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In re Taxotere (Docetaxel) Products Liability Litigation

United States District Court, E.D. Louisiana

August 29, 2019

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

         SECTION: “H” (5)



         Before the Court is Plaintiff's Motion to Exclude Dr. Shapiro's and Dr. Smart's Stem Cell Opinions (Doc. 7322). The Court held oral argument on the Motion on July 25, 2019. For the following reasons, the Motion is DENIED and DEFERRED.


         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]


         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 Pharmaceuticals, 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]


         In the instant Motion, Plaintiff asks the Court to exclude testimony from Defendants' experts Dr. Jerry Shapiro and Dr. Chandra Smart. Dr. Shapiro is a dermatologist, and Dr. Smart is a dermatopathologist. Plaintiff first argues that the doctors are not qualified to interpret certain stem cell testing because they are not stem cell experts. Plaintiff next argues that the doctors' opinions are unreliable because they rest on incorrect assumptions, specifically: (1) that Ki-67 and Cytokeratin 15 staining is a reliable method for identifying stem cells in the bulge of the hair follicle, and (2) that the presence of stem cells in this region means that hair loss is not permanent.

         The Court rejects Plaintiff's argument that these experts are not qualified because they are not stem cell experts. First, Dr. Shapiro has specialized knowledge that would assist a trier of fact. Through his decades of experience as a doctor, he has gained an understanding of stem cell testing. He testified about this at his deposition:

Q: Do you -- did you make any attempt to search the peer-reviewed literature to see if cytokeratin-15 was or was not a reliable test for stem cells in the hair follicle bulge region before authoring your supplemental report?
A: As a doctor who has devoted his -- his three years -- 30 decades -- sorry. Three decades of work and when stem cells were first discovered I remember when that all came to be, and I remember these stains were important stains. But I did not look up the latest or anything like that.
All I know is that they help identify stem cells. They also help to identify proliferation of stem cells. But I don't know the latest ...

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