United States District Court, E.D. Louisiana
IN RE TAXOTERE DOCETAXEL PRODUCTS LIABILITY LITIGATION This document relates to Barbara Earnest, 16-17144
ORDER AND REASONS
TRICHE MILAZZO UNITED STATES DISTRICT JUDGE
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.
in this multidistrict litigation (“MDL”) are
suing several pharmaceutical companies that manufactured
and/or distributed a chemotherapy drug, Taxotere or
docetaxel,  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.
admissibility of expert testimony is governed by Federal Rule
of Evidence 702, which provides as follows:
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
current version of Rule 702 reflects the Supreme Court's
decisions in Daubert v. Merrell Dow Pharmaceuticals,
Inc. and Kumho Tire Co. v.
Carmichael. The threshold inquiry in determining
whether an individual may offer expert testimony under Rule
702 is whether the individual has the requisite
qualifications. After defining the permissible scope of
the expert's testimony, a court next assesses whether the
opinions are reliable and relevant. As the
“gatekeeper” of expert testimony, the trial court
enjoys broad discretion in determining
to assess reliability, a court considers whether the
reasoning or methodology underlying the expert's
testimony is valid. The party offering the testimony bears the
burden of establishing its reliability by a preponderance of
the evidence. Courts should exclude testimony based
merely on subjective belief or unsupported
speculation. Courts must, however, give proper
deference to the traditional adversary system and the role of
the jury within that system. “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.” After assessing reliability, a
court evaluates relevance. 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
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.
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 ...