Opinion ID: 2033455
Heading Depth: 1
Heading Rank: 7

Heading: Comment k. Exception for Unavoidably Unsafe Products

Text: Under the Second Restatement, prescription drugs are treated specially under § 402 A, comment k. Comment k. at 353-54 provides an exception from strict liability when a product is deemed to be unavoidably unsafe and 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. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. Application of comment k. has been justified under the law in some jurisdictions as a way to strike a balance between a manufacturer's responsibility and the encouragement of research and development of new products. Under certain instances, it is in the public interest to allow products to be marketed which are unsafe, because the benefits of the product justify its risks. See, Hill v. Searle Laboratories, 884 F.2d 1064 (8th Cir.1989) (describing policy considerations); Tansy v. Dacomed Corp., 890 P.2d 881 (Okla.1994). We applied § 402 A, comment k., to a products liability action involving a prescription drug in McDaniel v. McNeil Laboratories, Inc., 196 Neb. 190, 241 N.W.2d 822 (1976). In McDaniel, a woman was rendered permanently comatose after being given doses of a prescription drug, Innovar, during surgery. At the time of her surgery, Innovar and the warnings and information contained in the package inserts had been approved for use by the FDA. At trial, it was contended that the manufacturer was negligent in failing to warn, strictly liable under § 402 A of the Second Restatement, and liable under a theory of either express or implied warranty. The trial court submitted the issue of negligence to the jury but did not submit the issue of strict liability or warranty to the jury. On appeal, we placed emphasis on FDA approval of the drug, and citing to § 402 A, comment k., we held: An unavoidably unsafe drug which has been approved for marketing by the United States Food and Drug Administration, properly prepared, compounded, packaged, and distributed, and accompanied by proper approved directions and warnings, as a matter of law, is not defective nor unreasonably dangerous, in the absence of proof of inaccurate, incomplete, misleading, or fraudulent information furnished by the manufacturer in connection with such federal approval or later revisions thereof. McDaniel, 196 Neb. at 201, 241 N.W.2d at 828. Under the evidence presented, we determined that it was not error for the trial court to refuse to submit the issue of strict liability or warranty, either express or implied, to the jury.