Chapter 9 - § 9.3 • UNAVOIDABLY UNSAFE (COMMENT k)

• Jurisdiction: Colorado

§ 9.3 • UNAVOIDABLY UNSAFE (COMMENT k)

A frequently litigated defense is the unavoidably unsafe defense, often referred to as the comment k defense. It applies to products that are incapable of being made safe, where the social utility from the product is sufficient to justify the risk.⁷⁴ This exception to liability is most commonly applied in the drug and medical product contexts.⁷⁵

The Colorado Supreme Court, in the seminal case of Belle Bonfils Memorial Blood Bank v. Hansen, described the comment k defense as follows: "the manufacturer or seller of a product which is vitally important yet unavoidably unsafe is not held strictly liable when it can prove that the product's preparation, marketing, and accompanying warnings were carried out in conformance with the highest known scientific and technical standards."⁷⁶

Practice Pointer
Two of the key cases addressing comment k, Belle Bonfils Memorial Blood Bank v. Hansen and Ortho Pharmaceutical Corp. v. Heath, have been overruled/superseded on other grounds. Although practitioners will encounter red flags from Shepards^® and KeyCite on these cases, they are still the major Colorado decisions on the comment k defense.

This defense is usually referred to as the comment k defense as it is based upon comment k to the Restatement (Second) of Torts § 402A. Comment k, itself, provides:

k. Unavoidably unsafe products. 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.⁷⁷

This section will address comment k. Initially, this section will review to which claims the defense applies and does not apply. Next, this section will discuss the burden of proof to establish the comment k defense. Third, this section will briefly discuss the interaction between the state of the art presumptions and the comment k defense. Finally, this section will address the various factors applicable in proving a comment k defense.

§ 9.3.1—Claims To Which Comment k Applies

As comment k refers to comment k of § 402A of the Restatement (Second) of Torts, the defense applies in strict liability cases.⁷⁸ It does not appear that there are any published decisions on the applicability of comment k to negligence cases. The Colorado Pattern Jury Instructions assert that it is not a defense to a negligence cause of action,⁷⁹ but the cases it cites for the proposition never address the issue.⁸⁰

Comment k does not apply to breach of express warranty claims, because comment k cannot apply to unavoidably unsafe products when the manufacturer "expressly warrants that the product is free from danger."⁸¹

As a general matter, the comment k defense applies to breach of implied warranty claims (both merchantability and fitness for a particular purpose).⁸² However, this general rule is not applicable if (1) the implied warranties overlap with the express warranties that the product is safe, or (2) the product was "impliedly warranted as fit for some other particular purpose," even if it was "unavoidably unsafe in its most common use."⁸³

§ 9.3.2—Burden Of Proof To Establish The Comment k Defense

The defendant manufacturer bears the burden to establish the comment k defense.⁸⁴ And, as the Belle Bonfils court explained,

the defendant's proof must rise to a higher level than that of a plaintiff in a prima facie case of negligence. The manufacturer is held to the knowledge and experience of an expert in the field, and the product must conform to the highest standards of available scientific and technical knowledge-not merely that knowledge available to the particular manufacturer.⁸⁵

If the manufacturer introduces...