JANE TRICHE MILAZZO, District Judge.
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
Plaintiffs in this multidistrict litigation ("MDL") are suing several pharmaceutical companies that manufactured and/or distributed a chemotherapy drug, Taxotere or docetaxel,
The admissibility of expert testimony is governed by Federal Rule of Evidence 702, which provides as follows:
The current version of Rule 702 reflects the Supreme Court's decisions in Daubert v. Merrell Dow Pharms., Inc.
First, to assess reliability, a court considers whether the reasoning or methodology underlying the expert's testimony is valid.
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.
To prevail in a pharmaceutical products liability case, a plaintiff must establish both general and specific causation through reliable expert testimony.
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."
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."
Defendants next argue that Dr. Thompson's opinions are unreliable and irrelevant for three reasons: (1) unreliable biopsies were the foundation of his entire opinion; (2) his methodology failed to account for the specific facts and circumstances of Plaintiff; and (3) his opinion does not answer the relevant question of whether Taxotere, and not something else, caused Plaintiff's alleged permanent alopecia. The Court has already ruled that Dr. Claiborne's work was reliable, leaving only two arguments against Dr. Thompson.
In arguing that Dr. Thompson's methodology was flawed, Defendants re-urge the argument they made with respect to Dr. Claiborne. Defendants take issue with the fact that Dr. Thompson did not consider Plaintiff's clinical history before making a diagnosis. He knew only Plaintiff's age, gender, and the fact that she had chemotherapy treatment. This was, however, consistent with his defined role in Dr. Tosti's division of labor, and Dr. Thompson explained as much in his deposition. He testified that his job was to provide an "objective read" of the tissue samples and that pathologists "focus on getting the information that's important for each diagnosis and not beyond that."
In arguing that Dr. Thompson's opinions are unhelpful, Defendants point to testimony from Dr. Thompson in which he said that he cannot offer an opinion on which specific chemotherapy drug caused Plaintiff's hair loss. Defendants emphasize again that Dr. Thompson was not provided with Plaintiff's medical history or any information about her background. As the Court has explained, Dr. Thompson conducted his work as part of Dr. Tosti's division of labor. He provided an "objective read" of the tissue samples and then shared his findings with Dr. Tosti, who then conducted a differential diagnosis. It was Dr. Tosti who considered Plaintiff's medical history and other pertinent information. Accordingly, the Court rejects Defendant's argument that Dr. Thompson's opinions are unhelpful and therefore inadmissible. His work served a purpose for Dr. Tosti, and this is permissible under Rule 703.
Defendants raise several attacks against Dr. Tosti. They argue that her opinions must be excluded for three reasons: (1) she relied on Dr. Thompson's unreliable punch biopsies; (2) she failed to reliably rule out other causes; and (3) she relied on literature that is not sufficient to support her ultimate opinion. The Court has already ruled that Dr. Thompson's work was reliable, leaving only two arguments against Dr. Tosti.
Defendants argue that Dr. Tosti conducted a flawed differential diagnosis. Defendants aver that Dr. Tosti did not start by "ruling in" all scientifically plausible causes of Plaintiff's alopecia and she did not appropriately "rule out" the least plausible causes, including diseases and other medications. Instead, according to Defendants, Dr. Tosti took Dr. Thompson's conclusion that the pathology results were "consistent with permanent alopecia after chemotherapy" and conducted physical examinations to confirm this diagnosis.
Defendants misrepresent Dr. Tosti's report. Dr. Tosti does in fact provide a differential diagnosis. She first explains that alopecia can be classified into one of four categories based on shape and topographic distribution: (1) patchy alopecia; (2) patterned alopecia; (3) marginal alopecia; and (4) diffuse alopecia.
Dr. Tosti then explains why she rules out three of these causes. Telogen effluvium results in a positive "pull test," and Dr. Tosti conducted a pull test on Earnest that was negative.
Dr. Tosti further "rules in" and then "rules out" another possible cause, "androgenetic alopecia," even though this type of alopecia does not cause "diffuse alopecia" like Earnest has.
Accordingly, despite what Defendants argue, Dr. Tosti does in fact "rule in" and "rule out" the plausible causes of Earnest's hair loss.
For the foregoing reasons,