Fourth DCA Adopts Risk-Utility Test as the Standard for Some Design Defect Claims

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Recently, the Florida Fourth District Court of Appeal opened the door to moving away from the consumer expectations test and adopting the risk-utility test for strict liability design defect claims involving complex products.  While the decision is limited, it is a significant move that could help pave the way for applying the risk-utility test to more product liability claims asserting design defects. 

There are two tests for proving design defects: “consumer expectations” and “risk-utility.”  The consumer expectations test considers whether a product is unreasonably dangerous because it failed “to perform as safely as an ordinary consumer would expect when us[ing it] as intended or [] in a reasonably foreseeable manner.”[1]  On the other hand, the risk-utility test shifts the focus on whether the utility of a product outweighs any risk of using it.[2]

Background on Proving Design Defect in Florida

In 1997, the American Law Institute (ALI) published the Third Restatement of Torts for product liability.  One of its more significant and controversial changes was adoption of the risk-utility test.  Manufacturers favor the risk-utility test because it offers more objective factors, such as the nature and usefulness of the product, the cost of the product, the costs associated with added safety and the obviousness of the danger associated with the product.  The consumer expectations test is more subjective because it relies upon the ordinary consumer’s expectations of product safety. The consumer expectations test is problematic because some products can be either too complex or technical for an ordinary consumer to have formed a reasonable expectation on how the product should perform. 

The Florida Supreme Court considered whether to adopt the Third Restatement’s risk-utility test in 2015.  In Aubin v. Union Carbide Corp.,[3] the Court specifically adopted the consumer expectations test to prove design defects.  While some tend to confuse this decision as mandating only using the consumer expectations test, the Court kept open the opportunity for parties to present evidence using the risk-utility standard as well.  In fact, before a recent change in Feb. 2020, the Florida Standard Jury Instruction allowed for both the consumer expectations test and risk-utility test as alternative definitions of design defect. 

Even the recent change to the jury instructions further shows that Aubin did not hold that the consumer expectations test is the exclusive test for design defect.  The Supreme Court amended the jury instructions by deleting “and” between the consumer expectations and risk-utility tests “to reflect that parties may choose to prove/defend a design defect claim through the risk [utility] test but is not required to do so pursuant to [Aubin].”[4]  Despite this change, the committee on jury instructions states “it takes no position on whether both the consumer expectations and risk[ utility] tests should be given alternatively or together.”[5]  The question remains whether risk-utility test could be used independently without using the consumer expectations test. 

The Case

In Cavanaugh v. Stryker Corp.,[6] the Fourth District affirmed a defense verdict in favor of a medical device manufacturer and, in the process, approved of the trial court’s application of the risk-utility test and its rejection of the consumer expectations test in the jury instructions.  This is the first appellate decision after Aubin to hold that the consumer expectations test does not apply in certain contexts.

Cavanaugh involves a wrongful death lawsuit where a patient died during lung removal surgery.[7]  The plaintiff, wife of the deceased patient, filed her lawsuit against multiple defendants, including a manufacturer of a medical device used to remove blood and surgical waste.[8]  Plaintiff asserted several claims against the manufacturer, including strict liability based on design defects, strict liability based on failure to warn and negligence.[9]  At trial, only Plaintiff’s claims against the medical device manufacturer remained.[10] 

During trial, the plaintiff proposed design defect jury instructions which contained both the risk-utility and consumer expectations tests.[11]  The trial court rejected the plaintiff’s proposed instructions and adopted the defendant’s risk-utility instruction.[12]

Fourth DCA’s Ruling

The Fourth District concluded that the trial court correctly refused to instruct the jury using the consumer expectations test because the test was inappropriate for the medical device at hand.[13]  The court distinguished Aubin because Aubin involved asbestos, not a “complex” medical product.[14]  The court asserted that Aubin allowed courts to recognize “some products may be too complex for a logical application of the consumer expectations test.”[15]  The court decided the medical device at issue was too complex because it was available to an ordinary consumer “only as an incident to a medical procedure” and medical device manufacturers generally do not market their products to “ordinary customers.”[16]  In other words, a patient could not have formed a reasonable expectation about a medical device accessed only through his medical professional. 

A closer reading of the opinion cautions parties that adoption of the risk-utility test requires more than just determining whether a product is complex or not.  Footnote number four in the court’s opinion limits when the risk-utility test may be more appropriate than the consumer expectations test.  The court explained:

“[w]e do no hold that complexity alone is necessarily enough to preclude the application of the consumer expectations test.  Indeed, [m]any familiar consumer products involve complex technology.  The applicability of the consumer expectations test does not depend necessarily on a product’s complexity in technology or use[,] but rather depends on whether prolonged use, knowledge, or familiarity of the product’s performance by consumers is sufficient to allow consumers to form reasonable expectations of the product’s safety.”[17]

The court concluded that the facts in Cavanaugh undermined the overall rationale for the consumer expectations test.  The court explained that the consumer expectations test traditionally views the manufacturer as playing a central role in establishing an ordinary consumer’s expectations and in turn motivating consumers to buy their products.[18]  Ultimately, the court held the consumer expectations test did not apply because the ordinary consumer, who was the patient, could not have formed a reasonable expectation on the performance of the medical device used during his surgery.[19] 

Conclusion/Final Thoughts

While it may be a limited decision, Cavanaugh is significant because it is the first appellate decision since the holding in Aubin to hold that the consumer expectations test was not the appropriate standard for proving a design defect.  This case may set the stage for expanding situations where the risk-utility test should be the standard for design defects.

A critical issue moving forward will be expansion of this holding to other “complex” products outside of certain medical devices.  To increase the chances of the risk-utility test being the standard, manufacturers should use the factors highlighted in footnote number four in Cavanaugh to show the consumer expectations test is not appropriate.  Those factors include not only the product’s complexity, but:

  • There has not been a prolonged use of the product by ordinary consumers;
    • There is limited knowledge of the product by ordinary consumers; and
    • There is little or no familiarity of the product’s performance by ordinary consumers.

If it can be shown that an ordinary consumer could not have formed a reasonable expectation about the performance of the product at issue, a good argument exists that risk-utility is the only appropriate test for proving a design defect .


[1] Cavanaugh v. Stryker Corp., No. 4D19-523, at 6.

[2] Aubin v. Union Carbide Corp., 177 So. 3d 489, 500-12 (Fla. 2015).

[3] 177 So. 3d 489 (Fla. 2015).

[4] In re Standard Jury Instructions in Civil Cases – Report No. 19-03, 290 So. 3d 840, 842 (Fla. 2020).

[5] Id.

[6] No. 4D19-523 (4th DCA October 7, 2020).

[7] Cavanaugh v. Stryker Corp., No. 4D19-523, at 1-4.

[8] Id.

[9] Id.

[10] Id. at 2.

[11] Id. at 5-6.

[12] Id. at 6.

[13] Cavanaugh v. Stryker Corp., No. 4D19-523,at 8.

[14] Id.

[15] Id. (Emphasis added).

[16] Id. at 9.

[17] Id. (Citations and internal quotations omitted).

[18] Id.

[19] Cavanaugh v. Stryker Corp., No. 4D19-523, at 9.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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