Trial News

A jury must decide whether hip implants were “unavoidably unsafe” under Utah law after a man was injured by defects in the medical devices. The decision sets forth Utah’s interpretation of the unavoidably unsafe doctrine as applied to medical devices cleared for market under the FDA’s premarket notification process, allowing Utah residents to hold device manufacturers accountable when defective devices have not gone through the FDA’s more rigorous premarket approval process. (Burningham v. Wright Med. Tech., Inc., 2019 WL4231947 (Utah Sept. 5, 2019).)

Dale Burningham underwent surgeries on both of his hips in 2012 and 2013. He received three implanted medical devices as part of the surgeries, including a Profemur Modular Neck in his left hip and Conserve Components implants in both hips. Wright Medical Technology, Inc. designed, manufactured, marketed, and sold the devices. The Modular Neck implant fractured, and both Conserve Components implants experienced metal-on-metal failure, which resulted in microscopic bits of metal entering Burningham’s bloodstream.

In 2013, he and his wife sued Wright Medical in California state court, alleging that the implants were defectively designed and caused his injuries. The case was one of hundreds of coordinated cases brought against the company. In 2016, the trial court granted the Burninghams’ motion to release the case from the coordinated proceeding, and they filed a complaint in Utah federal district court in 2017, alleging strict liability, negligence, and breach of express warranty.

The district court agreed with Wright Medical that the negligence and breach of express warranty claims should be dismissed because the Burninghams had not proven reliance on Wright Medical’s careless or negligent misrepresentation or express warranty. Wright Medical also argued that the Profemur Modular Neck and the Conserve Components implants were “unavoidably unsafe” and therefore the strict liability design defect claims should be dismissed. Utah has adopted §402A of The Restatement (Second) of Torts, and comment k, which provides an exception to strict products liability for unavoidably unsafe products. And in 1991, the Utah Supreme Court expressly stated it would apply the unavoidably unsafe doctrine to prescription drugs. (Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991).) However, the district court found that Utah had not yet addressed whether the strict liability exception for unavoidably unsafe products also applies to implanted medical devices such as Burningham’s.

The district court certified to the Utah Supreme Court the questions of whether the unavoidably unsafe doctrine is an affirmative defense in implanted medical device defect claims and if so, whether it applies categorically to all implanted devices or on a case-by-case basis. It also certified the question of whether the defense requires a showing that the device was brought to market through the FDA’s premarket approval process rather than through the premarket notification process.

In considering the application of the “unavoidably unsafe” doctrine to medical devices, the court found that it need not determine whether devices brought to market under the premarket approval process are immune from strict products liability claims because federal law preempts such claims under Riegel v. Medtronic, Inc. (552 U.S. 312 (2008).) However, claims regarding devices that have gone through the premarket notification process under §510(k) of the Food, Drug and Cosmetic Act are not necessarily preempted. This is because devices are cleared for market under §510(k), rather than undergoing a more comprehensive premarket approval, because of their “substantial equivalence” to a device already on the market. The FDA does not investigate the safety of devices brought to market through the §510(k) process, and in fact, new devices cleared under §510(k) may be “substantially equivalent” to a grandfathered device that was never approved under the more rigorous premarket approval process.

Addressing whether this affirmative defense applies to devices cleared under §510(k), the court concluded that the question is fact-intensive and must be evaluated on a case-by-case basis. The court distinguished the FDA’s prescription drug approval process from its §510(k) device approval process, finding that “[w]ithout an FDA evaluation of a medical device’s safety, we cannot know whether the device is incapable of being made safe (although it is beneficial), or whether it is ‘unreasonably dangerous.’” When a device enters the market through the §510(k) process, “the unavoidably unsafe exception might immunize some implanted medical devices from strict products liability,” the court said, but it could not “say this will always be the case as a matter of law.”

The court then turned to how to determine when the exception applies for medical devices cleared under §510(k). The Burninghams argued for the adoption of the Oklahoma Supreme Court’s test in Tansy v. Dacomed Corp., which requires manufacturers seeking to raise the unavoidably unsafe affirmative defense to establish that a product is incapable of being made safe under present technology, there is societal need for the product, and the product was properly manufactured and contains adequate warnings. (890 P.2d 881 (Okla. 1994).) Wright Medical countered that the proper test should be the Model Utah Jury Instruction, which calls for defendants to demonstrate that the product could not have been made safe for its intended use when it was made, and its benefits justified the risk. The court adopted the middle ground, holding that the Model Utah Jury Instruction is the appropriate test, but that the affirmative defense is unavailable when a plaintiff proves a manufacturing flaw or inadequate warning claim by a preponderance of the evidence.

Denver attorney Thomas Leemon, who represented the plaintiffs, called this a very important decision with “big implications.” “It preserves the ability of Utahns to hold a medical device manufacturer accountable for a defectively designed device and confirms that the §510(k) clearance process does not provide any assurance that a medical device is safe or effective. The decision was closely watched by the medical device industry which, through various organizations, filed multiple amicus briefs in support of the manufacturer.” Leemon added, “the Utah Supreme Court was able to sift through all of the arguments and issue a thoughtful decision, which should become a common reference for all courts when addressing regulatory issues pertaining to medical devices.”