Florida Appellate Court Authorizes the Use of the Risk-Utility Test in Complex Medical Device Cases

On October 7, 2020, Florida’s Fourth District Court of Appeal affirmed a defense verdict in favor of a medical device manufacturer and in doing so approved of the trial court’s use of the risk-utility test and not the consumer expectations test in the jury instructions. Cavanaugh v. Stryker Corp., — So. 2d —, 2020 WL 5937405 (Fla. 4th DCA Oct. 7, 2020). The wrongful death lawsuit was filed against multiple defendants, including the manufacturer of a medical device used to remove blood and clear the surgical field, following the death of a patient during lung removal surgery. The claims against the medical device manufacturer included strict liability design defect, strict liability failure to warn, and negligence.

The plaintiff settled with several health care professionals and only the claims against the manufacturer proceeded to trial. At trial, the plaintiff proposed a jury instruction where the jury could find that the product was unreasonably dangerous if the plaintiff established either the consumer expectations test (which determines liability based on whether 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) or the risk-utility test (which determines liability based on whether the risk of danger in the design outweighs the benefit). The defendant manufacturer, however, proposed that the jury instruction include only the risk-utility test (a product is unreasonably dangerous if the risk of danger in the design outweighs the benefit). The trial court rejected the plaintiff’s proposed instruction and adopted the defendant’s risk-utility instruction.

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FDA Issues Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

As the COVID-19 pandemic continues to alter ways of life across the globe, clinical trials must be adapted for participant safety while maintaining accuracy in the midst of the ongoing crisis. In September 2020, the U.S. Food and Drug Administration (FDA) updated its “Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency,” providing specific recommendations for ongoing or upcoming clinic trial activities.

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District Court Requires Plaintiff to Disclose Evidence About Noneconomic Loss

When plaintiffs request damages for noneconomic loss such as pain and suffering, courts are split on whether a defendant can require a plaintiff to disclose during discovery how much the plaintiff intends to ask the jury to award in noneconomic damages. A recent decision from a federal district court in Minnesota, however, required the plaintiff to do just that.

In Lewis v. City of Burnsville, 2020 WL 3496990 (D. Minn. June 29, 2020), the defendants asked the plaintiff during discovery to itemize the damages that she was seeking and “produce documentary support for her damages claim.” The plaintiff declined to provide this information, arguing that it was impossible to calculate her noneconomic loss. The magistrate judge, however, ruled that the plaintiff had to disclose how much she was seeking in noneconomic damages “along with the basis for that figure,” if the plaintiff intended to ask the jury for a specific dollar amount (or range) of noneconomic damages at trial.

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PREP Act Does Not Require Federal Forum for State Law Negligence Claims Related to COVID-19

A New Jersey District Court Judge has ruled that the March 2020 federal liability immunity statute for pandemic-related countermeasures does not create a basis for federal jurisdiction, resulting in the remand of two COVID-19-related personal injury actions.

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Maryland Adopts Daubert Standard for Admissibility of Expert Testimony

The Maryland Court of Appeals has retired the inflexible Frye-Reed standard and adopted the framework of Daubert for evaluating the admissibility of expert testimony. In Rochkind v. Stevenson (August 28, 2020), Maryland officially joined the supermajority of states that have considered the issue and now follow Daubert.

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