A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe products” exemption recognized in Restatement (Second) of Torts Sec. 402A cmt. k (“Comment k”)—only this time with a direct certification.
On Thursday, the Third Circuit Court of Appeals certified that question to the Pennsylvania Supreme Court, along with a question about which negligent design defect theory—or theories—a Pennsylvania plaintiff may assert against a medical device manufacturer. Pet. for Certification of Questions of State Law, ECF No. 50, Ebert v. C.R. Bard, Inc., et al., No. 20-2139 (3d Cir. June 24, 2021) (“Ebert Pet.”). Last spring, Judge Pappert of the Eastern District of Pennsylvania dismissed Ms. Ebert’s strict liability claim, finding her IVC filter “an ‘unavoidably unsafe product’” under Hahn v. Richter, 673 A.3d 888 (Pa. 1996), and she appealed that order granting summary judgment to the Third Circuit.
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.
The first appellate shoe has dropped in the litigation involving the herbicide Roundup, Johnson v. Monsanto Co., decided July 20, 2020, by California’s 1st District Court of Appeal, Division One. We discussed the verdict and the trial court’s post-trial rulings here, and we now follow through with an update.
Initially, the price tag for allowing questionable science into the courtroom, as measured by this verdict, has been reduced. The court of appeal lowered the compensatory damages award from $39 million to about $10.25 million, concluding the jury had improperly awarded noneconomic damages that plaintiff would likely never suffer. Because plaintiff’s counsel had argued to the jury that plaintiff’s Non-Hodgkins Lymphoma had reduced his future life expectancy to two years, the jury could not award pain and suffering damages beyond that two-year span. And, agreeing with the trial court that constitutional limits required a 1:1 ratio between compensatory and punitive damages, the court slashed the $78 million punitive award to about $10.5 million.
Recap: Part 1 (here) discussed the background of the consumer expectations test (CET) and part 2 (here) described the California Supreme Court’s seemingly definitive decision in Soule v. General Motors Corp., 8 Cal.4th 548 (1994) explaining the types of cases where CET can be applied.
Recap: The background and prior post for this multi-part series can be found here.
In 1994, the California Supreme Court took up Soule v. General Motors Corp., 8 Cal.4th 548 (1994), to provide much-needed guidance as to when it is and is not appropriate to allow a jury to decide the design defect issue based on the consumer expectations test (CET). “Much-needed” may be an understatement – trial courts routinely allowed plaintiffs freely to elect what design defect standard the jury would consider, often both CET and the risk-benefit test (RBT), gaining the proverbial two bites at the apple, and the courts of appeal had not prescribed any meaningful limiting theory or principle. Continue reading
In the 50-plus years since the inception of the doctrine of strict products liability in tort, a vexing issue for product manufacturers has been how to evaluate and defend against accusations of design defect. Manufacturing defects are relatively easy to evaluate – something either did or did not go wrong on the assembly line, the product either did or did not conform to specifications. But except for the rare and extreme cases where, in hindsight, the design is so clearly misguided that no reasonable engineer would consider it safe, courts, commentators and lawyers have hotly debated the proper benchmark to judge the alleged defectiveness of an entire product line.