Product Safety

The electric vehicle (“EV”) revolution is reshaping the automotive industry, promising a greener future and reduced reliance on fossil fuels. However, as EV adoption accelerates, manufacturers face a growing legal and regulatory challenge: the risk of lithium-ion battery fires, which has sparked a wave of product liability lawsuits and regulatory scrutiny in recent months. For EV manufacturers, understanding the legal implications of these issues and proactively addressing safety concerns is critical to mitigating liability and maintaining consumer trust.

In December 2024, we reported on a City of St. Louis, Missouri jury verdict in favor of baby formula manufacturers in a lawsuit claiming their specialized infant formulas for premature babies caused an infant to develop necrotizing enterocolitis (NEC), a potentially fatal condition. This was a landmark win for the manufacturers who have been embroiled in ongoing litigation for several years, especially considering the plaintiff in this case asked the jury for a staggering $6 billion in punitive damages. Although the defense verdict in this case seemingly cleared the manufacturers, a St. Louis Court recently negated the verdict and ordered a new trial.

Overview of the Ban

On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As noted in a prior Husch Blackwell Legal Update, the FDA based its decision on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the approval of additives found to induce cancer in humans or animals. The FDA recognizes that although the hormonal mechanism causing cancer in rats is not applicable to humans, Red Dye No. 3’s presence in the food and drug supply is sufficient to require a ban under the Delaney Clause. The FDA’s decision marks a pivotal shift in food and drug safety regulations.

There have been recent growing concerns regarding the inhalation of crystalline silica dust in the California stone countertop industry, with attempts by the California State Legislature to enact regulations improving the occupational safety of workers fabricating stone slab products.1, 2 As this proposed legislation has developed, multiple studies have been conducted regarding safety measures that can be implemented for stone fabrication workers. Notably, some of those studies have revealed that effective methods to reduce occupational exposure to silica dust during fabrication exist and are feasible to implement by employers. While the research in the California stone countertop industry is still ongoing, the National Institute for Occupational Safety and Health (“NIOSH”) has found that combining engineering controls and safer work practices would help greatly reduce the risk of harmful exposure to respirable silica dust.3, 4 Employers following this combination suggested by NIOSH in 2024 should make it feasible to safely work with stone slab products in California.

On June 21, 2023, U.S. Senator Jon Ossoff introduced the Kids Online Safety and Privacy Act (the “Act”) (Senate Bill 2073), which is legislation focused on online experiences of minors. Recently passed by both the House and Senate, the Act soon awaits President Biden’s review. If signed into law, it will impose significant obligations on online gaming and media platforms, particularly those serving users under 17.

The recent wave of lawsuits against TikTok by over a dozen states and the District of Columbia[1] marks a significant moment in the ongoing scrutiny of social media platforms and their impact on youth mental health. The lawsuits allege that TikTok’s design and algorithm are intentionally addictive, contributing to various psychological harms among young users.

Over one-third of Americans (36%) now report that they would continue to use products even after a recall, according to recent data collected by MasterControl, a provider of quality management and manufacturing software. The proportion of individuals continuing to use recalled products increases in younger age groups: 45 percent of Millennials (born from 1980 to 1994) and 59 percent of Gen Z (born from 1995 to 2012) admitted they would continue to use at least one kind of recalled product, whereas only 18 percent of Boomers (born 1946 to 1964) and 23 percent of Gen X (born 1965 to 1979) admitted the same.

The United States Court of Appeals for the Third Circuit, in Schaffner v. Monsanto, No. 22-3075 (3rd Cir. 2024), recently held that a state-law duty to warn claim was expressly preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). To reach the conclusion, the 3rd Circuit diverged from the 9th and 11th Circuits, thus creating a split between circuits and providing an opportunity for the United States Supreme Court to step in and make a definitive ruling on FIFRA preemption.  If the Supreme Court were to adopt the 3rd Circuit’s reasoning, FIFRA would preempt any state-law duty to warn claims that were inconsistent with EPA’s approved label for products containing glyphosate.