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What a company knew and when is a critical question in any lawsuit involving recalled products. And the answer may be complicated, particularly when a manufacturer announces multiple recalls and expands previous recalls.Continue Reading Recall Litigation Report: Mid-America Pet Food Faces Putative Class Action Over Recalled Pet Food Products

On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, the electronic submission portal for facility registration and product listing required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and published a User Guide for the portal.[1] Cosmetics Direct contains user friendly data entry forms, performs initial validations, creates and saves the structured product labeling (SPL) submission, and submits the SPL to FDA.Continue Reading FDA Launches Cosmetics Direct and Issues Final Guidance on Facility Registration & Product Listings Required under MoCRA

On December 14, 2023, the FDA issued an update with further instructions on  serious adverse event reporting under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), which is enforceable starting December 29, 2023.Continue Reading FDA Provides Updated Instructions for Reporting Serious Adverse Events under MoCRA

Just over a month after the Food and Drug Administration (FDA) announced its intent to delay enforcement of facility registration and product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the Government Accountability Office (GAO) issued a report, “COSMETIC SAFETY: Better Planning Would Enhance FDA Efforts to Implement New Law,” with seven recommendations to strengthen FDA efforts to implement its new cosmetic oversight responsibilities.Continue Reading GAO Report Concludes that the FDA Needs to Strengthen its Efforts to Implement MoCRA

On October 13, 2023 The FDA announced that two of the requirements set forth in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)— facility registration and product listing—will be included as part of the Structured Product Labeling (SPL) framework. SPL is a document formatting standard adopted by FDA for exchanging product-related information. Continue Reading FDA Publishes SPL Guide for MoCRA Facility Registration and Product Listings

Bayer Healthcare LLC (Bayer) is the latest in a long line of companies to be hit with a consumer class action lawsuit over recalled personal care products containing benzene—a carcinogen found in a variety of consumer products, including most notoriously, aerosol deodorant, sunscreen, and dry shampoo.Continue Reading Recall Litigation Report: Benzene Continues To Be A Hot Button Issue

More than two years after consumers across the country first started filing suit against Philips Respironics (Philips) over certain recalled sleep apnea devices, the company announced that it has reached an agreement to pay $479 million to compensate consumers. Philips voluntarily recalled several different models of continuous positive airway pressure (CPAP) and bilateral positive airway pressure (BiPAP) machines and ventilators back in June 2021. In the months that followed, Philips was inundated with lawsuits by consumers, which alleged that Philips knew about the serious risk of injury posed by its recalled devices long before any public announcement. Hundreds of consumer-facing lawsuits were ultimately consolidated in the U.S. District Court for the Western District of Pennsylvania in In re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation.Continue Reading Recall Litigation Report: Philips Reaches Settlement in CPAP/BiPAP MDL

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) establishes a number of new requirements for the cosmetics industry. Among other things, facilities that manufacture and process cosmetics in the U.S. will need to be registered with the FDA, and companies that manufacture cosmetics will need to submit a list of all cosmetics (and their ingredients) to the FDA.Continue Reading FDA Seeks Comments on COSMETICS Direct for MoCRA Facility Registration and Product Listing

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