In a decision that may impact future e-commerce, the California Court of Appeal held in Bolger v. Amazon.com, LLC that under California law, Amazon could be strictly liable for an allegedly defective battery manufactured by a third-party and sold on its website. The Court further found Amazon was not immune from liability under the Communications Decency Act. The Court reversed the trial court’s grant of summary judgment in favor of Amazon.
Preemption of Structure/Function Claims
Seen frequently on grocery items, and especially on dietary supplements, structure/function claims describe the role of a nutrient or ingredient in the structure or function of the human body. Examples include “Calcium builds strong bones,” “St. John’s Wort supports mood,” and “Vitamin E supports the immune system.”
The FDA defines and regulates structure/function claims, and FDA requirements generally preempt state-law requirements that are “not identical.” 21 U.S.C. § 343-1(a)(5). So, does compliance with FDA regulations for structure/function claims shield food and supplement manufacturers from lawsuits claiming their structure/function claims are false and misleading?
“Fruit Puree” Held a Fair Game First Ingredient in Fruit Snacks Label by California Court of Appeal
The California Court of Appeal, First Appellate District, recently affirmed judgment in favor of a fruit snack manufacturer who claimed “fruit” was stated to be the first ingredient on a front label but listed “fruit puree” first in the product’s ingredient list.
Plaintiff’s Fruit Snack–Based Claims
Defendants in Iglesias v. Welch Foods, Inc., et al., No. A159565, manufactured fruit snacks with a label that stated, “Fruit is our 1st Ingredient!” at the top of the front label. The snacks’ “Nutrition Fact Panel” then listed “FRUIT PUREE” as the first ingredient, followed by corn syrup.
Illinois Supreme Court Holds Employee’s Office At Home Not Sufficient to Establish Venue
The Illinois Supreme Court recently held that the presence of an employee’s home office was not sufficient to establish venue in Cook County for a negligence action arising out of a vehicle accident in Ohio. Tabirta v. Cummings, et al., 2020 IL 124798 (Ill. Oct. 22, 2020). Reversing the trial and appellate courts, the Court held that having a sole employee with a home office in Cook County did not establish an “other office” of the corporate defendant for purposes of the venue statute, 735 ILCS 5/2-101(a), and that the employee’s activities and the company’s minimal sales in Cook County did not meet the “doing business” prong of the venue statute.
The underlying negligence action arose out of a collision in Delaware County, Ohio, in which the plaintiff suffered severe injuries after his truck was hit by a tractor-trailer owned by the driver’s employer, Gilster-Mary Lee Corporation (GML). The plaintiff, who was a Cook County resident, brought suit in Cook County against GML and the other driver, who was not a resident of Cook County. GML is a Missouri corporation with a principal place of business and registered agent in Randolph County, Illinois.
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.
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.