By Pamela C. Maloney, J.D.
Jury instruction on the risk-utility test in a case involving alleged design defects in a complex medical device was proper despite Florida high court’s rejection of Restatement Third.
The consumer expectation test set forth in the Restatement (Second) of Torts §402A did not apply in cases involving complex medical devices that were available to ordinary consumers only as an incident to a medical procedure, the Florida District Court of Appeal for the Fourth District ruled, finding that the trial court did not abuse its discretion in using the risk-utility test jury instruction proffered by the manufacturer of a high-flow suction device used during lung-removal surgery. In so holding, the court of appeal distinguished a Florida Supreme Court’s ruling that when approaching design defect claims, the state adhered to the Second Restatement’s consumer expectations test, not the Restatement Third’s risk-utility test, which required proof of a reasonable alternative design (Cavanaugh v. Stryker Corp., October 7, 2020, per curiam).
A patient died from complications that arose during lung removal surgery when a chest tube inserted by the surgeon was connected to a high-flow suction device, known as the Neptune 2, which was intended to collect and dispose of surgical fluid waste. The device was not intended to be connected or used during passive chest drainage. The patient’s widow filed a wrongful death action against Stryker Corp., the manufacturer of the device, alleging strict liability and negligence claims based on defective design and failure to warn. The trial judge refused to accept the widow’s jury instructions, which contained both the risk utility and the consumer expectations tests and were taken directly from Florida’s standard jury instruction in effect at the time. Instead, the judge gave the manufacturer’s jury instruction which contained only the risk utility test and that portion of the consumer expectations test stating that a product was unreasonably dangerous if the risk of the danger in the design outweighed the benefit. The jury found in favor of the manufacturer and the widow appealed.
Consumer expectation test. The widow argued that the trial court was required to instruct the jury on the consumer expectations test in accordance with the Florida Supreme Court’s decision in Aubin v. Union Carbide Corp. [see Products Liability Law Daily’s October 30, 2015 analysis], which held that in design defect cases, Florida adhered to the consumer expectations test as set forth in the Second Restatement of Torts. In its ruling, the Florida high court rejected the categorical adoption of the Third Restatement and its reasonable alternative design requirement. Rejecting this argument, the court of appeal determined that because Aubin involved asbestos, which was not a complex product, it was distinguishable from the case at bar. According to the intermediary court, Aubin did not express disagreement with or disapproval of previous cases recognizing that some products could be too complex for a logical application of the consumer expectations test. Instead, Aubin stood for the proposition that a plaintiff could elect to prove a design defect claim under the consumer expectations test in any case in which an ordinary consumer could form expectations about the product at issue. The issue of whether it was logical to apply the consumer expectations test to a complex medical device accessible to the consumer only through a medical professional was not addressed by the high court in Aubin, the appellate court explained.
Addressing that issue, the court of appeal ruled that the consumer expectations test could not be applied to the case at bar which involved a complex medical device available to an ordinary consumer only as an incident to a medical procedure. Medical device manufacturers generally did not market their products to "ordinary consumers" and, therefore, the rationale for the test—that a manufacturer played a central role in establishing the consumers’ expectations for a particular product, which in turn motivated consumers to purchase the product—simply did not apply to the device at issue.
Even assuming that some version of the consumer expectations test should be applied to complex medical products provided to consumers through a learned intermediary, the standard instruction would need to be modified in order to inform the jury that the relevant expectations were those of the health care professional. As proposed, the widow’s proffered instruction would have been misleading because it failed to inform the jury of this point. Based on its finding that the widow’s proposed instruction was not an accurate statement of the law under the specific facts of this case and that it would have been confusing to the jury, the court of appeal found that the trial court did not abuse its discretion in refusing to give the proposed instruction.
The case is No. 4D19-523.
Attorneys: Paul M. Silva (Somera & Silva, LLP) and Adam Richardson (Burlington & Rockenbach, P.A.) for Lisa Cavanaugh. Hildy M. Saste (Shook, Hardy & Bacon, L.L.P.) for Stryker Corp.
Companies: Stryker Corp.
MainStory: TopStory EvidentiaryNews DesignManufacturingNews MedicalDevicesNews FloridaNews
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