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Burningham v. Wright Medical Technology, Inc.

Supreme Court of Utah

September 5, 2019

DALE BURNINGHAM AND LANA BURNINGHAM, Plaintiffs-Appellants,
v.
WRIGHT MEDICAL TECHNOLOGY, INC. AND WRIGHT MEDICAL GROUP, INC., Defendants-Appellees.

          On Certification from the United States District Court for the District of Utah The Honorable Jill N. Parrish Case No. 2:17-CV-92

          Attorneys: [1] Brian C. Stewart, Salt Lake City, George E. McLaughlin, Thomas R. Leemon, Denver, for plaintiffs-appellants

          Elisabeth M. McOmber, Salt Lake City, Dana J. Ash, Robert M. Palumbos, Sean K. Burke, Ryan J. O'Neil, Philadelphia, for defendants-appellees

          Justice Petersen authored the opinion of the Court, in which Chief Justice Durrant, Associate Chief Justice Lee, Justice Himonas, and Justice Pearce joined.

          OPINION

          PETERSEN, JUSTICE

         INTRODUCTION

         ¶1 The federal district court certified four questions to us related to a case before it involving artificial hip implants. Plaintiff Dale Burningham had artificial hips surgically implanted in both sides of his body. He alleges that parts of both hips have failed, necessitating several surgeries to address problems with the equipment. Defendants Wright Medical Technology, Inc. and Wright Medical Group, Inc. (collectively, Wright Medical) manufactured the equipment at issue. Burningham and his wife sued Wright Medical in federal court under various theories of liability, including strict liability for design defects.

         ¶2 The federal court asks us to resolve whether and to what extent implanted medical devices should be immune from strict liability design defect claims under Utah law because they are "unavoidably unsafe"-meaning they are "incapable of being made safe for their intended and ordinary use," but their marketing and use is justified because of the benefit they provide. Restatement (Second) of Torts § 402A cmt. k (A.L.I. 1965). While some implanted medical devices might very well be unavoidably unsafe, we conclude that under current federal regulations, this question should be treated as an affirmative defense and determined by the factfinder on a case-by-case basis with regard to devices that enter the market through the 510(k) process. For devices that go through the more rigorous premarket approval process, the United States Supreme Court has held that federal law preempts any state law tort claims, so we do not opine on whether such devices might be unavoidably unsafe as a matter of law because they are already exempt from design defect claims.

         BACKGROUND

         ¶3 Burningham received hip implants in both of his hips. Over time, parts of the implants failed, and Burningham underwent several revision surgeries. He and his wife sued Wright Medical in federal district court, alleging that the implanted hip devices injured Burningham. The Burninghams claimed that there were defects in the Profemur® Modular Neck implanted in Burningham's left hip, and the metal-on-metal Conserve® components implanted in his right and left hips. Some of the Burninghams' claims rested on a theory of strict liability for design defect.

         ¶4 Wright Medical filed a motion to dismiss, arguing that the "unavoidably unsafe" doctrine, which Utah has adopted, should immunize its hip implant devices from strict liability design defect claims. Wright Medical supported its argument with Utah case law extending the unavoidably unsafe doctrine to categorically immunize prescription drugs from such claims. See Grundberg v. Upjohn Co., 813 P.2d 89, 99 (Utah 1991). Burningham responded that while Utah has held that all prescription drugs are deemed unavoidably unsafe as a matter of law, no Utah appellate court has similarly applied the unavoidably unsafe exception to implanted medical devices.

         ¶5 Confronted with these issues, the federal district court determined that there was no controlling Utah law on this issue. We appreciate the federal court's recognition that "resolution of these questions will have a significant impact on the bounds of strict liability for design defect claims brought under Utah law."[2] The federal court ultimately certified the following questions to us:

1. Under Utah law, does the unavoidably unsafe exception to strict products liability in design defect claims recognized in Comment k to Section 402A of the Restatement (Second) of Torts apply to implanted medical devices?
2. If the answer to Question 1 is in the affirmative, does the exception apply categorically to all implanted medical devices, or does the exception apply only to some devices on a case-by-case basis?
3. If the exception applies on a case-by-case basis, what is the proper analysis to determine whether the exception applies?
4. If the answer to Question 1 is in the affirmative, does the exception require a showing that such devices were cleared for market through the FDA's premarket approval process as opposed to the § 510(k) clearance process?

         STANDARD OF REVIEW

         ¶6 "A certified question from the federal district court does not present us with a decision to affirm or reverse a lower court's decision; as such, traditional standards of review do not apply. On certification, we answer the legal questions presented without resolving the underlying dispute." Egbert v. Nissan N. Am., Inc., 2007 UT 64, ¶ 7, 167 P.3d 1058 (citations omitted) (internal quotation marks omitted). We have jurisdiction to answer certified questions pursuant to Utah Code section 78A-3-102(1).

         ANALYSIS

         I. STRICT PRODUCTS LIABILITY AND THE 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 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 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, ...


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