Two recent decisions from Florida—one from a state appellate court and the other from a federal district court—not only provide clarity for defendants facing product liability suits in Florida but also offer persuasive authority for cases outside of Florida. For a jurisdiction traditionally viewed as being unfriendly toward defendants, these opinions focused on design defect and failure to warn claims illustrate that it is not all “bad news bears” for those defending against product liability claims in Florida courts.
First up is Cavanaugh v. Stryker Corp., — So. 2d —, 2020 WL 5937405 (Fla. 4th DCA Oct. 7, 2020), a decision from Florida’s Fourth District Court of Appeal. The plaintiff in Cavanaugh challenged the trial court’s decision to instruct the jury on the risk-utility test instead of the consumer expectations test on plaintiff’s design defect claim. The product at issue was a medical device used to remove blood and clear the surgical field. The court of appeal held that in cases involving complex medical devices, the consumer-expectations test (the product fails to perform as safely as an ordinary consumer would expect when used as intended or when used in a manner reasonably foreseeable by the manufacturer) is not applicable to design defect claims; instead, plaintiffs must prove design defect claims using the risk-utility test (the risk of danger in the design outweighs the benefit).
Significantly, the court of appeal in Cavanaugh distinguished the Florida Supreme Court’s decision in Aubin v. Union Carbide Corp., an asbestos case, which adopted the consumer expectations test and rejected the “categorical adoption of the Third Restatement and its reasonable alternative design requirement.” Id. at *4 (quoting Aubin, 177 So. 3d 489, 510 (Fla. 2015)). The court of appeal found that, unlike in asbestos cases, the consumer expectations test cannot be logically applied where the product in question is a complex medical device available to a patient only through a medical professional (i.e. a learned intermediary).
- Cavanaugh clarifies that the consumer expectations test does not apply in cases involving complex medical devices; plaintiffs must instead prove a design defect claim through the risk-utility test.
- In the context of a medical device available only through a learned intermediary, the relevant expectations are those of the health care professional not the patient.
- Utilization of the consumer expectations test in cases involving complex medical devices would be an inaccurate statement of the law based on the facts of the case and would be confusing and misleading to the jury.
- Even if a court utilizes the consumer-expectations test in a case involving a complex medical device, the test must be modified to reflect that the relevant expectations are those of the learned intermediary (not the patient).
Next up is Dye v. Covidien LP, 2020 U.S. Dist. LEXIS 105676 (S.D. Fla. June 16, 2020). In Dye, the Southern District of Florida dismissed the plaintiff’s failure to warn claim against a hernia mesh manufacturer based upon the product’s Instructions for Use (IFU).
Applying the learned intermediary doctrine, the district court rejected each of the plaintiff’s attempts to circumvent the IFU. First, the court ruled that a plaintiff cannot maintain a failure to warn claim for injuries that the plaintiff himself did not experience. The court also rejected the plaintiff’s argument that the IFU was inadequate because it failed to warn about the “duration, frequency, or severity” of complications, as well as any potential surgical interventions stemming from such complications. The court reasoned that defendants “need only warn of complications stemming from the use of the Product—not the subsequent measures medical professionals may employ to treat those complications.” Lastly, the court rejected the plaintiff’s argument that the IFU did not properly warn his physician of the defects associated with the product. The court noted that the relevant inquiry is not whether the manufacturer warned of defects but whether it warned of risks.
It's worth mentioning that Dye was decided at the motion to dismiss stage. In dismissing the failure to warn claim, the court noted its disagreement with the belief that a warnings adequacy issue is necessarily a “fact intensive affirmative defense which should not be resolved pursuant to a motion to dismiss.” Rather, this issue can be decided as a matter of law at the motion to dismiss phase where the warning is “accurate, clear, and unambiguous.”
- Defendants should consider moving to dismiss failure to warn claims at the pleadings stage.
- Whether proceeding at the motion to dismiss stage or the summary judgment stage, defendants should focus on the complications actually suffered (or alleged to be suffered) by the plaintiff and the IFU warnings applicable to those specific complications.
- Defendants should emphasize that a manufacturer’s duty is to warn of the potential complications stemming from the product, not all of the possible subsequent surgeries, procedures, or repairs that may later result from a complication.
- Similarly, defendants should emphasize that a manufacturer’s duty is to warn of potential risks of injury, not regarding particular alleged defects in the product.