Many products liability actions contain a failure to warn claim, i.e., an allegation that the manufacturer did not provide adequate warnings regarding the proper use of a particular product. To support failure to warn claims, plaintiffs often attempt to introduce reports and testimony of “warnings experts.” Even the idea that there are warnings “experts” is an area of contention.

This is an especially important point for product manufacturers because of the disproportionate weight some juries afford experts. It is also a critically important area because many warnings experts simply rely on their own beliefs regarding a warning instead of being able to identify a reliable scientific basis for an opinion regarding a particular warning. However, manufacturers have a remedy available by being able to file in limine motions to preclude reports and/or testimony of a plaintiff’s warnings expert for a variety of reasons.

The United States Supreme Court delineated the standard for admissibility of expert opinions in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) and its progeny.1 Although Daubert was limited to the admissibility of scientific testimony, the court in Kumho Tire Company, Ltd. v. Carmichael, 526 U.S. 137, 119 S.Ct. 1167, 143 L. Ed. 2d 238 (1999) extended this gatekeeping function to expert testimony of any nature.

Federal Rule of Evidence 702 was amended to embody the principles set forth in Daubert and Kumho: “If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training or education, may testify thereto in a form of an opinion or otherwise, if (i) the testimony is based upon sufficient facts or data, (ii) the testimony is the product of reliable principles and methods, and (iii) the witness has applied the principles and methods reliably to the facts of the case.”

Federal Rule of Evidence 702 has three fundamental requirements for the general admissibility of expert testimony: (1) the proffered witness must qualify as an expert by knowledge, skill, experience, training or education; (2) the expert must testify to scientific, technical or other specialized knowledge; and (3) the expert’s testimony must assist the trier of fact.2 Since Daubert and Kumho, federal courts have consistently maintained valid reasoning and reliable methodology as critical requisites in the court’s analysis of proposed expert testimony.3

After the enactment of Federal Rule of Evidence 702, several federal courts have held that expert testimony shall only be permitted if (1) the testimony is based on sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.4

Several federal courts have concluded that four factors are relevant to whether an expert’s reasoning or methodology is valid: “(1) whether the opinion or theory is susceptible to testing and has been subjected to such testing; (2) whether the opinion or theory has been subjected to peer review; (3) whether there is a known or potential rate of error associated with the methodology used and whether there are standards controlling the technique’s operation; and (4) whether the theory has been generally accepted in the scientific community.”5

Based on these factors, various federal courts have reasoned that the opinions of plaintiffs’ warnings experts do not meet the standards for admissibility under the law and therefore should be excluded.6

Absence of a proposed alternative warning drafted by the plaintiff’s warnings expert is one of the easiest ways to preclude a plaintiff’s warnings expert. Courts have routinely held that the testimony of a warnings expert who has not drafted a proposed alternative warning is unreliable.7 Experts who have not drafted proposed alternative warnings are deemed to be “talking off the cuff” as courts have emphasized that the opinions of experts are only admissible to the extent that they are reasoned, employ the methods of the discipline and are founded on data.8 Even if the plaintiff’s warnings expert has drafted a proposed alternative warning for the product at issue, that warning is still subject to peer review and acceptance in the relevant scientific community, or a court will preclude the proffered warnings expert’s opinion.9

Another strong factor in support of precluding the opinion of a plaintiff’s warnings expert is the absence of testing the subject product’s warning.10 Moreover, even if the proffered expert has conducted some testing of the subject warning and/or a proposed alternative, that testing must still be deemed reliable by the court in order to be admissible.11 Courts have also precluded warnings experts when those experts do not have any experience with the product at issue and when the experts have no specific warnings education and/or training.12

Accordingly, while a product manufacturer may be understandably concerned about the possibility of a federal court jury hearing and lending credence to the unreliable subjective opinion of a plaintiff’s warnings expert that is not based on sufficient testing, or even any testing, a manufacturer can use the Federal Rules of Evidence and aforementioned cases as possible recourse in an effort to ensure that the jury never hears those opinions.