Opinion ID: 2033455
Heading Depth: 1
Heading Rank: 9

Heading: Cases Applying Risk-Utility Analysis Under Comment k.

Text: An application of comment k. to provide a blanket immunity from strict liability is widely criticized. Comment k. has proved to be difficult to interpret and apply, thus, supporting the argument that it should not be applied so strictly. See, Richard L. Cupp, Jr., Rethinking Conscious Design Liability for Prescription Drugs: The Restatement (Third) Standard Versus a Negligence Approach, 63 Geo. Wash. L.Rev. 76 (1994); Winchester, supra. Further, it is said that an approach that entirely excepts manufacturers from immunity limits the discretionary powers of the courts. Id. Also, it is argued that a blanket immunity leads to patently unjust results. Id. One court has stated: We believe that a more selective application [of comment k. ] will encourage, rather than discourage, improvements in prescription products. Comment k was designed in part to protect new and experimental drugs.... Comment k states: `There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.' Obviously, for this to be true, the design must be as safe as the best available testing and research permits. ... Thus, a product which is as safe as current testing and research permits should be protected. The reverse is also true; a product which is not as safe as current technology can make it should not be protected. (Citation omitted.) Adams v. G.D. Searle & Co., Inc., 576 So.2d 728, 732 (Fla.App. 1991). The majority of jurisdictions that have adopted comment k. apply it on a case-by-case basis, believing that societal interests in ensuring the marketing and development of prescription drugs will be adequately served without the need to resort to a rule of blanket immunity. See, e.g., Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 528 (6th Cir.1993); Hill v. Searle Laboratories, 884 F.2d 1064 (8th Cir.1989); Castrignano v. E.R. Squibb & Sons, Inc., 546 A.2d 775 (R.I.1988); Toner v. Lederle Laboratories, 112 Idaho 328, 732 P.2d 297 (1987); Ortho Pharmaceutical Corp. v. Heath, 722 P.2d 410 (Colo.1986), overruled on other grounds, Armentrout v. FMC Corp., 842 P.2d 175 (Colo.1992); Feldman v. Lederle Laboratories, 97 N.J. 429, 479 A.2d 374 (1984); Belle Bonfils Memorial Blood Bank v. Hansen, 665 P.2d 118 (Colo.1983) (superseded by statute in regard to blood banks, as recognized in United Blood Services v. Quintana, 827 P.2d 509 (Colo.1992)). A few courts have not specifically adopted comment k. and have instead either fashioned their own rules or treated prescription drugs in the same manner as that of all other products. See, e.g., Shanks v. Upjohn Co., 835 P.2d 1189 (Alaska, 1992); Collins v. Eli Lilly Co., 116 Wis.2d 166, 342 N.W.2d 37 (1984); Thomas V. Van Flein, Prospective Application of the Restatement (Third) of Torts: Products Liability in Alaska, 17 Alaska L.Rev. 1 (2000) (citing cases). Although a variety of tests are employed among jurisdictions that apply comment k. on a case-by-case basis, the majority apply the comment as an affirmative defense, with the trend toward the use of a risk-utility test in order to determine whether the defense applies. See Annot., 96 A.L.R.3d 22 (1980). See, e.g., Tansy v. Dacomed Corp., 890 P.2d 881 (Okla.1994); Castrignano, supra ; Toner, supra ; Belle Bonfils Memorial Blood Bank, supra . When a risk-utility test is applied, the existence of a reasonable alternative design is generally the central factor. See, e.g., Tansy, supra ; Toner, supra ; Belle Bonfils Memorial Blood Bank, supra . Because the application of comment k. is traditionally viewed as an exception and a defense to strict liability, courts generally place the initial burden of proving the various risk utility factors on the defendant. See, e.g., Tansy, supra ; Belle Bonfils Memorial Blood Bank, supra . Thus, under these cases, the plaintiff's burden of proof for his or her prima facie case remains the same as it is in any products liability case in the given jurisdiction. At the time McDaniel v. McNeil Laboratories, Inc., 196 Neb. 190, 241 N.W.2d 822 (1976), was decided, it reflected a minority view. Since that time, a clear majority of courts have decided on a case-by-case basis, through the application of a comment k. defense, the issue of liability of a manufacturer for a design defect in a prescription drug. On further reflection, we conclude that the rule of law expressed in McDaniel has not held up over time. We now believe that societal interests in ensuring the marketing and development of prescription drugs can be served without resorting to a rule which in effect amounts to a blanket immunity from strict liability for manufacturers. Accordingly, we overrule McDaniel to the extent it applies comment k. to provide a blanket immunity from strict liability for prescription drugs. Accordingly, we must address how, or if, comment k. should be applied, or whether we should consider adopting provisions of the Third Restatement. We next address those provisions in considering what test should be applied.