As drug and device lawyers we live in a comment k dominated world. When we say comment k on this blog, everyone knows what we mean. We aren’t talking about a scientific discovery regarding potassium. We aren’t reviewing a new flavor of k-cup for the Keurig. We aren’t posting about breakfast cereals. And we definitely are not passing comment on the Kardashians, Kobe, Keanu, or K-Fed.
But just in case you need a refresher, here is the comment k that concerns us:
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. . . . 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. . . . 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.
Restatement (Second) of Torts §402A, comment k (1965) (emphasis added). As you can see from the highlighted language, comment k recognizes that some products – drugs and medical devices in particular – are “unavoidably unsafe” and therefore not defective if properly prepared and accompanied by an adequate warning. Most courts to have considered the issue have interpreted comment k to mean that manufacturers do not face strict liability for properly manufactured prescription drugs that are accompanied by adequate warnings. That is true in Washington. Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 63 (Wash. 1996) (under comment k, a prescription drug manufacturer is liable “only if it failed to warn of a defect of which it either knew or should have known . . . it is liable in negligence and not in strict liability”).Continue Reading No Error With Comment k Jury Instruction