Plaintiff's experts-specifically, Dr. Curtis Thompson and Dr. Antonella Tosti-do not present reliable evidence on the issue.


         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 methods; and
(d) the expert has reliably applied the principles and methods to the facts of the case.[3]

         The current version of Rule 702 reflects the Supreme Court's decisions in Daubert v. Merrell Dow Pharms., Inc.[4] and Kumho Tire Co. v. Carmichael.[5]The threshold inquiry in determining whether an individual may offer expert testimony under Rule 702 is whether the individual has the requisite qualifications.[6] After defining the permissible scope of the expert's testimony, a court next assesses whether the opinions are reliable and relevant.[7] As the “gatekeeper” of expert testimony, the trial court enjoys broad discretion in determining admissibility.[8]

         First, to assess reliability, a court considers whether the reasoning or methodology underlying the expert's testimony is valid.[9] The party offering the testimony bears the burden of establishing its reliability by a preponderance of the evidence.[10] Courts should exclude testimony based merely on subjective belief or unsupported speculation.[11] Courts must, however, give proper deference to the traditional adversary system and the role of the jury within that system.[12] “Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.”[13] After assessing reliability, a court evaluates relevance.[14] In doing so, a court must determine whether the expert's reasoning or methodology “fits” the facts of the case and will thereby assist the trier of fact in understanding the evidence.[15]

         Federal Rule of Evidence 703 further provides that an expert may offer opinions based on otherwise inadmissible facts or data but only if (1) they are of the kind reasonably relied upon by experts in the particular field; and (2) the testimony's probative value substantially outweighs its prejudicial effect.[16]


         To prevail in a pharmaceutical products liability case, a plaintiff must establish both general and specific causation through reliable expert testimony.[17] “General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual's injury.”[18]The standard method for assessing specific causation is “a differential diagnosis.”[19] “In performing a differential diagnosis, a physician begins by ‘ruling in' all scientifically plausible causes of the plaintiff's injury. The physician then ‘rules out' the least plausible causes of injury until the most likely cause remains.”[20]

         Plaintiff explains that Dr. Tosti is Plaintiff's primary specific causation expert and that her analysis relied on the work of other experts. Dr. Tosti is a dermatologist who has treated many women for chemotherapy-induced hair loss. In connection with this case, Dr. Tosti recommended that her colleague, Dr. Thompson, conduct a “pathology analysis” for her to consider in forming her opinion on Plaintiff Earnest. This analysis required Dr. Thompson to study “punch biopsies, ” or tissue samples, taken from Plaintiff's scalp. Dr. Thompson explained that as a pathologist, his job was to render “an objective read” on the samples. To create these tissue samples, Plaintiff Earnest, a New Orleans resident, visited a local dermatologist, Dr. Cole Claiborne. Dr. Claiborne took two samples from Earnest's scalp. Plaintiff's counsel asked for one from the most affected area of her scalp and one from the least affected area. Heeding this instruction, Dr. Claiborne chose the precise locations for the samples. In her briefing, Plaintiff nicely summarizes the division of labor between Dr. Claiborne, Dr. Thompson, and Dr. Tosti: “[O]btaining the biopsies fell to Dr. Claiborne as the local physician; pathology fell to the expertise of Dr. Thompson; and the overall synthesizing analysis went to Dr. Tosti, who has spent years studying all forms of alopecia.”[21]

         I. Defendants' Arguments Regarding Dr. Claiborne

         Defendants first argue that the punch biopsies taken by Dr. Claiborne are unreliable because they were litigation-driven and because Dr. Claiborne did not follow standard practice in taking the biopsies. Defendants note that Dr. Claiborne was not provided with clinical histories or other information needed to make a differential diagnosis. Defendants emphasize testimony from Dr. Claiborne, in which he agreed that outside the litigation context, what was done with Earnest is something he would never do and was not consistent with his clinical practice.

         Defendants' arguments have no merit. Dr. Claiborne was not tasked with conducting a differential diagnosis. Dr. Claiborne's work was at the direction of Dr. Tosti. As Dr. Claiborne testified, he was a “proceduralist in this instance.”[22] Consistent with Dr. Tosti's instructions, he provided tissue samples for Dr. Thompson to analyze and the differential diagnosis was left to Dr. Tosti. Under Rule 703, an expert can rely on the work of another expert provided that the reliance is reasonable.[23] Defendants have failed to show that Dr. Tosti unreasonably divided the labor here and jeopardized the reliability of her work in doing so. Further, despite Defendants' argument that Dr. Claiborne's biopsies were litigation-driven, this Court has been provided no opinion that the biopsy process was faulty. Because Defendants have failed to show that his work was unreliable, the Court rejects this argument.

         II. Defendants' Arguments ...

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