Opinion ID: 4436393
Heading Depth: 2
Heading Rank: 1

Heading: strict products liability and the

Text: UNAVOIDABLY UNSAFE EXCEPTION ¶7 Plaintiffs’ causes of action against Wright Medical include strict liability design defect claims. Wright Medical argues that its hip implants should be categorically immune from such claims based on the “unavoidably unsafe doctrine,” an exception to strict products liability. ¶8 We have adopted section 402A of the Restatement (Second) of Torts, which imposes liability upon “[o]ne who sells any product in a defective condition unreasonably dangerous to the user or consumer, or to his [or her] property.” RESTATEMENT (SECOND) OF TORTS § 402A(1) (A.L.I. 1965); see also Ernest W. Hahn, Inc. v. Armco Steel Co., 601 P.2d 152, 158 (Utah 1979). This liability is strict in that it applies whether or not “the seller has exercised all possible care in the preparation and sale of his [or her] product.” RESTATEMENT (SECOND) OF TORTS § 402A(2)(a). Comment g defines a “[d]efective condition” as a condition “not contemplated by the ultimate consumer, which will be unreasonably dangerous to [that consumer].” Id. § 402A cmt. g; see also Dowland v. Lyman Prods. for Shooters, 642 P.2d 380, 381 n.2 (Utah 1982) (applying comment g). ¶9 The unavoidably unsafe doctrine is an exception to strict products liability. Comment k of section 402A describes a category of products that are incapable of being made entirely safe, but when they are “properly prepared, and accompanied by proper directions and warning, [are] not defective, nor . . . unreasonably dangerous.” Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991) (alterations in 4 Cite as: 2019 UT 56 Opinion of the Court original) (citation omitted) (internal quotation marks omitted). Comment k provides in its entirety: 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. RESTATEMENT (SECOND) OF TORTS § 402A cmt. k. ¶10 Almost thirty years ago, in Grundberg, this court agreed “with the principle comment k embodies, that manufacturers of unavoidably dangerous products should not be liable for a claim of design defect.” 813 P.2d at 95. In that case we extended comment k beyond its borders to categorically immunize all prescription drugs from strict liability design defect claims. Id. at 99. We held that “a 5 BURNINGHAM v. WRIGHT MEDICAL Opinion of the Court drug approved by the [FDA], properly prepared, compounded, packaged, and distributed, cannot as a matter of law be ‘defective’ in the absence of proof of inaccurate, incomplete, misleading, or fraudulent information furnished by the manufacturer in connection with FDA approval.” Id. at 90. ¶11 At the time, we recognized this was an extension of comment k. Id. We noted that “[e]ven in the case of a clearly alleged design defect, . . . comment k is unclear on the scope of its protection.” Id. at 92. But we chose to apply comment k categorically to prescription drugs for policy reasons, noting we were not “bound by the specific language of comment k and may adopt and apply its fundamental policy without restricting ourselves to what we perceive to be its literal interpretation.” Id. at 95. Our reasons for deeming all prescription drugs to be unavoidably unsafe as a matter of law included their “unique nature and value, the elaborate regulatory system overseen by the FDA, the difficulties of relying on individual lawsuits as a forum in which to review a prescription drug’s design, and . . . significant public policy considerations.” Id. ¶12 Here, we are asked how we will apply comment k to implanted medical devices. Essentially, the question before us is whether we will treat all implanted medical devices as unavoidably unsafe as a matter of law, as we did with prescription drugs in Grundberg, or whether we will conclude comment k should apply differently to these devices. ¶13 Wright Medical argues that because “medical devices present the same unique risks and benefits as prescription drugs, while also being subject to premarket and post-market scrutiny from the [FDA] and physician oversight, the court should apply the same categorical protection of the unavoidably unsafe doctrine to implanted medical devices that it applies to prescription drugs.” The Burninghams disagree, noting that it was the FDA’s rigorous review process that convinced us all prescription drugs should receive comment k protection, and arguing that the FDA does not necessarily subject all medical devices to the same thorough screening.