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In re Taxotere Docetaxel Products Liability Litigation

United States District Court, E.D. Louisiana

September 3, 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 of David A. Kessler, M.D., J.D. (Doc. 6146) filed by Defendants Sanofi-Aventis U.S. LLC and Sanofi U.S. Services, Inc. (collectively, “Sanofi” or “Defendants”). The Court held oral argument on the Motion on July 25, 2019. For the following reasons, the Motion is GRANTED IN PART, DENIED IN PART, and DEFERRED IN PART.


         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] At trial, Plaintiff intends to introduce the testimony of Dr. David Kessler. Dr. Kessler served as Commissioner of the FDA from 1990 to 1997. He has an M.D. from Harvard Medical School and a J.D. from the University of Chicago Law School. Defendants have filed the instant Motion seeking to limit his testimony.


         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]

         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]


         In the instant Motion, Defendants raise several arguments relating to Dr. Kessler's testimony that as early as 2009 Sanofi had “reasonable evidence of a causal association” between Taxotere and irreversible alopecia. This “causal association” language stems from the FDA regulations, which provide that a drug's label “must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug.”[17] Notably, the regulations further state that “a causal relationship need not have been definitely established.”[18]

         Defendants' first concern is that the jury will confuse “reasonable evidence of a causal association” with medical or legal causation. Defendants further argue that any testimony from Dr. Kessler on medical or legal causation would be inappropriate because Dr. Kessler did not apply a reliable methodology, such as the Bradford Hill factors, to form an opinion on medical or legal causation.[19] Defendants emphasize that “reasonable evidence of a causal association” is a lower threshold of proof than that which is required by state tort law to establish causation.

         The Court first notes that Dr. Kessler is not offering any opinions on medical or legal causation. His opinions relate to Sanofi's duty to warn and its failure to do so. Dr. Kessler, therefore, did not need to rely on the Bradford Hill factors, which courts use to assess general causation.[20] As Defendants note, the FDA's test looks only for a “causal association, ” not necessarily a definite causal relationship, and the Bradford Hill factors are used after a statistical association is found “to determine whether [the] association reflects a truly causal relationship.”[21] Dr. Kessler, therefore, did not need to apply the Bradford Hill factors to determine whether, under the FDA regulations, Sanofi had “reasonable evidence of a causal association” that required it to update Taxotere's label.

         Using the experience that he gained as Commissioner of the FDA, Dr. Kessler considered the seven factors that the FDA uses in determining whether there is “reasonable evidence of a causal association.” Because Dr. Kessler is qualified and used a reliable methodology in forming his opinion, which will help the jury decide whether Sanofi breached its duty to warn, the Court will not exclude his testimony on the basis that it may confuse the jury. On cross-examination, Defendants can make clear for the jury that “reasonable evidence of a causal association” is distinct from medical or legal causation.

         Defendants next argue that Dr. Kessler should not be permitted to opine on whether there was reasonable evidence to warn of a risk of “irreversible alopecia” because (1) Dr. Kessler cannot define “irreversible alopecia” and (2) the evidence he identified did not reliably meet an acceptable definition of that risk. The Court can see that defining “irreversible alopecia” is a challenge. In his report, however, Dr. Kessler, adequately articulated the definition he used and his support for it. He wrote that the medical literature generally defines the condition as the “complete loss of growth or partial regrowth at least 6 months after chemotherapy.”[22] To the extent Defendants disagree with this definition or believe that Dr. ...

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