Consumer-driven lawsuits that follow a product recall often focus on what the company knew, when it knew it, and how it acted in response. And for companies who are hoping to avoid such a lawsuit, one of the biggest questions is what do they need to disclose to consumers and how far does that obligation reach? Certainly, companies cannot disclose what they did not know, and manufacturers are not required to warn for every conceivable risk, regardless of how remote. A recent class action, Gurkov v. Real Kosher Ice Cream Inc., No. 1:23-cv-06128 (E.D.N.Y Aug. 14, 2023), brings these issues into focus.

Continue Reading Recall Litigation Report: Real Kosher Ice Cream Sued Over Listeria Contamination

In December 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”)—the most significant expansion of the U.S. Food and Drug Administration’s authority to regulate cosmetics in nearly 85 years—was signed into law. Among other things, MoCRA gives the FDA authority to require facility registration and reporting of serious adverse events, impose certain record-keeping obligations, recall cosmetic products, and establish good manufacturing practices. With many of MoCRA’s provisions going into effect at the end of this year, cosmetics companies need to prepare to address these requirements and regulations, which may also have a considerable impact on the litigation landscape.

Crowell’s Product Risk Management team has written two publications to help cosmetics companies prepare for the big changes ahead.

Continue Reading Modernization of Cosmetics Regulation Act (“MoCRA”) White Paper

Products are commonly recalled due to a hazard (i.e., a risk of harm), even where large swaths of consumers have never had a problem with the products they purchased. When those consumers then file suit, they often seek to recover economic harm based on the “benefit of the bargain” theory—because the recalled products that they previously purchased are now worth less than what they paid for them. Where a consumer does experience the hazard (i.e., suffers personal injury or property damage) and subsequently files suit, that suit often seeks to recover not just economic harm but also for personal injury or property damage. Regardless of the nature of the harm, the alleged injury naturally precedes any recall of the product.

Continue Reading Recall Litigation Report: Consumer Lawsuit Alleges Electrolux Dehumidifier Caused Church Fire Years After Recall

On Tuesday, June 20, 2023, the Federal Trade Commission sent letters to 50 online marketplaces notifying them of their responsibility to fully comply with the new Integrity, Notification, and Fairness in Online Retail Marketplaces for Consumers Act – or the INFORM Consumers Act – as soon as the law takes effect on June 27, 2023.

Continue Reading Consumer Protection Law Taking Effect This Month Could Subject Online Marketplaces to Civil Penalties of up to $50,120 Per Violation

A recent article published by MedTech, “Could Bassinet Clearance Expand FDA Authority? Law Firm Expresses Concern,” quotes a Crowell client alert and Crowell attorney, Robbie Jost, on this development. According to the client alert, “To the extent the FDA considers the SNOO a medical device based on its intended impact on infant sleep position, many

On May 5, 2023, the U.S. Consumer Product Safety Commission (“CPSC”) announced that it agreed to a civil penalty settlement with Generac Power Systems, Inc., (“Generac”) to resolve charges that Generac failed to report immediately to the CPSC under Section 15(b) of the Consumer Product Safety Act (“CPSA”). Specifically, the CPSC alleged that certain models of Generac’s portable generators contained a defect that could create a substantial product hazard and unreasonable risk of serious injury to consumers. This settlement includes a $15,800,000 civil penalty, and requirements that Generac (1) implement and maintain a compliance program and system of internal controls and procedures designed to ensure compliance with the CPSA; and (2) file annual reports with the agency for the next three years regarding the Company’s compliance program, internal controls and procedures, internal audits of the effectiveness of the new compliance program and internal controls.

Continue Reading CPSC and Company Reach Agreement on $15.8 Million Civil Penalty for Failure to Report

On March 30, 2023, the FDA authorized marketing of Happiest Baby’s SNOO Smart Sleeper, an over-the-counter infant sleep system intended to keep infants on their back throughout sleep. This marks the first time we are aware of that the FDA has given de novo marketing authorization to a product designed to keep sleeping babies positioned on their backs,[1] and signals a potential expansion of what the FDA considers to be a “medical device” within its regulatory purview.

Continue Reading The FDA Appears to Expand Its Definition of a “Medical Device” to Include CPSC-Regulated Infant Sleep Products

Last Thursday, April 6, the Department of Justice (DOJ) and Consumer Product Safety Commission (CPSC) sued SunSetter Products LP (SunSetter) in a Massachusetts federal court in a rare civil penalty lawsuit. SunSetter manufactures motorized retractable awnings for outdoor use. The Government alleges in its complaint that SunSetter knowingly failed to timely report under Section 15(b) of the Consumer Product Safety Act (CPSA) a hazardous defect related to vinyl covers for its retractable awnings. The complaint seeks permanent injunctive relief, including a third-party monitorship over the company, and civil penalties.

Continue Reading CPSC Seeks Civil Penalty Against SunSetter in Rare Federal Court Action

In December 2022, the U.S. District Court for the Eastern District of Michigan dismissed a putative class action against FCA US LLC on prudential mootness grounds because FCA announced a voluntary safety recall shortly after plaintiffs filed suit. Earlier this year, LG Energy Solution Michigan (“LG”) showed, yet again, how a voluntary recall can prove an effective defense to pending litigation.

Continue Reading Recall Litigation Report: LG Energy Solution Michigan Reaps the Benefit of a Quick and Comprehensive Recall

After a pause in 2022, there has been much talk of the continuation, or resumption, of a wave of retail bankruptcy cases as we begin 2023.  2022 was highlighted by Revlon’s filing (discussed here: Revlon May Signal Another Wave of Retail Bankruptcies | Retail & Consumer Products Law Observer (retailconsumerproductslaw.com)).  Revlon pointed to a number of issues that led to its filing, including most prominently, supply chain issues. Severe impediments in the supply chain – whether the inability to source product or the costs and delays in received goods — have been cited by many debtors since Revlon since as a leading cause of their distress.  And it may get much worse before it gets better, particularly for companies that source, directly or indirectly, from China.

Continue Reading Continued Pain in the Retail Sector:  Coming Enforcement of Forced Labor Laws