Beard v. Johnson & Johnson, Inc.
This appeal arose out of a medical-device product liability action in which a strict liability, design-defect theory was asserted. Given that the surgical instrument at issue was said to have multiple applications, the Supreme Court was asked to determine whether the trial court's threshold risk-utility analysis should have been limited to the particular one alleged to have caused the decedent harm. Additionally, the appeal was allowed to consider the degree to which an appellate court is bound by such weight and credibility determinations as may be made by a trial court in a risk-utility assessment. The decedent Sandra Selepec, underwent gastric bypass surgery in August 2002. The surgeon used a product manufactured by Appellee Ethicon Endo-Surgery, Inc. known as an ETS-Flex45 Articulating Endoscopic Linear Cutter, or an "endocutter." Appellee also marketed its product as being useful in more traditional surgery, in which larger incisions are made to expose organs to open view and accessibility. Mrs. Selepec's surgery was of this latter kind. During recovery, Mrs. Selepec experienced complications, and surgeons reentered her abdomen to discover that two of the bypass staples failed. On the merits, Appellee argued that courts applying the risk-utility analysis have always considered the risks, benefits, and design constraints associated with all intended uses of a product; to artificially limit the risk utility analysis to the particular use to which a plaintiff put a product in a particular case would be to ignore the inherent, essential characteristics that informed the design; and to hold multi-use products to the same standard as single-use products would be tantamount to requiring the sale of multiple single-use products, which would be inefficient and impractical, if not impossible. Upon review, the Supreme Court held that trial courts are not restricted to considering a single use of a multiuse product in design defect, threshold, risk-utility balancing. The Court also declined to disturb the Superior Court's legal determination as to the appropriate risk-utility calculus. View "Beard v. Johnson & Johnson, Inc." on Justia Law