By David Yucht, J.D.
The doctrine applies to actions involving implanted medical devices approved through the streamlined 510(k) process. Federal law preempts product liability actions involving such devices approved through the more rigorous PMA process.
Whether "unavoidably unsafe" implanted medical devices that entered the market through the 510(k) process should be immune from strict liability claims is an affirmative defense to be determined by factfinders on a case-by-case basis, according to the Utah Supreme Court. For devices that go through the more rigorous premarket approval (PMA) process, the U.S. Supreme Court already has held that federal law preempts any state law tort claims. Thus, the state high court declined to opine on whether those devices might be unavoidably unsafe (Burningham v. Wright Medical Technology, Inc., September 5, 2019, Petersen, P.).
A patient had artificial hips, manufactured by Wright Medical Technology, Inc. and Wright Medical Group, Inc. (collectively, Wright Medical), surgically implanted in both sides of his body. He alleged that parts of both hips failed, necessitating several surgeries. The patient sued Wright Medical in federal court under various theories, including strict liability for design defects. Wright Medical filed a motion to dismiss, arguing that the "unavoidably unsafe" doctrine immunized its devices from strict liability claims because those devices were "incapable of being made safe for their intended and ordinary use," but their marketing and use were justified because of the benefit they provided. Because this issue had yet to be resolved by the Utah state courts, the federal court asked the Utah Supreme Court to resolve whether and to what extent implanted medical devices should be immune from strict liability design defect claims [see Products Liability Law Daily’s February 16, 2018 analysis].
Unavoidably unsafe doctrine. The Utah Supreme Court extended the unavoidably unsafe doctrine to actions involving certain implanted medical devices. Utah has adopted section 402A of the Restatement (Second) of Torts, which makes liable a seller of "any product in a defective condition unreasonably dangerous to the user or consumer." This liability applies even if the seller "exercised all possible care in the preparation and sale" of its product. A "defective condition" is an unreasonably dangerous condition "not contemplated by the ultimate consumer." The unavoidably unsafe doctrine is an exception to strict products liability by which it is recognized that there are some products, especially certain medications, that are incapable of being made safe for their intended and ordinary use, but their marketing and use were justified because of the benefit they provide. The Utah Supreme Court previously held that Food and Drug Administration-approved drugs that were properly prepared, compounded, packaged, and distributed cannot be "defective" unless the manufacturer provided inaccurate, incomplete, misleading, or fraudulent information in connection with FDA approval.
In determining whether this doctrine should be extended to medical devices, the state supreme court reviewed the FDA approval process for devices. It noted that before implanted medical devices like the ones made by Wright Medical may be marketed, the FDA categorizes each device into one of three categories: Class I, II, or III, graded by their potential for causing serious injury. Unlike Class I and Class II devices, which present lesser risks, Class III devices include those that "present a potential unreasonable risk of illness or injury." Because of the risk involved, all new Class III devices must undergo a process to provide "reasonable assurance" that the devices are effective and safe for medical use before they reach the market. The most rigorous process is the PMA process, which requires manufacturers to provide the FDA with comprehensive information about the device. In contrast to the PMA process, the "510(k) process" allows a device to be cleared for market usage when the FDA determines that the device is "substantially equivalent" to a device already on the market. The FDA does not evaluate devices entering the market through the 510(k) process for safety and efficacy. Wright Medical used the 510(k) process to bring its hip implant devices to market, thus avoiding the PMA process. In Riegel v. Medtronic, Inc. (552 U.S. 312, 321–25 (2008)), the U.S. Supreme Court held that federal law preempts state law tort claims involving PMA-approved medical devices. However, the same is not true for devices that have been cleared through the 510(k) process because that process is focused on equivalence, not on safety or efficacy.
Here, the Utah Supreme Court did not opine on whether PMA-approved medical devices were unavoidably unsafe as a matter of law because they were already exempt from all state product liability claims. However, recognizing that other devices have not undergone a rigorous FDA approval process, the state high court concluded that whether a particular 510(k)-cleared medical device is unavoidably unsafe is a fact-intensive question that must be raised as an affirmative defense and determined by the factfinder on a case-by-case basis. Consequently, the court held that when an implanted medical device enters the market through the 510(k) process, and a manufacturer raises the affirmative defense that the product is unavoidably unsafe in response to a design defect claim, the manufacturer must prove by a preponderance of the evidence that: (1) when the product was made, it could not be made safe for its intended use even applying the best available testing and research; and (2) the benefits of the product justified its risk. This standard will also apply to improper manufacturing and inadequate warning claims.
The case is No. 20180143.
Attorneys: Brian C. Stewart (Siegfried & Jensen PC) for Dale Burningham. Dana J. Ash (Duane Morris LLP) for Wright Medical Technology, Inc. and Wright Medical Group, Inc.
Companies: Wright Medical Technology, Inc.; Wright Medical Group, Inc.
MainStory: TopStory DesignManufacturingNews DefensesLiabilityNews MedicalDevicesNews UtahNews
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