Opinion ID: 1403899
Heading Depth: 1
Heading Rank: 5

Heading: proper forum for risk/benefit analysis

Text: Finally, we do not believe that a trial court in the context of a products liability action is the proper forum to determine whether, as a whole, a particular prescription drug's benefits outweighed its risks at the time of distribution. In a case-by-case analysis, one court or jury's determination that a particular drug is or is not defectively designed has no bearing on any future case. As a result, differences of opinion among courts in differing jurisdictions leaves unsettled a drug manufacturer's liability for any given drug. Although the FDA may have internal differences of opinion regarding whether a particular new drug application should be approved, the individuals making the ultimate judgment will have the benefit of years of experience in reviewing such products, scientific expertise in the area, and access to the volumes of data they can compel manufacturers to produce. Nor is the FDA subject to the inherent limitations of the trial process, such as the rules of evidence, restrictions on expert testimony, and scheduling demands. [9] One commentator has argued that courts as a whole are unsuited to render responsible judgments in the design defect area generally. See Henderson, Judicial Review of Manufacturers' Conscious Design Choices: The Limits of Adjudication, 73 Colum.L.Rev. 1531 (1973). He argues that decisions in this area are arbitrary due to their polycentric nature in which each point for decision is related to all the others as are the strands of a spider web. Id. at 1536. These issues are difficult to litigate because [i]f one strand is pulled, a complex pattern of readjustments will occur throughout the entire web. If another strand is pulled, the relationships among all the strands will again be readjusted. A lawyer seeking to base [an] argument upon established principle and required to address himself in discourse to each of a dozen strands, or issues, would find [the] task frustratingly impossible. Id. Although we do not accept the notion that courts are unsuited to address design defect claims in any products liability action, we do agree that prescription drug design presents precisely this type of polycentric problem. A drug is designed to be effectively administered to specific individuals for one or a number of indications. To determine whether a drug's benefit outweighs its risk is inherently complex because of the manufacturer's conscious design choices regarding the numerous chemical properties of the product and their relationship to the vast physiologic idiosyncracies of each consumer for whom the drug is designed. Society has recognized this complexity and in response has reposed regulatory authority in the FDA. Relying on the FDA's screening and surveillance standards enables courts to find liability under circumstances of inadequate warning, mismanufacture, improper marketing, or misinforming the FDA  avenues for which courts are better suited. Although this approach denies plaintiffs one potential theory on which to rely in a drug products liability action, the benefits to society in promoting the development, availability, and reasonable price of drugs justifies this conclusion. In light of the strong public interest in the availability and affordability of prescription medications, the extensive regulatory system of the FDA, and the avenues of recovery still available to plaintiffs by claiming inadequate warning, mismanufacture, improper marketing, or misrepresenting information to the FDA, we conclude that a broad grant of immunity from strict liability claims based on design defects should be extended to FDA-approved prescription drugs in Utah. [10] HALL, C.J., and ZIMMERMAN, J., concur.